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Athenex, Inc. (ATNX) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, June 30, 2021

Athenex, Inc.

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CIK: 1626450 Ticker: ATNX

Exhibit 99.1

Athenex Provides Second Quarter 2021 Corporate and Financial Update

Updated investors on FDA Type A Meeting for oral paclitaxel

Klisyri® approved by the European Commission in July 2021

KUR-501 GD2 CAR-NKT Phase 1 data in neuroblastoma presented at ASGCT 2021

Abstract for oral paclitaxel + pembrolizumab Phase 1 combination study accepted for ESMO Congress 2021

Management to host conference call and webcast today at 8:00 a.m. ET

Buffalo, N.Y., August 5, 2021 (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 second quarter ended June 30, 2021.

“During the second quarter, we held a Type A meeting with the FDA to discuss the path forward for oral paclitaxel and encequidar in metastatic breast cancer and the deficiencies that were raised in the Complete Response Letter (CRL) we received in February,” said Johnson Lau, Chief Executive Officer of Athenex. “The FDA has indicated that a well-designed and well-conducted trial may adequately address these deficiencies. We are now evaluating the optimal design for a new clinical study which we plan to present to the FDA in the fourth quarter of 2021. We are continuing to advance oral paclitaxel in angiosarcoma towards registration.”

“Our acquisition of Kuur Therapeutics and its innovative allogeneic CAR-NKT technology was a strategically important development for Athenex and we believe it has the potential to unlock tremendous value,” continued Dr. Lau. “Kuur’s technology, combined with our TCR program, could propel us into a leadership position in cell therapy. We are pleased with the smooth integration of the Kuur team and operations to date and look forward to providing further updates as the programs advance.”

Second Quarter 2021 and Recent Business Highlights

Clinical Programs

Oral Paclitaxel and Encequidar

 

•  

Athenex held a Type A meeting with the US Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for oral paclitaxel in metastatic breast cancer during second quarter 2021. The Company is evaluating the optimal design for a new clinical study which it plans to present to the FDA in 4Q 2021.

 

•  

An abstract “Phase 1 Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of oral paclitaxel + encequidar in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies” has been accepted for e-Poster presentation at the European Society for Medical Oncology (ESMO) Congress 2021.

Cell Therapy

 

•  

Presented data from a Phase 1 study (GINAKIT2) of KUR-501 in neuroblastoma at the annual meeting of the American Society of Gene and Cell Therapy (ASGCT) 2021. The data showed one complete response and one partial response out of 11 evaluable and heavily pre-treated pediatric neuroblastoma patients. The therapy was well tolerated with only one Grade 2 CRS.

The following information was filed by Athenex, Inc. (ATNX) on Thursday, August 5, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Assess how Athenex, Inc.'s management team is paid from their Annual Proxy

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Athenex, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors

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Inside Athenex, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited)
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Additional Information (Detail)
Accrued Expenses - Schedule Of Accrued Expenses (Detail)
Business Combination - Additional Information (Details)
Business Combination - Schedule Of Unaudited Pro Forma Consolidated Financial Information (Details)
Business Combination - Summary Of Purchase Price And Initial Estimates Of Fair Values Of Assets And Liabilities Acquired (Details)
Business Combination - Summary Of Purchase Price And Initial Estimates Of Fair Values Of Assets And Liabilities Acquired (Parenthetical) (Details)
Business Combinations
Business Combinations (Tables)
Business Segment, Geographic, And Concentration Risk Information
Business Segment, Geographic, And Concentration Risk Information (Tables)
Business Segment, Geographic, And Concentration Risk Information - Additional Information (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Customer Revenue And Accounts Receivable Concentration (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Depreciation, Amortization And Assets By Segment (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Property And Equipment By Geographical Segment (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Revenue By Geographical Segment (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Revenue By Product Group (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Revenue By Segments (Detail)
Business Segment, Geographic, And Concentration Risk Information - Summary Of Segment Information (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Schedule Of Future Minimum Payments Under Non-Cancelable Leases (Detail)
Company And Nature Of Business
Company And Nature Of Business - Additional Information (Detail)
Contingent Consideration
Contingent Consideration (Tables)
Contingent Consideration - Additional Information (Detail)
Contingent Consideration - Schedule Of Reconciliation Of Contingent Consideration Liability Related To Acquisition (Detail)
Debt And Lease Obligations
Debt And Lease Obligations (Tables)
Debt And Lease Obligations - Additional Information (Detail)
Debt And Lease Obligations - Schedule Of Future Minimum Payments And Maturities Of Leases (Detail)
Debt And Lease Obligations - Schedule Of Supplemental Balance Sheet Information Related To Leases Of Debt (Detail)
Debt And Lease Obligations - Schedule Of Supplemental Cash Flow Information Related To Leases (Detail)
Debt And Lease Obligations - Summary Of Balances Of Debt (Detail)
Debt And Lease Obligations - Summary Of Balances Of Debt (Parenthetical) (Detail)
Debt And Lease Obligations - Summary Of Components Of Lease Expense (Detail)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Additional Information (Detail)
Fair Value Measurements - Schedule Of Assets And Liabilities Measured At Fair Value On A Recurring Basis (Detail)
Income Taxes
Income Taxes - Additional Information (Detail)
Intangible Assets, Net
Intangible Assets, Net (Tables)
Intangible Assets, Net - Additional Information (Details)
Intangible Assets, Net - Summary Of Identifiable Intangible Asset, Net (Details)
Inventories
Inventories (Tables)
Inventories - Schedule Of Inventories (Detail)
Net Loss Per Share Attributable To Athenex, Inc. Common Stockholders
Net Loss Per Share Attributable To Athenex, Inc. Common Stockholders (Tables)
Net Loss Per Share Attributable To Athenex, Inc. Common Stockholders - Schedule Outstanding Shares Of Common Stock Equivalents Excluded From The Calculation Of Diluted Net Loss Per Share (Detail)
Related Party Transactions
Related Party Transactions - Additional Information (Detail)
Restricted Cash
Restricted Cash - Additional Information (Detail)
Revenue Recognition
Revenue Recognition (Tables)
Revenue Recognition - Additional Information (Detail)
Revenue Recognition - Schedule Of Company's Revenue For Reportable Segment By Country Based On Locations Of Customer (Detail)
Revenue Recognition - Summary Of Accounts Receivable And Contract Assets Balances By Reportable Segments (Detail)
Revenue Recognition - Summary Of Receivables And Contract Liabilities From Contracts With Customers (Detail)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Detail)
Stock-Based Compensation - Schedule Of Stock Option Activity (Detail)
Stock-Based Compensation - Schedule Of Stock-Based Compensation Cost (Detail)
Stock-Based Compensation - Schedule Of Weighted-Average Assumptions Used As Inputs To Black-Scholes Option Pricing Model (Detail)
Subsequent Event
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Ticker: ATNX
CIK: 1300699
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-21-041708
Submitted to the SEC: Thu Aug 05 2021 5:07:00 PM EST
Accepted by the SEC: Thu Aug 05 2021
Period: Wednesday, June 30, 2021
Industry: Pharmaceutical Preparations

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