On August 8, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, reported operational highlights and financial results for the second quarter 2024, ending June 30, 2024 (Press release, Lantern Pharma, AUG 8, 2024, View Source [SID1234645612]).
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"The team at Lantern Pharma is making solid, thoughtful and disciplined progress in our clinical trials and in our collaborative research and AI efforts. This past quarter saw a significant milestone where our clinical trials are getting to the point of having initial patient data that we can share, including our unique Harmonic clinical trial for never smokers with lung cancer. We continue to also improve the functionality and abilities of our AI platform, RADR, to guide the next phase of our therapeutic programs which will be heavily marked by trials with combination regimens, and ADC development." said Panna Sharma, President and CEO of Lantern Pharma.
Highlights of AI-Powered Pipeline:
Ø LP-300: The Harmonic Phase 2 Clinical Trial – Preliminary results at the completion of the 7-patient lead-in part of the Harmonic study demonstrated predictable safety profiles that are consistent with the chemotherapy regimen alone and seemed to demonstrate clinical benefit for 6 out of the 7 patients – an 86% clinical benefit rate (CBR). No patients experienced dose limiting toxicities, and no discontinuations were observed due to treatment related toxicity. Six patients experienced clinical benefit from the combination of LP-300 and chemotherapy while 1 patient experienced progressive disease. The clinical benefit rate is 86% for this group with an objective response rate (ORR) of 43%. Of the 6 patients experiencing clinical benefit – 3 patients showed partial responses with an average tumor size reduction of 51% and 3 patients have stable disease with an average tumor size reduction of 13%. Encouraging preliminary efficacy results were observed regardless of prior tyrosine kinase inhibitor (TKI) treatment(s), demographics, and metastatic disease sites. In the initial set of patients, those having low to intermediate TMB (tumor mutation burden) were found to be responsive to LP-300 + chemotherapy.
The phase 2 Harmonic clinical trial sites in the US, and certain sites in Japan are screening for eligible patients and we expect the pace of enrollment to increase in the coming months. This past quarter we also initiated IRB approvals and site initiation visits in Asia. The expansion of the Phase 2 clinical trial in Japan and Taiwan is expected to accelerate the collection of patient and response data that are needed for the next-stage of development of LP-300, a therapeutic for the treatment of relapsed and inoperable primary adenocarcinoma of the lung given in combination with chemotherapy. Additionally, it may also bring a needed therapeutic option for never-smokers with NSCLC in Japan and Taiwan, where one-third or more of all lung cancer diagnoses are made among those who have never smoked. Dr. Yashushi Goto, a physician and researcher focused on lung cancer at the National Cancer Center of Japan, will be leading the phase 2 trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States. Lantern believes that this improves the positioning for drug-candidate LP-300 to develop collaborative and co-development partnerships with global biopharma companies with a primary focus in serving the Asian markets.
The Harmonic trial is assessing the effect of LP-300 in combination with standard-of-care chemotherapy in never-smoker patients with relapsed NSCLC where they have failed TKI therapies. Globally, never-smokers with NSCLC are a growing population of patients and do not respond well to PD-1/PD-L1-based therapies or the available chemotherapy doublets, leaving them with reduced treatment options. In the US it is estimated that the treatment indication of never smokers with NSCLC has an annual market potential of $1.5 billion, and a global estimated annual market potential of over $2.6 billion.
Ø LP-184 – Seven cohorts of patients have been enrolled and dosed – in escalating doses – in the ongoing Phase 1A clinical trial – a first-in-human Phase 1 basket trial across multiple solid tumor indications that are advanced and refractory to existing standard-of-care therapies. We expect to reach a dosage level in the coming cohort where therapeutic concentrations of the drug should be attainable based on our pharmacokinetic and pharmacodynamic analyses. The trial is actively enrolling patients across multiple US centers that have relapsed/refractory advanced solid tumors, such as pancreatic cancer, glioblastoma (GBM), lung, triple-negative breast cancer, and multiple other solid tumor types with DNA damage response deficiencies. No dose-limiting toxicities have been observed to date in the LP-184 trial, and the Company believes that enrollment should be complete this year and on-track for an initial readout of safety and molecular correlation data by the close of the year. The dosage and safety data obtained in the Phase 1A trial are expected to be used to advance the central nervous system (CNS) indications for a future Phase 1b/2 trial to be sponsored by Lantern’s wholly owned subsidiary, Starlight Therapeutics, as well as other later phase trials in select tumors that have shown superior responsiveness to LP-184 and meet with genomically guided criteria related to drug-response. Lantern has also made advancements toward a key milestone related to the development of a quantitative PCR-based molecular diagnostic test that may help in identifying patients with the best likelihood of response and benefit from treatment with LP-184.
AI and preclinical studies are also ongoing to further refine drug combination studies supporting the use of LP-184 to improve the durability or overall response rates in combination with FDA approved drugs that are widely used in cancer treatment – especially PARP inhibitors, and immune checkpoint inhibitors. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $12+ billion, consisting of $4.5+ billion for CNS cancers and $7.5+ billion for solid tumors.
Ø LP-284 – The third cohort of patients are being dosed, and no dose-limiting toxicities have been observed in the LP-284 Phase 1A clinical trial. We expect to open additional sites in the US throughout the third quarter with the potential to advance to Phase 1B and 2 by the close of 2024 or early 2025. LP-284 has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with compromised functioning of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions. Nearly all MCL, DHL, and HGBL patients relapse from the current standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic options for these patients. In the US and Europe, MCL, DHL, and HGBLs are diagnosed in 16,000-20,000 patients each year and have an estimated annual market potential of over $3+ billion.
We have also begun a review of some notable mechanisms-of-action of LP-284 that may be leveraged in other diseases and conditions. Lantern expects to review those preclinical studies and findings later this quarter.
RADR Platform Growth and Development:
Ø RADR continues to advance in size, scope, and capabilities and is also progressing towards becoming recognized as a standard for AI-driven drug development in oncology – for both early-stage development and later-stage patient biomarker and combination therapy identification. Lantern will potentially focus additional data growth efforts of the RADR platform on: drug sensitivity data, combination treatment outcome data, and biomarker data in rare cancers, and on emerging synthetic lethal targets that are aimed at accelerating the development of new therapies for Lantern and its partners. The scope of RADR’s data has broadened with a strategic focus on additional classes of compounds, detailed data on chemical and biochemical features and drug-interaction data. Real-world data from clinical studies such as those being obtained from liquid biopsy, and data from preclinical combination studies that aim to define drug interaction and optimal dosage are being incorporated into the datapoints and data sets powering RADR.
Lantern also leveraged the RADR platform in developing a drug-development collaboration with Oregon Therapeutics with a focus on accelerating the development and decision path towards a first-in-human launch of the drug-candidate, XCE853 into the clinic. The AI-enabled collaboration with Oregon Therapeutics aims to refine and expand the positioning of XCE853, a novel protein disulfide isomerase (PDI) inhibitor, in new and targeted oncology indications, including for drug-resistant tumors. Lantern Pharma is receiving equal IP co-ownership and drug development rights in newly discovered biomarkers, novel indications, and use for new pharmacological strategies for XCE853.
Additionally, the RADR platform’s generative AI capabilities, focusing on molecular optimization and automated feature extraction to improve understanding and prediction of molecular dynamics, safety, and drug-drug interactions are planned to increase in functionality and scope in the coming quarters for both small molecule development and increasingly for ADC development, analytics and characterization.
Second Quarter 2024 Financial Highlights
Ø Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $33.3 million as of June 30, 2024, compared to approximately $41.3 million as of December 31, 2023. The quarterly cash burn rate continues to reflect our capital-efficient, collaborator-centered business model.
Ø R&D Expenses: Research and development expenses were approximately $3.9 million for the quarter ended June 30, 2024, compared to approximately $3.6 million for the quarter ended June 30, 2023.
Ø G&A Expenses: General and administrative expenses were approximately $1.5 million for the quarter ended June 30, 2024, compared to approximately $1.6 million for the quarter ended June 30, 2023.
Ø Net Loss: Net loss was approximately $4.96 million (or $0.46 per share) for the quarter ended June 30, 2024, compared to a net loss of approximately $4.75 million (or $0.44 per share) for the quarter ended June 30, 2023.
Ø Total Share and Warrant Count: There were no warrant exercises during the three months ended June 30, 2024. Following June 30, 2024, additional warrants were exercised which increased the Company’s total shares outstanding and reduced the number of outstanding warrants. As of the date of this press release, the Company has 10,764,725 shares of common stock outstanding, and outstanding warrants to purchase 70,000 shares of common stock.
Additional Operational Highlights:
Ø A publication was made in the AACR (Free AACR Whitepaper) Journals, Cancer Research Communications showcasing the potential for LP-184 to synergize with PARP inhibitors in a wide range of solid tumors that are HRD (homologous repair deficient). The preclinical findings in the paper illustrate the potential of LP-184 to be a pan-HRD cancer therapeutic – which could be the first drug of this type in this class. We believe the data and results support clinical evaluation of LP-184 in a large subset of HRD solid tumors.
Ø New data and scientific findings conducted in conjunction with Drs. Yong Du and Shiaw-Yih (Phoebus) Lin at MD Anderson were presented at The Immuno-Oncology Summit 2024. The findings showcased what Lantern believes to be the role of LP-184 to be combined with checkpoint inhibitors to provide greater response in TNBC due to synergy and to potentially transform TNBC tumors that are unresponsive (cold) to checkpoint inhibitors to responsive (hot). The poster was titled: LP-184, a Novel Acylfulvene, Sensitizes Immuno-Refractory Triple Negative Breast Cancers (TNBCs) To Anti-PD1 Therapy by Affecting the Tumor Microenvironment.
Ø With a focus on increasing visibility and awareness of the Lantern portfolio and capabilities, the Company launched Webinar Wednesdays in April. They are currently planned to be held on the last Wednesday of each month and are designed to showcase industry leaders in AI and drug development, as well as clinicians working in collaboration with Lantern’s portfolio of drug-candidates. The next three Webinar Wednesdays will include the topics of: 1) LP-300’s clinical results to-date, 2) RADR and our industry-leading ability to predict if a molecule or drug-compound will cross the BBB (Blood-Brain-Barrier), and 3) The role of LP-184 in synergizing with checkpoint inhibitors and IO agents.
Earnings Call and Webinar Details:
Lantern will host its 2nd quarter 2024 earnings call and webinar today, August 8th, 2024, at 4:30 p.m. ET. A link to register can be accessed at: Lantern 2nd Quarter 2024 Earnings Call & Webinar Link
Ø Related presentation materials will be accessible at: View Source
Ø A replay of the 2nd quarter 2024 earnings call and webinar will be available at: View Source