Onconetix Inc.

11/13/2025 | Press release | Distributed by Public on 11/13/2025 16:27

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

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 in the process of destroying its 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.

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.

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 (i) Proclarix and (ii) ENTADFI, which has not generated any revenue from product sales; we have determined to abandon commercialization of ENTADFI and are in the process of destroying our inventory of the product.

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:

Termination of Business Combination Agreement:

On July 16, 2025, the Company entered into an Agreement and Plan of Merger with (i) Onconetix Merger Sub, Inc., a Delaware corporation and a direct, wholly owned subsidiary of the Company, and (ii) Ocuvex Therapeutics, Inc., a Delaware corporation ("Ocuvex", and such agreement, the "Merger Agreement"). Pursuant to the Merger Agreement, Merger Sub will merge with and into Ocuvex, with Ocuvex surviving the merger as a direct, wholly owned subsidiary of the Company (the "Merger" and the other transactions contemplated by the Merger Agreement, the "Transactions").

Effective September 24, 2025, pursuant to Section 9.01(a) of the Merger Agreement, the Company and Ocuvex entered into a Termination and Release Agreement (the "Termination Agreement") pursuant to which they agreed to terminate the Merger Agreement and the transactions contemplated thereby. The Termination Agreement also terminates and makes void the anciliary documents entered into in connection with the Merger Agreement. The Termination Agreement also provides for a mutual release of claims among Company and Ocuvex and their affiliates and in consideration of the foregoing, the Company agreed to pay to Ocuvex, an amount equal to $302,343.55 (the "Termination Payment"), which represents all amounts payable by the Company to Ocuvex pursuant to Section 6.02(f) of the Merger Agreement.

As of September 24, 2025, Ocuvex confirmed receipt of the Termination Payment, and as a result the Merger Agreement is of no further force and effect.

Reverse Stock Split

On June 13, 2025, the Company effected a reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-eighty-five (1:85). 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 these condensed 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.

Series C 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 Preferred Stock, each Series C Preferred Stock 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 Series C Preferred Stock at a rate of fifteen percent (15.0%) (the "Default Rate") per annum. Each holder is entitled to convert any portion of the outstanding Series C Preferred Stock 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 Series C Preferred Stock by (y) the Conversion Price, $4.5056, subject to adjustment as provided in the Certificate of Designations.

On October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the "Series C 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 Series C PIPE Investors' irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 6,963 shares of Common Stock ("Series C Warrants") for aggregate net cash proceeds to the Company of $1.9 million. The exercise price of the Series C Warrants is $372.30 on a post-reverse split basis, and the Series C 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 also entered into the ELOC Purchase Agreement 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 the limitations described herein. 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").

On July 16, 2025, the Company exercised its voluntary Series C Preferred Stock adjustment right to lower the conversion price of the Series C Preferred Stock to $3.50, and holders of 1,920 Series C Preferred Stock shares agreed to convert their shares into shares of common stock.

As of September 30, 2025, 7 shares of Series C Preferred Stock were outstanding, after the exchange of 203 shares of Series C Preferred Stock into 244 shares of Series D Preferred Stock (as defined below).

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 Series C Preferred Shares held by such holder into shares of Common Stock at the Alternate Conversion Price (each, an "Alternate Conversion").

At any time, the Company has the right to redeem in cash all or part of the Series C Preferred Stock 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 Series C Preferred Stock 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 Series C Preferred Stock be converted (or Series C 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 Series C Preferred Stock (or exercise of the Series C 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 "Series C PIPE Blocker". The Series C 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 Series C Preferred Stock (or Series C Warrants), except that any raise will only be effective upon 61-days' prior notice to the Company.

Series D PIPE Financing

On September 22, 2025, the Company entered into a securities purchase agreement (the "Series D Securities Purchase Agreement") with eleven institutional investors, and sold or exchanged debt, to such investors (collectively, the "Series D PIPE Investors") an aggregate of 16,099 shares of Series D convertible preferred stock, par value $0.00001 per share ("Series D Preferred Stock"), which includes an issuance of 500 shares of Series D Preferred Stock to the lead investor in consideration for the Series D PIPE Investors' irrevocable commitment to purchase shares of the Series D Preferred Stock, and warrants (the "Series D Warrants") to purchase 4,362,827 shares of Common Stock, for an aggregate purchase price of approximately $12.9 million and net cash proceeds of $9.3 million. The exercise price of the Series D Warrants is $3.6896, and the Series D Warrants are exercisable beginning on the issuance date and expire on the third anniversary of the issuance date.

Concurrently with entering into the Securities Purchase Agreement, the Company also entered into a registration rights agreement with the Series D PIPE Investors, pursuant to which it has agreed to provide the Series D PIPE Investors with certain registration rights related to the shares of Common Stock underlying the shares of Series D Preferred Stock and Series D Warrants.

Veru Settlement Agreement and Release

On April 19, 2023, the Company entered into an asset purchase agreement with Veru (the "Veru APA"). Pursuant to, and subject to the terms and conditions of, the Veru APA, the Company purchased substantially all of the assets related to Veru's ENTADFI business, in a transaction that closed in April 2023. Pursuant to the terms of the Veru APA, the Company agreed to provide Veru with initial consideration totaling $20.0 million, including (i) $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii) $10.0 million in the form of two equal (i.e. each for $5.0 million) non-interest bearing notes payable, each due on April 19, 2024 (the "April Veru Note") and September 30, 2024 (the "September Veru Note" and together with the April Veru Note, the "Veru Notes").

Subsequently, the Company and Veru modified and extended the payment terms under the Veru Notes on various occasions. On August 28, 2025, Veru and the Company agreed to amend and restate the September Veru Note (as amended and restated, the "Second A&R September Veru Note"). Pursuant to the Second A&R September Veru Note, the principal amount owed to Veru was increased by $100,000 to an aggregate principal amount of $5.2 million, and the maturity date was amended to September 19, 2025. All other terms of the September Veru Note remained the same. On August 28, 2025, Veru and the Company also entered into a waiver agreement (the "August 2025 Veru Waiver") pursuant to which Veru agreed to waive and extend the date for payment of the April Veru Note to September 19, 2025.

As of September 22, 2025, approximately $8.8 million was payable to Veru under the Veru Notes and related amendments. On September 22, 2025, the Company and Veru entered into a Settlement Agreement and Release (the "Veru Settlement Agreement"), pursuant to which Veru agreed to accept a cash payment of approximately $6.3 million (including interest accrued through receipt of the Settlement Amounts (as defined herein), 3,125 shares of Series D Preferred Stock and 846,975 Series D Warrants (such cash payment, shares of Series D Preferred Stock and Series D Warrants, collectively, the "Settlement Amounts") in full satisfaction of all amounts due under the Veru Notes, as amended by all preceding amendments, forbearance agreements, and waivers, and Veru agreed that such acceptance constituted complete discharge of all obligations thereunder. The Settlement Agreement contains customary release provisions that upon timely delivery of the Settlement Amounts, Veru shall release all claims or actions against the Company. As of September 24, 2025, Veru confirmed receipt of all Settlement Amounts in satisfaction of all outstanding amounts, and all Veru Notes and related amendments were deemed cancelled and terminated, respectively, and of no further force or effect.

As of September 24, 2025, Veru confirmed receipt of all Settlement Amounts in satisfaction of all outstanding amounts, and all Veru Notes and related amendments were deemed cancelled and terminated, respectively, and of no further force or effect. The extinguishment of the Veru Notes was accounted for as a debt extinguishment in accordance with ASC 405-20 and ASC 470-50. The Company derecognized the carrying amount of the Veru Notes and recognized a gain or loss on extinguishment equal to the difference between the reacquisition price-measured at the fair value of the cash and equity instruments transferred-and the net carrying value of the debt. The Company recognized a loss on extinguishment related to this transaction of $3,516,811 recorded within loss on extinguishment of notes payable in the accompanying condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2025.

Keystone Notes Payable

During the nine months ended September 30, 2025, the Company issued six subordinated promissory notes to Keystone Capital Partners, LLC, each with an original issue discount and payable upon the earlier of (i) receipt of sufficient proceeds from the Company's Equity Line of Credit ("ELOC") with the Investor or (ii) a specified maturity date. All notes are subordinated to the Company's existing debt obligations to Veru, do not initially bear interest, and are subject to a late charge of 15% per annum on any unpaid amounts past due.

On February 12, 2025, the Company issued a note with an aggregate principal amount of $117,647, including an original issue discount of $17,647. The note matures on November 12, 2025, unless prepaid earlier upon receipt of sufficient capital from other securities offerings (the "February Keystone Note").
On May 16, 2025, the Company issued a note with an aggregate principal amount of $294,118, including an original issue discount of $44,118. The note matures on February 16, 2026, subject to the same prepayment provisions (the "May Keystone Note").
On June 5, 2025, the Company issued a note with an aggregate principal amount of $147,059, including an original issue discount of $22,059. The note matures on March 5, 2026, subject to the same prepayment provisions (the "June Keystone Note").
On August 6, 2025, the Company issued a note with an aggregate principal amount of $117,647, including an original issue discount of $17,647. The note matures on March 6, 2026, subject to the same prepayment provisions (the "August 6 Keystone Note").
On August 28, 2025, the Company issued two notes with an aggregate principal amount of $58,824 each, including an original issue discount of $8,824 each. The notes mature on May 28, 2026, subject to the same prepayment provisions (the "August 28 Keystone Notes").

On September 22 2025, Keystone Capital Partners, LLC and the Company agreed to exchange the principal owed under the May Keystone Note, the June Keystone Note, the August 6 Keystone Note and the August 28 Keystone Notes for Series D Preferred Stock of 3,125 shares and Warrants of 846,975 shares of common stock in connection with the Series D PIPE Financing. The February Keystone Note has a balance as of September 30, 2025 of $113,725 and matures on November 12, 2025. The transaction was accounted for as a debt extinguishment in accordance with ASC 405-20 and ASC 470-50. The Company derecognized the carrying amount of the Keystone Notes and recognized a gain or loss on extinguishment equal to the difference between the reacquisition price, measured at the fair value of the cash and equity instruments transferred, and the net carrying value of the debt. The Company recognized a loss on extinguishment related to this transaction of $1,867,908 recorded within loss on extinguishment of notes payable in the accompanying condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2025. The extinguishment of the May Keystone Note, the June Keystone Note, the August 6 Keystone Note and the August 28 Keystone Notes was accounted as a debt extinguishment in accordance with ASC 405-20 and ASC 470-50. The Company derecognized the carrying amount of the Veru Notes and recognized a gain or loss on extinguishment equal to the difference between the reacquisition price-measured at the fair value of the cash and equity instruments transferred-and the net carrying value of the debt. The Company recognized a loss on extinguishment related to this transaction of $3,516,811 recorded within loss on extinguishment of notes payable in the accompanying condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2025.

During the three and nine months ended September 30, 2025, the Company recorded approximately $0.3 million and $0.8 million of interest expense, respectively, which includes accrued interest and amortization of the debt discount. The unamortized debt discount as of September 30, 2025 and December 31, 2024 was $0 and $5,000, respectively. As of September 30, 2025 and December 31, 2024, the Company has recorded accrued interest of approximately $0 million and $0.1 million, respectively, which is included in accrued expenses in the accompanying condensed consolidated balance sheets.

Series E PIPE Financing

On October 1, 2025, the Company entered into a securities purchase agreement (the "Series E Securities Purchase Agreement") with institutional investor(s) and sold to such institutional investors(s)(collectively, the "Series E PIPE Investors"), an aggregate of 7,813 shares of Series E convertible preferred stock, par value $0.00001 per share ("Series E Preferred Stock"), which are convertible into common stock of the Company, $0.00001 par value per share and warrants (the "Series E Warrants") to purchase 2,025,223 shares of Common Stock, for an aggregate purchase price of approximately $6.25 million, which was also equal to the net cash proceeds. The exercise price of the Series E Warrants is $3.8576, and the Series E Warrants are exercisable beginning on the issuance date and expire on the third anniversary of the issuance date.

Concurrently with entering into the Series E Securities Purchase Agreement, the Company also entered into a registration rights agreement with the Series E PIPE Investors, pursuant to which it has agreed to provide the Series E PIPE Investors with certain registration rights related to the shares of Common Stock underlying the shares of Series E Preferred Stock and Series E Warrants.

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.

Immunovia-Proteomedix Licensing Agreement

On September 17, 2025, Proteomedix entered into a licensing agreement (the "Immunovia Agreement") with Immunovia, Inc. ("Immunovia"), a pancreatic cancer diagnostics company based in Lund, Sweden. Under the Agreement, Proteomedix will provide Immunovia with master cell lines required to produce antibodies for three of the five biomarkers used in the PancreaSure test, as well as a license to key intellectual property related to the manufacturing of associated reagents.

In return, Immunovia will make two payments of $300,000 each to Proteomedix, due on September 30, 2025, and March 31, 2026. Additionally, Immunovia will make a $100,000 payment for materials and pay a 3% royalty on net sales of PancreaSure and any other products incorporating the licensed intellectual property from January 1, 2026, through December 31, 2032.

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, net periodic benefit costs, 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.

We anticipate that our selling, general and administrative expenses related to Proteomedix will decrease when compared to historical levels due to cost reduction efforts, including headcount reductions, and the termination of the pension plan.

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, loss on extinguishment of notes payables and preferred stock, loss on issuance of preferred stock and warrants, the change in fair value of financial instruments that are recorded as liabilities; which includes the related party subscription agreement liability, Series D warrant and derivative liabilities, and the contingent warrant liabilities; and other financing-related costs.

Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

The following table summarizes our statements of operations for the periods indicated:

Three Months
Ended
September 30,
2025
Three Months
Ended
September 30,
2024
$
Change
%
Change
Revenue $ 303,651 $ 406,859 $ (103,208 ) (25.4 )%
Cost of revenue 34,757 301,445 (266,688 ) (88.5 )%
Gross profit 268,894 105,414 163,480 155.1 %
Operating expenses
Selling, general and administrative $ 2,341,347 $ 2,641,916 (300,569 ) (11.4 )%
Research and development (3,211 ) 109,365 (112,576 ) (102.9 )%
Total operating expenses 2,338,136 2,751,281 (413,145 ) (15.0 )%
Loss from operations (2,069,242 ) (2,645,867 ) 576,625 (21.8 )%
Other income (expense)
Loss on extinguishment of note payable (5,384,719 ) - (5,384,719 ) 100 %
Loss on issuance of preferred stock and warrants (2,543,329 ) - (2,543,329 ) 100 %
Loss on extinguishment of preferred stock (196,244 ) - (196,244 ) 100 %
Interest expense - related party - (153,302 ) 153,302 (100 )%
Interest expense (300,069 ) (231,656 ) (68,413 ) 29.5 %
Change in fair value of subscription agreement liability - related party - (928,400 ) 928,400 (100 )%
Change in fair value of contingent warrant liabilities (36 ) 30,448 (30,484 ) (100.1 )%
Change in fair value of warrant liabilities 1,934,000 - 1,934,000 100 %
Change in fair value of derivative liabilities (216,000 ) - (216,000 ) 100 %
Other income (loss) (8,063 ) 44,988 (53,051 ) (117.9 )%
Total other expense (6,714,460 ) (1,237,922 ) (5,476,538 ) 442.4 %
Loss before income taxes (8,783,702 ) (3,883,789 ) (4,899,913 ) 126.2 %
Income tax benefit - 56,384 (56,384 ) (100 )%
Net loss $ (8,783,702 ) $ (3,827,405 ) (4,956,297 ) 129.5 %
Deemed dividend Series C preferred stock - - - - %
Net loss applicable to common stockholders' $ (8,783,702 ) $ (3,827,405 ) (4,956,297 ) 129.5 %

Revenue, Cost of Revenue, and Gross Margin

For the three months ended September 30, 2025, the Company had approximately $0.3 million of revenue, which was attributable to other revenue including license revenue with Immunovia through an agreement that grant rights to use its intellectual property and proprietary materials generated by Proteomedix. Cost of revenue of approximately $0.03 million was mostly attributable to costs incurred on Proteomedix revenue. For the three months ended September 30, 2024, the Company had approximately $0.4 million of revenue, which was attributable to sales and development services generated by Proteomedix. The cost of revenue of approximately $0.3 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 September 30, 2025, selling, general and administrative expenses decreased by approximately $0.3 million compared to the same period in 2024. This decrease was primarily driven by a reduction of approximately $0.4 million in net periodic benefit cost, due to the settlement of the defined benefit plan.

Research and Development Expenses

For the three months ended September 30, 2025 and 2024, there were no substantial research and development expenses. There has been no substantial R&D activity since the Company decided to halt its vaccine programs and focus on commercialization activities in the third quarter of 2023. This change in business strategy led to a halt in the Company's clinical and other research activities.

Other Expense

Other expense during the three months ended September 30, 2025, increased by approximately $5.5 million compared to the same period in 2024. The increase was primarily attributable to a $5.4 million loss on extinguishment of notes payable and $2.5 million loss on issuance of preferred stock and warrants, partially offset by a $1.9 million gain on the change in fair value of Series D warrant liabilities.

Income Tax Benefit

The Company did not record any income tax benefit or expense during the three months ended September 30, 2025. For the same period in 2024, the Company recorded an income tax benefit of approximately $0.06 million, related to foreign deferred income taxes recorded in connection with Proteomedix.

Comparison of the Nine months Ended September 30, 2025 and 2024

The following table summarizes our statements of operations for the periods indicated:

Nine months
Ended
September 30,
2025
Nine months
Ended
September 30,
2024
$
Change
%
Change
Revenue $ 511,775 $ 1,812,140 $ (1,300,365 ) (71.8 )%
Cost of revenue 126,546 1,417,010 (1,290,464 ) (91.1 )%
Gross profit 385,229 395,130 (9,901 ) (2.5 )%
Operating expenses
Selling, general and administrative $ 5,539,144 $ 8,599,642 (3,060,498 ) (35.6 )%
Research and development (90,426 ) 154,649 (245,075 ) (159 )%
Impairment of ENTADFI - 3,530,716 (3,530,716 ) (100 )%
Impairment of goodwill 11,512,000 15,453,000 (3,941,000 ) (25.5 )%
Total operating expenses 16,960,718 27,738,007 (10,777,289 ) (38.9 )%
Loss from operations (16,575,489 ) (27,342,877 ) 10,767,388 (39.4 )%
Other income (expense)
Loss on extinguishment of note payable (5,384,719 ) - (5,384,719 ) 100 %
Loss on issuance of preferred stock and warrants (2,543,329 ) - (2,543,329 ) 100 %
Loss on extinguishment of preferred stock (196,244 ) - (196,244 ) 100 %
Interest expense - related party - (534,245 ) 534,245 (100 )%
Interest expense (746,758 ) (625,084 ) (121,674 ) 19.5 %
Change in fair value of subscription agreement liability - related party 3,127,962 (950,000 ) 4,077,962 429.3 %
Change in fair value of contingent warrant liabilities (10,060 ) 30,448 (40,508 ) (133 )%
Change in fair value of warrant liabilities 1,934,000 - 1,934,000 100 %
Change in fair value of derivative liabilities (216,000 ) - (216,000 ) 100 %
Gain on forgiveness of accounts payable 944,694 - 944,694 100 %
Other income (loss) (36,086 ) 41,894 (77,980 ) (186.1 )%
Total other expense (3,126,540 ) (2,036,987 ) (1,089,553 ) 53.5 %
Loss before income taxes (19,702,029 ) (29,379,864 ) 9,677,835 (32.9 )%
Income tax benefit - 127,183 (127,183 ) (100 )%
Net loss $ (19,702,029 ) $ (29,252,681 ) 9,550,652 (32.6 )%
Deemed dividend Series C preferred stock (1,498,595 ) - (1,498,595 ) 100 %
Net loss applicable to common stockholders' $ (21,200,624 ) $ (29,252,681 ) 8,052,057 (27.5 )%

Revenue, Cost of Revenue, and Gross Margin

For the nine months ended September 30, 2025, the Company had approximately $0.5 million of revenue, which was attributable to other revenue including license revenue with Immunovia through an agreement that grant rights to use its intellectual property and proprietary materials generated by Proteomedix. Cost of revenue of approximately $0.1 million was mostly attributable to costs incurred on Proteomedix revenue. For the nine months ended September 30, 2024, the Company had approximately $1.8 million of revenue, which was attributable to sales and development services generated by Proteomedix. The cost of revenue of approximately $1.4 million is attributable to costs incurred on Proteomedix revenue including amortization of the product rights intangible asset of approximately $0.5 million, in addition to approximately $0.4 million related to the full impairment of ENTADFI inventory.

Selling, General and Administrative Expenses

For the nine months ended September 30, 2025, selling, general and administrative expenses decreased by approximately $3.1 million compared to the same period in 2024. The decrease primarily reflects a reduction of approximately $1.0 million in net periodic benefit cost due to the settlement of the defined benefit plan, a reduction of approximately $0.4 million in professional fees, a reduction of approximately $0.4 million in director and officers insurance fees, and a reduction of approximately $1.1 million in payroll related expenses, largely driven by cost containment efforts.

Research and Development Expenses

For the nine months ended September 30, 2025 and 2024, there were no substantial research and development expenses. There has been no substantial R&D activity since the Company decided to halt its vaccine programs in 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 nine months ended September 30, 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 $3.5 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 nine months ended September 30, 2025 totaling $11.5 million, as compared to an impairment of $15.5 million recognized for the same period last year in connection with the same acquisition.

Other Income (Expense)

Other income (expense) incurred during the nine months ended September 30, 2025, increased by approximately $1.0 million compared to the same period in 2024. The increase was primarily attributable to a $5.4 million loss on extinguishment of notes payable and $2.5 million loss on issuance of preferred stock and warrants, partially offset by a $1.9 million gain on the change in fair value of Series D warrant liabilities, a $4.1 million increase in the change in fair value of the subscription agreement liability - related party and a $0.9 million gain on forgiveness of accounts payable related to the settlement of IQVIA balances.

Income Tax Benefit

The Company did not record any income tax benefit or expense during the nine months ended September 30, 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 September 30, 2025, the Company had cash of approximately $0.8 million, a working capital deficit of approximately $15.0 million and an accumulated deficit of approximately $136.9 million. During the nine months ended September 30, 2025, the Company used approximately $6.6 million in cash for operating activities. In addition, as of November 10, 2025, the Company's cash balance was approximately $6.1 million.

During the third quarter of 2025, the Company successfully closed a Series D financing, and in October 2025, it completed a Series E financing. These financings provided the Company with additional cash flow to support near-term operations. While these capital raises may enable the Company to sustain current operations and meet existing obligations, the Company continues to generate recurring net operating losses and has not yet established sustained positive cash flows to support its strategic growth initiatives, which includes the commercialization of Proclarix, and the development and commercialization of the Company's future product candidates. These factors 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 condensed consolidated financial statements.

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 pursue additional equity or debt financing to support operations and strategic initiatives. However, there are currently no committed sources of financing, and there is no assurance that additional funding will be available on favorable terms, if at all. This uncertainty raises significant concern about the Company's ability to sustain operations and execute its strategic initiatives. If additional capital is not secured, the Company may need to curtail clinical trials, development, and commercialization efforts, and take further measures to reduce expenses to conserve cash.

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 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. In December 2024, the Company began utilizing the ELOC entered into in October 2024 on an as-needed basis to fund current operating needs, subject to certain restrictions and beneficial ownership constraints. When the Company can again utilize the ELOC, it may be able to raise up to $17.9 million in gross proceeds remaining under the ELOC. However, given the terms of the ELOC and the uncertainty to drawdown fully from the ELOC, there are no assurances that the Company may not have funds to sustain operations for the next 12 months.

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 it's required to, file for bankruptcy.

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 may 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 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:

Nine months
Ended
September 30,
2025
Nine months
Ended
September 30,
2024
Net cash used in operating activities $ (6,587,805 ) $ (9,578,169 )
Net cash provided by (used in) investing activities - (24,597 )
Net cash provided by financing activities 7,905,978 5,440,310
Effect of exchange rate changes on cash (1,128,117 ) (50,384 )
Net decrease in cash $ 190,056 $ (4,212,840 )

Cash Flows from Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $6.6 million, which primarily resulted from a net loss of approximately $19.7 million, a non-cash change in fair value of subscription liability of approximately $3.1 million, a gain on forgiveness of accounts payable of approximately $0.9 million, a non-cash change in fair value of Series D warrant liability of approximately $1.9 million, and net changes in our operating assets and liabilities of $1.3 million. These items were offset by several non-cash items, which primarily include impairment of goodwill of approximately $11.5 million, loss on extinguishment of notes payable of approximately $5.4 million, and loss on issuance of Series D preferred stock of approximately $2.5 million.

Net cash used in operating activities for the nine months ended September 30, 2024 was approximately $9.6 million, which primarily resulted from a net loss of approximately $29.3 million and a net change in our operating assets and liabilities of approximately $2.3 million and net change of deferred tax benefit by approximately $0.1 million. These items were offset by several non-cash items, which include: impairments of goodwill and ENTADFI of approximately $15.5 million and $3.5 million, respectively, depreciation and amortization expense of approximately $0.6 million, loss on impairment of ENTADFI inventory of approximately $0.4 million, noncash interest expense and amortization of debt discounts of approximately $1.1 million, and increase in the fair value of subscription liability of $1.0 million.

Cash Flows from Investing Activities

Net cash used in investing activities for the nine months ended September 30, 2025 was $0.

Net cash used in investing activities for the nine months ended September 30, 2024 of approximately $25,000 resulted from purchases of property and equipment.

Cash Flows from Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $7.9 million, and resulted primarily from proceeds of approximately $9.1 million from the issuance proceeds of Series D preferred stock and warrants, $6.4 million from the purchase of common stock in connection with the ELOC and $0.9 million from the issuance of notes payable. These proceeds were offset by payments on notes payable of approximately $6.9 million and a payment of approximately $1.7 million related to redemption of the Series C Preferred Stock.

Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $5.4 million, and resulted primarily from the issuance of an aggregate of approximately $5.9 million in notes payable, consisting of a $5.0 million debenture and approximately $0.9 million for the financing of director and officer liability insurance policy premiums and the proceeds received from the exercise of preferred investment options in connection with the warrant inducement transaction of approximately $0.9 million. These proceeds were offset by approximately $0.9 million in payments on the notes payable and $0.4 million in the payment of financing costs.

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 September 30, 2025, there have been 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. Please refer to "Critical Accounting Policies and Estimates - Accounting for Series D PIPE Securities including Warrant and Derivative Liabilities" below.

Accounting for Series D PIPE Securities including Warrant and Derivative Liabilities

In connection with the Series D PIPE Financing, we issued Series D Preferred Stock and Series D Warrants certain institutional investors on September 22, 2025. The accounting determinations in connection with the Series D PIPE Securities have a significant effect on our reported financial position and results of operations.

We determine the accounting classification of the instruments by first assessing each instrument under ASC 480, Distinguishing Liabilities from Equity, then assessing each instrument under ASC 815, Derivatives and Hedging Activities. Under ASC 480, instruments are considered liability classified if they are mandatorily redeemable, obligate us to settle the warrants or the underlying shares by paying cash or other assets, and instruments that must or may require settlement by issuing variable number of shares. If instruments do not meet the liability classification under ASC 480-10, we assess the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the financial instruments do not require liability classification under ASC 815-40, in order to conclude equity classification, we also assess whether the instruments are indexed to our Common Stock and whether the instruments are classified as equity under ASC 815-40 or other GAAP. After all such assessments, we conclude whether the instruments are classified as liability or equity.

In addition, ASC 815 requires companies to bifurcate certain features from their host instruments and account for them as free-standing derivative financial instruments should certain criteria be met. We evaluate our financial instruments to determine whether such instruments are derivatives or contain features that qualify as embedded derivatives. Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract and the features of the derivatives. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the consolidated statements of operations each period. Bifurcated embedded derivatives are classified with the related host contract in our consolidated balance sheets. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period.

Liability classified instruments require fair value accounting at issuance and subsequent to initial issuance with all changes in fair value after the issuance date recorded in the consolidated statements of operations.

The Company concluded the Series D Preferred Stock was more akin to an equity-like host than a debt-like host and was classified as permanent equity as it was not redeemable in any manner that would require classification outside of permanent equity pursuant to ASC 480-10-S99. The Series D Warrants and certain embedded share-settled redemption features of the Series D Preferred Stock issued were determined to be liability-classified instruments pursuant to ASC 480 and ASC 815. The embedded features of the Series D Preferred Stock were bifurcated and accounted for separately as derivative liabilities.

Fair Value Measurements for Warrant and Derivative Liabilities

The Company measured its bifurcated embedded derivative and warrant liabilities as of September 30, 2025 and September 22, 2025, at fair value on a recurring basis using level 3 inputs. These financial instruments are measured using management's best estimate of fair value, where the inputs into the determination of fair value require significant management judgment to estimation. The derivative and warrant liabilities were both measured using Monte Carlo valuation models. Valuations based on unobservable inputs are highly subjective and require significant judgments. Changes in such judgments could have a material impact on fair value estimates.

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.

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.

Onconetix Inc. published this content on November 13, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 13, 2025 at 22:28 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]