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Ayala Pharmaceuticals announced interim results from its Phase 2 ACCURACY clinical trial of AL101 for recurrent/metastatic adenoid cystic carcinoma (ACC) with Notch-activating mutations. The 4mg monotherapy arm showed a robust 68% disease control rate from 40 evaluable patients, with a notable improvement compared to the 61% rate reported in 2019. The drug was well-tolerated, with most adverse events being mild to moderate. A virtual KOL event is scheduled for further data discussion.
Ayala Pharmaceuticals (NASDAQ: AYLA) will host a virtual Key Opinion Leader (KOL) event on September 18, 2020, to present interim data from the Phase 2 ACCURACY study on AL101, aimed at treating recurrent/metastatic adenoid cystic carcinoma with Notch activating mutations. The event, featuring Ayala management and Dr. Alan L. Ho from Memorial Sloan Kettering, will be available via webcast. AL101 has received Fast Track and Orphan Drug Designations from the U.S. FDA and targets cancer driven by aberrant Notch pathway activation.
Ayala Pharmaceuticals (NASDAQ: AYLA) announced participation in two upcoming investor conferences: the H.C. Wainwright & Co. 22nd Annual Global Healthcare Conference on September 15, 2020 at 12:30 PM ET, and the Oppenheimer & Co. Fall Healthcare Life Sciences & MedTech Summit on September 21, 2020 at 1:40 PM ET. Live webcasts can be accessed on Ayala's website, with archived replays available for 90 days. The company focuses on developing small molecule therapeutics for rare and aggressive cancers, with lead candidate AL101 currently in Phase 2 clinical trials.
Ayala Pharmaceuticals (Nasdaq: AYLA) announced the appointment of Vered Bisker-Leib, Ph.D., to its Board of Directors, effective August 20, 2020. Dr. Bisker-Leib, with over 17 years of experience in the biotechnology industry, will join the Audit and Compensation Committees. Her previous roles include Chief Operating Officer at Compass Therapeutics and key positions at Bristol-Myers Squibb. The company aims to leverage her expertise to advance its pipeline of novel therapies for rare and aggressive genetically defined cancers, including its lead candidate, AL101, currently in Phase 2 trials.
Ayala Pharmaceuticals (Nasdaq: AYLA) reported Q2 2020 financial results, revealing a net loss of $6.7 million, or $0.74 per share. The company highlighted its successful IPO, boosting cash reserves to $57.4 million, funding operations through H2 2022. Significant developments include the ongoing Phase 2 ACCURACY study of AL101 for R/M ACC, with interim data expected at the ESMO Virtual Congress on September 18, 2020, and plans to initiate the Phase 2 TENACITY study for TNBC.
Ayala Pharmaceuticals (NASDAQ: AYLA) announced interim results from its Phase 2 ACCURACY clinical trial for its lead product AL101, aimed at treating recurrent/metastatic adenoid cystic carcinoma harboring Notch mutations. These results will be presented at the European Society for Medical Oncology Virtual Congress 2020, scheduled for September 19-21. The trial seeks to evaluate the effectiveness of AL101, a selective gamma secretase inhibitor, in targeting this rare cancer. The presentation is set for September 18, with details available post-event on Ayala's investor website.
Ayala Pharmaceuticals (AYLA) raised $59.1 million from its upsized IPO, expected to fund operations into the second half of 2022. The company received Fast Track Designation for AL101, targeting recurrent/metastatic adenoid cystic carcinoma (R/M ACC), and initiated dosing in a Phase 2 study. Ayala's IND for AL101 in triple-negative breast cancer (TNBC) was also accepted by the FDA, with trials set to start in late 2020. The cash balance as of March 31, 2020, was $10.1 million. The net loss for Q1 2020 was $6.6 million, reflecting higher R&D expenses.
Ayala Pharmaceuticals (NASDAQ: AYLA) announced that its management will present at two investor conferences: the Jefferies Virtual Global Healthcare Conference on June 3, 2020, at 10:30 am ET and the Raymond James 2020 Human Healthcare Innovation Conference on June 18, 2020, at 8:20 am ET. Both presentations will be accessible via a live webcast on Ayala's website, with archived replays available for 90 days. Ayala focuses on developing targeted therapies for rare and aggressive cancers, with key candidates AL101 and AL102 currently under clinical development.
Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA) has successfully closed its initial public offering of 3,666,667 shares at $15.00 per share, generating approximately $55.0 million in gross proceeds. The shares began trading on NASDAQ on May 8, 2020. Citigroup and Jefferies led the offering, supported by Oppenheimer & Co. and Raymond James. The registration statement for this offering was filed with the SEC and became effective on May 7, 2020. The offering is solely for securities sold by Ayala, and details for obtaining the prospectus have been provided.
Ayala Pharmaceuticals, with ticker symbol AYLA, has priced its initial public offering (IPO) at $15.00 per share for 3,666,667 shares, aiming to raise $55 million in gross proceeds. The offering, entirely by Ayala, is expected to close on May 12, 2020, subject to customary conditions. Additionally, underwriters have a 30-day option to purchase an extra 550,000 shares at the same price. Trading on the NASDAQ Global Market under the ticker AYLA is set to commence on May 8, 2020, with Citigroup and Jefferies as lead managers.
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