8-K
false 0001300699 0001300699 2020-09-08 2020-09-08

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 8, 2020

 

 

ATHENEX, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38112   43-1985966

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

1001 Main Street, Suite 600, Buffalo, New York   14203
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (716) 427-2950

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.001 per share   ATNX   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company                      

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 7.01.

Regulation FD Disclosure.

On September 8, 2020, Athenex, Inc. (the “Company”) issued a press release announcing the inclusion of oral paclitaxel plus encequidar (“Oral Paclitaxel”) in the I-SPY 2 TRIAL sponsored by Quantum Leap Healthcare Collaborative. A copy of the press release is furnished as Exhibit 99.1 and incorporated herein by reference.

The Company is scheduled to host a conference call and webcast on September 8, 2020 commencing at 10:30 a.m. Eastern Time at which the Company will discuss Oral Paclitaxel’s inclusion in the I-SPY 2 TRIAL and related updates. Management will make a presentation at the event and the slides that will be provided during this presentation are furnished as Exhibit 99.2 to this Current Report on Form 8-K. The details regarding the conference call are included in the press release which is attached hereto as Exhibit 99.1. The live conference call and replay can also be accessed via audio webcast at the Company’s website www.athenex.com under the Investor Relations tab.

The information in Item 7.01 of this Current Report on Form 8-K (including Exhibits 99.1 and 99.2 attached hereto) is being furnished pursuant to Item 7.01 and shall not be deemed to be filed for purposes of Section 18 of the Exchange Act, or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

EXHIBIT INDEX

 

Exhibit

Number

  

Description

99.1    Press release dated September 8, 2020
99.2    Conference Call and Webcast Presentation dated September 8, 2020
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

   

ATHENEX, INC.

Date: September 8, 2020    

  /s/ Randoll Sze

    Name:   Randoll Sze
    Title:   Chief Financial Officer
EX-99.1

Exhibit 99.1

Quantum Leap Healthcare Collaborative and Athenex Announce the Selection of Oral Paclitaxel plus Encequidar in Combination with dostarlimab, an anti-PD-1, in the I-SPY 2 TRIAL targeting Stage 2/3 HER2+ and HER2- Breast Cancers

Athenex’s oral paclitaxel plus encequidar is being evaluated in combination with GSK’s dostarlimab in the neoadjuvant chemotherapy setting

Company to host conference call and webcast today at 10:30 a.m. Eastern Time

San Francisco, and BUFFALO, N.Y., September 8, 2020 — Quantum Leap Healthcare Collaborative (Quantum Leap) and Athenex, Inc. (Nasdaq: ATNX) announce the launch of two new study arms of the I-SPY 2 TRIAL to evaluate Athenex’s combination of oral paclitaxel plus encequidar with GSK’s dostarlimab, an investigational antibody binding PD-1, in the neoadjuvant chemotherapy setting. The goal of this study is to evaluate the safety and efficacy of oral paclitaxel plus encequidar with dostarlimab +/- carboplatin in Stage 2/3 HER2- breast cancer patients and plus trastuzumab in HER2+ patients, followed, if needed, by doxorubicin plus cyclophosphamide chemotherapy (AC) and surgical resection of breast tissue.

The primary objective is to determine whether this regimen increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy alone for any of the tumor subtypes established at trial entry, and to determine the predictive probability of success in a subsequent Phase 3 trial.

The primary endpoint is to assess objective response rates, as measured by pCR. This measurement will occur after the end of therapy during pathologic assessment of residual disease. pCR is defined as no residual invasive cancer in the breast (at the time of definitive surgical resection) or in the lymph nodes (no invasive tumor as determined by hematoxylin and eosin [H&E] stain).

Secondary endpoints include safety assessments and additional information on response to be obtained by measuring the change in MRI volume before, during and after therapy in order to calculate the change in residual cancer burden (RCB) at time of pathologic assessment of residual disease.

This regimen has several innovative components including: (1) assessment of extending PD-1 blockade to HER2+, (2) an orally bioavailable investigational paclitaxel that may be more convenient and tolerable over many more cycles compared to the IV formulation, and (3) the assessment of the impact of carboplatin on efficacy across all tumor subtypes, which may drastically enhance outcomes for some patients.

“We’re very excited to enter this treatment combination into the trial,” noted Laura Esserman, MD, the lead investigator for the I-SPY 2 study. “We believe Athenex’s oral paclitaxel combined with encequidar will be much easier for patients, may be more tolerable, and in combination, improve the chance of complete response, which is our goal. We are looking to test combinations that have greater efficacy and less toxicity. Importantly, I-SPY 2 allows us to determine which combinations work best for patients based on tumor biology. The change to an oral taxane backbone is a very important step to reducing toxicity for all patients.”


“Our NDA for oral paclitaxel and encequidar was accepted by the FDA for Priority Review in metastatic breast cancer. We are very excited to evaluate oral paclitaxel plus encequidar in early stage breast cancer, by participating in the I-SPY 2 trial” said Dr. Rudolf Kwan, Chief Medical Officer at Athenex. “We look forward to working with Quantum Leap and GSK, as well as the study participants and investigators.”

The I-SPY 2 TRIAL, sponsored by Quantum Leap, is a standing Phase 2 randomized, controlled, multicenter platform with an innovative Bayesian adaptive randomization design aimed to rapidly screen and identify promising new treatments in specific subgroups of adults with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage 2/3). GSK will provide dostarlimab. Athenex will provide oral paclitaxel and encequidar. Quantum Leap will be responsible for running the trial.

Conference Call and Webcast Information

To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13709162. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at http://ir.athenex.com/.

About Quantum Leap Healthcare Collaborative

Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit https://www.quantumleaphealth.org/.

About the I-SPY TRIALs

The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.

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 drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different platform technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in

 

Page- 2 -


Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan; multiple locations in Chongqing, China; Manchester, UK; Guatemala City, Guatemala and Buenos Aires, Argentina. For more information, please visit http://www.athenex.com.

Company 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,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” 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: the development stage of the company’s primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our ability to obtain and maintain regulatory approvals for our product candidates; the company’s reliance on third parties for success in certain areas of Athenex’s business; the company’s history of operating losses and need to raise additional capital to continue as a going concern; uncertainties around the company’s ability to meet funding conditions under its financing agreements and access to capital thereunder; risks and uncertainties related to the COVID-19 pandemic and its potential impact on the company’s operations, cash flow and financial condition; our ability to integrate acquired assets and businesses into our existing operations; competition; intellectual property risks; risks relating to doing business internationally and in China; the risk of production slowdowns or stoppages or other interruptions at the company’s Chongqing facilities; and the other risk factors set forth from time to time in Athenex’s SEC filings, copies of which are available for free in the Investor Relations section of the company’s website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from the Investor Relations Department. All information provided in this release is as of the date hereof and Athenex assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

CONTACTS

Athenex, Inc.:

Daniel Lang, MD

Corporate Development and Corporate Communications

Email: danlang@athenex.com

Jacqueline Li

Corporate Development and Investor Relations

Email: jacquelineli@athenex.com

Investor Relations:

Tim McCarthy

Managing Director, LifeSci Advisors, LLC

Email: tim@lifesciadvisors.com

 

Page- 3 -

EX-99.2

Exhibit 99.2 CONFERENCE CALL & WEBCAST: ORAL PACLITAXEL AND ENCEQUIDAR September 8, 2020 NASDAQ:ATNX www.athenex.comExhibit 99.2 CONFERENCE CALL & WEBCAST: ORAL PACLITAXEL AND ENCEQUIDAR September 8, 2020 NASDAQ:ATNX www.athenex.com


Forward Looking Statements Except for historical information, all of the statements, expectations, and assumptions contained in this presentation constitute forward- looking statements. These statements include descriptions regarding the intent, belief or current expectations of Athenex, Inc. (the “Company”), its officers or its management with respect to the consolidated results of operations and financial condition of the Company. These statements can be recognized by the use of words such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “guidance,” “intend,” “likely,” “may,” “opportunity,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” or words of similar expressions. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties. 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: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our ability to obtain and maintain regulatory approvals for our product candidates; our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and need to raise additional capital to continue as a going concern; our ability to service our existing and any future debt obligations and comply with financial and restrictive covenants contained in the agreements governing our indebtedness; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; our ability to integrate acquired assets and businesses into our existing operations; competition; intellectual property risks; risks relating to doing business internationally and in China; the risk of production slowdowns or stoppages or other interruptions at our Chongqing facilities; and the other risk factors set forth from time to time in the Company’s public filings with the U.S. Securities and Exchange Commission (the “SEC”), copies of which are available for free in the Investor Relations section of the Company’s website at https://ir.athenex.com/financial-information/sec-filings or upon request from the Company’s Investor Relations Department. Information about the Company and any forward-looking statements contained in this presentation are provided and made only as of 8 September 2020 and should not be relied upon as predictions of future events. The Company assumes no obligation and does not undertake to revise or update forward-looking statements to reflect future events or circumstances, except as required by law. DISCLAIMER This presentation does not constitute or form part of any offer for sale or subscription of or solicitation or invitation of any offer to buy or subscribe for any securities. Neither this presentation nor any part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever. Specifically, this presentation does not constitute a “prospectus” within the meaning of the Securities Act of 1933, as amended. Our historical results are not necessarily indicative of results to be expected for any future period. The financial data contained in this presentation for the periods and as of the dates indicated are qualified by reference to and should be read in conjunction with our financial statements and related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our public filings with the SEC. 2 September 2020Forward Looking Statements Except for historical information, all of the statements, expectations, and assumptions contained in this presentation constitute forward- looking statements. These statements include descriptions regarding the intent, belief or current expectations of Athenex, Inc. (the “Company”), its officers or its management with respect to the consolidated results of operations and financial condition of the Company. These statements can be recognized by the use of words such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “guidance,” “intend,” “likely,” “may,” “opportunity,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” or words of similar expressions. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties. 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: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our ability to obtain and maintain regulatory approvals for our product candidates; our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and need to raise additional capital to continue as a going concern; our ability to service our existing and any future debt obligations and comply with financial and restrictive covenants contained in the agreements governing our indebtedness; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; our ability to integrate acquired assets and businesses into our existing operations; competition; intellectual property risks; risks relating to doing business internationally and in China; the risk of production slowdowns or stoppages or other interruptions at our Chongqing facilities; and the other risk factors set forth from time to time in the Company’s public filings with the U.S. Securities and Exchange Commission (the “SEC”), copies of which are available for free in the Investor Relations section of the Company’s website at https://ir.athenex.com/financial-information/sec-filings or upon request from the Company’s Investor Relations Department. Information about the Company and any forward-looking statements contained in this presentation are provided and made only as of 8 September 2020 and should not be relied upon as predictions of future events. The Company assumes no obligation and does not undertake to revise or update forward-looking statements to reflect future events or circumstances, except as required by law. DISCLAIMER This presentation does not constitute or form part of any offer for sale or subscription of or solicitation or invitation of any offer to buy or subscribe for any securities. Neither this presentation nor any part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever. Specifically, this presentation does not constitute a “prospectus” within the meaning of the Securities Act of 1933, as amended. Our historical results are not necessarily indicative of results to be expected for any future period. The financial data contained in this presentation for the periods and as of the dates indicated are qualified by reference to and should be read in conjunction with our financial statements and related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our public filings with the SEC. 2 September 2020


Agenda and Introduction INTRODUCTION Johnson Lau, Chief Executive Officer ORAL PACLITAXEL: DEVELOPMENT UPDATE • NDA Filing for Metastatic Breast Cancer • Initiation of Oral Paclitaxel in the I-SPY 2 Trial Rudolf Kwan, Chief Medical Officer ORAL PACLITAXEL: COMMERCIAL STRATEGY Timothy Cook, SVP, Global Commercial Oncology ORAL PACLITAXEL: LABEL EXPANSION STRATEGIES Rudolf Kwan, Chief Medical Officer Timothy Cook, SVP, Global Commercial Oncology KEY TAKEAWAYS Johnson Lau, Chief Executive Officer Q&A 3 September 2020Agenda and Introduction INTRODUCTION Johnson Lau, Chief Executive Officer ORAL PACLITAXEL: DEVELOPMENT UPDATE • NDA Filing for Metastatic Breast Cancer • Initiation of Oral Paclitaxel in the I-SPY 2 Trial Rudolf Kwan, Chief Medical Officer ORAL PACLITAXEL: COMMERCIAL STRATEGY Timothy Cook, SVP, Global Commercial Oncology ORAL PACLITAXEL: LABEL EXPANSION STRATEGIES Rudolf Kwan, Chief Medical Officer Timothy Cook, SVP, Global Commercial Oncology KEY TAKEAWAYS Johnson Lau, Chief Executive Officer Q&A 3 September 2020


Increasing Importance of Oral Chemotherapy Options • Consideration of alternative dosing schedule to allow for fewer in-person visits to the cancer center and/or the infusion center • Switch from infusional therapy to oral oncolytics if equivalent formulation is available 4 Source: https://www.nccn.org/about/news/newsinfo.aspx?NewsID=2025 https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-myelodysplastic-syndromes-mds-can-be-taken-home September 2020Increasing Importance of Oral Chemotherapy Options • Consideration of alternative dosing schedule to allow for fewer in-person visits to the cancer center and/or the infusion center • Switch from infusional therapy to oral oncolytics if equivalent formulation is available 4 Source: https://www.nccn.org/about/news/newsinfo.aspx?NewsID=2025 https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-myelodysplastic-syndromes-mds-can-be-taken-home September 2020


D E V E L O P M E N T U P D A T E : O r a l P a c l i t a x e l N D A f o r M e t a s t a t i c B r e a s t C a n c e rD E V E L O P M E N T U P D A T E : O r a l P a c l i t a x e l N D A f o r M e t a s t a t i c B r e a s t C a n c e r


Oral Paclitaxel and Encequidar Regulatory Update • NDA of Oral Paclitaxel for metastatic breast cancer accepted for filing by the U.S. FDA • Priority Review granted • U.S. FDA grants Priority Review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or 1 prevention of serious conditions when compared to standard applications • PDUFA target action date of February 28, 2021 • FDA indicated it is currently not planning to hold an advisory committee meeting • NDA submission based on data from Phase III pivotal study – a randomized, controlled clinical trial designed to compare the safety and efficacy of Oral Paclitaxel monotherapy versus IV Paclitaxel monotherapy for the treatment of metastatic breast cancer 6 1 Source: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review September 2020Oral Paclitaxel and Encequidar Regulatory Update • NDA of Oral Paclitaxel for metastatic breast cancer accepted for filing by the U.S. FDA • Priority Review granted • U.S. FDA grants Priority Review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or 1 prevention of serious conditions when compared to standard applications • PDUFA target action date of February 28, 2021 • FDA indicated it is currently not planning to hold an advisory committee meeting • NDA submission based on data from Phase III pivotal study – a randomized, controlled clinical trial designed to compare the safety and efficacy of Oral Paclitaxel monotherapy versus IV Paclitaxel monotherapy for the treatment of metastatic breast cancer 6 1 Source: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review September 2020


Study Met Primary ORR Endpoint Statistically Significant Improvement in ORR Compared to IV Paclitaxel (Presented at 2019 SABCS) Confirmed Response Rate Confirmed Response Rate (ITT Population) (Prespecified mITT Population) Δ=14.8% Δ=12.4% p=0.005 p=0.011 40.4% 35.8% 25.6% 23.4% Oral Paclitaxel Group IV Paclitaxel Group Oral Paclitaxel Group IV Paclitaxel Group 7 ITT, intent-to-treat population (N=402); mITT, modified intent-to-treat population (N=360) September 2020Study Met Primary ORR Endpoint Statistically Significant Improvement in ORR Compared to IV Paclitaxel (Presented at 2019 SABCS) Confirmed Response Rate Confirmed Response Rate (ITT Population) (Prespecified mITT Population) Δ=14.8% Δ=12.4% p=0.005 p=0.011 40.4% 35.8% 25.6% 23.4% Oral Paclitaxel Group IV Paclitaxel Group Oral Paclitaxel Group IV Paclitaxel Group 7 ITT, intent-to-treat population (N=402); mITT, modified intent-to-treat population (N=360) September 2020


Overall Survival in Prespecified mITT Population Demonstrated Survival Benefit (Data cut: July 2019) (Presented at 2019 SABCS) OPE IVP HR=0.684 (95% CI: 0.475, 0.985) P=0.0353 Months (Relative to Randomization) Numbers of Subjects at Risk 235 229 218 190 162 130 107 84 66 48 42 31 27 23 18 10 7 4 2 0 OPE 125 121 114 99 85 65 47 40 33 24 17 14 12 11 5 4 3 1 1 IVP Median Censored Patient Discontinued patients Patients ongoing or OS, mITT Estimate, Summary, deaths and survival status being followed up (N=360) mo % (events), % unknown (censored), % (censored), % OPE (n=235) 27.9 68.9 31.1 17.9 51.1 IVP (n=125) 16.9 58.4 41.6 18.4 40.0 8 OPE, Oral Paclitaxel Group; IVP, IV Paclitaxel Group mITT, modified intent-to-treat population (N=360) CI, confidence interval; HR, hazard ratio September 2020 Cumulative Overall SurvivalOverall Survival in Prespecified mITT Population Demonstrated Survival Benefit (Data cut: July 2019) (Presented at 2019 SABCS) OPE IVP HR=0.684 (95% CI: 0.475, 0.985) P=0.0353 Months (Relative to Randomization) Numbers of Subjects at Risk 235 229 218 190 162 130 107 84 66 48 42 31 27 23 18 10 7 4 2 0 OPE 125 121 114 99 85 65 47 40 33 24 17 14 12 11 5 4 3 1 1 IVP Median Censored Patient Discontinued patients Patients ongoing or OS, mITT Estimate, Summary, deaths and survival status being followed up (N=360) mo % (events), % unknown (censored), % (censored), % OPE (n=235) 27.9 68.9 31.1 17.9 51.1 IVP (n=125) 16.9 58.4 41.6 18.4 40.0 8 OPE, Oral Paclitaxel Group; IVP, IV Paclitaxel Group mITT, modified intent-to-treat population (N=360) CI, confidence interval; HR, hazard ratio September 2020 Cumulative Overall Survival


1 Neuropathy-relevant TEAEs (CTCAE Grade ≥2) Safety Population (N=399) (Presented at 2019 SABCS) Numbers of Subjects at Risk OPE 264 263 248 239 225 215 198 185 180 171 158 149 137 128 121 114 103 95 85 78 71 65 60 57 51 IVP 135 129 126 120 117 111 103 96 92 86 70 67 58 52 49 40 34 33 33 29 24 20 20 19 15 9 TEAE, treatment emergent adverse event; OPE, Oral Paclitaxel Group; IVP, IV Paclitaxel Group 1 Neuropathy-relevant TEAEs include burning sensation, dysesthesia, hypoesthesia, hyporeflexia, neuralgia, neuropathy peripheral, neurotoxicity, paresthesia, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy September 20201 Neuropathy-relevant TEAEs (CTCAE Grade ≥2) Safety Population (N=399) (Presented at 2019 SABCS) Numbers of Subjects at Risk OPE 264 263 248 239 225 215 198 185 180 171 158 149 137 128 121 114 103 95 85 78 71 65 60 57 51 IVP 135 129 126 120 117 111 103 96 92 86 70 67 58 52 49 40 34 33 33 29 24 20 20 19 15 9 TEAE, treatment emergent adverse event; OPE, Oral Paclitaxel Group; IVP, IV Paclitaxel Group 1 Neuropathy-relevant TEAEs include burning sensation, dysesthesia, hypoesthesia, hyporeflexia, neuralgia, neuropathy peripheral, neurotoxicity, paresthesia, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy September 2020


D E V E L O P M E N T U P D A T E : I n i t i a t i o n o f O r a l P a c l i t a x e l i n t h e I - S P Y 2 T r i a lD E V E L O P M E N T U P D A T E : I n i t i a t i o n o f O r a l P a c l i t a x e l i n t h e I - S P Y 2 T r i a l


I-SPY 2 Trial Overview • I-SPY 2 employs an innovative adaptive randomization trial model, including: Neoadjuvant model Endpoint is pCR Curable population Systemic therapy first I-SPY 2’s early A breast cancer lets you see how surrogate efficacy population where tumors respond to endpoint, pCR, gets standard of care has treatment results faster much room to improve • I-SPY 2 is a Phase 2 trial designed to screen novel agents in the neoadjuvant breast cancer setting • Patients randomized to chemotherapy +/- a novel agent • Endpoint is pathological complete response (pCR) • Graduation: 85% probability of success in a Phase 3 I-SPY 2 TRIAL is sponsored by Quantum Leap Healthcare Collaborative 11 Source: https://www.ispytrials.org/i-spy-platform/i-spy2 September 2020I-SPY 2 Trial Overview • I-SPY 2 employs an innovative adaptive randomization trial model, including: Neoadjuvant model Endpoint is pCR Curable population Systemic therapy first I-SPY 2’s early A breast cancer lets you see how surrogate efficacy population where tumors respond to endpoint, pCR, gets standard of care has treatment results faster much room to improve • I-SPY 2 is a Phase 2 trial designed to screen novel agents in the neoadjuvant breast cancer setting • Patients randomized to chemotherapy +/- a novel agent • Endpoint is pathological complete response (pCR) • Graduation: 85% probability of success in a Phase 3 I-SPY 2 TRIAL is sponsored by Quantum Leap Healthcare Collaborative 11 Source: https://www.ispytrials.org/i-spy-platform/i-spy2 September 2020


I-SPY 2 Trial: Adaptive Overall Study Schema 12 Source: Quantum Leap Healthcare Collaborative September 2020I-SPY 2 Trial: Adaptive Overall Study Schema 12 Source: Quantum Leap Healthcare Collaborative September 2020


I-SPY 2 Principal Investigators from Leading Cancer Centers Institution Site PI Name and Title Institution Site PI Name and Title 13 Source: Quantum Leap Healthcare Collaborative September 2020I-SPY 2 Principal Investigators from Leading Cancer Centers Institution Site PI Name and Title Institution Site PI Name and Title 13 Source: Quantum Leap Healthcare Collaborative September 2020


Surgery I-SPY 2 Launches New Study Arm with Oral Paclitaxel In Combination with GSK’s dostarlimab (PD-1 Antibody) Goal of Study: Evaluate the safety and efficacy of Oral Paclitaxel in combination with dostarlimab +/- carboplatin in the neoadjuvant breast cancer setting Primary Objective: Determine whether this regimen increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy alone in specific biomarker signatures Targeting stage 2/3 HER2+ and HER2- breast cancer patients Experimental arm Oral Paclitaxel + AC Dostarlimab * Experimental arm Oral Paclitaxel + Dostarlimab + AC Carboplatin * Control arm IV Paclitaxel * AC AC = doxorubicin / * HER2+ patients may also cyclophosphamide receive trastuzumab chemotherapy 14 September 2020Surgery I-SPY 2 Launches New Study Arm with Oral Paclitaxel In Combination with GSK’s dostarlimab (PD-1 Antibody) Goal of Study: Evaluate the safety and efficacy of Oral Paclitaxel in combination with dostarlimab +/- carboplatin in the neoadjuvant breast cancer setting Primary Objective: Determine whether this regimen increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy alone in specific biomarker signatures Targeting stage 2/3 HER2+ and HER2- breast cancer patients Experimental arm Oral Paclitaxel + AC Dostarlimab * Experimental arm Oral Paclitaxel + Dostarlimab + AC Carboplatin * Control arm IV Paclitaxel * AC AC = doxorubicin / * HER2+ patients may also cyclophosphamide receive trastuzumab chemotherapy 14 September 2020


Ongoing Phase II Study of Oral Paclitaxel in Angiosarcoma Interim Data Presented at ASCO20 Virtual Scientific Program 1 Early Onset of Response – CR at Week 13 Baseline Week 1 Week 2 2 Early Onset of Response – CR at Week 6 15 ASCO20 Poster Presentation ”A Phase II Study of Oral Paclitaxel with Encequidar in the Treatment of Unresectable Cutaneous Angiosarcoma” 1 Scalp Angiosarcoma, male, age 93 2 Breast Angiosarcoma, female, age 69 September 2020Ongoing Phase II Study of Oral Paclitaxel in Angiosarcoma Interim Data Presented at ASCO20 Virtual Scientific Program 1 Early Onset of Response – CR at Week 13 Baseline Week 1 Week 2 2 Early Onset of Response – CR at Week 6 15 ASCO20 Poster Presentation ”A Phase II Study of Oral Paclitaxel with Encequidar in the Treatment of Unresectable Cutaneous Angiosarcoma” 1 Scalp Angiosarcoma, male, age 93 2 Breast Angiosarcoma, female, age 69 September 2020


I-SPY 2 Agent Timeline 16 Source: Quantum Leap Healthcare Collaborative September 2020I-SPY 2 Agent Timeline 16 Source: Quantum Leap Healthcare Collaborative September 2020


C O M M E R C I A L S T R A T E G YC O M M E R C I A L S T R A T E G Y


Establishing Athenex’s Leadership in Oncology Positioning Oral Paclitaxel to become the preferred chemotherapy in metastatic breast cancer (MBC)* • Strong Phase III clinical data, comparing to IV Paclitaxel, in MBC Oral Paclitaxel potential label expansion opportunities to multiple indications* • IV Paclitaxel is a foundational chemotherapy • Exploring additional indications, monotherapy and in combination Seeking to revolutionize other IV chemotherapies into oral agents • Orascovery platform: converting other commonly used IV chemotherapy agents into oral • Encequidar, a specific and potent P-gp pump inhibitor, is designed to enable oral administration of chemotherapy agents Broad oncology-focused pipeline 18 * If approved for MBC September 2020Establishing Athenex’s Leadership in Oncology Positioning Oral Paclitaxel to become the preferred chemotherapy in metastatic breast cancer (MBC)* • Strong Phase III clinical data, comparing to IV Paclitaxel, in MBC Oral Paclitaxel potential label expansion opportunities to multiple indications* • IV Paclitaxel is a foundational chemotherapy • Exploring additional indications, monotherapy and in combination Seeking to revolutionize other IV chemotherapies into oral agents • Orascovery platform: converting other commonly used IV chemotherapy agents into oral • Encequidar, a specific and potent P-gp pump inhibitor, is designed to enable oral administration of chemotherapy agents Broad oncology-focused pipeline 18 * If approved for MBC September 2020


Commercial Strategy for Oral Paclitaxel in MBC* Executing a Potential U.S. Launch around Critical Success Factors Emphasize strong clinical data Optimize messaging Increased demand for oral therapies Build company and product awareness Build awareness Highlight strong clinical results Enhance U.S. doctor and patient experience Develop patient engagement services Ensure strong patient support & access Remove economic barriers Elevate importance of Increase awareness and understanding of the problem of neuropathy CIPN Rapid adoption into priority MBC patient segments Establish success in MBC Establish thought leader endorsement 19 * If approved September 2020Commercial Strategy for Oral Paclitaxel in MBC* Executing a Potential U.S. Launch around Critical Success Factors Emphasize strong clinical data Optimize messaging Increased demand for oral therapies Build company and product awareness Build awareness Highlight strong clinical results Enhance U.S. doctor and patient experience Develop patient engagement services Ensure strong patient support & access Remove economic barriers Elevate importance of Increase awareness and understanding of the problem of neuropathy CIPN Rapid adoption into priority MBC patient segments Establish success in MBC Establish thought leader endorsement 19 * If approved September 2020


Commercial Preparations on Track MARKETING SALES MEDICAL AFFAIRS MARKET ACCESS Scientific Trade and distribution “Facing MBC Together” Account targeting communication platform strategy defined campaign launched complete established Data infrastructure being Payer value proposition Brand positioning and Key data generation built out along with research in process customer segmentation and publication plans in customer relationship established process management platform Pricing and contracting research complete Go-to-market tactical Health economics Target team of 50-55 plan identified studies initiated sales reps Patient support strategies in HCP unbranded MSL team fully staffed • Hiring on schedule; development campaign launched to and engaging with 25 territory reps elevate CIPN thought leaders upon approval to Director of Payor team cover 70% of the hired; payor account Oncology nurse highest prescribers team hiring in progress educator team hired 20 September 2020Commercial Preparations on Track MARKETING SALES MEDICAL AFFAIRS MARKET ACCESS Scientific Trade and distribution “Facing MBC Together” Account targeting communication platform strategy defined campaign launched complete established Data infrastructure being Payer value proposition Brand positioning and Key data generation built out along with research in process customer segmentation and publication plans in customer relationship established process management platform Pricing and contracting research complete Go-to-market tactical Health economics Target team of 50-55 plan identified studies initiated sales reps Patient support strategies in HCP unbranded MSL team fully staffed • Hiring on schedule; development campaign launched to and engaging with 25 territory reps elevate CIPN thought leaders upon approval to Director of Payor team cover 70% of the hired; payor account Oncology nurse highest prescribers team hiring in progress educator team hired 20 September 2020


Market Opportunity for Oral Paclitaxel in MBC in the U.S. Metastatic Breast Cancer HER2+ HR+/HER2- TNBC Unknown 1 1 1 1 ~14% ~68% ~10% ~8% Endocrine therapy Oral Paclitaxel and Common regimens 1L +/- CDK 4 & 6 inhibitor Encequidar • Herceptin in combination with paclitaxel • Herceptin Oral Paclitaxel and 2L monotherapy Encequidar • Kadcyla monotherapy • Perjeta in combination with Oral Paclitaxel and Herceptin and 3L Encequidar docetaxel 2 Addressable Market of ~70,000 in MBC 1 National Cancer Institute (SEER 2013-2017) 21 2 Estimated target patients that would be eligible for chemotherapy (various sources, Breast Cancer, United States, 2019). Forecast figures and/or estimates are not guarantees of future performance and involve risks and uncertainties. Actual results might differ materially from September 2020 the forecast figures and/or estimatesMarket Opportunity for Oral Paclitaxel in MBC in the U.S. Metastatic Breast Cancer HER2+ HR+/HER2- TNBC Unknown 1 1 1 1 ~14% ~68% ~10% ~8% Endocrine therapy Oral Paclitaxel and Common regimens 1L +/- CDK 4 & 6 inhibitor Encequidar • Herceptin in combination with paclitaxel • Herceptin Oral Paclitaxel and 2L monotherapy Encequidar • Kadcyla monotherapy • Perjeta in combination with Oral Paclitaxel and Herceptin and 3L Encequidar docetaxel 2 Addressable Market of ~70,000 in MBC 1 National Cancer Institute (SEER 2013-2017) 21 2 Estimated target patients that would be eligible for chemotherapy (various sources, Breast Cancer, United States, 2019). Forecast figures and/or estimates are not guarantees of future performance and involve risks and uncertainties. Actual results might differ materially from September 2020 the forecast figures and/or estimates


L A B E L E X P A N S I O N S T R A T E G I E SL A B E L E X P A N S I O N S T R A T E G I E S


Label Expansion Strategies Pursue opportunities Pursue emerging where paclitaxel is, and combination opportunities will continue to be, the standard of care Time to Regulatory Commercial approval pathway opportunity - Probability of Unmet success medical need Financial Competitive Partner investment landscape participation and ROI 22 September 2020Label Expansion Strategies Pursue opportunities Pursue emerging where paclitaxel is, and combination opportunities will continue to be, the standard of care Time to Regulatory Commercial approval pathway opportunity - Probability of Unmet success medical need Financial Competitive Partner investment landscape participation and ROI 22 September 2020


Potential Areas of Interest Pursue opportunities Pursue emerging where paclitaxel is, and combination opportunities will continue to be, the standard of care Expanding into indications where Combining with immunotherapies Paclitaxel is SOC Early stage breast cancer Lung cancer Ovarian cancer Gastroesophageal (GE) cancer Lung cancer Genitourinary (GU) cancer Gastric cancer TNBC Indications with ongoing studies 24 September 2020Potential Areas of Interest Pursue opportunities Pursue emerging where paclitaxel is, and combination opportunities will continue to be, the standard of care Expanding into indications where Combining with immunotherapies Paclitaxel is SOC Early stage breast cancer Lung cancer Ovarian cancer Gastroesophageal (GE) cancer Lung cancer Genitourinary (GU) cancer Gastric cancer TNBC Indications with ongoing studies 24 September 2020


Opportunity to Expand Oral Paclitaxel’s Addressable Market Potential Addressable US Patients: 545,000 > 545,000 (US Incidence) 25,000 42,000 18,000 35,000 149,000 276,000 Early Stage BC Metastatic 70,000 Current Total Breast Metastatic Metastatic Metastatic Metastatic Head Metastatic 1 Addressable Cancer NSCLC Gastric & Ovarian Cancer & Neck Cancer Bladder Cancer Market in MBC Esophageal Cancer 25 Source: New cases in 2020 estimated based on SEER by National Cancer Institute Note: The graph is for illustrative purpose only. It may not reflect the actual scale and the selected diseases do not represent our comprehensive list of targeted indications September 2020 1 Including laryngeal, oral cavity and pharyngeal cancersOpportunity to Expand Oral Paclitaxel’s Addressable Market Potential Addressable US Patients: 545,000 > 545,000 (US Incidence) 25,000 42,000 18,000 35,000 149,000 276,000 Early Stage BC Metastatic 70,000 Current Total Breast Metastatic Metastatic Metastatic Metastatic Head Metastatic 1 Addressable Cancer NSCLC Gastric & Ovarian Cancer & Neck Cancer Bladder Cancer Market in MBC Esophageal Cancer 25 Source: New cases in 2020 estimated based on SEER by National Cancer Institute Note: The graph is for illustrative purpose only. It may not reflect the actual scale and the selected diseases do not represent our comprehensive list of targeted indications September 2020 1 Including laryngeal, oral cavity and pharyngeal cancers


K E Y T A K E A W A Y SK E Y T A K E A W A Y S


Oral Paclitaxel is the first step in establishing Athenex’s leadership in oral chemotherapy and oncology Advance development of the broader Orascovery pipeline Oral Paclitaxel provides further validation of the technology platform Expand usage of Oral Paclitaxel in other cancer Establish Oral Oral docetaxel and encequidar types Paclitaxel as • Phase II study in planning SOC in breast cancer Opportunities where Oral irinotecan and encequidar paclitaxel is currently • Phase II study in planning used and in emerging Metastatic breast combinations, e.g.: cancer • Gastric cancer Oral eribulin and encequidar Early stage breast • Lung cancer • Phase I study ongoing cancer (I-SPY 2) • Ovarian cancer • TNBC 27 September 2020Oral Paclitaxel is the first step in establishing Athenex’s leadership in oral chemotherapy and oncology Advance development of the broader Orascovery pipeline Oral Paclitaxel provides further validation of the technology platform Expand usage of Oral Paclitaxel in other cancer Establish Oral Oral docetaxel and encequidar types Paclitaxel as • Phase II study in planning SOC in breast cancer Opportunities where Oral irinotecan and encequidar paclitaxel is currently • Phase II study in planning used and in emerging Metastatic breast combinations, e.g.: cancer • Gastric cancer Oral eribulin and encequidar Early stage breast • Lung cancer • Phase I study ongoing cancer (I-SPY 2) • Ovarian cancer • TNBC 27 September 2020


Q&A THANK YOU Our goal is to become a global leader in bringing innovative cancer treatments to the market and improving health outcomes NASDAQ:ATNX www.athenex.comQ&A THANK YOU Our goal is to become a global leader in bringing innovative cancer treatments to the market and improving health outcomes NASDAQ:ATNX www.athenex.com

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Document and Entity Information
Sep. 08, 2020
Cover [Abstract]  
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Entity Central Index Key 0001300699
Document Type 8-K
Document Period End Date Sep. 08, 2020
Entity Registrant Name ATHENEX, INC.
Entity Incorporation State Country Code DE
Entity File Number 001-38112
Entity Tax Identification Number 43-1985966
Entity Address, Address Line One 1001 Main Street
Entity Address, Address Line Two Suite 600
Entity Address, City or Town Buffalo
Entity Address, State or Province NY
Entity Address, Postal Zip Code 14203
City Area Code (716)
Local Phone Number 427-2950
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Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, par value $0.001 per share
Trading Symbol ATNX
Security Exchange Name NASDAQ
Entity Emerging Growth Company false