On May 3, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported financial results and operational highlights for the first quarter ended March 31, 2022 (Press release, Lantern Pharma, MAY 3, 2022, View Source/news/press-releases/detail/87/lantern-pharma-reports-first-quarter-2022-financial-results" target="_blank" title="View Source/news/press-releases/detail/87/lantern-pharma-reports-first-quarter-2022-financial-results" rel="nofollow">View Source [SID1234613398]).
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"Lantern is at a very exciting inflection point as we continue to make significant and meaningful progress in translating key insights generated by our A.I. platform into preclinical and clinical programs," stated Panna Sharma, President and CEO of Lantern Pharma. "Our proprietary RADR A.I. platform recently surpassed 20 billion data points and is on a solid trajectory to surpass our year-end goal of 25 billion data points. This accelerates our ability to generate new insights to further power our development decisions for our drug candidates, as well as drug candidates from our biopharma collaborators."
"In mid-April, an amendment to the IND application for the planned Phase 2 trial for LP-300, the HARMONIC clinical trial, was submitted to the FDA. The Harmonic trial is focused on never-smokers with non-small cell lung cancer (NSCLC) and is expected to begin enrolling patients in the second half of this year. Additionally, we remain on track to launch up to two Phase 1 trials for LP-184 in cancers with significant clinical need. We also anticipate reporting data from multiple preclinical programs this year, including programs focused on pediatric cancers and those that exploit the synthetic lethality potential of our compounds." continued Sharma.
Operational Highlights:
RADR Platform Growth and Development
Surpassed 20 billion data points for RADR A.I. platform and we expect to reach our goal of over 25 billion data points by year end.
RADR utilizes over 150 different algorithms that have yielded insights for our drug programs. These algorithms are focused on critical questions in oncology drug discovery and development.
Filed a patent application covering claims for the development of ensemble and deep learning methods and algorithms, including automated algorithm development within RADR.
Future RADR growth will focus on additional functionality and modules that aid in the discovery and development of compounds that can leverage synthetic lethality, and in the prediction of potential combination regimens across multiple drug classes, including those that have not previously been utilized in cancer.
Lantern’s Portfolio of Targeted Therapies
Lantern Pharma is currently developing four drug candidates and an Antibody-Drug Conjugate (ADC) program across nine disclosed tumor targets, and several undisclosed targets. Lantern’s portfolio currently includes:
LP-300 – is preparing to enter a Phase 2 clinical trial, the HARMONIC clinical trial, in the Summer of 2022. The HARMONIC trial will be a 90 patient, two-arm, randomized, open label clinical trial focused on never-smoker patients with relapsed primary adenocarcinoma of the lung, a type of NSCLC. An amendment to the IND, including a finalized clinical study protocol, was submitted to the FDA in mid-April and the first patients are anticipated to be enrolled in the Summer of 2022. The HARMONIC trial is anticipated to include 15-20 sites in the US, of which multiple are currently being contracted for enrollment.
LP-100 – is in a Phase 2 trial in Denmark for patients with metastatic castration resistant prostate cancer (mCRPC) that meet a certain genomic signature that correlates to enhanced sensitivity to LP-100. In the initial cohort of patients, nine patients experienced a median overall survival of 12.5 months. We are evaluating possibilities for further enrollment in the current Phase 2 trial as well as other potential clinical development opportunities that we believe can further de-risk the program while increasing the potential for patient benefit that exceeds the current standards of care.
Based on existing data demonstrating synergy between LP-100 and PARP inhibitors, we are currently investigating the potential of combination therapy for these two agents.
LP-184 – is in preparation for potentially multiple Phase 1 clinical trial launches for genomically defined pancreatic and bladder cancers as well as CNS cancers including glioblastoma multiforme (GBM), atypical teratoid rhabdoid tumors (ATRT), and brain metastases (brain mets).
The IND enabling studies for LP-184 are in progress and are anticipated to be completed by Q3 2022. Based on current timeline projections, the Company is targeting to file the LP-184 IND submission with the FDA in Q3 and should be in a position to initiate in-human Phase 1 clinical testing before the end of 2022.
Lantern announced data supporting the efficacy of LP-184 in brain mets in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 annual meeting. The poster highlighted the in vitro anti-tumor activity of LP-184 in brain mets cell models from lung, skin, and breast cancers. In the US, brain mets occur in around 10-30% of all cancer cases and are diagnosed in well over 100,000 patients each year.
There is an urgent and unmet clinical need for new therapies for brain mets due to a current lack of novel agents that can cross the blood brain barrier (BBB). LP-184’s favorable BBB permeability, paired with its observed preclinical efficacy in certain CNS cancers, underscore its potential to become a vital treatment option for patients relapsed from current standard of care treatment or for use in combination with other agents.
LP-284 – is in preclinical development and has demonstrated potency at low nanomolar levels in hematological cancer cell lines, including lymphoma, multiple myeloma, and leukemia. LP-284’s indications in hematological cancers are distinct from the indications targeted by LP-184 and were generated with the assistance of RADR insights.
Antibody Drug Conjugate (ADC) Program – we have selected and ranked multiple targeting antibodies of interest with potential to be linked to selected cytotoxic payloads. We are in late-stage candidate selection of various cytotoxic compounds and targeted classes of agents to be used as ADC payloads.
Establishment of Australian Subsidiary
In September 2021, Lantern created an Australian subsidiary, Lantern Pharma Australia Pty Ltd. The subsidiary was created to enable Lantern to take advantage of Australia’s R&D Tax Incentive program, which provides tax offsets for eligible R&D expenditures.
This program will provide the opportunity for Lantern to conduct upcoming preclinical and clinical trials with increased financial flexibility and capital efficiency. Lantern has already initiated preclinical and IND enabling studies under the subsidiary in Australia.
Lantern may conduct first in-human phase 1 clinical trials in Australia due to its historical capability for cost-effectiveness, accelerated timelines, and timely regulatory approval. We believe that this aligns with the Company’s focus to develop oncology therapies with reduced time and cost.
Scientific Collaborations Updates
In early 2022, Lantern entered a collaboration with The Greehey Children’s Cancer Research Institute (GCCRI) at University of Texas Health Science Center-San Antonio to expand Lantern’s drug portfolio research into several additional pediatric cancers with unmet clinical needs.
The studies from this collaboration have been initiated beginning with LP-184 treatment of nine in vitro models of pediatric cancers. The preliminary results have been promising and will be completed in Q2 2022.
Lantern is evaluating additional collaborations with leading academic cancer institutions and researchers for LP-284.
First Quarter 2022 Financial Overview
Balance Sheet: Cash, cash equivalents, and marketable securities were $65.2 million as of March 31, 2022, compared to $70.7 million as of December 31, 2021. The quarterly cash burn continues to reflect our capital-efficient, collaborator-centered business model. $5.3 million in cash was utilized during the three months ended March 31, 2022, of which $2.5 million was for the share repurchase program, with the remainder primarily attributable to core operations.
R&D Expenses: Research and development expenses were $2.7 million for the quarter ended March 31, 2022 compared to $1.3 million for the quarter ended March 31, 2021. The increase in R&D expense was primarily attributable to increases in manufacturing related expenses for product candidates, research studies, and an escrow payment released to Allarity under the Allarity Asset Purchase Agreement, which payment was a nonrecurring expense.
G&A Expenses: General and administrative expenses were $1.4 million for the quarter ended March 31, 2022 compared to $1.2 million for the quarter ended March 31, 2021, respectively.
Net Loss: Net loss was $4.1 million (or $0.38 per share) for the quarter ended March 31, 2022, compared to a net loss of $2.5 million (or $0.24 per share) for the quarter ended March 31, 2021.
Additional Financial Highlights
In March 2022, Lantern’s Board of Directors authorized an extension of the existing share repurchase program to acquire up to $7 million of the Company’s common stock. Under the share repurchase program, through March 31, 2022 the Company has purchased a total of 475,157 shares of its common stock at a total cost of approximately $3.4 million, including fees. The Company is authorized to additionally purchase up to a total of $3.6 million of the Company’s common stock through July 31, 2022, pursuant to the repurchase program.
Nomination of New Board Member for Election and Annual Meeting of Stockholders
Lantern recently announced that Dr. Maria Maccecchini, Ph.D. was nominated for election to our Board of Directors. She is the current CEO, President, and a Director of Annovis Bio Inc., a biopharma company focused on developing therapies for neurodegenerative diseases. If elected, Dr. Maccecchini will bring decades of experience in progressing drug candidates through late-stage clinical trials. Dr. Maccecchini will be presented alongside a slate of five existing Directors at Lantern’s upcoming Annual Meeting of Stockholders to be held on June 8, 2022. Additionally, Leslie W. Kreis, Jr., a member of Lantern Pharma’s Board of Directors since 2019, has advised Lantern’s Board of his determination not to stand for reelection as a Director at Lantern’s Annual Meeting.
The Annual Meeting of Stockholders will be held on June 8, 2022 at 11:00 am EST/ 8:00 am PST, which will be held via webcast. Register for the Annual Meeting here.
2022 Outlook:
"During the year we expect to bring multiple assets into focused clinical trials where there is demonstrated clinical need, while remaining focused on capital efficiency. Additionally, our A.I. platform, RADR, will continue to grow significantly across all measures – data, analytical rigor, generation of new publishable insights, and new functionality. As data and A.I. continue to drive changes in the cost, speed and efficiency of drug discovery and development, our team at Lantern will remain at the forefront of transforming oncology therapeutic development."
Earnings Call and Webinar Details
Lantern will host its first quarter fiscal year 2022 earnings call and webinar today, Tuesday, May 3 at 4:30 p.m. ET.
View Source
Related presentation materials will be accessible at: View Source
Replay Details
A replay of the Q1 2022 earnings call and webinar will be available at View Source.