On May 17, 2026 Ferring Pharmaceuticals reported a new real-world case series demonstrating that re-induction with ADSTILADRIN (nadofaragene firadenovec-vncg) resulted in complete responses (CR) in approximately 31% (4/13) of patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) who did not respond to an initial dose of therapy. The study included patients with carcinoma in situ (CIS), with or without papillary tumors (±Ta/T1).

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The findings – presented at the 2026 American Urological Association (AUA) Annual Meeting and scheduled for publication in Translational Andrology and Urology later in May – reflect outcomes observed following a re-induction dose (second dose overall) of ADSTILADRIN in a real-world clinical setting, including two patients (2/13) with CIS with papillary disease (T1).1

ADSTILADRIN is the first and only non-replicating intravesical gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with high-risk BCG-unresponsive NMIBC with CIS, with or without papillary tumors (±Ta/T1), and is administered once every three months.

"These findings offer a promising signal that some patients who do not achieve a complete response after an initial dose of ADSTILADRIN may still benefit from re-induction," said Chad Reichard, MD, urologic oncologist and Director of Oncology at Urology of Indiana. "Real-world evidence provides important insight into how ADSTILADRIN is being used in routine clinical practice, and the responses observed in this study support the feasibility of re-induction as a potential option for certain patients despite an initial non-response, while highlighting the need for further study."

The retrospective, observational cohort study analyzed electronic health record data from U.S. private urology practices. Thirteen patients with BCG‑unresponsive NMIBC were eligible, including eight with CIS alone, two with CIS and papillary disease (Ta), and three with CIS and papillary disease (T1). Patients had a mean age of 77.5 years; all were male and had received a mean of 11 prior BCG doses. Prior treatments included gemcitabine (n=4) and pembrolizumab (n=5). Median follow‑up following re‑induction was 379 days (range, 135–519). After re‑induction, four patients (30.8%) achieved a complete response, including two patients with CIS and T1 disease.

Among patients who achieved a complete response, three went on to receive additional doses of ADSTILADRIN; one patient has maintained a complete response at last follow‑up. One patient experienced progression to muscle‑invasive disease (T2a), and one patient underwent cystectomy approximately 51 weeks after initiation of therapy. At the time of analysis, no patient deaths had been reported.

"These new data add to the growing body of real-world evidence generated in urology practices and help inform how re-induction with ADSTILADRIN is being evaluated outside of the controlled clinical trial setting, particularly in a heavily pretreated patient population," said Daniel Shoskes, MD, MSc, FRCS(C), Vice President, Global Medical Director Uro-Oncology, Ferring Pharmaceuticals. "In the Phase 2 and Phase 3 clinical trials, patients who did not achieve a complete response at three months were not retreated with ADSTILADRIN. However, re-induction is an approach that has been used with some immune-based therapies. These real‑world findings provide insight into how re-induction may improve complete response outcomes over the course of treatment."

About Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.2 In the United States, bladder cancer is the sixth most common cancer,3 fourth among men,4 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.4 Historically, 75% of bladder cancer presents as NMIBC.5 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.6 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).7

About ADSTILADRIN
ADSTILADRIN (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1). It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.

ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC, who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology).8-9

INDICATION
ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.

WARNINGS AND PRECAUTIONS:

Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.
DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use or oral administration.

USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.

ADVERSE REACTIONS: The most common (>10%) adverse reactions; including, laboratory abnormalities (>15%), were increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition (urination urgency), increased creatinine, hematuria (blood in urine), decreased phosphate, chills, pyrexia (fever) and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit View Source or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

Please click to see the full Prescribing Information.

(Press release, Ferring Pharmaceuticals, MAY 17, 2026, View Source [SID1234665813])

On May 17, 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 Part 1 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 ("NSCLC"), at the 2026 European Society for Radiotherapy and Oncology Annual Meeting (ESTRO 2026).

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PRESENTATION #116: Radiographic Response in Patients with Stage III Unresectable Non-Small Cell Lung Cancer Treated with an Intratumoral Radioenhancer (JNJ-90301900)

Jeffrey Bradley,1 Benjamin T. Cooper,2 Sushma Patel,3 David DiBardino,4 Michael Pritchett,5 Kevin C. Ma,4 Isaac Laniado,6 Melina E. Marmarelis,7 Matthew Scarlotta,8 Joshua K. Sabari,9 Yi -Wen Ma,10 Tori Stromp,10 Yina Kuang,10 Balaji Laxmanan,10 Kiran Devisetty,10 Steven Feigenberg1

Study Conclusions

Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLC
Initial efficacy responses observed in 7 patients following the full treatment regimen of concurrent chemoradiotherapy, JNJ-1900 (NBTXR3), and consolidation with durvalumab are promising:
Overall response rate ("ORR") = 85.7% (6/7 patients)
Complete response rate ("CRR") = 57.1% (4/7 patients)
With the current standard of care, concurrent chemoradiation therapy (cCRT) ± durvalumab, depth of response remains limited in Stage 3 Inoperable NSCLC with very low rates of complete response (<5%) *
Disease control rate ("DCR") = 100.0% (7/7 patients)
Absence of progressive disease and deepening response over time suggests potential for long-term durability
1Radiation Oncology, University of Pennsylvania, Philadelphia, USA; 2Radiation Oncology, NYU Langone Health, New York, USA; 3Radiation Oncology, FirstHealth of the Carolinas, Pinehurst, USA; 4University of Pennsylvania, Philadelphia, USA; 5Interventional Pulmonology, FirstHealth of the Carolinas, Pinehurst, USA; 6Interventional Pulmonology, NYU Langone Health, New York, USA; 7Medical Oncology, University of Pennsylvania, Philadelphia, USA; 8Medical Oncology, FirstHealth of the Carolinas, Pinehurst, USA; 9Medical Oncology, NYU Langone Health, New York, USA; 10Johnson & Johnson, New Brunswick, NJ, USA

* Antonia SJ, et al. N Engl J Med. 2017.

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, MAY 17, 2026, View Source [SID1234665815])

On May 17, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, reported updated results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial carcinoma (UTUC). These data will be shared during a podium presentation and in an interactive poster at the American Urological Association (AUA) Annual Meeting taking place May 15-18, 2026, in Washington, D.C.

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"These updated efficacy and durability results from the Phase 3 ENLIGHTED trial continue to reinforce Padeliporfin VTP’s potential to become an attractive alternative, minimally invasive ureteroscopic treatment option for patients with low-grade UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. "The promising complete response rate and encouraging durability observed to date, alongside a well-established safety profile, further support the opportunity to provide a meaningful organ-sparing treatment for patients with limited options in UTUC and additional solid tumor indications. We look forward to sharing topline data from ENLIGHTED later this year and preparing for regulatory submission in 2027, while exploring strategic opportunities to commercialize the program and maximize Padeliporfin VTP’s impact for UTUC patients facing great unmet need."

Key updated results from the ongoing Phase 3 ENLIGHTED study of Padeliporfin VTP:

As of April 20, 2026, the data cut-off for the poster presentation at AUA 2026, 82 patients had begun treatment, of which 72 had completed PRE and were evaluable for efficacy.

Efficacy Profile:

Overall response rate: 88%
50 of the 72 (70%) response-evaluable patients achieved a CR at the end of PRE.
13 of the 72 (18%) response-evaluable patients achieved a partial response (PR) at the end of PRE.

Durability Profile:

18 of the 21 (85.7%) response-evaluable patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date, with additional patients ongoing the MTP that have yet to complete the 12-month evaluation period. Padeliporfin VTP treatment has demonstrated evidence of efficacy and durability.
The current median duration of response (DoR) in the treated area for evaluable patients is 23.9 months based on available follow-up, with ongoing responses still being observed.

Safety and Tolerability Profile:

Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results. Padeliporfin VTP treatment has demonstrated a consistent and acceptable safety profile.
Adverse events (AEs): the majority of treatment-emergent adverse events (TEAEs) were mild or moderate, primarily related to the ureteroscopic procedure, and resolved within a few days. Two patients had Grade 3 serious adverse events related to VTP treatment which resolved within two days. No TEAEs of special interest were reported and no TEAE led to discontinuation of the study treatment.

While the Company is pursuing strategic partnering opportunities to support the commercialization of its low-grade UTUC program, ImPact recently presented initial data supporting the advancement of Padeliporfin VTP in locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) at the Society of Interventional Radiology (SIR) 2026 Annual Meeting, which demonstrated a consistent tolerability profile alongside early signs of clinical efficacy, showing potential to convert patients with unresectable stage III LA tumors to surgically resectable candidates.

Additional updates from both programs will be presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.

AUA Presentation Details:

Interactive Poster Title: The ENLIGHTED Phase 3 Trial: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: IP30-04
Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma I
Session Date & Time: Saturday, May 16, 2026 at 7:00 AM ET

Podium Presentation Title: ENLIGHTED Phase 3 Trial of Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC)
Presenter: Jonathan Coleman, M.D., Urologic Surgeon, Memorial Sloan Kettering Cancer Center
Session Title: Clinical Trials in Progress: Bladder Cancer
Session Date & Time: Sunday, May 17, 2026 at 9:16 AM ET

About ENLIGHTED
The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of
the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an ureteroscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

(Press release, ImPact Biotech, MAY 17, 2026, View Source [SID1234665816])

On May 16, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory ("JBL"), the Tokyo-based developer and manufacturer of the Tokyo strain of BCG (Tokyo-172 BCG). The agreement provides ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG.

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JBL’s Tokyo strain of BCG is supported by the February 2026 positive Phase III readout of SWOG S1602, a randomized Phase III study sponsored by the National Cancer Institute (NCI), which demonstrated non-inferiority of the Tokyo strain of BCG to TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer (NMIBC). The pre-specified non-inferiority margin was a hazard ratio of 1.34 (hazard ratio 0.82; 95.8% CI 0.63–1.08). The Tokyo strain of BCG is investigational in the United States and has not been approved by the FDA.

Dr. Patrick Soon-Shiong will discuss the JBL agreement and provide updates on ImmunityBio’s efforts to expand BCG access and advance research in the BCG-naïve setting during his presentation, "The Role of IL-15 in the Urological Setting," at the American Urological Association Annual Meeting on May 16, 2026 at 1:30 EDT. The presentation will also highlight the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer. A livestream of the presentation will be available through the 2026 AUA Annual Meeting website.

"For more than 70 years, Japan BCG Laboratory has been dedicated to the development and manufacture of high-quality BCG products," said Seiichi Inoue, President of Japan BCG Laboratory. "We are pleased to partner with ImmunityBio to bring the Tokyo strain of BCG to patients in the United States, and we look forward to supporting ImmunityBio in its engagement with the FDA."

ImmunityBio plans to engage with the FDA to pursue U.S. approval of the Tokyo strain of BCG and will lead all regulatory submissions, clinical development, and commercialization in the United States as the sole BLA applicant. Upon any approval, ImmunityBio will be the sole Marketing Authorization Holder. The Tokyo strain of BCG has been used in Japan for almost 30 years for the treatment of high-risk NMIBC.

SWOG S1602 (NCT03091660) is a Phase III randomized controlled trial that enrolled 1,000 patients (984 eligible) between February 2017 and December 2020 with BCG-naïve high-grade NMIBC, randomized 1:1:1 to intravesical TICE BCG (n=330), intravesical Tokyo-172 BCG (n=327), or intradermal priming, followed by intravesical Tokyo-172 BCG (n=327). The pre-specified non-inferiority margin for the primary endpoint of high-grade recurrence-free survival (HGRFS) was a hazard ratio of 1.34.

At a median follow-up of 4.6 years, results presented at the February 2026 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (Svatek RS, et al. J Clin Oncol. 2026;44[7 suppl]:LBA629) demonstrated non-inferiority of intravesical Tokyo strain of BCG versus intravesical TICE BCG on the primary endpoint of HGRFS (HR 0.82; 95.8% CI 0.63–1.08), with the upper confidence bound well below the pre-specified non-inferiority margin of HR 1.34. Complete response (CR) in carcinoma in situ (CIS) at 6 months was 66.4% (Tokyo) versus 70.2% (TICE). Progression-free survival was similar across arms. The estimated 5-year HGRFS was 64% in the Tokyo arm, 58% in the TICE arm.

ImmunityBio is in discussions with the SWOG Cancer Research Network, the NCI, and Fred Hutchinson Cancer Research Center to establish a Data Use Agreement that would allow incorporation of the S1602 data into the company’s planned BLA submission.

"SWOG and the National Cancer Institute have our deep respect for designing and completing SWOG S1602, a randomized controlled trial of approximately one thousand patients in BCG-naïve high-grade NMIBC that took nearly a decade to read out," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "S1602 is the kind of rigorous, publicly funded science that should inform FDA decision-making. Its non-inferiority finding for the Tokyo strain of BCG, alongside our rBCG partnership with Serum Institute and the FDA-approved use of ANKTIVA with BCG in BCG-unresponsive disease, points to a future where U.S. patients with bladder cancer will have the supply and the treatment options they need."

With the JBL agreement, ImmunityBio now has a second potential BCG source for the United States. The Company’s ongoing partnership with Serum Institute of India, one of the world’s largest vaccine manufacturers, supports the supply of recombinant BCG (rBCG), an investigational product. ImmunityBio will continue its FDA Expanded Access Program (EAP) for rBCG, so eligible patients can receive treatment while the regulatory path for the Tokyo strain of BCG moves forward. Taken together, the two partnerships aim to give U.S. urologists and their patients a more reliable BCG supply.

"U.S. urologists and their patients have lived with a chronic BCG shortage for more than a decade," said Richard Adcock, President and Chief Executive Officer of ImmunityBio. "This agreement with Japan BCG Laboratory for the Tokyo strain of BCG gives ImmunityBio a second potential BCG source for the United States. We plan to work with the FDA on the regulatory path for the Tokyo strain of BCG. In the meantime, through our ongoing partnership with the Serum Institute of India, rBCG remains available to eligible patients through our FDA Expanded Access Program."

ANKTIVA is approved by the FDA in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in-situ (CIS), with or without papillary tumors. ImmunityBio expects to provide further updates on the U.S. regulatory pathway for the Tokyo strain of BCG, including the timing of pre-FDA interactions and any anticipated BLA submission, in future communications.

Important Safety Information

U.S. IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

Investigational Use Notice: The Tokyo strain of BCG (manufactured by Japan BCG Laboratory) and recombinant BCG or rBCG (manufactured by Serum Institute of India under ongoing partnership with ImmunityBio) are investigational in the United States and have not been approved by the FDA. The safety and effectiveness of these investigational products have not been established. Availability of rBCG is limited to ImmunityBio’s FDA Expanded Access Program for eligible patients. To enroll in the Expanded Access Program for recombinant BCG, please visit View Source

(Press release, ImmunityBio, MAY 16, 2026, View Source [SID1234665810])

On May 15, 2026 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE) reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

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"The first quarter of 2026 was transformational for the Company, with the acquisition of Faeth Therapeutics and the concurrent $200 million private placement in February, supported by a group of leading life sciences investors," said Christopher Gerry, President & General Counsel of Sensei Biotherapeutics. "This acquisition and injection of new capital will allow us to advance PIKTOR, a differentiated multi-node pathway inhibitor, through key clinical milestones."

"New data across the industry continues to support the significant potential of multi-node inhibition of the PI3K/AKT/mTOR pathway," said Anand Parikh, Chief Operating Officer of Sensei Biotherapeutics. "We believe PIKTOR is differentiated as an orally administered multi-node therapy specifically targeting PI3K-alpha, mTORC1 and mTORC2, with the potential to treat a variety of solid tumors. With our Phase 2 trial in advanced endometrial cancer expected to read out by the end of the year and the recent initiation of our Phase 1b/2 trial in advanced breast cancer, we are making great strides towards delivering the next generation of solid tumor therapies."

Clinical Program Highlights

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.

In April 2026, the first patient was dosed in the Phase 1b/2 trial evaluating PIKTOR for the treatment of HR+/HER2- advanced breast cancer (Study FTH-PIK-101). Interim data from the trial is expected in 2027.

The Phase 2 trial evaluating PIKTOR in advanced endometrial cancer (Study FTH-PIK-201) is on track to report topline data in the second half of 2026.
First Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $202.8 million as of March 31, 2026, as compared to $21.2 million as of December 31, 2025.

Research and Development (R&D) Expenses: R&D expenses were $18.0 million for the quarter ended March 31, 2026, compared with $3.7 million for the quarter ended March 31, 2025. The increase in R&D expenses was primarily attributable to the inclusion of Faeth R&D operations as well as one-time costs associated with the Faeth acquisition, partially offset by a reduction in the SNS-101 clinical trial costs.

General and Administrative (G&A) Expenses: G&A expenses were $19.7 million for the quarter ended March 31, 2026, compared to $3.5 million for the quarter ended March 31, 2025. The increase in G&A expense was primarily attributable to one-time costs associated with the Faeth acquisition.

Acquired In-Process Research and Development (Acquired IPR&D) Expenses: Acquired IPR&D expenses were $133.0 million for the quarter ended March 31, 2026. This represents the fair value of IPR&D assets obtained in connection with asset acquisition where the acquired IPR&D has no alternative future use as of the acquisition date.

Net Loss: Net loss was $170.2 million, or $131.45 per basic and diluted share, for the quarter ended March 31, 2026, compared with a net loss of $6.9 million, or $5.45 per basic and diluted share, for the quarter ended March 31, 2025.

Weighted-average common shares outstanding, basic and diluted, were 1,295,052 for the quarter ended March 31, 2026, compared with 1,259,531 for the quarter ended March 31, 2025.

Condensed Statements of Operations

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

For the Three Months
Ended March 31,

2026

2025

Operating expenses:

Research and development

$

17,957

$

3,725

General and administrative

19,713

3,549

Acquired in-process research and development

132,957

—

Total operating expenses

170,627

7,274

Loss from operations

(170,627

)

(7,274

)

Total other income

391

410

Net loss

(170,236

)

(6,864

)

Net loss per share, basic and diluted

$

(131.45

)

$

(5.45

)

Weighted-average common shares outstanding, basic and diluted

1,295,052

1,259,531

Selected Condensed Balance Sheet Data

(Unaudited, in thousands)

March 31,
2026

December 31,
2025

Cash and cash equivalents

$

152,325

$

8,668

Marketable securities

50,468

12,516

Total assets

205,381

22,902

Total liabilities

14,191

4,310

Series B redeemable convertible preferred stock

328,476

—

Total stockholders’ (deficit) equity

(137,286

)

18,592

(Press release, Sensei Biotherapeutics, MAY 15, 2026, View Source [SID1234665779])