0001193125-22-074097.txt : 20220314 0001193125-22-074097.hdr.sgml : 20220314 20220314080901 ACCESSION NUMBER: 0001193125-22-074097 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220314 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220314 DATE AS OF CHANGE: 20220314 FILER: COMPANY DATA: COMPANY CONFORMED NAME: F-star Therapeutics, Inc. CENTRAL INDEX KEY: 0001566373 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 522386345 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37718 FILM NUMBER: 22735127 BUSINESS ADDRESS: STREET 1: 35 PARKWOOD DRIVE STREET 2: BABRAHAM RESEARCH CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB22 3AT BUSINESS PHONE: 44 1223 497400 MAIL ADDRESS: STREET 1: 35 PARKWOOD DRIVE STREET 2: BABRAHAM RESEARCH CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB22 3AT FORMER COMPANY: FORMER CONFORMED NAME: Spring Bank Pharmaceuticals, Inc. DATE OF NAME CHANGE: 20130108 8-K 1 d282563d8k.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): March 14, 2022

 

 

F-STAR THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware

   001-37718  

52-2386345

(State or other jurisdiction

of incorporation)

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

 

Eddeva B920 Babraham Research Campus
Cambridge, United Kingdom
CB22 3AT
(Address of principal executive offices)

+44-1223-497400

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)

  

(Trading

Symbol)

  

(Name of each exchange

on which registered)

Common stock, $0.0001 par value   FSTX  

The Nasdaq Stock Market

(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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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 March 14, 2022, F-star Therapeutics, Inc. issued a press release announcing its financial results for the year ended December 31, 2021 and providing a business update. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

 

(d)

Exhibits

The following exhibit is furnished with this report:

 

Exhibit
Number		   

Description

99.1    Press release dated March 14, 2022.
104    Cover Page Interactive Data File (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.

 

    F-STAR THERAPEUTICS, INC.  
Date: March 14, 2022    

/s/ Darlene Deptula-Hicks

  
    Name: Darlene Deptula-Hicks  
    Title: Chief Financial Officer  
EX-99.1 2 d282563dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

F-star Therapeutics Reports Full-Year 2021 Financial Results and Provides Corporate Update

Multiple Clinical Program Updates Expected in 2022

Continued Expansion of Leading Bispecific Antibody IP Estate

Two New Significant Partnerships with Janssen and AstraZeneca

Company to Host Conference Call Today at 9 a.m. EST

CAMBRIDGE, United Kingdom and CAMBRIDGE, Mass., March 14, 2022 (GLOBE NEWSWIRE) -- F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer, today announced full-year 2021 financial results and will provide a corporate update.

“Bispecifics have come of age, and F-star is exceptionally well positioned in this field with our unique tetravalent bispecific platform,” said Eliot Forster, Chief Executive Officer of F-star Therapeutics. “With all four of our clinical programs poised to generate clinical data later this year, F-star is now entering a period with multiple, data-driven inflection points, each of which has the potential to be transformative to our company. Reaching these important readouts is possible as a result of diligence, tenacity and execution by the F-star team. During 2021, we successfully navigated the challenges of COVID-19 to advance our clinical programs, secured two new partnerships, closed a significant financing, strengthened our patent portfolio, and added even more depth and experience to our leadership team. We want to thank investors, our staff, partners and patients and look forward to continuing our important work together this year and beyond.”

Highlights:

FS222 Trial-in-Progress update at ESMO Immuno-Oncology Congress 2021: The clinical study (Part A) comprised an Accelerated Dose Titration (ADT) component, followed by a 3+3 dose escalation and dose-expansion cohorts. FS222 targets CD137 (4-1BB) and PD-L1 in patients with advanced malignancies. Part B consists of tumor-specific efficacy expansion cohorts. The ADT component of Part A was completed successfully, and identification of optimal patient groups, dose and schedule is ongoing. FS222 is a potentially best in class bispecific antibody targeting CD137 and PD-L1 and is designed to improve treatment outcomes in patients with cancer, including those with low PD-L1 tumors. FS222 is currently in Part A of a Phase 1 study that will assess safety, PK/PD, biomarkers and preliminary efficacy.

FS120 poster presented at the Society for Immunotherapy of Cancer (SITC) 2021 Conference highlighting the benefits of triple immune activation: FS120 in combination with anti-PD-1 (pembrolizumab) was shown to enhance T cell activity in multiple human primary immune assays. In combination with an anti-PD-1, FS120 surrogate increased antitumor efficacy in a mouse tumor model with pharmacodynamic changes related specifically to T cell activation, when compared to monotherapies supporting the development of FS120 in combination with Keytruda in patients with cancers that are resistant to checkpoint inhibitor therapy. FS120 is a first-in-class conditional OX40/CD137 (4-1BB) dual stimulator bispecific antibody which has been designed to improve check point inhibitor (CPI) and chemotherapy outcomes. FS120 is currently in Part A of a Phase 1 trial as a monotherapy in patients with solid tumors to determine the optimal pharmacologically active dose. Part B of the Phase 1 study will evaluate FS120 in combination with Merck’s KEYTRUDA® (pembrolizumab) and will assess safety, PK/PD, and biomarker data.                

Further strengthening of patent protection with the issuance of U.S. Patent to protect FS118: United States Patent and Trademark Office (USPTO) has granted a patent protecting the composition of matter of FS118, a tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors. U.S. Patent No. 11,214,620 is entitled “Binding Molecules Binding PD-L1 and LAG-3“and is expected to provide F-star with exclusivity for FS118 until at least August 2038.

Additional partnership validation and potential revenue through Merck KGaA, Darmstadt, Germany exercising a Fourth Licensing Option: Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will be responsible for all future development and commercialization costs of the bispecific program and will pay future success-based milestones and royalties on any net sales resulting from programs covered by the agreement.

License Agreement with Janssen to Develop and Commercialize Multiple Next Generation Bispecific Antibody Therapeutics: Under the terms of the agreement, F-star will grant Janssen a worldwide, exclusive royalty-bearing license to research, develop, and commercialize up to five novel bispecific antibodies directed to Janssen therapeutic targets using F-star’s proprietary Fcab™ and mAb2™ platforms. Janssen will be responsible for all research, development, and commercialization activities under the agreement. F-star is entitled to receive potential future milestones of up to $1.35 billion.

Anticipated Program Milestones:

In 2022:

 

  •  

A clinical efficacy readout of FS118 in PD-1 acquired resistance head and neck cancer patients who have failed checkpoint therapies.

 

  •  

Clinical update on FS222 Phase 1 trial.

 

  •  

Program update on the Phase 1 trial of FS120.

 

  •  

FS120 trial part B initiation, in combination with Merck’s pembrolizumab.

 

  •  

Program update of the dose-escalation study of SB 11285, a next-generation intravenously administered novel STING agonist.

Full-Year 2021 Financial Update

Cash Position

Cash and cash equivalents totalled $78.5M for the year ended December 31, 2021, compared to $18.5M for the year ended December 31, 2020. The increase in cash and cash equivalents was driven primarily by proceeds from our ATM and equity financing, debt financing and collaboration revenue, offset by the Company’s operational needs during 2021.

R&D Expense

R&D expense was $28.8M for the year ended December 31, 2021, compared to $14.1 M for the 2020 year-end. The increase in R&D expense was due primarily to the expansion of our FS118 clinical trial into acquired resistance head & neck patients, as well as our CPI naïve trial in NSCLC and DLBCL, a full year of spend on the mono and combo SB11285 clinical trial, and continued progression of our FS120 and FS222 clinical programs.

G&A Expense

G&A expenses were $23.1M for the year ended December 31, 2021, compared to $19.5M for the full year 2020. This increase is primarily due to a $2.4M increase in stock-based compensation expense, $1.6M increase in public company Directors & Officers insurance for a full year, $1.0M in facilities and IT costs, offset by a $1.4M reduction in legal and professional fees and G&A staff costs.

Net Loss Attributable to Common Shareholders

Net loss attributable to common shareholders was $31.3million or ($1.88) per share, for the year ended December 31, 2021, as compared to a net loss of $25.6 million or ($9.69) per share for the year ended December 31, 2020.

Conference Call and Webcast

F-star will host a conference call today, March 14, 2021, beginning at 9:00 a.m. EST.

To access the call, participants may join via a live webcast on the Investors & News section of the F-star Therapeutics website, under Events and Presentations. To join by phone, participants may dial the following numbers at least 10 minutes prior to the start of the call:

 

US/Canada:    1-833-471-0868
International:    1-914-987-7751
United Kingdom:    800 0288438 or 0203 1070289

A replay of the conference call will be available for 90 days from the call and may be accessed in the Investors & News/Events and Presentations section on the F-star Therapeutics website.

About F-star Therapeutics, Inc.

F-star Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer. F-star is pioneering the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in cancer therapy. The Company has four second-generation immuno-oncology therapeutics in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive intellectual property estate. F-star has over 500 granted patents and pending patent applications relating to its platform technology and product pipeline. The Company has attracted multiple partnerships with biopharma targeting significant unmet needs across several disease areas, including oncology, immunology, and CNS.

For more information visit our website and follow us on LinkedIn and Twitter.

FORWARD LOOKING STATEMENTS

Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. F-star undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. In some cases, you can identify forward-looking statements by terminology such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the cash balances of F-star, the ability of F-star to remain listed on the Nasdaq Capital Market, F-star’s status as a clinical stage immuno-oncology company and its need for substantial additional funding in order to complete the development and commercialization of its product candidates, that F-star may experience delays in completing, or ultimately be unable to complete, the development and commercialization of its product candidates, that F-star’s clinical trials may fail to adequately demonstrate the safety and efficacy of its product candidates, that preclinical drug development is uncertain, and some of F-star’s product candidates may never advance to clinical trials, that results of preclinical studies and early stage clinical trials may not be predictive of the results of later stage clinical trials, that F-star relies on patents and other intellectual property rights to protect its product candidates, and the enforcement, defense and maintenance of such rights may be challenging and costly, and that F-star faces significant competition in its drug discovery and development efforts.

New factors emerge from time to time and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in F-star’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the SEC. Forward-looking statements included in this communication are based on information available to F-star as of the date of this communication. F-star does not assume any obligation to update such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

For investor inquiries:

Lindsey Trickett

VP Investor Relations & Communications

+1 240 543 7970

lindsey.trickett@fstar.com

John Fraunces

Managing Director

LifeSci Advisors LLC

+1 917 355 2395

jfraunces@lifesciadvisors.com

For media inquiries:

Helen Shik

Shik Communications LLC

+1 617-510-4373

helen@shikcommunications.com

F-star Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(in thousands)

 

     December 31,  
     2021      2020  

Cash and cash equivalents

    $ 78,549      $ 18,526  

Prepaid and other current assets

      6,190        7,539  

Other assets

      38,282        37,544  
  

 

 

     

 

 

  

Total assets

    $ 123,021      $ 63,609  
  

 

 

     

 

 

  

Current liabilities

    $ 12,135      $ 16,977  

Other liabilities

      14,029        3,638  
  

 

 

     

 

 

  

Total liabilities

      26,164        20,615  
  

 

 

     

 

 

  

Total stockholder’s equity

      96,857        42,994  
  

 

 

     

 

 

  

Total liabilities and stockholders’ equity

    $ 123,021      $ 63,609  
  

 

 

     

 

 

  

F-star Therapeutics, Inc.

Condensed Consolidated Statement of Operations and Comprehensive Loss

(in thousands, except share and per share data)

 

     Year Ended December 31,  
     2021      2020  

License revenue

    $ 21,167      $ 11,256  

Operating expenses:

      

Research and development

      28,750        14,128  

General and administrative

      23,131        19,513  
  

 

 

     

 

 

  

Total operating expenses

      51,881        33,641  
  

 

 

     

 

 

  

Loss from operations

      (30,714 )       (22,385 ) 

Other non-operating (expense) income:

      

Other income

      1,240        152  

Interest expense

      (844 )       (1,001 ) 

Change in fair value of contingent value rights

      (1,337 )       —    

Change in fair value of convertible debt

      —          (2,386 ) 
  

 

 

     

 

 

  

Total other non-operating (expense) income, net

      (941 )       (3,235 ) 
  

 

 

     

 

 

  

Net loss before income taxes

      (31,655 )       (25,620 ) 

Income tax benefit

      372        1  
  

 

 

     

 

 

  

Net loss

      (31,283 )       (25,619 ) 
  

 

 

     

 

 

  

Basic and diluted adjusted net loss per common shares

    $ (1.88 )     $ (9.69 ) 
  

 

 

     

 

 

  

Weighted-average number of common shares outstanding, basic and diluted

      16,647,481        2,643,175  
  

 

 

     

 

 

  
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Document and Entity Information
Mar. 14, 2022
Cover [Abstract]  
Entity Address, Country GB
Amendment Flag false
Entity Central Index Key 0001566373
Document Type 8-K
Document Period End Date Mar. 14, 2022
Entity Registrant Name F-STAR THERAPEUTICS, INC.
Entity Incorporation State Country Code DE
Entity File Number 001-37718
Entity Tax Identification Number 52-2386345
Entity Address, Address Line One Eddeva B920 Babraham Research Campus
Entity Address, City or Town Cambridge
Entity Address, Postal Zip Code CB22 3AT
City Area Code 1223
Local Phone Number 497400
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
Trading Symbol FSTX
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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