Pre-Market: OS Therapies Incorporated (NYSE: OSTX) Makes an Approx 10% Move Ahead of the Bell

Announcing Krypton Street’s Brand New Profile! Take a Look at OS Therapies Incorporated (NYSE American: OSTX)! OS Therapies Incorporated (NYSE American: OSTX) Comes Backed by Several Potential Catalysts Including:  Recent IPO Success: Raised $6.4M in its IPO with no warrants, signaling strong market confidence! Market Recognition: Shares surged 34% in the past month, from $3.10 to $4.18, reflecting increased market interest! Small Public Float: Only 1.86M shares available to the public, suggesting potential for significant price movements! EF Hutton's Coverage: EF Hutton set a $21 target, highlighting confidence in the company's cancer therapies and market potential! Innovative Cancer Treatment: OST-HER2 targets HER2-expressing cancer cells, with a $1.72B TAM for osteosarcoma by 2027 and potential for other cancers totaling $55.27B TAM! Fast Track & Rare Disease Designations: OST-HER2 has FDA fast track and rare pediatric disease status, positioning it for faster approval! Expanding Clinical Trials: Clinical trials are advancing, with a strong fiscal runway extending into mid-2025, positioning the company for significant progress in oncology! Keep reading to see why you should keep an eye on  OS Therapies Incorporated (NYSE American: OSTX)! September 11, 2024 Dear Reader, Get OS Therapies Incorporated (NYSE American: OSTX) on your watchlist as soon as you can. (OSTX) just made an approximate 10% move in the pre-market, reaching $4.1283, surpassing several key moving averages, including the 5-Day at $4.04 and 20-Day at $3.86. After its July 31, 2024 IPO, the company is already gaining major market confidence—and here’s the kicker: this happened after Q2, so the full impact is yet to hit the fiscal results.  You’ll want to get (OSTX) on your watchlist early. In tandem with the IPO, all outstanding preferred shares and debt were converted into equity, leaving OS Therapies Incorporated (NYSE American: OSTX) in an enviable position: debt-free and well-capitalized.  With 20.85M common shares now outstanding, only 1.86M are currently available to the public, due to underwriter lockups on the remaining 18.99M shares. This leaves OS Therapies Incorporated (NYSE American: OSTX) with a very small float.   In the last month, OS Therapies Incorporated (NYSE American: OSTX) has moved approximately 34%, from $3.10 on 8/9/2024, to $4.18 on 9/9/2024. Bolstered by this momentum and market interest, OS Therapies Incorporated (NYSE American: OSTX) is poised to advance its lead program, OST-HER2, with a solid ca-sh runway extending into mid-2025. In fact, last Tuesday, EF Hutton initiated coverage on OS Therapies Incorporated (NYSE American: OSTX) with a target of $21. The firm highlighted the company's innovative use of modified Listeria bacteria to target cancer cells expressing the HERII protein. This novel approach is seen as a potential game-changer in the treatment of HERII cancers, starting with the ultra-orphan indication of Osteosarcoma. OS Therapies Incorporated (NYSE American: OSTX)’s technology involves a Listeria-based immunotherapy that specifically targets Herceptin-expressing cells.  The early data suggests that this therapy could enhance the effectiveness of existing dr-ugs like Herceptin, with potential therapeutic and prophylactic benefits.  The firm's decision to set a $21 target reflects confidence in the therapy's unique mechanism of action and its market potential. Keep reading to see why OS Therapies Incorporated (NYSE American: OSTX) needs to be on your watchlist. OS Therapies Incorporated (NYSE American: OSTX) is a clinical-stage biopharmaceutical company that focuses on the development and commercialization of innovative treatments for osteosarcoma (OS) and other solid tumors.  Osteosarcoma, a rare and aggressive form of bone cancer, primarily affects children and young adults.  The company aims to address the unmet need for new therapies in this cancer type, which has not seen new treatment approvals in over 40 years.  OS Therapies Incorporated (NYSE American: OSTX)  is focused on advancing therapies that target cancers with high recurrence rates and complex treatment challenges. The Need for New Osteosarcoma Treatments Osteosarcoma is notoriously difficult to treat due to its location, genetic variability, and high recurrence rates.  Despite advancements in cancer research, osteosarcoma patients often face bleak survival prospects, especially after recurrence.  According to studies in the Journal of Clinical Oncology, approximately 50% of osteosarcoma patients experience relapse within 12 to 18 months of remission, with metastasis commonly occurring in the lungs or brain.  Survival rates for those with metastatic disease drop to just 13% within a year. Given the challenges of osteosarcoma treatment, OS Therapies Incorporated (NYSE American: OSTX) is developing innovative approaches to fill this gap.  Its lead product, OST-HER2 (also known as OST31-164), is designed to provide immunotherapy for osteosarcoma and other solid tumors with similar recurrence mechanisms, including breast, esophageal, and lung cancers.  This product holds great promise in targeting multiple types of tumors and expanding treatment options for patients who currently face limited therapeutic choices.  OST-HER2 (OST31-164): A Promising Immunotherapy OST-HER2 is the company's most advanced product candidate.  It is an off-the-shelf immunotherapy comprised of a genetically engineered strain of Listeria monocytogenes that expresses HER2 peptides.  This unique formulation is designed to stimulate the immune system to fight cancer cells expressing HER2, a protein overexpressed in many aggressive cancer types. In August 2021, OST-HER2 received rare pediatric disease designation and fast track designation from the U.S. FDA, underscoring its potential as a breakthrough treatment for osteosarcoma. OS Therapies Incorporated (NYSE American: OSTX) is conducting a Phase IIb clinical trial of OST-HER2 for osteosarcoma patients aged 12 to 39 years.  The trial aims to measure event-free survival at 12 months and overall survival at three years, compared to historical controls.  This trial is expected to be completed by late 2024, with the possibility of advancing to the FDA review process pending positive results. If approved, OST-HER2 could represent a step forward in osteosarcoma treatment. Expanding Beyond Osteosarcoma: Other Solid Tumor Targets While osteosarcoma remains OS Therapies' primary focus, the company intends to expand the application of OST-HER2 to other solid tumors.  HER2-expressing cancers, such as breast, esophageal, and lung cancers, may benefit from this immunotherapy.  These cancers share a common recurrence mechanism, making OST-HER2 an attractive candidate for broader use. OS Therapies has also developed a pipeline of product candidates, including the OST-Tunable Dr-ug Conjugate (OST-TDC) platform. This next-generation antibody-dr-ug conjugate (ADC) technology uses "tunable" SiLinkers™ to deliver cytotoxic agents directly to cancer cells.  The tunable nature of these linkers allows for precise dr-ug release in the tumor microenvironment, reducing damage to healthy tissues.  The OST-TDC platform is in preclinical development, targeting ovarian, lung, and pancreatic cancers.  These cancers are often difficult to treat with traditional therapies, making OST-TDC a potential game-changer in oncology. The Pipeline  OS Therapies Incorporated (NYSE American: OSTX) is advancing the oncology field with a strong pipeline of innovative cancer treatments at different stages of clinical development. One of their flagship programs, OST-HER2 (ADXS31-164), has already received USDA provisional approval for Canine Osteosarcoma and is currently seeking a global partner. This treatment is moving closer to full approval, with a projected Total Addressable Market (TAM) of: $50 million by 2027 for Canine Osteosarcoma. The same program is under development for Human Osteosarcoma, where it is in Phase 2 clinical trials. This market holds significant potential with a TAM of: $1.72B by 2027 for Human Osteosarcoma. Another major focus for OS Therapies is Breast, Esophageal, and Other Solid Tumors, which is currently in the pre-clinical phase. This program targets a substantial TAM of: $55.27B by 2027 for these solid tumors. OS Therapies is also working on its OST-tADC Folate Receptor Targeted TDC program, aimed at Ovarian Cancer, which is in pre-clinical stages. The potential market for this therapy is projected to reach: $10.1B by 2027 for Ovarian Cancer. Additionally, this targeted dr-ug conjugate technology is being developed to address Pancreatic, Lung, Gastrointestinal (GI), and Osteosarcoma cancers, with a TAM of: $4.01B by 2027 for these cancers. Lastly, the company's Novel TDC Programs, still in pre-clinical phases, aim to tackle various cancer indications, with a significant market projection of: $50B by 2027 for various cancer indications. With such a diverse range of programs and high market potential, OS Therapies is well-positioned to make an impact in the oncology space through innovative, targeted treatments. Orphan Designation and Future Directions OST-HER2 has been granted orphan designation by the FDA, a status reserved for dr-ugs intended to treat rare diseases affecting fewer than 200,000 individuals in the United States.  This designation provides market exclusivity for the first approved treatment for a given condition, offering a potential competitive advantage.  With only 1,000 new osteosarcoma cases per year in the U.S., the rarity of the disease makes such designations crucial for encouraging pharmaceutical innovation. OS Therapies Incorporated (NYSE American: OSTX) also holds a conditional license for OST-HER2 for veterinary use in treating osteosarcoma in dogs.  This license, granted by the U.S. Department of Agriculture (USDA), allows the company to market OST-HER2 for dogs diagnosed with osteosarcoma.  The company is considering out-licensing this veterinary application to animal health companies, further expanding its commercialization prospects. OST-TDC Platform: Next-Generation ADC Technology The OST-TDC platform represents OS Therapies' commitment to cutting-edge cancer treatment.  This next-generation ADC technology delivers cytotoxic agents via tunable SiLinkers™, which release their payloads in response to the acidic tumor microenvironment.  The platform allows for the attachment of various payloads, including antibodies, chemotherapeutics, and even mRNA treatments, creating a versatile "plug-and-play" system for targeted cancer therapy. The OST-TDC platform is being developed to target cancers that overexpress specific receptors, such as the folate receptor alpha in ovarian and endometrial cancers.  The tunable linkers enable precise dr-ug delivery within cancer cells, minimizing off-target effects and improving therapeutic outcomes.  This platform holds significant potential for advancing ADC technology in oncology. Growth Strategies and Collaborative Initiatives OS Therapies Incorporated (NYSE American: OSTX) is committed to pursuing multiple growth strategies, including the development of OST-HER2 for various solid tumors and the advancement of the OST-TDC platform.  The company is also exploring potential out-licensing prospects for OST-HER2 in veterinary medicine and partnering with pharmaceutical and biotechnology companies to expand its product portfolio. The company has already partnered with BlinkBio, Inc. to in-license the OST-TDC technology, demonstrating its willingness to collaborate with industry leaders to accelerate dr-ug development.  As interest in ADC technology grows within the pharmaceutical industry, OS Therapies is well-positioned to leverage its proprietary platforms to create new cancer treatments and expand its market presence. OS Therapies Incorporated (NYSE American: OSTX) is focused on biopharmaceutical innovation, targeting osteosarcoma and other solid tumors with cutting-edge immunotherapies and ADC technologies.  With its lead product candidate OST-HER2 advancing through clinical trials and the OST-TDC platform in preclinical development, the company is poised to make significant contributions to oncology.  As OS Therapies continues to advance its pipeline and explore new therapeutic areas, it holds great promise for addressing unmet needs in cancer treatment and improving patient outcomes across multiple cancer types. 7 reasons to add OS Therapies Incorporated (NYSE American: OSTX) to your watchlist today… 1. Recent IPO Success: OS Therapies Incorporated (NYSE American: OSTX) raised $6.4M in its IPO, demonstrating strong market confidence by doing so without any warrants. This could be worth keeping an eye on as the company builds on this fiscal foundation. 2. Market Recognition: In the last month, shares of OS Therapies Incorporated (NYSE American: OSTX) have moved approximately 34%, increasing from $3.10 on 8/9/2024 to $4.18 on 9/9/2024. This momentum potentially reflects heightened market interest and confidence in the company’s future developments. 3. Small Public Float: With only 1.86M shares available to the public, the limited float could lead to significant price movements, especially given the recent 34% increase in its stock price over the last month. 4. EF Hutton's Coverage: EF Hutton initiated coverage on OS Therapies Incorporated (NYSE American: OSTX) with a target of $21, reflecting confidence in the company's innovative cancer therapies and potential market impact. This endorsement adds credibility and may signal further market attention. 5. Innovative Cancer Treatment: OS Therapies Incorporated (NYSE American: OSTX)’s lead product, OST-HER2, uses a novel Listeria-based immunotherapy to target HER2-expressing cells, including those in osteosarcoma. This therapy is targeting a potential $1.72B Total Addressable Market (TAM) for human osteosarcoma by 2027. Beyond osteosarcoma, OST-HER2 could address a $55.27B TAM for HER2-expressing cancers like breast, esophageal, and lung cancers. OS Therapies is also advancing its OST-TDC platform, which has the potential to tap into a $10.1B TAM for ovarian cancer, and a $4.01B TAM for pancreatic, lung, and gastrointestinal cancers by 2027. 6. Fast Track & Rare Disease Designations: OST-HER2 has received important FDA designations, including fast track and rare pediatric disease status. These regulatory advantages could accelerate the approval process and provide competitive market positioning. 7. Expanding Clinical Trials: With clinical trials advancing and a solid runway of funds extending into mid-2025, the company's progression could lead to substantial advancements in the oncology field. As OS Therapies Incorporated (OSTX) continues to make waves, it’s clear the company is positioned for innovation and potential growth in the biopharmaceutical industry. With its recent IPO and the approximate 34% move, market confidence appears to be on the rise. The limited public float adds to the potential for significant movement, while EF Hutton's coverage with a $21 target reflects optimism in the company.  OS Therapies Incorporated (OSTX)’s cancer treatments, especially OST-HER2, are aimed at capturing significant market potential across multiple cancer types. With FDA fast track and rare disease designations, along with a robust clinical trial timeline extending into mid-2025, OS Therapies is positioning itself for future progress in oncology.  This is one company to keep an eye on. Pull up (OSTX) and make sure it's on your watchlist early this morning.. Sincerely, Alex Ramsay Co-Founder / Managing Editor Krypton Street Newsletter KryptonStreet (KryptonStreet . com) is owned by Media 1717 LLC, a limited liability company. Disclosure: I am not a lice.nsed finan.cial adviser. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. KryptonStreet full disclosure is to be read and fully understood before using KryptonStreet website, or joining KryptonStreet's email or text list. 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