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What changed in Onconetix, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Onconetix, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+550 added−540 removedSource: 10-K (2026-03-13) vs 10-K (2025-06-02)

Top changes in Onconetix, Inc.'s 2025 10-K

550 paragraphs added · 540 removed · 325 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

111 edited+73 added−59 removed184 unchanged
Biggest changeEach Assumed Option: (i) represented the right to acquire a number of shares of Common Stock equal to the product of (A) the number of Proteomedix Common Shares that were subject to the corresponding Proteomedix Option immediately prior to the Share Exchange Closing, multiplied by (B) the Exchange Ratio (as defined in the Share Exchange Agreement); 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. 5 From and after the Share Exchange Closing and until the first anniversary of the Share Exchange Closing, Sellers, severally and not jointly, are required to indemnify Onconetix and its affiliates and their respective representatives (collectively, the “Onconetix Indemnitees”) against (i) any inaccuracy in or breach of any of the representations or warranties of such Seller contained in the Share Exchange Agreement and (ii) breach or non-fulfillment of any covenant, agreement or obligation to be performed by such Seller pursuant to the Share Exchange Agreement.
Biggest changeFrom and after the Share Exchange Closing and until the first anniversary of the Share Exchange Closing, Sellers, severally and not jointly, are required to indemnify Onconetix and its affiliates and their respective representatives (collectively, the “Onconetix Indemnitees”) against (i) any inaccuracy in or breach of any of the representations or warranties of such Seller contained in the Share Exchange Agreement and (ii) breach or non-fulfillment of any covenant, agreement or obligation to be performed by such Seller pursuant to the Share Exchange Agreement.
The vision for Prosgard is to add more information to the existing Proclarix risk score in the future such as other biomarkers, clinical information, or MRI imaging data to provide an even more powerful tool to guide the patient’s diagnostic journey. Prognosis (Px) A subset of Proteomedix’s protein biomarkers also correlate with prostate cancer prognosis.
The vision for Prosgard is to add more information to the existing Proclarix risk score in the future such as other biomarkers, clinical information, or MRI imaging data to provide an even more powerful tool to guide the patient’s diagnostic journey. 15 Prognosis (Px) A subset of Proteomedix’s protein biomarkers also correlate with prostate cancer prognosis.
After these five years, the authorization may be renewed for an unlimited period on the basis of a reevaluation of the risk-benefit balance, unless the EMA decides, on justified grounds relating to pharmacovigilance, to mandate one additional five-year renewal period. Data and marketing exclusivity The EU also provides opportunities for market exclusivity.
After these five years, the authorization may be renewed for an unlimited period on the basis of a reevaluation of the risk-benefit balance, unless the EMA decides, on justified grounds relating to pharmacovigilance, to mandate one additional five-year renewal period. 22 Data and marketing exclusivity The EU also provides opportunities for market exclusivity.
In 2021, Proteomedix entered into a research and development partnership with New Horizon Health Limited, Grand Cayman, Cayman Islands. The partnership builds on complimentary platform and biomarker developments with utility in cancer patient management. In 2022, Immunovia AB (Sweden) partnered with Proteomedix to leverage Proteomedix’s research and development capabilities and advances their research and development efforts.
In 2021, Proteomedix entered into a research and development partnership with New Horizon Health Limited, Grand Cayman, Cayman Islands. The partnership builds on complimentary platform and biomarker developments with utility in cancer patient management. In 2022, Immunovia AB (Sweden) (“Immunovia”) partnered with Proteomedix to leverage Proteomedix’s research and development capabilities and advances their research and development efforts.
Fedasz received an MBA with an emphasis in finance from Columbia Business School and a BA from University California at Los Angeles (UCLA). She holds an inactive CPA in the state of California. 2 Additionally, members of our board of directors (“Board”) have extensive expertise in the fields of life sciences, business and finance.
Fedasz received an MBA with an emphasis in finance from Columbia Business School and a BA from University California at Los Angeles (UCLA). She holds an inactive CPA in the state of California. Additionally, members of our board of directors (“Board”) have extensive expertise in the fields of life sciences, business and finance.
The AUA/SUO guidelines advice that use of laboratory biomarkers such as Proclarix, prostate MRI, and biopsy techniques may improve detection and safety when a prostate biopsy is deemed necessary following prostate cancer screening. 12 The inclusion of Proclarix in the European and U.S. guidelines is an important recognition of the clinical value of Proclarix.
The AUA/SUO guidelines advice that use of laboratory biomarkers such as Proclarix, prostate MRI, and biopsy techniques may improve detection and safety when a prostate biopsy is deemed necessary following prostate cancer screening. The inclusion of Proclarix in the European and U.S. guidelines is an important recognition of the clinical value of Proclarix.
Of these tests the best established is %fPSA, which is also available from all suppliers of the PSA test, including market leaders Abbott Laboratories, Roche Diagnostics, Siemens Healthineers AG and Beckman Coulter, Inc. However, the sensitivity and specificity improvements are very modest. The 4Kscore from OPKO Health, Inc.
Of these tests the best established is %fPSA, which is also available from all suppliers of the PSA test, including market leaders Abbott Laboratories, Roche Diagnostics, Siemens Healthineers AG and Beckman Coulter, Inc. However, the sensitivity and specificity improvements are very modest. 18 The 4Kscore from OPKO Health, Inc.
In addition, Decision Support Systems support the clinical decision-making by integrating different inputs in a risk score (see Figure 1). Figure 1 : Product Pipeline Proclarix Proclarix Proclarix is used to indicate the risk of clinically significant prostate cancer through a risk score derived from a clinical decision support system (Figure 2).
In addition, Decision Support Systems support the clinical decision-making by integrating different inputs in a risk score (see Figure 1). Figure 1 : Product Pipeline 12 Proclarix Proclarix is used to indicate the risk of clinically significant prostate cancer through a risk score derived from a clinical decision support system (Figure 2).
Both Proclarix and the phi test accurately predicted clinically significant cancer. When using predefined cut-offs recommended by the manufacturers, Proclarix (cut-off 10) outperformed phi (cut-off 27) in terms of specificity and positive predictive value (p Clinical evaluation of Proclarix .
Both Proclarix and the phi test accurately predicted clinically significant cancer. When using predefined cut-offs recommended by the manufacturers, Proclarix (cut-off 10) outperformed phi (cut-off 27) in terms of specificity and positive predictive value (p 14 Clinical evaluation of Proclarix .
This results in reduced anxiety about prostate cancer diagnosis and less complications and side effects from biopsies. Physicians: Focus on relevant patients with clinically significant cancer and increased patient satisfaction by significantly reducing unneeded prostate biopsies and its accompanying complications.
This results in reduced anxiety about prostate cancer diagnosis and less complications and side effects from biopsies. 19 Physicians: Focus on relevant patients with clinically significant cancer and increased patient satisfaction by significantly reducing unneeded prostate biopsies and its accompanying complications.
On April 24, 2025, the Company received an additional deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in Listing 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, 2024, and that this matter serves as an additional basis for delisting the Company’s securities from Nasdaq.
On April 24, 2025, the Company received an additional deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq’s continued listing standards as set forth in Listing Rule 5250(c)(1) (the “Filing Rule”) given the Company’s failure to timely file its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and that this matter serves as an additional basis for delisting the Company’s securities from Nasdaq.
We believe these results demonstrate that Proclarix is a valuable test identifying clinically significant prostate cancer thereby facilitating informed decision making for patients considering a prostate biopsy. 11 Validation Study .
We believe these results demonstrate that Proclarix is a valuable test identifying clinically significant prostate cancer thereby facilitating informed decision making for patients considering a prostate biopsy. Validation Study .
At any time after the initial issuance date of Series C convertible Preferred Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock.
At any time after the initial issuance date of Series C Preferred Stock, each Series C Preferred Stock shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock.
On October 7, 2022, Proclarix gained CE marking under the IVD Regulation (IVDR) and was registered in the United Kingdom and Switzerland under applicable regulations. Clinical studies have confirmed that Proclarix accurately identifies clinically significant prostate cancer through a risk score derived from a clinical decision support system and could help avoid many unneeded biopsies.
On October 7, 2022, Proclarix gained CE marking under the IVD Regulation (IVDR) and was registered in the United Kingdom and Switzerland under applicable regulations. Clinical studies have confirmed that Proclarix accurately identifies clinically significant prostate cancer through a risk score derived from a clinical decision support system and can help avoid many unneeded biopsies.
In the United States, the development and commercialization of Proclarix is being pursued by Laboratory Corporation of America Holdings, more commonly called LabCorp, pursuant to an exclusive license agreement entered into between Proteomedix and LabCorp in 2023. 4 Proteomedix was founded by a multi-disciplinary group of scientists and clinicians that include Prof. Emeritus Dr.
In the United States, the development and commercialization of Proclarix is being pursued by Laboratory Corporation of America Holdings, more commonly called LabCorp, pursuant to an exclusive license agreement entered into between Proteomedix and LabCorp in 2023. Proteomedix was founded by a multi-disciplinary group of scientists and clinicians that include Prof. Emeritus Dr. med.
The accompanying consolidated financial statements of Onconetix, as of and for the year ended December 31, 2024, included elsewhere in this Report do not include any adjustment that might be necessary if the Company is unable to continue as a going concern.
The accompanying consolidated financial statements of Onconetix, as of and for the year ended December 31, 2025, included elsewhere in this Report do not include any adjustment that might be necessary if the Company is unable to continue as a going concern.
Proclarix addresses the unsolved problem of prostate cancer overdiagnosis, which can lead to negative prostate biopsies that increase costs for the healthcare system and uncertainty for patients. Proclarix is approved for sale in the European Union under the IVDR. Proclarix was first CE marked under the IVD Directive in Europe on January 31, 2019.
Proclarix addresses the unsolved problem of prostate cancer overdiagnosis, which can lead to excessive use of MRI and negative prostate biopsies that increase costs for the healthcare system and uncertainty for patients. Proclarix is approved for sale in the European Union under the IVDR. Proclarix was first CE marked under the IVD Directive in Europe on January 31, 2019.
If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations.
If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations. Realbotix Corp.
Stockholder Subscription Agreement and Debenture In connection with the PMX Transaction, on December 18, 2023, Onconetix entered into a Subscription Agreement (the “Subscription Agreement”) with the PMX Investor for a private placement of $5.0 million of units (the “Units”), each Unit comprised of (i) one share of Common Stock and (ii) one pre-funded warrant (collectively, the “Warrants”) to purchase 0.3 shares of Common Stock at an exercise price of $0.04 per share, for an aggregate purchase price per Unit of $10.00 (the “Purchase Price”).
Stockholder Subscription Agreement and Debenture In connection with the PMX Transaction, on December 18, 2023, Onconetix entered into a Subscription Agreement (the “Subscription Agreement”) with the PMX Investor for a private placement of $5.0 million of units (the “Units”), each Unit comprised of (i) one share of Common Stock and (ii) one pre-funded warrant (collectively, the “Warrants”) to purchase 0.3 shares of Common Stock at an exercise price of $3.40 per share, for an aggregate purchase price per Unit of $850 (the “Purchase Price”).
Founded in 2010, Proteomedix develops, markets and sells non-invasive diagnostic tests accompanied by decision support systems to detect and assess the prognosis of cancer. Proteomedix’s lead product, Proclarix ® , is an in vitro diagnostic test for prostate cancer.
Business of the Company Business Model Founded in 2010, Proteomedix develops, markets and sells non-invasive diagnostic tests accompanied by decision support systems to detect and assess the prognosis of cancer. Proteomedix’s lead product, Proclarix ® , is an in vitro diagnostic test for prostate cancer.
Additional shares are issuable to Altos to the extent Altos continues to hold Common Stock included in the Units and if the VWAP during the 270 days following closing is less than $10.00, as set forth in the Subscription Agreement.
Additional shares are issuable to Altos to the extent Altos continues to hold Common Stock included in the Units and if the VWAP during the 270 days following closing is less than $850, as set forth in the Subscription Agreement.
MRI is not regarded as competitive to the Proclarix positioning, but complementary. 16 Competitive Advantages of Proclarix We believe Proclarix has important competitive advantages: ● Blood-based test - Minimally invasive, high reproducibility, no prostate massage required, suitably stable for shipment, the most common sample type in clinical laboratories and therefore fitting in current lab workflow ● Immunoassay-based - Compatible with existing laboratory instrumentation in local laboratory ● Easy to automate - Adaptable to clinical routine, fast time to result ● Objective result generation - Comparable results independent of operator ● Genetics-guided discovery - Cancer-related, highly plausible biomarkers Proclarix can be applied in any diagnostic laboratory, using readily available immunoassay technology platforms.
Competitive Advantages of Proclarix We believe Proclarix has important competitive advantages: ● Blood-based test - Minimally invasive, high reproducibility, no prostate massage required, suitably stable for shipment, the most common sample type in clinical laboratories and therefore fitting in current lab workflow ● Immunoassay-based - Compatible with existing laboratory instrumentation in local laboratory ● Easy to automate - Adaptable to clinical routine, fast time to result ● Objective result generation - Comparable results independent of operator ● Genetics-guided discovery - Cancer-related, highly plausible biomarkers Proclarix can be applied in any diagnostic laboratory, using readily available immunoassay technology platforms.
Pursuant to the terms of the Veru APA, the Company agreed to provide Veru with initial consideration totaling $20.0 million, consisting of (i) $6.0 million paid upon the closing of the 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 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 19, 2024 and September 30, 2024.
Pursuant to the terms of the Veru APA, the Company agreed to provide Veru with initial consideration totaling $20.0 million, consisting of (i) $6.0 million paid upon the closing of the 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 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 19, 2024 (the “April Veru Note”) and September 30, 2024 (the “September Veru Note,” together with the “April Veru Note”, the “Veru Notes”).
On September 24, 2024, upon obtaining stockholder approval and pursuant to the Subscription Agreement, the Company issued an aggregate of 513,424 units (the “Units”) to Altos, each Unit comprised of (i) one share of Common Stock and (ii) one pre-funded warrant (collectively, the “Altos Warrants”) to purchase 0.3 shares of Common Stock at an exercise price of $0.04 per share.
On September 24, 2024, upon obtaining stockholder approval and pursuant to the Subscription Agreement, the Company issued an aggregate of 6,040 units (the “Units”) to Altos, each Unit comprised of (i) one share of Common Stock and (ii) one pre-funded warrant (collectively, the “Altos Warrants”) to purchase 0.3 shares of Common Stock at an exercise price of $3.40 per share.
The Milestone Payments are payable as follows: (i) $10.0 million is payable if the Company’s annual net sales from the ENTADFI business equal or exceed $100.0 million, (ii) $20.0 million is payable if the Company’s annual net sales 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.
The Milestone Payments were to be payable as follows: (i) $10.0 million is payable if the Company’s annual net sales from the ENTADFI business equal or exceed $100.0 million, (ii) $20.0 million is payable if the Company’s annual net sales 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.
Through our recent acquisition of Proteomedix, we own Proclarix, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union under the In Vitro Diagnostic Regulation (“IVDR”), which we anticipate will be marketed in the U.S. as a lab developed test through our license agreement with LabCorp.
Through our acquisition of Proteomedix, which closed on December 15, 2023, we own Proclarix, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union under the In Vitro Diagnostic Regulation (“IVDR”), which we anticipate will be marketed in the U.S. as a lab developed test through our license agreement with LabCorp.
The closing of the acquisition of Proteomedix for all stock consideration provided Proteomedix shareholders with an initial 16.4% ownership stake of Onconetix, and Series B Preferred Stock convertible into 6,741,820 shares of Onconetix Common Stock, subject to Onconetix stockholder approval of the same (“Stockholder Approval”).
The closing of the acquisition of Proteomedix for all stock consideration provided Proteomedix shareholders with an initial 16.4% ownership stake of Onconetix, and Series B Preferred Stock convertible into 79,315 shares of Onconetix Common Stock, subject to Onconetix stockholder approval of the same (“Stockholder Approval”).
After deprioritizing our vaccine programs, the Company subsequently shifted its focus toward building a foundation of therapeutic, diagnostic, and service products in the field of men’s health and oncology. Karina M. Fedasz, our Interim Chief Financial Officer since June 2024, was appointed as Interim Chief Executive Officer on April 2, 2025. For more than two decades, Ms.
After deprioritizing our vaccine programs, the Company subsequently shifted its focus toward building a foundation of therapeutic, diagnostic, and service products in the field of men’s health and oncology. 5 Karina M. Fedasz had been appointed as our Interim Chief Executive Officer since April 2025 and Chief Financial Officer since June 2024, respectively. For more than two decades, Ms.
The clinical decision support system is a web-based software running a proprietary algorithm that integrates the values for THBS1 and CTSD, the patient’s age and total and free PSA levels from third party providers (e.g., Roche Diagnostics, Siemens Healthineers) to calculate a risk score. 10 Figure 2 : Proclarix: Assays and software algorithm for risk score calculation.
The clinical decision support system is a web-based software running a proprietary algorithm that integrates the values for THBS1 and CTSD, the patient’s age and total and free PSA levels from third party providers (e.g., Roche Diagnostics, Siemens Healthineers) to calculate a risk score.
Proteomedix’s biomarkers have shown the potential to distinguish between those prostate cancer patients who are more likely to respond to certain drug-based interventions. With this information, better choices for drug therapies can be made to maximize the likelihood of efficacious treatment.
Proteomedix’s biomarkers have shown the potential to distinguish between those prostate cancer patients who are more likely to respond to certain drug-based interventions. With this information, better choices for drug therapies can be made to maximize the likelihood of efficacious treatment. Proteomedix’s biomarkers could also aid in clinical drug development.
Schiess resigned from his positions as the Interim Chief Executive Officer of the Company and Chief Science Officer of Proteomedix, effective immediately, and from his position as Chief Executive Officer of Proteomedix, effective May 31, 2025.
On February 24, 2025, Dr. Schiess resigned from his positions as the Interim Chief Executive Officer of the Company and Chief Science Officer of Proteomedix, effective immediately, and from his position as Chief Executive Officer of Proteomedix, effective May 31, 2025.
We are currently not a party to any material legal proceedings. 27
We are currently not a party to any material legal proceedings. 29
Dollars ($75,000,000) (the “Exchange Consideration”) less the value of the Proteomedix Shares for which the Proteomedix Stock Options (as defined below) are exercisable immediately prior to the Share Exchange Closing, subject to adjustment for indemnification as described below. Following the Share Exchange Closing, 571,049 and 558,114 shares of Common Stock were issued and outstanding, respectively.
Dollars ($75,000,000) (the “Exchange Consideration”) less the value of the Proteomedix Shares for which the Proteomedix Stock Options (as defined below) are exercisable immediately prior to the Share Exchange Closing, subject to adjustment for indemnification as described below. Following the Share Exchange Closing, 6,718 and 6,566 shares of Common Stock were issued and outstanding, respectively.
Proclarix is used as an aid in prostate cancer diagnosis as a second-line test after PSA and DRE testing. It enables a personalized decision for each patient based on objective risk parameters (4 serum glycoproteins + age) to triage between biopsy or a monitoring approach.
Figure 2 : Proclarix: Assays and software algorithm for risk score calculation. 13 Proclarix is used as an aid in prostate cancer diagnosis as a second-line test after PSA and DRE testing. It enables a personalized decision for each patient based on objective risk parameters (4 serum glycoproteins + age) to triage between biopsy or a monitoring approach.
Pursuant to each Lock-Up Agreement, each signatory thereto will agree not to, during the period commencing from the Share Exchange Closing Date and ending on the 6-month anniversary of the date of Stockholder Approval: (i) lend, offer, pledge, hypothecate, encumber, donate, assign, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, the Exchange Shares or the Conversion Shares, (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Exchange Shares or the Conversion Shares, or (iii) publicly disclose the 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 of the Exchange Shares or the Conversion Shares or other securities, in cash or otherwise (subject to certain exceptions).
Pursuant to each Lock-Up Agreement, each signatory thereto will agree not to, during the period commencing from the Share Exchange Closing Date and ending on the 6-month anniversary of the date of Stockholder Approval: (i) lend, offer, pledge, hypothecate, encumber, donate, assign, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, the Exchange Shares or the Conversion Shares, (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Exchange Shares or the Conversion Shares, or (iii) publicly disclose the 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 of the Exchange Shares or the Conversion Shares or other securities, in cash or otherwise (subject to certain exceptions). 8 Non-Competition and Non-Solicitation Agreement Simultaneously with the execution of the Share Exchange Agreement, certain executive officers (each, a “Management Shareholder”) of Proteomedix each entered into a non-competition and non-solicitation agreement (collectively, the “Non-Competition and Non-Solicitation Agreements”) with Onconetix.
A patent application describing and claiming a method measuring a blood-based protein combination with prognostic utility in prostate cancer patients was filed by Proteomedix on June 29, 2021. The patent was originally filed in Switzerland followed by an international application (WO2018011212A1).
A patent application describing and claiming a method measuring a blood-based protein combination with prognostic utility in prostate cancer patients was filed by Proteomedix on June 29, 2021. The patent was originally filed in Switzerland followed by an international application (WO2018011212A1). National applications were filed in Europe, United States and China.
In addition, as part of cost reduction efforts and in connection with our initial pause in commercializing ENTADFI, we terminated three employees involved with the ENTADFI program, effective April 30, 2024, with such individuals to continue assisting the Company on an as-needed, consulting basis.
In addition, as part of cost reduction efforts and in connection with our initial pause in commercializing ENTADFI, we terminated three employees involved with the ENTADFI program, effective April 30, 2024, with such individuals to continue assisting the Company on an as-needed, consulting basis. At December 31, 2024 and 2025, the ENTADFI assets were fully impaired.
We will need to raise additional capital within the next 12 months to sustain operations. 1 Until we generate revenue sufficient to support self-sustaining cash flows, if ever, we will need to raise additional capital to fund our continued operations, including our product development and commercialization activities related to our current and future products.
Until we generate revenue sufficient to support self-sustaining cash flows, if ever, we will need to raise additional capital to fund our continued operations, including our product development and commercialization activities related to our current and future products.
Proteomedix announced commercial availability of Proclarix in Europe on February 26, 2020 and began marketing Proclarix to selected pilot laboratories offering Proclarix in Switzerland, Germany, Italy and the United Kingdom. Proclarix is currently not reimbursed in Europe, and therefore patients pay for Proclarix out of pocket.
Proclarix can be performed in any laboratory using standard equipment. Proteomedix announced commercial availability of Proclarix in Europe on February 26, 2020 and began marketing Proclarix to selected pilot laboratories offering Proclarix in Switzerland, Germany, Italy and the United Kingdom. Proclarix is currently not reimbursed in Europe, and therefore patients pay for Proclarix out of pocket.
The markers and the bioinformatics algorithm used are patent-protected. The guidelines of the European Association of Urology (“EAU”) and of the American Urological Association/Society of Urologic Oncology (“AUA/SUO”) both recommend the use of blood-based biomarker tests, such as Proclarix, to aid in the early detection and evaluation of prostate cancer. Proclarix can be performed in any laboratory using standard equipment.
The markers and the bioinformatics algorithm used are patent-protected. 11 The guidelines of the European Association of Urology (“EAU”) and of the American Urological Association/Society of Urologic Oncology (“AUA/SUO”) both recommend the use of blood-based biomarker tests, such as Proclarix, to aid in the early detection and evaluation of prostate cancer.
Pursuant to, and subject to the terms and conditions of, the Veru APA, the Company purchased substantially all of the assets related to Veru’s ENTADFI business. The transaction closed on April 19, 2023. The Company purchased substantially all of Veru’s assets, rights and property related to ENTADFI for a total possible consideration of $100.0 million (as described below).
The transaction closed on April 19, 2023. The Company purchased substantially all of Veru’s assets, rights and property related to ENTADFI for a total possible consideration of $100.0 million (as described below).
As MRI instrumentation is costly and its availability is still limited, there is a need for diagnostics supporting the decision to perform MRI that Proclarix can fulfill.
As MRI instrumentation is costly and its availability is still limited, there is a need for diagnostics supporting the decision to perform MRI that Proclarix can fulfill. MRI is not regarded as competitive to the Proclarix positioning, but complementary.
Corporate Information We were incorporated on October 22, 2018 under the laws of the State of Delaware. Our principal executive offices are located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, and our telephone number is (513) 620-4101. Our corporate website address is www.onconetix.com .
Either party may terminate the lease with twelve months’ written notice. 28 Corporate Information We were incorporated on October 22, 2018 under the laws of the State of Delaware. Our principal executive offices are located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, and our telephone number is (513) 620-4101. Our corporate website address is www.onconetix.com .
In particular, non-clinical studies, both in vitro and in vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which define a set of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies.
In particular, non-clinical studies, both in vitro and in vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which define a set of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies. These GLP standards reflect the Organization for Economic Co-operation and Development requirements.
PSA is not a highly cancer specific marker, meaning it picks up many benign conditions of raised PSA levels in the blood—such as clinically not significant enlargement of the prostate or inflammation. The consequences are prostate cancer overdiagnosis, leading to unnecessary prostate biopsies.
Currently, standard prostate cancer screening combines a digital rectal exam (“DRE”) with the measurement of PSA. PSA is not a highly cancer specific marker, meaning it picks up many benign conditions of raised PSA levels in the blood—such as clinically not significant enlargement of the prostate or inflammation. The consequences are prostate cancer overdiagnosis, leading to unnecessary prostate biopsies.
These GLP standards reflect the Organization for Economic Co-operation and Development requirements. 18 Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations and the International Conference on Harmonization (ICH) guidelines on good clinical practices (GCP) as well as the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations and the International Conference on Harmonization (ICH) guidelines on good clinical practices (GCP) as well as the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.
The Company had 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 of the Company’s securities pending the Panel’s decision. On May 27, 2025, the Company appeared before the Nasdaq Hearings Panel and requested a stay of suspension.
The Company had 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 of the Company’s securities pending the Panel’s decision.
Failure to comply with the requirements of GDPR and the applicable national data protection laws of the EU member states may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties. 21 EU Medical device legislation Medical device legislation is harmonized in the European Union (EU) through the European Commission’s New Legislative Framework.
Failure to comply with the requirements of GDPR and the applicable national data protection laws of the EU member states may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties.
On October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “PIPE Investors”), pursuant to the securities purchase agreement an aggregate of 3,499 shares of Series C convertible preferred stock, par value $0.00001 per share, which includes an issuance of 840 shares of Series C Preferred Stock to the lead investor in consideration for the PIPE Investors’ irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 591,856 shares of Common Stock, (together, the “PIPE Securities”) for aggregate net cash proceeds to the Company of $1.9 million.
On October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “Series C PIPE Investors”), pursuant to a securities purchase agreement, an aggregate of 3,499 shares of Series C Preferred Stock, which includes an issuance of 840 shares of Series C Preferred Stock to the lead investor in consideration for the Series C PIPE Investors’ irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 6,963 shares of Common Stock, for aggregate net cash proceeds to the Company of $1.9 million.
The product name “Proclarix” was filed on July 1, 2019, and registered under no. 733974 in Switzerland on July 22, 2019. This application served as the basis for the international trademark application. The product name “Prosgard” was filed on July 1, 2019, and registered under no. 733975 in Switzerland on July 22, 2019.
Trademarks The brand “Proteomedix” was filed on June 4, 2010, and registered under no. 602190 in Switzerland on June 22, 2010. This application served as the basis for the international trademark application. The product name “Proclarix” was filed on July 1, 2019, and registered under no. 733974 in Switzerland on July 22, 2019.
All of the key reagents used in Proteomedix’s IVD kits (i.e., antigens and antibodies) are proprietary and owned exclusively by Proteomedix, which uses an independent supplier in Germany to produce these reagents and supply them to its CMO.
All of the key reagents used in Proteomedix’s IVD kits (i.e., antigens and antibodies) are proprietary and owned exclusively by Proteomedix. These reagents are produced by an independent supplier in Germany and shipped to the CMO for manufacturing of the IVD kits.
Terms of the PMX Transaction Consideration Pursuant to the Share Exchange Agreement, on December 15, 2023, in full payment for the Purchased Shares, Onconetix issued shares (the “Exchange Shares”) consisting of: (i) 91,885 shares of Common Stock equal to approximately 19.99% of the total issued and outstanding Common Stock prior to the acquisition and (ii) 2,696,729 shares of Series B Preferred Stock convertible into 6,741,820 shares of Common Stock.
On September 24, 2024, all outstanding shares of Series B Preferred Stock converted into an aggregate of 79,315 shares of Onconetix Common Stock. 7 Terms of the PMX Transaction Consideration Pursuant to the Share Exchange Agreement, on December 15, 2023, in full payment for the Purchased Shares, Onconetix issued shares (the “Exchange Shares”) consisting of: (i) 1,081 shares of Common Stock equal to approximately 19.99% of the total issued and outstanding Common Stock prior to the acquisition and (ii) 2,696,729 shares of Series B Preferred Stock convertible into 79,315 shares of Common Stock.
The number of sold Proclarix tests current corresponds to the early market development stage and selected few laboratories offering Proclarix. In 2024, we had revenues of $86,957 from sales of Proclarix. Prior to being acquired by Onconetix in 2023, Proteomedix had $67,380 from sales of Proclarix.
The number of sold Proclarix tests currently corresponds to the market development stage and selected laboratories are offering Proclarix. In 2025, we had revenues of $23,091 from sales of Proclarix. Prior to being acquired by Onconetix in 2023, Proteomedix had $67,380 from sales of Proclarix.
Since 2022, due to different reasons, the European Commission issued various updates to the IVDR to introduce transitional provisions for certain IVDs, which are already on the EU market prior to the Date of Application (legacy devices) and which are not to be substantially changed by function and design (Regulation (EU) 2022/112 and Regulation (EU) 2023/6074).
Overall, the IVDR is a significant expansion of the previous EU-Directive 98/79/EC (IVDD), which has been effective for IVDs since 1998. 24 Since 2022, due to different reasons, the European Commission issued various updates to the IVDR to introduce transitional provisions for certain IVDs, which are already on the EU market prior to the Date of Application (legacy devices) and which are not to be substantially changed by function and design (Regulation (EU) 2022/112 and Regulation (EU) 2023/6074).
Publication of clinical studies proving the medical benefit of the test and KOLs advocating it at scientific conferences will trigger the usage by other physicians. Additionally, demand is created through urology centers specialized in prostate cancer that cover a large geographical area. Their influence on other urologists and general practitioners in the region will lead to multiplier effects.
Market adoption of a new test is driven by KOLs and clinical urology centers. Publication of clinical studies proving the medical benefit of the test and KOLs advocating it at scientific conferences will trigger the usage by other physicians. Additionally, demand is created through urology centers specialized in prostate cancer that cover a large geographical area.
European Union European Union Coverage Reimbursement and Pricing In the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price has been agreed.
Guidance on implementation and compliance practices are often updated or otherwise revised. 20 European Union European Union Coverage Reimbursement and Pricing In the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price has been agreed.
In the EU, the collection and use of personal health data is governed by the provisions of the General Data Protection Regulation, or GDPR. The GDPR became effective on May 25, 2018, repealing its predecessor directive and increasing responsibility and liability of pharmaceutical companies in relation to the processing of personal data of EU subjects.
The GDPR became effective on May 25, 2018, repealing its predecessor directive and increasing responsibility and liability of pharmaceutical companies in relation to the processing of personal data of EU subjects.
Data protection authorities from the different EU member states may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of processing personal data in the EU. Guidance on implementation and compliance practices are often updated or otherwise revised.
Data protection authorities from the different EU member states may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of processing personal data in the EU.
Cancer arises from different genetic mutations that can be linked to specific signaling pathways often referred to as cancer pathways. Depending on what pathway is affected in a patient, results in different cancer subtypes that are more or less aggressive and further determines if a patient responds to a certain drug treatment or not.
Depending on what pathway is affected in a patient, results in different cancer subtypes that are more or less aggressive and further determines if a patient responds to a certain drug treatment or not.
Acquisitions Proteomedix On December 15, 2023, Onconetix entered into a Share Exchange Agreement (the “Share Exchange Agreement”), by and among (i) Onconetix, (ii) Proteomedix, (iii) each of the holders of outstanding capital stock, convertible securities, or stock options of Proteomedix named therein (collectively, the “Sellers”) and (iv) Thomas Meier, in the capacity as the representative of Sellers in accordance with the terms and conditions of the Share Exchange Agreement. 3 Pursuant to the Share Exchange Agreement, subject to the terms and conditions set forth therein, the Sellers agreed to sell to Onconetix, and Onconetix agreed to buy, all of the issued and outstanding voting equity interests of Proteomedix in exchange for newly issued shares of Common Stock and newly issued shares of Series B Preferred Stock (the “Share Exchange”).
Acquisitions Proteomedix On December 15, 2023, Onconetix entered into a Share Exchange Agreement (the “Share Exchange Agreement”), by and among (i) Onconetix, (ii) Proteomedix, (iii) each of the holders of outstanding capital stock, convertible securities, or stock options of Proteomedix named therein (collectively, the “Sellers”) and (iv) Thomas Meier, in the capacity as the representative of Sellers in accordance with the terms and conditions of the Share Exchange Agreement.
Pursuant to the Veru Amendment, the $4.0 million note payable originally 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 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 converted in to 142,749 shares of Common Stock on September 24, 2024. 7 Additionally, the terms of the Veru APA require the Company to pay Veru up to an additional $80.0 million based on the Company’s net sales from the ENTADFI business after closing.
Pursuant to the Veru Amendment, the $4.0 million note payable originally 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 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 converted in to 1,679 shares of Common Stock on September 24, 2024.
The fair value of the 91,885 shares of Common Stock, was determined using the closing price of the Common Stock as of the Share Exchange Closing Date, which was $9.528.
The fair value of the 1,081 shares of Common Stock, was determined using the closing price of the Common Stock as of the Share Exchange Closing Date, which was $809.88.
Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the member states in which the MA is sought, one of which is selected by the applicant as the Reference member state. 19 Under the above-described procedures, in order to grant the MA, the EMA or the competent authorities of the EU member states make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
Under the above-described procedures, in order to grant the MA, the EMA or the competent authorities of the EU member states make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
In the United States, Proteomedix entered into an exclusive partnership with LabCorp in 2023 pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix, and other products developed by LabCorp using Proteomedix’s intellectual property covered by the license, in the United States for identification, screening, staging, predisposition, diagnosis, prognosis, monitoring, prevention or treatment selection with respect to prostate cancer.
We have initiated outreach to commercial laboratories and hospital laboratories that are routinely serving study sites and academic collaboration partners, and have established pilots with laboratories in Switzerland, Germany, Italy, and the United Kingdom. 16 In the United States, Proteomedix entered into an exclusive partnership with LabCorp in 2023 pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix, and other products developed by LabCorp using Proteomedix’s intellectual property covered by the license, in the United States for identification, screening, staging, predisposition, diagnosis, prognosis, monitoring, prevention or treatment selection with respect to prostate cancer.
Although general requirements for advertising and promotion of medicinal products are established under EU directives, the details are governed by regulations in each member state and can differ from one country to another. The aforementioned EU rules are generally applicable in the European Economic Area (“EEA”) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.
Although general requirements for advertising and promotion of medicinal products are established under EU directives, the details are governed by regulations in each member state and can differ from one country to another.
On October 1, 2024, the Board authorized the Company to create a series of 10,000 shares of preferred stock designated as “Series C convertible Preferred Stock”, with a par value of $0.00001, pursuant to the certificate of designations.
Alternatively, you may also access our reports at the SEC’s website at www.sec.gov. Fundraising Activities On October 1, 2024, the Board authorized the Company to create a series of 10,000 shares of preferred stock designated as “Series C Preferred Stock”, with a par value of $0.00001, pursuant to the Certificate of Designations of Series C Preferred Stock.
(formerly Blue Water Vaccines Inc. and Blue Water Biotech, Inc.) was founded in October 2018. The Company’s initial goal was to develop a transformational universal flu vaccine to treat and prevent infections in patients globally.
Governing Law The Share Exchange Agreement is governed by the laws of the State of Delaware. Management and History Onconetix, Inc. (formerly Blue Water Vaccines Inc. and Blue Water Biotech, Inc.) was founded in October 2018. The Company’s initial goal was to develop a transformational universal flu vaccine to treat and prevent infections in patients globally.
Diagnostic testing in clinical urology centers is provided either by an in-house hospital laboratory or a commercial laboratory where Proclarix will be implemented. General practitioners recruit patients for screening and decide whether to refer a patient to a specialist. They have an important gatekeeper role and Proclarix is a helpful tool for this triage.
Their influence on other urologists and general practitioners in the region will lead to multiplier effects. Diagnostic testing in clinical urology centers is provided either by an in-house hospital laboratory or a commercial laboratory where Proclarix will be implemented. General practitioners recruit patients for screening and decide whether to refer a patient to a specialist.
Once the CTA is approved by the national health authority and the ethics committee has granted a positive opinion in relation to the conduct of the trial in the relevant member state(s), in accordance with a country’s requirements, clinical study development may proceed.
Once the CTA is approved by the national health authority and the ethics committee has granted a positive opinion in relation to the conduct of the trial in the relevant member state(s), in accordance with a country’s requirements, clinical study development may proceed. 21 The CTA must include, among other things, a copy of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation.
A subset of 8 serum biomarkers could individually predict reaching the primary endpoint (progression free survival at 12 weeks) with an accuracy of at least 75%. 13 Decision Support Systems Recent initiatives are incorporating as well as interpreting clinical information from various sources (e.g., biomarker information and other patient data) enabling physicians to have more comprehensive biochemical insight into each patient’s disease in order to determine the optimal treatment plan for the patient.
Decision Support Systems Recent initiatives are incorporating as well as interpreting clinical information from various sources (e.g., biomarker information and other patient data) enabling physicians to have more comprehensive biochemical insight into each patient’s disease in order to determine the optimal treatment plan for the patient.
For UK, IVD manufacturers must comply with the UK MDR 2002 (Medical device Regulation), which has been revised several times with new guidelines addressed in the Guidance on the Regulation of In Vitro Diagnostic Medical Devices in Great Britain.
As a consequence, Swiss manufacturers must appoint an EU-based AR and/or importer in line with Article 11 and Article 13 of the IVDR. 25 For UK, IVD manufacturers must comply with the UK MDR 2002 (Medical device Regulation), which has been revised several times with new guidelines addressed in the Guidance on the Regulation of In Vitro Diagnostic Medical Devices in Great Britain.
For other countries outside of the EU, such as countries in Latin America or Asia (e.g., China and Japan), the requirements governing the conduct of clinical studies, product licensing, pricing and reimbursement vary from country to country.
The aforementioned EU rules are generally applicable in the European Economic Area (“EEA”) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland. 23 For other countries outside of the EU, such as countries in Latin America or Asia (e.g., China and Japan), the requirements governing the conduct of clinical studies, product licensing, pricing and reimbursement vary from country to country.
Third, for the Proclarix devices marketed since 2019 in EU, there is automatically systematic post market surveillance data collected from the field, which further can support the clinical evidence (validity) of the Proclarix devices. 22 Proteomedix AG also has an appointed Data Protection Officer (DPO) for data safety in line to requirements from General Data Protection Regulation (EU) 2016/679 (GDPR) and Swiss Data Protection Act although there are no personnel data included or affected in the Proclarix IVDs.
Proteomedix AG also has an appointed Data Protection Officer (DPO) for data safety in line to requirements from General Data Protection Regulation (EU) 2016/679 (GDPR) and Swiss Data Protection Act although there are no personnel data included or affected in the Proclarix IVDs.
We have no internal manufacturing capabilities, and we will continue to rely on third parties, of which the main suppliers are single-source suppliers, for commercial products.
We have no internal manufacturing capabilities, and we will continue to rely on third parties, of which the main suppliers are single-source suppliers, for commercial product. We do not have any products approved for sale, aside from Proclarix. We have abandoned commercialization of ENTADFI and have destroyed our inventory of the product.
Thomas Cerny, president of the Swiss Cancer Research Foundation, Prof. Ruedi Aebersold, a pioneer in proteomics technology development, and the late Prof. Wilhelm Krek, a leader in cancer research. Proteomedix’s management consists of Dr. Ralph Schiess (Chief Executive Officer), who developed the biomarker technology, and Christian Brühlmann (Chief Business Officer), with seasoned experience in finance, business development and product management.
Thomas Cerny, president of the Swiss Cancer Research Foundation, Prof. Ruedi Aebersold, a pioneer in proteomics technology development, and the late Prof. Dr. Wilhelm Krek, a leader in cancer research. Proteomedix’s management consists of Dr.
Once the MA is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible for six months’ supplementary protection certificate extension (if any is in effect at the time of authorization). 20 Post-Approval Requirements Similar to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the competent regulatory authorities of the member states.
Once the MA is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible for six months’ supplementary protection certificate extension (if any is in effect at the time of authorization).
Local diagnostic laboratories can integrate this multiparametric test into their current workflow because Proclarix assays use the enzyme-linked immunosorbent assay (ELISA) standard, which most diagnostic laboratories are already equipped to process.
Local diagnostic laboratories can integrate this multiparametric test into their current workflow because Proclarix assays use the enzyme-linked immunosorbent assay (ELISA) standard, which most diagnostic laboratories are already equipped to process. Proclarix is CE-marked and for sale in Europe. We continue our sales efforts and expect growing revenues from sales of Proclarix in 2026 and beyond.
Different serum glycoproteins were combined to form multiplexed biomarker signatures predictive for tissue PI3K/PTEN status as well as diagnosis and prognosis of prostate cancer (Figure 5). The genetic-guided proteomics approach enabled the fast discovery and validation of several biomarkers which in different combinations correspond to diagnosis, prognosis and potentially to therapy response.
Different serum glycoproteins were combined to form multiplexed biomarker signatures predictive for tissue PI3K/PTEN status as well as diagnosis and prognosis of prostate cancer (Figure 5).
None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppage. We believe we have good relations with our employees. Properties and Facilities We currently lease an office located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.
We believe we have good relations with our employees. Properties and Facilities We currently lease an office located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis. Additionally, Proteomedix leases office and lab space located at Wagistrasse 23, 8952 Schlieren, Switzerland.
On February 18, 2025, Christian Brühlmann resigned from his position as Chief Strategy Officer of the Company. Mr. Brühlmann will remain in his position as Chief Business Officer of Proteomedix. On February 24, 2025, Dr.
Ralph Schiess (Chief Executive Officer), who developed the biomarker technology, and Christian Brühlmann (Chief Business Officer), with seasoned experience in finance, business development and product management. On February 18, 2025, Christian Brühlmann resigned from his position as Chief Strategy Officer of the Company. Mr. Brühlmann will remain in his position as Chief Business Officer of Proteomedix.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeMoreover, it is possible that the patent applications owned by Proteomedix and/or licensed pending patent applications will not result in granted patents, and even if such pending patent applications grant as patents, they may not provide a basis for intellectual property protection of commercially viable vaccine products or may not provide us with any competitive advantages.
Biggest changeEven if patents issue from these applications, there is no assurance that the patents will be free from defects or survive validity or enforceability challenges, the licensors may fail to maintain these patents, may decide not to pursue litigation against third-party infringers, may fail to prove infringement or may fail to defend against counterclaims of patent invalidity or unenforceability. 53 Moreover, it is possible that the patent applications owned by Proteomedix and/or licensed pending patent applications will not result in granted patents, and even if such pending patent applications grant as patents, they may not provide a basis for intellectual property protection of commercially viable vaccine products or may not provide us with any competitive advantages.
As a result, the patents and patent applications owned or licensed to us may not provide us with sufficient rights to exclude others from commercializing methods/products similar or identical to ours.
As a result, the patents and patent applications owned or licensed may not provide us with sufficient rights to exclude others from commercializing methods/products similar or identical to ours.
The laws include: ● the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; ● Federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which can be enforced by individuals through civil whistleblower and qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.; ● The federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by Covered Recipients, as defined at 42 CFR Part 403, Subpart I; ● HIPAA which prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services, and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information and certain notification requirements and criminal and civil penalties for failure to comply with those requirements; 58 ● the FDCA which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.
The laws include: ● the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; 59 ● Federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which can be enforced by individuals through civil whistleblower and qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.; ● The federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by Covered Recipients, as defined at 42 CFR Part 403, Subpart I; ● HIPAA which prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services, and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information and certain notification requirements and criminal and civil penalties for failure to comply with those requirements; ● the FDCA which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.
Contracts and grants funded by the U.S. government and its agencies, contain provisions that reflect the government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the government to: ● reduce or modify the government’s obligations under such agreements without the consent of the other party; ● claim rights, including Intellectual Property rights, in products and data developed under such agreements; ● audit contract-related costs and fees, including allocated indirect costs; ● suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations. ● impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements; ● suspend or debar the contractor or grantee from doing future business with the government; ● control and potentially prohibit the export of products; ● pursue criminal or civil remedies under the False Claims Act, False Statements Act, and similar remedy provisions specific to government agreements; and ● limit the government’s financial liability to amounts appropriated by the U.S.
Contracts and grants funded by the U.S. government and its agencies, contain provisions that reflect the government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the government to: ● reduce or modify the government’s obligations under such agreements without the consent of the other party; ● claim rights, including Intellectual Property rights, in products and data developed under such agreements; ● audit contract-related costs and fees, including allocated indirect costs; 61 ● suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations. ● impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements; ● suspend or debar the contractor or grantee from doing future business with the government; ● control and potentially prohibit the export of products; ● pursue criminal or civil remedies under the False Claims Act, False Statements Act, and similar remedy provisions specific to government agreements; and ● limit the government’s financial liability to amounts appropriated by the U.S.
Any such disagreement could result in one or more of the following, each of which could delay or prevent the commercialization of our current product, and in turn prevent us from generating revenues: ● unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration; ● uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations; 41 ● unwillingness by the partner to cooperate in the manufacture of the product, including providing us with product data or materials; ● unwillingness on the part of a partner to keep us informed regarding the progress of its commercialization activities or to permit public disclosure of the results of those activities; ● initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or ● attempts by either party to terminate the agreement.
Any such disagreement could result in one or more of the following, each of which could delay or prevent the commercialization of our current product, and in turn prevent us from generating revenues: ● unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration; ● uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations; ● unwillingness by the partner to cooperate in the manufacture of the product, including providing us with product data or materials; ● unwillingness on the part of a partner to keep us informed regarding the progress of its commercialization activities or to permit public disclosure of the results of those activities; ● initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or ● attempts by either party to terminate the agreement.
Some of our competitors have: ● substantially greater name recognition; ● broader, deeper, or longer-term relations with healthcare professionals, customers, and third-party payers; ● more established distribution networks; 47 ● additional lines of diagnostic tests and the ability to offer rebates or bundle them to offer greater discounts or other incentives to gain a competitive advantage; ● greater experience in conducting research and development, manufacturing, clinical trials, marketing and obtaining regulatory clearance or approval for diagnostic tests; and ● greater financial and human resources for product development, mergers and acquisitions, sales and marketing and possible patent litigation.
Some of our competitors have: ● substantially greater name recognition; ● broader, deeper, or longer-term relations with healthcare professionals, customers, and third-party payers; ● more established distribution networks; ● additional lines of diagnostic tests and the ability to offer rebates or bundle them to offer greater discounts or other incentives to gain a competitive advantage; ● greater experience in conducting research and development, manufacturing, clinical trials, marketing and obtaining regulatory clearance or approval for diagnostic tests; and ● greater financial and human resources for product development, mergers and acquisitions, sales and marketing and possible patent litigation.
We are subject to numerous risks relating to our manufacturing capabilities, including: ● quality or reliability defects in product components that we source from third-party suppliers, including manufacturing compliance with federal and state regulations; ● our inability to secure product components in a timely manner, in sufficient quantities or on commercially reasonable terms; 40 ● our failure to increase production of product to meet demand; ● our inability to modify production lines to enable us to efficiently implement changes in response to regulatory requirements; and ● Potential damage to or destruction of our manufacturing equipment or manufacturing facility.
We are subject to numerous risks relating to our manufacturing capabilities, including: ● quality or reliability defects in product components that we source from third-party suppliers, including manufacturing compliance with federal and state regulations; ● our inability to secure product components in a timely manner, in sufficient quantities or on commercially reasonable terms; ● our failure to increase production of product to meet demand; ● our inability to modify production lines to enable us to efficiently implement changes in response to regulatory requirements; and ● Potential damage to or destruction of our manufacturing equipment or manufacturing facility.
Specifically, we have identified the following control deficiencies which we believe are material weaknesses. ● We did not maintain an effective control environment as there was an inadequate segregation of duties with respect to certain cash disbursements. ● We do not have an effective risk assessment process or effective monitoring of compliance with established accounting policies and procedures, and do not demonstrate a sufficient level of precision in the application of our controls. ● Our controls over the approval and reporting of expense payments were not designed and maintained to achieve the Company’s objectives. ● We have insufficient accounting resources to maintain adequate segregation of duties, maintain adequate controls over the approval and posting of journal entries, and to provide optimal levels of oversight in order to process financial information in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements. 63 ● The Company did not design, implement, and maintain effective controls to ensure information technology (“IT”) policies and procedures set the tone at the top, to mitigate the risks to the achievement of IT objectives and ITGCs in the change management, logical security and computer operations domains.
Specifically, we have identified the following control deficiencies which we believe are material weaknesses. ● We did not maintain an effective control environment as there was an inadequate segregation of duties with respect to certain cash disbursements. ● We do not have an effective risk assessment process or effective monitoring of compliance with established accounting policies and procedures, and do not demonstrate a sufficient level of precision in the application of our controls. 64 ● Our controls over the approval and reporting of expense payments were not designed and maintained to achieve the Company’s objectives. ● We have insufficient accounting resources to maintain adequate segregation of duties, maintain adequate controls over the approval and posting of journal entries, and to provide optimal levels of oversight in order to process financial information in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements. ● The Company did not design, implement, and maintain effective controls to ensure information technology (“IT”) policies and procedures set the tone at the top, to mitigate the risks to the achievement of IT objectives and ITGCs in the change management, logical security and computer operations domains.
Upon the expiration, we will not be able to assert such licensed patent rights against potential competitors, which would materially adversely affect our business, financial condition, results of operations and prospects. We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms or at all.
Upon the expiration, we will not be able to assert such licensed patent rights against potential competitors, which would materially adversely affect our business, financial condition, results of operations and prospects. 55 We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms or at all.
These rules and regulations will cause us to incur significant legal and financial compliance costs and will make some activities more time-consuming and costly. To comply with the requirements of being a public company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting or internal audit staff.
These rules and regulations will cause us to incur significant legal and financial compliance costs and will make some activities more time-consuming and costly. 68 To comply with the requirements of being a public company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting or internal audit staff.
Complying with these various laws and satisfying healthcare providers’ and patients’ evolving expectations with respect to data protection, could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business. We do not maintain insurance policies for cybersecurity-related matters, data handling or data security liabilities.
Complying with these various laws and satisfying healthcare providers’ and patients’ evolving expectations with respect to data protection, could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business. 70 We do not maintain insurance policies for cybersecurity-related matters, data handling or data security liabilities.
We may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate problems caused by such breaches. 43 We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.
We may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate problems caused by such breaches. We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.
Moreover, the perception by the investment community or shareholders that recommendations, guidelines, or studies will result in decreased use of our product could adversely affect the prevailing market price for our common stock. We face competition from many sources, including larger companies, and we may be unable to compete successfully.
Moreover, the perception by the investment community or shareholders that recommendations, guidelines, or studies will result in decreased use of our product could adversely affect the prevailing market price for our common stock. 48 We face competition from many sources, including larger companies, and we may be unable to compete successfully.
To that end, we must be able to hire, train and integrate additional management, manufacturing, administrative and sales and marketing personnel. The failure to accomplish any of these tasks could prevent us from successfully growing our company. Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.
To that end, we must be able to hire, train and integrate additional management, manufacturing, administrative and sales and marketing personnel. The failure to accomplish any of these tasks could prevent us from successfully growing our company. 45 Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.
Under such a scenario, our assets would be distributed to our creditors leaving nothing to be distributed to our stockholders. Risks Related to the Commercialization of our Product The marketing approval processes in the United States are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for Proclarix, our business may be harmed.
Under such a scenario, our assets would be distributed to our creditors leaving nothing to be distributed to our stockholders. 31 Risks Related to the Commercialization of our Product The marketing approval processes in the United States are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for Proclarix, our business may be harmed.
In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.
In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. 56 We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.
Our employment arrangements with our employees provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice, which may lead to more difficulty in retaining qualified salespeople and other talent. We depend on our information technology systems and any failure of these systems could harm our business.
Our employment arrangements with our employees provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice, which may lead to more difficulty in retaining qualified salespeople and other talent. 50 We depend on our information technology systems and any failure of these systems could harm our business.
Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position. We may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets.
Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position. 57 We may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets.
Speculation in the industry about our existing or potential relationships with diagnostic laboratories and biopharmaceutical companies can also be a catalyst for adverse speculation about us, our tests and our technology, which can adversely affect our reputation and our business. We need to ensure strong product performance and quality to maintain and grow our business.
Speculation in the industry about our existing or potential relationships with diagnostic laboratories and biopharmaceutical companies can also be a catalyst for adverse speculation about us, our tests and our technology, which can adversely affect our reputation and our business. 38 We need to ensure strong product performance and quality to maintain and grow our business.
A public health emergency could also affect the operations of the FDA and other regulatory or public health authorities, resulting in delays to meetings and ultimately review of regulatory submissions. Our employees, independent contractors, principal investigators, consultants, and vendors and engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
A public health emergency could also affect the operations of the FDA and other regulatory or public health authorities, resulting in delays to meetings and ultimately review of regulatory submissions. 46 Our employees, independent contractors, principal investigators, consultants, and vendors and engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
Section 22 of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. 64 An active trading market for our common stock may not develop or be sustained.
Section 22 of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. An active trading market for our common stock may not develop or be sustained.
In addition, if we are unable to continue to meet these requirements, we may not be able to remain listed on Nasdaq. 68 The rules and regulations applicable to public companies have substantially increased our legal and financial compliance costs and make some activities more time-consuming and costly.
In addition, if we are unable to continue to meet these requirements, we may not be able to remain listed on Nasdaq. The rules and regulations applicable to public companies have substantially increased our legal and financial compliance costs and make some activities more time-consuming and costly.
In many jurisdictions outside the United States, a product must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our product is also subject to approval. 31 We may also submit marketing applications in other countries.
In many jurisdictions outside the United States, a product must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our product is also subject to approval. We may also submit marketing applications in other countries.
Any internet service interruption or hardware failure could affect availability of the online resource and thus negatively impact our business. 48 Cost-containment efforts of our customers, purchasing groups and governmental purchasing organizations could have a material adverse effect on our future sales and profitability.
Any internet service interruption or hardware failure could affect availability of the online resource and thus negatively impact our business. Cost-containment efforts of our customers, purchasing groups and governmental purchasing organizations could have a material adverse effect on our future sales and profitability.
Such proceedings are also expensive and time consuming. The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.
Such proceedings are also expensive and time consuming. 51 The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.
Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and other malicious code or similar disruptive problems. Proclarix is comprised of two components: Proclarix Assays and Proclarix Risk Calculator.
Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and other malicious code or similar disruptive problems. 69 Proclarix is comprised of two components: Proclarix Assays and Proclarix Risk Calculator.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace. 55 Competitors may infringe or otherwise violate our intellectual property, including patents that may be issued to or be licensed by us.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace. Competitors may infringe or otherwise violate our intellectual property, including patents that may be issued to or be licensed by us.
If we do not successfully commercialize our product or we experience significant delays in doing so, this product may not be profitable. Our business currently depends heavily on the successful commercialization of our product. We cannot be certain that our product will be successfully commercialized.
If we do not successfully commercialize our product or we experience significant delays in doing so, this product may not be profitable. Our business currently depends heavily on the successful commercialization of our product Proclarix. We cannot be certain that our product will be successfully commercialized.
The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. 57 Additionally, the U.S.
The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. Additionally, the U.S.
For example, depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of the U.S. patents licensed to us may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments.
For example, depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of the U.S. patents licensed may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments.
If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product, which would materially harm our business, financial condition, and results of operations.
If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product, which would materially harm our business, financial condition, and results of operations. In addition, we may not successfully commercialize our product.
For example: ● others may be able to make compounds/assays that are similar to our product and/or product candidates and/or assays, but that are not covered by the claims of our licensed patents; ● any patents that we obtain from licensing or otherwise may not provide us with any competitive advantages; ● any granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties; and ● the patents of others may have an adverse effect on our business. 50 We are dependent on licensed intellectual property.
For example: ● others may be able to make compounds/assays that are similar to our product and/or product candidates and/or assays, but that are not covered by the claims of our licensed patents; ● any patents that we obtain from licensing or otherwise may not provide us with any competitive advantages; ● any granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties; and ● the patents of others may have an adverse effect on our business.
We may not be able to file for regulatory approvals and even if we file, we may not receive necessary approvals to commercialize our product in any market. 33 Company shareholders may not realize a benefit from the ENTADFI or Proteomedix acquisitions commensurate with the ownership dilution they have experienced in connection with the transactions.
We may not be able to file for regulatory approvals and even if we file, we may not receive necessary approvals to commercialize our product in any market. Company shareholders may not realize a benefit from the Proteomedix acquisitions commensurate with the ownership dilution they have experienced in connection with the transactions.
We may not successfully commercialize our product. We or our collaboration partners in any potential commercial marketing efforts of our product may not be successful in achieving widespread patient or physician awareness or acceptance of this product.
We or our collaboration partners in any potential commercial marketing efforts of our product may not be successful in achieving widespread patient or physician awareness or acceptance of this product.
The degree of market acceptance of our current and future diagnostic tests and services depends on a number of factors, including: ● whether there is adequate utilization of our tests by clinicians, laboratories and other target groups based on the potential and perceived advantages of our diagnostic tests over those of our competitors; ● the convenience and ease of use of our diagnostic tests relative to those currently on the market; ● the effectiveness of our sales and marketing efforts; ● the ability of our distribution partners to meet sales forecasts; ● our ability to provide incremental data that show the clinical benefits and cost effectiveness, and operational benefits, of our diagnostic tests; ● the coverage and reimbursement acceptance of our product and services; ● pricing pressure, including from group purchasing organizations (“GPOs”), seeking to obtain discounts on our diagnostic tests based on the collective bargaining power of the GPO members; ● negative publicity regarding our or our competitors’ diagnostic tests resulting from defects or errors; and ● the diagnostic sensitivity and diagnostic specificity of our tests relative to those of our competitors.
These constituents must believe that our diagnostic tests offer benefits over other available alternatives. 37 The degree of market acceptance of our current and future diagnostic tests and services depends on a number of factors, including: ● whether there is adequate utilization of our tests by clinicians, laboratories and other target groups based on the potential and perceived advantages of our diagnostic tests over those of our competitors; ● the convenience and ease of use of our diagnostic tests relative to those currently on the market; ● the effectiveness of our sales and marketing efforts; ● the ability of our distribution partners to meet sales forecasts; ● our ability to provide incremental data that show the clinical benefits and cost effectiveness, and operational benefits, of our diagnostic tests; ● the coverage and reimbursement acceptance of our product and services; ● pricing pressure, including from group purchasing organizations (“GPOs”), seeking to obtain discounts on our diagnostic tests based on the collective bargaining power of the GPO members; ● negative publicity regarding our or our competitors’ diagnostic tests resulting from defects or errors; and ● the diagnostic sensitivity and diagnostic specificity of our tests relative to those of our competitors.
Termination of any of these license agreements would have a material adverse impact on our ability to develop and commercialize derived products under each respective agreement. We may enter into additional licenses to third-party intellectual property that are necessary or useful to our business.
We have entered into several licenses to support our various programs. Termination of any of these license agreements would have a material adverse impact on our ability to develop and commercialize derived products under each respective agreement. We may enter into additional licenses to third-party intellectual property that are necessary or useful to our business.
If the Company is unable to realize the full strategic and financial benefits previously anticipated from the recent ENTADFI and Proteomedix acquisitions, our shareholders may experience a dilution of their ownership interests in our Company without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the Company is able to realize only part of the strategic and financial benefits previously anticipated from the transactions.
If the Company is unable to realize the full strategic and financial benefits previously anticipated from acqusition, our shareholders may experience a dilution of their ownership interests in our Company without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the Company is able to realize only part of the strategic and financial benefits previously anticipated from the transactions.
If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product and/or product candidates, if approved.
We are dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product and/or product candidates, if approved.
If Nasdaq delists our common stock from trading on its exchange for failure to meet the Bid Price Rule or any other listing standards, we and our stockholders could face significant material adverse consequences including: ● a limited availability of market quotations for our securities; ● a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock; ● a limited amount of analyst coverage; and ● a decreased ability to issue additional securities or obtain additional financing in the future.
If the Company does not obtain a favorable decision from the Panel, its Common Stock will become subject to delisting. 66 If Nasdaq delists our common stock from trading on its exchange for failure to meet the Bid Price Rule or any other listing standards, we and our stockholders could face significant material adverse consequences including: ● a limited availability of market quotations for our securities; ● a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock; ● a limited amount of analyst coverage; and ● a decreased ability to issue additional securities or obtain additional financing in the future.
We also generated negative operating cash flows of $10.5 million for the year ended December 31, 2024. We expect to continue to spend significant resources to commercialize our product. We expect to incur substantial and increasing operating losses over the next several years. As a result, our accumulated deficit will also increase significantly.
We also generated negative operating cash flows of $9.7 million for the year ended December 31, 2025. We expect to continue to spend significant resources to commercialize our product. We expect to incur substantial and increasing operating losses over the next several years. As a result, our accumulated deficit will also increase significantly.
In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing capacity may not be available when required on terms that are acceptable to us, or at all, or suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements, which will adversely affect our business, financial condition and results of operations.
In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing capacity may not be available when required on terms that are acceptable to us, or at all, or suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements, which will adversely affect our business, financial condition and results of operations. 39 The timing of our new product offerings is uncertain.
We do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business.
We have never declared or paid cash dividends on our common stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business.
The success of our product will depend on several additional factors, including: ● establishing commercial manufacturing capabilities; ● launching commercial sales, marketing and distribution operations; ● establishing relationships with partners having established distribution, marketing and sales capabilities; ● the prevalence and severity of adverse events experienced with our product; ● acceptance of our product by patients, the medical community, and third-party payors; ● a continued acceptable safety profile following approval; ● obtaining and maintaining healthcare coverage and adequate reimbursement for our product; ● competing effectively with other therapies and diagnostics, including with respect to the sales and marketing of our product; and ● qualifying for, maintaining, enforcing and defending our intellectual property rights and claims.
The success of our product will depend on several additional factors, including: ● establishing commercial manufacturing capabilities; ● launching commercial sales, marketing and distribution operations; ● establishing relationships with partners having established distribution, marketing and sales capabilities; ● the prevalence and severity of adverse events experienced with our product; ● acceptance of our product by patients, the medical community, and third-party payors; ● a continued acceptable safety profile following approval; ● obtaining and maintaining healthcare coverage and adequate reimbursement for our product; ● competing effectively with other therapies and diagnostics, including with respect to the sales and marketing of our product; and ● qualifying for, maintaining, enforcing and defending our intellectual property rights and claims. 32 Many of these factors are beyond our control, including potential threats to our intellectual property rights and changes in the competitive landscape.
As of May 30, 2025, we had 5 full-time and 2 subcontracted employees. We will need to increase the size of our organization in order to support our continued commercialization of our product. As our commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales, marketing, financial and other resources may increase.
As of March 11, 2026, we had 2 full-time and 6 subcontracted employees. We will need to increase the size of our organization in order to support our continued commercialization of our product. As our commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales, marketing, financial and other resources may increase.
Our stock price could be subject to wide fluctuations in response to a variety of factors, which include: ● whether we achieve our anticipated corporate objectives; ● actual or anticipated fluctuations in our financial condition and operating results; ● changes in financial or operational estimates or projections; ● our execution of our sales and marketing, manufacturing and other aspects of our business plan; ● performance of third parties on whom we rely to manufacture our product and product components, including their ability to comply with regulatory requirements; 61 ● results of operations that vary from those of our competitors and the expectations of securities analysts and investors; ● changes in expectations as to our future financial performance, including financial estimates by securities analysts and investors; ● our announcement of significant contracts, acquisitions, or capital commitments; ● announcements by our competitors of competing products or other initiatives; ● announcements by third parties of significant claims or proceedings against us; ● regulatory and reimbursement developments in the United States and abroad; ● future sales of our common stock; ● product liability claims; ● healthcare reform measures in the United States; ● additions or departures of key personnel; and ● general economic or political conditions in the United States or elsewhere.
Our stock price could be subject to wide fluctuations in response to a variety of factors, which include: ● whether we achieve our anticipated corporate objectives; ● actual or anticipated fluctuations in our financial condition and operating results; ● changes in financial or operational estimates or projections; ● our execution of our sales and marketing, manufacturing and other aspects of our business plan; ● performance of third parties on whom we rely to manufacture our product and product components, including their ability to comply with regulatory requirements; ● results of operations that vary from those of our competitors and the expectations of securities analysts and investors; ● changes in expectations as to our future financial performance, including financial estimates by securities analysts and investors; ● our announcement of significant contracts, acquisitions, or capital commitments; ● announcements by our competitors of competing products or other initiatives; ● announcements by third parties of significant claims or proceedings against us; ● regulatory and reimbursement developments in the United States and abroad; ● future sales of our common stock; ● product liability claims; ● healthcare reform measures in the United States; ● additions or departures of key personnel; and ● general economic or political conditions in the United States or elsewhere. 63 In addition, the stock market in general, and the stock of medical biotechnology companies like ours, in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the issuer.
The timing of our new product offerings is uncertain. There can be no assurance that our development activities will always produce tests with the sensitivity and specificity necessary to be clinically and commercially competitive, or that any test will result in a commercially successful product.
There can be no assurance that our development activities will always produce tests with the sensitivity and specificity necessary to be clinically and commercially competitive, or that any test will result in a commercially successful product.
Market acceptance of our product by healthcare providers, patients and payors, will depend on a number of factors, many of which are beyond our control, including the following: ● the clinical indications for which our product is approved; ● acceptance by healthcare providers and payors of our product as safe and effective treatment or test; ● the cost in relation to alternative treatments or tests; ● the relative convenience and ease of administration of our product for the conditions for which it is intended; ● the availability and efficacy of competitive drugs or tests; ● the effectiveness of our sales and marketing efforts; ● the extent to which our product is approved for inclusion on formularies of hospitals and managed care organizations; ● the availability of coverage and adequate reimbursement by third parties, such as insurance companies and other health care payors, or by government health care programs, including Medicare and Medicaid; ● limitations or warnings contained in a product’s FDA or other applicable regulatory agency’s approved labeling; and ● prevalence and severity of adverse side effects.
Market acceptance of our product by healthcare providers, patients and payors, will depend on a number of factors, many of which are beyond our control, including the following: ● the clinical indications for which our product is approved; ● acceptance by healthcare providers and payors of our product as safe and effective treatment or test; ● the cost in relation to alternative treatments or tests; ● the relative convenience and ease of administration of our product for the conditions for which it is intended; ● the availability and efficacy of competitive drugs or tests; ● the effectiveness of our sales and marketing efforts; ● the extent to which our product is approved for inclusion on formularies of hospitals and managed care organizations; ● the availability of coverage and adequate reimbursement by third parties, such as insurance companies and other health care payors, or by government health care programs, including Medicare and Medicaid; ● limitations or warnings contained in a product’s FDA or other applicable regulatory agency’s approved labeling; and ● prevalence and severity of adverse side effects. 36 Even if the medical community accepts that our product is safe and efficacious for its approved indications, healthcare providers may not immediately be receptive to the use or may be slow to adopt such product as an accepted treatment or test for the conditions for which it is intended.
We have outstanding 44,358,422 shares of common stock as of the date hereof, assuming no exercise of outstanding options or warrants, are or will be freely tradable, without restriction, in the public market.
We have outstanding 3,584,245 shares of common stock as of the date hereof, assuming no exercise of outstanding options or warrants, are or will be freely tradable, without restriction, in the public market.
To the extent aggregate short exposure exceeds the number of shares of our common stock available for purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders of our common stock.
Speculation on the price of our common stock may involve long and short exposures. To the extent aggregate short exposure exceeds the number of shares of our common stock available for purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders of our common stock.
Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. We are not aware of any third-party proprietary rights that our planned methods and/or product will infringe or misappropriate, but we have not conducted any freedom to operate study as we are in the earliest stages of development.
We are not aware of any third-party proprietary rights that our planned methods and/or product will infringe or misappropriate, but we have not conducted any freedom to operate study as we are in the earliest stages of development.
Alternatively, if a court were to find the choice of forum provision contained in our Amended and Restated Certificate of Incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.
Alternatively, if a court were to find the choice of forum provision contained in our Amended and Restated Certificate of Incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition. 65 Our Amended and Restated Certificate of Incorporation provides that the exclusive forum provision will be applicable to the fullest extent permitted by applicable law.
Disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; ● whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● our right to sublicense patent and other rights to third parties; ● our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product and/or product candidates, and what activities satisfy those diligence obligations; ● our obligation to pursue or license others to pursue development of indications we are not currently pursuing; ● the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; ● our right to transfer or assign the license; and ● the effects of termination.
Disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; ● whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● our right to sublicense patent and other rights to third parties; ● our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product and/or product candidates, and what activities satisfy those diligence obligations; ● our obligation to pursue or license others to pursue development of indications we are not currently pursuing; ● the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; ● our right to transfer or assign the license; and ● the effects of termination. 52 If disputes over intellectual property that we own or have licensed prevent or impair our ability to maintain our patents or current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected products and/or product candidates.
We are a commercial-stage biotechnology company that was incorporated in October 2018. Our net loss was $58.7 million and $37.4 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $115.7 million.
We are a commercial-stage biotechnology company that was incorporated in October 2018. Our net loss was $14.0 million and $58.7 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $131.2 million.
Manufacturing risks may adversely affect our ability to manufacture our product and could reduce our gross margin and profitability. Our business strategy depends on our ability to manufacture our product in sufficient quantities and on a timely basis so as to meet consumer demand, while adhering to product quality standards, complying with regulatory requirements and managing manufacturing costs.
Our business strategy depends on our ability to manufacture our product in sufficient quantities and on a timely basis so as to meet consumer demand, while adhering to product quality standards, complying with regulatory requirements and managing manufacturing costs.
Our current liabilities are significant, and if those to whom we owe accounts payable, such as Veru or other vendors, were to demand payment, we would be unable to pay.
Our current liabilities are significant, and if those to whom we owe accounts payable, were to demand payment, we would be unable to pay.
If we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, FDA debarment, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our operating results. 45 Macroeconomic pressures in the markets in which we operate, including, but not limited to, the current conflicts in Ukraine and the Middle East may alter the ways in which we conduct our business operations and manage our financial capacities.
If we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, FDA debarment, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our operating results.
If the actual number of patients who would benefit from our diagnostic tests, the price at which we can sell them or the annual total addressable market for them is smaller than we have estimated, it may impair our sales growth and negatively affect our business, financial condition and results of operations. 37 We have a significant customer concentration, with a limited number of customers accounting for a large portion or all of our revenues.
If the actual number of patients who would benefit from our diagnostic tests, the price at which we can sell them or the annual total addressable market for them is smaller than we have estimated, it may impair our sales growth and negatively affect our business, financial condition and results of operations.
We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce or terminate our business activities. We owe a significant amount of money to Veru, which funds we do not have.
We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce or terminate our business activities.
Conditions in the global economy may adversely affect our business, financial condition and results of operations. Although demand for in vitro diagnostics is considered inelastic in developed economies, the in vitro diagnostic industry that we sell to may be affected by material changes in supply, market prices, exchange rates and general economic conditions.
Although demand for in vitro diagnostics is considered inelastic in developed economies, the in vitro diagnostic industry that we sell to may be affected by material changes in supply, market prices, exchange rates and general economic conditions.
Our ability to establish or maintain a technological or competitive advantage over our competitors may be diminished because of these uncertainties. 52 Even if patents are issued based on patent applications to which we have been granted a license or owned by Proteomedix, because the patent positions of diagnostic methods and/or pharmaceutical and biotechnology products are complex and uncertain, we cannot predict the scope and extent of patent protection for our product and/or product candidates.
Even if patents are issued based on patent applications to which we have been granted a license or owned by Proteomedix, because the patent positions of diagnostic methods and/or pharmaceutical and biotechnology products are complex and uncertain, we cannot predict the scope and extent of patent protection for our product and/or product candidates.
Litigation may be necessary to defend against these claims. If we fail to defend any such claims, in addition to paying monetary damages, we could lose valuable intellectual property rights or personnel, which could adversely impact our business.
Litigation may be necessary to defend against these claims. If we fail to defend any such claims, in addition to paying monetary damages, we could lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
If our existing stockholders sell substantial amounts of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship between such sales and the performance of our business.
If our existing stockholders sell substantial amounts of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship between such sales and the performance of our business. 67 The issuance or conversion of securities would result in significant dilution in the equity interest of existing shareholders and adversely affect the market price of the securities.
Any such litigation, investigations or other proceedings may divert our management team’s and board’s attention and resources away from our affairs and may negatively affect our reputation and our business. 44 Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent review of regulatory submissions in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent review of regulatory submissions in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
If we fail to reach an agreement with any commercialization partner, or upon reaching such an agreement that partner fails to sell a large volume of our product, it may have a negative impact on our business, financial condition, and results of operations. 39 We have no experience manufacturing our product on a commercial scale and are dependent on third parties for the manufacture of our product.
If we fail to reach an agreement with any commercialization partner, or upon reaching such an agreement that partner fails to sell a large volume of our product, it may have a negative impact on our business, financial condition, and results of operations.
If LabCorp terminates the agreement or demands terms that are less favorable to us, we may experience disruptions in our product development and commercialization efforts, potentially leading to a loss of revenue and market share.
LabCorp may terminate or seek to renegotiate the terms of this agreement, which could adversely affect our business operations and financial condition. If LabCorp terminates the agreement or demands terms that are less favorable to us, we may experience disruptions in our product development and commercialization efforts, potentially leading to a loss of revenue and market share.
If we are unable to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on our business, financial condition, results of operations and prospects. 54 We may infringe the intellectual property rights of others, which may prevent or delay our method and/or product development efforts and stop us from commercializing or increase the costs of commercializing our methods and/or product and/or product candidates.
If we are unable to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we do not comply with these restrictions, we may be subject to enforcement actions. 32 In addition, later discovery of previously unknown problems with our product, manufacturers or manufacturing processes and facilities or failure to comply with regulatory requirements, may result in, among other things: ● restrictions on our product, manufacturers or manufacturing processes or facilities; ● restrictions on the labeling, marketing, distribution, or use of a product; ● requirements to conduct post-approval clinical trials, other studies, or other post-approval commitments; ● warning or untitled letters; ● withdrawal or recall of our product from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● fines, restitution or disgorgement of profits or revenue; ● suspension or withdrawal of marketing approval; ● refusal to permit the import or export of our product; ● product seizure; and ● injunctions or the imposition of civil or criminal penalties.
In addition, later discovery of previously unknown problems with our product, manufacturers or manufacturing processes and facilities or failure to comply with regulatory requirements, may result in, among other things: ● restrictions on our product, manufacturers or manufacturing processes or facilities; ● restrictions on the labeling, marketing, distribution, or use of a product; ● requirements to conduct post-approval clinical trials, other studies, or other post-approval commitments; ● warning or untitled letters; ● withdrawal or recall of our product from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● fines, restitution or disgorgement of profits or revenue; ● suspension or withdrawal of marketing approval; ● refusal to permit the import or export of our product; ● product seizure; and ● injunctions or the imposition of civil or criminal penalties. 34 Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our product and product candidates internationally.
There may be significant delays in obtaining coverage and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved by the FDA or similar regulatory authorities outside the United States.
If coverage and reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize our product. 33 There may be significant delays in obtaining coverage and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved by the FDA or similar regulatory authorities outside the United States.
In addition, even if our product achieves market acceptance, we may not be able to maintain that market acceptance over time if: ● new products or technologies are introduced that are more favorably received than our product, are more cost effective or render our product obsolete; ● unforeseen complications arise with respect to use of our product or ● sufficient third-party insurance coverage or reimbursement does not remain available. 35 Proclarix is subject to competition from other prostate cancer diagnostics and larger, well-established companies with substantially greater resources than us.
In addition, even if our product achieves market acceptance, we may not be able to maintain that market acceptance over time if: ● new products or technologies are introduced that are more favorably received than our product, are more cost effective or render our product obsolete; ● unforeseen complications arise with respect to use of our product or ● sufficient third-party insurance coverage or reimbursement does not remain available.
Regardless of the merits or eventual outcome, liability claims may result in: ● decreased demand for our product; ● injury to our reputation and significant negative media attention; ● significant costs to defend the related litigation; ● substantial monetary awards to patients; ● loss of revenue; ● diversion of management and scientific resources from our business operations; ● the inability to commercialize our product; ● the initiation of investigations by regulators; and ● product recalls, withdrawals or labeling, marketing, or promotional restrictions. 42 We have product liability insurance coverage at a level that we believe is customary for similarly situated companies and adequate to provide us with insurance coverage for foreseeable risks.
Regardless of the merits or eventual outcome, liability claims may result in: ● decreased demand for our product; ● injury to our reputation and significant negative media attention; ● significant costs to defend the related litigation; ● substantial monetary awards to patients; ● loss of revenue; ● diversion of management and scientific resources from our business operations; ● the inability to commercialize our product; ● the initiation of investigations by regulators; and ● product recalls, withdrawals or labeling, marketing, or promotional restrictions.
Diagnostic companies or manufacturers of biosimilar drugs may challenge the scope, validity or enforceability of the patents underlying our technology in court or before a patent office, and the patent holder may not be successful in enforcing or defending those intellectual property rights and, as a result, we may not be able to develop or market the relevant method/product candidate exclusively, which would materially adversely affect any potential sales of that product. 53 Given the amount of time required for the development, testing and regulatory review of new diagnostic methods and/or vaccine candidates, patents protecting such diagnostic methods and/or vaccine candidates might expire before or shortly after such methods or vaccine candidates are commercialized.
Diagnostic companies or manufacturers of biosimilar drugs may challenge the scope, validity or enforceability of the patents underlying our technology in court or before a patent office, and the patent holder may not be successful in enforcing or defending those intellectual property rights and, as a result, we may not be able to develop or market the relevant method/product candidate exclusively, which would materially adversely affect any potential sales of that product.
The costs described above and any unanticipated costs and expenses, many of which will be borne by us even if the Ocuvex Business Combination is not completed, could have an adverse effect on our financial condition and operating results. Item 1B. Unresolved Staff Comments. None.
We will continue to assess the magnitude of theses costs, and we may incur additional unanticipated costs. The costs described above and any unanticipated costs and expenses, many of which will be borne by us even if the Realbotix Transaction is not completed, could have an adverse effect on our financial condition and operating results. Item 1B. Unresolved Staff Comments.
The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of December 31, 2024, the Company had cash of approximately $0.6 million, a working capital deficit of approximately $17.3 million and an accumulated deficit of approximately $115.7 million.
We has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of December 31, 2025, we had cash of approximately $5.2 million, a working capital deficit of approximately $3.1 million and an accumulated deficit of approximately $131.2 million.
Also, we may be subject to pricing pressures from competitive products or from governmental or commercial payors or regulatory bodies that could make it difficult or impossible for us to commercialize our product. Any failure to commercialize our product could have a material adverse effect on our future revenue and our business.
Also, we may be subject to pricing pressures from competitive products or from governmental or commercial payors or regulatory bodies that could make it difficult or impossible for us to commercialize our product.
In the event we would be subject to the U.S. government’s exercise such march-in rights, we may receive compensation that is deemed reasonable by the U.S. government in its sole discretion, which may be less than what we might be able to obtain in the open market. 60 Additionally, the U.S. government requires that any products embodying any invention generated through the use of U.S. government funding be manufactured substantially in the United States.
In the event we would be subject to the U.S. government’s exercise such march-in rights, we may receive compensation that is deemed reasonable by the U.S. government in its sole discretion, which may be less than what we might be able to obtain in the open market.
As of May 30, 2025, our officers and directors, together with holders of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 2,695,931 shares of our common stock, which in the aggregate represents approximately 6.08% of the outstanding shares of our common stock.
As of March 11, 2026, our officers and directors, together with holders of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 557,604 shares of our common stock, which in the aggregate represents approximately 15.6% of the outstanding shares of our common stock.
For example, in the EEA, medicinal products can only be commercialized after obtaining a Marketing Authorization, or MA. Before granting the MA, the European Medicines Agency, or the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
Before granting the MA, the European Medicines Agency, or the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
Further, if any of our employees or third-party service providers absconded with our proprietary data or know-how in order to compete with us, our competitive position may be materially and adversely affected. 46 Any improper conduct or use of funds by any of our employees or third-party service providers in contravention of our protocols and policies may lead to regulatory and disciplinary proceedings involving us.
Further, if any of our employees or third-party service providers absconded with our proprietary data or know-how in order to compete with us, our competitive position may be materially and adversely affected.
Under some license agreements, termination may also result in the transfer of or granting in rights under certain of our intellectual property and information related to the product candidate being developed under the license, such as regulatory information. 51 The agreements under which we license intellectual property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.
Under some license agreements, termination may also result in the transfer of or granting in rights under certain of our intellectual property and information related to the product candidate being developed under the license, such as regulatory information.
Any provision of our Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws or Delaware law that has the effect of delaying, preventing, or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock, and could also affect the price that some investors are willing to pay for our common stock.
Any provision of our Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws or Delaware law that has the effect of delaying, preventing, or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock, and could also affect the price that some investors are willing to pay for our common stock. 71 We do not anticipate paying any cash dividends on our common stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe Audit Committee is tasked with monitoring the effectiveness of our cybersecurity risk management program as implemented by management. The Audit Committee receives regular updates from management on the state of cybersecurity risks facing the Company. This includes briefings on any significant cyber incidents and ongoing risk management efforts.
Biggest changeThe Audit Committee receives regular updates from management on the state of cybersecurity risks facing the Company. This includes briefings on any significant cyber incidents and ongoing risk management efforts. These updates enable the Audit Committee to provide informed reports on cybersecurity matters to the full Board.
Central to our cybersecurity efforts is a robust incident response plan designed to address potential cyber incidents swiftly and effectively. In designing and evaluating our cybersecurity program, we have adopted the National Institute of Standards and Technology Cybersecurity Framework (“NIST CSF 2.0”) as a guiding principle.
Central to our cybersecurity efforts is a robust incident response plan designed to address potential cyber incidents swiftly and effectively. 74 In designing and evaluating our cybersecurity program, we have adopted the National Institute of Standards and Technology Cybersecurity Framework (“NIST CSF 2.0”) as a guiding principle.
The key components of our cybersecurity program will include: ● conducting risk assessments to pinpoint material cybersecurity threats to our critical systems, data, product, services, and overall IT infrastructure; ● a third-party security expert consultant overseeing the risk assessment process, maintenance of security controls, and coordination of responses to cybersecurity incidents; ● engagement with external service providers to evaluate, enhance, or support our security measures; ● an incident response plan outlining specific procedures for managing cybersecurity incidents; and 73 Cybersecurity Governance The governance of cybersecurity risks is a critical function of our Board, with the Audit Committee playing a key role in the oversight of cybersecurity and related technology risks.
The key components of our cybersecurity program include: ● conducting risk assessments to identify material cybersecurity threats to our critical systems, data, product, services, and overall IT infrastructure; ● a third-party security expert consultant overseeing the risk assessment process, maintenance of security controls, and coordination of responses to cybersecurity incidents; ● engagement with external service providers to evaluate, enhance, or support our security measures; ● an incident response plan outlining specific procedures for managing cybersecurity incidents; and ● Cybersecurity awareness training for employees to promote a security-conscious culture and reduce the risk of human error.
These updates enable the Audit Committee to provide informed reports on cybersecurity matters to the full Board. The responsibility for day-to-day management of cybersecurity risks lies with our management team, including the Interim Chief Financial Officer. This team is at the forefront of our cybersecurity initiatives, coordinating both internal and external resources to anticipate, identify, and mitigate cyber threats.
The responsibility for day-to-day management of cybersecurity risks lies with our management team, including the Interim Chief Financial Officer. This team is responsible for our cybersecurity initiatives, coordinating both internal and external resources to anticipate, identify, and mitigate cyber threats.
We are in the process of implementing our cybersecurity program, which is aimed at safeguarding the confidentiality, integrity, and availability of our essential systems and information, and is designed to detect and mitigate risks from cybersecurity threats to our data and our systems.
We have implemented our cybersecurity program, which is aimed at safeguarding the confidentiality, integrity, and availability of our essential systems and information, and is designed to detect and mitigate risks from cybersecurity threats to our data and our systems. The program is subject to ongoing review and improvement as our threat environment and operations evolve.
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Cybersecurity Governance The governance of cybersecurity risks is a critical function of our Board, with the Audit Committee playing a key role in the oversight of cybersecurity and related technology risks. The Audit Committee is tasked with monitoring the effectiveness of our cybersecurity risk management program as implemented by management.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties We currently lease an office located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis. Additionally, Proteomedix leases office and lab space located at Wagistrasse 23, 8952 Schlieren, Switzerland. This lease expires on June 30, 2025, subject to renewal for successive two-year terms.
Biggest changeItem 2. Properties We currently lease an office located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis. Additionally, Proteomedix leases office and lab space located at Wagistrasse 23, 8952 Schlieren, Switzerland.
The lease will automatically renew unless terminated. Either party may terminate the lease with 12 months’ written notice.
Either party may terminate the lease with twelve months’ written notice.
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This lease expired on December 31, 2025, and was renewed for a successive two-year term, resulting in an additional right-of-use asset and lease liability of approximately $49,000. The lease, as renewed, requires payments of approximately $24,000 over the next twelve months. The lease will automatically renew for successive two-year terms, unless terminated.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings. From time to time, we may be involved in various disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any material legal proceedings. Item 4. Mine Safety Disclosures. Not applicable. 74 PART II
Biggest changeItem 3. Legal Proceedings. From time to time, we may be involved in various disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any material legal proceedings. Item 4. Mine Safety Disclosures. Not applicable. 75 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeDividend Policy As of the date of this Annual Report on Form 10-K, we have not paid any cash dividends to stockholders.
Biggest changeRecent Sales of Unregistered Securities None that have not been previously reported on a Quarterly Report on Form 10-Q or Current Report on Form 8-K. Dividend Policy As of the date of this Annual Report on Form 10-K, we have not paid any cash dividends to stockholders.
This number does not include stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities. Recent Sales of Unregistered Securities None.
This number does not include stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is traded on Nasdaq under the symbol “ONCO.” Holders As of May 30, 2025, there were approximately 30 holders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is traded on Nasdaq under the symbol “ONCO.” Holders As of March 11, 2026, there were approximately 27 holders of record of our common stock.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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Biggest changeItem 6. [Reserved] 75 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 75 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 91 Item 8. Financial Statements and Supplementary Data 91 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 91 Item 9A. Controls and Procedures 92
Biggest changeItem 6. [Reserved] 76 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 76 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 92 Item 8. Financial Statements and Supplementary Data 92 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 92 Item 9A. Controls and Procedures 93

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeResults of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes our statements of operations and comprehensive loss for the periods indicated: Year Ended December 31, 2024 Year Ended December 31, 2023 $ Change % Change Revenue $ 2,524,116 $ 58,465 $ 2,465,651 4217.3 % Cost of revenue 1,469,018 1,185,630 283,388 23.9 % Gross profit (loss) 1,055,098 (1,127,165 ) 2,182,263 (193.6 )% Operating expenses Selling, general and administrative $ 11,231,982 $ 14,770,678 (3,538,696 ) (24.0 )% Research and development 154,359 1,949,406 (1,795,047 ) (92.1 )% Impairment of ENTADFI assets 3,530,716 14,687,346 (11,156,630 ) (76.0 )% Impairment of Goodwill 32,347,000 - 32,347,000 100.0 % Impairment of Intangibles 10,279,796 - 10,279,796 100.0 % Impairment of deposit on asset purchase agreement - 3,500,000 (3,500,000 ) (100.0 )% Total operating expenses 57,543,853 34,907,430 22,636,423 64.8 % Loss from operations (56,488,755 ) (36,034,595 ) (20,454,160 ) 56.8 % Other income (expense) Loss on extinguishment of note payable - (490,000 ) 490,000 (100 )% Interest expense – related party (534,245 ) - (534,245 ) 100 % Interest expense (873,433 ) (671,625 ) (201,808 ) 30 % Interest Income 18 - 18 100 % Change in fair value of subscription agreement liability (3,259,000 ) (134,100 ) (3,124,900 ) 2330.3 % Change in fair value of contingent warrant liabilities 1,250,466 (91,967 ) 1,342,433 (1459.7 )% Other 168,746 - 168,746 100 % Total other (expense) (3,247,448 ) (1,387,692 ) (1,859,756 ) 134 % Loss before income taxes (59,736,203 ) (37,422,287 ) (22,313,916 ) 59.6 % Income tax benefit 1,045,180 12,593 1,032,587 8199.7 % Net loss $ (58,691,023 ) $ (37,409,694 ) (21,281,329 ) 56.9 % Deemed dividend Series C preferred stock (206,404 ) - (206,404 ) 100 % Net loss applicable to common stockholders’ $ (58,897,427 ) $ (37,409,694 ) (21,487,733 ) 57.4 % 84 Revenue, Cost of Revenue, and Gross Margin For the year ended December 31, 2024, the Company had $2.5 million in revenue, which was attributable to Proteomedix revenue.
Biggest changeOther Income (Expense) Other income (expense) is comprised of interest expense on notes payable, loss on extinguishment of notes payable, loss on issuance of preferred stock and warrants, loss on extinguishment of preferred stock, gain on forgiveness of accounts payable, the change in fair value of financial instruments that are recorded as liabilities, which includes the related party subscription agreement liability, the contingent warrant liability, derivative and warrant liabilities for share of Series D and E preferred stock, and other income. 84 Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes our statements of operations and comprehensive loss for the periods indicated: Year Ended December 31, 2025 Year Ended December 31, 2024 $ Change % Change Revenue $ 815,371 $ 2,524,116 $ (1,708,745 ) (67.7 )% Cost of revenue 182,458 1,469,018 (1,286,560 ) (87.6 )% Gross profit (loss) 632,913 1,055,098 (422,185 ) (40.0 )% Operating expenses Selling, general and administrative $ 7,043,902 $ 11,231,982 (4,188,080 ) (37.3 )% Research and development (66,133 ) 154,359 (220,492 ) (142.8 )% Impairment of ENTADFI assets — 3,530,716 (3,530,716 ) (100.0 )% Impairment of Goodwill 11,512,000 32,347,000 (20,835,000 ) (64.4 )% Impairment of Intangibles — 10,279,796 (10,279,796 ) (100.0 )% Total operating expenses 18,489,769 57,543,853 (39,054,084 ) (67.9 )% Loss from operations (17,856,856 ) (56,488,755 ) 38,631,899 (68.4 )% Other income (expense) Loss on extinguishment of note payable (5,384,719 ) — (5,384,719 ) 100.0 % Loss on issuance of preferred stock and warrants (3,674,329 ) — (3,674,329 ) 100.0 % Loss on extinguishment of preferred stock (196,244 ) — (196,244 ) 100.0 % Interest expense – related party — (534,245 ) 534,245 (100.0 )% Interest expense (751,005 ) (873,433 ) 122,428 (14.0 )% Interest Income 2 18 (16 ) (88.9 )% Change in fair value of subscription agreement liability 3,127,962 (3,259,000 ) 6,386,962 196.0 % Change in fair value of contingent warrant liabilities 16,499 1,250,466 (1,233,967 ) (98.7 )% Change in fair value of Series D Warrant Liability 10,377,638 — 10,377,638 100.0 % Change in fair value of Series D Derivative Liability (3,809,333 ) — (3,809,333 ) 100.0 % Change in fair value of Series E Warrant Liability 4,486,847 — 4,486,847 100.0 % Change in fair value of Series E Derivative Liability (1,539,014 ) — (1,539,014 ) 100.0 % Gain on forgiveness of accounts payable 944,694 — 944,694 100.0 % Other income 226,041 168,746 57,295 34.0 % Total other income (expense) 3,825,039 (3,247,448 ) 7,072,487 217.8 % Loss before income taxes (14,031,817 ) (59,736,203 ) 45,704,386 (76.5 )% Income tax (expense) benefit (525 ) 1,045,180 (1,045,705 ) (100.1 )% Net loss $ (14,032,342 ) $ (58,691,023 ) 44,658,681 (76.1 )% Deemed dividend Series C preferred stock (1,498,595 ) (206,404 ) (1,292,191 ) 626.0 % Net loss applicable to common stockholders’ $ (15,530,937 ) $ (58,897,427 ) 43,366,490 (73.6 )% Revenue, Cost of Revenue, and Gross Margin For the year ended December 31, 2025, revenue decreased by approximately $1.7 million to $0.8 million from $2.5 million for the year ended December 31, 2024.
Additionally, LabCorp may deduct royalties or other payments made to third parties related to the manufacture or sale of Licensed Products up to a maximum amount of any royalty payments due to Proteomedix. The license agreement and related royalty payment provisions expire during 2038, which approximates the expiration of the last patent covered by the license agreement.
Additionally, LabCorp may deduct royalties or other payments made to third parties related to the manufacture or sale of Licensed Products up to a maximum amount of any royalty payments due to Proteomedix. The LabCorp License Agreement and related royalty payment provisions expire during 2038, which approximates the expiration of the last patent covered by the LabCorp License Agreement.
LabCorp has the right to terminate the license agreement for any reason by providing 90 days written notice to Proteomedix. Either party may terminate the license agreement due to a material breach of the terms of the license agreement with 30 days’ notice, provided such breach is not cured within the foregoing 30-day period.
LabCorp has the right to terminate the LabCorp License Agreement for any reason by providing 90 days written notice to Proteomedix. Either party may terminate the LabCorp License Agreement due to a material breach of the terms of the LabCorp License Agreement with 30 days’ notice, provided such breach is not cured within the foregoing 30-day period.
Recent Accounting Pronouncements Not Yet Adopted See Note 3 to our consolidated financial statements included elsewhere in this Report for more information. Critical Accounting Policies and Estimates Our consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”).
Recent Accounting Pronouncements Not Yet Adopted See Note 3 to our consolidated financial statements included elsewhere in this Report for more information. 89 Critical Accounting Policies and Estimates Our consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”).
All issued and outstanding common stock, common stock warrants, and share-based awards’ exercise prices and per share data have been adjusted in the consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented.
All issued and outstanding common stock, common stock warrants, and share-based awards’ exercise prices and per share data have been adjusted in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented.
At any time after the initial issuance date of Series C convertible Preferred Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock.
At any time after the initial issuance date of Series C Preferred Stock, each Series C Preferred Stock shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock.
Since our inception in October 2018 until April 2023, when we acquired ENTADFI, we devoted substantially all of our resources to performing research and development, undertaking preclinical studies and enabling manufacturing activities in support of our product development efforts, hiring personnel, acquiring and developing our technology and now deprioritized vaccine candidates, organizing and staffing our company, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand such activities.
Since our inception in October 2018 until April 2023, when we acquired ENTADFI, we devoted substantially all of our resources to performing research and development, undertaking preclinical studies and enabling manufacturing activities in support of our product development efforts, hiring personnel, acquiring and developing our technology and now halted vaccine candidates, organizing and staffing our company, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand such activities.
If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization of Proclarix and any future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations, or, if it is required to, file for bankruptcy.
If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization of future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations, or, if it’s required to, file for bankruptcy.
Laboratory Corporation of America On March 23, 2023, Proteomedix entered into a license agreement with LabCorp pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix and other products developed by LabCorp using Proteomedix’s intellectual property covered by the license, in the United States (“Licensed Products”).
Laboratory Corporation of America On March 23, 2023, Proteomedix entered into a license agreement with LabCorp (“LabCorp License Agreement”) pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix and other products developed by LabCorp using Proteomedix’s intellectual property covered by the license, in the United States (“Licensed Products”).
Cash Flows from Investing Activities Net cash used in investing activities for the year ended December 31, 2024 was approximately $30,000, of which all was due to the purchase of property and equipment.
Cash Flows from Investing Activities Net cash used in investing activities for the year ended December 31, 2025 was $0. Net cash used in investing activities for the year ended December 31, 2024 was approximately $30,000, of which all was due to the purchase of property and equipment.
On January 15, 2025, the Company and IQVIA entered into a Settlement Agreement (the “Settlement Agreement”) concerning potential termination payments under the Master Services Agreement and statements of work.
On January 15, 2025, the Company and IQVIA entered into a Settlement Agreement (the “IQVIA Settlement Agreement”) concerning potential termination payments under the Master Services Agreement and statements of work.
Cash Flows from Financing Activities Net cash provided by financing activities for the year ended December 31, 2024 was approximately $6.7 million, which resulted from proceeds from issuance of notes payable for related parties of $5.0 million, net proceeds from the exercise of preferred investment options of $0.9 million, proceeds from the purchase of series C preferred stock of $1.9 million, and proceeds from purchases of common stock of $0.7 million.
Net cash provided by financing activities for the year ended December 31, 2024 was approximately $6.7 million, which resulted from proceeds from issuance of notes payable for related parties of $5.0 million, net proceeds from the exercise of preferred investment options of $0.9 million, proceeds from the issuance of series C preferred stock of $1.9 million, and proceeds from sale of common stock of $0.7 million.
In consideration for granting LabCorp an exclusive license, Proteomedix received an initial license fee in the mid-six figures upon signing of the contract.
In consideration for granting LabCorp an exclusive license, Proteomedix received an initial license fee in the mid-six figures upon signing of the LabCorp License Agreement.
We have elected to avail ourselves of this extended transition period. 90 For as long as we remain an “emerging growth company” under the recently enacted JOBS Act, we will, among other things: ● be exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act, which requires that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting; ● be permitted to omit the detailed compensation discussion and analysis from proxy statements and reports filed under the Exchange Act and instead provide a reduced level of disclosure concerning executive compensation; and ● be exempt from any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.
For as long as we remain an “emerging growth company” under the recently enacted JOBS Act, we will, among other things: ● be exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act, which requires that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting; ● be permitted to omit the detailed compensation discussion and analysis from proxy statements and reports filed under the Exchange Act and instead provide a reduced level of disclosure concerning executive compensation; and ● be exempt from any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.
Although we anticipate these sales to offset some expenses relating to commercial scale up and development, we expect our expenses will increase substantially in connection with our ongoing activities, as we: ● commercialize Proclarix ● hire additional personnel; ● operate as a public company; and ● obtain, maintain, expand, and protect our intellectual property portfolio.
We anticipate these sales to offset some expenses relating to commercial scale up and development, but we expect our expenses also to increase in connection with our ongoing activities, as we: ● commercialize Proclarix ● hire additional personnel; ● operate as a public company; and ● obtain, maintain, expand, and protect our intellectual property portfolio.
Series C Preferred Stock On October 1, 2024, the Board authorized the Company to create a series of 10,000 shares of preferred stock designated as “Series C convertible Preferred Stock”, with a par value of $0.00001, pursuant to the certificate of designations.
Series C PIPE Financing and ELOC On October 1, 2024, the Board authorized the Company to create a series of 10,000 shares of preferred stock designated as “Series C Preferred Stock”, with a par value of $0.00001, pursuant to the certificate of designations.
The Company had approximately $1.1 million and $1.8 million recorded in related accounts payable as of December 31, 2024 and 2023, respectively, which includes amounts due for early termination of the contract. See Note 6 to our consolidated financial statements included elsewhere in this Report.
The Company had approximately $0 and $1.1 million recorded in related accounts payable as of December 31, 2025 and 2024, respectively, which includes amounts due for early termination of the contract. See Note 5 to our consolidated financial statements included elsewhere in this Report.
During the third quarter of 2023, we halted our vaccine discovery and development programs, and accordingly, we now operate in one segment: commercial. The commercial segment was new in the second quarter of 2023 and is currently dedicated to the development and commercialization of Proclarix.
During the third quarter of 2023, we halted our vaccine discovery and development programs, and accordingly, we now operate in one segment: commercial. The commercial segment was new in the second quarter of 2023 and is currently dedicated to the development and commercialization of Proclarix. Proclarix is CE-marked and for sale in Europe.
On October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “PIPE Investors”), pursuant to the securities purchase agreement an aggregate of 3,499 shares of Series C Preferred Stock which includes an issuance of 840 shares of Series C Preferred Stock to the lead investor in consideration for the PIPE Investors’ irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 591,856 shares of Common Stock, (together, the “PIPE Securities”) for aggregate net cash proceeds to the Company of $1.9 million.
On October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “Series C PIPE Investors”), pursuant to the securities purchase agreement an aggregate of 3,499 shares of Series C Preferred Stock which includes an issuance of 840 shares of Series C Preferred Stock to the lead investor in consideration for the Series C PIPE Investors’ irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 6,963 shares of Common Stock (“Series C Warrants”) for aggregate net cash proceeds to the Company of $1.9 million.
Additionally, Proteomedix is entitled to royalty payments between 5% and 10% on the net sales recognized by LabCorp of any Licensed Products plus milestone payments as follows: ● after the first sale of Proclarix as a laboratory developed test, LabCorp will pay an amount in the mid-six figures; ● after LabCorp achieves a certain amount in the low seven figures in net sales of the Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures; and ● after a certain amount in the mid-seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures. 82 A total of $2.5 million in milestone payments are payable under the license agreement.
Additionally, Proteomedix is entitled to royalty payments between 5% and 10% on the net sales recognized by LabCorp of any Licensed Products plus milestone payments as follows: ● after the first sale of Proclarix as a laboratory developed test, LabCorp will pay an amount in the mid-six figures; ● after LabCorp achieves a certain amount in the low seven figures in net sales of the Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures; and ● after a certain amount in the mid-seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures.
Accordingly, until such time as we can generate significant revenue, if ever, we expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding and to rely on third-party resources for marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches, to support our operations.
Accordingly, until such time as we can generate significant revenue, if ever, we expect to finance our cash needs through public or private equity or debt financings, third-party (including government) funding and to rely on third-party resources for marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches, to support our operations. 77 Some recent key developments affecting our business include the following: Realbotix Corp.
It is estimated over 50% of biopsies with elevated PSA are negative or clinically insignificant resulting in an overdiagnosis and overtreatment that impacts the physician’s routine, our healthcare system, and the quality of patients’ lives.
PSA results can be confusing for many patients and even physicians. It is estimated over 50% of biopsies with elevated PSA are negative or clinically insignificant resulting in an overdiagnosis and overtreatment that impacts the physician’s routine, our healthcare system, and the quality of patients’ lives.
Reverse Stock Split On September 24, 2024, the Company effected a Reverse Stock Split of all shares of its issued and outstanding Common Stock at a ratio of one-for-forty (1:40). The Company accounted for the reverse stock split on a retrospective basis pursuant to Accounting Standards Codification (“ASC”) 260, Earnings Per Share .
Reverse Stock Split On June 13, 2025, the Company effected a reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-eighty-five (1:85). The Company accounted for the reverse stock split on a retrospective basis pursuant to Accounting Standards Codification (“ASC”) 260, Earnings Per Share.
The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of December 31, 2024, the Company had cash of approximately $0.6 million, a working capital deficit of approximately $17.3 million and an accumulated deficit of approximately $115.7 million.
The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of December 31, 2025, the Company had cash of approximately $5.2 million, a working capital deficit of approximately $3.1 million and an accumulated deficit of approximately $131.2 million.
In other words, an “emerging growth company” can delay the adoption of new or revised accounting standards until those standards would otherwise apply to private companies.
In other words, an “emerging growth company” can delay the adoption of new or revised accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period.
Our future capital requirements will depend on many factors, including: ● the costs of future commercialization activities, including product manufacturing, marketing, sales, royalties, and distribution, for Proclarix, and other products for which we may receive marketing approval; ● the timing, scope, progress, results and costs of research and development, testing, screening, manufacturing, preclinical and non-clinical studies and clinical trials; ● the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform field efficacy studies, require more studies than those that we currently expect or change their requirements regarding the data required to support a marketing application; ● our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; ● any product liability or other lawsuits related to our product; ● the expenses needed to attract, hire and retain skilled personnel; ● the revenue, if any, received from commercial sales of Proclarix, or other products for which we may have received or will receive marketing approval; ● the costs to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing our patents or other intellectual property rights; and ● the costs of operating as a public company.
Our future capital requirements will depend on many factors, including: ● the costs of future development and commercialization activities, including product manufacturing, marketing, sales, royalties, and distribution, for Proclarix, and other products for which we may receive marketing approval; ● our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; ● any product liability or other lawsuits related to our product; ● the expenses needed to attract, hire and retain skilled personnel; ● the revenue, if any, received from commercial sales of Proclarix, or other products for which we may have received or will receive marketing approval; ● the costs to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing our patents or other intellectual property rights; and ● the costs of operating as a public company.
An additional $0.5 million was paid to Proteomedix as an initial license fee in 2023. LabCorp is wholly responsible for the cost, if any, of research, development and commercialization of Licensed Products in the United States but has the right to offset a portion of those costs against future royalty and milestone payments.
LabCorp is wholly responsible for the cost, if any, of research, development and commercialization of Licensed Products in the United States but has the right to offset a portion of those costs against future royalty and milestone payments.
Future Funding Requirements We anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to commercialize Proclarix. 86 We will require significant amounts of additional capital in the short-term, to continue to fund our continuing operations, satisfy existing and future obligations and liabilities, including the remaining payments due under the Veru APA and other contracts entered into in support of the Company’s commercialization plans, in addition to funds needed to support our working capital needs and business activities, including the development and commercialization of Proclarix, and the development and commercialization of our future product candidates.
We will require significant amounts of additional capital in the short-term, to continue to fund our continuing operations, satisfy existing and future obligations and liabilities contracts entered into in support of the Company’s commercialization plans, in addition to funds needed to support our working capital needs and business activities, including the development and commercialization of Proclarix, and the development and commercialization of our future product candidates.
Pursuant to the Settlement Agreement, the Company agreed to pay to IQVIA an aggregate of $150,000 in exchange for a mutual release of all claims in connection with the Master Services Agreement. As a result of the Settlement Agreement, the Company will record an adjustment of approximately $(0.9) million in accounts payable.
Pursuant to the IQVIA Settlement Agreement, the Company agreed to pay to IQVIA an aggregate of $150,000 in exchange for a mutual release of all claims in connection with the Master Services Agreement.
Finally, Proteomedix may terminate the license agreement with 60 days’ notice in the event LabCorp fails to make any undisputed payment due, provided that LabCorp does not remit the payment within the foregoing 60-day period.
Finally, Proteomedix may terminate the LabCorp License Agreement with 60 days’ notice in the event LabCorp fails to make any undisputed payment due, provided that LabCorp does not remit the payment within the foregoing 60-day period. 82 On December 6, 2025, Proteomedix and LabCorp entered into an amendment (the “LabCorp Amendment”) of the LabCorp License Agreement.
The consolidated financial statements have been prepared assuming the Company will continue as a going concern. These consolidated financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.
The consolidated financial statements have been prepared assuming the Company will continue as a going concern. These consolidated financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty. Future Funding Requirements We anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to commercialize Proclarix.
A reporting unit is an operating segment or sub-segment to which goodwill is assigned when initially recorded. The Company tests indefinite lived intangible assets for impairment, on an annual basis in the fourth quarter, or more frequently if an event occurs or circumstances indicate that the indefinite lived assets may be impaired.
The Company tests indefinite lived intangible assets for impairment, on an annual basis in the fourth quarter, or more frequently if an event occurs or circumstances indicate that the indefinite lived assets may be impaired.
We have no internal manufacturing capabilities, and we will continue to rely on third parties, of which the main suppliers are single-source suppliers, for commercial product. 76 We do not have any products approved for sale, aside from Proclarix and ENTADFI, from which we have not generated any revenue from product sales and for which we have determined to abandon commercialization activities To date, we have financed our operations primarily with proceeds from our sale of preferred securities to seed investors, the initial public offering (“IPO”), and subsequent offerings of debt and equity securities.
We do not have any products approved for sale, aside from (i) Proclarix and (ii) ENTADFI, which has not generated any revenue from product sales; we have determined to abandon commercialization of ENTADFI and no longer holds inventory of the product, we have financed our operations primarily with proceeds from our sale of preferred securities to seed investors, the initial public offering (“IPO”), and subsequent offerings of debt and equity securities.
These business activities include the development and commercialization of Proclarix, and the development and commercialization of the Company’s future product candidates. Management’s plans for funding the Company’s operations include generating product revenue from sales of Proclarix, which is still subject to further successful commercialization activities within certain jurisdictions.
Management’s plans for funding the Company’s operations include generating product revenue from sales of Proclarix, which is still subject to further successful development and commercialization activities within certain jurisdictions. Management also intends to pursue additional equity or debt financing to support operations and strategic initiatives.
We are currently focusing our efforts on commercializing Proclarix. Proclarix is an easy-to-use next generation protein-based blood test that can be done with the same sample as a patient’s regular Prostate-Specific Antigen (“PSA”) test. The PSA test is a well-established prostate specific marker that measures the concentration of PSA molecules in a blood sample.
Based on the circumstances surrounding ENTADFI, at June 30, 2024, the ENTADFI assets were fully impaired. 76 We are currently focusing our efforts on commercializing Proclarix. Proclarix is an easy-to-use next generation protein-based blood test that can be done with the same sample as a patient’s regular Prostate-Specific Antigen (“PSA”) test.
Goodwill and intangible assets deemed to have indefinite lives are not amortized but are subject to impairment tests on an annual basis, and whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Goodwill is allocated to the reporting unit from which it was created.
Goodwill Goodwill represents the excess of the cost of a business combination over the fair value of the net assets acquired. Goodwill and intangible assets deemed to have indefinite lives are not amortized but are subject to impairment tests on an annual basis, and whenever events or changes in circumstances indicate that the carrying value may not be recoverable.
Net cash used in operating activities for the year ended December 31, 2023 was $13.6 million, which primarily resulted from a net loss of $37.4 million.
Net cash used in operating activities for the year ended December 31, 2024 was approximately $10.5 million, which primarily resulted from the net loss of $58.7 million.
Components of Results of Operations Selling, General and Administrative Expenses Selling, general and administrative expenses consist principally of commercialization activities , payroll, and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and tax services, information technology costs, costs incurred with respect to acquisitions and potential acquisitions, and other general operating expenses.
As of December 31, 2025, the Company paid IQVIA the agreed upon amount of $150,000 and recorded a gain of approximately $(0.9) million on settlement of accounts payable. 83 Components of Results of Operations Selling, General and Administrative Expenses Selling, general and administrative expenses consist principally of commercialization activities, payroll, and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and tax services, information technology costs, costs incurred with respect to acquisitions and potential acquisitions, and other general operating expenses.
We anticipate that our selling, general and administrative expenses related to Proteomedix will increase when compared to historical levels as a result of efforts to commercialize Proclarix, and costs associated with integration of Proteomedix’s operations. 83 Research and Development Expenses Historically, substantially all of our research and development expenses consisted of expenses incurred in connection with the development of our product candidates.
We anticipate that our selling, general and administrative expenses related to Proteomedix will decrease when compared to historical levels due to cost reduction efforts, including headcount reductions, and the termination of Proteomedix’s pension plan. Research and Development Expenses Historically, substantially all of our research and development expenses consisted of expenses incurred in connection with the development of our product candidates.
The Company recorded an impairment of goodwill related to the PMX acquisition during the year ended December 31, 2024 totaling $32.3 million. The Company also recorded an impairment of intangible assets related to the PMX acquisition during the year ended December 31, 2024 totaling $10.3 million.
During the year ended December 31, 2024, the Company recorded impairments of goodwill and intangibles related to the PMX acquisition of $32.3 million and $10.3 million, respectively. In addition, the Company recorded an impairment charge of the ENTADFI asset of $3.5 million.
These proceeds from investing activities was offset by payments in deferred financing costs and payments of note payable totaling $1.7 million.
These proceeds from investing activities was offset by payments in deferred financing costs and payments of note payable totaling $1.7 million. Legal Contingencies From time to time, we may become involved in legal proceedings arising from the ordinary course of business.
Until we can generate a sufficient amount of revenue from sales of Proclarix if at all, we expect to finance our future cash needs through public or private equity or debt financings, third-party funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches.
Until we can generate a sufficient amount of revenue from sales of Proclarix if at all, we expect to finance our future cash needs through public or private equity or debt financings, third-party funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. 87 While the Company closed the Series D and E Preferred Stock financings in 2025, there are currently no other commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable terms, if at all.
Quantitative and Qualitative Disclosures About Market Risk We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.
Amortization is calculated using the straight-line method, and recorded within selling, general, and administrative expenses, or cost of revenue, depending on the nature and use of the asset. 91 Quantitative and Qualitative Disclosures About Market Risk We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.
A high level of PSA can be a sign of prostate cancer. However, PSA levels can also be elevated for many other reasons including infections, prostate stimulation, vigorous exercise or even certain medications. PSA results can be confusing for many patients and even physicians.
The PSA test is a well-established prostate specific marker that measures the concentration of PSA molecules in a blood sample. A high level of PSA can be a sign of prostate cancer. However, PSA levels can also be elevated for many other reasons including infections, prostate stimulation, vigorous exercise or even certain medications.
A change in the outcome of any of these or other variables could significantly change the costs and timing associated with our business activities.
A change in the outcome of any of these or other variables could significantly change the costs and timing associated with our business activities. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such change.
Certain Significant Relationships We have entered into grant, license and collaboration arrangements with various third parties as summarized below. For further details regarding these and other agreements, see the section titled “Business - Intellectual Property” and Note 6 to our consolidated financial statements included elsewhere in this Report.
For further details regarding these and other agreements, see the section titled “Business - Intellectual Property” and Note 5 to our consolidated financial statements included elsewhere in this Report.
We rely and will continue to rely on third parties for the manufacturing of Proclarix.
We rely and will continue to rely on third parties for the manufacturing of Proclarix. We have no internal manufacturing capabilities, and we will continue to rely on third parties, of which the main suppliers are single-source suppliers, for commercial product.
The exercise price of the warrants is $4.38, and the warrants are exercisable six months after the issuance date and expire on the third anniversary of the initial exercisability date. 81 On October 2, 2024, the Company entered into a Common Stock ELOC Purchase Agreement relating to a Committed Equity Facility with an institutional investor (the “ELOC Purchaser”), whereby the Company may offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser has committed to purchase, up to $25.0 million of the Company’s newly issued Common Stock, subject to certain limitations.
On October 2, 2024, in connection with the ELOC, the Company also entered into the ELOC Purchase Agreement with the ELOC Purchaser, whereby the Company may offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser has committed to purchase, up to $25.0 million of the Company’s newly issued Common Stock, subject to the limitations described herein.
Selling, General and Administrative Expenses For the year ended December 31, 2024, selling, general and administrative expenses decreased by approximately $3.5 million to $11.2 million compared to $14.8 million in 2023. The decrease was mainly due to approximately $1.3 million in expense reduction due to the halting of most of operations in late 2023.
Selling, General and Administrative Expenses For the year ended December 31, 2025, selling, general and administrative expenses decreased by approximately $4.2 million to $7.0 million compared to $11.2 million in 2024.
On April 23, 2025, Veru and the Company entered into a limited waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024 Promissory Note to June 30, 2025.
On August 28, 2025, Veru and the Company also entered into a waiver agreement (the “August 2025 Veru Waiver”) pursuant to which Veru agreed to waive and extend the date for payment of the April Veru Note to September 19, 2025. As of September 22, 2025, approximately $8.8 million was payable to Veru under the Veru Notes and related amendments.
The number of authorized shares and par value of the preferred stock and common stock were not adjusted because of the reverse stock split.
The number of authorized shares and par value of the preferred stock and common stock were not adjusted because of the reverse stock split. 79 Veru Settlement Agreement and Release On April 19, 2023, the Company entered into an asset purchase agreement with Veru (the “Veru APA”).
However, in light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets.
However, in light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company’s cash runway and indebtedness, the Company abandoned commercialization of ENTADFI and no longer holds remaining inventory of the product as of December 31, 2025.
Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such change. 87 Cash Flows The following table summarizes our cash flows for the periods indicated: Year Ended December 31, 2024 Year Ended December 31, 2023 Net cash used in operating activities $ (10,495,816 ) $ (13,581,018 ) Net cash used in investing activities (28,471 ) (8,649,035 ) Net cash provided by financing activities 6,743,110 1,035,060 Effect of exchange rate changes on cash (126,658 ) (3,331 ) Net (decrease) in cash $ (3,907,835 ) $ (21,198,324 ) Cash Flows from Operating Activities Net cash used in operating activities for the year ended December 31, 2024 was approximately $10.5 million, which primarily resulted from the net loss of $58.7 million.
Cash Flows The following table summarizes our cash flows for the periods indicated: Year Ended December 31, 2025 Year Ended December 31, 2024 Net cash used in operating activities $ (9,678,390 ) $ (10,495,816 ) Net cash used in investing activities — (28,471 ) Net cash provided by financing activities 14,452,686 6,743,110 Effect of exchange rate changes on cash (200,142 ) (126,658 ) Net increase (decrease) in cash $ 4,574,154 $ (3,907,835 ) 88 Cash Flows from Operating Activities Net cash used in operating activities for the year ended December 31, 2025, was approximately $9.7 million, which primarily resulted from a net loss of approximately $14.0 million, a non-cash change in fair value of subscription liability of approximately $3.1 million, a non-cash gain on forgiveness of accounts payable of approximately $0.9 million, a non-cash change in fair value of Series D warrant liability of approximately $10.4 million, a non-cash change in fair value of Series E warrant liability of approximately $4.5 million, and net changes in our operating assets and liabilities of $2.4 million.
In December 2024, the Company began drawing on the Equity Financing Line of Credit (“ELOC”), which it entered into on October 2, 2024, referred herein as the ELOC Purchase Agreement. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date of the issuance of these consolidated financial statements.
These factors raise substantial doubt about the Company’s ability to continue as a going concern for one year from the date of issuance of the consolidated financial statements for the year ended December 31, 2025.
Intangible assets with finite lives are reported at cost, less accumulated amortization, and are amortized over their estimated useful lives, starting when sales for the related product begin. Amortization is calculated using the straight-line method, and recorded within selling, general, and administrative expenses, or cost of revenue, depending on the nature and use of the asset.
Based on its evaluation, the Company identified and recognized partial impairment charges of goodwill during the years ended December 31, 2025 and 2024. Intangible assets with finite lives are reported at cost, less accumulated amortization, and are amortized over their estimated useful lives, starting when sales for the related product begin.
Cost of revenue of approximately $1.5 million, and the resulting positive margin, is attributable to costs incurred on Proteomedix revenue including amortization of the product rights intangible asset of approximately $457,000, and standard cost of production and sales of $1.01 million.
Overall, gross margins were positive in both periods, and cost of revenue in 2025 primarily relates to product costs. Cost of revenue in 2024 primarily consisted of amortization of the product rights intangible asset of approximately $0.5 million as well as standard production and sales costs of approximately $1.0 million.
In addition, the Company incurred approximately $2.2 million related to the acquisition of Proteomedix, which consists primarily of transaction costs and Proteomedix’s selling, general and administrative expenses since the acquisition date. Research and Development Expenses For the year ended December 31, 2024, research and development expenses decreased by approximately $1.8 million compared to 2023.
Research and Development Expenses For the year ended December 31, 2025, there was a gain of approximately $0.1 million in research and development expenses, compared to an expense of approximately $0.2 million in the year ended December 31, 2024.
The related party subscription agreement liability is measured at fair value at the commitment date and at each subsequent reporting period, with changes in fair value recorded as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss.
The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period. Liability classified instruments require fair value accounting at issuance and subsequent to initial issuance with all changes in fair value after the issuance date recorded in the consolidated statements of operations.
During the year ended December 31, 2024, the Company used approximately $10.5 million in cash for operating activities. The Company’s current cash balance is not sufficient to fund its operations through the end of December 2025.
During the year ended December 31, 2025, the Company used approximately $9.7 million in cash for operating activities. In addition, as of March 11, 2026, the Company’s cash balance was approximately $3.6 million. During 2025, the Company closed a Series D Preferred Stock financing in September 2025 and a Series E Preferred Stock financing in October 2025.
Other Income (Expense) Other expense incurred during the year ended December 31, 2024 increased by approximately $1.9 million compared to 2023 and relates to the change in fair value of the subscription agreement liability of approximately $3.1 million, $0.7 million of interest expense, $0.2 million that is attributable to transaction exchange rate gains and losses, and offset by the change in fair value of the contingent warrant liability of approximately $1.3 million. 85 Income Tax Benefit The Company recorded an income tax benefit of approximately $1.0 million during the year ended December 31, 2024, in connection with the acquisition accounting for the Proteomedix transaction.
Other Income (Expense) For the year ended December 31, 2025, other income (expense) increased by approximately $7.1 million to $3.8 million, compared to $(3.2) million in 2024.
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 transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.
Added
We continue our sales efforts and expect growing revenues from sales of Proclarix in 2026 and beyond.
Removed
Based on the current circumstances surrounding ENTADFI, at June 30, 2024, the ENTADFI assets were fully impaired. Refer to Note 4 and 5 in the accompanying consolidated financial statements included elsewhere in the Report for further discussion. 75 The Company continues to search for a permanent Chief Executive Officer and Chief Financial Officer.
Added
Share Exchange Agreement On February 11, 2026, we entered into a Share Exchange Agreement (the “Share Exchange Agreement”), by and among (i) Onconetix, (ii) Realbotix Corp., a company existing under the laws of the Province of Ontario (“Parent”), (iii) Simulacra Corporation, a Delaware corporation and a wholly-owned subsidiary of Parent (the “Seller”) and (iv) Realbotix, LLC, a Delaware limited liability company and wholly owned subsidiary of the Seller (the “Realbotix”).
Removed
Given Proclarix is CE-marked for sale in the European Union, we expect to generate revenue from sales of Proclarix by 2027.
Added
Pursuant to the Share Exchange Agreement, subject to the terms and conditions set forth therein, the Seller agreed to contribute and transfer to us, and we agreed to acquire and accept, all of the issued and outstanding equity interests of Realbotix (the “Realbotix Interests”) in exchange for newly issued shares of Common Stock.
Removed
Some recent key developments affecting our business include the following: Altos Units On January 23, 2024, the Company issued a non-convertible debenture (the “Altos Debenture”) in the principal sum of $5.0 million, in connection with a Subscription Agreement, to Altos Ventures, a stockholder of the Company and related party (“Altos”).
Added
(the “Share Exchange” and the other transactions contemplated by the Share Exchange Agreement, the “Realbotix Transactions”). For more information about the Realbotix Transaction, see “ Realbotix Corp. Share Exchange Agreement ” in Item 1.
Removed
The Altos Debenture was originally payable in full upon the earlier of (i) the closing under the Subscription Agreement and (ii) June 30, 2024. On April 24, 2024, the Altos Debenture was amended to extend the maturity date to the earlier of (i) the closing under the Subscription Agreement and (ii) October 31, 2024 (the “Altos Amendment”).
Added
February 2026 Special Meeting of Stockholders On February 3, 2026, the Company held a special meeting of stockholders (the “Special Meeting”), whereby its stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of all of the outstanding shares of Common Stock at a ratio in the range of 1-for-2 to 1-for-50, at any time prior to the one-year anniversary date of the Special Meeting, with such ratio to be determined by the Board or without further approval or authorization of the Company’s stockholders.
Removed
On September 24, 2024, upon obtaining stockholder approval and pursuant to the Subscription Agreement, dated December 18, 2023, the Company issued an aggregate of 513,424 units (the “Units”) to Altos, each Unit comprised of (i) one share of Common Stock and (ii) one pre-funded warrant (collectively, the “Altos Warrants”) to purchase 0.3 shares of Common Stock at an exercise price of $0.04 per share.
Added
Series E PIPE Financing On October 1, 2025, the Company entered into a securities purchase agreement (the “Series E Securities Purchase Agreement”) with institutional investor(s) and sold to such institutional investors(s)(collectively, the “Series E PIPE Investors”), an aggregate of 7,813 shares of Series E convertible preferred stock, par value $0.00001 per share (“Series E Preferred Stock”), which are convertible into common stock of the Company, $0.00001 par value per share and warrants (the “Series E Warrants”) to purchase 2,025,223 shares of Common Stock, for an aggregate purchase price of approximately $6.25 million, which was also equal to the net cash proceeds.
Removed
The Altos Warrants were immediately exercisable at any time on or after the date of issuance and had a term of exercise of five (5) years from the date of issuance. The outstanding debt, as per the Altos Debenture agreement, is considered settled through the unit issuance.
Added
The exercise price of the Series E Warrants is $3.8576, and the Series E Warrants are exercisable beginning on the issuance date and expire on the third anniversary of the issuance date.
Removed
Additional shares are issuable to Altos to the extent Altos continues to hold Common Stock included in the Units and if the VWAP during the 270 days following closing is less than $10.00, as set forth in the Subscription Agreement.
Added
Concurrently with entering into the Series E Securities Purchase Agreement, the Company also entered into a registration rights agreement with the Series E PIPE Investors, pursuant to which it has agreed to provide the Series E PIPE Investors with certain registration rights related to the shares of Common Stock underlying the shares of Series E Preferred Stock and Series E Warrants.
Removed
On September 24, 2024, Altos exercised all the Altos Warrants, and the Company issued to Altos an additional 154,027 shares of Common Stock upon such exercise.
Added
Termination of Ocuvex Business Combination Agreement: On July 16, 2025, the Company entered into an Agreement and Plan of Merger with (i) Onconetix Merger Sub, Inc., a Delaware corporation and a direct, wholly owned subsidiary of the Company, and (ii) Ocuvex Therapeutics, Inc., a Delaware corporation (“Ocuvex”, and such agreement, the “Ocuvex Merger Agreement”).
Removed
Amended Forbearance Agreement On September 19, 2024, the Company entered into an Amended and Restated Forbearance Agreement with Veru (the “Amended and Restated Forbearance Agreement” or “A&R Forbearance Agreement”), which amends and restates the Original Forbearance Agreement in its entirety.
Added
Pursuant to the Merger Agreement, Merger Sub will merge with and into Ocuvex, with Ocuvex surviving the merger as a direct, wholly owned subsidiary of the Company (the “Ocuvex Merger” and the other transactions contemplated by the Merger Agreement, the “Ocuvex Transactions”). 78 Effective September 24, 2025, pursuant to Section 9.01(a) of the Ocuvex Merger Agreement, the Company and Ocuvex entered into a Termination and Release Agreement (the “Termination Agreement”) pursuant to which they agreed to terminate the Merger Agreement and the transactions contemplated thereby.

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