On May 19, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the first quarter of 2025 and provided a corporate update (Press release, Compugen, MAY 19, 2025, View Source [SID1234653223]).

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"We continued to advance our diverse innovative clinical and early-stage pipeline," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We initiated and activated the first site in our randomized placebo-controlled trial evaluating single agent COM701 maintenance therapy in patients with relapsed platinum sensitive ovarian cancer (sub-trial 1). We are working diligently to dose the first patient and activate additional sites. In addition, we continue to advance our Phase 1 trial for GS-0321 a potential first-in-class anti-IL18BP antibody licensed to Gilead."

Dr. Cohen-Dayag continued, "We are encouraged by the progress our partner AstraZeneca is making with its rilvegostomig program which is notably the largest ongoing Phase 3 program in the TIGIT space. Rilvegostomig is a PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from COM902. AstraZeneca has increased the number of its Phase 3 trials with rilvegostomig to ten trials across lung, gastrointestinal and endometrial cancers. At the upcoming ASCO (Free ASCO Whitepaper) 2025 conference, as part of poster presentations, AstraZeneca plans to share early data for rilvegostomig in combination with the ADC Datroway in first-line advanced non-small-cell-lung cancer and in combination with chemotherapy in first-line advanced biliary tract cancer. AstraZeneca’s broad development strategy for rilvegostomig to replace existing PD(L)-1 inhibitors represents a significant potential revenue source for Compugen as we are eligible for both future milestone payments and mid-single digit tiered royalties on future sales."

Dr. Cohen-Dayag added, "Our solid financial position with a cash runway expected to fund our operations into 2027 allows us to advance our innovative clinical and early-stage pipeline. Additionally, it enables us to continue to leverage our AI/ML powered predictive computational discovery platform, UnigenTM, to accelerate our research efforts supporting our early-stage pipeline. We are also excited about the upcoming leadership changes which will come into effect in September 2025. I will assume the newly created role of Executive Chair of the Board of Directors, and Dr. Eran Ophir, currently Chief Scientific Officer, will become President and Chief Executive Officer and will join the Board of Directors. We believe this combination of leadership ensures a solid foundation for the Company’s next phase of growth."

Next Planned Milestones
•
ASCO 2025: Compugen’s partner, AstraZeneca, plans to present early data as poster presentations from two ongoing Phase 2 rilvegostomig trials:

o
First-line Dato-DXd + rilvegostomig in advanced or metastatic non-small cell lung cancer: Results from TROPION-Lung04 (cohort 5)

o
First-line rilvegostomig plus chemotherapy in advanced biliary tract cancer: Primary analysis of GEMINI-Hepatobiliary sub-study 2 (cohort A)
•
H2 2026: data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer

First Quarter 2025 Financial Highlights
Cash: As of March 31, 2025, Compugen had approximately $103.7 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities. The cash balance includes the previously reported proceeds raised through the Company’s ATM, in January and February 2025.

Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2027. This does not include any additional cash inflows. The Company has no debt.

Revenue: Compugen reported approximately $2.3 million in revenues for the first quarter ended March 31, 2025, compared to approximately $2.6 million in revenues for the comparable period in 2024. The revenues reported in the first quarter of 2025 reflect recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead. The revenues reported in the first quarter of 2024 reflect recognition of portions of the upfront payment from the license agreement with Gilead.

R&D expenses for the first quarter of 2025 were approximately $5.8 million compared with approximately $6.4 million for the comparable period in 2024.

G&A expenses were approximately $2.4 million for the first quarters of 2025 and 2024.

Net loss for the first quarter of 2025 was approximately $7.2 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $7.3 million, or $0.08 per basic and diluted share, in the first quarter of 2024.

Full financial tables are included below.

Conference Call and Webcast Information
The Company will hold a conference call today, May 19, 2025, at 8:30 AM ET to review its first quarter 2025 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On May 19, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present 16 abstracts featuring new data across its approved cancer therapies at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30 – June 3) (Press release, Astellas, MAY 19, 2025, View Source [SID1234653222]). The research underscores Astellas’ dedication as a pioneer in oncology and focus on clinical outcomes that matter to patients.

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The abstracts include new post hoc analyses of long-term overall survival (OS) data for XTANDI (enzalutamide) and two analyses for PADCEV (enfortumab vedotin), which demonstrate how these standard-of-care medicines can continue to treat patients in metastatic, non-metastatic, castration-resistant, or hormone-sensitive prostate cancer patients and unresectable, locally advanced or metastatic urothelial cancer patients, respectively.

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"At Astellas, we are dedicated to transforming cancer care through innovative treatment approaches. The data we will present at ASCO (Free ASCO Whitepaper) this year, including new long-term follow-up data for advanced prostate and bladder cancers, reflect the pioneering role we continue to play in delivering outcomes that matter to patients. We continue to push the boundaries of cancer treatment with our growing pipeline, using novel modalities and precision medicine approaches, to benefit all eligible patients now and in the future."

Highlights from Astellas at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting will include a strong focus on Overall Survival (OS) data updates, confirming the value that these therapies bring to patients:

Enzalutamide:

The ARCHES five-year follow-up OS analysis of enzalutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) will be featured in an oral presentation

In addition to the ARCHES five-year follow-up presentation, Astellas is supporting investigator-sponsored studies. Eight-year data assessing outcomes of enzalutamide vs non-steroidal anti-androgen (NSAA) in mHSPC will be presented from an independent, investigator-sponsored trial (ENZAMET) led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).

Enfortumab vedotin
Urothelial carcinoma

Two analyses of the phase 3 EV-302 study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)
Exploratory analysis of responders will be presented in an oral presentation
Poster presentation featuring long-term subgroup analysis
Bladder cancer

A systematic review and meta-analysis of surrogate endpoints in muscle-invasive bladder cancer trials will be featured in a poster presentation.

Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas
"Long-term overall survival is the gold standard endpoint in cancer research. New post hoc analysis data from the ARCHES enzalutamide trial demonstrates our mission to help patients live longer, healthier lives. We are committed to maximizing the impact of our therapies as we continue to pioneer the oncology medicines of tomorrow."

Astellas Presentations at 2025 ASCO (Free ASCO Whitepaper) Annual Meeting

Enzalutamide

Presentation Title

Lead Author

Presentation Details

ARCHES 5-year follow-up overall survival analysis of enzalutamide plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer

A. Armstrong

Type: Oral Presentation

Abstract Number: 5005

Date: June 3, 2025, 9:45am – 12:45pm CDT

Cardiovascular event risk in patients with metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone acetate in the United States

A. Bryce

Type: Poster Presentation

Abstract Number: 5041

Date: June 2, 2025, 9:00am – 12:00pm CDT

Secondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer treated with enzalutamide monotherapy: EMBARK post hoc analysis

S. Freedland

Type: Poster Presentation

Abstract Number: 5103

Date: June 2, 2025, 9:00am – 12:00pm CDT

How low do you need to go? Association between various prostate-specific antigen response measures and clinical outcomes in metastatic castration‑sensitive prostate cancer in the Veteran Health Administration data

S. Freedland

Type: Poster Presentation

Abstract Number: 5092

Date: June 2, 2025, 9:00am – 12:00pm CDT

Abiraterone acetate is associated with shorter overall survival than enzalutamide in patients with chemotherapy naïve metastatic castration-resistant prostate cancer: Real world data from the Flatiron electronic health records database

D. George

Type: E-Publication Only

Abstract Number for Publication: e17033

Secondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer (treated with enzalutamide plus leuprolide (combo): EMBARK post hoc analysis

N. Shore

Type: E-Publication Only

Abstract Number for Publication: e17127

Corticosteroid Use and Risk of Adverse Events in Patients Treated for Metastatic Hormone-Sensitive Prostate Cancer

U. Swami

Type: E-Publication Only

Abstract Number for Publication: e17097

Enfortumab vedotin

Presentation Title

Lead Author

Presentation Details

EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma

J. Bedke

Type: Poster Presentation

Abstract Number: 4571

Date: June 2, 2025, 9:00am – 12:00pm CDT

Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma

S. Gupta

Type: Oral Presentation

Abstract Number: 4502

Date: June 1, 2025, 9:45am – 12:45pm CDT

Evaluation of surrogate endpoints in muscle-invasive bladder cancer: A systematic review and meta-analysis

M. Galsky

Type: Poster Presentation

Abstract Number: 4580

Date: June 2, 2025, 9:00am – 12:00pm CDT

Study EV-103 Cohort H: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle-invasive bladder cancer: 3-year efficacy results

N. Mar

Type: Poster Presentation

Abstract Number: 4583

Date: June 2, 2025, 9:00am – 12:00pm CDT

Recent trends in US real-world first-line treatment patterns for patients with locally advanced or metastatic urothelial carcinoma

G. Sonpavde

Type: E-Publication Only

Abstract Number for Publication: e16556

Patient and clinician expert perspectives on the impactful symptoms of head and neck squamous cell carcinoma and its treatment

E. Theodorou

Type: E-Publication Only

Abstract Number for Publication: e18001

Zolbetuximab

Presentation Title

Lead Author

Presentation Details

A real-world study on epidemiology, biomarker test results, clinical characteristics, and treatment patterns of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in China

Y. Chen

Type: E-Publication Only

Abstract Number for Publication: e16013

Gilteritinib

Presentation Title

Lead Author

Presentation Details

Real-world adherence and tolerability of FLT3 inhibitors s post-allogeneic transplant maintenance therapy in
older adults with AML: A Medicare claims cohort study

V. Kennedy

Type: E-Publication Only

Abstract Number: e18505

Pipeline

Presentation Title

Lead Author

Presentation Details

Trial in progress: Phase 1 study of the selective protein degrader ASP4396 in patients with locally advanced or metastatic solid tumors with KRAS G12D mutation

Shiraj Sen

Type: Poster Presentation

Abstract Number: TPS3178

Date: June 2, 2025, 1:30 – 4:30pm CDT

On May 19, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported first quarter 2025 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAY 19, 2025, View Source [SID1234653221]).

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"2025 has started off with a bang at Alpha Tau, with a flurry of important milestones as we continue to evaluate Alpha DaRT in treating internal organ tumors, expand our manufacturing capabilities, and prepare for commercial activities," said Alpha Tau Chief Executive Officer Uzi Sofer. "With four active U.S. IDEs approved by the FDA, and U.S. trials expected to begin soon in patients with newly-diagnosed pancreatic cancer and recurrent GBM, construction of the first phase of our Hudson, NH facility nearing completion, and our ambitions for the continued expansion of our clinical trial program, our recently completed financing came at the perfect time to ensure that our momentum continues to accelerate throughout the course of the year."

Recent Corporate Highlights:

● In April, Alpha Tau announced the completion of a $36.9 million registered direct financing from, and strategic marketing alliance with, an affiliate of Oramed Pharmaceuticals, Inc. (Oramed). Oramed CEO, President and Chairman Nadav Kidron has also joined the Alpha Tau Board of Directors, bringing years of public company biotech experience.

● In April, Alpha Tau announced receipt of an IDE from the FDA to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM). The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation.

● In February, Alpha Tau announced achievement of Medical Device Single Audit Program (MDSAP) certification for the Company’s manufacturing facility in Jerusalem. MDSAP was established by a coalition of international medical device regulatory authorities from Australia, Brazil, Canada, Japan and the U.S., to enable medical device manufacturers to be audited once for compliance with ISO 13485 and the standards of these five different markets. MDSAP certification may also speed the timetable to commercialization within these participating geographies, as it allows for a streamlined auditing process, providing manufacturers with a comprehensive approach to meet international regulatory standards efficiently.

● In January, Alpha Tau hosted a virtual R&D Update Day to present interim results from multiple trials as well as more information regarding the expected regulatory path forward in internal organs. Principal investigators presented data showing high disease control rate and strong interim safety results observed across three trials exploring the use of Alpha DaRT in pancreatic cancer patients, following a subset of the data presented by investigators at Hadassah Medical Center on a poster at the prestigious 2025 ASCO (Free ASCO Whitepaper) GI Symposium. Principal investigators also reported strong interim results in median survival of patients treated with Alpha DaRT after prior therapy as compared to previously published studies of alternative monotherapies, across all analyzed subgroups.

● At the R&D Update Day, positive interim results were also reported for the first eight patients recruited in a combination trial of Alpha DaRT with pembrolizumab (Keytruda), a checkpoint inhibitor, in treating patients with recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC). A reported systemic objective response rate of 75% and complete response rate of 37.5% were observed, compared to historical benchmarks of 19% and 5%, respectively, for pembrolizumab on its own in the KEYNOTE-048 trial.

● Approvals for two forthcoming clinical trials exploring the use of Alpha DaRT in treating pancreatic cancer were also announced during the R&D Update Day:

o IDE received from the FDA to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed pancreatic cancer, the first step toward regulatory approval in the U.S. The trial was initially approved for 12 patients with metastatic cancer and was then expanded to 30 patients in two cohorts of 15 patients each, one cohort of patients with newly diagnosed locally advanced cancer and the other of patients with newly diagnosed metastatic cancer.

o Approval from France’s Ministry of Health to commence a French multicenter clinical trial of Alpha DaRT alongside capecitabine for patients with locally advanced pancreatic cancer, as well as a second study at a single center in France examining the use of Alpha DaRT delivered via Fine Needle System, or FNS, in the treatment of locally advanced pancreatic cancer.

Expected Upcoming Milestone Targets:

● First patient enrolled in pancreatic cancer pilot study in the U.S. in Q3 2025. For more information, please see here: View Source

● First patient treated in Israel for brain cancer in Q2 or Q3 2025.

● Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q3 2025. For more information, please see here: View Source

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

● First patient treated in U.S. GBM pilot study in H2 2025. For more information, please see here: View Source

● Response from Japan’s PMDA in H2 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.

Financial results for quarter ended March 31, 2025

R&D expenses for the three months ended March 31, 2025 were $7.2 million, compared to $6.4 million for the same period in 2024, due to increased employee compensation and benefits, increased production expenses and reduced government grants, offset by lower share-based compensation expenses.

Marketing expenses for the three months ended March 31, 2025 were $0.5 million, compared to $0.5 million for the same period in 2024.

G&A expenses for the three months ended March 31, 2025 were $1.7 million, compared to $1.4 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal expenses).

Financial income, net, for the three months ended March 31, 2025 was $0.7 million, compared to $0.4 million for the same period in 2024, due to a decrease in expense from remeasurement of warrants, offset by a decrease in interest from bank deposits.

For the three months ended March 31, 2025, the Company had a net loss of $8.7 million, or $0.12 per share, compared to a net loss of $8.0 million, or $0.11 per share, in the three months ending March 31, 2024.

Balance Sheet Highlights

As of March 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $54.8 million, compared to $62.9 million at December 31, 2024. In April 2025, Alpha Tau raised $36.9 million through a registered direct financing transaction.

On May 19, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that four abstracts with Innate’s drugs in clinical development have been accepted for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, taking place May 30-June 3, 2025 in Chicago, Illinois (Press release, Innate Pharma, MAY 19, 2025, View Source [SID1234653219]).

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"We are looking forward to participating in the ASCO (Free ASCO Whitepaper) Annual Meeting 2025, where four abstracts with Innate’s drugs in clinical development have been selected. In particular, we are pleased to share the long-term follow-up data from the TELLOMAK Phase 2 study, which underscores our continued commitment to advancing innovative therapies for patients," commented Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.

ASCO abstract details:

Lacutamab

Abstract: 2522
Abstract Title: Lacutamab in patients with relapsed and refractory Sézary syndrome: Long term follow-up from the TELLOMAK phase 2 trial
Session Type: Poster Session
Session Title: Developmental Therapeutics—Immunotherapy
Session Date and Time: Monday, June 2, 2025 – 1:30 – 4:30 PM CDT

Abstract: 2523
Abstract Title: Lacutamab in patients with relapsed and/or refractory mycosis fungoides: Long-term follow-up and translational data from the TELLOMAK phase 2 trial
Session Type: Poster Session
Session Title: Developmental Therapeutics—Immunotherapy
Session Date and Time: Monday, June 2, 2025 – 1:30 – 4:30 PM CDT

IPH4502

Abstract: TPS3159
Abstract Title: A phase 1, open-label, multi-center study of the safety, tolerability, and efficacy of IPH4502 as a single agent in advanced solid tumors
Session Type: Poster Session
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Monday, June 2, 2025 – 1:30 – 4:30 PM CDT

Monalizumab (partnered with AstraZeneca)

Abstract: 8046
Abstract Title: Neoadjuvant durvalumab (D) + chemotherapy (CT) + novel anticancer agents and adjuvant D ± novel agents in resectable non-small-cell lung cancer (NSCLC): Updated outcomes from NeoCOAST-2.
Session Type: Poster Session
Session Title: Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Session Date and Time: Saturday, May 31, 2025 – 1:30 – 4:30 PM CDT

On May 19, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported that members of the management team will participate in two upcoming investor conferences (Press release, Molecular Partners, MAY 19, 2025, View Source [SID1234653218]).

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H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ:

Fireside Chat on Tuesday May 20, 2025 beginning at 3:30pm ET
TD Cowen’s 6th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper):

Fireside chat on Wednesday, May 28, 2025 beginning at 10:00am ET
Both events will be webcast and available on the Molecular Partners website, under the investors tab.