Lantern Pharma Reports Third Quarter 2022 Financial Results and Operational Highlights
November 07 2022 - 4:01PM
Business Wire
- The Harmonic™ clinical trial activated the first two clinical
trial sites for a Phase 2 study in never-smoker patients with
non-small lung cancer and anticipates multiple additional sites in
the US during 2022
- IND-enabling studies for both LP-184 and LP-284 are expected to
be complete in Q1 2023
- First in human Phase 1 clinical trials for both LP-184 and
LP-284 drug candidates are targeted for launch in first half of
2023
- Intellectual property (IP) estate was strengthened with the
addition of a new issued patent for LP-300 uses
- RADR®, a drug development platform focused on oncology and
leveraging artificial intelligence, is ahead of schedule for both
datapoint and functional module expansion
- $57.8 million in cash, cash equivalents, and marketable
securities as of September 30, 2022
- A net decrease of $4.3 million in cash, cash equivalents, and
marketable securities occurred during the three months ended
September 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 third quarter ended September 30,
2022.
“Leveraging large scale biomarker and clinical data, machine
learning and artificial intelligence to fundamentally transform the
cost, timeline and risk in developing oncology medicines has been
the focus of Lantern. We are now advancing two drug-candidates in
the Phase 2 clinical stage, and expect to launch two additional
drug-candidates into first in human clinical trials in early 2023.
We have rapidly advanced our new drug-candidates, LP-184 and
LP-284, and been focused on advancing our rescued drug-candidates,
LP-100 and LP-300 towards precise and meaningful treatment
indications. Also, we have several additional therapeutic programs
that we expect to introduce in the coming quarters with both our
existing molecules and with new molecules and combinations that we
have been validating with both AI-guided development and in highly
targeted wet-lab studies,” stated Panna Sharma, CEO and President
of Lantern Pharma.
“The compression of costs and timeline, that we are creating
with our drug development process, have allowed us to grow our
portfolio from 3 programs 15 months ago to 11 programs today. We
expect many of these programs to create high-value opportunities
for our investors and potentially life-transforming therapies for
patients,” continued Sharma.
Portfolio Highlights:
- LP-300 – Harmonic™ is a Phase 2 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. This quarter Northwest Oncology and Hematology and
Gabrail Cancer Center were activated as Harmonic™’s first two
clinical trial sites. Both sites are in the process of screening
patients and are targeting to enroll the first patients this
quarter. Several additional trial sites across the US are expected
to be activated in Q4 2022 and Q1 2023 and will bolster patient
recruitment and enrollment. Additional trial information on the
Harmonic™ trial can be found at the new Harmonic™ website and the
clinicaltrials.gov website. The United States Patent and Trademark
Office (USPTO) issued U.S. Patent No. 11,471,431 for LP-300 uses,
extending commercial protection for uses of LP-300 until late 2032.
The patent is directed at increasing the survival time of cancer
patients receiving LP-300 for cancers that are marked by
overexpression of the regulatory proteins thioredoxin (TRX) or
glutaredoxin (GRX) and/or exhibition of TRX- or GRX-mediated
resistance to one or more chemotherapeutic interventions. Lantern’s
current patent estate for LP-300 includes 43 patents, covering 8
patent families. Additionally, Lantern has multiple additional
pending patent applications relating to LP-300 and is continuing to
file patent applications in this area. The strengthened patent
estate relating to LP-300 will stimulate the opportunity for future
partnering discussions with biopharma companies.
- LP-184 – The completion of IND enabling studies and the
submission of the IND application to the US Food and Drug
Administration (FDA) are anticipated for Q1 2023. LP-184 is under
development for two major classes of cancers: solid tumors,
including genetically defined pancreatic and bladder cancers, and
several central nervous system (CNS) cancers, including
glioblastoma (GBM) and brain metastases (brain mets.). Based on the
differences in clinical needs and SOC for these cancer classes, two
separate Phase 1 clinical trials are planned for LP-184 and are
anticipated to launch in Q2 2023. In the US, the stand-alone market
potential of these programs is estimated to be $5.0 billion for CNS
cancers and over $1.0 billion for solid tumors. In addition to
LP-184’s adult cancer programs, LP-184 is also being developed for
several rare pediatric cancers, including Atypical Teratoid
Rhabdoid Tumors (ATRT), a highly aggressive and malignant pediatric
CNS cancer with no existing SOC therapy. Lantern is in discussions
with ATRT key opinion leaders (KOLs) about a pediatric trial design
for a potential Phase 1 clinical trial. Lantern presented new
preclinical data at the American Association for Cancer Research
(AACR) Special Conference for Pancreatic Cancer in collaboration
with Igor Astsaturov, M.D., Ph.D. from The Marvin and Concetta
Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center.
The presentation highlighted results demonstrating that LP-184 has
potent anti-tumor effects in pancreatic cancer mouse models
harboring mutations in the DNA damage response genes ATR and BRCA1.
Additionally, LP-184 was demonstrated to act synergistically in
vitro and in vivo with several SOC agents including spironolactone
and radiation therapy. These combined results exemplify the
potential for LP-184 as a therapeutic agent for pancreatic cancer
as a monotherapy or in combination with other approved therapies.
The LP-184 AACR poster can be viewed on Lantern’s website.
- LP-284 – The IND enabling studies for LP-284 are
estimated to be completed in Q1 2023, with the IND filing to the US
FDA and Phase 1 clinical trial launch anticipated for Q2 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. NHL indications for LP-284 are targeted to include:
Mantle Cell Lymphoma (MCL), Double Hit Lymphoma (DHL), and other
NHL cancer subtypes. 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. At the Society of Hematology and Oncology (SOHO)
annual meeting, Lantern scientists presented new research on LP-284
for NHLs. The poster presentation featured results demonstrating
that LP-284 has nanomolar anti-tumor potency in several MCL cell
lines, including those that are resistant to SOC agents Ibrutinib
and Bortezomib. LP-284’s anti-tumor efficacy in MCL SOC resistant
cell lines supports its potential for patients who relapse or are
resistant to these agents. The LP-284 SOHO poster can be viewed on
Lantern’s website.
RADR® Platform Growth and Development:
- RADR®, Lantern’s A.I and M.L. platform, continues to rapidly
expand its oncology focused datapoints, at a pace well ahead of our
year end goal. RADR®’s data growth has advanced concurrently with
significant upgrades to its functionality, computational
infrastructure, and library of 200+ advanced machine learning
algorithms, all of which continue to markedly accelerate and
de-risk the drug programs of Lantern and its collaborators.
- The RADR® collaboration between Lantern and Actuate
Therapeutics is advancing for the development of Actuate’s drug
candidate elraglusib (formerly 9-ING-41). RADR®-aided insights have
accelerated development initiatives for elraglusib including
identification of candidate biomarkers and development of M.L.
models for clinical response. Highlights from the ongoing success
of this collaboration are planned to be shared in an upcoming
webinar.
- Novel RADR®-driven research was recently published and provides
foundational insights into how A.I. can be applied to discover new
indications for cancer drugs in record times and at significantly
reduced costs. The research was done in collaboration with the
National Cancer Institute (NCI) and highlights how large scale
biological data, A.I., and M.L. were leveraged to rapidly identify
ATRT as an indication for LP-184. A PDF of the new publication can
be downloaded here, or read online on the Frontiers in Drug
Discovery website.
Scientific Collaborations Update:
- Lantern and Johns Hopkins University extended their productive
research collaboration until the second half 2023. The
collaboration will continue to facilitate future work for Lantern’s
drug candidates for GBM and other CNS cancers.
- In December, Lantern will host a KOL webinar on synthetic
lethality, a key mechanism of action of Lantern’s drug candidates
LP-184, LP-284, and LP-100. The webinar will feature an
internationally recognized expert in synthetic lethality, Zoltan
Szallasi, M.D., who serves joint appointments as principal
investigator at The Danish Cancer Research Center and as assistant
professor of pediatrics at Boston Children’s Hospital, a Harvard
Medical School affiliate. Additional details about the KOL webinar
will be announced in the coming weeks.
- During Childhood Cancer Awareness Month in September, Lantern
hosted a KOL webinar featuring Dr. Peter Houghton, Ph.D., a leading
expert in childhood cancers at the Greehey Children's Cancer
Research Institute at the University of Texas Health Science Center
- San Antonio. The webinar focused on challenges in drug
development for pediatric cancers and preliminary results from
Lantern’s drug candidates in preclinical pediatric cancer models. A
replay of the KOL webinar can be found here.
Third Quarter 2022 Financial Overview
- Balance Sheet: Cash, cash equivalents, and marketable
securities were approximately $57.8 million as of September 30,
2022, compared to approximately $70.7 million as of December 31,
2021. The quarterly cash burn rate continues to reflect our
capital-efficient, collaborator-centered business model.
- R&D Expenses: Research and development expenses were
approximately $0.7 million for the quarter ended September 30, 2022
compared to approximately $2.96 million for the quarter ended
September 30, 2021. A substantial portion of this decrease in
expenses relates to a $935,000 payment we received in July 2022
from one of our service providers in connection with the resolution
of a difference of views regarding the service provider agreement.
This payment contributed to an approximately $1,555,000 reduction
in product candidate manufacturing related expenses during the
three months ended September 30, 2022. In addition, we made a
$1,000,000 upfront payment to Allarity Therapeutics during the
three months ended September 30, 2021, which is nonrecurring.
- G&A Expenses: General and administrative expenses
were approximately $1.4 million for the quarter ended September 30,
2022, compared to approximately $1.2 million for the quarter ended
September 30, 2021.
- Net Loss: Net loss was approximately $2.3 million (or
$0.21 per share) for the quarter ended September 30, 2022, compared
to a net loss of approximately $4.1 million (or $0.36 per share)
for the quarter ended September 30, 2021.
Earnings Call and Webinar Details
Lantern will host its third quarter fiscal year 2022 earnings
call and webinar today, Monday, November 7, 2022 at 4:30 p.m.
ET.
-
https://us06web.zoom.us/webinar/register/3516649838262/WN_xlduE8e8Q_Wm_KgnTUDYVg
- Related presentation materials will be accessible at:
https://ir.lanternpharma.com
Replay Details
A replay of the Q3 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
eleven 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:
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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 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/20221107005752/en/
Nicole Leber Investor Relations Associate
ir@lanternpharma.com
Lantern Pharma (NASDAQ:LTRN)
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