8-K
false 0001651431 0001651431 2021-11-12 2021-11-12

 

 

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 12, 2021

 

 

CHECKMATE PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39425   36-4813934

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

Checkmate Pharmaceuticals, Inc.
245 Main Street, 2nd Floor
Cambridge, MA 02142
(Address of principal executive offices, including zip code)

(617) 682-3625

(Registrant’s telephone number, including area code)

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 Act:

 

Title of each class

 

Trade

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share   CMPI   The Nasdaq Global 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 2.02

Results of Operations and Financial Condition

On November 12, 2021, Checkmate Pharmaceuticals, Inc. announced its financial results for the quarter ended September 30, 2021. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

 

99.1    Press release issued by Checkmate Pharmaceuticals, Inc. on November 12, 2021, furnished herewith.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURE

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.

 

    Checkmate Pharmaceuticals, Inc.
Date: November 12, 2021     By:  

/s/ Robert Dolski

      Robert Dolski
      Chief Financial Officer
EX-99.1

EXHIBIT 99.1

Checkmate Pharmaceuticals Announces Third Quarter 2021 Financial Results and Provides Business Update

Alan Fuhrman appointed interim President and CEO

Clinical trials with vidutolimod (CMP-001) in melanoma, head and neck cancer ongoing

Clinical data readouts anticipated in 2022

CAMBRIDGE, Mass., November 12, 2021Checkmate Pharmaceuticals, Inc. (Nasdaq: CMPI) (“Checkmate”), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced third quarter 2021 financial results and provided a business update.

“We are excited about the future of vidutolimod as a potential novel treatment for multiple tumor types, including melanoma and head and neck cancer. We continue to advance our clinical trials towards potential data readouts in 2022,” said Alan Fuhrman, interim President and Chief Executive Officer of Checkmate.

Recent Business Updates

 

   

During The Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting, Dr. John Kirkwood from the University of Pittsburgh Medical Center presented a poster on the final clinical data from the Phase 1b study of vidutolimod in combination with pembrolizumab or as a monotherapy in patients with anti-PD-1 refractory melanoma.

 

   

Vidutolimod in combination with pembrolizumab led to an ORR of 23.5% by RECIST v1.1, a complete response rate of 7.1%, and a median duration of response of 25.2 months.

 

   

Vidutolimod monotherapy resulted in a 20.0% ORR by RECIST v1.1 and a median duration of response of 5.6 months.

 

   

The most frequent treatment-related adverse events were consistent with flu-like symptoms and injection site reactions and were most commonly Grade 1 or 2.

 

   

We appointed Alan Fuhrman, an experienced biotech executive and Checkmate board member, as interim President and CEO.

 

   

Ongoing patient recruitment activities and enrollment across our clinical trials evaluating vidutolimod, including:

 

   

A Phase 2 trial of vidutolimod in combination with nivolumab in anti-PD-1 refractory advanced melanoma, supported by a clinical collaboration with Bristol Myers Squibb.

 

   

A randomized Phase 2/3 trial of vidutolimod in combination with nivolumab vs. nivolumab monotherapy in first-line metastatic or unresectable melanoma, also supported by the clinical collaboration with Bristol Myers Squibb.

 

   

A Phase 2 trial of vidutolimod in combination with pembrolizumab in recurrent or metastatic squamous cell head and neck cancer.


   

Start-up activities underway for the planned expansion of the development program for vidutolimod in combination with cemiplimab in cutaneous squamous cell carcinoma and Merkel cell carcinoma, supported by a clinical collaboration with Regeneron.

Third Quarter 2021 Financial Results

 

   

Research and development expenses (R&D): R&D expenses for the three months ending September 30, 2021, were $11.4 million, compared to $6.7 million for the same period in the prior year. This increase reflects higher third-party CRO and manufacturing costs directly related to the vidutolimod clinical trials, in addition to higher personnel and operating expense for the planning and execution of the clinical trials.

 

   

General and administration expenses (G&A): G&A expenses for the three months ending September 30, 2021, were $3.6 million, compared to $3.2 million for the same period in the prior year. This increase was primarily attributable to increases in personnel and operating expense incurred in connection with Checkmate operating as a publicly traded company.

 

   

Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $80.8 million as of September 30, 2021.

About Checkmate Pharmaceuticals

Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer. Checkmate Pharmaceuticals’ product candidate, vidutolimod (CMP-001), is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component, designed to trigger the body’s innate immune system to attack tumors in combination with other therapies. Information regarding Checkmate Pharmaceuticals is available at www.checkmatepharma.com.

Availability of Other Information About Checkmate Pharmaceuticals

Investors and others should note that we communicate with our investors and the public using our website (www.checkmatepharma.com), our investor relations website (ir.checkmatepharma.com), and on social media (Twitter and LinkedIn), including but not limited to: investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Checkmate Pharmaceuticals posts on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.


Forward Looking Statements

Various statements in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. These statements include those regarding vidutolimod (formerly CMP-001), including its development and therapeutic potential and the advancement of our clinical and preclinical pipeline; expectations regarding the results and analysis of clinical data and timing thereof; expectations regarding the timing, initiation, implementation and success of its planned and ongoing clinical trials for vidutolimod and the benefits and related implications of current and future partnerships and/or collaborations; and expectations regarding the Company’s use of capital, expenses and other financial results. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. These forward-looking statements are subject to risks and uncertainties, including those related to the development of our product candidate, including any delays in our ongoing or planned preclinical or clinical trials, the results from clinical trials, including the fact that positive results from a trial may not necessarily be predictive of the results of future or ongoing clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and obtaining, maintaining and protecting our intellectual property. These and additional risks are discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Quarterly Report on Form 10-Q for the period ending September 30, 2021 and in our Annual Report on Form 10-K for the year ending December 31, 2020, as filed with the Securities and Exchange Commission (“SEC”) which is available on the SEC’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the SEC. All information in this press release is as of the date of the release, and we undertake no duty to update this information unless required by law.

Investor Contact

Rob Dolski

Chief Financial Officer

rdolski@checkmatepharma.com

Media Contact

Karen Sharma

MacDougall

781-235-3060

ksharma@macbiocom.com


CHECKMATE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share amounts)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2021     2020     2021     2020  

Operating expenses:

        

Research and development

   $ 11,375     $ 6,673     $ 36,618     $ 19,462  

General and administrative

     3,605       3,160       11,498       6,465  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     14,980       9,833       48,116       25,927  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (14,980     (9,833     (48,116     (25,927
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense), net:

        

Interest income

     14       4       87       32  

Loss on sale of available-for-sale investments

     —         —         (35     —    

Change in fair value of convertible loan notes

     —         —         —         (83
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     14       4       52       (51
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (14,966   $ (9,829   $ (48,064   $ (25,978
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares outstanding – basic and diluted

     21,626       13,580       21,611       5,519  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to common stockholders – basic and diluted

   $ (0.69   $ (0.84   $ (2.22   $ (5.79
  

 

 

   

 

 

   

 

 

   

 

 

 

CHECKMATE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands)

 

     September 30,
2021
     December 31,
2020
 

Cash, cash equivalents and investments

   $ 80,844      $ 125,859  

Other assets

     8,495        7,215  
  

 

 

    

 

 

 

Total assets

   $ 89,339      $ 133,074  
  

 

 

    

 

 

 

Total liabilities

     7,812        7,875  

Total stockholders’ equity

     81,527        125,199  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 89,339      $ 133,074