On May 10, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Cellectar Biosciences, MAY 10, 2022, View Source [SID1234614111]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

First Quarter and Recent Corporate Highlights

Announced that an independent data monitoring committee (DMC) has completed its planned futility/efficacy assessment of the company’s pivotal Phase 2b study of iopofosine in Waldenstrom’s macroglobulinemia (WM) and unanimously recommended continuation of the trial as planned. The DMC is an independent committee of clinical research experts charged with the review of data from the company’s ongoing pivotal trial. The DMC assessment was based on a pre-specified futility analysis within the first 10 patients as defined in the study protocol.

Announced the appointment of two key executives to its commercial team: Matthew Hagan as vice president marketing and strategic alliances and David Lasecki as executive director, strategic alliances.
"The unanimous agreement of the independent DMC that the pre-specified futility analysis for our pivotal Phase 2b trial of iopofosine I-131 in WM was achieved represents an important milestone," said James Caruso, president and CEO of Cellectar. "We look forward to continuing iopofosine’s clinical development and remain appreciative of the strong support by the patient advocacy groups, community clinicians and WM academic thought leadership as we collectively partner to treat this orphan designated cancer. In multiple myeloma, we continue to enrich our CLOVER-1 trial and are optimistic that iopofosine I-131 will help to address an unmet medical need in this indication."

First Quarter 2022 Financial Highlights

Cash and Cash Equivalents: As of March 31, 2022, the company had cash and cash equivalents of $30.6 million, compared to $35.7 million as of December 31, 2021. Net cash used in operating activities during the three months ended March 31, 2022 was approximately $5.0 million. The company believes its cash on hand is adequate to fund basic budgeted operations for at least 12 months from the filing of the first quarter 2022 financial statements.

Research and Development Expense: R&D expense for the three months ended March 31, 2022 was approximately $3.9 million, compared to approximately $4.6 million for the three months ended March 31, 2021. The overall decrease in R&D expense of approximately $746,000 was primarily the result of a reduction in clinical project costs of approximately $1.5 million, partially offset by an increase in manufacturing and related costs related to production sourcing, general research and development costs resulting from an increase in personnel, and pre-clinical project costs.

General and Administrative Expense: G&A expense for the three months ended March 31, 2022 was $2.3 million, compared to $1.7 million for the same period in 2021. The overall increase in G&A expense of $527,000 was primarily driven by an increase in professional fees and personnel costs, including stock-based compensation expense and a resumption of travel.

Net Loss: The net loss attributable to common stockholders for the quarter ended March 31, 2022 was ($6.1) million, or ($0.10) per share, compared to ($6.4) million, or ($0.13) per share, in the quarter ended March 31, 2021.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."