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ROC
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2023
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____________ to _____________
Commission File Number: 001-39485
TANGO THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware |
85-1195036 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
201 Brookline Ave., Suite 901 Boston, MA |
02215 |
(Address of principal executive offices) |
(Zip Code) |
(857) 320-4900
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common stock, par value $0.001 per share |
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TNGX |
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Nasdaq Global Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of November 1, 2023, the registrant had 101,989,696 shares of common stock, $0.001 par value per share, outstanding.
Table of Contents
i
Summary of Material Risks Associated with Our Business
Our business is subject to numerous material and other risks that you should be aware of before making an investment decision with respect to our securities. These risks are described more fully in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022. These risks include, among others, the following (which is not an exhaustive list of all such risks):
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We are a precision oncology company with a limited operating history. We have no products approved for commercial sale, have not generated any revenue from product sales and may never become profitable. Further, we face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do. |
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We have incurred significant net losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. We expect our operating results to fluctuate significantly in the future as our business advances. |
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We will need to raise substantial additional funding. If we are unable to raise capital when needed or on terms acceptable to us, we would be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts. Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. |
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We have never successfully completed any clinical trials and we may be unable to do so for any product candidates we develop. Certain of our programs are still in preclinical development and may never advance to clinical development. |
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Our programs are focused on the development of oncology therapeutics for patients with genetically defined or biomarker-driven cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop drugs is novel and may never lead to approved or marketable products. |
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If we are unable to successfully validate, develop and obtain regulatory approval for screening tests and companion diagnostic tests for our product candidates that require or would commercially benefit from such tests, or experience significant delays in doing so, we may not realize the full commercial potential of these product candidates. We will also rely on third-parties for screening for biomarkers that enable patient selection for trials. |
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Clinical product development involves a lengthy and expensive process, with an uncertain outcome. Further, our current and potential future collaborations may not realize the anticipated benefits. |
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Interim, top-line, and initial data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to confirmation, audit and verification procedures that could result in material changes in the final data. |
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Results from earlier preclinical studies of our programs and product candidates are not necessarily predictive of the results of later preclinical studies and clinical trials of our programs and product candidates. If we cannot replicate the results from our earlier preclinical studies of our programs and product candidates in our later preclinical studies and clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our product candidates. |
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If we experience delays or difficulties in the initiation, enrollment or dosing of patients in clinical trials, the announcement of clinical trial results and our receipt of necessary regulatory approvals (if any) could be delayed or prevented. |
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Our clinical trials or those of our current or future collaborators may reveal significant adverse events not seen in our preclinical or nonclinical studies and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates. |
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Some of our product candidates modulate pathways for which there are currently no approved or effective therapies, and utilize novel binding locations, which may result in greater research and development expenses, regulatory issues that could delay or prevent approval, or discovery of unknown or unanticipated adverse effects. |
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If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired. |
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The COVID-19 pandemic, or a similar pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our product candidates and the initiation and completion of clinical trials. |
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We expect to rely on third parties to conduct our clinical trials, as well as investigator-sponsored clinical trials of our product candidates (if any). If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed. |
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We contract with third parties for the manufacture of our product candidates for preclinical development and clinical trials and expect to continue to do so for future clinical testing and commercialization (if approved). This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts. |
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The third parties upon whom we rely for the supply of the active pharmaceutical ingredients and drug product to be used in our product candidates are our sole source of supply, and the loss of any of these suppliers could significantly harm our business. |
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If we cannot obtain new patents, maintain our existing patents and protect the confidentiality and proprietary nature of our trade secrets and other intellectual property, our business and competitive position may be harmed. |
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If we are found to be infringing third party patents, we may be forced to pay damages to the patent owner and/or obtain a license to continue the manufacture, sale or development of our products. If we cannot obtain a license, we may be prevented from the manufacture, sale or development of our products or product candidates, which may adversely affect our business. |
Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Words such as "anticipates," "continue," "could," "may," "forecasts," "expects," "intends," "plans," "potentially," "believes," "seeks," "estimates," "predict," "target," and variations of such words and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict; therefore, actual results may differ materially from those expressed or forecasted in any such statements. Such forward-looking statements are based on current expectations, estimates and projections about our industry and business, management's beliefs, and certain assumptions made by our management, and may include, but are not limited to, statements regarding:
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the initiation, timing, progress, results, and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of IND filings and acceptance, active enrollment in clinical trials, dosing in clinical trials, and initiation and completion of studies or clinical trials and related preparatory work, and the period during which the results of the clinical trials (including initial and final trial results) will become available; |
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our ability to discover and develop product candidates efficiently (including the advancement of development candidates on the timelines identified and the ability to identify clinical trial investigators to use our product candidates in trials); |
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our ability and the potential to manufacture our drug substances and product candidates successfully for preclinical use, for clinical trials and on a larger scale for commercial use, if approved; |
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the ability and willingness of our third-party strategic collaborators to license and to continue research and development activities relating to our development candidates and product candidates; |
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our ability to obtain funding for our operations necessary to complete further research, development and commercialization of our product candidates (and that existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements at least into 2026); |
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our ability to obtain and, if approved, maintain regulatory approval of our product candidates; |
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our ability to commercialize our products, if approved; |
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the pricing and reimbursement of our product candidates, if approved; |
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the implementation of our business model, and strategic plans for our business and product candidates; |
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates; |
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estimates of our future expenses, capital requirements, and our need for additional financing; |
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the potential benefits of strategic collaboration agreements, our ability to enter into strategic collaborations or arrangements, and our ability to attract collaborators with development, regulatory and commercialization expertise; |
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future agreements with third parties in connection with the commercialization of product candidates (if approved) and any other approved products; |
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the size and growth potential of the markets for our product candidates, and our ability to serve those markets; |
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our financial performance, including the expectation that we will continue to incur operating losses and negative cash flow; |
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the rate and degree of market acceptance of our product candidates, if approved; |
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regulatory developments in the United States and foreign countries, including pricing regulations by U.S. (such as CMS) and foreign regulatory authorities; |
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our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
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our ability to produce our products or product candidates with advantages in turnaround times or manufacturing cost; |
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our ability to deliver the deep, sustained target inhibition necessary to optimize tumor response and clinical benefit as a result of the unique ability of synthetic lethal targeting to spare normal cells, as well as the success of competing therapies that are or may become available; |
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our ability to attract and retain key scientific or management personnel; |
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the impact of laws and regulations; |
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developments relating to our competitors and industry; |
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the effect of the on-going COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations, including but not limited to our preclinical studies and clinical trials and any future studies or trials; and |
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other risks and uncertainties, including those identified in Part II, Item 1A of this Quarterly Report on Form 10-Q and in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022 - in both cases, see section titled “Risk Factors.” |
The forward-looking statements contained in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022 and Part II, Item 1A of this Quarterly Report on Form 10-Q are based on current expectations and beliefs concerning future developments and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects
iv
from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that we currently consider immaterial or which are unknown. It is not possible to predict or identify all such risks. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
USE OF DEFINED TERMS IN THIS QUARTERLY REPORT ON FORM 10-Q
Unless the context otherwise requires in this Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2023, we use the following defined terms:
i."the Company", "we", "our" and "us" mean Tango Therapeutics, Inc. and its wholly-owned subsidiaries;
ii."Business Combination" means the merger of BCTG Merger Sub Inc. with and into Tango Therapeutics, Inc. (now known as Tango Therapeutics Sub, Inc.) on August 10, 2021, with Tango Therapeutics, Inc. as the surviving company in the merger as a wholly-owned subsidiary of BCTG Acquisition Corp. (now known a Tango Therapeutics, Inc.);
iii."CoREST” means Co-repressor of Repressor Element-1 Silencing Transcription;
iv.“Gilead” means Gilead Sciences, Inc.;
v.“GBM” means glioblastoma;
vi.“HRD+” means homologous recombination deficient;
vii.“MTA” means methylthioadenosine;
viii.“MTAP” means methylthioadenosine phosphorylase;
ix.“NSCLC” means non-small cell lung cancer;
x.“PRMT5” means protein arginine methyltransferase 5;
xi."Quarterly Report" means this Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2023;
xii.“SDMA” means symmetric di-methylation of specific arginine;
xiii.“STK11” means serine-threonine kinase 11; and
xiv.“USP1” means ubiquitin-specific protease 1.
Corporate Information
We were formerly known as BCTG Acquisition Corp. (“BCTG”) and were incorporated in Delaware in May 2020 as a special purpose acquisition company, formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or other similar business combination. On August 10, 2021, we consummated the merger pursuant to the Agreement and Plan of Merger, dated as of April 13, 2021, by and among BCTG, BCTG Merger Sub Inc. and Tango Therapeutics Sub, Inc. Upon the consummation of the merger, we changed our name to Tango Therapeutics, Inc.
Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, including exhibits, proxy and information statements and amendments to those reports filed or furnished pursuant to Sections 13(a), 14, and 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available through the “Investors” portion of our website free of charge as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission (“SEC”). We also make available, free of charge on our website, the reports filed with the SEC by our executive officers, directors and 10% stockholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after copies of those filings are provided to us by those persons. Accordingly, investors should monitor such portions of the company’s website, in addition to following the company’s press releases, SEC filings and public conference calls and webcasts (if any). Information on our website is not to be deemed to be incorporated by reference in, and is not part of, this Quarterly Report on Form 10-Q or any of our other securities filings, unless specifically incorporated herein by reference, and should not be relied upon in making a decision as to whether or not to purchase our common stock. Our filings with the SEC may be accessed through the SEC’s Interactive Data Electronic Applications system at http://www.sec.gov. All statements made in any of our securities filings, including all forward-looking statements or information, are made as of the date of the document in which the statement is included, and we do not assume or undertake any obligation to update any of those statements or documents unless we are required to do so by law.
v
Further, the company intends to use its website http://www.tangotx.com as a means of disclosing material non-public information and for complying with its disclosure obligations under the SEC Regulation FD. Such disclosures will be included on the company’s website under the heading “Investors.” Accordingly, investors should monitor such portions of the company’s website, in addition to following the company’s press releases, SEC filings and public conference calls and webcasts (if any). The information contained on, or that may be accessed through, the website is not part of, and is not incorporated into, this Quarterly Report on Form 10-Q.
Our principal executive office is located at 201 Brookline Avenue, Suite 901, Boston, Massachusetts.
vi
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
TANGO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
58,533 |
|
|
$ |
59,968 |
|
Marketable securities |
|
|
301,347 |
|
|
|
306,165 |
|
Accounts receivable |
|
|
— |
|
|
|
2,000 |
|
Restricted cash |
|
|
856 |
|
|
|
567 |
|
Prepaid expenses and other current assets |
|
|
10,155 |
|
|
|
6,572 |
|
Total current assets |
|
|
370,891 |
|
|
|
375,272 |
|
Property and equipment, net |
|
|
10,261 |
|
|
|
10,884 |
|
Operating lease right-of-use assets |
|
|
44,422 |
|
|
|
46,886 |
|
Restricted cash, net of current portion |
|
|
2,567 |
|
|
|
3,423 |
|
Other assets |
|
|
48 |
|
|
|
5 |
|
Total assets |
|
$ |
428,189 |
|
|
$ |
436,470 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,837 |
|
|
$ |
4,453 |
|
Accrued expenses and other current liabilities |
|
|
11,467 |
|
|
|
17,495 |
|
Operating lease liabilities |
|
|
2,040 |
|
|
|
1,770 |
|
Deferred revenue |
|
|
27,072 |
|
|
|
31,792 |
|
Income tax payable |
|
|
— |
|
|
|
35 |
|
Total current liabilities |
|
|
43,416 |
|
|
|
55,545 |
|
Operating lease liabilities, net of current portion |
|
|
37,466 |
|
|
|
39,361 |
|
Deferred revenue, net of current portion |
|
|
70,712 |
|
|
|
92,088 |
|
Total liabilities |
|
|
151,594 |
|
|
|
186,994 |
|
Commitments and contingencies (Note 7) |
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively |
|
|
— |
|
|
|
— |
|
Stockholders' equity: |
|
|
|
|
|
|
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 101,847,154 and 88,179,374 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively |
|
|
102 |
|
|
|
88 |
|
Additional paid-in capital |
|
|
617,667 |
|
|
|
522,605 |
|
Accumulated other comprehensive loss |
|
|
(681 |
) |
|
|
(3,705 |
) |
Accumulated deficit |
|
|
(340,493 |
) |
|
|
(269,512 |
) |
Total stockholders’ equity |
|
|
276,595 |
|
|
|
249,476 |
|
Total liabilities and stockholders’ equity |
|
$ |
428,189 |
|
|
$ |
436,470 |
|
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
1
TANGO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
$ |
10,732 |
|
|
$ |
6,920 |
|
|
$ |
26,096 |
|
|
$ |
18,449 |
|
License revenue |
|
|
— |
|
|
|
— |
|
|
|
5,000 |
|
|
|
— |
|
Total revenue |
|
|
10,732 |
|
|
|
6,920 |
|
|
|
31,096 |
|
|
|
18,449 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
27,149 |
|
|
|
28,744 |
|
|
|
83,859 |
|
|
|
76,815 |
|
General and administrative |
|
|
9,209 |
|
|
|
8,099 |
|
|
|
26,397 |
|
|
|
22,138 |
|
Total operating expenses |
|
|
36,358 |
|
|
|
36,843 |
|
|
|
110,256 |
|
|
|
98,953 |
|
Loss from operations |
|
|
(25,626 |
) |
|
|
(29,923 |
) |
|
|
(79,160 |
) |
|
|
(80,504 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,872 |
|
|
|
350 |
|
|
|
4,383 |
|
|
|
865 |
|
Other income, net |
|
|
1,514 |
|
|
|
523 |
|
|
|
3,883 |
|
|
|
526 |
|
Total other income, net |
|
|
3,386 |
|
|
|
873 |
|
|
|
8,266 |
|
|
|
1,391 |
|
Loss before income taxes |
|
|
(22,240 |
) |
|
|
(29,050 |
) |
|
|
(70,894 |
) |
|
|
(79,113 |
) |
Provision for income taxes |
|
|
(23 |
) |
|
|
— |
|
|
|
(87 |
) |
|
|
(3 |
) |
Net loss |
|
$ |
(22,263 |
) |
|
$ |
(29,050 |
) |
|
$ |
(70,981 |
) |
|
$ |
(79,116 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share – basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.90 |
) |
Weighted average number of common shares outstanding – basic and diluted |
|
|
97,033,273 |
|
|
|
87,892,195 |
|
|
|
91,268,133 |
|
|
|
87,868,081 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(22,263 |
) |
|
|
(29,050 |
) |
|
|
(70,981 |
) |
|
|
(79,116 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
836 |
|
|
|
(509 |
) |
|
|
3,024 |
|
|
|
(4,091 |
) |
Comprehensive loss |
|
$ |
(21,427 |
) |
|
$ |
(29,559 |
) |
|
$ |
(67,957 |
) |
|
$ |
(83,207 |
) |
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
2
TANGO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Accumulated Other |
|
|
|
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Equity |
|
Balance at December 31, 2022 |
|
|
88,179,374 |
|
|
$ |
88 |
|
|
$ |
522,605 |
|
|
$ |
(3,705 |
) |
|
$ |
(269,512 |
) |
|
$ |
249,476 |
|
Issuance of common stock from exercise of options and employee stock purchase plan |
|
|
30,590 |
|
|
|
— |
|
|
|
73 |
|
|
|
— |
|
|
|
— |
|
|
|
73 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
4,219 |
|
|
|
— |
|
|
|
— |
|
|
|
4,219 |
|
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,504 |
|
|
|
— |
|
|
|
1,504 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(28,008 |
) |
|
|
(28,008 |
) |
Balance at March 31, 2023 |
|
|
88,209,964 |
|
|
$ |
88 |
|
|
$ |
526,897 |
|
|
$ |
(2,201 |
) |
|
$ |
(297,520 |
) |
|
$ |
227,264 |
|
Issuance of common stock from exercise of options and employee stock purchase plan |
|
|
252,880 |
|
|
|
— |
|
|
|
586 |
|
|
|
— |
|
|
|
— |
|
|
|
586 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
5,121 |
|
|
|
— |
|
|
|
— |
|
|
|
5,121 |
|
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
684 |
|
|
|
— |
|
|
|
684 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(20,710 |
) |
|
|
(20,710 |
) |
Balance at June 30, 2023 |
|
|
88,462,844 |
|
|
$ |
88 |
|
|
$ |
532,604 |
|
|
$ |
(1,517 |
) |
|
$ |
(318,230 |
) |
|
$ |
212,945 |
|
Issuance of common stock from exercise of options and employee stock purchase plan |
|
|
187,639 |
|
|
|
— |
|
|
|
441 |
|
|
|
— |
|
|
|
— |
|
|
|
441 |
|
Issuance of common stock from private placement financing, net |
|
|
13,196,671 |
|
|
|
14 |
|
|
|
79,762 |
|
|
|
— |
|
|
|
— |
|
|
|
79,776 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
4,860 |
|
|
|
— |
|
|
|
— |
|
|
|
4,860 |
|
Other comprehensive income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
836 |
|
|
|
— |
|
|
|
836 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(22,263 |
) |
|
|
(22,263 |
) |
Balance at September 30, 2023 |
|
|
101,847,154 |
|
|
$ |
102 |
|
|
$ |
617,667 |
|
|
$ |
(681 |
) |
|
$ |
(340,493 |
) |
|
$ |
276,595 |
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Accumulated Other |
|
|
|
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Equity |
|
Balance at December 31, 2021 |
|
|
87,598,184 |
|
|
$ |
88 |
|
|
$ |
506,760 |
|
|
$ |
(765 |
) |
|
$ |
(161,336 |
) |
|
$ |
344,747 |
|
Issuance of common stock from exercise of options and employee stock purchase plan |
|
|
111,315 |
|
|
|
— |
|
|
|
265 |
|
|
|
— |
|
|
|
— |
|
|
|
265 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
3,205 |
|
|
|
— |
|
|
|
— |
|
|
|
3,205 |
|
Business combination and PIPE financing, issuance costs |
|
|
— |
|
|
|
— |
|
|
|
(8 |
) |
|
|
— |
|
|
|
— |
|
|
|
(8 |
) |
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,645 |
) |
|
|
— |
|
|
|
(2,645 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(25,208 |
) |
|
|
(25,208 |
) |
Balance at March 31, 2022 |
|
|
87,709,499 |
|
|
$ |
88 |
|
|
$ |
510,222 |
|
|
$ |
(3,410 |
) |
|
$ |
(186,544 |
) |
|
$ |
320,356 |
|
Issuance of common stock from exercise of options and employee stock purchase plan |
|
|
288,450 |
|
|
|
— |
|
|
|
718 |
|
|
|
— |
|
|
|
— |
|
|
|
718 |
|
Stock based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
3,425 |
|
|
|
— |
|
|
|
— |
|
|
|
3,425 |
|
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(937 |
) |
|
|
— |
|
|
|
(937 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(24,858 |
) |
|
|
(24,858 |
) |
Balance at June 30, 2022 |
|
|
87,997,949 |
|
|
$ |
88 |
|
|
$ |
514,365 |
|
|
$ |
(4,347 |
) |
|
$ |
(211,402 |
) |
|
$ |
298,704 |
|
Issuance of common stock from exercise of options and employee stock purchase plan |
|
|
69,305 |
|
|
|
— |
|
|
|
112 |
|
|
|
— |
|
|
|
— |
|
|
|
112 |
|
Stock based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
3,815 |
|
|
|
— |
|
|
|
— |
|
|
|
3,815 |
|
Other comprehensive loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(509 |
) |
|
|
— |
|
|
|
(509 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(29,050 |
) |
|
|
(29,050 |
) |
Balance at September 30, 2022 |
|
|
88,067,254 |
|
|
$ |
88 |
|
|
$ |
518,292 |
|
|
$ |
(4,856 |
) |
|
$ |
(240,452 |
) |
|
$ |
273,072 |
|
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
4
TANGO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
Cash flows from operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(70,981 |
) |
|
$ |
(79,116 |
) |
Adjustments to reconcile net loss to net cash from operating activities: |
|
|
|
|
|
|
Depreciation |
|
|
1,798 |
|
|
|
1,038 |
|
Noncash operating lease expense |
|
|
2,692 |
|
|
|
1,538 |
|
Stock-based compensation |
|
|
14,200 |
|
|
|
10,445 |
|
(Accretion) amortization on marketable securities |
|
|
(1,030 |
) |
|
|
(219 |
) |
Other, net |
|
|
22 |
|
|
|
15 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts Receivable |
|
|
2,000 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
|
(3,582 |
) |
|
|
(1,299 |
) |
Right-of-use asset |
|
|
- |
|
|
|
(10,125 |
) |
Other long-term assets |
|
|
(42 |
) |
|
|
63 |
|
Accounts payable |
|
|
(1,617 |
) |
|
|
2,137 |
|
Accrued expenses and other liabilities |
|
|
(6,026 |
) |
|
|
5,849 |
|
Operating lease liabilities |
|
|
(1,853 |
) |
|
|
1,309 |
|
Deferred revenue |
|
|
(26,096 |
) |
|
|
(12,449 |
) |
Net cash used in operating activities |
|
|
(90,515 |
) |
|
|
(80,814 |
) |
Cash flows from investing activities |
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(1,300 |
) |
|
|
(6,651 |
) |
Sales and maturities of marketable securities |
|
|
268,423 |
|
|
|
160,602 |
|
Purchases of marketable securities |
|
|
(259,549 |
) |
|
|
(114,947 |
) |
Net cash provided by investing activities |
|
|
7,574 |
|
|
|
39,004 |
|
Cash flows from financing activities |
|
|
|
|
|
|
Proceeds from issuance of common stock upon exercise of stock options and purchase of shares under ESPP |
|
|
1,100 |
|
|
|
1,096 |
|
Proceeds from issuance of common stock and pre-funded warrants |
|
|
80,017 |
|
|
|
- |
|
Payments of transaction costs |
|
|
(178 |
) |
|
|
(8 |
) |
Net cash provided by financing activities |
|
|
80,939 |
|
|
|
1,088 |
|
Net change in cash, cash equivalents and restricted cash |
|
|
(2,002 |
) |
|
|
(40,722 |
) |
Cash, cash equivalents and restricted cash, beginning of period |
|
|
63,958 |
|
|
|
145,024 |
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash, end of period |
|
$ |
61,956 |
|
|
$ |
104,302 |
|
|
|
|
|
|
|
|
Supplemental cash flow information: |
|
|
|
|
|
|
Cash paid for leases |
|
$ |
4,116 |
|
|
$ |
1,413 |
|
Supplemental disclosure of noncash investing and financing activity: |
|
|
|
|
|
|
Purchases of property and equipment included in accounts payable and accrued expenses |
|
$ |
- |
|
|
$ |
952 |
|
Operating lease liabilities from obtaining right-of-use assets |
|
$ |
- |
|
|
$ |
38,227 |
|
Financing offering costs included in accounts payable and accrued expenses |
|
$ |
63 |
|
|
$ |
- |
|
Revaluation of right-of-use asset and lease liability upon lease remeasurement |
|
$ |
(228 |
) |
|
$ |
311 |
|
The accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
5
TANGO THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1.Nature of the Business and Basis of Presentation
Tango Therapeutics, Inc. is a precision oncology company committed to the discovery and development of novel drugs in defined patient populations with high unmet medical need.
Tango Therapeutics, Inc. (together with its consolidated subsidiaries, Tango or the Company) formerly known as BCTG Acquisition Corp. (BCTG), was incorporated in Delaware on May 21, 2020. BCTG was a special purpose acquisition company (SPAC) formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination.
Private Placement
On August 10, 2023, the Company entered into a securities purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of 13,196,671 shares of common stock at a price of $5.15 per share and pre-funded warrants to purchase 2,340,579 shares of common stock at a purchase price of $5.1499 per pre-funded warrant, resulting in gross proceeds of $80.0 million. The pre-funded warrants have an exercise price of $0.0001 per share of common stock, were immediately exercisable and will remain exercisable until exercised in full. After deducting expenses related to the private placement of $0.2 million, the net proceeds to the Company from the private placement were $79.8 million. The private placement closed on August 11, 2023.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP). The year-end balance sheet data was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. The accompanying unaudited condensed consolidated financial statements reflect the operations of Tango and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated. The functional and reporting currency of the Company and its subsidiaries is the U.S. dollar.
In the opinion of management, all adjustments necessary for a fair statement of the financial information, which are of a normal and recurring nature, have been made for the interim periods reported. Results of operations for the three and nine months ended September 30, 2023 and 2022 are not necessarily indicative of the results for the year ending December 31, 2023, any other interim periods, or any future year or period. The unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2023 and 2022 have been prepared on the same basis as and should be read in conjunction with the audited consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the SEC on March 27, 2023.
2.Summary of Significant Accounting Policies
There have been no significant changes from the significant accounting policies disclosed in Note 2, Summary of Significant Accounting Policies, of the audited consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
Use of Estimates
The preparation of consolidated financial statements requires that the Company make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. Significant estimates and assumptions made in the consolidated financial statements include, but are not limited to, the revenue recognized from collaboration agreements, the valuation of stock-based awards and the accrual for research and development expenses. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. As of the date of issuance of these consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.
6
Recently Issued Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements.
3.Collaboration Agreements
2018 Gilead Agreement
In October 2018, the Company entered into a Research Collaboration and License Agreement (the 2018 Gilead Agreement) with Gilead Sciences, Inc. (Gilead). Pursuant to the 2018 Gilead Agreement, the Company performed target discovery and validation activities in accordance with an agreed-upon multi-year research plan. During the initial three-year research term, Gilead had the option to obtain exclusive, worldwide licenses to develop and commercialize up to five validated programs (Gilead Program License). Gilead paid the Company a $50.0 million non-refundable upfront payment upon the execution of the 2018 Gilead Agreement and is eligible to receive certain milestone payments.
The Company assessed this arrangement in accordance with ASC 606, Revenue from Contracts with Customers, and concluded that the contract counterparty, Gilead, was a customer. The Company identified a single performance obligation under the arrangement consisting of the combination of participating on the joint steering committee and the research and development services provided during the research term. The identified promises were determined to not be individually distinct due to the specialized nature of the early-stage research services to be provided by the Company and the interdependent relationship between the promises. The Company determined that the option for Gilead to extend the term of the arrangement was not priced at a discount, and therefore did not provide Gilead with a material right. This option will be excluded from the transaction price until exercised. At the inception of the 2018 Gilead Agreement, the Company also determined that the Gilead program license options provided to Gilead did not include a material right.
The total transaction price, subject to variable consideration constraints, was allocated to the combined single performance obligation. The Company determined that the single combined performance obligation is satisfied over time as the customer is simultaneously receiving and consuming the benefit of the Company’s performance. The future milestone payments represent variable consideration that is fully constrained at inception of the arrangement as the achievement of the milestone events are highly uncertain.
Amended Gilead Agreement
In August 2020, Gilead made an equity investment of $20.0 million into the Company as a participant in the Company’s Series B-1 preferred stock offering. At the time of the original investment, as well as of the September 30, 2023 balance sheet date, Gilead maintains an ownership of less than 10% of the Company's common stock and is thus not considered to be a related party to the Company.
In August 2020, the Company and Gilead also entered into an Amended Research Collaboration and License Agreement (the Gilead Agreement), which superseded and replaced the 2018 Gilead Agreement. The Gilead Agreement represents a continuation of the initial target discovery and validation research and development efforts begun under the 2018 Gilead Agreement. Under the Gilead Agreement:
•The Company received upfront, non-refundable consideration of $125.0 million from Gilead upon execution of the Gilead Agreement in 2020;
•The term of the 2018 Gilead Agreement ended on the date the Gilead Agreement was executed. The Gilead Agreement has a research term of seven years;
•Gilead expanded its option to license up to 15 programs for which Gilead may obtain exclusive, worldwide licenses to develop and commercialize therapies, subject to applicable license fees;
•Prior to exercising its option to license a program, Gilead may “extend” such program, in which case Gilead will pay research option-extension fees and the Company will continue to collaborate with Gilead to discover and develop programs, potentially through early clinical development;
•Gilead has the option to “reserve” a target during which Gilead may: (i) license the target, (ii) “extend” the target, or (iii) decline the target, during the designated reserve target period. If, during the reserve target period Tango elects to work on the reserved target, Tango will retain full rights to the target program and Gilead receives a right of first negotiation in connection with any future partnering or licensing of such target by Tango, if any; and
7
•For up to five programs licensed by Gilead, the Company has the option to co-develop and co-promote the lead product in the U.S., subject to certain exceptions, and is eligible to receive tiered royalties in the first decile on ex-U.S. sales.
The Company is eligible to receive up to $410.0 million per program in license, research option-extension, and clinical, regulatory, and commercial milestones and royalties on future sales of commercialized products, if any.
The Gilead Agreement was accounted for as a modification of the 2018 Gilead Agreement under ASC 606 as both the scope and price of the contract were changed under the Gilead Agreement. The additional goods and services to be provided under the Gilead Agreement are not distinct from the combined performance obligation identified under the 2018 Gilead Agreement which was only partially satisfied at the date of contract modification. As such, the Company identified a single combined performance obligation under the Gilead Agreement consisting of the research services and continued participation on the joint steering committee during the research term. As a result, the Company’s progress towards completing its research services to Gilead over the seven-year term of the Gilead Agreement was lower than its progress under the three-year term of the 2018 Gilead Agreement and a cumulative catch-up adjustment was recorded during the third quarter of 2020 resulting in a charge of $11.3 million against revenue previously recognized through the date of the Gilead Agreement.
In December 2020 and in September 2021, Gilead elected to extend two programs for a research extension fee of $12.0 million each. The Company determined that the additional goods and services relating to the continued research services were not distinct from the early-stage research services already promised to Gilead under the on-going research plan. Consideration pertaining to each of the research option-extensions is paid to the Company in equal quarterly installment payments over an agreed upon payment schedule. The research option-extension consideration was added to the transaction price under the Gilead Agreement.
In June 2023, Gilead licensed a program for a $5.0 million license fee. The $5.0 million license fee was received and recognized as revenue in the second quarter of 2023 as the Company has no continued involvement in the advancement of the program, Gilead can benefit from the license on its own, and the license is separately identifiable from the research services.
Gilead Revenue Recognized
The total transaction price allocated to the combined performance obligation under the Gilead Agreement was $199.0 million at September 30, 2023. The total transaction price was comprised of the $50.0 million upfront payment pursuant to the 2018 Gilead Agreement, the $125.0 million upfront payment pursuant to the Gilead Agreement, and $24.0 million pursuant to the research option-extension fee payments related to decisions made in 2020 and 2021. During the nine months ended September 30, 2023 and 2022, the Company recognized $26.1 million and $18.4 million, respectively, of collaboration revenue associated with the Gilead agreements based on performance completed during each period.
The Company reevaluates the transaction price and the total estimated costs expected to be incurred to satisfy the performance obligations at the end of each reporting period and as uncertain events, such as changes to the expected timing and cost of certain research and development activities that the Company is responsible for, are resolved or other changes in circumstances occur. As of September 30, 2023 and December 31, 2022, the Company had short-term deferred revenue of $27.1 million and $31.8 million, respectively, and long-term deferred revenue of $70.7 million and $92.1 million, respectively, related to the Gilead collaboration. The remaining deferred revenue is expected to be recognized proportionally to the completed obligations over an expected remaining contractual term of approximately 3.9 years.
Amounts due to the Company that have not yet been received are recorded as accounts receivable and amounts received that have not yet been recognized as revenue are recorded as deferred revenue on the Company’s unaudited condensed consolidated balance sheets.
Costs incurred pursuant to the Gilead Agreements are recorded as research and development expense.
8
4.Fair Value Measurements
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Market Value Measurements as of September 30, 2023 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
|
(in thousands) |
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
15,807 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
15,807 |
|
U.S. Treasury bills |
|
|
— |
|
|
|
9,292 |
|
|
|
— |
|
|
|
9,292 |
|
Marketable debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
|
— |
|
|
|
195,000 |
|
|
|
— |
|
|
|
195,000 |
|
U.S. government agency bonds |
|
|
— |
|
|
|
106,347 |
|
|
|
— |
|
|
|
106,347 |
|
Total assets |
|
$ |
15,807 |
|
|
$ |
310,639 |
|
|
$ |
— |
|
|
$ |
326,446 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Market Value Measurements as of December 31, 2022 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
|
(in thousands) |
|
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
7,577 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
7,577 |
|
U.S. Treasury bills |
|
|
— |
|
|
|
16,030 |
|
|
|
— |
|
|
|
16,030 |
|
Marketable debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
|
— |
|
|
|
199,245 |
|
|
|
— |
|
|
|
199,245 |
|
U.S. government agency bonds |
|
|
— |
|
|
|
106,920 |
|
|
|
— |
|
|
|
106,920 |
|
Total assets |
|
$ |
7,577 |
|
|
$ |
322,195 |
|
|
$ |
— |
|
|
$ |
329,772 |
|
There were no transfers between fair value levels during the nine months ended September 30, 2023.
The Company values its marketable securities using independent pricing services which normally derive security prices from recently reported trades for identical or similar securities, making adjustments based on significant observable transactions. At each balance sheet date, observable market inputs may include trade information, broker or dealer quotes, bids, offers or a combination of these data sources.
The following table summarizes the Company’s marketable debt securities, classified as available-for-sale:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as of September 30, 2023 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Loss |
|
|
Fair Value |
|
|
|
(in thousands) |
|
Marketable debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
$ |
195,338 |
|
|
$ |
10 |
|
|
$ |
(348 |
) |
|
$ |
195,000 |
|
U.S. government agency bonds |
|
|
106,690 |
|
|
|
— |
|
|
|
(343 |
) |
|
|
106,347 |
|
|
|
$ |
302,028 |
|
|
$ |
10 |
|
|
$ |
(691 |
) |
|
$ |
301,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as of December 31, 2022 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Loss |
|
|
Fair Value |
|
|
|
(in thousands) |
|
Marketable debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
$ |
201,834 |
|
|
$ |
21 |
|
|
$ |
(2,610 |
) |
|
$ |
199,245 |
|
U.S. government agency bonds |
|
|
108,036 |
|
|
|
— |
|
|
|
(1,116 |
) |
|
|
106,920 |
|
|
|
$ |
309,870 |
|
|
$ |
21 |
|
|
$ |
(3,726 |
) |
|
$ |
306,165 |
|
9
The Company holds marketable debt securities with an aggregate fair value of $39.8 million as of September 30, 2023 with contractual maturity dates greater than one year.
The following table summarizes the fair value and gross unrealized losses aggregated by category and the length of time that individual securities have been in an unrealized loss position:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
Less than twelve months |
|
|
Greater than twelve months |
|
|
Total |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
(in thousands) |
|
U.S. Treasury bills |
$ |
118,259 |
|
|
$ |
(111 |
) |
|
$ |
24,726 |
|
|
$ |
(237 |
) |
|
$ |
142,985 |
|
|
$ |
(348 |
) |
U.S. government agency bonds |
|
89,282 |
|
|
|
(106 |
) |
|
|
17,064 |
|
|
|
(237 |
) |
|
|
106,346 |
|
|
|
(343 |
) |
|
$ |
207,541 |
|
|
$ |
(217 |
) |
|
$ |
41,790 |
|
|
$ |
(474 |
) |
|
$ |
249,331 |
|
|
$ |
(691 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2022 |
|
|
Less than twelve months |
|
|
Greater than twelve months |
|
|
Total |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
(in thousands) |
|
U.S. Treasury bills |
$ |
44,213 |
|
|
$ |
(640 |
) |
|
$ |
84,997 |
|
|
$ |
(1,970 |
) |
|
$ |
129,210 |
|
|
$ |
(2,610 |
) |
U.S. government agency bonds |
|
68,919 |
|
|
|
(627 |
) |
|
|
38,000 |
|
|
|
(489 |
) |
|
|
106,919 |
|
|
|
(1,116 |
) |
|
$ |
113,132 |
|
|
$ |
(1,267 |
) |
|
$ |
122,997 |
|
|
$ |
(2,459 |
) |
|
$ |
236,129 |
|
|
$ |
(3,726 |
) |
The Company holds investment grade marketable securities considered to be in an unrealized loss position. Although these marketable securities are held at an unrealized loss position at September 30, 2023, the Company does not intend to sell the marketable securities prior to the value of the securities being recovered and the Company has concluded that it is more likely than not that the marketable securities cost basis values will be recovered prior to sale of the securities and that there are no conditions or events that might require the Company to sell the securities before recovery of the cost basis occurs. Further, the Company did not record any impairments to marketable securities or reserves for credit losses related to its marketable debt securities during the periods then ended. Marketable securities include $1.5 million and $0.5 million in accrued interest as of September 30, 2023 and December 31, 2022, respectively.
6.Supplemental Balance Sheet Information
Property and Equipment
Property and equipment, net, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(in thousands) |
|
Laboratory equipment |
|
$ |
8,581 |
|
|
$ |
7,720 |
|
Computer equipment |
|
|
2,312 |
|
|
|
2,235 |
|
Computer software |
|
|
125 |
|
|
|
125 |
|
Furniture and fixtures |
|
|
1,737 |
|
|
|
1,699 |
|
Leasehold improvements |
|
|
2,857 |
|
|
|
2,778 |
|
Construction in progress |
|
|
20 |
|
|
|
8 |
|
|
|
|
15,632 |
|
|
|
14,565 |
|
Less: Accumulated depreciation |
|
|
(5,371 |
) |
|
|
(3,681 |
) |
Property and equipment, net |
|
$ |
10,261 |
|
|
$ |
10,884 |
|
Depreciation expense was $1.8 million and $1.0 million for the nine months ended September 30, 2023 and 2022, respectively.
10
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities include the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(in thousands) |
|
Payroll and employee-related costs |
|
$ |
5,415 |
|
|
$ |
5,738 |
|
Research and development costs |
|
|
4,613 |
|
|
|
10,490 |
|
Other |
|
|
1,439 |
|
|
|
1,267 |
|
Total accrued expenses and other current liabilities |
|
$ |
11,467 |
|
|
$ |
17,495 |
|
Restricted Cash
As of September 30, 2023 and 2022, the Company maintained a restricted cash balance of $3.4 million and $4.0 million, respectively, all of which was related to security deposits associated with the Company’s facility leases. The cash will remain restricted in accordance with the lease agreements absent the event of a lease termination or modification. The reconciliation of cash and cash equivalents and restricted cash to amounts presented in the condensed consolidated statements of cash flows are as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
September 30, 2022 |
|
|
|
(in thousands) |
|
Cash and cash equivalents |
|
$ |
58,533 |
|
|
$ |
100,312 |
|
Restricted cash |
|
|
3,423 |
|
|
|
3,990 |
|
Cash, cash equivalents and restricted cash |
|
$ |
61,956 |
|
|
$ |
104,302 |
|
7.Commitments and Contingencies
Other Funding Commitments
As of September 30, 2023, the Company had ongoing preclinical and clinical studies. The Company enters into contracts in the normal course of business with contract research organizations in connection with preparation and operation of clinical trials, professional consultants for expert advice and other vendors for clinical supply manufacturing or other preclinical and clinical services. These contracts are generally cancellable, with notice, at the Company's option and do not have significant cancellation penalties.
Guarantees
The Company enters into certain agreements with other parties in the ordinary course of business that contain indemnification provisions. These typically include agreements with directors and officers, business partners, contractors, landlords, construction companies, contract research organizations, clinical trial sites, and other parties. Under these provisions, the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party under the terms of the contract, including as a result of the Company’s activities. These indemnification provisions generally survive termination of the underlying agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification provisions is unlimited. However, to date the Company has not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of these obligations is minimal.
Litigation
The Company, from time to time, may be party to litigation arising in the ordinary course of business. The Company was not subject to any material legal proceedings as of September 30, 2023, and no material legal proceedings are currently pending or threatened. Because of uncertainties related to claims, proceedings and litigation, assessments of potential liabilities are based on the Company's best estimates based on information available at the time of the assessment. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation, court decisions or settlement of claims (and offers of settlement), the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in a material adverse effect on the operating results of the Company. Costs associated with involvement in legal proceedings are expensed as incurred. The outcome of any such proceedings, regardless of the merits, is inherently uncertain. If the Company were to
11
be unable to prevail in any such proceedings, the consolidated financial position, results of operations, and future cash flows of the Company may be materially impacted.
Other Items
In August 2023, Tango received an inconsequential equity stake in another biotech company, a related party, in exchange for providing lab space and resources for the early phases of company development.
8.Redeemable Convertible Preferred Stock
Undesignated Preferred Stock
The Company’s Certificate of Incorporation, as amended and restated, authorizes the Company to issue shares of preferred stock with a par value of $0.001 per share. The number of shares of preferred stock authorized to be issued is 10,000,000 shares as of September 30, 2023. The shares of preferred stock are currently undesignated and no shares are issued or outstanding.
9.Stock-Based Compensation
Stock Incentive Plan
In March 2017, the Company's stockholders approved the 2017 Stock Option and Grant Plan, pursuant to which stock options, restricted stock awards, unrestricted stock awards, restricted stock units (RSUs), or any combination of the forgoing could be issued to eligible employees, officers, directors, consultants, or other key persons who provide services to the Company.
The 2021 Stock Option and Incentive Plan (the 2021 Plan) became effective upon the closing of the Business Combination and replaced the 2017 Stock Option and Grant Plan. The 2021 Plan allows the Company to issue stock options, stock appreciation awards, restricted stock awards, unrestricted stock awards, restricted stock units (RSUs) and cash-based awards, or any combination of the forgoing to eligible employees, officers, directors, or consultants. As of September 30, 2023, the Company had 6,200,500 shares available for future issuance under the 2021 Plan.
The 2023 Inducement Plan (the Inducement Plan) became effective upon approval of the Company's board of directors in February 2023. The Inducement Plan allows the Company to make equity and equity-based incentive awards to individuals who were not previously employees or directors of the Company. As of September 30, 2023, the Company had 2,256,250 shares available for future issuance under the Inducement Plan.
The Company recorded stock-based compensation expense in the following expense categories in its accompanying condensed consolidated statements of operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands) |
|
|
(in thousands) |
|
Research and development |
|
$ |
2,573 |
|
|
$ |
1,791 |
|
|
$ |
7,516 |
|
|
$ |
5,089 |
|
General and administrative |
|
|
2,287 |
|
|
|
2,024 |
|
|
|
6,684 |
|
|
|
5,356 |
|
Total |
|
$ |
4,860 |
|
|
$ |
3,815 |
|
|
$ |
14,200 |
|
|
$ |
10,445 |
|
12
Stock Option Activity
The following table summarizes the stock option activity for the nine months ended September 30, 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
Weighted Average Exercise Price |
|
|
Weighted Average Contractual Term |
|
|
Aggregate Intrinsic Value |
|
|
|
(in years) |
|
Options outstanding as of December 31, 2022 |
|
|
12,924,086 |
|
|
$ |
6.50 |
|
|
|
8.13 |
|
|
$ |
24,267,448 |
|
Granted |
|
|
5,113,352 |
|
|
|
5.19 |
|
|
|
|
|
|
|
Exercised |
|
|
(246,848 |
) |
|
|
2.26 |
|
|
|
|
|
|
|
Cancelled |
|
|
(695,585 |
) |
|
|
8.01 |
|
|
|
|
|
|
|
Options outstanding as of September 30, 2023 |
|
|
17,095,005 |
|
|
$ |
6.12 |
|
|
|
7.83 |
|
|
$ |
87,902,516 |
|
Options exercisable as of September 30, 2023 |
|
|
7,372,207 |
|
|
$ |
5.65 |
|
|
|
7.14 |
|
|
$ |
41,520,355 |
|
As of September 30, 2023, total unrecognized compensation expense related to stock options was $39.3 million, which the Company expects to recognize over a remaining weighted-average period of 2.5 years.
Restricted Stock Unit Activity
The following table summarizes the RSU activity for the nine months ended September 30, 2023:
|
|
|
|
|
|
|
|
|
|
|
Number of Stock Units |
|
|
Weighted Average Grant Date Fair Value Per Share |
|
Unvested and outstanding as of December 31, 2022 |
|
|
— |
|
|
$ |
- |
|
Granted |
|
|
809,738 |
|
|
|
4.94 |
|
Vested |
|
|
(37,500 |
) |
|
|
2.67 |
|
Forfeited |
|
|
(14,591 |
) |
|
|
4.60 |
|
Unvested and outstanding as of September 30, 2023 |
|
|
757,647 |
|
|
$ |
5.05 |
|
As of September 30, 2023, total unrecognized compensation expense related to RSUs was $3.1 million, which the Company expects to recognize over a remaining weighted-average period of 2.3 years.
2021 Employee Stock Purchase Plan
The 2021 Employee Stock Purchase Plan (the ESPP) was adopted and approved by the Company’s board of directors and by the Company’s stockholders and became effective upon the closing of the Business Combination. During the nine months ended September 30, 2023, the Company issued 186,761 shares of common stock under the ESPP.
Basic and diluted net loss per share attributable to common stockholders was calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
(in thousands, except per share data) |
|
|
(in thousands, except per share data) |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(22,263 |
) |
|
$ |
(29,050 |
) |
|
$ |
(70,981 |
) |
|
$ |
(79,116 |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding – basic and diluted |
|
|
97,033,273 |
|
|
|
87,892,195 |
|
|
|
91,268,133 |
|
|
|
87,868,081 |
|
Net loss per share – basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.90 |
) |
In August 2023, the Company completed a private placement, in which 13,196,671 shares of common stock were sold together with pre-funded warrants to purchase 2,340,579 shares of common stock with an exercise price of $0.0001 per share. The pre-funded warrants were classified as a component of permanent equity in the Company's condensed consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of shares of common stock upon exercise. All of the shares underlying
13
the pre-funded warrants have been included in the weighted-average number of shares of common stock used to calculate net loss per share attributable to common stockholders because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date of the pre-funded warrants.
The Company’s potential dilutive securities, which include common stock options and unvested restricted common stock, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
2023 |
|
|
2022 |
|
Stock options to purchase common stock |
|
|
17,095,005 |
|
|
|
12,701,089 |
|
Unvested restricted common stock |
|
|
757,647 |
|
|
|
— |
|
Total |
|
|
17,852,652 |
|
|
|
12,701,089 |
|
The Company’s effective income tax rate was -0.1% and 0.0% for the three months ended September 30, 2023 and 2022, respectively, and -0.1% and 0.0% for the nine months ended September 30, 2023 and 2022, respectively. The income tax provision was $23,000 and $0 for the three months ended September 30, 2023 and 2022, respectively, and the income tax provision was $87,000 and $3,000 for the nine months ended September 30, 2023 and 2022, respectively. Consistent with the prior year, for 2023 the Company assessed the requirement to capitalize and amortize research and experimentation expenditures for US tax purposes, which remains effective as of September 30, 2023. The Company is forecasting a taxable loss position in 2023 for which no tax benefit is recorded due to the valuation allowance maintained against the Company’s deferred tax assets.
The effective income tax rate for the three and nine months ended September 30, 2023 and 2022 differed from the 21.0% federal statutory rate primarily due to the valuation allowance maintained against the Company’s deferred tax assets.
14
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes for the year ended December 31, 2022 included in our Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.
Overview
Tango Therapeutics was founded with a clear mission: discover the next generation of precision medicines to help patients with cancer through addressing the specific genetic alterations that fuel the cancer. We leverage our state-of-the-art target discovery platform to identify novel targets and develop new drugs directed at tumor suppressor gene loss in defined patient populations with high unmet medical need. Tumor suppressor gene loss remains a largely unaddressed target space specifically because these genetic events cannot be directly targeted. Our novel small molecules are designed to be selectively active in cancer cells with specific tumor suppressor gene loss, killing those cancer cells while sparing normal cells. We also are extending this target space beyond the classic, cell-autonomous effects of tumor suppressor gene loss to include the discovery of novel targets that reverse the effects of tumor suppressor gene loss that prevent the immune system from recognizing and killing cancer cells (immune evasion). We believe our approach will provide the ability to deliver the deep, sustained target inhibition necessary to optimize tumor response and clinical benefit as a result of the unique ability of synthetic lethal targeting to spare normal cells.
Our lead program, TNG908, is an MTA-cooperative inhibitor of PRMT5 designed to work selectively in cancer cells with an MTAP deletion. MTAP-deletion occurs in approximately 10% to 15% of all human tumors including NSCLC, mesothelioma, pancreatic cancer, cholangiocarcinoma and GBM. In preclinical studies, TNG908 demonstrated 15-fold greater potency in MTAP-deleted cancer cells versus normal cells and robust efficacy in vitro and in vivo. Patients are actively being enrolled in the Phase 1/2 clinical trial. Initial pharmacodynamic (PD) data from the ongoing TNG908 dose escalation study, released in May 2023, provided proof-of-mechanism of MTA-cooperative PRMT5 inhibition, demonstrated by marked reduction of SDMA staining in MTAP-deleted cancer cells versus normal tissue. Pre-treatment and on-treatment biopsies demonstrated dose-dependent decreases in tumor SDMA staining with minimal or no decrease in normal tissue. The selective inhibition of PRMT5 in MTAP-deleted cancer cells is essential to enable the therapeutic index needed for efficacy. Additional TNG908 clinical data are expected in 2024.
Given the large number of patients with MTAP-deleted cancers who may benefit from a PRMT5 inhibitor, and the resulting potential business opportunity, we also developed a next-generation PRMT5 inhibitor, TNG462, with increased potency, MTAP-deletion selectivity, as well as longer target coverage. TNG462 is 45 times more potent in cells with an MTAP deletion than those without and induces deep tumor regressions in preclinical models of multiple cancer types which is expected to significantly increase the therapeutic index. The clinical development path for TNG462 is similar to TNG908, evaluating safety and efficacy in multiple tumor types in a Phase 1/2 clinical trial. GBM is excluded from the clinical trial as TNG462 is not expected to cross the blood-brain barrier. The TNG462 IND cleared in the first quarter of 2023 and we announced the first patient in the Phase 1/2 clinical trial was dosed in July 2023.
Discovered as part of our immune evasion target discovery platform, TNG260 is a first-in-class, CoREST inhibitor, which reverses the immune evasion effect of STK11 loss-of-function mutations. STK11 loss-of-function mutations are present in approximately 15% of NSCLC, 15% of cervical cancers, 10% of carcinoma of unknown primary, 5% of breast cancers and 3% of pancreatic cancers. In syngeneic models with an STK11 mutation and an intact immune system, the combination of TNG260 with an anti-PD-1 antibody resulted in sustained complete tumor regressions and the induction of immune memory against re-implantation of tumors. These preclinical data demonstrate that TNG260 in combination with an anti-PD-1 antibody is active in cancers with STK11 deletion, a setting where an anti-PD-1 antibody alone is inactive. In the first quarter of 2023, the FDA cleared the TNG260 IND and we announced the first patient in the Phase 1/2 clinical trial was dosed in July 2023. The trial is evaluating the safety, pharmacokinetics (PK), PD and efficacy of TNG260 in combination with pembrolizumab, with a one cycle single agent run-in phase to evaluate the safety and PK of TNG260, in patients with locally advanced or metastatic cancer solid tumors with an STK11 loss-of-function mutation. We believe that TNG260 could be among the first oncology molecules to leverage the benefits of genetically-based patient selection (STK11-mutation) with checkpoint inhibitor therapy.
We are developing TNG348, a novel allosteric inhibitor of USP1 for treatment of BRCA1, BRCA2-mutant and other HRD+ cancers. HRD+ cancers, including BRCA 1/2 mutations, represent approximately 50% of ovarian, 25% of breast, 10% of prostate and
15
5% of pancreatic cancers. In vivo preclinical studies for TNG348 have shown single agent efficacy and combination benefit with PARP inhibitors in BRCA1, BRCA2-mutant and other HRD+ cell-line and patient derived xenografts, including those that are intrinsically resistant to PARP inhibition. These preclinical data further demonstrate that TNG348 is synergistic with PARP inhibition across a panel of human ovarian and breast cancer cell lines, including both PARP inhibitor sensitive and resistant lines. Clinically, we expect TNG348 to have single agent activity in PARP inhibitor-naïve and PARP inhibitor-resistant BRCA1/2 mutant and other HRD+ cancers. Additionally, we expect TNG348 to synergize with PARP inhibitors in these settings effectively restoring sensitivity to PARPi in the setting of acquired resistance. The FDA cleared the TNG348 IND in the third quarter of 2023 and we expect to initiate the TNG348 clinical trial in the first half of 2024.
Financial Overview
Since the Company's inception, we have focused primarily on organizing and staffing our company, business planning, raising capital, discovering product candidates, securing related intellectual property, and conducting research and development activities for our programs. To date, we have funded our operations primarily through equity financings and from the proceeds received from our collaboration agreement with Gilead. Since inception, we have raised an aggregate of $166.9 million of gross proceeds from the sale of our preferred shares, $342.1 million in gross proceeds through the closing of the Business Combination and simultaneous financing transactions, $80.0 million of gross proceeds through the private placement of common shares and pre-funded warrants to purchase common shares, and another $225.1 million through our collaboration with Gilead.
We believe that our existing cash, cash equivalents and marketable securities on hand as of September 30, 2023 of $359.9 million will enable us to fund our operating expenses and capital expenditure requirements at least into 2026. Since inception, we have incurred significant operating losses. For the nine months ended September 30, 2023 and 2022, our net losses were $71.0 million and $79.1 million, respectively. We had an accumulated deficit of $340.5 million as of September 30, 2023. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, and maintain and expand our intellectual property portfolio. We also expect to hire additional personnel, pay for accounting, audit, legal, regulatory and consulting services, and pay costs associated with maintaining compliance with Nasdaq listing rules and the requirements of the U.S. Securities and Exchange Commission, director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies, our clinical trials, and our expenditures on other research and development activities.
We do not have any product candidates approved for sale and have not generated any revenue from product sales. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates, if ever. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. Our failure to raise capital or enter into such agreements as, and when needed, could have a negative effect on our business, results of operations and financial condition.
Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate revenues from the sale of our therapies, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.
Private Placement
On August 10, 2023, we entered into a securities purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of 13,196,671 shares of common stock at a price of $5.15 per share and pre-funded warrants to purchase 2,340,579 shares of common stock at a purchase price of $5.1499 per pre-funded warrant, resulting in gross proceeds of $80.0 million. The pre-funded warrants have an exercise price of $0.0001 per share of common stock, were immediately exercisable and will remain exercisable until exercised in full. After deducting expenses related to the private placement of $0.2 million, the net proceeds to us from the private placement were $79.8 million. The private placement closed on August 11, 2023. The securities purchase agreement also provided for the registration for resale of the shares of common stock. The shares were
16
registered for resale pursuant to pursuant to a registration statement filed on Form S-3 with the SEC on September 9, 2023. Based in part upon the representations of the investors in the securities purchase agreement, the offering and sale of the shares of common stock was made in reliance on the exemption afforded by Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D under the Securities Act and corresponding provisions of state securities or “blue sky” laws.
Revenue
To date, we have not recognized any revenue from product sales, and we do not expect to generate any revenue from the sale of products in the next several years. If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.
Collaboration Agreements with Gilead Sciences
In October 2018, we entered into a collaboration agreement with Gilead (2018 Gilead Agreement). Pursuant to the terms of the 2018 Gilead Agreement, we received an initial upfront payment of $50.0 million. The upfront payment was initially recorded as deferred revenue on our balance sheet and is recognized as revenue as or when the performance obligation under the contract is satisfied. In August 2020, the 2018 Gilead Agreement was expanded into a broader collaboration via an amended and restated research collaboration and license agreement (Gilead Agreement). Pursuant to the terms of the Gilead Agreement, we received an upfront payment of $125.0 million. Consistent with the treatment of the previously received upfront payment, this upfront payment was recorded as deferred revenue on our balance sheet and is recognized as revenue as or when the performance obligation under the contract is satisfied. In 2020 and 2021, Gilead elected to extend two programs for research extension fees totaling $24.0 million, which was added to our estimate of the transaction price to total $199.0 million. In June 2023, Gilead licensed a program for a $5.0 million fee, which was recognized as license revenue in the second quarter of 2023.
As of September 30, 2023, $101.2 million has been recognized as collaboration revenue related to the upfront and research option-extension payments from the Gilead agreements.
During the three months ended September 30, 2023 and 2022, we recognized $10.7 million and $6.9 million, respectively, and during the nine months ended September 30, 2023 and 2022, we recognized $26.1 million and $18.4 million, respectively, of collaboration revenue associated with the Gilead agreements based on performance completed during each period.
Refer to Note 3 to our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and related notes for the year ended December 31, 2022 included in our Annual Report on Form 10-K for additional information regarding our revenue recognition accounting policy and our collaboration agreement with Gilead.
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our drug discovery efforts and the development of our product candidates. We expense research and development costs as incurred, which include:
•employee-related expenses, including salaries, bonuses, benefits, stock-based compensation, other related costs for those employees involved in research and development efforts;
•external research and development expenses incurred under agreements with contract research organizations, or CROs, as well as consultants that conduct our preclinical studies and development services;
•costs related to manufacturing material for our preclinical and clinical studies;
•laboratory supplies and research materials;
•costs to fulfill our obligations under the collaboration with Gilead;
•costs related to compliance with regulatory requirements; and
•facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent, utilities and insurance.
17
Costs for certain activities are recognized based on an evaluation of the progress to completion of specific tasks using data such as information provided to us by our vendors and analyzing the progress of our preclinical studies or other services performed. Significant judgment and estimates are made in determining the accrued expense balances at the end of any reporting period.
Our direct external research and development expenses consist primarily of fees paid to CROs and outside consultants in connection with our preclinical and clinical development and manufacturing activities. Our direct external research and development expenses also include fees incurred under license agreements. We track these external research and development costs on a program-by-program basis once we have identified a product candidate.
We do not allocate employee costs, costs associated with our target discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We characterize research and development costs incurred prior to the identification of a product candidate as discovery costs. We use internal resources primarily to conduct our research and discovery activities as well as for managing our preclinical, development and manufacturing activities.
The following table summarizes our research and development expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands) |
|
|
(in thousands) |
|
TNG908 direct program expenses |
|
$ |
3,165 |
|
|
$ |
3,802 |
|
|
$ |
7,353 |
|
|
$ |
8,609 |
|
TNG462 direct program expenses |
|
|
1,795 |
|
|
|
2,890 |
|
|
|
6,969 |
|
|
|
7,855 |
|
TNG260 direct program expenses |
|
|
1,565 |
|
|
|
1,624 |
|
|
|
5,731 |
|
|
|
6,756 |
|
TNG348 direct program expenses |
|
|
922 |
|
|
|
2,826 |
|
|
|
4,454 |
|
|
|
6,725 |
|
Discovery direct program expenses |
|
|
5,206 |
|
|
|
6,047 |
|
|
|
17,804 |
|
|
|
16,115 |
|
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Personnel related expenses |
|
|
9,598 |
|
|
|
7,032 |
|
|
|
28,347 |
|
|
|
20,704 |
|
Facilities and other related expenses |
|
|
4,898 |
|
|
|
4,523 |
|
|
|
13,201 |
|
|
|
10,051 |
|
Total research and development expenses |
|
$ |
27,149 |
|
|
$ |
28,744 |
|
|
$ |
83,859 |
|
|
$ |
76,815 |
|
The successful development of our product candidates is highly uncertain. We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of our product candidates and manufacturing processes and conduct discovery and research activities for our preclinical programs. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates or the timing of regulatory filings in connection with clinical trials or regulatory approval, due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. Our clinical development costs have, and are expected to increase significantly with the commencement and continuation of our clinical trials. We anticipate that our expenses will increase substantially, particularly due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of:
•the scope, rate of progress, and expenses of our ongoing research activities as well as any preclinical studies, clinical trials and other research and development activities;
•establishing an appropriate safety profile with IND-enabling studies;
•successful enrollment in and completion of clinical trials;
•whether our product candidates show safety and efficacy in our clinical trials;
•receipt of marketing approvals from applicable regulatory authorities;
•the progress of our collaboration with Gilead;
•establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
•obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;
•commercializing product candidates, if and when approved, whether alone or in collaboration with others; and
18
•continued acceptable safety profile of products following any regulatory approval.
Any changes in the outcome of any of these variables with respect to the development of our product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on other product candidates. For example, if the FDA, European Medicines Agency (EMA), or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate.
General and Administrative Expenses
General and administrative expenses consist primarily of employee related costs, including salaries, bonuses, benefits, stock-based compensation and other related costs. General and administrative expense also includes professional services, including legal, accounting and audit services and other consulting fees as well as facility costs not otherwise included in research and development expenses, insurance and other general administrative expenses.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company.
Other Income, Net
Interest Income
Interest income consists of income earned and losses incurred in connection with our investments in money market funds, U.S. Treasury bills and U.S. government agency bonds.
Other Expense, Net
Other expense, net consists of miscellaneous expense unrelated to our core operations.
Provision for Income Taxes
Our provision for income tax consists of an estimate for U.S. federal and state income taxes based on enacted rates, as adjusted for allowable credits, deductions, uncertain tax positions, changes in deferred tax assets and liabilities and changes in tax law. We recorded an insignificant provision for income taxes for each of the three and nine months ended September 30, 2023 and 2022.
19
Results of Operations
Comparison of the three months ended September 30, 2023 and 2022
The following table summarizes our results of operations for the three months ended September 30, 2023 and 2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
2023 |
|
|
2022 |
|
|
Change |
|
|
|
(in thousands) |
|
Collaboration revenue |
|
$ |
10,732 |
|
|
$ |
6,920 |
|
|
$ |
3,812 |
|
Total revenue |
|
|
10,732 |
|
|
|
6,920 |
|
|
|
3,812 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
27,149 |
|
|
|
28,744 |
|
|
|
(1,595 |
) |
General and administrative |
|
|
9,209 |
|
|
|
8,099 |
|
|
|
1,110 |
|
Total operating expenses |
|
|
36,358 |
|
|
|
36,843 |
|
|
|
(485 |
) |
Loss from operations |
|
|
(25,626 |
) |
|
|
(29,923 |
) |
|
|
4,297 |
|
Other income: |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,872 |
|
|
|
350 |
|
|
|
1,522 |
|
Other income, net |
|
|
1,514 |
|
|
|
523 |
|
|
|
991 |
|
Total other income, net |
|
|
3,386 |
|
|
|
873 |
|
|
|
2,513 |
|
Loss before income taxes |
|
|
(22,240 |
) |
|
|
(29,050 |
) |
|
|
6,810 |
|
Provision for income taxes |
|
|
(23 |
) |
|
|
— |
|
|
|
(23 |
) |
Net loss |
|
$ |
(22,263 |
) |
|
$ |
(29,050 |
) |
|
|
6,787 |
|
Collaboration Revenue
Collaboration revenue of $10.7 million and $6.9 million for the three months ended September 30, 2023 and 2022, respectively, was derived from the Gilead collaboration. The increase of $3.8 million was due to higher research costs incurred under the collaboration during the three months ended September 30, 2023 resulting in higher collaboration revenue recognized.
Research and Development Expenses
Research and development expense was $27.1 million for the three months ended September 30, 2023 compared to $28.7 million for the three months ended September 30, 2022. The decrease of $1.6 million was due to a $4.6 million decrease primarily for manufacturing and other activities for our TNG462 and TNG348 programs, which was partially offset by a $2.6 million increase in personnel-related costs, including share-based compensation expense and additional headcount to support our research and development activities.
General and Administrative Expenses
General and administrative expense was $9.2 million for the three months ended September 30, 2023 compared to $8.1 million for the three months ended September 30, 2022. The increase of $1.1 million was primarily due to a $1.3 million increase in personnel-related costs, including share-based compensation expense and additional headcount.
Interest Income
Interest income was $1.9 million for the three months ended September 30, 2023 compared to $0.4 million for the three months ended September 30, 2022. The increase of $1.5 million was primarily due to an increase in interest rates in 2023 as compared to 2022.
Other Income, Net
Other income, net was $1.5 million for the three months ended September 30, 2023 compared to $0.5 million for the three months ended September 30, 2022. The increase was primarily due to accretion on investments purchased at a discount.
20
Provision for Income Taxes
Provision for income taxes was less than $0.1 million for three months ended September 30, 2023 compared to $0 for the three months ended September 30, 2022. The tax provision is insignificant in each of the periods ended September 30, 2023 and 2022.
Comparison of the nine months ended September 30, 2023 and 2022
The following table summarizes our results of operations for the nine months ended September 30, 2023 and 2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
2023 |
|
|
2022 |
|
|
Change |
|
|
|
(in thousands) |
|
Collaboration revenue |
|
$ |
26,096 |
|
|
$ |
18,449 |
|
|
$ |
7,647 |
|
License revenue |
|
|
5,000 |
|
|
|
— |
|
|
|
5,000 |
|
Total revenue |
|
|
31,096 |
|
|
|
18,449 |
|
|
|
12,647 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
83,859 |
|
|
|
76,815 |
|
|
|
7,044 |
|
General and administrative |
|
|
26,397 |
|
|
|
22,138 |
|
|
|
4,259 |
|
Total operating expenses |
|
|
110,256 |
|
|
|
98,953 |
|
|
|
11,303 |
|
Loss from operations |
|
|
(79,160 |
) |
|
|
(80,504 |
) |
|
|
1,344 |
|
Other income: |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
4,383 |
|
|
|
865 |
|
|
|
3,518 |
|
Other income, net |
|
|
3,883 |
|
|
|
526 |
|
|
|
3,357 |
|
Total other income, net |
|
|
8,266 |
|
|
|
1,391 |
|
|
|
6,875 |
|
Loss before income taxes |
|
|
(70,894 |
) |
|
|
(79,113 |
) |
|
|
8,219 |
|
Provision for income taxes |
|
|
(87 |
) |
|
|
(3 |
) |
|
|
(84 |
) |
Net loss |
|
$ |
(70,981 |
) |
|
$ |
(79,116 |
) |
|
|
8,135 |
|
Collaboration Revenue
Collaboration revenue of $26.1 million and $18.4 million for the nine months ended September 30, 2023 and 2022, respectively, was derived from the Gilead collaboration. The increase of $7.6 million was due to higher research costs incurred under the collaboration during the nine months ended September 30, 2023 resulting in higher collaboration revenue recognized.
License Revenue
License revenue of $5.0 million and $0 for the nine months ended September 30, 2023 and 2022, respectively, was derived from the Gilead collaboration. The increase of $5.0 million is due to Gilead licensing a program for $5.0 million during the second quarter of 2023 as compared to no programs being licensed during the nine months ended September 30, 2022.
Research and Development Expenses
Research and development expense was $83.9 million for the nine months ended September 30, 2023 compared to $76.8 million for the nine months ended September 30, 2022. The increase of $7.0 million was primarily due to $7.6 million in personnel-related costs, including share-based compensation expense and additional headcount to support our research and development activities. Additionally, facilities costs increased by $2.3 million due to expenses incurred related to the new lease at 201 Brookline Avenue in Boston, Massachusetts. These increases were partially offset by a decrease of $3.8 million primarily due to manufacturing and other activities for our TNG908 and TNG348 programs.
General and Administrative Expenses
General and administrative expense was $26.4 million for the nine months ended September 30, 2023 compared to $22.1 million for the nine months ended September 30, 2022. The increase of $4.3 million was primarily due to $3.1 million in personnel-related costs, including share-based compensation expense and additional headcount.
21
Interest Income
Interest income was $4.4 million for the nine months ended September 30, 2023 compared to $0.9 million for the nine months ended September 30, 2022. The increase of $3.5 million was primarily due to an increase in interest rates in 2023 as compared to 2022.
Other Income, Net
Other income, net was $3.9 million for the nine months ended September 30, 2023 compared to $0.5 million for the nine months ended September 30, 2022. The increase was primarily due to accretion on investments purchased at a discount.
Provision for Income Taxes
Provision for income taxes was less than $0.1 million for both the nine months ended September 30, 2023 and 2022. The tax provision is insignificant in each of the periods ended September 30, 2023 and 2022.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have generated recurring net losses. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception, we have funded our operations primarily through proceeds from the issuance of equity in the form of stock and from the proceeds received from our collaboration with Gilead. To date, we have raised an aggregate of approximately $166.9 million of gross proceeds from the private placement of preferred shares, $342.1 million of gross proceeds from the Business Combination and PIPE Financing transactions, $80.0 million of gross proceeds through the August 2023 private placement of common shares and pre-funded warrants to purchase common shares, and $225.1 million through the collaboration with Gilead. As of September 30, 2023, we had cash and cash equivalents and marketable securities of $359.9 million.
Funding Requirements
We believe that our existing cash, cash equivalents and marketable securities on hand as of September 30, 2023 of $359.9 million will enable us to fund our operating expenses and capital expenditure requirements at least into 2026. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.
Cash Flows
Comparison of the nine months ended September 30, 2023 and 2022
The following table summarizes our cash flows for each of the nine month periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
2023 |
|
|
2022 |
|
|
Change |
|
|
|
(in thousands) |
|
|
|
|
Net cash used in operating activities |
|
$ |
(90,515 |
) |
|
$ |
(80,814 |
) |
|
$ |
(9,701 |
) |
Net cash provided by investing activities |
|
|
7,574 |
|
|
|
39,004 |
|
|
|
(31,430 |
) |
Net cash provided by financing activities |
|
|
80,939 |
|
|
|
1,088 |
|
|
|
79,851 |
|
Net decrease in cash, cash equivalents and restricted cash |
|
$ |
(2,002 |
) |
|
$ |
(40,722 |
) |
|
$ |
38,720 |
|
Operating Activities
Net cash used in operating activities was $90.5 million for the nine months ended September 30, 2023 compared to net cash used in operating activities of $80.8 million for the nine months ended September 30, 2022. The increase in net cash used in operating activities for the nine months ended September 30, 2023 was primarily due to an increase in operating expenses, including higher non-cash expenses such as stock compensation.
22
Investing Activities
Net cash provided by investing activities was $7.6 million for the nine months ended September 30, 2023 compared to net cash provided by investing activities of $39.0 million for the nine months ended September 30, 2022. The decrease in net cash provided by investing activities was primarily due to an increase in purchases of marketable securities as compared to the nine month period ended September 30, 2022.
Financing Activities
Net cash provided by financing activities was $80.9 million for the nine months ended September 30, 2023 compared to net cash provided by financing activities of $1.1 million for the nine months ended September 30, 2022. The cash provided by financing activities for the nine months ended September 30, 2023 consisted of the net proceeds received from our private placement financing transaction in August 2023 of $79.8 million, as well as the cash provided from the exercises of stock options and ESPP purchases. The cash provided by financing activities for the nine months ended September 30, 2022 was the result of cash provided from the exercises of stock options and ESPP purchases.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations at September 30, 2023 and the effects that such obligations are expected to have on our liquidity and cash flows in future periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
Total |
|
|
Less than 1 Year |
|
|
1 – 3 Years |
|
|
3 – 5 Years |
|
|
More than 5 Years |
|
|
|
(in thousands) |
|
Operating lease commitments |
|
$ |
56,916 |
|
|
$ |
5,109 |
|
|
$ |
11,301 |
|
|
$ |
11,989 |
|
|
$ |
28,517 |
|
Total |
|
$ |
56,916 |
|
|
$ |
5,109 |
|
|
$ |
11,301 |
|
|
$ |
11,989 |
|
|
$ |
28,517 |
|
The commitment amounts in the table above primarily reflect the minimum payments due under our amended operating lease for office and laboratory space at our 201 Brookline Avenue, Boston, Massachusetts location. These commitments are also recognized as operating lease liabilities in our balance sheet at September 30, 2023. Refer to Note 8 to our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2022 for additional discussion of the lease.
Purchase Obligations
In the normal course of business, we enter into contracts with third parties for preclinical studies, clinical operations, manufacturing and research and development supplies. These contracts generally do not contain minimum purchase commitments and generally provide for termination on notice, and therefore are cancellable contracts. These payments are not included in the table above as the amount and timing of such payments are not known as of September 30, 2023.
License Agreement Obligations
We have also entered into a license agreement under which we may be obligated to make milestone and royalty payments. We have not included future milestone or royalty payments under the agreement in the table above since the payment obligations are contingent upon future events, such as achieving certain development, regulatory, and commercial milestones or generating product sales. As of September 30, 2023 and December 31, 2022, we were unable to estimate the timing or likelihood of achieving these milestones or generating future product sales. Refer to Note 9 to our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2022 for a description of our license agreement.
Critical Accounting Policies and Significant Judgments and Estimates
Our consolidated financial statements have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances and at the time these estimates are made, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Some of the judgments and estimates we make can be subjective and complex. Our actual results may differ from these estimates under different
23
assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the consolidated financial statements prospectively from the date of change in estimates.
While our significant accounting policies are described in more detail in Note 2 to our audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2022, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Revenue Recognition
The terms of our collaboration agreements may include consideration such as non-refundable up-front payments, license fees, research extension fees, and clinical, regulatory and sales-based milestones and royalties on product sales.
We recognize revenue under ASC Topic 606, Revenue from Contracts with Customers, or ASC 606, which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. ASC 606 provides a five-step framework whereby revenue is recognized when control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of the revenue standard, we perform the following five steps: (i) identify the promised goods or services in the contract; (ii) determine whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measure the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when collectability of the consideration to which we are entitled in exchange for the goods or services we transfer to the customer is determined to be likely. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct bundle is identified. We then allocate the transaction price (the amount of consideration we expect to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognize the associated revenue when (or as) each performance obligation is satisfied. Our estimate of the transaction price for each contract includes all variable consideration to which we expect to be entitled.
We recognize the transaction price allocated to license payments as revenue upon delivery of the license to the customer and resulting ability of the customer to use and benefit from the license, if the license is determined to be distinct from the other performance obligations identified in the contract. If the license is considered to not be distinct from other performance obligations, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied (i) at a point in time, but only for licenses determined to be distinct from other performance obligations in the contract, or (ii) over time; and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from license payments. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
We evaluate whether it is probable that the consideration associated with each milestone payment will not be subject to a significant reversal in the cumulative amount of revenue recognized. Amounts that meet this threshold are included in the transaction price using the most likely amount method, whereas amounts that do not meet this threshold are considered constrained and excluded from the transaction price until they meet this threshold. Milestones tied to regulatory approval, and therefore not within our control, are considered constrained until such approval is received. Upfront and ongoing development milestones under our collaboration agreements are not subject to refund if the development activities are not successful. At the end of each subsequent reporting period, we re-evaluate the probability of a significant reversal of the cumulative revenue recognized for the milestones, and, if necessary, adjust the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues from collaborators in the period of adjustment. We exclude sales-based milestone payments and royalties from the transaction price until the sale occurs (or, if later, until the underlying performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied), because the license to our intellectual property is deemed to be the predominant item to which the royalties relate as it is the primary driver of value.
ASC 606 requires us to allocate the arrangement consideration on a relative standalone selling price basis for each performance obligation after determining the transaction price of the contract and identifying the performance obligations to which that amount should be allocated. The relative standalone selling price is defined in ASC 606 as the price at which an entity would sell a promised good or service separately to a customer. If other observable transactions in which we have sold the same performance obligation separately are not available, we are required to estimate the standalone selling price of each performance obligation. Key assumptions
24
to determine the standalone selling price may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.
Whenever we determine that multiple promises to a customer are not distinct and comprise a combined performance obligation that includes services, we recognize revenue over time using the cost-to-cost input method, based on the total estimated cost to fulfill the obligation. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement.
Consideration that does not meet the requirements to satisfy the above revenue recognition criteria is a contract liability and is recorded as deferred revenue in the consolidated balance sheets. We have recorded short-term and long-term deferred revenue on our consolidated balance sheets based on our best estimate of when such revenue will be recognized. Short-term deferred revenue consists of amounts that are expected to be recognized as revenue in the next 12 months. Amounts that we expect will not be recognized within the next 12 months are classified as long-term deferred revenue.
In certain instances, the timing of and total costs of satisfying these obligations under our collaboration agreement can be difficult to estimate. Accordingly, our estimates may change in the future. If these estimates and judgments change over the course of these agreements, it may affect the timing and amount of revenue that we will recognize and record in future periods.
Under ASC 606, we will recognize revenue when we fulfill our performance obligations under the agreement with Gilead. As the required performance obligation is satisfied, we will recognize revenue for the portion satisfied and record a receivable for any fees that have not been received. Amounts are recorded as short-term collaboration receivables when our right to consideration is unconditional. A contract liability is recognized when a customer prepays consideration or owes payment to an entity in advance of our performance according to a contract. We do not assess whether a contract has a significant financing component if the expectation at contract inception is that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less or the amount is immaterial.
Accrued Research and Development Expenses
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments, which would be recorded as a prepaid expense in other assets, or if there is the right of offset, offset against our liability balance with the counterparty. We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time. At each period end, we corroborate the accuracy of these estimates with the service providers and make adjustments, if necessary.
We record the expense and accrual related to research and development activities performed by our vendors based on our estimates of the services received and efforts expended considering a number of factors, including our knowledge of the progress towards completion of the research and development activities; invoicing to date under the contracts; communication from the vendors of any actual costs incurred during the period that have not yet been invoiced; and the costs included in the contracts and purchase orders. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.
Stock-Based Compensation
We estimate the fair value of our stock-based awards using the Black Scholes method utilizing the “simplified method,” for determining the expected life of the award, which is based on the mid-point between the vesting date and the end of the contractual term. We determine the volatility for stock-based awards granted based on an analysis of reported data for a peer group of companies. The expected volatility of stock-based awards granted has been determined using a weighted-average of the historical volatility measures of this peer group of companies. We will continue to apply this method until a sufficient amount of historical information regarding the volatility of our own stock price becomes available. The fair value of each share of common stock underlying
25
stock-based awards is based on the closing price of our common stock as reported by Nasdaq on the date of grant. The risk-free interest rate utilized in our calculations is based on a treasury instrument whose term is consistent with the expected life of the stock-based award. The expected dividend yield is assumed to be zero as we have never paid dividends and do not have current plans to pay any dividends on our common stock.
We measure stock-based awards granted to employees, non-employees and directors based on their fair value on the date of the grant using the Black-Scholes option-pricing model for options or the difference between the purchase price per share of the award, if any, and the fair value of our common stock for restricted common stock awards.
Compensation expense for awards is recognized over the requisite service period, which is generally the vesting period of the respective award for employees and directors and the period during which services are performed for non-employees. We use the straight-line method to record the expense of awards with service-based vesting conditions.
We believe our methodologies are reasonable based upon our internal peer company analyses. If different assumptions had been made, equity-based compensation expense, consolidated net loss and consolidated net loss per share could have been significantly different.
Recently Adopted Accounting Pronouncements
A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed within Note 2 of our unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and also in Note 2 to our audited consolidated financial statements and related notes in our Annual Report on Form 10-K for the year ended December 31, 2022.
Emerging Growth Company and Smaller Reporting Company Status
We are an “emerging growth company,” under the JOBS Act. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of delayed adoption of new or revised accounting standards and, therefore, we will be subject to the same requirements to adopt new or revised accounting standards as private entities. As an emerging growth company, we may take advantage of certain exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company:
•we may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations in our periodic reports and registration statements, including this Quarterly Report on Form 10-Q;
•we may avail ourselves of the exemption from providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;
•we may provide reduced disclosure about our executive compensation arrangements; and
•we may not require nonbinding advisory votes on executive compensation or stockholder approval of any golden parachute payments.
We will remain an emerging growth company until the earliest of (i) December 31, 2025, (ii) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, provided we have been subject to the Exchange Act for at least 12 calendar months and have filed at least one annual report pursuant to the Exchange Act or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. We may choose to take advantage of some but not all of these exemptions.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.
26
Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to certain market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates.
Interest Rate Risk
We had cash, cash equivalents and marketable securities of $359.9 million and $366.1 million as of September 30, 2023 and December 31, 2022, respectively, which consisted of cash, money market funds, U.S. Treasury bills and U.S. government agency bonds. Interest income is sensitive to changes in the general level of interest rates. Due to the short-term duration of our investment portfolio and the low risk profile of our investments, we believe an immediate 1% change in interest rates would not have a material effect on the fair market value of our investment portfolio. We have the ability to hold our investments until maturity, and therefore, we would not expect our operating results or cash flows to be affected to any significant degree by the effect of a change in market interest rates on our investment portfolio.
Foreign Currency Exchange Risk
Our reporting and functional currency is the U.S. dollar. We currently do not have significant exposure to foreign currencies as we hold no foreign exchange contracts, option contracts, or other foreign hedging arrangements. Our operations may be subject to fluctuations in foreign currency exchange rates in the future.
Effects of Inflation
We do not believe that inflation has had a material effect on our business, financial condition or results of operations. Our operations may be subject to inflation in the future. Inflation generally affects us by increasing our cost of labor, clinical trial and manufacturing costs and indirectly increasing interest rates. Inflation rates, particularly in the U.S., have increased recently to levels not seen in years. We have not seen a significant impact from inflation on our business, financial condition or results of operations during the three months ended September 30, 2023. However, if inflation remains at current levels for an extended period of time, or increases, our costs are likely to increase, which may negatively impact our cash flows.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives. Our disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of September 30, 2023.
Changes in Internal Controls Over Financial Reporting
There were no changes in the Company’s internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Exchange Act Rules 13a-15 or 15d-15 that occurred during the quarter ended September 30, 2023 that materially affected, or were reasonably likely to materially affect, the Company’s internal control over financial reporting.
27
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in litigation or other legal proceedings. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.
We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business.
28
Item 1A. Risk Factors.
Investing in our securities involves a high degree of risk. In addition to the other information set forth in this Quarterly Report on Form 10-Q, careful consideration should be given to the risk factors discussed in Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, which could materially affect our business, financial condition, and/or future results. The risks described in our Annual Report on Form 10-K are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results. There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the SEC on March 27, 2023.
29
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Effective November 6, 2023, the Board of Directors of Tango Therapeutics, Inc. (the “Board”) appointed Kanishka Pothula as a director of the Company. Mr. Pothula will serve as a Class II director until his term expires at the 2026 annual meeting of stockholders at which time he will stand for election by the Company’s stockholders.
Mr. Pothula has not been named to any committee of the Board at this time. Mr. Pothula has elected not to receive any compensation for his service as a director of the Company. The Company expects to enter into an indemnification agreement with Mr. Pothula in the same form as the indemnification agreements the Company has entered into with its other directors, which form has been filed with the Securities and Exchange Commission (the “SEC”).
Except as set forth above, there are no arrangements or understandings between Mr. Pothula and any other person pursuant to which Mr. Pothula was selected as a director of the Company, there are no family relationships between Mr. Pothula and any of the Company’s other directors or executive officers, and Mr. Pothula is not a party to any transaction that would require disclosure under Item 404(a) of Regulation S-K promulgated by the SEC.
Reid Huber, a member of the Board of Directors, serving as a Class I director, notified the Company that he is resigning from the Company’s Board of Directors, such resignation effective upon Mr. Pothula’s appointment as a director. Mr. Huber has indicated that his departure from the Board was not the result of any disagreement with management or the Board or on any matter relating to the Company’s operations, policies or practices.
Item 6. Exhibits.
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Exhibit Number |
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Description |
4.1 |
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Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed by the Registrant on August 10, 2023). |
10.1# |
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Securities Purchase Agreement, dated August 10, 2023, by and among Tango Therapeutics, Inc. and the parties named therein (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by the Registrant on August 10, 2023). |
31.1* |
|
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2* |
|
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1** |
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2** |
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH* |
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Inline XBRL Taxonomy Extension Schema Document |
101.CAL* |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF* |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB* |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE* |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
30
|
|
|
104* |
|
Cover Page Interactive Data File (formatted in as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101) |
* Filed herewith.
** The certifications furnished in Exhibit 32.1 and Exhibit 32.2 hereto are deemed to be furnished with this Quarterly Report on Form 10-Q and will not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
# Schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request.
31
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Tango Therapeutics, Inc. |
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Dated: November 8, 2023 |
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By: |
/s/ Barbara Weber |
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Barbara Weber, MD |
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|
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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Tango Therapeutics, Inc. |
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By: |
/s/ Daniella Beckman |
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Daniella Beckman |
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Chief Financial Officer |
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(Principal Financial Officer) |
32
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO RULE 13a-14(a) / RULE 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
I, Barbara Weber, M.D., certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Tango Therapeutics, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Dated: November 8, 2023 /s/ Barbara Weber, M.D.
Barbara Weber, M.D.
Chief Executive Officer
(Principal Executive Officer)
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO RULE 13a-14(a) / RULE 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
I, Daniella Beckman, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Tango Therapeutics, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Dated: November 8, 2023 /s/ Daniella Beckman
Daniella Beckman
Chief Financial Officer
(Principal Financial Officer)
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Tango Therapeutics, Inc. (the “Company”) for the fiscal quarter ended September 30, 2023 as filed with the Securities and Exchange Commission (the “Report”), I, Barbara Weber, M.D., Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, to my knowledge, that:
(1)the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: November 8, 2023 /s/ Barbara Weber, M.D.
Barbara Weber, M.D.
Chief Executive Officer
(Principal Executive Officer)
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Tango Therapeutics, Inc. (the “Company”) for the fiscal quarter ended September 30, 2023 as filed with the Securities and Exchange Commission (the “Report”), I, Daniella Beckman, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, to my knowledge, that:
(1)the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: November 8, 2023 /s/ Daniella Beckman
Daniella Beckman
Chief Financial Officer
(Principal Financial Officer)
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
v3.23.3
Document And Entity Information
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9 Months Ended |
Sep. 30, 2023 |
Cover [Abstract] |
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Entity Registrant Name |
TANGO THERAPEUTICS, INC.
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Trading Symbol |
TNGX
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Document Type |
10-Q
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Current Fiscal Year End Date |
--12-31
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Amendment Flag |
false
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Entity Central Index Key |
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Entity Current Reporting Status |
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Entity Filer Category |
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Document Period End Date |
Sep. 30, 2023
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Document Fiscal Year Focus |
2023
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Document Fiscal Period Focus |
Q3
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Entity Ex Transition Period |
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Document Quarterly Report |
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Document Transition Report |
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Entity Incorporation, State or Country Code |
DE
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Entity File Number |
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Entity Tax Identification Number |
85-1195036
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Entity Address, Address Line One |
201 Brookline Ave.
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Entity Address, Address Line Two |
Suite 901
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Entity Address, City or Town |
Boston
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Entity Address, State or Province |
MA
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Entity Address, Postal Zip Code |
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City Area Code |
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Local Phone Number |
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Title of 12(b) Security |
Common stock, par value $0.001 per share
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NASDAQ
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v3.23.3
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 58,533
|
$ 59,968
|
Marketable securities |
301,347
|
306,165
|
Accounts receivable |
|
2,000
|
Restricted cash |
856
|
567
|
Prepaid expenses and other current assets |
10,155
|
6,572
|
Total current assets |
370,891
|
375,272
|
Property and equipment, net |
10,261
|
10,884
|
Operating lease right-of-use assets |
44,422
|
46,886
|
Restricted cash, net of current portion |
2,567
|
3,423
|
Other assets |
48
|
5
|
Total assets |
428,189
|
436,470
|
Current liabilities: |
|
|
Accounts payable |
2,837
|
4,453
|
Accrued expenses and other current liabilities |
11,467
|
17,495
|
Operating lease liabilities |
2,040
|
1,770
|
Deferred revenue |
27,072
|
31,792
|
Income tax payable |
|
35
|
Total current liabilities |
43,416
|
55,545
|
Operating lease liabilities, net of current portion |
37,466
|
39,361
|
Deferred revenue, net of current portion |
70,712
|
92,088
|
Total liabilities |
151,594
|
186,994
|
Commitments and contingencies (Note 7) |
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively |
|
|
Stockholders' equity: |
|
|
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022;104,187,733 and 88,179,374 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively |
102
|
88
|
Additional paid-in capital |
617,667
|
522,605
|
Accumulated other comprehensive loss |
(681)
|
(3,705)
|
Accumulated deficit |
(340,493)
|
(269,512)
|
Total stockholders' equity |
276,595
|
249,476
|
Total liabilities and stockholders' equity |
$ 428,189
|
$ 436,470
|
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v3.23.3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Temporary Equity, Par or Stated Value Per Share |
$ 0.001
|
$ 0.001
|
Temporary Equity, Shares Authorized |
10,000,000
|
10,000,000
|
Temporary Equity, Shares Issued |
0
|
0
|
Temporary Equity, Shares Outstanding |
0
|
0
|
Common Stock, Par or Stated Value Per Share |
$ 0.001
|
$ 0.001
|
Common Stock, Shares Authorized |
200,000,000
|
200,000,000
|
Common Stock, Shares, Issued |
101,847,154
|
88,179,374
|
Common Stock, Shares, Outstanding |
101,847,154
|
88,179,374
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v3.23.3
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Collaboration revenue |
$ 10,732,000
|
$ 6,920,000
|
$ 31,096,000
|
$ 18,449,000
|
Operating expenses: |
|
|
|
|
Research and development |
27,149,000
|
28,744,000
|
83,859,000
|
76,815,000
|
General and administrative |
9,209,000
|
8,099,000
|
26,397,000
|
22,138,000
|
Total operating expenses |
36,358,000
|
36,843,000
|
110,256,000
|
98,953,000
|
Loss from operations |
(25,626,000)
|
(29,923,000)
|
(79,160,000)
|
(80,504,000)
|
Other income: |
|
|
|
|
Interest income |
1,872,000
|
350,000
|
4,383,000
|
865,000
|
Other income, net |
1,514,000
|
523,000
|
3,883,000
|
526,000
|
Total other income, net |
3,386,000
|
873,000
|
8,266,000
|
1,391,000
|
Loss before income taxes |
(22,240,000)
|
(29,050,000)
|
(70,894,000)
|
(79,113,000)
|
Provision for income taxes |
(23,000)
|
0
|
(87,000)
|
(3,000)
|
Net loss |
$ (22,263,000)
|
$ (29,050,000)
|
$ (70,981,000)
|
$ (79,116,000)
|
Net loss per common share - basic |
$ (0.23)
|
$ (0.33)
|
$ (0.78)
|
$ (0.90)
|
Net loss per common share - diluted |
$ (0.23)
|
$ (0.33)
|
$ (0.78)
|
$ (0.90)
|
Weighted average number of common shares outstanding - basic |
97,033,273
|
87,892,195
|
91,268,133
|
87,868,081
|
Weighted average number of common shares outstanding - diluted |
97,033,273
|
87,892,195
|
91,268,133
|
87,868,081
|
Net loss |
$ (22,263,000)
|
$ (29,050,000)
|
$ (70,981,000)
|
$ (79,116,000)
|
Other comprehensive income (loss): |
|
|
|
|
Unrealized gain (loss) on marketable securities |
836,000
|
(509,000)
|
3,024,000
|
(4,091,000)
|
Comprehensive loss |
(21,427,000)
|
(29,559,000)
|
(67,957,000)
|
(83,207,000)
|
Collaboration Revenue [Member] |
|
|
|
|
Collaboration revenue |
$ 10,732,000
|
$ 6,920,000
|
26,096,000
|
$ 18,449,000
|
License Revenue [Member] |
|
|
|
|
Collaboration revenue |
|
|
$ 5,000,000
|
|
X |
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v3.23.3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands |
Total |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Accumulated Other Comprehensive Loss [Member] |
Accumulated Deficit [Member] |
Balance at the beginning at Dec. 31, 2021 |
$ 344,747
|
$ 88
|
$ 506,760
|
$ (765)
|
$ (161,336)
|
Balance at the beginning (in Shares) at Dec. 31, 2021 |
|
87,598,184
|
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan |
265
|
|
265
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan (in Shares) |
|
111,315
|
|
|
|
Stock based compensation expense |
3,205
|
|
3,205
|
|
|
Business combination and PIPE financing, issuance costs |
(8)
|
|
(8)
|
|
|
Other comprehensive income (loss) |
(2,645)
|
|
|
(2,645)
|
|
Net loss |
(25,208)
|
|
|
|
(25,208)
|
Balance at the ending at Mar. 31, 2022 |
320,356
|
$ 88
|
510,222
|
(3,410)
|
(186,544)
|
Balance at the ending (in Shares) at Mar. 31, 2022 |
|
87,709,499
|
|
|
|
Balance at the beginning at Dec. 31, 2021 |
344,747
|
$ 88
|
506,760
|
(765)
|
(161,336)
|
Balance at the beginning (in Shares) at Dec. 31, 2021 |
|
87,598,184
|
|
|
|
Net loss |
(79,116)
|
|
|
|
|
Balance at the ending at Sep. 30, 2022 |
273,072
|
$ 88
|
518,292
|
(4,856)
|
(240,452)
|
Balance at the ending (in Shares) at Sep. 30, 2022 |
|
88,067,254
|
|
|
|
Balance at the beginning at Mar. 31, 2022 |
320,356
|
$ 88
|
510,222
|
(3,410)
|
(186,544)
|
Balance at the beginning (in Shares) at Mar. 31, 2022 |
|
87,709,499
|
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan |
718
|
|
718
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan (in Shares) |
|
288,450
|
|
|
|
Stock based compensation expense |
3,425
|
|
3,425
|
|
|
Other comprehensive income (loss) |
(937)
|
|
|
(937)
|
|
Net loss |
(24,858)
|
|
|
|
(24,858)
|
Balance at the ending at Jun. 30, 2022 |
298,704
|
$ 88
|
514,365
|
(4,347)
|
(211,402)
|
Balance at the ending (in Shares) at Jun. 30, 2022 |
|
87,997,949
|
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan |
112
|
|
112
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan (in Shares) |
|
69,305
|
|
|
|
Stock based compensation expense |
3,815
|
|
3,815
|
|
|
Other comprehensive income (loss) |
(509)
|
|
|
(509)
|
|
Net loss |
(29,050)
|
|
|
|
(29,050)
|
Balance at the ending at Sep. 30, 2022 |
273,072
|
$ 88
|
518,292
|
(4,856)
|
(240,452)
|
Balance at the ending (in Shares) at Sep. 30, 2022 |
|
88,067,254
|
|
|
|
Balance at the beginning at Dec. 31, 2022 |
249,476
|
$ 88
|
522,605
|
(3,705)
|
(269,512)
|
Balance at the beginning (in Shares) at Dec. 31, 2022 |
|
88,179,374
|
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan |
73
|
|
73
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan (in Shares) |
|
30,590
|
|
|
|
Stock based compensation expense |
4,219
|
|
4,219
|
|
|
Other comprehensive income (loss) |
1,504
|
|
|
1,504
|
|
Net loss |
(28,008)
|
|
|
|
(28,008)
|
Balance at the ending at Mar. 31, 2023 |
227,264
|
$ 88
|
526,897
|
(2,201)
|
(297,520)
|
Balance at the ending (in Shares) at Mar. 31, 2023 |
|
88,209,964
|
|
|
|
Balance at the beginning at Dec. 31, 2022 |
249,476
|
$ 88
|
522,605
|
(3,705)
|
(269,512)
|
Balance at the beginning (in Shares) at Dec. 31, 2022 |
|
88,179,374
|
|
|
|
Net loss |
(70,981)
|
|
|
|
|
Balance at the ending at Sep. 30, 2023 |
276,595
|
$ 102
|
617,667
|
(681)
|
(340,493)
|
Balance at the ending (in Shares) at Sep. 30, 2023 |
|
101,847,154
|
|
|
|
Balance at the beginning at Mar. 31, 2023 |
227,264
|
$ 88
|
526,897
|
(2,201)
|
(297,520)
|
Balance at the beginning (in Shares) at Mar. 31, 2023 |
|
88,209,964
|
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan |
586
|
|
586
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan (in Shares) |
|
252,880
|
|
|
|
Stock based compensation expense |
5,121
|
|
5,121
|
|
|
Other comprehensive income (loss) |
684
|
|
|
684
|
|
Net loss |
(20,710)
|
|
|
|
(20,710)
|
Balance at the ending at Jun. 30, 2023 |
212,945
|
$ 88
|
532,604
|
(1,517)
|
(318,230)
|
Balance at the ending (in Shares) at Jun. 30, 2023 |
|
88,462,844
|
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan |
441
|
|
441
|
|
|
Issuance of common stock from exercise of options and employee stock purchase plan (in Shares) |
|
187,639
|
|
|
|
Issuance of common stock and pre-funded warrants, net (in Shares) |
|
13,196,671
|
|
|
|
Issuance of common stock and pre-funded warrants, net |
79,776
|
$ 14
|
79,762
|
|
|
Stock based compensation expense |
4,860
|
|
4,860
|
|
|
Other comprehensive income (loss) |
836
|
|
|
836
|
|
Net loss |
(22,263)
|
|
|
|
(22,263)
|
Balance at the ending at Sep. 30, 2023 |
$ 276,595
|
$ 102
|
$ 617,667
|
$ (681)
|
$ (340,493)
|
Balance at the ending (in Shares) at Sep. 30, 2023 |
|
101,847,154
|
|
|
|
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v3.23.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash flows from operating activities |
|
|
Net loss |
$ (70,981)
|
$ (79,116)
|
Adjustments to reconcile net loss to net cash from operating activities: |
|
|
Depreciation |
1,798
|
1,038
|
Noncash operating lease expense |
2,692
|
1,538
|
Stock-based compensation |
14,200
|
10,445
|
(Accretion) amortization on marketable securities |
(1,030)
|
(219)
|
Other, net |
22
|
15
|
Changes in operating assets and liabilities: |
|
|
Accounts Receivable |
2,000
|
|
Prepaid expenses and other current assets |
(3,582)
|
(1,299)
|
Right-of-use asset |
|
(10,125)
|
Other long-term assets |
(42)
|
63
|
Accounts payable |
(1,617)
|
2,137
|
Accrued expenses and other liabilities |
(6,026)
|
5,849
|
Operating lease liabilities |
(1,853)
|
1,309
|
Deferred revenue |
(26,096)
|
(12,449)
|
Net cash used in operating activities |
(90,515)
|
(80,814)
|
Cash flows from investing activities |
|
|
Purchase of property and equipment |
(1,300)
|
(6,651)
|
Sales and maturities of marketable securities |
268,423
|
160,602
|
Purchases of marketable securities |
(259,549)
|
(114,947)
|
Net cash provided by investing activities |
7,574
|
39,004
|
Cash flows from financing activities |
|
|
Proceeds from issuance of common stock upon exercise of stock options and purchase of shares under ESPP |
1,100
|
1,096
|
Proceeds from issuance of common stock and pre-funded warrants, net |
80,017
|
|
Payments of transaction costs |
(178)
|
(8)
|
Net cash provided by financing activities |
80,939
|
1,088
|
Net change in cash, cash equivalents and restricted cash |
(2,002)
|
(40,722)
|
Cash, cash equivalents and restricted cash, beginning of period |
63,958
|
145,024
|
Cash, cash equivalents and restricted cash, end of period |
61,956
|
104,302
|
Supplemental cash flow information: |
|
|
Cash paid for leases |
4,116
|
1,413
|
Supplemental disclosure of noncash investing and financing activity: |
|
|
Purchases of property and equipment included in accounts payable and accrued expenses |
|
952
|
Operating lease liabilities from obtaining right-of-use assets |
|
38,227
|
Revaluation of right-of-use asset and lease liability upon to lease remeasurement |
$ (228)
|
$ 311
|
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v3.23.3
Nature of the Business and Basis of Presentation
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Nature of the Business and Basis of Presentation |
1.Nature of the Business and Basis of Presentation Tango Therapeutics, Inc. is a precision oncology company committed to the discovery and development of novel drugs in defined patient populations with high unmet medical need. Tango Therapeutics, Inc. (together with its consolidated subsidiaries, Tango or the Company) formerly known as BCTG Acquisition Corp. (BCTG), was incorporated in Delaware on May 21, 2020. BCTG was a special purpose acquisition company (SPAC) formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination. Private Placement On August 10, 2023, the Company entered into a securities purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of 13,196,671 shares of common stock at a price of $5.15 per share and pre-funded warrants to purchase 2,340,579 shares of common stock at a purchase price of $5.1499 per pre-funded warrant, resulting in gross proceeds of $80.0 million. The pre-funded warrants have an exercise price of $0.0001 per share of common stock, were immediately exercisable and will remain exercisable until exercised in full. After deducting expenses related to the private placement of $0.2 million, the net proceeds to the Company from the private placement were $79.8 million. The private placement closed on August 11, 2023. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP). The year-end balance sheet data was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. The accompanying unaudited condensed consolidated financial statements reflect the operations of Tango and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated. The functional and reporting currency of the Company and its subsidiaries is the U.S. dollar. In the opinion of management, all adjustments necessary for a fair statement of the financial information, which are of a normal and recurring nature, have been made for the interim periods reported. Results of operations for the three and nine months ended September 30, 2023 and 2022 are not necessarily indicative of the results for the year ending December 31, 2023, any other interim periods, or any future year or period. The unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2023 and 2022 have been prepared on the same basis as and should be read in conjunction with the audited consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the SEC on March 27, 2023.
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v3.23.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.Summary of Significant Accounting Policies There have been no significant changes from the significant accounting policies disclosed in Note 2, Summary of Significant Accounting Policies, of the audited consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Use of Estimates The preparation of consolidated financial statements requires that the Company make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. Significant estimates and assumptions made in the consolidated financial statements include, but are not limited to, the revenue recognized from collaboration agreements, the valuation of stock-based awards and the accrual for research and development expenses. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. As of the date of issuance of these consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known. Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements.
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v3.23.3
Collaboration Agreements
|
9 Months Ended |
Sep. 30, 2023 |
Collaboration Agreements [Abstract] |
|
Collaboration Agreements |
3.Collaboration Agreements 2018 Gilead Agreement In October 2018, the Company entered into a Research Collaboration and License Agreement (the 2018 Gilead Agreement) with Gilead Sciences, Inc. (Gilead). Pursuant to the 2018 Gilead Agreement, the Company performed target discovery and validation activities in accordance with an agreed-upon multi-year research plan. During the initial three-year research term, Gilead had the option to obtain exclusive, worldwide licenses to develop and commercialize up to five validated programs (Gilead Program License). Gilead paid the Company a $50.0 million non-refundable upfront payment upon the execution of the 2018 Gilead Agreement and is eligible to receive certain milestone payments. The Company assessed this arrangement in accordance with ASC 606, Revenue from Contracts with Customers, and concluded that the contract counterparty, Gilead, was a customer. The Company identified a single performance obligation under the arrangement consisting of the combination of participating on the joint steering committee and the research and development services provided during the research term. The identified promises were determined to not be individually distinct due to the specialized nature of the early-stage research services to be provided by the Company and the interdependent relationship between the promises. The Company determined that the option for Gilead to extend the term of the arrangement was not priced at a discount, and therefore did not provide Gilead with a material right. This option will be excluded from the transaction price until exercised. At the inception of the 2018 Gilead Agreement, the Company also determined that the Gilead program license options provided to Gilead did not include a material right. The total transaction price, subject to variable consideration constraints, was allocated to the combined single performance obligation. The Company determined that the single combined performance obligation is satisfied over time as the customer is simultaneously receiving and consuming the benefit of the Company’s performance. The future milestone payments represent variable consideration that is fully constrained at inception of the arrangement as the achievement of the milestone events are highly uncertain. Amended Gilead Agreement In August 2020, Gilead made an equity investment of $20.0 million into the Company as a participant in the Company’s Series B-1 preferred stock offering. At the time of the original investment, as well as of the September 30, 2023 balance sheet date, Gilead maintains an ownership of less than 10% of the Company's common stock and is thus not considered to be a related party to the Company. In August 2020, the Company and Gilead also entered into an Amended Research Collaboration and License Agreement (the Gilead Agreement), which superseded and replaced the 2018 Gilead Agreement. The Gilead Agreement represents a continuation of the initial target discovery and validation research and development efforts begun under the 2018 Gilead Agreement. Under the Gilead Agreement: •The Company received upfront, non-refundable consideration of $125.0 million from Gilead upon execution of the Gilead Agreement in 2020; •The term of the 2018 Gilead Agreement ended on the date the Gilead Agreement was executed. The Gilead Agreement has a research term of seven years; •Gilead expanded its option to license up to 15 programs for which Gilead may obtain exclusive, worldwide licenses to develop and commercialize therapies, subject to applicable license fees; •Prior to exercising its option to license a program, Gilead may “extend” such program, in which case Gilead will pay research option-extension fees and the Company will continue to collaborate with Gilead to discover and develop programs, potentially through early clinical development; •Gilead has the option to “reserve” a target during which Gilead may: (i) license the target, (ii) “extend” the target, or (iii) decline the target, during the designated reserve target period. If, during the reserve target period Tango elects to work on the reserved target, Tango will retain full rights to the target program and Gilead receives a right of first negotiation in connection with any future partnering or licensing of such target by Tango, if any; and •For up to five programs licensed by Gilead, the Company has the option to co-develop and co-promote the lead product in the U.S., subject to certain exceptions, and is eligible to receive tiered royalties in the first decile on ex-U.S. sales. The Company is eligible to receive up to $410.0 million per program in license, research option-extension, and clinical, regulatory, and commercial milestones and royalties on future sales of commercialized products, if any. The Gilead Agreement was accounted for as a modification of the 2018 Gilead Agreement under ASC 606 as both the scope and price of the contract were changed under the Gilead Agreement. The additional goods and services to be provided under the Gilead Agreement are not distinct from the combined performance obligation identified under the 2018 Gilead Agreement which was only partially satisfied at the date of contract modification. As such, the Company identified a single combined performance obligation under the Gilead Agreement consisting of the research services and continued participation on the joint steering committee during the research term. As a result, the Company’s progress towards completing its research services to Gilead over the seven-year term of the Gilead Agreement was lower than its progress under the three-year term of the 2018 Gilead Agreement and a cumulative catch-up adjustment was recorded during the third quarter of 2020 resulting in a charge of $11.3 million against revenue previously recognized through the date of the Gilead Agreement. In December 2020 and in September 2021, Gilead elected to extend two programs for a research extension fee of $12.0 million each. The Company determined that the additional goods and services relating to the continued research services were not distinct from the early-stage research services already promised to Gilead under the on-going research plan. Consideration pertaining to each of the research option-extensions is paid to the Company in equal quarterly installment payments over an agreed upon payment schedule. The research option-extension consideration was added to the transaction price under the Gilead Agreement. In June 2023, Gilead licensed a program for a $5.0 million license fee. The $5.0 million license fee was received and recognized as revenue in the second quarter of 2023 as the Company has no continued involvement in the advancement of the program, Gilead can benefit from the license on its own, and the license is separately identifiable from the research services. Gilead Revenue Recognized The total transaction price allocated to the combined performance obligation under the Gilead Agreement was $199.0 million at September 30, 2023. The total transaction price was comprised of the $50.0 million upfront payment pursuant to the 2018 Gilead Agreement, the $125.0 million upfront payment pursuant to the Gilead Agreement, and $24.0 million pursuant to the research option-extension fee payments related to decisions made in 2020 and 2021. During the nine months ended September 30, 2023 and 2022, the Company recognized $26.1 million and $18.4 million, respectively, of collaboration revenue associated with the Gilead agreements based on performance completed during each period. The Company reevaluates the transaction price and the total estimated costs expected to be incurred to satisfy the performance obligations at the end of each reporting period and as uncertain events, such as changes to the expected timing and cost of certain research and development activities that the Company is responsible for, are resolved or other changes in circumstances occur. As of September 30, 2023 and December 31, 2022, the Company had short-term deferred revenue of $27.1 million and $31.8 million, respectively, and long-term deferred revenue of $70.7 million and $92.1 million, respectively, related to the Gilead collaboration. The remaining deferred revenue is expected to be recognized proportionally to the completed obligations over an expected remaining contractual term of approximately 3.9 years. Amounts due to the Company that have not yet been received are recorded as accounts receivable and amounts received that have not yet been recognized as revenue are recorded as deferred revenue on the Company’s unaudited condensed consolidated balance sheets. Costs incurred pursuant to the Gilead Agreements are recorded as research and development expense.
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v3.23.3
Fair Value Measurements
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
4.Fair Value Measurements The following tables present information about the Company’s financial assets measured at fair value on a recurring basis:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Market Value Measurements as of September 30, 2023 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
|
(in thousands) |
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
15,807 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
15,807 |
|
U.S. Treasury bills |
|
|
— |
|
|
|
9,292 |
|
|
|
— |
|
|
|
9,292 |
|
Marketable debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
|
— |
|
|
|
195,000 |
|
|
|
— |
|
|
|
195,000 |
|
U.S. government agency bonds |
|
|
— |
|
|
|
106,347 |
|
|
|
— |
|
|
|
106,347 |
|
Total assets |
|
$ |
15,807 |
|
|
$ |
310,639 |
|
|
$ |
— |
|
|
$ |
326,446 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Market Value Measurements as of December 31, 2022 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
|
(in thousands) |
|
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
7,577 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
7,577 |
|
U.S. Treasury bills |
|
|
— |
|
|
|
16,030 |
|
|
|
— |
|
|
|
16,030 |
|
Marketable debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
|
— |
|
|
|
199,245 |
|
|
|
— |
|
|
|
199,245 |
|
U.S. government agency bonds |
|
|
— |
|
|
|
106,920 |
|
|
|
— |
|
|
|
106,920 |
|
Total assets |
|
$ |
7,577 |
|
|
$ |
322,195 |
|
|
$ |
— |
|
|
$ |
329,772 |
|
There were no transfers between fair value levels during the nine months ended September 30, 2023.
|
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v3.23.3
Marketable Securities
|
9 Months Ended |
Sep. 30, 2023 |
Marketable Securities [Abstract] |
|
Marketable Securities |
The Company values its marketable securities using independent pricing services which normally derive security prices from recently reported trades for identical or similar securities, making adjustments based on significant observable transactions. At each balance sheet date, observable market inputs may include trade information, broker or dealer quotes, bids, offers or a combination of these data sources. The following table summarizes the Company’s marketable debt securities, classified as available-for-sale:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as of September 30, 2023 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Loss |
|
|
Fair Value |
|
|
|
(in thousands) |
|
Marketable debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
$ |
195,338 |
|
|
$ |
10 |
|
|
$ |
(348 |
) |
|
$ |
195,000 |
|
U.S. government agency bonds |
|
|
106,690 |
|
|
|
— |
|
|
|
(343 |
) |
|
|
106,347 |
|
|
|
$ |
302,028 |
|
|
$ |
10 |
|
|
$ |
(691 |
) |
|
$ |
301,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as of December 31, 2022 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Loss |
|
|
Fair Value |
|
|
|
(in thousands) |
|
Marketable debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
$ |
201,834 |
|
|
$ |
21 |
|
|
$ |
(2,610 |
) |
|
$ |
199,245 |
|
U.S. government agency bonds |
|
|
108,036 |
|
|
|
— |
|
|
|
(1,116 |
) |
|
|
106,920 |
|
|
|
$ |
309,870 |
|
|
$ |
21 |
|
|
$ |
(3,726 |
) |
|
$ |
306,165 |
|
The Company holds marketable debt securities with an aggregate fair value of $39.8 million as of September 30, 2023 with contractual maturity dates greater than one year. The following table summarizes the fair value and gross unrealized losses aggregated by category and the length of time that individual securities have been in an unrealized loss position:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
Less than twelve months |
|
|
Greater than twelve months |
|
|
Total |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
(in thousands) |
|
U.S. Treasury bills |
$ |
118,259 |
|
|
$ |
(111 |
) |
|
$ |
24,726 |
|
|
$ |
(237 |
) |
|
$ |
142,985 |
|
|
$ |
(348 |
) |
U.S. government agency bonds |
|
89,282 |
|
|
|
(106 |
) |
|
|
17,064 |
|
|
|
(237 |
) |
|
|
106,346 |
|
|
|
(343 |
) |
|
$ |
207,541 |
|
|
$ |
(217 |
) |
|
$ |
41,790 |
|
|
$ |
(474 |
) |
|
$ |
249,331 |
|
|
$ |
(691 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2022 |
|
|
Less than twelve months |
|
|
Greater than twelve months |
|
|
Total |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
(in thousands) |
|
U.S. Treasury bills |
$ |
44,213 |
|
|
$ |
(640 |
) |
|
$ |
84,997 |
|
|
$ |
(1,970 |
) |
|
$ |
129,210 |
|
|
$ |
(2,610 |
) |
U.S. government agency bonds |
|
68,919 |
|
|
|
(627 |
) |
|
|
38,000 |
|
|
|
(489 |
) |
|
|
106,919 |
|
|
|
(1,116 |
) |
|
$ |
113,132 |
|
|
$ |
(1,267 |
) |
|
$ |
122,997 |
|
|
$ |
(2,459 |
) |
|
$ |
236,129 |
|
|
$ |
(3,726 |
) |
The Company holds investment grade marketable securities considered to be in an unrealized loss position. Although these marketable securities are held at an unrealized loss position at September 30, 2023, the Company does not intend to sell the marketable securities prior to the value of the securities being recovered and the Company has concluded that it is more likely than not that the marketable securities cost basis values will be recovered prior to sale of the securities and that there are no conditions or events that might require the Company to sell the securities before recovery of the cost basis occurs. Further, the Company did not record any impairments to marketable securities or reserves for credit losses related to its marketable debt securities during the periods then ended. Marketable securities include $1.5 million and $0.5 million in accrued interest as of September 30, 2023 and December 31, 2022, respectively.
|
X |
- DefinitionThe entire disclosure for investments in certain debt and equity securities.
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v3.23.3
Supplemental Balance Sheet Information
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Supplemental Balance Sheet Information |
6.Supplemental Balance Sheet Information Property and Equipment Property and equipment, net, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(in thousands) |
|
Laboratory equipment |
|
$ |
8,581 |
|
|
$ |
7,720 |
|
Computer equipment |
|
|
2,312 |
|
|
|
2,235 |
|
Computer software |
|
|
125 |
|
|
|
125 |
|
Furniture and fixtures |
|
|
1,737 |
|
|
|
1,699 |
|
Leasehold improvements |
|
|
2,857 |
|
|
|
2,778 |
|
Construction in progress |
|
|
20 |
|
|
|
8 |
|
|
|
|
15,632 |
|
|
|
14,565 |
|
Less: Accumulated depreciation |
|
|
(5,371 |
) |
|
|
(3,681 |
) |
Property and equipment, net |
|
$ |
10,261 |
|
|
$ |
10,884 |
|
Depreciation expense was $1.8 million and $1.0 million for the nine months ended September 30, 2023 and 2022, respectively. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities include the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(in thousands) |
|
Payroll and employee-related costs |
|
$ |
5,415 |
|
|
$ |
5,738 |
|
Research and development costs |
|
|
4,613 |
|
|
|
10,490 |
|
Other |
|
|
1,439 |
|
|
|
1,267 |
|
Total accrued expenses and other current liabilities |
|
$ |
11,467 |
|
|
$ |
17,495 |
|
Restricted Cash As of September 30, 2023 and 2022, the Company maintained a restricted cash balance of $3.4 million and $4.0 million, respectively, all of which was related to security deposits associated with the Company’s facility leases. The cash will remain restricted in accordance with the lease agreements absent the event of a lease termination or modification. The reconciliation of cash and cash equivalents and restricted cash to amounts presented in the condensed consolidated statements of cash flows are as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
September 30, 2022 |
|
|
|
(in thousands) |
|
Cash and cash equivalents |
|
$ |
58,533 |
|
|
$ |
100,312 |
|
Restricted cash |
|
|
3,423 |
|
|
|
3,990 |
|
Cash, cash equivalents and restricted cash |
|
$ |
61,956 |
|
|
$ |
104,302 |
|
|
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v3.23.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
7.Commitments and Contingencies Other Funding Commitments As of September 30, 2023, the Company had ongoing preclinical and clinical studies. The Company enters into contracts in the normal course of business with contract research organizations in connection with preparation and operation of clinical trials, professional consultants for expert advice and other vendors for clinical supply manufacturing or other preclinical and clinical services. These contracts are generally cancellable, with notice, at the Company's option and do not have significant cancellation penalties. Guarantees The Company enters into certain agreements with other parties in the ordinary course of business that contain indemnification provisions. These typically include agreements with directors and officers, business partners, contractors, landlords, construction companies, contract research organizations, clinical trial sites, and other parties. Under these provisions, the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party under the terms of the contract, including as a result of the Company’s activities. These indemnification provisions generally survive termination of the underlying agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification provisions is unlimited. However, to date the Company has not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of these obligations is minimal. Litigation The Company, from time to time, may be party to litigation arising in the ordinary course of business. The Company was not subject to any material legal proceedings as of September 30, 2023, and no material legal proceedings are currently pending or threatened. Because of uncertainties related to claims, proceedings and litigation, assessments of potential liabilities are based on the Company's best estimates based on information available at the time of the assessment. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation, court decisions or settlement of claims (and offers of settlement), the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in a material adverse effect on the operating results of the Company. Costs associated with involvement in legal proceedings are expensed as incurred. The outcome of any such proceedings, regardless of the merits, is inherently uncertain. If the Company were to be unable to prevail in any such proceedings, the consolidated financial position, results of operations, and future cash flows of the Company may be materially impacted. Other Items In August 2023, Tango received an inconsequential equity stake in another biotech company, a related party, in exchange for providing lab space and resources for the early phases of company development.
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v3.23.3
Redeemable Convertible Preferred Stock
|
9 Months Ended |
Sep. 30, 2023 |
Temporary Equity Disclosure [Abstract] |
|
Redeemable Convertible Preferred Stock |
8.Redeemable Convertible Preferred Stock Undesignated Preferred Stock The Company’s Certificate of Incorporation, as amended and restated, authorizes the Company to issue shares of preferred stock with a par value of $0.001 per share. The number of shares of preferred stock authorized to be issued is 10,000,000 shares as of September 30, 2023. The shares of preferred stock are currently undesignated and no shares are issued or outstanding.
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v3.23.3
Stock-Based Compensation
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-Based Compensation |
9.Stock-Based Compensation Stock Incentive Plan In March 2017, the Company's stockholders approved the 2017 Stock Option and Grant Plan, pursuant to which stock options, restricted stock awards, unrestricted stock awards, restricted stock units (RSUs), or any combination of the forgoing could be issued to eligible employees, officers, directors, consultants, or other key persons who provide services to the Company. The 2021 Stock Option and Incentive Plan (the 2021 Plan) became effective upon the closing of the Business Combination and replaced the 2017 Stock Option and Grant Plan. The 2021 Plan allows the Company to issue stock options, stock appreciation awards, restricted stock awards, unrestricted stock awards, restricted stock units (RSUs) and cash-based awards, or any combination of the forgoing to eligible employees, officers, directors, or consultants. As of September 30, 2023, the Company had 6,200,500 shares available for future issuance under the 2021 Plan. The 2023 Inducement Plan (the Inducement Plan) became effective upon approval of the Company's board of directors in February 2023. The Inducement Plan allows the Company to make equity and equity-based incentive awards to individuals who were not previously employees or directors of the Company. As of September 30, 2023, the Company had 2,256,250 shares available for future issuance under the Inducement Plan. The Company recorded stock-based compensation expense in the following expense categories in its accompanying condensed consolidated statements of operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands) |
|
|
(in thousands) |
|
Research and development |
|
$ |
2,573 |
|
|
$ |
1,791 |
|
|
$ |
7,516 |
|
|
$ |
5,089 |
|
General and administrative |
|
|
2,287 |
|
|
|
2,024 |
|
|
|
6,684 |
|
|
|
5,356 |
|
Total |
|
$ |
4,860 |
|
|
$ |
3,815 |
|
|
$ |
14,200 |
|
|
$ |
10,445 |
|
Stock Option Activity The following table summarizes the stock option activity for the nine months ended September 30, 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
Weighted Average Exercise Price |
|
|
Weighted Average Contractual Term |
|
|
Aggregate Intrinsic Value |
|
|
|
(in years) |
|
Options outstanding as of December 31, 2022 |
|
|
12,924,086 |
|
|
$ |
6.50 |
|
|
|
8.13 |
|
|
$ |
24,267,448 |
|
Granted |
|
|
5,113,352 |
|
|
|
5.19 |
|
|
|
|
|
|
|
Exercised |
|
|
(246,848 |
) |
|
|
2.26 |
|
|
|
|
|
|
|
Cancelled |
|
|
(695,585 |
) |
|
|
8.01 |
|
|
|
|
|
|
|
Options outstanding as of September 30, 2023 |
|
|
17,095,005 |
|
|
$ |
6.12 |
|
|
|
7.83 |
|
|
$ |
87,902,516 |
|
Options exercisable as of September 30, 2023 |
|
|
7,372,207 |
|
|
$ |
5.65 |
|
|
|
7.14 |
|
|
$ |
41,520,355 |
|
As of September 30, 2023, total unrecognized compensation expense related to stock options was $39.3 million, which the Company expects to recognize over a remaining weighted-average period of 2.5 years. Restricted Stock Unit Activity The following table summarizes the RSU activity for the nine months ended September 30, 2023:
|
|
|
|
|
|
|
|
|
|
|
Number of Stock Units |
|
|
Weighted Average Grant Date Fair Value Per Share |
|
Unvested and outstanding as of December 31, 2022 |
|
|
— |
|
|
$ |
- |
|
Granted |
|
|
809,738 |
|
|
|
4.94 |
|
Vested |
|
|
(37,500 |
) |
|
|
2.67 |
|
Forfeited |
|
|
(14,591 |
) |
|
|
4.60 |
|
Unvested and outstanding as of September 30, 2023 |
|
|
757,647 |
|
|
$ |
5.05 |
|
As of September 30, 2023, total unrecognized compensation expense related to RSUs was $3.1 million, which the Company expects to recognize over a remaining weighted-average period of 2.3 years. 2021 Employee Stock Purchase Plan The 2021 Employee Stock Purchase Plan (the ESPP) was adopted and approved by the Company’s board of directors and by the Company’s stockholders and became effective upon the closing of the Business Combination. During the nine months ended September 30, 2023, the Company issued 186,761 shares of common stock under the ESPP.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Net Loss Per Share
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Net Loss Per Share |
Basic and diluted net loss per share attributable to common stockholders was calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
(in thousands, except per share data) |
|
|
(in thousands, except per share data) |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(22,263 |
) |
|
$ |
(29,050 |
) |
|
$ |
(70,981 |
) |
|
$ |
(79,116 |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding – basic and diluted |
|
|
97,033,273 |
|
|
|
87,892,195 |
|
|
|
91,268,133 |
|
|
|
87,868,081 |
|
Net loss per share – basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.90 |
) |
In August 2023, the Company completed a private placement, in which 13,196,671 shares of common stock were sold together with pre-funded warrants to purchase 2,340,579 shares of common stock with an exercise price of $0.0001 per share. The pre-funded warrants were classified as a component of permanent equity in the Company's condensed consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of shares of common stock upon exercise. All of the shares underlying the pre-funded warrants have been included in the weighted-average number of shares of common stock used to calculate net loss per share attributable to common stockholders because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date of the pre-funded warrants. The Company’s potential dilutive securities, which include common stock options and unvested restricted common stock, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
2023 |
|
|
2022 |
|
Stock options to purchase common stock |
|
|
17,095,005 |
|
|
|
12,701,089 |
|
Unvested restricted common stock |
|
|
757,647 |
|
|
|
— |
|
Total |
|
|
17,852,652 |
|
|
|
12,701,089 |
|
|
X |
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v3.23.3
Income Taxes
|
9 Months Ended |
Sep. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
The Company’s effective income tax rate was -0.1% and 0.0% for the three months ended September 30, 2023 and 2022, respectively, and -0.1% and 0.0% for the nine months ended September 30, 2023 and 2022, respectively. The income tax provision was $23,000 and $0 for the three months ended September 30, 2023 and 2022, respectively, and the income tax provision was $87,000 and $3,000 for the nine months ended September 30, 2023 and 2022, respectively. Consistent with the prior year, for 2023 the Company assessed the requirement to capitalize and amortize research and experimentation expenditures for US tax purposes, which remains effective as of September 30, 2023. The Company is forecasting a taxable loss position in 2023 for which no tax benefit is recorded due to the valuation allowance maintained against the Company’s deferred tax assets. The effective income tax rate for the three and nine months ended September 30, 2023 and 2022 differed from the 21.0% federal statutory rate primarily due to the valuation allowance maintained against the Company’s deferred tax assets.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Use of Estimates |
Use of Estimates The preparation of consolidated financial statements requires that the Company make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. Significant estimates and assumptions made in the consolidated financial statements include, but are not limited to, the revenue recognized from collaboration agreements, the valuation of stock-based awards and the accrual for research and development expenses. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. As of the date of issuance of these consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from these estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.
|
Recently Issued Accounting Pronouncements |
Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements.
|
X |
- DefinitionDisclosure of accounting policy for recently issued accounting pronouncements.
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- DefinitionDisclosure of accounting policy for the use of estimates in the preparation of financial statements in conformity with generally accepted accounting principles.
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v3.23.3
Fair Value Measurements (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Summary of Financial Assets Measured at Fair Value on a Recurring Basis |
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Market Value Measurements as of September 30, 2023 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
|
(in thousands) |
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
15,807 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
15,807 |
|
U.S. Treasury bills |
|
|
— |
|
|
|
9,292 |
|
|
|
— |
|
|
|
9,292 |
|
Marketable debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
|
— |
|
|
|
195,000 |
|
|
|
— |
|
|
|
195,000 |
|
U.S. government agency bonds |
|
|
— |
|
|
|
106,347 |
|
|
|
— |
|
|
|
106,347 |
|
Total assets |
|
$ |
15,807 |
|
|
$ |
310,639 |
|
|
$ |
— |
|
|
$ |
326,446 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Market Value Measurements as of December 31, 2022 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
|
(in thousands) |
|
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
7,577 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
7,577 |
|
U.S. Treasury bills |
|
|
— |
|
|
|
16,030 |
|
|
|
— |
|
|
|
16,030 |
|
Marketable debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
|
— |
|
|
|
199,245 |
|
|
|
— |
|
|
|
199,245 |
|
U.S. government agency bonds |
|
|
— |
|
|
|
106,920 |
|
|
|
— |
|
|
|
106,920 |
|
Total assets |
|
$ |
7,577 |
|
|
$ |
322,195 |
|
|
$ |
— |
|
|
$ |
329,772 |
|
|
X |
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v3.23.3
Marketable Securities (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Marketable Securities [Abstract] |
|
Summary of Debt Securities, Available-for-sale |
The following table summarizes the Company’s marketable debt securities, classified as available-for-sale:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as of September 30, 2023 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Loss |
|
|
Fair Value |
|
|
|
(in thousands) |
|
Marketable debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
$ |
195,338 |
|
|
$ |
10 |
|
|
$ |
(348 |
) |
|
$ |
195,000 |
|
U.S. government agency bonds |
|
|
106,690 |
|
|
|
— |
|
|
|
(343 |
) |
|
|
106,347 |
|
|
|
$ |
302,028 |
|
|
$ |
10 |
|
|
$ |
(691 |
) |
|
$ |
301,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements as of December 31, 2022 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Loss |
|
|
Fair Value |
|
|
|
(in thousands) |
|
Marketable debt securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills |
|
$ |
201,834 |
|
|
$ |
21 |
|
|
$ |
(2,610 |
) |
|
$ |
199,245 |
|
U.S. government agency bonds |
|
|
108,036 |
|
|
|
— |
|
|
|
(1,116 |
) |
|
|
106,920 |
|
|
|
$ |
309,870 |
|
|
$ |
21 |
|
|
$ |
(3,726 |
) |
|
$ |
306,165 |
|
|
Summary of Fair value and Gross Unrealized Losses on Securities |
The following table summarizes the fair value and gross unrealized losses aggregated by category and the length of time that individual securities have been in an unrealized loss position:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
Less than twelve months |
|
|
Greater than twelve months |
|
|
Total |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
(in thousands) |
|
U.S. Treasury bills |
$ |
118,259 |
|
|
$ |
(111 |
) |
|
$ |
24,726 |
|
|
$ |
(237 |
) |
|
$ |
142,985 |
|
|
$ |
(348 |
) |
U.S. government agency bonds |
|
89,282 |
|
|
|
(106 |
) |
|
|
17,064 |
|
|
|
(237 |
) |
|
|
106,346 |
|
|
|
(343 |
) |
|
$ |
207,541 |
|
|
$ |
(217 |
) |
|
$ |
41,790 |
|
|
$ |
(474 |
) |
|
$ |
249,331 |
|
|
$ |
(691 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2022 |
|
|
Less than twelve months |
|
|
Greater than twelve months |
|
|
Total |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
Fair value |
|
|
Unrealized loss |
|
|
(in thousands) |
|
U.S. Treasury bills |
$ |
44,213 |
|
|
$ |
(640 |
) |
|
$ |
84,997 |
|
|
$ |
(1,970 |
) |
|
$ |
129,210 |
|
|
$ |
(2,610 |
) |
U.S. government agency bonds |
|
68,919 |
|
|
|
(627 |
) |
|
|
38,000 |
|
|
|
(489 |
) |
|
|
106,919 |
|
|
|
(1,116 |
) |
|
$ |
113,132 |
|
|
$ |
(1,267 |
) |
|
$ |
122,997 |
|
|
$ |
(2,459 |
) |
|
$ |
236,129 |
|
|
$ |
(3,726 |
) |
|
X |
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v3.23.3
Supplemental Balance Sheet Information (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Schedule of Property, Plant and Equipment |
Property and equipment, net, consists of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(in thousands) |
|
Laboratory equipment |
|
$ |
8,581 |
|
|
$ |
7,720 |
|
Computer equipment |
|
|
2,312 |
|
|
|
2,235 |
|
Computer software |
|
|
125 |
|
|
|
125 |
|
Furniture and fixtures |
|
|
1,737 |
|
|
|
1,699 |
|
Leasehold improvements |
|
|
2,857 |
|
|
|
2,778 |
|
Construction in progress |
|
|
20 |
|
|
|
8 |
|
|
|
|
15,632 |
|
|
|
14,565 |
|
Less: Accumulated depreciation |
|
|
(5,371 |
) |
|
|
(3,681 |
) |
Property and equipment, net |
|
$ |
10,261 |
|
|
$ |
10,884 |
|
|
Schedule of Accrued Expenses and Other Current Liabilities Current |
Accrued expenses and other current liabilities include the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(in thousands) |
|
Payroll and employee-related costs |
|
$ |
5,415 |
|
|
$ |
5,738 |
|
Research and development costs |
|
|
4,613 |
|
|
|
10,490 |
|
Other |
|
|
1,439 |
|
|
|
1,267 |
|
Total accrued expenses and other current liabilities |
|
$ |
11,467 |
|
|
$ |
17,495 |
|
|
Schedule of Cash, Cash Equivalents Restricted Cash and Restricted Cash Equivalents |
The reconciliation of cash and cash equivalents and restricted cash to amounts presented in the condensed consolidated statements of cash flows are as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
September 30, 2022 |
|
|
|
(in thousands) |
|
Cash and cash equivalents |
|
$ |
58,533 |
|
|
$ |
100,312 |
|
Restricted cash |
|
|
3,423 |
|
|
|
3,990 |
|
Cash, cash equivalents and restricted cash |
|
$ |
61,956 |
|
|
$ |
104,302 |
|
|
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v3.23.3
Stock-Based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Schedule of Stock-based Compensation Expense |
The Company recorded stock-based compensation expense in the following expense categories in its accompanying condensed consolidated statements of operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands) |
|
|
(in thousands) |
|
Research and development |
|
$ |
2,573 |
|
|
$ |
1,791 |
|
|
$ |
7,516 |
|
|
$ |
5,089 |
|
General and administrative |
|
|
2,287 |
|
|
|
2,024 |
|
|
|
6,684 |
|
|
|
5,356 |
|
Total |
|
$ |
4,860 |
|
|
$ |
3,815 |
|
|
$ |
14,200 |
|
|
$ |
10,445 |
|
|
Schedule of Stock Option Activity |
The following table summarizes the stock option activity for the nine months ended September 30, 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
Weighted Average Exercise Price |
|
|
Weighted Average Contractual Term |
|
|
Aggregate Intrinsic Value |
|
|
|
(in years) |
|
Options outstanding as of December 31, 2022 |
|
|
12,924,086 |
|
|
$ |
6.50 |
|
|
|
8.13 |
|
|
$ |
24,267,448 |
|
Granted |
|
|
5,113,352 |
|
|
|
5.19 |
|
|
|
|
|
|
|
Exercised |
|
|
(246,848 |
) |
|
|
2.26 |
|
|
|
|
|
|
|
Cancelled |
|
|
(695,585 |
) |
|
|
8.01 |
|
|
|
|
|
|
|
Options outstanding as of September 30, 2023 |
|
|
17,095,005 |
|
|
$ |
6.12 |
|
|
|
7.83 |
|
|
$ |
87,902,516 |
|
Options exercisable as of September 30, 2023 |
|
|
7,372,207 |
|
|
$ |
5.65 |
|
|
|
7.14 |
|
|
$ |
41,520,355 |
|
|
Summary of Restricted Stock Unit Activity |
The following table summarizes the RSU activity for the nine months ended September 30, 2023:
|
|
|
|
|
|
|
|
|
|
|
Number of Stock Units |
|
|
Weighted Average Grant Date Fair Value Per Share |
|
Unvested and outstanding as of December 31, 2022 |
|
|
— |
|
|
$ |
- |
|
Granted |
|
|
809,738 |
|
|
|
4.94 |
|
Vested |
|
|
(37,500 |
) |
|
|
2.67 |
|
Forfeited |
|
|
(14,591 |
) |
|
|
4.60 |
|
Unvested and outstanding as of September 30, 2023 |
|
|
757,647 |
|
|
$ |
5.05 |
|
|
X |
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v3.23.3
Net Loss Per Share (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Schedule of Earnings Per Share, Basic and Diluted |
Basic and diluted net loss per share attributable to common stockholders was calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
(in thousands, except per share data) |
|
|
(in thousands, except per share data) |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(22,263 |
) |
|
$ |
(29,050 |
) |
|
$ |
(70,981 |
) |
|
$ |
(79,116 |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding – basic and diluted |
|
|
97,033,273 |
|
|
|
87,892,195 |
|
|
|
91,268,133 |
|
|
|
87,868,081 |
|
Net loss per share – basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.90 |
) |
In August 2023, the Company completed a private placement, in which 13,196,671 shares of common stock were sold together with pre-funded warrants to purchase 2,340,579 shares of common stock with an exercise price of $0.0001 per share. The pre-funded warrants were classified as a component of permanent equity in the Company's condensed consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its own shares and permit the holders to receive a fixed number of shares of common stock upon exercise. All of the shares underlying the pre-funded warrants have been included in the weighted-average number of shares of common stock used to calculate net loss per share attributable to common stockholders because the shares may be issued for little or no consideration, are fully vested and are exercisable after the original issuance date of the pre-funded warrants.
|
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share |
The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
2023 |
|
|
2022 |
|
Stock options to purchase common stock |
|
|
17,095,005 |
|
|
|
12,701,089 |
|
Unvested restricted common stock |
|
|
757,647 |
|
|
|
— |
|
Total |
|
|
17,852,652 |
|
|
|
12,701,089 |
|
|
X |
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v3.23.3
Nature of the Business and Basis of Presentation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands |
|
9 Months Ended |
Aug. 11, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Organization Consolidation And Presentation Of Financial Statements [Line Items] |
|
|
|
Stock issuance cost |
|
$ 178
|
$ 8
|
Private Placement [Member] |
|
|
|
Organization Consolidation And Presentation Of Financial Statements [Line Items] |
|
|
|
Number of units issued in transaction |
13,196,671
|
|
|
Unit price |
$ 5.15
|
|
|
Gross proceeds |
$ 80,000
|
|
|
Stock issuance cost |
200
|
|
|
Net proceeds from private placement |
$ 79,800
|
|
|
Private Placement [Member] | Pre-funded Warrants [Member] |
|
|
|
Organization Consolidation And Presentation Of Financial Statements [Line Items] |
|
|
|
Unit price |
$ 5.1499
|
|
|
Warrants to purchase shares of common stock |
2,340,579
|
|
|
Exercise price |
$ 0.0001
|
|
|
X |
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v3.23.3
Collaboration Agreements - Additional Information (Details)
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
12 Months Ended |
|
|
|
Jun. 30, 2023
USD ($)
|
Aug. 31, 2020
USD ($)
Program
|
Oct. 31, 2018
Program
|
Jun. 30, 2023
USD ($)
|
Sep. 30, 2020
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2018
USD ($)
|
Dec. 31, 2022
USD ($)
|
Sep. 30, 2021
USD ($)
|
Dec. 31, 2020
USD ($)
|
2018 Gilead Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Research term |
|
|
3 years
|
|
|
|
|
|
|
|
|
Number of licensed product | Program |
|
|
5
|
|
|
|
|
|
|
|
|
Non-refundable upfront payment received |
|
|
|
|
|
$ 50,000,000
|
|
$ 50,000,000
|
|
|
|
Amended Gilead Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Research term |
|
7 years
|
|
|
|
|
|
|
|
|
|
Number of licensed product | Program |
|
15
|
|
|
|
|
|
|
|
|
|
Non-refundable upfront payment received |
|
|
|
|
|
$ 125,000,000
|
|
|
|
|
|
Milestone payments receivable |
|
$ 410,000,000
|
|
|
|
|
|
|
|
|
|
Temporary equity, par value |
|
125,000,000
|
|
|
|
|
|
|
|
|
|
Revenue recognized, cumulative catch-up adjustment |
|
|
|
|
$ (11,300,000)
|
|
|
|
|
|
|
Research extension fee |
|
|
|
|
|
|
|
|
|
$ 12,000,000
|
$ 12,000,000
|
License fee amount |
$ 5,000,000
|
|
|
|
|
|
|
|
|
|
|
Contract with customer liability, revenue recognized |
|
|
|
$ 5,000,000
|
|
|
|
|
|
|
|
Amended Gilead Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Ownership percentage in common stock |
|
|
|
|
|
10.00%
|
|
|
|
|
|
Amended Gilead Agreement [Member] | Series B-1 Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Temporary equity, par value |
|
$ 20,000,000
|
|
|
|
|
|
|
|
|
|
Gilead Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Transaction price allocated to performance obligation |
|
|
|
|
|
$ 199,000,000
|
|
|
|
|
|
Cummulative research extension fee |
|
|
|
|
|
24,000,000
|
|
|
|
|
|
Short-term deferred revenue |
|
|
|
|
|
27,100,000
|
|
|
$ 31,800,000
|
|
|
Long-term deferred revenue |
|
|
|
|
|
70,700,000
|
|
|
$ 92,100,000
|
|
|
Collaboration Revenue [Member] | Gilead Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Contract with customer liability, revenue recognized |
|
|
|
|
|
$ 26,100,000
|
$ 18,400,000
|
|
|
|
|
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v3.23.3
Fair Value Measurements - Summary Financial Assets Measured at Fair Value on a Recurring Basis (Details) - Fair Value Measurements Recurring [Member] - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents, Money market funds |
$ 15,807
|
$ 7,577
|
Cash equivalents, U.S. Treasury bills |
9,292
|
16,030
|
Total assets |
326,446
|
329,772
|
Marketable Debt Securities [Member] | U.S. Treasury Bills [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable debt securities |
195,000
|
199,245
|
Marketable Debt Securities [Member] | U.S. Government Agency Bonds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable debt securities |
106,347
|
106,920
|
Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents, Money market funds |
15,807
|
7,577
|
Total assets |
15,807
|
7,577
|
Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents, U.S. Treasury bills |
9,292
|
16,030
|
Total assets |
310,639
|
322,195
|
Level 2 [Member] | Marketable Debt Securities [Member] | U.S. Treasury Bills [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable debt securities |
195,000
|
199,245
|
Level 2 [Member] | Marketable Debt Securities [Member] | U.S. Government Agency Bonds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable debt securities |
$ 106,347
|
$ 106,920
|
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v3.23.3
Marketable Securities - Summary of Debt Securities, Available For Sale (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] |
|
|
Amortized Cost |
$ 302,028
|
$ 309,870
|
Gross Unrealized Gains |
10
|
21
|
Gross Unrealized Loss |
(691)
|
(3,726)
|
Fair Value |
301,347
|
306,165
|
U.S. Treasury Bills [Member] |
|
|
Debt Securities, Available-for-Sale [Line Items] |
|
|
Amortized Cost |
195,338
|
201,834
|
Gross Unrealized Gains |
10
|
21
|
Gross Unrealized Loss |
(348)
|
(2,610)
|
Fair Value |
195,000
|
199,245
|
U.S. Government Agency Bonds [Member] |
|
|
Debt Securities, Available-for-Sale [Line Items] |
|
|
Amortized Cost |
106,690
|
108,036
|
Gross Unrealized Loss |
(343)
|
(1,116)
|
Fair Value |
$ 106,347
|
$ 106,920
|
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v3.23.3
Marketable Securities - Summary of Fair Value and Gross Unrealized Losses on Securities (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] |
|
|
Securities Less than twelve months, Fair value |
$ 207,541
|
$ 113,132
|
Securities Less than twelve months, Unrealized loss |
(217)
|
(1,267)
|
Securities Greater than twelve months, Fair value |
41,790
|
122,997
|
Securities Greater than twelve months, Unrealized loss |
(474)
|
(2,459)
|
Securities, Total Fair value |
249,331
|
236,129
|
Securities, Total Unrealized loss |
(691)
|
(3,726)
|
U.S. Treasury Bills [Member] |
|
|
Debt Securities, Available-for-Sale [Line Items] |
|
|
Securities Less than twelve months, Fair value |
118,259
|
44,213
|
Securities Less than twelve months, Unrealized loss |
(111)
|
(640)
|
Securities Greater than twelve months, Fair value |
24,726
|
84,997
|
Securities Greater than twelve months, Unrealized loss |
(237)
|
(1,970)
|
Securities, Total Fair value |
142,985
|
129,210
|
Securities, Total Unrealized loss |
(348)
|
(2,610)
|
U.S. Government Agency Bonds [Member] |
|
|
Debt Securities, Available-for-Sale [Line Items] |
|
|
Securities Less than twelve months, Fair value |
89,282
|
68,919
|
Securities Less than twelve months, Unrealized loss |
(106)
|
(627)
|
Securities Greater than twelve months, Fair value |
17,064
|
38,000
|
Securities Greater than twelve months, Unrealized loss |
(237)
|
(489)
|
Securities, Total Fair value |
106,346
|
106,919
|
Securities, Total Unrealized loss |
$ (343)
|
$ (1,116)
|
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v3.23.3
Marketable Securities - Additional Information (Details) - USD ($)
|
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] |
|
|
Marketable securities, Accrued interest |
$ 1,500,000
|
$ 500,000
|
Fair Value |
301,347,000
|
306,165,000
|
Marketable Debt Securities [Member] |
|
|
Debt Securities, Available-for-Sale [Line Items] |
|
|
Impairments to marketable securities or reserves for credit losses |
0
|
$ 0
|
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$ 39,800,000
|
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v3.23.3
Supplemental Balance Sheet Information - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Property, Plant and Equipment, Gross |
$ 15,632
|
$ 14,565
|
Less: Accumulated depreciation |
(5,371)
|
(3,681)
|
Property and equipment, net |
10,261
|
10,884
|
Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property, Plant and Equipment, Gross |
8,581
|
7,720
|
Computer Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property, Plant and Equipment, Gross |
2,312
|
2,235
|
Computer Software [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property, Plant and Equipment, Gross |
125
|
125
|
Furniture and Fixtures [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property, Plant and Equipment, Gross |
1,737
|
1,699
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property, Plant and Equipment, Gross |
2,857
|
2,778
|
Construction in Progress [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property, Plant and Equipment, Gross |
$ 20
|
$ 8
|
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Supplemental Balance Sheet Information - Schedule of Accrued Expenses and Other Current Liabilities Current (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
|
Payroll and employee-related costs |
$ 5,415
|
$ 5,738
|
Research and development costs |
4,613
|
10,490
|
Other current liabilities |
1,439
|
1,267
|
Total accrued expenses and other current liabilities |
$ 11,467
|
$ 17,495
|
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Supplemental Balance Sheet Information - Schedule of Restricted Cash (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents [Line Items] |
|
|
|
Cash and cash equivalents |
$ 58,533
|
$ 59,968
|
|
Construction in Progress [Member] |
|
|
|
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents [Line Items] |
|
|
|
Cash and cash equivalents |
58,533
|
|
$ 100,312
|
Restricted cash |
3,423
|
|
3,990
|
Cash, cash equivalents and restricted cash |
$ 61,956
|
|
$ 104,302
|
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3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] |
|
|
|
|
Stock-based compensation expense |
$ 4,860
|
$ 3,815
|
$ 14,200
|
$ 10,445
|
Research and Development [Member] |
|
|
|
|
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|
|
|
|
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2,573
|
1,791
|
7,516
|
5,089
|
General and Administrative [Member] |
|
|
|
|
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|
|
|
|
Stock-based compensation expense |
$ 2,287
|
$ 2,024
|
$ 6,684
|
$ 5,356
|
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v3.23.3
Stock-Based Compensation - Schedule of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands |
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
Number of Shares, Options outstanding Beginning balance |
12,924,086
|
|
Number of Shares Granted |
5,113,352
|
|
Number of Shares Exercised |
(246,848)
|
|
Number of Shares Cancelled |
(695,585)
|
|
Number of Shares, Options outstanding Ending balance |
17,095,005
|
12,924,086
|
Number of Shares Options exercisable |
7,372,207
|
|
Weighted Average Exercise Price, Options outstanding Beginning balance |
$ 6.50
|
|
Weighted Average Exercise Price Granted |
5.19
|
|
Weighted Average Exercise Price Exercised |
2.26
|
|
Weighted Average Exercise Price Cancelled |
8.01
|
|
Weighted Average Exercise Price, Options outstanding Ending balance |
6.12
|
$ 6.50
|
Weighted Average Exercise Price Options exercisable |
$ 5.65
|
|
Weighted Average Contractual Term, Options outstanding |
7 years 9 months 29 days
|
8 years 1 month 17 days
|
Weighted Average Contractual Term Options exercisable |
7 years 1 month 20 days
|
|
Aggregate Intrinsic Value, Options outstanding |
$ 87,902,516
|
$ 24,267,448
|
Aggregate Intrinsic Value Options exercisable |
$ 41,520,355
|
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v3.23.3
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Unit [Member]
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
Number of Stock Units, Granted | shares |
809,738
|
Number of Stock Units, Vested | shares |
(37,500)
|
Number of Stock Units, Forfeited | shares |
(14,591)
|
Number of Stock Units, Unvested and outstanding Ending balance | shares |
757,647
|
Weighted Average Grant Date Fair Value Per Share, Granted | $ / shares |
$ 4.94
|
Weighted Average Grant Date Fair Value Per Share, Vested | $ / shares |
2.67
|
Weighted Average Grant Date Fair Value Per Share, Forfeited | $ / shares |
4.6
|
Weighted Average Grant Date Fair Value Per Share, Unvested and outstanding Ending balance | $ / shares |
$ 5.05
|
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v3.23.3
Net Loss Per Share - Schedule of Earnings Per Share, Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Numerator: |
|
|
|
|
|
|
|
|
Net loss |
$ (22,263)
|
$ (20,710)
|
$ (28,008)
|
$ (29,050)
|
$ (24,858)
|
$ (25,208)
|
$ (70,981)
|
$ (79,116)
|
Denominator: |
|
|
|
|
|
|
|
|
Weighted-average common stock outstanding - basic |
97,033,273
|
|
|
87,892,195
|
|
|
91,268,133
|
87,868,081
|
Weighted-average common stock outstanding - diluted |
97,033,273
|
|
|
87,892,195
|
|
|
91,268,133
|
87,868,081
|
Net loss per common share - basic |
$ (0.23)
|
|
|
$ (0.33)
|
|
|
$ (0.78)
|
$ (0.90)
|
Net loss per common share - diluted |
$ (0.23)
|
|
|
$ (0.33)
|
|
|
$ (0.78)
|
$ (0.90)
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.3
Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount |
17,852,652
|
12,701,089
|
Stock options to purchase common stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount |
17,095,005
|
12,701,089
|
Unvested restricted common stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount |
757,647
|
|
X |
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