On May 6, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported financial results for the first quarter ended March 31, 2025, and provided a pipeline update on its clinical-stage investigational molecules across multiple common cancers (Press release, Arcus Biosciences, MAY 6, 2025, View Source [SID1234652568]).

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"Beginning with an oral presentation at ASCO (Free ASCO Whitepaper) for casdatifan in ccRCC, we expect to report a steady stream of data from ARC-20 throughout the remainder of 2025 and into 2026. We believe these data will support our robust development plan for casdatifan across multiple settings. This includes our Phase 3 trial, PEAK-1 in the IO-experienced setting, our clinical trial with AstraZeneca, which will combine casdatifan with their anti-PD-1/CTLA-4 bispecific antibody in the IO-naive setting, and three new cohorts in ARC-20 evaluating casdatifan in first- and second-line ccRCC," said Terry Rosen, Ph.D., chief executive officer of Arcus. "We believe that casdatifan has the potential to change the treatment paradigm for ccRCC, including the displacement of TKIs in earlier line settings, and our development plan is designed to establish casdatifan as the HIF-2a inhibitor of choice. Our balance sheet remains strong, and our operational plan and priorities are focused on ensuring that casdatifan is funded through its first Phase 3 readout."
Pipeline Highlights:

Casdatifan (HIF-2a inhibitor)
Casdatifan Updates:
•New clinical data from three monotherapy expansion cohorts in ARC-20 were presented in an oral session at the 2025 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium in February. At the time of data cut-off (DCO, January 3, 2025), the efficacy-evaluable population included a total of 87 patients with ccRCC who had received at least two prior lines of therapy, including both anti-PD-1 and a vascular endothelial growth factor receptor 2 (VEGFR)-TKI therapy. These data support the potential for casdatifan to be a best-in-class HIF-2a inhibitor for the treatment of ccRCC:
◦Despite limited follow-up, two of the cohorts exceeded 30% confirmed overall response rate (inclusive of one partial response confirmed after the DCO)
◦A 9.7-month median progression-free survival (PFS) was reached for the 50mg twice-daily casdatifan monotherapy cohort; median PFS was not yet reached for other cohorts
◦No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses.

Planned Data Readouts:
•June 2025: Safety and initial efficacy data for the ARC-20 cohort evaluating casdatifan plus cabozantinib in IO-experienced patients will be presented in an oral session at the ASCO (Free ASCO Whitepaper) Annual Meeting.
•Fall 2025: More mature data from the cohorts evaluating casdatifan monotherapy in patients who had progressed on both an anti-PD-1 and a TKI therapy.
•2026: More mature data from the casdatifan plus cabozantinib cohort and initial data from the new ARC-20 cohorts evaluating casdatifan in the first-line (1L) and IO-experienced settings.
Upcoming Study and Cohort Initiations:
•The PEAK-1 Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in IO-experienced ccRCC is expected to initiate in the second quarter of 2025.
•Shortly thereafter, Arcus and AstraZeneca expect to initiate a clinical study, part of AstraZeneca’s eVOLVE portfolio, evaluating casdatifan plus volrustomig, AstraZeneca’s investigational anti-PD-1/CTLA-4 bispecific antibody, in IO-naive ccRCC. This study will be operationalized by AstraZeneca.

Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)
•Overall survival data from the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) adenocarcinomas, are expected to be presented in the fall of 2025.
•The first Phase 3 data readout for domvanalimab plus zimberelimab will be from the ongoing Phase 3 study STAR-221, evaluating domvanalimab plus zimberelimab and chemotherapy in PD-L1 all-comer 1L metastatic upper GI adenocarcinomas and is expected in 2026.

CD73-Adenosine Axis: Quemliclustat (small-molecule CD73 inhibitor) and Etrumadenant (A2a/A2b receptor antagonist)

Quemliclustat:

•In the fourth quarter of 2024, Arcus initiated PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line treatment of metastatic pancreatic cancer. PRISM-1 is recruiting rapidly, with enrollment completion expected by the end of 2025.
Etrumadenant:
•In March 2025, we engaged with the U.S. Food and Drug Administration (FDA) regarding promising results from the ARC-9 study evaluating etrumadenant in third-line metastatic colorectal cancer (mCRC); although the FDA’s feedback confirmed the potential for a registrational path for this program in third-line mCRC, based on our strategic priorities, we are not pursuing a Phase 3 study at this time.

Financial Results for First Quarter 2025:

•Cash, Cash Equivalents and Marketable Securities were $1.0 billion as of March 31, 2025, compared to $992 million as of December 31, 2024. The increase during the period is primarily due to the net proceeds from our underwritten offering in February 2025, partially offset by the use of cash in our research and development activities. We believe our cash, cash equivalents, and marketable securities, together with available facilities, will be sufficient to fund operations through the initial pivotal readouts for domvanalimab, quemliclustat and casdatifan, which include PEAK-1.
•Revenues were $28 million for the first quarter 2025, compared to $145 million for the same period in 2024. In the first quarter 2025, Arcus recognized $20 million in license and development services revenue related to the advancement of programs, as well as $8 million in other collaboration revenue primarily related to Gilead’s ongoing rights to access Arcus’s research and development pipeline in accordance with the Gilead collaboration agreement. Arcus expects to recognize GAAP revenue of between $75 million and $90 million for the full year 2025.
•Research and Development (R&D) Expenses were $122 million for the first quarter 2025, compared to $109 million for the same period in 2024. The net increase of $13 million was primarily driven by higher costs in our early-stage development and preclinical program activities, driven by higher enrollment in our Phase 2 studies. The overall increase was partially offset by reduced spend in our late-stage development activities due to lower manufacturing costs driven by the timing of manufacturing activities. Non-cash stock-based compensation expense was $8 million for the first quarter 2025, compared to $10 million for the same period in 2024. For the first quarters 2025 and 2024, Arcus recognized gross reimbursements of $38 million and $37 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.
•General and Administrative (G&A) Expenses were $28 million for the first quarter 2025, compared to $32 million for the same period in 2024. The decrease was primarily driven by the costs incurred to obtain the Third Gilead Agreement Amendment in 2024. Non-cash stock-based compensation expense was $8 million for the first quarter 2025, compared to $10 million for the same period in 2024.
•Net Loss was $112 million for the first quarter 2025, compared to $4 million for the same period in 2024.

Conference Call Information:

Arcus will host a conference call and webcast today, May 6th, at 1:30 PM PT / 4:30 PM ET to discuss its first-quarter 2025 financial results and pipeline updates. To access the call, please dial +1 (404) 975-4839 (local) or +1 (833) 470-1428 (toll-free), using Access Code: 762544. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.

Arcus Ongoing and Announced Clinical Studies:
Trial Name
Arms
Setting
Status
NCT No.
Kidney Cancer
PEAK-1
cas + cabo vs. cabo
Post-IO ccRCC
Planned Phase 3
TBD
AstraZeneca Collaboration (part of eVOLVE portfolio)
cas + volru
2L+ IO-Naive ccRCC
Planned
TBD
ARC-20
cas, cas + cabo, cas +zim
1L, 2L, and 2L+ Cancer Patients/ccRCC
Ongoing Phase 1/1b
NCT05536141
Upper Gastrointestinal Cancers
STAR-221
dom + zim + chemo vs. nivo + chemo
1L Gastric, GEJ and EAC
Ongoing Registrational Phase 3
NCT05568095
EDGE-Gastric (ARC-21)
dom +/- zim +/- chemo
1L/2L Upper GI Malignancies
Ongoing
Randomized Phase 2
NCT05329766
Lung Cancer
STAR-121
dom + zim + chemo vs. pembro + chemo
1L NSCLC (PD-L1 all-comers)
Ongoing Registrational Phase 3
NCT05502237
PACIFIC-8
dom + durva vs. durva
Unresectable Stage 3 NSCLC
Ongoing Registrational Phase 3
NCT05211895
EDGE-Lung
dom +/- zim +/- quemli +/- chemo
1L/2L NSCLC (lung cancer platform study)
Ongoing Randomized Phase 2
NCT05676931
VELOCITY-Lung
dom +/- zim +/- sacituzumab govitecan-hziy or other combos
1L/2L NSCLC (lung cancer platform study)
Ongoing Randomized Phase 2
NCT05633667
Pancreatic Cancer
PRISM-1
quemli + gem/nab-pac vs. gem/nab-pac
1L PDAC
Ongoing Randomized Phase 3
NCT06608927
ARC-8
quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac
1L PDAC
Ongoing Randomized Phase 1/1b
NCT04104672
Other
ARC-25
AB598
Gastric Cancer
Ongoing Phase 1
NCT05891171
ARC-27
AB801
NSCLC
Ongoing Phase 1
NCT06120075

cabo: cabozantinib; cas: casdatifan; ccRCC: clear cell renal cell carcinoma; dom: domvanalimab; durva: durvalumab; EAC: esophageal adenocarcinoma; GEJ: gastroesophageal junction; gem/nab-pac: gemcitabine/nab-paclitaxel; GI: gastrointestinal; IO: immunotherapy; nivo: nivolumab; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma; pembro: pembrolizumab; quemli: quemliclustat; volru: volrustomig; zim: zimberelimab.

On May 6, 2025 Formosa Pharmaceuticals, Inc. ("Formosa"; 6838.TW ticker-symbol on the Taiwan Stock Exchange) and Almac Discovery reported a global licensing agreement for development and commercialisation of ALM-401, a first-in-class engineered bispecific Antibody-Drug Conjugate (ADC), addressing the high unmet needs of cancer patients worldwide suffering with intractable and aggressive solid tumours (Press release, Almac, MAY 6, 2025, View Source [SID1234652564]).

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The agreement facilitates the next phases of CMC and drug development by Formosa, including IND submission and early clinical proof-of-concept in international clinical trials.

ALM-401 has been the culmination of a multi-year R&D programme at Almac Discovery deploying their proprietary OmniaScape informatics platform, protein engineering and medicinal chemistry capabilities.

The design of ALM-401 has built upon the recent clinical successes within the ADC field, including selection of a linker-payload matched to potential clinical cancer indications, and the molecule also benefits from being approximately half the size of conventional ADCs, thereby facilitating enhanced solid tumour penetration. The main features of ALM-401 include:

Innovative bi-specific target-pairing based on co-expression and functional analysis of specific, aggressive solid tumours
Sustained high-efficacy in vivo in PDX models; as presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR; Chicago) annual meeting
Half-the-size of conventional ADCs for enhanced solid tumour penetration and optimised manufacturing.
Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology, with particular CMC and manufacturing expertise for specialist ADC therapeutics. "Formosa Pharma is pleased to have this opportunity to bring ALM-401 into our development pipeline. This novel, next-generation ADC complements our corporate strategy and resources and promises to deliver a differentiated therapy to cancer patients worldwide. We look forward to collaborating closely with Almac Discovery in advancing this exciting program through clinical trials, commercialization, and beyond." said Dr. Erick Co, President and CEO of Formosa Pharmaceuticals.

"We are pleased to have met Formosa’s exacting selection requirements for Next Generation ADC candidates," said Dr Stephen Barr, President and Managing Director of Almac Discovery. "This agreement allows the seamless progression of the molecule into clinical evaluation, driven by Formosa."

"In addition to an excellent preclinical efficacy profile, high-quality, robust and scalable CMC and manufacturing is a key competitive advantage for ADCs in the fast-moving race for effective cancer therapeutics" commented Dr Graham Cotton, Vice-President of Protein Therapeutics, Almac Discovery.

On May 6, 2025 Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported that management will participate in the following upcoming investor conferences (Press release, Alector, MAY 6, 2025, View Source [SID1234652563]):

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Bank of America Securities Health Care Conference (Las Vegas, Nevada)
Tuesday, May 13, 2025, at 2:20 p.m. PT, corporate presentation
H.C. Wainwright 3rd Annual BioConnect Investor Conference (New York, New York)
Tuesday, May 20, 2025, at 12:00 p.m. ET, fireside chat
A webcast of each conference presentation will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source Replays of the webcasts will be available on the Alector website for 90 days following the presentation dates.

On May 6, 2025 Alchemab Therapeutics (Alchemab), the next generation biopharmaceutical company which uses the power of human immune evolution to identify and develop naturally occurring therapeutic antibodies from resilient individuals, reported that it has entered into a licensing agreement with Eli Lilly and Company (Lilly) for ATLX-1282, Alchemab’s first-in-class IND-ready programme for amyotrophic lateral sclerosis (ALS) and other neurodegenerative conditions (Press release, Alchemab Therapeutics, MAY 6, 2025, View Source [SID1234652562]).

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The transaction is worth up to a total of $415m, including an undisclosed upfront payment, potential discovery, development, and commercialisation payments and royalties. Under the terms of the agreement, Alchemab will be taking the programme through early Phase 1 clinical trials after which Lilly will lead all further development and commercialisation.

Alchemab’s unique platform uses state-of-the-art machine learning and AI to analyse the complexities of the human immune response and identify antibodies that are uniquely associated with resilience to untreatable diseases. This is achieved using over 6,000 carefully selected and highly curated patient samples across neurodegeneration, immunology, oncology and healthy aging. Weaving together lab-based protein science and biology with machine learning, human samples and proprietary data analysis, and leveraging Nvidia’s supercomputer in Cambridge, Alchemab has sequenced and analysed millions of antibody sequences to unveil novel targets and antibodies with unique mechanisms of action.

Through its research, Alchemab has identified an antibody in people with mutations that normally lead to frontotemporal dementia (FTD), but who remain well into old age. These samples were sourced from a collaboration with the Genetic Frontotemporal Initiative (GENFI) consortium, which has built the largest global cohort of FTD patients.

Starting from the antibody sequence, Alchemab was able to identify the target and has subsequently demonstrated its importance in neuroprotection, and across multiple neurodegenerative conditions including ALS and FTD.

Alchemab’s Chief Executive Officer, Jane Osbourn, commented: "As the first programme from our highly novel platform, this is a landmark transaction for Alchemab. With Lilly’s deep expertise in neurological conditions, they are ideally placed to speedily advance ATLX-1282 through the clinic, and maximise the potential to help patients. We believe this innovative programme has enormous promise and look forward to working with Lilly to bring this to fruition.

"Today’s announcement is also a tremendous endorsement for Alchemab’s unique approach to drug discovery. Our revolutionary computational and wet lab-based workflow has enabled us to sift through millions of antibodies to identify this target. We think this is a powerful story demonstrating both the discovery of a novel antibody to treat neurogenerative diseases and the development of a unique platform which has great potential to provide innovative treatments across many disease settings. The transaction will support our work to progress our pipeline, which includes metabolic, immunology and oncology programmes, towards the clinic and we look forward to unveiling highly differentiated assets in these areas in due course."

This transaction builds on a separate discovery collaboration agreement with Lilly announced in January 2025 to discover, develop and commercialise up to five novel therapeutic candidates for ALS.

On May 5, 2025 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met the primary endpoints and achieved statistical significance in topline results from its ongoing Phase 2 (Actuate-1801 Part 3B) trial in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) (Press release, Actuate Therapeutics, MAY 6, 2025, View Source [SID1234652561]).

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The topline results, which demonstrate a substantial improvement in median overall survival benefit in the elraglusib/GnP combination arm compared to the results announced in December 2024, will be presented on May 31, 2025, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

"Pancreatic cancer is one of the most aggressive and difficult-to-treat malignancies, where patients urgently need new therapeutic options," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "There have been no major advances in improving survival in first-line treatment of metastatic pancreatic cancer in over a decade. Demonstrating statistically significant increases in both median overall survival and percent of patients reaching one-year survival and beyond, along with a favorable risk-benefit profile in this Phase 2 trial, further demonstrates elraglusib’s potential to shift the treatment paradigm in mPDAC. We are incredibly excited to present the topline data at ASCO (Free ASCO Whitepaper). Based on the significant improvement in survival we have seen to date in the combination arm, we look forward to working with US and EU regulators in the second half of this year to map out the path to advancing elraglusib to NDA and registration and making the drug available to patients as expeditiously as possible."

ASCO Presentation Details:

Abstract Title: Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

Abstract Number: 4006

Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Presenter: Devalingam Mahalingam, MD, PhD

Oral Presentation Date and Time: Saturday, May 31, 2025, 4:48 PM CDT

About Actuate-1801 Part 3B Study

The Actuate-1801 Part 3B study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first-line mPDAC. The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. The primary endpoint for this study is median overall survival, with OS summarized throughout the study by estimates of 1-year survival. Secondary endpoints are DCR, ORR, PFS, and AE.

About GSK-3β

Inhibition of GSK-3β may inhibit tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, activation of innate anti-tumor immunity, and regulation of gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT).