- Lantern is advancing three AI-guided precision-oncology drug
candidates in active Phase 1 and Phase 2 clinical trials, while
evaluating additional ADC-based preclinical molecules for
development.
- Preliminary patient data and clinical readouts for the Phase 2
LP-300 Harmonic™ Trial showed an 86% clinical benefit rate
in the initial 7 patient lead-in cohort, and additional patients
continue to be enrolled in the US.
- The Harmonic™ Trial has been expanded to both Japan and
Taiwan with an expected 10 sites in East Asia; 5 in each country
where the population of never-smokers is 33 to 35 percent of new
cases in NSCLC.
- Phase 1 clinical trials for both synthetic lethal drug
candidates, LP-184 and LP-284, continue to advance
with no dose-limiting toxicities observed in any of the patient
cohorts enrolled and over 50 patients dosed to-date across both
trials.
- LP-184, which will be developed as STAR-001 for
CNS and other neuro-oncology indications, received Fast Track
Designation in Glioblastoma (GBM) from the FDA.
- Patients with recurrent GBM have been enrolled in the
LP-184 Phase 1a trial at 2 academic centers, including Johns
Hopkins, and 1 community site; the data will help guide later stage
clinical development planned to be sponsored by Starlight
Therapeutics during early 2025.
- Biomarker analysis for PTGR1 expression using qPCR for
the first 7 cohorts of patients enrolled in the Phase 1a
LP-184 clinical trial has begun, and will help guide the
advancement of PTGR1 as a key RNA biomarker that can guide
patient response prediction.
- Three U.S. FDA Rare Pediatric Disease Designations were
granted to LP-184 in three ultra rare children’s
cancers.
- Three scientific publications in Q3 including: a peer-reviewed
paper regarding the unique AI-powered module for ADC development as
part of the RADR® platform; and findings presented at conferences
regarding the ongoing development of Lantern’s synthetically-lethal
drug candidates at the Immuno-Oncology Summit for LP-184 and The
Society of Hematologic Oncology for LP-284.
- Approximately $28.1 million in cash, cash equivalents,
and marketable securities as of September 30, 2024.
- The conference call and webcast are scheduled for Thursday,
November 7, 2024 at 4:30 p.m. ET.
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:
- LP-300: The Harmonic™ Phase 2 Clinical Trial – The Phase
2 Harmonic™ trial is aimed at making a significant advancement in
addressing an urgent unmet need for never-smoker patients with
non-small cell lung cancer (NSCLC). In the initial safety lead-in
cohort of 7 patients, LP-300 demonstrated encouraging preliminary
results when combined with standard-of-care chemotherapy
(pemetrexed and carboplatin), achieving an 86% clinical benefit
rate and a 43% objective response rate. Of particular note, 3
patients achieved partial responses with an average tumor size
reduction of 51%, while 3 additional patients achieved stable
disease with an average tumor reduction of 13%. Importantly, these
preliminary results were observed regardless of prior tyrosine
kinase inhibitor (TKI) treatments, patient demographics, or
metastatic disease sites, suggesting broad potential applicability
across the never-smoker NSCLC population.
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.
- LP-184 – LP-184 continues to advance through its Phase
1a first-in-human basket trial (NCT05933265) across multiple solid
tumor indications. Nine patient cohorts have been successfully
dosed at escalating dose levels, and no dose-limiting toxicities
observed to date. The trial is actively enrolling patients with
relapsed/refractory advanced solid tumors, including pancreatic
cancer, glioblastoma (GBM), triple-negative breast cancer, and
other solid tumor types with DNA damage response deficiencies.
Based on pharmacokinetic analyses, the upcoming cohorts are
expected to reach dosage levels where therapeutic concentrations
should be attainable, with enrollment projected to complete this
year and initial safety and molecular correlation data expected by
year-end 2024 or early 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.
- LP-284 – The fourth cohort of patients are being dosed,
and no dose-limiting toxicities have been observed in the LP-284
Phase 1a clinical trial. We are in the process of opening
additional hematology-focused sites later this year, with the
potential to advance to Phase 1b or 2 by early to mid 2025. LP-284
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. Nearly all MCL, DHL, and 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 these indications
represent an estimated annual market potential of over $3+
billion.
Third Quarter 2024 Financial Highlights
- Balance Sheet: Cash, cash equivalents, and marketable
securities were approximately $28.1 million as of September 30,
2024, compared to approximately $41.3 million as of December 31,
2023. The quarterly cash burn rate continues to reflect our
capital-efficient, collaborator-centered business model.
- R&D Expenses: Research and development expenses were
approximately $3.7 million for the quarter ended September 30,
2024, compared to approximately $2.2 million for the quarter ended
September 30, 2023.
- G&A Expenses: General and administrative expenses
were approximately $1.5 million for the quarter ended September 30,
2024, compared to approximately $1.3 million for the quarter ended
September 30, 2023.
- Net Loss: Net loss was approximately $4.5 million (or
$0.42 per share) for the quarter ended September 30, 2024, compared
to a net loss of approximately $3.2 million (or $0.29 per share)
for the quarter ended September 30, 2023.
- Total Share and Warrant Count: During the three months
ended September 30, 2024, the Company issued 2,088 shares of common
stock relating to the cashless exercise of warrants to purchase
7,664 shares, which warrants were expiring. Also during the three
months ended September 30, 2024, the Company issued 3,832 shares of
common stock for aggregate proceeds of $11,994 relating to the
exercise of warrants that were expiring. As of the date of this
press release, the Company has 10,784,725 shares of common stock
outstanding, and outstanding warrants to purchase 70,000 shares of
common stock.
Additional Operational Highlights:
- Lantern is building an efficient internal clinical operations
team that it is leveraging across a range of clinical activities,
from project management to site startup through data and quality
management, and as a result is expected to rely less on external
CRO providers with the aim of further managing ongoing clinical
trial costs.
- Lantern published new research in PLOS ONE highlighting its
data-driven approach to ADC design and development. The
publication, titled 'Expanding the repertoire of Antibody Drug
Conjugate (ADC) targets with improved tumor selectivity and range
of potent payloads through in-silico analysis,' demonstrates a
multi-step filtering approach to identify optimal ADC targets and
payloads. Starting with over 20,000 protein-coding genes, they
systematically narrowed candidates using membrane protein status,
expression levels in critical tissues, and surface protein
validation. The study uniquely analyzed how 416 different mutations
across 22 tumor types affect target expression, revealing how
specific mutations like KRAS in pancreatic cancer and EGFR in
gliomas influence target levels. The analysis identified 82
promising ADC targets and 729 potential payloads, including novel
candidates and repurposing opportunities for existing compounds
with picomolar to nanomolar potency. We believe this comprehensive
approach provides a framework for developing more precise and
effective ADC therapeutics and assessing the utility and viability
of an ADC design earlier in the development process.
- New data and scientific findings conducted in conjunction with
Drs. Yong Du and Shiaw-Yih (Phoebus) Lin at MD Anderson were
presented at The Immuno-Oncology Summit 2024. The findings
showcased what Lantern believes to be the role of LP-184 to be
combined with checkpoint inhibitors to provide greater response in
TNBC due to synergy and to potentially transform TNBC tumors that
are unresponsive (cold) to checkpoint inhibitors to responsive
(hot). The poster was titled: LP-184, a Novel Acylfulvene,
Sensitizes Immuno-Refractory Triple Negative Breast Cancers (TNBCs)
To Anti-PD1 Therapy by Affecting the Tumor Microenvironment.
- Lantern will host its final Webinar Wednesday of 2024 on
December 11, 2024, focusing on the company's unique ability to
predict blood-brain barrier penetration of drug compounds. The
webinar will also discuss future development plans and potential
commercial availability of this RADR® platform module, which
leverages extensive molecular feature analysis enriched with
proprietary insights and data. According to the Therapeutic Data
Commons, a coordinated initiative to access and evaluate artificial
intelligence capability across therapeutic modalities and stages of
discovery, Lantern’s BBB algorithms are 5 of the top 10 performing
algorithms on the “Leaderboard".
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)
- Related presentation materials will be accessible at:
https://ir.lanternpharma.com
- A replay of the 3rd quarter 2024 earnings call and webinar will
be available at: https://ir.lanternpharma.com
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:
- Website: www.lanternpharma.com
- LinkedIn: https://www.linkedin.com/company/lanternpharma/
- X: @lanternpharma
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.
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Investor Relations ir@lanternpharma.com (972)277-1136
Lantern Pharma (NASDAQ:LTRN)
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