- Lantern has launched the Phase 2 clinical trial, Harmonic™, for
LP-300. The Harmonic™ clinical trial is focused on never smokers
with advanced non-small cell lung cancer (NSCLC) and will begin
patient enrollment during Q3 2022.
- The IND applications for both LP-184 and LP-284 are being
targeted for submission in early 2023.
- Lantern anticipates launching two Phase 1 clinical trials for
LP-184 and one Phase 1 clinical trial for LP-284 in early
2023.
- RADR® has surpassed 21 billion data points and has had
significant improvements in performance, parallelization and the
robustness of the algorithms which can facilitate future
partnering.
- New preclinical results from several programs will be presented
at multiple conferences in the second half of 2022.
- $62.2 million of cash, cash equivalents, and marketable
securities as of June 30, 2022.
- A net decrease of $3.1 million in cash, cash equivalents, and
marketable securities occurred during the three months ended June
30, 2022.
- Lantern has a cash runway into 2025.
- Conference call scheduled for 4:30 p.m. ET / 1:30 p.m. PT
today.
Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage
biopharmaceutical company using its proprietary RADR® artificial
intelligence ("A.I.") and machine learning (“M.L.”) platform to
transform the cost, pace, and timeline of oncology drug discovery
and development, today announced operational highlights and
financial results for the second quarter ended June 30, 2022.
“This quarter was marked with very exciting and important
milestones for Lantern as we advance the majority of our drug
candidates into and towards clinical trials. In mid-July, we
received notice from the FDA that our Phase 2, Harmonic™ trial, for
LP-300 was cleared to launch and we anticipate enrolling the first
patients in the third quarter of this year. The Harmonic™ trial is
focused on a unique population of lung cancer patients who are
never smokers and have relapsed non-small cell lung cancer (NSCLC).
Not only are never smokers with NSCLC unique, but they also
represent a large population of patients with over 200,000 people
diagnosed annually worldwide,” stated Panna Sharma, President and
CEO of Lantern Pharma.
“Lantern has also established a path to bring our drug
candidates LP-184 and LP-284 into Phase 1 clinical trials in the
first half of 2023. The structural similarities of these molecules
have allowed us to develop synergies in manufacturing, chemical
synthesis, and scale-up and we now believe we can bring both of
these drug candidates to the clinic near-simultaneously. We are
anticipating two Phase 1 clinical trials for LP-184, one in central
nervous system (CNS) indications and one in genomically-defined
solid tumors, and one Phase 1 clinical trial for LP-284 in
non-Hodgkin’s B-cell lymphomas,” continued Sharma.
“In addition to the exciting clinical developments, the RADR®
team has been focused on making substantial improvements to RADR®’s
infrastructure, automation capabilities, and algorithms. These
advances will not only streamline RADR® insights for Lantern, but
will facilitate future commercial partnering opportunities.”
Operational Highlights:
Lantern’s Portfolio:
- LP-300 – In July, Lantern announced the launch of the
Phase 2 clinical trial, Harmonic™, for LP-300. Harmonic™ is a
clinical trial for never smoker patients with relapsed NSCLC and
will assess the effect of LP-300 in combination with standard of
care (SOC) chemotherapy, pemetrexed and carboplatin, on patient
overall and progression-free survival. The trial will begin
enrolling patients this quarter across multiple sites in the US,
and enrollment is anticipated to last from 12-16 months. The
Company anticipates initial results from the trial will be
available in Q4 2023. The Company is also engaging in global
partnering discussions for regions of the world where there is a
higher prevalence of never smokers with NSCLC, including parts of
Asia, South America, and Europe. Additional trial information on
the Harmonic™ clinical trial can be found at the clinicaltrials.gov
website and in the press release for the Harmonic™ trial
launch.
- LP-184 – Lantern anticipates completing the IND enabling
studies and submitting an IND application for LP-184 to the U.S.
Food and Drug Administration in Q1 2023. A Phase 1 clinical trial
in genomically defined pancreatic, bladder cancers, and other solid
tumors is anticipated for Q2 2023. This quarter Lantern has also
established a pathway towards a second Phase 1 trial for LP-184 in
central nervous system (CNS) tumors in collaboration with Johns
Hopkins University. Indications for this trial are anticipated to
include gliomas and brain metastases, which collectively are
diagnosed in over 100,000 patients in the US annually and are
estimated to represent a $4 billion global market size. Conducting
two Phase 1 trials will allow Lantern to maximize the potential of
LP-184 for these two different cancer classes that have varying
clinical needs and standards of care.
- LP-284 – Lantern has accelerated the development of
LP-284, aided by manufacturing process and synthesis similarities
between LP-284 and LP-184. IND enabling animal studies for LP-284
have been initiated and are targeted to be completed by Q1 2023,
with the IND filing for an LP-284 Phase 1 clinical trial
anticipated for Q1 2023. Lantern is developing LP-284 for
non-Hodgkin’s B-cell lymphomas (NHL), where LP-284 has shown
nanomolar potency across multiple in vitro and in vivo studies and
where there is a demonstrated clinical need. Early NHL indications
for LP-284 may include: Mantle Cell Lymphoma (MCL), Double Hit
Lymphoma (DHL), and other NHL cancer subtypes. Based on new and
ongoing preclinical studies as well as modeling driven by RADR®,
LP-284 has demonstrated nanomolar potency across a range of NHL
cancers both as a stand-alone agent and in synergy with today’s
standard of care drugs such as Ibrutinib and Bortezomib. Lantern
will be presenting additional data from these studies later this
year. Globally, MCL and DHL alone are estimated to impact over
45,000 patients each year, with virtually all patients relapsing
2-5 years after treatment. There is a significant clinical need for
additional late stage therapeutic options for these patients.
- 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 continuing to evaluate clinical development possibilities for
LP-100 that we believe can further de-risk the program while
increasing the potential for patient benefit that exceeds the
current standards of care. At this time, our in silico, in vitro,
and in vivo data indicate that co-administration of LP-100 in
conjunction with PARP (Poly ADP-Ribose Polymerase) inhibitors can
have a synergistic effect in cancer treatment and may represent an
improvement over existing standards of care for prostate cancer
patients with loss of HRR (homologous recombination repair)
function. About 20-25% of all patients with advanced prostate
cancer present germline or tumor mutations in HRR-related genes,
the most common being BRCA2, mutated in approximately 10-12% of all
advanced prostate cancers - representing an estimated global
opportunity approaching 2.5 billion USD annually in prostate cancer
alone.
RADR® Platform Growth and Development
- RADR®, Lantern’s A.I. and M.L. platform, surpassed 21 billion
data points and is on pace to reach our year end goal of over 25
billion data points. This past quarter, RADR® has undergone
significant upgrades to its automation, data interfaces,
infrastructure, and integration of a wider range of algorithms. The
algorithms are additionally being automated to track performance
and precision and also to leverage an ensemble approach to
determine fit based on both biological and statistical measures.
Further automation is expected to increase the performance of RADR®
by a factor of 2x to 4x in the coming months. These advances will
increase the power and speed of generating insights from RADR® for
Lantern and its collaborators, as well as facilitate additional
partnering opportunities.
- In May 2021, Lantern entered a collaboration with Actuate
Therapeutics, Inc. to leverage RADR® to accelerate the
identification and development of actionable clinical biomarkers
for Actuate’s drug candidate, elraglusib (9-ING-41). Using advanced
ML ensemble algorithms RADR®-aided computational approaches have
been successful in identifying candidate predictive biomarkers and
modeling clinical response to elraglusib. These insights are being
used to inform the development of elraglusib and the design of
Phase II randomized clinical trials. These methods will be further
applied to future biomarker validation and will be expanded to
incorporate modeling with additional forms of patient data in the
future, including RNA, ctDNA, soluble biomarkers, and others. Based
our collaboration agreement with Actuate, Lantern will receive
equity based on meeting development milestones and the application
of computational models to elraglusib pharmacodynamics in future
development.
Scientific Collaborations Updates
- This May, Lantern hosted a key opinion leader webinar for Brain
Tumor Awareness Month which focused on glioblastoma (GBM) and the
potential of LP-184 for GBM and other brain cancers. The webinar
featured two leading experts in GBM and brain cancer research from
John Hopkins, John Laterra, M.D., Ph.D. and Matthias Holdhoff,
M.D., Ph.D. A replay of the webcast can be found here.
- During Childhood Cancer Awareness Month in September, Lantern
will host a KOL webinar featuring Dr. Peter Houghton, Ph.D., a
leading expert in childhood cancers at the Greehey Children's
Cancer Institute at the University of Texas San Antonio Health
Science Center. The webinar will focus on challenges in drug
development for pediatric cancers and preliminary results from
Lantern’s drug candidates in preclinical pediatric cancer models.
Details of the KOL webinar will be released in early
September.
Upcoming Conferences
- In the second half of 2022, Lantern will be presenting new
preclinical data at several scientific conferences, including the
American Association for Cancer Research (AACR) special conference
for pancreatic cancer, the Society of Hematologic Oncology (SOHO)
Tenth Annual Meeting, and several others. Results and conference
details will be announced in the coming weeks.
- Lantern Pharma’s President and CEO, Panna Sharma will be
presenting at two investor conferences in the fall, the MicroCap
Rodeo in Chicago, October 12-13th and at the ThinkEquity Conference
in New York, October 26th, where he will also be leading a panel
discussion on “How established and emerging biopharma companies are
leveraging AI to transform drug development costs and
timelines”.
Additional Highlights
- At Lantern’s annual meeting of stockholders held on June 8th,
2022, Dr. Maria Maccecchini, Ph.D. was elected to Lantern’s Board
of Directors, along with 5 existing Directors.
Second Quarter 2022 Financial Overview
- Balance Sheet: Cash, cash equivalents, and marketable
securities were approximately $62.2 million as of June 30, 2022,
compared to approximately $79.6 million as of June 30, 2021. The
quarterly cash burn continues to reflect our capital-efficient,
collaborator-centered business model.
- R&D Expenses: Research and development expenses were
approximately $3.0 million for the quarter ended June 30, 2022
compared to approximately $1.2 million for the quarter ended June
30, 2021.
- G&A Expenses: General and administrative expenses
were approximately $1.4 million for the quarter ended June 30,
2022, compared to approximately $1.3 million for the quarter ended
June 30, 2021.
- Net Loss: Net loss was approximately $4.5 million (or
$0.41 per share) for the quarter ended June 30, 2022, compared to a
net loss of approximately $2.3 million (or $0.21 per share) for the
quarter ended June 30, 2021.
Earnings Call and Webinar Details
Lantern will host its second quarter fiscal year 2022 earnings
call and webinar today, Monday, August 8th, 2022 at 4:30 p.m.
ET.
-
https://us06web.zoom.us/webinar/register/4016584141964/WN_OUXnk5T_Tb6cMYD6uGhSng
- Related presentation materials will be accessible at:
https://ir.lanternpharma.com
Replay Details
- A replay of the Q2 2022 earnings call and webinar will be
available at https://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; 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," "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.
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/20220808005552/en/
Lantern’s Investor Relations Contact Nicole Leber Investor
Relations Associate ir@lanternpharma.com
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