LTRN: Expanding Horizons into Asia

    Date:

    By John Vandermosten, CFA

    NASDAQ:LTRN

    READ THE FULL LTRN RESEARCH REPORT

    Lantern Pharma, Inc (NASDAQ:LTRN) reported first quarter 2024 financial results and achievements. Over the last few months, the company has been granted yet another orphan designation, strengthened its management team and progressed in its antibody drug conjugate (ADC) program. It has also participated in scientific and investor events, accumulated over 60 billion data points for RADR and dosed its first patient in the LP-284 trial for non-Hodgkin’s lymphoma. We review these developments along with the company’s 2023 financial results.

    On May 9th, 2024, Lantern announced first 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 1Q:24 and incurred operating expense of $5.7 million, producing a net loss of ($5.4) million or ($0.51) per share.

    For the quarter ending March 31st, 2024 and versus the same comparable prior year period:

    ➢ Research & development expenses totaled $4.3 million, rising 67% from $2.6 million as spending on the LP-300 and LP-184 programs increased materially. Spending on the ADC program, RADR and LP-284 also rose, but to a lesser extent while funding allocated to the LP-100 program declined;

    ➢ General & administrative expenses were $1.5 million, falling 15% from $1.7 million. Lower payroll and compensation expense, decreases in insurance, lower professional fees and contractions in office and administrative fees contributed to the change. This was partially offset by an expansion in business development, legal and patent, and travel expenses;

    ➢ Interest income was $201,000 versus $134,000 while other income fell to $90,000 from $285,000. Other income fell on account of lower research and development tax incentives related to the Australian subsidiary, increases in foreign currency losses and increases in dividend income;

    ➢ Net loss was ($5.4) million, or ($0.51) per share, compared to ($3.9) million, or ($0.36) per share.

    As of March 31st, cash and marketable securities on the balance sheet totaled $38.4 million, compared to year end 2023 cash balances of $41.3 million. Cash burn for 1Q:240 was ($3.1) million versus ($3.8) million in the prior year comparable quarter. Cash from financing was $55,000 which was related to warrant exercises. This compares to no financing cash flows in 1Q:23.

    Expansion of Harmonic Trial to Asia

    An April 22nd press release informed investors that the Harmonic trial for non-small cell lung cancer (NSCLC) in never smokers will expand into Japan and Taiwan. One statistic from UCSF’s cancer center found that over 50% of Asian American females diagnosed with lung cancer did not smoke. In Chinese females, the proportion went as high as 80%.1 The susceptibility to lung adenocarcinomas from never-smoker females can be in part attributable to oncogenic mutations.2 Lantern identified a source that finds one-third of all lung cancer patients in East Asia are non-smokers. Clearly, this is an important market for LP-300 and expansion into this region will provide the data necessary for regulatory approval in areas that require additional studies conducted in target ethnic populations. These studies are frequently done in Asian populations, particularly in countries such as Japan, China and South Korea. Success in these populations would be an important tailwind for LP-300 as there is a material unmet need. Expansion into Asia may also increase the attractiveness of Lantern with global biopharma companies. A quick check of clinicaltrials.gov shows that the sites have not yet been listed, but we expect them to be added soon. Management expects to launch 5 sites in Japan and 5 sites in Taiwan, which should be sufficient to achieve a sufficient representation.

    Oregon Therapeutics

    Lantern established an AI-driven collaboration with Paris, France-based Oregon Therapeutics as described in a May 6th press release. Oregon will use RADR to optimize development of its protein disulfide isomerase (PDI) inhibitor designated XCE853. The candidate is intended to treat drug-resistant tumors and will leverage RADR’s algorithms and models to identify biomarkers and molecular signs of efficacy. Lantern’s platform will further propose potential combinations for XCE853. In return for use of its proprietary RADR platform, Lantern will receive equal IP ownership with Oregon and drug development rights in biomarkers, indications and pharmacological strategies for XCE853.

    Publications

    In April and May 2024, Lantern promulgated two publications highlighting the RADR platform, LP-284 and LP-184 which were presented at the American Association for Cancer Research conference. Below we summarize details from each.

    LP-184, a Novel Acylfulvene Molecule, Exhibits Anticancer Activity against Diverse Solid Tumors with Homologous Recombination (HR) Deficiency

    o Published in Cancer Research Communications, April 2024

    o Investigates the potential of LP-184 in targeting multiple tumors with impaired HR function and its mechanism of action as a DNA damaging agent

    o LP-184 induced elevated DNA double strand breaks in HR-deficient cancer cells

    o Depletion of key HR components BRCA2 or ATM in cancer cells conferred up to 12-fold increased sensitivity to LP-184

    o LP-184 showed nanomolar potency in a diverse range of HRD cancer models, including prostate cancer organoids, leiomyosarcoma cell lines and patient-derived tumor graft models of lung, pancreatic, and prostate cancers

    o LP-184 demonstrated complete, durable tumor regression in 10 patient-derived xenograft models of HRD triple-negative breast cancer including those resistant to PARP inhibitors

    o LP-184 displayed strong synergy with PARPi in ovarian and prostate cancer cell lines

    Phase 1a/1b clinical trial of LP-284, a highly potent TP53 mutation agnostic DNA damaging agent, in patients with refractory or relapsed lymphomas and solid tumors

    o LP-284 inhibited tumor growth at least 3-fold more than ibrutinib and bortezomib

    o LP-284 led to 99% tumor growth inhibition when used as a single agent and showed synergy with rituximab

    o Poster provided Phase Ia clinical study design including structure, enrollment criteria, endpoints and future objectives

    STAR-001

    Mouse model data for STAR-001, also known as LP-184 in the Lantern portfolio, has demonstrated potent anti-tumor efficacy in methylated and unmethylated glioblastoma (GBM). The candidate offers potency 3,000x higher in vitro compared to temozolomide, which is the standard of care for GBM. These results are independent of the repair enzyme O6-methylguanine-DNA methyltransferase enzyme (MGMT) status. In MGMT negative models, the inhibitory concentration 50% (IC50) value is 209 nmol/L in certain cell lines. In MGMT positive models, the IC50 value is below 100 nmol/L. STAR-001 in GBM is an attractive target as no effective single-agent therapy has been approved in decades and the candidate has shown effectiveness in preclinical models. Starlight is planning to launch a Phase Ib/II study in GBM in 2H:24.

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    ________________________

    1. Addressing High Lung Cancer Rates Among Female Asian Non-Smokers. Karen Gehrman. January 13, 2022.

    2. Ha, S., et al. Lung cancer in never-smoker Asian females is driven by oncogenic mutations, most often involving EGFR. Oncotarget. March 2015.

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