On May 5, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, reported that the first patient has been dosed in the Phase 3 ASPENOVA clinical trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27) evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).

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"Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. "With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and ASPENOVA now enrolling to evaluate azenosertib versus standard-of-care chemotherapy to support full approval, we are executing on a comprehensive development and regulatory strategy designed to bring this therapy to patients as quickly as possible. We are deeply grateful to the patients participating in this important trial and to our collaborators at The GOG Foundation, Inc. (GOG-F), ENGOT, and APGOT for their partnership in advancing this research."

"Cyclin E1-overexpressing ovarian cancers are associated with platinum-resistance and poor outcomes, representing a clinical unmet need," said Fiona Simpkins, M.D., Professor at the University of Pennsylvania Perelman School of Medicine and Lead Investigator for the ASPENOVA trial and GOG-F. "This biomarker has yet to be exploited therapeutically and azenosertib, a WEE1 inhibitor, is an oral, targeted treatment that is showing exciting activity in Cyclin E1-overexpressing ovarian cancer (SGO Annual Meeting, 2025). The biomarker-driven approach now being studied in this Phase 3 randomized trial has the potential to identify patients most likely to benefit while sparing them from the inconvenience of intravenous regimens. On behalf of GOG Foundation, we are pleased to collaborate with Zentalis, ENGOT, and APGOT on this important trial for this underserved patient population."

ASPENOVA is a randomized, controlled Phase 3 trial designed to confirm the clinical benefit of azenosertib and support full approval as part of Zentalis’ dual-track regulatory strategy. The company is pursuing accelerated approval based on the ongoing registration-intended DENALI Phase 2 trial, with a topline readout expected by year-end 2026, while simultaneously advancing ASPENOVA as the confirmatory study to satisfy FDA requirements for conversion to full approval. Both trials are evaluating azenosertib at 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2), the dose selected based on the DENALI Part 2a interim analysis announced in April 2026. The planned interim analysis showed a meaningful, clearly differentiated response rate at 400mg QD 5:2 over 300mg QD 5:2 and comparable safety profiles between the two dose groups.

The ASPENOVA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), and Asia-Pacific Gynecologic Oncology Trials Group (APGOT), reflecting the global clinical and scientific community’s recognition of the significant unmet need in this patient population.

About ASPENOVA Clinical Trial
ASPENOVA (NCT07546500, GOG-3147, ENGOT-ov109) is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator’s choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The primary endpoint is progression-free survival (PFS); key secondary endpoints include overall survival (OS) and overall response rate (ORR). The trial design was aligned with the U.S. Food and Drug Administration (FDA) to meet requirements for the accelerated approval pathway and potential conversion to full approval.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.

Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff.

Part 2, in total, is designed to support accelerated approval, pending study outcome and discussions with the FDA. The study design consists of the following parts:
•Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
•Part 2b: Enrollment expansion at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at this dose in Part 2a. This cohort is currently enrolling.
•Part 2c: Broadening study population to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. This cohort is currently enrolling.

Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 (2a, 2b, 2c) and provide a topline readout by year-end 2026.

For physician and patient information about the DENALI trial, please visit www.denalitrial.com.

About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.
Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.

(Press release, Zentalis Pharmaceuticals, MAY 5, 2026, View Source [SID1234665135])

On May 5, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported financial results for the first quarter ended March 31, 2026.

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"We had a strong start to the year, with Decipher and Afirma volume growth surpassing expectations and exceeding our profitability targets," said Marc Stapley, Veracyte’s CEO. "Our growing clinical evidence continues to set us apart, and this quarter strengthened it even further. We believe we are approaching an inflection point with the upcoming launches of Prosigna LDT and TrueMRD, two of the most significant new products in our history, creating meaningful opportunities for market expansion in Breast, Bladder and other cancers, alongside continued growth in our Prostate and Thyroid businesses."

Key Financial Highlights

For the three-month period ended March 31, 2026, as compared to the same period in 2025:

Increased total revenue by 21% to $139.1 million and testing revenue by 26% to $135.1 million, driven by Decipher growth of 30% to $86.5 million and Afirma growth of 21% to $46.4 million.
Increased total volume by 17% to 47,615 tests and testing volume by 19% to 45,248 tests, driven by Decipher growth of 24% to approximately 28,000 tests and Afirma growth of 12% to approximately 17,200 tests.
Recorded GAAP net income of $28.7 million, or 20.6% of revenue, and delivered adjusted EBITDA of $42.8 million, or 30.8% of revenue.
Generated $35.2 million of cash from operations to end the quarter with $439.1 million of cash, cash equivalents, and short-term investments as of March 31, 2026.
Key Business Highlights

Advanced the evidence pipeline for Decipher with enrollment completed for GUIDANCE and G-MAJOR phase III trials.
Announced data published in European Urology Oncology showing Decipher’s ability to stratify risk among patients undergoing active surveillance.
Announced more than 15 studies featuring Decipher Prostate and Decipher Bladder will be presented at the AUA Annual Meeting next week, including the expanding impact of Decipher Prostate in studies using real-world data.
Strengthened the leadership team with the appointments of Kevin Haas as Chief Development and Technology Officer and Tracy Ward as Chief Human Resources Officer.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

First Quarter 2026 Financial Results

Total revenue for the first quarter of 2026 was $139.1 million, an increase of 21% compared to $114.5 million reported in the first quarter of 2025. Testing revenue was $135.1 million, an increase of 26% compared to $107.3 million in the first quarter of 2025, driven by growth in our Decipher Prostate and Afirma tests. Product revenue was $3.7 million, an increase of 3% compared to $3.6 million in the first quarter of 2025. Biopharmaceutical and other revenue was $0.3 million, an expected decrease compared to $3.6 million in the first quarter of 2025 given the restructuring and liquidation proceedings of Veracyte SAS.

Total gross margin for the first quarter of 2026 was 73%, compared to 69% in the first quarter of 2025. Non-GAAP gross margin was 76%, compared to 72% in the first quarter of 2025.

Operating expenses were $78.5 million for the first quarter of 2026 compared to $76.6 million in the first quarter of 2025. Non-GAAP operating expenses grew 7% to $64.6 million compared to $60.5 million in the first quarter of 2025.

Net income for the first quarter of 2026 was $28.7 million, an improvement of 307% compared to the first quarter of 2025. Diluted net earnings per common share was $0.35, an improvement of $0.26 compared to the first quarter of 2025. Non-GAAP diluted net earnings per common share was $0.52, an increase of $0.21 compared to the first quarter of 2025. Net cash provided by operating activities in the first three months of 2026 was $35.2 million, an improvement of $29.9 million compared to the same period in 2025.

Adjusted EBITDA for the first quarter of 2026 was $42.8 million, an improvement of 73% compared to the first quarter of 2025, representing 30.8% of revenue compared to 21.6% of revenue in the same period in 2025.

2026 Financial Outlook

The company is raising 2026 total revenue guidance to $582 million to $592 million, or 13% to 14% growth, from prior guidance of $570 to $582 million, or 10% to 13% growth. The company is also raising testing revenue guidance to $570 million to $580 million, or 16% to 18% growth, excluding the contribution from new tests.

Additionally, the company is raising guidance for adjusted EBITDA margin to greater than 26%, from approximately 25% prior.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA margin to the most directly comparable forward-looking GAAP measure without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, that are dependent on various factors, are out of the company’s control, or that cannot be reasonably predicted. Such adjustments include, but are not limited to, acquisition-related expenses, and other adjustments. Any associated estimate of these items and their impact on GAAP performance for the guidance period could vary materially. For more information on the non-GAAP financial measures, please refer to the section titled "Note Regarding Use of Non-GAAP Financial Measures" at the end of this press release.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering via the following link: View Source

(Press release, Veracyte, MAY 5, 2026, View Source [SID1234665134])

On May 5, 2026 Sona Nanotech Inc., (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), reported its clinical strategy to further the development of its Targeted Hyperthermia Therapy ("THT") cancer treatment. Based on both the success of Sona’s first-in-human clinical study with THT, which demonstrated its ability to shrink and prime tumors immunogenically when used alone, and the published results from preclinical testing of Sona’s THT showing the higher and more durable response rates that were observed when THT is combined with standard immunotherapies, the Company now intends to trial advanced applications of THT in two innovative clinical studies in melanoma patients combining THT with immunotherapy drugs.

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With a view to assessing how THT’s effectiveness and durability can be enhanced for late-stage melanoma sufferers, Sona will undertake its next clinical study of THT, (the "IGNITE-THT Study" – Immunotherapy + THT to Generate Novel Immune Tumor Eradication). In this study, Sona’s THT would be administered in conjunction with a regimen of intratumoral and systemic dosing of the same immunotherapy drugs on which a cohort of patients had previously failed. The IGNITE-THT Study is expected to demonstrate the same safety and tolerability as experienced in the Company’s previous clinical study, but with enhanced efficacy and long-term durability from the combination therapy anticipated after tumors are immunogenically activated by Sona’s THT treatment (as experienced in the Company’s recently published pre-clinical study).

A second study, (the "PRIME-THT Study" – Precision Regional Immunotherapy for Melanoma Enhanced by THT) will assess the same concept but in newly diagnosed early-stage melanoma sufferers, which represents a much larger number of affected people worldwide (estimated by management to be up to 275,000 globally each year). Patients in this study would be given THT in combination with intratumoral immunotherapy with a view to stopping tumors from spreading (metastasising) by THT activating strong immune responses prior to standard-of-care surgical tumor resection. In addition to evaluating the safety and tolerability of Sona’s THT treatment in an ‘up-front’ (neo-adjuvant) setting, the PRIME-THT Study will also measure the immediate treatment effect and the long-term durability of responses related to this novel, early-stage, neo-adjuvant combination therapy.

These new studies are designed to answer the same questions from different ends of the patient journey: can THT convert immunogenically ‘cold’ tumors into tumors that respond to immunotherapies? The IGNITE-THT Study will ask it for patients who have already failed on treatment and remain on immunotherapy’s treatment plateau. The PRIME-THT Study asks it earlier, enabling and bringing the benefits of immunotherapy forward into the pre-resection window, where stopping metastases is still possible.

Dr. Carman Giacomantonio, Sona’s Chief Medical Officer, commented, "Having shown Sona’s THT’s ability to safely prime and shrink tumors in humans, we will now assess THT’s ability to enable the efficacy of immunotherapy drugs, turning previously refractory tumors into responders. Our pre-clinical combination studies in multiple cancer model types have demonstrated success increasing immunotherapy response rates and response durability so we have good reason for optimism. Additionally, our intratumoral approach to administering the immunotherapy is expected to significantly reduce patient’s typical immunotherapy-related side-effects."

David Regan, Sona’s CEO, commented, "These studies test the central question THT was built to answer: can we improve response rates to immunotherapy while lowering the well-recognized immunotherapy-related toxicities patients frequently experience? With stage IV melanoma patients having less than a 50% chance of surviving past five years due to low immunotherapy response rates, a plateau the field has not been able to break, and up to 20% of resected stage II melanoma patients developing metastases, we have an opportunity to improve the quality of life for hundreds of thousands of patients affected by this growing problem. Our goal with these studies is to demonstrate the potential for Sona’s THT to improve on the current standards-of-care in multiple indications in our first solid cancer target."

Early result read-outs from the IGNITE-THT and PRIME-THT studies are expected within six and eight months of their initiation, respectively.

What This Means for Sona’s Shareholders:

An expansion to a second cancer indication. Demonstrating THT in both early and late-stage melanoma indications shows a greater breadth of potential treatment market size.
Two near-term valuation catalysts. A clear strategy to demonstrate long-term potential to the investment community with relatively near-term deliverables.
What This Means for Those Living With Melanoma:

Potential for greater chances of cure. Priming tumors with THT to engage the immune system prior to the administration of today’s best immunotherapy drugs could result in higher response rates to those drugs.
Potential for reduced risk of metastases. Pre-treating early-stage melanoma tumors could reduce the chances that the cancer spreads to lymph nodes prior to standard-of-care resection.
The Company also continues to lay the groundwork for a larger scale, clinical trial in Canada for late-stage melanoma patients, working with Health Canada to secure the required investigational testing authorization ("ITA"). Feedback received from Health Canada is guiding the Company’s ITA application for a combination strategy clinical trial which it expects to begin early in 2027 and run for up to 18 months with multiple read-out milestones.

The Company will hold an investor webinar on Thursday, May 7th, 2026, at 1pm ET. Registration link: https://bit.ly/4mZSoN2.

(Press release, Sona Nanotech, MAY 5, 2026, https://www.sonanano.com/sona-nanotech-announces-clinical-strategy-with-two-tht-combination-therapy-studies-in-melanoma/ [SID1234665133])

On May 5, 2026 Seres Therapeutics, Inc. (Nasdaq: MCRB), (Seres or the Company), a leading live biotherapeutics company, reported first quarter 2026 financial results and provided business updates.

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"We are approaching an important clinical milestone with the expected readout in the coming weeks from the investigator-sponsored study at Memorial Sloan Kettering Cancer Center, an institution with whom we’ve collaborated for over a decade, evaluating SER-155 in immune checkpoint inhibitor-related enterocolitis (irEC)," said Richard Kender, Executive Chair and interim Chief Executive Officer of Seres. "irEC is a serious condition which represents a meaningful therapeutic and commercial opportunity, and with positive data we will evaluate potential development pathways and adjacent expansion opportunities. In parallel, we are advancing our inflammatory and immunology portfolio, including SER-603 for inflammatory bowel disease, with IND-enabling work progressing. We have achieved Phase 2 readiness for SER-155 for the prevention of bloodstream infections in patients undergoing allo-HSCT for the treatment of blood cancer and are seeking funding to commence the study. We are continuing disciplined capital allocation while actively pursuing partnerships and other financing sources to support Seres’ pipeline advancement and long-term value creation."

Recent Highlights

•
As highlighted in recent press releases from February and March, Seres is prioritizing its emerging live biotherapeutic programs in inflammatory & immune (I&I) diseases, including SER-155 for immune checkpoint-related enterocolitis (irEC) and SER-603 for inflammatory bowel disease (IBD).

•
Seres is collaborating with Memorial Sloan Kettering Cancer Center on an investigator-sponsored trial evaluating SER-155 in participants with irEC. irEC is among the most frequent and severe immune-related adverse events (irAEs) in recipients of immune checkpoint-inhibitor therapy and can be observed in up to 50% of patients, with rates varying based on cancer drug and treatment regimen. Study enrollment is complete, with 15 patients enrolled, and clinical data are expected in the coming weeks. Positive data from this IST could further inform the expansion of indications well-suited to Seres’ live biotherapeutic approach.

•
The Company continues to advance its preclinical stage live biotherapeutic product candidates, including SER-603. The Company is conducting IND-enabling activities for SER-603 and is engaging potential collaborators to support the clinical advancement of this program as a mono and/or combination therapy for IBD.

•
In May, Seres presented new preclinical data supporting the design and potential of SER-603 at Digestive Disease Week (DDW). The Company’s poster, titled "The Rational Design of SER-603: A Next Generation Cultivated Microbial Consortia to Treat IBD," which was selected as a DDW ‘Poster of Distinction,’ highlights Seres’ integrated approach to the design of microbiome therapeutics, combining rational strain selection and a novel biomarker-driven patient stratification.

•
In May, Seres’ management will be attending Memorial Sloan Kettering’s (MSK) Innovation with Lasting Impact Summit which this year focuses on "Drug Discovery & Development and MSK" and will be presenting, along with Dr. Jonathan (Tsoni) Peled an oncologist at MSK specializing in bone marrow transplantation for blood cancers, on Seres’ decade-long research and clinical development collaboration with MSK.

•
SER-155 is Phase 2 ready for the prevention of serious bloodstream infections in patients undergoing allogeneic hematopoietic stem cell transplants (allo-HSCT) for the treatment of blood cancer, and efforts to secure funding to advance clinical development for this program continue.

•
Supported by a grant from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global nonprofit partnership accelerating the development of new antibacterial products to address drug-resistant bacteria, Seres is progressing development of an oral liquid formulation based on SER-155 strains, referred to as SER-428, for dosing in patients who cannot take oral capsules such as intubated patients in the medical ICU, and other medically vulnerable patients at high risk of AMR infections. Seres has advanced manufacturing of SER-428 and is designing a Phase 1b open label trial, in collaboration with Dr. Dan Freedberg at Columbia University, to evaluate this therapeutic candidate in medical ICU patients at high risk of infection.

•
The Company attended the ESCMID Global Conference in April and presented a poster highlighting biomarker and clinical pharmacology data from the Company’s SER-155 Phase 1b study in allo-HSCT. Data showed that administration of SER-155 induced a significant and durable shift in gastrointestinal (GI) microbiome composition relative to placebo, characterized by high relative abundance of SER-155 species. This shift is associated with improved GI epithelial barrier integrity that could reduce the likelihood of bacterial translocation from the GI to the bloodstream. These pharmacology results are consistent with the intended SER-155 mechanisms of action as well as the observation of significantly lower bloodstream infection incidence (77% relative risk reduction) post allo-HSCT in SER-155-administered participants in Seres’ Phase 1b study.

•
In January, the Company announced the publication of manuscripts in Nature Medicine and the Journal of Infectious Diseases, highlighting new insights into the functional mechanism and clinical impact of VOWST, which was developed by Seres and sold to Nestlé Health Science (Nestlé) in 2024. These publications further inform the continued development of Seres’ next-generation live biotherapeutics pipeline.

Financial Results

•
Net loss was $19.9 million for the first quarter of 2026, compared to net income of $32.7 million for the same period in 2025. Contributing to the net income in the first quarter of 2025 was a $50 million installment payment received from Nestlé, related to certain transition services following the sale of VOWST and $6.3 million in reimbursements from Nestlé for the costs of those services. Operating expenses were approximately $6 million lower in the first quarter of 2026 compared to the first quarter of 2025.

•
Research and development expenses were $13.2 million for the first quarter of 2026, compared with $11.8 million for the same period in 2025, primarily due to higher facilities and manufacturing-related costs that in 2025 were partially reimbursed by Nestlé under the transition services agreement (TSA), partially offset by lower personnel-related expenses.

•
General and administrative expenses were $8.1 million for the first quarter of 2026, compared with $11.9 million for the same period in 2025, reflecting lower personnel and professional services costs, and a reduction in IT costs, including those related to services provided under the TSA.

•
There were no manufacturing services expenses in the first quarter of 2026, compared with $3.5 million in the first quarter of 2025, as the Company completed such services, provided under the TSA, at the end of 2025.

Cash and Cash Runway

As of March 31, 2026, Seres had $29.8 million in cash and cash equivalents. Based on Seres’ current cash position and operating plans, the Company expects to fund operations through the third quarter of 2026. The Company continues to evaluate opportunities to extend its cash runway.

(Press release, Seres Therapeutics, MAY 5, 2026, View Source [SID1234665132])

On May 5, 2026 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage biotechnology company, reported that the first patient was dosed in Study FTH-PIK-101 (NCT07558733), a Phase 1b/2 trial of PIKTOR in patients with HR+/HER2- advanced breast cancer. PIKTOR, an investigational, 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, and became Sensei’s lead program after the company acquired Faeth Therapeutics in February 2026.

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Patients with HR+/HER2- advanced breast cancer whose tumors stop responding to current therapies have few effective options, particularly when their cancer is driven by the PI3K/AKT/mTOR signaling pathway, a network of growth and survival signals that is altered in approximately half of HR+/HER2- cases.¹ Study FTH-PIK-101, titled "Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients with HR+/HER2- Advanced or Metastatic Breast Cancer," is evaluating PIKTOR across HR+/HER2-advanced breast cancer patients, regardless of mutational status.

The study is a multi-center, dose-escalation Phase 1b/2 trial evaluating sapanisertib and serabelisib (PIKTOR) in combination with fulvestrant and/or other anticancer therapies in patients with HR+/HER2- advanced or metastatic breast cancer.

Approved drugs that target this pathway each block only one component, which often allows the cancer to reroute its growth signals through the parts that remain active. PIKTOR takes a different approach, combining two oral drugs, serabelisib (which blocks PI3K-alpha) and sapanisertib (which blocks mTORC1 and mTORC2), to target multiple nodes of the pathway simultaneously.

PIKTOR has already been tested in cancer patients. In a completed investigator-initiated Phase 1b study (NCT03154294), patients with advanced breast, endometrial and ovarian tumors who had failed an average of four prior treatments and were largely out of standard options received PIKTOR plus paclitaxel. Nearly half responded (47% overall response rate, n=15). Among patients whose tumors carried PI3K pathway mutations, 71% responded. Three patients had complete responses, all in endometrial cancer.² Sapanisertib in combination with fulvestrant has also shown activity in HR+/HER2- advanced breast cancer in an earlier Phase 2 study.³

"In our earlier trial, patients who had exhausted multiple lines of therapy, including chemotherapy, responded to the PIKTOR plus paclitaxel combination, and several had complete responses," said Anand Parikh, Chief Operating Officer of Sensei Biotherapeutics. "PIK-101 now takes that same oral combination into breast cancer, where a large share of tumors carry the pathway alterations that PIKTOR is designed to target."

As part of its broader clinical development program for PIKTOR, Sensei is also conducting Study FTH-PIK-201, an ongoing multicenter, open-label, single-arm Phase 2 study (n≈40) in patients with advanced endometrial cancer.

(Press release, Sensei Biotherapeutics, MAY 5, 2026, View Source [SID1234665131])