8-K
Lantern Pharma Inc. (LTRN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934
Date of Report (Date of earliest event reported):
November 1, 2021
Lantern Pharma Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39318 | 46-3973463 |
|---|---|---|
| (State or Other Jurisdiction<br><br> <br>of Incorporation) | (Commission<br><br> <br>File Number) | (IRS Employer<br><br> <br>Identification No.) |
| 1920 McKinney Avenue, 7th Floor<br><br> <br>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 November 1, 2021, Lantern Pharma Inc. (the “Company”) will issue a press release announcing its financial results for the third quarter ended September 30, 2021. 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 November 1, 2021, the Company will utilize a presentation to assist with the Company’s discussions during a conference call and live webcast hosted by the Company to discuss financial and operating results for the third quarter ended September 30, 2021. 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.
| Exhibit No. | Exhibit Description |
|---|---|
| 99.1 | Press Release dated November 1, 2021 announcing financial results for quarter ended September 30, 2021. |
| 99.2 | Presentation relating to November 1, 2021 conference call and live webcast to discuss financial and operating results for quarter ended September 30, 2021. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
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: November 1, 2021 | By: | /s/ David R. Margrave |
| David R. Margrave, Chief Financial Officer |
2
Exhibit 99.2
November 1 st , 2021 4:30 PM Eastern Third quarter 2021 Operating & Financial Results Conference Call / Webinar
TODAY’ S SPEAKERS Panna Sharma Chief Financial Officer and Secretary Chief Scientific Officer Finance and A d m inis t r a t i o n Chief Executive Officer, President and Director David Margrave Dr. Kishor Bhatia Nicole Leber NASDAQ:LTRN 1
This presentation contains forward - looking statements within the meaning of Section 27 A of the Securities Act of 1933 , as amended, and Section 21 E 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," "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 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 A . I . 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 , 2020 , filed with the Securities and Exchange Commission on March 10 , 2021 . You may access our Annual Report on Form 10 - K for the year ended December 31 , 2020 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 presentation 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 . Forward Looking Statements NASDAQ:LTRN 2
Co n t e n t s 01 02 03 04 Lantern Highlights Financial Overview R&D Updates Q&A NASDAQ:LTRN 3
A quarter of meaningful progress for Lantern Pharma on multiple fronts CLI N I CA L PR O GR E S S OP E R A T I ONA L PR O GR E S S RA D R ® PL A T F O R M DI S C O V E R Y EF F O R T S NASDAQ:LTRN 4
(x10 increase since Nov. 2020) accelerate drug development timelines NASDAQ:LTRN 5 uncover new therapeutic opportunities develop insights into the creation of combination - therapy programs expand our ability to collaborate with additional partners RADR ® Surpassed 10 billion datapoints this past month
R esponse A lgorithm for D rug Positioning & R escue What is RADR ® A proprietary integrated data analytics, experimental biology, oncology - focused, machine - learning - based platform focused on drug development Leverages cutting edge machine - learning approaches and techniques to generate powerful data - driven insights Enables rapid informatics based hypothesis generation which can be validated in wet - lab Uses biology driven machine - learning algorithms to achieve higher prediction accuracy in real world settings A scalable, robust, expanding and replicable platform to support a range of drug development needs NASDAQ:LTRN 6
3 rd Quarter 2021 and Subsequent Highlights NASDAQ:LTRN 7 • Achieved over 10 billion data points on our A.I. platform, RADR ® • LP - 184 granted Orphan Drug Designation for the treatment of pancreatic cancer, glioblastoma multiforme (GBM) and other malignant gliomas by the U.S. Food and Drug Administration (FDA) • Announced positive preclinical data in GBMwith LP - 184 and expanded GBM research collaboration with Johns Hopkins • Presentated at the AACR Virtual Special Conference on the effectiveness of LP - 184 in pancreatic cancers • Presented positive preclinical data for LP - 184 in pancreatic cancers that have either high levels of PTGR1 expression or deficiencies/mutations in DNA damage repair genes • Confirmed LP - 184 efficacy in the nanomolar range in the ultra - rare brain cancer, Atypical Teratoid Rhabdoid Tumor (ATRT) • Advanced two new undisclosed programs on rare cancers which are expected to advance into preclinical indications during 2022 • Entered strategic collaboration with Deep Lens • Entered into a strategic collaboration with Code Ocean
• Big data (genomic, clinical, response) assembled and analyzed • Patient subgroups identified through machine learning and artificial intelligence • Mechanisms of action clarified • Potential combinations identified • Potential for faster and more efficient path to relaunching in the clinical trial setting Abandoned Drug Assets & New Drug Development • Drugs that fell short of statistical significance or abandoned by pharma / biotech companies in late stage trials despite tens to hundreds of millions spent on development, PK analysis, safety and efficacy studies • Development of new compounds in drug classes that leverage our AI platform RADR ® Responders Non - Responders • Patient stratification based on A.I. enabled genomic biomarker discovery • New patient populations for failed or abandoned drugs based on validated biomarker signatures • Aimed to shorten time to market • Designed to reduce risk in development • Potential for orphan or fast track status • New Chemical Entities designed and filed Lantern leverages A.I. to reduce oncology drug development costs and improve the likelihood of success Potential to shorten clinical development by years, save tens to hundreds of millions of dollars in cost and substantially de - risk drug development versus the traditional model NASDAQ:LTRN 8
We believe our growing A.I. platform will be pivotal in uncovering potential new therapeutic opportunities and developing insights into the creation of combination - therapy programs , both internally and through third - party collaborations. We plan on continuing further data expansion by incorporating and curating additional datasets from proprietary studies and public data sources and further automating the evolution of RADR’s library of algorithms. Additionally, Lantern will be augmenting the 10.4 billion datapoints with additional data from immuno - oncology related studies and trials. Apr. 2021 Dec. 2021 2 0 22* 25M 100M 2019 275M 450M 2020 1.1 B 4.6 B 10.4 B 20 billion datapoints Our goal is to expand RADR to during 2022 ” “ NASDAQ:LTRN 9
L P - A 1 8 ( ADC Programs) Select Solid Tumors Leveraging novel linker library & with unique DNA - damaging agents with proven antibodies Phase I LP - 184 Program LP - 100 ( Ir ofu l v en) LP - 300 Preclinical Phase II Phase III Indication Prostate Cancer (Metastatic Castration - Resistant Prostate Cancer) Non - Small Cell Lung Cancer (Focused on Never - Smokers) Bladder Cancer (Identified by RADR® defined genomic signature) R &D CNS Cancers - Glioblastoma (Predicted by RADR® and confirmed in in - vivo studies) LP - 184 LP - 284 Hematologic Cancers (Predicted by RADR® confirmed with in - vitro studies) Accelerated Development by Leveraging the RADR ® A.I. platform Over 90+ issued patents and pending applications across 14 patent families LP - 184 Pancreatic Cancer (Identified by RADR® defined genomic signature) CNS Cancers - ATRT (Predicted by RADR® and confirmed in in - vivo studies) LP - 184 Targeting sub - population in NSCLC of Adenocarcinoma subtype Development Collaboration with - Fox Chase Cancer Center Development Collaboration with - Johns Hopkins School of Medicine Initial 9 patients showed median overall survival (mOS) of 12.5 months Development Collaboration with - Fox Chase Cancer Center Development Collaboration with - Johns Hopkins School of Medicine Lantern’s Unique & Rapidly Developing Pipeline NASDAQ:LTRN 10
LP - 184 Positive preclinical data in pancreatic cancer NASDAQ:LTRN 11 • Granted Orphan Drug Designation by FDA • Positive preclinical data in pancreatic cancers that have either high levels of PTGR1 expression or deficiencies/mutations in DNA damage repair genes • Presented at the AACR Virtual Special Conference : Pancreatic Cancer • Initiate Investigational New drug (IND) and Phase 1 human trial • Host virtual Key Opinion Leader (KOL) event on LP - 184 for the treatment of pancreatic cancer with Dr. Igor Astsaturov and Dr. Kishor G. Bhatia on November 18th, 2021, World Pancreatic Cancer Day H i g h li g h t s Upcoming Milestones
RADR Insight (in - silico) In - vitro Gene Editing Studies (CRISPR) 0 2 0 0 8 0 0 10 00 Pancreatic cancer cell line viability 400 600 LP - 184 test concentration [nM] Panc03.27 sgControl Panc03.27 sg PTGR1 Capan - 1 sgControl Capan - 1 sg PTGR1 1 0 . 8 0 . 6 0 . 4 0 . 2 0 LP - 184 activity positively correlates with PTGR1 transcript levels in the NCI60 cancer cell line panel CRISPR - mediated depletion of PTGR1 expression in a pancreatic cancer cell line (Panc03.27) is sufficient to fully diminish LP - 184 activity . This confirms the strict dependency of LP - 184 cytotoxicity on PTGR1 expression As predicted by RADR ®, LP - 184 cytotoxic activity is driven by PTGR1 NASDAQ:LTRN 12
Preclinical data demonstrated that LP - 184 demonstrated significant & rapid pancreatic tumor shrinkage, by over 90%, in in - vivo mouse models in 8 weeks. Tumor growth inhibition of 109% was observed with LP - 184 treatment relative to control with dosing occurring weekly over an 8 week period 0 10 0 2 0 0 3 0 0 4 0 0 5 0 0 6 0 0 0 10 40 50 60 Tumor volume in mm3 20 30 Days post implantation Vehicle control LP - 184 (3 mg/ kg) LP - 184 in vivo response in a Capan - 1 pancreatic cancer xenograft mouse model LP - 184 demonstrated significant tumor shrinkage (146x) in in - vivo mice PDX models Tumors From Vehicle Control Mice at the End of Study Period Average tumor volume = 587 mm 3 Tumors from LP - 184 (3mg/kg) Treated Mice at the End of Study Period Average tumor volume = 4 mm 3 No tumor Positive Preclinical Data in Pancreatic Cancer NASDAQ:LTRN 13
LP - 184 IC50 in the normal(non - cancerous) pancreatic epithelial cell HPNE line : 670 nM Drug / C o m po und s Range of IC50 [nM] across 6 cancer cell lines Median IC50 [nM] LP - 184 100 - 200 154 Gemcitabine 30 - 1,000 149 Irinotecan 3,000 - 70,000 12,052 5 - Fluorouracil 30,000 - 300,000 72,747 0 2 0 0 4 0 0 6 0 0 8 0 0 C a pan - 1 C F PA C - 1 P a n c 1 BxPC - 3 LP - 184 IC50 [nM] MiaPaCa2 Panc03.27 Cell Line HPNE (normal cells) LP - 184 shows nanomolar in vitro potency in pancreatic cancer cell lines NASDAQ:LTRN 14
LP - 184 Anticipated Upcoming Milestones • In discussions on the design of first - in - human clinical studies for LP - 184 in collaboration with Dr. Igor Astsaturov and other key opinion leaders in the pancreatic cancer treatment landscape. • Initiate IND application enabling animal studies later this year, and Phase 1 human trials following the filing of a future IND application NASDAQ:LTRN 15
KOL event on Nov. 18 th , World Pancreatic Cancer day Virtual Key Opinion Leader(KOL) event on LP - 184 for the treatment of pancreatic cancer Speakers Chief Scientific Officer of Lantern Pharma Dr. Kishor G. Bhatia Co - leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center Dr. Igor Astsaturov Save the date on November 18 th #LightupthePurple Lantern Pharma NASDAQ:LTRN 16
LP - 184 Positive preclinical data in Glioblastoma(GBM) NASDAQ:LTRN 17 • Completed a successful preclinical study demonstrating the ability of LP - 184 to inhibit tumor growth and improve survival in animal studies of glioblastoma (GBM) • Based on the encouraging results of the study, Lantern extended and expanded its collaborative agreement with Kennedy Krieger Institute and Johns Hopkins H i g h li g h t s Upcoming Milestones • Share detailed scientific results from LP - 184 collaborative research program in GBM after presentation at Society of Neuro Oncology conference November 18 - 21 in Boston, MA • Launch Phase 1/2 clinical trial for LP - 184 in GBM
• Complete regression during dosing • 3 out of 4 mice showed no tumor growth after final dosing • Complete Regression • No measurable tumors 12 days post final dosing (33 days after implantation) U87 - MG GBM Model M1123 GBM Model 5 0 0 4 5 0 4 0 0 35 0 3 0 0 2 5 0 2 0 0 1 5 0 1 0 0 50 0 Tumor volume (mm3) 1 5 1 7 1 9 2 1 2 3 2 5 2 7 2 9 31 33 35 Days post implantation 5 0 0 4 5 0 4 0 0 35 0 3 0 0 2 5 0 2 0 0 1 5 0 1 0 0 50 0 Tumor volume (mm3) 1 4 1 6 1 8 2 0 2 2 2 4 2 6 2 8 30 32 34 Days post implantation Orthotopic Subcutaneous Xenograft Neurospheres Patient Derived LP - 184 shows complete tumor regression in mice implanted with Glioblastoma in multiple models NASDAQ:LTRN 18
Antibody - Drug Conjugates (ADCs) novel class of highly potent biological drugs conjugate a cytotoxic drug with a monoclonal antibody (mAb) through an applicable linker • ADCs take advantage of the high potency of cytotoxic payloads and the superior specificity of antibodies. The drug antibody conjugate thus maximizes efficacy and minimizes systemic toxicity “ADC’s ability to harness mAb specificity and target the delivery of a cytotoxic agent to the tumor may significantly enhance both mAb and drug activities. ” Stephen C et al. Current Opinion in Chemical Biology - Elsevier 06 / 2010 FRCPC, of START Center for Cancer Care • 2 of the 4 largest oncology licensing deals in 2020 were for ADC assets AstraZeneca licensed a Ph 1 ADC from Daiichi Sanko for $6.0 billion Merck licensed a Ph2 ADC from Seagen for $3.2 billion “With so many ADCs in clinical development and the unprecedented approvals of the past year, it’s clear that ADCs will continue to be a critical part of the therapeutic armamentarium against cancer ” Dr. Amita Patnaik High specificity Gro w i ng L i n k e r Commercially availa b le antibodies Lantern small molecule drugs LP - 184, LP - 284 Antibody - drug Conjugates (ADC) NASDAQ:LTRN 19 - an area of increasing future focus of Lantern Pharma
strategic collaboration to accelerate patient enrollment for Phase 2 clinical trial for never - smokers with non - small cell lung cancer (NSCLC), utilizing LP - 300 in combination with chemotherapy accelerate the patient enrollment predict outcomes and response in specific patient subsets Help Patients to have access to the right medicine at the right time Lantern Pharma X DeepLens Collaboration with Deep Lens A.I. Clinical Trial Machine, VIPER NASDAQ:LTRN 20
Further enhances our already established RADR ® platform and provides additional efficiencies in terms of development time and cost. Lantern Pharma X Code Ocean Collaboration with Code Ocean’s Compute Capsule strategic collaboration to to facilitate the accelerated development of RADR ® while reducing development complexity and cost and increasing security and reproducibility Leveraging Code Ocean’s Compute Capsule technology • further power RADR ® platform for faster, more collaborative discoveries from billions of RADR data points, as well as data and insights from collaborators. • manage our external data and code collaborators with ease NASDAQ:LTRN 21
Anticipated Upcoming Milestones NASDAQ:LTRN 22 • Host virtual Key Opinion Leader (KOL) event on LP - 184 for the treatment of pancreatic cancer on World Pancreatic Cancer Day • Planned launch of 90 patient Phase 2 clinical trial in the US for LP - 300 in NSCLC focused on never - smokers that are chemo naïve and failed/relapsed on TKI therapy • Share detailed results from LP - 184 research program in GBM after presentation at Society of Neuro Oncology conference • Share results for LP - 184 in pancreatic, bladder, GBM, ATRT and other tumors over the next several months • Launch Phase 1 clinical trial for LP - 184 in solid tumors • Launch Phase 1/2 clinical trial for LP - 184 in GBM • Progress LP - 184 in ATRT towards Phase 1/2 clinical trial • Launch IND enabling studies for ADC program • Explore potential combinations for LP - 184 and LP - 300 with other existing approved drugs • Strategically grow RADR® A.I. platform to 20 billion datapoints, including continued expansion in additional rare cancers • Explore biopharma licensing and partnership opportunities
Co n t e n t s 01 02 03 04 Lantern Highlights Financial Overview R&D Updates Q&A 23
Summary Results of Operations Three Months Ended September 30, (Unaudited) 202 1 2020 NASDAQ:LTRN 24 Nine Months Ended September 30, (Unaudited) 2021 2020 Operating expenses: General and administrative 1,184,486 1,100,719 3,671,945 2,117,290 Research and development 2,964,391 600,769 5,408,320 894,896 Total operating expenses 4,148,877 1,701,488 9,080,265 3,012,186 Loss from operations (4,148,877) (1,701,488) (9,080,265) (3,012,186) In t ere s t in c om e 77, 219 - 125, 108 - Other income, net 17,679 - 132,402 - NET LOSS $ (4,053,979) $ (1,701,488) $ (8,822,755) $ (3,012,186) $ ( 0 . 36 ) $ ( 0 . 27 ) $ ( 0 . 82 ) $ ( 0 . 82 ) Net loss per common share, basic and diluted Weighted Avg. Common Shares Outstanding - Basic and Diluted 11,186,259 6,217,577 10,818,201 3,661,942
Balance Sheet Highlights & Summary NASDAQ:LTRN 25 9/30/2021 (unaudited) 12 / 31 / 2020 Cash, Cash equivalents and Marketable Securities $ 73,832,553 $ 19,229,232 Prepaid Expenses & Other Current Assets $ 2,504,089 $ 1,007,690 Total Assets $ 77,606,197 $ 20,359,634 Total Liabilities $ 1,877,623 $ 660,839 Total Stockholders’ Equity $ 75,728,574 $ 19,698,795
Shares Outstanding NASDAQ:LTRN 26 Common Shares Outstanding 11,186,999 Warrants 298,204 Options (Employees, Management and Directors) 801,588 Fully Diluted Shares Outstanding 12 , 286 , 791 September 30, 2021 LA N T E RN P H A RM A I N C. ( L T RN )
will fuel continued growth and evolution of our RADR ® A.I. platform, accelerate the development of our portfolio of targeted oncology drug candidates and allow us to introduce additional targeted product and collaboration opportunities in a capital efficient manner. ” “ We believe our solid financial position NASDAQ:LTRN 27
Co n t e n t s 01 02 03 04 Lantern Highlights Financial Overview R&D Updates Q&A 28
LP - 184 and LP - 284 targets NER deficient cells Mutant cell lines deficient in the Nucleotide Excision Repair (NER) pathway were more sensitive to LP - 184/ LP - 284 than the parent cell line NASDAQ:LTRN 29
LP - 184 is effective in multiple HR deficient prostate cancer models PC3M metastatic prostate cancer cell line LP - 184 and PARP inhibitor Olaparib are equipotent in vitro in the parental PC3M cell line. LP - 184 is 8X more active than Olaparib in the BRCA2 depleted PC3M line. LP - 18 4 Ola p a r ib NASDAQ:LTRN 30
LP - 184 is effective in a xenograft model of Atypical Teratoid/ Rhabdoid Tumor (ATRT) NASDAQ:LTRN 31 Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) applications submitted for the use of LP - 184 in ATRT treatment CHLA06 subcutaneous cell line derived xenograft model (SMARCB1 deletion, MYC elevation) Representative terminal tumors
LP - 184 CNS Bioavailabiity NASDAQ:LTRN 32
• Launch of multiple human clinical trials over the next 12 months • Ongoing growth of our RADR platform – Reach 20 billion datapoints during 2022. • With our network of strategic collaborators and recent additions to our team, we believe we are very well positioned with all members passionately invested and focused on developing drugs that benefit patients, while bringing them to market faster and at a lower cost. • Looking forward, we intend to explore licensing and collaboration opportunities with our portfolio and with our RADR platform. NASDAQ:LTRN 33 A Transformational year for Lantern 2022
Co n t e n t s 01 02 03 04 Lantern Highlights Financial Overview R&D Updates Q&A 34
Nasdaq: LTRN IR Contact: I R @ l a n t e r n p h a r m a . c o m 1 - 212 - 671 - 1021 www.lanternpharma.com @LanternPharma
Exhibit 99.1
Lantern Pharma Reports Third Quarter 2021 FinancialResults and Operating Highlights
| - | RADR^®^ A.I. platform surpasses 10 billion datapoints, significantly enhancing speed and scope of new drugdevelopment and expanding potential for biopharma collaborations |
|---|---|
| - | Drug candidate LP-184 granted Orphan Drug Designations by the FDA for the treatment of glioblastoma multiforme and pancreatic cancer |
| --- | --- |
| - | Preparing to launch multiple human clinical trials in the next several quarters for LP-300, LP-184 and LP-100 |
| --- | --- |
| - | $73.8 million of cash, cash equivalents and marketable securities as of September 30, 2021 |
| --- | --- |
| - | Conference call scheduled for 4:30 p.m. ET (Eastern Time) today |
| --- | --- |
DALLAS, November 1, 2021 /PRNewswire/ -- Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR^®^ artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, today provided a business update and reported financial results for the third quarter ended September 30, 2021.
“Lantern has continued to advance our portfolio, both clinically and in new preclinical indications, as well as rapidly expand our RADR^®^ A.I. platform this past quarter,” stated Panna Sharma, President & CEO of Lantern Pharma Inc. “Our A.I. driven approach to oncology drug development will be pivotal in discovering additional indications for our existing compounds, as well as the identification of entirely new drug candidates. Our strong balance sheet with over $73.8 million of cash, cash equivalents and marketable securities as of September 30, 2021 provides us with a solid foundation as we execute on our clinical programs and expand our proprietary RADR^®^ A.I. platform.”
Third Quarter 2021 and Subsequent Highlights:
| · | Achieved over 10 billion data points from highly curated oncology datasets<br>focused on increasing the performance and scale of our A.I. platform, RADR^®^, for oncology drug development |
|---|---|
| · | LP-184 granted Orphan Drug Designation for the treatment of glioblastoma<br>multiforme (GBM) and other malignant gliomas by the U.S. Food and Drug Administration (FDA) |
| --- | --- |
| · | Announced positive preclinical data in glioblastoma with LP-184<br>and expanded GBM research collaboration with Johns Hopkins University |
| --- | --- |
www.lanternpharma.com
| · | LP-184 granted Orphan Drug Designation for the treatment of pancreatic<br>cancer by the FDA |
|---|---|
| · | Submitted poster presentation on the effectiveness of LP-184 in pancreatic<br>cancers, which was accepted for presentation at the AACR Virtual Special Conference: Pancreatic Cancer |
| --- | --- |
| · | Presented positive preclinical data for LP-184 in pancreatic cancers that<br>have either high levels of PTGR1 expression or deficiencies/mutations in DNA damage repair genes |
| --- | --- |
| · | Confirmed LP-184 efficacy in the nanomolar range in the ultra-rare brain<br>cancer, Atypical Teratoid Rhabdoid Tumor (ATRT), using animal models |
| --- | --- |
| · | Advanced two new undisclosed programs focused on rare cancers which are expected<br>to advance into preclinical indications during 2022 |
| --- | --- |
| · | Entered strategic collaboration with Deep Lens to accelerate patient<br>enrollment for Lantern's planned Phase 2 clinical trial for never-smokers with non-small cell lung cancer (NSCLC), utilizing LP-300 in<br>combination with chemotherapy |
| --- | --- |
| · | Entered into a strategic collaboration with Code Ocean to facilitate the<br>accelerated development of RADR^®^ both internally and with external collaborators while reducing development complexity<br>and cost and increasing security and reproducibility |
| --- | --- |
“We continue to advance our pipeline of drug candidates and made significant progress across multiple areas of our business during the third quarter,” commented, Panna Sharma, President and CEO of Lantern Pharma. “Specifically, we reported positive preclinical data for LP-184 in pancreatic cancer and GBM. LP-184 demonstrated remarkable efficacy, in both in vivo and ex vivo models, validating the in-silico predictions generated by our RADR^®^ A.I. platform. Based upon our highly encouraging preclinical data, the FDA granted LP-184 Orphan Drug Designations for the treatment of pancreatic cancer and glioblastoma multiforme and other malignant gliomas. Our plan is to develop LP-184 for a number of targeted oncology indications where we can exploit the important mechanistic insights we have obtained about the compound.”
“Earlier today, we announced that our proprietary A.I. platform, RADR^®^, has now surpassed 10 billion datapoints powered by a growing library of algorithms designed specifically to help solve challenging data and correlation problems in cancer drug development. This directly advances our stated goal of building the world's largest A.I. platform for precision oncology drug development. Our RADR^®^platform will be pivotal in uncovering potential new therapeutic opportunities for Lantern and developing insights into the creation of combination-therapy programs, both internally and through third-party collaborations to drive long-term shareholder value. Our goal is to expand RADR^®^ to over 20+ billion datapoints during 2022. This will not only open more opportunities for collaborations with additional biopharma partners, but will also dramatically accelerate development timelines, derisk key decisions and reveal new opportunities that may have gone undeveloped — ultimately leading to additional therapeutic opportunities for patients and additional sources of value for our investors. By advancing our clinical pipeline, cultivating new discoveries, and growing our RADR® platform, we believe we have laid the groundwork for numerous upcoming catalysts in the quarters and years ahead. “
www.lanternpharma.com
2
Anticipated Upcoming Milestones:
| · | Lantern Pharma to host virtual Key Opinion Leader<br>(KOL) event on LP-184 for the treatment of pancreatic cancer with Dr. Igor Astsaturov, an established, NCI -funded, physician scientist<br>and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center and Dr. Kishor G. Bhatia,<br>Chief Scientific Officer of Lantern Pharma on November 18^th^, 2021, World Pancreatic Cancer Day |
|---|---|
| · | Planned launch of 90 patient Phase 2 clinical<br>trial in the US for LP-300 in NSCLC focused on never-smokers that are chemo naïve and failed/relapsed on TKI therapy |
| --- | --- |
| · | Share detailed scientific results from LP-184<br>collaborative research program in GBM after presentation at Society of Neuro Oncology conference November 18-21 in Boston, MA |
| --- | --- |
| · | Share results from other studies and preclinical<br>work with LP-184 in pancreatic, bladder, GBM, ATRT and other tumors over the next several months |
| --- | --- |
| · | Launch Phase 1 clinical trial for LP-184 in solid<br>tumors |
| --- | --- |
| · | Launch Phase 1/2 clinical trial for LP-184 in<br>GBM |
| --- | --- |
| · | Progress LP-184 in ATRT towards Phase 1/2 clinical<br>trial |
| --- | --- |
| · | Launch IND enabling studies for ADC program |
| --- | --- |
| · | Explore potential combinations for LP-184 and<br>LP-300 with other existing approved drugs for additional targeted cancer indications |
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| · | Strategically grow RADR® A.I. platform to<br>20 billion datapoints, including continued expansion in blood cancers and additional rare cancers under review by our development team |
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| · | Explore biopharma licensing and partnership opportunities |
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Third Quarter 2021 Financial Highlights:
| · | Balance Sheet: Cash, cash equivalents,<br>and marketable securities were $73.8 million as of September 30, 2021, compared to $19.2 million as of December 31, 2020. |
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| · | R&D Expenses: Research and development<br>expenses were $2.96 million for the three months ended September 30, 2021, compared to $0.6 million for the three months ended September<br>30, 2020. The increase was primarily attributable to increased manufacturing related expenses and expenditures to advance and expand the<br>Company’s product portfolio. |
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| · | G&A Expenses: General and administrative expenses were $1.2 million<br>for the three months ended September 30, 2021, compared to $1.1 million for the three months ended September 30, 2020. The nominal increase<br>was primarily attributable to increased business and corporate development expenses, legal and patent related fees, and general and administrative<br>related stock option expenses. |
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| · | Net Loss: Net loss was $4.1 million for the three months ended September<br>30, 2021, compared to a net loss of $1.7 million for the three months ended September 30, 2020. |
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A copy of the Company’s quarterly report on Form 10-Q for the third quarter ended September 30, 2021 has been filed with the Securities and Exchange Commission and posted on the Company’s website at https://ir.lanternpharma.com/financial-information.
Conference Call & Webcast:
Monday, November 1, 2021 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time
| · | To register for the live webcast, please sign up here: https://zoom.us/webinar/register/6716351795676/WN_s_xTDUXeRB6Lq55SItCPdQ |
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| · | To access the conference by phone: One-tap dial-in: +19292056099,,99145071949# |
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| · | A replay of the conference call will be available on the investor relations<br>section of the Company's website: ir.lanternpharma.com |
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About Lantern Pharma
Lantern Pharma (LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR^®^ A.I. platform and machine learning 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. More information is available at: www.lanternpharma.com and Twitter @lanternpharma.
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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; 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, 2020, filed with the Securities and Exchange Commission on March 10, 2021. You may access our Annual Report on Form 10-K for the year ended December 31, 2020 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.
CONTACTS:
Investor RelationsDavid Waldman, Crescendo Communications, LLC
IR@lanternpharma.com
212-671-1021
Public RelationsNicholas Koulermos, Vice President – 5W Public Relations
lantern@5wpr.com
646-843-1812
www.lanternpharma.com
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