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F-star Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

On May 10, 2022 F-star Therapeutics, Inc. (NASDAQ: FSTX) ("F-star" or the "Company"), a clinical-stage biopharmaceutical company dedicated to developing next-generation immunotherapies to transform the lives of patients with cancer, reported first quarter 2022 financial results and provided a corporate update (Press release, F-star, MAY 10, 2022, View Source [SID1234614110]).

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"This year is one of the most important years in F-star’s history, with data readouts expected across all four of our clinical programs, expansion of our partnering activities, and continued development of our organization," said Eliot Forster, CEO of F-star Therapeutics, Inc. "During the quarter, we increased the number of clinical sites for FS118 and FS120 by expanding beyond the US into the EU. We have also further advanced our understanding of the differentiated mechanism of FS118 in modulating LAG-3 cell surface expression. F-star continues to execute and create value for shareholders by advancing our programs and enabling our partners to develop next-generation bispecific therapeutics by leveraging the power of our discovery platform."

First Quarter 2022 and Recent Highlights:

Patients dosed in FS120 and FS118 trials in Europe, adding to the ongoing clinical activities in the US.
Appointment of James Sandy as Chief Development Officer: Mr. Sandy brings over 35 years of experience in the pharmaceutical and biotechnology industries. James brings valuable additional expertise to the team in accelerating cancer treatment programs through early and late-stage development that will greatly benefit our clinical development strategy.
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 tetravalent and unique structure of FS118 plays a critical role in evoking LAG-3 shedding and cell surface reduction by tumor-infiltrating lymphocytes (TILs), enabling FS118 to overcome compensatory upregulation of LAG-3 induced by PD-(L)1 blockade.
Fourth licensing option exercised by Merck KGaA, Darmstadt, Germany: 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.
IP portfolio expansion with the issuance of U.S. patent further protecting FS118: United States Patent and Trademark Office (USPTO) has granted a patent protecting the composition of matter of FS118, F-star’s 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 out to at least August 2038.
Participation in investor conferences: The management team participated in four investor conferences in the first quarter.
Anticipated 2022 Program Milestones:

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.
Clinical update on the Phase 1 trial of FS120 and initiation of the combination with Merck’s pembrolizumab.
Clinical update of the dose-escalation study of SB 11285.
First-Quarter 2022 Financial Update

Cash Position
Cash and cash equivalents were $68.8 million as of March 31, 2022, compared to $78.5 million at December 31, 2021.

Research & Development Expense
Research & Development (R&D) expenses were $8.0 million for the quarter ended March 31, 2022, compared to $7.1 million for the corresponding quarter in 2021. This increase of $0.9 million in R&D expense is primarily due to increased CRO costs as more patients are enrolled in clinical studies, increased R&D staff related costs primarily to support clinical operations, offset by a reduction in manufacturing costs.

General & Administrative Expense
General & Administrative (G&A) expenses were $5.7 million for the quarter ended March 31, 2022, compared to $6.4 million for the first quarter 2021. The $0.7 million decrease is primarily due to a decrease in stock compensation expense, and legal and professional costs due to costs incurred in the comparative period for work in relation to the share exchange transaction with Spring Bank Pharmaceuticals. These decreases were offset by increases in facilities-related costs and information technology costs.

Net Loss Attributable to Common Shareholders
Net loss attributable to common shareholders was $12.1 million or $0.57 per share, for the quarter ended March 31, 2022, as compared to a net loss of $9.7 million or $1.07 per share for the quarter ended March 31, 2021.

Conference Call and Webcast

F-star will host a conference call today, May 10, 2022, at 9:00 a.m. EDT.

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 Investor & News/Events and Presentations section of the F-star Therapeutics website.

Inhibikase Therapeutics to Participate at the H.C. Wainwright Global Investment Conference

On May 10, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported that Dr. Milton Werner, Ph.D., the Company’s President & Chief Executive Officer will present at the upcoming H.C. Wainwright Global Investment Conference being held in Miami Beach, FL on May 25, 2022 at 2:30 pm ET (Press release, Inhibikase Therapeutics, MAY 10, 2022, View Source [SID1234614109]).

Agenus Corporate Update and First Quarter 2022 Financial Report

On May 10, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported financial results for the first quarter 2022 (Press release, Agenus, MAY 10, 2022, View Source [SID1234614108]).

"In the current challenging environment for the biotech industry, we are prioritizing our most promising clinical programs, including botensilimab combinations, as well as preclinical programs with the highest potential for engagement from collaborators," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "Needless to say, we are also taking decisive steps to contain costs across the board despite our reasonable cash position."

Botensilimab, Agenus’ innate and adaptive immune stimulator, to advance to Phase 2

Present updated data from our ongoing development program in the 3rd quarter.
Phase 2 clinical studies to commence in colorectal, melanoma, and pancreatic cancers.
All trials designed to demonstrate superiority to other immunotherapies and/or other standards of care.
In addition, trials are designed to show benefit in cold tumors in combination with chemotherapy.
AGEN1571 clinical trials to commence; preclinical data presented at AACR (Free AACR Whitepaper)

Agenus’ first myeloid-targeting agent.
Overcomes the suppression of anti-tumor response via the ILT2 pathway which drives resistance to CTLA-4 and PD-1 directed therapies.
Rationale is further validated by the durable clinical responses achieved in PD-1 resistant cancers with an ILT4 antagonist discovered by Agenus and licensed to Merck.
Provides advantages in enhanced activation of T, NK and NKT cells and a superior ability to switch myeloid cells to a pro-inflammatory state.
Phase 1 study to commence.
Milestone payment received from Gilead for the clinical advancement of AGEN2373 targeting CD137

Another key pathway for antitumor immunity with enhancement of T cell and NK cell proliferation, cytokine secretion, and cellular cytotoxicity.
Phase 1b combination study with botensilimab ongoing in melanoma patients who have relapsed or are refractory to prior anti-PD-1 therapy.
Gilead has an exclusive option to license AGEN2373, while Agenus can opt-in for a 50:50 profit share and US co-commercialization rights.
Agenus received $5M milestone payment with up to $570 million in future potential option fees and milestones.
First Quarter 2022 Financial Results

We ended our first quarter 2022 with a cash and short-term investment balance of $263 million as compared to $307 million on December 31, 2021.

We recognized revenue of $26 million for the quarter ended March 31, 2022, which represents an increase of $14 million from the $12 million reported for the same quarter in 2021. Both numbers include revenue related to non-cash royalties earned, revenue recognized under our collaboration agreements, and in 2022, milestones received.

Net loss for the quarter ended March 31, 2022, was $51 million which includes non-cash expenses of $21 million compared to a net loss for the same period of 2021 of $54 million which includes non-cash expenses of $20 million. Per share losses were $0.19 in the first quarter of 2022 as compared to per share losses of $0.27 in the first quarter of 2021.

Cash used in operations for the three months ended March 31, 2022, was $52 million up from $43 million for the quarter ended March 31, 2021. The company has initiated cost containment measures with expected reductions in operating expenses in coming quarters.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

Neogene Therapeutics Announces Approval of Clinical Trial Application for its First Phase 1 Trial of Novel, Fully-Individualized TCR Therapy to Treat Advanced Solid Tumors

On May 10, 2022 Neogene Therapeutics, Inc., a global biotechnology company focused on discovering, developing, and manufacturing novel, transformative TCR therapies targeting neoantigens in solid cancers, reported the approval of the company’s first Clinical Trial Application (CTA) by the Dutch regulatory authority for a Phase 1 study of NT-125, an autologous, fully-individualized, multi-specific TCR therapy for the treatment of advanced solid tumors (Press release, Neogene Therapeutics, MAY 10, 2022, View Source [SID1234614107]). The Phase 1 study will enroll adult patients with various types of advanced solid tumors in partnership with the Netherlands Cancer Institute (NKI), an internationally acclaimed research institute and leading cancer clinic.

This authorization and transition to a clinical-stage company marks a significant milestone for Neogene and reinforces our ambition to make an impact on patients with advanced solid cancers with a novel, fully-individualized therapy," said Carsten Linnemann, Ph.D., President, Chief Executive Officer, and Co-Founder of Neogene. "At this new stage of growth, we remain focused on advancing our unique pipeline of fully-individualized and shared neoantigen TCR therapies with the goal of changing the paradigm of solid cancer treatment."

NT-125 is an investigational, autologous, fully-individualized, multi-specific TCR therapy targeting neoantigens for the treatment of advanced solid tumors. NT-125 is designed to contain up to five distinct neoantigen-specific TCRs per patient in a single cell product of highly functional engineered T cells, allowing multiple neoantigens presented by HLA class I and HLA class II molecules to be targeted with the goal to create a more impactful TCR therapy for more patients. NT-125 aims to reduce the probability of antigen escape and potentially maximize the depth and durability of clinical responses in a patient population with difficult to treat tumors and high unmet need.

"Patients with recurrent and metastatic solid tumors currently have a high unmet need and limited effective treatment options. We look forward to evaluating the safety and clinical activity of NT-125 as a potential new treatment option for this patient population," said Dr. Raphael Rousseau, M.D., Ph.D., Chief Medical Officer of Neogene. "Neogene’s approach to T cell therapy allows us to develop a fully-individualized treatment with a unique set of up to five specific TCR genes for each patient that may overcome the current limitations of cell therapies for solid cancers."

Quanterix Corporation Releases Operating Results for First Quarter 2022

On May 10, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported financial results for the three months ended March 31, 2022 (Press release, Quanterix, MAY 10, 2022, View Source [SID1234614106]).

"This is a pivotal time for growth in neurology and therapeutics, marked by breakthroughs in some of the world’s biggest health threats, including Alzheimer’s disease and multiple sclerosis (MS)," said Masoud Toloue, Chief Executive Officer, Quanterix. "I’m excited for the opportunity to lead Quanterix through this next chapter, and looking ahead, we’ll focus on several transformational changes around scaling with quality, innovation, and our ability to translate ultra-sensitive biomarker detection to help researchers and pharmaceutical companies drive earlier disease detection, better prognoses, and enhanced treatment methods."

Toloue continued, "Q1 revenue was in line with our expectations and full-year goals; however, gross margin fell well short of our expectations. As part of our larger goal of scaling with quality, we are implementing specific changes to our inventory management and quality processes, which we expect will improve our gross margins going forward."

First Quarter 2022 Financial Highlights

Key financial results for the first quarter of 2022 are shown below:

•Q1 total revenue was $29.6M versus prior year Q1 of $27.2M(1), an increase of 9%;
•Q1 product revenue was $20.7M versus prior year Q1 of $18.2M, an increase of 13%;
•Q1 service and other revenue was $8.8M versus prior year Q1 of $6.4M, an increase of 37%; and
Q1 gross margin was 49.3% versus prior year Q1 gross margin of 60.1%.

(1)Q1 2021 total revenue includes $2.3M in RADx-related grant revenue.

First Quarter Business Highlights

§Quanterix announced new agreements with Lilly to advance Alzheimer’s disease diagnosis and treatment; the agreements provide Quanterix access to Lilly’s P-tau217 antibody technology to create pathways for plasma-based biomarkers for use in Alzheimer’s disease and establishes framework for future collaboration and supports development of Quanterix tests to advance diagnosing and treating life-threatening diseases. Quanterix recognized $2.7M in service revenue during the first quarter of 2022 under these agreements.
§Quanterix received funding from the Alzheimer’s Drug Discovery Foundation (ADDF) to accelerate Alzheimer’s disease diagnostic plasma test development; the funding will power a series of prospective clinical trials to validate Quanterix’ multi-analyte test in collaboration with Amsterdam University Medical Centers (Amsterdam UMC).
§Quanterix’ Simoa technology powered a major breakthrough in Epstein-Barr Virus and MS, which was featured in the Journal of Science.

•Academic publication pull-through performance continued to be strong; Quanterix’ Simoa technology was highlighted in a record 151 new publications in the first quarter 2022, bringing total Simoa-specific inclusions to over 1,735.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on May 10, 2022 at 8:30 a.m. EST. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following Conference ID: 4589034.

A live webcast will also be available at: View Source You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.