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Section 1: 8-K (FORM 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 2, 2018

 

Checkpoint Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware
(State or Other Jurisdiction
of Incorporation)

 

 

001-38128
(Commission File Number)

 

 

47-2568632
(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.

   

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. ¨

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On November 2, 2018, Checkpoint Therapeutics, Inc. issued a press release to provide a corporate update and to announce its financial results for the third quarter ended September 30, 2018. 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 November 2, 2018.

 

 

 

 

SIGNATURES

 

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

 

Date: November 2, 2018 Checkpoint Therapeutics, Inc.  
  (Registrant)  
       
       
       
  By:  /s/ James F. Oliviero  
    James F. Oliviero  
    President and Chief Executive Officer  

  

 

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Section 2: EX-99.1 (EXHIBIT 99.1)

Exhibit 99.1

 

 

Checkpoint Therapeutics Reports Third Quarter 2018 Financial Results and Recent Corporate Highlights

 

New York, NY – November 2, 2018 – Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2018.

 

“In the third quarter of 2018, we announced positive interim safety and efficacy data from our ongoing Phase 1/2 clinical trial of CK-101, a third-generation EGFR inhibitor being evaluated in advanced non-small cell lung cancer (NSCLC), which was a significant milestone for the company,” said James F. Oliviero, President and Chief Executive Officer of Checkpoint. “Our plans remain on-track for the rest of the year as we continue enrollment to establish the optimal dose of CK-101, after which we plan to initiate a Phase 3 trial in 2019 in treatment-naïve EGFR mutation-positive NSCLC patients. We also look forward to reporting early next year interim data from the expansion cohort phase of our Phase 1 clinical trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers.”

 

Recent Corporate Highlights:

 

·In September 2018, Checkpoint announced positive interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being evaluated in advanced NSCLC. The data were presented in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer in Toronto. CK-101 was well tolerated across multiple dose groups and safe. Durable anti-tumor activity was observed, particularly in treatment-naïve EGFR mutation-positive NSCLC patients.
·In October 2018, Checkpoint appointed Christian Béchon to its Board of Directors.

 

Financial Results:

  

·Cash Position: As of September 30, 2018, Checkpoint’s cash and cash equivalents totaled $29.6 million, compared to $19.2 million at December 31, 2017, an increase of $10.4 million year-to-date.
·R&D Expenses: Research and development expenses for the third quarter of 2018 were $7.8 million, compared to $5.0 million for the third quarter of 2017, an increase of $2.8 million.

 

 

 

 

·G&A Expenses: General and administrative expenses for the third quarter of 2018 were $1.5 million, compared to $1.3 million for the third quarter of 2017, an increase of $0.2 million.
·Net Loss: Net loss attributable to common stockholders for the third quarter of 2018 was $9.3 million, or $0.32 per share, compared to a net loss of $5.9 million, or $0.26 per share, for the third quarter of 2017.

 

About Checkpoint Therapeutics

Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, CK-101, in a Phase 1/2 clinical trial for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). In addition, Checkpoint is currently evaluating its lead antibody product candidate, CK-301, an anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in a Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers. Checkpoint is headquartered in New York City. 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 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 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 Contact:

Jaclyn Jaffe

Checkpoint Therapeutics, Inc.

(781) 652-4500

[email protected]

 

Investor Relations Contact:

Jeremy Feffer

Managing Director, LifeSci Advisors, LLC

(212) 915-2568

[email protected]

 

Media Relations Contact:

Tony Plohoros

6 Degrees

(908) 940-0135

[email protected]

 

 

 

  

CHECKPOINT THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands, except share and per share amounts)

  

   September 30, 2018   December 31, 2017 
   (Unaudited)     
ASSETS          
Current Assets:          
Cash and cash equivalents  $29,600   $19,225 
Prepaid expenses and other assets   1,196    1,857 
Other receivables - related party   5    331 
Total current assets   30,801    21,413 
Total Assets  $30,801   $21,413 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current Liabilities:          
Accounts payable and accrued expenses  $8,118   $5,762 
Accounts payable and accrued expenses - related party   664    610 
Total current liabilities   8,782    6,372 
Total Liabilities   8,782    6,372 
           
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 September 30, 2018 and December 31, 2017   1    1 
Common shares,  26,996,238 and 18,512,429 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively   3    2 
Common stock issuable, 0 and 591,836 shares as of September 30, 2018 and December 31, 2017, respectively   -    2,296 
Additional paid-in capital   105,793    71,772 
Accumulated deficit   (83,778)   (59,030)
Total Stockholders’ Equity   22,019    15,041 
Total Liabilities and Stockholders’ Equity  $30,801   $21,413 

 

 

 

 

CHECKPOINT THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)

 

   For the three months ended September 30,   For the nine months ended September 30, 
   2018   2017   2018   2017 
Revenue - related party  $5   $349   $475   $1,393 
                     
Operating expenses:                    
Research and development   7,848    4,955    20,233    14,165 
General and administrative   1,544    1,344    5,090    4,064 
Total operating expenses   9,392    6,299    25,323    18,229 
Loss from operations   (9,387)   (5,950)   (24,848)   (16,836)
                     
Other income                    
Interest income   43    22    100    77 
Total other income   43    22    100    77 
Net Loss  $(9,344)  $(5,928)  $(24,748)  $(16,759)
                     
Loss per Share:                    
Basic and diluted net loss per common share outstanding  $(0.32)  $(0.26)  $(0.89)  $(0.74)
                     
Basic and diluted weighted average number of common shares outstanding   29,249,035    22,801,229    27,698,323    22,533,315 

 

 

 

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