2 unchanged sentences
focused on the research, development, and commercialization of innovative solutions for men’s health and oncology.
−Removed: Through our recent
−Removed: acquisition of Proteomedix, we own Proclarix, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and
−Removed: approved for sale in the European Union under the In Vitro Diagnostic Regulation (“IVDR”), which we anticipate will be marketed
+Added: acquisition of Proteomedix, which closed on December 15, 2023, we own Proclarix, an in vitro diagnostic test for prostate cancer originally
+Added: developed by Proteomedix and approved for sale in the European Union under the In Vitro Diagnostic Regulation (“IVDR”), which
+Added: we anticipate will be marketed in the U.S.
as a lab developed test through our license agreement with LabCorp.
−Removed: We also own ENTADFI, an FDA-approved, once daily pill
−Removed: that combines finasteride and tadalafil for the treatment of BPH, a disorder of the prostate.
+Added: Since our inception in October 2018 until April
+Added: 2023, when we acquired ENTADFI, we devoted substantially all of our resources to performing research and development, undertaking preclinical
+Added: studies and enabling manufacturing activities in support of our product development efforts, hiring personnel, acquiring and developing
+Added: our technology and now halted vaccine candidates, organizing and staffing our company, performing business planning, establishing our
+Added: intellectual property portfolio and raising capital to support and expand such activities.
+Added: ENTADFI is an FDA-approved, once daily pill that
+Added: combines finasteride and tadalafil for the treatment of BPH, a disorder of the prostate.
+Added: However, in light of (i) the time and resources
+Added: needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company abandoned
+Added: commercialization of ENTADFI and no longer holds remaining inventory of the product as of December 31, 2025.
+Added: In addition, as part of cost
+Added: reduction efforts and in connection with our initial pause in commercializing ENTADFI, we terminated three employees involved with the
+Added: ENTADFI program, effective April 30, 2024, with such individuals to continue assisting the Company on an as-needed, consulting basis.
+Added: Based on the circumstances surrounding ENTADFI, at June 30, 2024, the ENTADFI assets were fully impaired.
+Added: Refer to Note 4 in the consolidated
+Added: financial statements for the period ended December 31, 2024 for further discussion.
+Added: We are currently focusing our efforts on commercializing
Proclarix is an easy-to-use next generation protein-based
7 unchanged sentences
that impacts the physician’s routine, our healthcare system, and the quality of patients’ lives.
−Removed: Proclarix helps doctors and
−Removed: patients with unclear PSA test results through the use of our proprietary Proclarix Risk Score which delivers clear and immediate diagnostic
−Removed: support for further treatment decisions.
−Removed: No additional intervention is required, and results are available quickly.
−Removed: Local diagnostic laboratories
−Removed: can integrate this multiparametric test into their current workflow because Proclarix assays use the enzyme-linked immunosorbent assay
−Removed: (ELISA) standard, which most diagnostic laboratories are already equipped to process.
−Removed: In light of (i) the time and resources needed
−Removed: to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned
−Removed: commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI
−Removed: There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other
−Removed: transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.
+Added: Approximately 10% of all
+Added: men have elevated PSA levels., commonly referred to as the diagnostic “grey zone”, of which only 20 - 40% present clinically
+Added: Proclarix is intended for use in diagnosing these patients where it is difficult to decide if a biopsy is necessary to verify
+Added: a potential clinically significant cancer diagnosis.
+Added: Proclarix helps doctors and patients with unclear PSA test results through the use
+Added: of our proprietary Proclarix Risk Score which delivers clear and immediate diagnostic support for further treatment decisions.
+Added: No additional
+Added: intervention is required, and results are available quickly.
+Added: Local diagnostic laboratories can integrate this multiparametric test into
+Added: their current workflow because Proclarix assays use the enzyme-linked immunosorbent assay (ELISA) standard, which most diagnostic laboratories
+Added: are already equipped to process.
+Added: Proclarix is CE-marked and for sale in Europe.
+Added: We continue our sales
+Added: efforts and expect growing revenues from sales of Proclarix in 2026 and beyond.
+Added: We anticipate these sales to offset some expenses relating
+Added: to commercial scale up and development, we expect our expenses also to increase in connection with our ongoing activities, as we:
+Added: commercialize Proclarix;
+Added: hire additional personnel;
+Added: operate as a public company;
+Added: obtain, maintain, expand, and protect our intellectual property portfolio;
+Added: perform product validation studies in connection with a license agreement.
We rely and will continue to rely on third parties
1 unchanged sentence
We have no internal manufacturing capabilities, and we will continue to rely on third parties, of
−Removed: which the main suppliers are single-source suppliers, for commercial products.
+Added: which the main suppliers are single-source suppliers, for commercial product.
We do not have any products approved for sale,
−Removed: aside from Proclarix, from which we have generated revenue since acquisition, and ENTADFI, from which we have not generated any revenue
−Removed: from product sales, and for which we have now abandoned commercialization activities.
+Added: aside from Proclarix.
+Added: We have abandoned commercialization of ENTADFI and have destroyed our inventory of the product.
To date, we have financed our operations primarily
7 unchanged sentences
arrangements, or any combination of these approaches, to support our operations.
−Removed: We have incurred net losses since inception and
−Removed: expect to continue to incur net losses in the foreseeable future.
−Removed: Our net losses may fluctuate significantly from quarter-to-quarter and
−Removed: year-to-year, depending in large part on the timing of our preclinical studies, clinical trials and manufacturing activities, our expenditures
−Removed: on other research and development activities and commercialization activities.
−Removed: As of December 31, 2024, the Company had a working capital
−Removed: deficit of approximately $17.3 million and an accumulated deficit of approximately $113.0 million.
−Removed: We will need to raise additional capital
−Removed: within the next 12 months to sustain operations.
+Added: We have incurred net losses since inception and expect to continue to incur
+Added: net losses in the foreseeable future.
+Added: Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending in
+Added: large part on the timing of our preclinical studies, clinical trials and manufacturing activities, our expenditures on other research
+Added: and development activities and commercialization activities.
+Added: As of December 31, 2025, we had cash of approximately $5.2 million, a working
+Added: capital deficit of approximately $3.1 million and an accumulated deficit of approximately $131.2 million.
+Added: During the year ended December
+Added: 31, 2025, we used approximately $9.7 million in cash for operating activities.
+Added: In addition, as of March 11, 2026, our cash balance was
+Added: approximately $3.6 million.
+Added: We believe that our current cash balance is not sufficient to fund its operations for one year from the date
+Added: of issuance of the consolidated financial statements for the year.
+Added: As such, we have entered into Series D and Series E PIPE financings
+Added: with certain investors in September 2025 and October 2025, respectively, which provided us additional cash flow to support our near-term
+Added: While such capital raises may enable us to sustain current operations and meet existing obligations, we continue to generate
+Added: recurring net operating losses and have not yet established sustained positive cash flows to support our strategic growth initiatives.
+Added: Such initiatives include the commercialization of Proclarix and our development and commercialization of future product candidates.
+Added: factors raise substantial doubt on our ability to continue as a going concern for one year from the date of issuance of our consolidated
+Added: financial statements for the financial year ended December 31, 2025.
Until we generate revenue sufficient to support
11 unchanged sentences
Additionally, even if we are able to generate revenue from Proclarix, we may not become profitable.
−Removed: to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at
−Removed: planned levels and may be forced to reduce our operations.
−Removed: On April 30, 2025, Proteomedix, in accordance
−Removed: with Swiss law, provided notice to three employees that their respective employment relationships will end on July 31, 2025.
−Removed: is not expected to significantly impact operations.
−Removed: Potential Ocuvex Transaction
−Removed: On April 1, 2025, the
−Removed: Company and Ocuvex Therapeutics, Inc.
−Removed: (“Ocuvex”) signed a Non-Binding Letter of Intent (the “Ocuvex LOI”) contemplating
−Removed: a potential business combination transaction with Ocuvex, pursuant to which the Company will acquire all the issued and outstanding equity
−Removed: interests of Ocuvex in exchange for newly issued shares of common stock of the Company.
−Removed: Immediately following the closing of the proposed
−Removed: transaction, the pre-closing Ocuvex equity holders will own approximately 90% of the equity interests in the combined company.
−Removed: The Ocuvex LOI only represents
−Removed: a mutual indication of interest regarding the proposed transaction, and the terms of such transaction are subject to a number of contingencies,
−Removed: including the completion of customary due diligence and the negotiation and execution of definitive agreements.
−Removed: Upon execution of the
−Removed: definitive agreement, the completion of the transaction will be subject to, among other matters, satisfaction of the conditions negotiated
−Removed: therein, the buyer having secured adequate financing, and receipt of all third party (including governmental) approvals, licenses, consents,
−Removed: and clearances, as and when applicable.
+Added: fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations
+Added: at planned levels and may be forced to reduce our operations.
+Added: Realbotix Corp.
+Added: Share Exchange Agreement
+Added: On February 11, 2026,
+Added: we entered into a Share Exchange Agreement (the “Share Exchange Agreement”), by and among (i) Onconetix, (ii) Realbotix Corp.,
+Added: a company existing under the laws of the Province of Ontario (“Parent”), (iii) Simulacra Corporation, a Delaware corporation
+Added: and a wholly-owned subsidiary of Parent (the “Seller”) and (iv) Realbotix, LLC, a Delaware limited liability company and wholly
+Added: owned subsidiary of the Seller (the “Realbotix”).
+Added: Pursuant to the Share
+Added: Exchange Agreement, subject to the terms and conditions set forth therein, the Seller agreed to contribute and transfer to us, and we
+Added: agreed to acquire and accept, all of the issued and outstanding equity interests of Realbotix (the “Realbotix Interests”)
+Added: in exchange for newly issued shares of Common Stock.
+Added: (the “Share Exchange” and the other transactions contemplated by the
+Added: Share Exchange Agreement, the “Realbotix Transactions”).
+Added: Unless otherwise defined
+Added: herein, the capitalized terms used below are defined in the Share Exchange Agreement.
+Added: Consideration
+Added: In full consideration for the contribution of the Realbotix Interests,
+Added: we will issue shares of Common Stock to the Seller (the “Exchange Shares”), such that, immediately following the Closing and
+Added: after giving effect to such issuance, the Seller will own a percentage of our fully diluted shares (the “Fully Diluted Shares”)
+Added: that will be adjusted based on Net Cash (as defined below) as follows:
+Added: (i) if Net Cash is greater than or equal to $12.5 million, but
+Added: less than $15.0 million, Seller will own 90% of the Fully Diluted Shares, (ii) if Net Cash is greater than or equal to $15.0 million,
+Added: but less than $18.0 million, Seller will own 85% of the Fully Diluted Shares, (iii) if Net Cash is greater than or equal to $18.0 million,
+Added: but less than $20.0 million, Seller will own 80% of the Fully Diluted Shares and (iv) if Net Cash is greater than or equal to $20.0 million,
+Added: Seller will own 75% of the Fully Diluted Shares.
+Added: “Net Cash” means the amount of cash and cash equivalents held by us upon
+Added: the Closing, whether received by Realbotix or us in connection with the Realbotix Transactions, net of D&O tail insurance costs;
+Added: change-of-control
+Added: or other payments owed to our officers and director of as a result of the Realbotix Transactions;
+Added: all our indebtedness;
+Added: certain of our
+Added: liabilities and our transaction expenses.
+Added: Conversion of Company
+Added: Convertible Securities
+Added: Prior to the consummation of the Share Exchange, the holders of Realbotix
+Added: Convertible Securities will exercise their rights to receive Realbotix Interests pursuant to the terms of such Realbotix Convertible Securities
+Added: (as defined below) at the applicable conversion ratio as set forth in the Realbotix Convertible Securities (the “Realbotix Convertible
+Added: Securities Conversion”).
+Added: Upon completion of the Realbotix Convertible Securities Conversion and prior to Closing, all Realbotix
+Added: Convertible Securities will be canceled or terminated, as applicable, will no longer be outstanding and will cease to exist and no payment
+Added: or distribution will be made with respect thereto.
+Added: Each holder of Realbotix Convertible Securities thereafter will cease to have any rights
+Added: with respect to such securities.
+Added: Closing Conditions
+Added: The consummation of the Share Exchange is subject to customary closing
+Added: conditions, including (i) the accuracy of the representations and warranties of the parties (subject to customary materiality qualifiers);
+Added: (ii) compliance in all material respects by the parties with their respective covenants and agreements under the Share Exchange Agreement;
+Added: (iii) delivery of customary closing certificates and good standing certificates;
+Added: (iv) receipt by Board of a fairness opinion;
+Added: absence of any law, order or injunction prohibiting the consummation of the Realbotix Transactions and (vi) receipt of any required third-party
+Added: and regulatory approvals and consents.
+Added: The obligation of the
+Added: Realbotix, Parent and Seller to complete the Closing is subject to the condition that, at Closing, we shall have an aggregate of at least
+Added: $12.5 million in Net Cash (the “Net Cash Condition”).
+Added: Additionally, the obligation of Realbotix, Parent and us to complete
+Added: the Closing are subject to the conditions that (i) we have entered into an agreement with an investor, reasonably acceptable to us and
+Added: Realbotix, providing for an equity line of credit pursuant to which such investor would commit to purchase up to an aggregate of $125.0
+Added: million of Common Stock and (ii) the conversion of our Preferred Stock into Common Stock and the termination of or certain amendments
+Added: to of all Onconetix Options and Onconetix Warrants (the “Convertible Securities Condition”).
+Added: In addition to termination
+Added: by mutual written agreement, for the other party’s uncured breach or if a governmental order permanently prohibits the Closing,
+Added: the Share Exchange Agreement provides for termination:
+Added: either party if the Closing has not been consummated on or before November 30, 2026, provided
+Added: the terminating party is not in breach in a manner that caused the failure to close by such
+Added: The date is automatically extended to December 20, 2026 if all conditions to Closing
+Added: other than the Net Cash Condition have been satisfied.
+Added: By either party if our stockholder approval is not obtained at the
+Added: stockholder meeting (including any adjournment or postponement thereof).
+Added: By Realbotix if a Buyer Adverse Recommendation Change (as defined in the Share Exchange Agreement) occurs prior to receipt of Buyer stockholder approval.
+Added: By us in connection with entering into a definitive agreement for a Buyer Superior Proposal (as define in the Share Exchange Agreement).
+Added: By us if the audited Realbotix financial statements have not been delivered by April 30, 2026.
+Added: Each party will bear its own fees and expenses incurred in connection
+Added: with the negotiation, execution and performance of the Share Exchange Agreement and the Realbotix Transactions.
+Added: However, the Share Exchange
+Added: Agreement provides for the payment of termination fees and reimbursement of transaction expenses in the following termination scenarios:
+Added: the event of a termination of the Share Exchange Agreement as a result of a material breach
+Added: by either party, the breaching party will be required to pay a termination fee to the non-breaching
+Added: party of $500,000 plus transaction expenses, with such transaction expenses not to exceed
+Added: the event of a termination of the Share Exchange Agreement (i) by the Company as the result
+Added: of a Buyer Adverse Recommendation Change or (ii) by Buyer upon entering into an agreement
+Added: in respect of a Buyer Superior Proposal as a result of a Buyer Adverse Recommendation Change,
+Added: Buyer must pay a termination fee of (A) $500,000 plus all Seller transaction expenses plus
+Added: (B) if the transaction in respect of a Buyer Superior Proposal closes, an additional $1,500,000
+Added: upon closing of such transaction.
+Added: If the transaction contemplated by the Buyer Superior Proposal
+Added: doesn’t close, Buyer is only obligated to pay $500,000 plus all Seller transaction
+Added: In the event of a termination of the Share Exchange Agreement by Realbotix for failure to satisfy the Net Cash Condition, if Net Cash at the time of termination would be greater than $5.0 million (assuming the consummation of any Transaction Financing pursuant to Financing Agreements), we are obligated to pay Realbotix’s transaction expenses, with such transaction expenses not to exceed $500,000.
+Added: Representations and
+Added: We, Realbotix, and the
+Added: Seller have made customary representations and warranties in the Share Exchange Agreement.
+Added: The representations and warranties of us, Realbotix,
+Added: and the Seller will not survive the Closing.
+Added: Covenants of the
+Added: Each party to the Share
+Added: Exchange Agreement agreed to use its commercially reasonable efforts to consummate the Realbotix Transaction.
+Added: The Share Exchange Agreement
+Added: contains certain covenants by each of the parties, to be observed during the period between the execution of the Share Exchange Agreement
+Added: and Closing, including covenants regarding:
+Added: (1) the provision of access to information, properties, books, records and personnel;
+Added: delivery of audited financial statements of the Company;
+Added: (3) litigation support;
+Added: (4) the preparation and filing of a registration statement,
+Added: SEC reports and related disclosure documents and compliance with Nasdaq listing and reporting requirements;
+Added: (5) no insider trading;
+Added: further assurances;
+Added: (7) public announcements;
+Added: (8) confidentiality;
+Added: (9) indemnification of directors and officers and tail insurance;
+Added: (10) transfer taxes.
+Added: The parties have agreed
+Added: to take all necessary actions to cause our Board, immediately after closing, to consist of five directors, including:
+Added: (i) one person who
+Added: is designated by us and reasonably acceptable to Realbotix and (ii) four persons who are designated by Realbotix and reasonably acceptable
+Added: We have also agreed to
+Added: prepare and file with the Securities and Exchange Commission (“SEC”) a registration statement on Form S-4 in connection with
+Added: the registration under the Securities Act of 1933, as amended (the “Securities Act”), of the issuance of the Exchange Shares
+Added: to be issued under the Share Exchange Agreement and containing a proxy statement (a “Proxy Statement”) for the purpose of
+Added: soliciting proxies from our stockholders for the matters to be acted on at the special meeting of our stockholders.
+Added: We have also agreed
+Added: to use reasonable best efforts to maintain its listing on the Nasdaq and to enable the listing on Nasdaq of the Exchange Shares.
+Added: During the time between
+Added: the execution of the Share Exchange Agreement and the Closing, Realbotix agreed to conduct its business in the ordinary course of business
+Added: in all material respects and to comply with certain covenants regarding the operation of its business, including covenants related to
+Added: (i) amendments to the Realbotix’s organizational documents;
+Added: (ii) recapitalization of the Realbotix’s equity interests;
+Added: issuance of additional securities;
+Added: (iv) incurrence of additional indebtedness;
+Added: (v) material changes to tax elections;
+Added: (vi) amendments
+Added: to or termination of material contracts;
+Added: (vii) maintenance of books and records;
+Added: (viii) establishment of any subsidiary or entry into
+Added: a new line of business;
+Added: (ix) maintenance of insurance policies;
+Added: (x) revaluation of material assets or material changes in accounting methods,
+Added: principles or policies, except as required to comply with U.S.
+Added: (xi) waiver, settlement or compromise of material claims, actions
+Added: or proceedings, subject to specified thresholds;
+Added: (xii) acquisition of equity interests or assets, or any other form of business combination,
+Added: outside of the ordinary course of business;
+Added: (xiii) capital expenditures in excess of specified thresholds;
+Added: (xiv) adoption of a plan of
+Added: liquidation, dissolution, merger, consolidation, restructuring, recapitalization or other reorganization;
+Added: (xv) voluntary incurrence of
+Added: liabilities or obligations in excess of specified thresholds other than pursuant to contracts in existence as of the date of the Share
+Added: Exchange Agreement or entered into in the ordinary course of business;
+Added: (xvi) sale, lease, license or other disposition of any material
+Added: portion of the Realbotix’s assets, properties or rights;
+Added: (xvii) entry into any agreement, understanding or arrangement relating
+Added: to the voting of the Realbotix’s equity interests;
+Added: (xviii) taking any action that would reasonably be expected to materially delay
+Added: or impair the obtaining of any required governmental or regulatory consents in connection with the Share Exchange Agreement;
+Added: authorization or agreement to take any of the foregoing actions.
+Added: During the same period,
+Added: we also agreed to conduct its business in the ordinary course of business in all material respects and to comply with certain interim
+Added: operating covenants, including covenants restricting our ability, without Realbotix’s prior written consent (subject to specified
+Added: exceptions), to (i) amend its organizational documents;
+Added: (ii) effect mergers, consolidations, acquisitions, liquidations, restructurings
+Added: or other business combinations;
+Added: (iii) issue, repurchase, redeem or otherwise modify its equity securities or declare dividends or other
+Added: distributions;
+Added: (iv) incur additional indebtedness or guarantee obligations of third parties;
+Added: (v) dispose of material assets or subsidiaries;
+Added: (vi) make material loans, advances or capital contributions;
+Added: (vii) make material tax elections or changes in accounting methods, principles
+Added: or practices, except as required by applicable law, GAAP or Regulation S-K;
+Added: (viii) amend, terminate, waive or assign material contracts
+Added: other than in the ordinary course of business;
+Added: (ix) fail to maintain books, records or insurance coverage in the ordinary course of business;
+Added: (x) establish subsidiaries or enter into new lines of business;
+Added: (xi) settle material litigation or other proceedings other than within
+Added: specified thresholds;
+Added: (xii) make capital expenditures or incur liabilities in excess of specified thresholds;
+Added: (xiii) enter into arrangements
+Added: relating to the voting of Common Stock;
+Added: (xiv) take actions that would reasonably be expected to materially delay or impair the receipt
+Added: of required governmental or regulatory approvals;
+Added: or (xv) authorize, commit or publicly propose any of the foregoing actions.
+Added: Governing Law
+Added: The Share Exchange Agreement is governed by the laws of the State of
Management and History
6 unchanged sentences
shifted its focus toward building a foundation of therapeutic, diagnostic, and service products in the field of men’s health and
−Removed: Fedasz, our Interim Chief Financial
−Removed: Officer since June 2024, was appointed as Interim Chief Executive Officer on April 2, 2025.
+Added: Fedasz had been appointed as our Interim
+Added: Chief Executive Officer since April 2025 and Chief Financial Officer since June 2024, respectively.
For more than two decades, Ms.
−Removed: helped companies raise capital, model and forecast business, manage cash flow and conduct mergers and acquisitions.
+Added: has helped companies raise capital, model and forecast business, manage cash flow and conduct mergers and acquisitions.
She is a dynamic,
11 unchanged sentences
Fedasz served as Chief Financial Officer of MOCEAN, an integrated agency for entertainment, gaming, and
−Removed: Fedasz's breadth of experience has seen her lead teams in media, technology, services, manufacturing, and education, and she
−Removed: has worked with companies whose clients and customers include Fortune 500 companies such as Netflix, Disney, Amazon, Apple, Activision,
+Added: Fedasz's breadth of experience has seen her lead teams in media, technology, services, manufacturing, and education, and
+Added: she has worked with companies whose clients and customers include Fortune 500 companies such as Netflix, Disney, Amazon, Apple, Activision,
Fedasz received an MBA with an emphasis in finance from Columbia Business School and a BA from University California at Los
4 unchanged sentences
Our directors include Andrew Oakley,
−Removed: who had held several CFO positions at publicly-traded pharmaceutical companies, Simon Tarsh, a retired Deloitte Consulting managing director
−Removed: with experience in life sciences, Ajit Singh, a partner at a Silicon Valley-based fund, and Timothy Ramdeen, who has nearly a decade of
−Removed: experience in private equity and hedge fund investing, capital markets, and company formation.
+Added: who had held several CFO positions at publicly-traded pharmaceutical companies, Sarah Romano, who has over a decade of experience leading
+Added: the finance function of multiple publicly-traded companies, Dr.
+Added: Thomas Meier, who has over two decades of experience as life-science
+Added: and biotech entrepreneur, executive manager, and board member on life-science and biotech companies, and Timothy Ramdeen, who has nearly
+Added: a decade of experience in private equity and hedge fund investing, capital markets, and company formation.
Nasdaq Compliance
1 unchanged sentence
from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of the Company’s Common Stock
−Removed: from November 25, 2024 to January 10, 2025, the Company is no longer in compliance with the requirement for continued listing on The Nasdaq
−Removed: Capital Market to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum
+Added: from November 25, 2024 to January 10, 2025, the Company is no longer in compliance with the requirement for continued listing on The
+Added: Nasdaq Capital Market to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum
Bid Price Rule”).
2 unchanged sentences
On April 14, 2025, Nasdaq issued a further notice
−Removed: (the “Notice”) to the Company that it determined that the Company’s securities had a closing bid price of $0.10 or less
−Removed: for ten consecutive trading days.
+Added: (the “Notice”) to the Company that it determined that the Company’s securities had a closing bid price of $0.10 or
+Added: less for ten consecutive trading days.
Accordingly, the Company is subject to the provisions under Nasdaq Listing Rule 5810(c)(3)(A)(iii).
4 unchanged sentences
Hearings Panel and requested a stay of suspension.
−Removed: The Panel’s decision about the stay request is still pending as of the date these
−Removed: financials were filed.
+Added: The Panel’s decision about the stay request is still pending as of the date
+Added: these financials were filed.
On April 24, 2025, the Company received an additional
−Removed: deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in Listing
−Removed: Rule 5250(c)(1) given the Company’s failure to timely file its Annual Report on Form 10-K for the fiscal year ended December 31,
−Removed: 2024, and that this matter serves as an additional basis for delisting the Company’s securities from Nasdaq.
−Removed: As the Company was
−Removed: already before a Panel for its failure to comply with Minimum Bid Price Rule, the Company had seven calendar days from the date of the
−Removed: Notice, or until May 1, 2025, to request a stay of the suspension, which request would stay the suspension of the Company’s securities
−Removed: pending the Panel’s decision.
+Added: deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in
+Added: Listing Rule 5250(c)(1) (the “Filing Rule”) given the Company’s failure to timely file its Annual Report on Form 10-K
+Added: for the fiscal year ended December 31, 2024, and that this matter serves as an additional basis for delisting the Company’s securities
+Added: As the Company was already before a Panel for its failure to comply with Minimum Bid Price Rule, the Company had seven calendar
+Added: days from the date of the Notice, or until May 1, 2025, to request a stay of the suspension, which request would stay the suspension
+Added: of the Company’s securities pending the Panel’s decision.
The Company submitted a stay request on or before May 1, 2025.
On May 20, 2025, the Company received an additional
−Removed: deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in Listing
−Removed: Rule 5250(c)(1) given the Company’s failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025,
+Added: deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in
+Added: Listing Rule 5250(c)(1) given the Company’s failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March
31, 2025, and that this matter serves as an additional basis for delisting the Company’s securities from Nasdaq.
−Removed: The Company had seven calendar
−Removed: days from the date of the Notice, or until May 27, 2025, to request a stay of the suspension, which would stay the suspension of the Company’s
−Removed: securities pending the Panel’s decision.
−Removed: On May 27, 2025, the Company appeared before the Nasdaq Hearings Panel and requested a
−Removed: stay of suspension.
−Removed: The Panel’s decision about the stay request is still pending as of the date these financials were filed.
−Removed: However, there are no assurances that the Panel will grant the Company’s
−Removed: request for continued listing or an extension to demonstrate compliance.
−Removed: If the Company does not obtain a favorable decision from the
−Removed: Panel, its Common Stock will become subject to delisting.
+Added: The Company had
+Added: seven calendar days from the date of the Notice, or until May 27, 2025, to request a stay of the suspension, which would stay the suspension
+Added: of the Company’s securities pending the Panel’s decision.
+Added: On May 27, 2025, the Company appeared before the Panel and requested
+Added: a stay of suspension.
+Added: Following the hearing before the Panel, on June
+Added: 11, 2025, the Panel issued its decision, whereby it granted the Company’s request for continued listing, ultimately subject to
+Added: the Company’s compliance with all applicable continued listing criteria by June 30, 2025.
+Added: On June 2, 2025, the Company filed its Annual
+Added: Report on Form 10-K for the fiscal year ended December 31, 2024 with the SEC, and on June 12, 2025, its Quarterly Report for the period
+Added: ended March 31, 2025.
+Added: Effective with the open of the market on June 13, 2025, the Company implemented a reverse stock split of its outstanding
+Added: shares of Common Stock at a ratio of 1-for-85 shares.
+Added: On July 7, 2025, Nasdaq formally notified the
+Added: Company that it had regained compliance with both the Filing Rule and the Bid Price Rule and otherwise satisfied all other applicable
+Added: criteria for continued listing on The Nasdaq Capital Market.
+Added: Nasdaq further noted, however, that Onconetix is subject to a Mandatory
+Added: Panel Monitor, as defined in Nasdaq Listing Rule 5815(d)(4)(B), through July 7, 2026 (the “Panel Monitor”).
+Added: If, within the
+Added: one-year period, Nasdaq determines that the Company fails to satisfy the Filing Rule or the Bid Price Rule, Nasdaq will issue a delisting
+Added: determination, which determination would be stayed upon the Company’s subsequent timely request for a new hearing before the Panel,
+Added: rather than providing the Company with the opportunity to present a plan to regain compliance with the Filing Rule for consideration
+Added: by Nasdaq Listing Qualifications Staff or a 180-day grace period to regain compliance with the Bid Price Rule as otherwise provided in
+Added: the Nasdaq Listing Rules.
On December 15,
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(ii) Proteomedix, (iii) each of the holders of outstanding capital stock, convertible securities, or stock options of Proteomedix
−Removed: named therein (collectively, the “Sellers”) and (iv) Thomas Meier, in the capacity as the representative of Sellers in
−Removed: accordance with the terms and conditions of the Share Exchange Agreement.
+Added: named therein (collectively, the “Sellers”) and (iv) Thomas Meier, in the capacity as the representative of Sellers
+Added: in accordance with the terms and conditions of the Share Exchange Agreement.
Pursuant to the Share
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Stock and newly issued shares of Series B Preferred Stock (the “Share Exchange”).
−Removed: The consummation of the
−Removed: Share Exchange (the “Share Exchange Closing”) was subject to customary closing conditions and the execution of the Subscription
+Added: The consummation of
+Added: the Share Exchange (the “Share Exchange Closing”) was subject to customary closing conditions and the execution of the Subscription
Agreement entered into with Altos Ventures, a shareholder of Proteomedix prior to the closing of the Share Exchange (the “PMX Investor”).
7 unchanged sentences
into an aggregate of 79,315 shares of Onconetix Common Stock.
−Removed: Founded in 2010, Proteomedix
−Removed: develops, markets and sells non-invasive diagnostic tests accompanied by decision support systems to detect and assess the prognosis
−Removed: Proteomedix’s lead product, Proclarix ® , is an in vitro diagnostic test for prostate cancer.
−Removed: is working to address all stages in cancer management by developing tools for both more accurate detection and more efficient treatment
−Removed: of cancer including (i) diagnostic tests to early detect and define the stage of cancer;
−Removed: (ii) prognostic tools for the identification
−Removed: of patients with aggressive disease;
−Removed: and (iii) stratification biomarkers to match patients with therapies that are more likely to be safe
−Removed: and effective.
−Removed: Currently, prostate cancer
−Removed: stands as the most prevalent and second most fatal cancer type affecting men.
−Removed: The widespread utilization of PSA screening since it became
−Removed: broadly available in the 1980s helped reduce the occurrence of metastatic prostate cancers by over half, but also led to a notable increase
−Removed: in overdiagnosis, sometimes resulting in excessive treatment, severe complications, and potential psychological distress.
−Removed: a considerable population of men each year who are notified of their heightened risk for prostate cancer based on elevated PSA levels,
−Removed: with limited options beyond invasive needle biopsies for managing their cancer risk.
−Removed: Proclarix addresses the
−Removed: unsolved problem of prostate cancer overdiagnosis, which can lead to negative prostate biopsies that increase costs for the healthcare
−Removed: system and uncertainty for patients.
−Removed: Proclarix is approved for sale in the European Union under the IVDR.
−Removed: Proclarix was first CE marked
−Removed: under the IVD Directive in Europe on January 31, 2019.
−Removed: On October 7, 2022, Proclarix gained CE marking under the IVD Regulation (IVDR)
−Removed: and was registered in the United Kingdom and Switzerland under applicable regulations.
−Removed: Clinical studies have confirmed that Proclarix
−Removed: accurately identifies clinically significant prostate cancer through a risk score derived from a clinical decision support system and
−Removed: could help avoid many unneeded biopsies.
−Removed: Proclarix as a clinical support system is designed to aggregate multimodal information in an
−Removed: effort to develop a patient-centric diagnostic approach.
−Removed: We intend to add more information to the risk score in the future, such as other
−Removed: biomarkers or magnetic resonance imaging data, to provide an even more powerful tool to guide the patient’s diagnostic journey.
−Removed: The markers and the bioinformatics algorithm used are patent-protected.
−Removed: guidelines of the European Association of Urology (“EAU”) and of the American Urological Association/Society of Urologic Oncology
−Removed: (“AUA/SUO”) both recommend the use of blood-based biomarker tests, such as Proclarix, to aid in the early detection and evaluation
−Removed: of prostate cancer.
−Removed: Proclarix can be performed in any laboratory using standard equipment.
−Removed: Proteomedix announced commercial availability
−Removed: of Proclarix in Europe on February 26, 2020 and began marketing Proclarix to selected pilot laboratories offering Proclarix in Switzerland,
−Removed: Germany, Italy and the United Kingdom.
−Removed: Proclarix is currently not reimbursed in Europe, and therefore patients pay for Proclarix out of
−Removed: The number of sold Proclarix tests current corresponds to the early market development stage and selected few laboratories offering
−Removed: In 2024, we had revenues of $86,957 from sales of Proclarix.
−Removed: Prior to being acquired by Onconetix in 2023, Proteomedix had
−Removed: $67,380 from sales of Proclarix.
−Removed: In the United States, the development and commercialization of Proclarix is being pursued by Laboratory
−Removed: Corporation of America Holdings, more commonly called LabCorp, pursuant to an exclusive license agreement entered into between Proteomedix
−Removed: and LabCorp in 2023.
−Removed: Proteomedix was founded
−Removed: by a multi-disciplinary group of scientists and clinicians that include Prof.
−Removed: Thomas Cerny, president of the Swiss Cancer
−Removed: Research Foundation, Prof.
−Removed: Ruedi Aebersold, a pioneer in proteomics technology development, and the late Prof.
−Removed: Wilhelm Krek, a leader
−Removed: in cancer research.
−Removed: Proteomedix’s management consists of Dr.
−Removed: Ralph Schiess (Chief Executive Officer), who developed the biomarker
−Removed: technology, and Christian Brühlmann (Chief Business Officer), with seasoned experience in finance, business development and product
−Removed: On February 18, 2025, Christian Brühlmann resigned from his position as Chief Strategy Officer of the Company.
−Removed: will remain in his position as Chief Business Officer of Proteomedix.
−Removed: On February 24, 2025, Dr.
−Removed: Schiess resigned from his positions as
−Removed: the Interim Chief Executive Officer of the Company and Chief Science Officer of Proteomedix, effective immediately, and from his position
−Removed: as Chief Executive Officer of Proteomedix, effective May 31, 2025.
−Removed: Terms of the PMX Transaction
+Added: Terms of the PMX
Consideration
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The parties agreed that the aggregate value of the Exchange Shares at the Share Exchange Closing was equal to approximately Seventy-Five
−Removed: Dollars ($75,000,000) (the “Exchange Consideration”) less the value of the Proteomedix Shares for which the Proteomedix
−Removed: Stock Options (as defined below) are exercisable immediately prior to the Share Exchange Closing, subject to adjustment for indemnification
−Removed: as described below.
−Removed: Following the Share Exchange Closing, 571,049 and 558,114 shares of Common Stock were issued and outstanding, respectively.
+Added: Dollars ($75,000,000) (the “Exchange Consideration”) less the value of the Proteomedix Shares for which the
+Added: Proteomedix Stock Options (as defined below) are exercisable immediately prior to the Share Exchange Closing, subject to adjustment for
+Added: indemnification as described below.
+Added: Following the Share Exchange Closing, 6,718 and 6,566 shares of Common Stock were issued and outstanding,
+Added: respectively.
The fair value of the
1 unchanged sentence
which was $809.88.
−Removed: The fair value of the 2,696,729 shares of Series B Preferred Stock was based on the underlying fair value of the
−Removed: common shares issuable upon conversion, also based on the closing price of the Common Stock as of the Share Exchange Closing Date.
−Removed: aggregate fair value of the common and preferred shares issued as consideration was equal to approximately $65.1 million.
+Added: The fair value of the 2,696,729 shares of Series B Preferred Stock was based on the underlying fair value of
+Added: the common shares issuable upon conversion, also based on the closing price of the Common Stock as of the Share Exchange Closing Date.
+Added: The aggregate fair value of the common and preferred shares issued as consideration was equal to approximately $65.1 million.
Tungsten Advisors acted
15 unchanged sentences
(a) an option to acquire shares of Common Stock (each, an “Assumed Option”) or (b) such other derivative security as Onconetix
−Removed: and Proteomedix agreed, subject in either case to substantially the same terms and conditions as were applicable to such Proteomedix Stock
−Removed: Option immediately before the Share Exchange Closing.
+Added: and Proteomedix agreed, subject in either case to substantially the same terms and conditions as were applicable to such Proteomedix
+Added: Stock Option immediately before the Share Exchange Closing.
Each Assumed Option:
−Removed: (i) represented the right to acquire a number of shares of
−Removed: Common Stock equal to the product of (A) the number of Proteomedix Common Shares that were subject to the corresponding Proteomedix Option
−Removed: immediately prior to the Share Exchange Closing, multiplied by (B) the Exchange Ratio (as defined in the Share Exchange Agreement);
−Removed: (ii) had an exercise price (as rounded down to the nearest whole cent) equal to the quotient of (A) the exercise price of the corresponding
+Added: (i) represented the right to acquire a number of shares
+Added: of Common Stock equal to the product of (A) the number of Proteomedix Common Shares that were subject to the corresponding Proteomedix
+Added: Option immediately prior to the Share Exchange Closing, multiplied by (B) the Exchange Ratio (as defined in the Share Exchange Agreement);
+Added: and (ii) had an exercise price (as rounded down to the nearest whole cent) equal to the quotient of (A) the exercise price of the corresponding
Proteomedix Option, divided by (B) the Exchange Ratio.
−Removed: after the Share Exchange Closing and until the first anniversary of the Share Exchange Closing, Sellers, severally and not jointly, are
−Removed: required to indemnify Onconetix and its affiliates and their respective representatives (collectively, the “Onconetix Indemnitees”)
−Removed: against (i) any inaccuracy in or breach of any of the representations or warranties of such Seller contained in the Share Exchange
−Removed: Agreement and (ii) breach or non-fulfillment of any covenant, agreement or obligation to be performed by such Seller pursuant
−Removed: to the Share Exchange Agreement.
−Removed: Any payment due from any Seller in respect of an indemnification claim by any Onconetix Indemnitee shall
−Removed: solely be satisfied by recourse to the Exchange Shares and the shares of Common Stock issuable upon the Conversion, with each share of
−Removed: Common Stock valued at the same price per share of Common Stock used to determine the Exchange Ratio.
+Added: From and after the Share
+Added: Exchange Closing and until the first anniversary of the Share Exchange Closing, Sellers, severally and not jointly, are required to indemnify
+Added: Onconetix and its affiliates and their respective representatives (collectively, the “Onconetix Indemnitees”) against (i) any
+Added: inaccuracy in or breach of any of the representations or warranties of such Seller contained in the Share Exchange Agreement and (ii) breach
+Added: or non-fulfillment of any covenant, agreement or obligation to be performed by such Seller pursuant to the Share Exchange Agreement.
+Added: Any payment due from any Seller in respect of an indemnification claim by any Onconetix Indemnitee shall solely be satisfied by recourse
+Added: to the Exchange Shares and the shares of Common Stock issuable upon the Conversion, with each share of Common Stock valued at the same
+Added: price per share of Common Stock used to determine the Exchange Ratio.
Lock-Up Agreement
−Removed: Simultaneously with the
−Removed: execution of the Share Exchange Agreement, the Sellers and the Advisor Parties, as shareholders of Proteomedix, entered into Lock-Up Agreements
−Removed: (each, a “Lock-Up Agreement”).
−Removed: Pursuant to each Lock-Up Agreement, each signatory thereto will agree not to, during the period
−Removed: commencing from the Share Exchange Closing Date and ending on the 6-month anniversary of the date of Stockholder Approval:
−Removed: offer, pledge, hypothecate, encumber, donate, assign, sell, contract to sell, sell any option or contract to purchase, purchase any option
−Removed: or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, the
−Removed: Exchange Shares or the Conversion Shares, (ii) enter into any swap or other arrangement that transfers to another, in whole or in
−Removed: part, any of the economic consequences of ownership of the Exchange Shares or the Conversion Shares, or (iii) publicly disclose the
−Removed: intention to do any of the foregoing, whether any such transaction described in clauses (i), (ii) or (iii) above is to be settled by delivery
−Removed: of the Exchange Shares or the Conversion Shares or other securities, in cash or otherwise (subject to certain exceptions).
−Removed: Non-Competition and Non-Solicitation Agreement
−Removed: Simultaneously with the
−Removed: execution of the Share Exchange Agreement, certain executive officers (each, a “Management Shareholder”) of Proteomedix each
−Removed: entered into a non-competition and non-solicitation agreement (collectively, the “Non-Competition and Non-Solicitation Agreements”)
+Added: Simultaneously with
+Added: the execution of the Share Exchange Agreement, the Sellers and the Advisor Parties, as shareholders of Proteomedix, entered into Lock-Up
+Added: Agreements (each, a “Lock-Up Agreement”).
+Added: Pursuant to each Lock-Up Agreement, each signatory thereto will agree not to, during
+Added: the period commencing from the Share Exchange Closing Date and ending on the 6-month anniversary of the date of Stockholder Approval:
+Added: lend, offer, pledge, hypothecate, encumber, donate, assign, sell, contract to sell, sell any option or contract to purchase, purchase
+Added: any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly,
+Added: the Exchange Shares or the Conversion Shares, (ii) enter into any swap or other arrangement that transfers to another, in whole
+Added: or in part, any of the economic consequences of ownership of the Exchange Shares or the Conversion Shares, or (iii) publicly disclose
+Added: the intention to do any of the foregoing, whether any such transaction described in clauses (i), (ii) or (iii) above is to be settled
+Added: by delivery of the Exchange Shares or the Conversion Shares or other securities, in cash or otherwise (subject to certain exceptions).
+Added: Non-Competition and
+Added: Non-Solicitation Agreement
+Added: Simultaneously with
+Added: the execution of the Share Exchange Agreement, certain executive officers (each, a “Management Shareholder”) of Proteomedix
+Added: each entered into a non-competition and non-solicitation agreement (collectively, the “Non-Competition and Non-Solicitation Agreements”)
with Onconetix.
4 unchanged sentences
Non-Solicitation Agreement also contains customary confidentiality and non-disparagement provisions.
−Removed: Stockholder Support Agreement
−Removed: Simultaneously with the
−Removed: execution of the Share Exchange Agreement, Onconetix, Proteomedix and certain directors of Onconetix who are stockholders of Onconetix,
+Added: Stockholder Support
+Added: Simultaneously with
+Added: the execution of the Share Exchange Agreement, Onconetix, Proteomedix and certain directors of Onconetix who are stockholders of Onconetix,
entered into a Stockholder Support Agreement (the “Stockholder Support Agreement”), pursuant to which, among other things,
2 unchanged sentences
with respect thereto), subject to certain customary conditions.
−Removed: Stockholder Subscription Agreement and Debenture
+Added: Stockholder Subscription
+Added: Agreement and Debenture
In connection with the PMX Transaction, on December
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an aggregate purchase price per Unit of $850 (the “Purchase Price”).
−Removed: Additional shares are issuable to the PMX Investor
−Removed: to the extent the PMX Investor continues to hold Common Stock included in the Units and if the VWAP during the 270 days following the
−Removed: Share Exchange Closing is less than the Purchase Price, as set forth in the Subscription Agreement.
+Added: Additional shares are issuable to the PMX Investor to
+Added: the extent the PMX Investor continues to hold Common Stock included in the Units and if the VWAP during the 270 days following the Share
+Added: Exchange Closing is less than the Purchase Price, as set forth in the Subscription Agreement.
On January 23, 2024, the Company issued a non-convertible
1 unchanged sentence
the $5.0 million subscription amount for the Units pursuant to the Subscription Agreement.
−Removed: The Altos Debenture had
−Removed: an interest rate of 4.0% per annum, and the principal and accrued interest was originally repayable in full upon the earlier of (i) the
−Removed: closing under the Subscription Agreement and (ii) June 30, 2024.
−Removed: Additionally, the $5.0 million subscription amount under the Subscription
−Removed: Agreement shall be increased by the amount of interest payable under the Altos Debenture.
+Added: The Altos Debenture had an interest rate of 4.0%
+Added: per annum, and the principal and accrued interest was originally repayable in full upon the earlier of (i) the closing under the Subscription
+Added: Agreement and (ii) June 30, 2024.
+Added: Additionally, the $5.0 million subscription amount under the Subscription Agreement shall be increased
+Added: by the amount of interest payable under the Altos Debenture.
On April 24, 2024, the Altos Debenture was amended
14 unchanged sentences
Altos Warrants, and the Company issued to Altos an additional 1,812 shares of Common Stock upon such exercise.
+Added: On June 24, 2025, the 270-day volume weighted
+Added: average price after the closing of the Subscription Agreement was below $850.
+Added: In accordance with the Make-Whole Provision under the Subscription
+Added: Agreement, the Company issued 241,514 shares of common stock (the “Make-Whole Shares”) to Altos Venture AG, following the
+Added: determination that the 270-day volume weighted average price (“Issuer VWAP”) was below the $850 threshold.
+Added: The Company recorded
+Added: common stock of $2 and additional paid in capital of $995,036 related to the issuance of the 241,514 shares in the accompanying consolidated
+Added: balance sheet as of December 31, 2025.
On April 19, 2023, the Company entered into
−Removed: an asset purchase agreement with Veru Inc., a Wisconsin corporation (“Veru”) (the “Veru APA”).
−Removed: Pursuant to, and
−Removed: subject to the terms and conditions of, the Veru APA, the Company purchased substantially all of the assets related to Veru’s ENTADFI business.
+Added: an asset purchase agreement with Veru Inc., a Wisconsin corporation (“Veru”, and the asset purchase agreement, the “Veru
+Added: Pursuant to, and subject to the terms and conditions of, the Veru APA, the Company purchased substantially all of the assets
+Added: related to Veru’s ENTADFI business.
The transaction closed on April 19, 2023.
6 unchanged sentences
agreed to provide Veru with initial consideration totaling $20.0 million, consisting of (i) $6.0 million paid upon the closing of the
−Removed: transaction, (ii) an additional $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii) an
−Removed: additional $10.0 million in the form of two equal (i.e.
+Added: transaction, (ii) an additional $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii)
+Added: an additional $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
−Removed: 2024 and September 30, 2024.
−Removed: On April 24, 2024, Veru agreed to forbear its rights and remedies until March 31, 2025, which forbearance
−Removed: 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,
−Removed: 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
−Removed: 30, 2025 with respect to, among other things, our inability to pay amounts due on September 30, 2024.
−Removed: In addition, on November 26, 2024,
−Removed: the Company and Veru entered into a waiver and amendment to the forbearance agreement, pursuant to which Veru agreed to waive the due
−Removed: date for payment of applicable Company cash receipt payments generated in October 2024 in consideration for an increase in payments to
−Removed: be made to Veru out of future financing and strategic transactions through June 30, 2025.
−Removed: On September 29, 2023, the Company entered into
−Removed: an amendment (the “Veru Amendment”) of the Veru APA.
−Removed: Pursuant to the Veru Amendment, the $4.0 million note payable originally
−Removed: due on September 30, 2023 was deemed paid and fully satisfied upon (1) the payment to Veru of $1.0 million in immediately available funds
−Removed: on September 29, 2023, and (2) the issuance to Veru by October 3, 2023 of 3,000 shares of Series A Preferred Stock of the Company, which
−Removed: converted in to 142,749 shares of Common Stock on September 24, 2024.
−Removed: Additionally, the terms of the Veru APA require
+Added: 19, 2024 (the “April Veru Note”) and September 30, 2024 (the “September Veru Note,” together with the “April
+Added: Veru Note”, the “Veru Notes”).
+Added: Additionally, the terms of the Veru APA required
the Company to pay Veru up to an additional $80.0 million based on the Company’s net sales from the ENTADFI business after
−Removed: The Milestone Payments are payable as follows:
−Removed: (i) $10.0 million is payable if the Company’s annual net sales from
−Removed: the ENTADFI business equal or exceed $100.0 million, (ii) $20.0 million is payable if the Company’s annual net sales from
−Removed: the ENTADFI business equal or exceed $200.0 million, and (3) $50.0 million is payable if annual net sales from the ENTADFI business
+Added: The Milestone Payments were to be payable as follows:
+Added: (i) $10.0 million is payable if the Company’s annual net sales
+Added: from the ENTADFI business equal or exceed $100.0 million, (ii) $20.0 million is payable if the Company’s annual net sales
+Added: from the ENTADFI business equal or exceed $200.0 million, and (3) $50.0 million is payable if annual net sales from the ENTADFI business
equal or exceed $500.0 million.
6 unchanged sentences
6% royalty on all sales of tadalafil-finasteride and sales milestone payments of up to $22.5 million as follows:
−Removed: (i) $5.0 million is
−Removed: payable upon the first time the Company achieves net sales from ENTADFI of $100.0 million during a calendar year, (ii) $7.5 million
+Added: (i) $5.0 million
+Added: is payable upon the first time the Company achieves net sales from ENTADFI of $100.0 million during a calendar year, (ii) $7.5 million
is payable upon the first time the Company achieves net sales from ENTADFI of $200.0 million during a calendar year, and (3) $10.0 million
is payable upon the first time the Company achieves net sales from ENTADFI of $300.0 million during a calendar year.
+Added: On September 29, 2023, the Company entered into
+Added: an amendment (the “Veru Amendment”) of the Veru APA.
+Added: Pursuant to the Veru Amendment, the $4.0 million note payable originally
+Added: due on September 30, 2023 was deemed paid and fully satisfied upon (1) the payment to Veru of $1.0 million in immediately available funds
+Added: on September 29, 2023, and (2) the issuance to Veru by October 3, 2023 of 3,000 shares of Series A Preferred Stock of the Company, which
+Added: converted in to 1,679 shares of Common Stock on September 24, 2024.
+Added: In 2024 and 2025, the Company and Veru modified and extended the payment
+Added: terms under the Veru Notes on various occasions.
+Added: Subsequently, on August 28, 2025, Veru and the Company agreed to amend and restate
+Added: the September Veru Note (as amended and restated, the “Second A&R September Veru Note”).
+Added: Pursuant to the Second A&R
+Added: September Veru Note, the principal amount owed to Veru was increased by $100,000 to an aggregate principal amount of $5.2 million, and
+Added: the maturity date was amended to September 19, 2025.
+Added: All other terms of the September Veru Note remained the same.
+Added: On August 28, 2025,
+Added: Veru and the Company also entered into a waiver agreement (the “August 2025 Veru Waiver”) pursuant to which Veru agreed to
+Added: waive and extend the date for payment of the April Veru Note to September 19, 2025.
+Added: As of September 22, 2025, approximately $8.8
+Added: million was payable to Veru under the Veru Notes and related amendments.
+Added: On September 22, 2025, the Company and Veru entered into a Settlement
+Added: Agreement and Release (the “Veru Settlement Agreement”), pursuant to which Veru agreed to accept a cash payment of approximately
+Added: $6.3 million (including interest accrued through receipt of the Settlement Amounts (as defined herein), 3,125 shares of Series D Preferred
+Added: Stock (as defined below) and 846,975 Series D Warrants (as defined below and such cash payment, shares of Series D Preferred Stock and
+Added: Series D Warrants, collectively, the “Settlement Amounts”) in full satisfaction of all amounts due under the Veru Notes,
+Added: as amended by all preceding amendments, forbearance agreements, and waivers, and Veru agreed that such acceptance constituted complete
+Added: discharge of all obligations thereunder.
+Added: The Settlement Agreement contains customary release provisions that upon timely delivery of
+Added: the Settlement Amounts, Veru shall release all claims or actions against the Company.
+Added: As of September 24, 2025, Veru confirmed receipt
+Added: of all Settlement Amounts in satisfaction of all outstanding amounts, and all Veru Notes and related amendments were deemed cancelled
+Added: and terminated, respectively, and of no further force or effect.
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
−Removed: commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI
−Removed: There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other
−Removed: transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.
−Removed: In addition, as part of cost reduction
−Removed: efforts and in connection with our initial pause in commercializing ENTADFI, we terminated three employees involved with the ENTADFI program,
−Removed: effective April 30, 2024, with such individuals to continue assisting the Company on an as-needed, consulting basis.
−Removed: current circumstances surrounding ENTADFI, at June 30, 2024, the ENTADFI assets were fully impaired.
−Removed: On June 13, 2023 (the “Execution Date”),
−Removed: the Company entered into an asset purchase agreement with the WraSer Seller and Parent (the “WraSer APA”).
−Removed: Pursuant to, and
−Removed: subject to the terms and conditions of, the WraSer APA, on the WraSer Closing Date (as defined below) the Company will purchase six FDA-approved
−Removed: pharmaceutical assets across several indications, including cardiology, otic infections, and pain management (the “WraSer Assets”).
−Removed: Under the terms of the WraSer APA, the Company
−Removed: will purchase the WraSer Assets for (i) $3.5 million in cash at signing of the WraSer APA (the “Signing Cash”);
−Removed: million in cash on the later of (x) 90 days after the signing of the WraSer APA or (y) the date that all closing conditions under the
−Removed: WraSer APA are met or otherwise waived (the “WraSer Closing Date”);
−Removed: (iii) 1.0 million shares of the Company’s common
−Removed: stock (the “Closing Shares”) issuable on the WraSer Closing Date, and (iv) $500,000 in cash one year from the WraSer Closing
−Removed: The closing of the transaction is subject to certain customary closing conditions and the delivery to the Company of financial statements
−Removed: of WraSer Seller and Parent for the fiscal years ended December 31, 2022 and 2021 audited by a qualified auditor reasonably acceptable
−Removed: to the Company.
−Removed: Within 90 days of the WraSer Closing Date, the
−Removed: Company will use its best efforts to file with the SEC, (at its sole cost and expense,) a registration statement to register on Form S-3
−Removed: registering under the Securities Act, the resale of the Closing Shares and will use its best efforts to have the registration statement
−Removed: declared effective as soon as practicable after filing.
−Removed: In conjunction with the WraSer APA, the Company
−Removed: and the WraSer Seller entered into a Management Services Agreement (the “MSA”) on the Execution Date.
−Removed: Pursuant to the terms
−Removed: of the MSA, the Company was to act as the manager of the WraSer Seller’s business during the period between the Execution Date and
−Removed: WraSer Closing Date.
−Removed: During this period, the Company was to make advances to WraSer, if needed to sustain operations.
−Removed: The Company’s
−Removed: involvement as manager of the WraSer Seller’s business ended when WraSer filed for relief under chapter 11 of the U.S.
−Removed: Code in the Bankruptcy Court (see below).
−Removed: If, on the WraSer Closing Date, the WraSer Seller’s cash balance is in excess of the target
−Removed: amount specified in the MSA of $1.1 million (the “Cash Target”), the Company was to apply that excess to the $4.5 million
−Removed: cash payment due upon closing.
−Removed: Conversely, if there is a shortfall, the Company would have been required to remit the difference to the
−Removed: WraSer Seller over time.
−Removed: Specifically, as the Company would have collected accounts receivable generated after the WraSer Closing Date,
−Removed: the Company would have been required to remit 50% of the collections to the WraSer Seller until the shortfall is paid in full.
−Removed: terminates on the WraSer Closing Date.
−Removed: The WraSer APA can be terminated prior to closing
−Removed: as follows (i) upon agreement with all parties;
−Removed: (ii) upon breach of contract of either party, uncured within 20 days of notice.
−Removed: WraSer APA is terminated upon agreement with all parties or upon uncured breach of contract by the WraSer Seller, the initial $3.5 million
−Removed: payment is retained by the WraSer Seller.
−Removed: If it is determined that there is an uncured breach of contract by the WraSer Seller, and the
−Removed: WraSer APA is terminated, the Company will have an unsecured claim against WraSer for the $3.5 million payment made by the Company upon
−Removed: execution of the WraSer APA.
−Removed: The closing of the transaction was subject to various closing conditions, including submission of the FDA
−Removed: transfer documentation to transfer ownership of the acquired product regulatory approvals to the Company.
−Removed: On September 26, 2023, WraSer and its affiliates
−Removed: filed for relief under chapter 11 of the U.S.
−Removed: Bankruptcy Code in the Bankruptcy Court.
−Removed: On October 4, 2023, the parties agreed to amend
−Removed: the WraSer APA, subject to court approval.
−Removed: Shortly after its bankruptcy filing, WraSer filed a motion seeking approval of the WraSer APA
−Removed: The amendment, among other things, eliminates the $500,000 post-closing payment due June 13, 2024 and staggers the $4.5 million
−Removed: cash payment that the Company would otherwise have to pay at closing to:
−Removed: (i) $2.2 million to be paid at closing, (ii) $2.3 million, to
−Removed: be paid in monthly installments of $150,000 commencing January 2024 (the “Post-Closing Payment”) and (iii) 789 shares of Series
−Removed: A Preferred Stock to be paid at closing.
−Removed: The amendment also reduced the number of products we were acquiring by excluding pain medications
−Removed: and including only (i) Ciprofloxacin 0.3% and Fluocinolone 0.025% Otic Solution, under the trademark OTOVEL and its Authorized Generic
−Removed: Version approved under US FDA NDA No.
−Removed: 208251, (ii) Ciprofloxacin 0.2% Otic solution, under the trademark CETRAXAL, and (iii) Vorapaxar
−Removed: Sulfate tablets under the trademark Zontivity approved under US FDA NDA N204886.
−Removed: In October 2023, WraSer alerted us that its sole
−Removed: manufacturer for the active pharmaceutical ingredient (“API”) for Zontivity, the key driver for the WraSer acquisition, would
−Removed: no longer manufacture the API for Zontivity.
−Removed: We believe that this development constituted a Material Adverse Effect under the APA enabling
−Removed: us to terminate the APA and MSA.
−Removed: On October 20, 2023, we filed a motion for relief from the automatic stay in the Bankruptcy Court to
−Removed: exercise our termination rights under the WraSer APA, as amended.
−Removed: On December 18, 2023, the Bankruptcy Court entered an Agreed Order
−Removed: lifting the automatic stay to enable us to exercise our rights to terminate the APA and the MSA without prejudice to the parties’
−Removed: respective rights, remedies, claims, and defenses they had against one another under the APA and MSA.
−Removed: On December 21, 2023, we filed
−Removed: a Notice with the Bankruptcy Court terminating the APA and MSA.
−Removed: WraSer has advised us that it does not believe that a Material Adverse
−Removed: Event occurred.
−Removed: Due to the WraSer bankruptcy filing and our status as an unsecured creditor of WraSer, it is also unlikely that we will
−Removed: recover the $3.5 million Signing Cash or any costs and resources in connection with services provided by the Company under the WraSer
+Added: commercialization of ENTADFI and no longer holds inventory of ENTADFI.
+Added: There is currently no plan to resume commercialization of ENTADFI.
+Added: In addition, as part of cost reduction efforts and in connection with our initial pause in commercializing ENTADFI, we terminated three
+Added: employees involved with the ENTADFI program, effective April 30, 2024, with such individuals to continue assisting the Company on
+Added: an as-needed, consulting basis.
+Added: At December 31, 2024 and 2025, the ENTADFI assets were fully impaired.
Business of the Company
Business Model
−Removed: Proteomedix develops novel diagnostic tests in
−Removed: a highly regulated field.
−Removed: Proteomedix’s core competencies include the development of high-quality immunoassays and management of
−Removed: regulatory affairs.
−Removed: Our expertise in immunoassay development is the result of a highly specialized workforce that, together with an external
−Removed: software development company, developed the proprietary software integrated in the company’s lead IVD product, Proclarix.
−Removed: Our personnel
−Removed: also have extensive experience in implementing and maintaining a state-of-the-art quality management system to comply with regulatory
−Removed: requirements, including performing clinical studies and managing key opinion leaders (“KOLs”).
−Removed: Our experience and expertise
−Removed: in these fields was obtained by hiring experienced personnel as well as through key advisors.
−Removed: Proteomedix is initially focusing on seeking to
−Removed: license its intellectual property to third party laboratories.
−Removed: Sales will be through a specialized distributor and/or laboratory partner,
−Removed: but Proteomedix will still provide technical customer support to laboratories that offer the testing service to physicians.
−Removed: does not have production capabilities built up in-house, and instead outsources manufacturing to a CMO in Germany.
−Removed: All of the key reagents
−Removed: used in Proteomedix’s IVD kits (i.e., antigens and antibodies) are proprietary and owned exclusively by Proteomedix, which uses
−Removed: an independent supplier in Germany to produce these reagents and supply them to its CMO.
+Added: Founded in 2010, Proteomedix develops, markets
+Added: and sells non-invasive diagnostic tests accompanied by decision support systems to detect and assess the prognosis of cancer.
+Added: Proteomedix’s
+Added: lead product, Proclarix ® , is an in vitro diagnostic test for prostate cancer.
+Added: Proteomedix is working to address all stages
+Added: in cancer management by developing tools for both more accurate detection and more efficient treatment of cancer including (i) diagnostic
+Added: tests to early detect and define the stage of cancer;
+Added: (ii) prognostic tools for the identification of patients with aggressive disease;
+Added: and (iii) stratification biomarkers to match patients with therapies that are more likely to be safe and effective.
+Added: Currently, prostate cancer stands as the most
+Added: prevalent and second most fatal cancer type affecting men.
+Added: The widespread utilization of PSA screening since it became broadly available
+Added: in the 1980s helped reduce the occurrence of metastatic prostate cancers by over half, but also led to a notable increase in overdiagnosis,
+Added: sometimes resulting in excessive treatment, severe complications, and potential psychological distress.
+Added: There exists a considerable population
+Added: of men each year who are notified of their heightened risk for prostate cancer based on elevated PSA levels, with limited options beyond
+Added: invasive needle biopsies for managing their cancer risk.
+Added: Proclarix addresses the unsolved problem of prostate
+Added: cancer overdiagnosis, which can lead to excessive use of MRI and negative prostate biopsies that increase costs for the healthcare system
+Added: and uncertainty for patients.
+Added: Proclarix is approved for sale in the European Union under the IVDR.
+Added: Proclarix was first CE marked under
+Added: the IVD Directive in Europe on January 31, 2019.
+Added: On October 7, 2022, Proclarix gained CE marking under the IVD Regulation (IVDR) and
+Added: was registered in the United Kingdom and Switzerland under applicable regulations.
+Added: Clinical studies have confirmed that Proclarix accurately
+Added: identifies clinically significant prostate cancer through a risk score derived from a clinical decision support system and can help avoid
+Added: many unneeded biopsies.
+Added: Proclarix as a clinical support system is designed to aggregate multimodal information in an effort to develop
+Added: a patient-centric diagnostic approach.
+Added: We intend to add more information to the risk score in the future, such as other biomarkers or
+Added: magnetic resonance imaging data, to provide an even more powerful tool to guide the patient’s diagnostic journey.
+Added: The markers and
+Added: the bioinformatics algorithm used are patent-protected.
+Added: The guidelines of the European Association of
+Added: Urology (“EAU”) and of the American Urological Association/Society of Urologic Oncology (“AUA/SUO”) both recommend
+Added: the use of blood-based biomarker tests, such as Proclarix, to aid in the early detection and evaluation of prostate cancer.
+Added: can be performed in any laboratory using standard equipment.
+Added: Proteomedix announced commercial availability of Proclarix in Europe on
+Added: February 26, 2020 and began marketing Proclarix to selected pilot laboratories offering Proclarix in Switzerland, Germany, Italy and
+Added: the United Kingdom.
+Added: Proclarix is currently not reimbursed in Europe, and therefore patients pay for Proclarix out of pocket.
+Added: of sold Proclarix tests currently corresponds to the market development stage and selected laboratories are offering Proclarix.
+Added: we had revenues of $23,091 from sales of Proclarix.
+Added: Prior to being acquired by Onconetix in 2023, Proteomedix had $67,380 from sales
+Added: of Proclarix.
+Added: In the United States, the development and commercialization of Proclarix is being pursued by Laboratory Corporation of
+Added: America Holdings, more commonly called LabCorp, pursuant to an exclusive license agreement entered into between Proteomedix and LabCorp
+Added: Proteomedix was founded by a multi-disciplinary
+Added: group of scientists and clinicians that include Prof.
+Added: Thomas Cerny, president of the Swiss Cancer Research Foundation,
+Added: Ruedi Aebersold, a pioneer in proteomics technology development, and the late Prof.
+Added: Wilhelm Krek, a leader in cancer research.
+Added: Proteomedix’s management consists of Dr.
+Added: Ralph Schiess (Chief Executive Officer), who developed the biomarker technology, and Christian
+Added: Brühlmann (Chief Business Officer), with seasoned experience in finance, business development and product management.
+Added: 18, 2025, Christian Brühlmann resigned from his position as Chief Strategy Officer of the Company.
+Added: Brühlmann will remain
+Added: in his position as Chief Business Officer of Proteomedix.
+Added: On February 24, 2025, Dr.
+Added: Schiess resigned from his positions as the Interim
+Added: Chief Executive Officer of the Company and Chief Science Officer of Proteomedix, effective immediately, and from his position as Chief
+Added: Executive Officer of Proteomedix, effective May 31, 2025.
Proteomedix is seeking to develop diagnostic,
prognostic and predictive tools to enable more efficient cancer management at all stages of disease progression.
−Removed: Proteomedix’s tests
−Removed: use proprietary protein biomarkers to address the limitations in current cancer detection, prognosis, and therapy prediction.
−Removed: Decision Support Systems support the clinical decision-making by integrating different inputs in a risk score (see Figure 1).
+Added: Proteomedix’s
+Added: tests use proprietary protein biomarkers to address the limitations in current cancer detection, prognosis, and therapy prediction.
+Added: addition, Decision Support Systems support the clinical decision-making by integrating different inputs in a risk score (see Figure 1).
Product Pipeline
5 unchanged sentences
The clinical decision support system is a web-based software
−Removed: running a proprietary algorithm that integrates the values for THBS1 and CTSD, the patient’s age and total and free PSA levels from
−Removed: third party providers (e.g., Roche Diagnostics, Siemens Healthineers) to calculate a risk score.
+Added: running a proprietary algorithm that integrates the values for THBS1 and CTSD, the patient’s age and total and free PSA levels
+Added: from third party providers (e.g., Roche Diagnostics, Siemens Healthineers) to calculate a risk score.
Assays and software algorithm for risk
18 unchanged sentences
in peer-reviewed journals.
−Removed: We believe these results demonstrate that Proclarix is a valuable test identifying clinically significant prostate
−Removed: cancer thereby facilitating informed decision making for patients considering a prostate biopsy.
+Added: We believe these results demonstrate that Proclarix is a valuable test identifying clinically significant
+Added: prostate cancer thereby facilitating informed decision making for patients considering a prostate biopsy.
Validation Study .
The study leading to
−Removed: the granting of regulatory approval in Europe included 955 samples collected at two clinical sites, a screening center in Innsbruck, Austria,
−Removed: as well as a referral center in Hamburg, Germany.
−Removed: The results of this study demonstrated that by using the Proclarix test the burden of
−Removed: unneeded biopsies could have been lowered by approximately 43% — twice as much compared to clinical comparators percent free PSA
−Removed: (“%fPSA”) or PSA density.
−Removed: High sensitivity of 90% and a negative predictive value of 95% for clinically significant prostate
−Removed: cancer indicated that the diagnosis of very few cancers would have been delayed.
+Added: the granting of regulatory approval in Europe included 955 samples collected at two clinical sites, a screening center in Innsbruck,
+Added: Austria, as well as a referral center in Hamburg, Germany.
+Added: The results of this study demonstrated that by using the Proclarix test the
+Added: burden of unneeded biopsies could have been lowered by approximately 43% — twice as much compared to clinical comparators percent
+Added: free PSA (“%fPSA”) or PSA density.
+Added: High sensitivity of 90% and a negative predictive value of 95% for clinically significant
+Added: prostate cancer indicated that the diagnosis of very few cancers would have been delayed.
PROPOSe Study.
22 unchanged sentences
a broad range of patients without the need for prostate volume restriction.
−Removed: The aim of one such evaluation was the assessment of the diagnostic
−Removed: performance of Proclarix in combination with MRI.
−Removed: Blood samples from 721 men undergoing MRI followed by biopsy at two clinical centers
−Removed: were analyzed.
+Added: The aim of one such evaluation was the assessment of the
+Added: diagnostic performance of Proclarix in combination with MRI.
+Added: Blood samples from 721 men undergoing MRI followed by biopsy at two clinical
+Added: centers were analyzed.
The combined Proclarix-MRI score’s specificity (68%) was significantly (p<0.001) better compared to Proclarix
3 unchanged sentences
In another evaluation of a study of 517 men with suspected prostate cancer, Proclarix performed well in accurately diagnosing prostate
−Removed: cancer in the overall study population and in a subset of men with elevated PSA 2 to 10 ng/mL, prostate volume ≥35 mL, and normal DRE
−Removed: In addition, a sub-analysis of was performed specifically analyzing 169 men with an indeterminate MRI result and Proclarix was
−Removed: more accurate in selecting appropriate candidates for prostate biopsy when compared to PSA density and online risk calculators.
−Removed: evaluation describes which patients with suspected prostate cancer can benefit from Proclarix after MRI and concluded that Proclarix outperformed
−Removed: PSA density in the selection of candidates for prostate biopsy, especially in men with PI-RADS 1-3.
−Removed: In these studies, Proclarix proved
−Removed: to be effective before, after, and together with MRI assessment to identify men at risk of clinically significant prostate cancer and
−Removed: those who can safely avoid biopsy.
−Removed: Proclarix in combination with MRI reliably predicted clinically significant prostate cancer and ruled
−Removed: out men with no or indolent cancer.
+Added: cancer in the overall study population and in a subset of men with elevated PSA 2 to 10 ng/mL, prostate volume ≥35 mL, and normal
+Added: In addition, a sub-analysis of was performed specifically analyzing 169 men with an indeterminate MRI result and Proclarix
+Added: was more accurate in selecting appropriate candidates for prostate biopsy when compared to PSA density and online risk calculators.
+Added: third evaluation describes which patients with suspected prostate cancer can benefit from Proclarix after MRI and concluded that Proclarix
+Added: outperformed PSA density in the selection of candidates for prostate biopsy, especially in men with PI-RADS 1-3.
+Added: In these studies, Proclarix
+Added: proved to be effective before, after, and together with MRI assessment to identify men at risk of clinically significant prostate cancer
+Added: and those who can safely avoid biopsy.
+Added: Proclarix in combination with MRI reliably predicted clinically significant prostate cancer and
+Added: ruled out men with no or indolent cancer.
Clinical Guidelines
17 unchanged sentences
It serves as a validation for the clinical utility and
−Removed: importance of using Proclarix in the detection of prostate cancer and we believe it will lead to broader acceptance of Proclarix and accelerate
−Removed: payor adoption.
+Added: importance of using Proclarix in the detection of prostate cancer and we believe it will lead to broader acceptance of Proclarix and
+Added: accelerate payor adoption.
Product Quality and Safety
6 unchanged sentences
for obtaining CE-mark, the regulatory clearance requirement for market access, recognized by the European Commission (“EC”)
−Removed: Under the IVDR, diagnostic products are categorized under a new system of one of four classifications from class A (low risk)
−Removed: to class D (highest risk).
+Added: Under the IVDR, diagnostic products are categorized under a new system of one of four classifications from class A (low
+Added: risk) to class D (highest risk).
Proclarix, as class C device, was assessed by TÜV SÜD for conformity resulting in IVDR certification.
3 unchanged sentences
demonstrating the commitment to highest analytical and clinical performance.
−Removed: Prosgard as a clinical support system is designed
−Removed: to aggregate multimodal information in an effort to develop a patient centric diagnostic approach.
−Removed: The vision for Prosgard is to add more
−Removed: information to the existing Proclarix risk score in the future such as other biomarkers, clinical information, or MRI imaging data to
−Removed: provide an even more powerful tool to guide the patient’s diagnostic journey.
+Added: Prosgard as a clinical support system is designed to aggregate multimodal
+Added: information in an effort to develop a patient centric diagnostic approach.
+Added: The vision for Prosgard is to add more information to the
+Added: existing Proclarix risk score in the future such as other biomarkers, clinical information, or MRI imaging data to provide an even more
+Added: powerful tool to guide the patient’s diagnostic journey.
Prognosis (Px)
61 unchanged sentences
offset a portion of those costs against future royalty and milestone payments otherwise due to Proteomedix.
+Added: Additionally, in December
+Added: 2025, Proteomedix and LabCorp entered into an amendment to the exclusive partnership whereby LabCorp would conduct a new validation study
+Added: starting in 2026.
Sales, Distribution, Marketing and Advertising
32 unchanged sentences
Proclarix, the first diagnostic product of Proteomedix,
−Removed: is addressing unmet medical needs related to prostate cancer, which is the second most frequently diagnosed cancer in men.
−Removed: 1,467,854 new cases of prostate cancer and 397,430 prostate cancer related deaths worldwide in 2022 according to World Cancer Research
−Removed: Fund International.
+Added: is addressing unmet medical needs related to the early detection of prostate cancer, which is the second most frequently diagnosed cancer
+Added: There were 1,467,854 new cases of prostate cancer and 397,430 prostate cancer related deaths worldwide in 2022 according
+Added: to World Cancer Research Fund International.
The PSA test represents the current standard of
420 unchanged sentences
extended transition timelines for legacy devices, many IVD manufacturers are not yet setting compliance to IVDR on their highest priority.
+Added: As of the date of this Report, Proteomedix transitioned from IVDD to IVDR and the Proclarix devices are certified under the new legislation
+Added: and fully compliant with IVDR.
For the Proclarix IVDs (Assays and Risk Calculator
106 unchanged sentences
to therapy response.
−Removed: Proteomics approach to improve prostate cancer disease
+Added: Proteomedix’s approach to improve prostate cancer
+Added: disease management.
The biomarker assays were transferred from a mass
10 unchanged sentences
and biomarker developments with utility in cancer patient management.
−Removed: In 2022, Immunovia AB (Sweden) partnered with
−Removed: Proteomedix to leverage Proteomedix’s research and development capabilities and advances their research and development efforts.
+Added: In 2022, Immunovia AB (Sweden) (“Immunovia”)
+Added: partnered with Proteomedix to leverage Proteomedix’s research and development capabilities and advances their research and development
With this partnership, Immunovia gained a more flexible research and development organization, increased its research and development
4 unchanged sentences
and Proteomedix with Proclarix® in
+Added: In September 2025, Proteomedix and Immunovia furthered
+Added: their relationship by entering into a separate licensing agreement.
+Added: Under the licensing agreement, Proteomedix will produce master cell
+Added: lines for three of the five biomarkers used in PancreaSure, a Immunovia pancreatic cancer diagnostic test, and license key intellectual
+Added: property related to the manufacturing of associated reagents to Immunovia in consideration for two payments of $300,000 each to Proteomedix,
+Added: due on September 30, 2025, and March 31, 2026.
+Added: Additionally, Immunovia will make a $100,000 payment for materials and pay a 3% royalty
+Added: on net sales of PancreaSure and any other products incorporating the licensed intellectual property from January 1, 2026, through December
Proteomedix has exclusively licensed worldwide
5 unchanged sentences
(JP6025607B) and the United States (US10151755B2/ US9377463B2).
−Removed: Proteomedix has also obtained a non-exclusive
−Removed: license from ETH Zurich for certain patents pertaining to specific enrichment of glycoproteins, including EP1514107 (expired June 3, 2023)
−Removed: and US7183118 (to expire May 3, 2024), that ETH Zurich licensed from the Institute for Systems Biology (ISB), Seattle.
−Removed: The license enables
−Removed: Proteomedix to use the glycoprotein technology for the development of new diagnostic products.
+Added: Proteomedix also obtained a non-exclusive license from ETH Zurich for certain
+Added: patents pertaining to specific enrichment of glycoproteins, including EP1514107 (expired June 3, 2023) and US7183118 (expired May 3, 2024),
+Added: that ETH Zurich licensed from the Institute for Systems Biology (ISB), Seattle.
+Added: The license enabled Proteomedix to use the glycoprotein
+Added: technology for the development of new diagnostic products.
+Added: The license was terminated in connection with the expiration of the patent
+Added: and no further license payments are required.
In addition, a new patent covering the latest
34 unchanged sentences
and the hosting of the Proclarix risk calculator software are performed by external suppliers.
−Removed: As of May 30, 2025, we had 5 full-time and 2 subcontracted
−Removed: None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppage.
+Added: As of March 10, 2026,
+Added: we had 2 full-time and 6 subcontracted employees.
+Added: None of our employees are represented by a collective bargaining agreement, and we
+Added: have never experienced any work stoppage.
We believe we have good relations with our employees.
2 unchanged sentences
Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.
−Removed: Additionally, Proteomedix leases office and lab
−Removed: space located at Wagistrasse 23, 8952 Schlieren, Switzerland.
−Removed: This lease expires on June 30, 2025, subject to renewal for successive two-year
−Removed: The lease will automatically renew unless terminated.
−Removed: Either party may terminate the lease with 12 months’ written notice.
+Added: Additionally, Proteomedix leases office and lab space located at Wagistrasse
+Added: 23, 8952 Schlieren, Switzerland.
+Added: This lease expired on December 31, 2025 and was renewed for a two-year term with a monthly rent of $2,000
+Added: The lease will automatically renew for successive two-year terms, unless terminated.
+Added: Either party may terminate the lease with
+Added: twelve months’ written notice.
Corporate Information
10 unchanged sentences
also access our reports at the SEC’s website at www.sec.gov.
−Removed: Buyback Program
−Removed: On November 10, 2022, the Board approved a stock
−Removed: repurchase program (the “Repurchase Program”) to allow the Company to repurchase up to 125,000 shares of common stock with
−Removed: a maximum price of $1.00 per share, with discretion to management to make purchases subject to market conditions.
−Removed: On November 18, 2022,
−Removed: the Board approved an increase to the maximum price to $2.00 per share.
−Removed: There was no expiration date for this program and the maximum
−Removed: price per share was not adjusted in connection with the reverse split.
−Removed: Shares that are repurchased are classified as treasury stock pending
−Removed: future use and reduce the number of shares outstanding used in calculating earnings per share.
−Removed: On November 13, 2024, the Board terminated the
−Removed: Repurchase Program.
−Removed: During the fiscal year ended December 31, 2024, there were no repurchases.
−Removed: During the fiscal year ended December 31,
−Removed: 2023, the Company repurchased 1,441 shares of common stock under the Repurchase Program, for an aggregate of approximately $59,000, at
−Removed: an average price of $40.8 per share.
Fundraising Activities
−Removed: On July 11, 2024, the Company entered into the
−Removed: Inducement Letters with certain holders of existing preferred investment options to purchase shares of the Company’s common stock
−Removed: at the original exercise prices of $101.84 and $43.60 per share, issued on August 11, 2022 and August 2, 2023, respectively, pursuant
−Removed: to which the holders agreed to exercise for cash their Existing PIOs to purchase an aggregate of 186,466 shares of the Company’s
−Removed: common stock, at a reduced exercise price of $6.00 per share, in consideration for the Company’s agreement to issue new preferred
−Removed: investment options (the “Inducement PIOs”) to purchase up to an aggregate of 559,397 shares of the Company’s common
−Removed: 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
−Removed: Aside from the contractual terms, the Inducement PIOs have substantially the same terms as the Existing PIOs.
−Removed: On July 11, 2024, the Company consummated the
−Removed: transaction contemplated by the Inducement Letters upon unanimous written consent of the Board (the “Warrant Inducement”).
−Removed: The Company received aggregate net proceeds of approximately $0.9 million from the exercise of the Existing PIOs by the holders and the
−Removed: sale of the Inducement PIOs, after deducting placement agent fees and other offering expenses payable by the Company.
On October 1, 2024, the Board authorized the Company
−Removed: to create a series of 10,000 shares of preferred stock designated as “Series C convertible Preferred Stock”, with a par value
−Removed: of $0.00001, pursuant to the certificate of designations.
−Removed: At any time after the initial issuance date of Series C convertible Preferred
−Removed: Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock.
−Removed: 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “PIPE Investors”), pursuant
−Removed: to the securities purchase agreement an aggregate of 3,499 shares of Series C convertible preferred stock, par value $0.00001 per share,
−Removed: which includes an issuance of 840 shares of Series C Preferred Stock to the lead investor in consideration for the PIPE Investors’
−Removed: irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 591,856 shares of Common Stock, (together,
−Removed: the “PIPE Securities”) for aggregate net cash proceeds to the Company of $1.9 million.
+Added: to create a series of 10,000 shares of preferred stock designated as “Series C Preferred Stock”, with a par value of $0.00001,
+Added: pursuant to the Certificate of Designations of Series C Preferred Stock.
+Added: At any time after the initial issuance date of Series C Preferred
+Added: Stock, each Series C Preferred Stock shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock.
+Added: October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “Series C PIPE Investors”),
+Added: pursuant to a securities purchase agreement, an aggregate of 3,499 shares of Series C Preferred Stock, which includes an issuance of 840
+Added: shares of Series C Preferred Stock to the lead investor in consideration for the Series C PIPE Investors’ irrevocable commitment
+Added: to purchase shares of the Series C Preferred Stock, and warrants to purchase 6,963 shares of Common Stock, for aggregate net cash proceeds
+Added: to the Company of $1.9 million.
On October 2, 2024, the Company entered into a
2 unchanged sentences
up to $25.0 million of the Company’s newly issued Common Stock, subject to certain limitations.
−Removed: As of December 31, 2024 and May
−Removed: 30, 2025, the Company has sold approximately 2,757,933 shares and 33,256,563 shares under the ELOC Purchase Agreement for aggregate proceeds
−Removed: of approximately $0.9 million and $5.3 million, respectively, totaling 36,014,496 shares sold under the ELOC Purchase Agreement for gross
−Removed: proceeds of approximately $6.2 million.
−Removed: In January 2025, there were 3,492,067 shares that were settled bringing the total sold shares
−Removed: to approximately 6,250,000 shares under the ELOC Purchase Agreement.
−Removed: Additionally, as of May 30, 2025, an aggregate of 2,130 Series C
−Removed: Preferred Stock was outstanding, after redemptions of 1,369 shares for an aggregate of $1.71 million.
−Removed: An additional amount of $150,531
−Removed: is due to the PIPE Series C investors for 120 Series C preferred shares that remain due from the most recent ELOC draw.
−Removed: These 120 shares
−Removed: remain subject to future redemption.
+Added: As of December 31, 2025, the Company
+Added: has sold approximately 661,762 shares under the ELOC Purchase Agreement for gross proceeds of approximately $7.1 million.
+Added: On July 16, 2025, the Company exercised its voluntary
+Added: adjustment right under the Certificate of Designation of the Series C Preferred Stock to lower the conversion price of the Series C Preferred
+Added: Stock to $3.50, and holders of 1,920 shares Series C Preferred Stock agreed to convert their shares into shares of Common Stock.
+Added: As of December 31, 2025, 7 shares of Series C
+Added: Preferred Stock were outstanding from the original issuance of 3,499, after the redemption of 1,369 shares of Series C Preferred Stock
+Added: for an aggregate consideration of $1.71 million, the conversion of 1,920 shares of Series C Preferred Stock into common stock, and the
+Added: exchange of 203 shares of Series C Preferred Stock into 244 shares of Series D Preferred Stock.
+Added: On September 22, 2025, the Company entered into
+Added: a securities purchase agreement (the “Series D Securities Purchase Agreement”) with eleven institutional investors, and sold
+Added: or exchanged debt, to such investors (collectively, the “Series D PIPE Investors”) an aggregate of 16,099 shares of Series
+Added: D convertible preferred stock, par value $0.00001 per share (“Series D Preferred Stock”), which includes an issuance of 500
+Added: shares of Series D Preferred Stock to the lead investor in consideration for the Series D PIPE Investors’ irrevocable commitment
+Added: to purchase shares of the Series D Preferred Stock, and warrants (the “Series D Warrants”) to purchase 4,362,827 shares of
+Added: Common Stock, for an aggregate purchase price of approximately $12.9 million and net cash proceeds of $9.3 million.
+Added: The exercise price
+Added: 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
+Added: anniversary of the issuance date.
+Added: On October 1, 2025, the Company entered into a
+Added: securities purchase agreement (the “Series E Securities Purchase Agreement”) with institutional investor(s) and sold to such
+Added: institutional investors(s)(collectively, the “Series E PIPE Investors”), an aggregate of 7,813 shares of Series E convertible
+Added: preferred stock, par value $0.00001 per share (“Series E Preferred Stock”), which are convertible into shares of common stock
+Added: and warrants (the “Series E Warrants”) to purchase 2,025,223 shares of Common Stock, for an aggregate purchase price of approximately
+Added: $6.25 million, which was also equal to the net cash proceeds.
+Added: The exercise price of the Series E Warrants is $3.8576, and the Series E
+Added: Warrants are exercisable beginning on the issuance date and expire on the third anniversary of the issuance date.
Legal Proceedings
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