SEC Company Response from Genprex, Inc. (GNPX) (CIK 0001595248) (GNPX) — Jul 20, 2017
Genprex, Inc. (GNPX) (CIK 0001595248)
Date: July 20, 2017 · CIK: 0001595248 · Accession: 0001185185-17-001578
AI Filing Summary & Sentiment
Referenced dates: June 30, 2017
Show Raw Text
CORRESP 1 filename1.htm 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com July 20, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Suzanne Hayes Re: Genprex, Inc. Draft Registration Statement on Form S-1 Submitted June 5, 2017 2017 CIK No. 0001595248 Dear Ms. Hayes: Enclosed on behalf of our client, Genprex, Inc. (the “Company”), is a registration statement on Form S-1 (the “Registration Statement”). The Registration Statement updates the Company’s confidential draft registration statement on Form S-1 originally submitted to the Securities and Exchange Commission (the “Commission”) on June 5, 2017 (the “Confidential Draft Registration Statement”). The copy of the Registration Statement that is enclosed with the paper copy of this letter is marked to show changes from the Confidential Draft Registration Statement. The Registration Statement is being submitted in response to comments received from the staff of the Commission (the “Staff”) by letter dated June 30, 2017 with respect to the Confidential Draft Registration Statement (the “Comment Letter”) as well as to update the disclosure generally. The numbering of the paragraphs below corresponds to the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the responses below correspond to the page numbers of the Registration Statement. Staff Comments and Company Responses Prospectus Summary Overview, page 1 1. Please clarify the meaning of any significant scientific or technical terms the first time they are used in order to ensure that lay readers will understand the disclosure. For example, please briefly explain what you mean by “pan-kinase inhibitor,” “tyrosine kinase inhibitor,” “checkpoint inhibitor,” “angiogenesis,” “PI3K/AKT pathway,” and “Ras/MAPK pathway.” United States Securities and Exchange Commission July 20, 2017 Page 2 Response: The Company has expanded the disclosure on pages 1-4 of the Registration Statement, and on other pages, to include definitions of scientific and technical terms, including but not limited to those specifically identified by the Staff. 2. We refer to your statement in the first paragraph of this section and elsewhere in your prospectus that preclinical and clinical data indicate that your “product candidates are synergistic with other cancer drugs” including drugs marketed by large pharmaceutical companies such as Merck & Co., Inc. and Bristol-Myers Squibb Company. However your preclinical and clinical trial disclosure does not appear to discuss a synergistic effect with the specific drugs listed (e.g., nivolumab, pembrolizumab, atezolizumab, ipilimumab, or MK2206). Please revise your disclosure to clearly state whether the trials used the specific drugs listed or drugs that you perceive as equivalent, and if the latter, please explain how the drugs are equivalent. Please also clarify whether any of the companies listed were involved in the trials, and discuss the details of relevant trials, including the number of patients in such trials and the results that demonstrated a synergistic effect. In addition, if true, please disclose that the clinical data is only based on results from nine patients in your ongoing Phase I/II trial evaluating Oncoprex with erlotinib in NSCLC, and the rest are based on preclinical trials. Response: The Company has revised the Registration Statement to use the term “synergistic” only when describing the action of Oncoprex in combination with other lung cancer drugs where the Company has preclinical data for such action. In addition, the Company has revised and expanded the disclosure on pages 2, 56 and 57 of the Registration Statement to explain which of the drugs used in the clinical and preclinical studies were the drugs identified by the Staff and which were equivalent to those drugs, to explain how the equivalents are equivalent to the drugs identified by the Staff and to clarify that none of the companies listed by the Staff were involved in the trials. The Company has also revised the disclosure on pages 66, 72, 73 and 77 of the Registration Statement to discuss the details of the relevant studies, including the number of patients and the results of the studies. The Company has also expanded the disclosure on pages 3, 15, 57 and 78 of the Registration Statement to disclose that the clinical data are based on results from nine patients in the Phase I/II combination trial and that the rest are based on preclinical studies. 3. Please disclose the primary and secondary endpoints of each portion of your combined Phase I/II trial, and whether such endpoints for the Phase I portion were met. Response: The Company has revised and expanded the disclosure on pages 3, 4, 57 and 77 of the Registration Statement to disclose the primary and secondary endpoints of the combined Phase I/II trial and to disclose that such endpoints for the Phase I portion were met. United States Securities and Exchange Commission July 20, 2017 Page 3 4. We refer to your discussion of your Phase I/II trial and the comparison in the first paragraph on page 3 to a trial conducted by Boehringer Ingelheim. Please explain the term “median response duration.” Please also balance your discussion of the other trial here, and elsewhere as appropriate, by disclosing the number of patients who participated in that trial as compared to your ongoing trial and, if true, that the other trial’s endpoint was different. Response: The Company has revised and expanded the disclosure on page 3 of the Registration Statement to explain the term “median response duration” and to provide information about the Boehringer Ingelheim trial, including the number of patients who participated in that trial and its endpoints. 5. We note your statement in the fourth paragraph on page 3 that the Phase I trials demonstrated a “favorable” safety profile of Oncoprex. While we will not object to a statement that your drug candidate was well tolerated, a safety determination is solely within the FDA’s authority. Please remove the statement that the trial results demonstrated a favorable safety profile. Please make similar revisions to the statement on page 62 that your trials indicate that Oncoprex can be administered safely and your statement on page 69 that Oncoprex is safe. Response: The Company has revised the disclosure about the safety profile of Oncoprex on pages 4, 66 and 77 of the Registration Statement as requested by the Staff. Our Pipeline, page 3 6. Please reduce the length of the arrow shown in the first row since we note your statement on page 5 that the Phase II portion of your Phase I/II trial is at an early stage with a limited number of patients enrolled. Please also include a Phase III column in your pipeline table. Response: The Company has revised and expanded the “Our Pipeline” table on pages 5 and 59 to shorten the arrow shown in the first row and to add a Phase III column. 7. Please revise your product pipeline table here and in the Business section to remove programs that are currently listed in the preclinical phase (i.e., Oncoprex to treat various solid tumors, Oncoprex + Immunotherapies and additional 3p21.3 candidates), as it is premature to include them since it does not appear that you have started such programs and they are only contemplated at this time. We further note your disclosure on page 13 that you are actively pursuing development of only one product candidate for non-small cell lung cancer. Response: The Company has revised the “Our Pipeline” table on pages 5 and 59 to delete those programs that are contemplated but not yet in preclinical studies. United States Securities and Exchange Commission July 20, 2017 Page 4 Risks Relating to Our Business, page 5 8. Please expand your discussion in the fourth bullet to explain that prior to the combined trial, Oncoprex has previously been tested in only one prior Phase I trial involving 31 patients and which tested Oncoprex as a monotherapy. Response: The Company has expanded the disclosure on page 6 of the Registration Statement in accordance with the comment made by the Staff. 9. Please add a bullet to discuss the continued concentration of ownership by management after the offering. Response: The Company has expanded the disclosure on page 7 of the Registration Statement in accordance with the comment made by the Staff. Implications of Being an Emerging Growth Company, page 6 10. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Response: The Company acknowledges the Staff’s request and advises the Staff that, to date, no written communications, as defined in Rule 405 under the Securities Act, have been presented by the Company, or by anyone authorized to act on the Company’s behalf, to potential investors. The Company intends to provide the Staff supplementally with copies of all such written communications presented to potential investors in reliance on Section 5(d) of the Securities Act as promptly as practicable following such presentation, if any. Risk Factors The intellectual property rights we have licensed . . . , page 29 11. We note that there is a risk that the intellectual property rights you licensed from MD Anderson may be non-exclusive or void if a funding agreement related to the licensed technology between MD Anderson and the US government exists. Please tell us whether you are aware of such a funding agreement or whether you have spoken to MD Anderson about the existence of an agreement. To the extent you are aware of such an agreement, please revise your risk factor accordingly. Response: MD Anderson has informed us that certain of the technologies covered by the MD Anderson License Agreement were developed pursuant to one or more funding agreements with a U.S. government entity. The Company has therefore revised and expanded the referenced risk factor on page 30 of the Registration Statement to better explain the legal basis for the potential governmental rights to the licensed intellectual property rights. United States Securities and Exchange Commission July 20, 2017 Page 5 Certain provisions in our organizational documents. . ., page 41 12. We refer to your last bullet of this risk factor. Please expand your discussion of the risks of your exclusive forum provision to include a discussion that such a provision may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for such disputes and may discourage lawsuits with respect to such claims. Response: The Company has expanded the risk factor on page 43 of the Registration Statement in accordance with the comment made by the Staff. Use of Proceeds, page 44 13. Please clarify what is included by the line item “research and development costs” and whether it relates to either of the trials currently listed in the Use of Proceeds section. Please also consider adding disclosure that assumes you raise an amount in between the minimum and maximum offering amounts. Response: The Company has expanded the disclosure on page 45 of the Registration Statement to clarify what is included in the line item “research and development costs” and the trials to which such costs relate. In addition, the Company has added disclosure that assumes it raises an amount in between the minimum and maximum offering amounts. 14. Regarding your statement in the third paragraph of this section that you estimate you will require at least the specified amount of additional financing to “complete the trials,” please clarify the amount needed to complete the trial for Oncoprex combined with immunotherapy if you only receive the minimum and if you receive the maximum amount in the offering. Please also tell us whether you will be able to complete the Phase II trial for the Oncoprex and erlotinib trial if you only receive the minimum amount of the offering. Response: The Company has expanded the disclosure on page 43 of the Registration Statement to clarify the amount needed to complete the referenced trials if it receives the minimum and the maximum amounts in the offering, and to explain that it will be able to complete the Phase II trial of Oncoprex and erlotinib if it receives only the minimum amount of the offering. United States Securities and Exchange Commission July 20, 2017 Page 6 Business Overview, page 54 15. Please revise the illustration on page 55 so that it more clearly demonstrates the multimodal mechanism of action of Oncoprex. Response: The Company has deleted this illustration, as the mechanisms of action of Oncoprex are better illustrated by the illustrations on pages 62, 63 and 65 of the Registration Statement. Preclinical and Clinical Development, Rationale and Strategy Phase I Monotherapy Clinical Trial, page 64 16. Please disclose how “disease control” was defined in the Phase 1 Monotherapy trial. Response: The Company has expanded the disclosure on pages 3 and 57 of the Registration Statement to include an explanation of “disease control.” 17. Please disclose whether there were any serious adverse effects of the trial. Response: The Company has expanded the disclosure on page 69 of the Registration Statement to include disclosure of the reported serious adverse events observed in the trial. 18. In your discussion of the results of the Phase I monotherapy trial, please disclose whether the results were statistically significant, provide an explanation of the term and discuss how statistical significance relates to the FDA’s evidentiary standards of efficacy. Response: The Company has revised the disclosure on page 72 of the Registration Statement to explain the term “statistically significant” and to explain its relationship to FDA standards of efficacy, and to avoid the use of the terms “significant” and “statistically significant” in connection with the Phase I monotherapy trial, since those concepts were not directly applicable to that trial. 19. Please enlarge the graphs on pages 66 and 75 and figures D, F, G, and H on page 76 to be legible. Response: The Company has enlarged and revised the graphs on pages 71, 82 and 83 of the Registration Statement to make them legible. United States Securities and Exchange Commission July 20, 2017 Page 7 Phase I/II Combination Clinical Trial. . ., page 70 20. We note your statement in the second paragraph on page 72 that you are seeking FDA guidance regarding expanded enrollment in the trial with a view toward seeking accelerated approval. Please disclose here the number of patients contemplated by the current trial protocol, the number of patients currently participating in the Phase II trial, and how long you expect the trial to take under the current protocol. Response: The Company has expanded the disclosure on pages 77, 78 and 80 of the Registration Statement to disclose the number of patients contemplated by the protocol, the number of patients currently participating in the Phase II trial and to discuss the expected duration of the trial, based on certain assumptions. Preclinical Studies of TUSC2 in the Immune Response to Cancer, page 72 21. Please describe what the numbers on the vertical axis in Figure 7 on page 73 represent. Response: The Company has deleted Figure 7 because its information is better shown by the graph on page 81. 22. Please expand your narrative disclosure to discuss w