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):
March 10, 2022
Lantern Pharma Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39318 | 46-3973463 |
|---|---|---|
| (State or Other Jurisdiction<br><br>of Incorporation) | (Commission File Number) | (IRS Employer<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. ☒
Item2.02 Results of Operations and Financial Condition.
On March 10, 2022, Lantern Pharma Inc. (the “Company”) will issue a press release announcing its financial results for the fiscal year and fourth quarter ended December 31, 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.
Item7.01 Regulation FD Disclosure.
On March 10, 2022, 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 fiscal year and fourth quarter ended December 31, 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 9.01Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Exhibit Description |
|---|---|
| 99.1 | Press Release dated March 10, 2022 announcing financial results for fiscal year and quarter ended December 31, 2021. |
| 99.2 | Presentation relating to March 10, 2022 conference call and live webinar to discuss financial and operating results for fiscal year and quarter ended December 31, 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: March 10, 2022 | By: | /s/ David R. Margrave |
| David R. Margrave, Chief Financial Officer |
2
Exhibit99.1
LanternPharma Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Operational Highlights
| ● | RADR^®^,<br> Lantern’s proprietary A.I. and machine learning platform, grew from 1.2 billion to<br> over 18 billion data points, enhancing its precision, insights, and capabilities for oncology<br> drug discovery |
|---|---|
| ● | Preparing<br> for a 2022 launch of the Phase 2 trial for LP-300 in never smokers with NSCLC, which will<br> be Lantern Pharma’s second Phase 2 asset |
| --- | --- |
| ● | Received<br> Orphan Drug Designations for LP-184 for multiple indications and a Rare Pediatric Disease<br> Designation for ATRT, accelerating LP-184 towards IND submission and multiple Phase 1 clinical<br> trials in 2022 |
| --- | --- |
| ● | Expanded<br> focus on leveraging RADR^®^ for biopharma collaborations by increasing platform<br> functionality, scale, and security |
| --- | --- |
| ● | Strengthened<br> intellectual property estate with addition of 12 new patent applications |
| --- | --- |
| ● | $70.7<br> million of cash, cash equivalents and marketable securities as of December 31, 2021 |
| --- | --- |
| ● | Announced<br> share repurchase program with plans to acquire up to $7 million of common stock |
| --- | --- |
| ● | Conference<br> call scheduled for 4:30 p.m. EST today |
| --- | --- |
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.
“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 Harmonic™ 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 selections, and patient enrollment,” stated Sharma.
OperationalHighlights:
RADR^®^Platform Growth and Development
| ● | Surpassed<br> 18 billion data points for RADR^®^ platform, a significant growth of more than<br> 1,000% from year-end 2020; forecasting to reach more than 25 billion data points by year-end<br> 2022. |
|---|---|
| ● | The<br> ongoing growth of RADR^®^ data points is expected to drive continual improvement<br> in Lantern’s ability to rapidly identify new indications, combination therapies, and<br> mechanisms of action for Lantern’s drug candidates. |
| --- | --- |
| ● | Expanding<br> RADR’s^®^ capabilities with a focus on increasing the number of machine<br> learning algorithms and self-learning algorithms. |
| --- | --- |
| ● | Lantern<br> expects to continue to expand its focus on building biopharma collaborations to utilize and<br> expand on the growth of RADR^®^. |
| --- | --- |
Lantern’sPortfolio 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<br> cancer (mCRPC). We are evaluating possibilities for further enrollment in the current Phase<br> II trial as well as other potential clinical development opportunities. Lantern reacquired<br> global rights to LP-100 in July 2021. |
|---|---|
| ● | LP-300 - is preparing to enter a Phase 2 clinical trial, the Harmonic™ Clinical Trial,<br> during 2022. The Harmonic™ trial will be a 90 patient, two-arm, open label clinical<br> trial focused on never smoker patients with relapsed primary adenocarcinoma of the lung,<br> a type of NSCLC. |
| --- | --- |
| ● | LP-184 - is in preparation for potentially multiple Phase 1 clinical trial launches for genomically<br> defined cancers, including pancreatic, glioblastoma multiforme (GBM), bladder and atypical<br> 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<br> in hematological cancer cell lines, including lymphoma, multiple myeloma, and leukemia. LP-284’s<br> indications in hematological cancers are distinct from the indications targeted by LP-184<br> and were generated with the assistance of RADR^®^ insights. |
|---|---|
| ● | Antibody Drug Conjugate (ADC) Program – we have selected and ranked multiple targeting antibodies<br> of interest with potential to be linked to selected cytotoxic payloads. We are currently<br> evaluating various cytotoxic agents and classes of agents to be used as ADC payloads. |
| --- | --- |
2
World-ClassScientific Collaborations
| ● | Expanded<br> collaboration with the National Cancer Institute to accelerate the path to first in-human<br> clinical trials for drug candidates LP-184 and LP-284. |
|---|---|
| ● | Entered<br> collaboration with The Greehey Children’s Cancer Research Institute (GCCRI) at University<br> of Texas Health Science Center-San Antonio to expand Lantern’s drug portfolio research<br> into several additional pediatric cancers. |
| --- | --- |
| ● | Continued<br> GBM & brain cancer collaboration with Johns Hopkins & Kennedy Krieger Institute to<br> develop Phase 1 clinical design and further validate LP-184’s ability to works independently<br> of MGMT (a DNA repair enzyme) status. |
| --- | --- |
| ● | Expanded<br> collaboration with Fox Chase Cancer Center in pancreatic cancers with a focus on clinical<br> design and strategy for LP-184. |
| --- | --- |
| ● | Launched<br> a research collaboration with The Danish Cancer Society Research Center to support development<br> of drug candidates LP-100 and LP-184 in 9 solid tumor types that have a known deficiency<br> in DNA repair mechanisms. LP-100 and LP-184 have both been shown to have a synthetically<br> lethal impact on tumors deficient in DNA repair mechanisms. |
| --- | --- |
Publicationsand Presentations
| ● | Published<br> two scientific articles in Oncotarget and BMC Bioinformatics highlighting the<br> effectiveness of Lantern’s drug candidate LP-184 in potential tumor indications. |
|---|---|
| ● | Presented<br> positive preclinical data on the efficacy of LP-284 in hematologic cancers at the 63rd American<br> Society of Hematology (ASH) Annual Meeting. |
| --- | --- |
| ● | Preclinical<br> data supporting the effectiveness of LP-184 in select pancreatic cancers was presented at<br> the American Association for Cancer Research (AACR) Virtual Special Conference. |
| --- | --- |
| ● | The<br> effectiveness of LP-184 in multiple in vitro and in vivo Glioblastoma models was presented<br> at the Society for Neuro-Oncology (SNO) 2021 Annual Meeting. |
| --- | --- |
| ● | On<br> World Pancreatic Cancer Day, Lantern hosted a virtual KOL webinar on the potential of drug<br> candidate LP-184 for pancreatic cancer. |
| --- | --- |
AdditionalHighlights
| ● | Strengthened<br> intellectual property estate with 12 new patent applications, with the current total IP estate<br> at over 80 active patents and patent applications across 14 patent families. |
|---|---|
| ● | Completed<br> strategic hires to expand and strengthen Lantern’s data science, research, management,<br> and communications teams. |
| --- | --- |
FinancialHighlights:
| ● | Raised<br> gross proceeds of $69 million USD through January 2021 public offering and full exercise<br> of underwriter’s over-allotment option. |
|---|---|
| ● | Capital<br> raised extends cash runway into 2025, allowing the Company to focus on efficiently developing<br> its portfolio of promising oncology therapeutics. |
| --- | --- |
| ● | Authorized<br> a share repurchase program to acquire up to $7 million of the Company’s common stock. Repurchases<br> of shares of common stock pursuant to the repurchase program amounted to $0.9 million during<br> the quarter and year ended December 31, 2021 and an additional $2.2 million of repurchases<br> from January 1, 2022 through March 1, 2022. |
| --- | --- |
FourthQuarter and 2021 Financial Overview:
| ● | Balance Sheet: Cash, cash equivalents, and marketable securities were $70.7 million as of December<br> 31, 2021, compared to $19.2 million as of December 31, 2020. The quarterly and annual cash<br> burn for 2021 reflects our capital-efficient, collaborator-centered business model. |
|---|
3
| ● | R&D Expenses: Research and development expenses were $2.2 million and $7.6 million for the<br> quarter and year ended December 31, 2021 compared to $1.4 million and $2.2 million for the<br> quarter and year ended December 31, 2020, respectively. The annual increase was primarily<br> attributable to increases in product candidate manufacturing related expenses of approximately<br> $2.7 million, increases in research studies of approximately $0.8 million, increases in research<br> and development payroll expenses of approximately $0.7 million, and an increase of $1.0 million<br> related to the upfront payment to Allarity Therapeutics under the Allarity Asset Purchase<br> Agreement, which was a nonrecurring expense. |
|---|---|
| ● | G&A Expenses: General and administrative expenses were $1.4 million and $5.0 million for<br> the quarter and year ended December 31, 2021 compared to $1.6 million and $3.7 million for<br> the quarter and year ended December 31, 2020, respectively. The annual increase was primarily<br> attributable to increases in business and corporate development expense of approximately<br> $0.4 million, increases in corporate insurance expense of approximately $0.6 million, and<br> 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<br> share) for the quarter and year ended December 31, 2021, compared to a net loss of $2.9 million<br> (or $0.47 per share) and $5.9 million (or $1.37 per share) for the quarter and year ended<br> December 31, 2020, respectively. |
| --- | --- |
2022Key Objectives:
| ● | Launch<br> of The Harmonic™ Trial - Ph. 2 clinical trial for LP-300 in NSCLC |
|---|---|
| ● | Advance<br> LP-100 clinical trial |
| --- | --- |
| ● | Launch<br> Ph. 1 clinical trial for LP-184 in genomically-defined solid tumors |
| --- | --- |
| ● | Launch<br> Ph. 1/2 clinical trial for LP-184 in GBM |
| --- | --- |
| ● | Progress<br> LP-184 in ATRT towards Ph. 1/2 clinical trial |
| --- | --- |
| ● | Advance<br> pediatric cancer drug development program |
| --- | --- |
| ● | Advance<br> ADC preclinical studies to support future Phase 1 launch |
| --- | --- |
| ● | Explore<br> potential combinations for LP-184, LP-284, & LP-300 with other existing approved drugs |
| --- | --- |
| ● | Strategically<br> grow RADR^®^ A.I. platform to 25 billion datapoints |
| --- | --- |
| ● | Explore<br> licensing and partnership opportunities |
| --- | --- |
2022Outlook:
“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.”
4
EarningsCall 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<br> presentation materials will be accessible at: https://ir.lanternpharma.com |
| --- | --- |
Replay Details
| - | A<br>replay of the 2021 earnings call and webinar will be available at www.ir.lanternpharma.com |
|---|
Lantern’s Investor Relations Contact
Nicole Leber
Investor Relations Associate
ir@lanternpharma.com
1-972-277-1136
AboutLantern 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
5
Forward-lookingStatements
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.
6
Exhibit 99.2
NASDAQ:LTRN March 10 th , 2022 4:30 PM Eastern Time Fourth quarter 2021 Operating & Financial Results Conference Call / Webinar
NASDAQ:LTRN TODAY’S SPEAKERS Panna Sharma Chief Financial Officer and Secretary Chief Scientific Officer Investor Relations Chief Executive Officer, President and Director David Margrave Dr. Kishor Bhatia Nicole Leber 1
NASDAQ:LTRN 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," “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 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 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 . LTRN Forward Looking Statements 2
NASDAQ:LTRN Contents 01 Lantern Highlights 02 Financial Overview 03 R&D Updates 04 Q&A NASDAQ:LTRN 3
NASDAQ:LTRN NEW CANCER CATEGORIES RADR ® Surpassed 18 billion datapoints this past month • Rare Solid Tumors • Ultra Rare Cancers • Pediatric Cancers • Bladder Cancer • CNS & Brain Cancers • Immune Data • Protein Data • Hotspot Mutation Panels • Methylome Data • Epigenetic Data NEW CANCER CATEGORIES NEW DATA TYPES 4
NASDAQ:LTRN * - Based on current operational and development plans 10 Million 125 Million 1 Billion 10+ Billion 25+ Billion* 2018 2019 2020 2021 2022 Jan. 2019. Jan. 2020 May 2020 Aug. 2020 Oct. 2020 Apr. 2021 Oct. 2021. 2022* 25 100 275 450 1.1 B 4.6B 10.4 B Future Goals For A.I. Platform RADR ® Surpassed 18 Billion Datapoints • Accelerate drug development timelines • Develop insights into the creation of combination - therapy programs • Uncover new therapeutic opportunities • Expand our ability to collaborate with additional partners • Increase library of oncology trained algorithms • Increase focus on immuno - oncology related datasets (including antigen and immunomic data) • Increase focus on rare cancers • Enter into additional value - based biopharma collaborations Expanding RADR ® drives growth in our portfolio of therapies and potential collaborations with other biopharma companies 5
NASDAQ:LTRN 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 6
NASDAQ:LTRN • 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 • 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 • 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 Abandoned Drug Assets & New Drug Development RADR ® Responders Non - Responders Lantern l everages A.I. to reduce oncology drug development cost s 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 7
NASDAQ:LTRN Use RADR to find potential Mechanism of Action ( MoA ) of the Compound / Drug RADR can derive Machine Learning based gene signatures , which can guide biomarker strategies & CDx (Companion Diagnostics) Use different algorithms and methods from RADR to find potential Drug combinations Identify and prioritize type/subtype of cancer for your compound with use of RADR How RADR ® is used by Lantern & our collaborators 8
NASDAQ:LTRN Phase I Phase II Program Preclinical Indication Phase III R&D Lantern’s unique & rapidly d eveloping p ipeline ADC Programs Select Solid Tumors (Multiple targeting antibodies of interest for linkage to selected cytotoxic payloads) Phase I Phase II LP - 184 LP - 100 ( Irofulven ) LP - 300 Program Preclinical 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) Phase III 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 80+ 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 7DUJHWLQJ VXE SRSXODWLRQ LQ +DUPRQLF Ƞ WULDO 16&/& RI $GHQRFDUFLQRPD VXEW\SH Development Collaboration with - Johns Hopkins School of Medicine Development Collaboration with - Johns Hopkins School of Medicine, GCCRI at University of Texas Health Science Center - San Antonio Initial 9 patients showed median overall survival ( mOS ) of 12.5 months Development Collaboration with - Fox Chase Cancer Center LP - 184 Other Pediatric Cancers Development Collaboration with - GCCRI at University of Texas Health Science Center - San Antonio
NASDAQ:LTRN • 90 patient, two - arm, open label trial • trial focused on Never Smoking patients with relapsed primary adenocarcinoma of the lung, a type of NSCLC. • In a subset of Never Smoker patients from a larger NSCLC trial, patients who received LP - 300 with chemotherapy showed increased overall and 2 - year patient survival by 91% and 125% , respectively. +DUPRQLF Œ FOLQLFDO WULDO ± 3KDVH WULDO IRU /3 +DUPRQLF Ƞ FOLQLFDO WULDO LV D 3KDVH PXOWL FHQWHU VWXG\ WR HYDOXDWH /DQWHUQ ȇ V LQYHVWLJDWLRQDO GUXJ /3 ΖW LV IRFXVHG RQ WUHDWLQJ 1HYHU 6PRNHU SDWLHQWV ZLWK UHODSVHG DGYDQFHG SULPDU\ DGHQRFDUFLQRPD RI WKH OXQJ ZKLFK LV D W\SH RI QRQ VPDOO FHOO OXQJ FDQFHU 16&/& If lung cancer in never - smokers were a separate entity, it would be in the top 10 cancers in the U.S. “ ”
NASDAQ:LTRN Source: Phase 3 clinical trial, study ID DMS32212R, conducted by BioNumerik Pharmaceuticals - subpopulations receiving paclitaxel/cisplatin 30% 63% 72% 31% 32% All patients Females never-Smokers Female never-Smokers 2 Year Survival % LQFUHDVH LQ <HDU 6XUYLYDO &RPSDUHG WR 3ODFHER 125% increase in 2 Year Survival Compared to Placebo 65% increase In 2 Year Survival Compared to Placebo LQFUHDVH LQ <HDU 6XUYLYDO &RPSDUHG WR 3ODFHER (N=114) 1 (N=66) (N=288) /DQWHUQ ¶ V SUHFLVLRQ RQFRORJ\ DSSURDFK LQ WKH /3 3KDVH ,, WULDO EXLOGV RQ D SULRU 3KDVH ,,, WULDO WKDW GLG QRW PHHW FOLQLFDO HIILFDF\ HQGSRLQWV EXW GHPRQVWUDWHG VXUYLYDO EHQHILW LQ D SDWLHQW VXEJURXS LP - 300 + Cisplatin / Paclitaxel Placebo + Cisplatin / Paclitaxel 11
1$6'$4 /751 • Granted Orphan Drug Designation for the treatment of Pancreatic Cancer, GBM and ATRT • Granted Rare Pediatric Disease Designation for the treatment of ATRT • Positive preclinical data for LP - 184 in pancreatic cancer and GBM • Currently conducting IND enabling studies to support IND submission in 2022
1$6'$4 /751 LP - 184 Glioblastoma Multiforme (GBM) ‡ ,Q RUWKRWRSLF *%0 [HQRJUDIWV VKRZHG VLJQLILFDQW WXPRU UHGXFWLRQ DQG VXUYLYDO EHQHILW ZLWK /3 WUHDWPHQW ‡ &RPELQDWLRQ RI VSLURQRODFWRQH ZLWK /3 OHG WR [ HQKDQFHPHQWV LQ *%0 VHQVLWLYLW\ LQ YLWUR • Evaluation of in vivo anti - tumor efficacy of LP - 184 + Spironolactone combination in a subcutaneous xenograft tumor model of GBM • Protocol development for a phase 0/2 clinical trial testing LP - 184 in recurrent GBM/ MGMT unmethylated newly diagnosed GBM • A publication showing LP - 184 efficacy in GBM is being prepared for submission in collaboration with Dr. John Laterra Recent Highlights 8SFRPLQJ 0LOHVWRQHV 3XEOLFDWLRQ 3UHVHQWDWLRQ 12,914 Estimated new cases in the US in 2022 (VWLPDWHG *OREDO LQFLGHQFH LQ 250,000 Collaboration “LP - 184, a novel alkylating agent, is effective in glioblastoma” Ȋ *OLREODVWRPD 5HVSRQVH WR %ORRG %UDLQ %DUULHU 3HUPHDEOH 0*07 $JQRVWLF 7KHUDSHXWLF /3 DQG 6HQVLWL]DWLRQ E\ 1XFOHRWLGH ([FLVLRQ 5HSDLU 'HILFLHQF\ ȋ VXEPLWWHG
NASDAQ:LTRN 140% TGI with LP - 184 treatment 7XPRU 9ROXPHV IRU &7* In - vitro Blood Brain Permeability of LP - 184 Positive preclinical data in GBM Combination Therapy of LP - 184 with Spironolactone
NASDAQ:LTRN >W Ͳ ϭϴϰ Pancreatic Cancer ‡ ,Q +5 GHILFLHQW SDQFUHDWLF FDQFHU FHOO OLQH /3 FRPELQHG ZLWK JHPFLWDELQH LULQRWHFDQ DQG R[DOLSODWLQ SDUW RI WKH VWDQGDUG RI FDUH IRU SDQFUHDWLF FDQFHU LV V\QHUJLVWLF RYHU VHOHFWHG FRQFHQWUDWLRQ UDQJHV ‡ /DQWHUQ KRVWHG D YLUWXDO .2/ HYHQW RQ WKH SRWHQWLDO WUHDWPHQW RI 3DQFUHDWLF &DQFHU ZLWK /3 RQ :RUOG SDQFUHDWLF FDQFHU GD\ • Evaluation of in vivo anti - tumor efficacy of LP - 184 in combination with ( i ) selected SOC chemotherapeutic agents (ii) radiation in xenograft models • Complete IND enabling studies in first half of 2022 • Plan on Phase 1 clinical trial in second half of 2022 Recent Highlights Upcoming Milestones 3XEOLFDWLRQ 3UHVHQWDWLRQ 37,700 (VWLPDWHG QHZ FDVHV LQ WKH 86 LQ Estimated Global incidence in 2021 Collaboration ”Synthetic lethality of LP - 184, a next generation acylfulvene, in ex vivo PDX models with homologous recombination defects” ”LP - 184, a novel alkylating agent, is highly effective in pancreatic cancers with DNA damage repair defects”
NASDAQ:LTRN 3UHFOLQLFDO GDWD GHPRQVWUDWHG WKDW /3 GHPRQVWUDWHG VLJQLILFDQW UDSLG SDQFUHDWLF WXPRU VKULQNDJH E\ RYHU LQ LQ YLYR PRXVH PRGHOV LQ ZHHNV Tumor growth inhibition of 109% was observed with LP - 184 treatment relative to control with dosing occur r ing weekly o ver an 8 week period In August 2021, the U.S. FDA granted LP - 184 Orphan Drug Designation (ODD) for the treatment of Pancreatic Cancer Positive preclinical data in pancreatic cancer 0 100 200 300 400 500 600 0 10 20 30 40 50 60 Tumor volume in mm3 ĂLJƐ ƉŽƐƚ ŝŵƉůĂŶƚĂƚŝŽŶ Vehicle control LP-184 (3 mg/kg) /3 LQ YLYR UHVSRQVH LQ D &DSDQ SDQFUHDWLF FDQFHU [HQRJUDIW PRXVH PRGHO LP - 184 demonstrated significant tumor shrinkage (146x) in in - vivo mice PDX models 7XPRUV )URP 9HKLFOH &RQWURO 0LFH DW WKH (QG RI 6WXG\ 3HULRG 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
NASDAQ:LTRN &HOO OLQH NERD HRD LP - 184 + combination agent Bliss Synergy Score Capan1 No Yes Gemcitabine 13.76 5 - Fluorouracil 10.53 Irinotecan 16.50 Oxaliplatin 15.42 Panc03.27 No No Irinotecan 12.00 Oxaliplatin 12.09 Note: Bliss synergy score ranges from - 100 to 100. A synergy score >10 generally indicates synergism . /3 V\QHUJLVWLF FRPELQDWLRQV LQ SDQFUHDWLF FDQFHU FHOO OLQHV 17
NASDAQ:LTRN >W Ͳ ϭϴϰ Atypical Teratoid Rhabdoid Tumor (ATRT) • LP - 184 for ATRT granted Orphan Drug Designation and Rare Pediatric Disease Designation by FDA • ATRT is exceptionally sensitive to LP - 184, with response positively correlated to loss of SWI/SNF proteins that cause rhabdoid tumors and are altered in 20% of all cancers • Publications showing enhanced LP - 184 response with spironolactone combination and the effectiveness of LP - 184 in ATRT and other rhabdoid tumors are expected mid 2022 • Numerous Rhabdoid Tumors are believed to share ATRT sensitivity to LP - 184 and over 20 models are being tested at UT Health, with Dr. Peter Houghton • Protocol development for a Phase 1 trial in pediatric CNS cancers 5HFHQW +LJKOLJKWV Upcoming Milestones 60 (VWLPDWHG QHZ FDVHV LQ WKH 86 DQQXDOO\ Total existing cases of ATRT in the US 600 Collaboration 18
1$6'$4 /751 Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) were granted by FDA for the use of LP - 184 in ATRT treatment LP - 184 is effective in a xenograft model of Atypical Teratoid / Rhabdoid Tumor (ATRT) 7XPRU 9ROXPHV IRU &+/$ Representative terminal tumors CHLA06 subcutaneous cell line derived xenograft model (SMARCB1 deletion, MYC elevation) Vehicle Control LP - 184 4mg/kg
NASDAQ:LTRN Highlights and Milestones ȏ 'HVLJQLQJ D OLEUDU\ RI $'& PROHFXOHV IRU IHDVLELOLW\ DQG SUHFOLQLFDO VWXGLHV R /LEUDU\ ZLOO EH GHYHORSHG ZLWK ERWK FOHDYDEOH DQG QRQ FOHDYDEOH OLQNHUV R 7KUHH SRWHQW SD\ORDGV EHLQJ FRQVLGHUHG ȏ ΖQLWLDO VWXGLHV ZLOO IRFXV RQ WKUHH SRWHQWLDO DQWLERGLHV WR WDUJHW HSLWKHOLDO DQG O\PSKRLG WXPRUV ȏ /HDG FDQGLGDWHV ZLOO EH FKRVHQ EDVHG XSRQ HIILFDF\ WR[LFLW\ E\VWDQGHU HIIHFWV DQG IOH[LELOLW\ RI SD\ORDGV WR DFKLHYH DQ DFFHSWDEOH UDQJH RI '$5 'UXJ $QWLERG\ 5DWLR Characteristics 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 High Specificity 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 WƌŽŐƌĂŵ Antibody Drug Conjugate (ADC) Program for Select Solid Tumors Growing
NASDAQ:LTRN LP - 184 LP - 284 Gene signature development and drug sensitivity prediction LP - 184 Evaluation of efficacy of LP - 184 in glioblastoma (GBM) LP - 184 Determination of drug efficacy in pancreatic PDX tumor models >W Ͳ ϭϴϰ Evaluation of drug efficacy and sensitivity in prostate and pancreatic cancer organoid models and engineered pancreatic cancer cell lines LP - 100 LP - 184 Examine efficacy of Lantern’s drug portfolio in common solid tumors that harbor DNA damage repair deficiency LP - 184 LP - 284 Evaluation of drug efficacy in pediatric tumor models $FDGHPLF DQG UHVHDUFK FROODERUDWLRQV 21
NASDAQ:LTRN 6WUDWHJLF FROODERUDWLRQ WR DFFHOHUDWH SDWLHQW HQUROOPHQW IRU WKH +DUPRQLF Œ & OLQLFDO 7 ULDO IRU QHYHU VPRNHUV ZLWK QRQ VPDOO FHOO OXQJ FDQFHU 16&/& XWLOL]LQJ /3 LQ FRPELQDWLRQ ZLWK FKHPRWKHUDS\ 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 7HFKQRORJ\ FROODERUDWLRQV ZLWK 'HHS /HQV DQG &RGH 2FHDQ 22 Strategic collaboration to to facilitate the accelerated development of RADR ® while reducing development complexity and cost and increasing security and reproducibility /HYHUDJLQJ &RGH 2FHDQ ¶ V &RPSXWH &DSVXOH WHFKQRORJ\ • 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 Further enhances our already established RADR ® platform and provides additional efficiencies in terms of development time and cost.
NASDAQ:LTRN We believe our solid financial position 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. ´ “ NASDAQ:LTRN
NASDAQ:LTRN Contents 01 Lantern Highlights Financial Overview 03 5 ' 8SGDWHV 04 Q&A 24
NASDAQ:LTRN Three Months Ended December 31 , Year Ended December 31, Summary results of operations 2021 2020 2021 2020 2SHUDWLQJ H[SHQVHV General and administrative 1,348,983 1,547,675 5,020,928 3,664,965 Research and development 2,162,260 1,348,329 7,570,580 2,243,225 Total operating expenses 3,511,243 2,896,004 12,591,508 5,908,190 Loss from operations (3,511,243) (2,896,004) (12,591,508) (5,908,190) Interest + Other income, net (29,031) - 228,479 - NET LOSS $ (3,540,274) $ (2,896,004) $ (12,363,029) $ (5,908,190) Net loss per common share, basic and diluted $ (0.31) $ (0.47) $ (1.13) $ (1.37) Weighted avg. common shares outstanding - basic and diluted 11,403,339 6,219,871 10,904,927 4,304,918 25 (Unaudited)
NASDAQ:LTRN Balance sheet highlights & summary 12/31/2021 12/31/2020 Cash and Marketable Securities $ 70,725,447 $ 19,229,232 Prepaid Expenses & Other Current Assets $ 1,990,953 $ 1,007,690 Total Assets $ 73,950,477 $ 20,359,634 Total Liabilities $ 2,379,057 $ 660,839 Total Stockholders’ Equity $ 71,571,420 $ 19,698,795 26
NASDAQ:LTRN Shares Outstanding December 31, 2021 LANTERN PHARMA INC. (LTRN) Common Shares Outstanding 11,088,835 Warrants 273,777 Options (Employees, Management and Directors) 890,826 Fully Diluted Shares Outstanding 12,253,438 27
NASDAQ:LTRN Share repurchase program $7,000,000 is authorized for share repurchase under the Company’s share repurchase program implemented in 2021 Date Shares Repurchased Average Price Total Paid including Commissions FY 2021 121,490 $7.71 $939,666 January 1, 2022 – March 1, 2022 308,345 $6.97 $2,199,964 Total 429,835 $7.18 $3,139,630 28
NASDAQ:LTRN Migrating to a hybrid work environment HYBRID WORK ENVIRONMENT GROWING TEAM 29
NASDAQ:LTRN Contents 01 Lantern Highlights 02 Financial Overview 03 R&D Updates 04 Q&A 28 Contents 01 Lantern Highlights 02 Financial Overview 03 R&D Updates 04 Q&A 30
NASDAQ:LTRN wildtype – normal cell mutant 1 mutant 2 mutant 3 LP - 184 shows exquisite sensitivity in NERD as well as HRD cancers ! LP - 184 in HRD cancers LP - 184 treatment resulted in complete tumor regression in a PDX model of TNBC that is HR deficient and resistant to PARP inhibitors and doxorubicin/ cyclophosphamide LP - 184 in NERD cancers Mutant cell lines deficient in the Nucleotide Excision Repair (NER) pathway were more sensitive to LP - 184 than the parent cell line 31
NASDAQ:LTRN LP - 284 Mantle Cell Lymphoma • Showed nanomolar potency in a variety of hematological cancer cells including in mantle cell lymphoma, double - hit lymphoma, Burkitt's lymphoma, multiple myeloma, chronic myeloid leukemia, and acute lymphocytic leukemia • Presented at the 63rd ASH meeting and Exposition : chemical biology and experimental therapeutics • Investigate LP - 284’s potency in in vivo Mantle Cell Lymphoma models • Validate molecular biomarkers (unpublished data) that predict LP - 284 sensitivity • Examine LP - 284’s toxicity in animals Recent Highlights Upcoming Milestones Publication/ Presentation “The Positive Enantiomer of a Novel Chiral DNA Alkylating Agent Exhibits Nanomolar Potency in Hematologic Cancers” Jianli Zhou, Ph.D., Lantern Pharma 4,200 American Society of Hematology 2014 Estimated new cases in the US 2017 estimated Global incidence number 14,000 Collaboration 32
NASDAQ:LTRN LP - 284 demonstrated distinct anti - tumor activity in hematologic cancer cells LP - 284 • LP - 284 is a synthetic molecule belonging to the new generation of acylfulvenes, a family of naturally derived anti - cancer drug candidates. • LP - 284 is the stereoisomer (enantiomer) of LP - 184. LP - 284 exhibited nanomolar potency in mantle cell lymphoma, double - hit lymphoma, Burkitt’s lymphoma, multiple myeloma, chronic myeloid leukemia, and acute lymphocytic leukemia 33
NASDAQ:LTRN Ɣ /DXQFK RI 7KH +DUPRQLF Œ 7ULDO 3K FOLQLFDO WULDO IRU /3 LQ 16&/& Ɣ $GYDQFH /3 FOLQLFDO WULDO Ɣ /DXQFK 3K FOLQLFDO WULDO IRU /3 LQ JHQRPLFDOO\ GHILQHG VROLG WXPRUV Ɣ /DXQFK 3K FOLQLFDO WULDO IRU /3 LQ *%0 Ɣ 3URJUHVV /3 LQ $757 WRZDUGV 3K FOLQLFDO WULDO Ɣ $GYDQFH SHGLDWULF FDQFHU GUXJ GHYHORSPHQW SURJUDP Ɣ $GYDQFH $'& SUHFOLQLFDO VWXGLHV WR VXSSRUW IXWXUH 3KDVH ODXQFK Ɣ ([SORUH SRWHQWLDO FRPELQDWLRQV IRU /3 /3 /3 ZLWK RWKHU H[LVWLQJ DSSURYHG GUXJV Ɣ 6WUDWHJLFDOO\ JURZ 5$'5 p $ Ζ SODWIRUP WR ELOOLRQ GDWDSRLQWV Ɣ ([SORUH OLFHQVLQJ DQG SDUWQHUVKLS RSSRUWXQLWLHV A T ransformational year for Lantern 2022 34 Objectives
NASDAQ:LTRN Contents 01 /DQWHUQ +LJKOLJKWV 02 Financial Overview 04 Q&A 03 R&D Updates 35
1$6'$4 /751 Nasdaq: LTRN IR Contact: IR@lanternpharma.com 1 - 972 - 277 - 1136 www.lanternpharma.com @LanternPharma