On August 9, 2023 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 ended June 30, 2023 (Press release, Lantern Pharma, AUG 9, 2023, View Source [SID1234634081]).

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"We made significant strides over the past quarter in executing our mission of transforming the oncology drug discovery and development process, especially with advancing our programs for LP-184 and LP-284 into the clinical setting and increasing our focus on developing next-generation ADCs. Our RADR AI platform is revolutionizing the way we understand and predict drug-cancer interactions, enabling us to advance our newly developed drug programs from initial AI insights to first-in-human clinical trials in an average of two years and at a cost of roughly $1-2 million per program – a milestone unheard of in the realm of oncology drug discovery," said Panna Sharma, CEO of Lantern Pharma.

Sharma continued, "Computational and AI-driven approaches are increasing their presence and usage at both large and emerging pharma companies for all facets of drug discovery and development. Our leadership in the innovative use of AI and machine learning to transform costs and timelines in the development of precision oncology therapies should yield significant returns for investors and patients as our industry matures and adopts an AI-centric approach to drug development. Our top-ranked AI algorithms can predict any compound’s blood-brain barrier permeability with 89-92% accuracy, a major breakthrough that could accelerate the timeline for developing treatments for brain and CNS cancers and also for other neurological disorders. We also presented breakthrough RADR advancements at the AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper) annual meetings this quarter, demonstrating an 88% accuracy in predicting patient responses for our biopharma collaborator with a unique drug candidate."

"Our unwavering commitment to harnessing the power of AI for drug discovery has also led to the formation of a collaboration with Bielefeld University to develop the next-generation of ADCs that are designed and advanced using AI. This collaboration has the potential to pave the way for higher efficacy, faster development, and significantly reduced costs in this rapidly growing and emerging treatment modality. These specific instances of value creation along with the development of an entirely new company, Starlight Therapeutics, whose sole focus will be on CNS and brain cancers, demonstrate that Lantern continues to be at the forefront of a transformative approach to oncology drug discovery, and we look forward to sharing more breakthroughs and advancements as we move forward," Sharma concluded.

Highlights of AI-Powered Pipeline:

● LP-184 – Received Food and Drug Administration (FDA) clearance of the investigational new drug (IND) application for LP-184 during the second quarter of 2023. LP-184 is the first of Lantern’s drug candidates to be developed entirely internally, with the assistance of Lantern’s AI and ML platform RADR, to advance to a first-in-human Phase 1 basket trial. Lantern has rapidly accelerated the clinical advancement of LP-184 and has activated the first two Phase 1 clinical trial sites and begun screening patients. Indications for the trial are anticipated to include relapsed/refractory advanced pancreatic cancer, glioblastoma (GBM), brain metastases (brain mets.), and multiple other solid tumor types with DNA damage response deficiencies.

The dosage and safety data obtained in the Phase 1 trial will be used to advance the central nervous system (CNS) indications for a future Phase 2 trial to be sponsored by Lantern’s wholly-owned subsidiary, Starlight Therapeutics. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $10+ billion, consisting of $5+ billion for CNS cancers and $6+ billion for solid tumors.

● LP-284 – IND-enabling studies for LP-284 have been completed, and Lantern expects to submit the IND application to the FDA in August. The first-in-human Phase 1 clinical trial launch of LP-284 is targeted for Q4 of 2023 for B-cell non-Hodgkin’s lymphomas (NHL), where LP-284 has shown nanomolar potency across multiple 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 reduced expression of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions.

Nearly all MCL patients relapse from the current MCL 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 and DHL are diagnosed in approximately 9,000 patients each year and have an estimated annual market potential of $1.2 billion.

● LP-300 – Dosed initial patients in the Phase 2 Harmonic trial, which is assessing the effect of LP-300 in combination with standard-of-care chemotherapy in never-smoker patients with relapsed non-small cell lung cancer (NSCLC). In addition to the dosed patients, more than two dozen potential patients have been pre-screened and are being monitored for possible enrollment across the multiple trial sites in the US. The Company is accelerating efforts to bolster recruitment, including activating multiple additional strategic sites across the US, potentially expanding the trial to countries in Asia that are known to have a significantly higher prevalence of never-smokers with NSCLC, and adding key experienced personnel to the clinical development and operations team.

Dr. Joseph Treat MD of Fox Chase Cancer Center has been appointed lead principal investigator of the Harmonic study. Dr. Treat is a leading expert in lung malignancies, including NSCLC in never smokers, and has dedicated his career, since 1991, to serving patients with lung cancer.

Globally, never-smokers with NSCLC are a growing population of patients and do not respond well to PD-1/PD-L1 based therapies, leaving them with reduced treatment options. In the US, there are approximately 20,000-40,000 never-smokers with NSCLC diagnosed annually, representing an estimated US annual market potential of $1.5 billion and a global estimated annual market potential of over $2.5 billion. Additional information on the Harmonic trial can be found at the Harmonic website and clinicaltrials.gov.

RADR Platform Growth and Development:

● RADR continues to advance in size, scope, and capabilities to accelerate the Company’s pipeline of precision therapeutics and also become a standard for AI-driven drug development in oncology. RADR has now surpassed 34 billion oncology-focused datapoints and is projected to reach 50 billion datapoints by the end of 2023. The scope of RADR’s data has broadened with a strategic focus on additional classes of compounds including antibodies, checkpoint inhibitors, and DNA damaging agents, and data from additional studies such as those being conducted clinically as a liquid biopsy for cancer diagnosis and treatment or those from preclinical combination studies that aim to define drug interaction and optimal dosage.

These datapoints and the associated advancements in automation have advanced RADR’s drug development capabilities including 1) predicting patient responses and identifying optimal combination regimens for immuno-oncology (IO) drugs such as immune checkpoint inhibitors, 2) predicting the BBB permeability, with 89% to 92% accuracy, of any compound at a scale and speed that allows the analysis of tens of thousands of compounds a day, and 3) accelerating the design and development of drug-conjugate templates for next-generation antibody-drug conjugates (ADCs) that have increased potential for improved safety and efficacy. These 3 modules exemplify the type of rapid and grounded progress the RADR platform will make over the next several quarters as it aims to improve the speed and reduce the costs and risks associated with creating cancer therapies.

● Lantern initiated a new collaboration with Bielefeld University to develop breakthrough ADCs. The collaboration with Bielefeld University’s Professor Norbert Sewald, Ph.D., a leading researcher in the field and head of the Magicbullet::reloaded consortium, is focusing on the synthesis and evaluation of novel ADCs linked to cryptophycins, a promising group of potent antitumor molecules. The global ADC market, currently valued at over $4 billion, is projected to reach $14 billion by 2027 and Lantern is positioned to be at the forefront of this rapidly growing sector.

Starlight Therapeutics:

● In Q1 2023, Lantern formed a wholly-owned subsidiary, Starlight Therapeutics Inc. ("Starlight"), for the clinical development of drug candidate LP-184’s central nervous system (CNS) and brain cancer indications – including GBM, brain mets., and several rare pediatric CNS cancers. Starlight will refer to the molecule LP-184, as it is developed in CNS indications, as "STAR-001".

● The company has begun discussions with leading clinicians and key opinion leaders at CNS-focused cancer centers to serve as clinical trial sites for upcoming clinical trials in adult and pediatric CNS cancers. Additionally, the formation of Starlight’s Scientific/Clinical Advisory Board is advancing and will be announced in Q3. The Advisory Board members are anticipated to help sharpen the aims and heighten the awareness of upcoming Starlight clinical trials.

Additional Operational Highlights:

● New findings published in Oncotarget demonstrated that drug candidate LP-284 has in vitro and in vivo antitumor potency in over 15 NHL models, including MCL and DHL. The journal article titled "LP-284 Targets Non-Hodgkin’s Lymphoma and DNA Damage Repair Deficiency" includes fundamental LP-284 findings demonstrating 1) LP-284 inhibited tumor growth in mice implanted with MCL xenografts at a level greater than current MCL standard of care (SOC) agents ibrutinib and bortezomib and 2) in MCL xenografts that had grown resistant to these SOC agents, subsequent LP-284 treatment led to near complete tumor regression.

● Lantern Pharma received a notice of allowance from the United States Patent and Trademark Office (USPTO) for the composition of matter patent, no. 17/192,838, covering the molecule LP-284, including claims covering the new molecular entity. Lantern Pharma expects the resulting LP-284 patent will be Orange Book-listable with an anticipated expiration of early 2039.

Additionally during the quarter, five new patent applications were filed for LP-184 and LP-284, with claims covering the use of these drug candidates in combination regimens for specific tumor subtypes.

● New data and findings to be presented at several upcoming scientific conferences:

● Society of Neuro-Oncology/American Society of Clinical Oncology CNS Cancer Conference in San Francisco, CA, on August 10th, 2023 from 5:30-7:30 p.m. PT. Link to conference registration here.
Presentation Title: LP-184, a novel acylfulvene-derived tumor site activated small molecule inhibits adult and pediatric CNS tumor cell growth

● International Conference on Drug Conjugates for Directed Therapy in Darmstadt, Germany on Thursday, August 24th, 2023 from 9:45-10:15 a.m. CEST. Link to conference registration here.
Presentation Title: In-silico Approach for the Identification of ADC Targets with Improved Tumor Selectivity

● Society of Hematologic Oncology Annual Meeting in Houston, TX on Wednesday, September 6th, 2023 at 6:00 p.m. CT. Link to conference registration here.
Presentation Title: Targeting Homologous Recombination Deficiencies in B-Cell Non-Hodgkin’s Lymphomas with the Novel Anti-Tumor Small Molecule LP-284

Second Quarter 2023 Financial Overview:

● Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $48.0 million as of June 30, 2023, compared to approximately $55.2 million as of December 31, 2022. The quarterly cash burn rate continues to reflect our capital-efficient, collaborator-centered business model.

● R&D Expenses: Research and development expenses were approximately $3.6 million for the quarter ended June 30, 2023, compared to approximately $3.0 million for the quarter ended June 30, 2022.

● G&A Expenses: General and administrative expenses were approximately $1.6 million for the quarter ended June 30, 2023, compared to approximately $1.4 million for the quarter ended June 30, 2022.

● Net Loss: Net loss was approximately $4.7 million (or $0.44 per share) for the quarter ended June 30, 2023, compared to a net loss of approximately $4.5 million (or $0.41 per share) for the quarter ended June 30, 2022.

Earnings Call and Webinar Details:

Lantern will host its second quarter 2023 earnings call and webinar today, Wednesday, August 9, 2023, at 4:30 p.m. ET.

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● Related presentation materials will be accessible at: View Source
● A replay of the second quarter earnings call and webinar will be available at View Source