On March 27, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported that the first patient in Cohort 4 of its Phase I clinical trial has received their initial dose (Press release, TransCode Therapeutics, MAR 27, 2025, View Source [SID1234651545]). TransCode also reported that two additional patients in Cohort 4 are scheduled to receive TTX-MC138. The therapeutic candidate being evaluated, TTX-MC138, is TransCode’s lead candidate designed to inhibit microRNA-10b, a microRNA critical to the emergence and progression of metastatic cancer. No significant safety or dose limiting toxicities have been reported. The dose administered to the fourth cohort, as originally planned in the clinical protocol, is approximately fifty percent higher than the dose administered in the third cohort.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the clinical protocol, patients may remain on study absent safety events or disease progression. Of the ten patients treated with TTX-MC138 in the first four cohorts, seven remain on study for continued treatment as there have been no dose limiting toxicities or disease progression in these patients. In addition to approving opening the fourth cohort, the Safety Review Committee approved enrollment of additional patients in Cohort 3 to build upon the safety profile of TTX-MC138. Further, data analysis of both pharmacokinetic (PK) and pharmacodynamic (PD) activity from Cohorts 1, 2 and 3 is ongoing and suggests that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from TransCode’s Phase 0 clinical trial.

"Commencement of treatment in Cohort 4 has been our vision for evaluating the potential of TTX-MC138 at multiple dose levels. Cohort 4 builds upon our safety, PK/PD and exploratory data and is an important element of our clinical development strategy. We believe this milestone will inform the dose expansion stage of the clinical trial and may allow us to obtain initial evidence of clinical activity as the program continues to advance," commented Sue Duggan, TransCode’s Senior Vice President of Operations. Duggan added, "Enrollment into the study continues based on the cumulative safety data review. Additional Cohort 4 patients are scheduled for treatment in Cohort 4 for treatment with TTX-MC138 while preliminary data analysis continues."

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate that targets microRNA-10b, a micro-RNA widely believed to be a driver of metastatic disease. TransCode’s 2023 Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138.

About the Trial

TransCode’s Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study, designed to generate critical data to support evaluation of the safety and tolerability of TTX-MC138 in patients with a variety of metastatic solid cancers. While not an endpoint, the trial may provide early evidence of clinical activity of TTX-MC138. The trial comprises an initial dose-escalation phase followed by a dose-expansion phase. The primary objective of the dose-escalation phase is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion phase, the safety, tolerability and anti-tumor activity of TTX-MC138 will be further evaluated in certain tumor types selected based on preliminary results from the dose-escalation phase.

Further information is available at www.clinicaltrials.gov NCT Identifier: (NCT06260774).

On March 27, 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 financial results for the fourth quarter and full year ended December 31, 2024, and provided an update on its portfolio of AI-driven drug candidates, the RADR platform for precision oncology drug development enhancements, and other operational progress (Press release, Lantern Pharma, MAR 27, 2025, View Source [SID1234651525]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With three clinical precision oncology programs actively enrolling patients and critical data milestones on the horizon, we are at the forefront of using AI to transform the cost, pace, and timeline of oncology drug development. Lantern is a leader in the development of tech-bio to deliver the next generation of cancer medicines, where success is defined by both AI-driven progress and meaningful patient outcomes," said Panna Sharma, CEO & President of Lantern Pharma. "During 2025, we expect to have meaningful clinical readouts from our Phase 1 and Phase 2 programs and continue to launch highly innovative AI modules that can be used to accelerate and transform drug development in oncology."

AI-Powered Drug Development Pipeline Highlights:

LP-300

Lantern’s Phase 2 HARMONIC trial for LP-300 continued to expand globally in 2024 with sites opened in Japan and Taiwan, including at the National Cancer Center Japan. Patient enrollment was initiated in Taiwan and Japan during Q4 of 2024 and is expected to accelerate during 2025. Never-smokers with NSCLC in East Asia represent 33% to 40% of new NSCLC cases, as opposed to the US, where never smokers account for 15% of new NSCLC cases. LP-300 is being evaluated in combination with standard-of-care chemotherapy (carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after TKI therapy. The trial is designed to enroll approximately 90 patients across the U.S. and East Asia.

Phase 2 Clinical Results: Preliminary data from the Phase 2 U.S. safety, lead-in cohort showed an 86% clinical benefit rate and a 43% objective response rate. Additional patient data from the expansion cohort continues to support, at the current time, a similar patient response and clinical benefit rate trend. Lantern plans on sharing additional results, which will include data from patients enrolled in Taiwan and Japan from the expansion cohort, during Q2 of 2025.

Other LP-300 Advancements: Lantern’s RADR platform and in-vitro preclinical experiments have shown that LP-300 has mechanistic synergy with EGFR, ALK, MET, and RET inhibitors. Leading clinicians and KOLs are supportive of the use of LP-300 in combination with TKIs – most notably Osimertinib – in an earlier line setting. Lantern is working on developing a clinical protocol to advance the potential use of LP-300 in this setting.

LP-184

LP-184 continued advancement through a Phase 1a trial in multiple solid tumors, which is targeted to finish enrollment during Q2 of 2025. In 2024, LP-184 received Fast Track Designations from the FDA for both GBM (Glioblastoma Multiforme) and TNBC (Triple Negative Breast Cancer). Additionally, LP-184 received three Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors, in addition to its existing designation for ATRT. ATRT is an ultra-rare pediatric brain tumor with the genetic hallmark of loss-of-function or deletion of the SMARCB1 gene.

Phase 1a Results: Safety, Tolerability, Pharmacokinetics including MTD Determination – The trial is now on cohort 11, and early indications of clinical activity have been observed at higher dose levels, consistent with preliminary PK data. During Q4 of 2024, dose levels 7, 8, and 9 were cleared without safety concerns, and preliminary PK data suggest dose proportionality with exposure. Enrollment at dose level 9 and above is focused on inclusion of advanced solid tumor patients that have identified DNA damage repair mutations. A broader clinical data update is slated for Q2 2025 when recruitment for the trial is expected to be finished, and complete safety and dose response data is expected to be available.

Future Planned Phase 1b/2 Trials: Lantern has submitted a clinical trial protocol to the FDA for a Phase 1b/2 study in TNBC evaluating a combination regimen with the PARP inhibitor, Olaparib. The FDA has raised no objections to the protocol, and Lantern expects to initiate this trial in both the US and a leading academic cancer center in Nigeria, subject to clinical priorities and funding. An investigator-led study of LP-184 for recurrent bladder cancer is planned to begin in Denmark. This clinical trial will test LP-184 as a monotherapy specifically in advanced bladder cancer patients with DNA damage repair mutations.

Other LP-184 Advancements: LP-184 showed synergy with anti-PD1 checkpoint inhibitors in TNBC, suggesting the potential for use in immuno-oncology combinations for TNBC patients. LP-184 sensitizes immuno-refractory TNBCs to anti-PD1 therapy by affecting the tumor microenvironment as shown in preclinical models. This work was done in collaboration with MD Anderson and was recently presented at the AACR (Free AACR Whitepaper) IO Conference in February of 2025. During Q4 2024, Lantern completed a CRISPR-focused academic collaboration focused on highlighting and validating pathways and targets that show increased sensitivity to LP-184. These results and how they impact plans for potential upcoming trials will be further detailed in upcoming scientific communications.

LP-284

LP-284 continued enrollment in its Phase 1A, first-in-human clinical trial for relapsed/refractory non-Hodgkin’s lymphoma and solid tumors. No dose-limiting toxicities have been observed through cohort 4. LP-284 has shown nanomolar potency in multiple preclinical cancer models, including tumors that are resistant to Ibrutinib and Bortezomib.

Other LP-284 Advancements: LP-284 is a potent B-cell depleter, and has shown significant potency in reducing clonal CD-19+ and CD-20+ B cells. Lantern believes that this mechanism can be redirected as a potential therapeutic for auto-immune disorders, including lupus nephritis. Lantern plans on sharing data from these early preclinical studies during Q2 of 2025.

RADR A.I. Platform

Lantern’s proprietary RADR platform surpassed 100 billion oncology-focused data points across multiple sources (proprietary and public) of oncology, molecular, clinical and preclinical datasets in 2024. Across Lantern’s pipeline RADR continues to advance:

● drug candidate optimization,
● development and validation of clinically relevant drug-candidate combinations,
● identification of mechanism(s) of action,
● identification of optimal indications for drug-candidate advancement, and
● creation of biomarker signatures to support patient selection
● optimization and characterization of molecular features
● prediction of BBB capabilities of a molecule

Platform advancements contributed to LP-184’s clinical biomarker strategy, including a qPCR assay for PTGR1 to guide patient stratification, and aided in the identification of multiple indications leading to orphan and rare pediatric disease designations. Additionally, RADR also underpinned combination strategies, such as LP-184 with anti PD1 checkpoint inhibitors and LP-284 with rituximab. Future plans and developments include additional collaborations with leading oncology development groups and biopharma companies in both adult and pediatric cancers.

Lantern expects to publicly release multiple modules (validated A.I. frameworks) that can be accessed by Lantern collaborators for specific needs in oncology drug development, such as prediction of certain molecular features and identification of potential cancer indications that are more likely to show a higher sensitivity to a molecule or drug-candidate.

Starlight Therapeutics:

Lantern’s wholly owned subsidiary, Starlight Therapeutics, made key strides in 2024 toward developing potential therapies for CNS and brain cancers. LP-184, referred to as STAR-001 for CNS indications, was highlighted at the Society for Neuro-Oncology (SNO) 2024 conference, with a Phase 1b trial in recurrent GBM anticipated to begin in 2025 subject to successful additional funding. Additionally, Starlight appointed Dr. Marc Chamberlain as Chief Medical Officer and established its inaugural Scientific Advisory Board, which includes leading neuro-oncology researchers and clinicians during 2024.

Additional Operational Highlights:

Ø Advanced strategic RADR-based AI collaborations with Actuate Therapeutics (NASDAQ:ACTU) and Oregon Therapeutics, accelerating and refining the development of novel best-in-class cancer metabolism inhibitors.

Ø Achieved key development milestone in the creation of a qRT-PCR molecular diagnostic for PTGR1 assessment to identify patients most likely to respond to LP-184, potentially increasing success rates through precision patient selection for future clinical trials.

Ø Secured Japanese Patent Office protection for LP-284 composition of matter, extending IP coverage through 2039 in a strategic market with 7,000+ NHL cases annually.

Ø Advanced proprietary BBB permeability prediction algorithm with favorable PCT patent application report, advancing our AI leadership with Lantern’s algorithms holding five of the top ten positions on Therapeutic Data Commons Leaderboard.

Fourth Quarter and Full Year 2024 Financial Results:

Ø Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $24.0 million as of December 31, 2024, compared to approximately $41.3 million as of December 31, 2023.

Ø R&D Expenses: Research and development expenses were approximately $4.3 million for the quarter ended December 31, 2024, compared to approximately $3.6 million for the quarter ended December 31, 2023.

Ø G&A Expenses: General and administrative expenses were approximately $1.6 million for the quarter ended December 31, 2024, compared to approximately $1.3 million for the quarter ended December 31, 2023.

Ø Net Loss: Net loss was approximately $5.9 million (or $0.54 per share) for the quarter ended December 31, 2024, compared to a net loss of approximately $4.2 million (or $0.39 per share) for the quarter ended December 31, 2023.

Ø Full Year Net Loss Per Share: Net loss was $1.93 per share for the fiscal year 2024 compared to $1.47 per share for the fiscal year 2023.

Ø Shares Issued: In fiscal year 2024 the Company issued 21,313 shares of common stock for aggregate proceeds of $66,710, relating to the exercise of warrants that were expiring. The Company also issued 22,220 shares of common stock relating to the cashless exercise of warrants to purchase 86,685 shares during the year ended December 31, 2024. The Company also issued 20,000 shares of restricted common stock during fiscal year 2024.

On March 27, 2025 CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, reported 2024 annual results and recent business updates (Press release, CStone Pharmaceauticals, MAR 27, 2025, View Source [SID1234651546]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Business Highlights

For the year ended December 31, 2024 and up until the date of this results announcement, key milestones have been achieved across regulatory approvals, clinical advancements, and strategic collaborations, reinforcing our position as a leader in innovative therapeutics. A shortlist of our achievements over this period includes:

Commercial Products

• CEJEMLY (sugemalimab), anti-PD-L1 antibody

– Global expansion and regulatory approvals

Sugemalimab secured three new drug application approvals in 2024, including its fifth indication in mainland China for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). Sugemalimab also gained approvals in the EU and UK for first-line treatment of stage IV NSCLC, marking its entry into major international markets. We have recently completed the regulatory submission to the European Medicines Agency (EMA) for the new indication application of sugemalimab in the treatment of Stage III NSCLC.

– Strategic alliances drive global commercialization

Partnered with Ewopharma AG in May 2024 for commercialization in Central and Eastern Europe (CEE) and Switzerland.
Collaborated with Pharmalink Store – L.L.C – O.P.C in November 2024 to expand access across the Middle East, North Africa (MENA) Region and South Africa.
Entered an agreement with SteinCares in January 2025 for Latin America (LATAM).
Additional partnerships in Western Europe, Southeast Asia, and Canada are anticipated in 2025.
– Robust clinical data reinforce efficacy

GEMSTONE-304 Study: Final progression-free survival (PFS) and interim overall survival (OS) data for the first-line esophageal squamous cell carcinoma (ESCC) published in Nature Medicine (February 2024).
GEMSTONE-302 Study: Four-year OS data for stage IV NSCLC presented at the 2024 Congress of European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), confirming sustained survival benefits.
GEMSTONE-303 Study: Final PFS and OS analysis for GC/GEJC with combined positive score (CPS) ≥5 published in the top-tier medical journal-Journal of the American Medical Association (JAMA) (February 2025).
ESMO Guideline Recognition: CEJEMLY recommended as first-line NSCLC therapy in ESMO (Free ESMO Whitepaper)’s 2025 Non-Oncogene-Addicted Metastatic NSCLC Living Guidelines, covering both squamous and non-squamous NSCLC (February 2025).
• AYVAKIT (avapritinib), KIT/PDGFRA inhibitor

– Localized manufacturing in China

The National Medical Products Administration of China (NMPA) approved domestic production of AYVAKIT tablets (300 mg and 100 mg) in June and August 2024 respectively. Full transition to localized supply is expected in 2025, improving cost efficiency.

– NRDL inclusion enhances accessibility

AYVAKIT (avapritinib) has been included to China’s National Reimbursement Drug List (NRDL), effective January 1, 2024 for unresectable or metastatic gastrointestinal stromal tumor (GIST), harboring the PDGFRA exon 18-mutated, including PDGFRA D842V mutations. This significantly improves AYVAKIT’s affordability for eligible patients.

– Commercial partnership with Hengrui

In July 2024, we forged a new partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd., granting them the exclusive promotion rights in mainland China to amplify commercial reach and profitability.

• GAVRETO (pralsetinib), RET inhibitor

– Progress towards localized manufacturing

The NMPA’s Center for Drug Evaluation (CDE) accepted the manufacturing localization and bioequivalence (BE) study application in April 2024, and regulatory review is ongoing.

– Sustained collaboration with Allist

Commercial operations has been transferred to Shanghai Allist Pharmaceuticals Co., Ltd in the first half of 2024 under an exclusive agreement signed in November 2023. Collaboration remains strong to maximize market penetration.

Clinical Stage Core Assets

• CS5001 (ROR1 ADC)

– Phase Ib clinical trial with registration potential

A global multicenter clinical trial of CS5001 is actively enrolling patients across the United States of America (U.S.), Australia and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas with potential to be expanded into a Phase II single-arm registrational study. Additional cohorts, including CS5001 in combination with R-CHOP (Rituximab + Cyclophosphamide + Hydroxydaunorubicin + Vincristine + Prednisone) for the first-line diffuse large B-cell lymphoma (DLBCL), and CS5001 in combination with standard of cares (SOC) for front-line DLBCL will be initiated to expand the therapeutic potential of CS5001 across all DLBCL stages. CS5001 is also being studied as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors, underscoring its versatility across oncology indications.

– Compelling clinical data at ASCO (Free ASCO Whitepaper) & ASH (Free ASH Whitepaper) 2024

Phase Ia data for CS5001 presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrated that CS5001 is so far the first receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate (ADC) known to demonstrate clinical anti-tumor activity in both solid tumors and lymphomas. Clinical data of CS5001 revealed superior efficacy and favorable safety profile as a monotherapy for both aggressive and indolent advanced lymphomas. At the tentative recommended Phase II dose (RP2D) (125 μg/kg), CS5001 achieved an objective response rate (ORR) of 70% in non-Hodgkin lymphoma (NHL) and 100% in Hodgkin lymphoma (HL). These results support its potential as a faster-to-market candidate and a frontline combination therapy backbone.

• CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody)

– Global Phase I clinical trial initiated

A global multicenter first-in-human (FIH) trial among solid tumors has been launched in Australia in December 2024, with subsequent expansion to China and the U.S.. The first patient was dosed in March 2025.

– Potential FIC/BIC next-generation I/O backbone

Preclinical data presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) highlighted its first-in-class (FIC) or best-in-class (BIC) potential with superior antitumor activity compared to potential competitors benchmarks, including PD-1/CTLA-4 or PD-1/VEGF bispecific antibody and PD-1/ CTLA-4 combination therapies. Unique trispecific mechanism positions CS2009 as a next-generation immuno-oncology backbone with broad applicability.

Preclinical/IND-enabling Stage Programs and ADC Platform

CStone’s preclinical pipeline includes more than nine promising candidates, each with global rights and focusing on FIC/BIC profiles with broad indications. These candidates include multispecific antibodies, ADCs and radionuclide drug conjugates (RDC) covering various therapeutic fields such as oncology, autoimmune diseases, and metabolic disorders. The Company is dedicated to delivering clinical value through the development of these Pipeline 2.0 candidates, which will undergo international, multi-center clinical trials to maximize their global potential.

CStone has also developed an in-house ADC technology platform featuring proprietary linkers, optimized for diverse targets and payloads. This platform supports multiple upcoming ADC projects in Pipeline 2.0, including CS5007 (dual targeting epidermal growth factor receptor (EGFR) & human epidermal growth factor receptor 3 (HER3)), CS5005 (targeting somatostatin receptor 2 (SSTR2)), CS5008 (dual targeting delta-like ligand 3 (DLL3) & SSTR2) and CS5006 (targeting ITGB4).

Future and Outlook

As we look to the future, we reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing internal discovery capabilities and sustained R&D investments. Concurrently, we aim to maximize the global commercial potential of our approved therapies through strategic collaborations and localized manufacturing enhancements. Key growth drivers in 2025 include:

• Clinical milestones

– Progress CS5001 (ROR1 ADC) and CS2009 (PD-1/VEGF/CTLA-4 trispecific) towards pivotal trials and in parallel pursue global partnerships to expedite development.
– Advance early-stage candidates (e.g., CS2011, CS5007, CS5005, CS5008, CS5006) into clinical stages within the next two years.

• Commercial excellence

– Maximize the value of approved products through strategic collaborations and manufacturing localization (e.g., AYVAKIT, GAVRETO) to enhance profitability and market reach.
– Accelerate ex-China commercialization of CEJEMLY (sugemalimab) via regional partnerships.

• Innovation and technology

– Strengthen proprietary platforms (e.g., ADC technology) to sustain pipeline growth.
– Present key clinical data at major conferences (e.g., AACR (Free AACR Whitepaper), ESMO (Free ESMO Whitepaper), ASH (Free ASH Whitepaper))

Financial Highlights

International Financial Reporting Standards (IFRS) Measures:

• Revenue was RMB407.2 million for the year ended December 31, 2024, composed of RMB175.1 million in sales of pharmaceutical products (avapritinib and pralsetinib), RMB204.0 million in license fee income and RMB28.1 million in royalty income of sugemalimab, representing a year-on-year increase of RMB108.3 million, or 113.1%, in license fee which was largely offset by a decrease in revenue from sales of pharmaceutical products, such that total revenue decreased by RMB56.6 million, or 12.2%, year on year.

• Research and development expenses were RMB134.7 million for the year ended December 31, 2024, representing a decrease of RMB393.1 million from RMB527.8 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third-party contracting costs.

• Administrative expenses were RMB77.8 million for the year ended December 31, 2024, representing a decrease of RMB104.9 million from RMB182.7 million for the year ended December 31, 2023, primarily due to the decrease in employee costs.

• Selling and marketing expenses were RMB133.8 million for the year ended December 31, 2024, representing a decrease of RMB65.5 million from RMB199.3 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs and others which was partially offset by an increase in channel service fee.

• Loss for the year was RMB91.2 million for the year ended December 31, 2024, representing a decrease of RMB276.0 million, or 75.2%, from RMB367.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses.

• Cash and cash equivalents and time deposits were RMB672.9 million as of December 31, 2024.

Non-International Financial Reporting Standards (Non-IFRS) Measures:

• Research and development expenses excluding the share-based payment expenses were RMB124.7 million for the year ended December 31, 2024, representing a decrease of RMB410.0 million from RMB534.7 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third party contracting costs.

• Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB224.4 million for the year ended December 31, 2024, representing a decrease of RMB113.8 million from RMB338.2 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs.

• Loss for the year excluding the share-based payment expenses was RMB94.0 million for the year ended December 31, 2024, representing a decrease of RMB236.2 million, or 71.5%, from RMB330.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses.

2024 Annual Results Conference Call

The Company will host a 2024 annual results conference call at 10:00 a.m. (Beijing Time) on Friday March 28, 2025. Please attend the conference call through the link: View Source (Password:067784).

On March 27, 2025 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, reported an update on its recent activities (Press release, Lixte Biotechnology, MAR 27, 2025, View Source [SID1234651529]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Continued progress has been made in collaborative clinical studies with two global pharmaceutical companies for our lead proprietary compound, LB-100, to treat ovarian and colorectal cancer," said Bas van der Baan, LIXTE’s President and Chief Executive Officer. "We are encouraged that LB-100 has been found to be well tolerated in clear cell ovarian cancer patients at doses with anti-cancer activity, underscoring our mission and commitment to deliver effective solutions to patients battling cancer.

"LIXTE trials are underway for ovarian cancer at the M.D. Anderson Cancer Center and at Northwestern University, supported by GSK. Our colorectal trial, supported by F. Hoffmann-La Roche, is being conducted at the Netherlands Cancer Institute," Mr. van der Baan added.

Recent LIXTE Highlights Include:

● The first patient dosing in a Phase 1b/2 trial combining LIXTE’s LB-100 with GSK’s immunotherapy, dostarlimab-gxly, targeting ovarian clear cell carcinoma.

● Dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. ("Roche") for treatment of unresponsive (MSI Low) metastatic colorectal cancer.

● Further bolstering of LIXTE’s intellectual property portfolio, with receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent application number 16/467,721, titled, "Oxabicycloheptanes for Modulation of Immune Response," for combining the Company’s LB-100 compound with various innovative cancer immunotherapies.

● Completion of a registered direct offering, raising aggregate gross proceeds of approximately $1,050,000 to be used for working capital and other general corporate purposes.

● Study published in Cancer Discovery, revealing that LB-100 can force cancer cells to relinquish their malignant properties, suggesting a novel therapeutic approach.

● Study published in EMBO, highlighting how LB-100 forces cancer cells to create neo antigens and make them more vulnerable for immunotherapy.

On March 27, 2025 GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported that preclinical data on GNX1021 will be presented on April 28 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago, Illinois (Press release, GlycoNex, MAR 27, 2025, View Source [SID1234651547]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GNX1021 is an antibody-drug conjugate (ADC) targeting branched Lewis B/Y (bLeB/Y), a unique tumor-associated glycan antigen overexpressed in gastric cancer and other solid tumors. The poster will highlight in vivo efficacy and safety findings from gastric cancer models that demonstrate GNX1021’s tumor control activity.

"We are very pleased that research involving GNX1021, our glycan-targeting ADC, was accepted for presentation at AACR (Free AACR Whitepaper) 2025," said Dr. Mei-Chun Yang, CEO of GlycoNex. "AACR is one of the most influential oncology meetings in the world, and the opportunity to showcase the potential of GNX1021 to treat gastric cancer, an often-deadly cancer with few available therapies, highlights the importance of this program."

Presentation Details:

Event:

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025

Session Category:

Experimental and Molecular Therapeutics

Session:

Growth Factor Receptors and Other Surface Antigens as Targets for Therapy 1

Abstract Title: (#2932)

GNX1021, a novel ADC targeting glycans with branched Lewis B/Y, demonstrated preclinical tumor control activity in gastric cancer models and favorable safety

Date and Time:

April 28, 2025; 2:00 pm CDT

Location:

McCormick Place Convention Center, Chicago

Poster Section 17, Poster Board 6