UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
(Address of principal executive offices) | (Zip Code) |
(
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
The |
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.
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).
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. 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 | ☐ |
☒ | 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
On May 6, 2024, there were
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, including the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements, other than statements of historical facts contained herein, regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, statements about:
● | the implementation of our business strategies, including our ability to pursue development pathways and regulatory strategies for MT-6402, MT-8421, MT-0169 and other engineered toxin body (“ETB”) biologic candidates; |
● | our utilization of a de-immunized ETB scaffold that has been designed to reduce or eliminate the propensity for innate immunity, including capillary leak syndrome (“CLS”), via de-immunization of the Shiga-like Toxin A subunit (“SLTA”) as well as chemistry, manufacturing, and controls improvements; |
● | the timing and our ability to advance the development of our biologic candidates; |
● | our plans to pursue discussions with regulatory authorities, and the anticipated timing, scope and outcome of related regulatory actions or guidance; |
● | our ability to establish and maintain potential new partnering or collaboration arrangements for the development and commercialization of ETB biologic candidates; |
● | our ability to obtain the benefits we anticipate from partnering, collaboration, or supply agreements that we may enter into; |
● | our financial condition, including our ability to obtain the funding necessary to advance the development of our biologic candidates, and our ability to continue as a going concern; |
● | our ability to comply with the terms of our Contingent Value Rights Agreement pursuant to which our obligations are secured, subject certain limited exceptions, by substantially all of our assets; |
● | our ability to comply with applicable listing standards within the one year monitoring period that commenced on August 2, 2023 and to maintain the listing of shares of our common stock on the Nasdaq Capital Market; |
● | the ongoing effect of the reverse stock split of our common stock that we completed in August 2023 on the price or trading of our common stock; including potential continued adverse impacts on the liquidity of our common stock; |
● | the anticipated progress of our biologic candidate development programs, including whether our ongoing and potential future clinical trials will achieve clinically relevant results; |
● | our ability to generate data and conduct analyses to support the regulatory approval of our biologic candidates; |
● | our ability to establish and maintain intellectual property rights for our biologic candidates; |
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● | whether any biologic candidates that we are able to commercialize are safer or more effective than other marketed products, treatments or therapies; |
● | our ability to discover and develop additional biologic candidates suitable for clinical testing; |
● | our ability to identify, in-license or otherwise acquire additional drug or biologic candidates and development programs; |
● | our anticipated research and development activities and projected expenditures; |
● | our ability to complete preclinical and clinical testing successfully for new drug or biologic candidates that we may develop or license; |
● | our ability to have manufactured active pharmaceutical ingredient and biologic product that meet required release and stability specifications; |
● | our ability to have manufactured sufficient supplies of drug product for clinical testing and commercialization; |
● | our ability to obtain licenses to any necessary third-party intellectual property; |
● | our anticipated use of proceeds from any financing activities; |
● | potential uncertainty regarding the outcome of our exploration of strategic alternatives, and the impacts that it may have on our business; |
● | the expected cost savings from our strategic restructurings, including the reduction in force we completed in April 2024; |
● | the extent to which global economic and political developments, including the indirect and/or long-term impact of inflation, will affect our business operations, clinical trials, or financial condition; |
● | the impact of laws and regulations; |
● | our projected financial performance; |
● | the sufficiency of our cash resources; and |
● | other risks and uncertainties, including those listed under Part II, Item 1A, “Risk Factors.” |
Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A, “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the incidence and prevalence of certain medical conditions. 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
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and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.
As used in this Quarterly Report on Form 10-Q, unless otherwise stated or the context otherwise indicates, references to “Molecular,” the “Company,” “we,” “our,” “us” or similar terms refer to Molecular Templates, Inc., and our wholly-owned subsidiary.
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Molecular Templates, Inc.
TABLE OF CONTENTS
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Molecular Templates, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
|
| March 31, |
| December 31, | ||
ASSETS | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | | $ | | ||
Prepaid expenses | | | ||||
Grants revenue receivable | | | ||||
Other current assets | | | ||||
Total current assets | | | ||||
Operating lease right-of-use assets | | | ||||
Property and equipment, net | | | ||||
Other assets | | | ||||
Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
Current liabilities: | ||||||
Accounts payable | $ | | $ | | ||
Accrued liabilities | | | ||||
Deferred revenue, current | — | | ||||
Other current liabilities | | | ||||
Total current liabilities | | | ||||
Operating lease liabilities, long term portion | | | ||||
Contingent value right liability | | | ||||
Other liabilities | | | ||||
Total liabilities | | | ||||
Commitments and contingencies (Note 9) | ||||||
Stockholders’ equity | ||||||
Preferred stock, $ | ||||||
Authorized: | ||||||
Common stock, $ | ||||||
Authorized: | | | ||||
Additional paid-in capital | | | ||||
Accumulated deficit | ( | ( | ||||
Total stockholders’ equity | | | ||||
Total liabilities and stockholders’ equity | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
Three Months Ended | ||||||
|
| 2024 |
| 2023 | ||
Research and development revenue | $ | | $ | | ||
Grant revenue | | | ||||
Total revenue | | | ||||
Operating expenses: | ||||||
Research and development | | | ||||
General and administrative | | | ||||
Total operating expenses | | | ||||
Income/(loss) from operations | ( | | ||||
Interest and other income, net | | | ||||
Interest and other expense, net | ( | ( | ||||
Change in valuation of contingent value right (Note 4) | | — | ||||
Net income attributable to common stockholders | $ | | $ | | ||
Net income per share attributable to common stockholders: | ||||||
Basic | $ | | $ | | ||
Diluted | $ | | $ | | ||
Weighted average number of shares used in net income per share calculations: | ||||||
Basic | | | ||||
Diluted | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(in thousands, except share and per share data)
(unaudited)
Three Months Ended | ||||||
|
| 2024 |
| 2023 | ||
Net income | $ | | $ | | ||
Other comprehensive income: | ||||||
Unrealized gain on available-for-sale securities | — | | ||||
Comprehensive income | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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MOLECULAR TEMPLATES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands, except share data)
(unaudited)
| Three Months Ended | |||||
| 2024 |
| 2023 | |||
Total Stockholders' Equity (Deficit), beginning balances | $ | | $ | ( | ||
Common Stock (shares):1 | ||||||
Beginning balance | | | ||||
Ending balance | | | ||||
Common Stock (amount):1 | ||||||
Beginning balance | $ | | $ | | ||
Ending balance | | | ||||
Additional Paid-In Capital:1 | ||||||
Beginning balance | | | ||||
Stock-based compensation | | | ||||
Ending balance | | | ||||
Accumulated Other Comprehensive Income/(Loss): | ||||||
Beginning balance | — | ( | ||||
Other comprehensive income/(loss) | | | ||||
Ending balance | — | | ||||
Accumulated deficit: | ||||||
Beginning balance | ( | ( | ||||
Net income | | | ||||
Ending balance | ( | ( | ||||
Total Stockholders' Equity (Deficit) | $ | | $ | ( |
1.
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
| Three Months Ended | |||||
|
| 2024 |
| 2023 | ||
Cash flows from operating activities: | ||||||
Net income | $ | | $ | | ||
Adjustments to reconcile net income to net cash used in operating activities: | ||||||
Depreciation, amortization and other | | | ||||
Stock-based compensation expense | | | ||||
Amortization of debt discount and accretion related to debt | — | | ||||
Accretion of asset retirement obligations | | | ||||
Change in valuation of contingent value right | ( | — | ||||
Changes in operating assets and liabilities: | ||||||
Prepaid expenses | | | ||||
Grants revenue receivable | ( | ( | ||||
Other assets | | ( | ||||
Operating lease right-of-use assets and liabilities | ( | ( | ||||
Accounts payable | | | ||||
Accrued liabilities | ( | ( | ||||
Other liabilities | | — | ||||
Deferred revenue | ( | ( | ||||
Net cash used in operating activities | ( | ( | ||||
Cash flows from investing activities: | ||||||
Purchases of property and equipment | — | ( | ||||
Purchase of marketable securities | — | ( | ||||
Sales of marketable securities | — | | ||||
Net cash provided by investing activities | — | | ||||
Net (decrease)/increase in cash, cash equivalents, and restricted cash | ( | | ||||
Cash, cash equivalents and restricted cash, beginning of period | | | ||||
Cash, cash equivalents and restricted cash, end of period | $ | | $ | | ||
Reconciliation of cash, cash equivalents and restricted cash | ||||||
Cash and cash equivalents | $ | | $ | | ||
| | |||||
Total cash, cash equivalents and restricted cash | $ | | $ | | ||
Supplemental Cash Flow Information | ||||||
Cash paid for interest | $ | — | $ | | ||
Non-Cash Investing Activities | ||||||
Fixed asset additions in accounts payable and accrued expenses | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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Molecular Templates, Inc.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature of the Business
Molecular Templates, Inc. (the “Company”) is a clinical stage biopharmaceutical company formed in 2001, with a biologic therapeutic platform for the development of novel targeted therapeutics for cancer, headquartered in Austin, Texas. The Company’s focus is on the research and development of therapeutic compounds for a variety of cancers. The Company operates its business as a single segment, as defined by U.S. generally accepted accounting principles (“U.S. GAAP”).
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP and include the accounts of the Company and its wholly owned subsidiary and reflect the elimination of intercompany accounts and transactions.
The preparation of condensed consolidated financial statements requires management to make estimates and assumptions that affect the recorded amounts reported therein. A change in facts or circumstances surrounding the estimates could result in a change to estimates and impact future operating results. Certain accounts in the prior financial statements have been reclassified for comparative purposes to conform to the presentation in the current financial statements. These reclassifications have no material effect on previously reported financials. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation have been included.
The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 29, 2024.
On August 11, 2023, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to its Amended and Restated Certificate of Incorporation to effect a one-time reverse stock split of the Company’s common stock, at a ratio of (the “Reverse Stock Split”). The Reverse Stock Split was effective at 5 p.m. Eastern Time, after the close of trading on the Nasdaq Capital Market, on August 11, 2023 (the “Effective Time”). At the Effective Time, every 15 shares of the Company’s issued and outstanding common stock were automatically converted into one share of common stock, without any change in the par value per share. Any stockholder who was entitled to a fractional share of common stock created as a result of the Reverse Stock Split received a cash payment in lieu thereof equal to the fractional share to which the stockholder was entitled multiplied by the closing sales price of a share of common stock on August 11, 2023, as adjusted for the Reverse Stock Split. All common stock, per share and related information presented in the condensed consolidated financial statements and notes prior to the Reverse Stock Split have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented, to the extent applicable.
Going Concern
The Company has adopted as required the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements - Going Concern, which requires that management contemplate the realization of assets and liquidation of liabilities in the normal course of business, and evaluate whether there are relevant conditions and events that in the aggregate raise substantial doubt about the entity’s ability to continue as a going concern and to meet its obligations as they become due within one year after the date that
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the financial statements are issued. Under this standard, management’s assessment shall not take into consideration the potential mitigating effects of management’s plans that have not been fully implemented as of the date the financial statements are issued.
As of March 31, 2024, the Company had an accumulated deficit of $
Historically, the Company financed its operations to date primarily through partnerships, funds received from public offerings of common and preferred stock, private placements of equity securities, a reverse merger, upfront and milestone payments received from its prior and current collaboration agreements, a debt financing facility, as well as funding from governmental bodies and bank and bridge loans. The Company plans to address this condition through the sale of common stock in public offerings and/or private placements, debt financings, or through other capital sources, including collaborations with other companies or other strategic transactions, but there is no assurance these plans will be completed successfully or at all.
If the Company is unable to obtain additional capital when and as needed to continue as a going concern, it might have to further reduce or scale back its operations, cease operations entirely, and/or liquidate its assets, and the values it receives for its assets in liquidation or dissolution could be significantly lower than the values reflected in its financial statements.
These financial statements do not give effect to any adjustments which will be necessary should the Company be unable to continue as a going concern and therefore be required to realize its assets and discharge its liabilities in other than the normal course of business and at amounts different from those reflected in the accompanying financial statements.
Significant Accounting Policies
There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2024, as compared to the significant accounting policies disclosed in Note 1 “Organization and Summary of Significant Accounting Policies,” to the consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Cash and Cash Equivalents
The Company considers temporary investments having original maturities of three months or less from date of purchase to be cash equivalents. Restricted cash is recorded in other assets, based on when the restrictions expire. Other assets include $
Fair Value Measurement
The Company accounts for its marketable securities in accordance with ASC 820 “Fair Value Measurements and Disclosures.” ASC 820 defines fair value, establishes a framework for measuring fair value in U.S. GAAP, and expands disclosures about fair value measurements. ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value
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hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value:
Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
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 Company utilizes the market approach or probability approach to measure fair value for its financial assets and liabilities. The market approach uses prices and other relevant information generated by market transactions involving identical or comparable assets or liabilities. For Level 2 securities that have market prices from multiples sources, a “consensus price” or a weighted average price for each of these securities can be derived from a distribution-curve-based algorithm which includes market prices obtained from a variety of industrial standard data providers (e.g. Bloomberg), security master files from large financial institutions, and other third-party sources. Level 2 securities with short maturities and infrequent secondary market trades are typically priced using mathematical calculations adjusted for observable inputs when available. Level 3 securities utilize a probability weighted expected return method or Black-Scholes option-pricing model. Significant estimates and assumptions required for these valuations include, but are not limited to, probabilities related to the timing and outcome of future financing and/or liquidity events. These unobservable inputs represent a Level 3 measurement because they are supported by little or no market activity and reflect our own assumptions in measuring fair value.
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to concentrations of risk consist principally of cash and cash equivalents, investments, long term debt and accounts receivable.
The Company’s cash and cash equivalents are with
The Company performs an ongoing credit evaluation of its strategic partners’ financial conditions and generally does not require collateral to secure accounts receivable from its strategic partners. As of March 31, 2024, the Company’s exposure to credit risk associated with non-payment will be affected principally by conditions or occurrences within Bristol-Myers Squibb Company (“Bristol-Myers Squibb”). Bristol-Myers Squibb accounted for approximately
Biologic candidates developed by the Company require approvals or clearances from the U.S. Food and Drug Administration (the “FDA”) or international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s biologic candidates will receive any of the required approvals or clearances. If the Company were to be denied approval or clearance or any such approval or clearance were to be delayed, it would have a material adverse impact on the Company.
Recently Issued Accounting Pronouncements
In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (Subtopic 470-20: Debt with Conversion and Other Options and Subtopic 815-40: Derivatives and Hedging - Contracts in Entity’s Own Equity). The new guidance simplifies accounting for convertible instruments by removing major separation models, removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. The amendment is effective for the Company for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, using a modified retrospective approach. The impact of the adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
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In December 2023, the FASB issued ASU No. 2023-09, “Improvements to Income Tax Disclosures” (Topic 740: Income Taxes). The new guidance requires that public entities disclose more consistent categories and greater disaggregation of information in the income tax rate reconciliations and further disaggregate income taxes paid by jurisdiction. The amendment is effective for the Company for fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements.
NOTE 2 — NET INCOME PER COMMON SHARE
Basic net income per common share is computed by dividing net income by the weighted-average number of common shares outstanding during the period utilizing the two-class method. Preferred stockholders participate equally with common stockholders in earnings, but do not participate in losses, and are excluded from the basic net income calculation. Diluted net income per share is computed by giving effect to all potential dilutive common shares, including outstanding options, warrants, convertible common shares related to the Conversion Right, as defined in the CVR Agreement and described in Note 4 “Fair Value Measurements,” and convertible preferred stock.
The shares excluded from the diluted net income per share calculation were
The following table provides the calculation of diluted weighted-average shares outstanding:
Three Months Ended | ||||
2024 | 2023 | |||
Basic weighted-average shares outstanding | | | ||
Prefunded Warrants | | — | ||
Shares issuable under Conversion Right of CVR Agreement | | — | ||
Preferred shares | | — | ||
Diluted weighted-average shares outstanding | | |
NOTE 3 — RESEARCH AND DEVELOPMENT AGREEMENTS
Bristol-Myers Squibb Collaboration Agreement
In February 2021, the Company entered into a Collaboration Agreement, as amended (the “BMS Collaboration Agreement”), with Bristol-Myers Squibb to perform strategic research collaboration leveraging the Company’s engineered toxin body (“ETB”) technology platform to discover and develop novel products containing ETBs directed to multiple targets. On March 13, 2024, Bristol-Myers Squibb notified the Company that it does not intend to continue the research collaboration it entered into with the Company pursuant to the BMS Collaboration Agreement and would be terminating the BMS Collaboration Agreement in its entirety. The termination will be effective on June 13, 2024, or 90 days following the Company’s receipt of Bristol-Myers Squibb’s written notice of termination.
Pursuant to the terms of the BMS Collaboration Agreement, the Company granted Bristol-Myers Squibb a series of exclusive options to obtain one or more exclusive licenses under the Company’s intellectual property to exploit products containing ETBs directed against certain targets designated by Bristol-Myers Squibb.
Bristol-Myers Squibb paid the Company an upfront payment of $
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The Company would have been responsible for conducting the research activities through the designation, if any, of one or more development candidates. Upon the exercise of its option for a development candidate, Bristol-Myers Squibb would have been responsible for all development, manufacturing, regulatory and commercialization activities with respect to that development candidate, subject to the terms of the BMS Collaboration Agreement.
Unless earlier terminated, the BMS Collaboration Agreement would have expired (i) on a country-by-country basis and licensed product-by-licensed product basis, on the date of expiration of the royalty payment obligations under the BMS Collaboration Agreement with respect to such licensed product in such country and (ii) in its entirety upon the earlier of (a) the expiration of the royalty payment obligations under the BMS Collaboration Agreement with respect to all licensed products in all countries or (b) upon Bristol-Myers Squibb’s decision not to exercise any option on or prior to the applicable option deadlines. Bristol-Myers Squibb had the right to terminate the BMS Collaboration Agreement for convenience upon prior written notice to the Company. Either party had the right to terminate the BMS Collaboration Agreement (a) for the insolvency of the other party or (b) subject to specified cure periods, in the event of the other party’s uncured material breach. The Company had the right upon prior written notice to terminate the BMS Collaboration Agreement in the event that Bristol-Myers Squibb or any of its affiliates asserts a challenge against the Company’s patents.
The Company identified multiple performance obligations at the inception of the BMS Collaboration Agreement consisting of research and development services and material rights related to additional developmental targets. The transaction price of $
The Company recognized revenue for research and development services under the BMS Collaboration Agreement using a cost-based input measure. In applying the cost-based input method of revenue recognition, the Company would use actual costs incurred relative to budgeted costs expected to be incurred. These costs consisted primarily of internal employee efforts and third-party contract costs. Revenue was recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completed its performance obligation over the estimated service period.
For the three months ended March 31, 2024 and 2023, the Company recognized $
The Company had
Grant Agreements
In September 2018, the Company entered into a Cancer Research Agreement (the “CD38 CPRIT Agreement”) with the Cancer Prevention and Research Institute of Texas (“CPRIT”) which was extended in September 2023, under which CPRIT awarded a $
For the three months ended March 31, 2024 and 2023, the Company recognized grant revenue under this award of $
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Company recorded grant revenue receivable of $
NOTE 4 — FAIR VALUE MEASUREMENTS
The following table sets forth the Company’s financial assets (cash equivalents) at fair value on a recurring basis (in thousands):
Basis of Fair Value Measurements | ||||||||||||
| March 31, 2024 |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Money market funds | $ | | $ | | $ | | $ | | ||||
Total | $ | | $ | | $ | | $ | | ||||
Amounts included in: | ||||||||||||
Cash and cash equivalents | $ | | ||||||||||
Total cash equivalents | $ | |
Basis of Fair Value Measurements | ||||||||||||
| December 31, 2023 |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Money market funds | $ | | $ | | $ | — | $ | — | ||||
Total | $ | | $ | | $ | — | $ | — | ||||
Amounts included in: | ||||||||||||
Cash and cash equivalents | $ | | ||||||||||
Total cash equivalents | $ | |
The Company invests in highly-liquid, investment-grade securities.
March 31, 2024 | ||||||||||||
| Cost Basis |
| Unrealized |
| Unrealized |
| Fair | |||||
Cash equivalents - money market funds | $ | | $ | — | $ | — | $ | |
December 31, 2023 | ||||||||||||
| Cost Basis |
| Unrealized |
| Unrealized |
| Fair | |||||
Cash equivalents - money market funds | $ | | $ | — | $ | — | $ | |
As of both March 31, 2024 and December 31, 2023, all of the Company’s available-for-sale investments were due in one year or less.
The Company received
Contingent Value Right and Common Stock Warrant Valuation
On June 16, 2023, the Company entered into a Convertible Secured Contingent Value Right Agreement (the “CVR Agreement”) with K2 HealthVentures LLC (“K2HV”), as further described in Note 7 “Borrowing Arrangements and Debt Extinguishment.” ASC 815 “Derivatives and Hedging” requires the Conversion Right, as defined in the CVR Agreement, and Contingent Value Right, as defined in the CVR Agreement, to be accounted for as liabilities and changes to their fair value recognized in the condensed consolidated statement of operations. The Conversion Right and Contingent Value Right liability will be remeasured each reporting period. The Company utilized a probability weighted expected return method to value the Conversion Right and Contingent Value Right liability (collectively, the “CVR”). The CVR was split into
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scenario, the stock price at each event was forecasted to determine if K2VH would convert $
The following table sets forth the Company’s financial liabilities (convertible secured contingent value right) at fair value on a recurring basis (in thousands):
Basis of Fair Value Measurements | ||||||||||||
| March 31, 2024 |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Conversion right and contingent value right | $ | | $ | — | $ | — | $ | | ||||
Total | $ | | $ | — | $ | — | $ | |
Basis of Fair Value Measurements | ||||||||||||
| December 31, 2023 |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Conversion right and contingent value right | $ | | $ | — | $ | — | $ | | ||||
Total | $ | | $ | — | $ | — | $ | |
The following table is a reconciliation of the change in fair value of the Conversion Right and Contingent Value Right liability for the three months ended March 31, 2024 (in thousands):
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | ||||||
Conversion right and contingent value right liability | Total | |||||
Balance as of December 31, 2023 | $ | | $ | | ||
Change in valuation included in net income | ( | ( | ||||
Balance as of March 31, 2024 | $ | | $ | |
In satisfaction of its obligations to issue the warrant to K2HV’s affiliated holder pursuant to the CVR Agreement, the Company issued a warrant to purchase up to
June 16, 2023 | ||||
Risk-free interest rate | % | |||
Expected term (in years) | ||||
Dividend yield | — | |||
Volatility | % | |||
Stock price | $ |
On June 16, 2023, the Company determined the fair value of the warrants to be $
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NOTE 5 — BALANCE SHEET COMPONENTS
Accrued liabilities consisted of the following (in thousands):
| March 31, |
| December 31, | |||
Accrued liabilities: |
| |||||
General and administrative |
| $ | | $ | | |
Clinical trial related costs | | | ||||
Non-clinical research and manufacturing operations |
| | | |||
Payroll related |
| | | |||
Other accrued expenses |
| | | |||
Total Accrued liabilities |
| $ | | $ | |
NOTE 6—PROPERTY AND EQUIPMENT
Property and equipment consists of the following (in thousands):
March 31, | December 31, | |||||
| 2024 |
| 2023 | |||
Laboratory equipment | $ | | $ | | ||
Leasehold improvements | | | ||||
Furniture and fixtures | | | ||||
Computer and equipment | | | ||||
| | |||||
Less: Accumulated depreciation | ( | ( | ||||
Total property and equipment, net | $ | | $ | |
Depreciation expense was $
As of March 31, 2024 and December 31, 2023, the Company had net Asset Retirement Obligation (“ARO”) assets totaling $
NOTE 7 — BORROWING ARRANGEMENTS AND DEBT EXTINGUISHMENT
K2 HealthVentures Loan and Security Agreement
In May 2020, the Company entered into a Loan and Security Agreement with K2HV (the “K2 Loan and Security Agreement”) in the amount of $
On June 16, 2023, the Company entered into the CVR Agreement with K2HV to fully discharge and satisfy the Company’s outstanding loan obligations under the K2 Loan and Security Agreement, and to terminate the K2 Loan and Security Agreement, in exchange for an aggregate repayment in cash of $
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Agreement, occur, or if there is an Acceleration Event, as defined in the CVR Agreement. The payment due upon any Contingent Payment Event or an Acceleration Event is capped at an amount (the “Remaining Value”) which is initially $
For Contingent Payment Events, the Company must pay K2HV either a specified percentage of the proceeds received, up to an amount equaling the applicable Remaining Value,
In satisfaction of its obligations to issue the warrant to K2HV’s affiliated holder pursuant to the CVR Agreement, the Company issued a warrant to purchase up to
In accordance with ASC Topic 740-50 “Debt – Modifications and Extinguishments,” the transaction noted above was determined to be an extinguishment of the existing long-term debt. As a result, the Company recorded a gain on the extinguishment of long-term debt in the amount of $
NOTE 8 — LEASES
The Company has operating leases for administrative offices and research and development facilities, and certain finance leases for equipment. The operating leases have remaining terms of less than
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The following table summarizes the components of lease expense for the three months ended March 31, 2024 and 2023 (in thousands):
Three Months Ended | ||||||
| 2024 |
| 2023 | |||
Operating leases | ||||||
Operating lease expense | $ | | $ | | ||
Variable lease expense | | | ||||
Total operating lease expense | $ | | $ | |
The following table summarizes the balance sheet classification of leases as of March 31, 2024 (in thousands):
March 31, | |||
| 2024 | ||
Operating leases | |||
Operating lease right-of-use assets | $ | | |
| |||
$ | | ||
Operating lease liabilities, non-current | | ||
Total operating lease liabilities | $ | |
1. | Included in other current liabilities. |
The following table presents other information on leases as of March 31, 2024 and December 31, 2023:
March 31, | December 31, | ||||
| 2024 |
| 2023 |
| |
Weighted average remaining lease term, operating leases | years | years | |||
Weighted average discount rate, operating leases | | % | | % |
Maturities of lease liabilities were as follows as of March 31, 2024 (in thousands):
| Operating Leases | ||
2024 (remaining) | $ | | |
2025 | | ||
2026 | | ||
2027 | | ||
2028 | | ||
Thereafter | | ||
Total lease payments | $ | | |
Less: | |||
Imputed interest | ( | ||
Total lease liabilities | $ | |
Supplemental cash flow information related to the Company’s leases were as follows (in thousands):
Three Months Ended | |||
| 2024 | ||
Cash paid for amounts included in the measurement of lease liabilities: | |||
Operating cash flows operating leases | $ | |
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NOTE 9 — CONTRACTUAL COMMITMENTS
The Company has entered into project work orders for each of its clinical trials with clinical research organizations (each, a “CRO”) and related laboratory vendors. Under the terms of these agreements, the Company is required to pay certain upfront fees for direct services costs. Based on the particular agreement some of the fees may be for services yet to be rendered and are reflected as a current prepaid asset and have an unamortized balance of approximately
The Company has entered into estimated purchase obligations. These estimated purchase obligations total in range from $
NOTE 10 — STOCK-BASED COMPENSATION
Stock-based compensation expense, which consists of the compensation cost for employee stock options and the value of options issued to non-employees for services rendered, was allocated to research and development and general and administrative in the consolidated statements of operations as follows (in thousands):
| Three Months Ended | |||||
|
| 2024 |
| 2023 | ||
Research and development | $ | | $ | | ||
General and administrative | | | ||||
Total stock-based compensation | $ | | $ | |
As of March 31, 2024, the total unrecognized compensation cost related to unvested stock-based awards granted to employees under the Company’s equity incentive plans was approximately $
Valuation Assumptions
The Company estimated the fair value of stock options granted using the Black-Scholes option-pricing formula and a single option award approach. This fair value is being amortized ratably over the requisite service periods of the awards, which is generally the vesting period.
The fair value of employee stock options was estimated using the following weighted-average assumptions:
| Three Months Ended | ||||||
|
| 2024 |
| 2023 |
| ||
Employee Stock Options: | |||||||
Risk-free interest rate | | % | | % | |||
Expected term (in years) | |||||||
Dividend yield | | | |||||
Volatility | | % | | % | |||
Weighted-average fair value of stock options granted | $ | | $ | |
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Equity Incentive Plans
These plans consist of the 2018 Equity Incentive Plan; the 2014 Equity Incentive Plan, as amended; the 2004 Amended and Restated Equity Incentive Plan; and the Amended and Restated 2004 Employee Stock Purchase Plan. As of May 31, 2018, the 2014 Equity Incentive Plan and the 2004 Amended and Restated Equity Incentive Plan were terminated, and no further shares will be granted from those plans.
The following table summarizes stock option activity under the Company’s equity incentive plans:
| Outstanding Options |
| Weighted Average |
| Weighted Average |
| Aggregate Intrinsic | |||
Balances, December 31, 2022 | | $ | | $ | — | |||||
Granted | | $ | | |||||||
Exercised | ( | $ | | |||||||
Cancelled | ( | $ | | |||||||
Balances, December 31, 2023 | | $ | | $ | | |||||
Granted | | $ | | |||||||
Exercised | | $ | | |||||||
Cancelled | ( | $ | | |||||||
Balances, March 31, 2024 | | $ | | — | $ | | ||||
Vested and expected to vest, March 31, 2024 | | $ | | $ | | |||||
Exercisable at March 31, 2024 | | $ | | $ | |
The total intrinsic value of stock options exercised during the three months ended both March 31, 2024 and 2023, was
Cash received from stock option exercises was
NOTE 11 – RESTRUCTURING RELATED EXPENSES
On March 29, 2023 and June 16, 2023, the Company implemented a strategic reprioritization and corresponding reduction in workforce, by approximately
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The following table summarizes the activity for expenses related to the Restructuring accruals, which are included in Accrued liabilities in the Company’s condensed consolidated balance sheets (in thousands):
Balance, December 31, 2022 |
| $ | — |
Expenses related to the Restructuring | | ||
Cash payments | ( | ||
Balance, December 31, 2023 |
| $ | — |
Expenses related to the Restructuring | — | ||
Cash payments | — | ||
Balance, March 31, 2024 | $ | — |
NOTE 12 — STOCKHOLDERS’ EQUITY (DEFICIT)
K2HV CVR Agreement and Related Warrants
On June 16, 2023, in satisfaction of its obligations to issue the warrant to K2HV’s affiliated holder pursuant to the CVR Agreement, as further described in Note 7 “Borrowing Arrangements and Debt Extinguishment,” the Company issued a warrant to purchase up to
July 2023 Private Placement and Related Warrants
On July 12, 2023, the Company entered into a securities purchase agreement (the “July 2023 Purchase Agreement”) with certain institutional and accredited investors (the “July 2023 Purchasers”) which provided for the private placement (the “July 2023 Private Placement”) of shares of the Company’s common stock and warrants to purchase shares of the Company’s common stock in
The closing of the initial tranche occurred on July 17, 2023 and consisted of the issuance of (i)
The Company has assessed the July 2023 Pre-Funded Warrants for appropriate equity or liability classification. The July 2023 Pre-Funded Warrants are equity classified because they (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of shares of common stock upon exercise, (v) are indexed to the Company's common stock and (vi) meet the equity classification criteria.
In addition, the July 2023 Pre-Funded Warrants do not provide any guarantee of value or return and do not provide the warrant holders with the option to settle any unexercised warrants for cash outside of the Company's control. The July 2023 Pre-Funded Warrants also include a separate provision whereby the exercisability of the warrants may be limited if, upon exercise, the warrant holder or any of its affiliates would beneficially own more than
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Company’s common stock. The Company valued the pre-funded common stock warrants at issuance, concluding that their sale price approximated their fair value. Accordingly, the July 2023 Pre-Funded Warrants are accounted for as a component of additional paid-in capital at the time of issuance.
Pursuant to the July 2023 Purchase Agreement, the Company granted to the July 2023 Purchasers certain registration rights, pursuant to which, among other things, the Company agreed to (i) file with the SEC a registration statement on Form S-3 after each of the initial tranche and the second tranche to register for resale the shares of common stock issued (and the shares issuable upon exercise of any pre-funded warrants or Second Closing Warrants issued) in the applicable closing, within
Second Closing of July 2023 Private Placement
On March 28, 2024, the Company and certain institutional and accredited investors (the “March 2024 Purchasers”) entered into an Amended and Restated July 2023 Purchase Agreement, pursuant to which the Company issued, at closing, common stock, prefunded warrants, and common warrants with an aggregate purchase price of $
The Company has assessed the March 2024 Prefunded Warrants and March 2024 Common Warrants for appropriate equity or liability classification. The March 2024 Prefunded Warrants and March 2024 Common Warrants are equity classified because they (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of shares of common stock upon exercise, (v) are indexed to the Company's common stock, and (vi) meet the equity classification criteria.
In addition, the March 2024 Prefunded Warrants and March 2024 Common Warrants do not provide any guarantee of value or return and do not provide the warrant holders with the option to settle any unexercised warrants for cash outside of the Company's control. The March 2024 Prefunded Warrants and March 2024 Common Warrants also
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include a separate provision whereby the exercisability of the warrants may be limited if, upon exercise, the warrant holder or any of its affiliates would beneficially own more than a specified percentage limitation (4.99%/9.99%/19.99%) of the Company’s common stock. The Company valued the prefunded stock warrants and common stock warrants at issuance, concluding that their sale price approximated their fair value. Accordingly, the March 2024 Prefunded Warrants and March 2024 Common Warrants are accounted for as a component of additional paid-in capital at the time of issuance on April 2, 2024.
Pursuant to the Amended and Restated July 2023 Purchase Agreement, the Company granted to the March 2024 Purchasers certain registration rights, pursuant to which, among other things, the Company agreed to (i) file with the SEC a registration statement on Form S-3 after the second tranche of the July 2023 Private Placement to register for resale the shares of common stock (and the shares of common stock issuable upon exercise of the prefunded warrants and common warrants) issued in the second tranche of the July 2023 Private Placement, within 30 calendar days following the second tranche closing (the “Second Closing”), and (ii) use its commercially reasonable efforts to have the registration statement declared effective as soon as practicable, and in any event no later than 90 days following the Second Closing date (or 120 days following the Second Closing date if the registration statement is reviewed by the SEC). The registration rights covenants are subject to customary terms and conditions for a transaction of this type, including certain customary cash penalties on the Company for its failure to satisfy specified filing and effectiveness time periods. On April 25, 2024, the Company filed with the SEC a registration statement on Form S-3 (File No. 333-278932), which was declared effective by the SEC on May 3, 2024, registering for resale up to
NOTE 13 — SUBSEQUENT EVENTS
Reduction in Force
On April 11, 2024, the Company and Board of Directors approved the Reduction in Force in order to extend its resources to better position the organization and to allow the Company to continue to support its clinical studies for MT-6402, MT-8421 and MT-0169. The Reduction in Force reduced the Company’s current workforce by approximately
Second Closing of the July 2023 Private Placement
As described in Note 12 “Stockholders’ Equity (Deficit) - Second Closing of the July 2023 Private Placement,” the closing of the second tranche of the July 2023 Private Placement occurred on April 2, 2024.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited financial information and the notes thereto included appearing elsewhere in this Quarterly Report on Form 10-Q, and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (the “SEC”) on March 29, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.
Overview
Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted biologic therapeutics. Our proprietary biologic drug platform technology, known as engineered toxin bodies (“ETBs”), leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit (“SLTA”) to create novel therapies with potent and differentiated mechanisms of action for cancer.
Recent Developments
Restructuring Related Activities
On April 11, 2024, we and our Board of Directors approved a reduction in force (the “Reduction in Force”) in order to extend our resources to better position the organization and to allow us to continue to support our clinical studies for MT-6402, MT-8421 and MT-0169. The Reduction in Force reduced our current workforce by approximately 30%. We estimate that we will incur aggregate pre-tax charges of approximately $0.1 million in connection with the Reduction in Force, primarily consisting of legal fees and other related termination costs. The Reduction in Force was completed by the end of April 2024 and we expect that the one-time charges will be incurred in the second quarter of 2024.
July 2023 Private Placement
On July 12, 2023 and as described in Note 12 “Stockholders’ Equity (Deficit)” of the financial statements included in Item 1 of this Quarterly Report on Form 10-Q, we entered into a securities purchase agreement (the “July 2023 Purchase Agreement”) with certain institutional and accredited investors (the “July 2023 Purchasers”) which provided for the private placement of shares of our common stock and warrants to purchase shares of our common stock in two tranches (the “July 2023 Private Placement”). The initial tranche of the July 2023 Private Placement closed on July 17, 2023, and consisted of the issuance of (i) 1,617,365 shares of our common stock at a price of $7.05 per share (the closing price per share of our common stock as reported by the Nasdaq Capital Market on July 12, 2023), and (ii) pre-funded warrants (the “July 2023 Pre-Funded Warrants”) exercisable for up to 1,222,100 shares of our common stock. The price of the July 2023 Pre-Funded Warrants was $7.035 per underlying share of our common stock, and these warrants contain an exercise price of $0.015 per share. We received approximately $20 million in gross proceeds in connection with the closing of the initial tranche and net proceeds, following the payment of related offering expenses, of approximately $18.4 million.
On March 28, 2024, we and certain institutional and accredited investors (the “March 2024 Purchasers”) entered into an Amended and Restated July 2023 Purchase Agreement pursuant to which we issued, at closing, common stock, prefunded warrants, and common warrants with an aggregate purchase price of $9.5 million on amended and restated second tranche terms. The second tranche, as amended and restated, consisted of the sale and issuance of (i) 1,209,612 shares of our common stock (and, in lieu thereof, prefunded warrants to purchase 2,460,559 shares of our common stock (the “March 2024 Prefunded Warrants”) for a purchase price of $2.35 per share of our common stock (the closing price
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of our common stock on March 27, 2024 as reported by the Nasdaq Capital Market) and $2.349 per March 2024 Prefunded Warrant, and (ii) common stock warrants (the “March 2024 Common Warrants”) to purchase up to 7,340,342 shares of our common stock (or March 2024 Prefunded Warrants in lieu thereof) at an exercise price of $2.35 per share of our common stock underlying the March 2024 Common Warrants. The March 2024 Common Warrants were sold at a price equal to $0.125 per underlying share of common stock and have a term of five years. The March 2024 Prefunded Warrants will expire when fully exercised in accordance with their terms. The March 2024 Prefunded Warrants and March 2024 Common Warrants may not be exercised if the aggregate number of shares of our common stock beneficially owned by the holder thereof immediately following such exercise would exceed a specified beneficial ownership limitation (4.99%/9.99%/19.99%); provided, however, that a holder may increase or decrease the beneficial ownership limitation by giving 61 days’ notice to us, but not to any percentage in excess of 19.99%. The Amended and Restated July 2023 Purchase Agreement contains customary representations and warranties and agreements of us and the Purchasers and customary indemnification rights and obligations of the parties. The second tranche included gross proceeds of approximately $9.5 million and net proceeds, following the payment of related offering expenses, of approximately $8.8 million.
The second tranche of the July 2023 Private Placement closed on April 2, 2024. The Company intends to use the net proceeds from the second tranche of the July 2023 Private Placement to fund its ongoing clinical studies, working capital and for general corporate purposes.
Nasdaq Compliance and Reverse Stock Split
In connection with the deficiency and delisting notices received from the Nasdaq Stock Market LLC (“Nasdaq”), as previously disclosed on April 13, 2023, we presented our plan to the Nasdaq Hearings Panel (the “Panel”) to regain compliance with both the bid price and stockholders’ equity requirements as needed for continued listing on the Nasdaq Capital Market. We were granted an extension on May 8, 2023, to regain compliance with both requirements by August 28, 2023, subject to certain conditions as set forth by the Panel. On July 28, 2023 and regarding the stockholders’ equity requirement, we submitted an update to the Panel informing the Panel that we did meet an alternative continued listing standard, the market value of listed securities standard, which requires a company to have at least $35 million in market value of listed securities. On August 2, 2023, Nasdaq notified us that we had demonstrated compliance with this market value of listed securities standard but will be subject to a one-year monitoring period commencing on August 2, 2023. As of the date of this Quarterly Report on Form 10-Q, we no longer have at least $35 million in market value of listed securities and must therefore maintain at least $2.5 million in stockholders’ equity to retain compliance. As of March 31, 2024, our reported stockholders’ equity was greater than $2.5 million.
In connection with the bid price requirement, we effected a 1-for-15 reverse stock split, (the “Reverse Stock Split”) on August 11, 2023. On August 28, 2023, Nasdaq notified us that the Company has regained compliance with the bid price requirement. If Nasdaq again finds that we are not in compliance with the market value of listed securities standard (or an alternative continued listing standard) within the one year monitoring period, a delisting determination letter will be triggered without any grace period. We would then have the opportunity to respond to the Panel pursuant to applicable Nasdaq rules, following which, if our efforts are unsuccessful, our securities may be delisted from Nasdaq. In addition, the Panel may reconsider the matters described in the Panel decisions and notices, and any matters related to our efforts to regain compliance, which may be based upon future events, conditions or circumstances that may arise with the Company, which in the opinion of the Panel, may make continued listing on the Nasdaq Capital Market inadvisable.
Bristol-Myers Squibb Collaboration Agreement
On February 10, 2021, we entered into a Collaboration Agreement, as amended (the “BMS Collaboration Agreement”), with Bristol-Myers Squibb Company (“Bristol-Myers Squibb”) to perform strategic research collaboration leveraging our ETB technology platform to discover and develop novel products containing ETBs directed to multiple targets. On March 13, 2024, Bristol-Myers Squibb notified us that it does not intend to continue the research collaboration it entered into with us pursuant to the BMS Collaboration Agreement and would be terminating the BMS Collaboration Agreement in its entirety. The termination will be effective on June 13, 2024, or 90 days following our receipt of Bristol-Myers Squibb’s written notice of termination.
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Pursuant to the BMS Collaboration Agreement, Bristol-Myers Squibb paid us an upfront payment of $70.0 million. We would have been eligible to receive near term and development and regulatory milestone payments of up to an additional $874.5 million and would have been eligible to receive up to an additional $450.0 million in milestone payments upon the achievement of certain sales milestone events. We would have also been entitled to receive, subject to certain reductions, tiered royalties ranging from mid-single digits up to mid-teens as percentages of calendar year net sales, if any, on any licensed product.
Pipeline and Technology Overview
ETBs use a genetically engineered version of the SLTA, a ribosome inactivating bacterial protein. In its wild-type form, Shiga-like Toxin is thought to induce its own entry into a cell when proximal to the cell surface membrane, self-route to the cytosol, and enzymatically and irreversibly shut down protein synthesis via ribosome inactivation. SLTA is normally coupled to its cognate Shiga-like Toxin B subunit (“SLTB”) to target the CD77 cell surface marker, a non-internalizing glycosphingolipid. In our scaffold, a genetically engineered SLTA subunit with no cognate SLTB component is genetically fused to antibody domains or fragments specific to a target, resulting in a biologic therapeutic that can identify the particular target and specifically kill the cell. The antibody domains may be substituted with other antibody domains having different specificities to allow for the rapid development of new drugs to selected targets in cancer.
ETBs combine the specificity of an antibody with SLTA’s potent mechanism of cell destruction. Based on the disease setting, we have created ETBs that have a reduced propensity for triggering innate immunogenicity and attendant toxicities like capillary leak syndrome (“CLS”). To date, there have been no instances of CLS or other manifestations of innate immunity observed with any of our next-generation ETBs.
ETBs have relatively predictable pharmacokinetic profiles and can be rapidly screened for desired activity in robust cell-based and animal-model assays. Because SLTA can induce internalization against non- and poorly-internalizing receptors, the universe of targets for ETBs should be substantially larger than that seen with antibody drug conjugates (“ADCs”), which are not likely to be effective if the target does not readily internalize the ADC payload.
ETBs have a differentiated mechanism of cell kill in cancer therapeutics (the inhibition of protein synthesis via ribosome destruction), and we have preclinical and clinical data demonstrating the utility of these molecules in chemotherapy-refractory cancers. ETBs have shown good tolerability in multiple animal models as well as a generally favorable tolerability profile in our clinical studies to date. We believe the target specificity of ETBs, their ability to self-internalize, their potent and differentiated mechanism of cell kill and their tolerability profile provide opportunities for the clinical development of these agents to address multiple cancer types.
We have developed ETBs to various targets, including PD-L1, CD38, and CTLA-4. PD-L1 and CTLA-4 are key immune checkpoint pathways and are validated targets expressed in a variety of solid tumor cancers and immune cells. The differentiated mechanism of action of our ETBs allows for a novel approach to mediating anti-tumor T-cell activity against immuno-oncology targets by: (i) dismantling the tumor micro-environment (“TME”) through the depletion of immunosuppressive immune cells and (ii) delivering high avidity major histocompatibility complex-I antigens to the
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tumor to directly alter the tumor’s immunophenotype. The altering of the tumor’s immunophenotype is unique and leverages the intrinsic intracellular routing properties of ETBs through a mechanism we call Antigen Seeding.
Immuno-Oncology ETBs
MT-6402 – ETB Targeting PD-L1
We filed an Investigational New Drug (“IND”) application for MT-6402, our ETB targeting PD-L1, in December 2020 and the IND was accepted in January 2021. A Phase I study of MT-6402 in relapsed/refractory patients with PD-L1 expressing tumors began in July 2021 at a starting dose of 16 mcg/kg. The Phase I study for MT-6402 is a multi-center, open-label, dose escalation and dose expansion trial. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the TME are eligible for enrollment, irrespective of HLA genotype or CMV status. In November 2021, MT-6402 was granted Fast Track designation for the treatment of patients with advanced with non-small cell lung cancer (“NSCLC”) expressing PD-L1.
The Part A dose escalation of the Phase I study for MT-6402 has been completed. 48 patients have been dosed across seven dose escalation cohorts of 16, 24, 32, 42, 63, 83, and 100 mcg/kg in the MT-6402 study of in patients with relapsed/refractory solid tumors.
The 100 mcg/kg dose was deemed not tolerable based on two dose limiting toxicities (“DLTs”) of a grade 3 rash and a grade 1 high sensitivity troponin elevation without clinical sequalae that led to drug interruption for more than two weeks. Rash and high sensitivity troponin elevation are immune-related adverse events (“AEs”) that have been documented with approved checkpoint therapies. No grade 4 or grade 5 drug-related AEs have been observed to date. We continue to observe pharmacodynamic (“PD”) effects including the depletion of PD-L1+ monocytes, MDSCs, PD-L1+ dendritic cells, as well as concomitant T cell activation, which were observed at dose levels above 42 mcg/kg in a dose dependent manner. Further, monotherapy activity (partial responses) was observed during dose escalation with MT-6402 in checkpoint experienced relapsed/refractory solid tumor patients. The 63 and 83 mcg/kg doses will be further explored in the Part B dose expansion study.
In the Part A dose escalation, nine patients with head and neck cancer were treated. All patients had progressed after numerous lines of therapy including checkpoint therapy. Two of these patients were not evaluable for the cycle 1
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DLT period because of early progression and came off study after only receiving one or two doses of MT-6402, respectively. Of the remaining seven head and neck cancer patients, best responses observed were as follows: two patients had confirmed partial responses. The two responders currently remain in response at cycle 20 and cycle 11, respectively. Stable disease of 6, 6, 4, and 2 months, respectively, was observed in four other patients with two showing tumor reduction before disease progression or discontinuation. One patient progressed at the end of cycle 2. Of these seven patients, only one patient (a patient with stable disease through 6 cycles) had a PD-L1 TPS greater than 50%. One patient initially classified as a head and neck squamous cell carcinoma (“HNSCC”) was later determined to have squamous cell carcinoma of the auricular skin. The patient had an unconfirmed partial response and discontinued treatment after two doses due to a grade 1 troponin increase; an external review of scans showed a 36% reduction in tumor volume discontinued due to a grade 1 troponin increase.
The Part B dose expansion cohorts are currently enrolling. Dose levels of 63 and 83 mcg/kg will be studied in the two expansion cohorts: (i) in solid tumor patients with ≥50% tumor expression of PD-L1 and (ii) relapsed/refractory HNSCC with <50% tumor expression of PD-L1.
MT-8421—ETB Targeting CTLA-4
MT-8421, along with MT-6402, represent our unique approach to immuno-oncology based on dismantling the TME through direct cell-kill of tumor and immune cells and not only the blocking of ligand-ligand interactions seen with current antibody therapeutics. The ETB approach includes potent destruction of CTLA-4+ regulatory T cells (“Tregs”) via enzymatic ribosome destruction, and the mechanism of cell kill is independent of TME. MT-8421 preferentially destroys high CTLA-4 expressing Tregs in the TME relative to peripheral Tregs which are lower CTLA-4 expressing. Evidence of Treg depletion was observed in the first cohort of patients; no grade 3 or grade 4 toxicities have been observed. Dose escalation is on-going.
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Hematologic Malignancy Targeted ETBs
MT-0169—ETB Targeting CD38
MT-0169 represents a novel approach to targeting CD38 expressing cells implicated in both cancer and autoimmune diseases. MT-0169 specifically binds to CD38 on the target cell surface, efficiently induce its own internalization into the cell, and induces potent direct cell-kill via the enzymatic destructions of ribosomes. MT-0169 retains its potency even in the presence of competing anti-CD38 antibodies (e.g. daratumumab) and has activity against both high and low expressing CD38 cells. A phase 1 study of MT-0169 in patients with relapsed or refractory multiple myeloma was completed in December 2023. The study enrolled 14 patients and no drug-related Grade 4 or 5 adverse events have been observed. Pharmacodynamic response consistent with CD38+ immune cell depletion was obaserved and one patient with IgA myeloma with extramedullary disease, who was quad-refractory treated at 5 mcg/kg had a stringent Complete Response for 17 cycles (1 cycle = 4 weeks). We plan to evaluate MT-0169 for CD38+ leukemias and potentially in autoimmune diseases.
We expect to provide periodic updates on MT-6402, MT-8421, and MT-0169 throughout the remainder of 2024.
We have built up multiple core competencies around the creation and development of ETBs. We developed the ETB technology in-house and continue to make iterative improvements in the scaffold and identify new uses of the technology. We also developed the proprietary process for manufacturing ETBs under Current Good Manufacturing Process (“cGMP”) regulatory standards and continue to make improvements to our manufacturing processes.
We have conducted multiple cGMP manufacturing runs with our compounds and believe this process is robust and could support commercial production.
Financial Operations Overview
Revenue
To date, we have not generated any revenue from product sales to customers. We do not expect to receive any revenue from the commercial sale and marketing of any ETB candidates that we or our current or future collaboration partners develop, including MT-6402, MT-8421, MT-0169, until we obtain regulatory approval and commercialize such biologics. Our revenue consists principally of collaboration revenue and grant revenue.
Research and Development revenue primarily relates to our collaboration agreement with Bristol-Myers Squibb which is accounted for using the percentage-of-completion cost-to-cost method. As discussed below, this agreement will be terminated effective on June 13, 2024, or 90 days following the Company’s receipt of Bristol-Myers Squibb’s written notice of termination. As a result, we do not expect future revenues from this agreement following its termination.
Grant revenue relates to our Cancer Prevention and Research Institute of Texas (“CPRIT”) grant for a CD38 ETB (MT-0169). CPRIT grant funds for MT-0169 are provided to us in arrears as cost reimbursement where revenue is recognized as allowable costs are incurred. Revenue recognized in excess of amounts collected are recorded as grant receivable. Funds received in excess of expenditures incurred are recorded as deferred revenue.
For more information about our revenue recognition policy, please see Note 1 “Organization and Summary of Significant Accounting Policies” to our audited consolidated financial statements for the year ended December 31, 2023, included in our Annual Report on Form 10-K.
Research and Development Expenses
Research and development expenses consist principally of:
● | salaries for research and development staff and related expenses, including stock-based compensation expenses; |
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● | costs for cGMP manufacturing of drug substances and drug products by contract manufacturers; |
● | fees and other costs paid to clinical trials sites and clinical research organizations, (“CROs”), in connection with the performance of clinical trials and preclinical testing; |
● | costs for consultants and contract research; |
● | costs of laboratory supplies and small equipment, including maintenance; and |
● | depreciation of long-lived assets. |
Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including the initiation and enrollment of subjects in clinical trials and manufacture of biologic materials for clinical trials. We expect research and development expenses to increase as we advance the clinical development of MT-6402, MT-8421, and/or MT-0169. The successful development of our ETB candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and costs of the efforts that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from any of our ETB candidates. This is due to numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
● | the scope, rate of progress and expense of our research and development activities; |
● | clinical trials and early-stage results; |
● | the terms and timing of regulatory approvals; and |
● | the ability to market, commercialize and achieve market acceptance for MT-6402, MT-8421, MT-0169, or any other ETB candidate that we or our current or future collaboration partners may develop in the future. |
Any of these variables with respect to the development of MT-6402, MT-8421, MT-0169, or any other ETB candidate that we may develop could result in a significant change in the costs and timing associated with the development of such candidates. For example, if the FDA, the European Medicines Agency (“EMA”) or other regulatory authority were to require us to conduct pre-clinical and clinical studies beyond those which we currently anticipate will be required for the completion of clinical development or if we experience significant delays in enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of our clinical development programs.
General and Administrative Expenses
Our general and administrative expenses consist principally of:
● | salaries for employees other than research and development staff, including stock-based compensation expenses; |
● | professional fees for auditors and other consulting expenses related to general and administrative activities; |
● | professional fees for legal services related to the protection and maintenance of our intellectual property and regulatory compliance; |
● | cost of facilities, communication and office expenses; |
● | information technology services; and |
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