On May 1, 2025 Repare Therapeutics Inc. ("Repare") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that it has out-licensed its discovery platforms, including certain platform and program intellectual property, to DCx Biotherapeutics Corporation ("DCx"), a newly-launched Canadian biotechnology company developing next generation precision drug conjugates and supported by Amplitude Ventures (Press release, Repare Therapeutics, MAY 1, 2025, View Source [SID1234652453]). Additionally, DCx will retain certain preclinical research personnel, acquire lease rights to certain laboratory facilities in Montreal and acquire certain laboratory equipment.

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"We have taken careful steps to evaluate all aspects of our business to ensure continued value generation, and this out-licensing agreement with DCx for our discovery platforms enables us to further focus on our clinical portfolio and drive cost reductions while maintaining an economic interest in the platform technologies we have developed." said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "We look forward to reporting initial data from our two ongoing Phase 1 clinical trials in the second half of 2025, and continue to evaluate partnering and strategic alternatives across our portfolio assets."

Under the terms of the out-licensing agreement, Repare will receive upfront and near-term payments totaling $4 million, as well as a 9.99% common equity position in DCx (including certain dilution protection rights) and is eligible to receive potential future out-licensing, clinical and commercial milestone payments, as well as low-single digit tiered sales royalites for the development of certain products by DCx. Additionally, DCx will retain approximately 20 of Repare’s preclinical research employees. Repare has the right to appoint one nominee to the board of directors of DCx. In connection with the transaction, Repare out-licensed its clinically-validated SNIPRx platform and its early discovery-stage SNIPRx-surf and STEP2 platforms, along with other intellectual property. The SNIPRx-surf platform identifies cell surface targets based on gene expression and protein features in tumors or cancer models, including by clinically relevant biomarkers and machine learning algorithm. The STEP2 platform is a chemogenomic discovery platform, which uses CRISPR-enabled genetic screens with small molecule inhibitors to identify clinically relevant genetic lesions that are sensitive to small molecule inhibitors.

On May 1, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that management will participate in two upcoming investor conferences (Press release, Sutro Biopharma, MAY 1, 2025, View Source;utm_medium=rss&utm_campaign=sutro-biopharma-to-participate-in-upcoming-investor-conferences-6 [SID1234652454]).

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Conference Details:

The Citizens Life Sciences Conference
Date: May 7-8, 2025
Location: New York, NY

BofA Securities 2025 Health Care Conference
Date: May 13-15, 2025
Location: Las Vegas, NV

Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the event.

On May 1, 2025 Cerus Corporation (Nasdaq: CERS) reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Cerus, MAY 1, 2025, View Source [SID1234652435]).

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"We are off to a strong start in 2025, executing against our stated goals and making meaningful progress in advancing Cerus’ mission to transform the safety and availability of transfused blood components," said William "Obi" Greenman, Cerus’ president and chief executive officer. "We delivered 13% first quarter product revenue growth, in-line with our Q1 guidance, received CE Mark for the INT200, our next generation LED-based illumination device ahead of plan, and most recently, we have submitted our updated CE Mark application for the INTERCEPT red blood cell system to TÜV-SÜD, our notified body."

"Based on revenue growth prospects for 2025 and beyond, our expected gross margin profile, and demonstrated financial discipline, we believe we are in a position to deliver operating cash flow to fuel our growth and make INTERCEPT the standard of care for blood safety globally," continued Greenman.

Additional highlights include:

First-quarter 2025 total revenue was comprised of (in millions, except percentages):
Three Months Ended
March 31,

Change

2025

2024

$

%

Product Revenue
$

43.2

$

38.4

$

4.9

13

%

Government Contract Revenue
5.6

5.0

0.6

12

%

Total Revenue
$

48.9

$

43.4

$

5.5

13

%

Numbers may not sum due to rounding. Percentages are based on actuals.

Adoption of INTERCEPT Fibrinogen Complex (IFC) continues to increase; first quarter 2025 IFC revenue of $3.0 million compared to $1.9 million in the prior year period. The Company continues to collaborate with blood bank partners to increase IFC supply with the expectation of meeting increased customer demand.
Received CE mark for the INT200, the Company’s next-generation, LED-based illumination device.
Submitted an updated CE Mark application for the INTERCEPT red blood cell system with TÜV-SÜD, our notified body; that review process has begun.
Cash, cash equivalents, and short-term investments were $80.9 million at March 31, 2025.
Revenue

Product revenue during the first quarter of 2025 was $43.2 million, compared to $38.4 million for the prior year period. This year-over-year increase was led by robust 22% growth in North American product revenue, which was partially offset by a 4% decline in Europe, Middle East, and Africa (EMEA) revenue, largely due to the impact of foreign currency exchange rates. First quarter product revenue included IFC sales of $3.0 million, compared to $1.9 million during the prior year period.

First quarter 2025 government contract revenue was $5.6 million, compared to $5.0 million during the prior year period. Government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Blood Cells (RBCs) as well as efforts related to the development of next-generation pathogen reduction technology to treat whole blood and development of a lyophilized IFC. The year-over-year increase was primarily driven by increasing enrollment in the Phase 3 RedeS trial for INTERCEPT Red Blood Cell system and the commencement of activities covered under the Company’s awarded 2024 BARDA contract.

Product Gross Profit & Margin

Product gross profit for the first quarter of 2025 was $25.4 million, compared to $21.3 million, increasing by 20% over the prior year period. Product gross margin for the first quarter of 2025 increased to 58.8% compared to 55.4% for the same period of the prior year. Much of the year-over-year increase in gross margin was due to the combined effects of the capitalization of inventoriable charges, and the nonrecurring release of previously accounted for favorable variances during the first quarter of 2025.

Operating Expenses

Total operating expenses for the first quarter of 2025 were $36.9 million, compared to $34.3 million for the same period of the prior year, reflecting a year-over-year increase of 8%. Both R&D and selling, general, and administrative (SG&A) expenses increased year-over-year reflecting investments in our business to drive future revenue growth.

R&D expenses for the first quarter of 2025 were $16.6 million, compared to $14.5 million for the same period of the prior year, reflecting a 15% increase. The primary drivers for the increase in R&D expenses were related to development costs of INT200, the new LED-based illumination device, higher government contract costs incurred to support the higher government contract revenue and cost of living adjustments for employees.

SG&A expenses for the first quarter of 2025 totaled $20.3 million, compared to $19.8 million for the same period of the prior year, reflecting a 2% increase. The primary driver for the increase in SG&A expenses was modestly higher employee related expenses due to cost of living adjustments.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the first quarter of 2025 was $7.7 million, or $0.04 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $9.7 million, or $0.05 per basic and diluted share, for the same period of the prior year.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the first quarter of 2025 was positive $0.2 million, compared to non-GAAP adjusted EBITDA of negative $2.7 million for the same period of the prior year. The Company remains committed to its goal of achieving positive, full-year 2025 non-GAAP adjusted EBITDA. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet & Cash Flows

At March 31, 2025, the Company had cash, cash equivalents, and short-term investments of $80.9 million, compared to $80.5 at December 31, 2024.

As of March 31, 2025, the Company had $65.0 million outstanding on its term loan and $20.1 million drawn on its revolving credit facility. The Company’s revolving line of credit allows for an additional $14.9 million as of March 31, 2025, which is dependent on eligible assets supporting the borrowing base.

For the first quarter of 2025, cash use from operations totaled $0.8 million compared to $2.0 million generated during the same period of the prior year. Cash use from operations in the first quarter of 2025 was primarily tied to an increase in working capital, namely inventory in support of the expected growth implied by the Company’s revenue guidance.

Reiterating Full-Year 2025 Product Revenue Guidance

The Company expects full-year 2025 product revenue will be in the range of $194 million to $200 million, reflecting 8% to 11% growth from 2024. Included in this range is full-year 2025 IFC revenue guidance between $12 million to $15 million. Product revenue growth is expected to be fueled by continued penetration with U.S. platelet customers, geographic expansion of the INTERCEPT platelet business as well as increasing uptake of IFC in the U.S.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website and will be available approximately three hours after the call through May 22, 2025.

On May 1, 2025 SK Life Science Labs, a subsidiary of SK Biopharmaceuticals Co., Ltd., a global biotech focused on the research, development, and commercialization of treatments for cancer and disorders of the central nervous system (CNS), reported the publication of its research in the journal, Nature Communications, detailing the discovery of PVTX-405, a best-in-class IKZF2 molecular glue degrader (Press release, SK Life Science, MAY 1, 2025, View Source [SID1234652458]).

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"This novel agent represents a significant step toward improved oncology treatments, establishing PVTX-405 as a potent IKZF2 molecular glue degrader that supercharges the body’s immune response against cancer," said Ryan Kruger, Ph.D., Chief Scientific Officer at SK Life Science Labs. "By targeting IKZF2, PVTX-405 dramatically reduces immune suppression, allowing the patient’s own immune system to more effectively fight cancer."

Regulatory T-cells, also known as Tregs, are a major roadblock in cancer treatment, suppressing the immune system and allowing tumors to thrive. IKZF2 is a critical factor in maintaining Tregs stability within the tumor environment. By selectively degrading IKZF2, PVTX-405 weakens Tregs, boosting the activity of tumor-fighting effector T-cells and amplifying the immune response against cancer.

The findings of this research show that PVTX-405 offers superior selectivity, potency and safety over previous IKZF2 molecular glue degraders. It is designed to degrade IKZF2 more efficiently while reducing the risk of unintended immune or blood cell-related toxicities. Most importantly, once-daily oral administration of PVTX-405 demonstrates exceptional anti-tumor efficacy, substantially slowing tumor growth and enhancing the impact of immune checkpoint inhibitors. This combined effect results in greater tumor regression and prolonged survival in preclinical trials.

"These exciting results reinforce our enthusiasm for partnering with biopharma, research institutions, and investors to fast-track the clinical development of this groundbreaking immunotherapy, with the goal of improving and extending the lives of cancer patients," said Dr. Kruger. "This research not only showcases the potential of molecular glue degraders as powerful therapeutic agents but also highlights SK Life Science Labs’ dedication to advancing life-saving treatments."

On May 1, 2025 Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) reported that a phase II/III clinical trial of anti-HER2 bispecific antibody KN026 (Study ID: KN026-001) in combination with chemotherapy as second-line or above treatment of HER2-positive gastric cancer (GC) (including gastroesophageal junction cancer (GEJ)), has completed the first interim analysis and met the pre-specified primary endpoint of progression-free survival (PFS) as evaluated by an Independent Data Monitoring Committee (IDMC), with both statistical significance and clinical relevance.

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KN026-001 is a randomized, multicenter, Phase II/III clinical study designed to evaluate the efficacy of KN026 in combination with chemotherapy inpatients with HER2-positive advanced, unresectable, or metastatic GC (including GEJ) who have failed first-line treatment. Part 2 of KN026-001 is a randomized, double-blind, placebo-controlled Phase III study. Patients with HER2-positive GC (including GEJ) who had previously received and failed at least first line standard treatment were enrolled and randomized 1: 1 to receive either KN026 in combination with chemotherapy or placebo in combination with chemotherapy. The primary endpoints of this study are PFS and overall survival (OS) as assessed by the Independent Review Committee (IRC).

The interim PFS analysis results demonstrated that, compared to the current standard treatment, KN026 in combination with chemotherapy significantly improved PFS, reduced the risk of disease progression or death, and showed a trend toward OS benefit. Detailed data from this study will be presented at an upcoming international academic conference.

About KN026

KN026 is an anti-HER2 bispecific antibody independently developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can simultaneously bind two non-overlapping epitopes of HER2, leading to HER2 signal blockade. KN026 has demonstrated better tumor inhibition in HER2-positive tumor cell lines compared with trastuzumab and pertuzumab in combination. Additionally, KN026 has also shown inhibitory effect on tumor cells with trastuzumab-resistant cell lines.

The results of multiple clinical studies in different stages showed that KN026 has significant anti-tumor activities, even in heavily pretreated patients with HER2-positive breast cancer (BC) and gastric cancer (GC), including those with prior anti-HER2 treatment. Currently, several pivotal clinical trials of KN026 for the second-line and beyond treatment of HER2-positive GC/gastroesophageal junction cancer (GEJ), the first-line treatment of HER2-positive BC, neoadjuvant treatment for HER2-positive BC are being conducted. KN026 in combination with chemotherapy for the treatment of patients with HER2-positive GC (including GEJ) who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA).

In August 2021, the Company entered an agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China, pursuant to which, JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC an GC/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).

(Press release, Alphamab, MAY 1, 2025, View Source [SID1234657002])