On March 2, 2026 Day One Pharmaceuticals presented its corporate presentation.

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(Presentation, Day One, MAR 2, 2026, View Source [SID1234663175])

On March 2, 2026 Pulmatrix ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE technology, reported that on February 28, 2026, Cullgen Inc. notified Pulmatrix that Cullgen was terminating the Merger Agreement (as defined herein) and related transactions thereunder. This termination follows the December 2025 announcing that Pulmatrix and Cullgen had mutually agreed to waive the "No Solicitation" clause in the Merger Agreement in order to permit each party to explore alternate transactions in the period until closing. At this time, Pulmatrix continues to pursue alternative merger opportunities.

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Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Due to the significant delays at the Chinese Regulatory Authority (CSRC) in 2025, we initiated a process earlier this year to identify an alternative reverse merger opportunity for the Company, and we are encouraged by both the interest we’ve had to date as well as the recent increase in transaction activity within our industry."

Prior Proposed Merger with Cullgen

As previously reported, on November 13, 2024, the Company entered into an agreement and plan of merger with Cullgen, as amended by Amendment No. 1 thereto on April 7, 2025 (the "Merger Agreement" and the transactions contemplated thereunder, collectively, the "Merger").

Additional information about the Merger Agreement and the previously proposed Merger was previously disclosed in a registration statement on Form S-4 (File No. 333-284993) initially filed with the Securities and Exchange Commission (the "SEC") on February 14, 2025, as amended on April 17, 2025, and May 7, 2025, and declared effective on May 9, 2025.

On June 16, 2025, the Company held a special meeting in lieu of the annual meeting of Pulmatrix stockholders, at which meeting the Company’s stockholders approved the Merger and related proposals. The closing of the Merger was subject to certain closing conditions, including approval from the China Security Regulatory Commission which had not been obtained at the time of Cullgen’s termination.

Pulmatrix Clinical Assets and Proprietary iSPERSE Technology

iSPERSE Technology

iSPERSE, also licensed to MannKind Corporation and Cipla Technologies for certain fields of use, utilizes particles that are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases.

As of December 31, 2025, Pulmatrix’s patent portfolio related to iSPERSE included approximately 149 granted patents, 18 of which are U.S.-granted patents, plus approximately 48 pending patent applications in the U.S. and other jurisdictions.
PUR3100

PUR3100, a Phase 2-ready asset, is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix’s iSPERSE dry powder inhalation technology for the treatment of acute migraine has a Food and Drug Administration acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine.

The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in the peer-reviewed publication, Headache: The Journal of Head and Face Pain. The study showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting compared to observations of nausea and vomiting in the intravenously ("IV") administered DHE dose group.
PUR1800

PUR1800 is a Narrow Spectrum Kinase Inhibitor ("NSKI"), engineered with our iSPERSE technology, for the treatment of acute exacerbations in chronic obstructive pulmonary disease ("AECOPD"). In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for AECOPD, indicating PUR1800 was well-tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases.

In 2024, Pulmatrix published an abstract titled "Ex vivo evaluation of the potential for Narrow Spectrum Kinase inhibitors as a treatment for Idiopathic Pulmonary Fibrosis".
PUR1900

PUR1900, approved to proceed to a Phase 3 in India conducted by our partner Cipla, is the Company’s inhaled iSPERSE formulation of the antifungal drug itraconazole being investigated for various indications. The Company and its partner, Cipla, wound down a Phase 2b trial that the Company was operating in 2024. Cipla has continued clinical development outside the United States, and in 2025 completed their Phase 2 study in India and have been approved by India’s Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial.

Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States should Cipla successfully market PUR1900 outside the United States. Within the United States, the Company and Cipla share the rights 50/50 and will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need.

(Press release, Cullgen, MAR 2, 2026, View Source [SID1234663174])

On March 2, 2026 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") and Congruence Therapeutics reported that they have expanded their existing multi-target research partnership through the execution of a new research collaboration for two additional programs.

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The expanded collaboration is focused on two clinically validated high-value targets in the areas of neurology and immunology for which Congruence will lead the effort to discover small molecule modulators and advance them to the development candidate stage. Ono will have the option to secure exclusive worldwide rights to further develop and commercialize development candidates generated under the new agreement.

An original collaboration between the companies, which began in December 2024, is focused on leveraging Congruence’s proprietary computational engine, Revenir, to discover novel small molecule correctors directed to mutants of a difficult-to-drug cancer target.

"We are excited to expand our partnership with Ono, a global pioneer of innovative medicines," said Sharath Hegde PhD, Chief Scientific Officer of Congruence. "The expansion is a testament to the significant contributions we have made in our existing collaboration as well as the trust and confidence we continue to build with Ono. We look forward to leveraging the complementary strengths of both organizations to advance important research for the benefit of patients."

The new collaboration continues to leverage Congruence’s computational drug discovery engine, Revenir, which systematically captures the biophysical features of proteins in different functional states to enable a highly differentiated approach to small-molecule discovery.

Congruence’s wholly owned program directed to MC4R-deficient genetic obesity is entering a Phase 1/1b clinical study this month. In the next few weeks, Congruence will also nominate development candidates for each of its programs directed to GBA1-driven Parkinson’s Disease and Alpha-1 Antitrypsin deficiency.

"Congruence’s advanced computational discovery engine is attracting growing global attention with its lead program entering clinical development. We are honored that our ongoing collaboration with Congruence is expanding beyond oncology to other priority areas including both neurology and immunology," said Seishi Katsumata, Corporate Officer / Executive Director, Discovery & Research of Ono. "Through this partnership, we will be committed to accelerating the drug development so that we can deliver innovative new medicines to patients with unmet medical needs as quickly as possible."

Under the terms of the new agreement announced today, Congruence will receive an upfront payment and is eligible to receive additional payments upon the achievement of certain milestones in discovery, development, approval and commercialization – in addition to tiered royalties based on annual net sales of related products. Moreover, Ono will reimburse Congruence for the internal and external research costs it incurs in connection with the activities undertaken in the expanded partnership.

About Revenir Drug Discovery Platform

Revenir, Congruence’s proprietary computational drug discovery platform, captures the dynamic biophysical changes of proteins in different functional states, offering unique insights into protein function and their modulation. By examining surface features and a spectrum of biophysical descriptors across an ensemble of protein conformers, Revenir predicts small molecule induced modulation of underlying physiologic protein states. This platform-driven strategy underpins Congruence’s growing pipeline of first-in-class and best-in-class programs directed to genetically validated targets implicated in conditions associated with significant unmet medical need, supporting a readily scalable and repeatable value creation paradigm.

(Press release, Congruence Therapeutics, MAR 2, 2026, View Source [SID1234663173])

On March 2, 2026 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI/ML, reported financial results for the fourth quarter and full year 2025 and provided a corporate update.

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"We delivered important progress in 2025, highlighted by the extension of our cash runway into 2029 through a non-dilutive monetization agreement with AstraZeneca for rilvegostomig," said Eran Ophir, Ph.D., President and CEO of Compugen. "This strategic transaction strengthens our cash position while preserving the potential for significant long-term value of a multi-billion-dollar asset being advanced by AstraZeneca across 10 Phase 3 clinical trials in lung, gastrointestinal and endometrial cancers with further clinical data anticipated from Phase 1/2 clinical trials in 2026."

Dr. Ophir continued, "Across our pipeline, we continue to execute with discipline. In 2025, we initiated dosing in new clinical trials of COM701 MAIA-ovarian and of GS-0321 Phase 1 and expanded our clinical footprint across the U.S., Israel and France in the MAIA-ovarian clinical trial. At ESMO (Free ESMO Whitepaper) 2025, we presented pooled COM701 data from 3 platinum resistant ovarian cancer trials that we believe support the rationale for our MAIA-ovarian trial, evaluating COM701 as maintenance therapy in platinum sensitive ovarian cancer in a setting of significant unmet medical need with no current standard of care. We are on track to have interim analysis in Q1 2027. In parallel, we are advancing our Phase 1 trial of GS-0321, an anti-IL18BP antibody licensed to Gilead which utilizes a differentiated cytokine-based approach. Additionally, we continue to invest in multiple early-stage discovery programs, advancing potential breakthrough drug candidates against undisclosed drug targets."

Dr. Ophir concluded, "We enter 2026 uniquely positioned with a strengthened balance sheet, a validated computational AI/ML discovery engine, a clinical pipeline built on differentiated innovative biology, enhanced leadership and two validating partnerships with AstraZeneca and Gilead representing up to $1 billion in potential milestone payments in addition to future royalties. I am incredibly proud of what our team has delivered and excited for what lies ahead."

Fourth Quarter and Full Year 2025 Financial Highlights
Cash: As of December 31, 2025, Compugen had approximately $145.6 million in cash, cash equivalents, short-term bank deposits and investment in marketable securities. The cash balance at the end of 2025 includes the receipt of the upfront payment of $65 million from AstraZeneca for the monetization of a small portion of rilvegostomig royalties.

Key Highlights from Royalty Monetization Deal with AstraZeneca:

•
$65 million upfront payment and $25 million added to the next potential milestone payment upon BLA acceptance, for a small portion of Compugen’s existing royalty interest in rilvegostomig
•
Compugen retains the majority of its future royalties and remains eligible for tiered royalties of up to mid-single digits on future sales and potential future regulatory and commercial milestones of up to $195 million (amount includes the $25 million stated above)

Compugen currently expects that its current cash balances will be sufficient to fund its operating plans into 2029. The Company has no debt.

Revenues: Compugen reported approximately $67.3 million in revenues for the fourth quarter of 2025 and approximately $72.8 million in revenues for the year ended December 31, 2025, compared to approximately $1.5 million in revenues for the fourth quarter of 2024 and approximately $27.9 million in revenues for the year ended December 31, 2024. The revenues for 2025 include the upfront payment of $65 million from AstraZeneca and the portion of the upfront payment and the IND milestone payment from the license agreement with Gilead, while the revenues for 2024 reflect the portion of the upfront payment and the IND milestone payment from the license agreement with Gilead and the $5 million clinical milestone payment from AstraZeneca.

Cost of Revenues for the fourth quarter and year ended December 31, 2025, were approximately $3.5 million and $9.3 million, respectively, compared with approximately $0.7 million and $7.9 million for the respective comparable periods in 2024. Cost of revenues for 2025 represents the cost of Phase 1 activities related to the license agreement with Gilead and royalties to the Israeli Innovation Authority (IIA) in connection with Compugen’s revenues from AstraZeneca, while cost of revenues for 2024 represents the cost of IND and Phase 1 activities related to the license agreement with Gilead and royalties to the IIA in connection with Compugen’s revenues from AstraZeneca, offset by royalty reversal in 2024 due to exemption received from the Israeli Innovation Authority from the requirement to pay royalties on income derived from potential sales associated with products related to IL-18BP.

R&D expenses for the fourth quarter and year ended December 31, 2025, decreased to approximately $5.5 million and $22.8 million, respectively, compared with approximately $5.9 million and $24.8 million for the comparable periods in 2024, respectively. The decrease in 2025 was mainly due to lower clinical expenses resulting from winding down prior clinical trials, partially offset by an increase in clinical expenses related to MAIA-ovarian trial initiated in 2025.

G&A expenses for the fourth quarter ended December 31, 2025, were approximately $2.1 million compared with approximately $2.2 million for the comparable period in 2024, and the G&A expenses for the year ended December 31, 2025, were approximately $8.9 million compared with approximately $9.4 million for the comparable period in 2024.

Net Income / Loss: During the fourth quarter of 2025, Compugen reported a net profit of approximately $56.8 million, or approximately 60 cents per basic and diluted share, compared to a net loss of approximately $6.1 million, or approximately 7 cents per basic and diluted share in the comparable period of 2024. Net profit for the year ended December 31, 2025, was approximately $35.3 million, or approximately 38 cents per basic and diluted share, compared with a net loss of approximately $14.2 million, or approximately 16 cents per basic and diluted share in the comparable period in 2024.

Full financial tables are included below.

Conference Call and Webcast Information
The Company will hold a conference call today, March 2, 2026, at 8:30 AM ET to review its fourth quarter and full year 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.

(Press release, Compugen, MAR 2, 2026, View Source [SID1234663172])

On March 2, 2026 Cerus Corporation (Nasdaq: CERS) reported financial results for its full year and fourth quarter ended December 31, 2025.

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"Our strong 2025 results reflect our disciplined execution, as we continued to deliver on our mission of safeguarding the world’s blood supply. This past year, we achieved our highest annual kit shipments, enabling an estimated 600,000 patients worldwide to receive INTERCEPT-treated blood components," said William "Obi" Greenman, Cerus’ president and chief executive officer. "This translated into record product revenue of over $206 million, a narrowing of our GAAP net loss, and positive non-GAAP adjusted EBITDA for the second consecutive year. Looking ahead to 2026, we remain focused on improving global access to our INTERCEPT technologies, advancing our product development programs and building upon the solid financial foundation we have established."

Additional highlights include:

Full-year 2025 and fourth-quarter 2025 total revenue comprised of (in millions, except percentages):
Three Months Ended

Twelve Months Ended

December 31,

Change

December 31,

Change

2025

2024

$

%

2025

2024

$

%

Product Revenue

$

57.8

$

50.8

$

7.0

14%

$

206.1

$

180.3

$

25.8

14%

Government Contract Revenue

6.8

5.9

0.9

15%

27.7

21.1

6.6

31%

Total Revenue

$

64.6

$

56.8

$

7.8

14%

$

233.8

$

201.3

$

32.5

16%

Numbers may not sum due to rounding. Percentages calculated from unrounded figures.

INTERCEPT Fibrinogen Complex (IFC) demand increased during the fourth quarter, with fourth quarter volumes – including kits and finished therapeutic doses (measured in FC15* equivalent units) – up over 50% compared to the prior year period. Fourth quarter U.S. IFC sales totaled $4.2 million, up from $3.0 million in the prior year period. For full year 2025, IFC demand more than doubled compared to 2024, while revenue increased approximately 80% to $16.7 million.
Entered into a group purchasing agreement with Blood Centers of America (BCA) during the fourth quarter, covering the Company’s licensed product portfolio. BCA is the largest blood supply cooperative in the U.S., with its member centers collecting and distributing approximately 50% of the nation’s blood supply.
Recently announced the start of the INITIATE study by the German Red Cross Blood Donation Service Baden-Württemberg – Hessen. INITIATE is a Phase 4 study evaluating the routine clinical use in Germany of pathogen-inactivated platelets utilizing the INTERCEPT Blood System.
Not including government grant revenue, the Company expects full-year 2026 product revenue to grow 9% to 11% year over year.
Cash, cash equivalents, and short-term investments were $82.9 million at December 31, 2025.
Revenue

Product revenue for the fourth quarter of 2025 was $57.8 million, compared to $50.8 million for the prior year period, representing year-over-year growth of 14%. Fourth quarter growth was primarily driven by strength in EMEA across the platelets franchise and continued rollout of INT200, as well as increased U.S. IFC sales. Product revenue for the full year 2025 was $206.1 million, compared to $180.3 million for the prior year, representing 14% growth. Full-year growth was driven by continued expansion of the Company’s global platelet products, increased U.S. IFC sales, and the launch of INT200 in EMEA.

Government contract revenue for the fourth quarter of 2025 was $6.8 million, compared to $5.9 million during the prior year period. Full year 2025 government contract revenue was $27.7 million, compared to $21.1 million during the prior year period. The increase in fourth quarter and full year government contract revenue was largely driven by BARDA-related projects.

Product Gross Profit and Margin

Product gross profit for the fourth quarter of 2025 was $29.7 million, increasing by 9% over the prior year period. Product gross margin for the fourth quarter of 2025 was 51.5% compared to 53.9% in the same period last year. Full-year 2025 product gross profit was $112.3 million, representing 13% growth compared to 2024. Full-year product gross margin was 54.5%, compared to 55.2% in the prior year. Higher IFC therapeutic production costs, ongoing trade regulation and inflationary pressures, as well as foreign exchange rates contributed to the change in product gross margin percentage compared to the prior year for both periods.

Operating Expenses

Total operating expenses for the fourth quarter of 2025 were $37.2 million, compared to $34.8 million in the same period of the prior year, representing a 7% year-over-year increase. For the full year 2025, total operating expenses were $148.6 million, compared to $134.8 million in 2024.

Research and development (R&D) expenses for the fourth quarter of 2025 were $16.4 million, compared to $15.4 million in the prior year period. For the full year 2025, R&D expenses totaled $67.7 million, compared to $58.9 million in 2024. Higher government contract costs and workforce-related costs contributed to the increase in R&D expenses for the fourth quarter. For the full year, the increase was driven by the same factors as well as increased development costs associated with the Company’s red blood cell and INT200 programs.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2025 were $20.8 million, compared to $19.3 million in the prior year period. For the full year 2025, SG&A expenses totaled $80.9 million, compared to $75.9 million for the full year 2024.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation narrowed for the fourth quarter of 2025 and was $2.2 million, or $0.01 per basic and diluted share, compared to $2.5 million, or $0.01 per basic and diluted share, for the fourth quarter of 2024.

For the full year 2025, net loss attributable to Cerus Corporation was $15.6 million, or $0.08 per basic and diluted share, compared to $20.9 million, or $0.11 per basic and diluted share, in 2024.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the fourth quarter of 2025 was $3.4 million, compared to $3.3 million for the fourth quarter of 2024. Full-year 2025 non-GAAP adjusted EBITDA was $9.5 million, compared to $5.7 million in 2024. 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 and Cash Flows

At December 31, 2025, the Company had $82.9 million in cash, cash equivalents and short-term investments, compared to $80.5 million at December 31, 2024.

As of December 31, 2025, the Company had $65.0 million outstanding on its term loan and $19.0 million drawn on its revolving credit facility. The Company’s revolving line of credit allows for an additional $16.0 million as of December 31, 2025, which is dependent on eligible assets supporting the borrowing base.

For the fourth quarter of 2025, the Company generated $6.2 million in operating cash flow, compared to $4.9 million in the prior year period. The Company generated $8.1 million of operating cash flow in the second half of 2025 offsetting operating cash used during the first half of 2025. As a result, for the full year 2025, the Company generated $4.8 million in operating cash flow, compared to $11.4 million generated during 2024. These results were consistent with the Company’s previously communicated expectations which anticipated first-half cash use related to inventory investment, followed by stronger operating cash flow in the second half of 2025.

Reaffirming 2026 Product Revenue Guidance

The Company expects full-year 2026 product revenue to be in the range of $224 million to $228 million, representing year-over-year growth of 9% to 11% compared to 2025 product revenue. Included in the 2026 guidance range is expected full-year 2026 IFC revenue of $20 million to $22 million, representing year-over-year growth of approximately 20% to 30% from 2025.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. ET 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 approximately three hours after the call through March 23, 2026.

*FC15 equivalent to a therapeutic dose of a cryoAHF pool.

(Press release, Cerus, MAR 2, 2026, View Source [SID1234663171])