공시 • Apr 09
OS Therapies Incorporated (NYSEAM:OSTX) completed the acquisition of Immuno-Oncology Programs and IP Assets from Ayala Pharmaceuticals, Inc. (OTCPK:ADXS). OS Therapies Incorporated (NYSEAM:OSTX) agreed to acquire Immuno-Oncology Programs and IP Assets from Ayala Pharmaceuticals, Inc. (OTCPK:ADXS) for $8 million on January 29, 2025. A cash consideration of $0.5 million will be paid by OS Therapies Incorporated. Under the terms of the agreement, OS Therapies has agreed to pay $0.5 million in cash and issue $7.5 million worth of OS Therapies’ common shares to Ayala. OS Therapies previously completed a $7.1 million financing, priced at $4.00 per share primarily with existing shareholders, that provides the Company with sufficient cash runway into 2026 inclusive of payments to Ayala. As part of the financing agreement, OS Therapies agreed to appoint Karim Galzahr to the Company’s Board of Directors. The transaction is expected to close 60 days from execution of the agreement, subject to customary closing conditions.
OS Therapies Incorporated (NYSEAM:OSTX) completed the acquisition of Immuno-Oncology Programs and IP Assets from Ayala Pharmaceuticals, Inc. (OTCPK:ADXS) on April 9, 2025. 공시 • May 10
Ayala Pharmaceuticals Files Form 15 Ayala Pharmaceuticals, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.001 per share. 공시 • Apr 02
Ayala Pharmaceuticals, Inc. announced delayed annual 10-K filing On 04/01/2024, Ayala Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. 공시 • Mar 27
Immunome, Inc. (NasdaqCM:IMNM) completed the acquisition of Assets from Ayala Pharmaceuticals, Inc. (OTCPK:ADXS). Immunome, Inc. (NasdaqCM:IMNM) entered into a definitive asset purchase agreement to acquire Assets from Ayala Pharmaceuticals, Inc. (OTCPK:ADXS) for $94.2 million on February 6, 2024. Based on the terms of the agreement, Immunome will pay Ayala $20 million in cash and $30 million in Immunome common stock (valued at 30-day VWAP as of February 1, 2024) at the closing and will pay up to an additional $37.5 million in development and commercial milestone payments. Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval. A.G.P./Alliance Global Partners is acting as strategic advisor to Ayala Pharmaceuticals, Inc. in connection with the transaction.
Immunome, Inc. (NasdaqCM:IMNM) completed the acquisition of Assets from Ayala Pharmaceuticals, Inc. (OTCPK:ADXS) on March 26, 2024. 공시 • Feb 20
Ayala Pharmaceuticals, Inc. Announces Completion of Enrollment in Phase 3 Ringside Study Evaluating AL102 in Desmoid Tumors Ayala Pharmaceuticals, Inc. announced that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors. A total of 156 patients were enrolled. The Phase 3 segment of the RINGSIDE study is a double-blind, multi-center trial enrolling patients with progressive disease, randomized between AL102 1.2 mg dosed once daily or placebo. The primary endpoint is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures. RINGSIDE has been designed as a registration study to support a New Drug Application (NDA) in desmoid tumors. 공시 • Oct 25
Ayala Pharmaceuticals Presents Updated AL102 Results from Phase 2 Clinical Trial in Desmoid Tumors at ESMO Congress 2023 Ayala Pharmaceuticals, Inc. announced that new data from the RINGSIDE study evaluating its lead investigational candidate AL102 for the treatment of desmoid tumors (DT) are being presented at the European Society for Molecular Oncology (ESMO) Congress 2023, taking place October 20th to 24th in Madrid, Spain. The data are from Phase 2 (Part A) of the study and from the Open Label Extension (OLE). The results are featured in a poster being presented by Professor Robin Jones, Team Leader in Sarcoma Clinical Trials at The Institute of Cancer Research and Consultant Medical Oncologist at The Royal Marsden, UK. The ongoing Phase 2/3 RINGSIDE clinical trial is a randomized, global multi-center study evaluating AL102 in patients with progressing desmoid tumors. The study consists of two parts: Phase 2 (Part A) is an open-label, dose regimen finding study, and Phase 3 (Part B) is a double blind, placebo-controlled study and Open Label Extension utilizing the 1.2 mg once daily dose regimen selected based on data from Phase 2. Patients in Phase 2 were randomized to one of three dose regimens of AL102 (n=14 each), including 1.2 mg once daily (QD), 4 mg twice a week (BIW) or 2 mg BIW. Patients in the intermittent dosing arms were allowed to rollover to the Open Label Extension to receive 1.2 mg once daily after evaluations were completed in the Phase 2 part. The results presented at ESMO reflect a cut-off date as of July 5, 2023. Efficacy Results: 1.2 mg once daily achieved ORR of 83% per RECIST in the evaluable population as assessed by MRI BICR (Blinded Independent Central Review). ORR per RECIST was 64% in evaluable patients across the 3 dose arms (n=36). Efficacy results continue to demonstrate a dose-response pattern favoring the 1.2 mg once daily arm. First Partial Responses (PRs) observed at 16 weeks and 21 additional PRs and 1 Complete Response across all dose arms. Early and deep volume (-52%) and T2 signal intensity (-58%) reductions within 16 weeks after starting 1.2 mg once daily. Best overall median reductions of 88% and 85% in volume and T2 signal intensity, respectively, in the 1.2 mg once daily arm at 16.6 months of median time on treatment. Reductions in volume and T2 signal intensity were also observed across biweekly dose arms. 29 patients rolled over to the OLE between Oct 2022 and May 2023, with 27 still on study. Three patients from the 4 mg BIW arm achieved PR after rolling over to the OLE where they received 1.2 mg once daily. Safety: AL102 was generally well tolerated with a manageable safety profile across all dose arms. Adverse events (AEs) were consistent with gamma secretase inhibitors’ (GSI) mec anism of action. The most frequent treatment-related AEs with 1.2 mg once daily included diarrhea (92.8%), nausea (57.1%), fatigue (50%), dry skin (50%), alopecia (50%), stomatitis (50%) dermatitis acneiform (42.9%), dry mouth (42.9%), hypophosphatemia (42.9%), rash maculopapular (37.7%) and aspartate aminotransferase increased (28.6%). Regardless of dose regimen, AEs were Grade 1 or Grade 2 in >95% of the cases. There was one Grade 4 unrelated AE and no Grade 5 AEs. There were no treatment-related serious AEs. Ovarian dysfunction was reported in 56% of pre-menopausal women in the 1.2 mg once daily arm and 61% of pre-menopausal women across all dose arms. 공시 • Oct 23
Ayala Pharmaceuticals, Inc. Announces CFO Changes Effective as of the Effective Time, Roy Golan, CPA, LLM, will become the Ayala Pharmaceuticals, Inc.'s Chief Financial Officer. Igor Gitelman will cease to serve as the company's Interim Chief Financial Officer at that time. Mr. Golan, 50, is a registered CPA with a broad experience in aspects of Nasdaq, IPOs and M&As. Prior to joining BioSight, Mr. Golan served in several financial management positions in the biotech industry, including as the CFO of Neuroderm, where he had a pivotal role in their successful Nasdaq IPO, two Follow-On Offerings, and Neuroderm's acquisition by Mitsubishi Tanabe Pharmaceutical Corporation for a total of $1.1 billion. Mr. Golan started his career at PriceWaterhouseCoopers (PWC). Mr. Golan is a registered CPA, holds a B.A. in Accounting and Business from the Israeli College of Management School of Business and an LL.M. in Law from Bar Ilan University. Mr. Golan will continue, until such time as new compensation terms are agreed to with the Company, to be compensated in accordance with his existing arrangements at Biosight, including an annual salary of approximately $180,000, and insurance, severance, pension, disability and study fund benefits typical under Israeli employment arrangements.