On August 12, 2021 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, reported second quarter 2021 financial results and provides a corporate update (Press release, F-star, AUG 12, 2021, View Source [SID1234586419]).
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The Company today announces an expanded clinical development strategy for FS118, F-star’s first-in-class bispecific antibody targeting LAG-3 and PD-L1, into checkpoint inhibitor naïve patients. This new study with FS118 is in biomarker enriched subsets of patients with non-small cell lung cancer (NSCLC) and diffuse large B-cell lymphoma (DLBCL). By moving into earlier lines of therapy, FS118 has the potential not only to delay, but also to prevent checkpoint resistance, which could provide an alternative treatment for patients who do not see a durable benefit from currently approved immunotherapies.
In addition to the expanded FS118 clinical strategy, F-star has three other ongoing clinical stage programs. These programs are combined with a strong balance sheet, having closed an underwritten public offering of stock and its "at the market" facility during Q2, which will enable the company to deliver multiple clinical data milestones. At the end of the second quarter the company had over $80 million in cash and cash equivalents. In the past quarter, F-star has also delivered on clinical and business development objectives, specifically the recent interim Phase 1 update on SB 11285 and the announcement of two major collaborations, a licensing agreement with AstraZeneca Plc for STING inhibitors and a supply agreement with MSD (Merck & Co., Inc., Kenilworth, NJ, USA) to evaluate the combination of FS120, F-star’s first-in-class dual-agonist, tetravalent, bispecific antibody targeting CD137 and OX40, with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy.
Eliot Forster, CEO of F-star Therapeutics, Inc., said, "I’m happy to share today the expansion of the FS118 clinical development program into checkpoint naïve patients. By targeting LAG-3, which was recently externally validated in the clinic as an important target, and PD-L1 simultaneously, we believe FS118 has the opportunity to improve patient outcomes over those seen with first generation immunotherapies. We also continue to focus on the checkpoint inhibitor refractory patient population in our ongoing FS118 proof-of-concept study in head and neck cancers. We are also pleased to have concluded two new collaborations, with AstraZeneca and MSD for STING antagonists and combining Keytruda with FS120, respectively.
"We believe that our strong balance sheet, expanded strategy for FS118, continuing and beneficial partnerships, along with our dedicated staff and investors, position F-star for a promising 2021 and beyond. We look forward to sharing data with you at upcoming medical conferences, including at ESMO (Free ESMO Whitepaper) next month."
SECOND QUARTER 2021 AND RECENT HIGHLIGHTS
FS118 development expansion plans following recent external clinical validation of LAG-3: Phase 3 data with LAG-3 at ASCO (Free ASCO Whitepaper) 2021, further supported F-star’s expansion of the FS118 clinical development plan into checkpoint naïve, biomarker enriched NSCLC and DLBCL patients. This study is anticipated to begin in the second half of 2021.
Strong financial position: In Q2 2021, the Company received $82.6 million in gross proceeds through the combination of an underwritten public offering of stock and use of its "at the market" facility.
FS222 Poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in 2021: In April, F-star presented a poster at AACR (Free AACR Whitepaper) 2021 entitled ‘FS222, a Tetravalent Bispecific Antibody Targeting CD137 and PD-L1, is Designed for Optimal CD137 Interactions Resulting in Potent T cell Activation Without Toxicity’. This poster and the associated data showcased the differentiation of FS222 from competitor molecules and highlighted the importance of ‘tuning’ for both the affinity and avidity of bispecific antibodies.
Combination of FS120 with KEYTRUDA: Last week, F-star announced a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Kenilworth, NJ, USA), to evaluate the combination of FS120, F-star’s first-in-class dual-agonist tetravalent bispecific antibody targeting CD137 and OX40, with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy.
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 contingent value rights (CVR) agreement entered into in connection with the transaction with Spring Bank Pharmaceuticals, Inc., has been completed. Based on the positive emerging clinical data, further dose escalations are ongoing and a further clinical update is planned for 2022.
SB 11285 in Nature publication and composition of matter patent granted in the US: F-star published on its second-generation STING agonist, SB 11285, in the April 2021 issue of Nature Communications. The study, entitled ‘STING enhances cell death through regulation of reactive oxygen species and DNA damage’ demonstrated that systemic administration of a STING agonist in combination with radiation in a preclinical model enhances local control in Head and Neck Squamous Cell Carcinoma (HNSCC) and suggests that STING expression in the tumor is required for maximal therapeutic benefit. The US Patent Office granted a patent during the quarter with claims protecting the composition of matter of F-star’s SB 11285 molecule giving protection until 2037.
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 Stimulator of Interferon Genes (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. F-star retains rights to all STING agonists, currently in clinical development for patients with cancer. This agreement is subject to the second CVR with the former shareholders of Spring Bank Pharmaceuticals.
SECOND QUARTER 2021 FINANCIAL SUMMARY
Cash and cash equivalents as of June 30, 2021, were $81.6 million, compared to $18.5 million at December 31, 2020.
Research & Development (R&D) expenses were $8.4 million for the quarter ended June 30, 2021, compared to $2.1 million for the corresponding quarter in 2020. The $6.3 million increase was primarily related to manufacturing costs and clinical costs with four programs now in the clinic versus one clinical program in Q2 2020.
General & Administrative (G&A) expenses were $6.5 million for the quarter ended June 30, 2021, compared to $3.2 million for the second quarter of 2020. This $3.3 million increase in G&A expense was primarily due to increased non-cash stock-based compensation expense, legal and professional fees and costs associated with operating as a public company.
Net loss was $15.6 million or a loss per share of $0.92 (basic and diluted), for the quarter ended June 30, 2021, compared to a net loss of $6.5 million or a loss per share of $3.53 (basic and diluted) for the quarter ended June 30, 2020.
CONFERENCE CALL AND WEBCAST
F-star will host a conference call today, August 12, 2021, beginning at 9:00 AM EDT. To join the webcast, go to our website. To join by phone, participants may dial 1-833-471-0868 in the US/Canada or 1-914-987-7751 for International calls or 0800 0288438 or 0203 1070289 for the United Kingdom, at least 10 minutes prior to the start of the call.
A recording of the conference call will be available on the ‘Events & Presentations’ section of the Company’s website at www.f-star.com from August 13, 2021.