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Exhibit 99.1
Athenex Provides Fourth Quarter and Full Year 2021 Financial Results and
Provides Business Update
Announces Strategic Pivot to Focus on Cell Therapy Programs
Receives FDA Clearance for IND to Expand CD19 CAR-NKT ANCHOR to a Multi-center Study
Implementing Significant Cost Reduction Plan Targeting >50% Reduction in Operating Expenses
Plans to Extend Cash Runway in 2022 Through Monetization of Non-core Assets Consistent with Shift in Focus and Strategy
Management to host conference call and webcast today at 4:30 p.m. ET
Buffalo, N.Y., March 16, 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, today provided a corporate and financial update for the fourth quarter and full year ended December 31, 2021.
We are pleased to announce our new vision for the future of Athenex, by deploying our resources and harnessing our expertise toward the advancement of our promising cell therapy programs. The encouraging data that we have generated so far, along with our belief that cell therapy is driving the next major innovation cycle in cancer treatment, give us confidence in our new strategy, said Johnson Lau, Chief Executive Officer of Athenex. We are taking action to swiftly redirect our resources and have begun executing on cost savings measures to right-size the company and support our transformation to a lean, focused cell therapy company.
Corporate Developments
Key Program and Business Updates
| Focus R&D resources on developing cell therapy programs |
| Discontinue oral discovery program apart from oral paclitaxel |
| Reducing operating expenses: With the objective of extending its cash runway, the Company is implementing cost cutting initiatives and workforce reduction to lower operating expenses by over 50% |
| Plan to monetize non-core assets consistent with new focus and strategy of company |
Key Anticipated Milestones
| Update on ANCHOR data previously presented at ASH in 2021 at ASTCT on April 23-26, 2022 |
| Update from KUR-501, our autologous program in pediatric neuroblastoma at the American Society of Gene & Cell Therapy (ASGCT) annual meeting on May 16-19, 2022 |
| Preclinical data presentation of allogeneic GPC3 CAR-NKT cell program in liver cancer at ASCO in June |
| Expand CD19 CAR-NKT ANCHOR study to a multi-center study under the newly allowed IND |
| Data update from KUR-502 at American Society of Hematology (ASH) on December 10-13, 2022 |
| Potential regulatory update from MHRA for Oral Paclitaxel in metastatic breast cancer (mBC) in UK |
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Athenex, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:
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However, a lack of sustained recovery or further deterioration in market conditions related to the general economy and the industries in which we operate, a sustained trend of weaker than anticipated financial performance, further decline in our share price for a sustained period of time, or an increase in the market-based weighted average cost of capital, among other factors, could significantly impact the impairment analysis and may result in future impairment charges that, if incurred, could have a material adverse effect on our financial condition and results of operations.
However, our expenses could increase as we continue to fund clinical and preclinical development of our research programs by advancing our Cell Therapy programs, certain candidates in our pipeline, our specialty drug products, working capital and other general corporate purposes.
We may borrow additional funds on terms that may include restrictive covenants, including covenants that further restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets.
Additionally, Kuur shareholders and its former employees and directors are eligible to receive up to $115.0 million of milestone payments, which may be paid, at the Companys sole discretion, in either cash or additional common stock of the Company, or a combination of both.
This was primarily due to an increase in costs related to Oral Paclitaxel, drug licensing costs, cell therapy costs, and compensation, and included the following: $9.5 million increase in Oral Paclitaxel product development, API, and medical affairs costs associated with the potential product launch in 2021; $6.2 million increase in drug licensing costs, due to license payments for specialty pharmaceutical products, a license milestone payment related to Arginine deprivation therapy, and the repurchase of Orascovery rights from Xiangxue; and $4.4 million increase in cell therapy development costs.
The first tranche of $100.0...Read more
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Cellular therapies have generally not...Read more
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Identifiable amortizing intangible assets are...Read more
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KUR-502 is currently being evaluated...Read more
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TCRT-ESO-A2 is an autologous T...Read more
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Financial Statements, Disclosures and Schedules
Inside this 10-K Annual Report
Material Contracts, Statements, Certifications & more
Athenex, Inc. provided additional information to their SEC Filing as exhibits
Ticker: ATNX
CIK: 1300699
Form Type: 10-K Annual Report
Accession Number: 0000950170-22-003973
Submitted to the SEC: Wed Mar 16 2022 5:28:06 PM EST
Accepted by the SEC: Wed Mar 16 2022
Period: Friday, December 31, 2021
Industry: Pharmaceutical Preparations