0001193125-21-320821.txt : 20211105 0001193125-21-320821.hdr.sgml : 20211105 20211105061005 ACCESSION NUMBER: 0001193125-21-320821 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20211102 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20211105 DATE AS OF CHANGE: 20211105 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Calithera Biosciences, Inc. CENTRAL INDEX KEY: 0001496671 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 272366329 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36644 FILM NUMBER: 211382204 BUSINESS ADDRESS: STREET 1: 343 OYSTER POINT BLVD #200 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-870-1000 MAIL ADDRESS: STREET 1: 343 OYSTER POINT BLVD #200 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 d233634d8k.htm 8-K 8-K
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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): November 2, 2021

 

 

Calithera Biosciences, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36644   27-2366329

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

343 Oyster Point Blvd.

Suite 200

South San Francisco, California 94080

(Address of principal executive offices) (Zip Code)

(650) 870-1000

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations 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 Act:

 

Title of each Class

  

Trading
Symbol(s)

  

Name of each exchange
on which registered

Common stock, $0.0001 par value per share   CALA   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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Resignation of Director

On November 2, 2021, Jean M. George notified the board of directors of Calithera Biosciences, Inc. of her intention to resign from the board of directors and all its committees prior to December 31, 2021. Ms. George subsequently submitted her resignation effective as of November 5, 2021. The resignation is not a result of any disagreement between Ms. George and Calithera.

Resignation of Officer; Appointment of Director

On November 2, 2021, Keith Orford, M.D., Ph.D. notified us of his decision to resign as Chief Medical Officer. Dr. Orford is expected to assist in the transition of his duties to Emil T. Kuriakose, M.D., who will be promoted to Chief Medical Officer as of November 5, 2021. Dr. Kuriakose is our current Vice President and Head of Clinical Development. Dr. Orford will serve as a Senior Vice President of Calithera until his employment terminates on November 17, 2021.

On November 2, 2021, the board of directors appointed Dr. Orford, effective upon Ms. George’s resignation, to fill the vacancy on the board of directors resulting from such resignation, to serve as a Class I director with a term expiring at our 2024 annual meeting of stockholders. Dr. Orford joined Calithera in January 2015 and has served as our Chief Medical Officer since January 2019. He previously served as our Senior Vice President, Clinical Development since May 2016.

In connection with his appointment to the board of directors, Dr. Orford will be eligible to receive compensation in accordance with our non-employee director compensation policy, as may be amended from time to time. In January 2022, Dr. Orford will receive an initial stock option grant for 40,000 shares of common stock in connection with his appointment to the board of directors, which will vest monthly over three years from the date he is no longer an employee of Calithera. Dr. Orford’s existing equity awards will continue vesting in accordance with their terms through November 17, 2021, and Dr. Orford will have 90 days thereafter to exercise any outstanding awards. We previously entered into our standard form of indemnification agreement with Dr. Orford.

Dr. Orford’s biography was previously reported in our most recent Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on April 23, 2021.

Item 7.01. Regulation FD Disclosure.

On November 5, 2021, we issued press releases regarding our decision to discontinue the KEAPSAKE clinical trial and the appointment of Dr. Orford to the board of directors and Dr. Kuriakose as our Chief Medical Officer. Copies of the press releases are furnished with this Current Report on Form 8-K and attached hereto as Exhibit 99.1 and 99.2, respectively.

The information in this item, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended.

Item 9.01. Financial Statements and Exhibits.

(d)        Exhibits

 

Exhibit No.   

Description

99.1    Press Release, dated November 5, 2021, titled “Calithera Biosciences Announces Decision to Discontinue KEAPSAKE Clinical Trial”.
99.2    Press Release, dated November 5, 2021, titled “Calithera Biosciences Appoints Emil T. Kuriakose, MD, as Chief Medical Officer”.
104    Cover Page Interactive Data File (the cover page XBRL tags are 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.

 

  CALITHERA BIOSCIENCES, INC.
Dated: November 5, 2021  
  By:  

/S/ SUSAN M. MOLINEAUX

    Susan M. Molineaux, Ph.D.
    President and Chief Executive Officer
 EX-99.1 2 d233634dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Calithera Biosciences Announces Decision to Discontinue KEAPSAKE Clinical Trial

—KEAPSAKE interim analysis demonstrated lack of clinical benefit among patients treated with telaglenastat

—Company will focus on advancing newly acquired targeted oncology compounds sapanisertib and mivavotinib, as well as the ongoing trial of CB-280 for the treatment of cystic fibrosis

SOUTH SAN FRANCISCO, Calif., November 5, 2021 (GLOBE NEWSWIRE) – Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, announced today the decision to terminate its phase 2 KEAPSAKE clinical trial based on a lack of clinical benefit observed in patients treated with telaglenastat in an interim analysis.

“We are disappointed in this outcome for the KEAPSAKE trial, but it was a well-run study with an interim analysis that gave us an answer to an important clinical question. We also want to express our sincere gratitude to the patients who participated in the trial and their families, as well as the physicians who served as investigators for the trial and their site staff,” said Susan Molineaux, PhD, chief executive officer of Calithera. “We remain committed to patients with difficult-to-treat cancers and will continue to advance our investigational targeted therapies for biomarker-specific patient populations. Our near-term clinical development plans include leveraging our clinical and biomarker expertise in the KEAP1/NRF2 pathway in the development of our mTORC1/2 inhibitor sapanisertib in squamous non-small cell lung cancer, as well as advancing the development of our SYK inhibitor mivavotinib in specific biomarker-defined populations of diffuse large B-cell lymphoma. In addition, we are continuing the development of our arginase inhibitor CB-280 for the treatment of cystic fibrosis.”

The phase 2 randomized, placebo-controlled, double-blind KEAPSAKE study was designed to evaluate the safety and anti-tumor activity of telaglenastat plus standard-of-care chemoimmunotherapy as front-line therapy among patients with stage IV non-squamous non-small cell lung cancer (NSCLC) whose tumors have a KEAP1 or NRF2 mutation. At the time of unblinding on October 27, 2021, there were 40 patients randomized. The available efficacy data at unblinding, including investigator-assessed progression-free survival (PFS), did not demonstrate clinical benefit, and analysis of the data led to the conclusion that there was a very low probability for the study to achieve a positive result. No difference in safety profile was seen between the two arms. The company has communicated these findings to the U.S. Food & Drug Administration (FDA) and has voluntarily discontinued the phase 2 study with agreement from members of the KEAPSAKE Steering Committee. Calithera has no plans to continue the development of telaglenastat at this time. Calithera estimates the cost savings resulting from the discontinuation of this trial will be $10-15 million.

Webcast and Conference Call Information

Calithera will hold a webcast today, Friday, November 5 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. To access the link to the webcast, which will be broadcast live in listen-only mode, or the subsequent archived recording, visit the Investors section of the Calithera website at

www.calithera.com. Alternatively, the call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 9529058. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

About Calithera

Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a robust pipeline of investigational, small molecule oncology compounds with a biomarker-driven approach that targets genetic vulnerabilities in cancer cells to deliver new therapies for patients suffering from aggressive hematologic and solid tumor cancers for which there are currently limited treatment options. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “poised” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to Calithera’s clinical trials and our estimated cost savings associated with the discontinuation of the KEAPSAKE trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

###

CONTACTS:

Stephanie Wong

ir@Calithera.com

650.870.1063

INVESTORS:

Burns McClellan

Lee Roth

212.213.0006

lroth@burnsmc.com

MEDIA:

Sam Brown, Inc.

Hannah Hurdle

805.338.4752

hannahhurdle@sambrown.com

EX-99.2 3 d233634dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

LOGO

Calithera Biosciences Promotes Emil T. Kuriakose, MD, to Chief Medical Officer

— Dr. Kuriakose to succeed Keith Orford, MD, PhD, who will assume seat on Calithera Board of Directors

SOUTH SAN FRANCISCO, Calif., November 5, 2021 (GLOBE NEWSWIRE) – Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, today announces the promotion of current vice president and head of clinical development, Dr. Emil T. Kuriakose, to chief medical officer (CMO). Dr. Kuriakose will succeed Dr. Keith Orford, who has been appointed to Calithera’s board of directors.

“Emil has a proven track record of leading clinical programs across multiple disease areas, and he is well-suited to assume this role at Calithera based on his accomplishments and four-year tenure with the company,” said Susan Molineaux, PhD, chief executive officer of Calithera. “Keith played a critical role in building the company’s clinical team during his seven years at Calithera. We are deeply appreciative of his contributions to-date and look forward to his continued strategic input in his new role as a member of our board.”

During his time at Calithera, Dr. Kuriakose has overseen the advancement of the company’s clinical development programs, including the arginase inhibitor programs in oncology and cystic fibrosis, as well as multiple telaglenastat trials. As an integral member of the diligence team, Dr. Kuriakose played a key role in the company’s recent successful acquisition of sapanisertib and mivavotinib from Takeda Pharmaceuticals, and he led formulation of the clinical development plan for the newly acquired assets. Prior to Calithera, Dr. Kuriakose led global clinical development programs, most recently with Novartis. Dr. Kuriakose completed his clinical training in hematology/oncology at Weill Cornell Medical College, including a research fellowship at Memorial Sloan Kettering Cancer Center, and he completed his residency training in internal medicine at UT Southwestern Medical Center in Dallas, TX. Dr. Kuriakose received his medical degree from Stony Brook University School of Medicine and his Bachelor of Science in neuroscience from New York University.

“I have great confidence in our new strategic focus to develop targeted therapies for biomarker-specific patient populations.” said Dr. Kuriakose “I have had the privilege of working alongside Keith for the last four years and look forward to continuing our partnership as he joins the board.”

Dr. Orford will assume the seat being vacated by current board member Jean M. George. Ms. George, a biotech investment and business development industry veteran, has served on the Calithera Board of Directors since 2012.

About Calithera

Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a robust pipeline of investigational, small

molecule oncology compounds with a biomarker-driven approach that targets genetic vulnerabilities in cancer cells to deliver new therapies for patients suffering from aggressive hematologic and solid tumor cancers for which there are currently limited treatment options. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “poised” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to Calithera’s clinical trials and new strategic focus. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

###

CONTACTS:

Stephanie Wong

ir@Calithera.com

650.870.1063

INVESTORS:

Burns McClellan

Lee Roth

212.213.0006

lroth@burnsmc.com

MEDIA:

Sam Brown, Inc.

Hannah Hurdle

805.338.4752

hannahhurdle@sambrown.com

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Document and Entity Information
Nov. 02, 2021
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001496671
Document Type 8-K
Document Period End Date Nov. 02, 2021
Entity Registrant Name Calithera Biosciences, Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-36644
Entity Tax Identification Number 27-2366329
Entity Address, Address Line One 343 Oyster Point Blvd.
Entity Address, Address Line Two Suite 200
Entity Address, City or Town South San Francisco
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94080
City Area Code (650)
Local Phone Number 870-1000
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common stock, $0.0001 par value per share
Trading Symbol CALA
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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