On March 14, 2022 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, reported full-year 2021 financial results and will provide a corporate update (Press release, F-star, MAR 14, 2022, View Source [SID1234610045]).

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"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 (Free ESMO Whitepaper) 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) (Free SITC Whitepaper) 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:

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.