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.

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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 AB Science SA (Euronext – FR0010557264 – AB) reported that the United States Patent Office has formally granted a patent for methods of treating metastatic castrate resistant prostate cancer (mCRPC) with its lead compound masitinib. This new US patent (US 12,648,944) ensures intellectual property protection for masitinib until May 2042.

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This new US patent adds to the IP coverage already granted in Europe (EP4175639).

Counterpart patent applications have also been filed in other major international markets.

Masitinib positioning in metastatic prostate cancer after failure to hormone therapy

In metastatic prostate cancer, patients take hormone therapies (i.e., androgen-deprivation therapy) in first line and second line. Then when metastatic cancer advances patients have to be treated by chemotherapy. There is only one chemotherapy registered, docetaxel, and no drug in combination with docetaxel or replacement of docetaxel has improved PFS or OS and has been registered for the last 20 years.

Masitinib is positioned in combination with docetaxel as a treatment of mCRPC patients who are eligible to chemotherapy. That is to say, it is administered directly following the metastatic hormone-sensitive prostate cancer (mHSPC) treatment space.

Masitinib is one of the rare drugs to have generated positive data on progression free survival (PFS) in combination with docetaxel in this population.

Masitinib positioning in mCRPC with low metastatic involvement measured by a biomarker

More specifically, this patent provides protection for masitinib and related compounds for the treatment of mCRPC in a patient subpopulation with low metastatic involvement (as measured by baseline alkaline phosphatase levels).

This patient population is fully consistent with the results of the masitinib study AB12003 [1] and the ongoing clinical development program of masitinib in mCRPC.

As a reminder, the key results from study AB12003 include:

Masitinib (6.0 mg/kg/day) plus docetaxel conferred a significant progression-free survival (PFS) benefit in mCRPC patients with baseline alkaline phosphatase levels (ALP) less than or equal to 250 IU/L; hazard ratio of 0.79 [0.64,0.97] (p=0.0087), corresponding to a 21% reduction in risk of progression relative to control.
Assessment of PFS rates was convergent with this primary outcome, with 12-, 18-, and 24-month PFS rates showing significant improvement in favor of masitinib plus docetaxel relative to the control: 1.6-fold (p=0.0035), 1.9-fold (p=0.0001), and 1.9-fold (p=0.0028), respectively.
A progressively greater masitinib treatment effect was observed for lower baseline ALP levels (i.e., less advanced metastatic disease), with a significant 47% reduced risk of progression in patients with ALP less than or equal to 100 IU/L (hazard ratio=0.53, p=0.002).
The safety profile of masitinib plus docetaxel was acceptable and consistent with the known masitinib profile, with no new safety signals observed.
Unmet medical need in mCRPC

Although localized disease is associated with high survival rates, metastatic prostate cancer still represents an unmet medical need with a 5-years survival rate of approximately 32% [2]. Practically all patients with metastatic disease become resistant to androgen-deprivation therapy.

With 1.5 million new cases and 397,000 deaths worldwide, prostate cancer is the world’s second most frequent cancer and the fifth leading cause of cancer death among men [3]. It is estimated that there are at least 3.5 million men living with prostate cancer in the United States [4] and 2.5 million in Europe [5]. Approximately 2% of all prostate cancer cases are mCRPC [6], and practically all patients with metastatic disease will become resistant to androgen-deprivation therapy. As such, the population with mCRPC eligible to chemotherapy is around 50,000 in the EU and 70,000 in the USA.

(Press release, AB Science, JUN 17, 2026, View Source [SID1234668773])

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.

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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 16, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported it has amended the clinical study protocol for the Phase 1/1b trial of PAS-004 in neurofibromatosis type 1 (NF1) patients with symptomatic inoperable, incompletely resected, or recurrent plexiform neurofibroma (PN). The amendments include an update to the dose escalation part of the study (Part A) to allow for the enrollment of additional participants at two additional higher dose levels (24mg and 32mg), the ability to backfill completed dose cohorts (4mg, 8mg, 12mg and 18mg) with up to two participants, and the evaluation of intermediate dose levels.

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In addition, the protocol amendments allow patients to remain on treatment for up to 18 months in Part A, and include additional MRI scans to comprehensively evaluate PN, as well as adding more detailed cutaneous neurofibroma (CN) measurements, including tumor height and volume.

Pasithea has completed enrollment and multi-cycle dosing of the initial 4mg, 8mg, 12mg and 18mg cohorts, and enrolled the 24mg cohort and an intermediate 15mg cohort.

"We believe increasing the breadth and depth of Part A of the NF1 study will help inform dose selection for Part B and our future registrational studies," said Dr. Kartik Krishnan, Chief Medical Officer, Pasithea. "I am pleased that we rapidly enrolled and dosed an additional 6 patients and that the amendments will allow us to provide more comprehensive data in 2026."

This multicenter, phase 1/1b, open-label study is divided into two parts: a dose-escalation phase (part A) and an expansion cohort phase (part B). To date, the dose-escalation phase has enrolled and dosed 18 patients with NF1.

About NF1- PN
Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

(Press release, Pasithea Therapeutics, JUN 16, 2026, View Source [SID1234668758])

On June 16, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported the closing of its license agreement for VEPPANUTM (vepdegestrant), following the early termination of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976 and satisfaction of other customary closing conditions. Rigel previously announced it entered into an exclusive, global license agreement with Arvinas, Inc. (Arvinas) and Pfizer Inc. (Pfizer) to develop, manufacture and commercialize VEPPANU. VEPPANU is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

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The agreement is effective as of June 11, 2026 and Rigel has made the upfront payment of $70.0 million to be distributed evenly between Arvinas and Pfizer, consistent with the terms of the agreement.

Rigel expects to make VEPPANU commercially available in August.

About VEPPANUTM (vepdegestrant)

INDICATION
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor–1 (ESR1)–mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
QTc Interval Prolongation
VEPPANU can cause QT (QTc) interval prolongation. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and during treatment with VEPPANU. Perform an ECG prior to initiation of treatment with VEPPANU and do not initiate VEPPANU in patients with QTc >470 msec. Repeat ECG approximately 4 weeks after initiating treatment and as clinically indicated. Avoid concomitant use of VEPPANU with strong CYP3A inhibitors or drugs known to prolong the QTc interval.

Embryo-Fetal Toxicity
Based on findings from animal studies and its mechanism of action, VEPPANU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose.

ADVERSE REACTIONS
Serious adverse reactions occurred in 9% of patients who received VEPPANU. The serious adverse reactions included any fracture (1.3%), fall, hypercalcemia, hepatic injury, pneumonia, musculoskeletal pain (0.6% each), and QTc prolonged (0.3%). Fatal adverse reactions occurred in 1.0% of patients who received VEPPANU, including dyspnea, cerebral ischemia, and unknown cause (one patient each).

Permanent discontinuation of VEPPANU due to an adverse reaction occurred in 2.9% of patients, dosage interruptions of VEPPANU due to an adverse reaction occurred in 14% of patients, and dosage reductions of VEPPANU due to an adverse reaction occurred in 1.9% of patients.

The most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation.

Clinically relevant adverse reactions in <10% of patients who received VEPPANU included headache, hot flush, diarrhea, vomiting, bradycardia, and urinary tract infection.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid concomitant use of VEPPANU with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce VEPPANU dosage.
Strong CYP3A Inducers: Avoid concomitant use with strong CYP3A inducers in patients receiving VEPPANU. If concomitant use cannot be avoided, increase VEPPANU dosage.
Certain P-gp Substrates: Avoid concomitant use with certain P-gp substrates where minimal increases in concentration may lead to serious adverse reactions.
Certain UGT1A9 Substrates: Refer to the Prescribing Information for UGT1A9 substrates where minimal increases in the concentration may lead to serious adverse reactions.
Avoid concomitant use of VEPPANU with other drugs with a known potential to prolong the QTc interval.

LACTATION
Advise lactating women not to breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.

Click here for Important Safety Information and Full Prescribing Information.

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

VEPPANU is a trademark of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, JUN 16, 2026, View Source [SID1234668759])