Athenex Announces Publication of Phase 3 Study Data Comparing Oral Paclitaxel Plus Encequidar to Intravenous Paclitaxel in Patients With Metastatic Breast Cancer in the Journal of Clinical Oncology

Athens, Inc.

BUFFALO, NY, July 25 10, 2022 (GLOBE NEWSWIRE) — Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, announced today today the publication of their manuscript, “Open-Label, Randomized, Multicenter, Phase III Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients with Metastatic Breast Cancer”. The article, along with the results, can be viewed on the American Society of Clinical Oncology Journal website at this link.

“We are pleased with the release of Phase 3 data, which show that oral paclitaxel plus encequidar significantly improves tumor response in patients with metastatic breast cancer, compared to IV administration. Positive trends were seen in progression-free survival and overall survival,” said Hope S. Rugo, MD, professor of medicine, University of California San Francisco Comprehensive Cancer Center. “With oral administration of paclitaxel plus encequidar, we observed less frequent and less severe neuropathy, which is often a limiting toxicity with IV taxanes. In patients with abnormal liver function, we identified a predisposition to neutropenia early and to infections in patients with elevated liver enzymes at baseline, allowing for better management of toxicity in the future.We believe that for appropriate patients with advanced or metastatic breast cancer, this could potentially be a effective home treatment option.

About Athenex, Inc.

Founded in 2003, Athenex, Inc. is a global clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development and commercialization of next-generation cell therapy drugs for the treatment of cancer. In pursuing this mission, Athenex draws on years of experience in research and development, clinical trials, regulatory standards and manufacturing. The Company’s current clinical pipeline is primarily derived from the following core technologies: (1) cell therapy, based on NKT cells and (2) Orascovery, based on a P-glycoprotein inhibitor. Athenex employees around the world are dedicated to improving the lives of cancer patients by creating more active, accessible and tolerable treatments. For more information, visit www.athenex.com.

Forward-looking statements

Except for historical information, all statements, expectations and assumptions in this press release are forward-looking statements. These forward-looking statements are generally identified by words such as “continue”, “could”, “expect”, “intend”, “expect”, “may”, “potential”, “will” and similar expressions. Actual results may differ materially from those expressed or implied in the forward-looking statements. Important factors that could cause actual results to differ materially include: our ability to complete the sale of our interests in our Chinese subsidiaries; our history of operating losses and substantial doubt as to our ability to continue our business; our strategic pivot to focus on our cell therapy platform and our plan to dispose of non-strategic assets; our ability to obtain financing to fund our operations, successfully redirect our resources and reduce our operating expenses; our ability to refinance, extend or repay our substantial indebtedness owed to our primary secured lender; the stage of development of our lead clinical candidates, including NKT cell therapy and associated risks relating to drug development, clinical trials, regulation, uncertainties surrounding regulatory reviews and approvals; preclinical and clinical results of Athenex’s drug candidates, which may not support further development of such drug candidates; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates and to obtain approval of its drug candidates in a timely manner, if at all; the uncertainty of ongoing legal proceedings; risks related to our ability to successfully integrate Kuur Therapeutics’ businesses into our existing businesses, including uncertainties associated with maintaining relationships with customers, suppliers and employees, as well as differences in operations, cultures and management philosophies that may delay successful integration and our ability to bear the additional cost burden of Kuur’s business; risks relating to the performance of counterparties, including our dependence on third parties to succeed in certain areas of Athenex’s business; risks and uncertainties inherent in litigation, including purported shareholder class actions; the impact of the COVID-19 pandemic and other macroeconomic factors, such as the war in Ukraine, and their continued impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; risks relating to international business and China; the risk of development, operational delays, production slowdowns or stoppages or other disruptions at our manufacturing facility as well as our ability to secure alternate sources of supply to meet our obligations and requirements; the risk that our common stock may be delisted from the Nasdaq Global Market if we are unable to restore compliance with its continuous listing standards, and the other risk factors set forth from time to time in our filings with the SEC , copies of which are available free of charge from the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Department investor relations. All information provided in this release is as of the date hereof, and we undertake no obligation and do not intend to update these forward-looking statements except as required by law.

Athenex contacts

Investor Relations

Daniel Lang, MD
Athens, Inc.
Email: [email protected]

Caileigh Dougherty
Athens, Inc.
Email: [email protected]

Jacob L. Thornton