On May 15, 2026 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported first quarter 2026 results and provided a corporate update.

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"2026 is off to a productive start, as we now have a clear path forward for efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), following our recent Type C meeting with the U.S. Food and Drug Administration (FDA)," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "Based on feedback from the FDA, we plan to file an investigational new drug (IND) application next month for a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing forced vital capacity (FVC) as the primary endpoint of the study and the King’s Sarcoidosis Questionnaire (KSQ)-Lung score as a key secondary endpoint. We look forward to the continued advancement of efzofitimod in this form of ILD where there remains a high unmet medical need."

First Quarter 2026 and Subsequent Period Highlights

Announced plans to continue the development of efzofitimod in pulmonary sarcoidosis following a Type C meeting with the FDA to review the results of the Phase 3 EFZO-FIT study and determine the path forward for efzofitimod in pulmonary sarcoidosis. The Company plans to file an IND in June 2026 for a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing FVC as the primary endpoint of the study and the KSQ-Lung score as the key secondary endpoint. The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses. The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of ≤ 5.0 mg daily oral corticosteroid and/or a background immunosuppressant. All background treatment will remain stable throughout the duration of the study. The primary endpoint of the study will be change from baseline in FVC at week 48 and the key secondary endpoint will be change from baseline in the KSQ-Lung score at week 48.
On track to complete enrollment in the Phase 2 EFZO-CONNECT study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD) in the first half of 2026. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Promising interim data from the study were reported in the second quarter of 2025.
Poster related to the Company’s investigational new drug candidate, ATYR0101, accepted for presentation at the Extracellular Matrix Pharmacology Congress, which is scheduled to take place June 14 – 17, 2026 in Copenhagen, Denmark. The poster, which is titled, "Natural Asp-tRNA Synthetase Fragment Interacts with LTBP-1 on the ECM Promoting Myofibroblast Apoptosis and Reducing Fibrosis," presents research indicating that AYTR0101 selectively induces myofibroblast apoptosis via modulation of focal adhesion kinase (FAK) signaling through a novel binding interaction with latent-transforming growth factor beta binding protein 1 (LTBP-1) and results in a significant reduction of fibrosis in lung and kidney models. The poster will be available on the Company’s website once presented.
First Quarter 2026 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of March 31, 2026, were $68.3 million.
R&D Expenses: Research and development expenses were $7.3 million for the first quarter 2026, which consisted primarily of costs for the Phase 3 EFZO-FIT and Phase 2 EFZO-CONNECT studies and research and development costs for the Company’s preclinical product candidates.
G&A Expenses: General and administrative expenses were $4.1 million for the first quarter 2026.
About Efzofitimod

Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr intends to submit an investigational new drug (IND) application in June 2026 for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

(Press release, aTyr Pharma, MAY 15, 2026, View Source [SID1234665786])

On May 15, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 1,995,092 of the Company’s ordinary shares originally issued in August 2025 and September 2025 having a reduced exercise price of $0.50 per share. The ordinary shares issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-3 (File No. 333-290074) and an effective resale registration statement on Form S-3 (No. 333-291210). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $1 million, prior to deducting placement agent fees and estimated offering expenses. The offering is expected to close on or about May 18, 2026, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering as working capital for general corporate purposes.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered Series C warrants to purchase up to 2,045,000 of the Company’s ordinary shares and new unregistered Series D warrants to purchase up to 1,945,184 of the Company’s ordinary shares. The new warrants will have an exercise price of $0.50 per share and will be exercisable upon the effective date of shareholder approval of the issuance of the ordinary shares issuable upon exercise of the new warrants. The Series C new warrants will expire five years after the later of (i) the date of shareholder approval and (ii) the effective date of the Resale Registration Statement (as defined below) and the Series D new warrants will expire twenty-four months after the later of (x) the date of shareholder approval and (y) the effective date of the Resale Registration Statement.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the ordinary shares issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the ordinary shares issuable upon exercise of the new warrants (the "Resale Registration Statement").

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Silexion Therapeutics, MAY 15, 2026, View Source [SID1234665802])

On May 15, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported the publication of Phase 1b data evaluating botensilimab (BOT), an Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), an anti-PD-1 antibody, in patients with treatment-refractory hepatocellular carcinoma (HCC) who had progressed following prior immunotherapy. The manuscript, titled "A phase 1b study of botensilimab and balstilimab in treatment-refractory hepatocellular carcinoma," was published in Liver Cancer and is available at DOI: 10.1159/000551630.

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The publication reports results from an expansion cohort of the Phase 1b C-800-01 study in 19 patients with HCC who had progressed on or after prior immunotherapy. The cohort represents a difficult-to-treat population for which prospective data remain limited, including 47% of patients with albumin-bilirubin (ALBI) grade 2 liver function, a marker of poorer liver reserve and prognosis in HCC. In published HCC studies, ALBI grade 2 liver function has been linked to a 4- to 10-month decrement in median overall survival compared with ALBI grade 1, underscoring the poor prognosis and reduced responsiveness typically observed in this population.i

Among 18 efficacy-evaluable patients, BOT+BAL demonstrated an objective response rate (ORR) of 17%, including one complete response and two partial responses. The 18-week clinical benefit rate (CBR) was 50%. Median duration of response (mDOR) was not reached, median progression-free survival (mPFS) was 4.4 months, and median overall survival (mOS) was 12.3 months. All patients had received prior anti-PD-(L)1 therapy, 68% had received prior tyrosine kinase inhibitors, and 58% had received prior atezolizumab/bevacizumab. One patient experienced stable disease for 66 weeks, supporting the conclusion that benefit with BOT+BAL was not confined to RECIST response alone.

Treatment options after immune checkpoint inhibitor (ICI) therapy in advanced HCC remain limited, and available systemic therapies have generally shown modest activity. Published studies evaluating lenvatinib, cabozantinib and regorafenib after ICI-based therapy have reported objective response rates of 6–14%, median progression-free survival of approximately 4–5 months and median overall survival of ≤10.5 months.ii The BOT+BAL results therefore, provide early prospective evidence of activity in a post-ICI HCC population that included patients with adverse prognostic features often underrepresented in later-line studies.

"This publication adds to a consistent body of clinical evidence showing BOT plus BAL activity across difficult-to-treat, late-line solid tumors," said Steven O’Day, MD, Chief Medical Officer of Agenus. "In HCC, where tumor biology and underlying liver function both shape treatment outcomes, these data further support the rationale for botensilimab’s Fc-enhanced CTLA-4 design and its potential to drive immune activity in settings where conventional checkpoint approaches have had limited impact."

"Patients with advanced HCC who progress after immunotherapy have limited treatment options, and outcomes can be especially poor when liver function is compromised," said Anthony B. El-Khoueiry, MD, Chief of Section of Developmental Therapeutics and Associate Director for Clinical Research at USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC, and principal investigator of the study. "In this exploratory cohort, seeing objective responses, prolonged disease control and a median overall survival of 12.3 months is encouraging and supports continued study of BOT plus BAL in this post-immunotherapy setting."

The safety profile of BOT+BAL in the HCC cohort was consistent with prior reports across the broader Phase 1b program. There were no treatment-related deaths and no new class safety signals. Immune-mediated treatment-related adverse events occurred in 68% of patients, with grade 3 events in 37%. The most common immune-mediated treatment-related adverse events were diarrhea/colitis, hepatitis and dermatologic events. No grade 4 or higher immune-mediated treatment-related adverse events were reported. All immune-mediated hepatitis events resolved to grade 1 or lower.

HCC is the most common form of liver cancer and is often diagnosed at an advanced stage. Immune checkpoint inhibitor combinations have improved outcomes in the frontline setting, but patients who progress after immunotherapy have limited prospective evidence to guide subsequent treatment. In the published manuscript, the authors concluded that BOT+BAL demonstrated promising efficacy and manageable safety in previously treated HCC, including patients who progressed after frontline immunotherapy, and that these findings warrant further investigation.

About the C-800-01 Study

C-800-01 (NCT03860272) is an open-label, multicenter Phase 1b clinical trial evaluating botensilimab in combination with or without balstilimab in patients with advanced solid tumors. The trial enrolled over 400 patients with refractory disease and included tumor types with limited or no responsiveness to prior checkpoint inhibitors.

The HCC expansion cohort enrolled 19 patients between March 2021 and September 2023 across six U.S. sites. Patients received botensilimab at 1 mg/kg or 2 mg/kg once every six weeks plus balstilimab 3 mg/kg once every two weeks. The safety analysis included all 19 patients who received at least one dose of study drug, and the efficacy-evaluable analysis included 18 patients with at least one post-baseline imaging scan.

(Press release, Agenus, MAY 15, 2026, View Source [SID1234665787])

On May 15, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported first quarter 2026 financial results for the period ended March 31, 2026.

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"With the initiation of our GTB-5550 Phase 1 trial, we have now advanced three TriKE candidates into the clinic, a significant milestone that underscores the continued momentum of our pipeline," said Michael Breen, Executive Chairman and Chief Executive Officer. "GTB-3650 has demonstrated an excellent safety profile thus far, and we look forward to continuing enrollment progress. With sufficient cash runway through Q4 2026, we look forward to providing updates on both programs in the second half of 2026."

GTB-3650 TriKE for CD33 positive leukemias

The ongoing Phase 1 dose escalation study is evaluating GTB-3650 for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. Enrollment is ongoing, with Cohort 4 enrollment now complete and a total of 8 patients treated across the first four cohorts; the Company expects to provide continued progress updates throughout 2026. Dose escalation may continue up to Cohort 7 as necessary with the potential to evaluate GTB-3650 in a total of 14 patients (two patients per cohort). GTB-3650 is dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.

GTB-5550 TriKE for B7H3 positive solid tumor cancers

The ongoing Phase 1 trial with GTB-5550 is the first nanobody TriKE tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial is focused primarily on enrolling prostate cancer patients and will evaluate up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 1b expansion component will enroll patients with up to 7 different tumor types (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity.

GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. Subsequent cycles receive treatment three times weekly for 2 weeks followed by 2 weeks of no treatment. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS). More details can be found on clinicaltrials.gov with the identifier: NCT07541573.

First Quarter Ended March 31, 2026 Financial Summary

Cash Position: The Company had cash and cash equivalents of approximately $9 million as of March 31, 2026, which is anticipated to be sufficient to fund the Company’s operations through the fourth quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were approximately $400,000 compared to $1.1 million for the same comparable quarter of 2025. The $700,000 decrease was primarily due to a reduction in production costs. R&D expenses primarily relate to the Company’s continued licensing, development, production, and clinical trials of its most advanced TriKE product candidates GTB-3650 and GTB-5550 along with the progression on other promising product candidates.

Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the second quarter of 2026 were approximately $2.4 million compared to $800,000 for the same comparable quarter of 2025. The $1.6 million increase was primarily due to an increase in marketing expenses, and to a lesser extent, legal fees.

Loss from Operations: The Company reported a loss from operations for the second quarter of 2026 of approximately $2.8 million compared to $1.9 million for the same comparable quarter of 2025. The 900,000 increase was primarily due to $1.6 million increase in SG&A (as described above).

Net Loss: The Company reported a net loss of approximately $2.8 million for the second quarter of 2026, compared to $800,000 for same comparable quarter of 2025. The $2 million increase consisted primarily of a $1.6 million increase in SG&A (as described above), and a decrease in non-recurring other income of approximately $1.1 million.

(Press release, GT Biopharma, MAY 15, 2026, View Source [SID1234665803])

On May 15, 2026 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported business and financial results for the fiscal second quarter ended March 31, 2026, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR).

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"The first half of fiscal 2026 demonstrated meaningful commercial progress at our majority-owned subsidiary Citius Oncology. In the four months of commercial sales since the December 2025 launch of LYMPHIR, Citius Oncology generated $5.6 million in net revenue at approximately 80% gross margins, advanced 83% of target accounts to formulary inclusion or active review, and secured payer coverage representing near 100% of covered commercial lives with no reimbursement denials reported to date. Importantly, major academic centers have begun to transition patients to local community infusion centers for treatment, a critical next phase of commercial scaling. These results reflect our efforts to build a durable patient access foundation upon which to drive growth," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharma and Citius Oncology.

"Subsequent to quarter end, Citius Oncology secured up to $36.5 million in combined debt and equity financing through its senior secured credit facility with Avenue Capital and the exercise of outstanding warrants, complemented by Citius Pharma’s $5 million registered direct offering. Together, these proceeds are expected to fund Citius Pharma’s activities as well as the completion of the LYMPHIR commercial field force buildout by mid-summer. This will support expanded physician engagement and broader market penetration, positioning Citius Oncology to accelerate growth as the launch matures. We believe Citius Oncology maintains sufficient inventory to support anticipated commercial demand, as well as additional demand outside the U.S., as we begin to see orders for product through our global distribution partners."

"Moreover, we are encouraged by positive preliminary topline Phase 1 data from two investigator-initiated combination studies, with pembrolizumab and prior to CAR-T therapy, which reinforce LYMPHIR’s potential as a platform asset in combination regimens. At the Citius Pharma level, we also remain focused on advancing Mino-Lok and Halo-Lido with the FDA and on disciplined execution of our mission to bring first-in-class therapies to patients," concluded Mazur.

Fiscal Second Quarter 2026 Business Highlights and Subsequent Developments

● Reported key commercial metrics of LYMPHIR launch:

○ 83% of target accounts had added or were actively progressing LYMPHIR through formulary review;

○ Secured near 100% of covered commercial lives; no reimbursement denials or prior authorization barriers reported;

○ Initial accounts placing repeat orders;

○ Patients beginning to transition from larger academic cancer centers to community infusion centers;

● Announced initial shipment of LYMPHIR to Europe on April 29, 2026 through Uniphar, a leading international healthcare services company, with LYMPHIR being made available to eligible patients through Named Patient Programs (NPPs) in accordance with local regulations across 19 markets in Southern Europe, the Middle East, and additional European territories;

● Announced positive topline results from two investigator-initiated Phase 1 studies, including:

○ LYMPHIR in combination with pembrolizumab in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies;

○ LYMPHIR administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with positive topline safety and efficacy results; and,

● Continued FDA engagement on Mino-Lok, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and on Halo-Lido (CITI-002), a topical formulation for hemorrhoids.

Fiscal Second Quarter 2026 Financial Highlights and Subsequent Events

● Cash and cash equivalents of $4.6 million as of March 31, 2026;

● Citius Pharma closed a $5 million registered direct offering in April 2026;

● Citius Oncology secured up to $36.5 million in financing subsequent to quarter end, consisting of:

○ $11.5 million in gross proceeds received May 5, 2026 from the exercise of certain outstanding warrants;

○ a loan agreement of up to $25 million from Avenue Capital Group, with $10 million in gross proceeds funded at close on May 6, 2026, and up to $15 million available in subsequent tranches pending certain revenue and liquidity milestones; and,

● Citius Pharma and Citius Oncology collectively expect to have sufficient funds to continue operations through November 2026;

● Net product revenues of $1.7 million for the three months ended March 31, 2026, compared to no revenue in the three months ended March 31, 2025, and $5.6 million for the six months ended March 31, 2026, compared to no revenue in the six months ended March 31, 2025; quarter over quarter decline reflects larger initial orders from specialty distributors at launch in the first quarter;

● Gross profit of $1.3 million for the three months ended March 31, 2026, and $4.5 million for the six months ended March 31, 2026; approximately 80% in both periods, reflecting continued commercial progress since the December 2025 launch of LYMPHIR;

● R&D expenses of $1.6 million for the three months ended March 31, 2026, compared to $3.8 million for the three months ended March 31, 2025; and $3.2 million for the six months ended March 31, 2026, compared to $5.9 million for the six months ended March 31, 2025. The decrease in both periods primarily reflects reduced clinical development activity, as the prior-year periods included costs for a pre-license inspection batch of LYMPHIR previously manufactured;

● G&A expenses of $26.4 million for the three months ended March 31, 2026, compared to $4.8 million for the three months ended March 31, 2025, primarily driven by a $19.7 million one-time CMO contract cancellation charge. G&A expenses were $32.1 million for the six months ended March 31, 2026, compared to $10.2 million for the six months ended March 31, 2025;

● Stock-based compensation expense was $3.8 million for the three months ended March 31, 2026, compared to $2.7 million for the three months ended March 31, 2025. For the six months ended March 31, 2026, stock-based compensation was $8.1 million, compared to $5.2 million for the six months ended March 31, 2025;

● Recognized a gain of $3.8 million from the sale of New Jersey state net operating losses under the New Jersey Technology Business Tax Certificate Transfer Program; and,

● Net loss applicable to common stockholders of $21.2 million, or $(0.95) per share, for the three months ended March 31, 2026, compared to $10.9 million, or $(1.27) per share, for the three months ended March 31, 2025; and $29.5 million, or $(1.34) per share, for the six months ended March 31, 2026, compared to $20.7 million, or $(2.58) per share, for the six months ended March 31, 2025.

(Press release, Citius Pharmaceuticals, MAY 15, 2026, View Source [SID1234665768])