On June 17, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported significant progress across manufacturing, regulatory and clinical development activities supporting ERNA-101, the Company’s lead oncology candidate.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With manufacturing process development completed, GMP production underway, IND-enabling activities advancing and an Investigational New Drug (IND) submission planned for the third quarter of 2026, Ernexa believes it is well-positioned to initiate its first-in-human Phase 1 clinical study in the fourth quarter of 2026 and transition into a clinical-stage biotechnology company.

"ERNA-101 continues to advance toward the clinic as we execute across manufacturing, regulatory and clinical development activities," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "With GMP manufacturing underway, technology transfer activities progressing and our IND submission expected in the third quarter of 2026, we believe we are entering one of the most important periods in the Company’s history."

ERNA-101: A Novel Approach to Treating Immunologically Cold Tumors

ERNA-101 is an engineered, allogeneic induced mesenchymal stem cell (iMSC) therapy derived from induced pluripotent stem cells (iPSCs) and designed to selectively home to tumors while delivering a proprietary IL-7/IL-15 fusion cytokine directly into the tumor microenvironment.

The therapy is designed to address one of the most significant challenges in cancer treatment: immunologically "cold" tumors that evade immune recognition and often fail to respond to existing therapies. By activating T cells and natural killer (NK) cells while reshaping the local tumor environment, ERNA-101 is intended to enhance anti-tumor activity and potentially improve responses to checkpoint inhibitors.

Manufacturing and Regulatory Activities Continue to Advance

Ernexa recently achieved several key operational milestones supporting planned clinical entry, including:

Completion of ERNA-101 manufacturing process development
Transition of ERNA-101 into GMP manufacturing for clinical supply production
Initiation of technology transfer activities to support future manufacturing scalability
Advancement of IND-enabling studies and regulatory documentation
Continued execution of clinical readiness activities for Phase 1 study initiation
Maintenance of timeline toward planned Q3 2026 IND submission
These accomplishments build upon the successful completion of the Company’s FDA Pre-IND meeting and support continued advancement toward regulatory submission and clinical evaluation.

Compelling Preclinical Data Support Clinical Advancement

Preclinical studies evaluating ERNA-101 in combination with PD-1 blockade demonstrated:

Complete elimination of detectable tumors
100% long-term survival through study follow-up
Significant remodeling of the tumor microenvironment from immunosuppressive to immune-activated
Increased infiltration of CD4+ and CD8+ T cells
Enhanced T-cell persistence and anti-tumor activity
Reprogramming of tumor-associated macrophages into a tumor-fighting phenotype
Significant reductions in tumor burden and malignant ascites
Importantly, ERNA-101 demonstrated substantially greater anti-tumor activity when combined with PD-1 blockade compared to either treatment alone, supporting its potential as a complementary immunotherapy platform designed to enhance responses in difficult-to-treat solid tumors.

Strong Financial Position Supports Development Objectives

Following the completion of a $10.5 million financing, Ernexa believes it has sufficient resources to execute its near-term development strategy and pursue several anticipated value-driving milestones over the next 12 to 18 months.

Expected 2026 Milestones

Q3 2026

Release of first GMP clinical product batch
Completion of required IND-enabling studies
Submission of IND application for ERNA-101
Q4 2026

FDA review of IND application
Initiation of first-in-human Phase 1 clinical study
First patient enrollment in platinum-resistant ovarian cancer
Pre-IND meeting with FDA for ERNA-201 autoimmune disease program
Expected 2027 Milestones

First Half 2027

Initial clinical data from ERNA-101 Phase 1 study
Second Half 2027

Potential advancement into Phase 2 development
Potential strategic partnership opportunities
Potential expansion into additional solid tumor indications
"The anticipated initiation of our first-in-human study in the fourth quarter of 2026 will represent a defining milestone for Ernexa and the beginning of clinical validation for our engineered iMSC platform," Luther added. "We believe ERNA-101 has the potential not only to improve outcomes for patients with platinum-resistant ovarian cancer, but also to establish a new approach for treating immunologically cold tumors across multiple oncology indications."

For more information about ERNA-101 and the Company’s development plans, visit www.ernexatx.com

(Press release, Ernexa Therapeutics, JUN 17, 2026, View Source [SID1234668790])

On June 17, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, reported that it has priced a Public Offering of securities as described below for aggregate gross proceeds to the Company of $3.2 million, before deducting agent fees and other estimated expenses payable by the company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The offering consists of 4,000,000 shares of its common stock, par value $0.007 per share (or pre-funded warrants in lieu thereof) at a purchase price of $0.80 per share (or $0.793 per pre-funded warrant). Each pre-funded warrant will be exercisable for one share of common stock and will be immediately exercisable and will expire when exercised in full.

The closing of the offering is expected to occur on or about June 18, 2026, subject to the satisfaction of customary closing conditions.

WallachBeth Capital, LLC is acting as sole placement agent for the offering.

The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-296764), as amended, previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). This press release shall not constitute an offer to sell or the 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. The offering is being made only by means of a preliminary prospectus and final prospectus that will form a part of the registration statement. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at [email protected], by calling +1 (646) 237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, JUN 17, 2026, View Source [SID1234668789])

On June 17, 2026 Deciphera Pharmaceuticals, LLC, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported the first patient was dosed in the global pivotal Phase 3 INTREPID study evaluating sapablursen for the treatment of polycythemia vera (PV). Sapablursen is an investigational drug that has the potential to offer a once-monthly treatment option for patients with PV, a rare and potentially life-threatening hematologic disease.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to building upon the positive efficacy and safety results from the Phase 2a IMPRSSION study, which demonstrated the ability of sapablursen to reduce the frequency of phlebotomy, control hematocrit, and improve PV symptoms in patients treated with phlebotomy alone and those on cytoreductive therapies," said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. "Sapablursen has the potential to be an important new treatment option for patients with PV, and we are excited to begin our Phase 3 INTREPID study, which brings us one step closer to addressing the unmet needs of these patients."

INTREPID is a pivotal global Phase 3 study in patients with phlebotomy-dependent PV designed to compare the efficacy and safety of sapablursen to placebo over a 32-week double-blind treatment period followed by up to 124 weeks of open label treatment. The primary endpoint is response, defined by the absence of phlebotomy eligibility. Key secondary endpoints are number of phlebotomies, which is the primary endpoint for the European Medicines Agency for potential regulatory approval, hematocrit control, and improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Total T-score and the Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score. Durability of response will be evaluated in patients randomized to sapablursen over 52 weeks of study treatment, including 32 weeks of blinded treatment and 20 weeks of open-label treatment.

The INTREPID clinical trial has initiated in the United States and is planned in additional regions including North America, Latin America, Asia Pacific and Europe. For more information on the INTREPID study, please visit View Source

Sapablursen received Fast Track designation and Orphan Drug Designation in 2024 and Breakthrough Therapy Designation in 2025 by the U.S. Food and Drug Administration (FDA).

Sapablursen was discovered and advanced through Phase 2 clinical development by Ionis Pharmaceuticals. Ono obtained exclusive global rights for the development and commercialization of sapablursen after entering into a license agreement with Ionis in March 2025.

About Sapablursen

Sapablursen is designed to reduce the production of TMPRSS6 resulting in increased expression of hepcidin, the key regulator of iron homeostasis. By increasing the production of hepcidin, sapablursen has the potential to positively impact PV by decreasing hematocrit, reducing the need for phlebotomy, and improving quality of life.

About Polycythemia Vera

Polycythemia vera (PV) is a rare and potentially life-threatening hematologic disease characterized by the overproduction of red blood cells, which significantly increases the risk of serious blood clots, heart attack, stroke, and death. The primary treatment goal in PV is to maintain blood hematocrit levels <45% to prevent thrombotic events and alleviate burdensome symptoms, such as severe fatigue, difficulty concentrating, night sweats, and pruritus. Current treatment options often worsen symptoms and inadequately maintain hematocrit control.

(Press release, Deciphera Pharmaceuticals, JUN 17, 2026, View Source [SID1234668788])

On June 17, 2026 LabGenius Therapeutics ("LabGenius"), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise therapeutic antibodies, reported a multi-year research collaboration, option and licensing agreement with LG Chem. The collaboration aims to identify next-generation multispecific antibodies designed to overcome the key limitations of existing immunotherapies, including on-target, off-tumour toxicities. Together, the companies will aim to develop a novel, tumour-selective therapeutic targeting a solid tumour antigen expressed across multiple difficult-to-treat cancer types.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Partnering with LG Chem represents a very important moment for LabGenius and provides further validation of our platform’s ability to design highly optimised multispecific antibodies," said Dr. James Field, CEO of LabGenius. "We welcome this opportunity to leverage our proprietary discovery capabilities to advance the development of safer and more effective immunotherapies for patients with solid tumours."

Jineon So, Head of R&D, Life Sciences Division at LG Chem, commented: "LabGenius possesses a highly capable and systematic platform that enables rapid candidate exploration and early evaluation through a closed-loop structure integrating automated wet labs and computational dry labs. Through this collaboration, we aim to quickly identify novel oncology drug candidates with improved efficacy and reduced toxicity in areas of high unmet medical need."

Science Minister Lord Vallance said: "Cancer will touch many of us or our families over the course of our lives, but from drug discovery to faster diagnoses, emerging technologies like AI are transforming our ability to treat and cure this awful disease. By bringing together the power of machine learning and research expertise, this collaboration has the potential to deliver new treatments which are more efficient and have fewer side-effects – potentially improving outcomes for patients all over the world."

Under the terms of the licensing agreement, LabGenius will advance the programme through preclinical research, including in vitro efficacy studies, after which LG Chem will perform further pre-clinical development work, including in vivo studies, and then have the option to in-license the asset. LabGenius will receive an undisclosed upfront payment and potential early milestones, plus, if the option is exercised, potential triple-digit million clinical, regulatory and commercial milestones, along with royalties on net sales. LG Chem will fund all research and development activities conducted under the collaboration.

(Press release, LabGenius Therapeutics, JUN 17, 2026, View Source [SID1234668787])

On June 17, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that compelling results from its randomized, double-blind, placebo-controlled Phase II trial (AK117-206) of ligufalimab (AK117) were presented as an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress. Ligufalimab is Akeso’s proprietary next-generation humanized IgG4 anti-CD47 monoclonal antibody. The study evaluated ligufalimab in combination with azacitidine (AZA) and venetoclax (VEN) in patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ligufalimab-based combination therapy demonstrates a significant trend toward survival benefit

At a median follow-up of 10 months in the ligufalimab group and 8.8 months in the control group, median event-free survival (EFS) was 9.1 months in the ligufalimab group versus 6.9 months in the control group (hazard ratio [HR] = 0.46). The 6-month EFS rate was 67.8% versus 55.5% in the control group, and the 9-month EFS rate was 53.2% versus 14.1%.
Median overall survival (mOS) was not reached in the ligufalimab group versus 8.3 months in the control group (HR = 0.46). The 6-month OS rate was 83.3% versus 73.2%, and the 9-month OS rate was 78.7% versus 43.1% in the control group.
Ligufalimab-based combination therapy yields deep tumor responses

The objective response rate (ORR) was 80.0% in the ligufalimab group versus 66.7% in the control group, and the composite complete response (CRc) rate was 56.7% versus 53.3%; the proportion of patients achieving CRc with minimal residual disease (MRD) negativity was higher in the ligufalimab group than in the control group (46.7% vs. 36.7%).
The median duration of CRc was 10.4 months in the ligufalimab group, which was markedly superior to 5.6 months in the control group.
Favorable Safety Profile With No New Safety Signals Observed

The incidence of overall treatment-emergent adverse events (TEAEs) and serious adverse events was comparable between treatment arms. The most common TEAEs were generally consistent with those expected in the context of AML and AZA+VEN therapy.
Anemia occurred in 46.7% of patients in the ligufalimab arm versus 50.0% in the control arm.
Notably, ligufalimab has already received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of AML. Akeso is advancing its ligufalimab clinical development programs at a globally competitive pace across both hematologic malignancies and solid tumors. Ligufalimab is also the first anti-CD47 monoclonal antibody worldwide to enter a registrational Phase III clinical trial in solid tumors.

(Press release, Akeso Biopharma, JUN 17, 2026, View Source [SID1234668786])