SecProbe.io

CORRESP
1
filename1.htm

        Scott E. Bartel

        633 West 5th Street, Suite 4000

        Los Angeles, California 90071

        Scott.Bartel@lewisbrisbois.com

        Direct: 213.358.6174

April 16, 2020

Ms. Sasha Parikh

Ms. Vanessa Robertson

Ms. Irene Paik

Mr. Jeffrey Gabor

Division of Corporation Finance

Office of Life Sciences

Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

 Re: Lantern Pharma Inc.

Draft Registration Statement on
Form S-1

Submitted January 24, 2020

CIK No. 0001763950

Ladies and Gentleman:

On behalf of our client, Lantern Pharma
Inc. (the “Company”), we are submitting this letter in response comments received from the staff (the “Staff”)
of Securities and Exchange Commission’s (“SEC’s”) by letter dated February 20, 2020, (the “Comment
Letter”) with respect to the Company’s Draft Registration Statement on Form S-1 confidentially submitted to the Commission
on January 24, 2020 (the “Draft Registration Statement”).

In response to the Comment Letter, the Company
is publicly filing an amended version of the Draft Registration Statement via EDGAR (the “First Amended Registration Statement”)
with this response letter. We are providing the Staff a courtesy copy of the First Amended Registration Statement and a marked
version showing the changes from the Draft Registration Statement.

For the Staff’s convenience, the numbering
of the paragraphs below correspond to the numbering of the comments in the Comment Letter, the text of which we have restated in
italicized type, followed by the Company’s response. Page references in the responses correspond to the page numbers in the
First Amended Registration Statement.

ARIZONA
● CALIFORNIA ●
COLORADO ● CONNECTICUT ●
FLORIDA ● GEORGIA ●
ILLINOIS ● INDIANA ●
KANSAS ● KENTUCKY

LOUISIANA ● MARYLAND ●
MASSACHUSETTS ● MINNESOTA ●
MISSOURI ● NEVADA ●
NEW JERSEY ● NEW MEXICO ●
NEW YORK

NORTH CAROLINA ● OHIO ●
OREGON ● PENNSYLVANIA ●
RHODE ISLAND ● TEXAS ●
UTAH ● VIRGINIA ● WASHINGTON ● WEST VIRGINIA

Securities and Exchange Commission

April 16, 2020

Page 2

Draft Registration Statement on Form S-1 submitted January
24, 2020

Cover Page

1. Reference is
made to the “80%+ Blinded Prediction Success” claim in the center of your graphic under “RADRTM Data Architecture.”
The claim being made here is not clear and the footnote in reference to this claim is not legible. To the extent that this claim
relates to the LP-184 biomarker study on page 96, please ensure that the footnote clearly states that this claim is based solely
on your analysis of the dataset on preclinical LP-184 sensitivity and include a reference to the disclosure on page 96.

A footnote has been added next to the claim
“80%+ Blinded Prediction Success” in the graphic “RADR® DATA ARCHETECTURE” that now clarifies
the claim as follows: “*RADR®’s historical success in predicting responders and non-responders to treatment,
as determined through in-silico, retrospective analyses of historical patient data from 10 independent clinical trials conducted
by others.”

The reference claim does not relate to the
LP-184 preclinical biomarker study described elsewhere in the prospectus.

2. We note the inclusion
of LP-100 under “Our Portfolio” at the bottom of your graphic. Please explain why you believe it is appropriate to
present LP-100 as part of your portfolio given that Oncology Venture will be solely responsible for the development of LP-100,
including development of a plan for a clinical trial program; has the right to assign all or part of the agreement to a third party;
and the limitation of your financial interest to a right to milestones and royalties.

LP-100 has been included as part of the
Company’s portfolio even though it has been out-licensed to Oncology Venture A/S because the Company has retained and/or
exercises significant rights in and to the intellectual property underlying LP-100 besides the right to milestone payments and
royalties, including, but not limited to, the following:

 (i) Section 3.1 of the Drug License and Development Agreement (“DLDA”) between the Company and Oncology Venture, A/S,
contemplates a form of “alliance” between the two companies with each company appointing and maintaining an “Alliance
Manager” responsible for day-to-day interactions related to the Program, that Section 1.78 of the DLDA defines to mean “the
Development including Phase 2 Clinical Trial for Primary Indication and/or Secondary Indication(s) contemplated by this Agreement,
including all rights in and to the Compound and Products, including further development and commercialization rights, granted under
this Agreement.” Although Oncology Venture has a controlling interest in this “alliance,” the Company has an
active participation in the Program covered by the DLDA.

LEWIS BRISBOIS BISGAARD & SMITH LLP

www.lewisbrisbois.com

Securities and Exchange Commission

April 16, 2020

Page 3

 (ii) Section 2.2 of the DLDA provides that the Company and Oncology Ventures establish a “joint development committee”
or “JDC” with three (3) voting members, one (1) from the Company and two (2) from Oncology Venture together with two
(2) additional “non-voting” members mutually agreed to by the parties. Through the JDC, the Company has a right to
participate in the following responsibilities and authorities vested in the JDC:

 a. discuss, plan, revise and implement the Clinical Development Plan, including manufacturing of Irofulven for the Phase 2 Clinical
Trial;

 b. discuss, plan, and inform any further Development of Products in all indications in the Field in the Territory, including manufacturing
of Products in support of such activities;

 c. use Commercially Reasonable Efforts to align each Party’s strategy for the Development of the Products in the Territory;

 d. no less frequently than on a bi-annual basis, review, amend and approve any updates to the Clinical Development Plan, including
the activities, budget and timeline for Development;

 e. review and approve proposed Publications in scientific journals, which will need to be approved unanimously by the JDC members,
presentations at conferences, and/or press releases resulting from Development activities;

 f. establish subcommittees with the unanimous consent of the voting members;

 g. perform such other functions as are referred to the JDC as per the DLDA or otherwise agreed in writing;

 h. discuss, plan and inform of any opportunity to create new intellectual property in relation with Irofulven in the Field of
Irofulven in combination with DRP Biomarker or any other intellectual property;

 i. discuss with regard to the jurisdictions within the Territory where it could be relevant to seek Regulatory Approval and commence
Commercialization of the Product (for Primary Indication or Replacement Secondary Indication) pursuant to the DLDA; and

 j. discuss, plan and inform of any contact or discussion taking place with potential Program Acquirer or any update thereof.

 (iii) Section 3.7 of the DLDA obligates each of the parties, among other things, to “act in good faith to cooperate with one
another and to reach agreement with respect to issues to be decided by the JDC;” and

 (iv) Section 11.2 of the DLDA allows Oncology Venture to terminate the DLDA at will on a short 120 day notice. On such a termination,
all of the intellectual property rights to LP-100 revert back to the Company.

For all these reasons, the Company believes
that LP-100 should be included in its disclosure as a drug candidate in its portfolio. The Company has included an additional
footnote to the graphic “OUR PORTFOLIO” for “LP-100**) that reads: “** LP-100 has been out-licensed to
Oncology Venture A/S, see Business: LP-100.”

LEWIS BRISBOIS BISGAARD & SMITH LLP

www.lewisbrisbois.com

Securities and Exchange Commission

April 16, 2020

Page 4

3. Reference is
made to “LP-300” under “Our Portfolio” at the bottom of the graphic. Please revise to make clear that you have
not initiated clinical trials for LP-300 and the status of LP-300 depicted in the pipeline table is from a clinical program conducted
by another biotechnology company that failed to successfully develop LP-300. In addition, given that your business model involves
patient stratification, please indicate the subset of patients with adenocarcinoma you intend to study.

A footnote has been added to the graphic
“OUR PORTFOLIO” for “LP-300***” that reads as follows: “*** Lantern plans on launching a phase 2
trial based on prior, historical clinical trials and the outcomes and data of those phase 2 and 3 trials conducted by others, see
Business: LP-300.” The subset of patient stratification has been address in additional disclosure on pages 4, 74 and 78 of
the prospectus with disclosure stating “We are currently evaluating LP-300 for the launch of a phase II clinical trial, in
combination with paclitaxel and cisplatin in female non-smokers and never-smokers with NSCLC adenocarcinoma that
have a unique biomarker profile” or similar words to that effect.

Prospectus Summary

Company Overview, page 1

4. We note your
use of “rescuing” throughout the registration statement. The use of this term implies that the use of your proprietary
technology on data from previous trials performed by other parties has resolved issues relating to safety and/or efficacy and will
ultimately lead to the approval of your product candidates. You may disclose that administration of a product candidate was well
tolerated or resulted in no serious adverse events and provide a discussion of prior trial results. However, it is not appropriate
to imply that the use of your proprietary technology on data from previous trials performed by other parties has resolved issues
relating to safety and/or efficacy and will ultimately lead to the approval of your product candidates. Please review the registration
statement to eliminate the use of the term “rescuing.” If you choose to say that the product candidates were well tolerated
in previous clinical trials or that there were no serious adverse events or discuss prior clinical results, please clarify that
prior results are not necessarily predictive of the outcome of future trials.

The Company has revised its disclosure throughout
the registration statement to eliminate any implication or inference that the Company’s RADR® platform has
resolved any issues of safety and/or efficacy relating to any of its drug candidates. Because the term “rescue” is
an industry term widely used in the pharmaceutical industry and is a central focus of the Company’s business strategy, the
Company respectfully believes that it has addressed the Staff’s concerns by providing further disclosure that clarifies that
the use of its RADR® platform and its rescue efforts overall have not resolved issues of safety and/or efficacy
for any of its drug candidates. The Company respectfully believes that the use of a different term in describing its business and
strategy would not be as accurate. Consequently, the Company has continued using of the term “rescue” with further
definition and context to avoid any inferences that its drug candidates will be approved together with disclosure that only the
FDA or other relevant regulatory bodies can resolve issues of safety and efficacy. In this respect, the Company has provide the
following definition and clarification of the term “drug rescue” in the Prospectus Summary on page 2 and in the Business:
Overview section on page 73 of the prospectus:

Scientific literature offers a
definition for “drug rescue” as research involving abandoned small molecules and biologics that have not been approved
by the U.S. Food and Drug Administration (“FDA”). These rescued molecular compounds are often abandoned by pharmaceutical
companies in the drug discovery or preclinical testing phase, typically because they do not prove effective for the specific use
for which they were developed. Some of these compounds may be useful in treating other diseases for which they have not been tested.
See, Hemphill, Thomas A., “The NIH Promotes Drug Repurposing and Rescue,” Research Technology Management, v.
5, no. 5, pp. 6-8 (2012). Our use of the term “rescue”, “drug rescue”, or “drug rescuing” refers
to, “…a system of developing new uses for chemical and biological entities that previously were investigated in clinical
studies but not further developed or submitted for regulatory approval, or had to be removed from the market for safety reasons.”,
which is a definition we believe is recognized in the drug discovery, drug development and pharmaceutical and biotechnology industries.
See, Naylor, S. and Schonfeld J., “Therapeutic Drug Repurposing, Repositioning and Rescue”, DDW (Drug Discovery
World) Winter 2014, and Mucke, HAM, A New Journal for the Drug Repurposing Community. Drug Repurposing, Rescue & Repositioning
1, 3-4 (2014). The use of the term “drug rescue,” “rescuing,” or words of similar meaning in this prospectus
should not be construed to mean that our RADR® platform has resolved all issues of safety and/or efficacy for any
of our drug candidates. Issues of safety and efficacy for any drug candidate may only be determined by the U.S FDA or other applicable
regulatory authorities in jurisdictions outside the United States.

LEWIS BRISBOIS BISGAARD & SMITH LLP

www.lewisbrisbois.com

Securities and Exchange Commission

April 16, 2020

Page 5

In other areas of the prospectus, the Company
has revised its disclosure surrounding the use of the term “rescue” or “rescuing” in an effort to avoid
any implication that the drug itself has been rescued in a way that would lead the reader to believe that the Company’s proprietary
platform has resolved all safety and/or efficacy issues necessary to be resolved in order to obtain marketing approval from the
FDA or other applicable regulatory authority. See pages 2,17,73, and 85 of the prospectus for additional clarifying disclosure.

With respect to the Company’s disclosures
regarding prior clinical trials conducted by others, the Company has added disclosure to the effect that “Prior clinical
trial observations are not necessarily predictive of the outcome of any future clinical trials we may conduct.” See, pages
4 and 75 of the prospectus.

5. We note your
statements here and elsewhere regarding the efficacy of your product candidates, including claims of increased efficacy and claims
that LP-300 demonstrated efficacy in non-smoking females and that LP-100 showed efficacy when administered in combination with
certain chemotherapies on page 108. Please remove all statements suggesting that your product candidates are effective. Safety
and efficacy determinations are solely within authority of the FDA or other regulatory agencies. As your product candidates have
not received approval, it is premature to state or suggest that they are effective.

The Company has revised its disclosures
throughout the prospectus regarding the efficacy of the Company’s drug candidates and to remove the suggestion that their
drug candidate are effective.

Risk Factors

If we are required by the FDA to obtain approval of a companion
diagnostic..., page 24

6. Please revise
to clarify why this risk factor is applicable to your operations. To the extent that any of your product candidates may require
approval of a companion diagnostic device, please expand your disclosure generally and, as applicable, for each product candidate
to disclose whether approval of a companion diagnostic may be required for approval and subsequent commercialization of your therapeutic
products.

The Company believes this risk factor is
relevant to the Company’s business strategy, but believes it is impossible to say which of its drug candidates may require
the approval of a companion diagnostic because it is too early in each drug candidate’s development to know whether a companion
diagnostic would be required to select the patients who will likely re