On August 18, 2025 Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) reported its unaudited interim results for the six months ended 30 June 2025 (the "Reporting Period") (Press release, Kelun, AUG 18, 2025, View Source [SID1234655363]).

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In the first half of 2025, China’s biopharmaceutical industry reached an inflection point for high-quality growth, driven by accelerated innovation in drug research and development, the rollout of favorable policies, increasing momentum in industry collaboration and mergers and acquisitions. Kelun-Biotech capitalized on these opportunities by its proprietary technology platforms, innovation-led R&D, and a well-established commercialization infrastructure. These elements have worked together to enable the Company to establish a fully integrated model covering R&D, clinical development, manufacturing, and commercialization.

Focusing on addressing significant unmet medical needs in both oncology (such as breast cancer (BC), non-small cell lung cancer (NSCLC), and gastrointestinal (GI) cancers including gastric cancer (GC) and colorectal cancer (CRC)) and non-oncology diseases, the Company has developed a rich and diverse pipeline of over 30 candidates. More than 10 of these candidates have already entered clinical stage. At the same time, the Company continues to invest in next-generation conjugation technologies and a diversified portfolio of assets, aiming to deliver innovative therapies for patients worldwide and contribute to the improvement of global healthcare.

ADC & novel DC assets breakthroughs are redefining the treatment landscape.

sac-TMT (sacituzumab tirumotecan, SKB264/MK-2870,佳泰萊)

The first TROP2 ADC drug approved for marketing in LC globally.

TNBC: Approved by the National Medical Products Administration ("NMPA") for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies. The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus investigator-choice chemotherapy for 1L advanced TNBC.

HR+/HER2- BC. In May 2025, the NDA for sac-TMT for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the NMPA, and was included in the priority review and approval process. A Phase 3 registrational study of sac-TMT versus investigator’s choice of chemotherapy for treatment of patients with unresectable locally advanced, recurrent or metastatic HR+/HER2- BC who received prior endocrine therapy is in progress.

EGFR-mutant NSCLC. In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in ORR, PFS and OS compared with docetaxel. In addition, a Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC is in progress.

EGFR-wild type NSCLC. Two Phase 3 registrational studies of sac-TMT in combination with pembrolizumab are in progress. In June 2025, sac-TMT in combination with tagitanlimab was granted Breakthrough Therapy Designation by the NMPA for the first-line treatment of locally advanced or metastatic non-squamous NSCLC without actionable genomic alterations.

Other indications. The Company is actively exploring the potential of sac-TMT both as a monotherapy and in combination with other therapies for treating other solid tumors, including GC, EC, CC, OC, UC, CRPC and HNSCC.

Global clinical development. As of August 18, 2025, MSD is progressing 14 ongoing Phase 3 global, multi-center clinical studies for sac-TMT for several types of cancer including BC, LC, gynecological cancer and GI cancer. The Company is also collaborating with MSD on several global Phase 2 basket studies for sac-TMT as monotherapy or in combination with other agents for multiple solid tumors and those studies are ongoing.

Trastuzumab Botidotin (HER2 ADC, A166, 舒泰萊[1])

In January 2025, an NDA for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA.

Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ and advanced HER2+ BC based on results from the primary analysis, and the NDA has been submitted to the NMPA.

The Company has initiated an open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase 1 inhibitor ADC.

Other ADC Products

SKB315 (CLDN18.2 ADC): the company is conducting a Phase 1b clinical trial of SKB315 and have initiated the exploration in combination with immunotherapy for the treatment of GC/GEJC. Results of a Phase 1 study of SKB315 will be presented at 2025 ESMO (Free ESMO Whitepaper) Congress in October 2025.

SKB410/MK-3120 (Nectin-4 ADC): has shown promising Phase 1 clinical data. MSD, as the partner, has launched the global Phase 1/2 clinical trial of SKB410.

SKB571/MK-2750: a novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 2 clinical trial in China is to be initiated.

SKB518, SKB535/MK-6204 and SKB445: novel ADC drugs with potential FIC targets. The Phase 2 clinical trial for SKB518 and the Phase 1 clinical trials for SKB535 and SKB445 are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535.

SKB500 and SKB501: novel ADC drugs with verified targets but differentiated payload-linker strategies. The company been received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA.

SKB107: a RDC drug jointly developed by the Company and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院) targeting bone metastases in solid tumors. In March 2025, an IND application for SKB107 was approved by the NMPA and the Phase 1 study is ongoing.

Non-DC asset advancements are diversifying the innovation pipeline.

Tagitanlimab (PD-L1 mAb; A167; 科泰莱):

The first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC.

We have received marketing authorization of tagitanlimab in China from NMPA for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. In January 2025, we received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC in China from NMPA.

Cetuximab N01 (EGFR mAb; A140; 达泰莱)

An EGFR mAb compared with Cetuximab Solution for Injection (Erbitux)

In February 2025, we received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC.

A400/EP0031 (RET inhibitor): The Company is currently conducting pivotal clinical studies for 1L & 2L+ advanced RET+ NSCLC as well as a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China. Through the Company’s collaboration and license agreement, Ellipses Pharma is progressing their phase 2 clinical study globally outside of China.

SKB378/WIN378 (TSLP mAb): In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA. The Company’s collaboration partner, Windward Bio, has launched the Phase 2 POLARIS trial in patients with asthma.

SKB336 (FXI/FXIa mAb): The Phase 1 clinical trial has been completed in China.

A296 (STING agonist): A Phase 1 trial is being carried out in China.

Commercialization Accelerates: Sales & Market Access Expanding Footprint

Sac- TMT (佳泰莱), tagitanlimab (科泰莱) and Cetuximab N01 (达泰莱) have been successively launched, marking the full-scale initiation of commercialization. The Company expects to launch trastuzumab botidotin (舒泰莱) in the China market and file one NDA for A400 in the second half of 2025.

Sales performance: The total commercial sales reached RMB309.8 million for the first half of 2025. Among them, the sales of sac-TMT (佳泰莱) accounted for 97.6%. At the same time, all accounts receivables from sales of pharmaceutical products were collected within the payment period, ensuring efficient and stable cash flow.

Market coverage and academic promotion: Currently, the company’s businesses have covered 30 provinces, over 300 prefectures, and over 2,000 hospitals, where over 1,000 hospitals generated sales, and reached tens of thousands of healthcare professionals through various types of marketing campaigns to convey product and medical professional information. In addition, the company has obtained authoritative endorsement for its products from experts in clinical guidelines, providing further support for the commercialization process.

Commercialization system: The Company has established a fully-fledged marketing team of over 350 people, with a departmental structure that includes marketing, sales, medical affairs, strategic planning and commercial excellence, among other departments, as well as marketing compliance and KA functions. Through the efficient execution of the marketing team, the company has established relationships with multiple leading commercial and distribution groups, including 60+ Tier 1 distributors and 400+ DTP pharmacies. A hierarchical management system for pharmacy retail has been adopted and trainings have been provided to around 4,500 pharmacists in the first half of 2025. By organizing nationwide pharmacy trainings, the company has significantly enhanced the professionalism of terminal services and improved the ability to provide patients with medication guidance.

Market access: In the first half of 2025, sac-TMT (佳泰莱), tagitanlimab (科泰莱) and Cetuximab N01 (达泰莱) have been included in 29, 25 and 15 provincial networks, respectively, ensuring rapid market access through provincial procurement channels. Meanwhile, preparations for the National Reimburesement Drug List (國家醫保藥品目錄) access of marketed products are underway. Currently, sac-TMT (佳泰莱), tagitanlimab (科泰莱) and Cetuximab N01 (达泰莱) have all passed the preliminary formal examination of National Reimbursement Drug List.

Meanwhile, to further reduce the burden of patients and implement the concept of inclusive healthcare, the company been proactively facilitating the enrollment of sac-TMT (佳泰莱) in provincial and prefecture city level Inclusive Insurance (惠民保). As at the end of the Reporting Period, sac-TMT (佳泰莱) has been enrolled in more than 7 provinces and 20 cities.

Global market: Globally, we will continue to pursue a flexible strategy to capture the commercial value in major international markets, through forging synergistic license and collaboration opportunities worldwide.

Global Collaboration Network Expansion & Authoritative Industry Recognition

In the first half of 2025, the Company continued to expand its global collaboration network and deepen partnerships. Working closely with collaborators, it is advancing clinical research worldwide with the goal of maximizing the global value of its pipeline, delivering high-quality medical solutions to patients, and strengthening its leading position in the biopharmaceutical sector.

Collaboration with MSD: As of the date of this announcement, MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as monotherapy or in combination with pembrolizumab or other agents, for several types of cancer including BC, LC, gynecological cancer and GI cancer.

In addition to sac-TMT, the Company is also collaborating with MSD on certain ADC assets including SKB410/MK-3120, SKB571/MK-2750, SKB535/MK-6204, etc. to continuously explore favorable ADC pipeline portfolios.

Collaboration with Ellipses Pharma: The Company has deepened its collaboration with Ellipses Pharma on A400/EP0031, which has been cleared by the FDA to progress into Phase 2 clinical development. As of June 30, 2025, Ellipses Pharma had set up a total of 36 clinical sites in the United States, Europe and UAE for EP0031.

Collaboration with Windward Bio: In January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries).

In the first half of 2025, the Company earned high recognition from professional institutions and industry associations for its outstanding corporate management, product innovation, and strong performance in the capital market. In May 2025, the Company received "Asia’s Best Company" award from FinanceAsia (亞洲金融), as well as a series of awards from Extel, including "Most Honored Company", "Best Company Board", "Best CEO", "Best CFO", "Best ESG" and etc.. The Company was also awarded "IRM OF CHINESE LISTED COMPANIES" by Securities Times (證券時報). In July 2025, the Company was recognized with the "China Pharmaceutical Emerging Innovative Force Award" by the China National Pharmaceutical Industry Information Center (中國醫藥工業信息中心).

Additionally, the Company continues to strengthen its ESG strategy and improve its ESG governance structure to support sustainable development. The Company has established a comprehensive three-tier ESG governance structure consisting of the Board of Directors, ESG Working Group and ESG Executive Body. Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability.

On August 18, 2025 Foresight Diagnostics, a leader in ultrasensitive minimal residual disease (MRD) detection, reported the publication of a landmark pooled analysis in the Journal of Clinical Oncology demonstrating that MRD analysis using Foresight CLARITY at end of therapy provided greater prognostic accuracy than PET/CT in large B-cell lymphoma (LBCL) (Press release, Foresight Diagnostics, AUG 18, 2025, View Source [SID1234655362]). The findings highlight the potential of ultrasensitive MRD testing as a robust and reliable tool for remission assessment following frontline treatment.

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The study integrated data from five prospective clinical studies and included 137 patients treated with curative-intent chemotherapy. MRD was measured using the Foresight CLARITY assay, which leverages PhasED-Seq, a next-generation circulating-tumor DNA detection technology capable of identifying fewer than one mutant molecule per million.1

Key findings from the study include:

ctDNA-MRD assessment was prognostic as early as after two cycles of frontline chemotherapy. Patients with undetectable MRD after 2 cycles achieved a 2-year progression-free survival (PFS) of 96% compared to 67% for patients with detectable MRD (hazard ratio 6.9; p=0.0025).

ctDNA-MRD assessment was most prognostic at end of therapy: 78% of patients were MRD-negative and had a 2-year PFS of 97%, compared to just 29% among MRD-positive patients (hazard ratio 28.7; p<0.0001). By comparison, PET/CT status at end of therapy was less predictive, with a hazard ratio of 3.6.

MRD status further stratified risk within both PET-negative and PET-positive groups at end of therapy. Patients with detectable MRD faced a higher risk of relapse even if their imaging was negative. Conversely, PET-positive patients with undetectable MRD had significantly better outcomes than patients with both positive imaging and MRD results.

Overall, Foresight CLARITY demonstrated 86% clinical sensitivity for relapse detection and 91% clinical specificity for remission at end of therapy, based on a median follow-up of 37 months.2
"These findings highlight the clinical value of achieving ctDNA-MRD negativity at the end of treatment and underscore the limitations of relying solely on PET/CT for remission assessment," said Dr. David Kurtz, Chief Medical Officer at Foresight Diagnostics and co-author on the analysis. "With the ultra-high sensitivity of Foresight CLARITY, we can detect disease that imaging misses, offering clinicians a more accurate and actionable tool for post-treatment risk stratification."

"Our study illustrates the potential of ctDNA-MRD detection to more precisely define remission in B-cell lymphoma," said Dr. Mark Roschewski, Senior Clinician and Deputy Branch Chief of the Lymphoid Malignancies Branch at the Center for Cancer Research and lead author of the publication. "The results support the incorporation of novel surrogate endpoints such as molecular response into prospective studies evaluating how they could aid clinical decisions following frontline therapy."

Ongoing trials are already evaluating ctDNA-guided treatment decisions in B-cell lymphoma. These include the ALPHA3 trial (NCT06500273), which is enrolling patients who achieve remission following frontline treatment but retain detectable ctDNA-MRD, and the SHORTEN-ctDNA study (NCT06693830), which is evaluating early ctDNA-MRD clearance as a potential marker to support frontline chemotherapy de-escalation.

Additionally, the results from this pooled analysis were included in Foresight’s clinical recommendations to the National Comprehensive Cancer Network (NCCN) and supported the December 2024 update to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-Cell Lymphomas, which incorporated ctDNA-MRD testing as a tool to adjudicate PET-positive end-of-therapy scans.3

The full manuscript, titled "Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma," is available online in the Journal of Clinical Oncology. These findings were previously presented at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and the 2023 International Conference on Malignant Lymphoma (ICML).

On August 18, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported agenda topics for its in-person R&D Day in conjunction with the company’s 10-Year Anniversary on September 8, 2025 in New York from 8:00-10:30am EST (Press release, Ideaya Biosciences, AUG 18, 2025, View Source [SID1234655361]).

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Members of IDEAYA’s senior leadership team will provide an overview of the company’s progress to date, including presentation of new clinical data on darovasertib in neoadjuvant uveal melanoma (UM), IDE849 (DLL3 TOP1 ADC) and IDE397 (MAT2A), and outline key areas of focus as part of their future growth strategy. Details of the R&D Day agenda are below.

Agenda topics

IDEAYA 10-Year Anniversary and R&D Day Introduction
Darovasertib (PKC)
Phase 2 Neoadjuvant UM Data in Plaque Brachytherapy-eligible Patients
IDE849 (DLL3 TOP1 ADC)
Phase 1 SCLC Data from the 2025 World Conference on Lung Cancer (WCLC)
Mechanistic Data from 2025 WCLC to Support Combination of TOP1-ADCs with IDE161/PARG
IDE397 (MAT2A)
Combination Rationale with Trodelvy (TROP2 TOP1 ADC) in MTAP-deletion solid tumors
Initial Phase 1 Clinical Data from IDE397/Trodelvy Combination in MTAP-deletion urothelial cancer
IDE892 (PRMT5)
Potentially Best-in-Class PRMT5 Profile and Combination Opportunity with IDE397 (MAT2A) in MTAP-deletion solid tumors
Application of AI/ML in Our Discovery Capabilities
Closing Remarks and Q&A
Joining IDEAYA’s leadership team at the R&D Day will be Dr. Arun D. Singh, Director of the Department of Ophthalmic Oncology at the Cole Eye Institute, Cleveland Clinic. Dr. Singh will present data from IDEAYA’s Phase 2 trial of darovasertib in the neoadjuvant setting of UM and discuss the design and objectives of IDEAYA’s recently initiated Phase 3 OptimUM-10 trial to support a potential approval in this indication.

A live question and answer session will follow the presentation. Registration for this event can be accessed here or through the IDEAYA website View Source

On August 18, 2025 Merck & Co. reported that Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy (Press release, Merck & Co, AUG 18, 2025, View Source [SID1234655360]).

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Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines.

The FDA granted the BTD based on data from the IDeate-Lung01 Phase 2 trial, with support from the IDeate-PanTumor01 Phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 will be presented in a late-breaking oral presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25). This is the first BTD for ifinatamab deruxtecan and represents the first BTD since the start of the Daiichi Sankyo and Merck collaboration.

"This Breakthrough Therapy Designation granted by the FDA to ifinatamab deruxtecan highlights the urgent need for new treatment options for patients with pretreated extensive-stage small cell lung cancer," said Ken Takeshita, MD, global head, R&D, Daiichi Sankyo. "We are committed to advancing this medicine with the goal of bringing the first B7-H3 directed antibody drug conjugate to patients in order to transform the outcomes of those facing this aggressive disease."

"Patients living with extensive-stage small cell lung cancer often have limited therapeutic options following disease progression after standard of care treatments," said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "This Breakthrough Therapy Designation reinforces our confidence in the promise of ifinatamab deruxtecan to play an important role in the treatment of extensive-stage small cell lung cancer, and we are looking forward to sharing data at the upcoming IASLC 2025 World Conference on Lung Cancer that show the potential of this novel option."

About IDeate-Lung01

IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part Phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible.

In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan 8 or 12 mg/kg intravenously Q3W. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan 12 mg/kg intravenously Q3W.

The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response, progression-free survival, disease control rate, time to response, overall survival, pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis.

IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About IDeate-PanTumor01

IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label Phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists.

The Phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The Phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistance prostate cancer or esophageal squamous cell carcinoma.

The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating overall response rate, duration of response, disease control rate, progression-free survival, overall survival and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints will also be assessed.

IDeate-PanTumor01 enrolled approximately 250 patients in Asia and North America. For more information about the trial, visit ClinicalTrials.gov.

About small cell lung cancer

More than 2.48 million lung cancer cases were diagnosed globally in 2022. Small cell lung cancer (SCLC) is the second most common type of lung cancer, accounting for approximately 15% of cases. SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate. While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches.

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1. B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target. There are currently no B7-H3 directed medicines approved for the treatment of any cancer.

About ifinatamab deruxtecan

Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Ifinatamab deruxtecan has been granted orphan drug designation by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC.

About the ifinatamab deruxtecan clinical development program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other anticancer medicines across multiple cancers.

On August 18, 2025 PharmaCyte Biotech, Inc. (Nasdaq:PMCB) ("PharmaCyte" or the "Company") reported that it has entered into a securities purchase agreement for a $7.0 million financing with existing investors involving the sale of 7,000 shares of its newly designated Series C convertible preferred stock ("preferred stock"), with a stated value of $1,000 per share, convertible into an aggregate of 7,000,000 shares of its common stock and unregistered common stock purchase warrants to purchase up to an aggregate of 7,000,000 shares of its common stock in a private placement (Press release, PharmaCyte Biotech, AUG 18, 2025, View Source [SID1234655359]). The private placement is expected to close on or about August 19, 2025, subject to the satisfaction of customary closing conditions.

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GP Nurmenkari Inc. is acting as the sole placement agent for the private placement.

"This financing, priced at a premium to our current market price and led by our existing investors, reflects strong confidence in PharmaCyte’s future," said Josh Silverman, Interim Chief Executive Officer of PharmaCyte. "It meaningfully strengthens our balance sheet, positions us to enhance shareholder value, and enables us to continue pursuing strategic alternatives that we believe can maximize long-term returns for our stockholders."

The shares of preferred stock have a conversion price of $1.00 per share of common stock and accrue a 7.0% quarterly dividend payable in cash. The warrants have an exercise price of $1.00 per common share, are exercisable immediately and are exercisable for a term of five years from the date of issuance. The securities in the private placement were offered and sold in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws. Accordingly, the shares of common stock issuable upon conversion or exercise of the preferred stock and warrants offered and sold in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issuable upon conversion of the preferred stock and exercise of the warrants issued in connection with the private placement.

This press release is not 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 an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.