On August 13, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, reported its financial results for the second quarter ended June 30, 2025 (Press release, Moleculin, AUG 13, 2025, View Source [SID1234655205]).

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"The second quarter of 2025 marked a period of momentum for Moleculin. We continued to make meaningful progress in our MIRACLE trial, including a significant expansion into a number of countries, positioning ourselves to achieve our enrollment targets and, importantly, reach an expected pivotal data readout before the end of this year. In addition to progress in our AML program, we reported compelling topline data in our Phase 1B/2 soft tissue sarcoma lung metastases (STS lung mets) trial and continue to build a growing body of preclinical and clinical data showcasing the depth and breadth of the potential Annamycin has to treat a range of cancer indications," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "I am proud of the dedication our team continues to show, and we look forward to building on this progress in the second half of the year and beyond."

Recent Highlights

Annamycin for the Treatment of AML

Expanded its Phase 2B/3 MIRACLE trial with secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia;
Four active MIRACLE sites now screening subjects in Ukraine, Georgia, Spain and the US;
Expect to add more than 20 additional sites in the European Union (EU) and the US by the end of Q3 2025; and
Received positive FDA feedback on pediatric study plan for Annamycin in children with R/R AML, setting the start of that trial in 2027.
Other Annamycin

Announced the presentation of encouraging preclinical data for Annamycin, which demonstrated significant efficacy against various primary and metastatic liver cancers;
Bolstered Annamycin intellectual property portfolio with notice of intent to grant a new European patent;
Engaged industry veteran Adriano Treve to explore Annamycin related strategic partnerships; and
Reported positive topline efficacy results from U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of STS lung metastases (MB-107).
Clinical Development Update

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

The Company is currently evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") in a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be global, including sites in the US, Europe and the Middle East.

The MIRACLE study is a Phase 2B/3 clinical trial whereby data from the Phase 2B portion will be combined with the Phase 3 portion for purposes of measuring its primary efficacy endpoint. MIRACLE is subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, and utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized (1:1:1) in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, which Annamycin doses were specifically recommended by the FDA in the Company’s end of Phase 1B/2 meeting.

The protocol for the MIRACLE trial allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects). The first early unblinding will yield 30 subjects treated with Annamycin (190mg/m2 and 230 mg/m2) in combination with HiDAC and 15 subjects treated with just HiDAC plus placebo. The Company expects to reach the first unblinding (45 subjects) before the end of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due in part to the positive response the Company received in meetings during December with potential investigators regarding recruitment for the trial.

As previously announced regarding the EU, the clinical trial approval with EMA was granted under the condition that the Company present results of appropriate nonclinical GLP studies before initiating the Phase 3 portion (Part B) of the study. Results will be submitted as a substantial modification to the existing approved CTA.

For Part B of the trial, approximately 220 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomized 1:1). The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA’s new Project Optimus initiative.

Patient dosing has commenced, and the initial data readout is on track for the second half of 2025. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU is on euclinicaltrials.eu and the reference identifier there is 2024-518359-47-00.

Expected Milestones for Annamycin AML Development Program

Q3 2025 – Site and recruitment updates for MIRACLE trial
Q3 2025 – First patients treated in the US and the EU
Q4 2025 – Announcement of 45th subject being recruited and data readout (n=45) unblinded efficacy/safety review
Q1 2026 – Impact of data readout (n=45) on regulatory pathway; Recruitment update
1H 2026 – Interim efficacy and safety data (n=~75-90) unblinded and Optimum Dose set for MIRACLE trial
2027 – Begin enrollment of 3rd line subjects in MIRACLE2
2027 – Enrollment ends in 2nd line subjects
2027 – Prepare for the launch of an AML pediatric trial
2028 – Primary efficacy data for 2nd line subjects in MIRACLE
2028 – Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
2028 – Primary efficacy data for 2nd line subjects
Soft Tissue Sarcoma (STS) Lung Metastases

As previously announced, the Company reported positive topline efficacy results from its completed U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of STS lung mets (MB-107). The final topline results of MB-107 demonstrated median overall survival (OS) of 13.5 months for subjects as median 7th line therapy (n=36). This compares to OS of 8-12 months for standard of care treatments and 13.4 months for experimental treatments for advanced STS as 2nd line.1

For more information about the MB-107 trial visit clinicaltrials.gov and reference identifier NCT04887298.

Expected Milestones for Annamycin STS Lung Mets Development Program

Q4 2025 – Identify next phase of development / pivotal IIT (investigator-initiated-trial) program
Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

WP1066 & Brain Tumors

With regard to the Company’s WP1066 oral formula, the Company has an externally funded Phase 1B/2 in combination with radiation treating glioblastoma (GBM), a form of brain cancer, at Northwestern University (Northwestern) that is actively recruiting. This is an investigator-initiated trial where Moleculin’s main cost is supplying drug product. To date Northwestern has recruited 7 subjects, of which 5 have completed treatment and are undergoing follow-up while 2 continue with treatment. No data has been released. Also, the Company has signed an agreement with Emory University enabling Emory to study various WP1066 IV formulations in preclinical studies with the goal of selecting the best molecule to move into a clinical setting towards, most likely, brain cancers such as GBM. Study drug was delivered in April 2025 to Emory with results from such studies expected in the second half of 2025.

Summary of Financial Results for the Second Quarter 2025

Research and development (R&D) expense was $3.6 million and $4.1 million for the three months ended June 30, 2025 and 2024, respectively. The decrease of $0.5 million is mainly related to a reduction in the clinical trials activity.

General and administrative expense was $2.1 million each for the three months ended June 30, 2025 and 2024.

As of June 30, 2025, the Company had cash and cash equivalents of $7.6 million and believes that the cash on hand is sufficient to fund planned operations into the fourth quarter of 2025.

On August 13, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a business update and announced financial results for the second quarter ended June 30, 2025 (Press release, Mersana Therapeutics, AUG 13, 2025, View Source [SID1234655201]).

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"During the second quarter, we were excited to have Emi-Le clinical data presented in oral sessions at both ASCO (Free ASCO Whitepaper) 2025 and ESMO (Free ESMO Whitepaper) Breast Cancer 2025. These presentations highlighted Emi-Le’s encouraging clinical activity in patients with TNBC post-topo-1 treatment and those with adenoid cystic carcinoma type 1 (ACC-1)," said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. "Our team has continued to make important progress in recent months, as evidenced by the strong pace of enrollment in the two ongoing dose expansion cohorts in our Phase 1 clinical trial of Emi-Le. We look forward to reporting initial clinical data from these expansion cohorts later this year."

Emiltatug Ledadotin (Emi-Le; XMT-1660)
Mersana has continued to advance the development of Emi-Le, the company’s B7-H4-directed Dolasynthen ADC.

Medical Congress Presentations: During the second quarter of 2025, clinical data as of a March 8, 2025 data cut-off from dose escalation and backfill cohorts in the Phase 1 clinical trial of Emi-Le were included in oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting (ASCO 2025) in Chicago, IL and the European Society for Medical Oncology Breast Cancer 2025 Annual Congress (ESMO Breast Cancer 2025) in Munich, Germany. The ASCO (Free ASCO Whitepaper) 2025 presentation included data for patients across all enrolled tumor types, and the ESMO (Free ESMO Whitepaper) Breast Cancer 2025 presentation focused primarily on patients with post-topo-1 TNBC. These presentations can be accessed by visiting the Publications section of the Mersana website at www.mersana.com.

Expansion Update: Mersana continues to enroll patients with TNBC who have received one to four prior lines of therapy, including at least one topo-1 ADC. This stage of the trial is enrolling patients in two cohorts:

A "Dose A" cohort, in which patients are receiving 67.4 mg/m2 of Emi-Le every four weeks (Q4W), and
A "Dose B" cohort, in which patients are receiving 80 mg/m2 Q4W following a loading dose of 44.5 mg/m2 on days 1 and 8 of the first four-week cycle.
Collectively, more than 45 patients with TNBC have been enrolled across the two cohorts. Mersana plans to report initial clinical data from the expansion portion of its Phase 1 clinical trial in the second half of 2025.

XMT-2056
The dose escalation portion of Mersana’s Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate targeting a novel HER2 epitope, is ongoing. Additionally, in July 2025, Mersana achieved a $15 million development milestone under its agreement with GSK plc, which has an exclusive global license option to co-develop and commercialize XMT-2056. Payment of the milestone is due in the third quarter of 2025. Mersana expects to present initial clinical pharmacodynamic STING activation data for XMT-2056 in the second half of 2025.

Collaborations
Mersana continues to support its collaborations with both Johnson & Johnson (Dolasynthen research collaboration) and Merck KGaA, Darmstadt, Germany (Immunosynthen research collaboration).

Reverse Stock Split
A 1-for-25 reverse stock split of the issued and outstanding shares of Mersana’s common stock (the Reverse Stock Split) became effective at 5:00 p.m. ET on July 25, 2025, and the company’s common stock began trading on a split-adjusted basis on July 28, 2025. The Reverse Stock Split reduced the number of outstanding shares of the company’s common stock from approximately 124.8 million shares to approximately 5.0 million shares. The shares outstanding and per share amounts below have been adjusted to reflect the Reverse Stock Split.

On August 11, 2025, the company received formal notification from The Nasdaq Stock Market, LLC (Nasdaq) confirming that the company has regained compliance with Nasdaq’s minimum bid price requirement. The regaining of compliance is a result of the closing bid price per share of the company’s common stock being at least $1.00 for a minimum of 10 consecutive business days prior to the August 25, 2025 compliance deadline, as described in the initial notice from Nasdaq to the company dated February 25, 2025.

Second Quarter 2025 Financial Results and Recent Updates

Net cash used in operating activities for the second quarter of 2025 was $22.6 million, which included $2.4 million in severance-related payments.

Cash and cash equivalents as of June 30, 2025 were $77.0 million.

In July 2025, Mersana made a payment of approximately $17.9 million to satisfy in full its indebtedness and obligations under the company’s previous loan and security agreement. The company continues to expect that its capital resources will be sufficient to support its current operating plan commitments into mid-2026.
Collaboration revenue for the second quarter of 2025 was $3.1 million, compared to $2.3 million for the same period in 2024. The year-over-year change was primarily related to increased revenue recognized under the company’s collaboration and license agreements with Johnson & Johnson and Merck KGaA, Darmstadt, Germany, partially offset by reduced revenue recognized under its agreement with GSK.

Research and development (R&D) expense for the second quarter of 2025 was $16.2 million, compared to $17.2 million for the same period in 2024. Included in the second quarter of 2025 R&D expense was $0.9 million in non-cash stock-based compensation expense. The year-over-year change in R&D expense was primarily related to lower headcount and related employee compensation costs, partially offset by an increase in costs related to Emi-Le and XMT- 2056 clinical development activities and manufacturing activities associated with the company’s collaborations.
General and administrative (G&A) expense for the second quarter of 2025 was $7.4 million, compared to $10.5 million during the same period in 2024. Included in the second quarter of 2025 G&A expense was $1.1 million in non-cash stock-based compensation expenses. The year-over-year change in G&A expense was primarily related to lower headcount and related employee compensation costs and a reduction in consulting and professional services fees.
Mersana incurred $3.9 million in restructuring expenses for the second quarter of 2025 related primarily to severance and benefit payments, outplacement services and related expenses.

Net loss for the second quarter of 2025 was $24.3 million, or $4.87 per share, compared to a net loss of $24.3 million, or $4.96 per share, for the same period in 2024.

Conference Call Reminder

Mersana will host a conference call today at 8:00 a.m. ET to discuss business updates and its financial results for the second quarter of 2025. To access the call, please dial 833-255-2826 (domestic) or 412-317-0689 (international). A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.

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 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 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Kezar Life Sciences, AUG 13, 2025, View Source [SID1234655198]).

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"We are on track with our clinical development and regulatory submission plan for zetomipzomib in autoimmune hepatitis," said Chris Kirk, PhD, CEO and co-founder of Kezar. "We are committed to working closely with the FDA to align on our next trial design, which we have proposed as a registration-enabling study. The Type C meeting will be an important milestone as we continue to believe that zetomipzomib has the potential to positively transform the lives of patients living with autoimmune hepatitis."

Zetomipzomib: Selective Immunoproteasome Inhibitor
•In March, Kezar reported topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib in patients with autoimmune hepatitis (AIH). In relapsed or refractory AIH patients who entered screening on steroid-based therapy, 36% (5 of 14) of zetomipzomib-treated patients achieved a complete biochemical response (CR) and clinically significant steroid taper to 5 mg/day or less by 6 months, compared to 0 of 7 placebo patients. The median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks (including the ongoing open-label extension at the time of the data cutoff), and no disease flares were reported in any zetomipzomib-treated patient achieving CR during study. A favorable safety profile was observed during the 6-month blinded treatment period.

•In July, Kezar announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with AIH.
•Kezar submitted a Type C meeting request to the FDA to meet during the fourth quarter of 2025 to discuss the AIH development plan for zetomipzomib.

•Kezar submitted a complete response to the FDA Division of Rheumatology and Transplant Medicine with a request to remove the clinical hold on zetomipzomib in lupus nephritis.
Medical Conferences
•An abstract featuring PORTOLA Phase 2a data has been selected for an oral presentation at The Liver Meeting 2025, taking place November 7-11, in Washington, DC.
•An abstract featuring PORTOLA biomarker data has been selected for poster presentation at The Liver Meeting 2025.
Business Updates
•In June, Zung To was promoted to Chief Development Officer. Mr. To joined Kezar in 2023 as Senior Vice President & Head of Clinical Development and brings 35 years of industry experience, with more than 20 years in senior leadership roles in early-and late-stage clinical development. He has been instrumental in leading Kezar’s development strategy and has played a pivotal role in progressing the Company’s clinical trials with speed and precision.

Financial Results
•Cash, cash equivalents and marketable securities totaled $100.8 million as of June 30, 2025, compared to $132.2 million as of December 31, 2024. The decrease was primarily attributable to cash used in operations.
•Research and development (R&D) expenses for the second quarter of 2025 decreased by $6.7 million to $9.6 million, compared to $16.3 million in the second quarter of 2024. This decrease was primarily due to the decreased clinical activities resulting from the completion and closeout of clinical trials, a decrease in personnel costs including non-cash stock-based compensation and a decrease in facility related expenses.
•General and administrative (G&A) expenses for the second quarter of 2025 decreased by $0.6 million to $5.0 million compared to $5.6 million in the second quarter of 2024. The decrease was primarily due to a decrease in non-cash stock-based compensation and personnel-related expenses.
•Restructuring and impairment charges for the second quarter of 2025 decreased by $1.5 million, compared to the second quarter of 2024. The decrease was primarily attributed to the impairment charge in 2024 related to the right-of-use asset for the vacated floor in the company’s leased office facility.
•Net loss for the second quarter of 2025 was $13.7 million, or $1.87 per basic and diluted common share, compared to a net loss of $21.5 million, or $2.96 per basic and diluted common share, for the second quarter of 2024.
•Total shares of common stock outstanding were 7.3 million shares as of June 30, 2025.