Form 8-K

8-K — OS Therapies Inc

Accession: 0001213900-26-050211

Filed: 2026-04-30

Period: 2026-04-30

CIK: 0001795091

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0288588-8k_ostherapies.htm (Primary)

EX-99.1 — PRESS RELEASE ISSUED BY OS THERAPIES INCORPORATED ON APRIL 30, 2026 (ea028858801ex99-1.htm)

EX-99.2 — SLIDE PRESENTATION DATED APRIL 30, 2026 (ea028858801ex99-2.htm)

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8-K — CURRENT REPORT

8-K (Primary)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

April 30, 2026

OS THERAPIES INCORPORATED

(Exact name of registrant as specified in its charter)

Delaware

001-42195

82-5118368

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

115 Pullman Crossing Road, Suite 103

Grasonville, Maryland

21638

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including

area code: (410) 297-7793

N/A

(Former name or former address, if changed since

last report.)

Check the appropriate box below if the Form 8-K

filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General

Instruction A.2. below):

☐ Written communications pursuant

to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to

Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications

pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications

pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Trading Symbol(s)

Name of Each Exchange on Which Registered

Common Stock, par value $0.001 per share

OSTX

NYSE American

Indicate by check mark whether the registrant

is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the

Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check

mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting

standards provided pursuant to Section 13(a) of the Exchange Act. ☐

CURRENT REPORT ON FORM 8-K

OS Therapies Incorporated

April 30, 2026

Item 7.01. Regulation FD Disclosure.

On April 30, 2026, OS Therapies

Incorporated (the “Company”) issued a press release announcing, among other things, that the European Medicines Agency has

initiated a rolling review (continuous evaluation) of the Company’s regulatory dossier for OST-HER2 and providing an update on certain

other regulatory interactions and related Company developments. A copy of the press release is furnished as Exhibit 99.1 to this Current

Report on Form 8-K and is incorporated herein by reference.

On April 30, 2026, the Company

also held a conference call to review OST-HER2 immune pharmacodynamic biomarker response (seroconversion) data and to review regulatory

updates relating to the OST-HER2 program. A copy of the slide presentation that was used during the conference call is furnished as Exhibit

99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item

7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to

the liabilities of that section, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as

amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Cautionary Note Regarding Forward-Looking Statements

This report, including Exhibits

99.1 and 99.2, contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include

statements regarding the Company’s expectations, plans, prospects, anticipated timing of regulatory interactions, anticipated timing

and outcomes of regulatory review processes, anticipated clinical and regulatory milestones, anticipated commercialization and market

access opportunities, anticipated sales and other financial or operating expectations, and other statements that are not historical facts.

Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”

“forecast,” “intend,” “may,” “might,” “plan,” “potential,” “project,”

“should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking

statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements

are based on management’s current expectations and assumptions as of the date of this report 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. These risks and

uncertainties include, among others, risks and uncertainties related to regulatory processes and outcomes, the timing and results of clinical

trials and data analyses, the Company’s ability to obtain and maintain regulatory approvals, authorizations, designations, and reimbursement,

the Company’s ability to execute its development and commercialization strategy and other risks and uncertainties described in the

Company’s filings with the Securities and Exchange Commission (the “SEC”), including under the heading “Risk Factors”

in the Company’s most recent Annual Report on Form 10-K and other filings the Company may make with the SEC from time to time. Should

one or more of these risks or uncertainties materialize, or should underlying assumptions prove to be incorrect, actual results may vary

materially from those indicated or anticipated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking

statements.

The forward-looking statements

included in this report are made only as of the date of this report, and except as otherwise required by applicable securities law, the

Company assumes no obligation, nor does the Company intend to publicly update or revise any forward-looking statements to reflect subsequent

events or circumstances.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description

99.1

Press Release issued by OS Therapies Incorporated on April 30, 2026.

99.2

Slide Presentation dated April 30, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

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: April 30, 2026

By:

/s/ Paul A. Romness, MPH

Name:

Paul A. Romness, MPH

Title:

President and Chief Executive Officer

EX-99.1 — PRESS RELEASE ISSUED BY OS THERAPIES INCORPORATED ON APRIL 30, 2026

EX-99.1

Filename: ea028858801ex99-1.htm · Sequence: 2

Exhibit 99.1

OS Therapies Announces

EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence

in Fully Resected Pulmonary Metastatic Osteosarcoma

Conference call scheduled for Thursday, April

30, 2026, at 8:30 am ET to review new OST-HER2 immune pharmacodynamic biomarker response (seroconversion) data and review regulatory successes

validating the OST-HER2 approach. Participants will include strategic advisors Dr. Craig Eagle and Dr. Bob Langer, and Osteosarcoma key

opinion leader Dr. Peter Anderson from Cleveland Clinic.

● EMA and Australia TGA (ATGA) align on 3-year overall survival as the approvable clinical efficacy endpoint for Conditional Marketing

Authorizations (CMAs), with alignment also achieved on confirmatory Phase 3 initiation, initially only in Australia, planned for Q3 2026

to meet regulatory requirement to support early approvals in the U.S., U.K., Europe and Australia

● Alignment achieved with EMA and ATGA on Seroconversion data serving as surrogate clinical efficacy data to support CMAs for early

market access and eligibility for a Priority Review Voucher (PRV) under Rare Pediatric Disease Designation (RPDD)

● Alignment achieved with EMA and ATGA on non-clinical, CMC and safety data

● Alignment achieved with ATGA on existing drug product being used to initiate Phase 3

● EMA selects Company into Raw Data Pilot Program

● OST-HER2 granted ATMP designation by U.K. MHRA

● Company forecasts European peak OST-HER2 osteosarcoma sales exceeding $300 million following ATMP designation grant, with over

$50 million in sales expected in 2027

● Upcoming U.S. FDA and U.K MHRA meetings scheduled in 2nd quarter of 2026

● OST-504 Phase 1b castrate resistant prostate cancer trial biomarker analysis to mirror OST-HER2 Phase 2b osteosarcoma biomarker

analysis

● OST-503 Phase 2 non-small cell lung cancer candidate indications expanded to include pancreatic cancer following review of target

vector antigens include all KRAS G12 position mutations, which represents 76% of all KRAS mutations in cancer

New York, NY, April

30, 2026 – OS Therapies, Inc. (NYSE American: OSTX) (“OS Therapies” or “the Company”), the world leader

in gene-edited, listeria-based cancer immunotherapies, today announced that the European Medicines Agency (EMA)’s Committee for

Advanced Therapy (CAT), in conjunction with the Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment

Committee (PRAC), has initiated Continuous Evaluation (“Rolling Review”) of the OST-HER2 Conditional Marketing Authorisation

(CMA) request regulatory dossier for the prevention of recurrence in fully resected, pulmonary metastatic osteosarcoma.1 The

Company also announced that it was selected into EMA’s Raw Data Pilot programme that will done in concert with the EMA Scientific

Advice Working Party (SAWP).

Australia Therapeutic Goods Association (ATGA)

has also invited the OS Therapies to make an application for Provisional Determination, the Australian equivalent of a Conditional Marketing

Authorisation of the OST-HER2 regulatory dossier, and is expected to make a decision on rolling review following the receipt of the Clinical

Trial Notification (CTN) for the confirmatory Phase 3 trial later this quarter that will position the OS Therapies to initiate the confirmatory

Phase 3 in the third quarter of 2026.

“I am delighted with the regulatory

interactions OS Therapies has had to date, and I look forward to supporting OS Therapies in upcoming meetings with U.S. and U.K regulators,”

said Dr. Craig Eagle, strategic advisor for OS Therapies.

OST-HER2 Immune Pharmacodynamic Biomarkers

Conference Call Details

Title: OS Therapies (NYSE: OSTX) | Conference

Call: OST-HER2 immune pharmacodynamic response biomarkers

Date: April 30th, 2026

Time: 8:30 AM Eastern Time

Registration Link: https://zoom.us/webinar/register/WN_Xlmj7kdNTH6C0MA_xdwiiQ

EMA OST-HER2 Rolling Review Status

OS Therapies and EMA

have agreed that 3-year overall survival data will serve as the basis to complete evaluation of the CMA request. The Company’s

recently submitted clinical efficacy data includes 2-year overall survival data, with EMA requesting updated 2.5-year overall survival

data that will be available by the middle of the second quarter of 2026, and 3-year overall survival data that will become available

early in the fourth quarter of 2026, which will complete the CMA submission. The Company anticipates a potential CMA decision by EMA

in the fourth quarter of 2026. Market access interactions related to reimbursement with the UK’s NICE and EMA Health Technology

Assessment (HTA) processes have commenced simultaneously to minimize the time between regulatory approval(s) and patient access to treatment.

International regulatory coordination has also commenced under the EMA FDA Information Sharing programme2.

Additionally, the Company

has been granted Advanced Therapy Medicinal Product designation from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA)3

by virtue of its reciprocal designation agreement with EMA.

1 https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/use-clinical-study-data-medicine-evaluation

2 https://www.fda.gov/drugs/cder-international-program/international-agreements-information-sharing

3 https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing

“We are grateful for EMA and ATGA’s

strong support of our OST-HER2 program as we urgently work to improve outcomes for patients facing this rare and deadly pediatric cancer,”

said Paul Romness, Chair and Chief Executive Officer of OS Therapies. “With all currently available data submitted and key regulatory

alignment achieved, we are advancing toward early market access via Conditional Marketing Authorizations in Europe, the U.K., and Australia,

as well as a U.S. Biologics License Application (BLA) under Accelerated Approval. Following our recent ATMP designation in Europe, we

believe peak European sales could exceed $300 million annually, with the potential to generate more than $50 million in sales beginning

in 2027.” Mr. Romness continued: “We have aligned with EMA and ATGA on the provisional design of our global confirmatory Phase

3 trial that is required to be initiated prior to being granted early market access, including 3-year overall survival as the primary

efficacy endpoint. 3-year overall survival will also be the efficacy endpoint that will serve as the basis for potential early market

access in the U.S., U.K., Europe, and Australia. This gives us strong confidence as we head into upcoming FDA and MHRA meetings, while

reinforcing the growing recognition of our pharmacodynamic biomarker response seroconversion data as a meaningful surrogate for the key

overall survival efficacy endpoint, further supporting our global regulatory pathway. We are delighted that immunotherapies are becoming

more central in the approach to treating cancers globally, which bolsters OST-HER2 and the rest of our attenuated listeria monocytogenes

platform candidates.”

“With the significant momentum we now

have surrounding OST-HER2 in osteosarcoma, we are actively working to be prepared for the time when resources become available to advance

our exciting listeria monocytogenes platform pipeline,” said Robert Petit, PhD, Chief Medical and Scientific Officer at OS Therapies.

“Based upon the extensive biomarker work we have done to date on the OST-HER2 osteosarcoma program, we are now positioned to generate

congruent data for the OST-504 castration-resistant prostate cancer program. Additionally, following significant advancement in the exciting

KRAS-targeted antibody pancreatic cancer field with important clinical data showing significant survival benefit, we have identified that

our promising Phase 2 non-small cell lung cancer (NSCLC) candidate OST-503 was constructed to target all KRAS G12 position-related antigen

mutations, which represents 76% of all KRAS mutations in cancer. As a result, we believe OST-503 could represent a highly complementary

approach to KRAS-target antibodies currently in development.”

OST-HER2 has received Orphan Drug Designation

(ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the FDA, and ODD, FTD and ATMP from the EMA. Under

the RPDD program, if the Company receives a BLA in the United States, it will become eligible to receive a Priority Review Voucher (PRV)

that it intends to sell. The Company is seeking to obtain a BLA under the Accelerated Approval Program for OST-HER2 in osteosarcoma in

the second half of 2026, in addition to CMAs in Europe, the U.K. and Australia.

Upcoming 2nd Quarter Milestones

● 2.5-year overall survival data

● FDA Pre-BLA Type B meeting to gain alignment on surrogate clinical efficacy endpoints based on most up-to-date Phase 2b clinical,

biomarker and CMC, following the December 2025 alignment achieved non-clinical and safety data

● Regenerative Medicine Advanced Therapy designation (“RMAT” – FDA equivalent to EMA ATMP designation) decision to

be based upon preliminary evidence of efficacy supported by clinical and biomarker data metrics aligned upon

● FDA rolling review decision based upon pre-BLA meeting outcome

● FDA Type C meeting to gain alignment on the design of the confirmatory Phase 3 study

● Submission of the Accelerated Approval BLA request to FDA

● MHRA meeting to gain alignment on the design of the confirmatory Phase 3 study

● Submission of CMA request to MHRA

● MHRA rolling review decision based on Phase 3 confirmatory study design alignment

● Submission of CMA request to Australia in conjunction with Clinical Trial Notification (CTN) request for confirmatory Phase 3 study

● Receipt of approximately 1.45 million GBP in non-dilutive cash VAT tax refund

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 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 ATMP from the European Medicines Agency.

The Company reported positive data in its

Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung 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

anticipates receiving 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

Authorisations 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 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma.

The Company also anticipates reading out data from a Phase 1b study of OST-504 in castration resistant prostate cancer in the first half

of 2026.

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 silicone 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 about future

expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking

statements within the meaning of the federal securities laws. These forward-looking statements and terms such as “anticipate,”

“expect,” “intend,” “may,” “will,” “should” or other comparable terms involve risks

and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements

regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which

such statements are based. OS Therapies cautions readers that forward-looking statements are based on management’s expectations

and assumptions as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results

to differ materially, including, but not limited to our expected to provide cash runway into 2027, the intended use of net proceeds from

the offering, the potential approval of OST-HER2 by the U.S. FDA and other risks and uncertainties described in “Risk Factors”

in the Company’s most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and

Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required

by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as

a result of new information, future events or otherwise.

OS Therapies Contact Information:

Investor Relations

Harrison Seidner, PhD

WaterSeid Partners

OSTX@waterseid.com

Public Relations

Stephanie Chen

Elev8 New Media

media@ostherapies.com

https://x.com/OSTherapies

https://www.instagram.com/ostherapies/

https://www.facebook.com/OSTherapies/

https://www.linkedin.com/company/os-therapies/

EX-99.2 — SLIDE PRESENTATION DATED APRIL 30, 2026

EX-99.2

Filename: ea028858801ex99-2.htm · Sequence: 3

Exhibit

99.2

NYSE American: OSTX Biomarker - focused Conference Call April 30, 2026

Safe Harbor Statement This document contains forward - looking statements . In addition, from time to time, we or our representatives may make forward - looking statements orally or in writing . We base these forward - looking statements on our expectations and projections about future events, which we derive from the information currently available to us . Such forward - looking statements relate to future events or our future performance, including : our financial performance and projections ; our growth in revenue and earnings ; and our business prospects and opportunities . You can identify forward - looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms . In evaluating these forward - looking statements, you should consider various factors, including : our ability to change the direction of the Company ; our ability to keep pace with new technology and changing market needs ; and the competitive environment of our business . These and other factors may cause our actual results to differ materially from any forward - looking statement . Forward - looking statements are only predictions . The forward - looking events discussed in this document and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us . We are not obligated to publicly update or revise any forward - looking statement, whether as a result of uncertainties and assumptions, the forward - looking events discussed in this document and other statements made from time to time by us or our representatives might not occur .

Agenda 1. Introduction – Harrison Seidner, PhD 2. Corporate Update – Paul Romness, MPH 3. Biotech Innovation Curve – Dr. Robert Langer 4. Clinical, Biomarker and Safety Data – Andrew Exley, MD, FRCP, FRCPath 5. Regulatory status by Jurisdiction (Europe, Australia, U.K. and U.S.) – David Brindley, PhD 6. Insights on developing treatments for rare pediatric cancers – Dr. Craig Eagle 7. Questions

• Major form of pediatric bone cancer • ~1,000 cases diagnosed annually in US • Primarily affects adolescents C young adults: 12 – 39 yrs • Localized disease • Chemotherapy C Surgery can sometimes achieve remission • Recurrent / Metastatic disease e.g. in Lungs • No FDA - approved treatment options for recurrent, resected lung metastases • Systematic reviews highlight dearth of new therapies (Gazouli 2021, Biermann 2025) • Some progress on disease mechanisms BUT • Prognosis is dire with little improvement over the last 30 years (Cole 2022) • Justifies use of historical control data Osteosarcoma: Clinical Outline

Age - Related Incidence of Primary s Subsequent Osteosarcoma Cole 2022

Overall Survival in Primary Osteosarcoma: No Improvement in 30 years Cole 2022

Overall Survival in Metastatic Osteosarcoma: No Improvement in 30 years Cole 2022

OST31 - 164: Innovation – Novel Immunotherapy 1. 1 st in class microbial vector gene therapy (MVGT) • Attenuated Listeria (Lm) bearing plasmids encoding chimeric fusion protein • Truncated Listerolysin: promotes Ag presentation C acts as adjuvant * • Tumour - associated antigen (TAA): Her2 2. Triggers a multi - modal anti - tumour immune response • Induces Her2 specific T cells • Boosts specific T cells to structurally unrelated TAAs * • Intratumoral Lm induces anti - tumour immunity as a cytosolic bacterium * • Boosts innate immune response to tumor – DCs, M1 monocytes, NK cells • Modulates tumour microenvironment – reduces MDSCs C Tregs

12 A Her2 Expression in BREAST & OVARIAN CANCER cytoplasm NUCLEUS Cell membrane HER2 receptor: Upregulated Nucleus What this means: HER2 is an “oncogenic driver” It actively causes the cancer to grow and spread. Upregulated: increased levels of Her2 expressed at cell surface Targetable by Antibodies (Ab): Ab - Drug conjugates (ADCs) or CAR - T cells Clinical Efficacy of ADCs: Trastuzumab - emtansine, Trastuzumab - duocarmycin VS Her2 Expression in OSTEOSARCOMA (BONE CANCER) cytoplasm Few Her2 molecules at cell surface NUCLEUS HER2 expressed in cell cytoplasm Processed into peptides, captured by MHC molecules, transported to cell surface as peptide - MHC complexes Nucleus What this means: Not an oncogenic driver: expression not mechanistically linked to cancer ~80% express HER2 but mostly cytoplasmic, low intensity, variable density Antibody - based detection (ADCs / CAR - T cells) limited by sensitivity Highly - sensitive T cells detect even low levels of HER2 - peptide - MHC complexes OST31 - 164: multi - modal action including T cells against Her2 and other TAAs How OST - HER2 works

How OST - HER2 works 13 3 4 1 L. monocytogenes ( Lm) A ttenuated HER2 - tLLO payload The Construct Attenuated Lm carrying plasmids encoding chimeric fusion protein - truncated listerolysin tLLO (a potent innate immune adjuvant) - HER2 sequences Administered by iv Infusion 2 DC Macro - phage Trojan Horse Entry Lm naturally targets professional antigen presenting cells = dendritic cells (DCs). Lm intracellular cytosolic pathogen generates anti - tumour immunity to multiple TAAs Antigen - presenting cells MHC I MHC II MHC I HER2 peptide Peptide - MHC Array DCs process & present TAA derived peptides as complexes with MHC I & MHC II receptors. Dual - pathway presentation primes CD8+ & CD4+ T cells Activates CD8+ and CD4+ CD8+ Killer T CD4+ Helper T NK NK cell Mono Monocyte DC Dendritic cell Treg MDSC Suppressors neutralised ظ Immune Activation CD8+ & CD4+ T cells primed against HER2 & other TAAs NK cells & M1 Monocytes activated Tumour immune - evasion mediators, Tregs & MDSCs, suppressed Multi - modal immune response: T cells + NK cells + Monocytes tLLO Adjuvant Effect Immune activation of HER2 specific & TAAs specific T cells i.e. broadens anti - tumour effect 5 CD8+ NK HER2 TUMOUR CELL Tumour Destruction NK cells target cancer stem cells Cytotoxic CD8+ T cells kill cancer cells CD4+ T cells promote memory Osteosarcoma cells in Micro Metastases eliminated

14 Gene transcript modulation as the preferred biomarker of response to OST - HER2 (OST31 - 164) ظ Why Not ELiSpot Alone? Canine trials: clinical benefit but no correlation with HER2 - specific T cells by ELiSpot Logistically challenging: requires viable blood samples from multiple centres and assays for multiple TAAs Misses the multi - modal (innate + adaptive) nature of the immune response to OST - HER2 ELISpot = T cell antigen - specific IFN - γ assay — sensitive but narrow in scope Reveals modulation across monocyte, NK, T cell, and Ag presentation pathways simultaneously . Multi - modal by design 1 Captures full response Routine sampling techniques sufficient Scalable across centres Transcript upregulation after 3 doses of OST31 - 164 correlates with outcomes in canine & human trials. Canine + human correlation 3 Evidenced 2 Operationally practical Why Gene Transcript Modulation? ض Biomarker strategy and trial findings

Her2 Expression by ImmunoHistoChemistry (CB11 murine mAb to intracellular domain AA 1244 – 1246) in Relapsed Osteosarcoma 15 Osteosarcoma Tumour Cells Her2 positive (Percent) EMA UPDATES – APRIL 2026 85% Her2 +ve Her2 - ve Reed 2025

OST31 - 164: Proof of Principle: Comparative Oncology 3. NIH supported collaboration with comparative oncology experts demonstrates efficacy of OST31 - 164 in spontaneous osteosarcoma in canines

Canine Osteosarcoma: Parallels with Human Osteosarcoma I. Spontaneous onset in immunocompetent dogs: rate >10x human rate II. Many clinical, biological, and molecular features in common i. Primary lesion: typically, high - grade tumours in long bones ii. Standard treatment: chemotherapy C radical surgery iii. Disease course: metastatic disease often in the lungs iv. Highly rearranged genomes often affecting TP53, CDKN2A, RB1 genes Similar molecular pathway alterations of prognostic significance • TH 1 C TH 2 immune cell signalling, Interferon signalling, Inflammatory responses III. IV. Share 3 distinct TME subtypes – independent predictors of PFS • Immune Enriched [IE]; IE dense extracellular matrix - like; Immune Desert Makielski 2019, Mannheimer 2023, Mason 2025, Patkar 2024

Immunological responses and clinical outcomes in dogs with osteosarcoma receiving SOC + ADXS31 - 164 Mason NJ 2025

Mason NJ 2025 # Up - regulation of Cytotoxic T cell, NK cell, & Ag presenting cell gene transcripts Canine Osteosarcoma Elite vs Short - term Survivors: PBMCs D ifferentially E xpressed G enes – Baseline vs last ADXS31 - 164 #

Primary Diagnosis Resection of Primary Tumor ~ Week 11 Cycle of OST31 - 164 - four treatments over 12 weeks Disease surveillance imaging every 12 weeks 6x Cycles of MAP Therapy over 29 weeks. ~10% Mortality ~50% recurrence after MAP Variable Time to Recurrence Lm Surveillance s Survival follow up for 3 yrs from last OST31 - 164 Relapse Diagnosis Resection of Metastasis & Screening Further cycles until Week 48 or Relapse or Withdrawal From Trial Variable interval to 1 st dose OST31 - 164 - 01: Clinical Trial in Recurrent (Pulmonary) Osteosarcoma

OST31 - 164: Innovation – Historic Controls 4. Justification for use of Historic Controls i. Lack of improvement in OS (Cole 2022) i. Reduces risk of bias thru improvements in Standard Of Care (SOC) ii. Systematic identification of published trials iii. Systematic screening for comparable populations iv. Conservative approach : treatment effect of chemotherapy +/ - IND in controls v. Systematic extraction of data from comparable populations

Rationale for EFS vs Objective Response Rate (ORR) I. Radiographic response may not reflect critical cellular effect II. Surgical resection is standard approach to pulmonary recurrence i.e. no lesion to determine ORR III. Likely difference in drug activity in microscopic vs macroscopic disease IV. Propose EFS vs historical benchmark A. Measurable, unresectable osteosarcoma • EFS < 4 months vs >4 months = disease control failure v success B. Completely resected osteosarcoma • EFS < 12 months vs >12 months Lagmay 2016

Rationale for Preferring Overall Survival to Event Free Survival in the Assessment of Immunotherapies for Osteosarcoma 1. Patients value Overall survival over Event Free Survival (Tregear 2024) 2. Regulators prefer Overall Survival as a Hard Endpoint 3. Delayed effect of immunotherapies reduces discriminating power of 12month Event Free Survival

Measures Reducing Potential Bias in Single Arm Trial of OST31 - 164 Measures Adopted to Reduce Potential bias Parameter Hard endpoints: Overall survival (OS) 1. Assessment bias Overall survival preferred to Event - Free Survival; Sensitivity analyses 2. Attrition bias Statistical analysis plan (SAP) pre - specified before data completion 3. Pre - planning Standard criteria for patient selection 4. Regression to mean Systematic selection of comparable control populations 5. Variability in Disease History Estimands defined in Statistical analysis plan 6. Intercurrent events Systematic selection of comparable control populations 7. Selection bias with controls Standard criteria for patient selection 8. Selection bias in study No improvement in Overall Survival in last 3 decades Controls include treatment effect of chemotherapy +/ - IND in controls 9. Trial bias due to improved SOC EMA/CHMP/458061/2024: Reflection paper on establishing efficacy based on single - arm trials

EFS vs OS after Immunotherapy: Single Arm Trial of Denosumab (RANKL mAb) in Patients with Recurrent / Refractory Osteosarcoma EFS OS Janeway 2026

OS: OST - HER2 Phase 2b Trial vs. Historical Control

OS: OST - HER2 Phase 2b Trial vs. Pooled Historical Control P=0.0344

Isolation of Treatment Effect • Clinically significant improvement in Overall Survival C EFS I. Highly significant link between Overall Survival C Immune Response Gene Signature (IRGS) after 3 rd dose of OST31 - 164 II. IRGS includes cytotoxic effectors (NK/T cells) C T cell memory, and modulators of Tumour MicroEnvironment (M1/M2, MDSCs) III. IRGS maps directly to the Mechanism of Action of OST31 - 164 IV. Clinical trial extends findings in parallel population of spontaneous osteosarcoma in canines: multi - modal immune response links Overall Survival to Mechanism of Action

Immune Response Gene Signatures after 3 rd Dose of OST31 - 164 Link Mechanism of Action to OS in Canine s Human Osteosarcoma • Cox Proportional Hazards Model • Canine IRGS (optimized): p=10e - 8 for Overall Survival • Beneficial: Ag presentation, NK cell activation, T cell activation • Detrimental: Type 1 IFN; M2 polarization; Myeloid Derived Suppressor Cells • Human IRGS (optimized): p=10e - 4 for Overall Survival • Beneficial: Ag presentation; NK cell activation; T cell activation/differentiation; M1 polarization • Detrimental: M2 polarization; failure to generate central memory CD8+ T cells

Kaplan Meier Analysis of Overall Survival by Immune Response Gene Composite (Baseline vs Post 3 rd Dose) Overall Survival Probability Days from 1st dose (Arrow ~ 2yrs)

Safety Profile III. I. Infusion related cytokine release syndrome • Frequency C severity reduced by pre - infusion regimen; no Rx discontinued • IV fluids, antihistamine, NSAID, antiemetic, H2 - receptor antagonist Cytokine release syndrome: maximum grade 2 intensity, 1 st cycle II. Infection risk • Single episode of asymptomatic bacteraemia in subject with indwelling infusion port; responsive to antibiotics C removal of port On - Target Off Tumor Effects • Her2 widely expressed at low level including skeletal C cardiac muscle • 1 episode of ?rhabdomyolysis: grade 3 ( haematuria + raised CK) in body builder • No signal in canine spontaneous osteosarcoma despite intensive monitoring

Thank you for attending! OS Therapies, Inc. (NYSE American: OSTX)

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