OS Therapies appoints Frank Knuettel II as CFO
OS Therapies reports over $3 million in VAT refund capital received and over $7 million in accrued R&D tax credits.
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Rhea-AI Filing Summary
OS Therapies (OSTX) appointed Francis (Frank) Knuettel II as Chief Financial Officer and Kerry Clem as Chief Commercial Officer, effective September 29, 2026. Christopher P. Acevedo ceased serving as CFO and will continue providing services as a consultant. Both executives have three-year initial employment terms and $300,000 annual base salaries. Knuettel’s salary increases to $360,000 following a qualifying material transaction occurring after the date 30 days following his employment’s effective date. Clem’s awards, subject to board approval and award terms, include options for 700,000 common shares and 200,000 RSUs.
Clem will lead U.S., U.K. and European commercialization strategy and launch planning for investigational Herlystic; potential U.S. market entry is subject to regulatory approval. OS Therapies targeted an MHRA application submission for early in the fourth quarter of 2026, with timing and outcomes subject to regulatory review and other conditions. The company reports receiving over $3 million in non-dilutive capital from VAT refunds and accruing over $7 million in R&D tax credits, which will begin flowing to its U.K. subsidiary; funds are earmarked for R&D. Its largest vendors agreed to defer the majority of outstanding accounts payable until the second quarter of 2027.
Filing Explained
Both executives have conditional severance terms that can continue salary for 180 days and accelerate award vesting after specified qualifying departures.
Under the
Each award is scheduled to vest 20% upon grant, with the remaining 80% vesting in 12 equal quarterly installments, provided Clem remains employed on each vesting date.
Before the third anniversary, if either executive is terminated without Cause or resigns for Good Reason, the company must continue base salary for 180 days and accelerate outstanding awards to the amount that would have vested during that period. Health-premium reimbursement depends on timely COBRA election; severance benefits also require a signed, unrevoked release within 60 days and continued compliance with post-employment obligations.
8-K Event Classification
Key Figures
Key Terms
Conditional Marketing Authorization Application (CMAA) regulatory
Priority Review Voucher (PRV) regulatory
Evergreen Reimbursement financial
Accelerated Approval pathway regulatory
Orphan Drug Designation (ODD) regulatory
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How many options and RSUs will Kerry Clem receive at OSTX?
What counts as a material transaction for Frank Knuettel’s salary increase at OSTX?
When are most of OSTX’s outstanding accounts payable due?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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CURRENT REPORT ON FORM 8-K
OS Therapies Incorporated
September 29, 2026
Item 1.01. Entry into a Material Definitive Agreement.
The information set forth under Item 5.02 of this Current Report on Form 8-K is incorporated herein by reference.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Effective September 29, 2026, the Board of Directors of OS Therapies Incorporated (the “Company”) appointed Francis (Frank) Knuettel II to serve as Chief Financial Officer of the Company and Kerry Clem to serve as Chief Commercial Officer of the Company. In connection with Mr. Knuettel’s appointment, Christopher P. Acevedo ceased serving as Chief Financial Officer of the Company and will continue to provide services to the Company in a consulting capacity.
Frank Knuettel II, CFO
Frank Knuettel II, 60, brings more than three decades of executive leadership experience with early-stage public companies in the technology and life sciences sectors. From June 2022 through July 2025, Mr. Knuettel served as Chief Financial Officer of Channel Therapeutics Corporation (formerly NYSE American: CHRO), a developer of non-opioid pain therapeutics, and, beginning in July 2023, also served as Chief Executive Officer. Following Channel’s merger with LNHC, Inc. and the subsequent change of Channel’s name to Pelthos Therapeutics Inc. (NYSE American: PTHS) in July 2025, Mr. Knuettel served as Chief Financial Officer of Pelthos, a biopharmaceutical company focused on commercializing innovative, safe and efficacious therapeutic products to address unmet treatment needs, until April 2026. Prior to that, from December 2020 to March 2022, he served as Chief Executive Officer of Unrivaled Brands, Inc. (formerly OTCQX: UNRV), a California-based operator of cannabis assets. Mr. Knuettel also serves as a director of Endovia Health Sciences, Inc. (NYSE American: EDVA), a cannabinoid health sciences company, and Beeline Holdings, Inc. (Nasdaq: BLNE), a technology-driven mortgage lender and home equity platform. Over the course of his career, he has helped raise more than $500 million through equity and debt financings in the United States and Canada. In addition, he has managed more than 15 mergers and acquisitions as both a buyer and seller and has handled large-scale licensing transactions with Fortune 50 companies. Mr. Knuettel received a B.A. in Economics from Tufts University and an M.B.A. in Finance and Entrepreneurial Management from The Wharton School at the University of Pennsylvania.
In connection with Mr. Knuettel’s appointment as Chief Financial Officer, the Company entered into an employment agreement with Mr. Knuettel setting forth the terms of his employment and initial compensation. Mr. Knuettel’s employment agreement has an initial term of three years commencing September 29, 2026. If the Company elects not to extend the employment agreement, it must give at least 180 days’ prior written notice, and the term will be extended as necessary so that it ends no earlier than 180 days after notice. Pursuant to his employment agreement, Mr. Knuettel will receive a base salary of $300,000 per year, which will increase to $360,000 following a material transaction occurring at any time after the date that is 30 days following the effective date of his employment. A material transaction includes the sale of a priority review voucher, a financing or series of financings totaling more than $10 million, a royalty financing, the licensing by the Company of any of its programs resulting in cumulative payments in excess of $10 million, or any similar event in scope and magnitude.
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Subject to approval by the Company’s board of directors and the terms of the applicable award agreements, Mr. Knuettel will also receive the following equity awards under the Company’s Amended and Restated 2023 Incentive Compensation Plan:
| ● | Initial Grant. Options to purchase 750,000 shares of the Company’s common stock and 250,000 restricted stock units (“RSUs”). 20% of each award will vest upon grant, with the remaining 80% vesting in 12 equal installments on the last day of each calendar quarter, subject to Mr. Knuettel’s continued employment with the Company on each applicable vesting date. |
| ● | Performance Grants. |
| (a). | Options to purchase 150,000 shares of the Company’s common stock and 50,000 RSUs upon the completion by the Company of a capital raise in excess of $10 million. |
| (b). | Options to purchase 75,000 shares of the Company’s common stock and 25,000 RSUs upon each of the following events: |
| 1. | the execution of one or more out-license agreements with respect to any of the Company’s intellectual property resulting in cumulative gross proceeds to the Company in excess of $10 million; |
| 2. | the sale by the Company of any priority review voucher for consideration in excess of $100 million; |
| 3. | the entry into a royalty transaction pursuant to which the Company sells a royalty in return for an infusion of capital, with cumulative proceeds to the Company in excess of $10 million; and |
| 4. | the research initiation by an analyst at a mid-tier investment bank. |
Mr. Knuettel’s employment agreement also provides him with certain severance benefits. If, prior to the third anniversary of his employment commencement date, the Company terminates Mr. Knuettel’s employment other than for Cause (as defined in the employment agreement), or Mr. Knuettel terminates his employment for Good Reason (as defined in the employment agreement), the Company will (i) continue to pay his base salary for 180 days following termination, (ii) accelerate the vesting of his outstanding stock options and other equity awards such that the number of vested awards equals the number that would have vested had he remained employed through the 180-day severance period, and (iii) if he timely elects COBRA continuation coverage, pay or reimburse him for an amount equal to the Company’s share of the health insurance premiums based on his level of coverage immediately prior to termination. Receipt of the severance benefits is conditioned upon Mr. Knuettel’s execution, and non-revocation within 60 days following termination, of a separation and release of claims agreement and his continued compliance with his post-employment obligations, including those under his confidentiality and non-competition agreement.
Kerry Clem, CCO
Kerry Clem, 57, has extensive experience in commercial leadership and product launches in the biotechnology and specialty therapeutics sectors. Since May 2026, Mr. Clem has served as a managing director of WLH Consulting, Inc., a specialized consulting firm serving biopharma and life sciences organizations. From August 2024 to July 2025, Mr. Clem served as Chief Commercial Officer of Solaxa Inc., a clinical-stage biopharmaceutical company developing therapies for neurodegenerative diseases and nerve damage, and from August 2025 to May 2026, also served as its Chief Executive Officer. Prior to joining Solaxa, Mr. Clem served as Chief Commercial Officer of Acorda Therapeutics, Inc. (formerly Nasdaq: ACOR), a biopharmaceutical company developing therapies for neurological disorders, from September 2021 to August 2024, and held several senior positions at Acorda since January 2011. Mr. Clem has more than 25 years of sales and marketing experience in neurology, oncology, movement disorders, cardiology and pain. Over the course of his career, he has been involved in building commercial organizations and launching multiple products. Mr. Clem holds a B.S. degree from Florida State University.
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In connection with Mr. Clem’s appointment as Chief Commercial Officer, the Company entered into an employment agreement with Mr. Clem setting forth the terms of his employment and initial compensation. Mr. Clem’s employment agreement has an initial term of three years commencing September 29, 2026. If the Company elects not to extend the employment agreement, it must give at least 180 days’ prior written notice, and the term will be extended as necessary so that it ends no earlier than 180 days after notice. Pursuant to his employment agreement, Mr. Clem will receive a base salary of $300,000 per year.
Subject to approval by the Company’s board of directors and the terms of the applicable award agreements, Mr. Clem will also receive options to purchase 700,000 shares of the Company’s common stock and 200,000 RSUs under the Company’s Amended and Restated 2023 Incentive Compensation Plan. 20% of each award will vest upon grant, with the remaining 80% vesting in 12 equal installments on the last day of each calendar quarter, subject to Mr. Clem’s continued employment with the Company on each applicable vesting date. Mr. Clem’s employment agreement also contemplates that he may be granted additional performance-based equity awards upon the achievement of milestones to be determined by the Company’s board of directors.
Mr. Clem’s employment agreement also provides him with certain severance benefits. If, prior to the third anniversary of his employment commencement date, the Company terminates Mr. Clem’s employment other than for Cause (as defined in the employment agreement), or Mr. Clem terminates his employment for Good Reason (as defined in the employment agreement), the Company will (i) continue to pay his base salary for 180 days following termination, (ii) accelerate the vesting of his outstanding stock options and other equity awards such that the number of vested awards equals the number that would have vested had he remained employed through the 180-day severance period, and (iii) if he timely elects COBRA continuation coverage, pay or reimburse him for an amount equal to the Company’s share of the health insurance premiums based on his level of coverage immediately prior to termination. Receipt of the severance benefits is conditioned upon Mr. Clem’s execution, and non-revocation within 60 days following termination, of a separation and release of claims agreement and his continued compliance with his post-employment obligations, including those under his confidentiality and non-competition agreement.
In addition, each of Messrs. Knuettel and Clem entered into the Company’s standard form of confidentiality and non-competition agreement, pursuant to which each agreed to customary confidentiality and non-competition covenants. Each employment agreement provides that these covenants survive termination and that the Company is entitled to relief for breach. Each executive will also be subject to Company’s clawback policy.
There are no arrangements or understandings between either Mr. Knuettel or Mr. Clem and any other person pursuant to which either was selected as an officer of the Company. There are no family relationships between either Mr. Knuettel or Mr. Clem and any director or executive officer of the Company that would require disclosure under Item 401(d) of Regulation S-K, and neither Mr. Knuettel nor Mr. Clem has a direct or indirect material interest in any transaction or proposed transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
The foregoing descriptions of the employment agreements do not purport to be complete and are qualified in their entirety by reference to the full text of the applicable employment agreement, copies of which are filed as Exhibits 10.1 and 10.2 to this Current Report on Form 8-K and incorporated herein by reference.
Item 8.01. Other Events.
On October 1, 2026, the Company issued a press release announcing the appointments of Mr. Knuettel and Mr. Clem, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 8.01, including Exhibit 99.1, of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such filing.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number |
Description | |
| 10.1+ | Employment Agreement, dated as of September 29, 2026, between OS Therapies Incorporated and Francis Knuettel II. | |
| 10.2+ | Employment Agreement, dated as of September 29, 2026, between OS Therapies Incorporated and Kerry Clem. | |
| 99.1 | Press Release issued by OS Therapies Incorporated on October 1, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
| + | Indicates a management contract or any compensatory plan, contract or arrangement. |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| OS THERAPIES INCORPORATED | |||
| Dated: October 5, 2026 | By: | /s/ Paul A. Romness, MPH | |
| Name: | Paul A. Romness, MPH | ||
| Title: | President and Chief Executive Officer | ||
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Exhibit 99.1
| October 1, 2026 |  |
OS Therapies Appoints Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer
Experienced biotech leaders to focus on preparations for U.S., U.K., and European commercial launch of the Company’s lead product candidate Herlystic™(OST-HER2; daznelimgene lisbac)
Grasonville, Maryland--(Newsfile Corp. - October 1, 2026) - OS Therapies, Inc. (NYSE American: OSTX) (“OS Therapies” or the “Company”), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced the appointment of Kerry Clem as Chief Commercial Officer (CCO) and Frank Knuettel II as Chief Financial Officer (CFO).
Mr. Clem now leads the Company’s U.S., U.K., and European commercialization strategy and launch planning for Herlystic™ (OST-HER2; daznelimgene lisbac), the Company’s investigational immunotherapy for the prevention or delay of recurrence in patients with fully resected, pulmonary metastatic osteosarcoma. His responsibilities will include developing the commercial organization and launch infrastructure, assessing patient and treatment-center needs, and preparing for potential U.S. market entry, subject to regulatory approval.
Upon regulatory approval in each of the U.S., U.K., and Europe, the Company will launch Herlystic initially in the United States. The Company anticipates that the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) may be the first regulator to reach a regulatory decision, ahead of the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA). OS Therapies is pursuing MHRA Conditional Marketing Authorization Application (CMAA) under Project Orbis via its Innovative Licensing and Access Pathway (ILAP), with a submission targeted for early in fourth quarter of 2026. The Company has described plans to pursue a U.S. Biologics License Application (BLA) under the Accelerated Approval pathway and a CMAA in Europe in parallel. The timing and outcome of each review remain subject to regulatory review and other conditions.
Mr. Clem has extensive experience in commercial leadership and product launches within biotechnology and specialty therapeutics. His previous roles include serving as CEO of Solaxa, CCO at Acorda Therapeutics, and holding commercial leadership positions at Allos Therapeutics, Solstice Neurosciences, and Guilford Pharmaceuticals
“I’m excited to join OS Therapies at an important point in the development of Herlystic. My near-term focus will be building a disciplined, patient-centered launch plan and the commercial capabilities in the U.S. when the FDA approves the therapy, while the Company advances its regulatory work internationally,” said Mr. Clem.
Mr. Knuettel brings more than two decades of executive leadership experience across dynamic, early-stage public companies in the technology and life sciences sectors. He recently served as the CFO of Pelthos Therapeutics following its merger with Channel Therapeutics Corporation, where he was the CEO. Known for his operational discipline and M&A acumen, Mr. Knuettel has helped companies scale aggressively deep capital markets knowledge, a proven ability to lead and scale businesses, and transactional experience across more than 15 M&A deals. Throughout his career, Mr. Knuettel has raised over $500 million in public and private capital and has held leadership roles at multiple high-growth companies. Mr. Knuettel holds a B.A. with honors in Economics from Tufts University and earned his MBA in Finance and Entrepreneurial Management from The Wharton School at the University of Pennsylvania.
“I am excited to help OS Therapies transition from a development-stage biotechnology company into a commercial organization with significant growth potential through the full exploitation of its gene-edited, Listeria-based cancer immunotherapies,” said Mr. Knuettel.
“Kerry’s appointment reflects our commitment to preparing for the U.S. opportunity for Herlystic. While our current regulatory sequence may bring the U.K. review first, our commercial planning is focused on building the capabilities needed to serve patients and providers in the United States, should the product be approved,” said Paul Romness, MPH, Chairman and CEO of OS Therapies. “Frank’s expertise in helping to manage finance and accounting operations and corporate governances gives the Board of Directors confidence that we have the right financial stewardship to help guide the Company’s growth and revenue generations towards profitability.”
The appointments of Clem and Knuettel are made concurrent with the Company’s completed implementation of its U.K. subsidiary’s (OS Therapies UK Limited, “OSTUK”) research and development refundable tax credit strategy. As part of that, the Company has received over $3 million in non-dilutive capital to date from Value Added Tax (VAT) refunds, with additional VAT refunds pending, and has accrued over $7 million in R&D Tax Credits that will begin to flow back into OSTUK. The funds flowing back into the Company are earmarked to be spent on additional research and development activities, primarily centered on commercial manufacturing and confirmatory Phase 3 clinical development expenses for Herlystic. Under the R&D Tax Credits program, a portion of the R&D expenses become eligible to be reimbursed to OSTUK (the “Evergreen Reimbursement”) that will allow for additional reimbursement from those additional research and development expenses. In parallel, the Company disclosed that it has come to agreement with its largest vendors delaying the due date of the majority of its outstanding AP until the second quarter of 2027. Mr. Knuettel anticipates that this delay in AP due dates provides the Company with sufficient time to align the Company’s cash flow needs with its anticipated cash inflows.
OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD), and Rare Pediatric Disease Designation (RPDD) from the FDA. OST-HER2 has received ODD, FTD, and ATMP from the EMA. OST-HER2 has received ODD and ATMP from MHRA, who also recruited the Company into Project Orbis. Under the RPDD program, if the Company is granted a BLA in the United States, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell. A recent PRV sale occurred in August 2026 for $220 million. However, there can be no assurance that the Company would realize a comparable value, if any, in connection with any future PRV sale. OS Therapies has completed resubmission of a Regenerative Medicine Advanced Therapy (RMAT) request and the Company’s Commissioner’s National Priority Review Voucher (CNPV) letter of intent has been accepted by FDA. OS Therapies is seeking a Conditional Marketing Authorization Application from MHRA in the U.K. under Project Orbis for OST-HER2 in metastatic osteosarcoma in the fourth quarter of 2026, and immediately thereafter is seeking to obtain a BLA under the Accelerated Approval Program in the U.S., followed by CMAAs in Europe and Australia.
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About OS Therapies
OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. The Company is the world leader in gene-edited, Listeria-based cancer immunotherapies. OST-HER2, the Company’s lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 is designed to target two mutated extracellular epitopes and one mutated intracellular epitope of the HER2 oncogene, requiring only one of these three epitopes to be present in a tumor (or micro-metastasis) to trigger the desired immune response. OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and has received ODD, FTD, and Advanced Therapy Medicinal Products (ATMP) from the European Medicines Agency.
The Company reported positive data in its Phase 2b clinical trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma, demonstrating clinically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study and the overall survival (OS) secondary endpoint. The Company is seeking a Biologics License Application (BLA) from the U.S. FDA for OST-HER2 in osteosarcoma in 2026 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. The Company also anticipates receiving Conditional Marketing Authorisation Applications from the U.K.’s Medicines and Healthcare products Regulatory Agency and the EMA for OST-HER2 in 2026. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 was previously conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. The Company has also completed dosing in a Phase 1 study of OST-504 for castration-resistant prostate cancer.
In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company’s proprietary silicon Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com.
Forward-Looking Statements
Statements in this press release regarding future expectations, plans, prospects, or performance, as well as any other statements that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. Forward-looking statements are generally identified by words such as “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will,” and similar expressions, although not all forward-looking statements contain these words. These statements are based on the current expectations and assumptions of OS Therapies and its management and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the Company’s expectations regarding its cash runway; the timing, amount, and receipt of VAT refunds and R&D tax credits; the Company’s ability to obtain additional financing on acceptable terms or at all; the timing and outcome of regulatory submissions and potential approval of OST-HER2 by the U.S. Food and Drug Administration and applicable foreign regulatory authorities; and other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date of this press release and OS Therapies undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.
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OS Therapies Contact Information:
INVESTOR CONTACT
Harrison Seidner, PhD
WaterSeid Partners
OSTX@waterseid.com
MEDIA CONTACT
Steven Weiss
Executive Vice President
Rubenstein Public Relations
sweiss@rubensteinpr.com
212-805-3062
https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/
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To view the source version of this press release, please visit
https://www.newsfilecorp.com/release/316882
SOURCE OS Therapies
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