On March 30, 2026 CERo Therapeutics Holdings, Inc., (OTCQB: CERO) ("CERo" or the "Company") an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, reported it has dosed the second patient in the second cohort (fifth patient overall) in its Phase 1 CER-1236 clinical trial in hematologic malignancies, including acute myeloid leukemia (AML), with planned expansion into myelodysplastic syndromes (MDS) and myelofibrosis (MF). With more than seven days of follow-up completed after the second patient’s infusion, protocol-defined monitoring of safety, pharmacokinetic, pharmacodynamic, and clinical activity endpoints is ongoing.

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As previously presented at the February Tandem Meetings in Salt Lake City, investigators reported no cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, no dose-limiting toxicities during the 28-day assessment window, and in vivo cell expansion with peak levels observed between days 10 and 14 following infusion. In the same presentation, the Company reported observations from a single patient with inv(3) AML who received four CER-1236 infusions over five months at the lowest dose level and experienced 72 consecutive days of platelet transfusion independence. These data informed the protocol amendment expanding enrollment into patients with MDS and MF.

Robert Sikorski, M.D., Ph.D., CERo Chief Medical Officer, stated, "The study is progressing according to protocol, with ongoing evaluation of safety, pharmacokinetics, pharmacodynamics, and clinical activity. The data generated to date support continued dose escalation and planned expansion of enrollment into patients with advanced myelodysplastic syndrome (MDS) and myelofibrosis (MF). These are patient populations with substantial unmet need, and we are committed to continuing the clinical evaluation of CER-1236 as a potential new cell therapy approach for patients with these diseases."

The first-in-human, multi-center, open-label, Phase 1/1b study was initially designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated AML. The two-part study initiated with dose escalation to determine the highest tolerated dose and recommended dose for subsequent expansion, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose-limiting toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK). Based on emerging safety data and clinical observations, the trial has recently been amended to include transfusion-dependent myelodysplastic syndromes (TD-MDS), high-risk MDS (HR-MDS), or post-JAK-inhibitor myelofibrosis (MF).

CERo CEO Chris Ehrlich added, "CERo continues to execute the CERTAIN-T trial, with completion of the second cohort approaching. The study data continue to reinforce ongoing dose escalation and planned expansion into additional patient populations. We are grateful to the patients, investigators, study sites, and the CERo team for their contributions, and we look forward to sharing additional data as the study progresses."

(Press release, Cero Therapeutics, MAR 30, 2026, View Source [SID1234664048])

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).

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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])

On March 30, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported that the Company will have a poster presentation at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR"), taking place on April 17 through 22, 2026 in San Diego, California.

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Presentation Details:

Title: Plinabulin Boosts Antitumor Efficacy of Topoisomerase Inhibitor-based Antibody-drug Conjugates Without or With Immune Checkpoint Inhibitor
Presenter / Authors: Yingjuan June Lu, Xiaoyan He, Weiwei Cheng, Zhengyan Zhang, James Tonra, Lan Huang
Presentation Time: April 21, 2026, 2PM to 5PM PT
Location: Poster Section 8 at San Diego Convention Center
Session Category: Immunology
Session Title: T Cell Engagers 2 / Antibody-Drug Conjugates 1
Poster Board Number: 16
Poster Number: 5597

(Press release, BeyondSpring Pharmaceuticals, MAR 30, 2026, View Source [SID1234664049])

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.

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"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])

On March 30, 2026 Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-α (FRα), for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC).

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ZW191 is an ADC engineered to target FRα, a protein expressed in several tumor types, including approximately 75% of high-grade serous ovarian carcinomas1, over 50% of endometrial cancers,2,3 and ~70% of lung adenocarcinomas4. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.

The FDA’s Fast Track designation program is designed to expedite the development and review timelines of drugs that demonstrate the potential to treat serious conditions, aiming to deliver therapeutics to patients more quickly in areas of unmet need.

"Receiving Fast Track Designation for ZW191 highlights the potential of this program to address significant unmet medical needs for patients with previously treated advanced ovarian cancer. Notably, the designation was granted irrespective of FRα expression highlighting ZW191’s potential of extending treatment benefits to a broad group of patients without need for biomarker selection," said Sabeen Mekan, M.D., Senior Vice President and Chief Medical Officer at Zymeworks. "This designation also further reinforces our expertise in ADC development, and we look forward to working closely with the FDA to advance this program for patients with difficult-to-treat cancers."

Zymeworks is currently evaluating ZW191 in a Phase 1 clinical study (NCT06555744) designed to assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced solid tumors. The study is designed to further characterize ZW191’s clinical activity and safety to inform its future development strategy.

(Press release, Zymeworks, MAR 30, 2026, View Source [SID1234664050])