On May 11, 2026 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights.

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"We are entering a pivotal period for Aura as we advance our Phase 3 CoMpass trial toward enrollment completion and potential registration," said Natalie Holles, Chief Executive Officer of Aura Biosciences. "Bel-sar has the potential to become the first frontline, vision-preserving therapy for patients with early choroidal melanoma, and we are on track to deliver topline data from the CoMpass trial in the second half of 2027. Supported by our strengthened balance sheet, we are focused on executing against these priorities and translating this progress into long-term value for patients and shareholders."

Recent Pipeline Developments

Early Choroidal Melanoma

The ongoing Phase 3 CoMpass trial is the first registration-enabling study in early choroidal melanoma. This global, randomized Phase 3 trial is evaluating bel-sar versus a sham control. The trial is advancing toward enrollment completion, which is expected by mid-2026, with topline data for the 15-month primary endpoint anticipated in the second half of 2027.

Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.

Metastases to the Choroid

The ongoing Phase 2 clinical trial of bel-sar in metastases to the choroid continues to enroll patients. The study is designed to include patients with choroidal metastases arising from a range of primary solid tumors and to evaluate early proof-of-concept based on a four-week efficacy endpoint. The Company remains on track to report early data from this trial in 2026.

Cancers of the Ocular Surface

The Company is initiating a Phase 1 proof-of-concept trial in Australia to assess safety, feasibility and tumor response through histopathologic evaluation at a 2–4-week time point. Development activities for this program are ongoing, with early proof-of-concept data expected in 2026.

Bladder Cancer

The ongoing Phase 1b/2 trial evaluating additional doses and cycles of bel-sar across intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) patients continues to advance, with initial 3-month clinical data expected mid-2026.

The trial is evaluating two approaches: immune ablative and neoadjuvant. In the immune ablative arm, bel-sar is given in two cycles without a transurethral resection of the bladder tumor (TURBT). In the neoadjuvant arm, bel-sar is given in two cycles before TURBT. Patients are monitored for response, recurrence (at 3, 6, 9, and 12 months), and safety.

Corporate Updates

As previously announced on May 4, 2026, the Company’s Board of Directors appointed Natalie Holles as Chief Executive Officer and President and member of the Board of Directors, effective April 30, 2026. Ms. Holles succeeds Elisabet de los Pinos, Ph.D., the Company’s founder, who stepped down from her roles as Chief Executive Officer and President and a member of the Board of Directors, effective on the same date.

First Quarter 2026 Financial Results

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As of March 31, 2026, the Company had cash and cash equivalents and marketable securities totaling $114.7 million. On May 5, 2026, the Company completed an underwritten public offering of common stock and pre-funded warrants, which included the underwriters’ full exercise of their option to purchase additional shares of common stock. After deducting the underwriting discounts and commissions and estimated offering expenses, the Company received approximately $280.8 million in net proceeds from the offering, of which it subsequently used approximately $39.0 million to repurchase all the shares of its common stock held by Matrix Capital Management Master Fund, LP in the previously announced stock repurchase. The Company believes its current cash and cash equivalents and marketable securities, together with the net proceeds of the offering to the Company, are sufficient to fund its operations into the second half of 2028.

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Research and development expenses increased to $28.0 million for the three months ended March 31, 2026 from $23.3 million for the three months ended March 31, 2025, primarily due to ongoing clinical and clinical research organization (CRO) costs associated with the progression of our global Phase 3 trial of bel-sar in early choroidal melanoma and manufacturing and development costs for bel-sar.

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General and administrative expenses increased to $6.9 million for the three months ended March 31, 2026 from $5.7 million for the three months ended March 31, 2025. General and administrative expenses include $1.6 million of stock-based compensation for each of the three months ended March 31, 2026 and 2025. The increase in general and administrative expenses was primarily driven by higher personnel expenses related to growth of the Company and increased professional fees.

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Net loss for the three months ended March 31, 2026, was $33.7 million, compared to $27.5 million for the three months ended March 31, 2025.

(Press release, Aura Biosciences, MAY 11, 2026, View Source [SID1234665451])

On May 11, 2026 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, reported financial results for the quarter ended March 31, 2026, and provided an overview of recent operational highlights.

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"TONMYA is the first new fibromyalgia medicine in 15 years," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "TONMYA is a non-opioid analgesic designed for bedtime administration and long-term use by adults. Since launch in November 2025, TONMYA has shown growth in prescriptions, new writers, refills, and patient access. Our first managed care partnership was announced in May, providing access to approximately 35 million U.S. commercial lives. We will continue engagement with commercial and government payers to expand patient access. Our focus remains on operational excellence across sales, marketing, medical affairs, and market access to educate and deliver on TONMYA’s differentiated potential."

Dr. Lederman continued, "We also continue to meaningfully advance our mid-stage clinical programs and our earlier-stage pipeline. For TNX-4800, our investigational long-acting borreliacidal, human monoclonal antibody targeting OspA on Borrelia burgdorferi, which causes the majority of Lyme disease in the U.S., we announced positive Phase 1 data and plans for an adaptive Phase 2 field study in 2027, pending FDA agreement. We look forward to our scheduled Type C meeting with the FDA early in the third quarter of 2026 to discuss the study. We believe TNX-4800 offers several advantages over vaccines in development, including onset of protection within two days and a simpler two-dose regimen with a second booster dose two months after the first. We also expect to begin our Phase 2 study of TONMYA for the treatment of Major Depressive Disorder (MDD) mid-year. Our other programs across CNS, infectious disease, immunology, and rare disease remain well positioned for near-term milestones."

Commercial Updates

TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults

• On November 17, 2025, TONMYA became commercially available, following U.S. FDA approval in August 2025 for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. The approval was based on two double-blind, randomized, placebo-controlled Phase 3 clinical studies of nearly 1,000 patients that demonstrated durable and statistically significant reduction in daily pain scores compared to placebo. There are now approximately 100 TONMYA sales reps in the field.
• In the first quarter of 2026, the first full quarter since launch, key metrics include:
o 2,145 unique healthcare providers prescribed TONMYA to patients.
o 3,588 unique patients initiated treatment with TONMYA.
o Approximately 5,400 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company’s specialty pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue.
• For the period beginning November 17, 2025, through April 24, 2026, cumulative key metrics include:
o More than 2,700 unique healthcare providers have prescribed TONMYA to patients.
o Approximately 5,618 unique patients have initiated treatment with TONMYA.
• For the period beginning November 17, 2025, through May 1, 2026, cumulative key metrics include:
o Approximately 11,016 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company’s specialty pharmacy channel.
• Repeat prescriber and patient refill trends are encouraging.
• The Company is prioritizing engagement with commercial payers, Medicare, and Medicaid to increase access:
o In May 2026, Tonix secured commercial payer coverage with its first managed care partnership agreement with a leading GPO, which will provide access for approximately 35 million U.S. patients (20% of ~177 million commercial lives in the U.S.)
o To date, TONMYA is covered under Medicaid in 38 states, for approximately 55 million lives, representing 73% of the roughly 75 million Medicaid lives.
• Tonix has a robust patient access program and support services in place, including a TONMYA savings card, copay assistance, and prior authorization support, intended to reduce access barriers during early commercialization.
• To educate healthcare providers (HCPs), the Company held a multidisciplinary dialogue about TONMYA via a national webcast. Tonix also launched a national speaker training program with approximately 100 HCPs to maximize peer-to-peer speaker programs expected to occur across target specialties and regions this year.
• As part of a commitment to continued clinical evidence generation and education, Tonix presented clinical data on TONMYA at the 8th International Congress on Controversies in Fibromyalgia, 2026 American Academy of Pain Medicine (AAPM) PainConnect Annual Meeting, and 2026 Non-Opioid Pain Therapeutics Summit. The Company also published two articles in the peer-reviewed journal, Clinical Pharmacology in Drug Development.

Key Product Pipeline Candidates: Recent Highlights

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablets): in Phase 2 development for MDD; remains on track to initiate mid-year 2026

• In November 2025, the FDA cleared the IND for TNX-102 SL 5.6 mg for the treatment of MDD in adults. The IND clearance enables Tonix to proceed with the HORIZON study, a potentially pivotal Phase 2, 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with MDD. About 360 patients will be enrolled at approximately 30 U.S. sites, with the primary endpoint being the MADRS total score change from baseline at Week 6. Tonix plans to initiate enrollment in mid-2026.

TNX-102 SL in Phase 2 development for the treatment of acute stress disorder (ASD) and acute stress reaction (ASR)

• The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) study is being conducted by the University of North Carolina under an investigator-initiated IND. The OASIS study examines the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department after a motor vehicle collision. Topline data is expected to be reported in the second half of 2026.

TNX-1300 (double-mutant cocaine esterase) for cocaine intoxication; Phase 2-program has Breakthrough Therapy designation from the FDA, with no products on the market for this indication

• The Company plans to meet with the FDA in 2026 to inform the clinical design of the next Phase 2 study (a Phase 2a study has been completed).

TNX-1900 (intranasal potentiated oxytocin): in development for several CNS disorders

• TNX-1900 is currently being studied in four Phase 2 and one Phase 1 investigator-initiated studies. The Phase 2 investigator-initiated studies include binge-eating disorder (Massachusetts General Hospital, "MGH"), adolescent obesity (MGH), bone health in autism (MGH and University of Virgina), and arginine vasopressin deficiency (MGH).
• In March 2026, Tonix announced the dosing of the first participant in a Phase 1 investigator-initiated pharmacodynamic study with Erasmus University of TNX-1900 in healthy female volunteers, using capsaicin and electrical stimulation to model trigeminal neurovascular reactivity.

Infectious Disease Pipeline

TNX-4800 (anti-OspA mAb): Phase 2-ready long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease in the U.S., which has no FDA-approved vaccines or prophylactics

• In March 2026, Tonix presented Phase 1 data at the World Vaccine Congress Washington 2026 and announced plans to initiate an adaptive Phase 2 field study in the first half of 2027, pending FDA agreement. The Company also presented Phase 1 data in April 2026 at the 4th Annual Ticks and Tickborne Diseases Symposium at Johns Hopkins University.
o TNX-4800 demonstrated encouraging safety, tolerability, pharmacokinetics, and immunogenicity, with serum TNX-4800 measurable at the earlier sampling time of 48 hours and no significant clinical or laboratory safety signals. The Phase 1 study was conducted by a team at UMass Chan Medical School led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800.
• In April 2026, the Company announced it expects to lead a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose regimen of TNX-4800 subcutaneous (SC) in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 6 following administration). Each fixed dose is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. The first dose will be administered in the Spring and the second booster dose will be administered two months later. Participants will include adolescents and adults 16 years of age and older in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease for six months (comparison of TNX-4800 group and placebo group) following the initial dose.
• In April 2026, the Company announced it has scheduled a Type C meeting with the FDA early in the third quarter of 2026 to discuss the planned adaptive Phase 2 field study design.
• The Company expects to have GMP investigational product available for clinical testing in early 2027.

TNX-801 (recombinant horsepox virus): attenuated, pre-clinical live orthopoxvirus vaccine candidate for the prevention of smallpox and mpox

• In March 2026, Tonix presented animal and in vitro data on TNX-801 at the World Vaccine Congress Washington 2026. TNX-801 is expected to enter a Phase 1 study in 2027 pending FDA clearance of the Investigational New Drug (IND) application.

TNX-4200 (small molecule): broad spectrum anti-viral to protect against viral diseases

• TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments.
• The TNX-4200 program is supported by an up to $34 million contract over five years from the Department of Defense’s Defense Threat Reduction Agency (DTRA). In the first quarter of 2026, the Company received confirmation that the project was cleared to enter the next budgetary and developmental phase.

Immunology Pipeline

TNX-1500 (dimeric Fc modified anti-CD40L, humanized mAb): Phase 2-ready third generation anti-CD40L for prophylaxis of kidney transplant rejection and treatment of autoimmune disorders

• In November 2025, Tonix announced a collaboration with MGH to advance a Phase 2, open-label, investigator-initiated clinical study of TNX-1500 in kidney transplant recipients, planned for initiation mid-year 2026, pending FDA clearance of the IND. The study is expected to enroll five adult kidney transplant recipients.

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome, with Orphan Drug designation as well as Rare Pediatric Disease designation that could make Tonix eligible for a Priority Review Voucher upon approval

• In September 2025, Tonix announced plans to initiate a Phase 2, randomized, double-blind, placebo-controlled study in children and adolescents with Prader-Willi syndrome. The study is expected to initiate in the first quarter of 2027.

Immuno-oncology Pipeline

TNX-1700 (TFF2-albumin fusion protein): in preclinical development for gastric and colorectal cancer

• In March 2026, Tonix presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. Data presented in an oral presentation showed how TNX-1700 reversed aging-associated gastric inflammation and significantly attenuated tumor progression in an aged gastric microenvironment in preclinical models. Data in a poster presentation demonstrated TNX-1700 exhibited dose-independent, linear pharmacokinetics in animals.

TNX-4700 (human anti-BTLA mAb): in preclinical development for immuno-oncology indications

• In March 2026, Tonix presented preclinical data in a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2026 demonstrating TNX-4700 demonstrated potent, high-affinity binding and functional antagonism. The mAb technology was licensed from Curia.

Financial: Recent Highlights

Tonix had approximately $185.5 million of cash and cash equivalents as of March 31, 2026, compared to approximately $207.6 million as of March 31, 2025. Net cash used in operations was approximately $42.3 million for the first quarter ended March 31, 2026, compared to $16.6 million for the same period in 2025.

Subsequent to quarter-end, the Company has raised $22.6 million proceeds using its at-the-market (ATM) facility.

The Company believes that its cash resources as of March 31, 2026, together with the net proceeds that it raised from equity offerings in the second quarter of 2026, will fund its planned operating and capital expenditure requirements into early second quarter of 2027.

As of May 8, 2026, the Company had 15,940,601 shares of common stock outstanding.

First Quarter 2026 Financial Results

Net product revenue for the first quarter 2026 was approximately $6.9 million, compared to $2.4 million for the same period in 2025, and consisted of combined net sales of TONMYA, Zembrace SymTouch, and Tosymra. Net revenue from sales of TONMYA for the first quarter was approximately $3.7 million. TONMYA was launched in November 2025. Net revenue from sales of TONMYA for the period from November 17, 2025, to December 31, 2025, was approximately $1.4 million. Net revenue from sales of Zembrace SymTouch and Tosymra for the was approximately $3.2 million compared to $2.4 million for the same quarter in 2025. Cost of sales for the first quarter 2026 was approximately $1.6 million, compared to $0.9 million for the same period in 2025.

Research and development expenses for the first quarter 2026 were approximately $18.2 million, compared to $7.4 million for the same period in 2025. This increase is predominately due to pipeline prioritization period over period, and increased headcount.

Selling, general, and administrative expenses for the first quarter 2026 were $28.6 million, compared to $10.1 million for the same period in 2025. The increase is predominately due to spending on sales and marketing related to TONMYA, as well as increased headcount.

Net loss available to common stockholders was $40.2 million, or $2.93 per basic and diluted share, for the first quarter 2026, compared to net loss available to common stockholders of $16.8 million, or $2.84 per basic and diluted share, for the same period in 2025. The basic and diluted weighted average common shares outstanding for the first quarter 2026 was 13,707,104 compared to 5,927,231 shares for the same period in 2025.

(Press release, TONIX Pharmaceuticals, MAY 11, 2026, View Source [SID1234665444])

On May 11, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the first quarter 2026.

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"We remain focused on execution in 2026 and are on track with both SC451 and SG293," said Steve Harr, President and Chief Executive Officer. "We are working to file our IND and begin a Phase 1 trial later this year for SC451, our gene-modified, stem cell-derived pancreatic islet cell product candidate designed for patients with type 1 diabetes with the goal of a single treatment leading to long-term normal blood glucose without the need for any insulin therapy or immunosuppression. We are pleased to have recently entered into a strategic collaboration with Mayo Clinic, whose multidisciplinary expertise we expect will help accelerate the development, standardization of delivery for, and access to SC451. We also continue to advance SG293, our in vivo CAR T cell product candidate, which has the potential to offer a one-time, off-the-shelf treatment without conditioning chemotherapy to patients with blood cancers or B cell-mediated autoimmune disorders. We are making meaningful progress toward our goal of beginning clinical testing later this year. We are also preparing to begin a clinical trial for SG227, an in vivo BCMA-targeted CAR T cell therapy, by as early as mid-2027 assuming positive early safety and efficacy data for SG293. This near-term operational focus has the potential to generate meaningful proof of concept data across multiple programs over the coming 12-18 months, and we look forward to building on this momentum."

Corporate Highlights

Announced strategic collaboration with Mayo Clinic to advance development of SC451, a hypoimmune (HIP)-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes.

The collaboration will draw on Mayo Clinic’s multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments.
In connection with the collaboration, Mayo Clinic made an approximately $25.0 million equity investment in the company, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes. The organization also has the option to make an additional approximately $25.0 million equity investment.

Shared updated, positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with HIP technology, into a patient with type 1 diabetes without the use of any immunosuppression.

UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator.
Results of the study through 14 months after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increased with mixed meal tolerance tests (MMTT) performed over the course of the study, consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 are comparable to those observed in the first six months of the study. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study has identified no safety issues, and the HIP-modified islet cells have evaded immune detection.

Continued progress toward beginning clinical trials later this year for SC451 and SG293

SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy which uses the same HIP technology as UP421, is being developed as a one-time treatment for patients with type 1 diabetes with a goal of long-term normal blood glucose without the need for any insulin therapy or immunosuppression. Sana is currently conducting nonclinical testing, manufacturing transfer to contract manufacturers, and clinical trial preparation. Sana expects to file an IND and begin a Phase 1 clinical trial for SC451 as early as this year.
SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. Sana is currently conducting nonclinical testing, manufacturing transfer to a contract manufacturer, and clinical trial preparation. The fusogen technology used in SG293 has been designed to minimize potentially troublesome toxicities related to in vivo CAR T cells, including off-target delivery to tissues such as the liver and peri-infusion reactions. Preclinical data demonstrate that a SG293 surrogate, which is active in non-human primates, achieves cell-specific delivery and deep B cell depletion – as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return – in non-human primates without the use of any lymphodepleting chemotherapy. Details from this study will be presented at the upcoming ASGCT (Free ASGCT Whitepaper) Annual Meeting on May 12. Sana intends to explore SG293 initially in non-Hodgkin lymphoma and expects to generate first-in-human data as early as this year. If successful, the company intends to expand clinical development into B cell-mediated autoimmune diseases as well.

Advanced preclinical pipeline

SG227, a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells, is being developed as a potential treatment for patients with multiple myeloma. SG227 delivers a BCMA CAR that has been validated in the autologous CAR T setting for patients with multiple myeloma in a product that is currently approved in China. Sana is preparing to begin clinical testing as early as mid-2027, contingent upon the early clinical profile of SG293.

Strengthened leadership with the appointment of new Chief Financial Officer

Appointed Brian Piper as Executive Vice President, Chief Financial Officer. Mr. Piper has decades of experience in financial management within the biotechnology sector – including CFO roles at Scorpion Therapeutics, Antares Therapeutics, and Prelude Therapeutics – and has successfully led financings and worked with companies to maximize their assets.

First Quarter 2026 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of March 31, 2026 were $101.1 million compared to $138.4 million as of December 31, 2025. The decrease of $37.3 million was primarily driven by cash used in operations of $37.4 million.
Research and Development Expenses: For the three months ended March 31, 2026, research and development expenses, inclusive of non-cash expenses, were $28.7 million compared to $37.2 million for the same period in 2025. The decrease of $8.5 million was primarily due to lower personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount, a decrease in third-party manufacturing costs at contract development and manufacturing organizations primarily related to the suspension of Sana’s allogeneic CAR T programs, and lower facility and other allocated costs primarily related to depreciation, allocated personnel, and other costs. Research and development expenses include non-cash stock-based compensation of $3.1 million and $4.6 million for the three months ended March 31, 2026 and 2025, respectively.
Research and Development Related Success Payments and Contingent Consideration: For the three months ended March 31, 2026, Sana recognized non-cash expenses of $8.4 million compared to $2.0 million for the same period in 2025, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price.
General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2026, inclusive of non-cash expenses, were $11.5 million, unchanged from the same period in 2025. For the three months ended March 31, 2026, legal fees increased $0.2 million, offset by decreased personnel-related costs of $0.2 million, compared to the same period in 2025. General and administrative expenses include non-cash stock-based compensation of $2.6 million and $2.4 million for the three months ended March 31, 2026 and 2025, respectively.
Net Loss: Net loss for the three months ended March 31, 2026 was $47.2 million, or $0.17 per share, compared to $49.4 million, or $0.21 per share, for the same period in 2025.

(Press release, Sana Biotechnology, MAY 11, 2026, View Source [SID1234665443])

On May 11, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, reported a corporate update and announced first quarter 2026 financial results.

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"In the first quarter, our team showcased its clinical development capabilities, initiating FORTIFY, the Phase 1b trial of PLN-101095, ahead of schedule and dosing the first patient in April," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "We were excited to highlight encouraging recent data from the Phase 1a trial of PLN-101095 at AACR (Free AACR Whitepaper) showing deepening responses and increasing time on treatment. The team continues to make progress on pipeline programs emerging from Pliant’s proprietary integrin platform while evaluating opportunities to expand our clinical-stage pipeline."
Oncology Program
PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. Pliant is currently conducting a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT0670706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, as monotherapy and in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.

•FORTIFY, a Phase 1b indication expansion trial, enrolling and dosing patients. In April, the Company announced the dosing of its first participant in the FORTIFY Phase 1b indication expansion trial. The Phase 1b open-label, single dose trial will enroll three cohorts of patients including non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma and a subset of tumors with high tumor mutational burden. Tumor selection was based on data from the Phase 1 trial, as well as strong mechanistic rationale for integrin inhibition. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027.

•Oral presentation at AACR (Free AACR Whitepaper) of updated Phase 1 data from PLN-101095 highlighted deepening of confirmed responses. In April, at the Clinical Trials Mini Symposium of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting, the Company announced positive updated data from its Phase 1 trial of PLN-101095. Results showed that, in a heavily pretreated patient population, PLN-101095 demonstrated anti-tumor activity in combination with pembrolizumab, an FDA-approved ICI. One confirmed overall complete response, two confirmed overall partial responses, including one patient with a complete response of baseline target lesions, and one unconfirmed partial response were reported. These clinical responses were observed in patients with cholangiocarcinoma, NSCLC, melanoma and head and neck squamous cell carcinoma, respectively. All responding patients showed large increases in plasma interferon gamma (IFN-γ) after 14 days of monotherapy with PLN-101095 prior to the addition of pembrolizumab. At Week 10, all responders maintained more than a 2-fold increase in IFN-γ. No non-responders showed meaningful increases in plasma IFN- γ. PLN-101095 was generally well tolerated across all doses tested. IFN-γ is known to play a multifaceted role in modulating anti-tumor immunity, with increased tumor expression levels having previously been linked with better outcomes from immune checkpoint blockade. In addition to IFN- γ increases, all responding patients showed elevated plasma PD-L1 levels, known to be induced by increased IFN-γ and a predictor of an improved ICI response. Additionally, PLN-101095 was spotlighted as a novel immunotherapy approach as part of AACR (Free AACR Whitepaper)’s 2026 Annual Meeting Highlights Plenary Session.

Integrin-Targeted Delivery Platform

•Utilizing cell-specific integrin receptors, Pliant has developed a platform to deliver drug payloads, including siRNAs, to selective tissue types. Current programs are focused on delivering siRNAs to skeletal muscle cells and other tissues. Preclinical proof-of-concept studies are currently ongoing. The Company believes this integrin-targeting drug-delivery platform has the potential for broad applicability across multiple disease areas utilizing a variety of drug payloads.

First Quarter 2026 Financial Results
•Research and development expenses were $13.6 million, as compared to $43.4 million for the prior-year quarter. The decrease was primarily due to completing close-out activities for BEACON-IPF, a Phase 2b/3 study of bexotegrast, in 2025 and reduced personnel-related expenses, including stock based compensation, driven by decreased headcount compared to prior year.
•General and administrative expenses were $8.2 million, as compared to $15.5 million for the prior-year quarter. The decrease was primarily due to personnel-related expenses, including stock-based compensation, driven by decreased headcount compared to prior year.
•Net loss was $20.0 million as compared to $56.2 million for the prior-year quarter. The decrease was primarily due to significantly lower operating expenses following the termination of bexotegrast development in IPF in 2025 and decreased personnel-related expenses, including stock-based compensation, driven by reduced headcount compared to prior year.
•As of March 31, 2026, the Company had cash, cash equivalents and short-term investments of $172.4 million which the Company expects to be sufficient to fund operations into the second half of 2028.

(Press release, Pliant Therapeutics, MAY 11, 2026, View Source [SID1234665442])

On May 11, 2026 PharmaMar (MSE:PHM) reported that it has completed patient recruitment objective for the Phase III SaLuDo clinical trial (Sarcoma Patients treated with Lurbinectedin and Doxorubicin), which is evaluating lurbinectedin in combination with doxorubicin as a first-line treatment for patients with metastatic leiomyosarcoma (LMS).

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SaLuDo is a global, open-label, multicenter, randomized Phase III clinical trial in metastatic leiomyosarcoma (LMS). The primary endpoint of the study is progression-free survival (PFS), with overall survival (OS) as the key secondary endpoint. The trial includes three treatment arms: two arms evaluating different dose combinations of lurbinectedin and doxorubicin, and a control arm evaluating doxorubicin as a single agent. A total of 450 patients have been enrolled across more than 90 centers in the United States and several European countries.

Leiomyosarcoma is a subtype of soft tissue sarcoma that accounts for approximately 10–20% of all cases within this group of tumors. Soft tissue sarcoma represents around 1% of all cancers in the adult population, so leiomyosarcoma is considered a rare tumor. This type of cancer originates in smooth muscle tissue, which is found in organs such as the retroperitoneum, the gastrointestinal tract, blood vessels, and, in women, the uterus[1].

PharmaMar expects the results of the trial to be available during the first half of 2027, following completion of patient follow-up and data analysis.

(Press release, PharmaMar, MAY 11, 2026, View Source [SID1234665441])