On May 10, 2022 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update for the quarter ended March 31, 2022 (Press release, Transgene, MAY 10, 2022, View Source [SID1234614123]).

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Over the first quarter of 2022, all of Transgene’s preclinical and clinical assets progressed in line with expectations. All clinical-stage immunotherapies are slated to deliver data by the end of the year.

Key events of the period and upcoming news flow

TG4050

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 annual meeting, held in New Orleans, LA, April 8-13, Transgene discussed new preliminary positive data on TG4050, its individualized cancer vaccine. These immunological and clinical data highlight the potential of this highly innovative neoantigen vaccine.

A poster on the progress of the two ongoing Phase I trials of TG4050 has been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place in Chicago, IL, June 3-7, 2022. More information will be provided on May 27, 2022, after the release of the abstracts by ASCO (Free ASCO Whitepaper).

An article on the two ongoing trials with TG4050 was also published in the Journal for ImmunoTherapy of Cancer [[1]]. The publication demonstrated that it is possible to develop a patient specific vaccine within a few weeks for patients with a low to moderate tumor mutational burden.

BT-001

Promising preclinical data with BT-001 were presented at AACR (Free AACR Whitepaper) 2022 and published in the Journal for ImmunoTherapy of Cancer [[2]] demonstrating the broad and robust antitumor activity of this Invir.IO oncolytic virus.

Transgene and BioInvent will provide an update on the progress of the clinical trial of BT-001 in Q2 2022. Initial Phase I results will be presented at a scientific conference in H2 2022. These first results aim to establish the tolerability of BT-001 and to determine the dose and administration schedule for further development.

Invir.IO collaboration with PersonGen BioTherapeutics

Transgene announced the launch of a preclinical collaboration with PersonGen BioTherapeutics. This collaboration aims to evaluate the feasibility and efficacy of a combination therapy against solid tumors, combining PersonGen’s CAR-T cell injection with an oncolytic virus from the Invir.IO platform.

Governance

Transgene plans to reinforce its corporate governance by separating the roles of Chairman and CEO. Transgene’s Board of Directors has proposed Dr. Alessandro Riva, MD, as the Non-executive Chairman of the Company. If this nomination is accepted at the upcoming General Shareholder Meeting (May 25, 2022), the roles of Chairman and CEO will be separated. With 30 years of experience in the Life Sciences industry, Dr. Riva will be working closely with Transgene’s CEO Hedi Ben Brahim to realize the potential of the Company’s technology platforms and products to benefit cancer patients.

Transgene’s Board of Directors also proposed the appointment of Prof. Jean‑Yves Blay (subject to the authorization of the public authority to which he reports) and Laurence Espinasse as directors.

Steven Bloom joined Transgene as Vice President, Chief Business Officer (CBO). In this position, he has become a member of the executive committee, leading global business development strategy, alliance management and program management. In particular, he is focused on building the profile of Transgene in the US, where he is based, as part of establishing the Company as a world leader in virus-based immunotherapies.

Transgene also announced that the date of the release of the first half 2022 financial results and of the interim report has been advanced to September 7, 2022.

Summary of key ongoing clinical trials and expected milestones

myvac

TG4050

Phase I

NCT03839524

Targets: tumor neoantigens

ü Codeveloped with NEC

ü New positive data in first patients demonstrating the immunogenicity of the vaccine as well as first signs of clinical activity presented at AACR (Free AACR Whitepaper) 2022

Ü Additional data on the 2 trials expected at ASCO (Free ASCO Whitepaper) (June 2022) and H2 2022

Ovarian cancer – after surgery and first-line chemotherapy

ü Trial ongoing in the USA and in France

ü Patient enrollment progressing in line with forecast

TG4050

Phase I

NCT04183166

HPV-negative head and neck cancer – after surgery and adjuvant therapy

ü Trial ongoing in the UK and in France

ü Patient enrollment progressing in line with forecast

TG4001

+ avelumab
Phase II

NCT03260023

Targets: HPV16 E6 and E7 oncoproteins

Recurrent/metastatic anogenital HPV-positive – 1st (patients ineligible for chemotherapy) and 2nd lines

ü Randomized Phase II trial comparing the combination of TG4001 with avelumab versus avelumab alone

ü Active patient enrollment in Europe (France and Spain), trial initiated in the USA

Ü Results of the interim analysis expected in Q4 2022 (N≈50)

Invir.IO

BT-001

Phase I/IIa

NCT04725331

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

ü Co-development with BioInvent

ü Very encouraging preclinical results presented at AACR (Free AACR Whitepaper) 2022

ü Trial ongoing in France, Belgium and approved in the USA

Ü Update on clinical trial expected in Q2 2022

Ü First Phase I clinical results to be presented at a scientific congress in H2 2022

TG6002

Phase I/IIa

NCT03724071

Payload: FCU1 for the local production of a 5-FU chemotherapy

Gastro-intestinal cancer (colorectal cancer for Phase II) – Intravenous (IV) administration

ü Multicenter trial ongoing in Belgium, France and Spain

ü Proof-of-concept data of the IV administration presented in 2021 (ESMO & AACR (Free AACR Whitepaper))

ü Dose escalation completed to the maximum projected dose (3×109 pfu), confirming the good safety profile. Assessment of this intensified administration schedule ongoing

Ü End of Phase I expected mid-2022

TG6002

Phase I/IIa

NCT04194034

Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) administration

ü Multicenter trial ongoing in the UK and in France

ü Ongoing enrollment of patients from the latest dose escalation cohort (109 pfu)

Ü First data expected mid-2022

During the first quarter of 2022, revenue from collaborative and licensing agreements was mainly composed of revenue from the collaboration with AstraZeneca.

As of March 31, 2022, government financing for research expenditures mainly consisted of accrual of 25% of the research tax credit expected for 2022 (€1.7 million in the first quarter of 2022 compared to €1.5 million for the same period in 2021).

Cash, cash equivalents and other financial assets

Cash, cash equivalents and other financial assets stood at €46.8 million as of March 31, 2022, compared to €49.6 million as of December 31, 2021. In the first quarter of 2022, Transgene’s net cash burn was €2.8 million, compared to €7.2 million for the same period in 2021. This decrease is notably linked to the receipt in January 2022 of the $8 million payment from AstraZeneca following the exercise of a first license option in December 2021 for an oncolytic virus developed by Transgene.

The Company holds shares of Tasly BioPharmaceuticals valued at €18.9 million at the end of December 2021.

The Company has a financial visibility through the end of 2023.

On May 10, 2022 Boston Pharmaceuticals, a clinical stage biopharmaceutical company, reported the appointment of Dr. Sophie Kornowski as Chair of its Board of Directors and Acting Chief Executive Officer, effective immediately (Press release, Boston Pharmaceuticals, MAY 10, 2022, View Source [SID1234614139]). Dr. Kornowski succeeds interim Co-CEOs Dr. Joanne T. Beck and Dr. Craig T. Basson, who will continue in their positions as Chief Operations Officer and Chief Medical Officer, respectively. Since 2018, Sophie Kornowski has been a partner at Gurnet Point Capital, a private investment firm focused on the healthcare sector. In this role, she has worked closely with the Boston Pharmaceuticals team for several years, as a member of the Board of Directors and, at the request of the Board, has recently supported Corporate Development efforts.

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"We are very pleased that Sophie has accepted our invitation to lead Boston Pharmaceuticals into the next phase of its growth trajectory, which includes continued expansion and progress of the pipeline, and the development of a strategy for long-term evolution," said Stefan Meister, the current Chairman of Boston Pharmaceuticals and Vice Chairman of the B-Flexion investment group, which owns the company. "Boston Pharmaceuticals, greatly inspired by our legacy in innovative pharma and biotech, is an important investment for B-Flexion and we look forward to Sophie leading the company into its next phase of growth."

Sophie Kornowski said: "I have worked closely with the Boston Pharmaceuticals team for several years, and it is a great honor to expand my role at this exciting time for the company. Along with the rest of the board and management team, my focus will be upon building the company’s successful history of in-licensing differentiated molecules and developing them in a focused and nimble fashion. I am looking forward to leveraging the firm’s strong organizational capability, diverse pipeline and existing and future financial backing to build a sustainable, best-in-class growth biotech that will provide medicines for many patients in need of new options."

In her position at Gurnet Point Capital, Dr. Kornowski has been a successful investor in several innovative start-ups and high growth businesses that have products in the clinic or commercializing, in diseases such as Attention Deficit Disorder Hyperactivity, Cancer and Food Allergy.

Prior to joining Gurnet Point Capital, she was Executive Vice-President of Roche Partnering and member of the Extended Corporate Executive Committee of F. Hoffmann-La Roche AG, one of the world’s largest healthcare companies, and board member of Chugai Pharmaceuticals. In that role, working closely with R&D and Commercial teams at Roche and Genentech, she was responsible for the Partnering and the M&A strategy with Biotechs, Pharma, HealthTech and Research Institutions worldwide for Roche. Previously, Dr. Kornowski had led the largest affiliate of F. Hoffmann-La Roche outside of the US, based in France for many years. Earlier in her career, she held several leadership commercial roles across geographies in leading innovative pharmaceutical and diagnostic companies in France, Israel and the US. Dr. Kornowski holds an MBA from the University of Chicago Booth and a Doctorate in Pharmacy from Paris Descartes University.

On May 10, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the first quarter 2022 (Press release, Sana Biotechnology, MAY 10, 2022, View Source [SID1234614076]).

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"In the first quarter, we made significant progress in moving toward clinical trials for programs across our multiple platforms including the ex vivo hypoimmune allogeneic CAR T (SC291) and in vivo fusogen CAR T (SG295) programs, and we remain on track to file INDs for both of these programs this year," said Steve Harr, Sana’s President and Chief Executive Officer. "In addition to advancing these programs, we continue to make progress across our earlier pipeline, including SC451, our hypoimmune stem-cell derived pancreatic islet cell therapy for patients with type 1 diabetes, and multiple product candidates in our CAR T portfolio. Our people, broad set of technologies, and strong balance sheet enable us to pursue this ambitious pipeline."

Continued progress in building Sana’s hypoimmune ex vivo platform and in vivo fusogen platform with presentations at multiple conferences

Hypoimmune ex vivo platform: Presented preclinical data demonstrating that hypoimmune CAR T cells were able to evade both the innate and adaptive arms of the immune system in animal models while retaining their antitumor activity at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

In vivo fusogen platform: Scheduled to present preclinical data regarding hypoimmune pancreatic islet cells, generation of hypoimmune allogeneic regulatory T cells, retargeted fusosomes for in vivo delivery to T cells, fusosome-targeted gene transfer to human hepatocytes, and a novel vector copy number assay at the 2022 American Society of Gene & Cell Therapy meeting later in May.
Expanded Sana’s CAR T capability to potentially develop best-in-class, broadly accessible CAR T cell therapies

Entered into an exclusive agreement with the National Institutes of Health (NIH) for worldwide commercial rights to the NIH’s CD22 chimeric antigen receptor with a fully-human binder. This CAR construct has shown efficacy in several clinical studies, including in CD19 CAR T cell therapy failures. Targeting both CD19 and CD22 with an "off-the-shelf" product, whether in combination with Sana’s hypoimmune platform or fusogen platform, offers the potential of higher and more durable complete response rates in earlier-stage patients as well as in patients that have previously failed an autologous CD19 CAR T cell therapy.

Entered into a non-exclusive agreement with IASO Biotherapeutics and Innovent Biologics for commercial rights to a clinically validated fully-human B cell maturation antigen (BCMA) CAR construct, which Sana intends to incorporate into both the company’s ex vivo hypoimmune allogeneic and in vivo fusogen platforms for the treatment of multiple myeloma.
First Quarter 2022 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of March 31, 2022 were $657.4 million compared to $746.9 million as of December 31, 2021. The decrease of $89.5 million was primarily driven by cash used in operations of $77.7 million and cash used for the purchase of property and equipment of $7.5 million. Cash used in operations includes $6.2 million of upfront license payments related to licensing CD22 and BCMA as well as multiple cash payments that will not recur this year.

Research and Development Expenses: For the three months ended March 31, 2022, research and development expenses, inclusive of non-cash expenses, was $72.7 million compared to $41.9 million for the same period in 2021. The increase of $30.8 million was due to an increase in personnel expenses related to increased headcount to expand Sana’s research and development capabilities, increased costs for third-party manufacturing, laboratory supplies, facility and other allocated costs, and costs to acquire technology complementary to our own. Research and development expenses include non-cash stock-based compensation of $5.7 million and $2.7 million for the three months ended March 31, 2022 and 2021, respectively.

Research and Development Related Success Payments and Contingent Consideration: For the three months ended March 31, 2022, we recognized a non-cash gain of $55.4 million in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate, compared to expenses of $127.1 million for the same period in 2021. The value of these potential liabilities can fluctuate significantly with changes in our market capitalization and stock price.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2022, inclusive of non-cash expenses, were $14.4 million compared to $11.8 million for the same period in 2021. The increase of $2.6 million was primarily due to increased personnel-related expenses attributable to an increase in headcount to support our continued research and development activities. General and administrative expenses include stock-based compensation of $2.0 million and $1.5 million for the three months ended March 31, 2022 and 2021, respectively.

Net Loss: Net loss for the three months ended March 31, 2022 was $31.4 million, or $0.17 per share, compared to $180.6 million, or $1.52 per share, for the same period in 2021.
Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the three months ended March 31, 2022 was $82.0 million compared to $48.9 million for the same period in 2021. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, cash outflows from business development activities, and the purchase of property and equipment.

Non-GAAP Net Loss: Non-GAAP net loss for the three months ended March 31, 2022 was $86.9 million, or $0.47 per share, compared to $53.6 million, or $0.45 per share, for the same period in 2021. Non-GAAP net loss excludes certain one-time costs to acquire technology and non-cash expenses related to the change in the estimated fair value of contingent consideration and success payment liabilities.
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."

On May 10, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the first quarter of 2022 and provided a corporate update (Press release, Aclaris Therapeutics, MAY 10, 2022, View Source [SID1234614092]).

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"We have continued to progress our clinical programs, including activating multiple clinical sites in our Phase 2b trial of ATI-1777 in subjects with moderate to severe atopic dermatitis," said Dr. Neal Walker, President and CEO of Aclaris. "We look forward to advancing all of our clinical and preclinical programs."

Research and Development Highlights:

Clinical Programs

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:
Currently being developed as a potential treatment for immuno-inflammatory diseases

ATI-450-RA-202: This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) is ongoing.
Aclaris expects topline data in 2023.

ATI-450-HS-201: This Phase 2a trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of zunsemetinib (50 mg twice daily) in subjects with moderate to severe hidradenitis suppurativa (HS) is ongoing.
Aclaris expects topline data in the first half of 2023.

ATI-450-PsA-201: Aclaris expects to activate clinical sites in the coming weeks in this Phase 2a trial of zunsemetinib (50 mg twice daily) in subjects with moderate to severe psoriatic arthritis.
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor:
Currently being developing as a potential treatment for moderate to severe atopic dermatitis (AD)

ATI-1777-AD-202: Aclaris activated multiple clinical sites in May 2022 in this Phase 2b trial to determine the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate to severe AD. In this trial, Aclaris will explore multiple concentrations of twice daily treatment with ATI-1777 and a single concentration of once daily treatment with ATI-1777, in patients 12 years and older.
Aclaris expects topline data in the first half of 2023.
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor:
Currently being developed as a potential treatment for T cell-mediated autoimmune diseases

ATI-2138-PKPD-101: This Phase 1 single ascending dose (SAD) trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-2138 in healthy subjects is ongoing.
Aclaris expects topline data in 2022.

If the Phase 1 SAD trial is successful, Aclaris currently plans to initiate a two-week Phase 1 multiple ascending dose trial of ATI-2138 in subjects with psoriasis in 2022. Aclaris is also currently exploring alternative indications to the planned indication that are relevant to the mechanism of action.
Preclinical Programs

ATI-2231, an investigational oral MK2 inhibitor compound:
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer

Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long half-life.

IND-enabling studies are underway, and Aclaris expects to submit an IND by the end of 2022.
Discovery Programs

Currently developing oral gut-biased JAK inhibitors with limited systemic exposure as potential treatments for inflammatory bowel disease.
Central nervous system (CNS) kinase inhibitor targets:
Currently engaged in research to identify brain penetrant kinase inhibitor candidates and assess their impact on neuronal pro-inflammatory cytokine production, microglia growth and survival, and neurodegeneration.
Other Highlights

Aclaris continues to expand its senior R&D team and recently appointed Ian Anderson, Ph.D., as Executive Vice President, Translational Research & Development, and Rob Ortmann, M.D., as Vice President, Clinical Development. Dr. Anderson brings more than 30 years of immunology research experience in drug development, from discovery through Phase 2. He previously held senior scientific leadership roles at Flame Biosciences, Janssen Pharmaceutical, MedImmune and Cambridge Antibody Technology. Dr. Ortmann is a board-certified rheumatologist with more than 10 years of clinical research experience in autoimmune-related therapeutic areas. He previously held clinical development positions at Horizon Therapeutics and Eli Lilly and Company.

Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2022, Aclaris had aggregate cash, cash equivalents and marketable securities of $204 million compared to $226 million as of December 31, 2021. Additionally, in April 2022, Aclaris sold approximately 4.8 million shares under its ATM facility for aggregate net proceeds of $73 million.

Aclaris now anticipates that its cash, cash equivalents and marketable securities as of March 31, 2022 in combination with the $73 million in net proceeds from the April 2022 ATM sale will be sufficient to fund its operations through the end of 2025, without giving effect to any additional potential business development transactions or financing activities.

Financial Results

First Quarter 2022

Net loss was $18.8 million for the first quarter of 2022 compared to $28.8 million for the first quarter of 2021.
Total revenue was $1.5 million for the first quarter of 2022 compared to $1.8 million for the first quarter of 2021.
Research and development (R&D) expenses were $14.3 million for the quarter ended March 31, 2022 compared to $7.8 million for the prior year period.
The $6.5 million increase was primarily the result of:
Higher zunsemetinib development expenses, including costs associated with clinical activities for a Phase 2b trial for RA and a Phase 2a trial for HS.
Higher ATI-1777 development expenses related to drug candidate manufacturing and other preclinical activities and start-up costs associated with a Phase 2b clinical trial.
Higher preclinical development activities related to ATI-2231.

General and administrative (G&A) expenses were $6.1 million for the quarter ended March 31, 2022 compared to $4.8 million for the prior year period.
The $1.3 million increase was primarily the result of higher compensation-related costs, including stock-based compensation, due to increased headcount and the impact of new equity awards granted during the first quarter of 2022.
Revaluation of contingent consideration resulted in a $1.2 million credit for the quarter ended March 31, 2022 compared to a contingent consideration charge of $16.4 million for the prior year period.

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]).

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"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
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