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Juniper Biosciences Unveils JBS-002 and JBS-004, Advancing Two Late-Stage Diagnostic Programs to Registration Batch Manufacturing in the Fourth Quarter of 2026

On September 15, 2026 Juniper Biosciences reported two previously undisclosed radiopharmaceutical programs: JBS-002, a Ga-68 based cold kit for prostate cancer imaging, and JBS-004, a fluorine-18 labeled diagnostic imaging agent for Alzheimer’s disease. Both assets have been advanced privately through development and are disclosed today at the registrational stage, with registration batch manufacturing scheduled for the fourth quarter of 2026 in support of planned submissions to the U.S. Food and Drug Administration (FDA) in 2027.

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The Company is disclosing both assets now that they stand at the threshold of regulatory submission, revealing a deep late-stage diagnostic portfolio — two registrational programs addressing large, established imaging markets.

JBS-002: A Ga-68 based Kit for Precision Prostate Cancer Imaging

Prostate-specific membrane antigen (PSMA) is a transmembrane protein expressed at low levels in normal prostate tissue but dramatically overexpressed on the surface of prostate cancer cells, including in metastatic and hormone-resistant disease. JBS-002 is an investigational PET imaging agent that binds directly to PSMA-expressing lesions and renders them visible on a whole-body scan. PSMA PET imaging is now established in clinical practice for staging men with high-risk disease before definitive treatment and for localizing the site of recurrence in patients with rising PSA after surgery or radiation, findings that frequently change the intended course of therapy.

PSMA PET has become standard of care, and the U.S. market is now estimated at approximately $1.8 billion annually. Growth continues on two fronts: expanding NCCN-guideline use across the disease course, and the rapid adoption of PSMA-targeted radioligand therapy, which depends on PSMA imaging to select and monitor patients.

JBS-004: An F-18 Diagnostic Imaging Agent for Alzheimer’s Disease

JBS-004 is an investigational fluorine-18 labeled PET imaging agent designed to provide a non-invasive visual assessment of Alzheimer’s disease pathology in adult patients being evaluated for cognitive impairment. Historically, a definitive determination of Alzheimer’s pathology could be made only at autopsy, leaving clinicians to diagnose by exclusion. Molecular imaging changes that calculus by making the underlying pathology directly observable in living patients, supporting earlier diagnostic certainty, reducing misdiagnosis in a population where symptoms overlap with numerous other conditions, and identifying which patients are appropriate candidates for the new generation of disease-modifying Alzheimer’s therapies—treatments that require confirmation of pathology before they can be prescribed.

The commercial context for this imaging has changed fundamentally in recent years. The arrival of therapies converted Alzheimer’s PET from a research tool into a required gateway to treatment. Scan volumes have grown sharply against a small field of approved agents.

An Expanding Late-Stage Portfolio

With JBS-002 and JBS-004 both entering registration batch manufacturing in the fourth quarter of 2026, Juniper Biosciences has two late-stage diagnostic assets advancing in parallel toward FDA submission in 2027, alongside JBS-003, the Company’s previously disclosed Phase III program in HPV-positive oropharyngeal cancer. Three programs now sit in registrational or Phase III development across prostate cancer, Alzheimer’s disease, and head and neck cancer—a portfolio built by a team with deep operating experience in radiochemistry and complex manufacturing.

"Reaching registration batch manufacturing on two programs in the same quarter is a defining moment for a company of our size," said Alex Agnoletto, Chief Executive Officer of Juniper Biosciences. "JBS-002 and JBS-004 serve different physicians and different diseases, but they reflect the same conviction: better decisions require better information. Together with JBS-003, they give us three programs in registrational or Phase III development and a clear path to becoming a commercial-stage company in the near future"

Commercialization

Juniper Biosciences intends to commercialize JBS-002 and JBS-004 in the United States if the programs receive marketing approval from the FDA. The Company is advancing both agents through registration with the objective of transitioning from a development-stage organization to a commercial-stage one, and preparatory work to support a potential launch of each program is proceeding in parallel with the regulatory work described above.

JBS-002 and JBS-004 are investigational agents. Neither has been approved by the FDA or any other regulatory authority, and the safety and effectiveness of neither agent has been established. Any commercial launch is contingent on FDA approval, and neither the outcome nor the timing of the regulatory review process can be assured.

(Press release, Juniper Biosciences, SEP 15, 2026, View Source [SID1234670891])

Biodexa Enters Into Warrant Exercise Transaction for $2.3 Million in Gross Proceeds

On September 15, 2026 Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX) ("Biodexa" or the "Company"), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, reported that it has entered into a warrant exercise agreement with an existing accredited investor to exercise certain outstanding warrants to purchase an aggregate of 2,204,218 American Depositary Shares ("ADSs") of the Company (the "Existing Warrants") at an exercise price of $1.05 for gross cash proceeds of approximately $2.3 million, before deducting financial advisor fees and other transaction expenses. The ADSs issuable upon the exercise of the existing warrants have been registered pursuant to an effective registration statement on Form F-1, as amended (File No. 333-297473).

In consideration for the immediate exercise of the Existing Warrants for cash, the exercising holder will receive new unregistered warrants to purchase an aggregate of up to 4,408,436 ADSs (the "New Warrants"). The New Warrants will have an exercise price of $1.05, will be immediately exercisable upon issuance, and will have a term of exercise of five (5) years. The closing of the warrant inducement transaction is expected to occur on or about September 15, 2026, subject to satisfaction of customary closing conditions.

Maxim Group LLC acted as warrant inducement agent and financial advisor in connection with the transaction.

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 "Securities Act") and, along with the ADSs issuable upon their exercise, have not been registered under the Securities Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The New Warrants were offered only to accredited investors. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission covering the resale of the ADSs issuable upon exercise of the New Warrants.

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

(Press release, Biodexa Pharmaceuticals, SEP 15, 2026, View Source [SID1234670890])

CytoDyn Inc. to Present at the Life Sciences Investor Forum on September 17th

On September 15, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic colorectal cancer (mCRC) and triple-negative breast cancer (TNBC), reported that Robert E. Hoffman, Chief Financial Officer, will present live at the Life Sciences Investor Forum hosted by VirtualInvestorConferences.com on September 17th, 2026.

DATE: Thursday, September 17, 2026

TIME: 12:30 PM PT / 3:30 PM ET

The event will be conducted as a live, interactive online forum, offering investors and industry professionals within the life sciences community the opportunity to submit questions to management in real time. A replay of the webcast will be available following the conclusion of the conference.

It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates.

(Press release, CytoDyn, SEP 15, 2026, View Source [SID1234670889])

BlossomHill Therapeutics Presents Updated Data from Ongoing Phase 1/2 SOLARA Trial Demonstrating Encouraging Anti-Tumor Activity of OMNI-EGFR™ Inhibitor BH-30643 in EGFR C797S-Positive NSCLC at IASLC 2026 World Conference on Lung Cancer

On September 15, 2026 BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported updated data from the ongoing Phase 1/2 SOLARA trial of BH-30643 in non-small cell lung cancer (NSCLC) patients with secondary epidermal growth factor receptor (EGFR) resistance mutations such as EGFR C797S. The data were highlighted in a mini-oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer in Seoul, South Korea.

BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR inhibitor designed to overcome the limitations of currently approved EGFR inhibitors for the treatment of EGFR-mutant NSCLC. In patients with EGFR C797S-positive resistance to prior EGFR inhibitor treatment, with or without concurrent T790M, BH-30643 demonstrated a 45% objective response rate (ORR; 18/40) and an 88% disease control rate (DCR; 35/40). At the time of efficacy follow-up, 63% (25/40) of patients remained on treatment with a median follow-up of 6.9 months. BH-30643 also demonstrated a favorable safety profile with low rates of dose reduction or discontinuation due to treatment-related adverse events.

"C797S-driven resistance to third-generation EGFR inhibitors was first described over 10 years ago, yet patients whose tumors develop this mutation currently have no approved targeted treatment options," said Hidehito Horinouchi, M.D., Ph.D., National Cancer Center Hospital, Tokyo, and presenting author of the study. "The responses observed with BH-30643 in this heavily pretreated population, together with encouraging early evidence of durability, support the potential of BH-30643 to directly target this resistance mechanism. These results are particularly encouraging given the need for new precision treatment options that can extend the benefits of targeted therapy for patients with EGFR-mutant lung cancer."

"These updated results provide important clinical validation of the approach we took in intentionally designing BH-30643 to address on-target EGFR resistance, including C797S," said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. "We are encouraged to see meaningful anti-tumor activity across a molecularly diverse group of patients with C797S-positive disease, including patients with concurrent T790M and those who have received multiple prior therapies, with a favorable safety profile. Together with the recent FDA Fast Track designation, these data strengthen our conviction in the potential of BH-30643 and support our plans to advance into a Phase 2 trial in patients with C797S-positive NSCLC in 2027."

Presentation highlights:

As of the May 12, 2026 data cutoff, with efficacy follow-up through August 10, 2026:

Encouraging anti-tumor activity was observed in patients with C797S-positive resistance. Among 40 patients with EGFR C797S-positive resistance to prior EGFR inhibitor treatment, with or without concurrent T790M, 18 patients achieved a confirmed (16) or ongoing unconfirmed (2) partial response, representing an ORR of 45% (95% CI: 29%-62%). The DCR was 88% (35/40), and 25 patients (63%) remained on treatment at the time of efficacy follow-up. Median follow-up was 6.9 months.
Activity was observed across a clinically heterogeneous, previously treated population. Patients had received a median of two prior lines of therapy; 98% had received prior osimertinib, 53% had received prior chemotherapy and/or an antibody-drug conjugate, and 53% had a history of brain metastases. 35% of patients had concurrent T790M.
BH-30643 demonstrated a favorable safety profile at expansion doses. Among 174 patients treated at doses of 40 mg, 50 mg and 60 mg twice daily, treatment-related dose reductions and discontinuations occurred in 9% and 3% of patients, respectively. EGFR wild-type-associated treatment-related adverse events were primarily Grade 1. The most common treatment-related adverse event was bilirubin elevation, which was generally asymptomatic and predominantly unconjugated, consistent with UGT1A1 inhibition by BH-30643.
Development of BH-30643 is continuing across multiple EGFR-mutant populations. Expansion cohorts are evaluating on-target resistance mutations, targeted therapy-naive patients and BH-30643 in combination with chemotherapy. BlossomHill plans to initiate a global Phase 2 study targeting EGFR C797S-positive NSCLC in Q1 2027.
The presentation is available on the company’s Posters & Presentations page here: View Source

About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories – classical mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions – while maintaining marked selectivity over wild-type EGFR. BH-30643 has received Fast Track designation and is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial spanning more than 40 sites in 10 countries. Ongoing dose expansion cohorts are enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

About the SOLARA Trial
The Phase 1/2 SOLARA clinical trial (NCT06706076) is a global, open label, multicenter study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). Phase 1 will determine the recommended Phase 2 dose (RP2D) of BH-30643 as a monotherapy and in combination with chemotherapy. Phase 2 is designed to evaluate the antitumor efficacy and safety in specified cohorts determined by mutation subtypes and/or treatment history at the RP2D, as well as the population pharmacokinetics.

(Press release, BlossomHill Therapeutics, SEP 15, 2026, View Source [SID1234670888])

Remedy Plan Therapeutics Announces Multiple Development and Corporate Milestones as First-In-Class Hyperbolic NAMPT Inhibitor, RPT1G, Advances in Phase 1 Dose Escalation Trial in AML/MDS

On September 15, 2026 Remedy Plan Therapeutics ("Remedy Plan"), a clinical-stage biotechnology company developing novel therapies that target fundamental metabolic vulnerabilities in disease, reported clinical progress for lead asset RPT1G, a first-in-class hyperbolic NAMPT inhibitor, and provided corporate updates. In the Phase 1 dose escalation trial evaluating RPT1G in relapsed/refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndromes (HR-MDS), patients enrolled in Cohort 1 have successfully completed the first full 28-day treatment cycle, and the company has now initiated enrollment in Cohort 2. In addition, the U.S. Food and Drug Administration (FDA) has accepted Remedy Plan’s Investigational New Drug (IND) application for RPT1G for the treatment of solid tumors.

RPT1G targets NAMPT, an enzyme involved in cellular metabolism and energy production. Prior approaches to NAMPT inhibition have been limited by toxicity. RPT1G is designed to modulate NAMPT activity through a hyperbolic inhibition mechanism, with the goal of enabling therapeutic activity while maintaining tolerability.

"Our progress to date in this trial marks the first time that therapeutic NAMPT inhibition, without limiting toxicity, has been successfully achieved in patients with cancer for longer than just a few days. This represents a significant scientific advancement that had previously been considered impossible to accomplish," said Greg Crimmins, PhD, Founder and CEO of Remedy Plan. "Concurrently, the FDA’s acceptance of our IND application for RPT1G for the treatment of solid tumors marks an important milestone for patients and the growth of Remedy Plan, as we believe our novel approach to NAMPT inhibition unlocks value across the entire spectrum of oncology."

Dr. Crimmins continued, "In addition, we are very excited to have Dr. Oleg Zernovak join Remedy Plan, bringing over 20 years of clinical development experience at leading pharmaceutical and biotechnology companies. Oleg’s expertise in hematologic malignancies, with direct experience managing clinical trials in AML and MDS, will be deeply valuable as we advance RPT1G and expand our emerging pipeline of first-in-class NAMPT inhibitors. Meanwhile, the closing of our Series A extension directly supports our ability to generate deeper and strategically actionable data from the ongoing Phase 1 trial during this upcoming year of growth for our company."

The Phase 1 trial is an ongoing multi-center, open-label, dose escalation study in patients with R/R AML and HR-MDS assessing the safety, tolerability, pharmacokinetics, and pharmacologic activity of RPT1G. The study follows a traditional 3+3 dose escalation design, with the option to add additional patients to dosing cohorts after they clear their respective safety review.

Corporate Updates

Remedy Plan reported the closing of Series A extension financing totaling approximately $30 million, with participation from Schooner Capital and primarily existing investors. Proceeds from the financing will be used to accelerate the advancement of RPT1G, including expanding patient volume in the ongoing Phase 1 study in hematology, initiation of clinical activities around expansion into solid tumors, and support the continued development of proprietary NAMPT inhibitors across additional indications.

In addition, Remedy Plan reported the appointment of Oleg Zernovak, M.D. as Vice President, Clinical Development. Dr. Zernovak brings more than 20 years of drug development experience with expertise in hematologic malignancies and clinical trial execution. Most recently, Dr. Zernovak served as Executive Director, Hematology Clinical Development at BeOne Medicines, where he led clinical and medical oversight in early development in AML and MDS and provided clinical leadership for regulatory engagements. Previously, Dr. Zernovak served as a Vice President, Clinical Development for Curis, where he contributed to clinical strategy for assets in AML, MDS, and solid tumors. Earlier in his career, Dr. Zernovak served as a Senior Medical Director, Early Development, Hematologic Malignancies at Cellectis and Janssen. Dr. Zernovak also served as Medical Director at Daiichi-Sankyo, Celgene Corporation, and Novartis Oncology. Dr. Zernovak received his M.D. degree from Azerbaijan State Medical Academy.

About RPT1G
RPT1G is a novel small-molecule NAMPT inhibitor designed to selectively target cancer cell metabolism while avoiding the on-target toxicities that have historically limited NAMPT inhibitors. The drug utilizes a unique hyperbolic inhibition mechanism that allows controlled modulation of NAMPT activity rather than complete enzyme shutdown. This approach is designed to maintain metabolic function in healthy cells while disrupting the metabolic vulnerabilities of cancer cells.

(Press release, Remedy Plan, SEP 15, 2026, View Source [SID1234670886])