8-K

 

 

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 7, 2018

 

 

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)

Registrant’s telephone number, including area code: (650) 870-1000

 

 

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))

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 2.02.

Results of Operations and Financial Condition.

On November 7, 2018, Calithera Biosciences, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2018. A copy of this press release is attached hereto as Exhibit 99.1.

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed 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, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

    No.    

  

Description

99.1    Press Release, dated November 7, 2018


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 7, 2018  
  By:  

/s/ Susan M. Molineaux

    Susan M. Molineaux
    President and Chief Executive Officer
EX-99.1

Exhibit 99.1

 

LOGO

Calithera Biosciences Reports

Third Quarter 2018 Financial Results and Recent Highlights

-Calithera to Host Conference Call Today at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time

SOUTH SAN FRANCISCO, Calif., November 7, 2018 (GLOBE NEWSWIRE) — Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today its financial results for the third quarter ended September 30, 2018. As of September 30, 2018, cash, cash equivalents and investments totaled $141.5 million.

“Calithera continues to advance the development of our novel oncometabolism clinical candidates,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. “In this quarter we broadened the development of the novel glutaminase inhibitor CB-839 with two new clinical trial collaborations with Pfizer. We are actively enrolling CANTATA and ENTRATA, two randomized trials of CB-839 for the treatment of patients with renal cell carcinoma, with data from the ENTRATA trial expected in 2019. In addition, we and our partner Incyte expect data on INCB001158 to be presented at a medical meeting in the first half of 2019.”

Third Quarter 2018 and Recent Highlights

 

   

Announced two new clinical trial collaborations to evaluate Pfizer’s CDK4/6 inhibitor palbociclib, also known as IBRANCE®, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib also known as TALZENNA®, each in combination with Calithera’s glutaminase inhibitor CB-839. Calithera will initiate Phase 1/2 clinical studies in the first quarter of 2019. Preclinical data suggest that CB-839 synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. CB-839 also synergizes preclinically with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation.

 

   

Two Randomized Combination Trials of CB-839 in Combination for the Treatment of Renal Cell Carcinoma. The ENTRATA trial, a randomized double-blind study of late line patients, will enroll approximately 66 patients to receive either CB-839 plus everolimus or everolimus alone. Topline results are expected in 2019. The CANTATA trial is a randomized, global, double-blind trial comparing patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. Topline results are expected in 2020. The trial will enroll patients with clear cell renal cell carcinoma who have previously received one or two prior lines of therapy. The trial, originally designed to enroll 300 patents has been enlarged to approximately 400 patients. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population. Updated Phase 1b data of CB-839 combined with cabozantinib presented in the quarter demonstrated a disease control rate of 100%, and response rate of 50% in 10 evaluable patients with clear cell RCC.

 

   

INCB001158 Arginase Inhibitor Immuno-oncology Program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Data from INCB001158 is expected to be presented at a medical meeting in the first half of 2019.

 

   

CB-280 Arginase Inhibitor for the Treatment of Cystic Fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. An investigational new drug (IND) application for CB-280 with the FDA is planned for the first half of 2019.


   

CB-708 Oral Small Molecule CD73 Inhibitor. The immuno-oncology target CD73 is an enzyme that plays a critical role in the process of ATP conversion to adenosine. An IND application for CB-708, an orally administered small molecule inhibitor of CD73, is planned for 2019.

Selected Third Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $141.5 million at September 30, 2018.

Research and development expenses were $16.4 million for the three months ended September 30, 2018, compared with $10.8 million for the same period in the prior year. The increase of $5.6 million was due to an increase in the CB-839 program, including for the CANTATA trial which opened in 2018, an increase in the INCB001158 program, including Incyte’s co-funding of development costs, an increase in the CB-280 program, as well as investment in early stage research.

General and administrative expenses were $3.1 million for both the three months ended September 30, 2018 and 2017 due to consistent headcount and stock-based compensation expense.

Net loss from operations for the three months ended September 30, 2018 was $18.8 million, or $0.52 per share.

Conference Call Information

Calithera will host an update conference call today, November 7, at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 9368596. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

About Calithera

Calithera is a clinical-stage biopharmaceutical company focused on fighting cancer by discovering, developing, and commercializing novel small molecule drugs that target tumor and immune cell metabolism. 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 the timing and enrollment of Calithera’s clinical trials, the clinical and commercial potential of its product candidates, Calithera’s collaboration with Pfizer and Incyte, Calithera’s ability to fund its clinical programs, and Calithera’s receipt of clinical data from its clinical trials. 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 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.


Calithera Biosciences, Inc.

Selected Consolidated Statements of Operations Financial Data

(in thousands, except per share amounts)

(unaudited)

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2018      2017      2018      2017  

Revenue:

           

Collaboration revenue

   $ —        $ 7,254      $ 22,254      $ 18,701  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total revenue

     —          7,254        22,254        18,701  

Operating expenses:

           

Research and development

     16,420        10,833        49,218        27,615  

General and administrative

     3,087        3,074        10,093        9,230  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total operating expenses

     19,507        13,907        59,311        36,845  
  

 

 

    

 

 

    

 

 

    

 

 

 

Loss from operations

     (19,507      (6,653      (37,057      (18,144

Interest income, net

     658        582        1,927        1,292  
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss

   $ (18,849    $ (6,071    $ (35,130    $ (16,852
  

 

 

    

 

 

    

 

 

    

 

 

 

Net loss per share, basic and diluted

   $ (0.52    $ (0.17    $ (0.98    $ (0.53
  

 

 

    

 

 

    

 

 

    

 

 

 

Weighted average common shares used to compute net loss per share, basic and diluted

     36,405        35,475        36,021        32,072  
  

 

 

    

 

 

    

 

 

    

 

 

 

Calithera Biosciences, Inc.

Selected Consolidated Balance Sheet Financial Data

(in thousands)

(unaudited)

 

     September 30,     December 31,  
     2018     2017  

Balance Sheet Data:

    

Cash, cash equivalents and investments

   $ 141,456     $ 186,154  

Working capital

     134,213       128,640  

Total assets

     147,674       192,455  

Deferred revenue

     —         31,045  

Total liabilities

     11,764       42,148  

Accumulated deficit

     (176,671     (150,333

Total stockholders’ equity

     135,910       150,307  

Contact:

Jennifer McNealey

ir@Calithera.com

650-870-1071

###