TABLE OF CONTENTS
Forward-Looking Statements
Frequently Used Terms
Part I
ITEM 1. Condensed Consolidated Financial Statements
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
ITEM 4. Controls and Procedures
Part II
ITEM 1. Legal Proceedings
ITEM 1A. Risk Factors
ITEM 5. Other Information
ITEM 6. Exhibits
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Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The below discussion should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations and the audited consolidated financial statements and notes thereto for the year ended December 31, 2024 included in our Annual Report on Form 10-K for the year ended December 31, 2024 and with the unaudited condensed consolidated financial statements and the notes thereto contained elsewhere in this report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.
Overview
We are a clinical-stage biopharmaceutical company with products and technologies derived from the Bayer License Agreement, pursuant to which we were granted an exclusive, royalty-bearing, worldwide license under certain Bayer patents and know-how to develop, use, manufacture, commercialize, sublicense, and distribute bioconjugation and small molecule drug programs.
On April 17, 2025, the Company’s board of directors, after considering numerous factors, including the Company’s limited cash resources and inability to raise capital or complete any other strategic transaction, determined that it is in the best interests of the Company’s stockholders for the Company to dissolve, liquidate, and wind-up its business and affairs and distribute to stockholders any assets remaining after paying or providing for payment of its creditors and, accordingly, approved the Dissolution and Plan of Liquidation, subject to the approval of the Company’s stockholders. At such time, our board of directors also approved the voluntary delisting of the Company’s common stock from Nasdaq and deregistration under Section 12(b) of the Exchange Act.
License Agreement with Bayer
On October 7, 2020, the Company entered into the Bayer License Agreement, which became effective on December 23, 2020 upon the closing of the Business Combination. Pursuant to the Bayer License Agreement, the Company has an exclusive, worldwide, royalty-bearing license under certain Bayer patents and know-how to develop, use, manufacture, commercialize, sublicense, and distribute a bioconjugation program and a small molecule drug program. Although the Bayer License Agreement provides for payment of certain development and commercial sales milestones and royalty payments, given the approval by our board of directors of the Dissolution, it is expected that Bayer will terminate the License Agreement pursuant to its terms.
Basis of Presentation
We currently conduct operations through one operating segment. As a pre-revenue company with no commercial operations, our activities to date have been limited and were conducted primarily in the United States. Our historical results are reported under GAAP and in U.S. dollars.
Components of Results of Operations
Revenue
We have not recognized any revenue from product sales and, given our pending Dissolution, will not generate any revenue from product sales in the future.
Research and Development Expense
Research and development expenses consist of preclinical product development and discovery efforts (including conducting preclinical studies), manufacturing development efforts, preparing for and conducting clinical trials, and activities related to regulatory filings for product candidates. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. Costs incurred in obtaining technology licenses through asset acquisitions are charged to research and development expense if the licensed technology has not reached technological feasibility and has no alternative future use. Research and development expenses include:
employee-related expenses, including salaries, bonuses, benefits, stock-based compensation, and other related costs for those employees involved in research and development efforts;
external research and development expenses incurred under agreements with clinical research organizations, investigative sites, and consultants to conduct our preclinical studies;
costs related to manufacturing material for preclinical studies and clinical trials, including fees paid to contract manufacturing organizations;
laboratory supplies and research materials;
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costs related to compliance with regulatory requirements; and
facilities, depreciation, and other allocated expenses, which include direct and allocated expenses for rent, maintenance of facilities, insurance, and equipment.
General and Administrative Expenses
General and administrative expenses consist principally of salaries and related costs for personnel in executive and administrative functions, including stock-based compensation, travel expenses, and recruiting expenses. Other general and administrative expenses include professional fees for legal, accounting, and tax-related services and insurance costs.
Change in Fair Value of Warrant Liabilities
Certain of our private warrants are classified as liabilities pursuant to ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity. The change in fair value of warrant liabilities consists of the change in fair value of these private warrants.
Results of Operations
Comparison of the Three Months Ended March 31, 2025 and 2024
The following tables set forth our historical operating results for the periods indicated (amounts in thousands):
Operating expenses:
General and administrative
Research and development
Total operating expenses
Loss from operations
Other income (expense)
Change in fair value of warrant liabilities
Interest income
Write down of grant receivable
Total other income (expense)
Net loss
Research and Development
Research and development expenses decreased by approximately $3.5 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease for the three months ended March 31, 2025 compared to the same period in 2024 is primarily the result of decreases in personnel related expenses of approximately $1.5 million, clinical related expenses of approximately $1.1 million, and research services of approximately $0.7 million.
General and Administrative
General and administrative expenses decreased by approximately $0.6 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease for the three months ended March 31, 2025 compared to the same period in 2024 was due to a decrease in personnel related expenses of $0.7 million as a result of our significant headcount reduction in December 2024.
The change in fair value of warrant liabilities for the three months ended March 31, 2024 is primarily due to a significant increase in the volatility of our common stock.
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Interest Income
Interest income is primarily comprised of interest income and gains or losses realized on cash and cash equivalents. The decrease in interest income to nil for the three months ended March 31, 2025 from $0.1 million for the three months ended March 31, 2024 is a result of our declining portfolio of cash equivalents.
Other Income (Expense)
Other income (expense) is ordinarily comprised of estimated grant income earned in connection with our research activities conducted at our German subsidiary. During the first quarter ended March 31, 2025, the grant receivable was deemed to be not recoverable, and approximately $1.7 million has been charged to other income (expense).
Liquidity and Capital Resources
Based on our current plans and assumptions, we believe that our existing cash will be sufficient to fund our operating expenses and capital expenditure requirements into the third quarter of 2025, although this estimate is based on plans and assumptions that may prove to be wrong, and the Company could use its available cash resources sooner than it currently expects. Changing circumstances, some of which may be beyond our control, could result in less cash available to us or cause us to consume capital faster than we currently anticipate.
In accordance with ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we have evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern for a period of one year after the date that our unaudited condensed consolidated financial statements are issued. In light of our existing cash resources and current and expected operating losses and negative cash flows, and our planned Dissolution, we have concluded that these circumstances raise substantial doubt about our ability to continue as a going concern for a period of one year after the date that our unaudited condensed consolidated financial statements are issued.
Cash Flows
The following table provides a summary of our cash flow data for the periods indicated (amounts in thousands):
Net cash used in operating activities
Net cash provided by financing activities
Cash Flows from Operating Activities
Our cash flows used in operating activities to date have been primarily comprised of payroll and professional service fees related to research and development, clinical trials, and general and administrative activities.
Net cash used in operating activities was approximately $4.5 million for the three months ended March 31, 2025, consisting primarily of payments to clinical and manufacturing service providers, internal payroll and severance costs, and third-party professional services as we initiated the wind down of our operations and explored strategic alternatives. Our net loss during the three months ended March 31, 2025 was approximately $5.0 million, which included approximately $0.4 million related to stock-based compensation.
Cash Flows from Financing Activities
In January 2025, the Company entered into the Sales Agreement with H.C. Wainwright & Co., LLC. The Sales Agreement provides for the issuance and sale by the Company of shares of common stock in “at-the-market” offerings having an aggregate offering price of up to $30.0 million. As of March 31, 2025, the Company sold an aggregate of 2,624,276 shares of its common stock at an average price of $1.63 per share, resulting in net proceeds of approximately $3.9 million, after paying commissions and offering expenses of approximately $0.4 million.
Off-Balance Sheet Arrangements
We are not a party to any off-balance sheet arrangements, as defined under SEC rules.
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Critical Accounting Estimates
Our discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect our reported amounts of assets, liabilities, revenues, and expenses.
On an ongoing basis, we evaluate our estimates and judgments, including those related to derivative liabilities, accrued expenses, and stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources.
Our critical accounting estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2024. Other than described in Note 2 to our unaudited condensed consolidated financial statements in this report, our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.
Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risks in the ordinary course of our business, including the effects of interest rate changes and fluctuations in foreign currency exchange rates. Information on quantitative and qualitive disclosures about these market risks is set forth below.
Interest Rate Risk
Cash and restricted cash consist solely of cash held in depository accounts and as such are not affected by either an increase or decrease in interest rates. Furthermore, we consider all highly liquid investments as cash equivalents. As of March 31, 2025, we held cash only. The short-term nature of cash equivalents are not significantly impacted by changes in the interest rates. Any interest-bearing instruments carry a degree of risk; however, we have not been exposed to, nor do we anticipate being exposed to, material risks due to changes in interest rates. A hypothetical 10% change in interest rates during any of the periods presented would not have had a material impact on our unaudited condensed consolidated financial statements.
Foreign Currency Risk
Our operations are principally denominated by U.S. dollars, and we do not expect our future operating results to be significantly affected by foreign currency transaction risk. A hypothetical 10% change in foreign exchange rates during any of the periods presented would not have had a material impact on our unaudited condensed consolidated financial statements.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Based on their evaluation as of the end of the period covered by this report, our Acting Chief Executive Officer (our principal executive officer) and Acting Chief Financial Officer (our principal financial officer) have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) for the three months ended March 31, 2025 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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Exhibits.
Description
In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. 34-47986, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this report and will not be deemed “filed” for purposes of Section 18 of the Exchange Act, or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act, except to the extent that the registrant specifically incorporates it by reference.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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