NASDAQ:LTRN
READ THE FULL LTRN RESEARCH REPORT
Lantern Pharma, Inc (NASDAQ:LTRN) reported second quarter 2024 financial results and achievements in an August 8th, 2024 press release. Since our previous report, the company has been granted a patent for LP-284 in Japan, shared preclinical results for LP-184 and provided a clinical update on the lead-in cohort for the Phase II Harmonic trial in never smoker NSCLC. It has also participated in scientific and investor events earlier this year and accumulated over 100 billion data points for RADR. We review these developments along with the company’s 2Q:23 financial results.
On August 8th, 2024, Lantern announced second quarter 2024 financial and operational results, filed its Form 10-Q with the SEC and hosted a video webcast to review accomplishments. In the financial sphere, Lantern generated no revenues in 2Q:24 and incurred operating expense of $5.4 million, producing a net loss of ($5.0) million or ($0.46) per share.
For the quarter ending June 30th, 2024 and versus the same comparable prior year period:
➢ Research & development expenses totaled $3.9 million, rising 9% from $3.6 million as spending on the LP-184 and, to a lesser extent, on the RADR platform and other R&D programs increased. These increases were partially offset by lower spending on the LP-300, LP-100, LP-284 and ADC program. In terms of spending categories, Lantern experienced increases in research studies, consulting expenses and payroll and compensation expenses;
➢ General & administrative expenses were $1.5 million, falling 7% from $1.6 million. Lower payroll and compensation expense, decreases in insurance, lower professional fees and contractions in business development efforts contributed to the change. This was partially offset by an expansion in professional fees and legal and patent expenses;
➢ Interest income was $189,000 versus $118,000 while other income fell to $260,000 from $326,000. Other income fell on account of lower research and development tax incentives related to the Australian subsidiary, increases in unrealized gains on investments, and reductions in foreign currency losses;
➢ Net loss was ($5.0) million, or ($0.46) per share, compared to ($4.7) million, or ($0.44) per share.
As of June 30th, cash and marketable securities on the balance sheet totaled $33.3 million, compared to year end 2023 cash balances of $41.3 million. Cash burn for 2Q:24 was ($5.2) million versus ($3.6) million in the prior year comparable quarter. For the first half of 2024, cash burn was ($8.3) million vs. ($7.4) million for 1H:23. No cash from financing was recognized in 2Q:24. Management anticipates sufficient cash to support operations until 3Q:25.
Harmonic Lead-In Cohort Clinical Update
On August 5th, Lantern provided a clinical update to its Phase II Harmonic trial highlighting that six of seven patients experienced clinical benefit from LP-300 combination treatment. Of these patients comprising the lead-in cohort, three showed partial response (PR) and three others exhibit stable disease (SD). Average tumor size reduction for the partial responders was 51% and for those with stable disease, 13%. These results produce a clinical benefit1 and disease control2 rate of 86% and an objective response rate (ORR) of 43%.
Safety was another strong point for Harmonic. A preliminary analysis found no safety concerns, dose limiting toxicities or treatment related serious adverse events. The most common adverse events were a decrease in white blood cell count and thrombocytopenia.
Patients in this first stage of the trial were never smoker NSCLC patients who had failed on previous tyrosine kinase inhibitor (TKI) therapy. These individuals received treatment with LP-300 along with carboplatin and pemetrexed.
These results compare favorably to historical responses to other combination studies that measure an investigational drug with pemetrexed and carboplatin in non-small cell lung cancer (NSCLC) patients who have relapsed following TKI therapy.
Other highlights from the trial include a 57% reduction in tumor size for a patient that has been enrolled in the study for 14 months. The seventh patient that did not achieve a PR or SD experienced progressive disease. Investigators observed that the patients with low to intermediate tumor mutation burden were most responsive to LP-300 combination therapy.
A second stage of the trial is planned following the favorable safety profile generated in the first stage. The trial is now in the randomization and expansion phase where 80 additional patients will be placed in the LP-300 + SoC or SoC arms of treatment. Results from this portion of the study will be provided when 30 clinical events have been observed. If the data are supportive, Lantern will consider applying for a Breakthrough Therapy designation.
Summary
Lantern provided a first look at Harmonic’s initial cohort evaluating LP-300 in non-smoker NSCLC. Clinical benefit was observed in six of seven patients and there were no toxicities beyond what is expected from standard of care in these patients. Now that the first cohort has been evaluated, and new sites in Asia have been added, screening is taking place overseas and we expect an acceleration in enrollment to take place. Along with LP-300, Lantern has active trials advancing LP-184 and LP-284 in Phase I studies. Starlight Therapeutics, Lanterns CNS cancer subsidiary, initiating site selection and feasibility of a Phase Ib or Phase II trial in recurrent glioblastoma multiforme with its STAR-001 candidate. Collaborations continue to build with the recent addition of Oregon Therapeutics to the stable, bringing the total to four.
Lantern offers an artificial intelligence platform called RADR which offers multiple modules that evaluate mechanism of action, identify drug combinations, prioritize indications, enhance selection of ADC components among other features. The system has evolved to accumulate and curate data on its own. Lantern has combined AI and drug development to become a pioneer in the use of computer intelligence to identify high probability of success candidates.
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1. Clinical Benefit Rate (CBR) is the percentage of patients who had a complete response, partial response, or had stable disease for 6 months or more. This is the proportion of patients who received a benefit from the intervention.
2. Disease control rate (DCR) is the proportion of patients who, according to internationally recognized criteria for alleviating evaluation, achieve tumor relief (PR+CR) and stable disease (SD) after treatment and can maintain for the minimum duration requirement.
