DALLAS, March 10, 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 fourth quarter and
fiscal year ended December 31,
2021.
![Lantern Pharma (LTRN) Logo (PRNewsfoto/Lantern Pharma) Lantern Pharma (LTRN) Logo (PRNewsfoto/Lantern Pharma)](https://mma.prnewswire.com/media/1216507/Lantern_Pharma_Logo.jpg)
"2021 was a transformational year for Lantern Pharma as we
strengthened our financial position, significantly expanded our
A.I. platform, and achieved multiple key clinical milestones that
further advanced our oncology portfolio," stated Panna Sharma, President and CEO of Lantern
Pharma. "Our proprietary RADR® A.I. platform surpassed
18 billion data points and grew over 1,000% in 2021, significantly
exceeding our growth expectations. This further development of
RADR® is enabling an acceleration of the insights that
are powering development decisions for our drug candidates and also
support evaluation of drugs and drug candidates of other biopharma
companies."
"Across our entire portfolio of late-stage drug programs, we are
progressing towards launching Phase 1 and Phase 2 clinical trials
in 2022, including the Phase 2 trial for LP-300, The
Harmonicä Clinical Trial, for advanced non-small cell lung
cancer in never smokers. Our dedicated team is focused on
completing the requirements and details to launch these trials
including IND-enabling studies and submissions, clinical site
selection, and patient enrollment," stated Sharma.
Operational Highlights:
RADR® Platform Growth and Development
- Surpassed 18 billion data points for RADR® platform,
a significant growth of more than 1,000% from year-end 2020;
forecasting to reach more than 25 billion data points by year-end
2022.
- The ongoing growth of RADR® data points is expected
to drive continual improvement in Lantern's ability to rapidly
identify new indications, combination therapies, and mechanisms of
action for the Company's drug candidates.
- Expanding RADR's® capabilities with a
focus on increasing the number of machine learning algorithms and
self-learning algorithms.
- The Company expects to continue to expand its focus on building
biopharma collaborations to utilize and expand on the growth of
RADR®.
Lantern's Portfolio of Targeted
Therapies
Lantern Pharma is currently developing four drug
candidates and an Antibody-Drug Conjugate (ADC) program across
eight disclosed tumor targets, and several undisclosed targets.
Lantern's portfolio currently includes:
- LP-100 - is in a Phase 2 trial for the treatment of
metastatic castration resistant prostate cancer (mCRPC). We are
evaluating possibilities for further enrollment in the current
Phase II trial as well as other potential clinical development
opportunities. Lantern reacquired global rights to LP-100 in
July 2021.
- LP-300 - is preparing to enter a Phase 2 clinical trial,
the Harmonicä Clinical Trial, during 2022. The Harmonicä trial will
be a 90 patient, two-arm, open label clinical trial focused on
never smoker patients with relapsed primary adenocarcinoma of the
lung, a type of NSCLC.
- LP-184 - is in preparation for potentially multiple
Phase 1 clinical trial launches for genomically defined cancers,
including pancreatic, glioblastoma multiforme (GBM), bladder and
atypical teratoid rhabdoid tumors (ATRT).
The FDA granted LP-184 Orphan Drug
Designations for the treatment of pancreatic cancer, GBM, and ATRT
and a Rare Pediatric Disease Designation for treatment of ATRT.
These designations will assist the advancement of LP-184 towards
clinical studies. Under the Rare Pediatric Disease Priority Review
Voucher Program companies may be eligible to receive a priority
review voucher if the product satisfies certain conditions,
including receipt of regulatory marketing approval following
required clinical testing. Vouchers may be sold or transferred to
another sponsor, and past transfers of vouchers have occurred at
average prices of more than $100
million.
- 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 currently
evaluating various cytotoxic agents and classes of agents to be
used as ADC payloads.
World-Class Scientific Collaborations
- Expanded collaboration with the National Cancer Institute to
accelerate the path to first in-human clinical trials for drug
candidates LP-184 and LP-284.
- Entered 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.
- Continued GBM & brain cancer collaboration with
Johns Hopkins & Kennedy Krieger
Institute to develop Phase 1 clinical design and further validate
LP-184's ability to works independently of MGMT (a DNA repair
enzyme) status.
- Expanded collaboration with Fox Chase Cancer Center in
pancreatic cancers with a focus on clinical design and strategy for
LP-184.
- Launched a research collaboration with The Danish Cancer
Society Research Center to support development of drug candidates
LP-100 and LP-184 in 9 solid tumor types that have a known
deficiency in DNA repair mechanisms. LP-100 and LP-184 have both
been shown to have a synthetically lethal impact on tumors
deficient in DNA repair mechanisms.
Publications and Presentations
- Published two scientific articles in Oncotarget and
BMC Bioinformatics highlighting the effectiveness of
Lantern's drug candidate LP-184 in potential tumor
indications.
- Presented positive preclinical data on the efficacy of LP-284
in hematologic cancers at the 63rd American Society of Hematology
(ASH) Annual Meeting.
- Preclinical data supporting the effectiveness of LP-184 in
select pancreatic cancers was presented at the American Association
for Cancer Research (AACR) Virtual Special Conference.
- The effectiveness of LP-184 in multiple in vitro and in vivo
Glioblastoma models was presented at the Society for Neuro-Oncology
(SNO) 2021 Annual Meeting.
- On World Pancreatic Cancer Day, Lantern hosted a virtual KOL
webinar on the potential of drug candidate LP-184 for pancreatic
cancer.
Additional Highlights
- Strengthened intellectual property estate with 12 new patent
applications, with the current total IP estate at over 80 active
patents and patent applications across 14 patent families.
- Completed strategic hires to expand and strengthen Lantern's
data science, research, management, and communications teams.
Financial Highlights:
- Raised gross proceeds of $69 million
USD through January 2021
public offering and full exercise of underwriter's over-allotment
option.
- Capital raised extends cash runway into 2025, allowing the
Company to focus on efficiently developing its portfolio of
promising oncology therapeutics.
- Authorized a share repurchase program to acquire up to
$7 million of the Company's common
stock. Repurchases of shares of common stock pursuant to the
repurchase program amounted to $0.9
million during the quarter and year ended December 31, 2021 and an additional $2.2 million of repurchases from January 1, 2022 through March 1, 2022.
Fourth Quarter and 2021 Financial
Overview:
- Balance Sheet: Cash, cash equivalents, and marketable
securities were $70.7 million as of
December 31, 2021, compared to
$19.2 million as of December 31, 2020. The quarterly and annual cash
burn for 2021 reflects our capital-efficient, collaborator-centered
business model.
- R&D Expenses: Research and development expenses were
$2.2 million and $7.6 million for the quarter and year ended
December 31, 2021 compared to
$1.4 million and $2.2 million for the quarter and year ended
December 31, 2020, respectively. The
annual increase was primarily attributable to increases in product
candidate manufacturing related expenses of approximately
$2.7 million, increases in research
studies of approximately $0.8
million, increases in research and development payroll
expenses of approximately $0.7
million, and an increase of $1.0
million related to the upfront payment to Allarity
Therapeutics under the Allarity Asset Purchase Agreement, which was
a nonrecurring expense.
- G&A Expenses: General and administrative expenses
were $1.4 million and $5.0 million for the quarter and year ended
December 31, 2021 compared to
$1.6 million and $3.7 million for the quarter and year ended
December 31, 2020, respectively. The
annual increase was primarily attributable to increases in business
and corporate development expense of approximately $0.4 million, increases in corporate insurance
expense of approximately $0.6
million, and increases in legal and patent related expenses
of approximately $0.4 million.
- Net Loss: Net losses were $3.5
million (or $0.31 per share)
and $12.4 million (or $1.13 per share) for the quarter and year ended
December 31, 2021, compared to a net
loss of $2.9 million (or $0.47 per share) and $5.9
million (or $1.37 per share)
for the quarter and year ended December 31,
2020, respectively.
2022 Key Objectives:
- Launch of The Harmonicä Trial - Ph. 2 clinical trial for LP-300
in NSCLC
- Advance LP-100 clinical trial
- Launch Ph. 1 clinical trial for LP-184 in solid tumors
- Launch Ph. 1/2 clinical trial for LP-184 in GBM
- Progress LP-184 in ATRT towards Ph. 1/2 clinical trial
- Advance pediatric cancer program
- Advance ADC preclinical studies to support future Phase 1
launch
- Explore potential combinations for LP-184 & LP-300 with
other existing approved drugs
- Strategically grow RADR® A.I. platform to 25 billion
datapoints
- Licensing and partnership opportunities
2022 Outlook:
"During 2022 we expect to reach over 25
billion data points and also grow the methods and algorithms
powering the analysis and insights of our RADR®
platform. Our team has been developing machine learning modules and
algorithms that enable a wide range of analysis, correlations and
predictions that are central to cancer drug development," added
Sharma. "These additions to our platform are cornerstone to the
advancement of our programs, and we believe this will be clearly
demonstrated this year as we launch multiple clinical trials,
report new data, and expand our collaborations."
"Our team will continue to advance our portfolio and our
platform along with the development of new drug programs which we
will be able to accomplish through our significant cash position,
our focused strategy of collaborations and our data-driven drug
development model. We are looking forward to a year of significant
value creation for cancer patients and investors alike as we
transform and accelerate the drug development process in
oncology."
Earnings Call and Webinar Details
Lantern will host
its fourth quarter and fiscal year 2021 earnings call and webinar
today, Thursday, March 10 at
4:30 p.m. ET.
-
https://zoom.us/webinar/register/6316442460324/WN_IpjiP_QpT5ClHzrW1U7GwA
- Related presentation materials will be accessible at:
https://ir.lanternpharma.com
Replay Details
- A replay of the 2021 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
1-972-277-1136
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 eight 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/lantern-pharma-reports-fourth-quarter-and-fiscal-year-2021-financial-results-and-operational-highlights-301500497.html
SOURCE Lantern Pharma