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Ayala Pharmaceuticals (Nasdaq: AYLA) has dosed the first patient in a Phase 1 clinical trial for AL102, a gamma secretase inhibitor, in combination with Novartis’ WVT078 to treat relapsed/refractory multiple myeloma (MM). This trial aims to assess safety, tolerability, and preliminary anti-MM response. AL102 increases the expression of membrane-bound B-cell maturation antigen (BCMA) on MM cells, potentially enhancing therapeutic outcomes. This milestone underscores the ongoing collaboration with Novartis in developing novel treatments for this aggressive cancer.
Ayala Pharmaceuticals (Nasdaq: AYLA) completed a $25 million strategic financing, extending its cash runway into 2023. The company is set to accelerate the development of AL102 for treating desmoid tumors into a Phase 2/3 pivotal trial. In 2020, Ayala reported a net loss of $30.1 million, with cash and equivalents at $42.4 million, up from $16.8 million in 2019. Upcoming milestones include the initiation of the RINGSIDE clinical trial in the first half of 2021 and preliminary data from the TENACITY trial later this year.
Ayala Pharmaceuticals (NASDAQ: AYLA) announced its participation in three virtual investor conferences: H.C. Wainwright & Co. on March 9, Oppenheimer's Annual Healthcare Conference on March 16, and Roth Capital Partners on March 17, 2021. Each presentation will be available for on-demand viewing via Ayala's website. The company focuses on developing small molecule therapeutics for rare and aggressive cancers, with two candidates, AL101 and AL102, currently in clinical trials targeting various tumors. AL101 has received Fast Track and Orphan Drug Designation from the U.S. FDA.
Ayala Pharmaceuticals (NASDAQ: AYLA) announced a private placement agreement with institutional investors, expected to yield approximately $25 million. The funds will support the accelerated development of AL102 for treating desmoid tumors in a pivotal Phase 2/3 study, anticipated to start in the first half of 2021. The agreement includes the sale of 1,666,666 units at $15 per unit. Ayala's cash resources, supplemented by this funding, will secure operating expenses through multiple catalysts into 2023.
Ayala Pharmaceuticals (NASDAQ: AYLA) has announced the dosing of the first patient in the Phase 2 TENACITY trial evaluating AL101 as a treatment for Notch-activated recurrent or metastatic triple negative breast cancer (TNBC). This trial aims to assess the efficacy and safety of AL101 in heavily pre-treated patients, with a planned enrollment of up to 26 participants. Preliminary results are expected by the end of 2021. AL101 is a selective gamma secretase inhibitor, previously licensed from Bristol-Myers Squibb, and has received Fast Track and Orphan Drug designations for its potential therapeutic benefits.
Ayala Pharmaceuticals (NASDAQ: AYLA) will present at the Noble Capital Markets 17th Annual Small & Microcap Investor Conference on January 20, 2021, at 1:30 PM ET. The presentation will be led by CEO Roni Mamluk, Ph.D. Investors can access a live webcast via the Noble conference portal. A recording will be available the following day on Ayala’s website for 90 days. Ayala focuses on developing small molecule therapeutics for rare cancers.
Ayala Pharmaceuticals (NASDAQ: AYLA) announced that CEO Roni Mamluk will present at the H.C. Wainwright Bioconnect 2021 Virtual Conference, available on-demand from January 11, 2021, at 6:00 am ET. The presentation will provide insights into Ayala's focus on developing small molecule therapeutics for rare and aggressive cancers. The company is advancing two product candidates, AL101 and AL102, which target Notch pathway activation. AL101 holds Fast Track and Orphan Drug Designations from the FDA and is currently in Phase 2 trials for various cancers.
Ayala Pharmaceuticals has completed its end-of-Phase 1 meeting with the FDA for AL102, a gamma secretase inhibitor targeting desmoid tumors. The FDA has approved the progression to a pivotal Phase 2/3 study, RINGSIDE, expected to initiate in 1H21. This trial aims to evaluate the efficacy and safety of AL102 in up to 192 patients with desmoid tumors. Initial results are expected by mid-2022. With no current FDA-approved therapies for these tumors, AL102 could potentially fulfill a significant unmet medical need.
Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA) reported encouraging interim data from its Phase 2 ACCURACY study of AL101 for recurrent/metastatic adenoid cystic carcinoma (R/M ACC), showing a 68% disease control rate among 40 evaluable patients. The company also noted a net loss of $7.4 million for Q3 2020, with cash reserves of $48.8 million. Ayala plans to start patient dosing for the Phase 2 TENACITY study of AL101 in triple-negative breast cancer by year-end 2020, alongside two new Phase 2 trials set for 2021.
Ayala Pharmaceuticals (NASDAQ: AYLA) announced its participation in two virtual investor conferences. The conferences include the 6th Annual Israel Conference on November 12, 2020, at 8:30 am ET, and the Jefferies Virtual London Healthcare Conference on November 19, 2020, at 6:45 pm ET. Investors can access live webcasts of these events on Ayala's website, with archived replays available for 90 days. Ayala focuses on small molecule therapeutics for rare and aggressive cancers, with key products AL101 and AL102 targeting various tumors, supported by FDA designations.
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