AYLA Ayala Pharmaceuticals Inc.

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1. 14 May 2021 Ayala Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update

           - First Patient Dosed in Phase 1 AL102 Combination Trial with Novartis' Anti-BCMA Agent for the Treatment of Multiple Myeloma -
   

   - On Track to Initiate AL102 Phase 2/3 Pivotal Trial for the Treatment of Desmoid Tumors in 1H21-

   - Multiple Near-Term Milestones Expected Across Clinical-Stage Pipeline -

   REHOVOT, Israel and WILMINGTON, Del., May 14, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ:AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today reported financial results for the first quarter ended March 31, 2021 and highlighted recent progress…

           - First Patient Dosed in Phase 1 AL102 Combination Trial with Novartis' Anti-BCMA Agent for the Treatment of Multiple Myeloma -
   
   

   - On Track to Initiate AL102 Phase 2/3 Pivotal Trial for the Treatment of Desmoid Tumors in 1H21-

   - Multiple Near-Term Milestones Expected Across Clinical-Stage Pipeline -

   REHOVOT, Israel and WILMINGTON, Del., May 14, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ:AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today reported financial results for the first quarter ended March 31, 2021 and highlighted recent progress and upcoming milestones for its pipeline programs.

   "Continuing on the strong momentum set in 2020, we are pleased with our progress through the first quarter of 2021. With a strengthened balance sheet and extended cash runway into 2023, we are well positioned to further progress our innovative pipeline of assets targeting the inhibition of gamma secretase through key pathways implicated in rare and aggressive cancers, including adenoid cystic carcinoma, multiple myeloma, triple negative breast cancer and desmoid tumors," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "We have made great strides to advance our pipeline programs in 2021 with the first patients dosed in both the Phase 2 TENACITY trial in triple negative breast cancer and the Phase 1 combination trial with Novartis in multiple myeloma. We also remain on track to report additional data from the 6mg cohort of our Phase 2 ACCURACY trial of AL101 for the treatment of adenoid cystic carcinoma in the second half of this year."

   Recent Business Highlights and Upcoming Milestones:

   • First Patient was dosed in Phase 1 Clinical Trial of AL102 in Combination with Novartis' BCMA Targeting Agent, WVT087 for the Treatment of Relapsed/Refractory Multiple Myeloma: In April 2021, Ayala announced that the first patient was dosed in its Phase 1 combination trial of AL102 with Novartis' investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of relapsed and/or refractory multiple myeloma (MM).
     
     
     
     
   • Completed $25 million Strategic Financing: In February 2021, Ayala announced a $25 million strategic financing with investors including Redmile Group and SIO Capital Management, extending its cash runway into 2023.
     
     
     
     
   • Phase 2 TENACITY Clinical Trial Continues to Progress: In January 2021, Ayala announced the dosing of the first patient in the Phase 2 TENACITY clinical trial of its potent, selective small molecule, AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC). Ayala expects to report preliminary data from this ongoing trial by the end of 2021.
     
     
     
     
   • Accelerated Development of AL102 for the Treatment of Desmoid Tumors with Pivotal Trial; First site opened in the US for the Phase 2/3 RINGSIDE Trial: In January 2021, Ayala announced that based on its end-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) on AL102 for the treatment of desmoid tumors, and data from AL101 and AL102 Phase 1 studies including durable responses observed in patients with desmoid tumors, the FDA agreed to advance the program into a Phase 2/3 pivotal trial. Ayala expects to initiate the pivotal RINGSIDE clinical trial of AL102 in adult and adolescent patients with desmoid tumors in the first half of 2021. Ayala expects an initial interim data read-out from part A of the study and dose selection by mid-2022 with part B of the study commencing immediately thereafter.
     
     
   • On Track to Report Additional ACCURACY Phase 2 Data; Patient Enrollment in 6mg Cohort of Phase 2 ACCURACY Study Ongoing: Ayala continues to enroll patients in the 6mg cohort of the Phase 2 ACCURACY study of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma (R/M ACC), which will include up to 42 subjects. Further trial progress updates, including additional data, are expected in the second half of 2021.

   First Quarter 2021 Financial Results

   • Cash Position: Cash and cash equivalents totaled $56.0 million as of March 31, 2021.
   • Collaboration Revenue: Collaboration revenue was $1.0 million for the first quarter of 2021 and 2020.
   • R&D Expenses: Research and development expenses were $6.9 million for the first quarter of 2021, compared to $5.1 million for the same period in 2020. The increase was primarily driven by additional costs in connection with the advancement of the Desmoids, TNBC and ACC clinical trials.
   • G&A Expenses: General and administrative expenses were $2.3 million for the first quarter of 2021, compared to $1.3 million for the same period in 2020. This increase was primarily due to higher expenses in connection with becoming a public company, including director and officers insurance and stock-based compensation.
   • Net Loss: Net loss was $9.6 million for the first quarter of 2021, resulting in a basic and diluted net loss per share of $0.74. Net loss was $6.6 million for the same period in 2020, resulting in a basic and diluted net loss per share of $1.32.
     
     

   Financial Guidance

   Ayala expects its existing cash balance to fund operating expenses and capital expenditure requirements through multiple potential key clinical and development milestones into 2023.

   About Ayala Pharmaceuticals

   Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala's approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis' BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

   Contacts:

   Investors:
   
   Julie Seidel
   
   Stern Investor Relations, Inc.
   
   +1-212-362-1200
   
   

   Ayala Pharmaceuticals:
   
   +1-857-444-0553
   
   

   Forward-Looking Statements

   This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, upcoming milestones, including without limitation the timing and results of any clinical trials or readouts, patient enrollment and the sufficiency of cash to fund operations. These forward-looking statements are based on management's current expectations. The words "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our cash runway; our limited operating history and the prospects for our future viability; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our requirement to pay significant payments under product candidate licenses; the approach we are taking to discover and develop product candidates and whether it will lead to marketable products; the expense, time-consuming nature and uncertainty of clinical trials; enrollment and retention of patients; potential side effects of our product candidates; our ability to develop or to collaborate with others to develop appropriate diagnostic tests; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

   AYALA PHARMACEUTICALS, INC.
   CONDENSED CONSOLIDATED BALANCE SHEETS
   (In thousands, except share and per share amounts)
   	March 31,			December 31
   	2021			2020
   	(Unaudited)
   CURRENT ASSETS:
   Cash and Cash Equivalents	$	56,030		$	42,025
   Short-term Restricted Bank Deposits		117			90
   Trade Receivables		169			681
   Prepaid Expenses and other Current Assets		1,534			1,444
   Total Current Assets		57,850			44,240
   LONG-TERM ASSETS:
   Other Assets	$	264		$	305
   Property and Equipment, Net		1,119			1,283
   Total Long-Term Assets		1,383			1,588
   Total Assets	$	59,233		$	45,828
   LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY:
   CURRENT LIABILITIES:
   Trade Payables	$	3,004		$	3,726
   Other Accounts Payables		2,690			3,151
   Total Current Liabilities		5,694			6,877
   LONG TERM LIABILITIES:
   Long-term Rent Liability		505			553
   Total Long-Term Liabilities	$	505		$	553
   STOCKHOLDERS' DEFICIT:
   Common Stock of $0.01 par value per share; 200,000,000 shares authorized at March 31, 2021 and December 31,
   2020; 13,240,961 and 12,824,463 shares issued at March 31, 2021 and, respectively December 31, 2020;
   13,072,213 and 12,728,446 shares outstanding at March 31, 2021 and December 31, 2020, respectively	$	131		$	128
   Additional Paid-in Capital		133,358			109,157
   Accumulated Deficit		(80,455	)		(70,887	)
   Total Stockholders' Equity		53,034			38,398
   Total Liabilities, Convertible Preferred Stock, and Stockholders' Equity	$	59,233		$	45,828

   
   
   

   AYALA PHARMACEUTICALS, INC.
   CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
   (Unaudited)
   (In thousands, except share & per share amounts)
   		For the Three Months Ended
   		March 31,
   		2021				2020
   Revenues from licensing agreement	$	974			$	1,001
   Cost of Revenues		(974	)			(1,001	)
   Gross profit		—				—
   Operating expenses:
   Research and development		6,925				5,128
   General and administrative		2,303				1,311
   Operating loss		(9,228	)			(6,439	)
   Financial loss, net		(92	)			(38	)
   Loss before income tax		(9,320	)			(6,477	)
   Taxes on income		(248	)			(121	)
   Net loss attributable to common stockholders		(9,568	)			(6,598	)
   Net Loss per share attributable to common stockholders, basic and diluted	$	(0.74	)		$	(1.32	)
   Weighted average common shares outstanding, basic and diluted		12,888,340				4,999,563

   
   
   

   

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2. 21 April 2021 Ayala Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of AL102 in Combination with BCMA Targeting Agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma

   REHOVOT, Israel and WILMINGTON, Del., April 21, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ:AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced the dosing of the first patient in the ongoing Phase 1 clinical trial evaluating its potent investigational gamma secretase inhibitor (GSI), AL102, in combination with Novartis' investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).
   

   AL102 is an oral small molecule that inhibits gamma secretase. Inhibition of gamma secretase prevents the cleavage and shedding…

   REHOVOT, Israel and WILMINGTON, Del., April 21, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ:AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced the dosing of the first patient in the ongoing Phase 1 clinical trial evaluating its potent investigational gamma secretase inhibitor (GSI), AL102, in combination with Novartis' investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).
   
   

   AL102 is an oral small molecule that inhibits gamma secretase. Inhibition of gamma secretase prevents the cleavage and shedding of BCMA, which are ubiquitously expressed on MM cells. Preclinical data have demonstrated that treatment with AL102 increases expression of membrane-bound BCMA on the surface of MM cells and could enhance activity of WVT078.

   "The dosing of the first patient in this Phase 1 trial marks an important milestone in our collaboration with Novartis. We view this trial, not only as a significant opportunity to explore the clinical viability of enhancing BCMA-targeting agents with GSIs such as AL102, but also as an important step forward in bringing a novel treatment option to patients with MM," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "Despite numerous advances in the treatment landscape for MM, the disease remains incurable. BCMA is ubiquitously expressed on myeloma cells. Increasing BCMA expression on target cells and reducing the shedding in circulation is believed to potentially enhance therapies and increase responses. We look forward to further evaluating this potential as we bring this program into the clinic."

   The Phase 1, open-label, multicenter trial of AL102 in combination with Novartis' WVT078 is currently enrolling patients with relapsed and/or refractory multiple myeloma who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent. The first-in-human dose escalation trial is designed to assess the safety, tolerability and recommended dose regimen(s) of WVT078 alone and in combination with AL102. In addition, the trial will assess preliminary anti-MM response and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with AL102.

   Under the terms of the option and license agreement established in December 2018, Novartis is responsible for the conduct and expenses of any trials of AL102 in combination with their BCMA-targeting agents, as well as potential commercialization, in multiple myeloma. Ayala retains worldwide license rights to AL102 in all other indications.

   About AL102
   
   AL102 is a potent, selective and oral gamma secretase inhibitor (GSI). AL102 is currently being developed for the treatment of desmoid tumors, as well as in combination with Novartis' BCMA-targeting agents for the treatment of multiple myeloma (MM).

   About WVT078
   
   WVT078 is a bispecific antibody that engages both BCMA and CD3, resulting in the recruitment of cytotoxic T cells that target BCMA-positive MM cells.

   About Multiple Myeloma
   
   Multiple myeloma is a rare and aggressive blood cancer that accounts for approximately one percent of all cancers. In the U.S., there are nearly 90,000 people living with, or in remission from, multiple myeloma. Approximately, 26,850 Americans are diagnosed with multiple myeloma each year and 11,240 patient deaths are reported on an annual basis.

   About Ayala Pharmaceuticals
   
   Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers. Ayala's approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trial for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis' BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

   Contacts:

   Investors:
   
   Julie Seidel
   
   Stern Investor Relations, Inc.
   
   +1-212-362-1200
   
   

   Ayala Pharmaceuticals:
   
   +1-857-444-0553
   
   

   
   
   

   

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3. 02 April 2021 Ascentage Pharma Appoints Renowned Oncologist Dr. David Sidransky, MD, to its Board as an Independent Non-Executive Director

   SUZHOU, China and ROCKVILLE, Md., April 2, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced its appointment of Dr. David Sidransky, MD., a renowned oncologist, to the company's Board of Directors as an independent non-executive director, effective on March 31, 2021.

   

   Known for in research in biomarkers for early detection and therapy and profiled by TIME magazine in 2001 as one of America's best in science and medicine, Dr. Sidransky is a leading expert in oncology and precision medicine widely respected in the biopharmaceutical industry. Dr. Sidransky is currently the Director of the Head and Neck Cancer Research Division at Johns Hopkins University School of Medicine's Department of Otolaryngology; and Professor of Oncology, Cellular & Molecular Medicine, Urology, Genetics, and Pathology at the Johns Hopkins University School of Medicine. Dr. Sidransky is also serving as a member on the Scientific Advisory Boards of numerous professional organizations and institutions, including the American Association for Cancer Research (AACR), the American Society of Clinical Oncology (ASCO), and the National Cancer Institute (NCI) of the U.S. Having authored over 550 peer-reviewed publications, contributed 45 cancer reviews and chapters, and invented 28 biotechnology patents, Dr. Sidransky is one of the world's most highly cited researchers in clinical and medical journals.

   Dr. Sidransky has accumulated immense industry experience and exceptional expertise, not only in scientific research, but also in business operations, corporate governance and investment strategies. Dr. Sidransky is a founder of a number of biotechnology companies such as Champions Oncology (Nasdaq; CSBR). Previously, Dr. Sidransky was Vice Chairman of ImClone Systems Inc., a global biopharmaceutical company committed to advancing oncology care, until its acquisition by Eli Lilly. Dr. Sidransky is also a Co-Founder and Managing Partner of the Israel Biotech Fund. Furthermore, Dr. Sidransky is a highly-experienced board member, after having served as a director on the boards of Galmed Pharmaceuticals (NASDAQ:GLMD), Orgenesis (NASDAQ:ORGS), Advaxis (NASDAQ:ADXS), and Ayala (NASDAQ:AYLA).

   "It is our great pleasure to welcome Dr. Sidransky join us as an independent non-executive director. Dr. Sidransky is a true expert in science as well as in business operations, corporate governance, and investment management, and has made tremendous contributions to the biopharmaceutical industry," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Ascentage Pharma is currently advancing the global clinical development of its assets targeting a range of tumor types, and is gearing up for its first product launch. We are confident that the addition of Dr. Sidransky to our board will help sharpen our strategic focus and better position the company to capture future growth opportunities."

   "I am excited to join Ascentage Pharma's board as an independent non-executive director, and to have the opportunity to work with the company's leadership team and board members," commented Dr. Sidransky. "Ascentage Pharma is an emerging global leader in biopharmaceutical innovation. I look forward to supporting the company to realize its founding mission of 'addressing unmet clinical needs in China and around the world'."

   About Ascentage Pharma

   Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK.

   Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, and China. HQP1351, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and a New Drug Application (NDA) for the drug candidate has been submitted and subsequently granted Priority Review by the Center for Drug Evaluation (CDE) in China. To date, Ascentage Pharma has obtained a total of 11 ODDs from the US FDA for four of the company's investigational drug candidates.

   Forward-Looking Statements

   The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

   View original content to download multimedia:http://www.prnewswire.com/news-releases/ascentage-pharma-appoints-renowned-oncologist-dr-david-sidransky-md-to-its-board-as-an-independent-non-executive-director-301261367.html

   SOURCE Ascentage Pharma

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4. 25 March 2021 Ayala Pharmaceuticals Reports Full Year 2020 Financial Results and Provides Business Update

   - Completed $25 Million Strategic Financing; Extending Cash Runway into 2023
   

           - Accelerated Development of AL102 Desmoid Tumor Program into Phase 2/3 Pivotal Trial

   - On Track to Report Multiple Milestones in 2021 Across Clinical-Stage Pipeline

   REHOVOT, Israel and WILMINGTON, Del., March 25, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ:AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today reported financial results for the full year ended December 31, 2020 and highlighted recent progress and upcoming milestones for…

   - Completed $25 Million Strategic Financing; Extending Cash Runway into 2023
   
   

           - Accelerated Development of AL102 Desmoid Tumor Program into Phase 2/3 Pivotal Trial

   - On Track to Report Multiple Milestones in 2021 Across Clinical-Stage Pipeline

   REHOVOT, Israel and WILMINGTON, Del., March 25, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ:AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today reported financial results for the full year ended December 31, 2020 and highlighted recent progress and upcoming milestones for its pipeline programs.

   "We are pleased with all that we were able to accomplish in 2020 despite the ongoing challenges of the COVID-19 pandemic, keeping clinical execution and patient and employee safety at the forefront of our everyday work. In 2020, we announced encouraging new data from the Phase 2 ACCURACY study of AL101 in R/M ACC, demonstrating initial safety and efficacy for the 4mg monotherapy cohort and we look forward to reporting additional data, including new 6mg cohort results from this program later this year," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "With a strong foundation built in 2020, we have already achieved significant milestones across our broader pipeline in 2021 with the first patient dosing in our Phase 2 TENACITY trial in TNBC, accelerated development pathway and pivotal trial design for AL102 in desmoid tumors, as well as our $25 million strategic financing. We look forward to continuing this momentum with several key clinical milestones expected during the remainder of this year, including two new trial initiations and interim data readouts."

   Business and Clinical Highlights

   • Completed $25 million Strategic Financing: In February 2021, Ayala announced a $25 million strategic financing with investors including Redmile Group and SIO Capital Management, extending its cash runway into 2023.
     
     
     
     
   • Dosed First Patient in Phase 2 TENACITY Clinical Trial of AL101 for the Treatment of Notch-Activated Triple Negative Breast Cancer: In January 2021, Ayala announced the dosing of the first patient in the Phase 2 TENACITY clinical trial of its potent, selective small molecule, AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC).
     
     
     
     
   • Accelerated Development of AL102 for the Treatment of Desmoid Tumors with Pivotal Trial: In January 2021, Ayala announced that based on its end-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) on AL102 for the treatment of desmoid tumors, and data from AL101 and AL102 Phase 1 studies including durable responses observed in patients with desmoid tumors, the FDA agreed to advance the program into a Phase 2/3 pivotal trial.
     
     
     
     
   • Presented Updated Positive Interim Data from Phase 2 ACCURACY Study of AL101 for the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma at European Society for Medical Oncology (ESMO) Virtual Congress 2020: In September 2020, Ayala presented updated interim data from the 4mg cohort of its ongoing Phase 2 ACCURACY study of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma (R/M ACC) harboring Notch activating mutations, demonstrating meaningful clinical activity of AL101 4mg monotherapy with a 68% disease control rate across 40 evaluable patients. Partial responses were observed in six subjects (15%) and stable disease was observed in 21 subjects (53%).
     
     

   Upcoming Milestones

   • On Track to Initiate Phase 2/3 Pivotal RINGSIDE Clinical Trial of AL102 for the Treatment of Desmoid Tumors: Ayala expects to initiate the pivotal RINGSIDE clinical trial of AL102 in adult and adolescent patients with desmoid tumors in the first half of 2021. Ayala expects an initial interim data read-out from part A and dose selection by mid-2022 with part B of the study commencing immediately thereafter.
   • Patient Enrollment in 6mg Cohort of Phase 2 ACCURACY Study Ongoing: Ayala continues to enroll patients in the 6mg cohort of the Phase 2 ACCURACY study of AL101 for the treatment of R/M ACC, which will contain up to 42 subjects. The Company expects to provide further trial progress updates, including additional data, in the second half of 2021.
   • TENACITY Preliminary Data to be Reported in 2021: Ayala expects to report preliminary data from the recently initiated Phase 2 TENACITY clinical trial of AL101 for the treatment of R/M TNBC in the second half of 2021.
     
     

   Full Year 2020 Financial Results

   • Cash Position: Cash and cash equivalents were $42.4 million as of December 31, 2020, as compared to $16.8 million as of December 31, 2019. The increase in cash and cash equivalents was primarily due to Ayala's initial public offering in May 2020.
   • Collaboration Revenue: Collaboration revenue was $3.7 million for the full year of 2020, as compared to $2.3 million for the same period in 2019. The increase was primarily attributable to the advancement of Ayala's collaboration with Novartis in 2020.
   • R&D Expenses: Research and development expenses were $22.4 million for the full year 2020, compared to $14.4 million for the same period in 2019. The increase was primarily driven by an increase in expenses in connection with the advancement of the clinical trials in ACC and TNBC.
   • G&A Expenses: General and administrative expenses were $7.4 million for the full year 2020, compared to $4.3 million for the same period in 2019. The increase was primarily related to increased costs in connection with becoming a publicly traded company in 2020.
   • Net Loss: Net loss was $30.1 million for the full year 2020, resulting in a basic net loss per share of $3.06 and a diluted net loss per share of $3.06. Net loss was $17.8 million for the same period in 2019, resulting in a basic net loss per share of $3.57 and a diluted net loss per share of $3.57.
     
     

   Financial Guidance

   Ayala expects its existing cash balance to fund operating expenses and capital expenditure requirements through multiple potential key clinical and development milestones into 2023.

   About Ayala Pharmaceuticals

   Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala's approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). Ayala's lead product candidate, AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.

   Contacts:

   Investors:
   
   Julie Seidel
   
   Stern Investor Relations, Inc.
   
   +1-212-362-1200
   
   

   Ayala Pharmaceuticals:
   
   +1-857-444-0553
   
   

   Forward-Looking Statements

   This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, upcoming milestones, including without limitation the timing and results of any clinical trials or readouts, patient enrollment and the sufficiency of cash to fund operations. These forward-looking statements are based on management's current expectations. The words "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our cash runway; our limited operating history and the prospects for our future viability; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our requirement to pay significant payments under product candidate licenses; the approach we are taking to discover and develop product candidates and whether it will lead to marketable products; the expense, time-consuming nature and uncertainty of clinical trials; enrollment and retention of patients; potential side effects of our product candidates; our ability to develop or to collaborate with others to develop appropriate diagnostic tests; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

   AYALA PHARMACEUTICALS, INC.
   CONSOLIDATED BALANCE SHEETS
   U.S. dollars in thousands (except share and per share data)
   		December 31, 2019				December 31, 2020
   Assets
   Current Assets:
   Cash and Cash Equivalents		$	16,725			$	42,025
   Short-Term Restricted Bank Deposits			83				90
   Trade Receivables			469				681
   Prepaid Expenses and Other Current Assets			417				1,444
   Total Current Assets			17,694				44,240
   Long-Term Assets:
   Other Assets			283				305
   Deferred Offering Costs			656				—
   Property and Equipment, Net			1,421				1,283
   Total Long-Term Assets			2,360				1,588
   Total Assets		$	20,054			$	45,828
   Liabilities, Convertible Preferred Stock, and Stockholders' (Deficit) Equity:
   Current Liabilities:
   Trade Payables		$	2,922			$	3,726
   Other Accounts Payables			2,380				3,151
   Total Current Liabilities			5,302				6,877
   Long-Term Liabilities:
   Long-Term Rent Liability			299			$	553
   Total Long-Term Liabilities		$	299			$	553
   Convertible Preferred Stock, $0.01 par value:
   Series A Preferred Stock of $0.01 par value per share; 3,700,000 shares authorized at December 31, 2019; 3,679,778 issued and outstanding shares at December 31, 2019; aggregate liquidation preference value of $23,919 at December 31, 2019			23,823				—
   Series B Preferred Stock of $0.01 par value per share; 4,500,000 shares authorized at December 31, 2019; 3,750,674 issued and outstanding shares at December 31, 2019, respectively; aggregate liquidation preference value of $29,668 at December 31, 2019			29,550				—
   Total Convertible Preferred Stock			53,373				—
   Stockholders' (Deficit) Equity:
   Common Stock of $0.01 par value per share; 20,000,000 and 200,000,000 shares authorized at December 31, 2019 and 2020, respectively; shares issued at December 31, 2019 and 2020, respectively; 4,998,874 and 12,728,446 shares outstanding at December 31, 2019 and 2020, respectively		$	51			$	128
   Additional Paid-in Capital			1,770				109,157
   Accumulated Deficit			(40,741	)			(70,887	)
   Total Stockholders' (Deficit) Equity			(38,920	)			38,398
   Total Liabilities, Convertible Preferred Stock, and Stockholders' (Deficit) Equity		$	20,054			$	45,828

   
   
   

   AYALA PHARMACEUTICALS, INC.
   CONSOLIDATED STATEMENTS OF OPERATIONS
   U.S. dollars in thousands (except shares and per shares data)
   		Year ended December 31, 2019				Year ended December 31, 2020
   Revenue from License Agreement		$	2,334			$	3,708
   Cost of Revenue			(1,285	)			(3,708	)
   Gross Profit			1,049				—
   Research and Development		$	14,424			$	22,406
   General and Administrative			4,336				7,371
   Operating Loss			(17,711	)			(29,777	)
   Financial Income, Net			225				56
   Loss before Income Tax			(17,486	)			(29,721	)
   Taxes on Income			(306	)			(425	)
   Net Loss attributable to Common Stockholders		$	(17,792	)		$	(30,146	)
   Net Loss per Share attributable to Common Stockholders, Basic and Diluted		$	(3.57	)		$	(3.06	)
   Weighted Average Shares Used to Compute Net Loss per Share, Basic and Diluted			4,979,606				9,860,610

   
   
   

   

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5. 02 March 2021 Ayala Pharmaceuticals to Participate in Upcoming Virtual Investor Conferences

   REHOVOT, Israel and WILMINGTON, Del., March 02, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ:AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced that Ayala management will present at three upcoming virtual investor conferences:
   

   • H.C. Wainwright & Co. Global Life Sciences Investor Conference: Available for on-demand viewing starting Tuesday, March 9, 2021 at 7:00 am ET.
   • Oppenheimer & Co. 31^st Annual Healthcare Conference: Corporate Presentation on Tuesday, March 16, 2021 at 11:20 am ET.
   • 33^rd Annual Roth Capital Partners Conference: Fireside Chat on Wednesday, March 17, 2021 at 9:30 am ET.
     

   A live…

   REHOVOT, Israel and WILMINGTON, Del., March 02, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ:AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced that Ayala management will present at three upcoming virtual investor conferences:
   
   

   • H.C. Wainwright & Co. Global Life Sciences Investor Conference: Available for on-demand viewing starting Tuesday, March 9, 2021 at 7:00 am ET.
   • Oppenheimer & Co. 31^st Annual Healthcare Conference: Corporate Presentation on Tuesday, March 16, 2021 at 11:20 am ET.
   • 33^rd Annual Roth Capital Partners Conference: Fireside Chat on Wednesday, March 17, 2021 at 9:30 am ET.
     
     

   A live webcast of each event may be accessed by visiting the Events & Presentations section of Ayala's website at ir.ayalapharma.com. An archived replay of each webcast will be available on the website for approximately 90 days following the presentations.

   About Ayala Pharmaceuticals
   
   Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers. Ayala's approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently being advanced to a Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.

   Contacts:

   Investors:
   
   Julie Seidel
   
   Stern Investor Relations, Inc.
   
   +1-212-362-1200
   
   

   Ayala Pharmaceuticals:
   
   +1-857-444-0553
   
   

   
   
   

   

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