On August 13, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging its proprietary RADR artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported operational highlights and financial results for the second quarter 2025 ended June 30, 2025, and provided an update on its portfolio of AI-driven drug candidates and AI platform, RADR (Press release, Lantern Pharma, AUG 13, 2025, View Source [SID1234655199]).

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"This quarter we observed complete responses in patients across two of our clinical trials, delivering meaningful patient benefit and providing further validation of both the mechanisms and therapeutic potential of our drug candidates," said Panna Sharma, CEO & President of Lantern Pharma. Simultaneously, our team is transforming our AI platform into functional, accessible modules for the broader oncology community. These parallel advances mark a pivotal inflection point in our clinical and technological evolution, reinforcing our fiscally disciplined, AI-driven approach to addressing critical unmet patient needs with a clear pathway to commercialization and value creation."

Clinical Pipeline Developments

LP-184: Successful Completion of Enrollment for Phase 1a & Advancing Toward Phase 1b/2 Studies

Lantern successfully completed enrollment of its LP-184 Phase 1a first-in-human trial with 65 patients across multiple solid tumor indications. The trial established both the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), positioning LP-184 for advancement of planned Phase 1b/2 studies in indications with large multi-billion dollar annual market potential, including recurrent TNBC and recurrent bladder cancer.

LP-184 has received Fast Track Designations from the FDA for both glioblastoma multiforme (GBM) and triple negative breast cancer (TNBC), along with four Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, malignant rhabdoid tumors, and atypical teratoid rhabdoid tumors (ATRT). Through its wholly-owned subsidiary Starlight Therapeutics, Lantern is developing LP-184 as STAR-001 for central nervous system cancers.

During the quarter, Lantern announced findings from independent research conducted at Johns Hopkins validating Lantern’s data used to secure the FDA Rare Pediatric Disease Designation for LP-184 in ATRT and support planned pediatric clinical trials. The data demonstrated that LP-184, a next-generation acylfulvene clinical-stage drug candidate, significantly extended survival in mouse models of ATRT. In the CHLA06 model, median survival increased from 20 days in the control group to 89 days in the LP-184 treatment group, representing a 345% improvement (p<0.0001). In the BT37 model, median survival increased from 68 days to 98 days (p=0.0422).

LP-184 is a next-generation acylfulvene drug candidate, a synthetic small molecule belonging to a class of naturally-derived anti-cancer agents. LP-184 works by preferentially damaging DNA in cancer cells that overexpress specific biomarkers or that harbor mutations in DNA damage repair pathways. LP-184 is the product of years of research, including insights from RADR, Lantern’s proprietary AI platform that leverages over 200 billion oncology-focused data points. LP-184 is a prodrug that is converted to its bioactive form inside the cancer cell by PTGR1 (prostaglandin reductase 1), an enzyme that is overexpressed in certain cancers. Once activated, LP-184 creates cytotoxic metabolites that form adducts with DNA, leading to irreparable DNA damage and ultimately tumor cell death.

LP-300 HARMONIC Trial: Complete Response Observed Demonstrating Clinical Activity & Successful Completion of Enrollment in Japan

The Phase 2 HARMONIC trial continues to advance with enrollment across the United States and expansion sites in Asia. A remarkable complete response was observed in a 70-year-old never-smoker patient with advanced NSCLC who had exhausted three prior treatment regimens. This outcome builds on previously reported data showing an 86% clinical benefit rate and 43% objective response rate in the initial safety lead-in cohort.

Additionally the Phase 2 HARMONIC trial made advancements in Asia with completion of the Japanese cohort of 10 patients. Multiple centers in Japan participated in the clinical trial including The National Cancer Center Tokyo.

The study is strategically positioned in regions with high prevalence of never-smoker lung cancer patients, with active sites in Taiwan where over 40% of new lung cancer diagnoses occur in never-smokers. Additional clinical data and findings are anticipated in September 2025, including initial safety and response evaluations from the Asian expansion cohort.

The treatment of never-smokers with NSCLC represents a market opportunity estimated at over $4 billion annually. There are no approved therapies specifically targeted at the treatment of never-smokers with NSCLC currently. Lantern is actively exploring collaboration and partnering opportunities to maximize LP-300’s commercial potential in multiple geographies.

LP-284: Phase 1a Clinical Trial in Refractory Lymphoma Observed a Complete Response

LP-284 exhibited remarkable clinical activity in a heavily pretreated 41-year-old patient with aggressive Grade 3 diffuse large B-cell lymphoma (DLBCL). Following failure of standard R-CHOP/Pola-R-CHP chemotherapy, CAR-T cell therapy (liso-cel), and CD3xCD20 bispecific antibody therapy (glofitamab), the patient achieved complete metabolic response with non-avid lesions after completing just two doses of LP-284.

This represents the first complete response observed with LP-284. The complete response provides support to the mechanistic rationale and the potential for further future clinical activity in one of the most therapeutically challenging hematological malignancies. Lantern believes that this supports LP-284’s synthetic lethal mechanism and potential paradigm-shifting role in treating refractory aggressive lymphomas.

The complete metabolic response achievement positions LP-284 to seek a future role within a global blood cancer market focused on B-cell cancer that is estimated at $4 billion annually, with DLBCL representing the largest aggressive lymphoma subtype affecting approximately 200,000 patients globally each year. The critical unmet need in refractory/relapsed settings represents a substantial commercial opportunity for innovative therapeutic approaches that can deliver meaningful clinical benefit to therapeutically exhausted patient populations.

Intellectual Property Advancements

Lantern significantly strengthened its global intellectual property portfolio during the second quarter with two major patent developments:

European Patent Allowance for LP-284: The European Patent Office (EPO) issued a notice of allowance for a composition of matter patent covering LP-284, expected to be granted with exclusivity through early 2039. This EU patent complements existing composition of matter patents granted in the U.S. (April 2023) and Japan (June 2024), with additional patent allowances in India and Mexico, and applications pending in China, Australia, Canada, and Korea. This expanding international IP portfolio positions LP-284 for global commercialization and strategic partnerships.

Blood-Brain Barrier Prediction Patent Application: Lantern announced the publication of its PCT patent application (PCT/US2024/019851) covering a novel machine learning solution for predicting blood-brain barrier (BBB) permeability, which received a favorable PCT search report indicating no significant prior art. The technology powering predictBBB demonstrates exceptional performance, processing up to 100,000 molecules per hour with industry-leading accuracy. Lantern’s AI algorithms currently hold five of the top eleven positions on the Therapeutic Data Commons Leaderboard. The PCT application, if granted, will enable multi-country patent protection for 20 years from the filing date.

RADR AI Platform Enhancements

Lantern continues to expand the capabilities of its RADR platform, which now leverages over 200 billion oncology-focused data points and a library of 200+ advanced machine learning algorithms. Key enhancements this quarter include:

PredictBBB.ai Module Public Launch: The public release of predictBBB.ai, an AI module for predicting blood-brain barrier permeability with 94% prediction accuracy, 95% sensitivity and 89% specificity. This addresses a critical pharmaceutical development challenge where only 2-6% of small-molecule drugs can successfully cross the blood-brain barrier.

Drug Combination Prediction Module: An innovative AI-powered module to improve prediction of synergistic cancer drug combinations, with framework and analytics based on peer-reviewed research. The module focuses initially on DNA damaging agents and DNA repair inhibitors, aimed at a market opportunity where approximately $50 billion is spent annually on the development of combination therapies for cancer. The AI module, trained on 221 clinical trials, will be incorporated as part of Lantern’s AI platform, RADR, and will initially focus on tailored combinations of DNA damaging agents and DNA repair inhibitors. The framework and foundational data for the module was published in a peer-reviewed study published in Frontiers in Oncology, "Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review".

The company plans to make select RADR modules available to the broader scientific and research community, fostering collaborative, open-source innovation in oncology drug development while creating potential new revenue streams.

Financial Results for Second Quarter 2025

Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $15.9 million as of June 30, 2025, compared to approximately $24.0 million as of December 31, 2024. The company believes that its existing cash, cash equivalents, and marketable securities as of June 30, 2025 and anticipated expenditures will enable funding of operating expenses and capital expenditure requirements at least into June 2026.

Research and Development Expenses: R&D expenses were approximately $3.1 million for the quarter ended June 30, 2025, compared to approximately $3.9 million for the quarter ended June 30, 2024, reflecting continued disciplined cost management while advancing multiple clinical programs.

General and Administrative Expenses: G&A expenses were approximately $1.6 million for the quarter ended June 30, 2025, compared to approximately $1.5 million for the quarter ended June 30, 2024.

Net Loss: Net loss was approximately $4.33 million (or $0.40 per share) for the quarter ended June 30, 2025, compared to a net loss of approximately $4.96 million (or $0.46 per share) for the quarter ended June 30, 2024.

Capitalization: As of June 30, 2025, the Company had 10,784,725 shares of common stock outstanding, and options to purchase 1,239,766 shares of common stock at a weighted average exercise price of $5.72 per share were outstanding. There were no outstanding warrants as of June 30, 2025.

Quarterly Earnings Calls:

Lantern has determined not to host a quarterly earnings call at the present time given the concentration of resources required for a live video based webinar style call. In addition to quarterly press releases with earnings information, and more frequent updates regarding the progress of our portfolio and platform, we plan to focus our resources on other distribution channels that we believe will be more effective in conveying information to stockholders, including webinars, digital media resources and broader social media channels.

On August 13, 2025 Pilatus Biosciences, Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported a clinical trial collaboration with Roche (Press release, Pilatus Biosciences, AUG 13, 2025, View Source [SID1234655221]). Under the terms of the agreement, Roche will provide atezolizumab (Tecentriq), its anti-PD-L1 therapy, to support Pilatus’ upcoming first-in-human Phase 1 trial evaluating PLT012 in combination with atezolizumab in patients with hepatocellular carcinoma (HCC).

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PLT012 is Pilatus’ lead immunomodulatory candidate designed to reprogram the fibrotic and immunosuppressive tumor microenvironment (TME) characteristic of HCC. The investigational combination will be assessed in Pilatus-sponsored clinical trials to assess safety and tolerability.

"We are pleased to collaborate with Roche as we explore the potential synergy between PLT012 and atezolizumab in patients with HCC," said Raven Lin, Ph.D., Chief Executive Officer, Pilatus Biosciences. "Current treatments, including checkpoint inhibitors as monotherapy, often fail to generate durable responses in liver cancer. PLT012’s ability to reshape the TME may enhance immune activation and unlock deeper, more sustained responses when administered in combination with anti-PD-L1 therapies such as atezolizumab."

"This collaboration represents an opportunity to investigate how modulation of the TME can enhance immune checkpoint blockade in liver cancer," said Dr. Ann-Lii Cheng, NTU Chair professor and President Emeritus of the NTU Cancer Center of National Taiwan University, and scientific collaborator at Pilatus Biosciences. "Combining PLT012 with atezolizumab has the potential to overcome key mechanisms of resistance in HCC and potentially drive more durable patient response and potentially improve patient outcomes for this aggressive disease." Dr. Cheng also served as the global principal investigator of the landmark IMbrave150 trial (atezolizumab plus bevacizumab for HCC, published in NEJM 2020).

Atezolizumab, a standard of care treatment for first-line HCC in combination with bevacizumab (Avastin), will be provided by Genentech, a member of the Roche Group, for use in Pilatus’ clinical research. HCC is the most common type of primary liver cancer and remains one of the leading causes of cancer-related death worldwide.

Tecentriq (atezolizumab) and Avastin (bevacizumab) are registered trademarks of Genentech, a member of the Roche Group.

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it depletes immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing anti-tumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

On August 13, 2025 MAA Laboratories Inc., a specialty pharmaceutical company focused on developing clinically differentiated, value-added drug products, reported that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Dasatinib Nanoparticle Tablets (Press release, MAA Laboratories, AUG 13, 2025, View Source [SID1234655200]). This novel oral formulation was developed using MAA’s proprietary NanoCont technology platform, which was accepted into the FDA’s Emerging Technology Program in August 2024.

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This regulatory milestone paves the way for MAA Laboratories to initiate its Phase I clinical study in healthy volunteers under the 505(b)(2) regulatory pathway.

"We are extremely pleased to receive IND clearance from the FDA for our third consecutive clinical-stage asset, following Methotrexate and Nintedanib," said Anjani Jha, Founder and CEO of MAA Laboratories. "This achievement is a testament to the versatility and potential of our NanoCont platform to deliver advanced oral drug formulations with meaningful clinical, regulatory, and development advantages."

Key Highlights

IND clearance granted for Dasatinib Nanoparticle Tablets
505(b)(2) regulatory pathway confirmed for a Phase I BA/BE study in healthy volunteers
Developed using NanoCont, an FDA-recognized Emerging Technology
Designed to optimize systemic exposure and patient experience across both oral and subcutaneous reference formulations
Marks MAA’s third consecutive IND approval utilizing NanoCont technology
About Dasatinib Nanoparticle Tablets

MAA’s next-generation Dasatinib Nanoparticle Tablets are designed to address pharmacokinetic and patient-experience limitations associated with conventional Dasatinib formulations. By leveraging the NanoCont platform, the product aims to enhance absorption, achieve consistent dose proportionality across multiple strengths, and improve systemic exposure—supporting a modernized, patient-friendly approach to oral oncology formulation development.

On August 13, 2025 bioAffinity Technologies, Inc. (NASDAQ: BIAF, BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, reported that it has entered into securities purchase agreements with several institutional and accredited investors (the "Purchasers") for the purchase and sale of 990 shares of the Company’s Series B Convertible Preferred Stock (the "Preferred Stock") and warrants (the "Private Placement Warrants") to purchase approximately 6.7 million shares of common stock (the "Private Placement") (Press release, BioAffinity Technologies, AUG 13, 2025, View Source [SID1234655222]).

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The shares of Preferred Stock have a stated value of $1,000 per share and are initially convertible into an aggregate of approximately 4.3 million shares of common stock at a conversion price of $0.23 per share. The Private Placement Warrants will be exercisable following the date on which the Company obtains stockholder approval of the exercise thereof at an initial exercise price of $0.352 per share and expire five years from the original exercise date.

The Company also announced today it has entered into a warrant exercise agreement with an existing accredited investor to exercise (i) outstanding warrants to purchase 450,000 shares of the Company’s shares of common stock that were issued in August 2024 (the "August Warrants") and (ii) outstanding warrants to purchase 650,000 shares of the Company’s common stock that were issued in October 2024 (the "October Warrants" and together with the August Warrants, the "Existing Warrants"), which reduced the exercise prices of the August Warrants from $1.50 to $0.23 per share and the October Warrants from $1.25 to $0.23 per share and provided for the issuance to such investor of new unregistered warrants (the "New Warrants") to purchase up to an aggregate of 1.43 million shares of the Company’s common stock in consideration for the immediate exercise in full of the Existing Warrants for gross cash proceeds to the Company of approximately $253,000 (the "Warrant Inducement"). The New Warrants will have an exercise price of $0.352 per share and will be initially exercisable on the date that stockholder approval of the exercise of the New Warrants is obtained and will expire five years from the date of such approval.

The closing of the Private Placement and Warrant Inducement is expected to occur on or about August 14, 2025, subject to the satisfaction of customary closing conditions.

The expected aggregate proceeds (before expenses) of the Private Placement and Warrant Inducement will be approximately $1.2 million. The Company shall use the net proceeds from the Private Placement and Warrant Inducement for working capital and general corporate purposes.

WallachBeth Capital LLC is acting as the sole placement agent for the Private Placement and financial advisor for the Warrant Inducement.

The securities described above will be offered in a private placement exempt from the registration requirements under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and in a transaction not involving a public offering and have not been registered under the Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock underlying the Preferred Stock, the Private Placement Warrants and New Warrants within 15 calendar days after the closing date.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

On August 13th 2025, Suzhou, China, Evopoint Biosciences, a platform-based innovative pharmaceutical company dedicated to addressing major unmet clinical needs worldwide through a disease-oriented, innovation-driven approach, reported the completion of the first patient dosing of XNW27011 in a Phase III clinical trial for the treatment of patients with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have received at least two prior lines of systemic therapy (Press release, Evopoint Biosciences, AUG 13, 2025, View Source [SID1234656288]).

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XNW27011 is an investigational next-generation antibody-drug conjugate (ADC) targeting CLDN18.2, independently developed by Evopoint and classified as a Category 1 therapeutic biological product in China. The product has achieved significant milestones in clinical development and demonstrated strong global competitiveness: In December 2022, XNW27011 received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) followed by the IND approval from China’s National Medical Products Administration (NMPA) in April 2023, achieving an efficient dual filing in both countries; it was subsequently granted for Fast Track Designation (FTD) by the FDA in June 2024, and was included in the Breakthrough Therapy Designation (BTD) list by the NMPA’s Center for Drug Evaluation (CDE) in May 2025.

Businesswise, Evopoint has licensed the rights for global development and commercialization, excluding mainland China, Hong Kong, Macau, and Taiwan, to Astellas Pharma Inc. (Tokyo Stock Exchange: 4503). Under the license agreement, Evopoint is eligible to receive upfront and milestone payments totaling up to USD 1.54 billion, and royalties on net sales following the product’s launch in overseas markets.

Gastric cancer remains to be a major challenge in oncology due to its persistently high incidence and mortality worldwide. According to WHO data, approximately 968,000 new cases and 660,000 deaths were reported in 2022 globally. In China, the numbers for new cases and death of gastric cancer were reported as 358,000 and 260,000 respectively in 2022 by China’s National Cancer Center. Current first- and second-line regimens for gastric cancer typically combine the HER2-targeted agent trastuzumab with chemotherapy. However, in patients with advanced disease having mid/low or negative HER2 expression, the pronounced heterogeneity of gastric cancer and its complex tumor immune microenvironment often limit the efficacy of chemotherapy, resulting in minimal survival benefit and poor tolerability. Novel therapeutic targets, agents, and treatment strategies are urgently needed to improve clinical outcomes for this patient population.

In the Phase I/II clinical study, XNW27011 demonstrated promising efficacy in the target population, which is significantly superior to that of the currently recommended regiments, suggesting considerable potential for clinical benefit.