Core Viewpoint - OS Therapies is advancing its regulatory submissions for OST-HER2, focusing on obtaining marketing authorizations in the UK and US for the treatment of pulmonary metastatic osteosarcoma, with submissions expected in late 2025 and early 2026 [3][7]. Regulatory Update - The company has updated its regulatory filing sequence to prioritize the UK MHRA conditional Marketing Authorisation Application (MAA) submission, which is expected to be completed in December 2025, followed by the US FDA Biologics Licensing Application (BLA) submission in January 2026 [3][7]. - A conditional MAA Pre-Submission Request has been submitted to the MHRA, and the company anticipates receiving formal acceptance for a rolling review request soon [4]. Clinical Trial Insights - The information in the MHRA conditional MAA submission aligns closely with the planned US FDA BLA submission, with the exception of the acceptable comparator arm for efficacy data [5]. - The company aims to use immune activation biomarker data as a surrogate marker correlated with overall survival to support its Accelerated Approval request [5][7]. Company Background - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with OST-HER2 being its lead asset [8]. - OST-HER2 has received several designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track designation, and has shown statistically significant benefits in its Phase 2b clinical trial [8]. Future Developments - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [9].

Core Insights - OS Therapies has completed the last patient visit in its Phase 1b clinical trial for OST-504, focusing on biochemically recurrent prostate cancer, with a total of 7 patients enrolled [1][2] - The company is optimistic about the potential of OST-504 in various prostate cancer settings and plans to report study results in Q4 2025 [2] - Prostate cancer represents a significant market opportunity, with 1 in 8 men diagnosed and 1 in 44 men dying from the disease, making it the second leading cause of cancer death among men [2] - The company is also preparing for a rolling submission for a Biologics Licensing Application (BLA) for OST-HER2 in osteosarcoma, which could lead to accelerated market access for OST-504 if successful [2][5] - Updated 2-year overall survival data from the Phase 2b trial of OST-HER2 will be released on October 10, 2025 [4] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, with OST-HER2 as its lead asset [3][5] - OST-HER2 has received multiple designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status, and has shown positive results in its Phase 2b clinical trial [3][5] - The company is advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced drug delivery [6]

Core Insights - The analysis emphasizes the importance of reviewing both successful and unsuccessful stock picks to learn from mistakes and successes [1][2] - Ostin Technology (OST) experienced a significant decline in price due to a lack of due diligence and ignoring negative trends in revenue, earnings, and cash flow [2][3] - Bloom Energy (BE) demonstrated a positive performance with a 22.61% gain in six trading days, attributed to thorough research and favorable analyst projections [4][5] Summary of Ostin Technology - The company faced declining revenue, earnings, and cash flow over several years, which was overlooked during the initial analysis [3] - The price increase prior to the decline had no fundamental support, leading to a significant loss for investors who did not conduct proper due diligence [2][3] Summary of Bloom Energy - Bloom Energy was highlighted for its consistent revenue growth and positive analyst projections for both revenue and earnings [4][5] - The stock closed at $51.35 on September 2 and rose to $62.96 by September 10, marking a 22.61% increase [5] - The analysis stresses the necessity of examining multi-year revenue and earnings trends to avoid costly investment mistakes [5]

Core Viewpoint - OS Therapies is progressing towards the submission of a rolling Biologics Licensing Application (BLA) for its OST-HER2 program targeting recurrent, fully resected, pulmonary metastatic osteosarcoma, following a productive End of Phase 2 meeting with the FDA [1][2][6] Group 1: FDA Meeting Outcomes - The FDA and OS Therapies reached alignment on several critical areas necessary for a successful BLA, including clinical trial efficacy endpoints and statistical analysis plans [2] - A public meeting with key osteosarcoma stakeholders is scheduled for October 10, 2025, to discuss advancing drug development for osteosarcoma [2] - The FDA is committed to working closely with the Company, prioritizing both formal and informal meetings, with the first informal meeting set for mid-September 2025 [2][6] Group 2: Clinical Data and Safety Profile - No significant safety concerns were identified for OST-HER2 based on the clinical data available to date, indicating an excellent safety profile [3] - The Company is preparing necessary data for submission to the FDA as part of the rolling BLA submission expected in Q4 2025 [3] Group 3: Designations and Financial Aspects - OST-HER2 has received Rare Pediatric Disease Designation (RPDD) and is eligible for a Prescription Drug User Fee Act (PDUFA) small business fee waiver, with a decision expected by the end of Q3 2025 [5][7] - The Company anticipates significant progress towards Breakthrough Therapy designation (BTD) and either Accelerated Approval or full approval during the upcoming FDA/OSI workshop [4] Group 4: Future Developments - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced treatment delivery [8] - The Company is actively compiling data for the OST-400 natural history database to support the development of a synthetic control arm for future trials [2][6]

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]