- Active clinical trials across three AI-guided drug candidates
with initial data and clinical readouts for LP-184 on-track for the
second half of 2024.
- Obtained regulatory allowance to begin Phase 2 Harmonic™
clinical trial enrollment in Japan and Taiwan where approximately
30-35+% of all lung cancer cases occur in never-smokers with NSCLC;
Harmonic™ continues patient enrollment in the US.
- 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 dosed to date.
- The combined annual global sales market potential for LP-184
and LP-284 across multiple cancer indications is estimated to be
over $12 billion USD.
- Starlight Therapeutics, a wholly owned subsidiary of Lantern
Pharma focused on CNS and brain cancers with STAR-001, advanced
with the filing of a clinical trial protocol for the Phase 1B dose
optimization and expansion cohort in recurrent IDH wild-type high
grade gliomas.
- Advanced AI-powered module for streamlining and guiding
differentiated ADC development, which will be instrumental in the
next-generation of drug candidates for Lantern Pharma and its
collaborators.
- Established an AI driven collaboration with Oregon Therapeutics
where the RADR® platform will be leveraged to sharpen, expand and
derisk future clinical development strategies for a novel,
first-in-class inhibitor of cancer metabolism.
- Approximately $38.4 million in cash, cash equivalents,
and marketable securities as of March 31, 2024.
- The conference call and webcast are scheduled for today,
Thursday May 9, 2024, at 4:30 p.m. ET / 1:30 p.m. PT.
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
first quarter 2024, ended March 31, 2024.
“Our company made meaningful progress across multiple clinical
trials and in furthering our AI platform this past quarter while
advancing our internal capabilities to both support data-driven,
precision oncology trials and accelerate the cost-effective
development of drug-conjugates. Our team is at the forefront of
demonstrating how combining emerging AI technologies, cancer
biology and biomarker expertise along with focused clinical
operations holds the promise of transforming timelines and costs in
biopharma development.” said Panna Sharma, President and CEO of
Lantern Pharma.
Sharma continued, “Over the past several months, we have
experienced growing interest in machine-learning enabled drug
development and, in our RADR,® AI platform. Our team is energized
by the growing desire to adopt and leverage AI-driven innovations
in biopharma and in the meaningful progress we are making with our
own drug-candidates. We are excited about the opportunities we have
in front of us to drive increased collaborations on our AI platform
this year, and also propel the streamlined development of our own
portfolio of high-value, high-impact drug-candidates.”
Highlights of AI-Powered Pipeline:
- LP-184 – Five cohorts of patients, comprised of dose
levels 1 thru 5, have been enrolled and dosed – in escalating doses
– in the ongoing Phase 1A clinical trial. This is a first-in-human
Phase 1 trial across multiple solid tumor indications that are
advanced and refractory to existing standard-of-care therapies. The
trial is actively enrolling and dosing patients at dose level 6
that have relapsed/refractory advanced solid tumors, such as
pancreatic cancer, glioblastoma (GBM), lung, triple-negative breast
cancer, and multiple other solid tumor types. There have not been
any observed dose-limiting toxicities to date. The company believes
that enrollment should be complete this summer and on-track for a
readout of data in late summer or early fall. Current efforts are
underway to focus enrollment efforts on cancer patients with tumors
that have DDR(1) (DNA damage repair) deficiency. DDR deficient
tumors have been observed to have higher sensitivity to LP-184. The
company has also submitted a dose optimization and expansion
protocol (Supplement A) to the FDA related to LP-184 in non-CNS
solid tumors, including TNBC (triple negative breast cancer) with
DDR alterations. Additionally, the company in collaboration with
Starlight Therapeutics, has also submitted to the FDA a dose
optimization and expansion protocol in recurrent IDH wild-type high
grade gliomas (Supplement B). The dosage and safety data obtained
in the Phase 1a and 1b trials are expected to be used to advance
the central nervous system (CNS) indications for a future Phase 2
trial to be sponsored by Lantern’s wholly owned subsidiary,
Starlight Therapeutics. The Phase 1a data will also inform other
anticipated later phase trials in select solid tumors, most likely
with genomic signatures signifying DDR (DNA damage repair)
deficiency, that have shown responsiveness to LP-184. Genomic
identification of these patients and biomarker characterization of
their underlying tumor is central to our focus of personalizing
treatment and developing efficient later stage clinical trials. To
further this effort, Lantern has also initiated the development of
a PCR-based molecular diagnostic test that may help in identifying
cancer patients with the best likelihood of response and benefit
from treatment with LP-184. AI and preclinical studies are ongoing
to further refine drug combination studies supporting the use of
LP-184 to improve the durability or 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.
- LP-284 – The initial two cohorts of patients have been
dosed, and no dose-limiting toxicities have been observed in the
Phase 1a clinical trial. The company expects to open additional
sites in the US throughout the second quarter with the potential to
advance to Phase 1b/2 by the close of 2024. 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 and certain sarcomas
with DDR 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 have an estimated annual
market potential of over USD 3+ billion.
- LP-300 – The phase 2 Harmonic™ clinical trial sites in
the US are continuing to screen for patients and have also
increased the pace of enrollment. This past quarter we also
received approval to proceed with the Phase 2 clinical trial in
Japan and Taiwan. This is expected to accelerate the collection of
patient and response data needed for the next-stage of evaluation
and development of LP-300, an investigational therapeutic for the
treatment of relapsed and inoperable primary adenocarcinoma of the
lung given in combination with chemotherapy. Additionally, it may
also bring a needed therapeutic option for LCINS (Lung Cancer In
Never Smokers) diagnosed patients in Japan and Taiwan, where
one-third of all lung cancer diagnoses are made among those who
have never smoked. Dr. Yashushi Goto, a physician and researcher
focused on lung cancer at the National Cancer Center of Japan, will
be leading the phase 2 trial in Japan, where the incidence of
non-small cell lung cancer (NSCLC) in never-smokers is double or
more than that of the United States. Lantern believes that this
improves the positioning for drug-candidate LP-300 to develop
collaborative and co-development partnerships with global biopharma
companies with a primary focus in serving the Asian markets. The
Harmonic trial is assessing the effect of LP-300 in combination
with standard-of-care chemotherapy (carboplatin and pemetrexed) in
LCINS patients with relapsed NSCLC. Globally, LCINS patients are a
growing population of patients and do not respond well to
PD-1/PD-L1-based therapies or the available chemotherapy doublets,
leaving them with reduced treatment options. In the US it is
estimated that LP-300 has an annual market potential of $1.5
billion, and a global estimated annual market potential of over
$2.6 billion. LCINS is the eighth leading cause of cancer-related
mortality in the USA and the fifth most common cause of
cancer-related deaths worldwide.(2)
RADR® Platform Growth and Development:
- RADR® continues to advance in size, scope, and capabilities and
is progressing towards becoming a standard for AI-driven drug
development in oncology – for both early-stage development and
later-stage patient biomarker and combination therapy
identification. The company recently announced a artificial
intelligence (AI)-driven collaboration to optimize the development
of a protein disulfide isomerase (PDI) inhibitor drug candidate,
XCE853, for a variety of novel and targeted cancer indications. The
collaboration is leveraging RADR’s AI-based capabilities, including
200+ machine learning (ML) algorithms and foundational models for
oncology drug development to uncover biomarkers and molecular
correlates of efficacy and define potential combination regimens to
sharpen and accelerate XCE853’s drug development strategy. Lantern
Pharma is receiving equal IP co-ownership and drug development
rights in newly discovered biomarkers, novel indications, and use
for new pharmacological strategies for XCE853. The scope of RADR®’s
data has broadened with a strategic focus on additional classes of
compounds, including drug-conjugates such as ADCs and inclusion of
detailed data on chemical and biochemical features and
drug-interaction data. Additionally, data from clinical studies
such as those being obtained from liquid biopsy, and data from
preclinical combination studies that aim to define drug interaction
and optimal dosage are being incorporated into the datapoints and
data sets powering RADR®. Lantern expects to pursue additional
biopharma and technology partnerships during 2024 to further
advance and commercialize the RADR® AI platform.
Starlight Therapeutics:
- Starlight Therapeutics, a wholly owned subsidiary of Lantern
Pharma focused on CNS and brain cancers with STAR-001, continues
advancements with the filing of a clinical trial protocol for the
Phase 1B dose optimization and expansion cohort in recurrent IDH
wild-type high grade gliomas. IDH wild-type glioblastomas are the
most malignant glial tumors with median survival of only 14–16
months after diagnosis; patients aged ≥ 65 years have reportedly
worse outcomes.(3) Lantern formed a wholly-owned subsidiary,
Starlight Therapeutics Inc. (“Starlight”), in early 2023 for the
clinical development of drug candidate LP-184’s central nervous
system (CNS) and brain cancer indications – including GBM, brain
mets., and several rare pediatric CNS cancers. Starlight will refer
to the molecule LP-184, as it is developed in CNS indications, as
“STAR-001”. The indications and mechanistic insights powering the
creation of Starlight and the identification of multiple CNS tumors
that can be potentially impacted were largely driven by insights
and analysis from the RADR® AI platform. During Q4 of 2023 Lantern
announced that it had hired a CMO, Dr. Marc Chamberlain, who will
focus on Starlight’s clinical trials, development of personnel to
execute on the planned clinical trials and overall support in
corporate development activity. Starlight and Lantern expect to
initiate 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.
ADC & Drug Conjugate Programs:
- During the first quarter, Lantern, in collaboration with
academic research partners in Germany, advanced the development,
synthesis, and preclinical proof-of-concept of a novel, highly
potent, cryptophycin-based ADC (cpADC). The cpADC has shown
picomolar potency in a wide range of solid tumors tested in
preclinical development and is being further evaluated for clinical
potential in six solid tumor indications. In preclinical work, the
cpADC produced an 80% cancer cell kill rate which was more than
other commonly used approved ADCs, including in a cancer sub-type,
medium and low HER-2 expression cancers, which is an area of
critical patient need. Lantern expects to move towards IND
development of its ADC program during 2024 with a focus on select
solid tumors that are unresponsive or refractory to current
therapies. Additionally, Lantern has advanced its AI module for
differentiated, machine-learning based ADC development,
characterization, analysis and bioactivity prediction. The ADC
module is being developed as an extension to RADR® and leverages
the data and biomarker insights curated by and generated in RADR®.
Lantern has plans to further advance the development through
partnerships and collaborations with both technology and biopharma
companies.
Additional Operational Highlights:
- A new publication on the lethal activity of LP-184, inducing
elevated levels of DNA double-strand breaks, in HR deficient (HRD)
cancer cells was published by research scientists at Lantern Pharma
in collaboration with Georgetown University Medical Center in
Cancer Research Communications. The publication showcased that
depletion of key HR components BRCA2 or ataxia telangiectasia
mutated (ATM) in cancer cells conferred up to 12-fold increased
sensitivity to LP- 184 and that LP-184 showed nanomolar potency in
a diverse range of HRD cancer models. A link to the publication
titled “LP-184, a Novel Acylfulvene Molecule, Exhibits Anticancer
Activity against Diverse Solid Tumors with Homologous Recombination
Deficiency" can be accessed here.
- New data and scientific findings for LP-284 and the ongoing
clinical trial were presented at AACR (American Association for
Cancer Research) during the 2024 Annual Meeting in San Diego –
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 (NCT06132503)
- The company also announced during April that it will hosting a
series of educational and informative webinars focused on updates
on Lantern’s areas of research, clinical trials and AI efforts
titled Webinar Wednesdays. The first of these webinars was held on
April 24th and featured Dr. Joseph Treat, a Professor in the
Department of Hematology and Oncology, Vice Chair of Education, and
Medical Director of Ambulatory Care at Fox Chase Cancer Center
discussing LP-300 and the Harmonic clinical trial focused on LCINS
patients.
First Quarter 2024 Financial Highlights
Balance Sheet: Cash, cash equivalents,
and marketable securities were approximately $38.4 million as of
March 31, 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 $4.3 million for the
quarter ended March 31, 2024, compared to approximately $2.6
million for the quarter ended March 31, 2023. This increase was
largely driven by an increase in clinical trial activity and
clinical trial site activations.
G&A Expenses: General and
administrative expenses were approximately $1.5 million for the
quarter ended March 31, 2024, compared to approximately $1.7
million for the quarter ended March 31, 2023.
Net Loss: Net loss was approximately
$5.4 million (or $0.51 per share) for the quarter ended March 31,
2024, compared to a net loss of approximately $3.9 million (or
$0.36 per share) for the quarter ended March 31, 2023.
Warrant Exercises: Lantern issued
20,132 shares of common stock during Q1 2024, relating to the
cashless exercise of warrants to purchase 79,021 shares. Also, in
Q1 2024, Lantern issued 17,481 shares of common stock for aggregate
proceeds of approximately $55,000, relating to the exercise of
warrants for cash. Following these exercises, there remain 81,496
warrants outstanding to purchase Lantern common stock at a weighted
average exercise price of $16.55 per share.
Earnings Call and Webinar Details:
Lantern will host its 1st quarter 2024 earnings call and webinar
today, May 9, 2024, at 4:30 p.m. ET. A link to register can be
accessed at: Lantern 1st Quarter 2024 Earnings Call & Webinar
Link
- Related presentation materials will be accessible at:
https://ir.lanternpharma.com
- A replay of the 1st quarter 2024 earnings call and webinar will
be available at: https://ir.lanternpharma.com
(1)
DDR genomic alterations of
interest for the non-CNS solid tumor trials include but are not
limited to BRCA1, BRCA2, PTEN, PRKDC, ATR, POLE, ERCC6, FANCM,
DDB1, PSME4, SLX4, POLR2B, POLD1, MLH3, MDC1. Additional genomic
alterations might be considered or included based on emerging
data.
(2)
LoPiccolo, J., Gusev, A.,
Christiani, D.C. et al. Lung cancer in patients who have never
smoked — an emerging disease. Nat Rev Clin Oncol 21, 121–146
(2024). https://doi.org/10.1038/s41571-023-00844-0
(3)
Berger, K., Turowski, B.,
Felsberg, J. et al. Age-stratified clinical performance and
survival of patients with IDH-wildtype glioblastoma homogeneously
treated by radiotherapy with concomitant and maintenance
temozolomide. J Cancer Res Clin Oncol 147, 253–262 (2021).
https://doi.org/10.1007/s00432-020-03334-3
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 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.
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 Statements:
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 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
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 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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Lantern Pharma (NASDAQ:LTRN)
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