READ THE FULL LTRN RESEARCH REPORT
On May 3, 2022, Lantern Pharma, Inc. (NASDAQ:LTRN) announced 1Q:22 annual financial and operational results, filed its Form 10-Q with the SEC and hosted a video webcast to review accomplishments. Lantern expects its Phase II Harmonic trial to enroll its first patient in summer 2022 and announced that it had surpassed 20 billion data points on the RADR platform with future data collection centered upon synthetic lethality and drug combinations. LP-184 is conducting IND-enabling work that can potentially lead to multiple clinical trials following the expected 3Q:22 IND submission for the candidate. The company also elaborated on its establishment of an Australian subsidiary that can take advantage of tax credits down under and provide a resource for conducting clinical trials. Scientific collaborations were also featured, primarily the Greehey Children's Cancer Center Research Institute to investigate pediatric cancers.
Highlights for the first quarter and to-date include:
➢ Precision oncology collaboration with NCI expanded - January 2022
➢ Collaboration and research agreement executed with DCRC - January 2022
➢ LP-184 Rare Pediatric Disease and Orphan Drug Designations granted - January 2022
➢ Collaboration with Greehey Children's Cancer Research Institute, San Antonio - February 2022
➢ RADR exceeds 20 billion data points – May 2022
Lantern generated no revenues during the first quarter and incurred operating expense of $4.1 million, producing a net loss of ($4.1) million or ($0.38) per share.
For the quarter ending March 31, 2022 and versus the same ending March 31, 2021:
➢ Research & development expenses totaled $2.7 million, rising 108% from $1.3 million on increases in product candidate manufacturing related expenses, higher expenditures for research studies, greater consulting expense and the recognition of an escrow payment released to Allarity Therapeutics;
➢ General & administrative expenses were $1.4 million, rising 20% from $1.2 million, due to higher office and administrative expense, a rise in rent and travel expenses, increased stock compensation, legal and patent fees, and other costs partially offset by lower corporate insurance expense;
➢ Interest income was $22,000 vs. $0 in the prior period attributable to investments in marketable securities while other income was ($78,000) recognizing a loss on equity securities;
➢ Net loss was ($4.1) million, or ($0.38) per share, compared to ($2.5) million, or ($0.24) per share.
At the end of 1Q:22, cash and marketable securities on the balance sheet totaled $65.2 million, declining $5.5 million sequentially. Cash burn for the quarter was ($3.3) million, vs. ($2.1) million consumed in the prior year. Lantern consumed another ($2.2) million in cash from financing related to the repurchase of common stock.
AACR Poster for LP-184
Lantern presenter Aditya Kulkarni, Ph.D. presented a poster entitled "LP-184, a tumor site activated small molecule synthetic lethal therapeutic, is effective in central nervous system cancers" at the American Association of Cancer Research (AACR) annual meeting, April 8th, 2022, held in New Orleans, Louisiana. The poster highlighted the need for additional blood brain barrier permeable agents to treat glioblastoma multiforme (GBM) and atypical teratoid/ rhabdoid tumors (ATRT). Both cancers are lethal with short survival periods and are insufficiently responsive to existing treatments such as temozolomide. Preclinical in silico work has shown that LP-184 may be effective in O6-methylguanine-DNA methyltransferase (MGMT) unmethylated cancers. Activated LP-184 creates covalent DNA adducts that are selectively repaired. Consistent with this, Lantern observed 2-5x increase in cytotoxicity in several GBM cells treated with LP-184 in combination with Spironolactone relative to LP-184 alone. This supports LP-184's function as a synthetic lethal agent in the presence of DNA repair deficiencies.
Key findings from the study are:
➢ Subcutaneous xenograft models of both GBM and ATRT showed rapid and near complete tumor regression with durable responses after 2 treatment cycles with LP-184.
➢ Orthotopic xenograft models of GBM in mice treated with LP-184 showed statistically significant survival benefit after a single treatment cycle.
➢ Co-treatment of several GBM cell lines with LP-184 and Spironolactone, an ERCC3 inhibitor, results in 3-6x increased anti-tumor activity.
➢ LP-184 has favorable blood brain barrier penetration with a brain tumor to plasma ratio of 0.2.
➢ Efficacy of LP-184 may extend beyond primary brain cancers to other solid tumors that have metastasized to the brain as evidenced by in vitro efficacy in brain met cell lines.
Phase II Clinical Trial For LP-300
Lantern will soon begin its Phase II trial for LP-300 in never-smoker non-small cell lung cancer (NSCLC) patients in a study designated HARMONIC. Lung cancer is the leading cause of death among cancer patients in the US, and one in six lung cancer deaths will occur in never-smokers. Previous clinical results1 showed that the sub-population of never smokers, and especially female never smokers, benefited from a 125% increase in 2-year survival receiving LP-300 + cisplatin + paclitaxel compared to the doublet chemotherapy.
Over the last several quarters, delays related to equipment, materials and staffing at the drug manufacturer have slowed the delivery of product to clinical sites for LP-300. Logistics relating to the identification, staffing and briefing of clinical sites also caused a pause. Management informed investors that the hurdles have largely been addressed and the trial should enroll its first patient in summer 2022. Partner Deep Lens was added to the roster in order to accelerate recruitment of suitable patients in the never-smoker NSCLC study. The partner's technology will search through thousands of medical records to match the most appropriate patients with the objectives of the trial.
Harmonic will enroll an estimated 90 subjects at 15 - 20 sites with 4 to 5 patients expected per site which with the first enrollee expected in summer 2022. The subjects will be randomized into two arms 2:1, receiving LP-300 (18.4 g/m2) + cisplatin + paclitaxel vs cisplatin + paclitaxel, respectively. Inclusion criteria stipulates enrollment of never smoker patients with relapsed advanced primary adenocarcinoma of the lung. The trial will require approximately two years to produce the necessary data. Primary objectives will be to evaluate overall- and progression-free survival.
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1. DMS32212R, BioNumerik Pharmaceuticals
2. Source: Lantern Pharma April 2022 Presentation
