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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).

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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])

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%.

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])

Phio Pharmaceuticals Announces Agreement with U.S. cGMP Manufacturing Source for Drug Product, PH-762

On March 30, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that it has entered into a cGMP drug product manufacturing services agreement with a U.S. manufacturer for clinical supply for future clinical trial. The company will manufacture Phio’s lead compound PH-762 for both clinical and commercial supply.

"It is a pleasure to partner with an organization known for its quality and expertise in drug product manufacturing services," said Mr. Robert Bitterman, Phio’s President and CEO. "Further, we value the strategic advantages of working with a U.S. based organization."

Recent Company Highlights

Phio’s lead clinical candidate, PH-762, is being evaluated as an intratumoral therapy for cutaneous carcinomas. In its Phase 1b trial, Phio has reported that 22 patients completed treatment across five dose-escalation cohorts, with no dose-limiting toxicities or serious adverse events. The Company has also reported a pathological response rate in cSCC across all dosing cohorts of approximately 65%, including an 85% pathological response (6 of 7 patients) in the highest-dose cohort.

Phio has indicated that FDA engagement regarding next-stage clinical development is targeted for the second quarter of 2026 and has reported cash and cash equivalents projected to sustain operations into the first half of 2027.

(Press release, Phio Pharmaceuticals, MAR 30, 2026, View Source [SID1234664026])

PDS Biotech Reports Full Year 2025 Financial Results and Provides Update on PDS0101 Phase 3 Program and PDS01ADC Clinical Advancement

On March 30, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported a business and clinical programs update and announced financial results for the quarter and year ended December 31, 2025.

"The fourth quarter capped a year of important progress for PDS Biotech, marked by meaningful advances across our clinical programs, financial discipline, and intellectual property portfolio," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "Building on the compelling topline data from our VERSATILE-002 Phase 2 trial, we believe the VERSATILE-003 protocol amendment has the potential to create a more efficient path to accelerated approval — shortening the trial’s duration, reducing costs, and accelerating our timeline to regulatory submission — while preserving overall survival as the basis for full approval. For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a promising treatment option, and we remain focused on advancing it as efficiently as possible."

Dr. Bedu-Addo added: "Combined with early data from one of our PDS01ADC Phase 2 programs and expanded patent protections for the Versamune platform extending into the 2040s, we believe we have meaningful opportunities ahead as we continue to execute against our priorities in 2026."

Clinical and Corporate Update
•
Amended the VERSATILE-003 Phase 3 clinical trial protocol to incorporate progression-free survival (PFS) as an interim primary endpoint, creating a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the primary endpoint for full FDA approval. The amendment also reduces the number of enrolled patients while maintaining statistical power. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment.

•
Presented encouraging early results from an NCI-led trial investigating PDS01ADC, the Company’s investigational IL-12 tumor-targeted immunocytokine, at the AACR (Free AACR Whitepaper) special conference on prostate cancer research. In patients with metastatic castration-resistant prostate cancer (mCRPC) the majority of whom received third-line treatment options — the combination of PDS01ADC and docetaxel demonstrated encouraging median PFS of 9.6 months and a median PSA decline of 40%, with 6 of 16 patients achieving greater than 50% decline.

Strengthened the intellectual property estate for PDS0101 with new patents granted in the U.S. and Japan. The new U.S. patent, combined with anticipated biologics exclusivity, extends market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets.

Full Year 2025 Financial Results

Net loss for the year ended December 31, 2025, was approximately $34.5 million, or $0.74 per basic and diluted share, compared to a net loss of $37.6 million, or $1.03 per basic and diluted share for the year ended December 31, 2024.

Research and development expenses for the year ended December 31, 2025, were $19.0 million, compared to $22.6 million for the year ended December 31, 2024. The decrease of $3.6 million was primarily attributable to decreases in manufacturing costs of $2.5 million and personnel costs of $1.8 million, partially offset by an increase in clinical costs of $0.7 million.

General and administrative expenses for the year ended December 31, 2025, were $12.5 million, compared to $13.8 million for the year ended December 31, 2024. The $1.3 million decrease was primarily attributable to a decrease in personnel costs.

Total operating expenses for the year ended December 31, 2025, were $31.5 million compared to $36.3 million for the year ended December 31, 2024.

Net interest expense was $4.1 million for the year ended December 31, 2025, compared to $2.2 million for the year ended December 31, 2024. The change was primarily due to non-cash expenses related to extinguishment of debt, as well as lower interest income on the Company’s cash balances.

The Company’s cash balance as of December 31, 2025, was $26.7 million.

Conference Call Details
•
Date: March 30, 2026

•
Time: 8:00 a.m. Eastern Time

•
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)

•
Conference I.D.: 13759288

•
Webcast: Click Here

•
CallMeTM: Click Here (available 15 minutes prior to the call)

After the live webcast, the event will be archived on PDS Biotech’s website for six months.

(Press release, PDS Biotechnology, MAR 30, 2026, View Source [SID1234664025])

NANOBIOTIX Announces Presentation of First Data from a Randomized Phase 2 Clinical Trial Evaluating JNJ-1900 (NBTXR3) in Stage 3 Inoperable Lung Cancer

On March 30, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the presentation of first data from the CONVERGE study, a Johnson & Johnson-sponsored randomized Phase 2 clinical trial evaluating potential first-in-class Nanoradioenhancer JNJ-1900 (NBTXR3) for patients with stage 3 inoperable non-small cell lung cancer, at the 2026 European Lung Cancer Conference.

POSTER #297P: Novel Intratumoral Radioenhancer (JNJ -1900) with Chemoradiation and Consolidative Immunotherapy for Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC): Early Outcomes from the Phase II CONVERGE Study

Benjamin T. Cooper,1 Jeffrey D. Bradley,2 Sushma Patel,3 Michael A. Pritchett,4 Steven J. Feigenberg,2 Kevin C. Ma,5 Isaac Laniado,6 Melina E. Marmarelis,7 Matthew Scarlotta,8 Joshua K. Sabari,9 Yi -Wen Ma,10 Yina Kuang,10 Kiran Devisetty,10 Balaji Laxmanan,10 David M. DiBardino5

Study Conclusions

The procedure demonstrated an acceptable safety profile without serious treatment-emergent adverse events (TEAEs) and did not adversely impact patients’ ability to continue planned therapy
Initial efficacy responses observed in 7 patients at first disease evaluation following concurrent chemoradiotherapy, and before treatment with anti-PD-L1, are promising (ORR = 71.4%; DCR = 100%) relative to the estimated benchmark (ORR = 45%-50%).
About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, MAR 30, 2026, View Source [SID1234664024])