8-K
Lantern Pharma Inc. (LTRN)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of theSecurities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 30, 2020
LanternPharma 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 þ
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 July 30, 2020, Lantern Pharma Inc. (the “Company”) will issue a press release announcing its financial results for the second quarter ended June 30, 2020. 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 July 30, 2020, 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 second quarter ended June 30, 2020. 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.
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: July 30, 2020 | By: | /s/ David R. Margrave |
| David R. Margrave, Chief Financial Officer |
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Exhibit 99.1
LanternPharma Reports Second Quarter 2020 Financial Results and Continued Corporate Progress
ClosedInitial Public Offering Raising Gross Proceeds of $26.3 Million
Surpassed500 Million Curated Oncology Data Points for Company’s RADR^®^ A.I. Platform
AdvancedManufacturing Capabilities for LP-300 and LP-184 Trials
DALLAS,TX – JULY 30, 2020 – Lantern Pharma (NASDAQ: LTRN), a clinical stage biotechnology company using its proprietary RADR^®^ artificial intelligence (“A.I.”) platform to improve drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, today announced its financial results for the second quarter ended June 30, 2020, and provided an update on its R&D pipeline and other corporate developments.
“Lantern Pharma achieved important scientific and operational milestones during the quarter that have us well positioned for growth as we focus on being the leader in A.I.-enabled oncology drug development,” said Panna Sharma, CEO and President of Lantern Pharma. “Our proprietary RADR^®^ platform recently surpassed 500 million data points, further accelerating our path to one billion curated oncology data points in the next few quarters. We have also advanced our manufacturing capabilities and network for our upcoming clinical trials for LP-300 in non-small cell lung cancer among never smokers, and for LP-184 in genomically defined solid tumors and glioblastoma. On June 15, we completed a successful IPO, raising gross proceeds of $26.3 million, significantly strengthening the Company’s balance sheet and provides additional resources to support the continued development of our promising and growing pipeline of targeted cancer therapies. Our approach and vision is to bring cancer therapies to market faster and with reduced cost and risk and ultimately improve patient outcomes. We are entering what I believe is the Golden Age of A.I. where industries will continue to be rapidly transformed and massive advancements made that can benefit medicine, health and those willing to invest in and develop these disruptive opportunities.”
Corporateand Scientific Highlights
| ● | Closed initial public offering – In June 2020, Lantern Pharma closed its initial public offering of 1,750,000 shares of<br> its common stock at a public offering price of $15.00 per share, for gross proceeds of $26,250,000, before deducting underwriting<br> discounts, commissions and offering expenses. |
|---|---|
| ● | Initiated multiple preclinical studies for LP-184 in genomically defined solid tumors and Glioblastoma (GBM) - The studies aim to<br> further validate the genomic signature of LP-184 and help to inform IND development efforts. The data generated in these studies<br> will also support the continued expansion of our RADR^®^ (Response Algorithm for Drug Positioning and Rescue)<br> A.I. platform. |
| --- | --- |
| ● | RADR^®^surpasses 500 million data points – Lantern Pharma is ahead of its initial platform development schedule of<br> reaching 400 million data points by the end of 2020. The Company is now on track to reach over 1 billion data points within<br> the next several quarters. |
| --- | --- |
| ● | Presented at American Association for Cancer Research (AACR) – Two presentations that detailed Lantern Pharma’s use<br> of its RADR^®^ A.I. platform in the development of LP-184, a molecule with nanomolar potency and strong activity<br> in cancers with KEAP1 and KRAS mutations. LP-184 is one of three cancer drug candidates in Lantern Pharma’s pipeline. |
| --- | --- |
| ● | Advanced manufacturing capabilities and network to support LP-300 and LP-184 trials – the Company established a manufacturing<br> network in preparation for its Phase 2 clinical trial of LP-300 in non-small cell lung cancer among never smokers and for<br> LP-184 in preclinical development for genomically defined solid tumors that overexpress certain RNA as well as for glioblastoma<br> multiforme. |
| --- | --- |
| ● | Continue to advance our collaborations with leading academic and cancer research centers - for the purposes of examining<br> additional potential cancer indications for our drugs, improving and validating the existing genomic signatures that correspond<br> to patient response, establishing sites, and recruiting potential investigators for upcoming clinical trials. |
| --- | --- |
Q22020 Financial Highlights
CashPosition: Cash and cash equivalents were $23.8 million as of June 30, 2020, compared to $1.2 million as of December 31, 2019. The increase was primarily due to proceeds from the IPO in June 2020.
R&DExpenses: Research and development expenses were $157,023 for the quarter ended June 30, 2020, compared to $361,273 for the quarter ended June 30, 2019. The decrease was primarily attributable to reductions in product candidate manufacturing related expenses reflecting completion of process development and scale-up studies conducted in the prior year period.
G&AExpenses: General and administrative expenses were $676,399 for the quarter ended June 30, 2020, compared to $268,120 for the quarter ended June 30, 2019. This increase was primarily due to an increase in expenses associated with transitioning to and becoming a public company.
NetLoss: Net loss was $833,422 for the quarter ended June 30, 2020, compared to a net loss of $629,393 for the quarter ended June 30, 2019.
Sharma continued, “Developing drugs by leveraging artificial intelligence is central to transforming the cost and efficiency of the pharma industry and improving the personalization of therapies for cancer patients. By identifying clinical candidates, together with relevant genomic, clinical and phenotypic data, we believe our approach will help us design more efficient pre-clinical studies and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market. RADR^®^ is central to our process in achieving this outcome rapidly and with reduced costs. We currently have three compounds in development, one in a Phase 2 trial in prostate cancer with our partner, Oncology Venture, one that is preparing to enter into a Phase 2 trial, and one in preclinical development,”
“We believe we have developed a sustainable and scalable biopharma business model by combining a unique, oncology-focused big-data platform that leverages artificial intelligence and machine learning with active clinical and preclinical programs that are being advanced in targeted cancer therapeutic areas with significant clinical needs,” concluded Sharma.
ConferenceCall:
Lantern Pharma will host a conference call and webcast today at 8:00 a.m. ET.
ConferenceCall & Webcast Details
| ● | Toll-free<br> Domestic & Canada: 800.791.4813 – conference ID 10552 |
|---|---|
| ● | International:<br> 785-424-1102 – conference ID 10552 |
| ● | US<br> and Canada callers one touch dial: +1.800.791.4813,,10552# |
The webcast will be available in the “Investors” section of the company website at https://ir.lanternpharma.com/ under the News & Events page.
ReplayDetails
A replay of the conference call will be available for replay until 11:59 pm ET August 30, 2020.
Replay Number: 1-888-567-0053, no passcode will be needed.
A live audio-only webcast and related presentation materials will also be accessible on the Lantern Pharma corporate website: https://ir.lanternpharma.com/. Web participants are encouraged to register 15 minutes prior to the start of the call. The webcast will be archived on the Lantern Pharma website for 6 months.
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AboutLantern Pharma
Lantern Pharma (LTRN) is a clinical-stage biopharmaceutical company innovating the repurposing, revitalization and development of precision therapeutics in oncology. We leverage advances in machine learning, genomics, and artificial intelligence by using a proprietary A.I. platform to discover biomarker signatures that help identify patients more likely to respond to our pipeline of cancer therapeutics. Lantern’s focus is to improve the outcome for patients by leveraging our technology to uncover, rescue and develop abandoned or failed drugs. Our current pipeline of three drugs, with two programs in clinical stages and two in preclinical, focuses on cancers that have unique and unmet clinical needs with a clearly defined patient population. We believe that the use of machine learning, genomics and computational methods can help accelerate the revitalization, refocusing and development of small molecule-based therapies. By targeting drugs to patients whose genomic profile identifies them as having the highest probability of benefiting from the drug, this approach represents the potential to deliver best-in-class outcomes. Our team seeks out experienced industry partners, world-class scientific advisors, and innovative clinical-regulatory approaches to assist in delivering cancer therapies to patients as quickly and efficiently as possible. For more information, please visit the company’s website at www.lanternpharma.com or Twitter @lanternpharma.
Contact:
Marek Ciszewski, JD
Director, Investor Relations
628-777-3167
investor@lanternpharma.com
Forward-lookingStatement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR^®^ platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates; estimates regarding the development timing for our drug candidates; our strategic plans to expand the number of data points that our RADR^®^ platform can access and analyze; our research and development efforts of our internal drug discovery programs and the utilization of our RADR^®^ platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline the drug development process and to identify patient populations that would likely respond to a drug candidate; estimates regarding potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements to the effect that Lantern Pharma Inc. or our management “believes”, “expects”, “anticipates”, “estimates”, “plans” (and similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as the impact of the COVID-19 pandemic, the results of our clinical trials, and the impact of competition. Additional factors can be found in the Risk Factors section in our final prospectus, dated June 10, 2020, for our initial public offering, on file with the Securities and Exchange Commission. You may access our June 10, 2020 final prospectus under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC’s website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
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CondensedConsolidated Balance Sheets
| December 31, | |||||
|---|---|---|---|---|---|
| 2019 | |||||
| CURRENT<br> ASSETS | |||||
| Cash | 23,798,343 | $ | 1,232,030 | ||
| Other current asset | 1,728,539 | - | |||
| Prepaid expense | 70,775 | 788 | |||
| Total current assets | 25,597,657 | 1,232,818 | |||
| Property and equipment, net | 15,377 | 8,758 | |||
| Deferred offering costs | - | 191,000 | |||
| TOTAL ASSETS | 25,613,034 | $ | 1,432,576 | ||
| CURRENT LIABILITIES | |||||
| Accounts payable and accrued expenses | 467,988 | $ | 489,292 | ||
| Insurance payable | 1,705,846 | - | |||
| Note payable | 102,831 | - | |||
| Total current liabilities | 2,276,665 | 489,292 | |||
| Loan payable | 108,500 | - | |||
| TOTAL LIABILITIES | 2,385,165 | 489,292 | |||
| STOCKHOLDERS’ EQUITY | |||||
| Preferred Stock - Par Value (1,000,000 authorized at June 30, 2020; 3,480,000 authorized at December 31, 2019; .0001 par value) (Zero shares issued and outstanding at June 30, 2020; 2,438,866 shares issued and outstanding at December 31, 2019) | - | 244 | |||
| Common Stock – Par Value (25,000,000 authorized at June 30, 2020; 12,180,000 authorized at December 31, 2019; .0001 par value) (6,217,577 shares issued and outstanding at June 30, 2020; 1,978,269 shares issued and outstanding at December 31, 2019) | 622 | 198 | |||
| Additional paid-in capital | 31,289,650 | 7,694,547 | |||
| Accumulated deficit | (8,062,403 | ) | (6,751,705 | ) | |
| Total stockholders’ equity | 23,227,869 | 943,284 | |||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | 25,613,034 | $ | 1,432,576 |
All values are in US Dollars.
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CondensedConsolidated Statements of Operations (Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| June 30, | June 30, | |||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||
| Operating expenses | ||||||||||||
| General and administrative | 676,399 | 268,120 | 1,016,571 | 536,049 | ||||||||
| Research and development | 157,023 | 361,273 | 294,127 | 547,317 | ||||||||
| Total operating expenses | 833,422 | 629,393 | 1,310,698 | 1,083,366 | ||||||||
| NET LOSS | $ | (833,422 | ) | $ | (629,393 | ) | $ | (1,310,698 | ) | $ | (1,083,366 | ) |
| Net loss per share of common shares, basic and diluted | $ | (0.31 | ) | $ | (0.32 | ) | $ | (0.55 | ) | $ | (0.55 | ) |
| Weighted-average number of common shares outstanding, basic and diluted | 2,719,198 | 1,978,269 | 2,370,082 | 1,978,269 |
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Exhibit 99.2
https://ir.lanternpharma.com/
FORWARD - LOOKING STATEMENTS This presentation contains forward - looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward - looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR ® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates; estimates regarding the development timing for our drug candidates; our strategic plans to expand the number of data points that our RADR ® platform can access and analyze; our research and development efforts of our internal drug discovery programs and the utilization of our RADR ® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline the drug development process and to identify patient populations that would likely respond to a drug candidate; estimates regarding potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements to the effect that Lantern Pharma Inc. or our management "believes", "expects", "anticipates", "estimates", "plans", and words such as “targets,” “objectives” (and similar expressions) should be considered forward - looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward - looking statements such as the impact of the COVID - 19 pandemic, the results of our clinical trials, and the impact of competition. Additional factors can be found in the Risk Factors section in our final prospectus, dated June 10, 2020, for our initial public offering, on file with the Securities and Exchange Commission. You may access our June 10, 2020 final prospectus under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov . Given these risks and uncertainties, we can give no assurances that our forward - looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward - looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward - looking statements in this 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. 2
- Business Overview & Background 2. Financial Results & IPO Summary 3. Future Outlook & Milestones 4. Q&A Session 3
10 䘲 䘲 䘲 䘲 䘲 䘲 䘲 䘲 䘲 䘲 Lantern is at the forefront of this model of A.I. driven transformation in the area of personalized oncology drug development to drive value for cancer patients and our investors. 4
RADR ® RADR ® Platform Continues to Grow in Volume and Functionality RADR ® Platform Key Features & Architecture 5
RADR ® Output & Signature Development Process Biomarker Signature is Based on Statistical Significance and Biological Relevance 6
10 Million > 2018 125 Million > 2019 400 Million > 2020 1 Billion > 2021 3 - 5 Billion > 2022 Ɣ Ɣ Ɣ Ɣ Ɣ Ɣ Ɣ Ɣ Ɣ RADR ® 7
3 - 5 Billion > 2022 1. Rapid identification of potential compounds to rescue and develop 2. Improved and more nuanced understanding of responder groups, and non - responder groups based on biological networks 3. Feedback for potential mechanisms to be exploited in target - based development activity 4. More rapid entry into clinical trials and patient subgroups 5. Robust companion diagnostics that can be used to accelerate trials and commercial traction 6. Potential for improved patient outcomes with drastically reduced costs and economic burden RADR The RADR Platform Enables... Scientific Value + Patient Value + 10 Million > 125 Million > 400 Million > 1 Billion > 2018 2019 2020 2021 Curated Data Sources Include: ● Historical Trials ● Proprietary Internal Studies ● Studies & Collaborations w/ Partners ● Active Clinical Trials ● Trials in adjacent drug classes and tumors ● Proprietary Sequencing Campaigns ● Proprietary Drug Sensitivity Studies ● Open Sources from Publications and Research ● Clinical Outcome & Lab Data From Select Groups 8
Accelerated Development by Leveraging the RADR ® A.I. platform 108 issued patents and 7 pending applications across 14 patent families Phase I Phase II LP - 184 LP - 100 LP - 300 Drug Preclinical Indication Prostate Cancer Successfully partnered & out - licensed Non - Small Cell Lung Cancer (Focused on Never - Smokers) Solid Tumors (Location agnostic tumors identified by RADR® defined genomic signature) Phase III R&D Glioblastoma (Responsiveness predicted by RADR® and validated in wet - lab studies) LP - 184 Targeting a sub - population in NSCLC of Adenocarcinoma subtype 9
Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Operating expenses: General and administrative 676,399 268,120 1,016,571 536,049 Research and development 157,023 361,273 294,127 547,317 Total operating expenses 833,422 629,393 1,310,698 1,083,366 NET LOSS $ (833,422) $ (629,393) $ (1,310,698) $ (1,083,366) Net loss per common share, basic and diluted $ (0.31) $ (0.32) $ (0.55) $ (0.55) 10
June 15, 2020 Date Closed : Shares Sold : Price : 1,750,000 shares $15.00 per share Common Shares Outstanding 6,217,577 Warrants (Weighted Average Exercise Price of $3.13) 262,014 Underwriter Warrants (Exercise Price at $18.75) 70,000 Options (Employees, Management and Directors) 820,608 Fully Diluted Shares Outstanding 7,370,199 LANTERN PHARMA INC. ( Nasdaq : LTRN) Gross Proceeds $26,250,000 USD Net Proceeds $23,420,000 USD 11
06/30/2020 (Unaudited) 12/31/2019 Cash $ 23,798,343 $1,232,030 Other Current Asset $1,728,539 - Prepaid Expense $70,775 $788 Total Assets $ 25,613,034 $ 1,432,576 Total Liabilities $ 2,385,165 $ 489,292 Total Stockholders’ Equity $ 23,227,869 $ 943,284 12
Second Half of 2020 2021 - 22 Foundational Year Multiple Streams of Value Creation ● Advances for launch of LP - 184 IND - Enabling studies ● Data from collaboration with Georgetown in Prostate and Pancreatic Cancers ● Results from preclinical work in Glioblastoma w/ LP - 184 ● FDA related activity to explore launch of Phase 2 for LP - 300 as a rare cancer trial for never - smoking females ● Further validation of RADR ® platform and signatures ● Validate signature for LP - 184 to design pan - tumor clinical studies and trial ● Focus on increasing RADR ® A.I. Platform to 700+ million data points ● Readout from targeted Ph. 2 trial in Europe in prostate cancer by first half of 2021 with LP - 100 ● Launch Ph. 2 clinical trial for LP - 300 in NSCLC (never - smokers) by mid 2021 ● Launch Ph. 1 clinical trial for LP - 184 in solid tumors ● Launch Ph. 1/2 clinical trial for LP - 184 in GBM ● Explore potential combinations for LP - 184 & LP - 300 with other existing approved drugs (inc. I - O agents) ● Strategically grow RADR ® A.I. Platform beyond 1 Billion data - points ● Big pharma partnership and collaboration on drug rescue, repurposing or development 13
7/31/20 LD Micro -- “Zooming with L.D.” 8/24 - 8/27/20 World Orphan Drug Congress USA 9/8 - 9/10/20 MedInvest A.I., Big Data & Digital Health Conference 9/10/20 Colliers 5th Annual Institutional Investor Conference 9/14 - 9/16/20 H.C. Wainwright & Co. 22nd Annual Global Investment Conference Investor Contact: Marek Ciszewski, J.D. i nvestor@lanternpharma.com ph: 1.628.777.3167 14
Q & A LTRN Operating & Financial Results Call July 30, 2020 15