UroGen Pharma to Present at the TD Cowen 46th Annual Health Care Conference

UroGen Pharma to Present at the TD Cowen 46th Annual Health Care Conference




UroGen Pharma to Present at the TD Cowen 46th Annual Health Care Conference

PRINCETON, N.J., Feb. 24, 2026 (GLOBE NEWSWIRE) — UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will present at the TD Cowen 46th Annual Health Care Conference to take place March 2-4, 2026.

TD Cowen 46th Annual Health Care Conference

Date / Time: March 3, 2026, at 1:50 PM ET
Format: Presentation and 1×1 investor meetings
Location: Boston, MA
Webcast Link: here

The webcast from the conference will also be available on UroGen’s corporate website, under Events & Presentations. A replay will be available for approximately 30 days.

About UroGen Pharma Ltd.

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGen’s first product is approved to treat low-grade upper tract urothelial cancer, and UroGen’s second product is the first and only FDA-approved medication for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Both medicines are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X (Twitter), @UroGenPharma. 

INVESTORS:

Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@urogen.com
609-460-3588 ext. 1093

MEDIA:

Cindy Romano
Director, Corporate Communications
cindy.romano@urogen.com
609-460-3566 ext. 1083

Serina Therapeutics Announces Dosing of First Patient in Phase 1b Registrational Trial of SER-252 for Advanced Parkinson’s Disease

Serina Therapeutics Announces Dosing of First Patient in Phase 1b Registrational Trial of SER-252 for Advanced Parkinson’s Disease




Serina Therapeutics Announces Dosing of First Patient in Phase 1b Registrational Trial of SER-252 for Advanced Parkinson’s Disease

– Blinded evaluation of safety and tolerability data by the Safety Monitoring Committee from Cohort 1 and advancement to Cohort 2 is expected in 3Q 2026 –

– Advancement reflects continued execution of capital-efficient development strategy leveraging POZ Platform

HUNTSVILLE, AL, Feb. 24, 2026 (GLOBE NEWSWIRE) — Serina Therapeutics, Inc. (“Serina” or the “Company”) (NYSE American: SER), a clinical-stage biotechnology company advancing drug candidates enabled by its proprietary POZ Platform drug optimization technology, today announced that it has dosed the first patient in its Phase 1b registrational clinical trial evaluating SER-252 in patients with advanced Parkinson’s disease.

The Phase 1b registrational study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SER-252 in patients with advanced Parkinson’s disease whose symptoms are inadequately controlled by current standard-of-care therapies. Serina anticipates that blinded review of safety and tolerability by the Safety Monitoring Committee from Cohort 1 will allow advancement to Cohort 2 in the third quarter of 2026.

“Dosing the first patient represents an important inflection point for Serina as we begin generating clinical data with SER-252,” said Steve Ledger, Chief Executive Officer of Serina. “With FDA alignment on our 505(b)(2) NDA pathway and recognition of this Phase 1b trial as registrational, we are positioned to efficiently generate the clinical data necessary to bring SER-252 to market. We are grateful to our clinical investigators, the Parkinson’s community in Australia, and the patients who are making this trial possible.”

Serina has established relationships with Parkinson’s Australia and Neuroscience Trials Australia to support patient identification and enrollment activities. The Company plans to provide further updates on the trial as patient enrollment progresses.

Initial dosing activities are underway at global clinical sites, including Australia, where Serina has established strong investigator relationships to support efficient trial execution. The Company expects to provide additional clinical and operational updates as the study advances.

About Serina Therapeutics

Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina’s POZ Platform provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.

About the POZ Platform

Serina’s proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Serina’s POZ technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection. The therapeutic agents in Serina’s product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic profiles that can include toxicity, side effects and short half-life. Serina believes that by using POZ technology, drugs with narrow therapeutic windows can be designed to maintain more desirable and stable levels in the blood.

Serina’s POZ platform delivery technology has potential for use across a broad range of payloads and indications. Serina intends to advance additional applications of the POZ platform via out-licensing, co-development, or other partnership arrangements, including the non-exclusive license agreement with Pfizer, Inc. to use Serina’s POZ polymer technology for use in lipid nanoparticle drug (LNP) delivery formulations.

About SER-252 (POZ-apomorphine)

SER-252 is an investigational apomorphine therapy developed with Serina’s POZ platform and designed to provide continuous dopaminergic stimulation (CDS). CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) in Parkinson’s disease. Preclinical studies support the potential of SER-252 to provide CDS without skin reactions.

Cautionary Statement Regarding Forward-Looking Statements

This release contains forward-looking statements within the meaning of federal securities laws. All statements that are not historical fact, including statements about Serina’s planned clinical programs, including timing for patient enrollment and dosing, the potential of Serina’s POZ polymer technology, and the Company’s ability to advance its clinical trial, are forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These statements are based on management’s current expectations, plans, beliefs or forecasts for the future, and are subject to uncertainty and changes in circumstances. Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change.

Actual results may differ materially from those projected in such statements due to a variety of important factors including, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; Serina’s ability to continue as a going concern; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; and competitive developments. These risks as well as other risks are more fully discussed in the company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the company’s other periodic reports and documents filed from time to time with the SEC. The information contained in this release is as of the date hereof, and Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

For inquiries, please contact:
Stefan Riley
sriley@serinatherapeutics.com
(256) 327-9630

BridgeBio Reports Fourth Quarter and Full Year 2025 Financial Results and Commercial Updates

BridgeBio Reports Fourth Quarter and Full Year 2025 Financial Results and Commercial Updates




BridgeBio Reports Fourth Quarter and Full Year 2025 Financial Results and Commercial Updates

  • $154.2 million in total fourth quarter revenues, net, and $502.1 million in full year revenues, net, primarily comprised of net product revenue of $146.0 million and $362.4 million, respectively
  • BridgeBio reported three positive Phase 3 trial readouts in just over three months, a demonstration of its unique model for sustainable drug development as described in a recent peer-reviewed manuscript
  • Attruby continues to demonstrate clinical differentiation as a first-choice therapy in ATTR-CM with the greatest TTR stabilization on the market (≥90%) and the most rapid benefit on clinical outcomes observed within 1 month, with 7,804 unique patient prescriptions written by 1,856 unique prescribers as of February 20, 2026
  • PROPEL 3 for oral infigratinib successfully met its primary endpoint (p<0.0001). The change from baseline in AHV was superior to placebo at Week 52, with a mean treatment difference against placebo of +2.10 cm/year; topline results showed the first statistically significant improvements in body proportionality in achondroplasia
  • Positive interim Phase 3 FORTIFY results for BBP-418 in LGMD2I/R9 demonstrated a statistically significant and clinically meaningful 2.6-point NSAD improvement versus placebo at 12 months; FDA recommended pursuing traditional approval, supporting a planned 1H 2026 NDA submission and a U.S. launch anticipated in late 2026/early 2027
  • On track for a 1H 2026 NDA submission following positive Phase 3 CALIBRATE results for encaleret in ADH1 and successful completion of a pre-NDA meeting with FDA; U.S. launch anticipated in late 2026/early 2027
  • $587.5 million in cash, cash equivalents, and marketable securities as of December 31, 2025; additionally, the Company completed issuance of $632.5 million aggregate principal amount of 2033 convertible notes in January 2026, positioning it to fund planned commercial and pipeline operations

PALO ALTO, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today its financial results for the fourth quarter and full year ended December 31, 2025, and provided an update on Attruby’s commercial progress.

Pipeline Overview:

Program Status Next expected milestone
Acoramidis for ATTR-CM Approved in U.S., E.U., Japan, Switzerland, and U.K. New OLE data to be shared at ACC Scientific Sessions
BBP-418 for LGMD2I/R9 FORTIFY, Phase 3 study positive interim analysis topline results released Submit NDA to FDA in 1H 2026
Encaleret for ADH1 CALIBRATE, Phase 3 study positive topline results released Submit NDA to FDA in 1H 2026
Infigratinib for achondroplasia PROPEL 3, Phase 3 study positive topline results released Submit NDA to FDA in 2H 2026
Encaleret for chronic hypoparathyroidism Phase 2 proof-of-principle study and FDA End of Phase 2 interaction completed Phase 3 study to be initiated in 2H 2026
Infigratinib for hypochondroplasia ACCEL 2/3, Phase 2 portion enrollment completed Phase 2 data in 2H 2026
Depleter for ATTR-CM Development candidate nomination Submit IND to the FDA in 2027

“As we close our first decade at BridgeBio, we’re reflecting on just how far we’ve come – from a bold idea about a new type of biotech rooted in a hub-and-spoke model to a company with incredible commercial strength and multiple late-stage successes. In a little over three months, we’ve delivered three successful Phase 3 readouts, a testament to the rigor of our science, the dedication of our teams, and the trust of the patients and physicians we serve. In all, we hope this leads to 6 approved products as our first decade draws to a close. I am excited not only to live up to our responsibilities against these assets but further to see if we can do even better,” said Co-Founder and CEO, Neil Kumar, Ph.D.

Corporate Updates:

  • BridgeBio published its unique model for sustainable drug development in a peer-reviewed Drug Discovery Today manuscript, highlighting its ability to reduce asset-level risk, improve clinical success rates through genetic validation, and enhance capital efficiency to drive sustainable growth. This builds on the recent case studies at Harvard and MIT and BridgeBio case study published in 2024 as a peer reviewed manuscript in Journal of Portfolio Management that elucidates the BridgeBio approach.
  • In January 2026, BridgeBio completed issuance of $632.5 million aggregate principal amount Convertible Senior Notes due 2033. This transaction is part of BridgeBio’s strategy to lower interest expense, reduce dilution, and significantly extend debt maturity.
  • With the reauthorization of the Rare Pediatric Review Voucher (PRV) program, BBP-418, BBP-812, and infigratinib, each of which has received Rare Pediatric Disease designation, may be eligible to receive PRV upon approval. A PRV may be used to shorten the FDA review timeline for a subsequent drug application from 10 months to 6 months or can be sold upon receipt to another company.

Commercial Updates:

As of February 20, 2026, 7,804 unique patient prescriptions have been written by 1,856 unique prescribers since FDA approval in November 2024. The fourth quarter total revenues, net totaled $154.2 million, comprised of $146.0 million of U.S. Attruby net product revenue, $5.3 million from royalty revenue, and $2.9 million in license and services revenue. The full year 2025 net product revenue was $362.4 million.

“2025 reflected strong commercial momentum for Attruby and an important step forward as we advance three additional medicines toward potential commercialization,” said Matt Outten, Chief Commercial Officer of BridgeBio. “Attruby delivered 35% quarter-over-quarter growth in net product revenue in Q4, driven by its differentiated profile as the only near-complete stabilizer on the market, continued prescribing growth, repeat use, and patient persistence that has exceeded our expectations. As we prepare for the potential launches of BBP-418, encaleret, and infigratinib, we are intentionally applying the learnings established with Attruby. When successful, these approvals will bring BridgeBio to achieving six approved medicines, which marks a significant milestone for our platform and positions us to extend our impact to even more patients with genetic conditions.”

Pipeline Updates:

Attruby (acoramidis) First and only near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM):

  • At the American Heart Association (AHA) Scientific Sessions 2025, data from the ATTRibute-CM study showed that acoramidis significantly reduces all-cause mortality through Month 42 in the overall variant ATTR-CM population, and specifically in the p.Val142Ile (V142I, V122I) subpopulation. The V142I variant disproportionately affects individuals of Western African ancestry, with a carrier frequency of 3-4% in the U.S. Black population. These data were simultaneously published in JAMA Cardiology.1
  • More data on Attruby will be shared at the American College of Cardiology (ACC) Annual Scientific Sessions & Expo in March 2026 and in additional medical congresses throughout 2026.

________________
1 https://jamanetwork.com/journals/jamacardiology/fullarticle/2841140

BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):

  • FORTIFY, the Phase 3 clinical trial of BBP-418, successfully achieved all primary and secondary endpoints of its interim analysis. The topline results can be found here.
  • Based on the statistically significant and clinically meaningful interim analysis results, BridgeBio intends to submit an NDA to the FDA for traditional approval in the first half of 2026 with a U.S. launch anticipated in late 2026/early 2027.
  • Claudia Bujold, RN, MBA, joined the Company as Senior Vice President of Sales and Marketing to lead the U.S. commercial launch of BBP-418. Claudia brings more than 25 years of global commercialization experience and led the strategy and execution for multiple launches in both broad markets (Kisqali for early breast cancer) and rare conditions (Skyclarys for Friedreich’s Ataxia).
  • Based on the FORTIFY interim analysis results, BridgeBio is also engaging regulatory agencies to identify an expedited path to approval for BBP-418 in Europe.
  • If successful, BBP-418 could be the first approved therapy for individuals living with LGMD2I/R9, potentially representing the first approval of a therapy for any form of LGMD.
  • The Company intends to initiate clinical studies of BBP-418 in LGMD2I/R9 for individuals less than 12 years of age and in LGMD2M/2U in the near future.

Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism:

  • CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, successfully achieved all pre-specified primary and key secondary efficacy endpoints. The topline results can be found here.
  • BridgeBio has successfully completed a pre-NDA interaction and intends to submit an NDA to the FDA in the first half of 2026, and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) to follow.
  • The Company anticipates a U.S. launch in late 2026/early 2027. If approved, encaleret would be the first therapy indicated specifically for individuals living with ADH1.
  • Jeron Evans joined the Company as Senior Vice President of Sales and Marketing to lead the U.S. commercial launch of encaleret. Jeron brings more than 30 years of global commercialization experience across biopharma, medtech, and diagnostics.
  • Diagnosis of ADH1 in the U.S. has accelerated with >1,700 unique patients claimed under the dedicated ICD-10 code (E20.810) during the 24-month period from October 2023-2025.
  • The Company initiated CALIBRATE-PEDS, a registrational Phase 2/3 study of encaleret in pediatric ADH1.
  • The Company also plans to initiate RECLAIM-HP, a Phase 3 study of encaleret in chronic hypoparathyroidism in the second half of 2026.

Infigratinib – FGFR3 inhibitor:

  • PROPEL 3, the Phase 3 clinical trial of infigratinib in achondroplasia, successfully achieved its pre-specified primary efficacy endpoint of change from baseline in absolute height velocity (AHV) at Week 52 (p<0.0001). In addition, infigratinib showed the first statistically significant improvement in body proportionality against placebo in achondroplasia in children 3 to younger than 8 years old in a pre-specified exploratory analysis. The topline results can be found here.
  • Based on the statistically significant data, BridgeBio intends to submit an NDA to the FDA and a MAA to the EMA in the second half of 2026. If approved, the Company plans to launch in early to mid 2027.
  • Aaron McIlwain joined the Company as Senior Vice President, Sales and Marketing to lead the U.S. commercial launch of infigratinib for achondroplasia. Previously, Aaron was the global ATTR brand lead for Ionis Pharmaceuticals. He also brings over 20 years of commercial rare disease launch experience from Turning Point Therapeutics, Gilead, and Genentech.
  • The Company also intends to accelerate the development of infigratinib for hypochondroplasia and is enrolling participants in the observational run-in study for the Phase 3 trial. The Phase 2 data is expected in the second half of 2026.
  • If successful, infigratinib would be the first approved oral therapy option for children living with achondroplasia or with hypochondroplasia.

Financial Updates:

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities totaled $587.5 million as of December 31, 2025, compared to cash and cash equivalents of $681.1 million as of December 31, 2024. The $93.6 million decrease is primarily attributable to net cash used in operating activities of $445.9 million for the year ended December 31, 2025, the repayment of the Company’s previous term loan under its credit facility (including prepayment fees) of $459.0 million in February 2025, the repurchase of common stock of $48.3 million using proceeds from the 2031 Notes in February 2025, and payments for deferred royalty obligations of $15.5 million. These outflows were partially offset by net proceeds of $563.0 million from the issuance of the 2031 Notes in February 2025, net proceeds of $297.0 million from the execution of the Royalty Interest Purchase and Sale Agreement with HealthCare Royalty, a related party, and Blue Owl Capital in June 2025, and $19.9 million in net proceeds from equity incentive plan activities.

Total Revenues, Net

  Three Months Ended December 31, Years Ended December 31,
    2025     2024     2025     2024
  (in thousands)
Net product revenue $ 146,017   $ 2,884   $ 362,368   $ 2,884
License and services revenue   2,881     2,829     128,322     218,849
Royalty revenue   5,280     169     11,386     169
Total revenues, net $ 154,178   $ 5,882   $ 502,076   $ 221,902
                       

Total revenues, net for the three months ended December 31, 2025 were $154.2 million compared to $5.9 million for the same period in the prior year. The $148.3 million increase was primarily driven by a $143.1 million increase in net product revenue from Attruby, a $5.1 million increase in royalty revenue primarily earned on net product sales of BEYONTTRA in the EU and Japan, and a $0.1 million increase in license and services revenue.

Total revenues, net for the year ended December 31, 2025 was $502.1 million compared to $221.9 million in the prior year. The $280.2 million increase was primarily driven by a $359.5 million increase in net product revenue from Attruby and an $11.2 million increase in royalty revenue primarily earned on net product sales of BEYONTTRA in the EU and Japan. These increases were partially offset by a $90.5 million decrease in license and services revenue, reflecting the timing of recognition of upfront payments from the Company’s exclusive license agreements with collaboration partners as well as regulatory-related milestones recognized upon the approval of BEYONTTRA in the EU and pricing approval in Japan.

Operating Costs and Expenses

  Three Months Ended December 31, Years Ended December 31,
    2025     2024     2025     2024
  (in thousands)
Total cost of revenues $ 8,107   $ 2,084   $ 20,962   $ 3,878
Research and development   116,417     130,350     451,953     506,461
Selling, general and administrative   158,085     94,782     531,225     288,931
Restructuring, impairment, and related charges   11,131     4,693     21,347     15,605
Total operating costs and expenses $ 293,740   $ 231,909   $ 1,025,487   $ 814,875
                       

Operating costs and expenses for the three months ended December 31, 2025 were $293.7 million compared to $231.9 million for the same period in the prior year. The $61.8 million increase was primarily driven by a $63.3 million increase in selling, general and administrative (“SG&A”) expenses largely reflecting the Company’s investments in support of the commercial launch and ongoing activities of Attruby, a $6.4 million increase in restructuring, impairment, and related charges as a result of the Company’s reprioritization of its research and development (“R&D”) programs, and a $6.0 million increase in total cost of revenues, primarily due to the product costs of Attruby and royalty and license costs associated with BEYONTTRA net sales. These increases were partially offset by a $13.9 million decrease in R&D expenses primarily due to decreased R&D activities related to the Attruby and BEYONTTRA program following regulatory approval, the Company’s reprioritization of its R&D programs, and license fees incurred in 2024 related to program advancements.

Operating costs and expenses for the year ended December 31, 2025 were $1.0 billion compared to $814.9 million in the prior year. The $210.6 million increase was primarily driven by a $242.3 million increase in SG&A largely reflecting the Company’s investments to support the commercial launch and ongoing activities of Attruby, a $17.1 million increase in total cost of revenues primarily due to the product costs of Attruby and royalty and license costs associated with BEYONTTRA net sales, and a $5.7 million increase in restructuring, impairment, and related charges as a result of the Company’s reprioritization of its R&D programs. The increases were partially offset by a $54.5 million decrease in R&D expenses primarily due to decreased R&D activities related to the Attruby and BEYONTTRA program following regulatory approval, the Company’s reprioritization of its R&D programs, and license fees incurred in 2024 related to program advancements.

Stock-based compensation expenses included in operating costs and expenses for the three months ended December 31, 2025 were $34.9 million, of which $21.6 million was included in SG&A expenses, $11.7 million was included in R&D expenses, $0.9 million was included in restructuring impairment and related charges, and $0.7 million was included in cost of goods sold. Stock-based compensation expenses included in operating costs and expenses for the same period in 2024 were $36.4 million, of which $16.4 million was included in SG&A expenses and $20.0 million was included in R&D expenses.

Stock-based compensation expenses included in operating costs and expenses for the year ended December 31, 2025 were $136.9 million, of which $84.6 million was included in SG&A expenses, $49.3 million was included in R&D expenses, $1.7 million was included in restructuring impairment and related charges, and $1.3 million was included in cost of goods sold. Stock-based compensation expenses included in operating costs and expenses for the prior year were $113.9 million, of which $63.9 million was included in SG&A expenses, $49.8 million was included in R&D expenses, and $0.2 million was included in restructuring, impairment and related charges.

Total Other Income (Expense), Net

Total other income (expense), net for the three months and year ended December 31, 2025, was $(55.2) million and $(209.1) million, respectively, compared to $(40.2) million and $50.8 million, respectively, for the same periods in the prior year.

The change in total other income (expense), net of $(15.0) million for the three months ended December 31, 2025, compared to the same period in the prior year was primarily due to a $30.4 million increase in noncash interest expense on deferred royalty obligations and a $4.3 million increase in net loss from equity method investments; partially offset by a $9.9 million decrease in interest expense and a $10.2 million increase in other income primarily related to the change in fair value of our derivative liability.

The change in total other income (expense), net of $259.9 million for the year ended December 31, 2025, compared to the prior year was primarily due to a $178.3 million decrease in gain on deconsolidation of subsidiaries, a $116.8 million increase in noncash interest expense on deferred royalty obligations, and a $41.4 million increase in net loss from equity method investments. These increases were partially offset by a $37.9 million decrease in interest expense, a $19.7 million increase in other income for the change in fair value of our derivative liability, a $11.1 million increase in other income primarily due to gains related to our equity method and equity security investments, and a $5.4 million decrease in loss on extinguishments of debt.

Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share

For the three months and year ended December 31, 2025, the Company recorded a net loss attributable to common stockholders of BridgeBio of $192.9 million and $724.9 million, respectively, compared to $265.1 million and $535.8 million, respectively, for the same periods in the prior year.

For the three months and year ended December 31, 2025, the Company reported a net loss per share of $1.00 and $3.78, respectively, compared to $1.40 and $2.88, respectively, for the same periods in the prior year.

 
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share amounts)
 
  Three Months Ended December 31,   Years Ended December 31,
    2025       2024       2025       2024  
  (Unaudited)     (1)     (Unaudited)     (1)  
Revenues:              
Net product revenue $ 146,017     $ 2,884     $ 362,368     $ 2,884  
License and services revenue   2,881       2,829       128,322       218,849  
Royalty revenue   5,280       169       11,386       169  
Total revenues, net   154,178       5,882       502,076       221,902  
Operating costs and expenses:              
Cost of revenues:              
Cost of goods sold   6,777       1,442       15,687       1,442  
Cost of license, services, and royalty revenue   1,330       642       5,275       2,436  
Total cost of revenues   8,107       2,084       20,962       3,878  
Research and development   116,417       130,350       451,953       506,461  
Selling, general and administrative   158,085       94,782       531,225       288,931  
Restructuring, impairment, and related charges   11,131       4,693       21,347       15,605  
Total operating costs and expenses   293,740       231,909       1,025,487       814,875  
Loss from operations   (139,562 )     (226,027 )     (523,411 )     (592,973 )
Other income (expense), net:              
Interest income   4,332       4,683       19,854       17,249  
Interest expense   (11,636 )     (21,522 )     (53,103 )     (90,991 )
Noncash interest expense on deferred royalty obligations (2)   (38,678 )     (8,299 )     (125,138 )     (8,299 )
Gain on deconsolidation of subsidiaries                     178,321  
Loss on extinguishments of debt               (21,155 )     (26,590 )
Net loss from equity method investments   (21,029 )     (16,695 )     (72,608 )     (31,183 )
Other income, net   11,818       1,624       43,058       12,272  
Total other income (expense), net   (55,193 )     (40,209 )     (209,092 )     50,779  
Loss before income taxes   (194,755 )     (266,236 )     (732,503 )     (542,194 )
Provision for (benefit from) income taxes   (120 )     1,153       435       1,153  
Net loss   (194,635 )     (267,389 )     (732,938 )     (543,347 )
Net loss attributable to redeemable convertible noncontrolling
interests and noncontrolling interests
  1,772       2,339       8,007       7,585  
Net loss attributable to common stockholders of BridgeBio $ (192,863 )   $ (265,050 )   $ (724,931 )   $ (535,762 )
Net loss per share attributable to common stockholders of
BridgeBio, basic and diluted
$ (1.00 )   $ (1.40 )   $ (3.78 )   $ (2.88 )
Weighted-average shares used in computing net loss per share
attributable to common stockholders of BridgeBio, basic
and diluted
  193,552,280       189,437,438       191,527,482       186,075,873  

(1)   The condensed consolidated financial statements as of and for the year ended December 31, 2024 are derived from the audited consolidated financial statements as of that date.
(2)   Including related party amounts of $(5,383) and $(10,944) for the three months and year ended December 31, 2025, respectively.

  Three Months Ended December 31,   Years Ended December 31,
Stock-based Compensation   2025     2024     2025     2024
  (Unaudited)     (1)   (Unaudited)     (1)
Cost of goods sold $ 687   $   $ 1,265   $
Research and development   11,685     20,004     49,267     49,844
Selling, general and administrative   21,579     16,351     84,656     63,862
Restructuring, impairment and related charges   939     79     1,694     160
Total stock-based compensation $ 34,890   $ 36,434   $ 136,882   $ 113,866

(1)   The condensed consolidated financial statements as of and for the year ended December 31, 2024 are derived from the audited consolidated financial statements as of that date.

BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets
(In thousands)
 
  December 31,
2025
  December 31,
2024
  (Unaudited)     (1)  
Assets      
Cash, cash equivalents and marketable securities $ 587,482     $ 681,101  
Accounts receivable, net   139,444       4,722  
Inventories   26,753        
Prepaid expenses and other current assets   44,070       34,869  
Equity method investments   79,972       143,747  
Property and equipment, net   5,366       7,011  
Operating lease right-of-use assets   8,149       5,767  
Intangible assets, net   28,077       23,926  
Other assets   16,712       18,195  
Total assets $ 936,025     $ 919,338  
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit      
Accounts payable $ 36,228     $ 9,618  
Accrued and other current liabilities (2)   238,361       125,672  
Operating lease liabilities   10,003       9,202  
Deferred revenue   20,270       31,699  
2031 Notes, net   564,565        
2029 Notes, net   740,890       738,872  
2027 Notes, net   547,015       545,173  
Term loan, net         437,337  
Deferred royalty obligations, net (3)   855,030       479,091  
Other long-term liabilities   244       286  
Redeemable convertible noncontrolling interests   (570 )     142  
Total BridgeBio stockholders’ deficit   (2,086,610 )     (1,467,904 )
Noncontrolling interests   10,599       10,150  
Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit $ 936,025     $ 919,338  

(1)   The condensed consolidated financial statements as of and for the year ended December 31, 2024 are derived from the audited consolidated financial statements as of that date.
(2)   Including a related party amount of $2,003 as of December 31, 2025.
(3)   Including a related party amount of $204,650 as of December 31, 2025.

BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
 
  Years Ended December 31,
    2025       2024  
  (Unaudited)     (1)  
Operating activities:      
Net loss $ (732,938 )   $ (543,347 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Stock-based compensation   133,024       95,800  
Loss on extinguishments of debt   21,155       26,590  
Noncash interest expense on deferred royalty obligations (2)   125,138       8,299  
Amortization of debt discount and issuance costs   5,967       7,464  
Depreciation and amortization   5,434       6,075  
Noncash lease expense   4,902       4,110  
Net loss from equity method investments   72,608       31,183  
Change in fair value of the embedded derivative associated with the deferred royalty obligation   (19,652 )     (1,550 )
Noncash income from equity method investments   (8,833 )      
Gain on deconsolidation of subsidiaries         (178,321 )
Gain from investment in equity securities, net         (8,136 )
Other noncash adjustments, net   (1,651 )     (935 )
Changes in operating assets and liabilities:      
Accounts receivable, net   (134,722 )     (2,971 )
Inventories   (25,307 )      
Prepaid expenses and other current assets   (8,777 )     (13,918 )
Other assets   1,113       1,542  
Accounts payable   26,609       1,512  
Accrued compensation and benefits   23,022       16,986  
Accrued research and development liabilities   7,163       8,729  
Operating lease liabilities   (6,547 )     (5,902 )
Deferred revenue   (11,428 )     21,875  
Other liabilities (3)   77,810       4,189  
Net cash used in operating activities   (445,910 )     (520,726 )
Investing activities:      
Purchases of marketable securities   (28,197 )     (93,811 )
Maturities of marketable securities   11,000       95,000  
Purchases of investments in equity securities         (20,271 )
Proceeds from sales of investments in equity securities         63,229  
Proceeds from special cash dividends received from an investment in equity securities   2,302       25,682  
Payment for intangible assets   (8,495 )     (7,975 )
Purchases of property and equipment   (1,097 )     (933 )
Decrease in cash and cash equivalents resulting from deconsolidation of subsidiaries         (140 )
Net cash provided by (used in) investing activities   (24,487 )     60,781  
Financing activities:      
Proceeds from issuance of 2031 Notes   575,000        
Issuance costs and discounts associated with 2031 Notes   (12,034 )      
Repurchase of common stock   (48,276 )      
Proceeds from a royalty obligation under the Royalty Purchase Agreement   300,000        
Issuance costs associated with a royalty obligation under the Royalty Purchase Agreement   (3,010 )      
Proceeds from royalty obligation under Funding Agreement         500,000  
Issuance costs and discounts associated with royalty obligation under Funding Agreement         (27,513 )
Proceeds from term loan under the Amended Financing Agreement         450,000  
Issuance costs and discounts associated with term loan under the Amended Financing Agreement         (15,986 )
Repayment of term loans   (459,000 )     (473,417 )
Repayments of deferred royalty obligations (4)   (15,460 )      
Proceeds from issuance of common stock through public offerings, net         314,741  
Proceeds from common stock issuances under ESPP   6,414       4,502  
Proceeds from stock option exercises, net of repurchases   27,735       3,656  
Transactions with noncontrolling interests   2,150        
Repurchase of RSU shares to satisfy tax withholding   (14,226 )     (7,526 )
Net cash provided by financing activities   359,293       748,457  
Net increase (decrease) in cash, cash equivalents, and restricted cash   (111,104 )     288,512  
Cash, cash equivalents, and restricted cash at beginning of year   683,244       394,732  
Cash, cash equivalents, and restricted cash at end of year $ 572,140     $ 683,244  

(1)   The condensed consolidated financial statements as of and for the year ended December 31, 2024 are derived from the audited consolidated financial statements as of that date.
(2)   Including a related party amount of $10,944 for the year ended December 31, 2025.
(3)   Including a related party amount of $2,003 for the year ended December 31, 2025.
(4)   Including a related party amount of $(2,295) for the year ended December 31, 2025.

  Years Ended December 31,
    2025       2024  
  (Unaudited)     (1)  
Supplemental Disclosure of Cash Flow Information:      
Cash paid for interest $ 43,670     $ 91,342  
Cash paid for income taxes $ 1,198     $  
Supplemental Disclosures of Noncash Investing and Financing Information:      
Unpaid property and equipment $ 43     $ 279  
Transfers to noncontrolling interests $ (5,594 )   $ (5,819 )
Reconciliation of Cash, Cash Equivalents and Restricted Cash:      
Cash and cash equivalents $ 570,119     $ 681,101  
Restricted cash — Included in “Prepaid expenses and other current assets”   550       126  
Restricted cash — Included in “Other assets”   1,471       2,017  
Total cash, cash equivalents and restricted cash at end of years shown in the consolidated
statements of cash flows
$ 572,140     $ 683,244  

(1)   The condensed consolidated financial statements as of and for the year ended December 31, 2024 are derived from the audited consolidated financial statements as of that date.

Webcast Information
BridgeBio will host a conference call and webcast to discuss fourth quarter and full year 2025 financial results today, February 24, 2026, at 4:30 pm ET. This event can be accessed at https://events.q4inc.com/attendee/547644683 or by visiting the “Events & Presentations” page within the Investors section of the BridgeBio website at http://investor.bridgebio.com. A replay of the webcast will be available on the BridgeBio website for 30 days following the event.

About Attruby® (acoramidis)
INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio Pharma, Inc.
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including express and implied statements relating to the Company’s expectations regarding timing of regulatory submissions, approvals and launches, including for BBP-418 in LGMD2I/R9, encaleret in ADH1, infigratinib in achondroplasia; the timing of the Company’s clinical trials and milestones for its various programs, including RECLAIM-HP; the eligibility of BBP-418, BBP-812 and infigratinib under the Rare Pediatric Priority Review Voucher (PRV) program and related FDA review timeline; and the Company’s anticipated funding to finance its operations. Such statements reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to it and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company’s product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of the Company’s collaborations, the Company’s ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company’s share price, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Bubba Murarka, Executive Vice President
contact@bridgebio.com
(650)-789-8220

BridgeBio Investor Contact:
Chinmay Shukla, Senior Vice President, Strategic Finance
ir@bridgebio.com

Bicara Therapeutics Announces Proposed Public Offering of Common Stock

Bicara Therapeutics Announces Proposed Public Offering of Common Stock




Bicara Therapeutics Announces Proposed Public Offering of Common Stock

BOSTON, Feb. 24, 2026 (GLOBE NEWSWIRE) — Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that it has commenced an underwritten public offering of $150 million of shares of its common stock. Bicara intends to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares of common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions. All of the shares of common stock to be sold in the proposed offering will be sold by Bicara. Morgan Stanley, TD Cowen, BofA Securities, Cantor and Stifel are acting as joint book-running managers for the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

Bicara intends to use the net proceeds of the offering to further invest in and build its medical and commercial infrastructure to support a planned regulatory filing and commercial launch for ficerafusp alfa, if approved, in the U.S.; to further accelerate the development of ficerafusp alfa in 1L R/M HPV-negative HNSCC, including a less frequent dosing schedule; to fund manufacturing costs for ficerafusp alfa for ongoing and anticipated drug development efforts; to fund early signal-finding to support future indication expansion for ficerafusp alfa; and for other general corporate purposes.

The securities described above will be offered by Bicara pursuant to an effective “shelf” registration statement on Form S-3 (File No. 333-290707) that was filed with the Securities and Exchange Commission (the “SEC”) on October 3, 2025 and declared effective on November 26, 2025. The securities may be offered only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the proposed offering will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and, when available, copies of the final prospectus supplement, and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at TDManualrequest@broadridge.com; BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 E. 59th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Bicara Therapeutics
Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (“TGF-β”). Through this targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all contain identifying words. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, the proposed underwritten public offering, including the size, timing and structure of the proposed offering, the expectation to grant the underwriters an option to purchase additional shares, the completion of the proposed offering on the anticipated terms, and the anticipated use of proceeds from the proposed offering. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies, preliminary or interim data from earlier stage clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; whether Bicara’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Bicara’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2024, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and any subsequent filings Bicara makes with the SEC. In addition, any forward-looking statements represent Bicara’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Bicara explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Contacts:

Investors
Jenna Cohen
IR@bicara.com

Media
Amanda Lazaro
1AB
Amanda@1abmedia.com

Day One Reports Fourth Quarter and Full Year 2025 Financial Results and Reaffirms 2026 Outlook and Revenue Guidance

Day One Reports Fourth Quarter and Full Year 2025 Financial Results and Reaffirms 2026 Outlook and Revenue Guidance




Day One Reports Fourth Quarter and Full Year 2025 Financial Results and Reaffirms 2026 Outlook and Revenue Guidance

OJEMDA™ 2025 momentum reflected by Q4 and full year net product revenues of $52.8 million and $155.4 million, respectively

2026 U.S. net product revenue projected at $225 – $250 million

Expanded pipeline with January 2026 acquisition of Mersana Therapeutics; Emi-Le in Phase 1 trial for adenoid cystic carcinoma (ACC)

Day One to host conference call and webcast today, February 24, 4:30 p.m. ET

BRISBANE, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) — Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today reports its financial results for the fourth quarter and full year 2025, and reaffirms its outlook for 2026.

“2025 was a seminal year for Day One, marked by significant achievements across every pillar of our organization. By maintaining our strong commercial execution, leveraging our expertise to extend into additional rare cancers, and steadily advancing our early-stage pipeline, we are delivering on our mission to bring new medicines to people of all ages with life-threatening diseases,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “The commercial momentum we’ve established for OJEMDA and the important upcoming clinical data updates across our full pipeline position us for strong growth in 2026 and beyond.”

OJEMDA Commercial Performance

  • OJEMDA net product revenue of $52.8 million and $155.4 million for the fourth quarter and full year 2025, respectively
  • Full-year 2025 net product revenue represented 172% year-over-year growth, with double-digit sequential quarterly growth throughout the year
  • Fourth quarter prescription volumes increased to 1,394 and total 2025 prescriptions were 4,635, representing 181% growth versus 2024 (April launch), and demonstrating strong and growing patient demand, increasing treatment persistence and expanding prescriber adoption
  • Company reaffirmed its previously announced 2026 U.S. OJEMDA net product revenue guidance of $225 million to $250 million

Clinical and Pipeline Highlights

FIREFLY-1 Progress in 2025 and Frontline pLGG FIREFLY-2 Trial Enrollment Complete in 2026

  • Updated three-year data from the pivotal Phase 2 FIREFLY-1 trial presented at the Society for Neuro-Oncology Annual Meeting in November 2025, reinforcing the durability of response and long-term safety profile of OJEMDA in patients with relapsed or refractory pLGG
  • Long term follow-up data from FIREFLY-1 demonstrate that time to next treatment analyses better reflected clinical decision-making among FIREFLY-1 investigators versus radiographic-only tumor progression (as assessed via traditional progression free survival analyses)
  • Enrollment in the pivotal Phase 3 FIREFLY-2 trial evaluating OJEMDA in patients with frontline pLGG remains on track, with full enrollment anticipated in the first half of 2026

Pipeline Progress in 2026

  • Updated Phase 1 clinical data on Emi-Le, a B7-H4-directed ADC acquired from Mersana, expected to be available mid-2026
  • The Phase 1a clinical trial of DAY301, a PTK7-targeted ADC, is progressing through dose escalation, with initial clinical data and program update planned for the second half of 2026

2025 Financial Summary

  • Net Product Revenue: OJEMDA net product revenues were $52.8 million and $155.4 million for the fourth quarter and full year 2025, respectively
  • License Revenue: License revenues from the sale of ex-U.S. commercial rights for tovorafenib were $0.9 million and $2.8 million for the fourth quarter and full year 2025, respectively
  • R&D Expenses: Research and development expenses were $40.9 million and $148.1 million for the fourth quarter and full year 2025, respectively, as compared to $61.8 million and $227.7 million for the same periods in 2024
  • SG&A Expenses: Selling, general and administrative expenses were $34.2 million and $120.6 million for the fourth quarter and full year 2025, respectively, as compared to $29.8 million and $115.5 million for the same periods in 2024
  • Net Loss: Net loss totaled $21.3 million and $107.3 million for the fourth quarter and full year 2025, respectively, with non-cash stock-based compensation expense of $11.1 million and $44.4 million for the same periods. By comparison, net loss totaled $65.7 million and $95.5 million for the fourth quarter and full year 2024, respectively, with non-cash stock-based compensation expense of $11.0 million and $48.3 million for the same periods
  • Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $441.1 million as of December 31, 2025

Upcoming Events

  • 46th Annual TD Cowen Health Care Conference
    • Management will participate in a fireside chat on Tuesday, March 3 at 9:10 a.m. Eastern Time. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website
  • 2026 Leerink Partners Global Healthcare Conference
    • Management presentation on Wednesday, March 11 at 1:40 p.m. Eastern Time. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website

Conference Call
Day One will host a conference call and webcast today, February 24 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days following the event.

About Day One Biopharmaceuticals
Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company that believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.

Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. The Company’s pipeline includes tovorafenib (OJEMDA™), DAY301, and following the recently announced acquisition of Mersana Therapeutics, Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate (ADC) targeting the B7-H4 protein in clinical development to treat the rare cancer adenoid cystic carcinoma (ACC).

Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find the Company on LinkedIn or X.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s ability to grow revenue from OJEMDA, plans to develop and commercialize cancer therapies and its pipeline and the impact of Emi-Le and DAY301, and statements regarding its net product revenues, cash, cash equivalents and short-term investments. Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including risks related to the ability to realize the anticipated benefits of the Mersana acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of the consummation of the acquisition on the market price of Day One’s common stock and/or operating results; significant transaction costs; unknown liabilities, Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, government shutdowns, rising interest rates, instability in the global banking system, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

Day One Biopharmaceuticals, Inc.
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
 
  Year Ended December 31,
    2025       2024       2023  
Revenue:          
Product revenue, net $ 155,421     $ 57,217     $  
License revenue   2,761       73,944        
Total revenues   158,182       131,161        
Cost and operating expenses:          
Cost of product revenue   14,714       4,763        
Cost of license revenue   2,496       516        
Research and development   148,135       227,702       130,521  
Selling, general and administrative   120,587       115,450       75,543  
Total cost and operating expenses   285,932       348,431       206,064  
Loss from operations   (127,750 )     (217,270 )     (206,064 )
Non-operating income:          
Gain from sale of priority review voucher         108,000        
Investment income, net   18,471       19,701       17,187  
Other (expense) income, net   (19 )     1,217       (40 )
Total non-operating income, net   18,452       128,918       17,147  
Loss before income taxes   (109,298 )     (88,352 )     (188,917 )
Income tax benefit (expense)   1,976       (7,144 )      
Net loss   (107,322 )     (95,496 )     (188,917 )
Net loss per share – basic $ (1.04 )   $ (1.02 )   $ (2.37 )
Net loss per share – diluted $ (1.04 )   $ (1.02 )   $ (2.37 )
Weighted-average number of common shares used in net loss per share – basic   103,205,703       93,234,195       79,773,004  
Weighted-average number of common shares used in net loss per share – diluted   103,205,703       93,234,195       79,773,004  

Day One Biopharmaceuticals, Inc.
Selected Consolidated Balance Sheet Data
(in thousands)
(unaudited)
 
  December 31,
2025
  December 31,
2024
Cash, cash equivalents and short-term investments $ 441,113     $ 531,720  
Total assets   507,827       582,788  
Total liabilities   66,665       80,037  
Accumulated deficit   (661,403 )     (554,081 )
Total stockholders’ equity   441,162       502,751  


DAY ONE MEDIA

media@dayonebio.com

DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com

Cytokinetics Reports Fourth Quarter 2025 Financial Results and Provides Business Update

Cytokinetics Reports Fourth Quarter 2025 Financial Results and Provides Business Update




Cytokinetics Reports Fourth Quarter 2025 Financial Results and Provides Business Update

MYQORZO® Approved for Adults with Symptomatic Obstructive HCM in U.S., China and Europe; 
U.S. Launch Underway with First Prescriptions Dispensed within Days of Drug Availability

Supplemental NDA for MAPLE-HCM Submitted to FDA in Q1 2026

Expect to Share Topline Results from ACACIA-HCM in Q2 2026

Company Provides 2026 Financial Guidance;
~$1.2 Billion in Cash, Cash Equivalents and Investments as of December 31, 2025

SOUTH SAN FRANCISCO, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the fourth quarter and full year of 2025. The company also provided full year 2026 financial guidance.

“The fourth quarter of 2025 marked a defining moment for Cytokinetics with the FDA approval of MYQORZO and our transition into a commercial-stage company,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “With the U.S. launch of MYQORZO now underway and our first European launch planned in Germany in Q2, we’re entering 2026 with strong momentum. Early prescribing activity and initial customer feedback reinforce that our differentiated label and REMS are resonating with HCPs and patients. We took measures in 2025 to fortify our balance sheet to support our commercial plans and continue with potential label-expanding opportunities in HCM and ongoing clinical trials in heart failure. We are well-positioned to deliver for patients, advance our pipeline, and create long-term value.”

Q4 and Recent Highlights

Cardiac Muscle Programs

MYQORZO™ (aficamten) (cardiac myosin inhibitor)

  • Received approval in December from the U.S. Food and Drug Administration (FDA) for MYQORZO (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. 
  • Began U.S. commercial launch of MYQORZO in January:
    • Deployed Cardiovascular Account Specialists, who began promotion to healthcare providers (HCPs) in early January.
    • Launched patient and HCP marketing campaigns across promotional channels.
    • Activated online portal for MYQORZO REMS simultaneous with drug availability.
    • Launched MYQORZO & You™ to provide personalized patient support, access and reimbursement assistance and affordability programs for eligible patients.
  • Announced approval from the China National Medical Products Administration (NMPA) for MYQORZO for the treatment of adults with New York Heart Association (NYHA) class II-III oHCM, to improve exercise capacity and symptoms.
  • Received approval from the European Commission (EC) for MYQORZO for the treatment of symptomatic (NYHA class II-III) oHCM in adult patients, following the adoption of a positive opinion recommending marketing authorization in the European Union (EU) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
  • Advanced European commercial readiness activities, including preparing Health Technology Assessment (HTA) dossiers for all key European markets. Expanded launch readiness activities and continued hiring of medical and commercial teams in Germany ahead of expected Q2 2026 launch.
  • The New Drug Submission (NDS) for aficamten was accepted for review by Health Canada.
  • Submitted Supplemental New Drug Application (sNDA) to the FDA for MAPLE-HCM.
  • Advanced the ongoing clinical trials program for aficamten:
    • Continued conduct of ACACIA-HCM, a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). Continued conduct in the Japan cohort of ACACIA-HCM.
    • Completed enrollment of CAMELLIA-HCM, a Phase 3 clinical trial of aficamten in Japanese patients with oHCM. CAMELLIA-HCM is being conducted by Bayer in collaboration with Cytokinetics to support potential marketing authorization in Japan.
    • Continued enrolling patients in CEDAR-HCM, a clinical trial of aficamten in a pediatric population with symptomatic oHCM.
  • Presented additional data from MAPLE-HCM at the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions and American Heart Association Scientific Sessions 2025 expanding on the treatment effect of aficamten vs. metoprolol on patient symptom burden and cardiac biomarkers and showing that significantly more patients on aficamten achieved positive or complete response compared to metoprolol.
  • Published the following manuscripts:
    • “Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023” in Journal of the American College of Cardiology: Advances.
    • Aficamten in Obstructive Hypertrophic Cardiomyopathy: A Multi-Domain, Patient-Level Analysis of the MAPLE-HCM Trial” in Journal of the American College of Cardiology.
    • “Effect of Aficamten vs Metoprolol on Patient-Reported Health Status in Obstructive Hypertrophic Cardiomyopathy” in Journal of the American College of Cardiology.
    • “Effect of Aficamten in Women Compared with Men with Obstructive Hypertrophic Cardiomyopathy in SEQUOIA-HCM” in Circulation: Heart Failure.
    • “Efficacy and Safety of Aficamten in Children and Adolescents with Obstructive Hypertrophic Cardiomyopathy: Study Design and Rationale of CEDAR-HCM” in Circulation: Heart Failure.
    • “Efficacy and Safety of Extended Treatment with Aficamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy in FOREST-HCM” in European Heart Journal.
    • “Longitudinal Analyses of Healthcare Resource Utilization and Costs Among Patients with Obstructive Hypertrophic Cardiomyopathy” in Journal of Medical Economics.
    • “Impact of Cardiovascular Complications on Economic Burden for Patients with Hypertrophic Cardiomyopathy” in Journal of Cardiac Failure – Intersections.

omecamtiv mecarbil (cardiac myosin activator)

  • Continued conduct of COMET-HF, a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction.
  • Published the following manuscripts:
    • “Efficacy and Safety of Omecamtiv Mecarbil in Heart Failure with Reduced Ejection Fraction According to Age: the GALACTIC-HF Trial” in Journal of the American College of Cardiology – Heart Failure.
    • “Multiple-Dose Up-Titration Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Omecamtiv Mecarbil in Healthy Chinese Subjects” in Drugs in R&D.

ulacamten (cardiac myosin inhibitor)

  • Continued patient enrollment in Cohort 1 of AMBER-HFpEF, a Phase 2 clinical trial of ulacamten in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥ 60%.

Pre-Clinical Development and Ongoing Research

  • Continued pre-clinical development and research activities directed to additional muscle biology focused programs.

Corporate

  • Supported a three-year initiative led by the American Heart Association to address disparities in access to care, diagnosis, and treatment for people living with HCM.

Expected 2026 Corporate Milestones

Cardiac Muscle Programs

MYQORZO® (aficamten) (cardiac myosin inhibitor)

  • Report topline results from ACACIA-HCM in Q2 2026.
  • Launch MYQORZO in Germany in Q2 2026.
  • Receive potential FDA approval of the sNDA for MAPLE-HCM in Q4 2026.
  • Complete enrollment in the adolescent cohort of CEDAR-HCM in Q4 2026.
  • Receive potential approval from Health Canada in 2H 2026.

omecamtiv mecarbil (cardiac myosin activator)

  • Continue patient enrollment in COMET-HF through 2026.

ulacamten (cardiac myosin inhibitor)

  • Complete enrollment in Cohort 1 of AMBER-HFpEF in Q1 2026, and complete enrollment in Cohort 2 by the end of 2026.

Ongoing research

  • Continue ongoing pre-clinical development and research activities directed to additional muscle biology focused programs

Fourth Quarter and Full Year 2025 Financial Results

Cash Equivalents and Investments

  • As of December 31, 2025, the company had approximately $1.22 billion in cash, cash equivalents and investments compared to $1.25 billion at September 30, 2025. The 2025 year-end balance includes $100 million in proceeds from the drawing on the Tranche 5 of the Royalty Pharma Multi Tranche Loan. Excluding the proceeds from this loan, cash, cash equivalents and investments would have declined by approximately $134 million during the fourth quarter of 2025.

Revenues

  • Total revenues for the fourth quarter of 2025 were $17.8 million compared to $16.9 million for the same period in 2024. Total revenues for the full year of 2025 were $88.0 million compared to $18.5 million in 2024. Total revenues for the full year 2025 benefitted primarily from the successful completion of the technology transfer totaling $52.4 million to Bayer Consumer Care AG, an affiliate of Bayer AG, in the second quarter of 2025 and the recognition of $15.0 million in the fourth quarter of 2025 related to milestones triggered by the approvals of MYQORZO in the United States and China under the Sanofi License Agreement.

Research and Development (R&D) Expenses

  • R&D expenses for the fourth quarter of 2025 were $104.4 million, which included $14.2 million of non-cash stock-based compensation expense, compared to $93.6 million for the same period in 2024, which included $12.5 million of non-cash stock-based compensation expense. R&D expenses for the full year of 2025 were $416.0 million, which included $54.5 million of non-cash stock-based compensation compared to $339.4 million in 2024, which included $44.0 million of non-cash stock-based compensation expense. The increase for the full year was primarily due to advancing our clinical trials, higher personnel-related costs including stock-based compensation, and medical affairs activities.

General and Administrative (G&A) Expenses

  • G&A expenses for the fourth quarter of 2025 were $91.7 million, which included $16.3 million of non-cash stock-based compensation expense, compared to $62.3 million for the same period in 2024, which included $13.8 million of non-cash stock-based compensation expense. G&A expenses for the full year of 2025 were $284.3 million, which included $57.7 million of non-cash stock-based compensation compared to $215.3 million in 2024, which included $53.8 million of non-cash stock-based compensation expense. The increase for the full year was primarily driven by investments toward commercial readiness including the hiring of our U.S. sales force primarily in the fourth quarter of 2025 and higher non-sales personnel-related costs.

Net Income (Loss)

  • Net loss for the fourth quarter of 2025 was $183.0 million, or $(1.50) per share, basic and diluted, compared to a net loss of $150.0 million, or $(1.26) per share, basic and diluted, for the same period in 2024. Net loss for the year of 2025 was $785.0 million, or $(6.54) per share, basic and diluted, compared to a net loss of $589.5 million, or $(5.26) per share, basic and diluted, in 2024.

2026 Financial Guidance

The company today announced financial guidance for 2026:

GAAP Combined R&D and SG&A Expense* $830 million to $870 million
Non-cash stock-based compensation expense included in GAAP Combined R&D and SG&A Expense $130 million to $120 million

*GAAP Combined R&D and SG&A expense does not include 1) collaboration expenses which can include reimbursed expenses and cost of inventory sales of aficamten to partners, 2) potential costs related to commercialization of aficamten in nHCM, and 3) the effect of GAAP adjustments as may be caused by events that occur subsequent to publication of this guidance including, but not limited to, Business Development activities.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2025 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com or directly at the following link: Cytokinetics Q4 2025 Earnings Conference Call. An archived replay of the webcast will be available via Cytokinetics’ website for six months.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO™ (aficamten) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is also being studied for the potential treatment of non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Disclaimer 

Omecamtiv mecarbil and ulacamten are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our ability to launch MYQORZO in Germany in 2Q of 2026, our receipt of regulatory approval for our sNDA for MAPLE-HCM in Q4 of 2026, our or our partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of any of our clinical trials, or more specifically, our ability to complete enrollment of CEDAR-HCM and AMBER-HFpEF by any target date, our ability to complete patient enrollment of COMET-HF by any target date, our ability to announce the results of ACACIA-HCM in of the second quarter of 2026, our ability to announce the results of any of our clinical trials by any particular date, the timing of interactions with FDA or any other regulatory authorities in connection to any of our drug candidates and the outcomes of such interactions; statements relating to the potential patient population who could benefit from aficamten, omecamtiv mecarbil, ulacamten, CK-089 or any of our other drug candidates; statements relating to our ability to receive additional capital or other funding, including, but not limited to, our ability to meet any of the conditions relating to or to otherwise secure additional loan disbursements under any of our agreements with entities affiliated with Royalty Pharma or additional milestone payments from Sanofi or Bayer in connection with our collaborations for aficamten in China or Japan respectively; statements relating to our operating expenses or cash utilization for the remainder of 2025 or any other period, and statements relating to our cash balance at any particular date or the amount of cash runway such cash balances represent at any particular time. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZOTM is a trademark of Cytokinetics in the U.S., and a registered trademark in the European Union.

MYQORZO & You TM is a trademark of Cytokinetics in the U.S.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

 
Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)
         
         
    December 31, 2025   December 31, 2024
    (unaudited)    
ASSETS        
Current assets:        
Cash and short-term investments   $ 882,221     $ 1,076,014  
Other current assets     34,754       31,926  
Total current assets     916,975       1,107,940  
Long-term investments     335,048       145,055  
Property and equipment, net     79,194       65,815  
Operating lease right-of-use assets     75,979       75,158  
Other assets     17,341       7,705  
Total assets   $ 1,424,537     $ 1,401,673  
LIABILITIES AND STOCKHOLDERS’ DEFICIT        
Current liabilities:        
Accounts payable and accrued liabilities   $ 105,615     $ 75,692  
Short-term operating lease liabilities     19,111       18,978  
Current portion of convertible and long-term debt     41,181       11,520  
Derivative liabilities measured at fair value     31,100       11,300  
Deferred revenue     1,612       52,370  
Other current liabilities     3,833       9,814  
Total current liabilities     202,452       179,674  
Term loan, net     246,384       93,227  
Convertible notes, net     869,597       552,370  
Liabilities related to revenue participation right purchase agreements, net     520,559       462,192  
Long-term operating lease liabilities     107,970       112,582  
Liabilities related to RPI Transactions measured at fair value     137,200       137,000  
Total liabilities     2,084,162       1,537,045  
Commitments and contingencies        
Stockholders’ deficit        
Common stock     123       118  
Additional paid-in capital     2,826,341       2,563,876  
Accumulated other comprehensive income     630       2,398  
Accumulated deficit     (3,486,719 )     (2,701,764 )
Total stockholders’ deficit     (659,625 )     (135,372 )
Total liabilities and stockholders’ deficit   $ 1,424,537     $ 1,401,673  

Cytokinetics, Incorporated  
Condensed Consolidated Statements of Operations  
(in thousands except per share data)  
(unaudited)  
                 
    Three Months Ended December 31,   Years Ended December 31,
    2025   2024   2025   2024
Revenues:                
Collaboration revenues   $ 2,755     $ 1,927     $ 8,686     $ 3,474  
License and milestone revenues     15,000       15,000       79,353       15,000  
Total revenues     17,755       16,927       88,039       18,474  
Operating expenses:                
Research and development     104,398       93,629       416,026       339,408  
General and administrative     91,723       62,338       284,271       215,314  
Total operating expenses     196,121       155,967       700,297       554,722  
Operating loss     (178,366 )     (139,040 )     (612,258 )     (536,248 )
Interest expense     (14,274 )     (8,938 )     (45,579 )     (37,701 )
Non-cash interest expense on liabilities related to revenue participation right purchase agreements     (16,061 )     (13,656 )     (58,289 )     (48,811 )
Interest and other income, net     11,470       15,014       48,420       51,534  
Change in fair value of derivative liabilities     900       1,200       4,200       1,300  
Change in fair value of liabilities related to RPI Transactions     13,300       (4,600 )     (200 )     (19,600 )
Debt conversion expense                 (121,249 )      
Net loss   $ (183,031 )   $ (150,020 )   $ (784,955 )   $ (589,526 )
Net loss per share — basic and diluted   $ (1.50 )   $ (1.26 )   $ (6.54 )   $ (5.26 )
Weighted-average shares in net loss per share — basic and diluted     122,434       118,075       120,103       111,979  

Transpire Bio Strengthens its Leadership Team with Appointment of LaDuane Clifton as Chief Financial Officer

Transpire Bio Strengthens its Leadership Team with Appointment of LaDuane Clifton as Chief Financial Officer




Transpire Bio Strengthens its Leadership Team with Appointment of LaDuane Clifton as Chief Financial Officer

SUNRISE, Fla., Feb. 24, 2026 (GLOBE NEWSWIRE) — Transpire Bio Inc., an integrated clinical-stage biopharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases, today announced the appointment of R. LaDuane Clifton as Chief Financial Officer (CFO).

“As Transpire Bio continues to progress from a clinical-stage to commercial-stage biopharmaceutical company, we are aligning our leadership structure to support the next phase of our growth,” said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio. “We are thrilled to welcome Mr. Clifton as Chief Financial Officer. He brings extensive public company, global finance, and operations leadership experience.”

In addition to his public company and global finance experience, Mr. Clifton has broad experience in biopharmaceutical development and commercialization, as well as manufacturing, managed care contracting, compliance, investor relations, and business development.

“I am honored to join Transpire Bio as Chief Financial Officer and look forward to supporting the company’s corporate priorities as it continues to grow; it is exciting to be a part of this very talented leadership team,” said Mr. Clifton, Chief Financial Officer of Transpire Bio.

Prior to joining Transpire Bio, Mr. Clifton served as Chief Financial Officer and Treasurer of Zevra Therapeutics, Inc. (Nasdaq: ZVRA), a commercial-stage rare disease therapeutics company.  He previously held senior finance leadership roles, including Chief Financial Officer, Secretary, and Treasurer of The LGL Group, Inc., and Chief Financial Officer of a21, Inc.  Earlier in his career, Mr. Clifton was an auditor at KPMG LLP, and held finance and healthcare contracting roles at Aetna, Inc.

About Transpire Bio Inc.

Transpire Bio Inc. is an integrated, US-based, revenue-generating, clinical-stage, biopharmaceutical company headquartered in Sunrise, Florida. Transpire Bio harnesses its inhaled drug delivery expertise to improve patients’ lives by expanding access to important therapies and developing treatments for serious diseases where therapeutic options are significantly lacking.  Transpire Bio has developed multiple proprietary inhalation technology platforms, including dry-powder inhalers and soft-mist inhalers. Apart from advancing its innovative assets to clinical stages, Transpire Bio has also made significant progress in developing its complex generic pipeline, being the first company to have filed two Abbreviated New Drug Applications using Breo Ellipta and Trelegy Ellipta as the Reference Listed Drugs.  For more information, please visit www.transpirebio.com.

Contacts:
Corporate

info@transpirebio.com  
+1 954.908.2233

Investors
Stuart Loesch
Chief Commercial Officer, Transpire Bio
Stuart.loesch@transpirebio.com 

AB Science announces the identification of a plasma biomarker that indicates the activity of masitinib in treating ALS

AB Science announces the identification of a plasma biomarker that indicates the activity of masitinib in treating ALS




AB Science announces the identification of a plasma biomarker that indicates the activity of masitinib in treating ALS

PRESS RELEASE

AB SCIENCE ANNOUNCES THE IDENTIFICATION OF A PLASMA BIOMARKER THAT INDICATES THE ACTIVITY OF MASITINIB IN TREATING AMYOTROPHIC LATERAL SCLEROSIS, AND THAT IS CAPABLE OF IDENTIFYING PATIENTS WITH PRO INFLAMATORY MICROGLIA, WHICH ARE TARGETED BY MASITINIB

THIS BIOMARKER IS ALSO APPLICABLE TO PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS AND ALZHEIMER DISEASE

THIS BIOMARKER CAN BE STRATEGIC TO DETERMINE WHICH PATIENTS RESPOND TO TREATMENT AND POTENTIALLY INCREASE CHANCE OF REGISTRATION IN NEURODEGENERATIVE DISEASES

Paris, February 24, 2026, 6pm CET

AB Science SA (Euronext – FR0010557264 – AB) announced the identification of a potential biomarker for assessing the activity of masitinib in pathological microglial involvement in Amyotrophic Lateral Sclerosis (ALS).

The key characteristics of this newly identified biomarker are as follows:

  • It is a blood-based (plasmatic) biomarker, which has the advantages of being easy to collect and accurately evaluated using ELISA (enzyme-linked immunoassay).
  • It is produced by proinflammatory microglia.
  • It activates microglia and astrocytes and is therefore an activator contributing to a vicious neuroinflammation feedback loop.
  • It is also released by mast cells, establishing a link between mast cells and microglia, which are two major cellular targets of masitinib.
  • It is predictive of survival in ALS, potentially explaining why masitinib could extend survival in some specific patients.
  • In-house experiments showed that this biomarker was reduced by masitinib when mast cells and microglia were activated in vitro, underscoring the specific and potent activity of masitinib on mast cells and microglia.

Professor Olivier Hermine, President of AB Science’s Scientific Committee, member of the French Academy of Sciences and Head of the Hematology Department at Necker Hospital, commented: “Interestingly, this biomarker could be used in ALS but also in other neurodegenerative diseases of interest, namely progressive forms of multiple sclerosis (MS) and Alzheimer’s disease. In multiple sclerosis, for instance, this biomarker has normal plasmatic levels in clinically isolated syndrome (CIS), is elevated in RRMS during relapse, and is high in progressive forms, consistent with what we know about the involvement of microglia in MS”.

This biomarker will be introduced in the phase 3 program of masitinib in ALS, as well as in progressive MS and Alzheimer’s disease, to validate the mechanism of action of masitinib in humans and its clinical relevance. Once validated, it could facilitate registration by determining which patients respond best to treatment and serve as a surrogate endpoint of efficacy if necessary. Indeed, FDA Guidance on ALS states that “FDA encourages sponsors to incorporate exploratory biomarkers in all phases of development of ALS drugs. In the future, greater scientific understanding of ALS may provide opportunities for discussion of surrogate endpoints that are reasonably likely to predict clinical benefit and that might serve as a basis for accelerated approval.

This biomarker remains undisclosed for patent protection reasons.

About AB Science

Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development, and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action is key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, which are often lethal with short-term survival or rare or refractory to previous lines of treatment.

AB Science has developed a proprietary portfolio of molecules, and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is being developed for human medicine in oncology, neurological diseases, inflammatory diseases, and viral diseases. The company is headquartered in Paris, France and is listed on Euronext Paris (ticker: AB).

Further information is available on AB Science’s website: www.ab-science.com.

Forward-looking Statements – AB Science

This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions, and expectations regarding financial results, events, operations, future services, product development, and their potential or future performance.

These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan” as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science, which may imply that results and actual events significantly differ from those expressed, induced, or anticipated in the forward-looking information and statements. These risks and uncertainties include uncertainties related to the product development of the Company, which may not be successful, or to the marketing authorizations granted by competent authorities, or, more generally, any factors that may affect the marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.

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Validic Adds Epic Toolbox, Generative AI, Multi-Instance Support, and More to Existing Epic Integration

Validic Adds Epic Toolbox, Generative AI, Multi-Instance Support, and More to Existing Epic Integration




Validic Adds Epic Toolbox, Generative AI, Multi-Instance Support, and More to Existing Epic Integration

New Epic-integrated features including Toolbox alignment, multi-instance support, AI-powered RPM summarization, and expanded wearable integrations help health systems ensure timely, risk-reducing care

LOS ANGELES, Feb. 24, 2026 (GLOBE NEWSWIRE) — Validic, a leading healthcare technology company powering connected care data solutions, today announced expanded Epic integrations and new capabilities designed to eliminate the infrastructure complexity that slows deployment, patient prioritization, chronic disease management, and remote patient monitoring (RPM) programs.

Validic’s enhanced Epic support simplifies how device data is implemented, governed, and scaled, ensuring clinicians can act on insights quickly and confidently.

“As health systems endeavor to expand chronic disease programs and patient monitoring initiatives, the complexity of infrastructure has become one of the main barriers to progress,” said Drew Schiller, CEO of Validic. “We’ve built our platform to take that complexity out of the equation. With deep Epic alignment, AI-powered summarization, and scalable device integrations, we enable health systems to prioritize patients effectively, reduce risk, and ensure timely care, without the burden of managing fragmented integrations.”

Validic today supports leading health systems, including powering the largest remote patient monitoring program in the U.S. with a national IDN. For health systems looking to leverage best-in-class remote patient data as part of their Epic-first strategy, Validic’s deeply integrated, scalable, AI-powered remote care infrastructure is the natural choice. Benefits of choosing Validic include keeping clinicians in the workflow, future-proofing your programs against new devices and Epic upgrades, and management of complex, multi-region deployments.

A Scalable, Epic-Aligned Infrastructure for Connected Care

Validic’s expanded offering strengthens its position as a leading Epic-integrated connected care platform by delivering:

  • Epic Toolbox-aligned RPM infrastructure that follows Epic’s recommended integration practices, ensuring device data is actionable within native Epic workflows and owned by the health system, not the vendor.
  • Support for multiple Epic instances across regions, enabling enterprise health systems to standardize and scale RPM programs across diverse geographies and service lines.
  • Rapid RPM program deployment, allowing organizations to configure and launch chronic disease management initiatives in minutes rather than months.
  • AI-powered summarization of RPM data, transforming continuous device readings into concise, clinically relevant insights that support faster patient prioritization and intervention.
  • Expanded wearable and clinical-grade device integrations, abstracting device complexity through a unified infrastructure layer that simplifies onboarding new devices and use cases without re-architecting Epic integrations.

Validic’s platform has already proven to improve patient adherence, outcomes, and clinician workload. Together, these new capabilities reduce implementation variability, lower operational risk, and provide a future-ready foundation for scaling these outcomes to whole populations.

About Validic

Validic is a healthcare technology company that simplifies connected care data integration for health systems, life sciences organizations, and digital health companies. Through deep Epic alignment and scalable infrastructure, Validic enables clinically actionable remote patient monitoring and connected device programs that improve patient outcomes and operational efficiency.

To learn more, visit www.validic.com or connect with Validic at ViVE 2026.

CONTACT: Media Contact
Claudia Gallardo
claudia.gallardo@validic.com

Empathy in Medicine Initiative Announces Student Chapter Program to Empower High School and College Students in Healthcare Leadership

Empathy in Medicine Initiative Announces Student Chapter Program to Empower High School and College Students in Healthcare Leadership




Empathy in Medicine Initiative Announces Student Chapter Program to Empower High School and College Students in Healthcare Leadership

EMI launches Student Chapter Program to support students in starting empathy-focused healthcare clubs and community projects

Empathy in Medicine Initiative (EMI) Image

Empathy in Medicine Initiative (EMI) Image

NEW YORK, Feb. 24, 2026 (GLOBE NEWSWIRE) — The Empathy in Medicine Initiative (EMI) today announces the launch of its Student Chapter Program, a timely opportunity for high school and college students to engage in structured, empathy-centered activities in healthcare. This initiative comes at a time when students are increasingly seeking meaningful extracurriculars for premed preparation, leadership experiences, and community service opportunities. The program enables students to start EMI chapters in their schools, offering practical resources to implement workshops, events, and community projects focused on empathy in medicine.

Founded by Kevin Lin, a student at Great Neck South High School in Great Neck, New York, EMI is a student-led nonprofit dedicated to fostering empathy and communication in healthcare. The Student Chapter Program is designed to provide students with a structured and ethical framework to lead initiatives, create measurable impact, and develop skills that are crucial for future healthcare professionals.

Practical Resources to Launch Chapters

The Student Chapter Program equips students with comprehensive tools and resources to make establishing and managing a chapter straightforward and effective. Resources include detailed meeting and event guides that provide step-by-step instructions and templates for organizing workshops, events, and discussion sessions that prioritize empathy in healthcare communication. Students also receive communication scripts and training materials designed to help them facilitate exercises that develop active listening, compassionate communication, and patient-centered understanding. In addition, community project toolkits offer clear guidance on planning and implementing community-based service projects that promote awareness and education on empathy in medicine.

These resources aim to reduce the challenges students often face when trying to start healthcare-related clubs, providing a practical roadmap to start a medical/healthcare club while maintaining ethical standards and measurable outcomes.

Demonstrated Demand Among Students

EMI’s platform currently serves 233 registered users and has received 73 chapter applications, with 69 pending or under review, demonstrating strong interest among students seeking structured, impactful ways to engage with healthcare and develop leadership skills. This traction illustrates the growing demand for organized programs that enable young people to contribute meaningfully to the promotion of empathy in medicine.

“Too many students want to do meaningful healthcare-related service and leadership, but they do not have a clear structure to start,” said Kevin Lin, founder of the Empathy in Medicine Initiative and a student at Great Neck South High School in Great Neck, New York. “Our chapter program gives high school and college students a practical toolkit to launch empathy-focused clubs and projects that create measurable impact in their schools and communities.”

Why the Program Matters Now

The launch of the Student Chapter Program comes at a moment when healthcare communication and empathy are increasingly recognized as essential skills for future healthcare providers. While many students are motivated to pursue premed paths and healthcare service, they often lack structured avenues to explore these interests. EMI’s program addresses this gap by providing a scalable, ethical framework that fosters leadership, service, and measurable impact in student communities.

Through the program, students can document their initiatives and outcomes, demonstrating their commitment to patient-centered communication and leadership in healthcare. This approach not only benefits their personal and academic development but also strengthens the broader healthcare community by emphasizing the importance of empathy and communication skills in medical practice.

Empathy-Focused Chapter Activities

EMI chapters are designed to be adaptable to the unique needs of each school and community. Activities include communication skills workshops where students learn techniques for active listening, empathetic dialogue, and effective communication with peers and community members. Chapters may also host empathy-centered events such as seminars, speaker sessions, or interactive exercises that highlight the role of empathy in patient care. Additionally, students can organize community service and education projects in collaboration with local healthcare organizations, schools, or nonprofits to raise awareness about compassionate healthcare practices.

By providing these opportunities, EMI ensures that chapters can operate with meaningful structure while cultivating skills that are essential for aspiring healthcare professionals.

Leadership, Service, and Measurable Impact

The Student Chapter Program not only fosters skill development but also allows students to take on leadership roles, organize meaningful initiatives, and track the impact of their activities. Students gain organizational and leadership experience while managing a student-led chapter, participate in projects that generate tangible outcomes in schools and local communities, document their activities for college applications or premed extracurricular portfolios, and contribute to building a culture of empathy in healthcare that extends beyond the classroom.

These elements combine to provide a unique platform where students can learn, lead, and make a measurable difference, reinforcing the relevance of empathy in medicine as a core value in healthcare education and practice.

A Timely Initiative for Students

With the increasing emphasis on empathy, communication, and leadership in premedical and healthcare education, EMI’s launch of the Student Chapter Program represents a timely announcement for students seeking meaningful engagement. The initiative addresses a growing need among young people for structured, practical ways to contribute to healthcare-related service and leadership while cultivating skills that will be essential throughout their professional journeys.

“This program provides a pathway for students who are passionate about healthcare and service but don’t know where to start,” said Kevin Lin. “By offering a structured toolkit and clear guidance, EMI enables students to launch initiatives that have real impact, not just for their own growth, but for the communities they serve.”

How to Get Involved

Students interested in starting a chapter, accessing resources, or applying to participate can visit https://empathyinmedicine.org/. EMI offers guidance throughout the application process and ongoing support as chapters develop, grow, and execute their programs.

About the Empathy in Medicine Initiative (EMI)

Founded by Kevin Lin, a student at Great Neck South High School in Great Neck, New York, the Empathy in Medicine Initiative is a student-led nonprofit committed to promoting empathy and communication in healthcare. EMI provides students with practical resources, leadership opportunities, and structured programs that foster measurable impact in healthcare-related initiatives. Through the Student Chapter Program, EMI supports high school and college students in developing critical skills, contributing to their communities, and preparing for careers in medicine and healthcare.

The organization emphasizes that empathy in medicine is not just a professional skill, but a vital component of community health and patient well-being. EMI’s programs provide students with the tools, structure, and mentorship necessary to integrate these values into real-world projects, helping shape the next generation of healthcare leaders.

Media Contact:
Empathy in Medicine Initiative (EMI)
Kevin Lin
contact@empathyinmedicine.org
https://empathyinmedicine.org/Home

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/17e7ceeb-5f8c-4f5b-b534-1a8f946687ae