- Active clinical trials across three AI-guided drug
candidates with additional ADC-based preclinical
molecules in evaluation for development.
- Preliminary patient data and clinical readouts for Phase 2
LP-300 Harmonic™ Trial released showing an 86% clinical
benefit rate in the initial 7 patient safety lead-in
cohort.
- Issued a Certificate of Patent by the Japanese Patent
Office directed to Lantern Pharma’s drug candidate
LP-284, including claims covering the new molecular
entity.
- 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 40 patients dosed to-date.
- Achieved significant advancement towards key milestone in the
development of molecular diagnostic for use with drug
candidate LP-184 in future oncology clinical trials to
improve patient selection and stratification.
- Launched strategic drug development collaboration
leveraging our AI platform, RADR®, with Oregon Therapeutics
to optimize the development of first-in-class drug candidate XCE853
– a potent inhibitor of cancer metabolism.
- Starlight Therapeutics, a wholly owned subsidiary of Lantern
Pharma focused on CNS and brain cancers advanced with initiating
site selection and feasibility for a Phase 1B/Phase 2 trial in
recurrent GBM with drug candidate, STAR-001.
- Launched Webinar Wednesdays, a webinar series that
focuses on the areas of artificial intelligence and oncology drug
development with leading physicians, scientists and Lantern
collaborators.
- Approximately $33.3 million in cash, cash equivalents,
and marketable securities as of June 30, 2024.
- The conference call and webcast are scheduled for Thursday
August 8, 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
second quarter 2024, ending June 30, 2024.
“The team at Lantern Pharma is making solid, thoughtful and
disciplined progress in our clinical trials and in our
collaborative research and AI efforts. This past quarter saw a
significant milestone where our clinical trials are getting to the
point of having initial patient data that we can share, including
our unique Harmonic™ clinical trial for never smokers with lung
cancer. We continue to also improve the functionality and abilities
of our AI platform, RADR®, to guide the next phase of our
therapeutic programs which will be heavily marked by trials with
combination regimens, and ADC development,” said Panna Sharma,
President and CEO of Lantern Pharma.
Highlights of AI-Powered Pipeline:
- LP-300: The Harmonic™ Phase 2 Clinical Trial –
Preliminary results at the completion of the 7-patient lead-in part
of the Harmonic™ study demonstrated predictable safety
profiles that are consistent with the chemotherapy regimen alone
and seemed to demonstrate clinical benefit for 6 out of the 7
patients – an 86% clinical benefit rate (CBR). No patients
experienced dose limiting toxicities, and no discontinuations were
observed due to treatment related toxicity. Six patients
experienced clinical benefit from the combination of LP-300 and
chemotherapy while 1 patient experienced progressive disease. The
clinical benefit rate is 86% for this group with an objective
response rate (ORR) of 43%. Of the 6 patients experiencing clinical
benefit – 3 patients showed partial responses with an average tumor
size reduction of 51% and 3 patients have stable disease with an
average tumor size reduction of 13%. Encouraging preliminary
efficacy results were observed regardless of prior tyrosine kinase
inhibitor (TKI) treatment(s), demographics, and metastatic disease
sites. In the initial set of patients, those having low to
intermediate TMB (tumor mutation burden) were found to be
responsive to LP-300 + chemotherapy.
The phase 2 Harmonic™ clinical trial sites in
the US, and certain sites in Japan are screening for eligible
patients and we expect the pace of enrollment to increase in the
coming months. This past quarter we also initiated IRB approvals
and site initiation visits in Asia. The expansion of the Phase 2
clinical trial in Japan and Taiwan is expected to accelerate the
collection of patient and response data that are needed for the
next-stage of development of LP-300, a 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 never-smokers with NSCLC
in Japan and Taiwan, where one-third or more 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 in
never-smoker patients with relapsed NSCLC where they have failed
TKI therapies. Globally, never-smokers with NSCLC 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 the
treatment indication of never smokers with NSCLC has an annual
market potential of $1.5 billion, and a global estimated annual
market potential of over $2.6 billion.
- LP-184 – Seven cohorts of patients have been enrolled
and dosed – in escalating doses – in the ongoing Phase 1A clinical
trial – a first-in-human Phase 1 basket trial across multiple solid
tumor indications that are advanced and refractory to existing
standard-of-care therapies. We expect to reach a dosage level in
the coming cohort where therapeutic concentrations of the drug
should be attainable based on our pharmacokinetic and
pharmacodynamic analyses. The trial is actively enrolling patients
across multiple US centers that have relapsed/refractory advanced
solid tumors, such as pancreatic cancer, glioblastoma (GBM), lung,
triple-negative breast cancer, and multiple other solid tumor types
with DNA damage response deficiencies. No dose-limiting toxicities
have been observed to date in the LP-184 trial, and the Company
believes that enrollment should be complete this year and on-track
for an initial readout of safety and molecular correlation data by
the close of the year. The 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, as well as other later phase trials in select tumors
that have shown superior responsiveness to LP-184 and meet with
genomically guided criteria related to drug-response. Lantern has
also made advancements toward a key milestone related to the
development of a quantitative PCR-based molecular diagnostic test
that may help in identifying patients with the best likelihood of
response and benefit from treatment with LP-184.
AI and preclinical studies are also 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 – especially PARP inhibitors, and immune checkpoint
inhibitors. 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 third cohort of patients are being dosed,
and no dose-limiting toxicities have been observed in the LP-284
Phase 1A clinical trial. We expect to open additional sites in the
US throughout the third quarter with the potential to advance to
Phase 1B and 2 by the close of 2024 or early 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 have an estimated annual
market potential of over $3+ billion.
We have also begun a review of some notable
mechanisms-of-action of LP-284 that may be leveraged in other
diseases and conditions. Lantern expects to review those
preclinical studies and findings later this quarter.
RADR® Platform Growth and Development:
- RADR® continues to advance in size, scope, and capabilities and
is also progressing towards becoming recognized as a standard for
AI-driven drug development in oncology – for both early-stage
development and later-stage patient biomarker and combination
therapy identification. Lantern 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. The scope of RADR®’s data has broadened with a
strategic focus on additional classes of compounds, detailed data
on chemical and biochemical features and drug-interaction data.
Real-world 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 also leveraged the RADR® platform in
developing a drug-development collaboration with Oregon
Therapeutics with a focus on accelerating the development and
decision path towards a first-in-human launch of the
drug-candidate, XCE853 into the clinic. The AI-enabled
collaboration with Oregon Therapeutics aims to refine and expand
the positioning of XCE853, a novel protein disulfide isomerase
(PDI) inhibitor, in new and targeted oncology indications,
including for drug-resistant tumors. 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.
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 for
both small molecule development and increasingly for ADC
development, analytics and characterization.
Second Quarter 2024 Financial Highlights
- Balance Sheet: Cash, cash equivalents, and marketable
securities were approximately $33.3 million as of June 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 $3.9 million for the quarter ended June 30, 2024,
compared to approximately $3.6 million for the quarter ended June
30, 2023.
- G&A Expenses: General and administrative expenses
were approximately $1.5 million for the quarter ended June 30,
2024, compared to approximately $1.6 million for the quarter ended
June 30, 2023.
- Net Loss: Net loss was approximately $4.96 million (or
$0.46 per share) for the quarter ended June 30, 2024, compared to a
net loss of approximately $4.75 million (or $0.44 per share) for
the quarter ended June 30, 2023.
- Total Share and Warrant Count: There were no warrant
exercises during the three months ended June 30, 2024. Following
June 30, 2024, additional warrants were exercised which increased
the Company’s total shares outstanding and reduced the number of
outstanding warrants. As of the date of this press release, the
Company has 10,764,725 shares of common stock outstanding, and
outstanding warrants to purchase 70,000 shares of common
stock.
Additional Operational Highlights:
- A publication was made in the AACR Journals, Cancer Research
Communications showcasing the potential for LP-184 to synergize
with PARP inhibitors in a wide range of solid tumors that are HRD
(homologous repair deficient). The preclinical findings in the
paper illustrate the potential of LP-184 to be a pan-HRD cancer
therapeutic – which could be the first drug of this type in this
class. We believe the data and results support clinical evaluation
of LP-184 in a large subset of HRD solid tumors.
- 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.
- With a focus on increasing visibility and awareness of the
Lantern portfolio and capabilities, the Company launched Webinar
Wednesdays in April. They are currently planned to be held on the
last Wednesday of each month and are designed to showcase industry
leaders in AI and drug development, as well as clinicians working
in collaboration with Lantern’s portfolio of drug-candidates. The
next three Webinar Wednesdays will include the topics of: 1)
LP-300’s clinical results to-date, 2) RADR and our industry-leading
ability to predict if a molecule or drug-compound will cross the
BBB (Blood-Brain-Barrier), and 3) The role of LP-184 in synergizing
with checkpoint inhibitors and IO agents.
Earnings Call and Webinar Details:
Lantern will host its 2nd quarter 2024 earnings call and webinar
today, August 8th, 2024, at 4:30 p.m. ET. A link to register can be
accessed at: Lantern 2nd Quarter 2024 Earnings Call & Webinar
Link
- Related presentation materials will be accessible at:
https://ir.lanternpharma.com
- A replay of the 2nd 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 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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version on businesswire.com: https://www.businesswire.com/news/home/20240808654232/en/
Investor Relations ir@lanternpharma.com (972)277-1136
Lantern Pharma (NASDAQ:LTRN)
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