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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 15, 2024
_______________________________
Molecular Templates, Inc.
(Exact name of registrant as specified in its charter)
_______________________________
Delaware | 001-32979 | 94-3409596 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
9301 Amberglen Blvd, Suite 100
Austin, Texas 78729
(Address of Principal Executive Offices) (Zip Code)
(512) 869-1555
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
_______________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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, $0.001 Par Value | MTEM | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 15, 2024, Molecular Templates, Inc. (the "Company") announced its financial results for the first quarter of 2024 ended March 31, 2024. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this current report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
SIGNATURE
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 hereunto duly authorized.
| Molecular Templates, Inc. |
| | |
| | |
Date: May 15, 2024 | By: | /s/ Eric E. Poma, Ph.D. |
| | Eric E. Poma, Ph.D. |
| | Chief Executive Officer |
| | |
EXHIBIT 99.1
Molecular Templates, Inc. Reports First Quarter 2024 Financial Results and Corporate Update
AUSTIN, Texas, May 15, 2024 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (“ETBs”), to create novel therapies with potent differentiated mechanisms of action, today reported financial results and business updates for the first quarter of 2024.
Recent Company Highlights
- MTEM presented clinical data at the 2024 AACR Annual Meeting that demonstrated MT-6402's tolerable safety and promising efficacy profile in relapsed/refractory HNSCC patients. As monotherapy in 7 evaluable HNSCC patients (all heavily pretreated and checkpoint experienced), 2 confirmed PRs (ongoing at 10 and 20 months, respectively) and 4 SDs (two of whom showed tumor reduction) were observed. An expansion cohort in relapsed/refractory HNSCC with MT-6402 monotherapy is underway with data expected by year-end. A second monotherapy MT-6402 expansion cohort is enrolling for solid tumor patients with high PD-L1 (≥ 50%).
- The MT-8421 Phase 1 dose escalation is ongoing with continued observation of unique pharmacodynamic profile (peripheral and TME Treg depletion)
- In April, MTEM completed the second closing of the July 2023 financing with gross proceeds of approximately $9.5M
Eric Poma, PhD., Chief Executive and Chief Scientific Officer of MTEM, stated, “MT-6402 and MT-8421 represent novel approaches to validated immuno-oncology targets. Monotherapy activity with MT-6402 in patients that have progressed on available therapy, including checkpoint therapy, demonstrates the potential of our technology. We look forward to expanding on these promising data.”
Conferences and Upcoming Meetings
MTEM will participate at the BIO International conference taking place at the San Diego Convention Center from June 3 – 6, 2024. One-on-one meetings may be scheduled by directly contacting Molecular Templates.
First Quarter 2024 Financial Results
The net income attributable to common shareholders for the first quarter of 2024 was $0.6 million, or $0.11 per basic share and $0.08 per diluted share. This compares with a net income attributable to common shareholders of $10.8 million, or $2.89 per basic and diluted share, for the same period in 2023.
Revenues for the first quarter of 2024 were $11.1 million, compared to $36.6 million for the same period in 2023.
Total research and development expenses for the first quarter of 2024 were $7.4 million, compared with $19.0 million for the same period in 2023. Total general and administrative expenses for the first quarter of 2024 were $3.7 million, compared with $5.8 million for the same period in 2023.
As of March 31, 2024, MTEM’s cash and cash equivalents totaled $6.8 million. The Company expects that its cash and cash equivalents for the quarter ended March 31, 2024, and the subsequent second closing of the July 2023 financing with gross proceeds of approximately $9.5M, will support its ongoing operations into the fourth quarter of 2024.
Molecular Templates, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) |
| | | | | | |
| | Three Months Ended March 31, |
| | 2024
| | 2023
|
Research and development revenue | | $ | 10,924 | | | $ | 33,627 | |
Grant revenue | | | 162 | | | | 3,002 | |
Total revenue | | | 11,086 | | | | 36,629 | |
Operating expenses: | | | | | | |
Research and development | | | 7,405 | | | | 19,042 | |
General and administrative | | | 3,731 | | | | 5,802 | |
Total operating expenses | | | 11,136 | | | | 24,844 | |
Income/(loss) from operations | | | (50 | ) | | | 11,785 | |
Interest and other income, net | | | 109 | | | | 455 | |
Interest and other expense, net | | | (31 | ) | | | (1,395 | ) |
Change in valuation of contingent value right | | | 544 | | | | — | |
Net income attributable to common stockholders | | $ | 572 | | | $ | 10,845 | |
Net income per share attributable to common stockholders: | | | | | | |
Basic | | $ | 0.11 | | | $ | 2.89 | |
Diluted | | $ | 0.08 | | | $ | 2.89 | |
Weighted average number of shares used in net income per share calculations: | | | | | | |
Basic | | | 5,374,268 | | | | 3,756,711 | |
Diluted | | | 7,015,864 | | | | 3,756,711 | |
Molecular Templates, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) |
| | | | | | |
| | March 31, 2024 (unaudited) | | December 31, 2023 |
ASSETS | | | | | | |
Current assets: | | | | | | |
Cash and cash equivalents | | $ | 6,779 | | | $ | 11,523 | |
Prepaid expenses | | | 1,200 | | | | 2,195 | |
Grants revenue receivable | | | 412 | | | | 250 | |
Other current assets | | | 2,299 | | | | 2,804 | |
Total current assets | | | 10,690 | | | | 16,772 | |
Operating lease right-of-use assets | | | 8,647 | | | | 9,161 | |
Property and equipment, net | | | 6,284 | | | | 7,393 | |
Other assets | | | 1,498 | | | | 2,057 | |
Total assets | | $ | 27,119 | | | $ | 35,383 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | |
Current liabilities: | | | | | | |
Accounts payable | | $ | 2,681 | | | $ | 1,523 | |
Accrued liabilities | | | 2,748 | | | | 4,279 | |
Deferred revenue, current | | | — | | | | 9,031 | |
Other current liabilities | | | 3,152 | | | | 2,488 | |
Total current liabilities | | | 8,581 | | | | 17,321 | |
Operating lease liabilities, long term portion | | | 9,075 | | | | 9,742 | |
Contingent value right liability | | | 2,158 | | | | 2,702 | |
Other liabilities | | | 1,435 | | | | 1,406 | |
Total liabilities | | | 21,249 | | | | 31,171 | |
Commitments and contingencies | | | | | | |
Stockholders’ equity | | | | | | |
Preferred stock, $0.001 par value per share: | | | | | | |
Authorized: 2,000,000 shares as of March 31, 2024 and December 31, 2023; Issued and outstanding: 250 shares as of March 31, 2024 and December 31, 2023 | | | — | | | | — | |
Common stock, $0.001 par value per share: | | | | | | |
Authorized: 150,000,000 shares as of March 31, 2024 and December 31, 2023; Issued and outstanding: 5,374,268 shares as of March 31, 2024 and December 31, 2023 | | | 5 | | | | 5 | |
Additional paid-in capital | | | 458,185 | | | | 457,099 | |
Accumulated deficit | | | (452,320 | ) | | | (452,892 | ) |
Total stockholders’ equity | | | 5,870 | | | | 4,212 | |
Total liabilities and stockholders’ equity | | $ | 27,119 | | | $ | 35,383 | |
About Molecular Templates
Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation ADCs. Our drug platform technology, known as Engineered Toxin Bodies (ETBs), leverages the resident biology of a genetically engineered toxin payload to create novel therapies with potent and differentiated mechanisms of action for cancer and various disease indications.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. All statements, other than statements of historical facts, included in this press release, including, but not limited to those regarding strategy, future operations, the Company’s ability to execute on its objectives, prospects, plans, future clinical development of the Company’s product candidates, any implication that the preliminary results, interim results, or the results of earlier clinical trials or ongoing clinical trials will be representative of the results of future or later clinical trials or final results, the potential benefits, safety or efficacy and any evaluations or judgments regarding the Company’s product candidates, and future execution of corporate goals. In addition, when or if used in this press release, the words “may,” “could,” “should,” “continue”, “anticipate,” “potential”, “believe,” “estimate,” “appears”, “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Molecular Templates may identify forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differ materially from those discussed in the forward-looking statements as a result of various factors including, but not limited to the following: the continued availability of financing on commercially reasonable terms, whether Molecular Templates’ cash resources will be sufficient to fund its continuing operations; the results of MTEM’s ongoing clinical studies and the ability to effectively operate MTEM, and those risks identified under the heading “Risk Factors” in Molecular Templates’ filings with the Securities and Exchange Commission (the “SEC”), including its Form 10-Q for the first quarter year ended March 31, 2024 and any subsequent reports filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Molecular Templates specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.
Contacts:
Grace Kim
grace.kim@mtem.com
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