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Exhibit 99.1
Athenex Provides Third Quarter 2022 Financial Results and Business Update
| Bolstered balance sheet with $30 million public offering of common stock and warrants |
| Nasdaq Hearing Panel grants Athenexs request for continued listing |
| Athenex is in the final stages of closing the sale of the China API operations |
| I-SPY 2 study with Oral Paclitaxel expected to be completed by year-end 2022 |
| Phase 1 study updates for autologous KUR-501 (GD2 CAR-NKT cell therapy) in relapsed/refractory high-risk neuroblastoma (GINAKIT2) and allogeneic KUR-502 (CD19 CAR-NKT cell therapy) in relapsed/refractory B-cell malignancies (ANCHOR) expected by H1 2023 |
| Full-year 2022 product revenue guidance maintained at 20-25% growth year-over-year |
| Management to host conference call and webcast today at 8:00 am EDT |
Buffalo, N.Y., November 3, 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 third quarter ended September 30, 2022.
We are excited by the promise of our innovative, first-in-class NKT cell therapy platform with potential for improved efficacy, safety, and accessibility over current cell therapy approaches. This quarter, we continued to implement efficiencies by reducing cash used for operations by 53% and strengthening our balance sheet with our $30 million equity raise, said Dr. Johnson Lau, Chief Executive Officer of Athenex. As we look ahead, we have several exciting upcoming milestones and expect to report Phase 1 study data updates for our KUR-501 cell therapy program and our allogeneic KUR-502 cell therapy program by the first half of 2023. We also look forward to clinical updates from the Phase 2 trial of Oral Paclitaxel with a checkpoint inhibitor in neoadjuvant breast cancer, which is expected to complete by year-end.
Third Quarter 2022 and Recent Business Highlights
Business Updates
| Announced pricing of $30 million public offering of common stock and warrants |
| Successful Nasdaq hearing confirming the company can continue its listing on The Nasdaq Stock Market subject to demonstrating compliance with the minimum bid price requirement by March 14, 2023 |
| Athenex has met all closing conditions for the sale of the China API operations for approximately $18 million and is in the final stages of closing the transaction, which is expected to occur as soon as COVID-related restrictions are lifted. At closing, the company expects to receive 70% of the proceeds, with 20% and 10% of proceeds receivable within three months and six months of closing, respectively. Furthermore, the company anticipates entering into a supply agreement for API and a waiver of the rights of its senior secured lender to receive any additional proceeds from the sale |
| Cash Flows from Operating Activities in Continuing Operations was -$15.7M, a 53% year-over-year decrease |
NKT Cell Therapy Programs
KUR-501: Autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma
| Ongoing sequential enrollment of two additional cohorts in single-institution Phase 1 dose escalation GINAKIT2 study at the 2 highest dose levels (DL5: 3x108 cells/m2; DL6: 1x109 cells/m2) |
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This was primarily due to a $10.6 million decrease in costs for preparing to commercialize Oral Paclitaxel as the significant pre-launch activities slowed upon receipt of the Complete Response Letter in February 2021 and a $5.1 million gain on change in earnout liability related to the Kuur contingent consideration, with the discontinuation of the TCR-T therapy, while 2021 had a $3.6 million loss on change in earnout liability.
For the three and nine months ended September 30, 2021, the Company recognized license revenue of $5.1 million and $26.1 million, of which $20.0 million was recognized upon the achievement of the first commercial milestone pursuant to the 2017 Almirall out-license arrangement upon the launch of Klisyri in the U.S., $5.0 million was recognized upon the launch of Klisyri (tirbanibulin) in Europe pursuant to the 2017 Almirall out-license arrangement, and $0.5 million was recognized for an upfront fee upon transferring IP to the customer upon execution of the second amendment to the 2011 PharmaEssentia license agreement.
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.
If we are able to sell non-core assets, we may not realize in full the anticipated benefits, savings, and improvements in our strategic pivot efforts, we may not realize the cost savings we anticipate, the cost of disposing of the assets may exceed the cost savings generated, and the process of disposing of the assets may be disruptive to our daily operating activities and our execution of short- and long-term strategies.
This was primarily due to a decrease in Oral Paclitaxel 42 product development and medical affairs costs, costs of clinical and regulatory operations, and compensation costs and included the following: $9.6 million decrease in Oral Paclitaxel product development and medical affairs costs incurred in connection with the potential product launch of Oral Paclitaxel; $6.2 million decrease in costs of clinical operations and regulatory affairs after the completion of the Phase 3 study and FDA submission of Oral Paclitaxel; $4.8 million decrease in R&D related compensation expenses; $3.9 million decrease in drug licensing costs related to licenses for specialty drug products and a license milestone payment associated with Arginine deprivation therapy in 2021; and $1.7 million decrease in costs of preclinical operations, primarily related to the Orascovery platform.
We may borrow additional funds...Read more
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44 ATM Offering On August...Read more
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Debt financing, if available, may...Read more
For the commercial, sales-based royalties,...Read more
(2)Cellular therapies have generally not...Read more
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Revenue Revenue from product sales...Read more
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To the extent that we...Read more
With respect to TCRT-ESO-A2, an...Read more
The primary use of our...Read more
Identifiable amortizing intangible assets are...Read more
KUR-502 is currently being evaluated...Read more
This was primarily due to...Read more
Our obligations under the Senior...Read more
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In-process research and development ("IPR&D")...Read more
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503B product sales increased by...Read more
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Cost of sales also includes...Read more
These amounts, plus the remaining...Read more
We have assembled a strong...Read more
Variable consideration is only included...Read more
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Where a portion of the...Read more
(3)Our allogeneic (?off-the-shelf?) CAR-NKT cell...Read more
On February 14, 2022, we...Read more
On October 31, 2022, the...Read more
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Under Topic 606, the Company...Read more
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Financial Statements, Disclosures and Schedules
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Ticker: ATNX
CIK: 1300699
Form Type: 10-Q Quarterly Report
Accession Number: 0000950170-22-021640
Submitted to the SEC: Thu Nov 03 2022 10:53:51 AM EST
Accepted by the SEC: Thu Nov 03 2022
Period: Friday, September 30, 2022
Industry: Pharmaceutical Preparations