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])

On May 5, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentation at the BofA Securities 2026 Healthcare Conference at 2:20 p.m. PT on Tuesday, May 12, 2026. The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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The webcast will be accessible on the Investor Relations page of Sana’s website at View Source A replay of the presentation will be available at the same location for 30 days following the conference.

(Press release, Sana Biotechnology, MAY 5, 2026, View Source [SID1234665130])

On May 5, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported financial results for the first quarter ended March 31, 2026, including sales of TAVALISSE (fostamatinib disodium hexahydrate), GAVRETO (pralsetinib) and REZLIDHIA (olutasidenib), and recent business progress.

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"Rigel entered 2026 with continued year-over-year growth from our commercial portfolio and financial discipline, driving another quarter of profitability. We are operating from a position of financial strength with a solid cash balance that can fund our development plans and allows for financial flexibility to pursue potential in-license opportunities," said Raul Rodriguez, Rigel’s president and CEO. "During the first quarter we also continued to advance our development pipeline, including our ongoing Phase 1b study of R289 in patients with lower-risk MDS, which may be a transformational opportunity for Rigel."

First Quarter 2026 Business Update

Commercial

First quarter net product sales were $54.9 million, an increase of 26% from the same period of 2025.
Corporate

In February, Michael P. Miller joined Rigel’s Board of Directors as an independent director and member of the Compensation Committee.
In April, Rigel received notification from Eli Lilly and Company that it will terminate the collaboration agreement with Rigel, which included the development of ocadusertib (previously R552 or LY3871801), an investigational, potent and selective receptor-interacting protein kinase 1 (RIPK1) inhibitor. The termination will become effective on June 15, 2026.
In early May, Rigel restructured its credit relationship with MidCap Financial to replace its existing term loan credit facility with a revolving credit facility for $40.0 million, with an option to increase to $60.0 million, subject to customary conditions. As part of the transaction, Rigel repaid the remaining outstanding term loan balance of $40.0 million and drew down $8.0 million on the new revolving credit facility.
Clinical Development

Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the dose expansion phase of the study is ongoing.
Rigel is on track to complete enrollment of the dose expansion phase of the Phase 1b study and select the recommended Phase 2 dose for future clinical studies in the second half of 2026. The company anticipates sharing preliminary data from the dose expansion phase of the study by the end of 2026.
The first data release for pralsetinib from the TAPISTRY study (NCT04589845) was presented in a poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Gastrointestinal Cancers Symposium (ASCO-GI) in January. The analysis reported results from the Phase 2 global, open-label, multicohort study, in which the efficacy and safety of pralsetinib was evaluated in a cohort of patients with rearranged during transfection (RET) fusion-positive solid tumors, including pancreatic, colorectal, and hepatobiliary cancers. Pralsetinib demonstrated robust and durable activity against RET fusion-positive solid tumors, including gastrointestinal (GI) tumors, and in the efficacy evaluable population showed an overall response rate (ORR) of 67% (26/39). These data supports RET fusions as a tissue-agnostic target with sensitivity to RET inhibition, suggesting the potential therapeutic utility of pralsetinib in these patients.
Key Publications

A paper titled "Matching-Adjusted Indirect Comparison of Olutasidenib and Ivosidenib in Isocitrate Dehydrogenase 1-Mutated Relapsed/Refractory Acute Myeloid Leukemia," was published in Advances in Therapy in February. The publication analysis used a well-accepted methodology called matching-adjusted indirect comparison (MAIC), which adjusts for between study differences in baseline characteristics to better estimate comparative efficacy. The analysis suggests that olutasidenib and ivosidenib achieve similar response rates in R/R isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukemia (AML), but responses achieved with olutasidenib may be more durable. The longer duration of complete remission (CR) plus CR with partial hematologic recovery (CR+CRh) observed with olutasidenib may be clinically meaningful in a setting where sustained remissions are difficult to achieve. While indirect and non-confirmatory, these findings may provide important comparative context for clinicians, medical affairs, and health-policy stakeholders in the absence of head-to-head data.
A paper titled "Final Efficacy and Safety Data From the Phase 1/2 ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC)," was published in the Journal of Clinical Oncology in March. The publication reports the final data from the registrational trial evaluating pralsetinib for the treatment of patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The final data, which includes an additional 42 months of follow-up from data previously published, further support the robust, durable responses with a manageable toxicity profile seen in patients with RET fusion-positive NSCLC, and are consistent with previous reports from the ARROW study NSCLC cohort.
First Quarter 2026 Financial Update
For the first quarter ended March 31, 2026, total revenues were $58.8 million, consisting of $54.9 million in net product sales and $3.9 million in contract revenues from collaborations. Net product sales increased 26% compared to $43.6 million in the same period of 2025. TAVALISSE net product sales were $37.3 million, an increase of 31% compared to $28.5 million in the same period of 2025. GAVRETO net product sales were $9.6 million, an increase of 7% compared to $9.0 million in the same period of 2025. REZLIDHIA net product sales were $8.0 million, an increase of 31% compared to $6.1 million in the same period of 2025. Contract revenues from collaborations primarily consisted of $1.8 million of revenue from Grifols S.A. related to earned royalties, $1.8 million of revenue from Kissei Pharmaceutical Co., Ltd. related to delivery of drug supplies and $0.3 million of revenue from Medison Pharma related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included a one-time $3.0 million regulatory milestone in connection with the approval of TAVALISSE in the Republic of Korea.

Total costs and expenses were $46.9 million compared to $40.6 million for the same period of 2025. The increase in costs and expenses was primarily driven by increased research and development costs driven by the timing of clinical activities, including continued progress in our R289 program, as well as increased commercial-related expenses and personnel-related costs.

Income before income taxes was $11.7 million.

Rigel reported net income of $8.7 million, or $0.47 basic and $0.44 diluted per share, compared to $11.4 million, or $0.64 basic and $0.63 diluted per share, for the same period of 2025.

Cash, cash equivalents and short-term investments as of March 31, 2026 was $146.7 million, compared to $155.0 million as of December 31, 2025.

2026 Outlook
Rigel reaffirms its 2026 total revenues guidance of approximately $275 to $290 million, including:

Net product sales of approximately $255 to $265 million.
Contract revenues of approximately $20 to $25 million.
The company also continues to anticipate it will report positive net income for the full year 2026, while funding existing and new clinical development programs.

Conference Call and Webcast with Slides Today at 4:30 p.m. Eastern Time
Rigel will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP
In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About NSCLC
It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.2 RET fusions are implicated in approximately 1-2% of patients with NSCLC.3

About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,720 new cases in the United States, most in adults, in 2026.4

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow. 5,6 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.7 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About TAVALISSE
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

About GAVRETO
GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).*

*Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for GAVRETO.

About REZLIDHIA
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, MAY 5, 2026, View Source [SID1234665129])

On May 5, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported the presentation of two abstracts related to NDV-01 at the American Urology Association (AUA2026), taking place from May 15-18th in Washington D.C.

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Abstract Overview*

Abstract #1: Poster presentation: IP02-03: Prospective Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained-Release Gemcitabine Docetaxel combination (NDV-01) in High-Risk NMIBC: Update with 9-month Complete Response Data

Session: IP02: Bladder Cancer: Non-Invasive I
Location: Room 146A, Walter E. Washington Convention Center
Presentation Date: Friday, May 15, 2026
Presentation Time: 7:00 AM to 9:00 AM ET
Abstract #2: Oral presentation: Trial in Progress: REL-NDV01-301 (BOOST) – A Phase 3, Randomized Study of Adjuvant Intravesical Sustained-Release Gemcitabine-Docetaxel (NDV-01) Versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer.

Session: Clinical Trials in Progress: Bladder Cancer
Location: Hall B, The Square, Learning Lab, Walter E. Washington Convention Center
Presentation Date: Sunday, May 17, 2026
Presentation Time: 9:56 AM to 10:04 AM ET
*Exact conference presentation times and locations may be subject to change.

About NDV-01

NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in less than 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

About the Phase 2 Study

The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with high-grade non-muscle invasive bladder cancer (HG-NMIBC). Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 – 80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

(Press release, Relmada Therapeutics, MAY 5, 2026, View Source [SID1234665128])

On May 5, 2026 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

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"During the first quarter, we continued to execute on our two clinical stage in vivo gene editing programs. We advanced PBGENE-HBV into new cohorts in the ELIMINATE-B trial and drove PBGENE-DMD through Investigational New Drug (IND) approval and activated our first clinical site as we prepare to dose the first patient in the FUNCTION-DMD trial," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. "We remain focused on disciplined execution in 2026 as we generate additional clinical data from the ELIMINATE-B trial and enroll more sites and patients in the FUNCTION-DMD trial. We believe our ARCUS platform and targeted development strategy position us to deliver multiple important clinical and operational milestones this year."

Wholly Owned Portfolio:

PBGENE-HBV (Hepatitis B Viral Elimination Program)

PBGENE-HBV is Precision’s wholly owned in vivo gene editing program being evaluated in a global first-in-human clinical trial as a potential curative treatment for chronic hepatitis B. PBGENE-HBV is the only clinical stage program that targets the elimination of cccDNA, the sole source of viral replication, leading to sustained loss of HBV DNA and other downstream viral transcripts. PBGENE-HBV is the first in vivo gene editing approach to prospectively employ repeat administrations of lipid nanoparticle (LNP) in chronic hepatitis B.

As part of the ongoing assessment of the safety and efficacy profile of PBGENE-HBV after repeat doses in Part 1 dose finding, Precision has treated 16 patients with 38 administrations of PBGENE-HBV across five cohorts evaluating the impact of escalating dose levels as well as 8-week and 4-week dosing intervals. The goal during Part 1 of the study is to select the dose and schedule that achieves the desired therapeutic index to move to the expansion phase of the ELIMINATE-B trial.

Looking ahead, Precision expects to share further clinical data from the PBGENE-HBV program at hepatitis-focused medical conferences throughout 2026, starting with the European Association for the Study of the Liver (EASL).

On April 22nd, Precision BioSciences announced that a late-breaking poster for PBGENE-HBV was accepted for presentation at the EASL Congress 2026 taking place on May 27-30 in Barcelona, Spain. The poster titled, "First evidence of elimination and inactivation of cccDNA in liver biopsies collected from patients with chronic hepatitis B treated with PBGENE-HBV" will be presented by investigator, Man-Fung Yuen, Chair and Professor of Gastroenterology and Hepatology at The University of Hong Kong. The poster will be presented on May 27-30, 2026 during the Late-Breaker poster session.

In addition, in April the Company announced that it received Clinical Trial Application approval to expand ELIMINATE-B into France and Romania, broadening the study’s footprint in Europe. Site initiation activities are underway and initial patient screening in those countries is expected in the second quarter of 2026.

In March, Precision BioSciences received two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent applications relating to the Company’s PBGENE-HBV program. When issued, each patent arising from these applications is expected to have a standard expiration date in November 2044.

PBGENE-DMD (Muscle Targeted Gene Excision Program)

PBGENE-DMD is Precision’s development program for Duchenne muscular dystrophy (DMD), designed to restore a near full-length functional dystrophin protein through a gene excision approach using two ARCUS nucleases delivered in a single AAV.

Following U.S. Food and Drug Administration (FDA) IND clearance in early 2026, Precision advanced Institutional Review Board (IRB) activities and clinical trial site activation for the Phase 1/2 FUNCTION-DMD clinical trial. In April, the company activated Arkansas Children’s Hospital as the first clinical trial site and is now actively enrolling patients in the FUNCTION-DMD study of PBGENE-DMD.

Arkansas Children’s is a Parent Project Muscular Dystrophy (PPMD)-certified Duchenne Care Center, recognized for delivering specialized, multidisciplinary care for patients with DMD. PPMD’s Certified Duchenne Care Center Program is intended to help ensure that participating centers maintain high standards in clinical and sub-specialty services, rapidly incorporate evidence-based knowledge, and provide standardized multidisciplinary Duchenne care. Additionally, Arkansas Children’s is a designated Muscular Dystrophy Association (MDA) Care Center, providing specialized, multidisciplinary care for neuromuscular diseases including diagnosis, personalized treatment plans, and comprehensive support for patients.

In March 2026, PBGENE-DMD also received FDA Fast Track designation and hosted a DMD investor event, the replay is accessible here.

In addition, Precision presented preclinical PBGENE-DMD data highlighting durable dystrophin expression and functional benefit at the Muscular Dystrophy Association Clinical & Scientific Conference 2026 in March.

Partnered In Vivo Programs:

iECURE-OTC (Gene Insertion Program)

Led by iECURE, Inc. (iECURE) ECUR-506 is an ARCUS-mediated in vivo targeted gene insertion program currently in a first-in-human trial (OTC-HOPE) evaluating ECUR-506 as a potential treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency. iECURE previously announced alignment with the FDA on key study elements could support a potential Biologics License Application (BLA). The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain.

iECURE expects to present clinical data from the ongoing OTC-HOPE clinical trial at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting taking place May 11-15, 2026 in Boston. The oral presentation at ASGCT (Free ASGCT Whitepaper) will include preliminary data from study participants in the first three dose cohorts (n=7) of the ongoing OTC-HOPE study, including a decreased rate of hyperammonemic crises (HAC) following ECUR-506 administration. In addition, iECURE plans to present a poster at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting taking place May 17-20, 2026 in Puerto Rico featuring one-year post-treatment data from the first infant dosed in the study who achieved a complete clinical response as defined by study protocol, including sustained discontinuation of standard-of-care therapies.

Partnered Ex Vivo Programs:

Azer-Cel (Azercabtagene Zapreleucel Allogeneic CAR T Treatment for Cancer)

Imugene Limited continues development of Azer-Cel in diffuse large B-cell lymphoma and has received written guidance from the FDA regarding the registrational pathway for Azer-Cel. The guidance provided clear alignment with the FDA across key elements required to support advancement into a pivotal study, including dosing regimen, patient population, endpoints, and manufacturing readiness. Azer-Cel has been selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held on May 29-June 2, in Chicago.

Azer-Cel (Azercabtagene Zapreleucel Allogeneic CAR T Treatment for Multiple Sclerosis)

Separately, Azer-Cel is being evaluated by TG Therapeutics, Inc. (Nasdaq: TGTX) in a Phase 1 trial in progressive multiple sclerosis. In April 2026, Precision received a clinical milestone cash payment under its license agreement with TG Therapeutics. The payment of $7.5 million was inclusive of $5.25 million cash and $2.25 million for the purchase of shares of Precision common stock by TG Therapeutics. Anticipated 2026 events include presentation of preliminary Phase 1 Azer-Cel data in progressive multiple sclerosis in the second half of 2026 and commencement of additional exploratory studies in autoimmune diseases outside of multiple sclerosis.

Quarter Ended March 31, 2026 Financial Results:

Cash, Cash Equivalents, and Restricted Cash: As of March 31, 2026, Precision had approximately $125.8 million in cash, cash equivalents, and restricted cash. The Company expects that existing cash and cash equivalents, continued fiscal and operating discipline, and availability of Precision’s at-the-market (ATM) facility will fund the Company’s cash runway through 2028. Based on its expected cash runway, Precision believes it is sufficiently capitalized to achieve PBGENE-HBV and PBGENE-DMD data milestones through 2028.

Revenues: Total revenues for the quarter ended March 31, 2026, were $10.8 million, as compared to less than $0.1 million for the quarter ended March 31, 2025. The increase in revenue was the result of milestone revenue recognized under our license agreement with TG Therapeutics, Inc. and a legacy ARCUS agriculture gene editing collaboration agreement.

Research and Development Expenses: Research and development expenses were $13.1 million for the quarter ended March 31, 2026, as compared to $13.6 million for the quarter ended March 31, 2025. The decrease of $0.5 million was primarily due to decreases in platform development and research expenses, partially offset by increases in PBGENE-DMD program costs as the Company initiated IRB activities and clinical trial site activation for the FUNCTION-DMD Phase 1/2 clinical trial and PBGENE-HBV program costs

General and Administrative Expenses: General and administrative expenses were $6.8 million for the quarter ended March 31, 2026, as compared to $8.6 million for the quarter ended March 31, 2025. The decrease of $1.8 million was primarily a result of operational discipline and lower employee-related costs.

Other (Expense) Income: Total other expense was $9.4 million for the quarter ended March 31, 2026, compared to $1.5 million total other income for the quarter ended March 31, 2025. The decrease of $10.9 million was primarily due to fair value adjustments which did not impact cash, including a loss on change in fair value of the warrant liability, and a decrease in interest income.

Additionally, in the quarter ended March 31, 2026, there was no gain or loss recognized from the Company’s equity method investment compared to $1.3 million gain recognized during the quarter ended March 31, 2025.

Net Loss: Net loss was $18.4 million, or $(0.75) per share (basic and diluted), for the quarter ended March 31, 2026. Net loss was $20.6 million, or $(2.21) per share (basic and diluted), for the quarter ended March 31, 2025.

About Chronic Hepatitis B

Chronic hepatitis B virus causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis. There is no cure for chronic hepatitis B, and current treatments rarely result in a functional cure, primarily due to persistence of viral DNA in the liver. In patients with chronic hepatitis B, genetic material of the virus is converted within infected liver cells into cccDNA that acts as the only template to make new infectious viral particles. Hepatitis B virus also inserts fragments of its DNA into the human genome of infected liver cells. These integrated fragments are viral replication incompetent and cannot produce new infectious virus. Both cccDNA and integrated HBV DNA produce the viral protein, hepatitis B surface antigen (HBsAg), which is secreted in the blood.

Historically, the focus for drug development and regulatory approval of drugs for chronic hepatitis B has relied on the temporary suppression of HBsAg. Achieving undetectable HBsAg may lead to a functional cure if there is no rebound in HBV DNA or HBsAg after drug treatment has been discontinued for at least six months, but this is achieved in less than three out of 100 patients treated with the current standard of care. Since cccDNA is the only source of infectious particles (HBV DNA), elimination of cccDNA results in a cure of chronic hepatitis B. Sustained loss of HBV DNA alone as a result of cccDNA elimination is an approvable endpoint for the FDA and highly relevant for PBGENE-HBV.

About PBGENE-HBV, A Viral Elimination Program

PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic hepatitis B, cccDNA, while inactivating integrated HBV DNA. Elimination of cccDNA results in HBV cure as cccDNA is the only source of infectious replication (HBV DNA). The ELIMINATE-B trial is investigating PBGENE-HBV at multiple dose levels across a number of administrations per dose level in patients with chronic Hepatitis B. PBGENE-HBV has been granted Fast Track designation by the FDA.

PBGENE-HBV is the only clinical stage program targeting the elimination of cccDNA leading to sustained loss of HBV DNA. The FDA has previously provided guidance that sustained loss of HBV DNA is an approvable endpoint for chronic hepatitis B.

Further details on the trial can be found on Precision’s website and on clinicaltrials.gov identifier NCT06680232.

About PBGENE-DMD, A Muscle-Targeted Excision Program

PBGENE-DMD is Precision’s development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the U.S. alone. There are currently no approved therapies that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for approximately 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. Compared with DMD, deletion of exons 45-55 is often associated with a more mild prognosis for patients. The aim of this approach is to restore a near full-length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated microdystrophin approaches with minimal functional benefit. The Phase 1/2 FUNCTION-DMD study is expected to enroll ambulatory DMD patients with mutations between exons 45 and 55 impacting up to 60% of boys with DMD. The clinical trial will employ an appropriate immune modulation regimen and safety monitoring program to treat ambulatory patients at world class specialized DMD clinical sites.

PBGENE-DMD was granted Orphan Drug Designation by the FDA in July 2025. The PBGENE-DMD program is eligible for a Priority Review Voucher (PRV) via the Rare Pediatric Disease Priority Review Voucher (PRV) program, which was signed into law on February 3, 2026, as part of the Consolidated Appropriations Act of 2026. PBGENE-DMD received Fast Track designation from the FDA in February 2026.

Further details on the trial can be found on Precision’s website and on clinicaltrials.gov identifier NCT07429240.

(Press release, Precision Biosciences, MAY 5, 2026, View Source [SID1234665127])