- Obtained FDA clearance of the IND application for LP-184 and
activated initial clinical sites for the Phase 1 basket trial in
relapsed/refractory advanced solid tumors and brain cancers - a
patient population with unmet clinical needs.
- Completed IND-enabling studies for LP-284 and anticipate IND
submission in August; first-in-human Phase 1 clinical trial
targeted for Q4 in advanced non-Hodgkin’s lymphomas.
- Dosed initial patients in the Phase 2 Harmonic™ clinical trial
for never smokers with NSCLC, who make up 15-20% of all lung cancer
cases; continued expansion of additional clinical trial sites in
the US and increased patient recruitment activity.
- Initiated RADR® collaboration with Bielefeld University to
design and develop breakthrough antibody drug conjugates (ADCs)
with greater precision and efficacy.
- Received US Patent & Trademark Office notice of allowance
for composition of matter patent for LP-284, extending commercial
protection into early 2039.
- $48.0 million in cash, cash equivalents, and marketable
securities as of June 30, 2023, providing a cash runway into
2025.
- Conference call and webcast is scheduled for today 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 ended June 30, 2023.
"We made significant strides over the past quarter in executing
our mission of transforming the oncology drug discovery and
development process, especially with advancing our programs for
LP-184 and LP-284 into the clinical setting and increasing our
focus on developing next-generation ADCs. Our RADR® AI platform is
revolutionizing the way we understand and predict drug-cancer
interactions, enabling us to advance our newly developed drug
programs from initial AI insights to first-in-human clinical trials
in an average of two years and at a cost of roughly $1-2 million
per program - a milestone unheard of in the realm of oncology drug
discovery," said Panna Sharma, CEO of Lantern Pharma.
Sharma continued, "Computational and AI-driven approaches are
increasing their presence and usage at both large and emerging
pharma companies for all facets of drug discovery and development.
Our leadership in the innovative use of AI and machine learning to
transform costs and timelines in the development of precision
oncology therapies should yield significant returns for investors
and patients as our industry matures and adopts an AI-centric
approach to drug development. Our top-ranked AI algorithms can
predict any compound’s blood-brain barrier permeability with 89-92%
accuracy, a major breakthrough that could accelerate the timeline
for developing treatments for brain and CNS cancers and also for
other neurological disorders. We also presented breakthrough RADR®
advancements at the AACR and ASCO annual meetings this quarter,
demonstrating an 88% accuracy in predicting patient responses for
our biopharma collaborator with a unique drug candidate.”
“Our unwavering commitment to harnessing the power of AI for
drug discovery has also led to the formation of a collaboration
with Bielefeld University to develop the next-generation of ADCs
that are designed and advanced using AI. This collaboration has the
potential to pave the way for higher efficacy, faster development,
and significantly reduced costs in this rapidly growing and
emerging treatment modality. These specific instances of value
creation along with the development of an entirely new company,
Starlight Therapeutics, whose sole focus will be on CNS and brain
cancers, demonstrate that Lantern continues to be at the forefront
of a transformative approach to oncology drug discovery, and we
look forward to sharing more breakthroughs and advancements as we
move forward," Sharma concluded.
Highlights of AI-Powered Pipeline:
- LP-184 – Received Food and Drug Administration (FDA)
clearance of the investigational new drug (IND) application for
LP-184 during the second quarter of 2023. LP-184 is the first of
Lantern’s drug candidates to be developed entirely internally, with
the assistance of Lantern’s AI and ML platform RADR®, to advance to
a first-in-human Phase 1 basket trial. Lantern has rapidly
accelerated the clinical advancement of LP-184 and has activated
the first two Phase 1 clinical trial sites and begun screening
patients. Indications for the trial are anticipated to include
relapsed/refractory advanced pancreatic cancer, glioblastoma (GBM),
brain metastases (brain mets.), and multiple other solid tumor
types with DNA damage response deficiencies. The dosage and safety
data obtained in the Phase 1 trial will 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. Globally, the aggregate annual market potential of
LP-184’s target indications is estimated to be approximately $10+
billion, consisting of $5+ billion for CNS cancers and $6+ billion
for solid tumors.
- LP-284 – IND-enabling studies for LP-284 have been
completed, and Lantern expects to submit the IND application to the
FDA in August. The first-in-human Phase 1 clinical trial launch of
LP-284 is targeted for Q4 of 2023 for B-cell non-Hodgkin’s
lymphomas (NHL), where LP-284 has shown nanomolar potency across
multiple 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 reduced expression of the ataxia-telangiectasia mutated
(ATM) gene due to mutations or deletions. Nearly all MCL patients
relapse from the current MCL 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 and DHL are diagnosed in
approximately 9,000 patients each year and have an estimated annual
market potential of $1.2 billion.
- LP-300 – Dosed initial patients in the Phase 2 Harmonic™
trial, which is assessing the effect of LP-300 in combination with
standard-of-care chemotherapy in never-smoker patients with
relapsed non-small cell lung cancer (NSCLC). In addition to the
dosed patients, more than two dozen potential patients have been
pre-screened and are being monitored for possible enrollment across
the multiple trial sites in the US. The Company is accelerating
efforts to bolster recruitment, including activating multiple
additional strategic sites across the US, potentially expanding the
trial to countries in Asia that are known to have a significantly
higher prevalence of never-smokers with NSCLC, and adding key
experienced personnel to the clinical development and operations
team. Dr. Joseph Treat MD of Fox Chase Cancer Center has been
appointed lead principal investigator of the Harmonic™ study. Dr.
Treat is a leading expert in lung malignancies, including NSCLC in
never smokers, and has dedicated his career, since 1991, to serving
patients with lung cancer. Globally, 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 $2.5 billion. Additional
information on the Harmonic™ trial can be found at the Harmonic™
website and clinicaltrials.gov.
RADR® Platform Growth and Development:
- RADR® continues to advance in size, scope, and capabilities to
accelerate the Company’s pipeline of precision therapeutics and
also become a standard for AI-driven drug development in oncology.
RADR® has now surpassed 34 billion oncology-focused datapoints and
is projected to reach 50 billion datapoints by the end of 2023. The
scope of RADR®’s data has broadened with a strategic focus on
additional classes of compounds including antibodies, checkpoint
inhibitors, and DNA damaging agents, and data from additional
studies such as those being conducted clinically as a liquid biopsy
for cancer diagnosis and treatment or those from preclinical
combination studies that aim to define drug interaction and optimal
dosage. These datapoints and the associated advancements in
automation have advanced RADR®’s drug development capabilities
including 1) predicting patient responses and identifying optimal
combination regimens for immuno-oncology (IO) drugs such as immune
checkpoint inhibitors, 2) predicting the BBB permeability, with 89%
to 92% accuracy, of any compound at a scale and speed that allows
the analysis of tens of thousands of compounds a day, and 3)
accelerating the design and development of drug-conjugate templates
for next-generation antibody-drug conjugates (ADCs) that have
increased potential for improved safety and efficacy. These 3
modules exemplify the type of rapid and grounded progress the RADR®
platform will make over the next several quarters as it aims to
improve the speed and reduce the costs and risks associated with
creating cancer therapies.
- Lantern initiated a new collaboration with Bielefeld University
to develop breakthrough ADCs. The collaboration with Bielefeld
University's Professor Norbert Sewald, Ph.D., a leading researcher
in the field and head of the Magicbullet::reloaded consortium, is
focusing on the synthesis and evaluation of novel ADCs linked to
cryptophycins, a promising group of potent antitumor molecules. The
global ADC market, currently valued at over $4 billion, is
projected to reach $14 billion by 2027 and Lantern is positioned to
be at the forefront of this rapidly growing sector.
Starlight Therapeutics:
- In Q1 2023, Lantern formed a wholly-owned subsidiary, Starlight
Therapeutics Inc. (“Starlight”), 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 company has begun discussions with leading clinicians and
key opinion leaders at CNS-focused cancer centers to serve as
clinical trial sites for upcoming clinical trials in adult and
pediatric CNS cancers. Additionally, the formation of Starlight’s
Scientific/Clinical Advisory Board is advancing and will be
announced in Q3. The Advisory Board members are anticipated to help
sharpen the aims and heighten the awareness of upcoming Starlight
clinical trials.
Additional Operational Highlights:
- New findings published in Oncotarget demonstrated that drug
candidate LP-284 has in vitro and in vivo antitumor potency in over
15 NHL models, including MCL and DHL. The journal article titled
“LP-284 Targets Non-Hodgkin's Lymphoma and DNA Damage Repair
Deficiency” includes fundamental LP-284 findings demonstrating 1)
LP-284 inhibited tumor growth in mice implanted with MCL xenografts
at a level greater than current MCL standard of care (SOC) agents
ibrutinib and bortezomib and 2) in MCL xenografts that had grown
resistant to these SOC agents, subsequent LP-284 treatment led to
near complete tumor regression.
- Lantern Pharma received a notice of allowance from the United
States Patent and Trademark Office (USPTO) for the composition of
matter patent, no. 17/192,838, covering the molecule LP-284,
including claims covering the new molecular entity. Lantern Pharma
expects the resulting LP-284 patent will be Orange Book-listable
with an anticipated expiration of early 2039. Additionally during
the quarter, five new patent applications were filed for LP-184 and
LP-284, with claims covering the use of these drug candidates in
combination regimens for specific tumor subtypes.
- New data and findings to be presented at several upcoming
scientific conferences:
- Society of Neuro-Oncology/American Society of Clinical
Oncology CNS Cancer Conference in San Francisco, CA, on August
10th, 2023 from 5:30-7:30 p.m. PT. Link to conference registration
here. Presentation Title: LP-184, a novel
acylfulvene-derived tumor site activated small molecule inhibits
adult and pediatric CNS tumor cell growth
- International Conference on Drug Conjugates for Directed
Therapy in Darmstadt, Germany on Thursday, August 24th, 2023
from 9:45-10:15 a.m. CEST. Link to conference registration here.
Presentation Title: In-silico Approach for the
Identification of ADC Targets with Improved Tumor Selectivity
- Society of Hematologic Oncology Annual Meeting in
Houston, TX on Wednesday, September 6th, 2023 at 6:00 p.m. CT. Link
to conference registration here. Presentation Title:
Targeting Homologous Recombination Deficiencies in B-Cell
Non-Hodgkin’s Lymphomas with the Novel Anti-Tumor Small Molecule
LP-284
Second Quarter 2023 Financial Overview:
- Balance Sheet: Cash, cash equivalents, and marketable
securities were approximately $48.0 million as of June 30, 2023,
compared to approximately $55.2 million as of December 31, 2022.
The quarterly cash burn rate continues to reflect our
capital-efficient, collaborator-centered business model.
- R&D Expenses: Research and development expenses were
approximately $3.6 million for the quarter ended June 30, 2023,
compared to approximately $3.0 million for the quarter ended June
30, 2022.
- G&A Expenses: General and administrative expenses
were approximately $1.6 million for the quarter ended June 30,
2023, compared to approximately $1.4 million for the quarter ended
June 30, 2022.
- Net Loss: Net loss was approximately $4.7 million (or
$0.44 per share) for the quarter ended June 30, 2023, compared to a
net loss of approximately $4.5 million (or $0.41 per share) for the
quarter ended June 30, 2022.
Earnings Call and Webinar Details:
Lantern will host its second quarter 2023 earnings call and
webinar today, Wednesday, August 9, 2023, at 4:30 p.m. ET.
-
https://us06web.zoom.us/webinar/register/1016902973506/WN_h4QZ0ZyxR3mZZbNQxa2eMw
- Related presentation materials will be accessible at:
https://ir.lanternpharma.com
- A replay of the second quarter 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 over 34 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 including eleven
cancer indications 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 $1.0-2.0 million per program.
Our lead development programs include two Phase 2 clinical
programs and multiple upcoming Phase 1 clinical trials anticipated
for 2023. We have also established a wholly-owned subsidiary,
Starlight Therapeutics Inc., 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/Twitter: @lanternpharma Newsletter – The Spark: Sign-up here
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 biomarker
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 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, (iii) 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 (iv) those other factors set forth in the
Risk Factors section in our Annual Report on Form 10-K for the year
ended December 31, 2022, filed with the Securities and Exchange
Commission on March 20, 2023. You may access our Annual Report on
Form 10-K for the year ended December 31, 2022 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230809925278/en/
Nicole Leber Investor Relations Associate
ir@lanternpharma.com
Lantern Pharma (NASDAQ:LTRN)
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