UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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TABLE OF CONTENTS
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this “Report”) contains forward-looking statements that reflect our current expectations and views of future events. The forward-looking statements are contained principally in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Readers are cautioned that known and unknown risks, uncertainties and other factors, including those over which we may have no control and others listed in the “Risk Factors” section of this Report, may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future, although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity, performance, or achievement to differ materially from those expressed or implied by these forward-looking statements. These forward-looking statements include, but are not limited to, statements about:
| ● | our projected financial position and estimated cash burn rate; |
| ● | our estimates regarding expenses, future revenues and capital requirements; |
| ● | our ability to continue as a going concern; |
| ● | our need to raise substantial additional capital to fund our operations and repay indebtness; |
| ● | our ability to commercialize or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix AG (“Proteomedix”); |
| ● | our reliance on third parties, including Laboratory Corporation of America (“LabCorp”), to develop, market, distribute and sell Proclarix; |
| ● | the successful development of our commercialization capabilities, including sales and marketing capabilities; |
| ● | our ability to maintain the necessary regulatory approvals to market and commercialize our product; |
| ● | the results of market research conducted by us or others; |
| ● | our ability to obtain and maintain intellectual property protection for our current product; |
| ● | our ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual property rights; |
| ● | the possibility that a third party may claim we or our third-party licensors have infringed, misappropriated, or otherwise violated their intellectual property rights and that we may incur substantial costs and be required to devote substantial time defending against claims against us; |
| ● | our reliance on third parties, including manufacturers and logistics companies; |
| ● | the success of competing therapies or diagnostics and products that are or become available; |
| ● | our ability to successfully compete against current and future competitors; |
| ● | our ability to expand our organization to accommodate potential growth and our ability to attract, motivate and retain key personnel; |
| ● | the potential for us to incur substantial costs resulting from product liability lawsuits against us and the potential for these product liability lawsuits to cause us to limit our commercialization of our product; |
| ● | market acceptance of our product, the size and growth of the potential markets for our current product, and our ability to serve those markets; and |
| ● | disruptions in the business of Onconetix or Proteomedix, which could have an adverse effect on their respective businesses and financial results. |
These forward-looking statements involve numerous risks and uncertainties. Although we believe that our expectations expressed in these forward-looking statements are reasonable, our expectations may later be found to be incorrect. Our actual results of operations or the results of other matters that we anticipate herein could be materially different from our expectations. Important risks and factors that could cause our actual results to be materially different from our expectations are generally set forth in “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and other sections in this Report. You should thoroughly read this Report and the documents that we refer to with the understanding that our actual future results may be materially different from and worse than what we expect. We qualify all our forward-looking statements by these cautionary statements.
The forward-looking statements made in this Report relate only to events or information as of the date on which the statements are made in this Report. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this Report and the documents that we refer to in this Report and have filed as exhibits to this Report, completely and with the understanding that our actual future results may be materially different from what we expect.
ii
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
ONCONETIX, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash | $ | $ | ||||||
| Accounts receivable, net | ||||||||
| Inventories | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Operating right of use asset | ||||||||
| Goodwill | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Notes payable, net of debt discount of $ | ||||||||
| Operating lease liability, current | ||||||||
| Subscription agreement liability – Related Party | ||||||||
| Contingent warrant liabilities | ||||||||
| Due to Shareholders | ||||||||
| Total current liabilities | ||||||||
| Pension benefit obligation | ||||||||
| Total liabilities | ||||||||
| Commitments and Contingencies | ||||||||
| Series C Redeemable Preferred Stock, $ | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Treasury stock, at cost; | ( | ) | ( | ) | ||||
| Due from shareholders | ( | ) | ||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities, convertible preferred stock, and stockholders’ equity | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
ONCONETIX, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
| For the three months ended | ||||||||
| March 31, 2025 | March 31, 2024 | |||||||
| Revenue | $ | $ | ||||||
| Cost of revenue | ||||||||
| Gross profit | ||||||||
| Operating expenses | ||||||||
| Selling, general, and administrative | ||||||||
| Research and development | ||||||||
| Impairment of ENTADFI | ||||||||
| Impairment of goodwill | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other (expense) income | ||||||||
| Interest expense - related party | ( | ) | ||||||
| Interest expense | ( | ) | ( | ) | ||||
| Change in fair value of subscription agreement liability – related party | ||||||||
| Change in fair value of contingent warrant liabilities | ( | ) | ||||||
| Gain on forgiveness of accounts payable | ||||||||
| Other income (loss) | ( | ) | ||||||
| Total other income (loss) | ( | ) | ||||||
| Loss before income taxes | ( | ) | ( | ) | ||||
| Income tax benefit | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Deemed dividend Series C preferred stock | ( | ) | ||||||
| Net loss applicable to common stockholders | ( | ) | ( | ) | ||||
| Net loss per share, basic and diluted | $ | ( | ) | $ | ( | ) | ||
| Weighted average number of common shares outstanding, basic and diluted | ||||||||
| Other comprehensive income (loss) | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Foreign currency translation | ( | ) | ||||||
| Change in pension benefit obligation | ( | ) | ||||||
| Total comprehensive loss | $ | ( | ) | $ | ( | ) | ||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
ONCONETIX, INC.
Condensed Consolidated Statements of Convertible Preferred Stock and
Stockholders’ Equity (Deficit)
(Unaudited)
| Series A Preferred Stock | Common Stock | Additional Paid-in | Treasury Stock | Accumulated | Accumulated Other Comprehensive | Due from | Total Onconetix Equity | Non- controlling | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Shares | Amount | Deficit | Income | Shareholders | (Deficit) | Interest | (Deficit) | ||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | $ | ||||||||||||||||||||||||||||||||||
| Issuance of restricted common stock | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Change in pension benefit obligation | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2024 | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Series A Preferred Stock | Common Stock | Additional Paid-in | Treasury Stock | Accumulated | Accumulated Other Comprehensive | Due from | Total Onconetix | Non- controlling | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Shares | Amount | Deficit | Income | Shareholders | Equity | Interest | (Deficit) | ||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ( | ) | $ | $ | $ | |||||||||||||||||||||||||||||||||
| Issuance of common stock in connection with the ELOC | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Redemption of Series C Preferred Stock | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Change in pension benefit obligation | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | $ | $ | |||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
ONCONETIX, INC.
Consolidated Statements of Cash Flows
(Unaudited)
| Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Loss on impairment of goodwill | ||||||||
| Impairment of ENTADFI assets | ||||||||
| Amortization of debt discounts | ||||||||
| Amortization of debt discount - related party | ||||||||
| Depreciation and amortization | ||||||||
| Change in fair value of subscription agreement liability – related party | ( | ) | ( | ) | ||||
| Net periodic pension benefit | ( | ) | ( | ) | ||||
| Stock-based compensation | ||||||||
| Gain on forgiveness of accounts payable | ( | ) | ||||||
| Interest accrued on note payable – related party | ||||||||
| Change in fair value of contingent warrant liability | ||||||||
| Deferred tax benefit | ( | ) | ||||||
| Disposal of property and equipment | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ||||||
| Inventories | ( | ) | ( | ) | ||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Prepaid expenses, long-term | ( | ) | ||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Accrued expenses | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of property and equipment | ( | ) | ||||||
| Net cash Provided by (used in) investing activities | ( | ) | ||||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of note payable – related party | ||||||||
| Proceeds from issuance of note payable | ||||||||
| Payment of financing costs | ( | ) | ||||||
| Principal payments of notes payable | ( | ) | ( | ) | ||||
| Payment for redemption of Series C Preferred Stock | ( | ) | ||||||
| Proceeds from issuance of common stock in connection with the ELOC | ||||||||
| Net cash provided by financing activities | ||||||||
| Effect of exchange rate changes on cash | ( | ) | ||||||
| Net increase (decrease) in cash | ( | ) | ||||||
| Cash, beginning of period | ||||||||
| Cash, end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Noncash investing and financing activities: | ||||||||
| D&O insurance premium financed | $ | $ | ||||||
| Deemed dividend owed to Series C preferred stock shareholders | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 1 — Organization and Basis of Presentation
Organization and Nature of Operations
Onconetix, Inc. (formerly known as Blue Water Biotech, Inc. and Blue Water Vaccines Inc.) (the “Company” or “Onconetix”) was formed on October 26, 2018, and is a commercial stage biotechnology company focused on the research, development, and commercialization of innovative solutions for men’s health and oncology.
On December 15, 2023, Onconetix acquired
In April 2023, the Company acquired ENTADFI, a Food and Drug Administration (“FDA”)-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia.
Historically, the Company’s focus was on the research and development of transformational vaccines to prevent infectious diseases worldwide, until the third quarter of 2023, at which time the Company halted its efforts on vaccine development activities to focus on commercialization activities for ENTADFI and pursue other potential acquisitions. However, in light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is still working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if the Company is not able to consummate a sale or other transaction of the ENTADFI assets, it may abandon the assets and destroy its inventory of the product. Based on the circumstances surrounding ENTADFI, the ENTADFI assets were fully impaired at June 30, 2024 (see Note 4).
On April 21, 2023, the Company filed an amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to change its corporate name from “Blue Water Vaccines Inc.” to “Blue Water Biotech, Inc.” The name change was effective as of April 21, 2023. On December 15, 2023, the Company filed an amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to change its corporate name from “Blue Water Biotech, Inc.” to “Onconetix, Inc.” In connection with each of the name changes, the Company also amended the Company’s bylaws to reflect the new corporate name.
Reverse Stock Split
On September 24, 2024,
Basis of Presentation and Principles of Consolidation
The Company’s condensed consolidated financial
statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S.
GAAP”) and include the accounts of Onconetix and its
Unaudited Interim Consolidated Financial Statements
The accompanying condensed consolidated balance sheet as of March 31, 2025, and the condensed consolidated statements of operations and comprehensive loss and the condensed consolidated statements of convertible preferred stock and stockholders’ equity (deficit) for the three months ended March 31, 2025 and 2024, and the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 are unaudited. These unaudited interim consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements, and in management’s opinion, include all adjustments, consisting of only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2025 and its results of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, and its cash flows for the three months ended March 31, 2025 and 2024. The financial data and the other financial information disclosed in the notes to these condensed consolidated financial statements related to the three-month periods are also unaudited. Operating results for the three months ended March 31, 2025, are not necessarily indicative of the results that may be expected for the year ended December 31, 2025, any other interim periods, or any future year or period. The unaudited condensed consolidated financial statements included in this Report should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which includes a broader discussion of the Company’s business and the risks inherent therein.
5
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 2 — Going Concern and Management’s Plans
The Company’s operating activities to date have been devoted to seeking licenses, engaging in research and development activities, potential asset and business acquisitions, expenditures associated with the previously planned commercial launch of ENTADFI, and the commercialization of Proclarix.
The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future.
As of March 31, 2025, the Company had cash of approximately $
Management’s plans for funding the Company’s operations include generating product revenue from sales of Proclarix, which is still subject to further successful development and commercialization activities within certain jurisdictions. Management also intends to secure additional required funding through equity or debt financings if available, and to utilize the ELOC entered into in October 2024 (see Note 8) on an as-needed basis to assist with the paydown of notes issued to Veru and to fund current operating needs, subject to certain restrictions and beneficial ownership constraints. However, based on the terms of the ELOC and the current maximum availability, management determined that the funds readily available under the ELOC will not be sufficient to sustain operations. In addition, there are currently no other commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable terms, if at all. This creates significant uncertainty whether the Company will have the funds available to be able to sustain its operations and expand commercialization of Proclarix. If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization of future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations.
Because of historical and expected operating losses and net operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of the condensed consolidated financial statements, which is not alleviated by management’s plans. The condensed consolidated financial statements have been prepared under the going concern basis of accounting. These condensed consolidated financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.
6
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 3 — Summary of Significant Accounting Policies
During the three months ended March 31, 2025, there were no changes to the Company’s significant accounting policies described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. Selected significant accounting policies are discussed in further detail below:
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. The most significant estimates in the Company’s condensed consolidated financial statements relate to accounting for acquisitions, valuation of inventory, the useful life of the amortizable intangible assets, estimates of future cash flows used to evaluate impairment of intangible assets, assumptions related to the pension benefit obligation, assumptions related to the related party subscription agreement liability, assumption related to note payables, and accounting for income taxes. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Segment Information
Operating segments are defined as components
of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker (“CODM”),
or decision-making group, in deciding how to allocate resources and in assessing performance. As of March 31, 2025 and December 31, 2024,
the Company was operating in
7
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 3 — Summary of Significant Accounting Policies (cont.)
Fair Value Measurements
Fair value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:
| ● | Level 1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets; |
| ● | Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and |
| ● | Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
In some circumstances, the inputs used to measure fair value might be categorized within different levels of the fair value hierarchy. In those instances, the fair value measurement is categorized in its entirety in the fair value hierarchy based on the lowest level input that is significant to the fair value measurement. Financial instruments, including cash, inventory, accounts receivable, accounts payable, accrued liabilities, operating lease liabilities, and notes payable are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.
The fair value of the contingent warrant liability and the related party subscription agreement liability are valued using significant unobservable measures and other fair value inputs and are therefore classified as Level 3 financial instruments.
The fair value of financial instruments measured on a recurring basis is as follows as of March 31, 2025 and December 31, 2024:
| As of March 31, 2025 | ||||||||||||||||
| Description | Total | Level 1 | Level 2 | Level 3 | ||||||||||||
| Liabilities: | ||||||||||||||||
| Contingent warrant liability | $ | $ | ||||||||||||||
| Subscription agreement liability – related party | $ | $ | ||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
| As of December 31, 2024 | ||||||||||||||||
| Description | Total | Level 1 | Level 2 | Level 3 | ||||||||||||
| Liabilities: | ||||||||||||||||
| Contingent warrant liability | $ | $ | ||||||||||||||
| Subscription agreement liability – related party | $ | $ | ||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
During the year ended December 31, 2024, the Company recorded full impairments of the intangible assets acquired from the acquisitions of Proteomedix and ENTADFI. These non-financial assets had been valued using significant unobservable measures and other fair value inputs and were classified as Level 3 measurements.
None of the Company’s other non-financial assets or liabilities are recorded at fair value on a non-recurring basis as of March 31, 2025 and December 31, 2024. There were no transfers between levels during the periods presented.
8
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 3 — Summary of Significant Accounting Policies (cont.)
The following table summarizes the activity for the related party subscription agreement liability, using unobservable Level 3 inputs, for the three months ended March 31, 2025:
| Subscription Agreement Liability | ||||
| Balance at December 31, 2024 | $ | |||
| Change in fair value | ( | ) | ||
| Balance at March 31, 2025 | $ | |||
The following table summarizes the activity for the contingent warrant liability, using unobservable Level 3 inputs, for the three months ended March 31, 2025:
| Contingent Warrant Liability | ||||
| Balance at December 31, 2024 | $ | |||
| Change in fair value | ||||
| Balance at March 31, 2025 | $ | |||
Revenue Recognition
The following is a description of principal activities from which the Company generates its revenue:
Development Services
Proteomedix provides a range of services to life sciences customers referred to as “Development Services” including testing for biomarker discovery, assay design and development. These Development Services are performed under individual statement of work (“SOW”) arrangements with specific deliverables defined by the customer. Development Services are generally performed on a time and materials basis. During the performance and through completion of the service to the customer in accordance with the SOW, the Company has the right to bill the customer for the agreed upon price and recognizes the Development Services revenue over the period estimated to complete the SOW. The Company generally identifies each SOW as a single performance obligation.
Completion of the service and satisfaction of the performance obligation under a SOW is typically evidenced by access to the data or test made available to the customer or any other form or applicable manner of delivery defined in the SOW. However, for certain SOWs under which work is performed pursuant to the customer’s highly customized specifications, the Company has the enforceable right to bill the customer for work completed, rather than upon completion of the SOW. For those SOWs, the Company recognizes revenue over a period of time during which the work is performed based on the expended efforts (inputs). As the performance obligation under the SOW is satisfied, any amounts earned as revenue and billed to the customer are included in accounts receivable.
Product Sales
The Company derives revenue through sales of its products, which includes Proclarix, its diagnostic product, directly to end users, including laboratories, hospitals, and medical centers, and to distributors. The Company considers customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. For each contract, the Company considers the promise to transfer products, each of which is distinct, to be the identified performance obligations. In determining the transaction price, the Company evaluates whether the price is subject to refund or adjustment to determine the net consideration to which it expects to be entitled. The Company fulfills its performance obligation applicable to product sales once the product is transferred to the customer.
9
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 3 — Summary of Significant Accounting Policies (cont.)
During the three months ended March 31, 2025
and 2024, the Company recognized revenue of approximately $
The Company’s revenue was generated from the following geographic regions during the three months ended March 31, 2025:
| European Union | Non-European Union (UK) | United States | ||||||||||
| Development services | % | % | % | |||||||||
| Product sales | % | % | % | |||||||||
| European Union | Non-European Union (UK) | United States | Total Revenue | |||||||||||||
| Development services | $ | $ | $ | $ | ||||||||||||
| Product sales | $ | |||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
The Company’s revenue was generated from the following geographic regions during the three months ended March 31, 2024:
| European Union | Non-European Union (UK) | United States | ||||||||||
| Development services | % | % | % | |||||||||
| Product sales | % | % | % | |||||||||
| European Union | Non-European Union (UK) | United States | Total Revenue | |||||||||||||
| Development services | $ | $ | $ | $ | ||||||||||||
| Product sales | $ | |||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
The Company had the following customer concentrations for its revenue during the three months ended March 31, 2025 and 2024:
| For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | |||||||||||||||
| Development Services | Product Sales | Development Services | Product Sales | |||||||||||||
| Customer A | % | % | % | % | ||||||||||||
| Customer B | % | % | % | % | ||||||||||||
| Customer C | % | % | % | % | ||||||||||||
| Customer D | % | % | % | % | ||||||||||||
Any revenues earned but not yet billed to the
customer as of the date of the condensed consolidated financial statements are recorded as contract assets and are included in prepaid
expenses and other current assets in the accompanying condensed consolidated financial statements. The Company had no unbilled accounts
receivable as of March 31, 2025 and December 31, 2024. Amounts recorded in contract assets are reclassified to accounts receivable in
our condensed consolidated financial statements when the customer is invoiced according to the billing schedule in the contract. Accounts
receivable was approximately $
In relation to customer contracts, the Company incurs costs to fulfill a contract but does not incur costs to obtain a contract. These costs to fulfill a contract do not meet the criteria for capitalization and are expensed as incurred.
New Accounting Pronouncements
There were no new accounting pronouncements issued since the Company’s filing of the Annual Report on Form 10-K for the year ended December 31, 2024, which could have a significant effect on the accompanying condensed consolidated financial statements.
10
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 4 — Balance Sheet Details
Inventories
Inventories, which primarily relate to Proclarix product as of March 31, 2025 and Proclarix products as of December 31, 2024, consisted of the following:
| March 31, 2025 | December 31, 2024 | |||||||
| Raw materials | $ | $ | ||||||
| Finished goods | ||||||||
| Total | $ | $ | ||||||
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of March 31, 2025, and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |||||||
| Prepaid insurance | $ | $ | ||||||
| Prepaid professional fees | ||||||||
| VAT taxes receivable | ||||||||
| Prepaid other | ||||||||
| Other receivable | ||||||||
| Total | $ | $ | ||||||
Intangible Assets
Intangible assets acquired in connection with
the ENTADFI and Proteomedix acquisitions were comprised of customer relationships, product rights for developed technology, and a trade
name. These intangibles were fully impaired during the year ended December 31, 2024 resulting in a
Amortization for three months ended March 31, 2024
The finite lived intangible assets held by the
Company, which included customer relationships and product rights for developed technology, were amortized over their estimated useful
lives of
Impairment for three months ended March 31, 2024
During the three months ended March 31, 2024,
the Company became aware of a new competitor that received approval by the FDA for a combined finasteride-tadalafil capsule, which is
a direct competitor product to ENTADFI. This was determined to be a triggering event that could result in a decrease in future expected
cash flows, and thus indicated the carrying amount of the ENTADFI asset group may not be fully recoverable. The Company performed an
undiscounted cash flow analysis over the ENTADFI asset group and determined that the carrying value of the asset group is not recoverable.
The Company then estimated the fair value of the asset group to measure the impairment loss for the period. Significant assumptions used
to determine this non-recurring fair value measurement included projected sales driven by market share and product sales price estimates,
associated expenses, growth rates, the discount rate used to measure the fair value of the net cash flows associated with this asset
group, as well as Management’s estimates of an expected sales price for the asset group, and the probability of each potential
strategic alternative taking place. The Company recorded an intangible asset impairment charge of approximately $
Goodwill
Goodwill consisted of the following as of March 31, 2025 and December 31, 2024:
| Balance as of December 31, 2024 | $ | |||
| Impairment loss | ( | ) | ||
| Foreign currency translation | ||||
| Balance as of March 31, 2025 | $ |
11
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 4 — Balance Sheet Details (cont.)
Impairments for three months ended March 31, 2025 and 2024
During the three months ended March 31, 2025
and 2024, the Company’s stock price and market capitalization declined, and the Company determined that this was an indicator of
a potential impairment of its goodwill. Accordingly, as of March 31, 2025 and 2024, the Company performed quantitative analysis to identify
and measure the amount of impairment losses to be recognized. The Company recognized goodwill impairment losses of approximately $
The fair value estimate of the reporting units for the quarter ended March 31, 2025 was derived from the Company’s fully-diluted market capitalization using an indicative share price based on the 5- and 10-day trailing volume-weighted average price.
Accrued Expenses
Accrued expenses consisted of the following as of March 31, 2025 and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |||||||
| Accrued compensation | $ | $ | ||||||
| Accrued research and development | ||||||||
| Accrued professional fees | ||||||||
| Other accrued expenses | ||||||||
| Accrued franchise taxes | ||||||||
| Accrued interest | ||||||||
| Accrued license fees | ||||||||
| Total | $ | $ | ||||||
Note 5 — Significant Agreements
Services Agreement
On July 21, 2023, the Company, entered into a
Licensing and Services Master Agreement (“Master Services Agreement”) and a related statement of work with a vendor, pursuant
to which the vendor was to provide to the Company commercialization services for the Company’s products, including recruiting,
managing, supervising and evaluating sales personnel and providing sales-related services for such products, for fees totaling up to
$
Laboratory Corporation of America
On March 23, 2023, Proteomedix entered into a
license agreement with LabCorp, pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix, and other products
developed by LabCorp using Proteomedix’s intellectual property covered by the license, in the United States (“Licensed Products”).
In consideration for granting LabCorp an exclusive license, Proteomedix received an initial license fee in the mid-six figures upon signing
of the contract. Additionally, Proteomedix is entitled to royalty payments of between
| ● | After the first sale of Proclarix as a laboratory developed test, LabCorp will pay an amount in the mid-six figures, |
| ● | after LabCorp achieves a certain amount in the low seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures, |
| ● | after a certain amount in the mid-seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures. |
12
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 5 — Significant Agreements (cont.)
The total available milestone payments available
under the terms of this contract is $
LabCorp is wholly responsible for the cost, if any, of research, development and commercialization of Licensed Products in the United States but has the right to offset a portion of those costs against future royalty and milestone payments. Additionally, LabCorp may deduct royalties or other payments made to third parties related to the manufacture or sale of Licensed Products up to a maximum amount of any royalty payments due to Proteomedix.
The license agreement and related royalty payment provisions expire during 2038, which approximates the expiration of the last patent covered by the license agreement. LabCorp has the right to terminate the license agreement for any reason by providing 90 days written notice to Proteomedix. Either party may terminate the license agreement due to a material breach of the terms of the license agreement with 30 days’ notice, provided such breach is not cured within the foregoing 30-day period. Finally, Proteomedix may terminate the license agreement with 60 days’ notice in the event LabCorp fails to make any undisputed payment due, provided that LabCorp does not remit the payment within the foregoing 60-day period.
As of March 31, 2025, the sale of Licensed Products by LabCorp under the license agreement has not commenced. The Company has sold product to LabCorp for their use in internal trials of the test.
Notes 6 — Notes Payable
Veru Notes Payable
As of March 31, 2025 and December 31, 2024, the
Company has two non-interest-bearing notes payable (the “Notes”) outstanding with principal amounts of $
The Company imputed interest on the Notes using
an average discount rate of
On April 24, 2024, the Company entered into
a forbearance agreement with Veru (the “Original Forbearance Agreement”) due to the Company’s failure to repay the
principal balance on the $
Interest will accrue on any unpaid principal
balance of the April Veru Note at a rate of
In consideration for Veru’s entrance into the Original Forbearance Agreement, the Company agreed to pay Veru:
| ● | $ |
| ● |
| ● |
The Company also agreed to a general release of claims against Veru and its representatives arising out of or relating to any act or omission thereof prior to April 24, 2024.
The Company determined that the Original Forbearance Agreement should be accounted for as a modification of the April Veru Note and the September Veru Note in accordance with ASC 470-50, Debt - Modifications and Extinguishments (“ASC 470”), as the change in cash flows expected under the April Veru Note and the September Veru Note was not substantial. A new effective interest rate was established based on the carrying value of the original Notes and the revised cash flows and no gain or loss was recorded.
13
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Notes 6 — Notes Payable (cont.)
On September 19, 2024, the Company entered into an Amended and Restated Forbearance Agreement with Veru (the “Amended and Restated Forbearance Agreement” or “A&R Forbearance Agreement”), which amends and restates the Original Forbearance Agreement in its entirety. Pursuant to the A&R Forbearance Agreement, Veru will forbear from exercising its rights under both the April Veru Note and the September Veru Note, subject to the terms and conditions set forth below.
The A&R Forbearance Agreement extends the due date for the April 2024 and September 2024 Veru Notes until the earlier to occur of (i) June 30, 2025 or (ii) the occurrence of any Event of Default. The Amended and Restated Forbearance Agreement also effected certain modifications to the payment terms in the Original Forbearance Agreement and amended certain terms of the September Veru Note as summarized below.
Pursuant to the A&R Forbearance Agreement, the Company agreed to make the following required payments (the “Required Payments”) during the April 2024 Forbearance Period, first to accrued and unpaid interest under the April Veru Note and then any remainder to the outstanding principal amount of the April Veru Note:
| ● | Interest at the rate of |
| ● | Monthly payments equal to |
| ● | Payment of |
| ● | The remaining balance of the April Veru Note will be due at the end of the April 2024 Forbearance Period. |
The Company and Veru also agreed to the following amendments to the September Veru Note in the A&R Forbearance Agreement:
| ● | As noted above, an extension of the maturity date to June 30, 2025; |
| ● | The accrual of interest at the rate of |
| ● | Any amounts owed on the September Veru Note, including but not limited to unpaid principal and accrued interest, will be paid in cash or, upon the mutual written consent of Veru and the Company, in shares of the Company’s Common Stock or a combination of cash and the Company’s Common Stock; |
| ● | Following full repayment of all principal and interest under the April Veru Note, the Company will make the Required Payments first towards accrued and unpaid interest under the September Veru Note and then towards the remaining principal balance payable under the September Veru Note; |
| ● | If the aggregate unpaid principal outstanding under the April Veru Note and the September Veru Note and all accrued and unpaid interest thereon is repaid in cash on or before December 31, 2024, then the total principal balance under the September Veru Note that will be payable by the Company in satisfaction of its obligations under the September Veru Note will be reduced from $ |
The Company determined the A&R Forbearance Agreement should be accounted for as a modification of both the April and September Veru Notes in accordance with ASC 470-50, Debt - Modifications and Extinguishments (“ASC 470”), as the change in cash flows expected under the April Veru Note and the September Veru Note was not substantial. A new effective interest rate was established based on the carrying value of the original Notes and the revised cash flows and no gain or loss was recorded.
14
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Notes 6 — Notes Payable (cont.)
On November 26, 2024, the Company entered into
another Amended and Restated Forbearance Agreement with Veru (the “November Amended and Restated Forbearance Agreement” or
“November A&R Forbearance Agreement”), which amends and restates certain terms of the Amended and Restated Forbearance
Agreement. Pursuant to the November A&R Forbearance Agreement, Veru agreed to waive the due date for payment of applicable Cash Receipt
Payments (as such term is defined in the A&R Forbearance Agreement) generated in October 2024 until the Company receives funds of
at least $
During the three months ended March 31, 2025
and 2024, the Company recorded approximately $
Future minimum principal payments on the Notes
as of March 31, 2025 include $
Related Party Debenture
On January 23, 2024, the Company issued a non-convertible
debenture (the “Debenture”) to the PMX Investor, a related party, in the principal sum of $
On April 24, 2024, the maturity date of the related party debenture was extended to October 31, 2024, through the execution of an extension agreement (the “Extension Agreement”) between the Company and the PMX investor. No other terms of the Debenture were modified in connection with the Extension Agreement.
The Company considered the guidance of ASC 470-60, Troubled Debt Restructuring by Debtors, and concluded that the Extension Agreement should be accounted for as a troubled debt restructuring as the Company is experiencing financial difficulty and since the effective borrowing rate under the Extension Agreement is less than the effective borrowing rate under the original agreement, which indicates that a concession is deemed to have been granted. This did not result in a gain on restructuring as the future undiscounted cash outflows required under the Extension Agreement exceed the carrying value of the Debenture immediately prior to the extension. A new effective rate was established based on the carrying value of the original Debenture and the revised cash flows.
In connection with the issuance of the Debenture,
the Company incurred approximately $
On September 24, 2024, the Company converted all unpaid principal and
accrued interest due under the Debenture into
The Company recorded approximately $
15
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Notes 6 — Notes Payable (cont.)
Insurance Financing
During the three months ended March 31, 2025, the Company obtained financing for certain Director & Officer liability insurance policy premiums. The agreement assigns the lender a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies.
The total premiums, taxes and fees financed are
approximately $
Keystone Notes Payable
On February 12, 2025, the Company issued a promissory note to Keystone
Capital Partners, LLC with original issue discount of $
Note 7 — Subscription Agreement
On December 18, 2023, the Company entered into
a subscription agreement (the “Subscription Agreement”) with the PMX Investor, who became a stockholder of Onconetix at the
closing of the PMX Transaction (see Note 10), for the sale of
The Subscription Agreement is accounted for as
a liability in accordance with ASC 480, Distinguishing Liabilities from Equity, (“ASC 480”), as the make-whole provision
could result in a variable number of shares being issued upon settlement. The related party subscription agreement liability is measured
at fair value at the commitment date and at each subsequent reporting period, with changes in fair value recorded as a component of other
income (expense), net in the condensed consolidated statements of operations and comprehensive loss. As of March 31, 2025 and December
31, 2024, the fair value of the related party subscription agreement liability is estimated to be approximately $
| March 31, 2025 | December 31, 2024 | |||||||
| Exercise price | $ | $ | ||||||
| Term (years) | ||||||||
| Expected stock price volatility | % | % | ||||||
| Risk-free rate of interest | % | % | ||||||
16
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 8 — Convertible Preferred Stock and Stockholders’ Equity
Authorized Capital
As of March 31, 2025 and December 31, 2024, the
Company is authorized to issue
At March 31, 2025 and December 31, 2024, the
Company had designated
Preferred Stock
Series Seed Convertible Preferred Stock
The Company has
Series A Convertible Preferred Stock
On September 29, 2023, the Company filed a Certificate
of Designations of Rights and Preferences of Series A Preferred Stock of the Company (the “Series A Certificate of Designations”)
with the State of Delaware to designate and authorize the issuance of up to
On October 3, 2023, the Company issued
On September 24, 2024, Veru converted all
Series B Convertible Preferred Stock
On December 15, 2023, the Company filed a Certificate
of Designations of Rights and Preferences of Series B Convertible Preferred Stock of the Company (the “Series B Certificate of
Designations”) with the State of Delaware to designate and authorize the issuance of up to
On December 15, 2023, in connection with the
PMX Transaction, as part of the purchase consideration, the Company issued
The Company evaluated the terms of the Series B Preferred Stock, and in accordance with the guidance of ASC 480, the Series B Preferred Stock was classified as temporary equity in the accompanying consolidated balance sheets, as the shares may be redeemable by the holders for cash, upon certain conditions that are not within the control of the Company. Additionally, the Company does not control the actions or events necessary to deliver the number of required shares upon exercise by the holders of the conversion feature. The Series B Preferred Stock was recorded at its fair value as of the issuance date. The Series B Preferred Stock was not previously redeemable or probable of becoming redeemable because it was subject to, among other things, Stockholder Approval as described above, and therefore the carrying amount was not accreted to its redemption value in prior periods.
On September 5, 2024, Stockholder Approval was
obtained, and on September 24, 2024, the Company effected the conversion of all
17
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 8 — Convertible Preferred Stock and Stockholders’ Equity (cont.)
Series C Convertible Preferred Sock
On October 1, 2024, the Board of Directors authorized
the Company to create a series of
After the Stockholder Approval Date, if a Triggering
Event occurs and is continuing at any time after the earlier of the holders’ receipt of a Triggering Event Notice and such holder
becoming aware of such Triggering Event (such earlier date, the “Alternate Conversion Right Commencement Date”) and ending
on the twentieth (20th) Trading Day after the later of (x) the date of such Triggering Event is cured and (y) such holder’s
receipt of a Triggering Event Notice (such ending date, the “Alternate Conversion Right Expiration Date”), and each such
period, an “Alternate Conversion Right Period”), such holder may, at such holder’s option, by delivery of a Conversion
Notice to the Company (the date of any such Conversion Notice, each an “Alternate Conversion Date”), convert all, or any
number of Preferred Shares held by such holder into shares of Common Stock at the Alternate Conversion Price (each, an “Alternate
Conversion”). Alternate Conversion Price means, with respect to any Alternate Conversion that price will be the lowest of
In no event may any Preferred Shares be converted
(or Warrants be exercised) and shares of Common Stock be issued to any holder if after giving effect to the issuance of shares of Common
Stock upon such conversion of the Preferred Shares (or exercise of the Warrants), the holder (together with its affiliates, if any) would
beneficially own more than
During the three months ended March 31, 2025, the Company has redeemed
approximately
18
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 8 — Convertible Preferred Stock and Stockholders’ Equity (cont.)
Securities Purchase Agreement and ELOC
On October 2, 2024, the Company entered into
a Securities Purchase Agreement (the “Securities Purchase Agreement”) with six institutional and accredited investors. The
Company sold an aggregate of i)
Concurrently, on October 2, 2024, the Company
entered into a Common Stock Equity Line of Credit Purchase Agreement (the “ELOC Purchase Agreement”) with an institutional
investor, whereby the Company may sell up to $
Based on the terms of
the Series C Redeemable Preferred Stock and the Company’s Certificate of Designation, and in accordance with ASC 480, the Series
C Redeemable Preferred Stock is accounted for as mezzanine equity due to the contingent redemption feature upon any sale of common
stock under the ELOC Purchase Agreement. The initial cash proceeds of $
During the year ended
December 31, 2024, the Company received proceeds of $
During the three months
ended March 31, 2025, the Company received proceeds of approximately $
Common Stock
As of March 31, 2025 and December 31, 2024 there
were
Treasury Stock
On November 10, 2022, the Board approved a stock
repurchase program (the “Repurchase Program”) to allow the Company to repurchase up to
There were no repurchases of common stock during the three months ended March 31, 2025 and 2024.
On November 13, 2024, the Board terminated the Repurchase Program.
19
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 8 — Convertible Preferred Stock and Stockholders’ Equity (cont.)
Deferred offering costs associated with the ATM Agreement are reclassified to additional paid in capital on a pro-rata basis when the Company completes offerings under the ATM Agreement. Any remaining deferred costs will be expensed to the statements of operations should the planned offering be abandoned.
As of December 31, 2024 and March 31, 2025, no
shares have been sold under the ATM Offering, and the Company wrote off approximately $
Warrants
The following summarizes the Company’s outstanding warrants, excluding contingent warrants issuable upon exercise of the outstanding warrants as of March 31, 2025:
| Number of Shares | WA Average Exercise Price | WA Remaining Contractual Life (in years) | ||||||||||
| Outstanding as of December 31, 2024 | $ | |||||||||||
| Granted | — | |||||||||||
| Exercised | — | |||||||||||
| Cancelled | — | |||||||||||
| Outstanding as of March 31, 2025 | ||||||||||||
| Warrants vested and exercisable as of March 31, 2025 | $ | |||||||||||
As of March 31, 2025, the Company had outstanding
warrants, which are exercisable into
Contingent Warrant Liabilities
As of March 31, 2025, the fair value of contingent
warrant labilities includes the Series C PIPE warrants of $
As of December 31, 2024, the fair value of contingent
warrant labilities includes the Series C PIPE warrants of $
The maximum number of warrants issuable upon
settlement of the contingent warrants was
Onconetix Equity Incentive Plans
The Company’s 2019 Equity Incentive Plan
(the “2019 Plan”) was adopted by its board of directors and by its stockholders on July 1, 2019. On February 23, 2022 the
Company’s board of directors adopted the Company’s 2022 Equity Incentive Plan (the “2022 Plan”), which is the
successor and continuation of the Company’s 2019 Plan. Under the 2022 Plan, the Company may grant stock options, restricted stock,
restricted stock units, stock appreciation rights, and other forms of awards to employees, directors, and consultants of the Company.
In May 2023, the number of shares of common stock reserved for issuance under the 2022 Plan was increased to
20
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 8 — Convertible Preferred Stock and Stockholders’ Equity (cont.)
Stock Options
The following summarizes activity related to the Company’s stock options under the 2019 Plan and the 2022 Plan for the three months ended March 31, 2025:
| Weighted | ||||||||||||
| Average | ||||||||||||
| Weighted | Remaining | |||||||||||
| Average | Contractual | |||||||||||
| Number of | Exercise | Life | ||||||||||
| Shares | Price | (in years) | ||||||||||
| Outstanding as of December 31, 2024 | $ | |||||||||||
| Granted | — | |||||||||||
| Forfeited / cancelled | — | |||||||||||
| Exercised | — | |||||||||||
| Outstanding as of March 31, 2025 | ||||||||||||
| Options vested and exercisable as of March 31, 2025 | $ | |||||||||||
There were no stock options granted during the three months ended March 31, 2025 and 2024.
The aggregate fair value of stock options that
vested during the three months ended March 31, 2025 and 2024 was approximately $
Restricted Stock
On May 9, 2023, the Board’s Compensation
Committee approved the issuance of restricted stock, granted under the Company’s 2022 Plan, to the Company’s executive officers,
employees, and certain of the Company’s consultants. The restricted shares granted totaled
The following summarizes activity related to the Company’s restricted stock awards granted under the 2022 Plan for the three months ended March 31, 2025:
| Weighted | ||||||||
| Average | ||||||||
| Number of | Grant Date | |||||||
| Shares | Fair Value | |||||||
| Nonvested as of December 31, 2024 | $ | |||||||
| Granted | ||||||||
| Vested | ||||||||
| Forfeited | ||||||||
| Nonvested as of March 31, 2025 | $ | |||||||
Proteomedix Stock Option Plan
Proteomedix sponsors a stock option plan (the “PMX Option Plan”) which provides common stock option grants to be granted to certain employees and consultants, as was determined by the board of directors of Proteomedix. In connection with the PMX Transaction, the Company assumed the PMX Option Plan.
Generally, options issued under the PMX Option
Plan have a term of not more than
21
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 8 — Convertible Preferred Stock and Stockholders’ Equity (cont.)
On April 16, 2024, the board of directors of
Proteomedix approved a two-year extension of
There was no activity under the PMX Option Plan
for the three months ended March 31, 2025. In October 2024,
Stock-Based Compensation
Stock-based compensation expense related to stock options and restricted stock, for the three months ended March 31, 2025 and 2024 was as follows:
| For the Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Selling, general and administrative | $ | $ | ||||||
| Research and development | ||||||||
| Total | $ | $ | ||||||
Note 9 — Commitments and Contingencies
Office Lease
Proteomedix leases office and lab space in Zurich
Switzerland. On April 1, 2024, the original lease was amended to add additional office and laboratory space. The lease amendment was
accounted for as a separate lease, resulting in an additional right-of-use asset and lease liability of approximately $
Litigation
From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. As of March 31, 2025, the Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims. However, on December 21, 2023, the Company filed a notice with the Bankruptcy Court terminating the WraSer APA and the WraSer MSA, after having determined that a Material Adverse Effect had occurred. WraSer has advised the Company that it does not believe that a Material Adverse Effect occurred, and they recently filed a plan of reorganization that indicates it may seek damages from the Company due to the termination of the WraSer APA and WraSer MSA.
22
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 9 — Commitments and Contingencies (cont.)
Registration Rights Agreements
In connection with private placements consummated
in April 2022 and August 2022, the Company entered into Registration Rights Agreements with the purchasers. Upon the occurrence of any
Event (as defined in each Registration Rights Agreement), which, among others, prohibits the purchasers from reselling the securities
for more than ten consecutive calendar days or more than an aggregate of fifteen calendar days during any 12-month period, and should
the registration statement cease to remain continuously effective, the Company would be obligated to pay to each purchaser, on each monthly
anniversary of each such Event, an amount in cash, as partial liquidated damages and not as a penalty, equal to the product of
Indemnification
In the normal course of business, the Company
enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications.
The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the
future but have not yet been made. To date, the Company has not been required to defend any action related to its indemnification obligations.
However, during the third quarter of 2023, the Company received a claim from its former CEO and a former accounting employee requesting
advancement of certain expenses. The Company recorded approximately $
Note 10 — Related Party Transactions
On December 18, 2023, the Company entered into the Subscription Agreement
with the PMX Investor, a
On February 6, 2024, the Company appointed Thomas Meier, PhD, as a
member of the Company’s board of directors. Dr. Meier provides consulting services to Proteomedix, through a consulting agreement
that was effective January 4, 2024. The Company recorded approximately $
As of the three months ended March 31, 2025, there were related expenses recorded.
23
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 11 — Income Taxes
The Company’s tax provision for interim periods is determined using an estimate of the annual effective tax rate, adjusted for discrete items arising in that quarter. In each quarter, management updates the estimate of the annual effective tax rate, and any changes are recorded in a cumulative adjustment in that quarter. The quarterly tax provision and quarterly estimate of the annual effective tax rate are subject to significant volatility due to several factors, including management’s ability to accurately predict the portion of income (loss) before income taxes in multiple jurisdictions, and the effects of acquisitions and the integration of those acquisitions.
There was income tax provision or benefit
recorded for the three months ended March 31, 2025. For the three months ended March 31, 2024, the Company recorded an income tax benefit
of approximately $
The Company has incurred net operating losses for all of the periods presented and has not reflected any benefit in the accompanying condensed consolidated financial statements for its U.S. net operating loss carryforwards and only a partial benefit for its Swiss net operating loss carryforwards due to uncertainty around utilizing these tax attributes within their respective carryforward periods. The Company has recorded a full valuation allowance against its U.S. deferred tax assets as it is not more likely than not that such assets will be realized in the near future. As of December 31, 2024, all deferred tax liabilities, related to intangibles, on the books have been reversed creating an income tax benefit. All remaining deferred tax assets and deferred tax liabilities have a full valuation allowance booked against them therefore there were no additional income tax benefits during the three months ended March 31, 2025.
The Company’s policy is to recognize interest expense and penalties related to income tax as income tax expense. For the three months ended March 31, 2025 and 2024, the Company has recognized any interest or penalties related to income taxes.
Note 12 — Net Loss Per Share
Basic net loss per share is computed by dividing the net income or loss applicable to common shares by the weighted average number of common shares outstanding during the period. The weighted average number of shares of common stock outstanding includes pre-funded warrants because their exercise requires only nominal consideration for delivery of shares; it does not include any potentially dilutive securities or any unvested restricted shares of common stock. Certain restricted shares, although classified as issued and outstanding at March 31, 2025, are considered contingently returnable until the restrictions lapse and will not be included in the basic net loss per share calculation until the shares are vested. Unvested shares of the Company’s restricted stock do not contain non-forfeitable rights to dividends and dividend equivalents.
The two-class method is used to determine earnings per share based on participation rights of participating securities in any undistributed earnings. Each share of preferred stock that includes rights to participate in distributed earnings is considered a participating security and the Company uses the two-class method to calculate net income available to the Company’s common stockholders per common share — basic and diluted.
The following securities were excluded from the computation of diluted shares outstanding due to the losses incurred in the periods presented, as they would have had an anti-dilutive impact on the Company’s net loss:
| Three months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Options to purchase shares of common stock | ||||||||
| Warrants | ||||||||
| Unvested shares of restricted stock | ||||||||
| Common stock issuable upon conversion of Series A Preferred Stock | ||||||||
| Common stock issuable upon conversion of Series C Redeemable Preferred Stock | ||||||||
| Total | ||||||||
24
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 13 — Defined Benefit Plan
Proteomedix sponsors a defined benefit pension plan (the “Swiss Plan”) covering certain eligible employees. The Swiss Plan provides retirement benefits based on years of service and compensation levels.
The following significant actuarial assumptions were used in calculating the benefit obligation and the net periodic benefit cost as of March 31, 2025 and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |||||||
| Discount rate | % | % | ||||||
| Expected long-term rate of return on plan assets | % | % | ||||||
| Rate of compensation increase | % | % | ||||||
Changes in these assumptions may have a material impact on the plan’s obligations and costs.
The components of net periodic benefit cost for the three months ended March 31, 2025 and 2024, which is included within selling, general and administrative expenses in the accompanying condensed consolidated statements of operations and comprehensive loss, are as follows:
| For The Three Months Ended March 31, 2025 | For The Three Months Ended March 31, 2024 | |||||||
| Service cost | $ | $ | ||||||
| Interest cost | ||||||||
| Expected return on plan assets | ( | ) | ( | ) | ||||
| Amortization of net (gain) | ( | ) | ( | ) | ||||
| Total | $ | $ | ( | ) | ||||
During the three months ended March 31, 2025
and 2024, the Company made pension contributions of approximately $
The components of accumulated comprehensive loss attributable to the Company’s pension plan for the quarter ended March 31, 2025 and 2024 are as follows:
| For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | |||||||
| Net loss (gain) | $ | ( | ) | $ | ( | ) | ||
| Prior service cost (credit) | ( | ) | ||||||
| Amortization of prior service credit | ||||||||
| Amortization of net gain | ||||||||
| Effect of settlement | ||||||||
| Total recorded during the period | $ | ( | ) | $ | ( | ) | ||
As of March 31, 2025 and December 31, 2024, the funded status of the plan and the amounts recognized in the accompanying consolidated balance sheet are as follows:
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Projected benefit obligation | $ | $ | ||||||
| Fair value of plan assets | ||||||||
| Overfunded (underfunded) status | $ | ( | ) | $ | ( | ) | ||
25
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 13 — Defined Benefit Plan (cont.)
A reconciliation of the beginning and ending balances of the accumulated benefit obligation is provided in the table below:
| As of December 31, 2024 | $ | |||
| Service cost | ||||
| Interest cost | ||||
| Actuarial (gain) loss | ( | ) | ||
| Benefits paid | ( | ) | ||
| Ordinary contributions paid by employees | ||||
| Settlements | ( | ) | ||
| Projected benefit obligation as of March 31, 2025 | ||||
| Actuarial (gain)/loss due to assumption changes | ( | ) | ||
| Actuarial (gain)/loss due to plan experience | ||||
| Accumulated benefit obligation as of March 31, 2025 | $ |
A reconciliation of the beginning and ending balances of the plan assets is provided in the table below:
| As of December 31, 2024 | $ | |||
| Actual return on plan assets | ||||
| Contributions paid by employer | ||||
| Ordinary contributions paid by employees | ||||
| Benefits paid | ( | ) | ||
| Settlements | ( | ) | ||
| As of March 31, 2025 | $ |
Projected benefit payments for the next five years as of March 31, 2025 are as follows:
| Years ending December 31, | ||||
| 2025 | $ | |||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| Thereafter | ||||
| Total | $ |
Note 14 – Segment Information
The Company conducts its business activities and reports financial results as one business segment. The presentation of financial results as one reportable segment is consistent with the way the Company operates its business and is consistent with the manner in which the Chief Operating Decision Maker (“CODM”) evaluates performance and makes resource and operating decisions for the business. The Company’s CODM is the Chief Executive Officer. Furthermore, the Company notes that monitoring financial results as one reportable segment helps the CODM manage costs on a consolidated basis, consistent with the integrated nature of the operations. The CODM uses net loss, as reported on the Consolidated Statements of Operations and Comprehensive Loss, in evaluating performance of the Company and determining how to allocate resources of the Company as a whole. As the CODM evaluates performance on a consolidated basis, all required financial segment information is included in the consolidated financial statements.
Geographic Information
The distribution of revenue by geographical area was as follows:
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| United States | $ | $ | ||||||
| United Kingdom | ||||||||
| Switzerland | ||||||||
| Total | $ | $ | ||||||
26
ONCONETIX, INC.
Notes to Condensed Consolidated Financial Statements
March 31, 2025
(Unaudited)
Note 14 – Segment Information (cont.)
The distribution of long-lived assets by geographical area, which includes property and equipment and the Company’s right of use asset, was as follows:
Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| United States | $ | $ | ||||||
| Switzerland | ||||||||
| Total | $ | $ | ||||||
Note 15 — Subsequent Events
Potential Business Combination:
On April 8, 2025, the
Company issued a press release announcing the execution of a “Non-Binding Letter of Intent contemplating a potential business combination
transaction with Ocuvex Therapeutics, Inc. (“Ocuvex”), a privately held biopharmaceutical company focused on the development
and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options. The
Company and Ocuvex intend to continue negotiations to enter into a definitive agreement. Upon closing of the proposed transaction, the
Company will acquire all the issued and outstanding equity interests of Ocuvex in exchange for newly issued shares of common stock of
the Company. Immediately following the closing of the proposed transaction, the pre-closing Ocuvex equity holders will own approximately
ELOC Draws and Series C Preferred Stock Redemption:
As of June 12, 2025, the Company has sold approximately
As of June 12, 2025, an additional amount of $
Veru Agreement Waivers:
On April 23, 2025, Veru and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024 Promissory Note to June 30, 2025.
Reverse stock split:
On May 30, 2025, the Company’s Board of Directors approved a
reverse stock split of the Company’s common stock, par value $
Keystone Notes Payable:
On May 16, 2025, the
Company issued a promissory note to Keystone Capital Partners, LLC with original issue discount of $
On June 5, 2025, the Company issued a promissory note to Keystone Capital
Partners, LLC with original issue discount of $
27
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and the related notes to those statements included elsewhere in this Report and with the audited financial statements and the related notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as filed with the SEC, on June 2, 2025. In addition to historical financial information, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. Some of the numbers included herein have been rounded for the convenience of presentation. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. See “Cautionary Note Regarding Forward-Looking Statements.”
Overview
We are a commercial stage biotechnology company focused on the research, development, and commercialization of innovative solutions for men’s health and oncology. Through our acquisition of Proteomedix, which closed on December 15, 2023, we own Proclarix, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union under the In Vitro Diagnostic Regulation (“IVDR”), which we anticipate will be marketed in the U.S. as a lab developed test through our license agreement with LabCorp.
We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of BPH, a disorder of the prostate. However, in light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product. In addition, as part of cost reduction efforts and in connection with our initial pause in commercializing ENTADFI, we terminated three employees involved with the ENTADFI program, effective April 30, 2024, with such individuals to continue assisting the Company on an as-needed, consulting basis. Based on the current circumstances surrounding ENTADFI, at June 30, 2024, the ENTADFI assets were fully impaired. Refer to Note 4 in the accompanying condensed consolidated financial statements included elsewhere in this Report for further discussion.
The Company continues to search for a permanent Chief Executive Officer and Chief Financial Officer.
We are currently focusing our efforts on commercializing Proclarix.
Proclarix is an easy-to-use next generation protein-based blood test that can be done with the same sample as a patient’s regular Prostate-Specific Antigen (“PSA”) test. The PSA test is a well-established prostate specific marker that measures the concentration of PSA molecules in a blood sample. A high level of PSA can be a sign of prostate cancer. However, PSA levels can also be elevated for many other reasons including infections, prostate stimulation, vigorous exercise or even certain medications. PSA results can be confusing for many patients and even physicians. It is estimated over 50% of biopsies with elevated PSA are negative or clinically insignificant resulting in an overdiagnosis and overtreatment that impacts the physician’s routine, our healthcare system, and the quality of patients’ lives. Approximately 10% of all men have elevated PSA levels., commonly referred to as the diagnostic “grey zone”, of which only 20 - 40% present clinically with cancer. Proclarix is intended for use in diagnosing these patients where it is difficult to decide if a biopsy is necessary to verify a potential clinically significant cancer diagnosis. Proclarix helps doctors and patients with unclear PSA test results through the use of our proprietary Proclarix Risk Score which delivers clear and immediate diagnostic support for further treatment decisions. No additional intervention is required, and results are available quickly. Local diagnostic laboratories can integrate this multiparametric test into their current workflow because Proclarix assays use the enzyme-linked immunosorbent assay (ELISA) standard, which most diagnostic laboratories are already equipped to process.
Since our inception in October 2018 until April 2023, when we acquired ENTADFI, we devoted substantially all of our resources to performing research and development, undertaking preclinical studies and enabling manufacturing activities in support of our product development efforts, hiring personnel, acquiring and developing our technology and now halted vaccine candidates, organizing and staffing our company, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand such activities.
28
During the third quarter of 2023, we halted our vaccine discovery and development programs, and accordingly, we now operate in one segment: commercial. The commercial segment was new in the second quarter of 2023 and is currently dedicated to the development and commercialization of Proclarix.
Given Proclarix is CE-marked for sale in the European Union, we expect to generate revenue from sales of Proclarix by 2027. Although we anticipate these sales to offset some expenses relating to commercial scale up and development, we expect our expenses will increase substantially in connection with our ongoing activities, as we:
| ● | commercialize Proclarix; |
| ● | hire additional personnel; |
| ● | operate as a public company; and |
| ● | obtain, maintain, expand, and protect our intellectual property portfolio. |
We rely and will continue to rely on third parties for the manufacturing of Proclarix. We have no internal manufacturing capabilities, and we will continue to rely on third parties, of which the main suppliers are single-source suppliers, for commercial product.
We do not have any products approved for sale, aside from Proclarix and ENTADFI, from which we have not generated any revenue from product sales and for which we have determined to abandon commercialization activities To date, we have financed our operations primarily with proceeds from our sale of preferred securities to seed investors, the initial public offering (“IPO”), and subsequent offerings of debt and equity securities. We will continue to require significant additional capital to commercialize Proclarix, and to fund operations for the foreseeable future. Accordingly, until such time as we can generate significant revenue, if ever, we expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding and to rely on third-party resources for marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches, to support our operations.
Some recent key developments affecting our business include the following:
Altos Units
On January 23, 2024, the Company issued a non-convertible debenture (the “Altos Debenture”) in the principal sum of $5.0 million, in connection with a Subscription Agreement, to Altos Ventures, a stockholder of the Company and related party (“Altos”). The Altos Debenture was originally payable in full upon the earlier of (i) the closing under the Subscription Agreement and (ii) June 30, 2024. On April 24, 2024, the Altos Debenture was amended to extend the maturity date to the earlier of (i) the closing under the Subscription Agreement and (ii) October 31, 2024 (the “Altos Amendment”). On September 24, 2024, upon obtaining stockholder approval and pursuant to the Subscription Agreement, dated December 18, 2023, the Company issued an aggregate of 513,424 units (the “Units”) to Altos, each Unit comprised of (i) one share of Common Stock and (ii) one pre-funded warrant (collectively, the “Altos Warrants”) to purchase 0.3 shares of Common Stock at an exercise price of $0.04 per share. The Altos Warrants were immediately exercisable at any time on or after the date of issuance and had a term of exercise of five (5) years from the date of issuance. The outstanding debt, as per the Altos Debenture agreement, is considered settled through the unit issuance.
Additional shares are issuable to Altos to the extent Altos continues to hold Common Stock included in the Units and if the VWAP during the 270 days following closing is less than $10.00, as set forth in the Subscription Agreement.
On September 24, 2024, Altos exercised all the Altos Warrants, and the Company issued to Altos an additional 154,027 shares of Common Stock upon such exercise.
Amended Forbearance Agreement
On September 19, 2024, the Company entered into an Amended and Restated Forbearance Agreement with Veru (the “Amended and Restated Forbearance Agreement” or “A&R Forbearance Agreement”), which amends and restates the Original Forbearance Agreement in its entirety. Pursuant to the A&R Forbearance Agreement, Veru will forbear from exercising its rights under both April Veru Note and the September Veru note, subject to the terms and conditions set forth below.
The A&R Forbearance Agreement extends the due date for the April 2024 and September 2024 Veru Notes until the earlier to occur of (i) June 30, 2025 or (ii) the occurrence of any Event of Default. The Amended and Restated Forbearance Agreement also effected certain modifications to the payment terms in the Original Forbearance Agreement and amended certain terms of the September Veru Note as summarized below.
29
Pursuant to the A&R Forbearance Agreement, the Company agreed to make the following required payments (the “Required Payments”) during the April 2024 Forbearance Period first to accrued and unpaid interest under the April Veru note and then any remainder to the outstanding principal amount of the April Veru Note:
| ● | Interest at the rate of 10% per annum shall accrue on any unpaid principal balance of the April Veru Note commencing on April 20, 2024 through the date that the outstanding principal balance under the April Veru Note is paid in full; |
| ● | Monthly payments equal to 25% (increased from 15% in the Original Forbearance Agreement) of (i) the monthly cash receipts of Proteomedix for the licensing or sale of any products or services, (ii) monthly cash receipts of the Company or any of its subsidiaries for the sales of Proclarix anywhere in the world, and (iii) monthly cash receipts of the Company or any of its subsidiaries for milestone payments or royalties from LabCorp cash receipts of the Company of its subsidiaries from certain sale or licensing revenues or payments (the “Ordinary Cash Revenue”), which increased amount shall begin October 20, 2024 for cash receipts in September 2024; |
| ● | Payment of 20% (increased from 10% in the Original Forbearance Agreement) of the net proceeds from certain financing or other transactions outside the ordinary course of business completed by the Company or any of its subsidiaries during the April 2024 Forbearance Period, which increased amount will begin for any net proceeds received after September 19, 2024; and |
| ● | The remaining balance of the April Veru Note will be due at the end of the April 2024 Forbearance Period. |
The Company and Veru also agreed to the following amendments to the September Veru Note in the A&R Forbearance Agreement:
| ● | As noted above, an extension of the maturity date to June 30, 2025; |
| ● | The accrual of interest at the rate of 10% per annum on any unpaid principal balance of the September Veru Note commencing on October 1, 2024 through the date that the outstanding principal balance under the September Veru Note is paid in full; |
| ● | Any amounts owed on the September Veru Note, including but not limited to unpaid principal and accrued interest, will be paid in cash or, upon the mutual written consent of Veru and the Company, in shares of the Company’s Common Stock or a combination of cash and the Company’s Common Stock; and |
| ● | Following full repayment of all principal and interest under the April Veru Note, the Company will make the Required Payments first towards accrued and unpaid interest under the September Veru Note and then towards the remaining principal balance payable under the September Veru Note. |
November Amended and Restated Forbearance Agreement with Veru
On November 26, 2024, the Company entered into another Amended and Restated Forbearance Agreement with Veru (the “November Amended and Restated Forbearance Agreement” or “November A&R Forbearance Agreement”), which amends and restates certain terms of the A&R Forbearance Agreement. Pursuant to the November A&R Forbearance Agreement, Veru agreed to waive the due date for payment of applicable Cash Receipt Payments (as such term is defined in the A&R Forbearance Agreement) generated in October 2024 until the Company receives funds of at least $97,000 pursuant to its equity line of credit facility with Keystone Capital Partners LLC. In exchange, the Company agreed to increase its payments to be made to Veru out of future financing and strategic transactions through June 30, 2025, from 20% to 25% of net proceeds generated from such transactions. All other terms of the A&R Forbearance Agreement with Veru remain the same.
March 2025 Amended and Restated Forbearance Agreement with Veru on April 2025
On March 31, 2025, Veru and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024 Promissory Note to April 14, 2025.
On April 23, 2025, Veru and the Company entered into a limited waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024 Promissory Note to June 30, 2025.
30
Warrant Inducement
On July 11, 2024, the Company entered into the Inducement Letters with certain holders of existing preferred investment options to purchase shares of the Company’s common stock at the original exercise prices of $101.84 and $43.60 per share, issued on August 11, 2022 and August 2, 2023, respectively, pursuant to which the holders agreed to exercise for cash their Existing PIOs to purchase an aggregate of 186,466 shares of the Company’s common stock, at a reduced exercise price of $6.00 per share, in consideration for the Company’s agreement to issue new preferred investment options (the “Inducement PIOs”) to purchase up to an aggregate of 559,397 shares of the Company’s common stock. Of the 559,397 PIOs issued, 186,465 have a contractual term of 5 years, while the remaining 372,932 have a contractual term of 2 years. Aside from the contractual terms, the Inducement PIOs have substantially the same terms as the Existing PIOs.
On July 11, 2024, the Company consummated the transaction contemplated by the Inducement Letters upon unanimous written consent of the Board (the “Warrant Inducement”). The Company received aggregate net proceeds of approximately $0.9 million from the exercise of the Existing PIOs by the holders and the sale of the Inducement PIOs, after deducting placement agent fees and other offering expenses payable by the Company.
The Company agreed to file a registration statement covering the resale of the Inducement PIO Shares issued or issuable upon the exercise of the Inducement PIOs (the “Resale Registration Statement”) within 30 days after the date of the Inducement Letter and to use commercially reasonable efforts to cause such Resale Registration Statement to be declared effective by the SEC within 60 days following the date of the Inducement Letter (or within 90 days following the date of the Inducement Letter in the case of full review of the Resale Registration Statement by the SEC).
The Company engaged H.C. Wainwright & Co., LLC (“Wainwright”) to act as its exclusive placement agent in connection with the transactions summarized herein and will pay Wainwright a cash fee equal to 7.5% of the gross proceeds received form the exercise of the Existing PIOs as well as a management fee equal to 1.0% of the gross proceeds from the exercise of the Existing PIOs. The Company also agreed to reimburse Wainwright for its expenses in connection with the exercise of the Existing PIOs and the issuance of the Inducement PIOS, up to $50,000 for fees and expenses of legal counsel and other out-of-pocket expenses and agreed to pay Wainwright for non-accountable expenses in the amount of $35,000. The Company also agreed to issue to Wainwright or its designees warrants (the “Placement Agent Warrants”), and as such shares of common stock issuable thereunder, (the “Placement Agent Warrant Shares”) to purchase (i) 13,054 shares of common stock which will have the same terms as the Inducement PIOs except for an exercise price equal to $7.50 per share and a term of five (5) years following the date of stockholder approval and (ii) upon any exercise for cash of the Inducement PIOs, 7.5% of the aggregate exercise price and that number of shares of common stock equal to 7.0% of the aggregate number of such shares of common stock underlying the Inducement PIOs that have not been exercised, which will have substantially the same terms as the Placement Agent Warrants.
The Company evaluated the terms of the Inducement PIOs and the Wainwright Inducement Warrants (collectively, the “August 2023 Inducement Warrants”), and determined that they should be classified as equity instruments based upon accounting guidance provided in ASC 480 and ASC 815-40. The Company also evaluated the unissued shares held in abeyance, which represent a prepaid forward contract, and determined that it is an equity instrument based on the guidance provided in ASC 480 and ASC 815-40.
The Warrant Inducement, which resulted in the lowering of the exercise price of the Existing PIOs and the issuance of the Inducement PIOs, is considered a modification of the Existing PIOs under the guidance of Accounting Standards Update (“ASU”) No. 2021-04, Issuer’s Accounting for Certain Modifications or Exchanges of Equity Classified Written Call Options. The modification is consistent with the “Equity Issuance” classification under that guidance as the reason for the modification was to induce the holders of the Existing PIOs to cash exercise their warrants, resulting in the imminent exercise of the Existing PIOs, which raised equity capital and generated net proceeds for the Company of approximately $0.9 million. As the Existing PIOs and the Inducement PIOs were classified as equity instruments before and after the exchange, and as the exchange is directly attributable to an equity offering, the Company recognized the effect of the modification of approximately $1.9 million as an equity issuance cost.
In addition, the change in fair value of the contingent warrant liability associated with 3,729 of the August 2022 Contingent Warrants and 7,459 of the August 2023 Contingent Warrants was decreased to $0 upon the agreement with Wainwright that all prior contingent warrants were no longer issuable or due upon the Warrant Inducement Transaction. The fair value of the contingent warrant liability of approximately $2,700 was derecognized as of the settlement date, with the corresponding amount, representing the fair value of the Wainwright Inducement Warrants, was recognized as additional paid-in capital.
The Company evaluated the terms of the 39,158 Inducement Contingent Warrants (equivalent to 7.0% of the aggregate number of such shares of common stock underlying the Inducement PIOs that have not been exercised), which are issuable upon a future inducement, and determined that they should be classified as a liability based upon accounting guidance provided in ASC 815-40. Since the Inducement Contingent Warrants are a form of compensation to Wainwright, the Company recorded the value of the liability of approximately $158,000 as a reduction of additional paid in capital, with subsequent changes in the value of the liability recorded in other income (expense) in the accompanying statements of operations.
31
Reverse Stock Split
On September 24, 2024, the Company effected a Reverse Stock Split of all shares of its issued and outstanding Common Stock at a ratio of one-for-forty (1:40). The Company accounted for the reverse stock split on a retrospective basis pursuant to Accounting Standards Codification (“ASC”) 260, Earnings Per Share. All issued and outstanding common stock, common stock warrants, and share-based awards’ exercise prices and per share data have been adjusted in the consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented. The number of authorized shares and par value of the preferred stock and common stock were not adjusted because of the reverse stock split.
Conversion of Series A Preferred Stock
On September 24, 2024, the Company issued an aggregate of 142,749 shares of Common Stock to Veru Inc., following Veru’s election to convert all the 3,000 shares of Series A preferred stock (“Series A Preferred Stock”) of the Company issued to it on September 29, 2023. The Series A Preferred Stock was originally issued to Veru pursuant to an Amendment to the Asset Purchase Agreement, dated September 29, 2023, between the Company and Veru.
Conversion of Series B Preferred Stock
On September 24, 2024 the Company issued an aggregate of 6,741,820 shares of Common Stock (the “PMX Converted Shares”) to certain stockholders of the Company who were formerly holders of outstanding capital stock or convertible securities (the “Sellers”) of PMX, pursuant to the automatic conversion of all the 2,696,729 shares of Series B preferred stock (“Series B Preferred Stock”) of the Company, which Series B Preferred Stock was originally issued to the Sellers on December 15, 2023. The Series B Preferred Stock was originally issued to the Sellers pursuant to a Share Exchange Agreement, dated December 15, 2023, between the Company, PMX, and the Sellers (the “Share Exchange Agreement”), and was subject to the automatic conversion following (i) the Company’s receipt of stockholder approval for the issuance of the PMX Converted Shares and ii) the effectiveness of the Reverse Stock Split, which provided for a sufficient number of authorized shares to issue the PMX Converted Shares, as contemplated by the Share Exchange Agreement.
Series C Preferred Stock
On October 1, 2024, the Board authorized the Company to create a series of 10,000 shares of preferred stock designated as “Series C convertible Preferred Stock”, with a par value of $0.00001, pursuant to the certificate of designations. At any time after the initial issuance date of Series C convertible Preferred Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock. The holders of Series C Preferred Stock are entitled to dividends, on an as-if converted basis, equal to and in the same form as dividends actually paid on shares of Common Stock, when and if actually paid. Each holder is entitled to convert any portion of the outstanding Preferred Shares held by such holder into validly issued, fully paid and non-assessable Conversion shares at the Conversion Rate, which can be determined by dividing (x) the Conversion Amount of such Preferred Share by (y) the Conversion Price, $4.5056, subject to adjustment as provided in the Certificate of Designations. As of March 31, 2025, an aggregate of 2,130 Series C Preferred Stock was outstanding, after redemptions of 1,369 shares for an aggregate of $1.71 million. An additional amount of $150,531 is due to the PIPE Series C investors for 120 Series C preferred shares that remain due from the most recent ELOC draw. These 120 shares remain subject to future redemption.
PIPE Financing and ELOC
On October 1, 2024, the Board authorized the Company to create a series of 10,000 shares of preferred stock designated as “Series C convertible Preferred Stock”, with a par value of $0.00001, pursuant to the certificate of designations. At any time after the initial issuance date of Series C convertible Preferred Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock. The holders of Series C Preferred Stock are entitled to dividends, on an as-if converted basis, equal to and in the same form as dividends actually paid on shares of Common Stock, when and if actually paid. In addition, from and after the occurrence and during the continuance of any Triggering Event, dividends (“Default Dividends”) will accrue on the Stated Value of each Preferred Share at a rate of fifteen percent (15.0%) (the “Default Rate”) per annum. Each holder is entitled to convert any portion of the outstanding Preferred Shares held by such holder into validly issued, fully paid and non-assessable Conversion shares at the Conversion Rate, which can be determined by dividing (x) the Conversion Amount of such Preferred Share by (y) the Conversion Price, $4.5056, subject to adjustment as provided in the Certificate of Designations.
After the Stockholder Approval Date, if a Triggering Event occurs and is continuing at any time after the earlier of the holders’ receipt of a Triggering Event Notice and such holder becoming aware of such Triggering Event (such earlier date, the “Alternate Conversion Right Commencement Date”) and ending on the twentieth (20th) Trading Day after the later of (x) the date of such Triggering Event is cured and (y) such holder’s receipt of a Triggering Event Notice (such ending date, the “Alternate Conversion Right Expiration Date”), and each such period, an “Alternate Conversion Right Period”), such holder may, at such holder’s option, by delivery of a Conversion Notice to the Company (the date of any such Conversion Notice, each an “Alternate Conversion Date”), convert all, or any number of Preferred Shares held by such holder into shares of Common Stock at the Alternate Conversion Price (each, an “Alternate Conversion”). Alternate Conversion Price means, with respect to any Alternate Conversion that price will be the lowest of (i) the applicable Conversion Price as in effect on the applicable Conversion Date of the applicable Alternate Conversion, and (ii) the greater of (x) the Floor Price and (y) 80% of the lowest VWAP of the Common Stock during the five (5) consecutive Trading Day period ending and including the Trading Day immediately preceding the delivery or deemed delivery of the applicable Conversion Notice (such period, the “Alternate Conversion Measuring Period”).
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At any time, the Company has the right to redeem in cash all, but not less than all, of the Preferred Shares then outstanding at a price (the “Company Optional Redemption Price”) equal to 125% of the greater of (i) the Conversion Amount being redeemed and (ii) the product of (1) the Conversion Rate with respect to the Conversion Amount being redeemed multiplied by (2) the greatest closing sale price of the Company’s Common Stock on any Trading Day during the period commencing on the date immediately preceding the date the Company notifies the holders of its elections to redeem and the date the Company makes the entire payment required. Upon the occurrence of a Bankruptcy Triggering Event, the Company will immediately redeem, in cash, each of the Preferred Shares then outstanding at a redemption price equal to the greater of (i) the product of (A) the Conversion Amount to be redeemed multiplied by (B) 125% and (ii) the product of (X) the Conversion Rate with respect to the Conversion Amount in effect immediately following the date of initial public announcement of such Bankruptcy Triggering Event multiplied by (y) the product of (1) 125% multiplied by (2) the greatest closing sale price of the Common Stock on any Trading Day during the period commencing on the date immediately preceding such Bankruptcy Triggering Event and ending on the date the Company pays the entire payment required.
In no event may any Preferred Shares be converted (or Warrants be exercised) and shares of Common Stock be issued to any holder if after giving effect to the issuance of shares of Common Stock upon such conversion of the Preferred Shares (or exercise of the Warrants), the holder (together with its affiliates, if any) would beneficially own more than 4.99% of the outstanding shares of Common Stock, which we refer to herein as the “PIPE Blocker”. The PIPE Blocker may be raised or lowered to any percentage not in excess of 9.99% at the option of the applicable holder of the Preferred Shares (or Warrants), except that any raise will only be effective upon 61-days’ prior notice to the Company.
On October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “PIPE Investors”), pursuant to the securities purchase agreement an aggregate of 3,499 shares of Series C Preferred Stock which includes an issuance of 840 shares of Series C Preferred Stock to the lead investor in consideration for the PIPE Investors’ irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 591,856 shares of Common Stock, (together, the “PIPE Securities”) for aggregate net cash proceeds to the Company of $1.9 million. The exercise price of the warrants is $4.38, and the warrants are exercisable six months after the issuance date and expire on the third anniversary of the initial exercisability date.
On October 2, 2024, the Company entered into a Common Stock ELOC Purchase Agreement relating to a Committed Equity Facility with an institutional investor (the “ELOC Purchaser”), whereby the Company may offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser has committed to purchase, up to $25.0 million of the Company’s newly issued Common Stock, subject to certain limitations. Concurrently with entering into the ELOC Purchase Agreement, the Company also entered into a registration rights agreement with the ELOC Purchaser, pursuant to which it agreed to provide the ELOC Purchaser with certain registration rights related to the shares issued under the ELOC Purchase Agreement (the “ELOC Registration Rights Agreement”). In no event will the Company issue to the Purchaser under the ELOC Purchase Agreement more than 1,658,525 shares of Common Stock, representing 19.99% of the total number of shares of Common Stock outstanding immediately prior to the execution of the Common Stock Purchase Agreement (the “Exchange Cap”), unless (i) the Company obtains the approval of the issuance of such shares by its stockholders in accordance with the applicable stock exchange rules or (ii) sales of Common Stock are made at a price equal to or in excess of the lower of (A) the closing price immediately preceding the delivery of the applicable notice to the Purchaser and (B) the average of the closing prices of the Common Stock for the five business days immediately preceding the delivery of such notice, such that the sales of such Common Stock to the Purchaser would not count toward the Exchange Cap because they are “at market” under applicable stock exchange rules.
The Company may not issue or sell any shares of Common Stock to the ELOC Purchaser under the Common Stock Purchase Agreement, if it would result in the ELOC Purchaser beneficially owning more than 4.99% of the outstanding shares of Common Stock (the “ELOC Blocker”). The ELOC Blocker may be raised or lowered to any other percentage not in excess of 9.99% at the option of the ELOC Purchaser, except that any raise will only be effective upon 61 days’ prior notice to the Company.
Keystone Notes Payable
On February 12, 2025, the Company issued a promissory note to Keystone Capital Partners, LLC with original issue discount of $17,647.06, in an aggregate principal amount of $117,647.06. The note is due and payable upon the earlier of (i) the Company’s receipt of sufficient proceeds from the ELOC and (ii) November 12, 2025, subject to mandatory prepayment in the event that the Company raises sufficient additional capital through other securities offerings. The note is subordinate to the Company’s existing debt obligations to Veru Inc. The note does not initially bear interest, however, any amounts due under the note which are not paid when due shall incur a late charge of 15% per annum until such amount is paid in full.
On May 16, 2025, the Company issued a promissory note to Keystone Capital Partners, LLC with original issue discount of $44,117.65, in an aggregate principal amount of $294,117.65. The note is due and payable upon the earlier of (i) the Company’s receipt of sufficient proceeds from its Equity Line of Credit with the Investor or (ii) February 16, 2026, subject to mandatory prepayment in the event that the Company raises sufficient additional capital through other securities offerings. The note is subordinate to the Company’s existing debt obligations to Veru Inc. The note does not initially bear interest, however, any amounts due under the note which are not paid when due shall incur a late charge of 15% per annum until such amount is paid in full.
On June 5, 2025, the Company issued a promissory note to Keystone Capital Partners, LLC with original issue discount of $22,058.82, in an aggregate principal amount of $147,058.82. The note is due and payable upon the earlier of (i) the Company’s receipt of sufficient proceeds from the ELOC and (ii) March 5, 2026, subject to mandatory prepayment in the event that the Company raises sufficient additional capital through other securities offerings. The note is subordinate to the Company’s existing debt obligations to Veru Inc. The note does not initially bear interest, however, any amounts due under the note which are not paid when due shall incur a late charge of 15% per annum until such amount is paid in full.
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Potential Ocuvex Transaction
On April 1, 2025, the Company and Ocuvex Therapeutics, Inc. signed a Non-Binding Letter of Intent (the “Ocuvex LOI”) contemplating a potential business combination transaction with Ocuvex (the “Ocuvex Business Combination”). The Company and Ocuvex intend to continue negotiations to enter into a definitive agreement. Upon closing of the proposed transaction, the Company will acquire all the issued and outstanding equity interests of Ocuvex in exchange for newly issued shares of common stock of the Company. Immediately following the closing of the proposed transaction, the pre-closing Ocuvex equity holders will own approximately 90% of the equity interests in the combined company.
Certain Significant Relationships
We have entered into grant, license and collaboration arrangements with various third parties as summarized below. For further details regarding these and other agreements, see Notes 5 and 8 to each of our audited financial statements included in the Form 10-K and unaudited financial statements included elsewhere in this Report.
Laboratory Corporation of America
On March 23, 2023, Proteomedix entered into a license agreement with LabCorp pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix and other products developed by LabCorp using Proteomedix’s intellectual property covered by the license, in the United States (“Licensed Products”). In consideration for granting LabCorp an exclusive license, Proteomedix received an initial license fee in the mid-six figures upon signing of the contract. Additionally, Proteomedix is entitled to royalty payments between 5% and 10% on the net sales recognized by LabCorp of any Licensed Products plus milestone payments as follows:
| ● | after the first sale of Proclarix as a laboratory developed test, LabCorp will pay an amount in the mid-six figures; |
| ● | after LabCorp achieves a certain amount in the low seven figures in net sales of the Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures; and |
| ● | after a certain amount in the mid-seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures. |
A total of $2.5 million in milestone payments are payable under the license agreement. An additional $0.5 million was paid to Proteomedix as an initial license fee in 2023.
LabCorp is wholly responsible for the cost, if any, of research, development and commercialization of Licensed Products in the United States but has the right to offset a portion of those costs against future royalty and milestone payments. Additionally, LabCorp may deduct royalties or other payments made to third parties related to the manufacture or sale of Licensed Products up to a maximum amount of any royalty payments due to Proteomedix.
The license agreement and related royalty payment provisions expire during 2038, which approximates the expiration of the last patent covered by the license agreement. LabCorp has the right to terminate the license agreement for any reason by providing 90 days written notice to Proteomedix. Either party may terminate the license agreement due to a material breach of the terms of the license agreement with 30 days’ notice, provided such breach is not cured within the foregoing 30-day period. Finally, Proteomedix may terminate the license agreement with 60 days’ notice in the event LabCorp fails to make any undisputed payment due, provided that LabCorp does not remit the payment within the foregoing 60-day period.
Services Agreement
On July 21, 2023, the Company, entered into a Licensing and Services Master Agreement (“Master Services Agreement”) and a related statement of work with IQVIA, pursuant to which IQVIA was to provide to the Company commercialization services for the Company’s products, including recruiting, managing, supervising and evaluating sales personnel and providing sales-related services for such products, for fees totaling up to $29.1 million over the term of the statement of work. The statement of work had a term through September 6, 2026, unless earlier terminated in accordance with the Master Services Agreement and the statement of work. On July 29, 2023, a second statement of work was entered into with IQVIA for certain subscription services providing prescription market data access to the Company. The fees under the second statement of work totaled approximately $800,000, and the term was through July 14, 2025. On October 12, 2023, the Company terminated the Master Services Agreement and the statements of work. The Company recorded net credits of approximately $0.9 million related to this contract during the three months ended March 31, 2025, respectively, which is included in selling, general and administrative expense in the accompanying consolidated statements of operations and comprehensive loss. The Company had approximately $0 and $1.1 million recorded in related accounts payable as of March 31, 2025 and December 31, 2024, respectively, which includes amounts due for early termination of the contract.
On January 15, 2025, the Company and IQVIA entered into a Settlement Agreement (the “Settlement Agreement”) concerning potential termination payments under the Master Services Agreement and statements of work. Pursuant to the Settlement Agreement, the Company agreed to pay to IQVIA an aggregate of $150,000 in exchange for a mutual release of all claims in connection with the Master Services Agreement. As a result of the Settlement Agreement, the Company will record an adjustment of approximately $(0.9) million in accounts payable.
Components of Results of Operations
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist principally of commercialization activities, payroll, and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and tax services, information technology costs, costs incurred with respect to acquisitions and potential acquisitions, and other general operating expenses.
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We anticipate that our selling, general and administrative expenses related to Proteomedix will increase when compared to historical levels as a result of efforts to commercialize Proclarix, and costs associated with integration of Proteomedix’s operations.
Research and Development Expenses
Historically, substantially all of our research and development expenses consist of expenses incurred in connection with the development of our product candidates. These expenses historically have included fees paid to third parties to conduct certain research and development activities on our behalf, consulting costs, costs for laboratory supplies, product acquisition and license costs, certain payroll, and personnel-related expenses, including salaries and bonuses, employee benefit costs and stock-based compensation expenses for our research and product development employees. We expense both internal and external research and development expenses as they are incurred.
We do not allocate our costs by product candidate, as a significant amount of research and development expenses include internal costs, such as payroll and other personnel expenses, laboratory supplies, and external costs, such as fees paid to third parties to conduct research and development activities on our behalf, that are not tracked by product candidate.
As discussed above, we have terminated the vaccine programs that substantially all of our research and development historically related to. We do not anticipate incurring significant research and development expenses in the near future, unless we are able to resume such activities. Predicting the timing or cost to complete our clinical programs for future product candidates, or validation of our commercial manufacturing and supply processes is difficult and delays may occur because of many factors, including factors outside of our control, such as regulatory approvals. Furthermore, we are unable to predict when or if our future product candidates will receive regulatory approval with any certainty.
Other Income (Expense)
Other income (expense) is comprised of interest expense on notes payable, the change in fair value of financial instruments that are recorded as liabilities, which includes the related party subscription agreement liability and the contingent warrant liability, and other financing-related costs.
Results of Operations
Comparison of the Three Months Ended March 31, 2025 and 2024
The following table summarizes our statements of operations for the periods indicated:
| Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | $ Change | % Change | |||||||||||||
| Revenue | $ | 101,630 | $ | 700,433 | $ | (598,803 | ) | (85.5 | )% | |||||||
| Cost of revenue | 55,798 | 511,433 | (455,635 | ) | (89.1 | )% | ||||||||||
| Gross profit | 45,832 | 189,000 | (143,168 | ) | (75.8 | )% | ||||||||||
| Operating expenses | ||||||||||||||||
| Selling, general and administrative | $ | 1,674,206 | $ | 3,736,450 | (2,062,244 | ) | (55.2 | )% | ||||||||
| Research and development | 24,455 | 48,964 | (24,509 | ) | (50.1 | )% | ||||||||||
| Impairment of ENTADFI | - | 2,293,576 | (2,293,576 | ) | (100.0 | )% | ||||||||||
| Impairment of goodwill | 10,918,000 | 5,192,000 | 5,726,000 | 110.3 | % | |||||||||||
| Total operating expenses | 12,616,661 | 11,270,990 | 1,345,671 | 11.9 | % | |||||||||||
| Loss from operations | (12,570,829 | ) | (11,081,990 | ) | (1,488,839 | ) | 13.4 | % | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense – related party | - | (225,063 | ) | 225,063 | (100.0 | )% | ||||||||||
| Interest expense | (223,592 | ) | (187,993 | ) | (35,599 | ) | 18.9 | % | ||||||||
| Change in fair value of subscription agreement liability – related party | 3,319,000 | 226,400 | 3,092,600 | 1366.0 | % | |||||||||||
| Change in fair value of contingent warrant liability | (9,795 | ) | - | (9,795 | ) | 100.0 | % | |||||||||
| Gain on forgiveness of accounts payable | 944,694 | - | 944,694 | 100.0 | % | |||||||||||
| Other - net | (5,363 | ) | 28,507 | (33,870 | ) | (118.8 | )% | |||||||||
| Total other expense | 4,024,944 | (158,149 | ) | 4,183,093 | (2645.0 | )% | ||||||||||
| Loss before income taxes | (8,545,885 | ) | (11,240,139 | ) | 2,694,254 | (24.0 | )% | |||||||||
| Income tax benefit | - | 121,567 | (121,567 | ) | (100.0 | )% | ||||||||||
| Net loss | $ | (8,545,885 | ) | $ | (11,118,572 | ) | 2,572,687 | (23.1 | )% | |||||||
| Deemed dividend Series C preferred stock | (1,170,091 | ) | - | (1,170,091 | ) | 100 | % | |||||||||
| Net loss applicable to common stockholders’ | $ | (9,715,976 | ) | $ | (11,118,572 | ) | 1,402,596 | (12.6 | )% | |||||||
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Revenue, Cost of Revenue, and Gross Margin
For the three months ended March 31, 2025, the Company had approximately $0.1 million of revenue, which was attributable to sale of products generated by Proteomedix. Cost of revenue of approximately $0.06 million was mostly attributable to costs incurred on Proteomedix revenue. For the three months ended March 31, 2024, the Company had approximately $0.7 million of revenue, which was attributable to sales and development services generated by Proteomedix. The cost of revenue of approximately $0.5 million is attributable to costs incurred on Proteomedix revenue including amortization of the product rights intangible asset of approximately $0.2 million.
Selling, General and Administrative Expenses
For the three months ended March 31, 2025, selling, general and administrative expenses decreased by $2.1 million compared to the same period in 2024. The change includes a $0.8 million decrease in professional fees including accounting, legal, and regulatory fees, which were related to the acquisition of Proteomedix in 2024 and non-recurring into 2025. In addition, the Protemedix entity had a reduction in professional fees including legal and accounting of approximately $0.4 million due to the non-recurring transaction related efforts in early 2024. Other changes included a $0.4 million decrease in payroll-related expenses, a $0.1 million decrease in board fees, and $0.4 million decrease in miscellaneous other selling, general and administrative expenses during the three months ended March 31, 2025 compared to the three months ended March 31, 2024 due to reduced liquidity in the current quarter.
Research and Development Expenses
For the three months ended March 31, 2025 and 2024, there were no substantial research and development expenses. The lack of activity was primarily attributable to the Company’s decision to halt its vaccine programs and focus on commercialization activities, which occurred during the third quarter of 2023. This change in business strategy led to a halt in the Company’s clinical and other research activities.
Impairments
During the three months ended March 31, 2025, there was no impairment recorded related to the ENTADFI asset, as the asset had been fully impaired in the prior year. Specifically, an impairment charge of approximately $2.3 million was recognized during the same period in 2024, based on a valuation assessment conducted by an external specialist.
The Company recorded an impairment of goodwill related to the PMX acquisition during the three months ended March 31, 2025 totaling $10.9 million, as compared to an impairment of $5.2 million recognized for the same period last year in connection with the same acquisition.
Other Income (Expense)
Other income incurred during the three months ended March 31, 2025, increased by approximately $4.2 million compared to the same period in 2024. The increase was primarily driven by a $3.1 million increase in the change in fair value of the subscription agreement liability – related party, and the Company recognized a $0.9 million gain on forgiveness of accounts payable related to the settlement of IQVIA balances. In addition, there was a $0.3 million reduction in other expense items, including the absence of related party interest expense, lower interest expense due to fewer outstanding loans, and the change in fair value of contingent warrant liabilities.
Income Tax Benefit
The Company did not record any income tax benefit or expense during the three months ended March 31, 2025. For the same period in 2024, the Company recorded an income tax benefit of approximately $0.1 million, related to foreign deferred income taxes recorded in connection with Proteomedix.
Liquidity and Capital Resources
The Company’s operating activities to date have been primarily devoted to seeking licenses, engaging in research and development activities, potential asset and business acquisitions, and expenditures associated with the now halted commercial launch of ENTADFI and the commercialization of Proclarix.
The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of March 31, 2025, the Company had cash of approximately $1.6 million, a working capital deficit of approximately $11.6 million and an accumulated deficit of approximately $125.4 million.
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During the three months ended March 31, 2025, the Company used approximately $2.0 million in cash for operating activities. In addition, as of June 10, 2025, the Company’s cash balance was approximately $0.4 million. The Company’s current cash balance is not sufficient to fund its operations through the end of December 2025. In December 2024, the Company began drawing on the Equity Financing Line of Credit (“ELOC”), which it entered into on October 2, 2024, referred herein as the ELOC Purchase Agreement. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date of the issuance of these consolidated financial statements. The Company’s projections are also indicative that it is currently unable to meet its contractual commitments and obligations as they come due in the ordinary course of business. The Company will require significant additional capital in the short-term to fund its continuing operations, satisfy existing and future obligations and liabilities, including the remaining payments due for the acquisition of the ENTADFI assets, and funds needed to support the Company’s working capital needs and business activities. These business activities include the development and commercialization of Proclarix, and the development and commercialization of the Company’s future product candidates.
Management’s plans for funding the Company’s operations include generating product revenue from sales of Proclarix, which is still subject to further successful commercialization activities within certain jurisdictions. Management also intends to secure additional funding through equity or debt financings if available, and to utilize the ELOC entered into in October 2024 on an as-needed basis to assist with the paydown of the notes and to fund current operating needs, subject to certain restrictions and beneficial ownership constraints. However, based on the terms of the ELOC and the current maximum availability, management determined that the funds readily available under the ELOC will not be sufficient to sustain operations. In addition, there are currently no other commitments in place for further financing nor is there any assurance that such financing will be available to sustain its operations and expand commercialization of Proclarix. If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization of Proclarix and any future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations, or, if it is required to, file for bankruptcy.
Because of historical and expected operating losses, net operating cash flow deficits, and debts due within one year, there is substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of the consolidated financial statements, which is not alleviated by management’s plans. The consolidated financial statements have been prepared assuming the Company will continue as a going concern. These consolidated financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.
Future Funding Requirements
We anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to commercialize Proclarix.
We will require significant amounts of additional capital in the short-term, to continue to fund our continuing operations, satisfy existing and future obligations and liabilities, including the remaining payments due under the Veru APA and other contracts entered into in support of the Company’s commercialization plans, in addition to funds needed to support our working capital needs and business activities, including the development and commercialization of Proclarix, and the development and commercialization of our future product candidates. Until we can generate a sufficient amount of revenue from sales of Proclarix if at all, we expect to finance our future cash needs through public or private equity or debt financings, third-party funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. The future sale of equity or convertible debt securities may result in dilution to our stockholders, and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. Debt financing may subject us to covenant limitations or restrictions on our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable or acceptable to us. If we are unable to obtain adequate financing when needed or on terms favorable or acceptable to us, we may be forced to delay, reduce the scope of our business activities.
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Our future capital requirements will depend on many factors, including:
| ● | the costs of future commercialization activities, including product manufacturing, marketing, sales, royalties, and distribution, for Proclarix, and other products for which we may receive marketing approval; | |
| ● | the timing, scope, progress, results and costs of research and development, testing, screening, manufacturing, preclinical and non-clinical studies and clinical trials; | |
| ● | the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform field efficacy studies, require more studies than those that we currently expect or change their requirements regarding the data required to support a marketing application; | |
| ● | our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; | |
| ● | any product liability or other lawsuits related to our product; | |
| ● | the expenses needed to attract, hire and retain skilled personnel; | |
| ● | the revenue, if any, received from commercial sales of Proclarix, or other products for which we may have received or will receive marketing approval; | |
| ● | the costs to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing our patents or other intellectual property rights; and | |
| ● | the costs of operating as a public company. |
A change in the outcome of any of these or other variables could significantly change the costs and timing associated with our business activities. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such change.
Cash Flows
The following table summarizes our cash flows for the periods indicated:
| Three months Ended March 31, 2025 | Three months Ended March 31, 2024 | |||||||
| Net cash used in operating activities | $ | (1,999,680 | ) | $ | (5,232,063 | ) | ||
| Net cash provided by (used in) investing activities | — | (4,578 | ) | |||||
| Net cash provided by financing activities | 2,870,254 | 5,205,093 | ||||||
| Effect of exchange rate changes on cash | 60,119 | (58,917 | ) | |||||
| Net increase (decrease) in cash | $ | 930,693 | $ | (90,465 | ) | |||
Cash Flows from Operating Activities
Net cash used in operating activities for the three months ended March 31, 2025, was approximately $2.0 million, which primarily resulted from a net loss of approximately $8.5 million, a non-cash change in fair value of subscription liability of approximately $3.3 million, a gain on forgiveness of accounts payable of approximately $0.9 million, and net changes in our operating assets and liabilities of $0.07 million. These items were offset by several non-cash items, which primarily include impairment of goodwill of approximately $10.9 million.
Net cash used in operating activities for the three months ended March 31, 2024 was approximately $5.2 million, which primarily resulted from a net loss of $11.1 million, a decrease in the fair value of the subscription agreement liability of $0.2 million, a deferred tax benefit of $0.1 million, and a net change in our operating assets and liabilities of $1.9 million. This was offset by an impairment loss of $5.2 million related to goodwill recorded in connection with the acquisition of Proteomedix, an impairment loss of $2.3 million related to the ENTADFI assets, noncash interest expense of $0.4 million, and depreciation and amortization expense of $0.2 million.
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Cash Flows from Investing Activities
Net cash used in investing activities for the three months ended March 31, 2024 of approximately $5,000 resulted from purchases of property and equipment.
Cash Flows from Financing Activities
Net cash provided by financing activities for the three months ended March 31, 2025, was approximately $2.9 million, and resulted primarily from proceeds of approximately $5.0 million from the purchase of common stock in connection with the ELOC and $0.1 million from the issuance of notes payable. These proceeds were offset by payments on notes payable of approximately $0.9 million and a payment of approximately $1.3million related to redemption of the Series C Preferred Stock.
Net cash provided by financing activities for the three months ended March 31, 2024 was approximately $5.2 million, and resulted primarily from the issuance of an aggregate of $5.7 million in notes payable, consisting of a $5.0 million debenture and $0.7 million for the financing for certain director and officer liability insurance policy premiums, offset by the payment of $0.4 million in financing costs and $0.1 million in payment on one of the notes payable.
Legal Contingencies
From time to time, we may become involved in legal proceedings arising from the ordinary course of business. We record a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated.
Off-Balance Sheet Arrangements
During the periods presented we did not have, nor do we currently have, any off-balance sheet arrangements as defined in the rules and regulations of the SEC.
Recent Accounting Pronouncements Not Yet Adopted
See Note 3 to our condensed consolidated financial statements included elsewhere in this Report for more information.
Critical Accounting Policies and Estimates
Our consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience, known trends and events and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
As of March 31, 2025, there have been no material changes to our critical accounting policies and estimates from those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates,” included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on June 2, 2025.
JOBS Act
Section 107 of the Jumpstart Our Business Startups Act (“JOBS”) Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of new or revised accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period.
For as long as we remain an “emerging growth company” under the JOBS Act, we will, among other things:
| ● | be exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act, which requires that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting; |
| ● | be permitted to omit the detailed compensation discussion and analysis from proxy statements and reports filed under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), and instead provide a reduced level of disclosure concerning executive compensation; and |
| ● | be exempt from any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements. |
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We currently intend to take advantage of some or all of the reduced regulatory and reporting requirements that will be available to us so long as we qualify as an “emerging growth company,” including the extension of time to comply with new or revised financial accounting standards available under Section 102(b) of the JOBS Act. Among other things, this means that our independent registered public accounting firm will not be required to provide an attestation report on the effectiveness of our internal control over financial reporting so long as we qualify as an emerging growth company, which may increase the risk that weaknesses or deficiencies in our internal control over financial reporting go undetected. Likewise, so long as we qualify as an emerging growth company, we may elect not to provide you with certain information, including certain financial information and certain information regarding compensation of our executive officers, that we would otherwise have been required to provide in filings we make with the SEC, which may make it more difficult for investors and securities analysts to evaluate our company. As a result, investor confidence in our company and the market price of our common stock may be materially and adversely affected.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting company, we are not required to provide the information required by this Item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) that are designed to ensure that information required to be disclosed by us in reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the appropriate time periods, and that such information is accumulated and communicated to the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and Chief Financial Officer has evaluated the effectiveness of our disclosure controls and procedures. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer has concluded that the Company’s disclosure controls and procedures were not effective as of March 31, 2025, as a result of the material weaknesses described below.
Material Weaknesses in Internal Control Over Financial Reporting
A material weakness in internal control is a deficiency in internal control, or combination of control deficiencies, that adversely affects the Company’s ability to initiate, authorize, record, process, or report external financial data reliably in accordance with GAAP such that there is more than a remote likelihood that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected.
We have identified the following internal control deficiencies, which we believe to be material weaknesses as of March 31, 2025:
| ● | We did not maintain an effective control environment as there was an inadequate segregation of duties with respect to certain cash disbursements. |
| ● | We do not have an effective risk assessment process and effective monitoring of compliance with established accounting policies and procedures, and do not demonstrate a sufficient level of precision in the application of our controls. |
| ● | Our controls over the approval and reporting of expense payments were not designed and maintained to achieve the Company’s objectives. |
| ● | We do not yet have adequate internal controls in place for the timely identification, approval or reporting of related party transactions.” |
| ● | We have insufficient accounting resources to maintain adequate segregation of duties, maintain adequate controls over the approval and posting of journal entries, and to provide optimal levels of oversight in order to process financial information in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements. |
| ● | The Company did not design, implement and maintain effective controls to ensure information technology (“IT”) policies and procedures set the tone at the top, to mitigate the risks to the achievement of IT objectives and ITGCs in the change management, logical security and computer operations domains. Specifically, the design and implementation of user authentication, user access privileges, data backup and data recovery controls as well as the monitoring controls of excessive user access and elevated privileged access to financial applications and data were not appropriately designed and maintained. In addition, these inadequate ITGC controls combined with the use of personal devices to conduct business, can lead to an IT control environment vulnerable to breaches and social engineering persuasion. |
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The above material weaknesses did not result in a material misstatement of our previously issued financial statements but could have resulted in material misstatements of our account balances or disclosures of our annual or interim financial statements that would not be prevented or detected. We have developed a remediation plan for these material weaknesses which is described below in Remediation of Material Weaknesses.
Remediation of Material Weaknesses
As of the date of this Quarterly Report on Form 10-Q, management is re-assessing the design of controls and modifying processes designed to improve our internal control over financial reporting and remediate the control deficiencies that led to the material weaknesses, including but not limited to (a) improving consistency in change management supported by standard operating procedures to govern the authorization, testing and approval of changes to information technology systems supporting all of the Company’s internal control processes, (b) enhancing design and implementation of our control environment, including the expansion of formal accounting and IT policies and procedures and financial reporting controls, (c) continuing to identify and design and implement effective review and approval controls, and (d) implementing appropriate timely review and oversight responsibilities within the accounting and financial reporting functions and ensuring appropriate segregation of duties.
We will consider the material weaknesses remediated after the applicable controls operate for a sufficient period of time, and management has concluded, through testing, that the controls are operating effectively.
The process of designing and implementing an effective accounting and financial reporting system is a continuous effort that requires us to anticipate and react to changes in our business and the economic and regulatory environments and to expend significant resources to maintain an accounting and financial reporting system that is adequate to satisfy our reporting obligations. As we continue to evaluate and take actions to improve our internal control over financial reporting, we may determine to take additional actions to address control deficiencies or determine to modify certain of the remediation measures described above. We cannot assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to remediate the material weakness we have identified or avoid potential future material weaknesses.
Inherent Limitation on the Effectiveness of Internal Control Processes
Our Interim Chief Executive Officer and Interim Chief Financial Officer does not expect that our disclosure controls or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls is also 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; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Changes in Internal Control over Financial Reporting
During the fiscal quarter ended March 31, 2025, there were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently subject to any material legal proceedings, nor, to our knowledge, is any material legal proceeding threatened against us or any of our officers or directors in their corporate capacity.
Item 1A. Risk Factors
In addition to the following risk factors, you should carefully consider the risk factors included in our Annual Report on Form 10-K, filed with the SEC on June 2, 2025, as supplemented and updated by subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K that we have filed or will file with the SEC. Any of these factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations.
Risks Related to our Financial Position and Need for Capital
We have incurred significant net losses since inception, have only generated minimal revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve profitability. Our stock is a highly speculative investment.
We are a commercial-stage biotechnology company that was incorporated in October 2018. Our net loss was $8.5 million for the three months ended March 31, 2025. As of March 31, 2025, we had an accumulated deficit of $125.4 million. We also generated negative operating cash flows of $2.0 million for the three months ended March 31, 2025.
We expect to continue to spend significant resources to commercialize our product. We expect to incur substantial and increasing operating losses over the next several years. As a result, our accumulated deficit will also increase significantly. Additionally, there can be no assurance that our current product or those that may be under development by us in the future will be commercially viable. If we are unable to achieve profitability or raise sufficient working capital, we may be unable to continue our operations.
There is substantial doubt about our ability to continue as a “going concern,” and we will require substantial additional funding to finance our long-term operations. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate our product or other operations.
The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of March 31, 2025, the Company had cash of approximately $1.6 million, a working capital deficit of approximately $11.6 million and an accumulated deficit of approximately $125.4 million. In addition, as of June 10, 2025, the Company’s cash balance was approximately $0.4 million, and the Company has approximately $9.0 million of debt due within the next 12 months.
We estimate, as of the date of this Report, that our current cash balance is not sufficient to fund operations through the end of June 2026. We believe that we will need to raise substantial additional capital to fund our continuing operations, satisfy existing and future obligations and liabilities, and otherwise support the Company’s working capital needs and business activities, including making the remaining payments to Veru and the commercialization of Proclarix, which is still subject to further successful development and commercialization activities within certain jurisdictions.
Management also intends to secure additional required funding through equity or debt financings if available. In December 2024, the Company began utilizing the ELOC entered into in October 2024 (see Note 8) on an as-needed basis to fund current operating needs, subject to certain restrictions and beneficial ownership constraints. However, based on the terms of the ELOC and the current maximum availability, management determined that the funds readily available under the ELOC will not be sufficient to sustain operations. In addition, there are currently no other commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable terms, if at all. This creates significant uncertainty whether the Company will have the funds available to be able to sustain its operations and expand commercialization of Proclarix. If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization of future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations, or, if its required to, file for bankruptcy.
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These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of time within one year following the date of this Report. Our future capital requirements will depend on many factors, including:
| ● | the costs of future development and commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for Proclarix, and other products for which we have received or will receive marketing approval; |
| ● | our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty, or other payments due under any such agreement; |
| ● | any product liability or other lawsuits related to our product; |
| ● | the expenses needed to attract, hire, and retain skilled personnel; |
| ● | the revenue, if any, received from commercial sales of Proclarix or other products for which we may receive marketing approval; |
| ● | the costs to establish, maintain, expand, enforce, and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending, and enforcing our patents or other intellectual property rights; and |
| ● | the costs of operating as a public company. |
Our ability to raise additional funds will depend on financial, economic, and other factors, many of which are beyond our control. We cannot be certain that additional funding will be available on acceptable terms, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce or terminate our business activities.
We owe a significant amount of money to Veru, which funds we do not have. Veru may take action against us to enforce its rights to payment in the future, which could have a material adverse effect on us and our operations.
Due to recent financial constraints, the Company may be unable to timely pay amounts due to Veru, from whom we purchased ENTADFI in April 2023. We may not have sufficient funds to pay amounts due to Veru in the near term, if at all, including but not limited to $10 million, $5 million of which was due on April 19, 2024 and is subject to certain forbearance terms and $5 million of which was due on March 31, 2025, and is subject to certain forbearance terms. On April 24, 2024, Veru agreed to forbear its rights and remedies until March 31, 2025, which forbearance period was further extended until June 30, 2025 by limited waiver on March 31, 2025 and April 24, 2025, with respect to, among other things, our inability to pay amounts due on April 19, 2024, and on September 19, 2024, Veru agreed to forbear its rights and remedies until June 30, 2025 with respect to, among other things, our inability to pay amounts due on September 30, 2024. In addition, on November 26, 2024, the Company and Veru entered into a waiver and amendment to the forbearance agreement, pursuant to which Veru agreed to waive the due date for payment of applicable Company cash receipt payments generated in October 2024 in consideration for an increase in payments to be made to Veru out of future financing and strategic transactions through June 30, 2025. However, Veru may take future action against us, including filing legal proceedings against us seeking amounts due and interest accrued or attempting to terminate its relationship with us. If Veru were to take legal action against us, we may be forced to scale back our business plan and/or seek bankruptcy protection. We may be subject to litigation and damages for our failure to pay amounts due to Veru, and may be forced to pay interest and penalties, which funds we do not currently have.
In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.
We plan to seek funding to support our operations and to pay amounts due to Veru, through a combination of equity offerings, debt financing or other capital sources, including potential collaborations, licenses, sales, and other similar arrangements, which may not be available on favorable terms, if at all. The sale of additional equity or debt securities, if accomplished, may result in dilution to our stockholders. Furthermore, any revenue or financing proceeds that we are required to pay to Veru will detract from our ability to use such funds to support our operations.
Our current liabilities are significant, and if those to whom we owe accounts payable, such as Veru or other vendors, were to demand payment, we would be unable to pay.
As of March 31, 2025, we had total current liabilities of approximately $14.0 million, including accounts payable of approximately $3.0 million, accrued expenses of approximately $1.2 million, the related party subscription liability of $0.8 million, proceeds due to shareholders of $0.4 million, and approximately $9.0 million (net of discounts) related to the notes payable. As of the same date, we had cash of only $1.6 million. In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product. We plan to seek funding to support our operations. We have also concurrently reduced our liabilities by entering into a settlement agreement, dated January 15, 2025, with IQVIA, Inc. concerning potential termination payments, whereby we recorded an adjustment of approximately ($0.9) million in accounts payable. However, the level of our current liabilities may make it more difficult for us to obtain adequate financing on favorable terms, if at all. If those to whom these payments are due were to demand immediate payment, as they are entitled to do, and we are not able to make the required payments, we would be subject to liability if our creditors chose to enforce their rights, which could result in our bankruptcy and insolvency. Under such a scenario, our assets would be distributed to our creditors leaving nothing to be distributed to our stockholders.
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Risks Related to Pending Business Combination
If completed, the Ocuvex Business Combination may not achieve its intended results and may result in us assuming unanticipated liabilities.
We entered into the Ocuvex LOI with the expectation that the Ocuvex Business Combination would result in various benefits and growth opportunities. Achieving the anticipated benefits of the transaction is subject to a large number of risks and uncertainties, including our ability to raise the substantial capital required for the Ocuvex Business Combination. Additionally, the success of the Ocuvex Business Combination depends on, among other things, the accuracy of our assessment of the assets associated with the acquired assets, operating costs and various other factors. These assessments are necessarily inexact. As a result, we may not recover the purchase price for the acquisition or recognize an acceptable return on sales.
The transactions contemplated by the Ocuvex LOI are subject to conditions that may not be satisfied on a timely basis or at all. Failure to complete the transactions contemplated by the Ocuvex LOI could have material and adverse effects on us.
Completion of the Ocuvex Business Combination is subject to a number of conditions, including the accuracy of the parties’ representations in the transactions as contemplated by the Ocuvex LOI. Such conditions, some of which are beyond our control, may not be satisfied or waived in a timely manner or at all and therefore make the completion and timing of the completion of the Ocuvex Business Combination uncertain. In addition, the Ocuvex LOI contains certain termination rights for both parties, which if exercised will also result in the Ocuvex Business Combination not being consummated.
If the transactions contemplated by the Ocuvex LOI are not completed, our business may be adversely affected and, without realizing any of the benefits of having completed the Ocuvex Business Combination, we will be required to pay our costs relating to the Ocuvex Business Combination, such as legal, accounting, and financial advisory fees. In addition, time and resources committed by our management to matters relating to the Ocuvex Business Combination could otherwise have been devoted to pursuing other beneficial opportunities; and the market price of our common stock could be impacted to the extent that the current market price reflects a market assumption that the Ocuvex Business Combination will be completed.
We will be subject to business uncertainties while the Ocuvex Business Combination is pending, which could adversely affect our business.
It is possible that certain persons with whom we have a business relationship may delay certain business decisions relating to us, or seek to terminate, change or renegotiate their relationships with us, in connection with the pendency of the Ocuvex Business Combination. This could negatively affect our revenues, earnings and cash flows, as well as the market price of our common stock, regardless of whether the Ocuvex Business Combination is completed.
We expect to incur significant transaction costs in connection with the Ocuvex Business Combination.
We expect to incur a number of non-recurring costs associated with negotiating and completing the Ocuvex Business Combination. These fees and costs have been, and will continue to be, substantial and, in many cases, will be borne by us whether or not the Ocuvex Business Combination is completed. A substantial majority of our non-recurring expenses will consist of transaction costs related to the Ocuvex Business Combination and include, among others, fees paid to financial, legal, accounting and other advisors. We will continue to assess the magnitude of these costs, and we may incur additional unanticipated costs. The costs described above and any unanticipated costs and expenses, many of which will be borne by us even if the Ocuvex Business Combination is not completed, could have an adverse effect on our financial condition and operating results.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
There are no transactions that have not been previously included in a Current Report on Form 8-K.
Issuer Purchases of Equity Securities
None.
Item 3. Default Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5.
On June 12, 2025, the Company filed a Certificate of Correction (the “Correction”) to the Certificate of Designation, Preferences and Rights of Series C Convertible Preferred Stock originally filed on October 2, 2024 (the “Certificate”). Due to a scrivener’s error, Section 9 of the original Certificate erroneously only provided for redemptions of all, and not less than all, of the Series C Convertible Preferred Stock.
The foregoing description of the Correction does not purport to be complete and is qualified in its entirety by reference to the full text of the Correction, which is filed as Exhibit 3.7 to this Quarterly Report on Form 10-Q and incorporated by reference herein.
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Item 6. Exhibits
The following documents are filed as exhibits to this Report.
EXHIBIT INDEX
| * | Filed herewith. |
| ** | Furnished herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Onconetix, Inc. | |
| Date: June 12, 2025 | /s/ Karina M. Fedasz |
| Karina M. Fedasz | |
| Interim Chief Executive Officer and Interim Chief Financial Officer (principal executive officer, and principal financial and accounting officer) |
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