OS THERAPIES INCORPORATED Stock Price, News & Analysis

OS Therapies (NYSE American: OSTX) announces the completion of the treatment period for its AOST-2121 Phase 2b clinical trial of OST-HER2 in recurred, resected Osteosarcoma. The last patient has completed their final 52-week radiographical evaluation. The company is preparing to request a Type C Meeting with the FDA and make any necessary protocol adjustments before locking the clinical trial database for data analysis.

The topline data readout is expected in Q4 2024. OST-HER2 is designed to prevent metastasis, delay recurrence, and increase overall survival in Osteosarcoma patients. The trial involved 41 patients across 21 U.S. sites, with primary endpoints of Event Free Survival at 12 months and Overall Survival at 36 months. OS Therapies will ring the closing bell at the NYSE, with CEO Paul Romness scheduled for interviews on Fintech.TV and the Schwab Network on October 3, 2024.

OS Therapies (NYSE American: OSTX) has announced the development of two novel tunable Antibody Drug Conjugate (tADC) therapeutic candidates using its proprietary SiLinker™ technology. The first candidate targets Breast, Lung, and Gastric Cancer, while the second focuses on platinum-resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer. The company has completed target engagement tests for both candidates, confirming their therapeutic potential.

OS Therapies aims to advance its tADC platform through product development milestones and plans to out-license certain therapeutic candidates and components, particularly the ph-sensitive SiLinker™. The company's first tADC asset, OST-tADC-FRα-H, has achieved proof of concept in animal models of ovarian cancer. With these new additions to its pipeline, OS Therapies is positioning itself as a key provider of intellectual property for new therapeutic product development to partners.

OS Therapies (NYSE American:OSTX) has announced positive preclinical data for its ovarian cancer therapeutic candidate developed using its proprietary tunable Antibody Drug Conjugate (tADC) platform. The candidate, OST-tADC-FRA-H, combines a folate receptor alpha targeting small molecule with hexa-exatecan payloads linked by the company's SiLinker™ technology.

Key findings include:

• Strong antitumor activity in KB and IGROV-1 mouse models of ovarian cancer
• Excellent safety profile with no bodyweight loss compared to control animals
• Potential to improve safety and efficacy of existing ADC combinations

This proof-of-concept study paves the way for developing multiple tADC-based drug candidates for preclinical and clinical evaluation, potentially revolutionizing ADC construction.

OS Therapies (NYSE American: OSTX) has announced its participation in the H.C. Wainright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024, in New York City. The company's President & CEO, Paul Romness, MPH, will deliver a virtual presentation highlighting:

• The company's potentially pivotal fully-enrolled Phase 2b trial of OST-HER2 for preventing resected, recurrent human osteosarcoma
• OST-HER2's pending pivotal safety study in treating canine osteosarcoma
• The company's tunable Antibody Drug Conjugate (tADC) therapeutic platform technology

The virtual presentation will be available starting at 7:00 AM ET on September 9, 2024. Interested parties can register for the conference at https://hcwevents.com/annualconference/.

OS Therapies (NYSE American: OSTX) announced the completion of treatment for the final patient in its Phase 2b clinical trial of OST-HER2 for recurred, resected Osteosarcoma. The trial, AOST-2121 (NCT04974008), enrolled 41 patients across 21 U.S. sites. The primary endpoint is 12-month Event Free Survival, with final evaluation expected in early Q4 2024. OST-HER2 is a Listeria-based immunotherapeutic vaccine designed to prevent metastasis and increase survival in Osteosarcoma patients.

The study aims to demonstrate efficacy in patients with high recurrence risk. Topline data, including 12-month Event Free Survival and interim 2-year Overall Survival, is anticipated in Q4 2024. This trial is significant as no new FDA-approved treatments have improved Osteosarcoma outcomes in over 40 years.

OS Therapies (NYSE American: OSTX) has appointed Borys Shor, PhD to its Antibody Drug Conjugate (ADC) Advisory Board. Dr. Shor will assist in selecting antibodies and payloads for the company's tunable ADC platform, which uses proprietary pH-sensitive SiLinker™ silicone linker technology. With 20 years of experience in oncology discovery programs, Dr. Shor brings expertise from roles at Pfizer, Wyeth, and as CEO of Manhattan BioSolutions. His background includes developing small molecule kinase inhibitors, biologics, and nanoparticles. At Pfizer, he led teams developing novel ADCs and supported the BLA filing for Inotuzumab, approved for leukemia treatment in 2017. Dr. Shor's appointment aims to strengthen OS Therapies' ADC development capabilities.

OS Therapies (NYSE American: OSTX), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, has issued a clarification regarding the CUSIP identifier of its common stock. The company's stock began trading on the NYSE American on August 1st, 2024, under CUSIP 68764Y108. On August 5th, due to a pre-listing corporate action, a new CUSIP 68764Y207 was assigned. All shares under the old CUSIP are now identified under the new CUSIP, with no share splits or similar actions occurring between August 1-5, 2024. OS Therapies urges all market participants, especially brokerage firms, to update their records accordingly.

OS Therapies (NYSE American: OSTX), a clinical-stage biopharmaceutical company, has been accepted into Johnson & Johnson Innovation – JLABS. The company aims to develop its tunable Antibody Drug Conjugate (ADC) linker-based platform at JLABS. This platform uses pH sensitive linkers & coating technology to reduce off-target effects, potentially improving safety and increasing the diversity of therapeutic payloads delivered.

OS Therapies' goal is to offer improved efficacy compared to other ADCs in the market or in development. The company's unique linker platform allows for the creation of new intellectual property for both novel and off-patent targeting antibodies and drug payloads. This development could potentially lead to more effective and safer ADC-based therapies in the future.

OS Therapies (NYSE American: OSTX) reported Q2 2024 financial results, highlighting a successful IPO on July 31, 2024, raising $6.4 million without issuing warrants. The company converted all outstanding preferred shares and debt into equity, resulting in 20.85 million common shares outstanding post-IPO. Key points include:

1. Cash runway extended into mid-2025
2. $1.557 million net operating loss in Q2 2024, down from $2.505 million in Q2 2023
3. Net loss per share of $0.26 on 5.991 million weighted average shares
4. Fully enrolled Phase 2b clinical trial for OST-HER2 in osteosarcoma, with results expected in Q4 2024
5. Positive safety data from Phase 1 study of OST-HER2 in breast cancer