SEC Comment Letter for SciSparc Ltd. (SPRC) (CIK 0001611746) (SPRC) — Oct 21, 2016
SciSparc Ltd. (SPRC) (CIK 0001611746)
Date: Oct. 21, 2016 · CIK: 0001611746 · Accession: 0000000000-16-098033
AI Filing Summary & Sentiment
Reasoning
Letter
Mail Stop 4 546 Octo ber 21, 2016 Dr. Elran Haber Chief Executive Officer Therapix Biosciences Ltd. 5 Azrieli Center (Square Tower) Tel-Aviv 6702501, Israel
Re: Therapix Biosciences Ltd. Amendment No. 1 to Draft Registration Statement on Form F-1 Submitted October 7, 2016 CIK No. 0001611746
Dear Dr. Haber :
We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better underst and your disclosure.
Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to y our facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments .
Risk Factors Actual or perceived conflicts of interest may exist with respect to intellectual property rights that we license from an entity controlled by our Chairman, page 23
1. We note your response to comme nt 7. However, your revised disclosure addresses potential conflicts of interest if there are disputes with Dekel and does not acknowledge the conflicts that existed when you entered into the agreement with Dekel in June 2015. Please revise the discussio n to acknowledge the conflict of interest and describe the potential consequences.
Dr. Elran Haber Therapix Biosciences Ltd. Octo ber 21, 2016 Page 2
Capitalization, page 41
2. Refer to the changes you made in response to previous comment 10 and address the following: Tell us why you continue to present current liabiliti es here when capitalization normally includes only long -term debt and other long -term obligations; and Revise to present NIS accumulated loss in parentheses.
Management’s Discussion and Analysis of Financial Condition and Results of Operations Liquidity a nd Capital Resources Contractual Obligations, page 51
3. Refer to your response to previous comment 21. Please provide disclosure that explains the types of expenses included in “license agreements” and indicate the aggregate amount of milestone payments yo u may be obligated to make under all the license agreements.
Business Overview, page 52 4. We note that your belief that sublingual and nasal administration of dronabinol is safe and effective appears to be based on preclinical studies and the fact that the use of dronabinol is FDA approved for other indications. Please note that safety and efficacy is solely an FDA determination. Please delete the statements related to your belief that the administration is safe and effective. Additionally, include a risk factor disclosing that the use of dronabinol has been associated with seizures, paranoia, rapid heart rate and unusual thoughts and behaviors.
Clinical Strategy and P reclinical Results, page 56
5. We refer to your expanded discussion on the section 505(b)(2) regulatory pathway in response to our prior comment 12. As previously requested, please also identify and describe the studies and results you intend to rely on, in cluding the identification of the parties that performed the studies.
Intellectual Property, page 58
6. We note your disclosure on page 19 indicating that you have a license agreement with Yissum. Please update this discussion accordingly. Please also fil e the license agreement as an exhibit.
7. We acknowledge your response to our prior comment 23. The identity to the party of a material agreement is not appropriate for confidential treatment. As previously requested, please identify the party to the agree ment and the indication you plan to
Dr. Elran Haber Therapix Biosciences Ltd. Octo ber 21, 2016 Page 3
address using this technology. In addition, if known, please disclose the timing of the PK/bioavailability study.
Noted to Interim Consolidated Financial Statements Note 3: Events During the Reporting Period, page F -65
8. Please revise subnote j. on page F -67 to clarify whether you have signed a license agreement with Yissum as you disclose in a risk factor on page 19 that you have exclusively licensed six patents from them. In addition, please disclose the aggregate amount of milestone payments you may be obligated to make under your arrangement with Yissum, and i nclude this obligation in a footnote to your contractual obligations table on page 51 and the discussion of your licensed patents and patent applications on page 59.
You may contact Keira Nakada at 202 -551-3659 or Mark Brunhofer at 202 -551-3638 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202-551-8776 or me at 202-551-3675 with any oth er questions.
Sincerely,
/s/ Suzanne Hayes
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Mail Stop 4 546 Octo ber 21, 2016 Dr. Elran Haber Chief Executive Officer Therapix Biosciences Ltd. 5 Azrieli Center (Square Tower) Tel-Aviv 6702501, Israel Re: Therapix Biosciences Ltd. Amendment No. 1 to Draft Registration Statement on Form F-1 Submitted October 7, 2016 CIK No. 0001611746 Dear Dr. Haber : We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better underst and your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to y our facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments . Risk Factors Actual or perceived conflicts of interest may exist with respect to intellectual property rights that we license from an entity controlled by our Chairman, page 23 1. We note your response to comme nt 7. However, your revised disclosure addresses potential conflicts of interest if there are disputes with Dekel and does not acknowledge the conflicts that existed when you entered into the agreement with Dekel in June 2015. Please revise the discussio n to acknowledge the conflict of interest and describe the potential consequences. Dr. Elran Haber Therapix Biosciences Ltd. Octo ber 21, 2016 Page 2 Capitalization, page 41 2. Refer to the changes you made in response to previous comment 10 and address the following: Tell us why you continue to present current liabiliti es here when capitalization normally includes only long -term debt and other long -term obligations; and Revise to present NIS accumulated loss in parentheses. Management’s Discussion and Analysis of Financial Condition and Results of Operations Liquidity a nd Capital Resources Contractual Obligations, page 51 3. Refer to your response to previous comment 21. Please provide disclosure that explains the types of expenses included in “license agreements” and indicate the aggregate amount of milestone payments yo u may be obligated to make under all the license agreements. Business Overview, page 52 4. We note that your belief that sublingual and nasal administration of dronabinol is safe and effective appears to be based on preclinical studies and the fact that the use of dronabinol is FDA approved for other indications. Please note that safety and efficacy is solely an FDA determination. Please delete the statements related to your belief that the administration is safe and effective. Additionally, include a risk factor disclosing that the use of dronabinol has been associated with seizures, paranoia, rapid heart rate and unusual thoughts and behaviors. Clinical Strategy and P reclinical Results, page 56 5. We refer to your expanded discussion on the section 505(b)(2) regulatory pathway in response to our prior comment 12. As previously requested, please also identify and describe the studies and results you intend to rely on, in cluding the identification of the parties that performed the studies. Intellectual Property, page 58 6. We note your disclosure on page 19 indicating that you have a license agreement with Yissum. Please update this discussion accordingly. Please also fil e the license agreement as an exhibit. 7. We acknowledge your response to our prior comment 23. The identity to the party of a material agreement is not appropriate for confidential treatment. As previously requested, please identify the party to the agree ment and the indication you plan to Dr. Elran Haber Therapix Biosciences Ltd. Octo ber 21, 2016 Page 3 address using this technology. In addition, if known, please disclose the timing of the PK/bioavailability study. Noted to Interim Consolidated Financial Statements Note 3: Events During the Reporting Period, page F -65 8. Please revise subnote j. on page F -67 to clarify whether you have signed a license agreement with Yissum as you disclose in a risk factor on page 19 that you have exclusively licensed six patents from them. In addition, please disclose the aggregate amount of milestone payments you may be obligated to make under your arrangement with Yissum, and i nclude this obligation in a footnote to your contractual obligations table on page 51 and the discussion of your licensed patents and patent applications on page 59. You may contact Keira Nakada at 202 -551-3659 or Mark Brunhofer at 202 -551-3638 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202-551-8776 or me at 202-551-3675 with any oth er questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Oded Har -Even — Sullivan & Worcester LLP