Exploring a range of strategic alternatives
Revenues from product sales from continued operations increased +27% Y/Y in 4Q 2022 and +33% for full year 2022
Net Loss attributable to
Cash, cash equivalents, and restricted cash balance of
Additional Phase 1 dose escalation study safety and preliminary efficacy data for KUR-502 CAR-NKT cell therapy product anticipated in 2H 2023
Phase 1 GINAKIT2 study of KUR-501 on clinical hold; pending serious adverse event investigation and safety risk mitigation planning to reopen clinical trial
Graduation of Oral Paclitaxel combination regimen in the neoadjuvant triple-negative breast cancer treatment subgroup of I-SPY 2 trial
“In 2022, we focused on executing our strategic vision to advance our differentiated NKT cell therapy platform and reported positive clinical data for our two lead investigational CAR-NKT cell therapy products in both neuroblastoma and non-Hodgkin lymphoma,” said Dr.
Fourth Quarter 2022 and Recent Business Highlights
Corporate Updates:
- Closed the sale of China API business
- Ended the manufacturing of 503B sterile compounded products and will exit the market in
April 2023 - Effected a 20:1 reverse stock split of
Athenex common stock onFebruary 15, 2023 ; the Company received notice onMarch 16, 2023 that it regained compliance with Nasdaq's continued listing requirements
Clinical Development Programs:
NKT Cell Therapy Platform
KUR-501: Autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma (R/R HRNB)
- Recent FDA-imposed clinical hold of the KUR-501 Investigational New Drug Application (IND) following the death of a young heavily pretreated male patient with R/R HRNB treated at the fifth dose level of 300 million cells/m2 approximately three weeks after CAR-NKT cell therapy product administration.
Baylor College of Medicine (BCM), the IND holder, continues to investigate the etiology and pathogenesis of this event- Subject was found to have human metapneumovirus infection, then Grade 1 cytokine release syndrome (CRS) that was treated with immunosuppressants
- Subject later developed polyclonal hyperleukocytosis complicated by multiorgan dysfunction without evidence of sepsis
BCM is devising a safety risk mitigation plan to reopen the clinical trial, one that could include excluding patients with concomitant viral infections, but can provide no assurances that the clinical hold will be lifted or when it will be lifted. The Company is working closely with BCM to help address the FDA’s questions and remains committed to the continued safe clinical development of what it believes is a promising new CAR-NKT cell therapy product for a high unmet medical need in a pediatric orphan indication.
Anticipated Upcoming Milestones
- Targeting Phase 1 GINAKIT2 study of KUR-501 reopening mid-2023, pending FDA potentially lifting clinical hold
- Phase 1 GINAKIT2 dose escalation study safety and preliminary efficacy data update anticipated in 2H 2023
KUR-502: Allogeneic CD19 CAR-NKT cell therapy for relapsed/refractory B-cell malignancies
- Ongoing multicenter expansion of Phase 1 dose-escalation study (ANCHOR2) initiated in Q4 2022
Anticipated Upcoming Milestones
- Next clinical trial data update from the ongoing ANCHOR and ANCHOR2 studies anticipated in 2H 2023
KUR-503: Allogeneic GPC3 CAR-NKT cell therapy for previously treated advanced GPC3-expressing hepatocellular carcinoma
Anticipated Upcoming Milestones
- IND application filing for the investigational treatment of adults with previously treated advanced GPC3-expressing hepatocellular carcinoma planned in 2024
Oral Paclitaxel and Encequidar
- Graduation of Oral Paclitaxel combination regimen (encequidar, a PD-1 inhibitor, and carboplatin) in the neoadjuvant triple-negative breast cancer treatment subgroup of the I-SPY2 Phase 2 trial
- Received marketing authorization denial from MHRA for the treatment of metastatic breast cancer based solely on chemistry, manufacturing and controls (CMC) issues
Anticipated Upcoming Milestones
- Plan to discuss the I-SPY 2 Phase 2 trial data with the FDA in connection with the New Drug Application (NDA) of Oral Paclitaxel for metastatic breast cancer
- Data update from I-SPY 2 Phase 2 trial for Oral Paclitaxel regimen in the neoadjuvant breast cancer treatment setting anticipated at upcoming national meetings in 2Q 2023 by Quantum Leap Healthcare Collaborative
- Expecting independent panel review of MHRA decision
Specialty Pharmaceutical Business:
- Athenex Pharmaceutical Division (APD) currently markets a total of 39 products with 74 SKUs
Fourth Quarter and Full Year 2022 Financial Highlights
Revenues from product sales from continuing operations increased to
License fees and other revenue for the three months and year ended
Cost of sales for the three months ended
R&D expenses totaled
SG&A expenses totaled
The Company recorded impairment of
Interest expense totaled
Loss on extinguishment of debt amounted to
Income tax (expense) benefit for the three months ended
Net losses attributable to
Revenue from product sales from continuing and discontinued operations were
For further details on the Company’s financial results, including the results for the full year ended
Liquidity and Capital Resources Update
As of
On
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next-generation cell therapy products for the treatment of cancer. The Company’s mission is to become a leader in bringing innovative cancer treatments to the market and to improve patient health outcomes. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company is focused on its innovative
Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “expect,” “intend,” “look forward,” “may,” “mission,” “potential,” “plan,” “strategy,” “target,” “vision,” “will,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our history of operating losses and the substantial doubt about our ability to continue as a going concern; our ability to repay, refinance, or restructure our substantial indebtedness owed to our senior secured lender at maturity or upon an event of default; our ability to obtain financing to fund operations, successfully redirect our resources and reduce our operating expenses; our strategic pivot to focus on our cell therapy platform and our plan to dispose of non-core assets; the development stage of our primary clinical candidates, including NKT Cell Therapy and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; the preclinical and clinical results for 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 gain approval of its drug candidates on a timely basis, if at all; the uncertainty of ongoing legal proceedings; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; risks and uncertainties inherent in litigation, including purported stockholder class actions; the impact of macroeconomic factors, like inflation, supply chain disruptions and the war in
Athenex Contacts
Investors
Email: danlang@athenex.com
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
2022 | 2021 | |||||||
(In thousands) | ||||||||
Selected Balance sheet data: | ||||||||
Cash, cash equivalents, and restricted cash | $ | 35,620 | $ | 51,702 | ||||
Short-term investments | $ | 1,071 | $ | 10,207 | ||||
Working capital(1) | $ | 10,050 | $ | 37,347 | ||||
Total assets attributable to discontinued operations | $ | 7,308 | $ | 72,528 | ||||
Total assets | $ | 204,055 | $ | 267,448 | ||||
Debt and lease obligations | $ | 37,220 | $ | 141,683 | ||||
Royalty financing liability | $ | 86,745 | $ | — | ||||
Total liabilities attributable to discontinued operations | $ | 5,718 | $ | 19,305 | ||||
Total liabilities | $ | 228,236 | $ | 232,996 | ||||
Non-controlling interests | $ | (17,675 | ) | $ | (16,679 | ) | ||
Total stockholders' (deficit) equity | $ | (24,181 | ) | $ | 34,452 |
(1) Working capital: total current assets less total current liabilities
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(In thousands)
(Unaudited)
Three months ended | Year ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
(in thousands) | (in thousands) | (in thousands) | (in thousands) | |||||||||||||
Revenue | ||||||||||||||||
Product sales, net | $ | 21,811 | $ | 17,148 | $ | 90,884 | $ | 68,505 | ||||||||
License and other revenue | 3,253 | 773 | 11,937 | 26,864 | ||||||||||||
Total revenue | 25,064 | 17,921 | 102,821 | 95,369 | ||||||||||||
Cost of sales | (18,185 | ) | (15,714 | ) | (76,118 | ) | (62,892 | ) | ||||||||
Gross profit | 6,879 | 2,207 | 26,703 | 32,477 | ||||||||||||
Research and development expenses | (16,400 | ) | (18,391 | ) | (51,758 | ) | (77,668 | ) | ||||||||
Selling, general, and administrative expenses | (7,200 | ) | (10,778 | ) | (44,880 | ) | (64,230 | ) | ||||||||
Impairments | — | (41,011 | ) | (79 | ) | (41,011 | ) | |||||||||
Interest income | 132 | 31 | 363 | 128 | ||||||||||||
Interest expense | (10,754 | ) | (5,042 | ) | (25,843 | ) | (20,654 | ) | ||||||||
Loss on extinguishment of debt | (1,684 | ) | — | (3,134 | ) | — | ||||||||||
Income tax (expense) benefit | 258 | (16 | ) | (347 | ) | 10,604 | ||||||||||
Net loss from continuing operations | (28,769 | ) | (73,000 | ) | (98,975 | ) | (160,354 | ) | ||||||||
Loss from discontinued operations | (5,476 | ) | (32,082 | ) | (5,448 | ) | (41,682 | ) | ||||||||
Net loss | (34,245 | ) | (105,082 | ) | (104,423 | ) | (202,036 | ) | ||||||||
Less: net loss attributable to non-controlling interests | (67 | ) | (695 | ) | (996 | ) | (2,268 | ) | ||||||||
Net loss attributable to | $ | (34,178 | ) | $ | (104,387 | ) | $ | 103,427 | ) | $ | (199,768 | ) | ||||
Net loss per share attributable to | $ | (4.28 | ) | $ | (19.08 | ) | $ | (15.81 | ) | $ | (38.44 | ) | ||||
Weighted-average shares used in computing net loss per share attributable to | 7,981,109 | 5,470,574 | 6,541,068 | 5,196,923 |
Source:
2023 GlobeNewswire, Inc., source