Harbour BioMed Reports Full Year 2025 Financial Results: Sustained Global Collaboration Underpins Long-Term Growth

On March 30, 2026 Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, reported its financial results for the year ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "2025 marked a pivotal year for Harbour BioMed as we entered the third phase of our strategic evolution, with a clear roadmap toward our 2028 vision of becoming a global leading platform-based biopharmaceutical group.

The Company’s strategy is powered by three integrated growth engines. These include building a global leading AI-driven antibody discovery ‘new infrastructure’ through Nona Biosciences, expanding global partnerships through platform-based collaborations with multinational pharmaceutical companies, and unlocking the global value of its mid- to late-stage pipeline in immunology, oncology and other areas through Harbour Therapeutics. These three engines connect technology platforms, global partnerships and pipeline development, forming a scalable model for sustainable innovation and long-term growth.

Leveraging our proprietary antibody discovery platforms and continued innovation in AI-enabled drug development, Harbour BioMed has built a strong global collaboration ecosystem. Looking ahead, we will continue to focus on innovation and accelerate the development of next-generation biologics to deliver transformative therapies for patients worldwide."

2025 Financial Highlights: Strong Growth and Profitability

Total Revenue reached approximately US$158 million, representing an increase of 314.6% year over year, primarily driven by long-term strategic collaborations with multinational pharmaceutical companies, global licensing agreements, and robust revenue growth fueled by the strong performance of Nona Biosciences.
Net Profit for the Year surged to approximately US$92 million, a 33-fold increase compared to full year 2024, reflecting strong revenue growth and continuous improvement in operational efficiency.
Adjusted net profit for the year[1] was approximately US$101 million, representing a 11-fold year-over-year increase.
Cash and Cash Equivalents stood at approximately US$403 million as of December 31, 2025, representing an increase of 141.6% from the end of 2024. The Company maintains strong financial resources and flexibility to execute efficient capital management initiatives.

Strategic Collaborations Fuel Global Expansion

Over the past several years, Harbour BioMed has steadily transformed the strength of its technology platforms into high-value global partnerships, building an expanding international innovation ecosystem. The Company has deepened its ties with global pharmaceutical leaders in antibody discovery and next-generation biologics development, ensuring its innovative platform technologies reached new heights.

In 2025 alone, the Company established multiple collaborations with global biotechnology innovators and multinational pharmaceutical companies, including Windward Bio, AstraZeneca, Otsuka, Pfizer and Bristol Myers Squibb. Among these, Harbour BioMed’s expanding collaboration with AstraZeneca stands as a representative example of the Company’s evolving partnership model—progressing from product licensing to a deep strategic collaboration covering multiple targets and programs. The collaboration between the two parties in 2025 is further distinguished by an innovative, multi-faceted framework that combines R&D collaboration, equity investment, and the establishment of the Harbour BioMed-AstraZeneca Innovation Lab.

Together, these collaborations underscore Harbour BioMed’s evolving platform-driven partnership model, enabling the Company to accelerate global innovation while creating long-term strategic and commercial value.

Advancing a Robust and Differentiated Pipeline

Harbour BioMed continues to advance a diversified pipeline of innovative therapeutics addressing diseases with significant unmet medical needs. With almost 20 drug candidates spanning preclinical to late-stage clinical development, the Company is building a broad portfolio across immunology, oncology and other areas, while expanding into next-generation modalities including bispecific and tri-specific T cell engagers, antibody-drug conjugates, metabolic disease therapies and central nervous system programs.

Key products in the mid-late clinical stage include:

Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody completed Phase I to pivotal trials in China. As a novel, fully human anti-FcRn monoclonal antibody, batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases. The Phase III pivotal clinical trial results of batoclimab were published in JAMA Neurology in March 2024, demonstrating sustained efficacy and safety with long-term use of batoclimab in the treatment of generalized myasthenia gravis (gMG). In July 2024, NMPA accepted the BLA for batoclimab for the treatment of gMG.

HBM9378 is a fully human monoclonal antibody against thymic stromal lymphopoietin (TSLP) generated from the H2L2 Harbour Mice platform. It potently binds to the TSLP ligand and inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological conditions, including asthma and COPD where inhibition has demonstrated benefit in a wide array of inflammatory phenotypes. HBM9378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered.

The Company received the IND approval of HBM9378 for moderate-to-severe asthma from the NMPA in February 2022 and completed a Phase I clinical trial in healthy subjects in China. In November 2024, the Company submitted an IND application for HBM9378 for chronic obstructive pulmonary disease (COPD) to the NMPA, which was approved in January 2025.

In January 2025, it was announced that the Company and Kelun-Biotech entered into an exclusive license agreement with Windward Bio, under which Windward Bio was granted an exclusive license for the research, development, manufacturing and commercialization of HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In July 2025, Windward Bio launched global Phase II POLARIS clinical study, assessing long-acting dosing of HBM9378/WIN378 for people living with asthma.

Note: HBM9378 is known as SKB378 in Kelun-Biotech’s pipeline and WIN378 in Windward Bio’s pipeline.

Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favourable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. The Company has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, colorectal cancer (CRC), neuroendocrine neoplasm (NEN) and hepatocellular carcinoma (HCC).

In October 2025, the Company published positive Phase II clinical data in combination with tislelizumab, for the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC). Of the 23 evaluable patients, the objective response rate (ORR) is 34.8%, disease control rate (DCR) is 60.9%, and 12-month overall survival (OS) Rate is 84%.

In February 2026, the Company entered a license agreement and equity partnership with Solstice Oncology, a clinical stage biotechnology company established by a syndicate of major venture capital investors, for the exclusive development and commercialization of HBM4003 outside Greater China.

HBM7575 is a long-acting bispecific antibody targeting TSLP and an undisclosed antigen, with a dual mechanism of action. On one hand, by blocking the interaction between TSLP and its receptor, it inhibits TSLP-mediated signaling pathways and the activation of Th2 immune cells. On the other hand, binding to and blocking the undisclosed target generates a synergistic effect, overcoming resistance issues associated with TSLP single-target antibodies. HBM7575 has been engineered to possess an extended half-life and favourable developability, enabling subcutaneous administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.

In December 2025, NMPA accepted the IND application for HBM7575 for the treatment of atopic dermatitis. In March 2026, the China IND application for the treatment of atopic dermatitis, has been approved by the NMPA.

Key products in the next-generation innovation portfolio include:

HBM7020 is a BCMAxCD3 bispecific antibody generated using the fully human HBICE bispecific technology and Harbour Mice platform. HBM7020 can crosslink targeted cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and cell elimination. By incorporating dual anti-BCMA binding sites for optimal cell targeting and monovalent-optimized CD3 activity to minimize CRS, HBM7020 demonstrated potent cytotoxicity with broad applications in both immunological and oncology diseases. In August 2023, HBM7020 obtained IND clearance from the NMPA to commence a Phase I trial for cancer in China. In June 2025, the Company entered a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to advance HBM7020 for the treatment of autoimmune diseases.

HBM7004 is a novel B7H4xCD3 bispecific antibody. Using HBICE bispecific technology and Harbour Mice platform, this bispecific antibody was designed to provide innovative solutions for cancer immunotherapy from both efficacy and safety perspectives. The development of B7H4xCD3 bispecific HBICE further consolidates the Company’s bispecific immune cell engager platform, demonstrating the HBICE platform’s versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window. In 2025, the Company continued the development in pre-clinical and advanced to IND-enabling stage for HBM7004.

Metabolic Disease Programs: The Company is developing innovative therapies for obesity-related conditions to address key challenges in current obesity treatments, including muscle preservation and long-term efficacy. Multiple programs currently in preclinical development, each designed to offer innovative mechanisms of action, including targeted hormone modulation and enhanced metabolic regulation. By integrating dual-targeting strategies with enhanced safety profiles, these therapies have the potential to complement and expand upon existing treatment options, including various agonists of GLP-1 receptor, GIP receptor, and GCG receptor. These programs are supported by the Company’s antibody discovery platform and Hu-mAtrIxTM AI platform, with AI applications guiding antibody sequence discovery, enrichment, optimization, bispecific geometry design, and developability/immunogenicity/pharmacokinetics (PK) assessments, as well as patient biomarker studies.

CNS Disease Programs: Resilience Neuroscience, a wholly-owned subsidiary of the Company, is advancing a next-generation central nervous system (CNS) pipeline focused on Alzheimer’s disease, Parkinson’s disease, and other neurodegenerative disorders. Multiple programs are currently in preclinical development, targeting well-validated CNS pathways. By significantly enhancing central nervous system delivery and extending half-life, these programs aim to amplify therapeutic efficacy and deliver next-generation best-in-class (BIC) and first-in-class (FIC) therapeutics. This approach is enabled by our proprietary platform technologies, including HCAb-based blood-brain barrier (BBB) shuttle platforms for brain-penetrant antibody delivery and BBB shuttle-conjugated ASO/siRNA modalities, designed to overcome the key barriers in CNS drug development.

Powering Next-Generation Therapeutics Through Platform Innovation and Venture Incubation

Technology platform innovation remains a core pillar of Harbour BioMed’s long-term strategy and a key driver of its research productivity and business development success. By continuously advancing its proprietary antibody discovery platforms including Harbour Mice, HCAb-based antibody technologies and multi-specific antibody engineering capabilities, the Company is enhancing the efficiency of antibody discovery while enabling the development of next-generation biologics across multiple therapeutic areas.

Building on the foundation, Harbour BioMed is increasingly integrating artificial intelligence with advanced antibody engineering to further accelerate discovery. One of Harbour BioMed’s most exciting innovations in 2025 has been the launch of its first fully human Generative AI HCAb Model powered by the Hu-mAtrIx AI platform. Built on more than nine million next-generation sequencing-derived HCAb sequences, the platform integrates AI-driven design, intelligent screening and wet-lab validation to establish a closed-loop discovery process for antibody development. To further advance AI-enabled innovation, Harbour BioMed also launched the Global AI + Pharmaceutical Ecosystem Alliance in 2025, bringing together technology partners, industry experts and investors to accelerate AI-driven drug discovery.

These platform capabilities have played an important role in supporting the Company’s expanding pipeline and global collaborations with leading pharmaceutical partners, further demonstrating the commercial and scientific value of Harbour BioMed’s technology platforms.

Beyond advancing internal R&D capabilities, Harbour BioMed is also leveraging its proprietary technologies to drive new innovation models. Through its "technology for equity" approach, the Company continues to incubate next-generation biotechnology ventures, expanding the application scenarios of its platform technologies while creating additional long-term value.

With flexible capital investment, Harbour BioMed has incubated several ventures focused on cutting-edge therapeutic areas, ranging from multivalent antibodies to cell therapies. These include collaborations with NK Cell-Tech in NK cell therapies, as well as incubating Élancé Therapeutics, which focuses on next-generation obesity treatments, and Resilience Neuroscience, dedicated to therapies for neurodegenerative diseases. Harbour BioMed has also co-founded Sobour Biopharma to develop innovative therapies for cancer and inflammatory diseases.

Together, these initiatives highlight the broad potential of Harbour BioMed’s technology platforms and demonstrate how the Company’s platform-driven innovation model continues to generate new opportunities for scientific advancement and future growth.

Outlook: Driving the Next Phase of Global Growth

Looking ahead, Harbour BioMed will continue to drive sustainable business growth and fulfill its 2028 vision of becoming a global leading platform-based biopharmaceutical group through the three integrated growth engines.

In 2026, the Company expects to advance multiple high-potential assets into mid- to late-stage clinical development and progress additional innovative candidates into the clinical stage across immunology, oncology, and other therapeutic areas with high unmet medical needs. Meanwhile, the Company will actively explore various opportunities to accelerate its portfolio and platform value realization and strengthen its role in the global innovation ecosystem by expanding collaborations with global partners.

By integrating technology platforms, pipeline innovation and global partnerships, Harbour BioMed remains committed to delivering transformative biologic therapies to patients worldwide and further strengthening its position as a globally competitive innovator in next-generation biotherapeutics.

(Press release, Harbour BioMed, MAR 30, 2026, View Source [SID1234664036])

Journal of Urology Publishes ENVISION Trial Results Showing 72.2% 24-Month Duration of Response with ZUSDURI

On March 30, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the publication of results from the pivotal Phase 3 ENVISION trial of ZUSDURI (mitomycin) for intravesical solution in The Journal of Urology. ZUSDURI is indicated for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The publication reports a 72.2% probability of remaining event-free at 24 months after complete response (CR) (95% CI: 64%, 79%) as determined by Kaplan-Meier analysis. The CR rate at three months was 79.6%. The median follow-up time after three-month CR was 23.7 months, and the median DOR was not reached.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The publication of these long-term data in The Journal of Urology provides important peer-reviewed validation of the durability of ZUSDURI treatment observed in the ENVISION trial," said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, New Jersey, and Principal Investigator of the ENVISION trial. "For patients who achieved a complete response, the likelihood of remaining event-free through two years was substantial, underscoring the potential of ZUSDURI to change the long-term management of this highly recurrent disease with a six-week induction treatment alone without maintenance. For the first time, adult patients with recurrent LG-IR-NMIBC have an FDA-approved therapy."

The existing standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates, patients, who are often elderly with multiple comorbidities, may require repeated TURBT procedures over their lifetime, which can negatively impact quality of life and may be associated with increased health risks. An estimated 59,000 patients with LG-IR-NMIBC experience recurrence annually in the United States.

"Now that the 24-month duration of response data from ENVISION are published in a leading urology journal, we’re seeing even stronger validation of ZUSDURI’s clinical impact," said Mark Schoenberg, Chief Medical Officer, UroGen. "As the first and only approved treatment for recurrent LG-IR-NMIBC, ZUSDURI gives patients a real chance at meaningful, recurrence-free periods. These results suggest we may finally be able to break the long-standing cycle of repeated recurrences and surgeries that has defined care for patients with recurrent LG-IR-NMIBC."

The most common (≥10%) adverse reactions, including laboratory abnormalities, observed in patients treated with ZUSDURI were dysuria, hematuria, urinary tract infection, increased creatinine, increased potassium, decreased hemoglobin, decreased lymphocytes, decreased neutrophils, increased eosinophils, and increased liver enzymes (AST and ALT). Adverse reactions were primarily mild to moderate in severity. Serious adverse reactions occurred in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%).

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

(Press release, UroGen Pharma, MAR 30, 2026, View Source [SID1234664030])

Tempest Reports Year End 2025 Financial Results and Provides Business Update

On March 30, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported financial results for the year ended December 31, 2025, and provided a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2025 was a transformative year for Tempest as we strengthened our pipeline with the strategic acquisition of a portfolio of next-generation CAR-T assets," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "The portfolio is already proving potentially fruitful as we reported encouraging early clinical data from our lead CAR-T program, TPST-2003, which is being tested in a Phase 1/2a trial in patients with relapsed or refractory multiple myeloma. The data, which suggests a favorable safety and efficacy profile for TPST-2003, reinforced our belief that this therapy has the potential to differentiate itself from currently approved CAR-T treatments and provide a meaningful option for patients who continue to face limited durable treatment options. We look forward to the potential initiation of a U.S. registrational study of TPST-2003 in patients with rrMM later this year, while we continue our strategy of leveraging partner-funded and externally supported development where possible to advance our pipeline."

2025 & Recent Accomplishments

TPST-2003
Announced positive interim results from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with rrMM, which is being sponsored and conducted by Tempest’s partner, Novatim Immune Therapeutics:
100% complete response (CR) rate among all six efficacy evaluable patients as of the January 31, 2026 data cutoff
Favorable safety profile with no Grade >3 cytokine release syndrome ("CRS") or immune effector cell-associated neurotoxicity syndrome ("ICANS") appears to be emerging as a potentially differentiating attribute in its class
Prior investigator-initiated trial ("IIT") reached median progression free survival (PFS) of 23.1 months, including in patients with extramedullary disease
36 patients with rrMM treated to date across two studies
Corporate:
Announced closing of strategic acquisition of new dual-targeting CAR-T assets from Factor Bioscience Inc. and its affiliates
All-stock transaction brought Tempest a portfolio of next-generation CAR-T assets, including TPST-2003, a clinical-stage dual-targeting CD-19/BCMA CAR-T with strategic partner-funded biologics license application (BLA) filing in China planned for 2027
In November 2025, announced up to $8.35 million registered direct offering (an "RDO" and, such offering, the "November Offering") of common stock and concurrent private placement of warrants priced at-the-market under Nasdaq
In March 2026, announced up to $6 million private placement (the "2026 Offering") of common stock and warrants, with $2 million upfront and up to $4 million of potential aggregate gross proceeds upon the exercise in full of warrants
Amezalpat (TPST-1120) (clinical PPARα antagonist):
Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma ("HCC") in China
Granted orphan drug designation from the European Medicines Agency for amezalpat for the treatment of patients with HCC
Reported new data at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supporting the immune component of amezalpat’s dual mechanism of action and reinforcing its potential as a novel cancer treatment
Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration ("FDA") for amezalpat for the treatment of patients with HCC
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
Granted Orphan Drug designation by the FDA to treat patients with Familial Adenomatous Polyposis ("FAP")
Received a "Study May Proceed" letter from the FDA to evaluate TPST-1495 in a Phase 2 Trial for the treatment of FAP
Potential Future Milestones

TPST-2003
Present results from the ongoing Phase 1/2a REDEEM-1 study, as well as updated data from the Phase 1/2 IIT, in 2026
Submit a U.S. IND application and, subject to clearance, initiate a Phase 2b U.S. registrational study of TPST-2003 in patients with rrMM in 2026
TPST-1495
Initiate a Phase 2 study of TPST-1495 in FAP, with first patient enrollment expected in 2026. The study is expected to be funded by the National Cancer Institute and conducted through the Cancer Prevention Clinical Trials Network, enabling advancement without internal capital deployment.
Financial Results

Year End 2025

Tempest ended the year with $7.7 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by net proceeds from the issuance of common stock of $4.1 million from the RDO in June, $3.8 million from the November Offering and $2.8 million from Tempest’s at-the-market offering program.
Net loss and net loss per share for the year were $26.3 million and $6.33, respectively, compared to $41.8 million and $19.50, respectively, for the same period in 2024.
Research and development expenses for the year were $12.6 million compared to $28.5 million for the same period in 2024. The $15.9 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the year were $14.0 million compared to $13.6 million for the same period in 2024. The $0.4 million increase was primarily due to one-time separation costs for employees terminated during the period.

(Press release, Tempest Therapeutics, MAR 30, 2026, View Source [SID1234664029])

Sensei Biotherapeutics Reports Full Year 2025 Financial Results and Provides Corporate Update

On March 30, 2026 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE) reported financial results for the full year ended December 31, 2025, following its previously announced acquisition of Faeth Therapeutics and concurrent $200 million private placement. The financing, together with the Company’s cash on hand, is expected to support advancement of PIKTOR through key clinical milestones, including topline data readouts from both the ongoing Phase 2 trial in advanced endometrial cancer (Study FTH-PIK-201) and the planned Phase 1b trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Acquired through the Faeth transaction, PIKTOR is now Sensei’s lead program. The investigational, proprietary, all-oral combination of serabelisib and sapanisertib is designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway through PI3K-alpha and dual mTORC1/2 targeting.

"2025 was a year of focus and discipline for Sensei, and with the addition of Faeth and injection of new capital, we are entering 2026 with a clear path forward," said Christopher Gerry, President & General Counsel of Sensei Biotherapeutics. "We are now focused on advancing PIKTOR through key clinical milestones, including topline data from the ongoing Phase 2 trial in advanced endometrial cancer and initiation of the planned Phase 1b trial in HR+/HER2- advanced breast cancer, both expected by year-end 2026."

"The data to date suggest PIKTOR may achieve more comprehensive pathway suppression than single-node approaches, with an emerging tolerability profile that compares favorably to existing therapies, highlighting its potential to address significant unmet need in multiple solid tumor indications," said Anand Parikh, Chief Operating Officer of Sensei Biotherapeutics. "We are focused on disciplined execution as we advance PIKTOR through clinical trials in endometrial and breast cancer, with additional opportunities in ovarian and lung cancer."

Full Year 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $21.2 million as of December 31, 2025 as compared to $41.3 million as of December 31, 2024.

Research and Development (R&D) Expenses: R&D expenses were $11.0 million for the year ended December 31, 2025, compared with $18.6 million for the year ended December 31, 2024. The decrease in R&D expenses was primarily attributable to reduced costs across personnel, facilities, lab supplies, clinical trials, and manufacturing.

General and Administrative (G&A) Expenses: G&A expenses were $11.3 million for the year ended December 31, 2025, compared to $13.0 million for the year ended December 31, 2024. The decrease in G&A expense was primarily attributable to lower personnel costs, partially offset by higher restructuring costs in 2025 and higher consulting costs.

Net Loss: Net loss was $21.1 million, or $(16.72) per basic and diluted share, for the year ended December 31, 2025, compared with a net loss of $30.2 million, or $(24.01) per basic and diluted share, for the year ended December 31, 2024.

Weighted-average common shares outstanding, basic and diluted, were 1,260,772 for the year ended December 31, 2025, compared with 1,255,776 for the year ended December 31, 2024.

Condensed Statements of Operations

(Unaudited, in thousands except share and per share data)

Year Ended 2025

Year Ended 2024

Operating expenses:

Research and development

$

10,960

$

18,627

General and administrative

11,328

13,036

Long-lived asset impairment

951

Total operating expenses

22,288

32,614

Loss from operations

(22,288

)

(32,614

)

Total other income

1,203

2,457

Net loss

$

(21,085

)

(30,157

)

Net loss attributable to common stockholders

(21,085

)

(30,157

)

Net loss per share, basic and diluted

$

(16.72

)

$

(24.01

)

Weighted-average common shares outstanding, basic and diluted

1,260,772

1,255,776

Selected Condensed Balance Sheet Data

(Unaudited, in thousands)

December 31, 2025

December 31, 2024

Cash and cash equivalents

$

8,668

$

9,994

Marketable securities

12,516

31,341

Total assets

22,902

45,361

Total liabilities

4,310

6,975

Total stockholders’ equity

18,592

38,386

(Press release, Sensei Biotherapeutics, MAR 30, 2026, View Source [SID1234664028])

Protara Therapeutics, Inc. reported update on ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ

On March 30, 2026, Protara Therapeutics, Inc. (the "Company" or "Protara") reported that the Company has received confirmation on the six-month complete response ("CR") rate of the 25th Bacillus Calmette-Guérin ("BCG")-Unresponsive patient in its ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer ("NMIBC"). The average six-month CR rate in the 25 BCG-Unresponsive patients is 68.0%, which is consistent with the 68.2% CR rate at six months that was announced by the Company on February 24, 2026, and is meaningfully above 41.9%.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As a result, the Company has determined that it has satisfied the condition set forth in its common stock purchase warrants issued in April 2024 (the "April 2024 Common Warrants") for fixing the termination date for exercise of the April 2024 Common Warrants. Specifically, the April 2024 Common Warrants are exercisable at an exercise price of $5.25 per share and may be exercised at any time on or prior to June 29, 2026.

The information contained in Item 7.01 of this Current Report on Form 8-K is being furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

(Press release, Protara Therapeutics, MAR 30, 2026, View Source [SID1234664027])