On May 7, 2026 Generate Biomedicines, Inc. (NASDAQ: GENB) ("Generate") reported financial results for the first quarter ended March 31, 2026, and highlighted progress across its clinical portfolio.

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"We saw strong progress in the first quarter across our clinical pipeline, next generation of therapeutic programs, and advancing our platform," said Mike Nally, chief executive officer of Generate Biomedicines, Inc. "We are advancing GB-0895 in Phase 3 for severe asthma and Phase 1b for COPD. In oncology, we expect to progress two clinical trials this year with GB-4362, an MMAE neutralizer, and GB-5267, a MUC16 CAR T developed with Roswell Park. Together, these programs reflect the breadth of our clinical portfolio across therapeutic areas, modalities, and both wholly owned and partnered programs."

Recent Progress
Generate continues to advance its generative biology platform, applying its capabilities across therapeutic areas and modalities to advance programs into the clinic.

In inflammation and immunology, Generate’s GB-0895 (anti-TSLP) program continues to advance, with Phase 3 clinical trials underway in severe asthma with its global SOLAIRIA-1 and SOLAIRIA-2 replicate studies, and a Phase 1b trial is ongoing in COPD.

In oncology, Generate’s GB-4362 (MMAE neutralizer) program has activated clinical trial sites, and the first patient is expected to be dosed in mid-2026. This program has received FDA Fast Track designation.

Generate’s GB-5267 (MUC16 armored CAR T) program, developed in collaboration with Roswell Park Comprehensive Cancer Center, is expected to dose the first patient in the second half of 2026 in a Phase 1 clinical trial in solid tumors, initially targeting ovarian cancer.

Financial Results
Cash, cash equivalents, and marketable securities were $516.6 million as of March 31, 2026, compared with $221.5 million as of December 31, 2025. The cash, cash equivalents, and marketable securities as of March 31, 2026, reflects $369.3 million in net proceeds from Generate’s IPO, which was completed on March 2, 2026. Generate believes its existing cash, cash equivalents, and marketable securities will be sufficient to fund its operations into the first half of 2028. Generate expects to require additional capital to support long-term operations.

Revenue for the quarter ended March 31, 2026, was $7.2 million, compared with $8.8 million for the same period in 2025. This revenue reflects developments in the ongoing Amgen and Novartis research programs.

Research and development expenses were $57.8 million for the quarter, compared with $46.8 million for the same period in 2025. The increase was primarily driven by continued investment in the GB-0895 Phase 3 program in severe asthma, as well as by an increase in personnel-related costs, offset by a decrease in external discovery and other program related costs.

General and administrative expenses were $13.5 million for the quarter, compared with $10.1 million for the same period in 2025. The increase was primarily driven by an increase in stock-based compensation and professional fees associated with operating as a public company following Generate’s initial public offering in February 2026.

Net loss was $61.7 million for the quarter ended March 31, 2026, compared with $44.3 million for the same period in 2025, which includes non-cash stock-based compensation expense of $6.4 million and $4.7 million, respectively.

Net cash used in operating activities was $80.4 million for the quarter ended March 31, 2026, compared with $53.2 million for the same period in 2025.

(Press release, Generate Biomedicines, MAY 7, 2026, View Source [SID1234665356])

On May 7, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported financial results for the quarter ended March 31, 2026, and provided recent corporate highlights.

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"This quarter reflects continued progress across our pipeline as we advance Phase 1 dose-escalation studies for HWK-007 and HWK-016, with a third IND planned for HWK-206 mid-year," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "We remain focused on high quality execution as we build toward initial data anticipated in 1H 2027, with the goal of delivering meaningful benefits for patients."

Q1 2026 and Recent Operational Highlights:

Continued to enroll patients into ongoing Phase 1 dose-escalation trials for HWK-007 and HWK-016.
HWK‑007 is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814).
HWK‑016 is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853).
Presented comprehensive data highlighting preclinical proof-of-concept for Whitehawk’s next-generation ADC portfolio underpinned by its proprietary Carbon Bridge Cysteine Re-pairing (CBCR) platform. Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 demonstrate a consistent preclinical profile for HWK-007, HWK-016 and HWK-206 characterized by potent tumor regressions, high plasma stability and favorable tolerability in non‑human primates, coupled with low systemic levels of free payload.
Presented real-world analysis confirming MUC16 as a highly expressed clinically relevant target for gynecologic cancers. Whitehawk presented data at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting that established MUC16 as the highest-expressing ADC target in ovarian cancer, at least two-fold higher than other emerging targets, and showed MUC16 is highly and stably expressed in the most aggressive and most common subtypes of endometrial cancer.
First Quarter 2026 Financial Results:

Cash, cash equivalents and short-term investments as of March 31, 2026, were $123.0 million as compared to $145.7 million as of December 31, 2025. Cash is anticipated to fund operations into 2028 based on current plans.
Research and development expenses were $17.2 million for the three months ended March 31, 2026, including development milestone expenses of $5.3 million under our license agreement with WuXi Biologics, as compared to $8.8 million for the quarter ended March 31, 2025.
Net loss for the three months ended March 31, 2026, was $22.2 million as compared to a net income of $73.0 million for the three months ended March 31, 2025. The prior year quarter included an $87.4 million gain on the sale of Aadi Subsidiary.
Anticipated Milestones:

HWK-206 – plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration in mid-2026 for HWK-206 in small-cell lung cancer and neuroendocrine tumors; Phase 1 recruitment planned to start in Q3 2026.
HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.

(Press release, Whitehawk Therapeutics, MAY 7, 2026, View Source [SID1234665355])

On May 7, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported the Company entered into a global collaboration and license agreement with GSK. Under the collaboration, GSK has licensed Halozyme’s ENHANZE drug delivery technology for the development and potential commercialization of subcutaneous administration of multiple oncology targets, including antibody drug conjugates (ADCs), as well as an option for additional future drug targets.

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"We are excited to work with GSK to advance development of several oncology therapeutics. This agreement also marks our first collaboration on subcutaneous delivery of ADCs, where we believe subcutaneous delivery with ENHANZE may meaningfully improve the benefit–risk profile," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "This collaboration reflects the continued recognition of ENHANZE as the gold standard for rapid, large-volume subcutaneous delivery, and underscores the value it provides to a growing number of leading pharmaceutical and biotechnology companies. Extending use of ENHANZE with ADCs represents a meaningful expansion of our potential addressable market, positions us at the forefront of a rapidly growing therapeutic class and reinforces the durability of our high-margin royalty revenue business."

"Novel approaches are required to reduce treatment burden for patients with cancer and help access easier forms of treatment," said Eric Richards, SVP Head of Medicine Development Leaders Oncology, GSK. "We see significant potential for subcutaneous formulations of several promising cancer targets, including ADCs, with ENHANZE and look forward to progressing the first clinical program."

GSK will make an upfront payment to Halozyme and potential future milestone payments. Halozyme will also be entitled to royalties on net sales of products that incorporate ENHANZE.

(Press release, Halozyme, MAY 7, 2026, View Source [SID1234665354])

On May 7, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported participation at the following investor conferences:

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BofA Securities Health Care Conference 2026
Format: Virtual fireside chat and one-on-one investor meetings
Presentation Date/Time: Wednesday, May 13, 2026 at 10:40 am PT
Location: Las Vegas, NV

TD Cowen’s 7th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper)
Format: Fireside chat with Tyler van Buren
Presentation Date/Time: Tuesday, May 26, 2026 at 2:00 pm ET
Location: Virtual

Jefferies Global Healthcare Conference
Format: Hybrid fireside chat and one-on-one investor meetings
Presentation Date/Time: Wednesday, June 3, 2026 at 3:45 pm ET
Location: New York, NY

A live webcast of the presentations can be accessed by visiting the "For Investors" page on the Tyra Biosciences website and will be available for replay following the event.

(Press release, Tyra Biosciences, MAY 7, 2026, View Source [SID1234665353])

On May 7, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) reported that they have entered into an agreement to conduct a new clinical study investigating the Company’s lead drug narmafotinib in ovarian cancer. Narmafotinib is a best-in-class FAK inhibitor currently undergoing clinical development in pancreatic cancer where it is showing promising efficacy combined with good tolerability.

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The study is an investigator-initiated clinical trial led by Dr Gwo Yaw Ho of Monash Health and Monash University, and sponsored and coordinated through ANZGOG, an international cooperative clinical trials network spanning major hospitals across Australia and New Zealand. The study is expected to enrol approximately 15–20 patients with high-grade serous ovarian cancer (HGSOC) who demonstrate poor response to up-front standard-of-care platinum-based chemotherapy prior to planned interval debulking surgery.

The trial, to be called the PRROSE trial, will evaluate the safety of narmafotinib in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) in this patient population. Approximately one in five ovarian cancer patients do not respond adequately to initial chemotherapy, limiting their ability to undergo surgery and contributing to poor clinical outcomes. This study is designed to address this significant unmet medical need.

The study will therefore also explore whether the addition of narmafotinib can increase the proportion of patients eligible for successful surgical resection. Extensive tissue and blood biomarkers will be examined for insight into narmafotinib’s mechanism of action to further enrich data provided from the study.

Dr Chris Burns, CEO and Managing Director of Amplia, commented: "We are very pleased to be collaborating with ANZGOG and Dr Ho on this promising study. Based on the compelling biological rationale for the potential of FAK inhibitors in ovarian cancer, a clinical program in this indication is clearly warranted. Patients with ovarian cancer who do not respond to initial chemotherapy have very limited treatment options and this study will provide an opportunity to assess whether narmafotinib can improve outcomes for these patients. This trial also represents an important step in broadening the clinical utility of our FAK inhibitor program."

Dr Gwo Yaw Ho, Lead Investigator, said: "This study reflects the strength of ANZGOG’s collaborative clinical trials network and its ability to bring together leading clinical investigators to address areas of high unmet need in gynaecological cancers. This trial builds on ANZGOG’s established capability to design and deliver rigorous, potentially practice-changing clinical research across Australia and New Zealand. The study is underpinned by a commitment to translating promising scientific approaches, such as Amplia’s, into well- conducted clinical trials that can generate meaningful evidence to inform future treatment options for women with ovarian cancer."

(Press release, Amplia Therapeutics, MAY 7, 2026, View Source [SID1234665352])