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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2024

OR

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: 001-37544

ARMATA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Washington

91-1549568

(State or other jurisdiction of

(I.R.S. Employer Identification Number)

incorporation or organization)

5005 McConnell Avenue

Los Angeles, CA

90066

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (310) 665-2928

Not Applicable

(Former name, former address, and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.01 par value per share

ARMP

NYSE American

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, a smaller reporting company or an emerging growth company as defined in Rule 12b-2 of the Exchange Act. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer  

Accelerated filer  

Non-accelerated filer    

Smaller reporting company  

Emerging growth company  

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

The number of shares of the registrant’s Common Stock, par value $0.01 per share, outstanding as of November 8, 2024 was 36,183,067.

TABLE OF CONTENTS

Page

PART I. FINANCIAL INFORMATION

Item 1.

Financial Statements (unaudited)

6

Condensed Consolidated Balance Sheets

6

 

Condensed Consolidated Statements of Operations

7

 

Condensed Consolidated Statements of Stockholders’ Deficit

8

Condensed Consolidated Statements of Cash Flows

10

 

Notes to Condensed Consolidated Financial Statements

11

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

35

Item 4.

Controls and Procedures

35

PART II. OTHER INFORMATION

35

 

 

Item 1.

Legal Proceedings

35

 

 

Item 1A.

Risk Factors

35

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

36

 

 

Item 3.

Defaults upon Senior Securities

36

 

 

Item 4.

Mine Safety Disclosures

36

 

 

Item 5.

Other Information

36

 

 

Item 6.

Exhibits

36

 

 

SIGNATURES

38

2

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (this “Quarterly Report”) and certain information incorporated herein by reference contain forward-looking statements, which are provided under the “safe harbor” protection of the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to our future financial performance and involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance, or events to be materially different from any future results, performance, or events expressed or implied by the forward-looking statements. Forward-looking statements in this Quarterly Report include, but are not limited to, statements regarding:

our estimates regarding anticipated operating losses, capital requirements and needs for additional funds;

our ability to raise additional capital when needed and to continue as a going concern;

our ability to manufacture, or otherwise secure the manufacture of, sufficient amounts of our product candidates for our preclinical studies and clinical trials;

our research and development plans, including our clinical development plans and planned clinical trials;

our ability to select combinations of phages to formulate our product candidates;

our development of bacteriophage-based therapies;

the potential use of bacteriophages to treat bacterial infections;

the potential future of antibiotic resistance;

our ability for bacteriophage therapies to disrupt and destroy biofilms and restore sensitivity to antibiotics;

our planned development strategy, presenting data to regulatory agencies and defining planned clinical studies;

the expected timing of additional clinical trials, including Phase 1b/Phase 2 or registrational clinical trials;

our ability to manufacture and secure sufficient quantities of our product candidates for clinical trials;

the drug product candidates to be supplied by us for clinical trials;

the potential for bacteriophage technology being uniquely positioned to address the global threat of antibiotic resistance;

the safety and efficacy of our product candidates;

our anticipated regulatory pathways for our product candidates;

the activities to be performed by specific parties in connection with clinical trials;

our ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of our product candidates and commercialize any approved products on our expected timeframes or at all;

our pursuit of additional indications;

3

the content and timing of submissions to and decisions made by the U.S. Food and Drug Administration and other regulatory agencies;

our ability to leverage the experience of our management team and to attract and retain management and other key personnel;

the capacities and performance of our suppliers, manufacturers, contract research organizations and other third parties over whom we have limited control;

our ability to staff and maintain our production facility under fully compliant current Good Manufacturing Practices;

the actions of our competitors and success of competing drugs or other therapies that are or may become available;

our expectations with respect to future growth and investments in our infrastructure, and our ability to effectively manage any such growth;

the size and potential growth of the markets for any of our product candidates, and our ability to capture share in or impact the size of those markets;

the benefits of our product candidates;

potential market growth and market and industry trends;

maintaining collaborations with third parties including our partnership with the U.S. Department of Defense (the “DoD”);

potential future collaborations with third parties and the potential markets and market opportunities for product candidates;

our ability to achieve our vision, including improvements through engineering and success of clinical trials;

our ability to meet anticipated milestones in the development and testing of the relevant product;

our ability to be a leader in the development of phage-based therapeutics;

the expected compliance with DoD grant requirements;

the effects of government regulation and regulatory developments, and our ability and the ability of the third parties with whom we engage to comply with applicable regulatory requirements;

the accuracy of our estimates regarding future expenses, revenues, capital requirements and need for additional financing;

our expectations regarding future planned expenditures;

our ability to achieve and maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act;

our ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of any of our products and product candidates;

4

our ability to protect our intellectual property, including pending and issued patents;

our ability to operate our business without infringing the intellectual property rights of others;

our ability to advance our clinical development programs;

the effects of the ongoing conflict between Ukraine and Russia and the recent and potential future bank failures or other geopolitical events; and

statements of belief and any statement of assumptions underlying any of the foregoing.

In some cases, you can identify these statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of those terms, and similar expressions. These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Quarterly Report and are subject to risks and uncertainties. We discuss many of these risks in greater detail in the section hereof entitled “Risk Factors” and in our Annual Report on Form 10-K for the year ended December 31, 2023. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain. Given these uncertainties, you should not place undue reliance on any of the forward-looking statements included in this Quarterly Report. In addition, this Quarterly Report also contains estimates, projections, and other information concerning our industry, our business, and the markets for our product candidates, as well as data regarding market research, estimates, and forecasts prepared by our management. Information that is based on estimates, forecasts, projections, market research, or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information.

Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information, future events, or otherwise.

This Quarterly Report includes trademarks and registered trademarks of Armata Pharmaceuticals, Inc. Products or service names of other companies mentioned in this Quarterly Report may be trademarks or registered trademarks of their respective owners.

As used in this Quarterly Report, unless the context requires otherwise, the “Company,” “we,” “us,” and “our” refer to Armata Pharmaceuticals, Inc. and its wholly owned subsidiaries.

5

PART I. FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

Armata Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except share and per share data)

    

September 30, 2024

    

December 31, 2023

Assets

Current assets

Cash and cash equivalents

$

17,141

$

13,523

Prepaid expenses and other current assets

 

3,029

 

2,265

Other receivables

2,219

3,363

Total current assets

 

22,389

 

19,151

Restricted cash

5,480

5,720

Property and equipment, net

 

13,616

 

12,559

Operating lease right-of-use asset

 

42,251

 

44,717

In-process research and development

10,256

10,256

Goodwill

3,490

3,490

Other assets

 

755

 

2,470

Total assets

$

98,237

$

98,363

Liabilities and stockholders’ deficit

 

  

 

  

Current liabilities

 

  

 

  

Accounts payable and accrued liabilities

$

3,714

$

5,689

Accrued compensation

1,580

768

Convertible debt, current

41,357

Term debt, current

66,046

Current portion of operating lease liabilities

4,994

9,481

Other current liabilities

513

523

Total current liabilities

 

118,204

 

16,461

Operating lease liabilities, net of current portion

27,929

28,583

Convertible debt, non-current

58,633

Term debt, non-current

23,674

Deferred tax liability

3,077

3,077

Total liabilities

 

149,210

 

130,428

Commitments and contingencies (Note 12)

 

  

 

  

Stockholders’ deficit

 

  

 

  

Common stock, $0.01 par value; 217,000,000 shares authorized; 36,183,067 and 36,122,932 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively

 

362

 

361

Additional paid-in capital

 

279,000

 

276,393

Accumulated deficit

 

(330,335)

 

(308,819)

Total stockholders’ deficit

 

(50,973)

 

(32,065)

Total liabilities and stockholders’ deficit

$

98,237

$

98,363

See accompanying notes to condensed consolidated financial statements.

6

Armata Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share data)

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2024

    

2023

    

2024

    

2023

Grant revenue

$

2,973

$

1,225

$

3,939

$

3,001

Operating expenses

Research and development

 

9,485

7,978

 

25,975

25,842

General and administrative

 

3,244

3,583

 

9,861

8,470

Total operating expenses

12,729

11,561

35,836

34,312

Operating loss

 

(9,756)

 

(10,336)

 

(31,897)

 

(31,311)

Other income (expense)

 

  

 

 

 

  

Interest income

 

294

47

567

111

Interest expense

(2,923)

(1,176)

(7,462)

(1,176)

Change in fair value of convertible debt

6,904

(15,833)

17,276

(12,959)

Loss on convertible debt extinguishment

(3,863)

(3,863)

Total other income (expense), net

 

4,275

 

(20,825)

 

10,381

 

(17,887)

Net loss

$

(5,481)

$

(31,161)

$

(21,516)

$

(49,198)

Per share information:

Net loss per share, basic and diluted

$

(0.15)

$

(0.86)

$

(0.60)

$

(1.36)

Weighted average shares outstanding, basic and diluted

36,180,124

36,086,990

36,153,388

36,067,025

See accompanying notes to condensed consolidated financial statements.

7

Armata Pharmaceuticals, Inc.

Condensed Consolidated Statements of Stockholders’ Deficit

Three and Nine Months Ended September 30, 2024 and 2023

(unaudited)

(in thousands, except share data)

Stockholders’ Deficit

Common Stock

Additional

Total

Paid-in

Accumulated

Stockholders’

    

Shares

    

Amount

    

Capital

    

Deficit

    

Deficit

Balances, June 30, 2023

 

36,127,306

$

361

$

276,593

$

(257,811)

$

19,143

Forfeiture of restricted stock awards

 

(6,215)

Exercise of stock options

1,500

5

5

Share-based compensation expense

 

(373)

(373)

Net loss

 

(31,161)

(31,161)

Balances, September 30, 2023

 

36,122,591

$

361

$

276,225

$

(288,972)

$

(12,386)

Stockholders’ Deficit

Common Stock

Additional

Total

Paid-in

Accumulated

Stockholders’

    

Shares

    

Amount

    

Capital

    

Deficit

    

Deficit

Balances, June 30, 2024

 

36,155,992

$

362

$

278,391

$

(324,854)

$

(46,101)

Issuance of common stock upon release of restricted stock units, net of tax withholdings

27,075

(61)

(61)

Share-based compensation expense

 

670

670

Net loss

 

(5,481)

(5,481)

Balances, September 30, 2024

 

36,183,067

$

362

$

279,000

$

(330,335)

$

(50,973)

8

Stockholders’ Deficit

Common Stock

Additional

Total

Paid-in

Accumulated

Stockholders’

    

Shares

    

Amount

    

Capital

    

Deficit

    

Deficit

Balances, December 31, 2022

 

36,144,706

$

361

$

275,493

$

(239,774)

$

36,080

Forfeiture of restricted stock awards

(9,914)

Withholdings for taxes related to net share settlement of equity awards

(13,701)

(18)

(18)

Exercise of stock options

1,500

5

5

Stock-based compensation expense

 

745

 

745

Net loss

 

(49,198)

 

(49,198)

Balances, September 30, 2023

 

36,122,591

$

361

$

276,225

$

(288,972)

$

(12,386)

Stockholders’ Deficit

Common Stock

Additional

Total

Paid-in

Accumulated

Stockholders’

Shares

    

Amount

    

Capital

    

Deficit

    

Deficit

Balances, December 31, 2023

 

36,122,932

$

361

$

276,393

$

(308,819)

$

(32,065)

Exercise of stock options

37,282

1

129

130

Withholdings for taxes related to net share settlement of equity awards

(4,222)

Issuance of common stock upon release of restricted stock units, net of tax withholdings

27,075

(61)

(61)

Stock-based compensation expense

2,539

2,539

Net loss

 

(21,516)

(21,516)

Balances, September 30, 2024

 

36,183,067

$

362

$

279,000

$

(330,335)

$

(50,973)

See accompanying notes to condensed consolidated financial statements.

9

Armata Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited)

(in thousands)

Nine Months Ended September 30, 

    

2024

    

2023

Operating activities:

Net loss

$

(21,516)

$

(49,198)

Adjustments required to reconcile net loss to net cash used in operating activities:

Depreciation and amortization expense

 

945

 

679

Stock-based compensation expense

2,539

745

Change in fair value of convertible debt

(17,276)

12,959

Non-cash interest expense

7,483

1,176

Loss on convertible debt extinguishment

3,863

Change in right-of-use asset

1,489

662

Changes in operating assets and liabilities:

 

 

Prepaid expenses and other assets

 

2,095

 

(72)

Accounts payable and accrued liabilities

 

(2,031)

 

(321)

Accrued compensation

812

(87)

Operating lease liability

(4,164)

(9,723)

Net cash used in operating activities

 

(29,624)

 

(39,317)

Investing activities:

 

  

 

  

Purchases of property and equipment

(1,956)

(5,744)

Net cash used in investing activities

 

(1,956)

 

(5,744)

Financing activities:

 

  

 

  

Proceeds from issuance of convertible debt, net of issuance costs

29,101

Proceeds from issuance of term debt, net of issuance costs

34,889

24,925

Payments for taxes related to net share settlement of equity awards

(61)

Proceeds from exercise of stock options

130

5

Net cash provided by financing activities

 

34,958

 

54,031

Net increase in cash, cash equivalents and restricted cash

 

3,378

 

8,970

Cash, cash equivalents and restricted cash, beginning of period

 

19,243

 

20,812

Cash, cash equivalents and restricted cash, end of period

$

22,621

$

29,782

Supplemental disclosure of cash flow information:

 

  

 

  

Right-of-use asset obtained in exchange for operating lease liability

$

977

$

2,513

Property and equipment included in accounts payable and accrued liabilities

$

263

$

1,047

Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheet:

Nine Months Ended September 30, 

2024

    

2023

Cash and cash equivalents

$

17,141

$

23,958

Restricted cash

5,480

5,824

Cash, cash equivalents and restricted cash

$

22,621

$

29,782

See accompanying notes to condensed consolidated financial statements.

10

Armata Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Organization and Description of the Business

Armata Pharmaceuticals, Inc. (“Armata”) together with its subsidiaries (the “Company”), is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology.

Armata’s common stock, par value $0.01 per share (the “Common Stock”) is traded on the NYSE American exchange under the ticker symbol “ARMP.”

2. Liquidity and Going Concern

The Company has incurred significant operating losses since inception and has primarily relied on equity, debt financing and grants to fund its operations. As of September 30, 2024, the Company had an accumulated deficit of $330.3 million. The Company expects to continue to incur substantial losses, and its transition to profitability will depend on the successful development, approval and commercialization of product candidates and on the achievement of sufficient revenues to support its cost structure. The Company may never achieve profitability, and unless and until then, the Company will need to continue to raise additional capital. Existing cash and cash equivalents of $17.1 million as of September 30, 2024 will not be sufficient to fund the Company’s operations for the next 12 months from the date of these condensed consolidated financial statements. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern.

The Company has prepared its condensed consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning the Company’s ability to continue as a going concern.

Recent Financing:

2024 Credit Agreement

On March 4, 2024, the Company entered into a credit and security agreement (the “2024 Credit Agreement”) for a loan in an aggregate amount of $35.0 million (the “2024 Loan”) with Innoviva Strategic Opportunities LLC, a wholly owned subsidiary of Innoviva, Inc. (NASDAQ: INVA), our principal stockholder and a related party (collectively, “Innoviva”). The 2024 Loan bears interest at an annual rate of 14% and matures on June 4, 2025. Principal and accrued interest are payable at maturity. Repayment of the 2024 Loan is guaranteed by the Company’s domestic subsidiaries, and the loan is secured by substantially all of the assets of the Company and the subsidiary guarantors. Concurrently with the execution of the 2024 Credit Agreement, the Company amended certain provisions of its existing convertible loan (the “Convertible Loan”) (see Note 7) and secured credit and security agreement, dated January 10, 2023, with Innoviva (the “Convertible Credit Agreement”) and its existing secured term loan facility (the “2023 Loan”) and credit and security agreement, dated July 10, 2023, with Innoviva (the “2023 Credit Agreement”) to, among other things, conform certain terms relating to permitted indebtedness and permitted liens (see Note 8).

The Company plans to raise additional capital through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses and other similar arrangements. While the Company believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, these plans are not entirely within its control and cannot be assessed as being probable of occurring. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the United States and worldwide. The Company may not be able to secure additional financing in a timely manner or on favorable terms, if at all. Furthermore,

11

if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders. If the Company raises additional funds through collaboration, licensing or other similar arrangements, it may be necessary to relinquish valuable rights to its potential products on terms that are not favorable to the Company. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce or eliminate its research and development programs or other operations. If any of these events occur, the Company’s ability to achieve the development and commercialization goals would be adversely affected.

3. Significant Accounting Policies

Basis of Presentation

The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated.

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto as of and for the year ended December 31, 2023 included in the Company’s Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 21, 2024. The information as of December 31, 2023 included in the condensed consolidated balance sheets was derived from the Company’s audited financial statements. 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”) and the requirements of the SEC for interim reporting. In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments that are of a normal and recurring nature and that are necessary for the fair presentation of the Company’s financial position and the results of its operations and cash flows for the periods presented. Interim results are not necessarily indicative of results for the full year or any future period.

Any reference in the condensed consolidated financial statements to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

Significant Accounting Policies

The significant accounting policies used in preparation of the condensed consolidated financial statements for the three and nine months ended September 30, 2024 and 2023 are consistent with those discussed in Note 3 to the consolidated financial statements included in the Company’s Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024, except as noted below and within the “Recently Adopted Accounting Pronouncements” section.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates estimates and assumptions, including but not limited to those related to convertible debt, stock-based compensation expense, accruals for research and development costs, the valuation of deferred tax assets, impairment of goodwill and intangible assets and impairment of long-lived assets. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, 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. Actual results may differ materially from those estimates.

12

Segments

The Company operates and manages its business as one reportable operating segment, which is the business of developing pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat acute and chronic bacterial infections using its proprietary bacteriophage-based technology. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating resources and evaluating financial performance. The long-lived assets of $13.5 million, which represent 99.2% of the Company’s total long-lived assets, are maintained in the United States.

Concentration of Credit Risks and Certain Other Risks

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and restricted cash. As of September 30, 2024, cash equivalents and restricted cash was invested primarily in money market funds and U.S. treasury securities through highly rated financial institutions in accordance with the Company’s investment policy, to a concentration limit per issuer or sector. These are investment assets and are classified as cash equivalents in the condensed consolidated balance sheets as their original maturities are less than three months.

Other receivables represent amounts due from the Medical Technology Enterprise Consortium (“MTEC”) (Note 13) and reimbursement for tenant improvements (Note 12).

Recently Adopted Accounting Pronouncements

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted earnings (loss) per share (“EPS”) computation. The Company adopted this ASU as of January 1, 2024, which did not have an impact on its consolidated financial statements or related disclosures.

Recent Accounting Pronouncements Not Yet Adopted

In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. This ASU aligns the requirements in the ASC to the removal of certain disclosure requirements set out in Regulation S-X and Regulation S-K, announced by the SEC. The effective date for each amended topic in the ASC is either the date on which the SEC’s removal of the related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, or on June 30, 2027, if the SEC has not removed the requirements by that date. Early adoption is prohibited. The Company is currently evaluating the impact of adopting ASU 2023-06 on its consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07 on its consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09 on its consolidated financial statements.

13

4. Fair Value Measurements

The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following three levels:

Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2: Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The financial assets and liabilities measured and recognized at fair value were as follows as of September 30, 2024 and December 31, 2023 (in thousands):

September 30, 2024

Total

Level 1

Level 2

Level 3

Investments in money market fund – financial assets, included in cash and cash equivalents

$

10,355

$

10,355

$

$

Convertible debt– financial liabilities

41,357

41,357

December 31, 2023

Total

Level 1

Level 2

Level 3

Convertible debt– financial liabilities

$

58,633

$

$

$

58,633

The Company’s convertible debt (Note 7) is measured at fair value and remeasured at each quarter end, with changes in fair value recorded as other income (expense) in the condensed consolidated statement of operations. The Company estimates the fair value of its convertible debt using a weighted probability model of various debt settlement scenarios during its term discounted to the reporting date. Conversion option scenarios are valued using option pricing models with assumptions and estimates such as volatility, expected term and risk-free interest rates. Level 3 fair value inputs include probability and timing of various settlement scenarios and selection of comparable companies.

The Company estimated the fair value of its convertible debt using the following inputs as of September 30, 2024 and December 31, 2023:

September 30, 2024

December 31, 2023

Discount rate

19.50%

21.01%

Probabilities of settlement scenarios

0%-75%

0%-75%

Volatility

93.2%

120.3%

Expected term (in years)

0.26-0.28

0.16-1.04

Risk-free rate

4.58%-4.61%

4.66%-5.36%

14

The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial liabilities for the nine months ended September 30, 2024 (in thousands):

September 30, 2024

Convertible debt at December 31, 2023

$

58,633

Change in fair value

 

(17,276)

Convertible debt at September 30, 2024

$

41,357

The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial liabilities for the nine months ended September 30, 2023 (in thousands):

Convertible Loan
Pre Modification

Convertible Loan
Post Modification

Balance at December 31, 2022

$

$

Net issuance of Convertible Loan (1)

29,226

Initial recognition of modified Convertible Loan (1)

35,031

Change in fair value

 

(1,757)

14,716

Amount exchanged (2)

(31,332)

Loss on extinguishment

3,863

Balance at September 31, 2023

$

$

49,747

(1)The Convertible Loan is carried at fair value in the consolidated balance sheets. As such, the principal and accrued interest are included in the determination of fair value.
(2)The Company concluded that the amendment to the Convertible Loan was an extinguishment for accounting purposes and the amount exchanged was the relative fair value allocated to the Convertible Loan at the extinguishment date (Note 7).

5. Net Loss per Share

The computation of basic EPS is based on the weighted-average number of the Company’s Common Stock outstanding. The computation of diluted EPS is based on the weighted-average number of the Company’s Common Stock outstanding and potential dilutive common stock. Diluted EPS is computed using the more dilutive of the treasury stock method, which reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted to the Company’s Common Stock. Common Stock options, warrants, convertible debt and unvested restricted stock units were not included in dilutive EPS as their impact would be antidilutive.

15

The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders for the periods presented (in thousands, except share and per share data):

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

   

2024

   

2023

    

2024

  

2023

Numerator:

 

  

 

  

 

  

 

  

 

Net loss attributable to common stockholders

$

(5,481)

$

(31,161)

$

(21,516)

$

(49,198)

Denominator:

Weighted average common shares outstanding, basic and diluted

 

36,180,124

 

36,086,990

 

36,153,388

 

36,067,025

Net loss per share attributable to common stockholders, basic and diluted

$

(0.15)

$

(0.86)

$

(0.60)

$

(1.36)

The following outstanding securities as of September 30, 2024 and December 31, 2023 have been excluded from the computation of dilutive weighted average shares outstanding, as they would have been anti-dilutive:

    

September 30, 2024

    

December 31, 2023

    

Outstanding stock options

 

3,934,731

 

3,165,216

Unvested restricted stock units

230,000

200,000

Shares issuable upon the conversion of convertible debt

22,495,614

21,293,861

Outstanding warrants

19,365,847

19,365,847

Total

 

46,026,192

 

44,024,924

 

(1)The Company determined the number of shares issuable upon the conversion of convertible debt as of September 30, 2024 based on the convertible loan principal amount of $30.0 million, accrued and unpaid interest of $4.2 million as of that date calculated at an annual interest rate of 8%, converted at $1.52 per share.

6. Balance Sheet Details

Property and Equipment

Property and equipment as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

    

September 30, 2024

    

December 31, 2023

Laboratory equipment

$

21,311

$

19,678

Furniture and fixtures

831

817

Office and computer equipment

 

438

 

438

Leasehold improvements

 

3,802

 

3,447

Total

26,382

24,380

Less: accumulated depreciation

 

(12,766)

 

(11,821)

Property and equipment, net

$

13,616

$

12,559

Depreciation and amortization expense totaled $0.3 million and $0.2 million for the three months ended September 30, 2024 and 2023, and $0.9 and $0.7 million for the nine months ended September 30, 2024 and 2023, respectively. Construction in progress and fixed assets not in use were $9.6 million and $8.1 million as of September 30, 2024 and December 31, 2023, respectively, and are included in the laboratory equipment in the table above. These assets are not depreciated until they are placed in service.

16

Other receivables

Other receivables as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

September 30, 2024

    

December 31, 2023

Tenant improvement allowance receivable (Note 12)

$

597

$

1,835

Grant and award receivable (Note 13)

1,622

1,528

$

2,219

$

3,363

Accounts payable and accrued liabilities

Accounts payable and accrued liabilities as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

September 30, 2024

    

December 31, 2023

Accounts payable

$

1,815

$

1,585

Accrued clinical trial expenses

1,567

3,021

Other accrued expenses

332

1,083

$

3,714

$

5,689

7. Convertible Debt

On January 10, 2023, the Company received the Convertible Loan in the aggregate amount of $30.0 million from Innoviva pursuant to the Convertible Credit Agreement. The Convertible Loan bears interest at a rate of 8.0% per annum and was scheduled to mature on January 10, 2024. The Convertible Credit Agreement was amended on July 10, 2023, in connection with the Company’s entry into the 2023 Credit Agreement, to, among other changes, extend the maturity of the Convertible Loan to January 10, 2025. Subsequently, on November 12, 2024, the Company executed another amendment to the Convertible Credit Agreement, which, among other things, extended the Convertible Credit Agreement maturity date to January 10, 2026.

The Convertible Loan principal and accrued interest are payable at maturity. Repayment of the Convertible Loan is guaranteed by the Company’s domestic subsidiaries and foreign material subsidiaries, and the Convertible Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

The Convertible Credit Agreement provides that if there is a financing from new investors of at least $30.0 million (a “Qualified Financing”), the outstanding principal amount of and all accrued and unpaid interest on the Convertible Loan shall be converted into shares of the Company’s Common Stock, at a price per share equal to a 15.0% discount to the lowest price per share for Common Stock paid by investors in such Qualified Financing. The Convertible Credit Agreement also required the Company to file a registration statement for the resale of all securities issued to the lender in connection with any conversion under the Convertible Credit Agreement, which the Company originally filed on February 13, 2023 and which was declared effective by the SEC on April 6, 2023. The Convertible Credit Agreement also confers upon the lender the option to convert any outstanding Convertible Loan amount, including all accrued and unpaid interest thereon, at the lender’s option, into shares of Common Stock at a price per share equal to the greater of book value or market value per share of Common Stock on the date immediately preceding the effective date of the Convertible Credit Agreement, which was $1.52 (as may be appropriately adjusted for any stock split, combination or similar act).

The Company evaluated authoritative guidance for accounting for the Convertible Loan and concluded that the Convertible Loan should be accounted for at fair value under ASC 480, Distinguish Liabilities from Equity, due to the fact that the Convertible Loan will predominately be settled with the Company’s Common Stock. Consequently, the Company recorded the Convertible Loan in its entirety at fair value on its condensed consolidated balance sheet, with changes in fair value recorded as other income (expenses) in the condensed consolidated statements of operations during each reporting period.

17

The Company recognized gains of $6.9 million and losses of $15.8 million as the change in fair value of the Convertible Loan for the three months ended September 30, 2024 and 2023, and gains of $17.3 million and losses of $13.0 million for the nine months ended September 30, 2024 and 2023, respectively.

8. Term Debt

On July 10, 2023, the Company entered into the 2023 Credit Agreement. The 2023 Credit Agreement provides for the 2023 Loan, a secured term loan facility in an aggregate amount of $25.0 million at an interest rate of 14.0% per annum and has a maturity date of January 10, 2025. Principal and accrued interest are payable at maturity. Repayment of the 2023 Loan is guaranteed by the Company’s domestic subsidiaries, and the 2023 Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

The 2023 Loan was initially recognized at fair value of $21.2 million and subsequently recognized at the amortized cost net of debt issuance costs and debt discount. Debt issuance costs and debt discount in the amounts of $0.1 million and $3.8 million, respectively, are amortized using the effective interest method to interest expense over the term of the 2023 Loan. The 2023 Loan’s annual effective interest rate was 27.31% as of September 30, 2024.

On November 12, 2024, the Company executed an amendment to the 2023 Credit Agreement, which, among other things, extended the 2023 Loan maturity date to January 10, 2026.

On March 4, 2024, the Company entered into the 2024 Credit Agreement. The 2024 Credit Agreement provides for the 2024 Loan, a secured term loan facility in an aggregate amount of $35.0 million at an interest rate of 14.0% per annum and has a maturity date of June 4, 2025. Principal and accrued interest are payable at maturity. Repayment of the 2024 Loan is guaranteed by the Company’s domestic subsidiaries, and the 2024 Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

The 2024 Loan was initially recognized at cash proceeds of $35.0 million net of debt issuance costs of $0.1 million, and subsequently is recognized at the amortized cost. Debt issuance costs are amortized using the effective interest method to interest expense over the term of the 2024 Loan. The 2024 Loan’s annual effective interest rate was 14.25% as of September 30, 2024.

The 2023 Credit Agreement and the 2024 Credit Agreement contain customary affirmative and negative covenants and representations and warranties, including financial reporting obligations and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, investments, mergers or acquisitions and fundamental corporate changes. The 2023 Credit Agreement and the 2024 Credit Agreement also include customary events of default, including payment defaults, breaches of provisions under the loan documents, certain losses or impairment of collateral and related security interests, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the 2023 Credit Agreement and the 2024 Credit Agreement, certain bankruptcy or insolvency events, and a material deviation from the Company’s operating budget.

18

9. Stockholders’ Deficit

Warrants

As of September 30, 2024, outstanding warrants to purchase shares of Common Stock were as follows:

Shares

    

Exercise Price

    

Expiration Date

993,139

$

2.87

February 11, 2025

7,717,661

$

2.87

March 27, 2025

1,867,912

$

3.25

January 26, 2026

4,285,935

$

3.25

March 16, 2026

1,807,396

$

5.00

February 8, 2027

2,692,604

$

5.00

March 30, 2027

1,200

$

1,680.00

None

19,365,847

 

  

  

Shares Reserved for Future Issuance

As of September 30, 2024, the Company had reserved shares of its Common Stock for future issuance as follows:

    

September 30, 2024

Stock options outstanding

 

3,934,731

Unvested restricted stock units

230,000

Shares issuable under the Employee stock purchase plan

 

11,890

Shares available for future grants under the 2016 Plan

 

3,219,158

Warrants outstanding

 

19,365,847

Shares issuable upon the conversion of convertible debt

22,495,614

Total shares reserved

 

49,257,240

10. Equity Incentive Plans

Stock Award Plans

The Company maintains a 2016 Equity Incentive Plan (the “2016 Plan”), which provides for the issuance of incentive share awards in the form of non-qualified and incentive stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and performance-based stock awards. As of September 30, 2024, there were 3,219,158 shares available for issuance under the 2016 Plan.

Stock option transactions during the nine months ended September 30, 2024 are presented below:

Options Outstanding

Weighted

Average

Weighted

Remaining

Average

Contractual

Aggregate

Exercise

Term

Intrinsic

    

Shares

    

Price

    

(Years)

    

Value (in thousands)

Outstanding at December 31, 2023

 

3,165,216

$

5.04

 

5.9

$

429

Granted

 

1,784,054

$

3.38

 

 

Exercised

(37,282)

$

3.38

$

24

Forfeited/Cancelled/Expired

 

(977,257)

$

7.10

 

 

Outstanding at September 30, 2024

 

3,934,731

$

3.79

 

7.8

$

15

Vested and expected to vest at September 30, 2024

 

3,934,731

$

3.79

 

7.8

$

15

Exercisable at September 30, 2024

 

2,094,287

$

4.07

 

6.6

$

3

19

The aggregate intrinsic value of options at September 30, 2024 is based on the Company’s closing stock price on that date of $2.37 per share.

Restricted stock unit awards transactions during the nine months ended September 30, 2024 are presented below:

Weighted Avg

Grant Date

    

Shares

    

Fair Value

Outstanding at December 31, 2023

200,000

$

2.39

Granted

90,000

$

3.38

Vested

(50,000)

$

2.39

Cancelled

(10,000)

$

3.38

Outstanding at September 30, 2024

230,000

$

2.73

Share-based Compensation

The Company estimates the fair value of stock options with performance and service conditions using the Black-Scholes valuation model (“Black-Scholes”). Compensation expense related to stock options granted is measured at the grant date based on the estimated fair value of the award and is recognized on the accelerated attribution method over the requisite service period.

The assumptions used in the Black-Scholes model during the three and nine months ended September 30, 2024 and 2023 are presented below.

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

   

2023

    

2024

    

2023

Risk-free interest rate

0%-0%

5.49%-5.54%

4.24%-4.25%

3.54% - 5.54%

Expected volatility

0% - 0%

75.40%-116.96%

89.4%-92.5%

75.40%-116.96%

Expected term (in years)

0 - 0

0.1-0.6

5.1-7.0

0.1-7.0

Expected dividend yield

0%

0%

0%

0%

The table below summarizes the total share-based compensation expense included in the Company’s condensed consolidated statements of operations for the periods presented (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

Research and development

$

323

$

144

$

698

$

948

General and administrative

 

347

 

(517)

 

1,841

 

(203)

Total stock-based compensation

$

670

$

(373)

$

2,539

$

745

As of September 30, 2024, there was $3.0 million of total unrecognized compensation expense related to unvested stock options and restricted stock units, which the Company expects to recognize over the weighted average remaining period of approximately 1.9 years.

11. Income Taxes

The Company did not record a provision or benefit for income taxes during the three and nine months ended September 30, 2024 and 2023. The Company expects to generate net taxable losses and continues to maintain a full valuation allowance against all of its deferred tax assets.

12. Commitments and Contingencies

Operating Leases

The Company leases office and research and development space under a non-cancelable operating lease in Marina del Rey, CA. The lease commenced on January 1, 2012 and was amended in April 2020 to, among other things, extend the lease term through December 31, 2031 (the “2020 Lease Amendment”). Annual base rent is from $1.9 million and increases by 3% annually and will be $2.5 million by the end of the amended term.

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Concurrent with the Company’s execution of the 2020 Lease Amendment, an irrevocable letter of credit in the amount of $1.2 million was delivered to the landlord. Starting on February 1, 2022, and each year thereafter, the letter of credit will be reduced by 20% of the then outstanding amount. As of September 30, 2024, the letter of credit was $0.5 million.

On October 28, 2021, the Company entered into a lease for office and research and development space under a non-cancellable lease in Los Angeles, CA (the “2021 Lease”). The 2021 Lease payment start date was May 1, 2022 and the total lease term is for 16 years and runs through 2038. Monthly rent for 2022 and 2023 was fully or partially abated while the lessor and the Company completed planned tenant improvements to the facility. Base monthly rent is approximately $0.3 million in 2024. The Company was entitled to and fully received an allowance for tenant improvements of $7.2 million, as of September 30, 2024. The Company is responsible for construction costs over such allowance. Out-of-pocket expenses to be incurred by the Company are considered noncash lease payments, and included in the lease liability and right-of-use asset when the amount can be reasonably estimated.

In connection with the execution of the 2021 Lease, the Company delivered an irrevocable standby letter of credit in the amount of $5.0 million to the landlord in 2022.

Future minimum annual lease payments under the Company’s noncancelable operating leases as of September 30, 2024 are as follows (in thousands):

    

Operating

Leases

2024 (remaining three months)

 

$

836

2025

5,139

2026

5,293

2027

5,452

2028

5,616

Thereafter

43,779

Total minimum lease payments

66,115

Less: amount representing interest

(33,192)

Present value of operating lease obligations

32,923

Less: current portion

(4,994)

Noncurrent operating lease obligations

$

27,929

Operating lease expenses were $2.0 million and $2.1 million for the three months ended September 30, 2024 and 2023, and $6.3 million and $5.7 million for the nine months ended September 30, 2024 and 2023, respectively. Variable costs related to operating expenses and taxes, which are recognized as incurred, were $0.4 million and $0.5 million for the three months ended September 30, 2024 and 2023, and $1.4 million and $0.9 million for the nine months ended September 30, 2024 and 2023, respectively.

The following table summarizes supplemental cash flow information related to the Company’s operating leases for the nine months ended September 30, 2024 and 2023 (in thousands):

Nine Months Ended September 30, 

2024

    

2023

Cash paid for amounts included in the measurement of lease liabilities:

Operating cash flows from operating leases

$

2,006

$

3,223

The following table summarizes the weighted-average remaining lease term and weighted-average discount rate related to the Company’s operating leases as of September 30, 2024 and December 31, 2023:

September 30, 2024

December 31, 2023

Weighted-average remaining lease term, years

11.97

12.79

Weighted-average discount rate, %

13.9

13.9

21

Legal Proceedings

From time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that there is adequate insurance to cover many different types of liabilities, the Company’s insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the Company’s consolidated results of operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our consolidated results of operations or financial position.

13. Grant and Awards

MTEC Grant

On June 15, 2020, the Company entered into a Research Project Award agreement (the “MTEC Agreement”) with MTEC, pursuant to which the Company received a $15.0 million grant and entered into a three-year program administered by the U.S. Department of Defense through MTEC managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. On September 29, 2022, the MTEC Agreement was modified to increase the total award by $1.3 million to $16.3 million and extend the term into the third quarter of 2024. In July 2024, the MTEC Agreement was modified to increase the total award by $5.3 million to a total of $21.6 million and extend the term into the third quarter of 2025. The MTEC funds are to partially fund a Phase 1b/2a, randomized, double-blind, placebo-controlled, dose escalation clinical study of the Company’s therapeutic phage-based candidate, AP-SA02, for the treatment of complicated Staphylococcus aureus bacteremia infections. The MTEC Agreement specifies that the grant will be paid to the Company over the term of the award through a cost reimbursable model, based on agreed upon cost share percentages, and the grant money received is not refundable to MTEC.

Upon license or commercialization of intellectual property developed with the funding from the MTEC Agreement, additional fees will be due to MTEC. The Company will elect whether to (a) pay a fixed royalty amount, which is subject to a cap based upon total funding received, or (b) pay an additional assessment fee, which would also be subject to a cap based upon a percentage of total funding received.

The MTEC Agreement is effective through August 15, 2025. The MTEC Agreement may be terminated in whole or in part 30 calendar days following written notice from the Company to MTEC. In addition, MTEC has the right to terminate the MTEC Agreement upon material breach by the Company.

The Company determined that the MTEC Agreement is not in the scope of ASC 808 or ASC 606. Applying ASC 606 by analogy, the Company recognizes proceeds received under the MTEC Agreement as grant revenue in the statement of operations when related costs are incurred. The Company recognized $3.0 and $3.9 million in grant revenue from the MTEC Agreement during the three and nine months ended September 30, 2024, respectively. As of March 31, 2024, the Company recognized the entire $16.3 million award as grant revenue. The Company has and will recognize additional grant revenue of $5.3 million from July 2024 until the full amount is utilized. The Company recognized $1.2 million and $3.0 million in grant revenue from the MTEC Agreement during the three and nine months ended September 30, 2023. As of September 30, 2024, and December 31, 2023, the Company had $1.6 million and $1.5 million as awards receivable from MTEC, respectively.

CFF Therapeutics Development Award

On March 13, 2020, the Company entered into an award agreement (the “Award Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), pursuant to which the Company received a Therapeutics Development Award of up to $5.0 million (the “CFF Award”). The CFF Award was used to fund a portion of the Company’s Phase 1b/2a clinical trial of the Pseudomonas aeruginosa (“P. aeruginosa”) phage candidate, AP-PA02, as a treatment for Pseudomonas airway infections in people with cystic fibrosis (“CF”).

22

The first payment under the Award Agreement, in the amount of $1.0 million, became due upon signing the Award Agreement and was received in April 2020. The remainder of the CFF Award was payable to the Company incrementally in installments upon the achievement of certain milestones related to the development program and progress of the Phase 1b/2a clinical trial of AP-PA02, as set forth in the Award Agreement. The total amount of the CFF award was recognized through December 2023 and no additional payments are expected.

If the Company ceases to use commercially reasonable efforts directed to the development of AP-PA02, or any other Product (as defined in the Award Agreement), for a period of 360 days (an “Interruption”) and fails to resume the development of the Product after receiving from CFF notice of an Interruption, then the Company must either repay the amount of the CFF Award actually received by the Company, plus interest, or grant to CFF (1) an exclusive (even as to the Company), worldwide, perpetual, sublicensable license under technology developed under the Award Agreement that covers the Product for use in treating infections in CF patients (the “CF Field”), and (2) a non-exclusive, worldwide, perpetual, sublicensable license under certain background intellectual property covering the Product, to the extent necessary to commercialize the Product in the CF Field.

Upon commercialization by the Company of any Product, the Company will owe a fixed royalty amount to CFF, which is to be paid in installments determined, in part, based on commercial sales volumes of the Product. The Company will be obligated to make an additional fixed royalty payment upon achieving specified sales milestones. The Company may also be obligated to make a payment to CFF if the Company transfers, sells or licenses the Product in the CF Field, or if the Company enters into a change of control transaction.

The term of the Award Agreement commenced on March 10, 2020 and expires on the earlier of the date on which the Company has paid CFF all of the fixed royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier termination of the Award Agreement. Either CFF or the Company may terminate the Award Agreement for cause, which includes the Company’s material failure to achieve certain development milestones. The Company’s payment obligations survive the termination of the Award Agreement.

The Company concluded that the CFF Award is in the scope of ASC 808. Accordingly, as discussed in Note 3, the Company recognizes the award upon achievement of certain milestones as credits to research and development expenses. No credits to research and development expenses were recognized during the three and nine months ended September 30, 2024 and 2023, respectively, related to the CFF Award. In addition, the Company concluded under the guidance in ASC 730 that it does not have an obligation to repay funds received once related research and development expenses are incurred.

23

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 in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report, and our audited financial statements and notes thereto as of and for the year ended December 31, 2023 included in our Annual Report on Form 10-K filed on March 21, 2024 with the U.S. Securities and Exchange Commission (the “SEC”).

Our common stock, par value $0.01 per share (the “Common Stock”) is traded on the NYSE American exchange under the symbol “ARMP.” We are currently headquartered in Los Angeles, CA, and we have a research and development facility for product development to support advancing phage products from the bench to the clinic. In addition to microbiology, synthetic biology, formulation, chemistry and analytical laboratories, the facility is equipped with two licensed current good manufacturing practice (“cGMP”) drug manufacturing suites enabling the production, testing and release of clinical trial material.

Statements contained in this Quarterly Report that are not statements of historical fact are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements concerning product development plans, commercialization of our products, the expected market opportunity for our products, the use of bacteriophages and synthetic phages to kill bacterial pathogens, having resources sufficient to fund our operations into the first quarter of 2025, future funding sources, general and administrative expenses, clinical trial and other research and development expenses, costs of manufacturing, costs relating to our intellectual property, capital expenditures, the expected benefits of our targeted phage therapies strategy, the potential market for our products, tax credits and carry-forwards, and litigation-related matters. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These statements are subject to risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed on March 21, 2024 with the SEC, and under Item 1A, “Risk Factors” and elsewhere in this Quarterly Report. These forward-looking statements speak only as of the date on which they were made, and we undertake no obligation to update any forward-looking statements.

Overview

We are a clinical-stage biotechnology company focused on the development of high purity, pathogen-specific bacteriophage therapeutics for the treatment of chronic pulmonary diseases exacerbated by concurrent bacterial infection with antibiotic-resistant and difficult-to-treat bacteria using our proprietary bacteriophage-based technology. We see bacteriophages as a potentially safer and effective alternative to antibiotics and an essential response to the growing bacterial resistance to current classes of antibiotics. Bacteriophages or “phages” have a powerful and highly differentiated mechanism of action that enables binding to and killing of specific targeted bacteria while uniquely preserving the normal human microbiome or “healthy bacteria”. This is in direct contrast to traditional broad-spectrum antibiotics which can alter the human microbiome increasing susceptibility to opportunistic pathogens, such as C. difficile. We believe that phages represent a promising means to effectively treat bacterial infections as an alternative to broad-spectrum antibiotics, especially for patients with bacterial infections resistant to current standard of care therapies, including the multidrug-resistant or “superbug” strains of bacteria. We are a leading developer of clinical-stage phage therapeutics of high purity, and believe we are uniquely positioned to address the growing worldwide threat of antibiotic-resistant bacterial infections. We have completed three critical Phase 2 trials, two of which were completed this year, utilizing two distinct phage cocktails against two different pathogens with the potential to treat chronic pulmonary disease complicated by bacterial infection, as well as acute systemic bacterial infections. We believe we are on a critical pathway towards pivotal Phase 3 clinical studies.

We are combining our proprietary approach and expertise in identifying, characterizing and developing both naturally occurring and engineered (synthetic) bacteriophages with our proprietary phage-specific host-engineered

24

cGMP manufacturing capabilities to advance a target pipeline of high-quality bacteriophage product candidates for late-stage clinical development. We have improved our manufacturing processes by significantly increasing phage titers and improving production efficiency with the goal of ensuring commercial viability. We believe that we are uniquely advancing two lead candidates to address both chronic and acute bacterial infections.

Our first lead phage candidate, inhaled AP-PA02, is focused primarily on the treatment of chronic pulmonary infections with P. aeruginosa. On October 14, 2020, we received the approval to proceed from the U.S. Food and Drug Administration (the “FDA”) for our Investigational New Drug (“IND”) application for AP-PA02. In the first quarter of 2023, we announced positive topline results from the completed “SWARM-P.a.” study – a Phase 1b/2a, multicenter, double-blind, randomized, placebo-controlled, single ascending dose and multiple ascending dose clinical trial to evaluate the safety and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis and chronic pulmonary P. aeruginosa infection. Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event profile similar to placebo. Pharmacokinetics findings confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure, with single ascending doses and multiple ascending doses resulting in a proportional increase in exposure as measured in induced sputum. AP-PA02 exposures were generally consistent across subjects. Additionally, bacterial levels of P. aeruginosa in the sputum measured at several timepoints suggest improvement in bacterial load reduction for subjects treated with AP-PA02 at the end of treatment as compared to placebo after ten days of dosing. In addition, a correlation was seen between increasing phage dose (higher AP-PA02 exposures) and reduction in the bacterial load, supporting the biologic plausibility of a bacterial specific mechanism of action and creating the opportunity for phage as a therapeutic alternative to inhaled antibiotics. This study was supported by the CFF, which granted us a Therapeutics Development Award of $5.0 million. As of September 30, 2024, we received the full award’s amount, including the final payment of $0.3 million in January 2024. Following the promising Phase 1b/2a results of favorable safety and tolerability profile and plausible mechanism of action, an additional confirmatory Phase 2 trial was initiated in non-cystic fibrosis Bronchiectasis (“NCFB”) patients with similar chronic pulmonary disease with infections due to P. aeruginosa.

On February 22, 2022, we announced FDA approval to proceed with our IND application for inhaled AP-PA02, in a second indication, NCFB. We initiated a Phase 2 trial (“Tailwind”) in NCFB in 2022 and reported first patient dosing in the first quarter of 2023. The “Tailwind” study is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 phage therapeutic in subjects with NCFB and chronic pulmonary P. aeruginosa infection. The trial design included two cohorts in order to analyze AP-PA02 as monotherapy as well as AP-PA02 in combination with inhaled antibiotics. One cohort enrolled subjects not on chronic inhaled antibiotics, randomized to receive either inhaled AP-PA02 or placebo. The other cohort enrolled subjects on chronic inhaled antibiotics, randomized to receive either inhaled AP-PA02 plus their chronic inhaled antibiotic or placebo plus their chronic inhaled antibiotic. The aim of the study is to define a safe dose and dosing duration with promising biologic correlation in anticipation for a definitive Phase 3 trial in 2025. On July 11, 2024, we announced completion of enrollment of the Phase 2 Tailwind Study. The last patient final follow-up visit took place on August 7, 2024. We anticipate topline data from the Tailwind study by the end of 2024, followed by potential initiation of a pivotal bronchiectasis trial in 2025 in which we plan to evaluate inhaled AP-PA02 as an alternative to inhaled antibiotics in chronic pulmonary P. aeruginosa infections in subjects with NCFB. As there are no FDA approved anti-infective treatments for NCFB, a definitive pivotal placebo-controlled trial is plausible, providing a pathway to commercialization for chronic pulmonary diseases with concurrent chronic bacterial infection, pending positive clinical trial results.

In parallel, we have an acute bacterial infection clinical development plan focused on Staphylococcus aureus (“S. aureus”) bacteremia, a difficult-to-treat and often life-threatening human infection that can result in high morbidity and mortality and for which bacterial resistance to antibiotics is growing.

A key advantage of our phage manufacturing expertise is the purity profiles of our phage products, including AP-SA02, our phage product candidate for S. aureus; this has enabled us to pursue treatment of complicated S. aureus bacteremia, where repetitive intravenous dosing is required. On June 15, 2020, we entered into an agreement (the “MTEC Agreement”) with the Medical Technology Enterprise Consortium (“MTEC”), pursuant to which we received a $15.0 million grant and entered into a multi-year program administered by the U.S Department of Defense through MTEC and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. On September

25

29, 2022, the MTEC Agreement was modified to increase the total award by $1.3 million to $16.3 million and extend the term into the second half of 2024. In July 2024, the MTEC Agreement was modified to increase the total award by $5.3 million to $21.6 million and extend the term into the third quarter of 2025. The grant is being used to partially fund a Phase 1b/2a, multi center, randomized, double-blind, placebo-controlled dose escalation study that will assess the safety, tolerability and efficacy of our phage-based candidate, AP-SA02, for the treatment of adults with S. aureus (“diSArm” study).

On November 17, 2021, we announced that we had received approval from the FDA to proceed with our IND application for AP-SA02. Since dosing the first patient in the Phase 2a portion of the study on September 26, 2023, we have focused on accelerating enrollment of the diSArm study, evaluating safety with higher intravenous doses, which is possible due to the high purity of our phage product candidates. The high purity of our phages has allowed us to dose escalate to 5E10 PFU every six hours (2E11 PFU every 24 hours) for five days without clinically significant adverse events. In parallel with dose escalation, the evolution of two distinct blinded subsets of subjects receiving phage has been observed. One subset, comprising approximately half of the treated group, has evidence of persistence of detectable phage in the blood providing early evidence of in vivo phage amplification and resultant release of phage progeny. On November 12, 2024, we announced the completion of enrollment of the Phase 1b/2a diSArm study. We anticipate topline data from the diSArm study in the first quarter of 2025 where we can explore the two aforementioned subsets in an unblinded manner. We are committed to developing a pivotal S. aureus bacteremia trial in 2025 to evaluate the intravenous phage product candidate, AP-SA02, as an adjunct to standard of care broad-spectrum antibiotics and/or potentially as an alternative to broad-spectrum antibiotics, which would decrease the utilization of broad-spectrum antibiotics and their detrimental impact on the healthy human microbiome.

On August 1, 2022, we announced FDA approval to proceed with our IND application for AP-SA02 in a second indication, prosthetic joint infections (“PJI”) with S. aureus. We had planned to initiate a Phase 1b/2a trial in 2023; however, in light of the growing concerns of both PJI and wound infection, we are planning to revise the protocol to include both indications. Driven by data from the bacteremia study, and with sufficient funding, we may in the future initiate a Phase 1b/2a trial to assess the safety and tolerability of intravenous and intra-articular AP-SA02 as an adjunct to standard of care antibiotics in adults undergoing treatment of periprosthetic joint infections and/or wound infections caused by S. aureus.

We remain committed to conducting randomized controlled clinical trials required for FDA approval in order to move towards the commercialization of our phage products as alternatives and/or reinforcements to traditional antibiotics, providing a potential safe and effective method of treating patients suffering from drug-resistant and difficult-to-treat bacterial infections.

The following chart summarizes the status of our phage product candidate development programs and partners.

Graphic

We have incurred net losses since our inception and our operations to date have been primarily limited to research and development and raising capital. As of September 30, 2024, we had an accumulated deficit of $330.3 million. We currently expect to use our existing cash and cash equivalents for the focused research and development of our current product candidates and for working capital and other general corporate purposes. We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on completing the development of and

26

seeking to obtain regulatory approval for our product candidates. We do not expect to generate product revenue unless and until we successfully complete development and obtain marketing approval for at least one of our product candidates. We may also use a portion of our existing cash and cash equivalents for the potential acquisition of, or investment in, product candidates, technologies, formulations or companies that complement our business, although we have no current understandings, commitments or agreements to do so.

Our existing cash and cash equivalents of $17.1 million as of September 30, 2024 will not be sufficient to enable us to complete all necessary development of any potential product candidates. Accordingly, we will be required to obtain further funding through one or more other public or private equity offerings, debt financings, collaboration, strategic financing, grants or government contract awards, licensing arrangements or other sources. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and potential disruptions to, and volatility in, financial markets in the United States and worldwide. Adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed or on acceptable terms, we may be required to defer, reduce or eliminate significant planned expenditures, restructure, curtail or eliminate some or all of our development programs or other operations, dispose of assets, enter into arrangements that may require us to relinquish rights to certain of our product candidates, technologies or potential markets, file for bankruptcy or cease operations altogether. Any of these events could have a material adverse effect on our business, financial condition and results of operations and result in a loss of investment by our stockholders.

Recent Events

MTEC Agreement Modification

In July 2024, we amended the MTEC Agreement and increased the amount of the award by $5.3 million to a total of $21.6 million. We will recognize an increase in grant revenue from the third quarter of 2024 until the full amount of the amended award is utilized.

Debt

On November 12, 2024, we amended the Convertible Credit Agreement and the 2023 Credit Agreement, among other things, to extend the maturity dates of the Convertible debt and 2023 Loan from January 10, 2025 to January 10, 2026.

27

Results of Operations

Comparison of three and nine months ended September 30, 2024 and 2023 (in thousands):

Three Months Ended

Change

    

September 30, 2024

    

September 30, 2023

    

Amount

    

%

Grant revenue

$

2,973

$

1,225

$

1,748

142.7%

Operating expenses

Research and development

 

9,485

7,978

 

1,507

18.9%

General and administrative

 

3,244

3,583

 

(339)

(9.5%)

Total operating expenses

12,729

11,561

1,168

10.1%

Loss from operations

 

(9,756)

 

(10,336)

 

580

 

(5.6%)

Other income (expense)

 

  

 

  

 

  

 

  

Interest income

294

47

 

247

 

525.5%

Interest expense

(2,923)

(1,176)

(1,747)

148.6%

Change in fair value of convertible debt

6,904

(15,833)

22,737

(143.6%)

Loss on convertible debt extinguishment

(3,863)

3,863

(100.0%)

Total other income (expense), net

 

4,275

 

(20,825)

 

25,100

 

*

Net loss

$

(5,481)

$

(31,161)

$

25,680

 

(82.4%)

*Not meaningful

Nine Months Ended September 30, 

Change

    

2024

    

2023

    

Amount

    

%

Grant revenue

$

3,939

$

3,001

$

938

31.3%

Operating expenses

Research and development

 

25,975

25,842

 

133

0.5%

General and administrative

 

9,861

8,470

 

1,391

16.4%

Total operating expenses

35,836

34,312

1,524

4.4%

Loss from operations

 

(31,897)

 

(31,311)

 

(586)

 

1.9%

Other income (expense)

 

  

 

  

 

  

 

  

Interest income

567

111

 

456

 

*

Interest expense

(7,462)

(1,176)

(6,286)

534.5%

Change in fair value of convertible debt

17,276

(12,959)

30,235

(233.3%)

Loss on convertible debt extinguishment

(3,863)

3,863

(100.0%)

Total other income (expense), net

 

10,381

 

(17,887)

 

28,268

 

*

Net loss

$

(21,516)

$

(49,198)

$

27,682

 

(56.3%)

*Not meaningful

Grant Revenue

Our grant revenue represents MTEC’s share of the costs incurred for our AP-SA02 program for the treatment of S. aureus. The full amount of the MTEC award of $16.3 million was utilized as of March 31, 2024. In July 2024, we amended the MTEC agreement and increased the amount of the award by $5.3 million to a total of $21.6 million. We recognized $3.0 and $1.2 million of grant revenue during the three months ended September 30, 2024 and 2023, respectively, and $3.9 million and $3.0 million during the nine months ended September 30, 2024 and 2023, respectively, related to the MTEC award.

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Research and Development

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Three Months Ended

Change

    

September 30, 2024

    

September 30, 2023

    

Amount

    

%

External costs:

Clinical trials

$

3,244

$

2,518

$

726

28.8%

Other research and development costs, including laboratory materials and supplies

958

1,144

(186)

(16.3%)

Total external costs

 

4,202

3,662

 

540

14.7%

Internal costs:

 

 

Personnel-related costs

2,874

2,145

729

34.0%

Facilities and overhead costs

 

2,409

 

2,171

 

238

 

11.0%

Total research and development expense:

$

9,485

$

7,978

$

1,507

 

18.9%

Nine Months Ended September 30, 

Change

    

2024

    

2023

    

Amount

    

%

External costs:

Clinical trial expenses

$

7,623

$

7,060

$

563

8.0%

Other research and development costs, including consulting, laboratory supplies and other

2,734

3,466

(732)

(21.1%)

Total external costs

 

10,357

10,526

 

(169)

(1.6%)

Internal costs:

 

 

Personnel-related costs

8,296

8,164

132

1.6%

Facilities and overhead costs

 

7,322

 

7,152

 

170

 

2.4%

Total research and development expense:

$

25,975

$

25,842

$

133

 

0.5%

Research and development expenses increased by $1.5 million, from $8.0 million for the three months ended September 30, 2023 to $9.5 million for the three months ended September 30, 2024.

Research and development expenses totaled $25.8 million for the nine months ended September 30, 2024, remaining virtually unchanged compared with the same period in 2023 despite an increase in research and development activities due to increasing efficiencies.

Clinical trial costs increased by $0.7 million, from $2.5 million for the three months ended September 30, 2023, to $3.2 million for the three months ended September 30, 2024. The increase is primarily attributable to a $1.0 million increase in AP-PA02 NCFB trial costs and an additional $0.2 million increase in Bacteremia trial costs due to the increase in the number of enrolled patients, patient visits, and active sites increase in both trials since the second half of 2023. Also, the increase is due in part to achieving clinical contract research organization (“CRO”) milestones ahead of schedule, resulting increase in associated CRO expenses. The increase was partially offset by a decrease of $0.3 million in AP-PA02 CF study costs, as most activities under the trials were completed in 2023.

Clinical trial costs increased by $0.5 million, from $7.1 million for the nine months ended September 30, 2023, to $7.6 million for the nine months ended September 30, 2024. The increase is primarily due to an increase of $2.5 million in the AP-PA02 NCFB trial costs, offset by a decrease of $1.2 million in AP-PA02 CF trial costs, $0.4 million in Bacteremia trial costs and $0.2 million in AP-SA02 PJI trial costs. The AP-PA02 CF trial is substantially completed and study reconciliation is in process. The PJI trial is currently on hold, and we may in the future initiate a Phase 1b/2a trial to assess the safety and tolerability of combined intravenous and intra-articular AP-SA02. Bacteremia trial costs decreased due to a credit of $0.8 million received from a clinical research organization, offset by an increase of $0.4

29

million during the nine months ended September 30, 2024 compared to the same period in 2023. The AP-PA02 NCFB trial costs increased as the number of enrolled patients, patient visits, and active sites increased from the second half of 2023 through July 2024, when we completed patients’ enrollment for NCFB study.

Other external research and development costs decreased by $0.1 million from $1.1 million for the three months ended September 30, 2023, to $1.0 million for the three months ended September 30, 2024. The decrease was primarily due to a decrease of $0.1 million in consulting expenses.

Other external research and development costs decreased by $0.8 million from $3.5 million for the nine months ended September 30, 2023, to $2.7 million for the nine months ended September 30, 2024. The decrease was primarily due to a decrease of $0.5 million in consulting expenses and $0.3 million decrease in outsourced service costs.

Our expenses by product and by project for the three and nine months ended September 30, 2024 and 2023 were as follows (in thousands):

Three Months Ended

September 30, 2024

    

September 30, 2023

Product

Project name

AP-PA02

Non-Cystic Fibrosis Bronchiectasis

$

1,858

$

954

AP-PA02

Cystic Fibrosis

520

AP-SA02

Bacteremia

1,618

1,468

AP-SA02

Prosthetic Joint Infection

(217)

Expenses not allocated by projects*

726

937

Total external costs

 $

4,202

 $

3,662

Nine Months Ended September 30, 

2024

    

2023

Product

Project name

AP-PA02

Non-Cystic Fibrosis Bronchiectasis

$

5,459

$

3,016

AP-PA02

Cystic Fibrosis

235

1,879

AP-SA02

Bacteremia

2,752

3,006

AP-SA02

Prosthetic Joint Infection

8

243

Expenses not allocated by projects*

1,903

2,382

Total external costs

 $

10,357

 $

10,526

* Expenses not allocated by projects include consultants, lab supplies and outsourced services expenses.

Personnel-related costs, including employee payroll and related expenses, increased by $0.8 million, from $2.1 million for the three months ended September 30, 2023 to $2.9 million for the three months ended September 30, 2024. This increase was mainly driven by a $0.3 million increase in stock-based compensation expense, which was primarily due to options granted in March 2024, 2024 a mid-year bonus payments of $0.2 million, and an increase of $0.3 million in other personnel-related costs, offset by a $0.1 million decrease in severance costs.

Personnel-related costs, including employee payroll and related expenses, increased by $0.1 million, from $8.2 million for the nine months ended September 30, 2023 to $8.3 million for the nine months ended September 30, 2024. This increase was mainly driven by 2024 mid-year bonus payments of $0.2 million, severance payments of $0.2 million, and an increase of $0.2 million in other personnel-related costs offset by $0.3 million lower stock-based compensation expense (as there were no expenses related to the equity awards that fully vested after September 30, 2023) and $0.2 million payroll related costs reduction.

Facilities and overheads costs increased by $0.2 million, from $2.2 million for the three months ended September 30,2023 to $2.4 million for the three months ended September 30, 2024 mainly due to an increase in facilities maintenance costs.

30

Facilities and overheads costs increased by $0.1 million, from $7.2 million for the nine months ended September 30,2023 to $7.3 million for the nine months ended September 30, 2024 mainly due to an increase in facilities maintenance costs.

General and Administrative

General and administrative expenses were $3.2 million and $3.6 million for the three months ended September 30, 2024 and 2023, respectively. The decrease of $0.4 million is primarily related to a decrease of $1.0 million in professional services during the third quarter of 2024 as we continue to achieve efficiencies with in-house hires, offset by a $0.6 million increase in personnel expenses, including stock-based compensation.

General and administrative expenses were $9.9 million and $8.5 million for the nine months ended September 30, 2024 and 2023, respectively. The increase of $1.4 million is primarily related to an increase of $2.0 million in stock-based compensation expenses due to stock-based awards granted during the first quarter of 2024, increase in lease expenses of $0.3 million and an increase of $0.3 million in other facilities and overhead expenses, offset by a decrease of $1.1 million in professional and legal, accounting and other consulting expenses, and a decrease of $0.2 million in payroll and related costs.

Interest Income

Interest income for the three months ended September 30, 2024 and 2023 was $0.3 million and less than $0.1 million, respectively, and related to interest income on our money market fund investments.

Interest income for the nine months ended September 30, 2024 and 2023 was $0.6 million and $0.1 million, respectively, and related to interest income on our money market fund investments.

Interest Expense

We recognized interest expense of $2.9 million and $1.2 million for the three months ended September 30, 2024 and 2023, related to the interest expenses and the amortization of debt discount and issuance costs for the 2023 Loan and 2024 Loan received from Innoviva in July 2023 and March 2024, respectively. Stated interest is accrued and is payable at the maturity of the 2023 Loan and the 2024 Loan in 2025.

We recognized interest expense of $7.5 million and $1.2 million for the nine months ended September 30, 2024 and 2023, related to the interest expenses and the amortization of debt discount and issuance costs for the 2023 Loan and 2024 Loan received from Innoviva in July 2023 and March 2024, respectively. Stated interest is accrued and is payable at the maturity of the 2023 Loan and the 2024 Loan in 2025.

Change in Fair Value of Convertible Debt

We recognized a gain on change in the fair value of the Convertible Loan for the three months ended September 30, 2024 of $6.9 million. The gain of $6.9 million is primarily attributable to the decrease in our Common Stock price in the three months ended September 30, 2024. We recognized a loss of $15.8 million for three months ended September 30, 2023, which is primarily due to the increase in our Common Stock price in the three months ended September 30, 2023.

We recognized a gain on change in the fair value of the Convertible Loan for the nine months ended September 30, 2024 of $17.3 million and a loss of $13.0 million for the nine months ended September 30, 2023. Such fluctuations in fair values are primarily attributable to the changes in our estimated probabilities of various settlement scenarios, changes in our Common Stock price, remaining loan term and changes in volatilities. The Convertible Loan received from Innoviva in January 2023 and amended in July 2023 is accounted for at fair value using a weighted probability of various settlement scenarios of the Convertible Loan during its term discounted to each reporting date. Conversion option scenarios are valued using an option pricing model with significant assumptions and estimates such as volatility, expected term and risk-free interest rates.

31

Loss on Convertible Debt Extinguishment

We recognized a loss on convertible debt extinguishment for both three and nine months ended September 30, 2023 of $3.9 million which relates to the amendment to the Convertible Loan on July 10, 2023. The amendment was accounted for as an extinguishment in the third quarter of 2023.

Liquidity, Capital Resources and Financial Condition

We have incurred net losses since our inception and have negative operating cash flows. Our cash and cash equivalents of $17.1 million as of September 30, 2024 will not be sufficient to fund our operations for the next 12 months from the date of issuance of our condensed consolidated financial statements for the nine months ended September 30, 2024. We plan to control our expenses and to raise additional capital through a combination of public and private equity, debt financings, strategic alliances, and grant arrangements. These circumstances raise substantial doubt about our ability to continue as a going concern. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are not entirely within its control and cannot be assessed as being probable of occurring. We may not be able to secure additional financing in a timely manner or on favorable terms, if at all.

During the year ended December 31, 2023, we received the Convertible Loan in the aggregate amount of $30.0 million and the 2023 Loan in the aggregate amount of $25.0 million from Innoviva. The Convertible Loan and the 2023 Loan mature in January 2025, and principal and accrued interest are payable at maturity. The Convertible Loan provides for various conversion and repayment options, including the conversion of principal and accrued interest into shares of our Common Stock upon a Qualified Financing and the Company’s option to repay the Convertible Loan prior to maturity.

On March 4, 2024, we entered into the 2024 Credit Agreement for the 2024 Loan in an aggregate amount of $35.0 million with Innoviva. Concurrently with the execution of the 2024 Loan, we amended certain provisions of the Convertible Credit Agreement and the 2023 Credit Agreement to, among other things, conform certain terms relating to permitted indebtedness and permitted liens. The 2024 Loan bears interest at an annual rate of 14% and matures in June 2025. Principal and accrued interest are payable at maturity.

In July 2024, we amended the MTEC Agreement and increased the amount of the award by $5.3 million to a total of $21.6 million. We will recognize grant revenue from the third quarter of 2024 until the full amount of the amended award is utilized.

On November 12, 2024, we amended the Convertible Credit Agreement and the 2023 Credit Agreement, among other things, to extend the maturity dates of the Convertible debt and 2023 Loan from January 10, 2025 to January 10, 2026.

Future Capital Requirements

We will need to raise additional capital in the future to continue to fund our operations. Our future funding requirements will depend on many factors, including:

the costs and timing of our research and development activities;

the progress and cost of our clinical trials and other research and development activities;

manufacturing costs associated with our targeted phage therapies strategy and other research and development activities;

the costs and timing of seeking regulatory approvals;

32

the costs of filing, prosecuting and enforcing any patent applications, claims, patents and other intellectual property rights; and

the costs of potential lawsuits involving us or our product candidates.

We may seek to raise capital through a variety of sources, including:

the public equity market;
private equity financings;
collaborative arrangements;
government grants; or
strategic financing.

Any additional fundraising efforts may divert our management team from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Our ability to raise additional funds will depend, in part, on the success of our product development activities, including our targeted phage therapies strategy and any clinical trials we initiate, regulatory events, our ability to identify and enter into in-licensing or other strategic arrangements, and other events or conditions that may affect our value or prospects, as well as factors related to financial, economic and market conditions, many of which are beyond our control. We cannot be certain that sufficient funds will be available to us when required or on acceptable terms. If we are unable to secure additional funds on a timely basis or on acceptable terms, we may be required to defer, reduce or eliminate significant planned expenditures, restructure, curtail or eliminate some or all of our development programs or other operations, dispose of technology or assets, pursue an acquisition of our company by a third party at a price that may result in a loss on investment for our stockholders, enter into arrangements that may require us to relinquish rights to certain of our product candidates, technologies or potential markets, file for bankruptcy or cease operations altogether. Any of these events could have a material adverse effect on our business, financial condition and results of operations, increase the risk of insolvency and loss of investment by our stockholders. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities could result in dilution to our existing stockholders. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the United States and worldwide.

Cash Flows

The following table summarizes our sources and uses of cash for the periods presented (in thousands):

Nine Months Ended September 30, 

2024

    

2023

Net cash used in operating activities

$

(29,624)

$

(39,317)

Net cash used in investing activities

(1,956)

(5,744)

Net cash provided by financing activities

34,958

54,031

Net increase in cash, cash equivalents and restricted cash

$

3,378

$

8,970

Cash Flows Used in Operating Activities

Net cash used in operating activities was $29.6 million and $39.3 million for the nine months ended September 30, 2024 and 2023, respectively.

33

Cash used in operating activities in the nine months ended September 30, 2024 was primarily due to our net loss for the period of $21.5 million, adjusted by non-cash items of $4.8 million and a decrease of $3.3 million in our net operating assets and liabilities. The non-cash items consist of $17.3 million related to a gain from change in fair value of convertible debt, $7.5 million of non-cash interest expense on the 2023 Loan and the 2024 Loan, $2.5 million related to stock-based compensation expense, $1.5 million related to change in right-of-use asset and $0.9 million related to depreciation and amortization expense. The decrease in our net operating assets and liabilities was primarily due to a decrease of $4.2 million in operating lease liability related to lease payments and payments for the construction of office and laboratory and manufacturing space at our new leased facility in Los Angeles, CA, a decrease of $2.0 million in accounts payable and accrued liabilities, an increase of $0.8 million in accrued compensation, and a decrease of $2.1 million in prepaid expenses and other current assets.

Cash used in operating activities in the nine months ended September 30, 2023 was primarily due to our net loss for the period of $49.2 million, adjusted by non-cash items of $20.1 million and a decrease of $10.2 million in our net operating assets and liabilities. The non-cash items consist of $13.0 million related to a loss from change in fair value of convertible debt, $3.9 million related to a loss on convertible debt extinguishment, $1.2 million of non-cash interest expense on the 2023 Loan, $0.7 million related to stock-based compensation expense, $0.7 million related to depreciation and amortization expense and $0.7 million related to a change in right-of-use assets. The decrease in our net operating assets and liabilities was primarily due to a decrease of $9.7 million in operating lease liability, which primarily relates to payments to the construction of office and laboratory and manufacturing space at our new leased facility in Los Angeles, CA, a decrease of $0.3 million in accounts payable and accrued liabilities, a decrease of $0.1 million in accrued compensation, partially offset by an increase of $0.1 million in prepaid expenses and other current assets.

Cash Flows Used in Investing Activities

Net cash used in investing activities was $2.0 million and $5.7 million for the nine months ended September 30, 2024 and 2023, respectively, which is attributable to purchases of laboratory and manufacturing equipment in connection with the construction of a new office, laboratory and manufacturing space at our leased facility in Los Angeles, CA.

Cash Flows from Financing Activities

Cash provided by financing activities for the nine months ended September 30, 2024 was $34.9 million, which consisted primarily of proceeds from issuance of term debt, net of issuance costs of less than $0.1 million, and proceeds from exercise of stock options of $0.1 million.

Cash provided by financing activities for the nine months ended September 30, 2023 was $54.0 million, which consisted primarily of proceeds from issuance of convertible debt, net of issuance costs of $29.1 million, proceeds from issuance of term debt, net of issuance costs of $24.9 million, and proceeds from exercise of stock options of less than $0.1 million, partially offset by less than $0.1 million of the payments for taxes related to net share settlement of equity awards.

Off-Balance Sheet Arrangements

As of September 30, 2024, we did not have off-balance sheet arrangements.

Critical Accounting Policies and Estimates

Management’s discussion and analysis of financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate estimates and assumptions, including but not limited to those related to convertible debt, stock-based compensation expense, accruals for research and development costs, lease assets and liabilities, the valuation of deferred tax assets, valuation of uncertain income tax positions, impairment of goodwill and intangible assets and impairment of

34

long-lived assets. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, 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. Actual results may differ from these estimates under different assumptions or conditions.

Refer to Note 3 to the consolidated financial statements and critical accounting policies and estimated included in our Form 10-K filed with the SEC on March 21, 2024. There were no material changes to our critical accounting policies from December 31, 2023.

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and are not required to provide the information required under this item.

Item 4. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

Under the supervision of our Chief Executive Officer (“CEO”) and Senior Vice President, Finance and Principal Financial Officer (“PFO”), we evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act (the “Exchange Act”) as of September 30, 2024. Based on that evaluation, our CEO and PFO have concluded that our disclosure controls and procedures were effective as of September 30, 2024 to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our CEO and PFO, as appropriate to allow timely discussion regarding required disclosures.

In designing and evaluating our disclosure controls and procedures, management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined by Rules 13a-15(d) and 15d-15(d) of the Exchange Act) that occurred during the nine months ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1. LEGAL PROCEEDINGS

From time to time, we are a party to certain litigation that is either judged to be not material or that arises in the ordinary course of business. We intend to vigorously defend our interests in these matters. We expect that the resolution of these matters will not have a material adverse effect on our business, financial condition or results of operations. However, due to the uncertainties inherent in litigation, no assurance can be given as to the outcome of these proceedings.

Item 1A. RISK FACTORS

Our business is subject to a number of risks, including those identified in Item 1A of Part I of our 2023 Form 10-K. There have been no material changes to the risk factors described in our 2023 Form 10-K.

35

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

None.

Item 6. EXHIBITS

Number

    

Description

3.1

Amended and Restated Articles of Incorporation of the Company, as amended (incorporated by reference to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on November 16, 2015).

3.2

Articles of Amendment to Amended and Restated Articles of Incorporation of the Company (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K (File No. 001-37544), filed with the SEC on April 24), 2017.

3.3

Statement of Correction to Articles of Amendment to Amended and Restated Articles of Incorporation of the Company (incorporated by reference to Exhibit 3.2 to the Company’s Quarterly Report on Form 10-Q, filed on November 8, 2018).

3.4

Articles of Amendment to Amended and Restated Articles of Incorporation of the registrant (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, filed with the SEC on December 18, 2018).

3.5

Articles of Amendment to Amended and Restated Articles of Incorporation of the registrant (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, filed with the SEC on May 10, 2019).

3.6

Articles of Amendment to Amended and Restated Articles of Incorporation of the registrant (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K, filed with the SEC on December 11, 2019).

3.7

Articles of Amendment to Articles of Incorporation of the Company (effective March 26, 2020) (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the SEC on March 30, 2020).

3.8

Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.5 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 14, 2019).

3.9

Amendment to Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K, filed with the SEC on December 11, 2019).

3.10

Amendment to Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the SEC on February 26, 2020).

4.1

Reference is made to Exhibits 3.1 through 3.10.

36

10.1

Employment Letter Agreement by and between Mina Pastagia, M.D. and the Company, dated as of September 22, 2020 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on July 25, 2024).

10.2

Amendment No. 1, dated as of July 22, 2024, to that certain Employment Letter Agreement by and between Mina Pastagia, M.D. and the Company, dated as of September 22, 2020 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on July 25, 2024).

10.3

Employment Letter Agreement, dated July 31, 2024, by and between Armata Pharmaceuticals, Inc. and David House (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on August 15, 2024).

10.4

Confidential Separation and Release Agreement by and between Armata Pharmaceuticals, Inc. and

Richard Rychlik dated as of September 30, 2024 (incorporated by reference to Exhibit 10.1 to the

Company’s Current Report on Form 8-K, filed with the SEC on October 3, 2024).

31.1

Certification of Principal Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a).

31.2

 

Certification of Principal Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a).

32.1

 

Certification of Principal Executive Officer Required by Rule 13a-14(b) or Rule 15d-14(b) and 18 U.S.C. 1350.

32.2

 

Certification of Principal Financial Officer Required by Rule 13a-14(b) or Rule 15d-14(b) and 18 U.S.C. 1350.

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH

 

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.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

104

Cover Page Interactive Data File Cover Page Interactive Data File (embedded within the Inline XBRL document)

The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

37

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.

ARMATA PHARMACEUTICALS, INC.

Date: November 13, 2024

By

/s/ Deborah L. Birx

Name: Deborah L. Birx, M.D.

Title: Chief Executive Officer

(Principal Executive Officer)

By

/s/ David House

Name: David House

Title: Senior Vice President, Finance and

Principal Financial Officer

(Principal Financial Officer)

38

Exhibit 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Deborah L. Birx, certify that:

1.I have reviewed this quarterly report on Form 10-Q of Armata Pharmaceuticals, 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.

Date: November 13, 2024

/s/ Deborah L. Birx

Deborah L. Birx, M.D.

Chief Executive Officer

(Principal Executive Officer)


Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, David House, certify that:

1.I have reviewed this quarterly report on Form 10-Q of Armata Pharmaceuticals, 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.

Date: November 13, 2024

/s/ David House

David House

Senior Vice President, Finance and

Principal Financial Officer

(Principal Financial Officer)


Exhibit 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

In connection with the quarterly report of Armata Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2024 as filed with the Securities and Exchange Commission (the “Report”), I, Deborah L. Birx, Chief Executive Officer of the Company, hereby certify as of the date hereof, solely for purposes of Title 18, Chapter 63, Section 1350 of the United States Code, that to the best of my knowledge:

(1)the Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, 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 at the dates and for the periods indicated.

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version 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.

This Certification has not been, and shall not be deemed, “filed” with the Securities and Exchange Commission.

Date: November 13, 2024

/s/ Deborah L. Birx

Deborah L. Birx, M.D.

Chief Executive Officer

(Principal Executive Officer)


Exhibit 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

In connection with the quarterly report of Armata Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2024 as filed with the Securities and Exchange Commission (the “Report”), I, David House, Senior Vice President, Finance and

Principal Financial Officer of the Company, hereby certify as of the date hereof, solely for purposes of Title 18, Chapter 63, Section 1350 of the United States Code, that to the best of my knowledge:

(1)the Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, 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 at the dates and for the periods indicated.

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version 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.

This Certification has not been, and shall not be deemed, “filed” with the Securities and Exchange Commission.

Date: November 13, 2024

/s/ David House

David House

Senior Vice President, Finance and

Principal Financial Officer

(Principal Financial Officer)


v3.24.3
Document And Entity Information - shares
9 Months Ended
Sep. 30, 2024
Nov. 08, 2024
Document And Entity Information [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Sep. 30, 2024  
Document Transition Report false  
Securities Act File Number 001-37544  
Entity Registrant Name ARMATA PHARMACEUTICALS, INC.  
Entity Incorporation, State or Country Code WA  
Entity Tax Identification Number 91-1549568  
Entity Address, Address Line One 5005 McConnell Avenue  
Entity Address, City or Town Los Angeles  
Entity Address, State or Province CA  
Entity Address, Postal Zip Code 90066  
City Area Code 310  
Local Phone Number 665-2928  
Title of 12(b) Security Common Stock  
Trading Symbol ARMP  
Security Exchange Name NYSEAMER  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   36,183,067
Entity Central Index Key 0000921114  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q3  
Amendment Flag false  
v3.24.3
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Current assets    
Cash and cash equivalents $ 17,141 $ 13,523
Prepaid expenses and other current assets 3,029 2,265
Other receivables 2,219 3,363
Total current assets 22,389 19,151
Restricted cash 5,480 5,720
Property and equipment, net 13,616 12,559
Operating lease right-of-use asset 42,251 44,717
In-process research and development 10,256 10,256
Goodwill 3,490 3,490
Other assets 755 2,470
Total assets 98,237 98,363
Current liabilities    
Accounts payable and accrued liabilities 3,714 5,689
Accrued compensation 1,580 768
Convertible debt, current 41,357  
Term debt, current 66,046  
Current portion of operating lease liabilities 4,994 9,481
Other current liabilities 513 523
Total current liabilities 118,204 16,461
Operating lease liabilities, net of current portion 27,929 28,583
Convertible debt, non-current   58,633
Term debt, non-current   23,674
Deferred tax liability 3,077 3,077
Total liabilities 149,210 130,428
Commitments and contingencies (Note 12)
Stockholders' deficit    
Common stock, $0.01 par value; 217,000,000 shares authorized; 36,183,067 and 36,122,932 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 362 361
Additional paid-in capital 279,000 276,393
Accumulated deficit (330,335) (308,819)
Total stockholders' deficit (50,973) (32,065)
Total liabilities and stockholders' deficit $ 98,237 $ 98,363
v3.24.3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Sep. 30, 2024
Dec. 31, 2023
Condensed Consolidated Balance Sheets    
Common stock, par value (in dollars per share) $ 0.01 $ 0.01
Common stock, shares authorized 217,000,000 217,000,000
Common stock, shares issued 36,183,067 36,122,932
Common stock, shares outstanding 36,183,067 36,122,932
v3.24.3
Condensed Consolidated Statements of Operations - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Condensed Consolidated Statements of Operations        
Grant revenue $ 2,973 $ 1,225 $ 3,939 $ 3,001
Operating expenses        
Research and development 9,485 7,978 25,975 25,842
General and administrative 3,244 3,583 9,861 8,470
Total operating expenses 12,729 11,561 35,836 34,312
Operating loss (9,756) (10,336) (31,897) (31,311)
Other income (expense)        
Interest income 294 47 567 111
Interest expense (2,923) (1,176) (7,462) (1,176)
Change in fair value of convertible debt 6,904 (15,833) 17,276 (12,959)
Loss on convertible debt extinguishment   (3,863)   (3,863)
Total other income (expense), net 4,275 (20,825) 10,381 (17,887)
Net loss $ (5,481) $ (31,161) $ (21,516) $ (49,198)
Per share information:        
Net loss per share, basic $ (0.15) $ (0.86) $ (0.60) $ (1.36)
Net loss per share, diluted $ (0.15) $ (0.86) $ (0.60) $ (1.36)
Weighted average shares outstanding, basic 36,180,124 36,086,990 36,153,388 36,067,025
Weighted average shares outstanding, diluted 36,180,124 36,086,990 36,153,388 36,067,025
v3.24.3
Condensed Consolidated Statements of Stockholders' (Deficit) Equity - USD ($)
$ in Thousands
Common Stock
Additional Paid-in Capital
Accumulated Deficit
Total
Balances at Dec. 31, 2022 $ 361 $ 275,493 $ (239,774) $ 36,080
Balances (in shares) at Dec. 31, 2022 36,144,706      
Forfeiture of restricted stock awards (in shares) (9,914)      
Exercise of stock options   5   5
Exercise of stock options (in shares) 1,500      
Withholdings for taxes related to net share settlement of equity awards   (18)   (18)
Withholdings for taxes related to net share settlement of equity awards, shares (13,701)      
Stock-based compensation expense   745   745
Net loss     (49,198) (49,198)
Balances at Sep. 30, 2023 $ 361 276,225 (288,972) (12,386)
Balances (in shares) at Sep. 30, 2023 36,122,591      
Balances at Jun. 30, 2023 $ 361 276,593 (257,811) 19,143
Balances (in shares) at Jun. 30, 2023 36,127,306      
Forfeiture of restricted stock awards (in shares) (6,215)      
Exercise of stock options   5   5
Exercise of stock options (in shares) (1,500)      
Stock-based compensation expense   (373)   (373)
Net loss     (31,161) (31,161)
Balances at Sep. 30, 2023 $ 361 276,225 (288,972) (12,386)
Balances (in shares) at Sep. 30, 2023 36,122,591      
Balances at Dec. 31, 2023 $ 361 276,393 (308,819) (32,065)
Balances (in shares) at Dec. 31, 2023 36,122,932      
Exercise of stock options $ 1 129   $ 130
Exercise of stock options (in shares) 37,282     37,282
Withholdings for taxes related to net share settlement of equity awards, shares (4,222)      
Issuance of common stock upon release of restricted stock units, net of tax withholdings Share-based compensation expense   (61)   $ (61)
Issuance of common stock upon release of restricted stock units, net of tax withholdings Share-based compensation expense (In shares) 27,075      
Stock-based compensation expense   2,539   2,539
Net loss     (21,516) (21,516)
Balances at Sep. 30, 2024 $ 362 279,000 (330,335) (50,973)
Balances (in shares) at Sep. 30, 2024 36,183,067      
Balances at Jun. 30, 2024 $ 362 278,391 (324,854) (46,101)
Balances (in shares) at Jun. 30, 2024 36,155,992      
Issuance of common stock upon release of restricted stock units, net of tax withholdings Share-based compensation expense   (61)   (61)
Issuance of common stock upon release of restricted stock units, net of tax withholdings Share-based compensation expense (In shares) 27,075      
Stock-based compensation expense   670   670
Net loss     (5,481) (5,481)
Balances at Sep. 30, 2024 $ 362 $ 279,000 $ (330,335) $ (50,973)
Balances (in shares) at Sep. 30, 2024 36,183,067      
v3.24.3
Condensed Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Operating activities:    
Net loss $ (21,516) $ (49,198)
Adjustments required to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization expense 945 679
Stock-based compensation expense 2,539 745
Change in fair value of convertible debt (17,276) 12,959
Non-cash interest expense 7,483 1,176
Loss on convertible debt extinguishment   3,863
Change in right-of-use asset 1,489 662
Changes in operating assets and liabilities:    
Prepaid expenses and other assets 2,095 (72)
Accounts payable and accrued liabilities (2,031) (321)
Accrued compensation 812 (87)
Operating lease liability (4,164) (9,723)
Net cash used in operating activities (29,624) (39,317)
Investing activities:    
Purchases of property and equipment (1,956) (5,744)
Net cash used in investing activities (1,956) (5,744)
Financing activities:    
Proceeds from issuance of convertible debt, net of issuance costs   29,101
Proceeds from issuance of term debt, net of issuance costs 34,889 24,925
Payments for taxes related to net share settlement of equity awards (61)  
Proceeds from exercise of stock options 130 5
Net cash provided by financing activities 34,958 54,031
Net increase in cash, cash equivalents and restricted cash 3,378 8,970
Cash, cash equivalents and restricted cash, beginning of period 19,243 20,812
Cash, cash equivalents and restricted cash, end of period 22,621 29,782
Supplemental disclosure of cash flow information:    
Right-of-use asset obtained in exchange for operating lease liability 977 2,513
Property and equipment included in accounts payable and accrued liabilities $ 263 $ 1,047
v3.24.3
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Sep. 30, 2023
Dec. 31, 2022
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheet:        
Cash and cash equivalents $ 17,141 $ 13,523 $ 23,958  
Restricted cash 5,480 5,720 5,824  
Cash, cash equivalents and restricted cash $ 22,621 $ 19,243 $ 29,782 $ 20,812
v3.24.3
Organization and Description of the Business
9 Months Ended
Sep. 30, 2024
Organization and Description of the Business  
Organization and Description of the Business

1. Organization and Description of the Business

Armata Pharmaceuticals, Inc. (“Armata”) together with its subsidiaries (the “Company”), is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology.

Armata’s common stock, par value $0.01 per share (the “Common Stock”) is traded on the NYSE American exchange under the ticker symbol “ARMP.”

v3.24.3
Liquidity and Going Concern
9 Months Ended
Sep. 30, 2024
Liquidity and Going Concern  
Liquidity and Going Concern

2. Liquidity and Going Concern

The Company has incurred significant operating losses since inception and has primarily relied on equity, debt financing and grants to fund its operations. As of September 30, 2024, the Company had an accumulated deficit of $330.3 million. The Company expects to continue to incur substantial losses, and its transition to profitability will depend on the successful development, approval and commercialization of product candidates and on the achievement of sufficient revenues to support its cost structure. The Company may never achieve profitability, and unless and until then, the Company will need to continue to raise additional capital. Existing cash and cash equivalents of $17.1 million as of September 30, 2024 will not be sufficient to fund the Company’s operations for the next 12 months from the date of these condensed consolidated financial statements. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern.

The Company has prepared its condensed consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning the Company’s ability to continue as a going concern.

Recent Financing:

2024 Credit Agreement

On March 4, 2024, the Company entered into a credit and security agreement (the “2024 Credit Agreement”) for a loan in an aggregate amount of $35.0 million (the “2024 Loan”) with Innoviva Strategic Opportunities LLC, a wholly owned subsidiary of Innoviva, Inc. (NASDAQ: INVA), our principal stockholder and a related party (collectively, “Innoviva”). The 2024 Loan bears interest at an annual rate of 14% and matures on June 4, 2025. Principal and accrued interest are payable at maturity. Repayment of the 2024 Loan is guaranteed by the Company’s domestic subsidiaries, and the loan is secured by substantially all of the assets of the Company and the subsidiary guarantors. Concurrently with the execution of the 2024 Credit Agreement, the Company amended certain provisions of its existing convertible loan (the “Convertible Loan”) (see Note 7) and secured credit and security agreement, dated January 10, 2023, with Innoviva (the “Convertible Credit Agreement”) and its existing secured term loan facility (the “2023 Loan”) and credit and security agreement, dated July 10, 2023, with Innoviva (the “2023 Credit Agreement”) to, among other things, conform certain terms relating to permitted indebtedness and permitted liens (see Note 8).

The Company plans to raise additional capital through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses and other similar arrangements. While the Company believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, these plans are not entirely within its control and cannot be assessed as being probable of occurring. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the United States and worldwide. The Company may not be able to secure additional financing in a timely manner or on favorable terms, if at all. Furthermore,

if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders. If the Company raises additional funds through collaboration, licensing or other similar arrangements, it may be necessary to relinquish valuable rights to its potential products on terms that are not favorable to the Company. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce or eliminate its research and development programs or other operations. If any of these events occur, the Company’s ability to achieve the development and commercialization goals would be adversely affected.

v3.24.3
Significant Accounting Policies
9 Months Ended
Sep. 30, 2024
Significant Accounting Policies  
Significant Accounting Policies

3. Significant Accounting Policies

Basis of Presentation

The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated.

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto as of and for the year ended December 31, 2023 included in the Company’s Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 21, 2024. The information as of December 31, 2023 included in the condensed consolidated balance sheets was derived from the Company’s audited financial statements. 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”) and the requirements of the SEC for interim reporting. In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments that are of a normal and recurring nature and that are necessary for the fair presentation of the Company’s financial position and the results of its operations and cash flows for the periods presented. Interim results are not necessarily indicative of results for the full year or any future period.

Any reference in the condensed consolidated financial statements to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

Significant Accounting Policies

The significant accounting policies used in preparation of the condensed consolidated financial statements for the three and nine months ended September 30, 2024 and 2023 are consistent with those discussed in Note 3 to the consolidated financial statements included in the Company’s Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024, except as noted below and within the “Recently Adopted Accounting Pronouncements” section.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates estimates and assumptions, including but not limited to those related to convertible debt, stock-based compensation expense, accruals for research and development costs, the valuation of deferred tax assets, impairment of goodwill and intangible assets and impairment of long-lived assets. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, 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. Actual results may differ materially from those estimates.

Segments

The Company operates and manages its business as one reportable operating segment, which is the business of developing pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat acute and chronic bacterial infections using its proprietary bacteriophage-based technology. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating resources and evaluating financial performance. The long-lived assets of $13.5 million, which represent 99.2% of the Company’s total long-lived assets, are maintained in the United States.

Concentration of Credit Risks and Certain Other Risks

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and restricted cash. As of September 30, 2024, cash equivalents and restricted cash was invested primarily in money market funds and U.S. treasury securities through highly rated financial institutions in accordance with the Company’s investment policy, to a concentration limit per issuer or sector. These are investment assets and are classified as cash equivalents in the condensed consolidated balance sheets as their original maturities are less than three months.

Other receivables represent amounts due from the Medical Technology Enterprise Consortium (“MTEC”) (Note 13) and reimbursement for tenant improvements (Note 12).

Recently Adopted Accounting Pronouncements

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted earnings (loss) per share (“EPS”) computation. The Company adopted this ASU as of January 1, 2024, which did not have an impact on its consolidated financial statements or related disclosures.

Recent Accounting Pronouncements Not Yet Adopted

In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. This ASU aligns the requirements in the ASC to the removal of certain disclosure requirements set out in Regulation S-X and Regulation S-K, announced by the SEC. The effective date for each amended topic in the ASC is either the date on which the SEC’s removal of the related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, or on June 30, 2027, if the SEC has not removed the requirements by that date. Early adoption is prohibited. The Company is currently evaluating the impact of adopting ASU 2023-06 on its consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07 on its consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09 on its consolidated financial statements.

v3.24.3
Fair Value Measurements
9 Months Ended
Sep. 30, 2024
Fair Value Measurements  
Fair Value Measurements

4. Fair Value Measurements

The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following three levels:

Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2: Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The financial assets and liabilities measured and recognized at fair value were as follows as of September 30, 2024 and December 31, 2023 (in thousands):

September 30, 2024

Total

Level 1

Level 2

Level 3

Investments in money market fund – financial assets, included in cash and cash equivalents

$

10,355

$

10,355

$

$

Convertible debt– financial liabilities

41,357

41,357

December 31, 2023

Total

Level 1

Level 2

Level 3

Convertible debt– financial liabilities

$

58,633

$

$

$

58,633

The Company’s convertible debt (Note 7) is measured at fair value and remeasured at each quarter end, with changes in fair value recorded as other income (expense) in the condensed consolidated statement of operations. The Company estimates the fair value of its convertible debt using a weighted probability model of various debt settlement scenarios during its term discounted to the reporting date. Conversion option scenarios are valued using option pricing models with assumptions and estimates such as volatility, expected term and risk-free interest rates. Level 3 fair value inputs include probability and timing of various settlement scenarios and selection of comparable companies.

The Company estimated the fair value of its convertible debt using the following inputs as of September 30, 2024 and December 31, 2023:

September 30, 2024

December 31, 2023

Discount rate

19.50%

21.01%

Probabilities of settlement scenarios

0%-75%

0%-75%

Volatility

93.2%

120.3%

Expected term (in years)

0.26-0.28

0.16-1.04

Risk-free rate

4.58%-4.61%

4.66%-5.36%

The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial liabilities for the nine months ended September 30, 2024 (in thousands):

September 30, 2024

Convertible debt at December 31, 2023

$

58,633

Change in fair value

 

(17,276)

Convertible debt at September 30, 2024

$

41,357

The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial liabilities for the nine months ended September 30, 2023 (in thousands):

Convertible Loan
Pre Modification

Convertible Loan
Post Modification

Balance at December 31, 2022

$

$

Net issuance of Convertible Loan (1)

29,226

Initial recognition of modified Convertible Loan (1)

35,031

Change in fair value

 

(1,757)

14,716

Amount exchanged (2)

(31,332)

Loss on extinguishment

3,863

Balance at September 31, 2023

$

$

49,747

(1)The Convertible Loan is carried at fair value in the consolidated balance sheets. As such, the principal and accrued interest are included in the determination of fair value.
(2)The Company concluded that the amendment to the Convertible Loan was an extinguishment for accounting purposes and the amount exchanged was the relative fair value allocated to the Convertible Loan at the extinguishment date (Note 7).
v3.24.3
Net Loss per Share
9 Months Ended
Sep. 30, 2024
Net Loss per Share  
Net Loss per Share

5. Net Loss per Share

The computation of basic EPS is based on the weighted-average number of the Company’s Common Stock outstanding. The computation of diluted EPS is based on the weighted-average number of the Company’s Common Stock outstanding and potential dilutive common stock. Diluted EPS is computed using the more dilutive of the treasury stock method, which reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted to the Company’s Common Stock. Common Stock options, warrants, convertible debt and unvested restricted stock units were not included in dilutive EPS as their impact would be antidilutive.

The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders for the periods presented (in thousands, except share and per share data):

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

   

2024

   

2023

    

2024

  

2023

Numerator:

 

  

 

  

 

  

 

  

 

Net loss attributable to common stockholders

$

(5,481)

$

(31,161)

$

(21,516)

$

(49,198)

Denominator:

Weighted average common shares outstanding, basic and diluted

 

36,180,124

 

36,086,990

 

36,153,388

 

36,067,025

Net loss per share attributable to common stockholders, basic and diluted

$

(0.15)

$

(0.86)

$

(0.60)

$

(1.36)

The following outstanding securities as of September 30, 2024 and December 31, 2023 have been excluded from the computation of dilutive weighted average shares outstanding, as they would have been anti-dilutive:

    

September 30, 2024

    

December 31, 2023

    

Outstanding stock options

 

3,934,731

 

3,165,216

Unvested restricted stock units

230,000

200,000

Shares issuable upon the conversion of convertible debt

22,495,614

21,293,861

Outstanding warrants

19,365,847

19,365,847

Total

 

46,026,192

 

44,024,924

 

(1)The Company determined the number of shares issuable upon the conversion of convertible debt as of September 30, 2024 based on the convertible loan principal amount of $30.0 million, accrued and unpaid interest of $4.2 million as of that date calculated at an annual interest rate of 8%, converted at $1.52 per share.
v3.24.3
Balance Sheet Details
9 Months Ended
Sep. 30, 2024
Balance Sheet Details  
Balance Sheet Details

6. Balance Sheet Details

Property and Equipment

Property and equipment as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

    

September 30, 2024

    

December 31, 2023

Laboratory equipment

$

21,311

$

19,678

Furniture and fixtures

831

817

Office and computer equipment

 

438

 

438

Leasehold improvements

 

3,802

 

3,447

Total

26,382

24,380

Less: accumulated depreciation

 

(12,766)

 

(11,821)

Property and equipment, net

$

13,616

$

12,559

Depreciation and amortization expense totaled $0.3 million and $0.2 million for the three months ended September 30, 2024 and 2023, and $0.9 and $0.7 million for the nine months ended September 30, 2024 and 2023, respectively. Construction in progress and fixed assets not in use were $9.6 million and $8.1 million as of September 30, 2024 and December 31, 2023, respectively, and are included in the laboratory equipment in the table above. These assets are not depreciated until they are placed in service.

Other receivables

Other receivables as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

September 30, 2024

    

December 31, 2023

Tenant improvement allowance receivable (Note 12)

$

597

$

1,835

Grant and award receivable (Note 13)

1,622

1,528

$

2,219

$

3,363

Accounts payable and accrued liabilities

Accounts payable and accrued liabilities as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

September 30, 2024

    

December 31, 2023

Accounts payable

$

1,815

$

1,585

Accrued clinical trial expenses

1,567

3,021

Other accrued expenses

332

1,083

$

3,714

$

5,689

v3.24.3
Convertible Debt
9 Months Ended
Sep. 30, 2024
Convertible Debt  
Convertible Debt

7. Convertible Debt

On January 10, 2023, the Company received the Convertible Loan in the aggregate amount of $30.0 million from Innoviva pursuant to the Convertible Credit Agreement. The Convertible Loan bears interest at a rate of 8.0% per annum and was scheduled to mature on January 10, 2024. The Convertible Credit Agreement was amended on July 10, 2023, in connection with the Company’s entry into the 2023 Credit Agreement, to, among other changes, extend the maturity of the Convertible Loan to January 10, 2025. Subsequently, on November 12, 2024, the Company executed another amendment to the Convertible Credit Agreement, which, among other things, extended the Convertible Credit Agreement maturity date to January 10, 2026.

The Convertible Loan principal and accrued interest are payable at maturity. Repayment of the Convertible Loan is guaranteed by the Company’s domestic subsidiaries and foreign material subsidiaries, and the Convertible Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

The Convertible Credit Agreement provides that if there is a financing from new investors of at least $30.0 million (a “Qualified Financing”), the outstanding principal amount of and all accrued and unpaid interest on the Convertible Loan shall be converted into shares of the Company’s Common Stock, at a price per share equal to a 15.0% discount to the lowest price per share for Common Stock paid by investors in such Qualified Financing. The Convertible Credit Agreement also required the Company to file a registration statement for the resale of all securities issued to the lender in connection with any conversion under the Convertible Credit Agreement, which the Company originally filed on February 13, 2023 and which was declared effective by the SEC on April 6, 2023. The Convertible Credit Agreement also confers upon the lender the option to convert any outstanding Convertible Loan amount, including all accrued and unpaid interest thereon, at the lender’s option, into shares of Common Stock at a price per share equal to the greater of book value or market value per share of Common Stock on the date immediately preceding the effective date of the Convertible Credit Agreement, which was $1.52 (as may be appropriately adjusted for any stock split, combination or similar act).

The Company evaluated authoritative guidance for accounting for the Convertible Loan and concluded that the Convertible Loan should be accounted for at fair value under ASC 480, Distinguish Liabilities from Equity, due to the fact that the Convertible Loan will predominately be settled with the Company’s Common Stock. Consequently, the Company recorded the Convertible Loan in its entirety at fair value on its condensed consolidated balance sheet, with changes in fair value recorded as other income (expenses) in the condensed consolidated statements of operations during each reporting period.

The Company recognized gains of $6.9 million and losses of $15.8 million as the change in fair value of the Convertible Loan for the three months ended September 30, 2024 and 2023, and gains of $17.3 million and losses of $13.0 million for the nine months ended September 30, 2024 and 2023, respectively.

v3.24.3
Term Debt
9 Months Ended
Sep. 30, 2024
Term Debt  
Term Debt

8. Term Debt

On July 10, 2023, the Company entered into the 2023 Credit Agreement. The 2023 Credit Agreement provides for the 2023 Loan, a secured term loan facility in an aggregate amount of $25.0 million at an interest rate of 14.0% per annum and has a maturity date of January 10, 2025. Principal and accrued interest are payable at maturity. Repayment of the 2023 Loan is guaranteed by the Company’s domestic subsidiaries, and the 2023 Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

The 2023 Loan was initially recognized at fair value of $21.2 million and subsequently recognized at the amortized cost net of debt issuance costs and debt discount. Debt issuance costs and debt discount in the amounts of $0.1 million and $3.8 million, respectively, are amortized using the effective interest method to interest expense over the term of the 2023 Loan. The 2023 Loan’s annual effective interest rate was 27.31% as of September 30, 2024.

On November 12, 2024, the Company executed an amendment to the 2023 Credit Agreement, which, among other things, extended the 2023 Loan maturity date to January 10, 2026.

On March 4, 2024, the Company entered into the 2024 Credit Agreement. The 2024 Credit Agreement provides for the 2024 Loan, a secured term loan facility in an aggregate amount of $35.0 million at an interest rate of 14.0% per annum and has a maturity date of June 4, 2025. Principal and accrued interest are payable at maturity. Repayment of the 2024 Loan is guaranteed by the Company’s domestic subsidiaries, and the 2024 Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

The 2024 Loan was initially recognized at cash proceeds of $35.0 million net of debt issuance costs of $0.1 million, and subsequently is recognized at the amortized cost. Debt issuance costs are amortized using the effective interest method to interest expense over the term of the 2024 Loan. The 2024 Loan’s annual effective interest rate was 14.25% as of September 30, 2024.

The 2023 Credit Agreement and the 2024 Credit Agreement contain customary affirmative and negative covenants and representations and warranties, including financial reporting obligations and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, investments, mergers or acquisitions and fundamental corporate changes. The 2023 Credit Agreement and the 2024 Credit Agreement also include customary events of default, including payment defaults, breaches of provisions under the loan documents, certain losses or impairment of collateral and related security interests, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the 2023 Credit Agreement and the 2024 Credit Agreement, certain bankruptcy or insolvency events, and a material deviation from the Company’s operating budget.

v3.24.3
Stockholders' Deficit
9 Months Ended
Sep. 30, 2024
Stockholders' Deficit  
Stockholders' Deficit

9. Stockholders’ Deficit

Warrants

As of September 30, 2024, outstanding warrants to purchase shares of Common Stock were as follows:

Shares

    

Exercise Price

    

Expiration Date

993,139

$

2.87

February 11, 2025

7,717,661

$

2.87

March 27, 2025

1,867,912

$

3.25

January 26, 2026

4,285,935

$

3.25

March 16, 2026

1,807,396

$

5.00

February 8, 2027

2,692,604

$

5.00

March 30, 2027

1,200

$

1,680.00

None

19,365,847

 

  

  

Shares Reserved for Future Issuance

As of September 30, 2024, the Company had reserved shares of its Common Stock for future issuance as follows:

    

September 30, 2024

Stock options outstanding

 

3,934,731

Unvested restricted stock units

230,000

Shares issuable under the Employee stock purchase plan

 

11,890

Shares available for future grants under the 2016 Plan

 

3,219,158

Warrants outstanding

 

19,365,847

Shares issuable upon the conversion of convertible debt

22,495,614

Total shares reserved

 

49,257,240

v3.24.3
Equity Incentive Plans
9 Months Ended
Sep. 30, 2024
Equity Incentive Plans  
Equity Incentive Plans

10. Equity Incentive Plans

Stock Award Plans

The Company maintains a 2016 Equity Incentive Plan (the “2016 Plan”), which provides for the issuance of incentive share awards in the form of non-qualified and incentive stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and performance-based stock awards. As of September 30, 2024, there were 3,219,158 shares available for issuance under the 2016 Plan.

Stock option transactions during the nine months ended September 30, 2024 are presented below:

Options Outstanding

Weighted

Average

Weighted

Remaining

Average

Contractual

Aggregate

Exercise

Term

Intrinsic

    

Shares

    

Price

    

(Years)

    

Value (in thousands)

Outstanding at December 31, 2023

 

3,165,216

$

5.04

 

5.9

$

429

Granted

 

1,784,054

$

3.38

 

 

Exercised

(37,282)

$

3.38

$

24

Forfeited/Cancelled/Expired

 

(977,257)

$

7.10

 

 

Outstanding at September 30, 2024

 

3,934,731

$

3.79

 

7.8

$

15

Vested and expected to vest at September 30, 2024

 

3,934,731

$

3.79

 

7.8

$

15

Exercisable at September 30, 2024

 

2,094,287

$

4.07

 

6.6

$

3

The aggregate intrinsic value of options at September 30, 2024 is based on the Company’s closing stock price on that date of $2.37 per share.

Restricted stock unit awards transactions during the nine months ended September 30, 2024 are presented below:

Weighted Avg

Grant Date

    

Shares

    

Fair Value

Outstanding at December 31, 2023

200,000

$

2.39

Granted

90,000

$

3.38

Vested

(50,000)

$

2.39

Cancelled

(10,000)

$

3.38

Outstanding at September 30, 2024

230,000

$

2.73

Share-based Compensation

The Company estimates the fair value of stock options with performance and service conditions using the Black-Scholes valuation model (“Black-Scholes”). Compensation expense related to stock options granted is measured at the grant date based on the estimated fair value of the award and is recognized on the accelerated attribution method over the requisite service period.

The assumptions used in the Black-Scholes model during the three and nine months ended September 30, 2024 and 2023 are presented below.

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

   

2023

    

2024

    

2023

Risk-free interest rate

0%-0%

5.49%-5.54%

4.24%-4.25%

3.54% - 5.54%

Expected volatility

0% - 0%

75.40%-116.96%

89.4%-92.5%

75.40%-116.96%

Expected term (in years)

0 - 0

0.1-0.6

5.1-7.0

0.1-7.0

Expected dividend yield

0%

0%

0%

0%

The table below summarizes the total share-based compensation expense included in the Company’s condensed consolidated statements of operations for the periods presented (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

Research and development

$

323

$

144

$

698

$

948

General and administrative

 

347

 

(517)

 

1,841

 

(203)

Total stock-based compensation

$

670

$

(373)

$

2,539

$

745

As of September 30, 2024, there was $3.0 million of total unrecognized compensation expense related to unvested stock options and restricted stock units, which the Company expects to recognize over the weighted average remaining period of approximately 1.9 years.

v3.24.3
Income Taxes
9 Months Ended
Sep. 30, 2024
Income Taxes  
Income Taxes

11. Income Taxes

The Company did not record a provision or benefit for income taxes during the three and nine months ended September 30, 2024 and 2023. The Company expects to generate net taxable losses and continues to maintain a full valuation allowance against all of its deferred tax assets.

v3.24.3
Commitments and Contingencies
9 Months Ended
Sep. 30, 2024
Commitments and Contingencies.  
Commitments and Contingencies

12. Commitments and Contingencies

Operating Leases

The Company leases office and research and development space under a non-cancelable operating lease in Marina del Rey, CA. The lease commenced on January 1, 2012 and was amended in April 2020 to, among other things, extend the lease term through December 31, 2031 (the “2020 Lease Amendment”). Annual base rent is from $1.9 million and increases by 3% annually and will be $2.5 million by the end of the amended term.

Concurrent with the Company’s execution of the 2020 Lease Amendment, an irrevocable letter of credit in the amount of $1.2 million was delivered to the landlord. Starting on February 1, 2022, and each year thereafter, the letter of credit will be reduced by 20% of the then outstanding amount. As of September 30, 2024, the letter of credit was $0.5 million.

On October 28, 2021, the Company entered into a lease for office and research and development space under a non-cancellable lease in Los Angeles, CA (the “2021 Lease”). The 2021 Lease payment start date was May 1, 2022 and the total lease term is for 16 years and runs through 2038. Monthly rent for 2022 and 2023 was fully or partially abated while the lessor and the Company completed planned tenant improvements to the facility. Base monthly rent is approximately $0.3 million in 2024. The Company was entitled to and fully received an allowance for tenant improvements of $7.2 million, as of September 30, 2024. The Company is responsible for construction costs over such allowance. Out-of-pocket expenses to be incurred by the Company are considered noncash lease payments, and included in the lease liability and right-of-use asset when the amount can be reasonably estimated.

In connection with the execution of the 2021 Lease, the Company delivered an irrevocable standby letter of credit in the amount of $5.0 million to the landlord in 2022.

Future minimum annual lease payments under the Company’s noncancelable operating leases as of September 30, 2024 are as follows (in thousands):

    

Operating

Leases

2024 (remaining three months)

 

$

836

2025

5,139

2026

5,293

2027

5,452

2028

5,616

Thereafter

43,779

Total minimum lease payments

66,115

Less: amount representing interest

(33,192)

Present value of operating lease obligations

32,923

Less: current portion

(4,994)

Noncurrent operating lease obligations

$

27,929

Operating lease expenses were $2.0 million and $2.1 million for the three months ended September 30, 2024 and 2023, and $6.3 million and $5.7 million for the nine months ended September 30, 2024 and 2023, respectively. Variable costs related to operating expenses and taxes, which are recognized as incurred, were $0.4 million and $0.5 million for the three months ended September 30, 2024 and 2023, and $1.4 million and $0.9 million for the nine months ended September 30, 2024 and 2023, respectively.

The following table summarizes supplemental cash flow information related to the Company’s operating leases for the nine months ended September 30, 2024 and 2023 (in thousands):

Nine Months Ended September 30, 

2024

    

2023

Cash paid for amounts included in the measurement of lease liabilities:

Operating cash flows from operating leases

$

2,006

$

3,223

The following table summarizes the weighted-average remaining lease term and weighted-average discount rate related to the Company’s operating leases as of September 30, 2024 and December 31, 2023:

September 30, 2024

December 31, 2023

Weighted-average remaining lease term, years

11.97

12.79

Weighted-average discount rate, %

13.9

13.9

Legal Proceedings

From time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that there is adequate insurance to cover many different types of liabilities, the Company’s insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the Company’s consolidated results of operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our consolidated results of operations or financial position.

v3.24.3
Grant and Awards
9 Months Ended
Sep. 30, 2024
Grant and Awards  
Grant and Awards

13. Grant and Awards

MTEC Grant

On June 15, 2020, the Company entered into a Research Project Award agreement (the “MTEC Agreement”) with MTEC, pursuant to which the Company received a $15.0 million grant and entered into a three-year program administered by the U.S. Department of Defense through MTEC managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. On September 29, 2022, the MTEC Agreement was modified to increase the total award by $1.3 million to $16.3 million and extend the term into the third quarter of 2024. In July 2024, the MTEC Agreement was modified to increase the total award by $5.3 million to a total of $21.6 million and extend the term into the third quarter of 2025. The MTEC funds are to partially fund a Phase 1b/2a, randomized, double-blind, placebo-controlled, dose escalation clinical study of the Company’s therapeutic phage-based candidate, AP-SA02, for the treatment of complicated Staphylococcus aureus bacteremia infections. The MTEC Agreement specifies that the grant will be paid to the Company over the term of the award through a cost reimbursable model, based on agreed upon cost share percentages, and the grant money received is not refundable to MTEC.

Upon license or commercialization of intellectual property developed with the funding from the MTEC Agreement, additional fees will be due to MTEC. The Company will elect whether to (a) pay a fixed royalty amount, which is subject to a cap based upon total funding received, or (b) pay an additional assessment fee, which would also be subject to a cap based upon a percentage of total funding received.

The MTEC Agreement is effective through August 15, 2025. The MTEC Agreement may be terminated in whole or in part 30 calendar days following written notice from the Company to MTEC. In addition, MTEC has the right to terminate the MTEC Agreement upon material breach by the Company.

The Company determined that the MTEC Agreement is not in the scope of ASC 808 or ASC 606. Applying ASC 606 by analogy, the Company recognizes proceeds received under the MTEC Agreement as grant revenue in the statement of operations when related costs are incurred. The Company recognized $3.0 and $3.9 million in grant revenue from the MTEC Agreement during the three and nine months ended September 30, 2024, respectively. As of March 31, 2024, the Company recognized the entire $16.3 million award as grant revenue. The Company has and will recognize additional grant revenue of $5.3 million from July 2024 until the full amount is utilized. The Company recognized $1.2 million and $3.0 million in grant revenue from the MTEC Agreement during the three and nine months ended September 30, 2023. As of September 30, 2024, and December 31, 2023, the Company had $1.6 million and $1.5 million as awards receivable from MTEC, respectively.

CFF Therapeutics Development Award

On March 13, 2020, the Company entered into an award agreement (the “Award Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), pursuant to which the Company received a Therapeutics Development Award of up to $5.0 million (the “CFF Award”). The CFF Award was used to fund a portion of the Company’s Phase 1b/2a clinical trial of the Pseudomonas aeruginosa (“P. aeruginosa”) phage candidate, AP-PA02, as a treatment for Pseudomonas airway infections in people with cystic fibrosis (“CF”).

The first payment under the Award Agreement, in the amount of $1.0 million, became due upon signing the Award Agreement and was received in April 2020. The remainder of the CFF Award was payable to the Company incrementally in installments upon the achievement of certain milestones related to the development program and progress of the Phase 1b/2a clinical trial of AP-PA02, as set forth in the Award Agreement. The total amount of the CFF award was recognized through December 2023 and no additional payments are expected.

If the Company ceases to use commercially reasonable efforts directed to the development of AP-PA02, or any other Product (as defined in the Award Agreement), for a period of 360 days (an “Interruption”) and fails to resume the development of the Product after receiving from CFF notice of an Interruption, then the Company must either repay the amount of the CFF Award actually received by the Company, plus interest, or grant to CFF (1) an exclusive (even as to the Company), worldwide, perpetual, sublicensable license under technology developed under the Award Agreement that covers the Product for use in treating infections in CF patients (the “CF Field”), and (2) a non-exclusive, worldwide, perpetual, sublicensable license under certain background intellectual property covering the Product, to the extent necessary to commercialize the Product in the CF Field.

Upon commercialization by the Company of any Product, the Company will owe a fixed royalty amount to CFF, which is to be paid in installments determined, in part, based on commercial sales volumes of the Product. The Company will be obligated to make an additional fixed royalty payment upon achieving specified sales milestones. The Company may also be obligated to make a payment to CFF if the Company transfers, sells or licenses the Product in the CF Field, or if the Company enters into a change of control transaction.

The term of the Award Agreement commenced on March 10, 2020 and expires on the earlier of the date on which the Company has paid CFF all of the fixed royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier termination of the Award Agreement. Either CFF or the Company may terminate the Award Agreement for cause, which includes the Company’s material failure to achieve certain development milestones. The Company’s payment obligations survive the termination of the Award Agreement.

The Company concluded that the CFF Award is in the scope of ASC 808. Accordingly, as discussed in Note 3, the Company recognizes the award upon achievement of certain milestones as credits to research and development expenses. No credits to research and development expenses were recognized during the three and nine months ended September 30, 2024 and 2023, respectively, related to the CFF Award. In addition, the Company concluded under the guidance in ASC 730 that it does not have an obligation to repay funds received once related research and development expenses are incurred.

v3.24.3
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Pay vs Performance Disclosure        
Net Income (Loss) $ (5,481) $ (31,161) $ (21,516) $ (49,198)
v3.24.3
Insider Trading Arrangements
3 Months Ended
Sep. 30, 2024
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.3
Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2024
Significant Accounting Policies  
Basis of Presentation

Basis of Presentation

The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated.

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto as of and for the year ended December 31, 2023 included in the Company’s Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 21, 2024. The information as of December 31, 2023 included in the condensed consolidated balance sheets was derived from the Company’s audited financial statements. 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”) and the requirements of the SEC for interim reporting. In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments that are of a normal and recurring nature and that are necessary for the fair presentation of the Company’s financial position and the results of its operations and cash flows for the periods presented. Interim results are not necessarily indicative of results for the full year or any future period.

Any reference in the condensed consolidated financial statements to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

Use of Estimates

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates estimates and assumptions, including but not limited to those related to convertible debt, stock-based compensation expense, accruals for research and development costs, the valuation of deferred tax assets, impairment of goodwill and intangible assets and impairment of long-lived assets. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, 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. Actual results may differ materially from those estimates.

Segments

Segments

The Company operates and manages its business as one reportable operating segment, which is the business of developing pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat acute and chronic bacterial infections using its proprietary bacteriophage-based technology. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating resources and evaluating financial performance. The long-lived assets of $13.5 million, which represent 99.2% of the Company’s total long-lived assets, are maintained in the United States.

Concentration of Credit Risks and Certain Other Risks

Concentration of Credit Risks and Certain Other Risks

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and restricted cash. As of September 30, 2024, cash equivalents and restricted cash was invested primarily in money market funds and U.S. treasury securities through highly rated financial institutions in accordance with the Company’s investment policy, to a concentration limit per issuer or sector. These are investment assets and are classified as cash equivalents in the condensed consolidated balance sheets as their original maturities are less than three months.

Other receivables represent amounts due from the Medical Technology Enterprise Consortium (“MTEC”) (Note 13) and reimbursement for tenant improvements (Note 12).

Recently Adopted Accounting Pronouncements

Recently Adopted Accounting Pronouncements

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted earnings (loss) per share (“EPS”) computation. The Company adopted this ASU as of January 1, 2024, which did not have an impact on its consolidated financial statements or related disclosures.

Recent Accounting Pronouncements Not Yet Adopted

In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. This ASU aligns the requirements in the ASC to the removal of certain disclosure requirements set out in Regulation S-X and Regulation S-K, announced by the SEC. The effective date for each amended topic in the ASC is either the date on which the SEC’s removal of the related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, or on June 30, 2027, if the SEC has not removed the requirements by that date. Early adoption is prohibited. The Company is currently evaluating the impact of adopting ASU 2023-06 on its consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07 on its consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09 on its consolidated financial statements.

v3.24.3
Fair Value Measurements (Tables)
9 Months Ended
Sep. 30, 2024
Fair Value of Financial Assets and Liabilities - Derivative Instruments  
Schedule of assets and liabilities measured at fair value

The financial assets and liabilities measured and recognized at fair value were as follows as of September 30, 2024 and December 31, 2023 (in thousands):

September 30, 2024

Total

Level 1

Level 2

Level 3

Investments in money market fund – financial assets, included in cash and cash equivalents

$

10,355

$

10,355

$

$

Convertible debt– financial liabilities

41,357

41,357

December 31, 2023

Total

Level 1

Level 2

Level 3

Convertible debt– financial liabilities

$

58,633

$

$

$

58,633

Schedule of Fair Value Measurements

The Company estimated the fair value of its convertible debt using the following inputs as of September 30, 2024 and December 31, 2023:

September 30, 2024

December 31, 2023

Discount rate

19.50%

21.01%

Probabilities of settlement scenarios

0%-75%

0%-75%

Volatility

93.2%

120.3%

Expected term (in years)

0.26-0.28

0.16-1.04

Risk-free rate

4.58%-4.61%

4.66%-5.36%

Schedule of Changes in Fair Value of Liabilities

The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial liabilities for the nine months ended September 30, 2024 (in thousands):

September 30, 2024

Convertible debt at December 31, 2023

$

58,633

Change in fair value

 

(17,276)

Convertible debt at September 30, 2024

$

41,357

The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial liabilities for the nine months ended September 30, 2023 (in thousands):

Convertible Loan
Pre Modification

Convertible Loan
Post Modification

Balance at December 31, 2022

$

$

Net issuance of Convertible Loan (1)

29,226

Initial recognition of modified Convertible Loan (1)

35,031

Change in fair value

 

(1,757)

14,716

Amount exchanged (2)

(31,332)

Loss on extinguishment

3,863

Balance at September 31, 2023

$

$

49,747

(1)The Convertible Loan is carried at fair value in the consolidated balance sheets. As such, the principal and accrued interest are included in the determination of fair value.
(2)The Company concluded that the amendment to the Convertible Loan was an extinguishment for accounting purposes and the amount exchanged was the relative fair value allocated to the Convertible Loan at the extinguishment date (Note 7).
v3.24.3
Net Loss per Share (Tables)
9 Months Ended
Sep. 30, 2024
Net Loss per Share  
Computation of Basic and Diluted Net Loss Per Share

The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders for the periods presented (in thousands, except share and per share data):

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

   

2024

   

2023

    

2024

  

2023

Numerator:

 

  

 

  

 

  

 

  

 

Net loss attributable to common stockholders

$

(5,481)

$

(31,161)

$

(21,516)

$

(49,198)

Denominator:

Weighted average common shares outstanding, basic and diluted

 

36,180,124

 

36,086,990

 

36,153,388

 

36,067,025

Net loss per share attributable to common stockholders, basic and diluted

$

(0.15)

$

(0.86)

$

(0.60)

$

(1.36)

Schedule of Antidilutive Securities Excluded from Computation of Diluted Weighted Shares Outstanding

The following outstanding securities as of September 30, 2024 and December 31, 2023 have been excluded from the computation of dilutive weighted average shares outstanding, as they would have been anti-dilutive:

    

September 30, 2024

    

December 31, 2023

    

Outstanding stock options

 

3,934,731

 

3,165,216

Unvested restricted stock units

230,000

200,000

Shares issuable upon the conversion of convertible debt

22,495,614

21,293,861

Outstanding warrants

19,365,847

19,365,847

Total

 

46,026,192

 

44,024,924

 

(1)The Company determined the number of shares issuable upon the conversion of convertible debt as of September 30, 2024 based on the convertible loan principal amount of $30.0 million, accrued and unpaid interest of $4.2 million as of that date calculated at an annual interest rate of 8%, converted at $1.52 per share.
v3.24.3
Balance Sheet Details (Tables)
9 Months Ended
Sep. 30, 2024
Balance Sheet Details  
Schedule of Property and Equipment

Property and equipment as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

    

September 30, 2024

    

December 31, 2023

Laboratory equipment

$

21,311

$

19,678

Furniture and fixtures

831

817

Office and computer equipment

 

438

 

438

Leasehold improvements

 

3,802

 

3,447

Total

26,382

24,380

Less: accumulated depreciation

 

(12,766)

 

(11,821)

Property and equipment, net

$

13,616

$

12,559

Schedule of Other receivables

Other receivables as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

September 30, 2024

    

December 31, 2023

Tenant improvement allowance receivable (Note 12)

$

597

$

1,835

Grant and award receivable (Note 13)

1,622

1,528

$

2,219

$

3,363

Schedule of Accounts Payable and Accrued Liabilities

Accounts payable and accrued liabilities as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):

September 30, 2024

    

December 31, 2023

Accounts payable

$

1,815

$

1,585

Accrued clinical trial expenses

1,567

3,021

Other accrued expenses

332

1,083

$

3,714

$

5,689

v3.24.3
Stockholders' Deficit (Tables)
9 Months Ended
Sep. 30, 2024
Stockholders' Deficit  
Schedule of Warrant Information

Shares

    

Exercise Price

    

Expiration Date

993,139

$

2.87

February 11, 2025

7,717,661

$

2.87

March 27, 2025

1,867,912

$

3.25

January 26, 2026

4,285,935

$

3.25

March 16, 2026

1,807,396

$

5.00

February 8, 2027

2,692,604

$

5.00

March 30, 2027

1,200

$

1,680.00

None

19,365,847

 

  

  

Schedule of Shares Reserved for Future Issuance

    

September 30, 2024

Stock options outstanding

 

3,934,731

Unvested restricted stock units

230,000

Shares issuable under the Employee stock purchase plan

 

11,890

Shares available for future grants under the 2016 Plan

 

3,219,158

Warrants outstanding

 

19,365,847

Shares issuable upon the conversion of convertible debt

22,495,614

Total shares reserved

 

49,257,240

v3.24.3
Equity Incentive Plans (Tables)
9 Months Ended
Sep. 30, 2024
Equity Incentive Plans  
Schedule of Stock Option Activity

Options Outstanding

Weighted

Average

Weighted

Remaining

Average

Contractual

Aggregate

Exercise

Term

Intrinsic

    

Shares

    

Price

    

(Years)

    

Value (in thousands)

Outstanding at December 31, 2023

 

3,165,216

$

5.04

 

5.9

$

429

Granted

 

1,784,054

$

3.38

 

 

Exercised

(37,282)

$

3.38

$

24

Forfeited/Cancelled/Expired

 

(977,257)

$

7.10

 

 

Outstanding at September 30, 2024

 

3,934,731

$

3.79

 

7.8

$

15

Vested and expected to vest at September 30, 2024

 

3,934,731

$

3.79

 

7.8

$

15

Exercisable at September 30, 2024

 

2,094,287

$

4.07

 

6.6

$

3

Schedule of Restricted Stock Awards and Restricted Stock Unit Activity

Weighted Avg

Grant Date

    

Shares

    

Fair Value

Outstanding at December 31, 2023

200,000

$

2.39

Granted

90,000

$

3.38

Vested

(50,000)

$

2.39

Cancelled

(10,000)

$

3.38

Outstanding at September 30, 2024

230,000

$

2.73

Schedule of Assumptions Used in the Black-Scholes Model

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

   

2023

    

2024

    

2023

Risk-free interest rate

0%-0%

5.49%-5.54%

4.24%-4.25%

3.54% - 5.54%

Expected volatility

0% - 0%

75.40%-116.96%

89.4%-92.5%

75.40%-116.96%

Expected term (in years)

0 - 0

0.1-0.6

5.1-7.0

0.1-7.0

Expected dividend yield

0%

0%

0%

0%

Schedule of Stock-Based Compensation Expenses

The table below summarizes the total share-based compensation expense included in the Company’s condensed consolidated statements of operations for the periods presented (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

Research and development

$

323

$

144

$

698

$

948

General and administrative

 

347

 

(517)

 

1,841

 

(203)

Total stock-based compensation

$

670

$

(373)

$

2,539

$

745

v3.24.3
Commitments and Contingencies (Tables)
9 Months Ended
Sep. 30, 2024
Commitments and Contingencies.  
Future Minimum Lease Payments

Future minimum annual lease payments under the Company’s noncancelable operating leases as of September 30, 2024 are as follows (in thousands):

    

Operating

Leases

2024 (remaining three months)

 

$

836

2025

5,139

2026

5,293

2027

5,452

2028

5,616

Thereafter

43,779

Total minimum lease payments

66,115

Less: amount representing interest

(33,192)

Present value of operating lease obligations

32,923

Less: current portion

(4,994)

Noncurrent operating lease obligations

$

27,929

Operating leases

The following table summarizes supplemental cash flow information related to the Company’s operating leases for the nine months ended September 30, 2024 and 2023 (in thousands):

Nine Months Ended September 30, 

2024

    

2023

Cash paid for amounts included in the measurement of lease liabilities:

Operating cash flows from operating leases

$

2,006

$

3,223

September 30, 2024

December 31, 2023

Weighted-average remaining lease term, years

11.97

12.79

Weighted-average discount rate, %

13.9

13.9

v3.24.3
Organization and Description of the Business (Narrative) (Details) - $ / shares
Sep. 30, 2024
Dec. 31, 2023
Organization and Description of the Business    
Common stock, par value (in dollars per share) $ 0.01 $ 0.01
v3.24.3
Liquidity and Going Concern (Narrative) (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Mar. 04, 2024
Dec. 31, 2023
Sep. 30, 2023
Accumulated deficit $ (330,335)   $ (308,819)  
Cash and cash equivalents $ 17,141   $ 13,523 $ 23,958
Innoviva Strategic Opportunities LLC | Credit And Security Agreement        
Aggregate amount   $ 35,000    
Interest rate (as a percent)   14.00%    
v3.24.3
Significant Accounting Policies (Narrative) (Details)
$ in Thousands
9 Months Ended
Sep. 30, 2024
USD ($)
item
Dec. 31, 2023
USD ($)
Operating segment | item 1  
Long-lived assets $ 13,616 $ 12,559
UNITED STATES    
Long-lived assets $ 13,500  
Percentage of long-lived assets 99.20%  
v3.24.3
Fair Value Measurements (Assets and liabilities at fair value) (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Investments in money market fund - financial assets, included in cash and cash equivalents $ 10,355  
Convertible debt- financial liabilities 41,357 $ 58,633
Level 1    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Investments in money market fund - financial assets, included in cash and cash equivalents 10,355  
Level 3    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Convertible debt- financial liabilities $ 41,357 $ 58,633
v3.24.3
Fair Value Measurements (Company's Fair Value Measurements Using Level 3 Inputs) (Details)
9 Months Ended 12 Months Ended
Sep. 30, 2024
Y
Dec. 31, 2023
Y
Discount rate    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Debt instrument, measurement input, for the period 0.1950 0.2101
Probabilities of settlement scenarios | Minimum    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Debt instrument, measurement input, for the period 0 0
Probabilities of settlement scenarios | Maximum    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Debt instrument, measurement input, for the period 0.75 0.75
Volatility    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Debt instrument, measurement input, for the period 0.932 1.203
Expected term | Minimum    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Debt instrument, measurement input, for the period 0.26 0.16
Expected term | Maximum    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Debt instrument, measurement input, for the period 0.28 1.04
Risk-free rate | Minimum    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Debt instrument, measurement input, for the period 0.0458 0.0466
Risk-free rate | Maximum    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Debt instrument, measurement input, for the period 0.0461 0.0536
v3.24.3
Fair Value Measurement (Changes in Fair Value of Liabilities) (Details) - Fair Value, Inputs, Level 3 - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]    
Convertible debt opening balance $ 58,633  
Change in fair value (17,276)  
Convertible debt closing balance $ 41,357  
Convertible Loan Pre Modification    
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]    
Net issuance of Convertible Loan   $ 29,226
Change in fair value   (1,757)
Amount exchanged   (31,332)
Loss on extinguishment   3,863
Convertible Loan Post Modification    
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]    
Initial recognition of modified Convertible Loan   35,031
Change in fair value   14,716
Convertible debt closing balance   $ 49,747
v3.24.3
Net Loss per Share (Basic and Diluted EPS) (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Numerator:        
Net Income (Loss) $ (5,481) $ (31,161) $ (21,516) $ (49,198)
Denominator:        
Weighted average common shares outstanding - basic 36,180,124 36,086,990 36,153,388 36,067,025
Weighted average common shares outstanding - diluted 36,180,124 36,086,990 36,153,388 36,067,025
Net loss per share, basic $ (0.15) $ (0.86) $ (0.60) $ (1.36)
Net loss per share, diluted $ (0.15) $ (0.86) $ (0.60) $ (1.36)
v3.24.3
Net Loss per Share (Antidilutive Shares Excluded from Computation of Diluted Shares Outstanding) (Details) - USD ($)
$ / shares in Units, $ in Millions
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Jan. 10, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Antidilutive securities excluded from computation of diluted weighted shares outstanding 46,026,192 44,024,924  
Innoviva Strategic Opportunities LLC | Secured term loan      
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Convertible loan principal amount $ 30.0    
Accrued and unpaid interest $ 4.2    
Interest rate (as a percent) 8.00%   8.00%
Price per share $ 1.52   $ 1.52
Outstanding stock options      
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Antidilutive securities excluded from computation of diluted weighted shares outstanding 3,934,731 3,165,216  
Unvested restricted stock units      
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Antidilutive securities excluded from computation of diluted weighted shares outstanding 230,000 200,000  
Shares issuable upon the conversion of convertible debt      
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Antidilutive securities excluded from computation of diluted weighted shares outstanding 22,495,614 21,293,861  
Outstanding warrants      
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]      
Antidilutive securities excluded from computation of diluted weighted shares outstanding 19,365,847 19,365,847  
v3.24.3
Balance Sheet Details (Narrative) (Details) - USD ($)
$ in Millions
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Balance Sheet Details          
Depreciation $ 0.3 $ 0.2 $ 0.9 $ 0.7  
Construction in progress and fixed assets $ 9.6   $ 9.6   $ 8.1
v3.24.3
Balance Sheet Details (Property and Equipment) (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Property, Plant and Equipment [Line Items]    
Total $ 26,382 $ 24,380
Less: accumulated depreciation (12,766) (11,821)
Property and equipment, net 13,616 12,559
Laboratory equipment    
Property, Plant and Equipment [Line Items]    
Total 21,311 19,678
Office and computer equipment    
Property, Plant and Equipment [Line Items]    
Total 438 438
Furniture and fixtures    
Property, Plant and Equipment [Line Items]    
Total 831 817
Leasehold improvements    
Property, Plant and Equipment [Line Items]    
Total $ 3,802 $ 3,447
v3.24.3
Balance Sheet Details (Other receivables) (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Balance Sheet Details    
Tenant improvement allowance receivable (Note 12) $ 597 $ 1,835
Grant and award receivable (Note 13) 1,622 1,528
Other receivables $ 2,219 $ 3,363
v3.24.3
Balance Sheet Details (Accounts payable and accrued liabilities) (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Balance Sheet Details    
Accounts payable $ 1,815 $ 1,585
Accrued clinical trial expenses 1,567 3,021
Other accrued expenses 332 1,083
Accounts Payable and Accrued Liabilities, Current, Total $ 3,714 $ 5,689
v3.24.3
Convertible Debt (Narrative) (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 9 Months Ended
Jan. 10, 2023
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Change in fair value, gain (loss)   $ 6,904 $ (15,833) $ 17,276 $ (12,959)
Innoviva Strategic Opportunities LLC          
Proceeds from qualified financing per agreement benchmark $ 30,000        
Innoviva Strategic Opportunities LLC | Secured term loan          
Aggregate amount $ 30,000        
Interest rate (as a percent) 8.00% 8.00%   8.00%  
Discount on share price for conversion 15.00%        
Price per share $ 1.52 $ 1.52   $ 1.52  
Change in fair value, gain (loss)   $ 6,900 $ (15,800) $ 17,300 $ (13,000)
v3.24.3
Term Debt (Details) - Secured term loan - Innoviva Strategic Opportunities LLC - USD ($)
$ in Millions
Sep. 30, 2024
Mar. 04, 2024
Jul. 10, 2023
Jan. 10, 2023
Term Loan        
Aggregate amount       $ 30.0
Interest rate (as a percent) 8.00%     8.00%
2023 Credit Agreement        
Term Loan        
Aggregate amount     $ 25.0  
Interest rate (as a percent) 27.31%   14.00%  
Debt issuance costs     $ 0.1  
Recognized at fair value     21.2  
Debt discount     $ 3.8  
2024 Credit Agreement        
Term Loan        
Aggregate amount   $ 35.0    
Interest rate (as a percent) 14.25% 14.00%    
Debt issuance costs   $ 0.1    
v3.24.3
Stockholders' Deficit (Summary of Warrants Outstanding) (Details)
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Warrants 19,365,847
Exercise Price $2.87, February 11, 2025  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Warrants 993,139
Exercise Price | $ / shares $ 2.87
Warrant Expiration Date Feb. 11, 2025
Exercise Price $2.87, March 27, 2025  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Warrants 7,717,661
Exercise Price | $ / shares $ 2.87
Warrant Expiration Date Mar. 27, 2025
Exercise Price $3.25, January 26, 2026  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Warrants 1,867,912
Exercise Price | $ / shares $ 3.25
Warrant Expiration Date Jan. 26, 2026
Exercise Price $3.25, March 16, 2026  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Warrants 4,285,935
Exercise Price | $ / shares $ 3.25
Warrant Expiration Date Mar. 16, 2026
Exercise Price $5.00, February 8, 2027  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Warrants 1,807,396
Exercise Price | $ / shares $ 5.00
Warrant Expiration Date Feb. 08, 2027
Exercise Price $5.00, March 30, 2027  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Warrants 2,692,604
Exercise Price | $ / shares $ 5.00
Warrant Expiration Date Mar. 30, 2027
Exercise Price 1680.00  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Warrants 1,200
Exercise Price | $ / shares $ 1,680.00
v3.24.3
Stockholders' Deficit (Shares Reserved for Future Issuance) (Details) - shares
Sep. 30, 2024
Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Stock options outstanding 3,934,731 3,165,216
Shares issuable under the Employee stock purchase plan 11,890  
Shares available for future grants under the 2016 Plan 3,219,158  
Warrants outstanding 19,365,847  
Shares issuable upon the conversion of convertible debt 22,495,614  
Total shares reserved 49,257,240  
Restricted stock unit    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Unvested restricted stock units 230,000  
Equity Incentive Plan 2016    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Shares available for future grants under the 2016 Plan 3,219,158  
v3.24.3
Equity Incentive Plans (Narrative) (Details)
$ / shares in Units, $ in Millions
9 Months Ended
Sep. 30, 2024
USD ($)
$ / shares
shares
Shares available for future grants under the 2016 Plan | shares 3,219,158
Employee Stock Option  
Common stock closing price | $ / shares $ 2.37
Stock Options And Restricted Stock Awards  
Unrecognized compensation cost related to unvested options | $ $ 3.0
Weighted-average remaining period for recognition of compensation costs related to unvested options 1 year 10 months 24 days
v3.24.3
Equity Incentive Plans (Summary of Stock Option Activity) (Details) - USD ($)
$ / shares in Units, $ in Thousands
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Equity Incentive Plans    
Shares, Balance Beginning 3,165,216  
Shares, Granted 1,784,054  
Shares, Exercised (37,282)  
Shares, Forfeited/Cancelled/Expired (977,257)  
Shares, Balance Ending 3,934,731 3,165,216
Vested and expected to vest at September 30, 2024 3,934,731  
Exercisable at June 30, 2024 2,094,287  
Weighted Average Exercise Price, Outstanding Beginning $ 5.04  
Weighted Average Exercise Price, Granted 3.38  
Weighted Average Exercise Price, Exercised 3.38  
Weighted Average Exercise Price, Forfeited/Cancelled/Expired 7.10  
Weighted Average Exercise Price, Outstanding Ending 3.79 $ 5.04
Weighted Average Exercise Price, Vested and expected to vest at September 30, 2024 3.79  
Weighted Average Exercise Price, Exercisable at September 30, 2024 $ 4.07  
Weighted Average Remaining Contractual Term (Years), Outstanding 7 years 9 months 18 days 5 years 10 months 24 days
Weighted Average Remaining Contractual Term (Years), Vested and expected to vest at September 30, 2024 7 years 9 months 18 days  
Weighted Average Remaining Contractual Term (Years), Exercisable at September 30, 2024 6 years 7 months 6 days  
Aggregate Intrinsic Value, Outstanding Beginning $ 429  
Aggregate Intrinsic Value, Exercised 24  
Aggregate Intrinsic Value, Outstanding Ending 15 $ 429
Aggregate Intrinsic Value, Vested and expected to vest at September 30, 2024 15  
Aggregate Intrinsic Value, Exercisable at September 30, 2024 $ 3  
v3.24.3
Equity Incentive Plans (Restricted stock award and restricted stock unit award activity) (Details) - Restricted stock awards - C3J Stock Plan 2016
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Shares  
Outstanding at beginning of period (in shares) | shares 200,000
Granted (in shares) | shares 90,000
Vested (in shares) | shares (50,000)
Cancelled (in shares) | shares (10,000)
Outstanding at end of period (in shares) | shares 230,000
Weighted Avg Grant Date Fair Value  
Outstanding at beginning of period (in dollars per share) | $ / shares $ 2.39
Granted (in dollars per share) | $ / shares 3.38
Vested (in dollars per shares) | $ / shares 2.39
Cancelled (in dollars per share) | $ / shares 3.38
Outstanding at end of period (in dollars per share) | $ / shares $ 2.73
v3.24.3
Equity Incentive Plans (Assumptions Used in the Black-Scholes Model) (Details) - Common Stock Options
3 Months Ended 9 Months Ended
Sep. 30, 2024
Y
USD ($)
Sep. 30, 2023
Y
Sep. 30, 2024
Y
Sep. 30, 2023
Y
Expected dividend yield        
Fair value input, equity securities 0 0 0 0
Minimum | Risk-free interest rate        
Fair value input, equity securities 0 0.0549 0.0424 0.0354
Minimum | Expected volatility        
Fair value input, equity securities 0 0.7540 0.894 0.7540
Minimum | Expected term        
Fair value input, equity securities 0 0.1 5.1 0.1
Maximum | Risk-free interest rate        
Fair value input, equity securities 0 0.0554 0.0425 0.0554
Maximum | Expected volatility        
Fair value input, equity securities 0 1.1696 0.925 1.1696
Maximum | Expected term        
Fair value input, equity securities 0 0.6 7.0 7.0
v3.24.3
Equity Incentive Plans (Allocation of Share-Based Compensation Expense) (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total stock-based compensation $ 670 $ (373) $ 2,539 $ 745
Research and development        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total stock-based compensation 323 144 698 948
General and administrative        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total stock-based compensation $ 347 $ (517) $ 1,841 $ (203)
v3.24.3
Income Taxes (Narrative) (Detail) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Income Taxes        
Income tax expense (benefit) $ 0 $ 0 $ 0 $ 0
v3.24.3
Commitments and Contingencies (Narrative) (Details) - USD ($)
$ in Millions
1 Months Ended 3 Months Ended 9 Months Ended
Apr. 30, 2020
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Oct. 28, 2021
Annual increase in rent percentage 3.00%          
Standby letter of credit           $ 5.0
Lease term           16 years
Base annual rent for 2024           $ 0.3
Allowance for tenant improvements           $ 7.2
Rent expense under operating leases   $ 2.0 $ 2.1 $ 6.3 $ 5.7  
Variable lease payment   0.4 $ 0.5 1.4 $ 0.9  
Minimum            
Base rent at the end of lease term $ 1.9          
Maximum            
Base rent at the end of lease term 2.5          
Cash            
Standby letter of credit $ 1.2 $ 0.5   $ 0.5    
Annual reduction of standby letter of credit 20.00%          
v3.24.3
Commitments and Contingencies (Future Minimum Lease Payments) (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Commitments and Contingencies.    
2024 (remaining three months) $ 836  
2025 5,139  
2026 5,293  
2027 5,452  
2028 5,616  
Thereafter 43,779  
Total minimum lease payments 66,115  
Less: amount representing interest (33,192)  
Present value of operating lease obligations 32,923  
Less: current portion (4,994) $ (9,481)
Noncurrent operating lease obligations $ 27,929 $ 28,583
v3.24.3
Commitments and Contingencies (Operating leases) (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Commitments and Contingencies.      
Operating cash flows from operating leases $ 2,006 $ 3,223  
Weighted-average remaining lease term, years 11 years 11 months 19 days   12 years 9 months 14 days
Weighted-average discount rate, % 13.90%   13.90%
v3.24.3
Grant and Awards (Narrative) (Details) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Sep. 29, 2022
Jun. 15, 2020
Mar. 13, 2020
Jul. 31, 2024
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Mar. 31, 2024
Dec. 31, 2023
MTEC Grant                    
Government Assistance [Line Items]                    
Revenue from grants $ 16,300,000 $ 15,000,000.0   $ 21,600,000         $ 16,300,000  
Government assistance, transaction duration   3 years                
Increase in expected revenue from grants $ 1,300,000     $ 5,300,000            
Grant revenue from the MTEC Agreement         $ 3,000,000.0 $ 1,200,000 $ 3,900,000 $ 3,000,000.0    
Additional grant revenue to be recognized         5,300,000          
Grants receivable         1,600,000   1,600,000     $ 1,500,000
CFF Therapeutics Development Award                    
Government Assistance [Line Items]                    
Grant revenue from the MTEC Agreement         $ 0 $ 0 $ 0 $ 0    
Proceeds from governments grants     $ 1,000,000.0              
Award agreement interruption period     360 days              
CFF Therapeutics Development Award | Maximum                    
Government Assistance [Line Items]                    
Revenue from grants     $ 5,000,000.0              

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