By John Vandermosten, CFA
READ THE FULL LTRN RESEARCH REPORT
Lantern Pharma, Inc (NASDAQ:LTRN) reports 2024 results highlighting several achievements including progress on its HARMONIC, LP-184 and LP-284 trials, a portfolio of expedited designations in multiple indications and advances in the RADR platform with modules that offer predictive algorithms for blood brain barrier (BBB) penetration and antibody drug conjugate (ADC) design.
The company continues to enroll its HARMONIC trial for LP-300 at sites around the globe with the most recent focus on Taiwan and Japan, where the prevalence of never-smoker non-small cell lung cancer (NSCLC) is from two to three times higher than in the United States. Lantern’s RADR (Response Algorithm for Drug Positioning & Rescue) platform continues to break ground with new capabilities in predicting blood brain barrier (BBB) permeability of drug candidates and improving the development of antibody drug conjugate (ADC) design. Lantern’s LP-184 gains another Fast Track designation for triple negative breast cancer (TNBC) following the receipt of the same designation for glioblastoma last October. The company also directed a spotlight towards its STAR-001 (LP-184) program at the Society for Neuro-Oncology (SNO) 2024 conference. The associated poster provided support for the combination of spironolactone with the next-generation acylfulvene in glioblastoma multiforme (GBM) and clarified the path forward for STAR-001 with the candidate’s trial design. GBM also made an appearance in a recent transaction where Jazz Pharmaceuticals (NASDAQ:JAZZ) made a bid to acquire Chimerix (NASDAQ:CMRX) for its brain cancer drug for almost $1 billion. The deal should provide an additional framework for determining the value of Lantern’s STAR-001 asset in GBM.
On March 27th, 2025, Lantern announced 2024 financial and operational results, filed its Form 10-K with the SEC and hosted a video webcast to review accomplishments. A slide deck was included to guide the discussion. In the financial sphere, Lantern generated no revenues in 2024 and incurred operating expense of $22.2 million, producing a net loss of ($20.8) million or ($1.93) per share.
For the year ending December 31st, 2024 and versus the same prior year period:
- Research & development expenses totaled $16.1 million, rising 36% from $11.9 million as spending on the LP-184 and, to a lesser extent, on the LP-300 program contributed to the increase. There were also spending jumps for LP-284, the RADR platform and other costs which were partially offset by lower spending on the LP-100 and ADC program. In terms of spending categories, Lantern experienced increases in research study material costs, higher salary and benefits and expanded consulting expenses;
- General & administrative expenses were $6.1 million, rising 2% from $6.0 million. Higher professional fees were partially offset by lower wage and benefit costs, a decrease in insurance expense and a decline in stock-based compensation;
- Interest income was $742,000 versus $765,000 while other income fell to $693,000 from $1.2 million. Other income fell due to foreign currency translation loss and the absence of research and development tax incentives related to the Australian subsidiary;
- Net loss was ($20.8) million, or ($1.93) per share, compared to ($16.0) million, or ($1.47) per share.
As of December 31st, 2024 cash and marketable securities on the balance sheet totaled $24.0 million, compared to year end 2023 cash balances of $41.3 million. 2024 cash burn was ($17.8) million versus ($14.4) million in the prior year. 2024 cash from financing of $67,000 has been solely generated from warrant exercises. Management anticipates sufficient cash to support operations for the next 12 months.
LP-184 Trial in Multiple Solid Tumors
Triple Negative Breast Cancer
LP-184 Receives Fast Track Designation
The FDA granted Lantern’s LP-184 a Fast Track designation in triple negative breast cancer (TNBC) late last year. This is the second such designation that the FDA has granted LP-184 in 2024. In October 2024, LP-184 was awarded Fast Track for a glioblastoma indication. Fast Track is granted to drug candidates that address serious or life-threatening conditions and an unmet medical need. The designation enables more frequent communication with the FDA, eligibility for rolling review and potential qualification for accelerated approval or priority review.
LP-184 is being evaluated in a Phase Ia clinical trial in patients with advanced solid tumors (NCT05933265) including TNBC. In a similar approach to what was taken in the HARMONIC trial, Lantern has gone international to high prevalence areas to enroll TNBC patients. It will expand to a leading academic cancer center in Nigeria. This region is attractive as there is a high incidence of TNBC which present mutations that may be particularly well addressed by LP-184. The trial is also enrolling patients diagnosed with glioblastoma multiforme (GBM), which was also granted a Fast Track designation last October.
TNBC Poster
Several authors on behalf of Lantern presented a poster entitled LP-184, a Novel Acylfulvene, Sensitizes Immuno-refractory Triple Negative Breast Cancers (TNBCs) to Anti-PD1 Therapy by Affecting the Tumor Microenvironment at the AACR Immuno-Oncology Conference in February. The poster summarized LP-184 work examining synergistic anti-tumor efficacy in a mouse TNBC model, gene expression at the single cell level as well as antigen presentation and interferon signaling in tumor cells among other preclinical studies in TNBC.
Conclusions from the poster found a synergistic anti-tumor response for LP-184 in combination with anti-PD-1 compared to monotherapies in mouse TNBC tumors that are non-hypermutated and IO agent resistant. LP-184 treatment appeared to reshape the tumor microenvironment by decreasing M2 macrophages, increasing T cell infiltration and enhancing individual T cell function when combined with immune checkpoint blockade therapy.
Other LP-184 Indications
The Phase Ia LP-184 trial continues to advance and is now enrolling cohort 11. Indications of clinical activity have been observed at higher dose levels. Dose levels 7, 8 and 9 were cleared without safety concerns during 4Q:24 and preliminary pharmacokinetic data suggest dose proportionality with exposure. Enrollment at dose level 9 and above is focused on inclusion of advanced solid tumor patients that have identified DNA damage repair mutations. We expect an update in 2Q:25 after recruitment is complete. The announcement is expected to include safety and dose response data. Lantern has enrolled over 50 patients in this trial, nearing the anticipated 60 target.
Expansion of Harmonic Trial to Asia
An April 22nd, 2024 press release informed investors that the Harmonic trial for non-small cell lung cancer (NSCLC) in never smokers will expand into Japan and Taiwan. A 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. Asia is an important market for LP-300 and clinical work in this region will provide the data necessary for regulatory approval in areas that require additional studies conducted in target ethnic populations. 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 Lantern’s attractiveness with global biopharma companies. Management has activated ten sites in the region and as of mid-November enrolled its first patient in Japan and by early December, enrolled its first patient in Taiwan. All sites are continuing to actively screen patients. Lantern now has seven active sites in the US, five in Japan and five in Taiwan. Enrollment has been markedly faster and the time between screen and enrollment has been shorter in Asia compared with the US. In the SEC filing, Lantern noted that enrollment in the US had been challenging which was another justification beyond the indication prevalence to move there.
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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.
