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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): August 9, 2023
Lantern
Pharma Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-39318 |
|
46-3973463 |
(State
or Other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
1920
McKinney Avenue, 7th Floor
Dallas,
Texas |
|
75201 |
(Address of Principal Executive
Offices) |
|
(Zip Code) |
(972)
277-1136
(Registrant’s
telephone number, including area code)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act: Common Stock
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common Stock, $0.0001 par
value |
|
LTRN |
|
The Nasdaq Stock Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
2.02 Results of Operations and Financial Condition.
On
August 9, 2023, Lantern Pharma Inc. (the “Company”) will issue a press release announcing its financial results for the second
quarter ended June 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
The
information in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section,
nor shall it be deemed incorporated by reference in any filings under the Securities Act of 1933, as amended, or the Exchange Act, regardless
of any general incorporation language in such filings, unless expressly incorporated by specific reference in such filing.
Item
7.01 Regulation FD Disclosure.
On
August 9, 2023, the Company will utilize a presentation to assist with the Company’s discussions during a conference call and live
webinar hosted by the Company to discuss financial and operating results for the second quarter ended June 30, 2023. A copy of the presentation
is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
The
information in this Item 7.01, including Exhibit 99.2 hereto, shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section,
nor shall it be deemed incorporated by reference in any filings under the Securities Act of 1933, as amended, or the Exchange Act, regardless
of any general incorporation language in such filings, unless expressly incorporated by specific reference in such filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
Lantern Pharma Inc., |
|
A Delaware Corporation |
|
|
Dated: August 9, 2023 |
By: |
/s/
David R. Margrave |
|
|
David R. Margrave, Chief Financial Officer |
Exhibit
99.1
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-1_001.jpg)
Lantern
Pharma Reports Second Quarter 2023 Financial Results and Operational Highlights
|
● |
Obtained
FDA clearance of the IND application for LP-184 and activated initial clinical sites for the Phase 1 basket trial in relapsed/refractory
advanced solid tumors and brain cancers - a patient population with unmet clinical needs. |
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|
|
● |
Completed
IND-enabling studies for LP-284 and anticipate IND submission in August; first-in-human Phase 1 clinical trial targeted for Q4 in
advanced non-Hodgkin’s lymphomas. |
|
|
|
|
● |
Dosed
initial patients in the Phase 2 Harmonic™ clinical trial for never smokers with NSCLC, who make up 15-20% of all lung cancer
cases; continued expansion of additional clinical trial sites in the US and increased patient recruitment activity. |
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● |
Initiated
RADR® collaboration with Bielefeld University to design and develop breakthrough antibody drug conjugates (ADCs) with
greater precision and efficacy. |
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● |
Received
US Patent & Trademark Office notice of allowance for composition of matter patent for LP-284, extending commercial protection
into early 2039. |
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● |
$48.0
million in cash, cash equivalents, and marketable securities as of June 30, 2023, providing a cash runway into 2025. |
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|
|
|
● |
Conference
call and webcast is scheduled for today at 4:30 p.m. ET / 1:30 p.m. PT. |
DALLAS—(Business
Wire)—Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (“AI”) company developing targeted and transformative
cancer therapies using its proprietary RADR® AI and machine learning (“ML”) platform with multiple clinical-stage
drug programs, today announced operational highlights and financial results for the second quarter ended June 30, 2023.
“We
made significant strides over the past quarter in executing our mission of transforming the oncology drug discovery and development process,
especially with advancing our programs for LP-184 and LP-284 into the clinical setting and increasing our focus on developing next-generation
ADCs. Our RADR® AI platform is revolutionizing the way we understand and predict drug-cancer interactions, enabling us
to advance our newly developed drug programs from initial AI insights to first-in-human clinical trials in an average of two years and
at a cost of roughly $1-2 million per program - a milestone unheard of in the realm of oncology drug discovery,” said Panna Sharma,
CEO of Lantern Pharma.
Sharma
continued, "Computational and AI-driven approaches are increasing their presence and usage at both large and emerging pharma companies
for all facets of drug discovery and development. Our leadership in the innovative use of AI and machine learning to transform costs
and timelines in the development of precision oncology therapies should yield significant returns for investors and patients as our industry
matures and adopts an AI-centric approach to drug development. Our top-ranked AI algorithms can predict any compound’s blood-brain
barrier permeability with 89-92% accuracy, a major breakthrough that could accelerate the timeline for developing treatments for brain
and CNS cancers and also for other neurological disorders. We also presented breakthrough RADR® advancements at the AACR
and ASCO annual meetings this quarter, demonstrating an 88% accuracy in predicting patient responses for our biopharma collaborator with
a unique drug candidate.”
“Our
unwavering commitment to harnessing the power of AI for drug discovery has also led to the formation of a collaboration with Bielefeld
University to develop the next-generation of ADCs that are designed and advanced using AI. This collaboration has the potential to pave
the way for higher efficacy, faster development, and significantly reduced costs in this rapidly growing and emerging treatment modality.
These specific instances of value creation along with the development of an entirely new company, Starlight Therapeutics, whose sole
focus will be on CNS and brain cancers, demonstrate that Lantern continues to be at the forefront of a transformative approach to oncology
drug discovery, and we look forward to sharing more breakthroughs and advancements as we move forward," Sharma concluded.
Highlights
of AI-Powered Pipeline:
|
● |
LP-184
– Received Food and Drug Administration (FDA) clearance of the investigational new drug (IND) application for LP-184 during
the second quarter of 2023. LP-184 is the first of Lantern’s drug candidates to be developed entirely internally, with the
assistance of Lantern’s AI and ML platform RADR®, to advance to a first-in-human Phase 1 basket trial. Lantern
has rapidly accelerated the clinical advancement of LP-184 and has activated the first two Phase 1 clinical trial sites and begun
screening patients. Indications for the trial are anticipated to include relapsed/refractory advanced pancreatic cancer, glioblastoma
(GBM), brain metastases (brain mets.), and multiple other solid tumor types with DNA damage response deficiencies. |
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The
dosage and safety data obtained in the Phase 1 trial will be used to advance the central nervous system (CNS) indications for a future
Phase 2 trial to be sponsored by Lantern’s wholly-owned subsidiary, Starlight Therapeutics. Globally, the aggregate annual
market potential of LP-184’s target indications is estimated to be approximately $10+ billion, consisting of $5+ billion for
CNS cancers and $6+ billion for solid tumors. |
|
|
|
|
● |
LP-284
– IND-enabling studies for LP-284 have been completed, and Lantern expects to submit the IND application to the FDA in
August. The first-in-human Phase 1 clinical trial launch of LP-284 is targeted for Q4 of 2023 for B-cell non-Hodgkin’s lymphomas
(NHL), where LP-284 has shown nanomolar potency across multiple in vitro and in vivo studies, including mantle cell lymphoma (MCL),
double hit lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with reduced
expression of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions. |
|
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|
|
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Nearly
all MCL patients relapse from the current MCL standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic
options for these patients. In the US and Europe, MCL and DHL are diagnosed in approximately 9,000 patients each year and have an
estimated annual market potential of $1.2 billion. |
|
|
|
|
● |
LP-300
– Dosed initial patients in the Phase 2 Harmonic™ trial, which is assessing the effect of LP-300 in combination with
standard-of-care chemotherapy in never-smoker patients with relapsed non-small cell lung cancer (NSCLC). In addition to the dosed
patients, more than two dozen potential patients have been pre-screened and are being monitored for possible enrollment across the
multiple trial sites in the US. The Company is accelerating efforts to bolster recruitment, including activating multiple additional
strategic sites across the US, potentially expanding the trial to countries in Asia that are known to have a significantly higher
prevalence of never-smokers with NSCLC, and adding key experienced personnel to the clinical development and operations team. |
Dr.
Joseph Treat MD of Fox Chase Cancer Center has been appointed lead principal investigator of the Harmonic™ study. Dr. Treat
is a leading expert in lung malignancies, including NSCLC in never smokers, and has dedicated his career, since 1991, to serving patients
with lung cancer.
Globally,
never-smokers with NSCLC are a growing population of patients and do not respond well to PD-1/PD-L1 based therapies, leaving them with
reduced treatment options. In the US, there are approximately 20,000-40,000 never-smokers with NSCLC diagnosed annually, representing
an estimated US annual market potential of $1.5 billion and a global estimated annual market potential of over $2.5 billion. Additional
information on the Harmonic™ trial can be found at the Harmonic™ website and clinicaltrials.gov.
RADR®
Platform Growth and Development:
|
● |
RADR®
continues to advance in size, scope, and capabilities to accelerate the Company’s pipeline of precision therapeutics
and also become a standard for AI-driven drug development in oncology. RADR® has now surpassed 34 billion oncology-focused
datapoints and is projected to reach 50 billion datapoints by the end of 2023. The scope of RADR®’s data has
broadened with a strategic focus on additional classes of compounds including antibodies, checkpoint inhibitors, and DNA damaging
agents, and data from additional studies such as those being conducted clinically as a liquid biopsy for cancer diagnosis and treatment
or those from preclinical combination studies that aim to define drug interaction and optimal dosage. |
|
|
|
|
|
These
datapoints and the associated advancements in automation have advanced RADR®’s drug development capabilities
including 1) predicting patient responses and identifying optimal combination regimens for immuno-oncology (IO) drugs such as immune
checkpoint inhibitors, 2) predicting the BBB permeability, with 89% to 92% accuracy, of any compound at a scale and speed that allows
the analysis of tens of thousands of compounds a day, and 3) accelerating the design and development of drug-conjugate templates
for next-generation antibody-drug conjugates (ADCs) that have increased potential for improved safety and efficacy. These 3 modules
exemplify the type of rapid and grounded progress the RADR® platform will make over the next several quarters as it
aims to improve the speed and reduce the costs and risks associated with creating cancer therapies. |
|
|
|
|
● |
Lantern
initiated a new collaboration with Bielefeld University to develop breakthrough ADCs. The collaboration with Bielefeld University's
Professor Norbert Sewald, Ph.D., a leading researcher in the field and head of the Magicbullet::reloaded consortium, is focusing
on the synthesis and evaluation of novel ADCs linked to cryptophycins, a promising group of potent antitumor molecules. The global
ADC market, currently valued at over $4 billion, is projected to reach $14 billion by 2027 and Lantern is positioned to be at the
forefront of this rapidly growing sector. |
Starlight
Therapeutics:
|
● |
In
Q1 2023, Lantern formed a wholly-owned subsidiary, Starlight Therapeutics Inc. (“Starlight”), for the clinical
development of drug candidate LP-184’s central nervous system (CNS) and brain cancer indications – including GBM, brain
mets., and several rare pediatric CNS cancers. Starlight will refer to the molecule LP-184, as it is developed in CNS indications,
as “STAR-001”. |
|
|
|
|
● |
The
company has begun discussions with leading clinicians and key opinion leaders at CNS-focused cancer centers to serve as clinical
trial sites for upcoming clinical trials in adult and pediatric CNS cancers. Additionally, the formation of Starlight’s Scientific/Clinical
Advisory Board is advancing and will be announced in Q3. The Advisory Board members are anticipated to help sharpen the aims and
heighten the awareness of upcoming Starlight clinical trials. |
Additional
Operational Highlights:
|
● |
New
findings published in Oncotarget demonstrated that drug candidate LP-284 has in vitro and in vivo antitumor potency in over
15 NHL models, including MCL and DHL. The journal article titled “LP-284 Targets Non-Hodgkin's Lymphoma and DNA Damage Repair
Deficiency” includes fundamental LP-284 findings demonstrating 1) LP-284 inhibited tumor growth in mice implanted with
MCL xenografts at a level greater than current MCL standard of care (SOC) agents ibrutinib and bortezomib and 2) in MCL xenografts
that had grown resistant to these SOC agents, subsequent LP-284 treatment led to near complete tumor regression. |
|
|
|
|
● |
Lantern
Pharma received a notice of allowance from the United States Patent and Trademark Office (USPTO) for the composition of matter patent,
no. 17/192,838, covering the molecule LP-284, including claims covering the new molecular entity. Lantern Pharma expects the
resulting LP-284 patent will be Orange Book-listable with an anticipated expiration of early 2039. |
|
|
|
|
|
Additionally
during the quarter, five new patent applications were filed for LP-184 and LP-284, with claims covering the use of these drug candidates
in combination regimens for specific tumor subtypes. |
|
|
|
|
● |
New
data and findings to be presented at several upcoming scientific conferences: |
|
● |
Society
of Neuro-Oncology/American Society of Clinical Oncology CNS Cancer Conference in San Francisco, CA, on August 10th,
2023 from 5:30-7:30 p.m. PT. Link to conference registration here. |
|
|
Presentation
Title: LP-184, a novel acylfulvene-derived tumor site activated small molecule inhibits adult and pediatric CNS tumor cell
growth |
|
|
|
|
● |
International
Conference on Drug Conjugates for Directed Therapy in Darmstadt, Germany on Thursday, August 24th, 2023 from 9:45-10:15
a.m. CEST. Link to conference registration here. |
|
|
Presentation
Title: In-silico Approach for the Identification of ADC Targets with Improved Tumor Selectivity |
|
|
|
|
● |
Society
of Hematologic Oncology Annual Meeting in Houston, TX on Wednesday, September 6th, 2023 at 6:00 p.m. CT. Link to conference
registration here. |
|
|
Presentation
Title: Targeting Homologous Recombination Deficiencies in B-Cell Non-Hodgkin’s Lymphomas with the Novel Anti-Tumor Small
Molecule LP-284 |
Second
Quarter 2023 Financial Overview:
|
● |
Balance
Sheet: Cash, cash equivalents, and marketable securities were approximately $48.0 million as of June 30, 2023, compared to approximately
$55.2 million as of December 31, 2022. The quarterly cash burn rate continues to reflect our capital-efficient, collaborator-centered
business model. |
|
|
|
|
● |
R&D
Expenses: Research and development expenses were approximately $3.6 million for the quarter ended June 30, 2023, compared to
approximately $3.0 million for the quarter ended June 30, 2022. |
|
|
|
|
● |
G&A
Expenses: General and administrative expenses were approximately $1.6 million for the quarter ended June 30, 2023, compared to
approximately $1.4 million for the quarter ended June 30, 2022. |
|
|
|
|
● |
Net
Loss: Net loss was approximately $4.7 million (or $0.44 per share) for the quarter ended June 30, 2023, compared to a net loss
of approximately $4.5 million (or $0.41 per share) for the quarter ended June 30, 2022. |
Earnings
Call and Webinar Details:
Lantern
will host its second quarter 2023 earnings call and webinar today, Wednesday, August 9, 2023, at 4:30 p.m. ET.
|
● |
https://us06web.zoom.us/webinar/register/1016902973506/WN_h4QZ0ZyxR3mZZbNQxa2eMw |
|
● |
Related
presentation materials will be accessible at: https://ir.lanternpharma.com |
|
● |
A
replay of the second quarter earnings call and webinar will be available at https://ir.lanternpharma.com |
About
Lantern Pharma:
Lantern
Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary
AI and machine learning (ML) platform, RADR®, leverages over 34 billion oncology-focused data points and a library of
200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of
AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline
of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs
have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per
program.
Our
lead development programs include two Phase 2 clinical programs and multiple upcoming Phase 1 clinical trials anticipated for 2023. We
have also established a wholly-owned subsidiary, Starlight Therapeutics Inc., to focus exclusively on the clinical execution of our promising
therapies for CNS and brain cancers, many of which have no effective treatment options. Our AI-driven pipeline of innovative product
candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing
therapies to hundreds of thousands of cancer patients across the world.
Contact:
Nicole
Leber
Investor
Relations Associate
ir@lanternpharma.com
Please
find more information at:
Website:
www.lanternpharma.com
LinkedIn:
https://www.linkedin.com/company/lanternpharma/
X/Twitter:
@lanternpharma
Newsletter
– The Spark: Sign-up here
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 biomarker 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 risk that our research and the research of our collaborators may not be
successful, (ii) 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, (iii) the risk that no drug
product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated
into a commercial product, and (iv) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the
year ended December 31, 2022, filed with the Securities and Exchange Commission on March 20, 2023. You may access our Annual Report on
Form 10-K for the year ended December 31, 2022 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.
Exhibit 99.2
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_001.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_002.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_003.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_004.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_005.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_006.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_007.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_008.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_009.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_010.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_011.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_012.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_013.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_014.jpg)
![](https://www.sec.gov/Archives/edgar/data/1763950/000149315223027346/ex99-2_015.jpg)
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