Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (“AI”) company developing targeted and transformative cancer therapies using its proprietary RADR® AI and machine learning (“ML”...
DALLAS: Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (“AI”) company developing targeted and transformative cancer therapies using its proprietary RADR® AI and machine learning (“ML”) platform with multiple clinical-stage drug programs, today announced operational highlights and financial results for the third quarter 2024, ending September 30, 2024.
"Lantern is achieving remarkable momentum, balancing meticulous execution with innovation. While progressing on the initial positive results from our Harmonic™ trial in both the US and Asia, we are also advancing our RADR® AI platform to strategically guide our therapeutic pipeline. The emerging combination therapy opportunities we are identifying for both LP-184 and LP-284 underscore the strength of our AI-guided approach. Seeing our drug candidates advance in clinical trials, with the potential to meaningfully impact cancer patients' lives, reinforces our mission. Additionally, as Starlight Therapeutics enters its next chapter of growth in CNS cancers, we look ahead to our plans for a Phase1b/2 clinical trial for STAR-001. We remain focused on the objective of developing therapies—at a fraction of the cost and time of traditional drug development by using our AI platform and data-driven methodologies. Our goal is ultimately to address critical and often unmet patient needs in oncology," said Panna Sharma, President and CEO of Lantern Pharma.
Highlights of AI-Powered Pipeline:
The trial's safety profile has been especially promising, with no dose-limiting toxicities observed and no discontinuations due to LP-300 treatment-related toxicity. The most common adverse events were manageable decreases in white blood cell count and thrombocytopenia.
The Harmonic™ trial has now progressed to its randomization and expansion phase, which is designed to enroll up to an additional 84 patients in a 2:1 ratio comparing LP-300 plus standard-of-care chemotherapy versus chemotherapy alone. With regulatory approval to expand into multiple Asian countries, the trial is positioned to accelerate enrollment in the targeted patient population of never-smokers with NSCLC, which we believe represents a potential global market estimated at over $4 billion annually. Leading our Harmonic™ trial efforts in Japan is Dr. Yasushi Goto, a renowned physician and researcher at the National Cancer Center Japan, where the incidence of never-smoker NSCLC is more than double that of the United States. The company has also initiated five trial sites in Taiwan, where over 40% of the new lung cancer diagnoses are among never-smokers, strategically positioning the Harmonic™ trial in regions with the highest prevalence of the target patient population. Lantern believes that this improves the potential for drug-candidate LP-300 to develop collaboration and co-development partnerships with global biopharma companies with a primary focus in serving the Asian markets. The study's co-primary endpoints are progression-free survival (PFS) and overall survival (OS), with planned interim analysis after 31 patients have experienced disease progression which is expected by mid 2025.
The LP-184 development program received a significant boost with the FDA granting Fast Track Designation in glioblastoma, recognizing both the serious nature of GBM and the significant unmet medical need in this indication which affects more than 13,000 U.S. adults annually. Through Lantern's wholly-owned subsidiary Starlight Therapeutics, LP-184 (designated as STAR-001 for CNS indications) is being positioned for a Phase 1b/2a clinical trial in recurrent GBM that is targeted to begin in early 2025. Lantern has also made important progress towards developing a quantitative PCR-based molecular diagnostic test that could help identify patients most likely to respond to LP-184 treatment. Lantern is in the process of validating the PCR assay with patient samples from the initial seven cohorts from the LP-184 Phase 1a trial and we plan on using the molecular correlations to power future development and trial design.
Additional ongoing preclinical studies continue to demonstrate LP-184's potential, particularly in combination therapy settings with some of the most widely used FDA approved drugs. One of these combinations using an FDA approved agent, spironolactone, is directed at the treatment of GBM and will be part of the planned Phase 1b study. Recent data presented at scientific conferences has highlighted promising synergy when LP-184 is combined with various FDA-approved treatments, including PARP inhibitors and immune checkpoint inhibitors. LP-184 has also shown promise in cancers with DNA damage response deficiencies beyond deficiencies in homologous recombination repair, demonstrating synthetic lethality in indications beyond those traditionally considered for PARP inhibitors. With an estimated aggregate annual market potential of approximately $12+ billion across its target indications ($4.5+ billion for CNS cancers and $7.5+ billion for solid tumors), we believe LP-184 represents a significant commercial opportunity while potentially addressing critical unmet patient needs across multiple cancer types.
Third Quarter 2024 Financial Highlights
Additional Operational Highlights:
Earnings Call and Webinar Details:
Lantern will host its 3rd quarter 2024 earnings call and webinar today, November 7th, 2024, at 4:30 p.m. ET. A link to register can be accessed at: (LTRN: 3rd Quarter Earnings Call & Zoom link)
ABOUT LANTERN PHARMA
Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages billions of oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0 - 2.5 million per program.
Our lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials. We have also established a wholly-owned subsidiary, Starlight Therapeutics, to focus exclusively on the clinical execution of our promising therapies for CNS and brain cancers, many of which have no effective treatment options. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world.
Please find more information at:
FORWARD LOOKING STATEMENT:
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," “model,” "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that our research and the research of our collaborators may not be successful, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support existing and planned clinical trials and operations, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 18, 2024. You may access our Annual Report on Form 10-K for the year ended December 31, 2023 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
Lantern Pharma Disclosure Channels to Disseminate Information:
Lantern Pharma’s investors and others should note that we announce material information to the public about our company and its technologies, clinical developments, licensing matters and other matters through a variety of means, including Lantern Pharma’s website, press releases, SEC filings, digital newsletters, and social media, in order to achieve broad, non-exclusionary distribution of information to the public. We encourage our investors and others to review the information we make public in the locations above as such information could be deemed to be material information. Please note that this list may be updated from time to time.
Fonte: Business Wire
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