8-K
false000156637300015663732021-11-102021-11-10

 

 

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 10, 2021

 

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(s)

 

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 (§ 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 10,2021, F-star Therapeutics, Inc. (“F-star”) issued a press release announcing its financial results for the third quarter ended September 30, 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.

Item 7.01 Regulation FD Disclosure.

A slide presentation to be used by F-star’s management in connection with its discussions with investors regarding F-star’s financial results for the three and nine months ended September 30, 2021 is included in Exhibit 99.2 to this Current Report on Form 8-K and is being furnished in accordance with Regulation FD of the Securities and Exchange Commission.

The information in this Current Report on Form 8-K, including the exhibits furnished pursuant to Item 2.02 and 9.01, shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities under that Section. Furthermore, the information in this Current Report on Form 8-K, including the exhibits furnished pursuant to Item 2.02 and 9.01 shall not be deemed to be incorporated by reference into the filings of F-star under the Securities Act. Unless filed under Item 8.01, disclose under this item only information that the registrant elects to disclose through Form 8-K pursuant to Regulation FD (17 CFR 243.100 through 243.103).

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 November 10, 2021

99.2

 

Slides dated November 10, 2021

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Filed herewith.

 

2


 

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 thereunto duly authorized.

 

 

 

 

F-STAR THERAPEUTICS, INC.

 

 

 

 

Date: November 10, 2021

 

 

/s/ Darlene Deptula-Hicks

 

 

 

Name: Darlene Deptula-Hicks

 

 

 

Title: Chief Financial Officer

 

3


EX-99.1

Exhibit 99.1

https://cdn.kscope.io/6e97fe889169ceb7369edf47bc6cb029-img222233780_0.jpg 

 

F-star Therapeutics Reports Third Quarter 2021 Financial Results

and Provides Corporate Update

 

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

 

CAMBRIDGE, United Kingdom and CAMBRIDGE, Mass., November 10, 2021 (GLOBE NEWSWIRE) - F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation bispecific immunotherapies to transform the lives of patients with cancer, today announced third quarter 2021 financial results and a corporate update.

 

Eliot Forster, CEO of F-star Therapeutics, Inc., said, “A year on from listing on NASDAQ, we have delivered on our planned milestones, and through them value for patients, partners and our investors. Our agile, tenacious approach, working with world-leading investigators, continues to further F-star’s mission to bring our unique bispecific antibodies to patients who need them most. We continue to advance four clinical programs, initiate validating partnerships and execute our financial plan. This past quarter included a number of clinical updates and significant new partnerships with AstraZeneca and Janssen Biotech. I’m proud of the team paving the way with huge passion and dedication to make real the promise of next generation immunotherapies.”

 

The Company continues to advance FS118, F-star’s first-in-class bispecific antibody targeting LAG-3 and PD-L1, in checkpoint inhibitor relapsed head and neck cancer and in checkpoint inhibitor naïve patients with non-small cell lung cancer (NSCLC) and diffuse large B cell lymphoma (DLBCL), with a clinical trial in the latter two populations currently being initiated. FS120, F-star’s first-in-class dual-agonist, bispecific antibody targeting CD137 and OX40, remains on track in the clinic, having completed the accelerated dose titration phase, with presentations at ESMO 2021 and SITC 2021. SB 11285, a second-generation STimulator of INterferon Gene (STING) agonist, continues to advance well in the clinic, further to the update provided in the second quarter of 2021. FS222, the potentially best-in-class bispecific targeting PD-L1 and CD137, is also progressing well in the clinic.

 

The Company also announced during the third quarter significant new partnerships with both AstraZeneca PLC and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, leveraging our platform technology. With four clinical-stage programs in progress, F-star is focused on the further development of its wholly-owned pipeline of tetravalent bispecific antibodies, as well as collaborations that have the potential to bring value to shareholders and patients alike.

 

THIRD QUARTER 2021 AND RECENT HIGHLIGHTS

 

FS118 development expanded following external clinical validation of the LAG-3 target: The expansion of the FS118 clinical development into checkpoint naïve, biomarker enriched NSCLC and DLBCL patients will broaden the clinical reach of this exciting LAG-3 & PD-L1 targeting bispecific antibody. This adds to

 


 

the already ongoing checkpoint inhibitor relapsed head and neck cancer study that is anticipated to report data in mid-2022.

 

Combination of FS120 with KEYTRUDA: In August, F-star announced a clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (MSD) to evaluate the combination of FS120, F-star’s first-in-class dual-agonist bispecific antibody targeting CD137 and OX40, with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy. FS120 has completed the accelerated dose titration phase in monotherapy with no safety concerns identified, and the pharmacokinetics were in line with expectations. The Company continues dose escalation to determine an optimal dosing regimen to initiate the KEYTRUDA combination.

 

AstraZeneca licenses STING inhibitors: In July, F-star entered into an exclusive licensing agreement with AstraZeneca plc under which AstraZeneca received global rights to research, develop and commercialize next generation STING inhibitor compounds. AstraZeneca was granted exclusive access to F-star’s novel preclinical STING inhibitors and will be responsible for all future research, development and commercialization of the STING inhibitor compounds. This forms part of the second CVR agreement with the former shareholders of Spring Bank Pharmaceuticals, Inc. (Spring Bank). F-star retains rights to all STING agonists currently in clinical development for patients with cancer.

 

SB 11285 Phase 1 interim update: In July, F-star provided an interim update on the safety, tolerability and pharmacokinetics of its intravenously administered novel STING agonist, alone and in combination with atezolizumab. SB 11285 appeared to be well tolerated both alone and in combination across all dose levels tested to-date, including five dose levels as monotherapy and three dose levels as a combination. The Part 1a/1b study database lock (as defined in the first CVR agreement with Spring Bank’s former shareholders) has been completed. Based on the positive emerging clinical data, further dose escalations are ongoing, and a further clinical update is planned for the second half of 2022.

 

Johnson and Johnson licenses five new programs, based on platform technology: Under the terms of the license and collaboration agreement, F-star will grant Janssen Biotech 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.

 

THIRD QUARTER 2021 FINANCIAL SUMMARY

 

Cash and cash equivalents as of September 30, 2021, were $71.1 million, compared to $18.5 million as of December 31, 2020. The up-front payment of $17.5 million in connection with the license and collaboration agreement with Janssen Biotech is expected to be received in the fourth quarter of 2021.

 

Research & Development (R&D) expenses were $5.1 million for the quarter ended September 30, 2021, compared to $5.3 million for the corresponding quarter in 2020, which included non-cash stock-based compensation expense of $1.1 million and $1.1 million, respectively.

 

General & Administrative (G&A) expenses were $5.2 million for the quarter ended September 30, 2021, compared to $7.3 million for the third quarter of 2020, which included non-cash stock-based compensation expense of $0.4 million and $59,000, respectively.

 

 


 

Net loss was $10.8 million, or a loss per share of $0.52 (basic and diluted), for the quarter ended September 30, 2021, compared to a net loss of $3.5 million, or a loss per share of $1.88 (basic and diluted), for the quarter ended September 30, 2020.

 

CONFERENCE CALL AND WEBCAST

F-star will host a conference call today, November 10, 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 date of the call and may be accessed in the Investors & News section of the F-star Therapeutics website under Events and Presentations.

 

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 (IO) therapeutics in the clinic, each directed against some of the most promising IO targets. 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 companies targeting the significant unmet needs across several disease areas, including oncology, immunology, and the central nervous system. For more information visit www.f-star.com 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, the expected timing and potential outcomes of the reporting by F-star of key clinical data from its programs, 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, that 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, that the anticipated benefits and potential of F-star’s collaboration with AstraZeneca and Janssen Biotech may not be achieved, 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 most recent Annual Report on Form 10-K, subsequent 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.

 

 

 


 

F-star Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(in thousands)

 

 

 

September 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

 

 

Unaudited

 

 

 

 

Cash and cash equivalents

 

$

71,050

 

 

$

18,526

 

Prepaid and other current assets

 

 

5,111

 

 

 

7,539

 

Other assets

 

 

38,637

 

 

 

37,544

 

   Total assets

 

$

114,798

 

 

$

63,609

 

 

 

 

 

 

 

 

Term debt

 

$

9,535

 

 

$

 

Accounts payable and other current liabilities

 

 

8,835

 

 

 

16,977

 

Other liabilities

 

 

6,350

 

 

 

3,638

 

  Total liabilities

 

 

24,720

 

 

 

20,615

 

Total stockholders’ equity

 

 

90,078

 

 

 

42,994

 

  Total liabilities and stockholders' equity

 

$

114,798

 

 

$

63,609

 

 

F-star Therapeutics, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share data)

Unaudited

 

 

 

For the Three Months Ended
September 30,

 

 

For the Nine Months Ended
September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License revenue

 

$

751

 

 

$

9,195

 

 

$

3,668

 

 

$

11,093

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

   Research and development

 

 

5,113

 

 

 

5,321

 

 

 

20,536

 

 

 

10,695

 

   General and administrative

 

 

5,239

 

 

 

7,261

 

 

 

18,169

 

 

 

13,805

 

     Total operating expenses

 

 

10,352

 

 

 

12,582

 

 

 

38,705

 

 

 

24,500

 

Loss from operations

 

 

(9,601

)

 

 

(3,387

)

 

 

(35,037

)

 

 

(13,407

)

Other non-operating (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

  Other income (expense)

 

 

(746

)

 

 

506

 

 

 

230

 

 

 

(1,164

)

  Change in fair value of convertible debt

 

 

 

 

 

(446

)

 

 

 

 

 

(2,330

)

  Change in fair value of contingent value rights

 

 

(444

)

 

 

 

 

 

(1,027

)

 

 

 

    Loss before income taxes

 

 

(10,791

)

 

 

(3,327

)

 

 

(35,834

)

 

 

(16,901

)

Income tax expense

 

 

 

 

 

(124

)

 

 

(190

)

 

 

(171

)

Net loss

 

$

(10,791

)

 

$

(3,451

)

 

$

(36,024

)

 

$

(17,072

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to common shareholders

 

$

(10,791

)

 

$

(3,451

)

 

$

(36,024

)

 

$

(17,072

)

Basic and diluted adjusted net loss per common shares

 

$

(0.52

)

 

$

(1.88

)

 

$

(2.35

)

 

$

(9.34

)

Weighted-average number of shares outstanding, basic and diluted

 

 

20,617,822

 

 

 

1,832,194

 

 

 

15,300,433

 

 

 

1,828,597

 

 

 

 

 


 

For further information, please contact:

 

For investor inquiries
Lindsey Trickett
VP Investor Relations & Communications
+1 240 543 7970
lindsey.trickett@f-star.com 

 

For media inquiries
Helen Shik
Shik Communications LLC
+1 617 510 4373
Shik.Helen10@gmail.com 

 

 


Slide 1

Q4 2021 Next Generation Immunotherapies. Overcoming Cancer.  Exhibit 99.2


Slide 2

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, those provided in F-star’s reports to the SEC. Risks and uncertainties related to F-star that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to 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. Cautionary Note Regarding Forward-Looking Statements


Slide 3

CONFIDENTIAL Three Key Pillars for Success Validated, patent protected bispecific antibody platform Platform Combining clinically proven targets Pathway Biomarker driven patient selection Patient


Slide 4

Partnerships Developing next generation immunotherapies to transform the lives of patients with cancer Key Financial Highlights* NASDAQ: FSTX Headquarters: Cambridge, UK & Cambridge, US Common Shares Outstanding: 20.6M Cash: $71.0M Working on today’s ‘hot’ IO targets, LAG-3 & CD137 (4-1BB) *as of 30th September 2021 F-star at a Glance


Slide 5

Progression of FS118 Phase 2 POC CPI resistant trial and CPI naïve trial Progression of FS120 & FS222 in Phase 1 trials Progression of SB 11285 in Phase 1 trial CONFIDENTIAL A Year of Delivery Pipeline: Significant Progress on Clinical Programs Bringing Potential New Treatment Options to Patients Clinical demonstration of unique bispecific mechanism eg LAG-3 cleavage Platform validation and monetization through large pharma partnerships with Janssen, AZ and Merck KGaA Platform: Validated through Publications & Pharma Deals Strengthening our position as the only company able to leverage Fc antigen binding through US and European Composition of Matter grants Patents: Intellectual Property Unlocking greater potential through NASDAQ listing with average pricing target of ~$30 Strong financial position Financing: Transformation to Strong Public Company


Slide 6

Experienced Management Team Successful, experienced team with 20 approved drugs Three decades experience in the pharmaceutical and biotechnology industries Senior leadership roles  in drug development Eliot Forster CEO, PhD MBA Medical oncologist with 25+ years' experience in clinical research in Europe and US Experience in registrational studies, registration strategy and drug approval  Louis Kayitalire  CMO, MD 20+ years' experience in antibody engineering and drug discovery  Advanced novel platforms from inception to clinical proof of concept in oncology Neil Brewis CSO, PhD DSc 25+ years leading financial operations in public and private companies Proven track record in finance strategy, capital raising, M&A and strategic partnerships Darlene Deptula-Hicks CFO, MBA


Slide 7

Unique Bispecific Structure Natural human antibody format with only 15-20 amino acid substitutions Easy to make and well tolerated to date 2 natural binding sites 2 new Fc antigen binding (Fcab) sites FcR null for improved safety potential Tetravalency Drives Differentiated MoA Crosslinking: Potent tetravalent binding (avidity) bringing cells together Clustering: Fcabs drive potent immune cell activation Conditionality: Strong localized antitumor effect Differentiated Bispecific Platform


Slide 8

CONFIDENTIAL Advantages Over Other Approaches F-star mAb2 Traditional Antibody and Combinations Heterodimeric Bispecific Antibody Alternative Scaffold Bispecific Fragment Bispecific incl BITEs Tetravalent crosslinking Conditionality Potent, efficient clustering IgG-like structure 2 natural binding sites 2 new Fc antigen binding (Fcab) sites FcR null


Slide 9

Patent portfolio leveraged for BD Licensed to Denali, Janssen & Merck KGaA Only company able to leverage the potency of Fc antigen binding Strong Intellectual Property Estate Pipeline Products FS118:  Composition of matter until at least 2037  Dosing regimes and patient selection pending  FS120: Composition of matter until at least 2039 pending FS222: Composition of matter until at least 2039 pending SB 11285: Composition of matter until at least 2037  Platform Protection 500+ granted and pending patents


Slide 10

Proprietary and Partnered Pipeline CPI = Checkpoint Inhibitor Program Targets (Mechanism of action) Opportunity Preclinical Phase 1 Phase 2 Phase 3 FS118 LAG-3/PD-L1 (Dual inhibitor) Rescuing CPI treatment  failures Improving outcomes in CPI naïve FS222 CD137/PD-L1 (Stimulator/inhibitor) Improving outcomes in PD-L1 low tumors FS120 OX40/CD137 (Dual stimulator) Improving CPI and chemotherapy outcomes SB 11285 STING pathway (Stimulator) Improving CPI outcomes Preclinical programs Undisclosed Addressing unmet need INITIATING Program Partner Preclinical Early Clinical Late Clinical Blood Brain Barrier Programs Multiple Immuno-oncology Programs STING Inhibitor Multiple Next Generation Bispecifics Merck KGaA, Darmstadt DNL310 Potential Partnership Value Over $2.2B Potential Partnership Value Over $2.2B


Slide 11

Four Differentiated Clinical Programs FS120 Improving CPI and chemotherapy outcomes CONDITIONAL OX40/CD137 (4-1BB) DUAL STIMULATOR FS118 Rescuing CPI-treatment failures & improving outcomes in CPI naïve LAG-3/PD-L1 DUAL INHIBITOR Tetravalent Bispecific mAb2 FS222 Improving outcomes in PD-L1 low tumors CD137(4-1BB) STIMULATOR/PD-L1 INHIBITOR CPI = Checkpoint Inhibitor Cyclic Dinucleotide SB 11285 Improving CPI outcomes 2ND GENERATION STING AGONIST Phase 1 trial in solid tumors MSD clinical supply agreement in place for pembrolizumab PoC trial in head & neck PD-1 acquired resistance patients CPI-naïve NSCLC & DLBCL trial Differentiated patient selection biomarker strategy Phase 1 trial in solid tumors  Differentiated patient selection biomarker strategy Monotherapy and PD-L1 (atezo) combination trial  Dose escalation and pursuing strategic business development opportunities


Slide 12

Near Term Expected Clinical Data Milestones Financed for Multiple Clinical Milestones H2 2021 H1 2022 H2 2022 H2 2023 H1 2023 FS222 FS120 SB 11285 FS118 Business Development Additional Ph 1 data Ph 1a/b including Tecentriq combination update Update on dose escalation Safety, biomarker and preliminary efficacy data Safety update to support initiation of PK/PD expansion cohorts Update on accelerated dose titration Safety & biomarker update & initiation of Keytruda cohorts Agreement with MSD for supply of Keytruda Initial safety data from Ph 1 combinations Preliminary data from Ph 2 PoC trial in PD-(L)1 acquired resistance patients Initial data from DLBCL CPI-naïve trial Completion of PoC trial Licence agreement with AstraZeneca Completed Estimated readout Initial data from NSCLC CPI-naïve trial Licence agreement with Janssen


Slide 13

FS118 Rescuing CPI-treatment failures & improving outcomes in CPI naïve LAG-3 PD-L1


Slide 14

FS118: Profound Immune Activation through LAG-3 Shedding LAG-3 PD-L1 T cell Human PBMC cell assay PD-L1+ Tumor cell PD-L1 driven LAG-3 shedding & removal of LAG-3 from cell surface FS118 Phase 1 data: Soluble LAG-3 in serum


Slide 15

FS118 Clinical Strategy - Building Opportunity CPI = Checkpoint Inhibitor CPI resistant Rationale Benefits Value Superior to PD-1 alone CPI-naïve, PD-1 sensitive tumors Rescuing PD-1 treatment failures Acquired resistance Avoiding PD-1 resistance by preventing LAG-3 upregulation while inhibiting PD-L1 Overcoming PD-1 resistance by inducing LAG-3 shedding while inhibiting PD-L1 Market expansion (NSCLC & DLBCL) Potential for fast registration path (H&N) CPI naïve


Slide 16

FS118 Clinical Development Plan Preliminary data Mid-2022 Ph I: First in Human Monotherapy dose escalation Complete n = 43 Heavily pre-treated all comers Confidence to launch Phase 2 proof of concept trial Safety, RP2D, Biomarkers Post PD-(L)1 Key Takeaways: Ph 2: PD-1 Resistant SCCHN (Biomarker enriched) Proof of concept On-going n = ~35 Patient population with unmet medical need with potential to enable a rapid registration pathway Disease Control Rate, Overall Response Rate PD-1 relapsed Ph 2: NSCLC & DLBCL (Biomarker enriched) Dose expansion Initiating n = 60+ Preventing resistance in PD-1 sensitive patients Overall Response Rate, Duration of Response CPI naive 59% DCR in PD-(L)1 acquired resistant patients Clinical benefit observed in tumors co-expressing LAG-3/PD-L1 Patient with >2 years survival ongoing Well tolerated up to 20 mg/kg with RP2D of 10 mg/kg Novel anti-LAG-3 shedding mechanism Initiating Q4 2021


Slide 17

CD137 PD-L1 FS222 Improving outcomes in PD-L1 low tumors


Slide 18

CONFIDENTIAL Tetravalent mAb2 Activity Superior to Combination/Monotherapy Tetravalent bispecific mAb2 observed to potently synergize PD-1/PD-L1 pathway inhibition with CD137 agonism Mouse MC38 Tumor Model 1mg/kg (approx. 12 mice/group) Activity also observed in CT26 model 100% Tumor-free


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FS222: Potent PD-L1 Driven CD137 Agonism CD137 PD-L1 FS222: High affinity to PD-L1 drives crosslinking. Low affinity (but high avidity) to CD137 avoids self-competition Competitors: High affinity to PD-L1 and CD137 promotes monospecific binding and less crosslinking and activation PD-L1+ Tumor cell Human Primary CD8 Activation Assay (FS222 has no hook effect) FS222: Strong activation & no hook effect FS222 outperforms other bispecifics in multiple human primary immune cell assays Ref: Lakins et al, FS222, a Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is Designed for Optimal CD137 Interactions Resulting in Potent T cell Activation Without Toxicity, AACR 2021 Other Formats: Lower activation & hook effect Immune cell


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FS222 Phase 1 Study Design: Seamless & Adaptive Updates late 2021 & H2 2022 PART A PART B PART C Cohort expansion Planned Dose escalation & PK/PD expansion Confidence to proceed to indication specific expansion n = 50+ On-going Safety, PK/PD, Biomarkers, Preliminary Efficacy n = 25+ Colorectal n = 25+ Ovarian n = 25+ NSCLC (biomarker selected) n = 25+ Not disclosed Overall Response Rate, Duration of Response Proof of concept Combination cohorts Planned n = TBD Overall Response Rate, Duration of Response Proof of concept Indications and combination molecules based on results from part B


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OX40 CD137  FS120 Improving CPI and chemotherapy outcomes


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FS120: First in Class Dual Agonist with Broad Potential For Combination Tumor cell Destabilizes Tregs Treg Improving anti-tumor immune response* by “Triple Activation” Activates CD8+ and NK effector cells Increases CD4+ cell helper activity Destabilizes Tregs T cell helper activity Cytotoxic T cell activity CD4+ T cell CD8+ & NK T cell CD137 OX40 * in preclinical models FS120 + anti-PD-1 combination (CT26) FS120 + chemo combination (CT26)


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FS120: Phase 1 Study Design Safety and biomarker update H2 2022 PART A Initiate H2 2022 PART B PART C Determination of pharmacologically active dose Select FS120 dose in combination with pembrolizumab dose regimen​ Proof of concept​ Monotherapy dose escalation On-going PD-1 combo dosing frequency and dose escalation Planned Planned Combination dose expansion n = 40+ n = ~30 n = 25+ n = 25+ n = 25+ NSCLC (subset) Head & Neck Bladder Safety, PK/PD, Biomarkers Safety, PK/PD, Biomarkers Overall Response Rate, Duration of Response


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STING agonist SB 11285 Improving CPI outcomes STING = Stimulator of Interferon Genes


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SB 11285 Elicits Robust Antitumor Activity Following IV Administration Tumor cell Bridging the gap between innate and adaptive immunity: Durable antitumor responses via activation of Antigen Presenting Cells (APCs) Cytotoxic T cells NK cells CD8+ T cell & NK cell Antigen presentation & Type I IFN secretion drives T cell priming, proliferation and infiltration Cytotoxic T cell activity and NK cell activation SB 11285 administered IV inhibited tumor growth B16 Melanoma Model STING SB 11285 Activation and maturation of dendritic cells Tumor cell apoptosis & release of cancer antigens SB 11285 Tumor derived DNA cGAS cGAMP STING IRF-3 cytokines


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SB 11285 Phase 1 Study Design Key Takeaways: SB 11285 well tolerated alone and with atezolizumab across all dose levels to date Heavily pre-treated tumors with some early evidence of disease control PK profile aligns with expected immune cell uptake Biomarker data encourages further dose escalation Second generation STING agonist for intravenous administration Preclinical studies indicate potential advantages over intra-tumoral STING agonists First generation STING agonists had poor membrane permeability and weak activity Part 1a Part 1b Continued Dose Escalation Additional data Mid-2022 Confidence to continue combination dose escalation Monotherapy dose escalation Complete n = 20 n = 13 Complete PD-L1 combo dose escalation Confidence to initiate combination dose escalation Safety, Biomarkers Safety, Biomarkers Dose escalation On-going n = 20+ Determination of maximum tolerated dose and biomarkers in monotherapy and PD-L1 combination Safety, Biomarkers, RP2D


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CONFIDENTIAL FSTX – A Stellar Investment Opportunity © 2020 F-star. All rights reserved Validation of differentiated platform & pipeline with big pharma alliances Platform Four ongoing clinical programs with multiple data readouts in next 24 months Pipeline Broad patent portfolio protecting platform & pipeline Patent Strong balance sheet and support from top-tier biotech investors Financing


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CONFIDENTIAL F-star Potential Next Generation Immunotherapies


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Thank you.