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): May 6, 2020

 

Checkpoint Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware   001-38128   47-2568632

(State or Other Jurisdiction

of Incorporation)

  (Commission File Number)   (IRS Employer
Identification No.)

 

2 Gansevoort Street, 9th Floor

New York, New York 10014

(Address of Principal Executive Offices)

 

(781) 652-4500

(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 obligation of the registrant under any of the following provisions:

 

¨  Written communications pursuant to Rule 425 under the Securities Act.
¨  Soliciting material pursuant to Rule 14a-12 under the Exchange Act.
¨  Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.
¨  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

 

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 $0.0001 per share   CKPT   NASDAQ Capital 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 x

 

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. x

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On May 6, 2020, Checkpoint Therapeutics, Inc. issued a press release to provide a corporate update and to announce its financial results for the first quarter ended March 31, 2020. A copy of such press release is being furnished as Exhibit 99.1 to this report.

 

Item 9.01. Financial Statements and Exhibits.

 

(d)Exhibits.

 

The following exhibit is furnished herewith:

 

Exhibit
Number  
    Description
99.1     Press release issued by Checkpoint Therapeutics, Inc., dated May 6, 2020.

 

 

 

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.

  

Date: May 6, 2020 Checkpoint Therapeutics, Inc.
(Registrant)
   
  By  /s/ James F. Oliviero  
    James F. Oliviero
    President and Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

Checkpoint Therapeutics Reports First Quarter 2020 Financial Results and Recent Corporate Highlights

 

New York, NY – May 6, 2020 – Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, today announced financial results for the first quarter ended March 31, 2020, and recent corporate highlights.

 

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, “In the first quarter of 2020, we continued to make progress with the development of cosibelimab, our lead antibody product candidate that is poised to be a potentially differentiated treatment from currently marketed PD-1 and PD-L1 antibodies. As announced in January, the U.S. Food and Drug Administration (“FDA”) confirmed the registration submission pathway for cosibelimab in its initial indication of metastatic cutaneous squamous cell carcinoma (“CSCC”) based on the ongoing multicenter Phase 1 clinical trial. We look forward to reporting additional interim data from this clinical trial later this year. Additionally, we recently announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab, which provides broad, foundational composition of matter protection for our antibody through at least May 2038. With these developments, we look forward to continuing to enroll CSCC patients in order to support our first marketing application submission based on this ongoing clinical trial.”

 

Recent Corporate Highlights:

 

·In January 2020, Checkpoint announced confirmation of the registration path for cosibelimab in metastatic CSCC. FDA feedback supports the Company’s plan to submit a Biologics License Application (“BLA”) based on data from the ongoing Phase 1 trial. Over one-third of enrollment is complete in the cohort of patients with metastatic CSCC.

 

·In April 2020, Checkpoint announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available.

 

Financial Results:

 

·Cash Position: As of March 31, 2020, Checkpoint’s cash and cash equivalents totaled $21.5 million, compared to $26.1 million as of December 31, 2019, a decrease of $4.6 million.

 

·Revenue: Revenue for the first quarter of 2020 was $1.0 million, compared to $0.4 million for the first quarter of 2019, an increase of $0.6 million.

 

·R&D Expenses: Research and development expenses for the first quarter of 2020 were $2.6 million, compared to $4.6 million for the first quarter of 2019, a decrease of $2.0 million. Research and development expenses for the first quarter of 2020 included $0.1 million of non-cash stock expenses, compared to $0.2 million in the first quarter of 2019.

 

·G&A Expenses: General and administrative expenses for the first quarter of 2020 were $1.7 million, essentially flat as compared to the first quarter of 2019. General and administrative expenses for the first quarter of 2020 included $0.5 million of non-cash stock expenses, compared to $0.6 million for the first quarter of 2019.

 

·Net Loss: Net loss attributable to common stockholders for the first quarter of 2020 was $3.3 million, or $0.06 per share, compared to a net loss of $5.9 million, or $0.18 per share, in the first quarter of 2019.

 

 

 

About Checkpoint Therapeutics

 

Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potentially differentiated anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts intended to support one or more Biologics License Application submissions. In addition, Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, CK-101, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, in a Phase 1 clinical trial for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (“NSCLC”). Checkpoint is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.checkpointtx.com.

 

Forward-Looking Statements

 

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our plans to submit one or more BLAs and seek approvals for cosibelimab, statements regarding the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies, statements relating to the half-life and functional Fc domain of cosibelimab translating into potential enhanced efficacy, statements relating to how long we believe our cash will fund our operations, any statements relating to our growth strategy and product development programs, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the ongoing Phase 1 study; risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Company Contacts:

Jaclyn Jaffe and William Begien

Checkpoint Therapeutics, Inc.

(781) 652-4500

ir@checkpointtx.com

 

Investor Relations Contact:

Ashley R. Robinson

Managing Director, LifeSci Advisors, LLC

(617) 430-7577

arr@lifesciadvisors.com

 

Media Relations Contact:

Tony Plohoros

6 Degrees

(908) 591-2839

tplohoros@6degreespr.com

 

 

 

CHECKPOINT THERAPEUTICS, INC.

BALANCE SHEETS

(in thousands, except share and per share amounts)

 

   March 31,
2020
   December 31, 2019 
   (Unaudited)     
ASSETS          
Current Assets:          
Cash and cash equivalents  $21,481   $26,077 
Prepaid expenses and other assets   753    863 
Other receivables - related party   972    26 
Total current assets   23,206    26,966 
Total Assets  $23,206   $26,966 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current Liabilities:          
Accounts payable and accrued expenses  $5,839   $7,257 
Accounts payable and accrued expenses - related party   1,149    862 
Total current liabilities   6,988    8,119 
Total Liabilities   6,988    8,119 
           
Commitments and Contingencies          
           
Stockholders' Equity          
Common Stock ($0.0001 par value), 60,000,000 shares authorized          
Class A common shares, 7,000,000 shares issued and outstanding as of March 31, 2020 and December 31, 2019   1    1 
Common shares, 48,038,506 and 47,004,764 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively   5    5 
Common stock issuable, 1,459,305 and 1,459,305 shares as of March 31, 2020 and December 31, 2019, respectively   2,510    2,510 
Additional paid-in capital   137,094    136,442 
Accumulated deficit   (123,392)   (120,111)
Total Stockholders’ Equity   16,218    18,847 
Total Liabilities and Stockholders’ Equity  $23,206   $26,966 

 

 

 

CHECKPOINT THERAPEUTICS, INC.

STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)

 

   For the three months ended
March 31,
 
   2020   2019 
Revenue - related party  $972   $352 
           
Operating expenses:          
Research and development   2,635    4,581 
General and administrative   1,678    1,703 
Total operating expenses   4,313    6,284 
Loss from operations   (3,341)   (5,932)
           
Other income          
Interest income   60    42 
Total other income   60    42 
Net Loss  $(3,281)  $(5,890)
           
Loss per Share:          
Basic and diluted net loss per common share outstanding  $(0.06)  $(0.18)
           
Basic and diluted weighted average number of common shares outstanding   50,875,476    32,243,796