On August 11, 2022 F-star Therapeutics, Inc. (NASDAQ: FSTX) ("F-star" or the "Company"), a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, reported second quarter 2022 financial results and corporate highlights (Press release, F-star, AUG 11, 2022, View Source [SID1234618117]).

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"During the second quarter, we steadfastly remained focused on advancing our four clinical programs," said Eliot Forster, CEO of F-star Therapeutics, Inc., "We continued the enrollment for the FS118 study in PD-1 acquired resistance head and neck cancer patients and have cleared the initial futility hurdle. The dose-escalation study for FS222 continues to progress well, and we are happy to report that therapy remains well-tolerated and clinically active at pharmacologically active dose levels, including in patients with low levels of PD-L1 expression. We also initiated the combination study of FS120 with KEYTRUDA in patients with advanced cancers and we look forward to evaluating the potential clinical benefits of the combined therapies. Dose escalation of SB 11285 continues. Both the monotherapy and combination with atezolizumab remain well tolerated."

Second Quarter 2022 and Recent Highlights:

F-star planned acquisition by invoX Pharma: As previously disclosed, on June 22, 2022, the Company entered into a definitive agreement to be acquired by invoX Pharma Limited, a wholly owned subsidiary of Sino Biopharmaceutical Limited (HKEX 11771.HK), for $7.12 per share for an approximate total equity value of $161 million in cash. Subject to the satisfaction of customary closing conditions, including regulatory approvals, the transaction is expected to close in the second half of 2022.
License Agreement with Takeda to develop and commercialize a novel next-generation immuno-oncology bispecific antibody therapeutic: Under the terms of the agreement, F-star will grant Takeda a worldwide, exclusive royalty-bearing license to research, develop, and commercialize a bispecific antibody against an immuno-oncology target using F-star’s proprietary Fcab and mAb2 platforms. Takeda will be responsible for all research, development, and commercialization activities under the agreement.
FS118 in acquired resistance head and neck Phase 2 interim update: FS118 appeared to be well tolerated in line with Phase 1 results and has cleared the pre-determined futility hurdle for the initial stage of the head and neck acquired resistance cancer trial. We believe that we are on track to achieve the predefined efficacy levels and are pleased to be observing long-term clinical benefit for patients. The enrollment of the patients for the remainder of the study continues well, paving the way for combination therapy in this hard-to-treat patient population.
FS222 Phase 1 clinical trial update: The monotherapy dose-escalation progresses well. FS222 has demonstrated emerging clinical antitumor activity with a tolerability profile typical of checkpoint inhibitors and elicits dose-dependent increases in soluble CD137 and PD-L1 levels, indicative of target engagement and increases in immune cell activation and proliferation.
FS120 Initiation of KEYTRUDA combination dosing: Pharmacologically active dose levels have been reached and we have initiated dose escalation of FS120 in combination with Keytruda.
FS118 poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting demonstrating a novel LAG-3 reduction and shedding mechanism: Data revealed that the unique tetravalent structure of FS118 plays a critical role in evoking LAG-3 shedding, and cell surface reduction, in tumor-infiltrating lymphocytes (TILs), enabling FS118 to overcome compensatory upregulation of LAG-3 induced by PD-(L)1 blockade.
Second Quarter 2022 Financial Summary:

Cash Position
Cash and cash equivalents were $53.0 million as of June 30, 2022, compared to $78.5 million at December 31, 2021.

R&D Expense
R&D expenses were $8.7 million for the quarter ended June 30, 2022, compared to $8.3 million for the corresponding quarter in 2021. The $0.4 million increase is primarily due to an increase of $2.9 million in clinical trial costs, $0.9 million of R&D consulting, staff and other R&D costs, offset by the UK R&D tax credit of $3.4 million, which is treated as a reduction in expense.

G&A Expense
G&A expenses were $7.5 million for the quarter ended June 30, 2022, compared to $6.5 million for the second quarter 2021. This $1.0 million increase is primarily due to $2.5 million in transaction related costs, offset by reductions of $1.0 million of non-transaction related legal and professional fees, $0.4 million in stock-based compensation expense and $0.1 million in other G&A expense.

Net Loss Attributable to Common Shareholders
Net loss was $19.0 million or a loss per share of $0.88 (basic and diluted) for the quarter ended June 30, 2022, as compared to a net loss of $15.5 million or a loss per share of $0.91 (basic and diluted) for the quarter ended June 30, 2021.

Conference Call and Webcast:

F-star will not be hosting a conference call to discuss Q2 2022 financial results or corporate update in light of the pending transaction with invoX Pharma announced on June 23, 2022.