On November 13, 2025 RenovoRx, Inc. (Nasdaq: RNXT) ("RenovoRx" or the "Company"), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported its financial results and provided a business update to shareholders for the third quarter ended September 30, 2025.

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"We continue to make strong progress both in our commercial and clinical activities," said Shaun Bagai, CEO of RenovoRx. "On the commercial side, we are encouraged by the continued RenovoCath clinical adoption we are seeing in the field. Year-to-date revenue, through the end of the third quarter, was approximately $900,000, reflecting the growing clinical need and market demand for targeted drug-delivery solutions. Since organically launching commercial sales less than a year ago, we have expanded from five centers at the start of 2025 to 14 leading cancer centers now approved to purchase RenovoCath, including several that have already made repeat orders."

"With the recent hiring of Philip Stocton as Senior Director of Sales & Market Development and two regional sales managers, we are building the foundation for sustained growth while maintaining a lean operating structure and prudent capital deployment philosophy," continued Mr. Bagai. "Our team remains laser-focused on strategic, data-driven expansion and is encouraged by the increasing physician-to-physician advocacy for our TAMP (Trans-Arterial Micro-Perfusion) platform as we continue to position RenovoRx for long-term success. Our mission continues with the goal of integrating an approach to therapeutic drug-delivery into the standard of care and ultimately improving patient outcomes by offering a more targeted and tolerable treatment path."

"On the clinical side, we continue to advance our Phase III TIGeR-PaC trial towards enrollment completion in early 2026 and final data readout in 2027, and we’ve successfully launched a new post-marketing registry study from which we expect to garner real-world evidence on the use of the RenovoCath device. We look forward to continuing our progress in the Phase III trial and post-market registry study as we seek to drive value for our shareholders," concluded Mr. Bagai.

Commercialization Update

RenovoRx continued to execute on its RenovoCath commercialization strategy in the third quarter of 2025, demonstrating progress as year-to-date revenue grew to approximately $900,000. Although small revenue fluctuations can be expected quarter-by-quarter at this early stage of commercialization, the positive trends of expanding approved cancer center customers and increasing clinical adoption are very promising.

As of November 7, 2025, RenovoRx has expanded from five cancer center customers approved to purchase RenovoCath at the start of the year to 14 customers. These include additional high-volume National Cancer Institute (NCI)-designated cancer centers and community hospitals. The growth in patient procedures using RenovoCath at five active centers has led to an increase in repeat purchase orders, underscoring both physician satisfaction and growing demand. In addition to these 14 centers now approved to purchase RenovoCath, the Company has delivered product quotes to 10 additional leading centers across the nation, bringing the total to 24 centers who have formally requested quotes for RenovoCath. In addition, RenovoRx has engaged with dozens of physicians, both at various medical conferences and within their institutions, who have expressed commercial interest in utilizing RenovoCath for their patients.

Since organically launching commercial sales less than a year ago without a dedicated sales and marketing team, RenovoRx has achieved early commercial traction that reflects the strong clinical need for targeted drug-delivery solutions designed to reduce systemic toxicity and improve quality of life. The Company’s small but growing team has established a diverse domestic geographic network of academic institutions, NCI-designated cancer centers, and high-volume community hospitals, both successfully implementing and interested in utilizing RenovoCath-enabled TAMP technology.

RenovoRx continues to collect valuable market insights, including sales cycle trends, activation timelines, customer preferences, and other commercial data, as the Company seeks to grow its customer base, fulfill repeat RenovoCath orders, and build a strong foundation for long-term commercial growth. These insights from the first year of commercialization will inform the Company’s strategy and execution plans heading into 2026.

To strengthen and expand the Company’s commercial efforts, in August 2025, RenovoRx announced the hiring of Philip Stocton as Senior Director of Sales and Market Development. Mr. Stocton brings more than 25 years of MedTech leadership, including a decade focused on interventional oncology. His expertise has been invaluable as the Company continues to broaden its footprint across the U.S., while maintaining a lean operating structure. In alignment with the existing budget and to respond to growing demand, the Company has added two regional sales managers and plans to add a marketing director to drive additional physician engagement by the end of the year.

RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, with long-term, several-billion-dollar potential as the platform expands into additional solid tumor indications.

RenovoRx recently launched a commercial website for clinicians and staff to learn more about the RenovoCath device, as well for patients to find treatment cancer centers, which can be accessed here: View Source

Clinical Research and Scientific Programs Update

In the third quarter of 2025, RenovoRx continued advancing its ongoing Phase III TIGeR-PaC clinical trial evaluating the novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG). The trial remains on track, with enrollment expected to be completed in early 2026 and final data anticipated in 2027. Enabled by the RenovoCath device, TAMP is designed to deliver therapeutic agents across the arterial wall near the tumor site to bathe the target tumor, potentially optimizing local drug concentration while minimizing systemic exposure and related toxicities versus the standard of care, systemic intravenous therapy. TIGeR-PaC remains the cornerstone of RenovoRx’s clinical development program, validating its mechanism of action and safety profile through rigorous, long-term evaluation.

RenovoRx strengthened its Scientific Advisory Board during the third quarter with the additions of renowned surgeon and pancreatic cancer expert, Dr. Timothy Donahue, Director of the Agi Hirshberg Center for Pancreatic Diseases, Chief of the Division of Surgical Oncology at the David Geffen School of Medicine, and Garry Shandling Chair in Pancreatic Surgery at UCLA, and Dr. Thierry de Baère, Head of Interventional Radiology at the Gustave Roussy Cancer Centre and University Paris-Saclay in France.

During the third quarter, RenovoRx advanced its broader clinical programs. The Company’s post-marketing registry study continues to progress, generating real-world data on the safety and effectiveness of RenovoCath in patients with solid tumors. In September, the first registry-eligible patient procedure was initiated at the University of Vermont Cancer Center, with Baptist Health Miami Cancer Institute and the University of Pittsburgh Medical Center joining as additional study sites.

The Company also continues to support investigator-initiated trials in borderline resectable and oligometastatic pancreatic cancer. These capital-efficient studies are designed to be cost-neutral while providing meaningful data that may further broaden the application for the TAMP therapy platform.

Financial Highlights for the Third Quarter Ended September 30, 2025

Revenue: RenovoRx reported third quarter revenues of approximately $266,000, driven by both new customer orders and repeat purchases of the RenovoCath device. The quarter ended on September 30, 2025 marked the Company’s third full quarter of revenue generation from RenovoCath sales.

Cash Position: As of September 30, 2025, the Company had $10.0 million in cash and cash equivalents. Based on its current operating plan, RenovoRx believes this cash is sufficient to fund ongoing commercialization efforts for RenovoCath and the completion of enrollment in its Phase III TIGeR-PaC clinical trial in early 2026.

R&D Expenses: Research and development expenses were $1.7 million for the quarter ended September 30, 2025, remaining relatively unchanged from the same period in the prior year, reflecting continued investment in the TIGeR-PaC trial as well as support for investigator-initiated and registry studies.

SG&A Expenses: Selling, general, and administrative expenses were approximately $1.7 million for the quarter ended September 30, 2025, compared to $1.2 million for the same period in the prior year.

Net Loss: Net loss was $2.9 million for the quarter ended September 30, 2025, compared to a net loss of $2.5 million for the quarter ended September 30, 2024.

Shares Outstanding: As of November 7, 2025, common shares outstanding totaled approximately 36.6 million.

Conference Call Details

Event: RenovoRx Third Quarter 2025 Financial Results and Business Highlights Conference Call
Date: Thursday, November 13, 2025
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until November 27, 2025, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number: 13756201.

A question-and-answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

(Press release, Renovorx, NOV 13, 2025, View Source [SID1234659930])

On November 13, 2025 Adagene Inc. ("Adagene") (Nasdaq: ADAG) and Third Arc Bio, Inc. ("Third Arc Bio"), reported a licensing agreement under which Third Arc Bio will utilize Adagene’s SAFEbody technology platform to generate masked CD3 T cell engagers against unique tumor associated antigens. Under the terms of the agreement, Third Arc Bio will receive rights to research, develop and commercialize two candidate molecules worldwide. Adagene will receive an upfront payment of $5 million and is eligible to receive development and commercial-based milestones of up to $840 million (if all milestones and conditions are achieved) as well as royalties on end-user sales. In addition, Adagene has a no-cost option to develop and commercialize these candidate molecules in Greater China, Singapore and South Korea.

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Peter Luo, Ph.D., Chief Executive Officer of Adagene said, "Our SAFEbody technology allows activation of an antibody when it reaches the tumor microenvironment. The resulting wider therapeutic index from improved safety allows for higher dosing and potentially better efficacy, as seen from the data we continue to generate with muzastotug. We’re thrilled that Third Arc Bio will be utilizing our SAFEbody technology for a portion of their exciting pipeline programs."

"Our agreement with Adagene will allow Third Arc Bio to advance highly innovative molecules with a superior therapeutic index and help build on our growing portfolio of novel CD3- and CD28-targeting T cell engagers," said Peter Lebowitz, M.D., Ph.D., Chief Executive Officer of Third Arc Bio. "Adagene’s SAFEbody technology expands the reach of our ArcStim Platform to additional novel targets."

(Press release, Adagene, NOV 13, 2025, View Source [SID1234659889])

On November 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 third quarter 2025 ended September 30, 2025, and provided an update on its portfolio of AI-driven drug candidates and AI platform, RADR.

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"The third quarter represented a transformational period for Lantern Pharma as we announced successful enrollment completion of our LP-184 Phase 1a trial, achieving all primary endpoints with unique clinical benefit observations in multiple hard-to-treat solid tumors," said Panna Sharma, CEO & President of Lantern Pharma. "The observed 48% clinical benefit rate at or above the therapeutic dose threshold, combined with the favorable safety profile and clear biomarker signals, validates our AI-driven, precision medicine approach and positions us to advance multiple planned high-value Phase 1b/2 trials. Simultaneously, our productive FDA Type C meeting provides a clear regulatory pathway for our pediatric CNS cancer program under our subsidiary Starlight Therapeutics. Additionally, the interest generated for LP-284 at the LL&M Congress underscores the commercial potential across our pipeline. We are executing with discipline and focus as we advance toward pivotal value-creation milestones in multiple oncology indications."

Clinical Pipeline Developments

LP-184: Detailed Phase 1a Results Demonstrate Clinical Proof-of-Concept & Activity

In September, Lantern announced the completion of enrollment and initial clinical results from its LP-184 Phase 1a clinical trial (NCT05933265), which successfully achieved all primary endpoints. The data across the 63 patients enrolled provided critical insights into safety, pharmacokinetics, biomarker correlations, and clinical activity that position LP-184 for advancement into targeted planned Phase 1b/2 studies.

Highlights of the Phase 1a Results:

● Clinical Benefit and Activity: The trial demonstrated clinical benefit in 48% of evaluable cancer patients treated at or above the therapeutic dose threshold. This encouraging activity was observed in heavily pretreated patients who had exhausted available standard-of-care therapies, representing proof-of-concept for LP-184’s synthetic lethal mechanism.
● Safety Profile Supports Broad Development: LP-184 demonstrated a favorable safety and tolerability profile with minimal dose-limiting toxicities. The safety data support advancement into both monotherapy and combination therapy approaches with PARP inhibitors and immunotherapy agents.

● Activity in Difficult-to-Treat Cancers: Notable clinical benefits were observed in historically challenging tumor types including glioblastoma multiforme (GBM), gastrointestinal stromal tumor (GIST), and thymic carcinoma. Several patients have continued treatment beyond enrollment completion due to ongoing clinical benefit.
● Biomarker Strategy Strengthened: A key finding from the Phase 1a trial was the observation of marked tumor reductions in patients harboring specific DNA damage repair mutations, including CHK2, ATM, BRCA1, and STK11/KEAP1 alterations. These biomarker insights directly validate the AI-driven patient stratification approach developed through Lantern’s RADR platform and support the use of genomic selection criteria in future trials.
● Pharmacokinetics Enable Dose Optimization: The trial successfully characterized LP-184’s pharmacokinetic profile and established the recommended Phase 2 dose (RP2D) of 0.39 mg/kg, providing clear dosing guidance for planned Phase 1b/2 studies across multiple indications.

Based on the Phase 1a results and biomarker insights, Lantern is advancing development plans for LP-184 in three high-value indications:

● Triple-Negative Breast Cancer (TNBC), which represents a potential annual market opportunity exceeding $4 billion.
● NSCLC with STK11/KEAP1 Co-mutations: Phase 1b/2 study in a biomarker-defined subset of patients with mutations in STK11 and/or KEAP1 genes, representing a significant unmet medical need and a potential annual market approaching $1.5 billion.
● Bladder Cancer with DNA damage repair mutations in patients who have relapsed from SOC (standard of care) therapies, which is planned to be an investigator-led study initiating in Denmark.

Comprehensive results from the LP-184 Phase 1a trial are being prepared for submission to peer-reviewed journals and presentation at major oncology conferences. To provide additional insights and expert analysis of the clinical data, Lantern will host a Key Opinion Leader (KOL)-hosted scientific webinar on November 20, 2025 at 4:30 p.m. Eastern Time featuring detailed discussion of the Phase 1a results, biomarker findings, and clinical development strategy.

FDA Type C Meeting: Clarity in Regulatory Path for Pediatric CNS Cancer Program

A major third quarter regulatory milestone was the successful completion of a Type C meeting with the U.S. Food and Drug Administration during September. This meeting provided important guidance on the regulatory pathway and trial design for Starlight Therapeutics’ – a wholly owned subsidiary of Lantern Pharma – planned pediatric clinical trial focused on CNS cancers, including Atypical Teratoid Rhabdoid Tumor (ATRT). The FDA provided constructive and supportive feedback on the proposed clinical trial structure.

Key outcomes from the Type C meeting included:

● Parallel ATRT Cohort Supported: The FDA confirmed support for a parallel cohort design specifically for ATRT patients, which will accelerate data collection in this ultra-rare pediatric population while maintaining statistical rigor.
● Combination Strategy Confirmed: The agency confirmed the potential incorporation of spironolactone as a combination agent with LP-184/STAR-001. This combination strategy is based on preclinical data demonstrating synergistic activity and RADR platform predictions of enhanced efficacy in pediatric brain tumors.
● Trial Design Alignment: The FDA provided guidance on appropriate endpoints, patient selection criteria, and safety monitoring approaches for this vulnerable pediatric population, enabling Starlight Therapeutics to finalize the clinical protocol with confidence in the regulatory pathway.

Regulatory Designations and Market Opportunity:

● LP-184, which is being developed as STAR-001 by Starlight Therapeutics in CNS cancers, has received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for ATRT, along with additional Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors. These designations underscore the urgent unmet need for innovative therapies in aggressive pediatric cancers and provide potential pathways for possible priority review vouchers upon approval.
● ATRT is an ultra-rare pediatric brain tumor with the genetic hallmark of SMARCB1 gene loss or dysfunction, affecting primarily children under age 3. Current treatment options are limited and associated with significant long-term toxicities, creating substantial demand for novel targeted approaches.

LP-300 HARMONIC Trial: Enrollment and Follow-Up Progress

The Phase 2 HARMONIC trial continued patient enrollment and follow-up during the third quarter across sites in the United States, Japan, and Taiwan. The trial evaluates LP-300 in combination with standard-of-care chemotherapy (carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after tyrosine kinase inhibitor therapy.

● In late July, Lantern announced the completion of enrollment in Japan for the HARMONIC trial across five clinical sites in Japan, including the National Cancer Center Tokyo.
● During November, clinical investigators associated with the HARMONIC trial presented data from the ongoing study at the 66th Annual Meeting of the Japan Lung Cancer Society. Dr. Jonathan Dowell from UT Southwestern Medical Center presented, "A Phase II Trial of LP-300 plus Carboplatin and Pemetrexed in TKI-Progressed NSCLC Patients". Data from this presentation included the Asian and US cohorts of the study and will be further reviewed and presented in December by Lantern Pharma.

● Also, during the third quarter the company progressed with a change in clinical staffing and a transition of CRO services in Asia focused on significant cost reductions and efficiency in Taiwan.
● The study’s strategic positioning in Asia, where never-smokers represent 33-40% of NSCLC cases compared to approximately 15% in Western populations, positions Lantern for potential regional partnerships and co-development opportunities. The treatment of never-smokers with NSCLC represents an estimated $4+ billion annual market opportunity with no specifically approved therapies for this patient population.

LP-284: LL&M Congress Presentation & Future Development Plans

During October Lantern presented clinical data from its ongoing LP-284 Phase 1 trial at the 25th Annual Lymphoma, Leukemia & Myeloma (LL&M) Congress in New York City. The presentation showcased the confirmed complete metabolic response in a heavily pretreated DLBCL patient and highlighted LP-284’s novel mechanism of action and combination therapy potential.

LL&M Congress Impact and Additional Milestones:

● Presentation generated interest from biopharmaceutical companies and clinical investigators, with ongoing discussions focused on: combination therapy development with FDA-approved agents; post-immunotherapy treatment strategies; and LP-284’s mechanistic differentiation. LP-284 has demonstrated particular lethality in cells with deficient DNA damage response, a targetable vulnerability in NHL.
● Additional clinical sites being recruited with a focus on NHL and high-grade B-cell lymphoma patients to accelerate enrollment.
● Partnership and collaboration discussions advancing with emphasis on combination therapy protocols.
● Expansion into autoimmune and inflammatory indications under preclinical evaluation, leveraging LP-284’s B-cell depletion activity.

LP-284 benefits from strong intellectual property protection with composition of matter patents granted in the U.S., Europe, Japan, India, and Mexico, providing exclusivity through 2039. The drug candidate has received multiple FDA Orphan Drug Designations including for mantle cell lymphoma and high-grade B-cell lymphomas.

RADR AI Platform: Demonstrating Commercial Value and Industry Leadership

AI for Biology and Medicine Symposium: Showcasing Platform Capabilities

A key highlight of the third quarter was Lantern’s presentation at the inaugural AI for Biology and Medicine symposium at the University of North Texas on October 30, 2025. This presentation demonstrated the commercial readiness and real-world applicability of two RADR platform modules. An additional large-scale rollout of a multi-agentic system focused on addressing drug development and research needs in rare cancers that leverages Lantern’s unique approach to developing therapies and approaches in rare and orphan cancers is underway. This initiative is planned to be made public during December with broader industry rollout in early 2026.

predictBBB.ai Platform – Best-in-Class BBB Prediction:

● This ensemble machine learning model achieves 94.1% accuracy for blood-brain barrier permeability prediction and can screen 200,000 molecular candidates in under one week. Lantern’s algorithms currently hold five of the top eleven positions on the Therapeutic Data Commons Leaderboard, establishing clear technological leadership.
● The platform addresses a critical pharmaceutical challenge: only 2-6% of small-molecule drugs successfully cross the blood-brain barrier. The BBB technologies market is projected to grow from $1.4 billion in 2023 to $9.85 billion by 2032, representing significant commercial opportunity.

LBx-AI Liquid Biopsy Platform – Predictive Biomarker Discovery:

● This AI-powered liquid biopsy analysis platform has achieved 86% accuracy for predicting treatment response in non-small cell lung cancer and has demonstrated a 0.76 Pearson correlation for PD-L1 level inference from circulating tumor DNA analysis. This capability enables non-invasive patient stratification and real-time treatment monitoring.
● Lantern has entered into additional collaborations with leading research and cancer centers to further strengthen and validate this module in other cancers.

RADR Platform Impact Across Pipeline

The third quarter developments underscore RADR’s central role in Lantern’s drug development success:

● Biomarker Discovery: RADR predictions of LP-184 sensitivity in CHK2, ATM, and STK11/KEAP1-mutated cancers were validated in the Phase 1a trial, demonstrating the platform’s promise for identifying responsive patient populations.
● Combination Therapy Identification: RADR analysis identified LP-184’s synergy with PARP inhibitors and immunotherapy, as well as LP-284’s synergy with rituximab, directly informing clinical development strategies and partnership discussions.

● Development Efficiency: On average, Lantern’s newly developed AI-guided drug programs have advanced from initial insights to first-in-human trials in 2-3 years at approximately $1.0-2.5 million per program, demonstrating significant cost and time advantages over traditional development approaches.

Financial Results for Third Quarter 2025

Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $12.4 million as of September 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 on hand as of the date of this press release will enable it to fund anticipated operating expenses and capital expenditure requirements into approximately Q3 2026.

Research and Development Expenses: R&D expenses were approximately $2.4 million for the quarter ended September 30, 2025, compared to approximately $3.7 million for the quarter ended September 30, 2024. The decrease was primarily attributable to decreases in research studies and materials of approximately $1,032,000 relating to the conduct and support of clinical trials, decreases in consulting expenses of approximately $55,000 and decreases in payroll and compensation expenses of approximately $224,000. This was partially offset by increases in licensing expenses of approximately $31,000.

General and Administrative Expenses: G&A expenses were approximately $1.9 million for the quarter ended September 30, 2025, compared to approximately $1.5 million for the quarter ended September 30, 2024. The increase was primarily attributable to increases in business development and investor relations expenditures of approximately $321,000, increases in other professional fees of approximately $57,000, and increases in patent costs of approximately $37,000.

Net Loss: Net loss was approximately $4.2 million (or $0.39 per share) for the quarter ended September 30, 2025, compared to a net loss of approximately $4.5 million (or $0.42 per share) for the quarter ended September 30, 2024.

Capitalization: As of September 30, 2025, the Company had approximately 11.0 million shares of common stock outstanding. Options to purchase approximately 1.2 million shares of common stock at a weighted average exercise price of $5.74 per share were outstanding. As of September 30, 2025 there were no warrants outstanding.

In July 2025, the Company entered into an ATM Sales Agreement ("ATM"), with ThinkEquity LLC ("ThinkEquity"), as sales agent, pursuant to which the Company may offer and sell up to $15,530,000 of its common stock from time to time, in "at-the-market" offerings to or through its sales agent. During the quarter ended September 30, 2025, we sold 212,444 shares of common stock under the ATM for the gross proceeds of $989,061. Between October 1, 2025 and the date of this press release, we have sold an additional 144,204 shares of common stock under the ATM for the gross proceeds of $634,333.

Upcoming Milestones and Corporate Developments

Looking ahead to the fourth quarter of 2025 and early 2026, Lantern expects several key value-creation catalysts:

Immediate Near-Term (Q4 2025):

● November 20, 2025 at 4:30 p.m. ET: KOL hosted scientific webinar on LP-184 Phase 1a detailed results and clinical development strategy.
● December 2025: LP-300 further patient follow-up and clinical data.
● Q4 2025: Continued commercial developments for AI platform modules, including the multi-agentic system for rare cancer drug development.

Early 2026 Catalysts:

● Q1 2026: Planned Pediatric CNS cancer trial initiation through Starlight Therapeutics subsidiary (IND amendment submission)
● Q1 2026: Planned initiation of LP-184 Phase 1b/2 trials in TNBC and NSCLC (subject to funding)
● H1 2026: Investigator-led bladder cancer trial initiation in Denmark
● 2026: Additional HARMONIC trial data readouts and potential partnership announcements
● Scale up of AI platform commercial efforts
● Preparation for potential capital formation activities to support clinical advancement

Conference Call Information

Lantern Pharma will host a conference call and webcast to discuss third quarter 2025 financial results and business updates on Thursday, November 13, 2025 at 9:00 a.m. Eastern Time.

To participate in the conference call, please register at the Zoom webcast link. A replay of the earnings call webcast will be available after the call on the investor relations section of Lantern’s website at ir.lanternpharma.com.

KOL-Hosted LP-184 Scientific Webinar: In addition to the earnings call, Lantern will host a scientific webinar featuring key opinion leader analysis of the LP-184 Phase 1a results on November 20, 2025 at 4:30 p.m. Eastern Time. Please register at the Zoom webcast link.

(Press release, Lantern Pharma, NOV 13, 2025, View Source [SID1234659905])

On November 13, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported the pricing of its previously announced underwritten public offering of 8,543,794 shares of its common stock at an offering price to the public of $7.25 per share, and in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 3,870,000 shares of its common stock at an offering price to the public of $7.2499 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant.

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The gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Verastem Oncology, are expected to be approximately $90 million. In addition, Verastem Oncology has granted the underwriters a 30-day option to purchase up to an additional 1,862,069 shares of its common stock on the same terms and conditions. The offering is expected to close on or about November 17, 2025 subject to satisfaction of customary closing conditions. All of the securities to be sold in the offering are to be sold by Verastem Oncology.

Jefferies, Guggenheim Securities and Cantor are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

Verastem Oncology intends to use the net proceeds from the public offering to fund commercial activities for AVMAPKI FAKZYNJA CO-PACK that has been approved by the U.S. Food and Drug Administration to treat KRAS-mutated recurrent Low-Grade Serous Ovarian Cancer, continued clinical research and development of product candidates including the VS-7375 oral KRAS G12D (ON/OFF) inhibitor program, and for working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the securities described above was declared effective by the Securities and Exchange Commission (SEC) on November 20, 2023. The offering is being made by means of a written prospectus and prospectus supplement that form a part of the registration statement. Before you invest, you should read the preliminary prospectus supplement relating to and describing the terms of the public offering, the accompanying base prospectus, and the related registration statement and other documents that Verastem Oncology has filed with the SEC for more complete information about Verastem Oncology and the offering. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering is free and can be found by visiting EDGAR on the SEC website at www.sec.gov. An electronic copy of the final prospectus supplement and accompanying prospectus relating to the offering will be available on the SEC website at www.sec.gov or may be obtained, when available, by contacting Jefferies LLC, by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 E. 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

(Press release, Verastem, NOV 13, 2025, View Source [SID1234659934])

On November 13, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS and OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"Tuspetinib in combination with VEN+AZA standard treatment (TUS+VEN+AZA) has been highly active and so well tolerated in newly diagnosed AML patients with 40 mg, 80 mg, and 120 mg TUS, we dose escalated to the 160 mg TUS dose level in the triplet," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Patients evaluated at the higher dose levels of 80 mg and 120 mg TUS have all (6/6; 100%) achieved CR/CRh responses, exceeding the 66% rate expected from VEN+AZA alone. We now are dosing at 160 mg TUS, and we look forward to providing further updates next month at ASH (Free ASH Whitepaper)."

Key Corporate Highlights

Tuspetinib Data Reported at European School of Haematology (ESH) 7th International Conference Data from the ongoing TUSCANY trial of tuspetinib in combination with venetoclax and azacitidine (TUS+VEN+AZA) were presented in a poster presentation, "TUSCANY Study of Safety and Efficacy of Tuspetinib plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy," at the European School of Haematology (ESH) 7th International Conference on Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment, held in October in Estoril, Portugal. Data from 10 patients in the TUSCANY trial across all three cohorts, 40 mg, 80 mg or 120 mg TUS dose in TUS+VEN+AZA, reveal promising clinical safety and antileukemic activity and support the use of TUS with standard of care treatment across a broad range of AML populations, including those carrying adverse mutations regardless of FLT3 mutation status.

As reported, the addition of TUS to VEN+AZA achieved CR/CRh responses in 6/6 (100%) patients treated at the higher dose levels of 80 mg and 120 mg TUS, exceeding the 66% rate expected from VEN+AZA alone. Overall, TUS+VEN+AZA has delivered CR/CRh responses in 9/10 (90%) patients. CR/CRh responses were achieved across diverse mutational subtypes including unmutated FLT3, FLT3-ITD, NPM1c, biallelic TP53 with complex karyotype, RAS, and myelodysplasia related mutations. MRD-negativity with TUS+VEN+AZA was observed in 7/9 (78%) of responding patients by central flow cytometry, and hematopoietic stem cell transplants (HSCT) have been completed in 2 patients to date.

Aptose Clinical Data Accepted for Poster Presentation at ASH (Free ASH Whitepaper) – Aptose was notified that its abstract, "TUSCANY Study demonstrates safety and efficacy of tuspetinib plus standard of care venetoclax and azacitidine in patients with newly diagnosed AML ineligible for induction chemotherapy," has been selected for poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The meeting is scheduled to take place December 6-9, 2025, in Orlando, Florida. The abstract accepted for presentation can be viewed online at the ASH (Free ASH Whitepaper) conference website here, and will appear in the November supplemental issue of Blood. The actual presentation will include more recent updates and additional data not found in the abstract.
Completed and Planned Value-Creating Milestones

2025: 1H

Reported safety and efficacy with 40mg TUS+VEN+AZA
Reported safety and efficacy with 80mg TUS+VEN+AZA
2025: European Hematology Association (EHA) (Free EHA Whitepaper)

Reported maturing data from TUS+VEN+AZA triplet study
2025: 2H

Reported safety and efficacy with 120 mg TUS+VEN+AZA
CSRC review of data; decision to dose escalate to 160 mg TUS+VEN+AZA
2025: European School of Haematology (ESH) 7th International Conference

Reported excellent safety across three TUS dose levels of TUS+VEN+AZA
Reported CR/CRh responses in patients with biallelic TP53 mutations
Reported evolving data from 120 mg TUS+VEN+AZA triplet
2025: American Society of Hematology (ASH) (Free ASH Whitepaper)

Report evolving response rate and durability data from four (4) dose levels of TUS+VEN+AZA triplet
Report safety and tolerability of TUS with VEN+AZA in combination with unadjusted dosing of VEN+AZA
FINANCIAL RESULTS OF OPERATIONS
Aptose Biosciences Inc.
Statements of Operations Data
(unaudited)
($ in thousands, except for share and per share data)

Three months ended
September 30,
Nine months ended
September 30,
2025
2024
2025
2024
Operating expenses:
Research and development $ 2,205 $ 4,702 $ 7,867 $ 15,560
General and administrative 2,708 2,263 9,428 8,510
Total operating expenses 4,913 6,965 17,295 24,070
Other (expense) income, net (210 ) 12 (414 ) 225
Net loss $ (5,123 ) $ (6,953 ) $ (17,709 ) $ (23,845 )
Net loss per share, basic and diluted $ (2.01 ) $ (11.33 ) $ (7.34 ) $ (44.41 )
Weighted average number of common shares outstanding used in the calculation of basic and diluted loss per common share
2,552,429 613,604 2,411,943 536,891

Net loss for the quarter ended September 30, 2025 decreased by $1.8 million to $5.1 million, as compared to $7.0 million for the comparable period in 2024. Net loss for the nine months ended September 30, 2025 decreased by $6.1 million to $17.7 million, as compared to $23.8 million for the comparable period in 2024.

Aptose Biosciences Inc.
Balance Sheet Data
(unaudited)
($ in thousands)

September 30, December 31,
2025
2024
Cash, cash equivalents and restricted cash equivalents $ 1,637 $ 6,707
Working capital (3,302 ) 5,053
Total assets 6,341 10,127
Long-term liabilities 18,712 10,193
Accumulated deficit (558,676 ) (540,967 )
Shareholders’ deficit (19,450 ) (4,543 )

Total cash, cash equivalents and restricted cash equivalents as of September 30, 2025 were $1.6 million. The Company does not have sufficient cash to fund operations and relies on advances made by Hanmi to fund operations. The Company is actively deploying financing and cost reduction efforts to extend cash runway.
As of November 7, 2025, there were 2,552,429 common shares of the Company ("Common Shares") issued and outstanding. In addition, there were 37,370 Common Shares issuable upon the exercise of outstanding stock options and there were 1,267,585 Common Shares issuable upon the exercise of the outstanding warrants.
RESEARCH AND DEVELOPMENT EXPENSES

Research and development expenses for the three and nine months ended September 30, 2025 and 2024 were as follows:

Three months ended
Nine months ended
September 30,
September 30,
(in thousands) 2025
2024
2025
2024

Program costs – Tuspetinib $ 1,423 $ 4,067 $ 5,135 $ 10,656
Program costs – Luxeptinib 91 (225 ) 290 287
Program costs – APTO-253 - - - 13
Personnel related expenses 661 941 2,258 4,274
Stock-based compensation 30 (81 ) 184 317
Depreciation of equipment - - - 13
Total $ 2,205 $ 4,702 $ 7,867 $ 15,560

Research and development expenses decreased by $2.5 million to $2.2 million for the quarter ended September 30, 2025, as compared to $4.7 million for the comparable period in 2024. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for tuspetinib were $1.4 million for the quarter ended September 30, 2025, compared with $4.1 million for the comparable period in 2024. The lower program costs for tuspetinib in the current period are attributable to reduced activity in our APTIVATE clinical trial, reduced manufacturing activity, and related expenses.
Program costs for luxeptinib increased by approximately $0.3 million during the three months ended September 30, 2025 compared to the comparable period in 2024 due to a refund provided by one of our clinical vendors during the three months ended September 30, 2024.
The Company discontinued further development of APTO-253.
Personnel-related expenses decreased by $0.3 million due to lower headcount for research and development personnel in the current quarter.
Stock-based compensation increased by $0.1 million in the quarter ended September 30, 2025, compared to the comparable period in 2024, primarily due to forfeitures recognized during the three months ended September 30, 2024 in connection with employee terminations during the period.
Research and development expenses decreased by $7.7 million to $7.9 million for the nine months ended September 30, 2025, as compared to $15.6 million for the comparable period in 2024. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for tuspetinib were $5.1 million for the nine months ending September 30, 2025, compared to $10.7 million for the comparable period in 2024. The increased costs associated with the TUSCANY study were offset by a decrease in tuspetinib development expenses during the current period. This reduction is due to the conclusion of activities in our APTIVATE clinical trial during the current period, compared to higher APTIVATE activities during the nine months ended September 30, 2024, as well as lower manufacturing and related development costs.
Program costs for luxeptinib remained consistent during the nine months ended September 30, 2025 compared to the comparable period in 2024.
The Company discontinued further development of APTO-253.
Personnel-related expenses decreased by $2.0 million due to lower headcount for research and development personnel in the current quarter.
Stock-based compensation decreased by approximately $0.1 million in the nine months ended September 30, 2025, compared to the comparable period in 2024, primarily due to stock options forfeited and/or vested in prior periods that are no longer being expensed resulting in lower expense in the current period.

(Press release, Aptose Biosciences, NOV 13, 2025, View Source [SID1234659890])