Sutro Biopharma to Participate in Upcoming Investor Conferences

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.

Cerus Corporation Announces First Quarter 2025 Financial Results

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.

SK Life Science Labs Announces the Publication in Nature Communications of its Breakthrough Research on Molecular Glue Discovery to Advance Cancer Immunotherapy

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."

Agios Reports First Quarter 2025 Financial Results and Recent Business Highlights

On May 1, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, reported business highlights and financial results for the first quarter ended March 31, 2025 (Press release, Agios Pharmaceuticals, MAY 1, 2025, View Source [SID1234652420]).

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"We are pleased with our strong start to 2025, highlighted by the acceptance of our sNDA for thalassemia with a PDUFA goal date of September 7, 2025. Our engagement with the FDA is progressing as expected, and we are committed to bringing PYRUKYND to thalassemia patients, irrespective of genotype or transfusion needs," said Brian Goff, chief executive officer at Agios. "Looking ahead, our focus is also on delivering the topline results from the Phase 3 RISE UP study in sickle cell disease, which remains on track for year-end, and continuing to advance our early and mid-stage clinical programs. Supported by our strong financial position and highly experienced team, we are driving forward PYRUKYND’s multi-billion-dollar potential while building a pipeline designed for lasting impact, with the goal of creating significant value for shareholders and delivering transformative therapies for patients."

First Quarter 2025 and Recent Highlights

PYRUKYND Revenues: Generated $8.7 million in net revenue for the first quarter of 2025, compared to $8.2 million in the first quarter of 2024. A total of 234 unique patients have completed prescription enrollment forms, representing an increase of 5 percent over the fourth quarter of 2024. A total of 136 patients are on PYRUKYND therapy, inclusive of new prescriptions and continued therapy, as compared to 130 patients at the end of the fourth quarter 2024.
Thalassemia:
The U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The Prescription Drug User Fee Act (PDUFA) goal date is September 7, 2025. The FDA has communicated that at this time no advisory committee meeting is planned, and the review is ongoing.
Sickle Cell Disease:
The Phase 3 RISE UP study evaluating mitapivat for the treatment of sickle cell disease patients who are 16 years of age or older continued to progress as anticipated. This 52-week Phase 3 study completed enrollment in October 2024, enrolling more than 200 patients worldwide.
Advanced final preparations to initiate a Phase 2 clinical trial of tebapivat in patients with sickle cell disease in mid-2025.
Pediatric Pyruvate Kinase (PK) Deficiency:
Reported positive topline results from the ACTIVATE-Kids Phase 3 study of mitapivat in children aged 1 to <18 years with PK deficiency who are not regularly transfused.
Safety was consistent with the profile for mitapivat previously observed in adults with PK deficiency who are not regularly transfused.
ACTIVATE-Kids is the first study to demonstrate efficacy of an oral therapy for children with PK Deficiency who are not regularly transfused.
Lower-risk Myelodysplastic Syndromes (LR-MDS):
Progressed patient enrollment in the Phase 2b study of tebapivat in LR-MDS.
Corporate: Krishnan Viswanadhan, Pharm. D, joined Agios as Chief Corporate Development and Strategy Officer, responsible for leading the company’s corporate strategy, business development, and long-term growth initiatives. Previously, he served as President and Chief Operating Officer of Be Biopharma and at various senior roles at both Bristol Myers Squibb and Celgene.
Key Upcoming Milestones & Priorities

Agios expects to achieve the following key milestones in 2025:

Thalassemia: Receive FDA regulatory decision for PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia (PDUFA goal date is September 7, 2025). Continue progressing the review of regulatory applications with health authorities in the European Union, Kingdom of Saudi Arabia and United Arab Emirates.
Sickle Cell Disease: Announce topline results from the Phase 3 RISE UP study of mitapivat in sickle cell disease in late 2025, with a potential U.S. commercial launch in 2026. Additionally, begin patient enrollment for the Phase 2 study of tebapivat in sickle cell disease in mid-2025.
LR-MDS: Complete patient enrollment in the Phase 2b study of tebapivat for LR-MDS in late 2025.
Early-Stage Pipeline: File an Investigational New Drug Application for AG-236, an siRNA targeting TMPRSS6 intended for the treatment of polycythemia vera, in mid-2025.
First Quarter 2025 Financial Results

Revenue: Net product revenue from sales of PYRUKYND for the first quarter of 2025 was $8.7 million, compared to $8.2 million for the first quarter of 2024.

Cost of Sales: Cost of sales for the first quarter of 2025 was $1.1 million.

Research and Development (R&D) Expenses: R&D expenses were $72.7 million for the first quarter of 2025, compared to $68.6 million for the first quarter of 2024. The year-over-year increase was primarily attributed to an increase in workforce-related expenses and costs associated with clinical trials of tebapivat in LR-MDS and sickle cell disease, partially offset by lower costs associated with the clinical trials of mitapivat in thalassemia and pediatric PKD.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $41.5 million for the first quarter of 2025 compared to $31.0 million for the first quarter of 2024. The year-over-year increase was primarily attributable to an increase in commercial-related activities, including headcount, as the company prepares for the potential approval of PYRUKYND in thalassemia.

Net Loss: Net loss was $89.3 million for the first quarter of 2025 compared to $81.5 million for the first quarter of 2024.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of March 31, 2025, were $1.4 billion compared to $1.5 billion as of December 31, 2024. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to prepare for potential PYRUKYND launches in thalassemia and sickle cell disease, advance existing programs, and to opportunistically expand its pipeline through both internally and externally discovered assets.

Conference Call Information

Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s first quarter 2025 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

Coherus to Participate in Upcoming Investor Conferences

On May 1, 2025 Coherus BioSciences, Inc. ("Coherus," NASDAQ: CHRS) reported that the company will be webcasting its participation in the upcoming conferences (Press release, Coherus Biosciences, MAY 1, 2025, View Source [SID1234652436]):

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Citizens Life Science Conference in New York, NY on Thursday, May 8, 2025 at 9:00 a.m. Eastern Daylight Time / 6:00 a.m. Pacific Daylight Time – Webcast Link
HCW BioConnect @ Nasdaq NYC 2025 in New York, NY on Tuesday, May 20, 2025 at 12:00 p.m. Eastern Daylight Time / 9:00 a.m. Pacific Daylight Time – Webcast Link
TD Cowen 6th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper) taking place virtually on Tuesday, May 27, 2025 at 3:00 p.m. Eastern Daylight Time / 12:00 p.m. Pacific Daylight Time – Webcast Link
Jefferies Global Healthcare Conference in New York, NY on Wednesday, June 4, 2025 at 5:30 p.m. Eastern Daylight Time / 2:30 p.m. Pacific Daylight Time – Webcast Link

The presentations will be accessible via webcast links on the Investor Events section of the Coherus website: View Source Replays of the presentations will be available for 30 days.

If you would like to request a one-on-one meeting with company management during the conferences, please reach out to your respective bank representative.

Disclosure Information

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