- RADR®, Lantern's proprietary A.I. and machine
learning platform, has now surpassed 20 billion data points,
enhancing its precision, insights, and capabilities for oncology
drug discovery
- Launch and enrollment of the HARMONIC™ clinical trial expected
in Summer of 2022; the Phase 2 trial is for LP-300 in never-smokers
with lung cancer
- IND application for LP-184 targeted for submission with the FDA
in Q3 2022; enabling a first in-human clinical trial for
genomically defined solid tumors
- Announced brain metastases as a new indication being pursued
for LP-184 at the American Association of Cancer Research annual
meeting
- Advanced preclinical studies are underway in Australia, through Australian subsidiary,
Lantern Pharma Australia Pty Ltd., to take advantage of
Australia's R&D Tax Incentive
program
- $65.2 million of cash, cash
equivalents and marketable securities as of March 31, 2022
- $5.3 million in cash was utilized
during the three months ended March 31,
2022, of which $2.5 million
was for the share repurchase program, with the remainder primarily
attributable to core operations
- Conference call scheduled for 4:30 p.m.
EST / 1:30 p.m. PST today
DALLAS, May 3, 2022
/PRNewswire/ -- Lantern Pharma Inc. (NASDAQ: LTRN), a
clinical stage biopharmaceutical company using its proprietary
RADR® artificial intelligence ("A.I.") and machine
learning (ML) platform to transform the cost, pace, and timeline of
oncology drug discovery and development, today announced financial
results and operational highlights for the first quarter ended
March 31, 2022.
![Lantern Pharma (LTRN) Logo (PRNewsfoto/Lantern Pharma) Lantern Pharma (LTRN) Logo (PRNewsfoto/Lantern Pharma)](https://mma.prnewswire.com/media/1216507/Lantern_Pharma_Logo.jpg)
"Lantern is at a very exciting inflection point as we continue
to make significant and meaningful progress in translating key
insights generated by our A.I. platform into preclinical and
clinical programs," stated Panna
Sharma, President and CEO of Lantern Pharma. "Our
proprietary RADR® A.I. platform recently surpassed 20
billion data points and is on a solid trajectory to surpass our
year-end goal of 25 billion data points. This accelerates our
ability to generate new insights to further power our development
decisions for our drug candidates, as well as drug candidates from
our biopharma collaborators."
"In mid-April, an amendment to the IND application for the
planned Phase 2 trial for LP-300, the HARMONIC™ clinical trial, was
submitted to the FDA. The Harmonic™ trial is focused on
never-smokers with non-small cell lung cancer (NSCLC) and is
expected to begin enrolling patients in the second half of this
year. Additionally, we remain on track to launch up to two Phase 1
trials for LP-184 in cancers with significant clinical need. We
also anticipate reporting data from multiple preclinical programs
this year, including programs focused on pediatric cancers and
those that exploit the synthetic lethality potential of our
compounds." continued Sharma.
Operational Highlights:
RADR® Platform
Growth and Development
- Surpassed 20 billion data points for RADR® A.I.
platform and we expect to reach our goal of over 25 billion data
points by year end.
- RADR® utilizes over 150 different algorithms that
have yielded insights for our drug programs. These algorithms are
focused on critical questions in oncology drug discovery and
development.
- Filed a patent application covering claims for the development
of ensemble and deep learning methods and algorithms, including
automated algorithm development within RADR®.
- Future RADR® growth will focus on additional
functionality and modules that aid in the discovery and development
of compounds that can leverage synthetic lethality, and in the
prediction of potential combination regimens across multiple drug
classes, including those that have not previously been utilized in
cancer.
Lantern's Portfolio of Targeted Therapies
Lantern
Pharma is currently developing four drug candidates and an
Antibody-Drug Conjugate (ADC) program across nine disclosed tumor
targets, and several undisclosed targets. Lantern's portfolio
currently includes:
- LP-300 - is preparing to enter a Phase 2 clinical trial,
the HARMONIC™ clinical trial, in the Summer of 2022. The HARMONIC™
trial will be a 90 patient, two-arm, randomized, open label
clinical trial focused on never-smoker patients with relapsed
primary adenocarcinoma of the lung, a type of NSCLC. An amendment
to the IND, including a finalized clinical study protocol, was
submitted to the FDA in mid-April and the first patients are
anticipated to be enrolled in the Summer of 2022. The HARMONIC™
trial is anticipated to include 15-20 sites in the US, of which
multiple are currently being contracted for enrollment.
- LP-100 - is in a Phase 2 trial in Denmark for patients with metastatic
castration resistant prostate cancer (mCRPC) that meet a certain
genomic signature that correlates to enhanced sensitivity to
LP-100. In the initial cohort of patients, nine patients
experienced a median overall survival of 12.5 months. We are
evaluating possibilities for further enrollment in the current
Phase 2 trial as well as other potential clinical development
opportunities that we believe can further de-risk the program while
increasing the potential for patient benefit that exceeds the
current standards of care.
Based on existing data demonstrating synergy between LP-100 and
PARP inhibitors, we are currently investigating the potential of
combination therapy for these two agents.
- LP-184 - is in preparation for potentially multiple
Phase 1 clinical trial launches for genomically defined pancreatic
and bladder cancers as well as CNS cancers including glioblastoma
multiforme (GBM), atypical teratoid rhabdoid tumors (ATRT), and
brain metastases (brain mets).
The IND enabling studies for LP-184 are in progress and are
anticipated to be completed by Q3 2022. Based on current timeline
projections, the Company is targeting to file the LP-184 IND
submission with the FDA in Q3 and should be in a position to
initiate in-human Phase 1 clinical testing before the end of
2022.
Lantern announced data supporting the efficacy of LP-184 in brain
mets in a poster at the American Association for Cancer Research
(AACR) 2022 annual meeting. The poster highlighted the in vitro
anti-tumor activity of LP-184 in brain mets cell models from lung,
skin, and breast cancers. In the US, brain mets occur in around
10-30% of all cancer cases and are diagnosed in well over 100,000
patients each year.
There is an urgent and unmet clinical need for new therapies for
brain mets due to a current lack of novel agents that can cross the
blood brain barrier (BBB). LP-184's favorable BBB permeability,
paired with its observed preclinical efficacy in certain CNS
cancers, underscore its potential to become a vital treatment
option for patients relapsed from current standard of care
treatment or for use in combination with other agents.
- LP-284 - is in preclinical development and has
demonstrated potency at low nanomolar levels in hematological
cancer cell lines, including lymphoma, multiple myeloma, and
leukemia. LP-284's indications in hematological cancers are
distinct from the indications targeted by LP-184 and were generated
with the assistance of RADR® insights.
- Antibody Drug Conjugate (ADC) Program - we have selected
and ranked multiple targeting antibodies of interest with potential
to be linked to selected cytotoxic payloads. We are in late-stage
candidate selection of various cytotoxic compounds and targeted
classes of agents to be used as ADC payloads.
Establishment of Australian Subsidiary
- In September 2021, Lantern
created an Australian subsidiary, Lantern Pharma Australia Pty Ltd.
The subsidiary was created to enable Lantern to take advantage of
Australia's R&D Tax Incentive
program, which provides tax offsets for eligible R&D
expenditures.
- This program will provide the opportunity for Lantern to
conduct upcoming preclinical and clinical trials with increased
financial flexibility and capital efficiency. Lantern has already
initiated preclinical and IND enabling studies under the subsidiary
in Australia.
- Lantern may conduct first in-human phase 1 clinical trials in
Australia due to its historical
capability for cost-effectiveness, accelerated timelines, and
timely regulatory approval. We believe that this aligns with the
Company's focus to develop oncology therapies with reduced time and
cost.
Scientific Collaborations Updates
- In early 2022, Lantern entered a collaboration with The Greehey
Children's Cancer Research Institute (GCCRI) at University of Texas Health Science Center-San
Antonio to expand Lantern's drug portfolio research into
several additional pediatric cancers with unmet clinical
needs.
- The studies from this collaboration have been initiated
beginning with LP-184 treatment of nine in vitro models of
pediatric cancers. The preliminary results have been promising and
will be completed in Q2 2022.
- Lantern is evaluating additional collaborations with leading
academic cancer institutions and researchers for LP-284.
First Quarter 2022 Financial Overview
- Balance Sheet: Cash, cash equivalents, and marketable
securities were $65.2 million as of
March 31, 2022, compared to
$70.7 million as of December 31, 2021. The quarterly cash burn
continues to reflect our capital-efficient, collaborator-centered
business model. $5.3 million in cash
was utilized during the three months ended March 31, 2022, of which $2.5 million was for the share repurchase
program, with the remainder primarily attributable to core
operations.
- R&D Expenses: Research and development expenses were
$2.7 million for the quarter ended
March 31, 2022 compared to
$1.3 million for the quarter ended
March 31, 2021. The increase in
R&D expense was primarily attributable to increases in
manufacturing related expenses for product candidates, research
studies, and an escrow payment released to Allarity under the
Allarity Asset Purchase Agreement, which payment was a nonrecurring
expense.
- G&A Expenses: General and administrative expenses
were $1.4 million for the quarter
ended March 31, 2022 compared to
$1.2 million for the quarter ended
March 31, 2021, respectively.
- Net Loss: Net loss was $4.1
million (or $0.38 per share)
for the quarter ended March 31, 2022,
compared to a net loss of $2.5
million (or $0.24 per share)
for the quarter ended March 31,
2021.
Additional Financial Highlights
- In March 2022, Lantern's Board of
Directors authorized an extension of the existing share repurchase
program to acquire up to $7 million
of the Company's common stock. Under the share repurchase program,
through March 31, 2022 the Company
has purchased a total of 475,157 shares of its common stock at a
total cost of approximately $3.4
million, including fees. The Company is authorized to
additionally purchase up to a total of $3.6
million of the Company's common stock through July 31, 2022, pursuant to the repurchase
program.
Nomination of New Board Member for Election and Annual
Meeting of Stockholders
- Lantern recently announced that Dr. Maria Maccecchini, Ph.D.
was nominated for election to our Board of Directors. She is the
current CEO, President, and a Director of Annovis Bio Inc., a
biopharma company focused on developing therapies for
neurodegenerative diseases. If elected, Dr. Maccecchini will bring
decades of experience in progressing drug candidates through
late-stage clinical trials. Dr. Maccecchini will be presented
alongside a slate of five existing Directors at Lantern's upcoming
Annual Meeting of Stockholders to be held on June 8, 2022. Additionally, Leslie W. Kreis, Jr., a member of Lantern
Pharma's Board of Directors since 2019, has advised Lantern's Board
of his determination not to stand for reelection as a Director at
Lantern's Annual Meeting.
- The Annual Meeting of Stockholders will be held on June 8, 2022 at 11:00 am
EST/ 8:00 am PST, which will
be held via webcast. Register for the Annual Meeting here.
2022 Outlook:
"During the year we expect to bring
multiple assets into focused clinical trials where there is
demonstrated clinical need, while remaining focused on capital
efficiency. Additionally, our A.I. platform, RADR®, will
continue to grow significantly across all measures - data,
analytical rigor, generation of new publishable insights, and new
functionality. As data and A.I. continue to drive changes in the
cost, speed and efficiency of drug discovery and development, our
team at Lantern will remain at the forefront of transforming
oncology therapeutic development."
Earnings Call and Webinar Details
Lantern will host its first quarter fiscal year 2022 earnings
call and webinar today, Tuesday, May
3 at 4:30 p.m. ET.
-
https://us06web.zoom.us/webinar/register/3516500329459/WN_fOeTQP8mRru_FxXFWsR69w
- Related presentation materials will be accessible at:
https://ir.lanternpharma.com
Replay Details
- A replay of the Q1 2022 earnings call and webinar will be
available at https://ir.lanternpharma.com.
Lantern's Investor Relations Contact:
Nicole Leber
Investor Relations Associate
ir@lanternpharma.com
About Lantern Pharma
Lantern Pharma (NASDAQ: LTRN) is
a clinical-stage oncology-focused biopharmaceutical company
leveraging its proprietary RADR® A.I. and machine
learning platform to discover biomarker signatures that identify
patients most likely to respond to its pipeline of genomically
targeted therapeutics. Lantern is currently developing four drug
candidates and an ADC program across nine disclosed tumor targets,
including two phase 2 programs. By targeting drugs to patients
whose genomic profile identifies them as having the highest
probability of benefiting from the drug, Lantern's approach
represents the potential to deliver best-in-class outcomes.
Please find more information at:
Website: www.lanternpharma.com
LinkedIn: https://www.linkedin.com/company/lanternpharma/
Twitter: @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; 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 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," "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 impact of the COVID-19
pandemic, (ii) the risk that our research and the research of our
collaborators may not be successful, (iii) 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, (iv) the risk that no drug product based on our
proprietary RADR® A.I. platform has received FDA
marketing approval or otherwise been incorporated into a commercial
product, and (v) those other factors set forth in the Risk Factors
section in our Annual Report on Form 10-K for the year ended
December 31, 2021, filed with the
Securities and Exchange Commission on March
10, 2022. You may access our Annual Report on Form 10-K for
the year ended December 31, 2021
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.
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