OS Therapies Provides OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Program Update Following FDA End of Phase 2 MeetingSeptember 02, 2025 7:40 AM EDT | Source: OS TherapiesCompany on track to begin submission of a rolling Biologics Licensing Application (BLA) request for OST-HER2 to U.S. Food & Drug Administration in September 2025 New York, New York--(Newsfile Corp. - September 2, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clin ...

Core Viewpoint - OS Therapies reported significant clinical and regulatory progress in the second quarter of 2025, particularly regarding its lead asset OST-HER2 for treating osteosarcoma, with plans for a Biologics Licensing Application (BLA) submission by the end of 2025 [4][12]. Financial Results - The company recorded a net operating loss of $4.537 million in Q2 2025, compared to a loss of $1.557 million in Q2 2024, primarily due to regulatory expenses related to the OST-HER2 program [8]. - Net loss per share was $0.19 on 25.114 million weighted average shares outstanding in Q2 2025, compared to a loss of $0.26 per share on 5.991 million shares in Q2 2024 [8]. Clinical and Regulatory Updates - Updated interim data from the Phase 2b trial showed a statistically significant overall survival rate of 66.6% for OST-HER2 treated patients compared to 40% for controls (p = 0.0046) [7]. - The final 12-month Event Free Survival (EFS) data indicated a benefit of 35% for OST-HER2 treated patients versus 20% for historical controls (p = 0.0197) [7]. - The FDA confirmed that OST-HER2 meets the biological definition of Regenerative Medicine Advanced Therapy (RMAT) and issued a BLA number in preparation for the Accelerated Approval submission [5][6]. Strategic Partnerships and Market Position - The company has established a U.S. commercial partnership with Eversana, positioning OST-HER2 for a potential launch in the first half of 2026 [5][6]. - OS Therapies raised $4.2 million through a warrant exercise inducement and exchange offering, extending its cash runway into mid-2026 [5][6]. International Expansion - The company submitted an Innovative Licensing and Access Pathway (ILAP) request to the UK's MHRA and plans to synchronize the approval process with the FDA via Project Orbis [4][6]. - A rapporteur meeting with the European Medicines Agency (EMA) is scheduled for October 2025 to initiate the regulatory approval process in Europe [6][12]. Pipeline and Future Prospects - OS Therapies completed the acquisition of a listeria cancer immunotherapy platform, expanding its pipeline with four clinical-stage and eight preclinical-stage candidates [7]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC) [10].

Group 1 - A significant drop in stock prices of several Chinese micro-cap stocks listed in the US has resulted in investors losing billions of dollars, raising concerns about a potential "pump and dump" scheme [1] - Seven specific stocks, including Concorde International (CIGL.US) and Austin Technology (OST.US), have seen declines exceeding 80% in recent trading days, leading to a total market value loss of $3.7 billion [1] - Prior to the sharp declines, these stocks had experienced substantial increases and were promoted on social media platforms like WhatsApp [1] Group 2 - Brain Regen Technologies (RGC.US) has seen its stock price increase nearly 10,000% this year, with no current evidence linking the company to stock price fluctuations [2] - The FBI reported a 300% increase in complaints related to "pump and dump" stock fraud over the past year, indicating a rise in investor victimization [2] - Fraud groups are reportedly using social media ads and "investment club" promotions to lure investors, sometimes impersonating legitimate brokerage firms or well-known stock analysts [2]

Group 1 - The top five gaining Chinese concept stocks at market close were AirNet Technology, Hongli Construction, Haichuan Securities, Huami Technology, and Austin Technology Group, with significant percentage increases ranging from 22.45% to 45.51% [1] - AirNet Technology saw a price increase of 45.51%, closing at 3.405 with a trading volume of 3.3182 million [1] - Hongli Construction experienced a rise of 41.48%, closing at 0.0648 with a trading volume of 51.1176 million [1] Group 2 - Haichuan Securities increased by 32.95%, closing at 1.1600 with a trading volume of 446,300 [1] - Huami Technology rose by 27.97%, closing at 31.800 with a trading volume of 2.5546 million [1] - Austin Technology Group gained 22.45%, closing at 1.800 with a trading volume of 796,500 [1]

Group 1 - The top five Chinese concept stocks that experienced the largest declines in closing prices are: Golden Sun Entertainment down 24.92%, Antelope Holdings down 19.5%, Austin Technology Group down 17.51%, Skyemon Solar Group down 17.06%, and Himax Technologies down 17.03% [1][1][1] Group 2 - Golden Sun Entertainment's latest price is 0.4505 with a decline of 24.92%, resulting in a decrease of 0.1495 and a trading volume of 1.1039 million [1] - Antelope Holdings' latest price is 2.415 with a decline of 19.5%, resulting in a decrease of 0.585 and a trading volume of 0.3752 million [1] - Austin Technology Group's latest price is 1.460 with a decline of 17.51%, resulting in a decrease of 0.310 and a trading volume of 0.4572 million [1] - Skyemon Solar Group's latest price is 2.480 with a decline of 17.06%, resulting in a decrease of 0.510 and a trading volume of 1.6171 million [1] - Himax Technologies' latest price is 7.160 with a decline of 17.03%, resulting in a decrease of 1.470 and a trading volume of 30.0859 million [1]

Core Insights - OS Therapies has received positive feedback from the UK's MHRA regarding its OST-HER2 application for the prevention or delay of recurrent pulmonary metastatic osteosarcoma [1][2] - The company has initiated the regulatory process in Europe and plans to synchronize its application with the FDA's Accelerated Approval Program through Project Orbis [1][2][4] - OST-HER2 has shown statistically significant benefits in a Phase 2b clinical trial, with a focus on improving 12-month event-free survival rates [5] Regulatory Developments - The company held a successful Scientific Advice Meeting with the MHRA and submitted an Innovative Licensing and Access Pathway (ILAP) application [1][2] - MHRA recommended applying for Project Orbis to align the UK and US regulatory review processes [4] - A European Medicines Agency rapporteur has scheduled a Scientific Advice Meeting for October 2025 [4] Product Information - OST-HER2 is an immunotherapy targeting the HER2 protein, leveraging the immune-stimulatory effects of Listeria bacteria [3] - The product has received Rare Pediatric Disease Designation, Fast-Track, and Orphan Drug designations from the FDA and EMA [3] - The company anticipates submitting a Biologics Licensing Application (BLA) to the FDA in 2025, which could lead to a Priority Review Voucher [5] Future Developments - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6]

Group 1 - The article reports significant declines in the stock prices of several Chinese concept stocks, with the largest drop being 27.78% for LZMH (联掌科技控股) [1] - Other notable declines include PAVS (幸福来) down 20.94%, ORIS (闽东红) down 18.49%, EHGO (君长数码) down 17.88%, and OST (奥斯汀科技集团) down 17.29% [1] - The trading volumes for these stocks vary, with LZMH having a trading volume of 2.4457 million and PAVS at 25,300, indicating varying levels of investor interest [1]

7月28日，奥斯汀科技于2025-08-05合股,25合1(预案)。 资料显示，奥斯汀科技集团有限公司是中国显示模块和偏光片的供应商。 该公司根据客户的规格设计, 开发和制造各种尺寸和定制尺寸的TFT-LCD模块。 它们的显示模块主要用于消费电子,户外LCD显示器 和汽车显示器。 该公司还制造用于TFT-LCD显示模块的偏光片,并且正在开发用于OLED显示面板的偏 光片。 本文源自：金融界 作者：行情君 8月5日，奥斯汀科技(OST)开盘上涨3.51%，截至21:30，报2.07美元/股，成交4.18万美元，总市值2.76亿 美元。 财务数据显示，截至2025年03月31日，奥斯汀科技收入总额2084.31万美元，同比增长39.2%；归母净利 润-517.94万美元，同比减少11.6%。 大事提醒： ...

In conjunction with the Reverse Share Split, the Company also amended its Memorandum of Association to proportionately reduce the number of authorized shares for issuance and to adjust the par value of the post- reverse share split ordinary shares to $0.025 per share. Nanjing, China, July 28, 2025 (GLOBE NEWSWIRE) -- Ostin Technology Group Co., Ltd. ("the Company") (NASDAQ:OST), a leading supplier of display modules and polarizers based in China, today announced that it has resolved to effect a reverse shar ...

Core Viewpoint - Univest Securities, LLC has successfully closed a registered direct offering for Ostin Technology Group Co., Ltd., raising approximately $5 million through the sale of 41,666,667 Class A ordinary shares at a price of $0.12 per share [1][2][3]. Group 1: Offering Details - The offering involved a single institutional investor purchasing an aggregate of 41,666,667 Class A ordinary shares or pre-funded warrants at a purchase price of $0.12 per share [2]. - The gross proceeds from this offering amounted to approximately $5 million [3]. - The offering was conducted under a shelf registration statement on Form F-3, which was declared effective by the SEC on May 28, 2024 [4]. Group 2: Company Background - Ostin Technology Group Co., Ltd. is a supplier of display modules and polarizers based in China, founded in 2010 [7]. - The company specializes in designing, developing, and manufacturing TFT-LCD display modules used in consumer electronics, outdoor LCD displays, and automotive displays [7]. - Ostin also manufactures polarizers that are utilized in its TFT-LCD display modules [7]. Group 3: Univest Securities Overview - Univest Securities, LLC is a full-service investment bank and securities broker-dealer firm based in New York, registered with FINRA since 1994 [6]. - The firm has raised over $1.3 billion in capital for issuers globally since 2019 and has completed approximately 100 transactions across various industries [6].