Full Press Release Details
Pharma Reports Fourth Quarter & Fiscal Year 2023 Financial Results and Business Highlights
| Multiple clinical trials across three AI-guided drug candidates are active with first expected data and readouts for LP-184 in the second half of 2024; with additional next-generation drug development programs approaching IND studies. | ||
| Dosed initial patients in both Phase 1 clinical trials for synthetic lethal drug-candidates, LP-184 and LP-284 , each of which are first-in-human molecules with the potential for use across multiple cancer indications. | ||
| Expanded Phase 2 LP-300 Harmonic clinical trial into 12 sites in the US and advanced towards initial regulatory allowance for trial commencement in Japan, Taiwan and South Korea where approximately 30-35+% of all lung cancer cases occur in never-smokers with NSCLC. | ||
| Advanced Starlight Therapeutics with hiring of Chief Medical Officer (CMO) and preparing for potential Phase 1B/2 clinical trial in adult CNS tumors beginning in second half of 2024. | ||
| Demonstrated significant advancement of our cryptophycin focused antibody-drug-conjugate program (cpADC) in multiple solid tumor models, with additional preclinical data to be generated during 2024 in advance of IND studies. | ||
| Exceeded 2023 goal of 60 billion datapoints for oncology drug development AI platform, RADR , and announced 100 billion datapoint goal for 2024 to include additional advancements in integrating generative AI features into platform functionality. | ||
| Approximately $41.3 million in cash, cash equivalents, and marketable securities as of December 31, 2023. | ||
| The conference call and webcast are scheduled for today, Monday March 18, 2024, at 4:30 p.m. ET / 1:30 p.m. PT. |
Wire)-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 fourth quarter and fiscal year ended December 31,
past quarter and the entire year of 2023 was a period of meaningful and remarkable progress for our programs and our AI platform at Lantern
Pharma. Our team demonstrated how combining emerging AI technologies, cancer biology models and experiments, chemical, molecular, and
multiomic biomarker data, along with large-scale patient data holds the promise of transforming timelines and costs in drug development
for oncology. We are very enthusiastic about 2024 and will be actively focused on meeting and possibly exceeding the milestones ahead
of us, which include potential initial data from our LP-184 Phase 1A trial; advancing the new company born from AI - Starlight
Therapeutics, which is focused wholly on CNS cancers; and progressing our ADC oncology program." said Panna Sharma, President and
CEO of Lantern Pharma."
continued, "Computational and AI-driven approaches are increasing their value-driving impact on oncology drug development, and
our team continues to increase the capabilities and usefulness of our platform while also helping to de-risk and sharpen the focus of
our existing clinical drug candidates. Our leadership in the innovative use of AI and machine learning to transform costs and timelines
in the development of precision oncology therapies has guided three drug development programs in active clinical trials. We believe this
pace of development with our focused team and resources should yield significant future benefits for investors and patients as our industry
matures, adopts and accepts a data and AI-centric approach to drug development."
of AI-Powered Pipeline:
has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit
lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with compromised functioning
of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions.
all MCL, DHL, and High Grade B-Cell Lymphoma (HGBL) patients relapse from the current standard-of-care agents and there is an urgent
and unmet need for novel improved therapeutic options for these patients. In the US and Europe, MCL, DHL, and HGBLs are diagnosed in
16,000-20,000 patients each year and have an estimated annual market potential of over USD 3+ billion.
dosage and safety data obtained in the Phase 1A trial are expected to be used to advance the central nervous system (CNS) indications
for a future Phase 1b/2 trial to be sponsored by Lantern's wholly owned subsidiary, Starlight Therapeutics. Additionally, AI and
preclinical studies are ongoing to further refine drug combination studies supporting the use of LP-184 to improve the durability of
response and/or the overall response rates in combination with FDA approved drugs that are widely used in cancer treatment. Globally,
the aggregate annual market potential of LP-184's target indications is estimated to be approximately $12+ billion, consisting
of $4.5+ billion for CNS cancers and $7.5+ billion for solid tumors.
never-smokers with NSCLC are a growing population of patients and do not respond well to PD-1/PD-L1-based therapies, leaving them with
reduced treatment options. In the US, there are approximately 20,000-40,000 never-smokers with NSCLC diagnosed annually, representing
an estimated US annual market potential of $1.5 billion and a global estimated annual market potential of over $2.6 billion. Additional
information on the Harmonic trial can be found at the Harmonic website and clinicaltrials.gov.
Platform Growth and Development:
will potentially focus additional data growth efforts of the RADR platform on: drug sensitivity data, combination treatment
outcome data, and biomarker data in rare cancers, and on emerging synthetic lethal targets that are aimed at accelerating the development
of new therapies for Lantern and its partners. Additionally, the RADR platform's generative AI capabilities, focusing
on molecular optimization and automated feature extraction to improve understanding and prediction of molecular dynamics, safety, and
drug-drug interactions are planned to increase in functionality and scope in the coming quarters.
recently recruited a Starlight Chief Medical Officer who will focus on Starlight's clinical trials, development of personnel to
execute on the planned clinical strategy and overall support in corporate development activity. Starlight and Lantern plan on initiating
Phase 1B/2 clinical trials during the second half of 2024. The market potential for the currently planned indications for Starlight's
synthetically-lethal, cancer-cell DNA damaging agent - STAR-001 - is estimated to be $4.5 billion to $5+ billion USD across
both adult and pediatric primary and secondary CNS cancers.
leveraged RADR , a proprietary AI platform for oncology drug development, for target selection and molecular payload characterization
in ADCs, and a unique, controlled conjugation approach for maximizing drug-to-antibody ratios while controlling for non-specific conjugation.
Lantern expects to move towards IND development of the ADC program during 2024 with a focus on select solid tumors that are unresponsive
or refractory to current therapies.
Operational Highlights:
Quarter & Fiscal Year 2023 Financial Highlights:
Call and Webinar Details:
will host its 4th quarter & full year 2023 earnings call and webinar today, March 18, 2024, at 4:30 p.m. ET.
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 over 60 billion 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.
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.
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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 promising observations in preclinical studies do not ensure that later
studies and development will be successful, (iii) the risk that we may not be successful in licensing potential ADC candidates or in
completing potential partnerships and collaborations, (iv) 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, (v) 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 (vi) 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
presentation 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.
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