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): July 29, 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 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 29, 2021, Lantern Pharma Inc. (the “Company”) will issue a press release announcing its financial results for the second quarter ended June 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 July 29, 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 second quarter ended June 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.
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 29, 2021 | By: | /s/ David R. Margrave |
| David R. Margrave, Chief Financial Officer |
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Exhibit 99.1
Lantern Pharma Reports Second Quarter 2021 Financial Results and Operational Highlights
| ● | Obtained positive preclinical data in pancreatic cancer showing a significant reduction, averaging 93%, in tumor volume in in-vivo<br>animal models from research collaboration with Fox Chase Cancer Center |
|---|---|
| ● | Preparing clinical trial site selection and finalization of initial GMP drug material batch during Q3 for LP-300 phase 2 clinical<br>trial in non-small cell lung cancer |
| --- | --- |
| ● | Validated LP-184's potential as a synthetic lethal agent in HRD (homologous recombination deficient) and NERD (nucleotide excision<br>repair deficient) cancers |
| --- | --- |
| ● | Initiated targeted validation of new molecule, LP-284, in lymphomas |
| --- | --- |
| ● | Strengthened intellectual property portfolio with filing of 11 new patent applications, including 2 for the RADR platform |
| --- | --- |
| ● | RADR^®^A.I. platform continues rapid development with additional focus on hematological cancers and expansion of machine<br>learning functionality |
| --- | --- |
| ● | $79.6 million in cash, cash equivalents and marketable securities as of June 30, 2021 |
| --- | --- |
| ● | Conference call scheduled for 4:30 p.m. ET today |
| --- | --- |
DALLAS, TX - July 29, 2021 - Lantern Pharma Inc. (NASDAQ: LTRN) (“Lantern”), a clinical stage biopharmaceutical company using its proprietary RADR^®^artificial intelligence (“A.I.”) platform to transform oncology drug discovery and development today announced financial results for the second quarter ended June 30, 2021.
“We are committed to bringing our pipeline of targeted cancer therapies to patients faster by utilizing our RADR^®^ A.I. platform and making continual advances in our portfolio,” stated Panna Sharma, President and CEO of Lantern Pharma. “This past quarter we made significant advances in our LP-184 program in pancreatic cancer and in validating the role this potent molecule can play in being synthetically lethal in cancers with DNA repair deficiencies. This opens up opportunities for LP-184 in several additional cancers, such as bladder and ovarian, and as a potential combination agent with existing PARP inhibitors.”
“With the recently announced reacquisition of LP-100 earlier this week, we will use insights from the LP-100 trial and investigators to assess further enrollment of the Phase 2 trial in Denmark and initiation of other studies where LP-100 can play a role as a potential cancer therapy. We believe this molecule has the potential to address a market of nearly $200 million in the U.S. and approximately $700 million globally.”
www.lanternpharma.com
Lantern is developing four drug candidates and an ADC program across eight disclosed indications, including:
| ● | LP-100 (Irofulven), in a Phase 2 trial for the treatment of metastatic castration resistant prostate cancer (mCRPC), which<br>showed median overall survival (mOS) of 12.5 months in the initial 9 patients. |
|---|---|
| ● | LP-300, a small molecule drug-candidate that is preparing to enter a Phase 2 trial as a combination therapy in never-smokers<br>with non-small cell lung cancer (NSCLC). |
| --- | --- |
| ● | LP-184, a small molecule DNA damaging candidate in preclinical development for genomically-defined pancreatic and bladder cancers,<br>and potentially other cancers that overexpress PTGR1. |
| --- | --- |
| ● | LP-184, additionally in brain cancers such as: glioblastoma multiforme (GBM), and atypical teratoid rhabdoid tumors (ATRT)<br>and other undisclosed brain tumors. |
| --- | --- |
| ● | LP-284, an alkylating agent that is preferentially active in hematologic cancers and works by blocking transcription of translocated<br>fusion proteins required for survival of such cancers. |
| --- | --- |
| ● | LP-A18 - an antibody drug conjugate (ADC) program that is in late stage discovery to optimize conjugation among known and commercially<br>available antibodies, selected based on insights from RADR, with LP-184 or similar high-potency small molecules. |
| --- | --- |
Second Quarter 2021 Financial Highlights
| ● | Balance Sheet: Cash, cash equivalents, and marketable securities were $79.6 million as of June 30, 2021, compared to $19.2<br>million as of December 31, 2020. The increase reflects $69.0 million of gross proceeds from our January 20, 2021 follow-on public offering. |
|---|---|
| ● | R&D Expenses: Research and development expenses were $1,164,892 for the quarter ended June 30, 2021, compared to $157,023<br>for the quarter ended June 30, 2020. The increase was primarily attributable to increases in manufacturing related expenses, research<br>study expenses, research team expenses, and research and development related stock option compensation expense of $115,761 (a non-cash<br>item) for the quarter ended June 30, 2021. |
| --- | --- |
| ● | G&A Expenses: General and administrative expenses were $1,314,201 for the quarter ended June 30, 2021, compared to $676,399<br>for the quarter ended June 30, 2020. The increase was primarily attributable to expenses associated with operating as a public company<br>and general and administrative related stock option compensation expense of $129,923 (a non-cash item) for the quarter ended June 30,<br>2021. |
| --- | --- |
| ● | Net Loss: Net loss was $2,316,481 for the quarter ended June 30, 2021, or $0.21 per share, compared to a net loss of $833,422<br>for the quarter ended June 30, 2020, or $0.31 per share. The net loss for the quarter ended June 30, 2021 included $47,889 in interest<br>income and $114,723 in other income, net, primarily attributable to a gain on loan forgiveness of Lantern’s PPP loan. The net losses<br>include non-cash expenses related to employee stock options of $245,684 for the quarter ended June 30, 2021. |
| --- | --- |
www.lanternpharma.com
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Mr. Sharma continued, “We remain steadfast in building Lantern into a best-of-breed biopharmaceutical company that blends insights from our RADR^®^ A.I. platform with the experience and expertise of our research team and a roster of collaborations with world-renowned cancer research institutions. Machine learning enabled identification and validation of molecular drivers of cancer provides the potential for more targeted and more effective oncology therapies. We are confident that our portfolio of genetically targeted oncology drug candidates can deliver significant enduring value for our shareholders.”
Expected Upcoming Milestones
| ● | Clinical trial site selection for LP-300 Phase 2 trial aimed at never-smokers with NSCLC. |
|---|---|
| ● | Data from first phase of the collaboration in GBM (Glioblastoma multiforme) with The Brain Cancer Program at Johns Hopkins University<br>with LP-184. |
| --- | --- |
| ● | Preclinical data from ATRT (atypical teratoid rhabdoid tumors) studies -- an ultra rare brain cancer -- also in collaboration with<br>Johns Hopkins University with LP-184. |
| --- | --- |
| ● | Additional details regarding the research collaboration in pancreatic cancer with Fox Chase Cancer Center, including data regarding<br>efficacy in comparison with other targeted therapeutics. |
| --- | --- |
| ● | Additional detailed data from the existing Phase 2 clinical trial with LP-100 that showed a median overall survival of 12.5 months<br>for the initial 9 metastatic, castration-resistant prostate cancer patients. |
| --- | --- |
| ● | Collaborations with leading research and academic centers and companies that advance our platform and our portfolio. |
| --- | --- |
| ● | Data on the initial targeted indications for LP-284. |
| --- | --- |
| ● | Details on the designs, efficacy and disease targets of the ADC program. |
| --- | --- |
Conference Call
| ● | Toll-free US and Canada: 800–791–4813 – conference ID# 20284 |
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| ● | International: 785–424–1102 – conference ID# 20284 |
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| ● | Replay Number: 1-800-839–5642, no passcode -- available through 11:59 pm ET on August 29, 2021. |
| --- | --- |
www.lanternpharma.com
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Webcast
| ● | Live webcast will be available at: Lantern Pharma 2Q21 Earnings Call<br>Webcast |
|---|---|
| ● | The webcast will be archived on https://ir.lanternpharma.com through 11:59 pm ET on August<br>29, 2021. |
| --- | --- |
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 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.
Contact
Panna Sharma, CEO
IR@lanternpharma.com
(628)777-3339
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," "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 none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (iii) the risk that no drug product based on our proprietary RADR 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 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.
www.lanternpharma.com
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Lantern Pharma Inc. and Subsidiary
Condensed Consolidated Balance Sheets
| December 31, | |||||
|---|---|---|---|---|---|
| 2020 | |||||
| CURRENT ASSETS | |||||
| Cash and cash equivalents | 61,354,117 | $ | 19,229,232 | ||
| Marketable securities | 18,234,540 | - | |||
| Prepaid expenses and other current assets | 2,542,426 | 1,007,690 | |||
| Total current assets | 82,131,083 | 20,236,922 | |||
| Property and equipment, net | 30,598 | 21,507 | |||
| Deferred offering costs | - | 101,205 | |||
| Operating lease right-of-use assets | 252,503 | - | |||
| Other assets | 17,889 | - | |||
| TOTAL ASSETS | 82,432,073 | $ | 20,359,634 | ||
| CURRENT LIABILITIES | |||||
| Accounts payable and accrued expenses | 1,093,787 | $ | 552,339 | ||
| Insurance payable | 1,448,419 | - | |||
| Operating lease liabilities, current | 145,898 | - | |||
| Total current liabilities | 2,688,104 | 552,339 | |||
| Operating lease liabilities, net of current portion | 130,705 | - | |||
| PPP loan payable | - | 108,500 | |||
| TOTAL LIABILITIES | 2,818,809 | 660,839 | |||
| COMMITMENTS AND CONTINGENCIES | |||||
| STOCKHOLDERS’ EQUITY | |||||
| Preferred Stock - Par Value (1,000,000 authorized at June 30, 2021 and December 31, 2020; .0001 par value) (Zero shares issued and outstanding at June 30, 2021 and December 31, 2020) | - | - | |||
| Common Stock – Par Value (25,000,000 authorized at June 30, 2021 and December 31, 2020; .0001 par value) (11,184,039 shares issued and outstanding at June 30, 2021; 6,220,927 shares issued and outstanding at December 31, 2020) | 1,118 | 622 | |||
| Additional paid-in capital | 97,088,382 | 32,358,068 | |||
| Accumulated deficit | (17,428,671 | ) | (12,659,895 | ) | |
| Accumulated other comprehensive loss | (47,565 | ) | - | ||
| Total stockholders’ equity | 79,613,264 | 19,698,795 | |||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | 82,432,073 | $ | 20,359,634 |
All values are in US Dollars.
www.lanternpharma.com
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Lantern Pharma Inc. and Subsidiary
Condensed Consolidated Statements of Operations(Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| June 30, | June 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Operating expenses: | ||||||||||||
| General and administrative | 1,314,201 | 676,399 | 2,487,459 | 1,016,571 | ||||||||
| Research and development | 1,164,892 | 157,023 | 2,443,929 | 294,127 | ||||||||
| Total operating expenses | 2,479,093 | 833,422 | 4,931,388 | 1,310,698 | ||||||||
| Loss from operations | (2,479,093 | ) | (833,422 | ) | (4,931,388 | ) | (1,310,698 | ) | ||||
| Interest income | 47,889 | - | 47,889 | - | ||||||||
| Other income, net | 114,723 | - | 114,723 | - | ||||||||
| NET LOSS | $ | (2,316,481 | ) | $ | (833,422 | ) | $ | (4,768,776 | ) | $ | (1,310,698 | ) |
| Net loss per share of common shares, basic and diluted | $ | (0.21 | ) | $ | (0.31 | ) | $ | (0.45 | ) | $ | (0.55 | ) |
| Weighted-average number of common shares <br> outstanding, basic and diluted | 11,181,504 | 2,719,198 | 10,631,121 | 2,370,082 |
www.lanternpharma.com
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Lantern Pharma Inc. and Subsidiary
Condensed Consolidated Statements of ComprehensiveLoss (Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| June 30, | June 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| NET LOSS | $ | (2,316,481 | ) | $ | (833,422 | ) | $ | (4,768,776 | ) | $ | (1,310,698 | ) |
| Other comprehensive loss, net of tax | ||||||||||||
| Unrealized loss on available-for-sale securities, net of tax | (47,565 | ) | - | (47,565 | ) | - | ||||||
| Other comprehensive loss, net of tax | (47,565 | ) | - | (47,565 | ) | - | ||||||
| Comprehensive loss | $ | (2,364,046 | ) | $ | (833,422 | ) | $ | (4,816,341 | ) | $ | (1,310,698 | ) |
www.lanternpharma.com
7
Exhibit 99.2
Second Quarter 2021 Operating & Financial Results Conference Call July 29, 2021 4:30 PM Eastern https://ir.lanternpharma.com/
FORWARD - LOOKING STATEMENTS 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," "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 . LTRN 2
- Business Overview & Background Panna Sharma, CEO 2. Financial Results & Highlights David Margrave, CFO 3. Business Updates Panna Sharma, CEO 4. Milestones Panna Sharma, CEO 5. Q&A Session Panna Sharma, CEO 3 KEY TOPICS Second Quarter 2021 Operating & Financial Results Conference Call July 29 , 2021 4 : 30 PM Eastern
• Drugs that have failed clinical trials or have been abandoned by pharma and biotech companies in late stage trials • 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 Failed or Abandoned Drug Assets & New Drug Development RADR ® Responders Non - Responders Lantern leverages A.I. to rescue and develop cancer therapies and has the potential to transform the cost, risk and timeline of drug development 4
Targeting sub - population in NSCLC of Adenocarcinoma subtype Lantern’s Unique & Rapidly Developing Pipeline LP - A18 ( ADC Programs) Select Solid Tumors Leveraging novel linker library with unique DNA - damaging agents with proven antibodies Accelerated Development by Leveraging the RADR ® A.I. platform Over 80+ issued patents and pending applications across 14 patent families 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) Pancreatic Cancer & Bladder Cancer (Identified by RADR® defined genomic signature) Phase III R&D Glioblastoma & ATRT (Predicted by RADR® and confirmed in in - vivo studies) LP - 184 LP - 284 Hematologic Cancers (Activity predicted by RADR® confirmed with in - vitro studies) Development Collaboration with - Fox Chase Cancer Center Development Collaboration with - Johns Hopkins School of Medicine 5
Highlights & Key Milestones Attained During 2 Q’ 21 6 • Announced positive preclinical data in pancreatic cancer from in - vivo animal models where tumor shrinkage was observed as being an average of 93% over 8 weeks • Initiated development of LP - 184 in DNA damage repair deficient tumors, including bladder where nearly 40% of cancers have DNA repair gene mutations • Progressed on validating specific blood cancers in lymphoma that are highly sensitive to LP - 284 • Progressed clinical trial site selection and final manufacturing for LP - 300 Phase 2 trial • Filed 11 new patent applications, including 2 for the RADR A.I. Platform • Furthered development of RADR data - lake with additional focus on blood cancers and DNA damage repair gene mutated cancers
Summary Results of Operations Three Months Ended June 30, (Unaudited) Six Months Ended June 30, (Unaudited) 2021 2020 2021 2020 Operating expenses : General and administrative 1,314,201 676,399 2,487,459 1,016,571 Research and development 1,164,892 157,023 2,443,929 294,127 Total operating expenses 2,479,093 833,422 4,931,388 1,310,698 Loss from operations (2,479,093) (833,422) (4,931,388) (1,310,698) Interest income 47,889 - 47,889 - Other income, net 114,723 - 114,723 - NET LOSS $ (2,316,481) $ (833,422) $ (4,768,776) $ (1,310,698) Net loss per common share, basic and diluted $ (0.21) $ (0.31) $ (0.45) $ (0.55) Weighted Avg. Common Shares Outstanding - Basic and Diluted 11,181,504 2,719,198 10,631,121 2,370,082 7
6/30/2021 12/31/2020 Cash and Marketable Securities $ 79,588,657 $ 19,229,232 Prepaid Expenses & Other Current Assets $ 2,542,426 $ 1,007,690 Total Assets $ 82,432,073 $ 20,359,634 Total Liabilities $ 2,818,809 $ 660,839 Total Stockholders’ Equity $ 79,613,264 $ 19,698,795 Balance Sheet Highlights & Summary 8
June 30, 2021 LANTERN PHARMA INC. (LTRN) Common Shares Outstanding 11,184,039 Warrants 302,036 Options (Employees, Management and Directors) 823,826 Fully Diluted Shares Outstanding 12,309,901 Shares Outstanding 9
✦ Large - scale, relevant and readily available data - sets ✦ Methods, technologies and algorithms that are massively scalable ✦ Computing, storage and transmission continue exponential advances ✦ Rapid rise of global talent and collaboration networks ✦ Tremendous increase in quality of biological data and methods ✦ Rise of sequencing as a highly available, on - demand, low - cost service ✦ Consumers willing to share personal data in near - time ✦ Industries that have an increasing impetus to transform ✦ New generation of investors demanding novel value creation ✦ Executives and entrepreneurs rewarded for rapid change 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. Entering “The Golden Age of A.I. in Medicine” 10 Mega - Trends Setting The Stage for A.I. Led Transformation in Drug Development & Medicine 10
10 Million > 2018 125 Million > 2019 1 Billion > 2020 8 Billion* > 2021 15 Billion* > 2022 ➢ Rapid identification of potential compounds to rescue and develop ➢ Improved and more nuanced understanding of responder groups, and non - responder groups based on biological networks ➢ Feedback for potential mechanisms to be exploited in target - based development activity Data Points Powering RADR ® The RADR ® Platform Enables... Scientific Value + Patient Value + 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 11 * - Based on current operational and development plans ➢ More rapid entry into clinical trials and patient subgroups ➢ Robust companion diagnostics that can be used to accelerate trials and commercial traction ➢ Potential for improved patient outcomes with drastically reduced costs and economic burden
1 RADR ® rapidly identifies genetic & biomarker signatures for precision oncology drug development, clinical response prediction and CDx (companion diagnostic) enablement. We continue to invest in the platform’s functionality, scale, and volume of data. RADR ® Platform Continues to Grow in Volume and Functionality RADR ® Platform Key Features & Architecture 12 4.7+ Billion Data points from real world cancer data sets & preclinical studies 144+ Drug - Tumor Interactions: Over 90%+ of approved cancer drugs ~27,000+ Patient Records 80%+ Prediction Success
13 Growth in Data Drives Growth in Capabilities: 16.7x Growth Over Last 12 Months (July 2020 to July 2021) • Complete transcriptome data • RNA gene expression data • Drug sensitivity data • DNA copy number & mutation data • Clinical stage of tumor/cancer • Histology of tumor • Patient age and sex • Patient race or ethnicity • Prior treatment history and response • Methylation data * Expected amount of data based on development plan and pipeline
Reacquired Rights to LP - 100 (Irofulven) & Phase 2 Clinical Trial in Metastatic Prostate Cancer + Global Development & Commercialization of Irofulven (LP - 100 ) from Allarity Therapeutics A/S 14 ▪ LP - 100, Irofulven , is in an existing phase 2 clinical trial for patients with mCRPC (metastatic, castration - resistant prostate cancer) in Denmark ▪ 9 patients (out of a target enrollment of 27) have been treated based on meeting criteria established by Allarity's DRP (Drug Response Predictor) companion diagnostic technology ▪ Median overall survival ( mOS ) for the initial group of 9 patients was 12.5 months, which is an improvement over other similar fourth - line treatment regimens for mCRPC ▪ Annually, over $200 million USD is spent in the US and nearly $700 million globally, for treatment of late - stage metastatic prostate cancer ▪ Agreement terms include a payment of US $1.0 million upfront and an additional US $1.0 million over 24 months based on meeting development milestones, along with payments that can total to an additional $16 million based on regulatory filings and commercialization
Positive Preclinical Data in Pancreatic Cancer with drug candidate LP - 184 LP - 184 is a next generation DNA - damaging agent for pancreatic cancer in a research collaboration with Fox Chase Cancer Center Preclinical data demonstrated that LP - 184 had 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 . LP - 184 Delivered Complete Tumor Regression 15
Expanding LP - 184 in additional genomically - targeted indications – Large scale data mining suggests occurrence of NER pathway mutations in a significant proportion of Bladder Cancers Urothelial bladder cancers & NER pathway mutations ~ 40% Estimated Annual Cases 573,278 - Global 83,730 - USA @40% = 33,492 cases in USA 16
2021 2022 Foundational Year Advance Platform Prepare Trial Launches Prioritize Additional Compounds Multiple Streams of Value Creation Launch Multiple Precision Trials Leverage Platform for Pharma Partners Secure Additional Compounds Key Value Building Objectives ● LP - 300 - Initiate clinical trial site selection for NSCLC Phase 2 clinical trial aimed at never smokers ● LP - 184 – Share data and details from GBM & ATRT research programs with Johns Hopkins ● LP - 284 – Share initial indication details and results from validation studies ● LP - 100 – Provide details from initial nine enrolled patients and future potential expansion ● New collaborations with leading institutions ● RADR® A.I. platform to over 8 billion datapoints ● IND - Enabling studies for LP184 in solid tumors ● ADC – Share design and targets for initial ADC program ● Launch Ph. 1 ADC program in solid tumors ● Launch Ph. 1 clinical trial for LP - 184 in solid tumors ● Launch Ph. 1/2 clinical trial for LP - 184 in GBM ● Progress LP - 184 in ATRT towards Ph. 1/2 clinical trial ● Explore potential combinations for LP - 184 & LP - 300 with other existing approved drugs (inc. I - O agents) ● Strategically grow RADR ® A.I. platform to 15 billion datapoints ● Licensing and partnership opportunities 17
Q & A LTRN Operating & Financial Results Call July 29, 2021 18