DALLAS, Oct. 29, 2020 /PRNewswire/ -- Lantern Pharma
Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company
using its proprietary artificial intelligence ("A.I.") platform,
RADR® , to transform oncology drug discovery and
development, today announced financial results for the third
quarter ended September 30, 2020.
Panna Sharma, CEO and President
of Lantern Pharma, stated, "We have been extremely focused on
advancing our portfolio of compounds, increasing the functionality,
capabilities and data powering our A.I. platform, while also
strengthening our team with cancer biologists, data scientists and
drug development professionals who share our passion to transform
oncology drug development."
Lantern has three drug compounds in development where genomics
and data-driven methods have been used to refine and accelerate the
development process: LP-100 in a Phase 2 trial for the
treatment of metastatic, hormone-refractory prostate cancer
(MHRPC), which is partnered with a European biotech; LP-300
which is preparing to enter into a Phase 2 trial for non-small cell
lung cancer (NSCLC) as a combination therapy; and LP-184
which is in preclinical development for genomically defined
cancers, including prostate, pancreatic and glioblastoma multiforme
(GBM).
Mr. Sharma also commented, "Our proprietary
RADR® platform recently surpassed
one billion data points – which is roughly four times the
amount of data since our June IPO. The data is comprised largely of
genomic, transcriptomic and drug sensitivity datapoints that have
been thoughtfully curated from both our own studies and from
relevant published studies and cancer data sets.
RADR® was essential in helping determine
that GBM, a particularly deadly form of brain cancer, should be a
key focus in our portfolio development. Additionally,
RADR® has significantly accelerated the
process of developing an initial signature that could be used to
identify GBM patients, potentially resulting in a new more
effective treatment and in uncovering sub-types of GBM in which our
compound can be most effective. Our growing A.I. platform will be
pivotal in uncovering potential new therapeutic opportunities and
also in developing insights into the creation of
combination-therapy programs."
During the third quarter, Lantern also announced drug
development and research collaborations with two leading academic
and translational research cancer centers, Fox Chase Cancer Center
in Philadelphia and Georgetown University in Washington D.C. These collaborations are
focused on advancing LP-184 in specific, genomically defined
sub-types of pancreatic and prostate cancer. The focus of both
collaborations is to provide critical insights for the design of
our upcoming clinical testing for LP-184. The data and results from
these collaborative studies will provide data that will advance the
development of biomarker signatures and aid in defining the patient
groups most likely to benefit from our therapies.
Corporate and Scientific Highlights
- RADR® surpassed one billion curated data points
which will help further enhance our ability to better understand
the mechanisms of action behind drugs and drug classes being used
as anti-cancer agents and help determine signatures that correlate
to drug response. The milestone was reached ahead of schedule and
enables new capabilities such as the ability to identify and
suggest combination therapy programs and the ability to compare and
contrast signatures generated by a variety of machine learning
algorithms.
- The Company launched the next phase of a collaboration with
Georgetown University for LP-184, a
next-generation, targeted DNA-damaging agent. The first stage of
the joint research activities began in the fourth quarter of 2019
and generated compelling evidence of activity of LP-184 in solid
tumors that overexpress PTGR1. LP-184 anti-tumor activity can be
linked to the over-expression of PTGR1 and will be further
validated in the ongoing collaboration in specific sub-types of
prostate cancer. The research is also expected to help guide the
development of a signature that correlates to increased response
among certain sub-types of metastatic and metastatic,
hormone-refractory prostate cancer.
- The Company initiated a collaboration and research agreement
with Fox Chase Cancer Center for the further development of
Lantern's LP-184 in pancreatic cancer. This collaboration advances
the targeted use of LP-184 in genetically defined sub-types of
pancreatic cancer with the development of biologically relevant and
robust gene signatures to be used in upcoming clinical testing. If
successful, LP-184 could provide, in the future, pancreatic cancer
patients a personalized therapy option that has the potential to
improve survival.
- LP-300 development was advanced in preparation for a Phase 2
clinical trial in non-small cell lung cancer (NSCLC) among
never-smokers during 2021. The Company entered into discussions
with key opinion leaders in NSCLC to refine the patient selection
and treatment regimen decision criteria that are expected to guide
discussions with the FDA. In addition, the Company began selection
of clinical trial sites and potential investigators for the ongoing
development of LP-300 as a potential first-in-class combination
therapy for never smoking (or non-smoking) NSCLC patients with
histologically defined adenocarcinoma. Lantern also established a
manufacturing network and process for GMP production in preparation
for its Phase 2 clinical trial of LP-300.
- The Company conducted in vitro validation studies demonstrating
the ability of LP-184 to penetrate the Blood Brain Barrier (BBB)
while preserving neuronal cell viability. A critical property of
any drug for GBM is its ability to penetrate the blood brain
barrier without causing damage to the nerve cells and tissue. These
studies validated the in-silico generated results (from Q1, 2020)
that demonstrated that LP-184 would have a BBB permeability
equivalent to temozolomide and other drugs being used for GBM
patients. LP-184 demonstrated significant permeability to BBB,
in-line with existing standard of care agents and in the expected
range of nanomolar potency. The Company will be providing
additional details on this data, the biomarker signature, and the
IND-enabling studies involved in the clinical trial process during
Q4 2020.
Third Quarter Financial Highlights
- Cash Position: Cash and cash equivalents were
$20.8 million as of September 30, 2020, compared to $1.2 million as of December 31, 2019. The increase was primarily due
to proceeds from the IPO in June
2020.
- R&D Expenses: Research and development expenses
were $600,769 for the quarter ended
September 30, 2020, compared to
$228,401 for the quarter ended
September 30, 2019. The increase was
primarily attributable to increases in drug candidate research
studies and manufacturing related expenses and expansion of the
Company's research team.
- G&A Expenses: General and administrative
expenses were $1,100,719 for the
quarter ended September 30, 2020,
compared to $441,251 for the quarter
ended September 30, 2019. This
increase was primarily due to an increase in expenses associated
with transitioning to and becoming a public company.
- Net Loss: Net losses were $1,701,488 for the quarter ended September 30, 2020, or $0.27 per share, compared to a net loss of
$669,652 for the quarter ended
September 30, 2019.
Mr. Sharma continued, "We are changing the pace, risk and cost
of oncology drug discovery and development. The high failure rate
and protracted development process lead to development costs in
oncology that are not sustainable for our health-care system or for
patients globally. A.I. and large scale machine-learning
enabled systems that can leverage real-world oncology data and
biomarker driven approaches offer the tremendous potential of a
more sustainable route and one that can lead in the transformation
of oncology drug development to benefit patients and advance
medicine."
Conference Call
Lantern Pharma will host a conference call and webcast today,
Thursday, October 29 at 4:00 p.m. ET.
Conference Call & Webcast Details
- Toll-free Domestic & Canada: 866.342.8588 – conference ID
55977
- International: 203-518-9865 – conference ID 55977
- US and Canada callers one
touch dial: +1.866.342.8588,,55977#
- Live (audio-only) webcast and related presentation materials
will be accessiblevia a weblink at
https://www.webcaster4.com/Webcast/Page/2460/38336.
Web participants should register 15 minutes prior to the start
of the call. The webcast will be archived on the Lantern Pharma
website for 30 days.
Replay Details
A replay of the conference call will be available for replay
until 11:59 pm ET November 29, 2020.
- Replay Number: 1-800-925-9932 - passcode 55977.
About Lantern Pharma
Lantern Pharma (Nasdaq: LTRN) is a clinical-stage
biopharmaceutical company innovating the repurposing,
revitalization and development of precision therapeutics in
oncology. We leverage advances in machine learning, genomics, and
artificial intelligence by using a proprietary A.I. platform to
discover biomarker signatures that help identify patients more
likely to respond to our pipeline of cancer therapeutics. Lantern's
focus is to improve the outcome for patients by leveraging our
technology to uncover, rescue and develop abandoned or failed
drugs. Our current pipeline of three drugs, with two programs in
clinical stages and two in preclinical, focuses on cancers that
have unique and unmet clinical needs with a clearly defined patient
population. We believe that the use of machine learning, genomics
and computational methods can help accelerate the revitalization,
refocusing and development of small molecule-based therapies. By
targeting drugs to patients whose genomic profile identifies them
as having the highest probability of benefiting from the drug, this
approach represents the potential to deliver best-in-class
outcomes. Our team seeks out experienced industry partners,
world-class scientific advisors, and innovative clinical-regulatory
approaches to assist in delivering cancer therapies to patients as
quickly and efficiently as possible. For more information, please
visit the company's website at www.lanternpharma.com or
Twitter @lanternpharma.
Contact
Marek Ciszewski, JD
Director, Investor Relations
628-777-3167
IR@lanternpharma.com
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; estimates regarding the development timing for our drug
candidates; our strategic plans to expand the number of data points
that our RADR® platform can access and analyze; 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 to the effect that Lantern Pharma
Inc. or our management "believes", "expects", "anticipates",
"estimates", "plans" (and 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 the impact of
the COVID-19 pandemic, the results of our clinical trials, and the
impact of competition. Additional factors can be found in the Risk
Factors section in our final prospectus, dated June 10, 2020, for our initial public offering,
on file with the Securities and Exchange Commission. You may access
our June 10, 2020 final prospectus
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.
Condensed
Consolidated Balance Sheets
|
|
|
September
30,
|
December
31,
|
|
2020
(unaudited)
|
2019
|
CURRENT
ASSETS
|
|
|
Cash
|
$20,802,542
|
$1,232,030
|
Prepaid
expenses and other current assets
|
1,672,802
|
788
|
Total current assets
|
22,475,344
|
1,232,818
|
|
|
|
Property and
equipment, net
|
17,608
|
8,758
|
Deferred
offering costs
|
-
|
191,000
|
|
|
|
TOTAL
ASSETS
|
$22,492,952
|
$1,432,576
|
|
|
|
CURRENT
LIABILITIES
|
|
|
Accounts
payable and accrued expenses
|
$814,557
|
$489,292
|
|
|
|
Total
current liabilities
|
814,557
|
489,292
|
|
|
|
Loan
payable
|
108,500
|
-
|
|
|
|
TOTAL
LIABILITIES
|
923,057
|
489,292
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
Preferred Stock - Par
Value (1,000,000 authorized at September 30, 2020; 3,480,000
authorized at December 31, 2019; $.0001 par value) (Zero shares
issued and outstanding at September 30, 2020; 2,438,866 shares
issued and outstanding at December 31, 2019)
|
-
|
244
|
Common Stock – Par
Value (25,000,000 authorized at September 30, 2020; 12,180,000
authorized at December 31, 2019; $.0001 par value) (6,217,577
shares issued and outstanding at September 30, 2020; 1,978,269
shares issued and outstanding at December 31, 2019)
|
622
|
198
|
Additional paid-in
capital
|
31,333,164
|
7,694,547
|
|
|
|
Accumulated
deficit
|
(9,763,891)
|
(6,751,705)
|
|
|
|
Total
stockholders' equity
|
21,569,895
|
943,284
|
|
|
|
TOTAL LIABILITIES
AND STOCKHOLDERS' EQUITY
|
$22,492,952
|
$1,432,576
|
Condensed
Consolidated Statements of Operations (Unaudited)
|
|
|
Three Months
Ended
|
Nine Months
Ended
|
|
September
30,
|
September
30,
|
|
2020
|
2019
|
2020
|
2019
|
Operating
expenses:
|
|
|
|
|
General and
administrative
|
1,100,719
|
441,251
|
2,117,290
|
977,300
|
Research and
development
|
600,769
|
228,401
|
894,896
|
775,718
|
Total operating
expenses
|
1,701,488
|
669,652
|
3,012,186
|
1,753,018
|
|
|
|
|
|
NET LOSS
|
$(1,701,488)
|
$(669,652)
|
$(3,012,186)
|
$(1,753,018)
|
|
|
|
|
|
Net loss per share of
common shares, basic and diluted
|
$(0.27)
|
$(0.34)
|
$(0.82)
|
$(0.89)
|
|
|
|
|
|
Weighted-average
number of common shares outstanding, basic and diluted
|
6,217,577
|
1,978,269
|
3,661,942
|
1,978,269
|
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SOURCE Lantern Pharma