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Pluri Inc.
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Pluri Inc.
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Pluri Inc.
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1 company response(s)
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Pluri Inc.
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Pluri Inc.
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Pluri Inc.
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Pluri Inc.
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Pluri Inc.
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Pluri Inc.
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Pluri Inc.
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Pluri Inc.
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Pluri Inc.
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-23 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2025-09-22 | SEC Comment Letter | Pluri Inc. | NV | 333-290338 | Read Filing View |
| 2025-05-28 | SEC Comment Letter | Pluri Inc. | NV | 001-31392 | Read Filing View |
| 2025-05-21 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2025-04-15 | SEC Comment Letter | Pluri Inc. | NV | 001-31392 | Read Filing View |
| 2025-04-03 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2025-04-01 | SEC Comment Letter | Pluri Inc. | NV | 001-31392 | Read Filing View |
| 2025-03-27 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2025-03-26 | SEC Comment Letter | Pluri Inc. | NV | 001-31392 | Read Filing View |
| 2023-09-19 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2023-07-25 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2023-06-06 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2023-06-05 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-07-22 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-07-22 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-05-21 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-05-18 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-05-14 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-06-28 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-06-28 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-04-06 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-04-04 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-02-27 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-04-03 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-03-31 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-03-20 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-02-19 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-02-04 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-10-18 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-10-17 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-10-06 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-05-12 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-03-31 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-03-21 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-03-18 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-22 | SEC Comment Letter | Pluri Inc. | NV | 333-290338 | Read Filing View |
| 2025-05-28 | SEC Comment Letter | Pluri Inc. | NV | 001-31392 | Read Filing View |
| 2025-04-15 | SEC Comment Letter | Pluri Inc. | NV | 001-31392 | Read Filing View |
| 2025-04-01 | SEC Comment Letter | Pluri Inc. | NV | 001-31392 | Read Filing View |
| 2025-03-26 | SEC Comment Letter | Pluri Inc. | NV | 001-31392 | Read Filing View |
| 2023-07-25 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2023-06-05 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-07-22 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-05-21 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-05-14 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-06-28 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-04-06 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-02-27 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-04-03 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-03-20 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-02-04 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-10-06 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-05-12 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-03-18 | SEC Comment Letter | Pluri Inc. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-23 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2025-05-21 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2025-04-03 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2025-03-27 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2023-09-19 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2023-06-06 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-07-22 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2020-05-18 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-06-28 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2017-04-04 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-03-31 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2014-02-19 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-10-18 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-10-17 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-03-31 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
| 2011-03-21 | Company Response | Pluri Inc. | NV | N/A | Read Filing View |
2025-09-23 - CORRESP - Pluri Inc.
CORRESP 1 filename1.htm Pluri Inc. MATAM Advanced Technology Park, Building No. 5, Haifa, Israel 3508409 September 23, 2025 Via EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 RE: Pluri Inc. (CIK 0001158780) Registration Statement No. 333-290338 on Form S-3 (the "Registration Statement") Ladies and Gentlemen: Pluri Inc. (the " Registrant ") hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities Act of 1933, as amended (the " Securities Act "), so that it may become effective on September 25, 2025, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant respectfully requests that it be notified of such effectiveness by an email or phone call to Howard E. Berkenblit, Esq. of Sullivan & Worcester LLP at hberkenblit@sullivanlaw.com or 617-338-2979. Very truly yours, Pluri INC. By: /s/ Liat Zalts Liat Zalts Chief Financial Officer
2025-09-22 - UPLOAD - Pluri Inc. File: 333-290338
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 22, 2025 Yaky Yanay Chief Executive Officer Pluri Inc. MATAM Advanced Technology Park, Building No. 5, Haifa, Israel 3508409 Re: Pluri Inc. Registration Statement on Form S-3 Filed September 17, 2025 File No. 333-290338 Dear Yaky Yanay: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Howard E. Berkenblit, Esq. </TEXT> </DOCUMENT>
2025-05-28 - UPLOAD - Pluri Inc. File: 001-31392
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 28, 2025 Liat Zalts Chief Financial Officer Pluri Inc. Matam Advanced Technology Park Building No. 5 Haifa, Israel, 3508409 Re: Pluri Inc. Preliminary Proxy Statement on Schedule 14A Filed March 14, 2025 File No. 001-31392 Dear Liat Zalts: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Ron Ben-Bassat, Esq. </TEXT> </DOCUMENT>
2025-05-21 - CORRESP - Pluri Inc.
CORRESP 1 filename1.htm PLURI INC. Matam Advanced Technology Park Building No. 5 Haifa, 3508409, Israel May 21, 2025 Via EDGAR Doris Stacey Gama Tim Buchmiller Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Re: Pluri Inc. (the "Company") Preliminary Proxy Statement on Schedule 14A Filed March 14, 2025 File No. 001-31392 Dear Ms. Gama and Mr. Buchmiller, The purpose of this letter is to respond to the oral comment provided to us by the staff of the U.S. Securities and Exchange Commission, regarding the above-mentioned Preliminary Proxy Statement on Schedule 14A (the "Proxy Statement"). The Company's acquisition of Kokomodo Ltd., as well as the private placement transaction, were approved by the Company's Board of Directors and were memorialized in definitive binding agreements in January 2025, prior to any interested party or director becoming an interested party or director. Therefore, the aforementioned Company transactions complied with Nasdaq Rule 5635(a). In addition, we confirmed this analysis with Nasdaq on a named basis, and Nasdaq agreed with our conclusion that the transactions were compliant with Nasdaq Rule 5635(a). We thank you for your prompt attention to this letter and look forward to hearing from you at your earliest convenience. If you have any questions or require additional information, please contact our attorneys Ron Ben-Bassat, Esq. at (212) 660-5003, or Howard Berkenblit, Esq. at (617) 338 2979, each of Sullivan & Worcester LLP. Sincerely, pluri INC . By: /s/ Liat Zalts Chief Financial Officer
2025-04-15 - UPLOAD - Pluri Inc. File: 001-31392
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 15, 2025 Liat Zalts Chief Financial Officer Pluri Inc. Matam Advanced Technology Park Building No. 5 Haifa, Israel, 3508409 Re: Pluri Inc. Preliminary Proxy Statement on Schedule 14A Response dated April 3, 2025 File No. 001-31392 Dear Liat Zalts: We have reviewed your April 3, 2025 response to our comment letter and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our April 1, 2025 letter. Preliminary Proxy Statement on Schedule 14A Proposal No. 6 - Private Placement Proposal, page 14 1. We note your response to prior comments 1 and 3 and based on your specific facts and circumstances do not concur in your analysis regarding the applicability of Note A. Please revise your disclosure to include the remaining information required pursuant to Note A of Schedule 14A, including the information set forth in Items 11, 13, and 14 of Schedule 14A. April 15, 2025 Page 2 Please contact Doris Stacey Gama at 202-551-3188 or Tim Buchmiller at 202-551- 3635 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Ron Ben-Bassat, Esq. </TEXT> </DOCUMENT>
2025-04-03 - CORRESP - Pluri Inc.
CORRESP
1
filename1.htm
PLURI INC.
Matam Advanced Technology Park
Building No. 5
Haifa, 3508409, Israel
April 3, 2025
Via EDGAR
Doris Stacey Gama
Tim Buchmiller
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
Pluri Inc. (the "Company," "we," "our" and similar terminology)
Preliminary Proxy Statement on Schedule 14A
Filed March 14, 2025
File No. 001-31392
Dear Ms. Gama and Mr. Buchmiller,
The purpose of this letter is to respond to the letter
of April 1, 2025, received from the staff (the "Staff") of the U.S. Securities and Exchange Commission regarding the above-mentioned
Preliminary Proxy Statement on Schedule 14A (the "Proxy Statement"). For your convenience, your original comment appears in
bold text, followed by our response.
Unless otherwise stated, capitalized terms used herein
but not defined herein have the meanings given to such terms in the Proxy Statement.
Preliminary Proxy Statement on Schedule 14A
Proposal No. 6 – Private Placement Proposal, page 14
1. We note from your response to prior comment 1 that the Transactions (the Securities Purchase Agreement, and the Kokomodo Transaction contemplated by the Share Purchase Agreement) were not contingent upon, nor subject to, shareholder approval. However, we note from Section 4.5 of the Securities Purchase Agreement that the company is required to obtain Shareholder Approval for the exercise of the Warrants and for the consummation of the transactions set forth in the Kokomodo Term Sheet, and we note from Section 3.5.4 of the Share Purchase Agreement that obtaining such Shareholder Approval is a condition to the closing of the Kokomodo Transaction. Given these provisions, please either revise the proxy statement to include the remaining information required by Items 11, 13, and 14 of Schedule 14A or provide us with further analysis as to why the proposal seeking shareholder approval of the exercise of the Warrants, and the approval of the issuance of the Consideration Shares for the purchase of a majority of the equity interests in Kokomodo, does not involve the approval of the Kokomodo Transaction and are not integral parts of the consummation of the transactions contemplated by the Share Purchase Agreement.
Response:
The Company respectfully advises the Staff that it previously reviewed and considered Item 11, Item 13 and Item 14 ("Item 11",
"Item 13" and "Item 14", respectively) and Note A ("Note A") to Schedule 14A, as well as Question
and Answer 151.02 of the Compliance and Disclosure Interpretations for Proxy Rules ("Question 151.02"), in determining whether
to include in the Proxy Statement any additional disclosures under Item 11, Item 13 and Item 14. The Company determined, and continues
to maintain, that Item 13 and Item 14 are inapplicable to the Securities Purchase Agreement and the Kokomodo Transaction described in
the Proxy Statement (the "Transactions"), and that any information required by Item 11, is already disclosed in the Proxy
Statement.
The Company acknowledges that shareholder approval
is required for the issuance of the shares in the Kokomodo Transaction solely to comply with Nasdaq Listing Rule 5635(d)
(the "Nasdaq 20% Rule"). The Company plans to issue 976,139 common shares (the "Consideration Shares"), which
represents approximately 12.6% of its issued and outstanding shares on a pre-transaction basis, as consideration in the Kokomodo Transaction.
Normally, this issuance would not trigger the Nasdaq 20% Rule, as it remains below the 20% threshold. However, due to a prior private
placement pursuant to a securities purchase agreement, dated January 23, 2025 (the "PIPE SPA"), the Consideration Shares must
be aggregated with the securities issued in that transaction. The PIPE SPA involved the sale of 1,383,948 common shares, pre-funded warrants
to purchase up to 26,030 Common Shares, and warrants to purchase up to 84,599 Common Shares. As a result, Nasdaq rules require shareholder
approval for the Consideration Shares. Importantly, If the Kokomodo Transaction had closed before the PIPE SPA, shareholder approval
for the Consideration Shares would not have been necessary. In that case, the board alone could have approved the Kokomodo Transaction
and only the PIPE SPA would have required shareholders' approval. Notably, if approval were sought only for the PIPE SPA only, we
believe the Staff would not consider disclosure under Item 11, Item 13 or Item 14 applicable, as the approval relates strictly to compliance
with the Nasdaq 20% Rule in the context of a financing transaction.
Based on the above, we respectfully continue to maintain
that the disclosures required by Item 11, Item 13 and Item 14 are not relevant or applicable to the Kokomodo Transaction, due to the fact
that if the Kokomodo Transaction had been consummated prior to the PIPE SPA, no shareholder approval would be required at all and because
this proposal is solely triggered by the Nasdaq 20% Rule. As such, we do not believe that Item 11, Item 13 and Item 14 were intended to
require a registrant to provide comprehensive disclosures in a situation where such registrant is seeking shareholder approval for a technical
Nasdaq issue alone.
In addition, the Company is seeking shareholder approval
for the exercise of warrants sold pursuant to the PIPE SPA, which are completely unrelated to the Kokomodo Transaction. While the reference
to obtaining shareholder approval for the warrants is contemplated by a binding term sheet signed with respect to the Kokomodo Transaction,
the issuance of such warrants has been completed and did not require shareholder approval. The exercisability of the warrants is subject
to shareholder approval solely due to the Nasdaq 20% Rule; however, the disclosure in the Proxy Statement makes clear that if shareholders
do not approve the exercise of the warrants, the warrants will simply remain unexercisable. We intend to revise the Proxy Statement to
make clear that the failure to approve the exercise of the Warrants will have no impact on the Kokomodo Transaction. We also maintain
any disclosure to the shareholders that suggest that the approval of the warrants is somehow related to the approval of the Kokomodo Transaction
is misleading and improper, as they are wholly unrelated.
Consequences of Not Approving this Proposal, page 16
2. We note from your disclosure that if shareholders approve Proposal 6,
and you close the transactions under the Share Purchase Agreement, the company will acquire shares representing 71.1% of the equity of
Kokomodo (on a fully diluted basis), for an aggregate purchase price of $4.5 million, payable in the company's Common Shares. In
this section you also disclose that if shareholders do not approve Proposal 6, the company will be required to purchase a "certain
portion" of the Investor's shares in Kokomodo for a purchase amount of $1,000,000 (based on a $6,000,000 pre-money valuation of Kokomodo,
calculated prior to the investment of $500,000 in Kokomodo, as described in (b)), and (b) invest an additional $500,000 in Kokomodo under
a SAFE, providing a 20% discount of the price per share set in connection with a trigger event for conversion of the SAFE into equity
of Kokomodo and a pre-money valuation cap of $5,500,000 in connection with such conversion. Please revise to clarify the percentage of
the equity of Kokomodo you will be required to purchase if shareholders vote "Against" Proposal 6.
Response:
We acknowledge that the disclosure relating to the
potential percentage of equity of Kokomodo that the Company would be required to purchase if shareholders do not approve Proposal 6 should
be clarified in the Proxy Statement, and we intend to revise the Proxy Statement to include a specific percentage of Kokomodo that the
Company will own if shareholders do not approve the issuance of the Consideration Shares. Specifically, the revised disclosure will state
that if shareholders do not approve the issuance of the Consideration Shares, the Company will instead acquire a 25% equity stake in Kokomodo.
3. As noted above, since a vote "For" Proposal 6 will result in the acquisition of a 71% equity
interest of Kokomodo in exchange for common shares of Pluri, and a vote "Against" Proposal 6 will result in the acquisition
of a yet to be specified percentage of Kokomodo in exchange for Pluri's cash, it appears that shareholders are being asked to choose between
one of these two alternatives. Please either provide us with your analysis as to why the remaining information required by Items 11, 13,
and 14 of Schedule 14A is not material to a shareholder's voting decision on the proposal presented or provide such information so that
shareholders can make an informed voting decision as to these two alternatives.
Response:
We acknowledge that the disclosure relating to the
potential percentage of equity of Kokomodo that the Company would be required to purchase if shareholders do not approve Proposal 6 should
be clarified in the Proxy Statement, and we intend to revise the Proxy Statement to include a specific percentage of Kokomodo that the
Company will own if shareholders do not approve the issuance of the Consideration Shares. Specifically, the revised disclosure will state
that if shareholders do not approve the issuance of the Consideration Shares, the Company will instead acquire a 25% equity stake in Kokomodo.
We thank you for your prompt attention to this letter
and look forward to hearing from you at your earliest convenience. If you have any questions or require additional information, please
contact our attorneys Ron Ben-Bassat, Esq. at (212) 660-5003, or Howard Berkenblit, Esq. at (617) 338 2979, each of Sullivan & Worcester
LLP.
Sincerely,
pluri INC .
By:
/s/ Liat Zalts
Chief Financial Officer
2025-04-01 - UPLOAD - Pluri Inc. File: 001-31392
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 1, 2025 Liat Zalts Chief Financial Officer Pluri Inc. Matam Advanced Technology Park Building No. 5 Haifa, Israel, 3508409 Re: Pluri Inc. Preliminary Proxy Statement on Schedule 14A Response dated March 27, 2025 File No. 001-31392 Dear Liat Zalts: We have reviewed your March 27, 2025 response to our comment letter and have the following comments. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our March 26, 2025 letter. Preliminary Proxy Statement on Schedule 14A Proposal No. 6 - Private Placement Proposal , page 14 1. We note from your response to prior comment 1 that the Transactions (the Securities Purchase Agreement, and the Kokomodo Transaction contemplated by the Share Purchase Agreement) were not contingent upon, nor subject to, shareholder approval. However, we note from Section 4.5 of the Securities Purchase Agreement that the company is required to obtain Shareholder Approval for the exercise of the Warrants and for the consummation of the transactions set forth in the Kokomodo Term Sheet, and we note from Section 3.5.4 of the Share Purchase Agreement that obtaining such Shareholder Approval is a condition to the closing of the Kokomodo Transaction. Given these provisions, please either revise the proxy statement to include the remaining information required by Items 11, 13, and 14 of Schedule 14A or provide April 1, 2025 Page 2 us with further analysis as to why the proposal seeking shareholder approval of the exercise of the Warrants, and the approval of the issuance of the Consideration Shares for the purchase of a majority of the equity interests in Kokomodo, does not involve the approval of the Kokomodo Transaction and are not integral parts of the consummation of the transactions contemplated by the Share Purchase Agreement. Consequences of Not Approving this Proposal, page 16 2. We note from your disclosure that if shareholders approve Proposal 6, and you close the transactions under the Share Purchase Agreement, the company will acquire shares representing 71.1% of the equity of Kokomodo (on a fully diluted basis), for an aggregate purchase price of $4.5 million, payable in the company s Common Shares. In this section you also disclose that if shareholders do not approve Proposal 6, the company will be required to purchase a "certain portion" of the Investor's shares in Kokomodo for a purchase amount of $1,000,000 (based on a $6,000,000 pre-money valuation of Kokomodo, calculated prior to the investment of $500,000 in Kokomodo, as described in (b)), and (b) invest an additional $500,000 in Kokomodo under a SAFE, providing a 20% discount of the price per share set in connection with a trigger event for conversion of the SAFE into equity of Kokomodo and a pre-money valuation cap of $5,500,000 in connection with such conversion. Please revise to clarify the percentage of the equity of Kokomodo you will be required to purchase if shareholders vote "Against" Proposal 6. 3. As noted above, since a vote "For" Proposal 6 will result in the acquisition of a 71% equity interest of Kokomodo in exchange for common shares of Pluri, and a vote "Against" Proposal 6 will result in the acquisition of a yet to be specified percentage of Kokomodo in exchange for Pluri's cash, it appears that shareholders are being asked to choose between one of these two alternatives. Please either provide us with your analysis as to why the remaining information required by Items 11, 13, and 14 of Schedule 14A is not material to a shareholder's voting decision on the proposal presented or provide such information so that shareholders can make an informed voting decision as to these two alternatives. Please contact Doris Stacey Gama at 202-551-3188 or Tim Buchmiller at 202-551- 3635 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Ron Ben-Bassat, Esq. </TEXT> </DOCUMENT>
2025-03-27 - CORRESP - Pluri Inc.
CORRESP
1
filename1.htm
PLURI
INC.
Matam Advanced Technology Park
Building No. 5
Haifa, 3508409, Israel
March 27, 2025
Via EDGAR
Doris Stacey Gama
Tim Buchmiller
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
Pluri Inc. (the "Company," "we," "our" and similar terminology)
Preliminary Proxy Statement on Schedule 14A
Filed March 14, 2025
File No. 001-31392
Dear Ms. Gama and Mr. Buchmiller,
The purpose of this letter is to respond to the
letter of March 26, 2025, received from the staff (the "Staff") of the U.S. Securities and Exchange Commission regarding the
above-mentioned Preliminary Proxy Statement on Schedule 14A (the "Proxy Statement"). For your convenience, your original comment
appears in bold text, followed by our response.
Unless otherwise stated, capitalized terms used
herein but not defined herein have the meanings given to such terms in the Proxy Statement.
Proposal No. 6 – Private Placement Proposal, page 14
We note that Proposal No. 6 seeks shareholders of Pluri Inc. to approve the exercise of the Warrants and the issuance of the Consideration Shares in connection with the acquisition of a majority of the equity interests in Kokomodo Ltd. Insofar as your shareholders will not have a separate opportunity to vote on that transaction, please revise your disclosure to include the information required pursuant to Note A of Schedule 14A, including the information set forth in Items 11, 13, and 14 of Schedule 14A. Refer to Question and Answer 151.02 of the Compliance and Disclosure Interpretations for Proxy Rules and Schedules 14A/14C available on our website.
Response:
The Company respectfully advises the Staff that it previously reviewed and considered Item 11, Item 13 and Item 14 ("Item 11",
"Item 13" and "Item 14", respectively) and Note A ("Note A") to Schedule 14A, as well as Question
and Answer 151.02 of the Compliance and Disclosure Interpretations for Proxy Rules ("Question 151.02"), in determining whether
to include in the Proxy Statement any additional disclosures under Item 11, Item 13 and Item 14. The Company determined, and continues
to believe, that Item 13 and Item 14 are inapplicable to the Securities Purchase Agreement and the Kokomodo Transaction described in the
Proxy Statement (the "Transactions"), and that any information required by Item 11, is already disclosed in the Proxy Statement.
Note A
Note A to Schedule 14 A States that:
"Where any item calls for information with
respect to any matter to be acted upon and such matter involves other matters with respect to which information is called for by other
items of this schedule, the information called for by such other items also shall be given. For example, where a solicitation of security holders
is for the purpose of approving the authorization of additional securities which are to be used to acquire another specified company,
and the registrants' security holders will not have a separate opportunity to vote upon the transaction , the solicitation to
authorize the securities is also a solicitation with respect to the acquisition. Under those facts, information required by
Items 11, 13 and 14 shall be furnished." (emphasis added).
Unlike the underlined portion of Note A, the Company's
shareholders are not being asked to approve the exercise of the Warrants and the issuance of the Consideration Shares as part of
an approval of the Transactions. Under the Company's organizational documents, Nevada Law and Nasdaq listing rules, the Company
and its Board had full authority, without the need for shareholders' approval, to consummate the Transactions. No shareholder vote
is being sought via the Proxy Statement with respect to the authorization of additional securities, which are to be used to acquire another
specified company, as part of the shareholders vote on the Transactions. Rather, at the Annual Meeting, the Company's shareholders
will be asked to vote on the exercise of the Warrants and issuance of the Consideration Shares solely for purposes of complying with
Nasdaq Listing Rule 5635(d) (the "Nasdaq 20% Rule").
The Nasdaq 20% Rule requires shareholder approval
before a listed company can issue 20% or more of its outstanding common stock or voting power in a non-public offering at a price below
market value. Here, the Nasdaq 20% Rule is triggered since by the exercise of the Warrants and the issuance of the Consideration Shares,
the Company would cross the 20% threshold. The vote of the Company's shareholders on the exercise of the Warrants and the issuance
of the Consideration Shares is independent of, and will neither have any bearing on, nor facilitate, the completion of the Transactions.
The Transactions were not contingent upon, nor subject to, shareholder approval. The Company's shareholders neither have the legal
right to unwind the Transactions nor vote upon the Transactions. The only issue before the Company's shareholders under Proposal
No. 6 is with respect to the Nasdaq 20% Rule.
The exercise of Warrants and issuance of Conversion
Shares relates to the independent question of whether additional securities may be issued according to the Nasdaq 20% Rule. As disclosed
in the Proxy Statement, if shareholders' approval is not obtained for the exercise of warrants, then the holders of the Warrants
will be unable to exercise such Warrants to the extent that the 20% threshold will be crossed, but it will have no bearing on the approval
of the transaction pursuant to the Securities Purchase Agreement, in which the Warrants were purchased . Additionally, with respect
to the issuance of the Consideration Shares, if shareholders' approval is not obtained, the relevant information of such scenario
is properly disclosed in the Company's Proxy Statement.
Question 151.02
Question 151.02, which provides guidance interpreting
Note A, describes a scenario where the solicitation of shareholder approval by a registrant for the authorization of the issuance of additional
shares of common stock following the closing of an acquisition of another company would "involve" such acquisition
for purposes of Note A and therefore would require the registrant to include in the proxy statement information about the acquisition
called for by Schedule 14A.
The answer to Question 151.02 provides that "A
proposal "involves" another matter within the meaning of Note A when information about the other matter that is called for
by Schedule 14A is material to a security holder's voting decision on the proposal presented. The determination as to whether
there is a substantial likelihood that a reasonable security holder would consider the information important in making a voting
decision on a proposal ultimately depends on all the relevant facts and circumstances."
The Company has determined, and continues to believe,
that the information that is required to be disclosed by Items 13 and 14 is not material to a security holder's voting decision,
because the shareholders' voting is required only for the purpose of complying with the Nasdaq 20% Rule. As mentioned above, the
Company is not seeking shareholder approval for the execution of the Transactions.
2
Additionally, the answer to Question 151.02 provides
that, "The authorization of additional shares of common stock is an integral part of the acquisition because it is necessary for
the registrant to meet its obligation under the convertible securities issued as consideration for the acquisition". However, as
disclosed in the Proxy Statement, and as agreed upon by the parties to the Transactions, in case that shareholders approval is not obtained,
then (i) the holders of the Warrants will be unable to exercise such Warrants to the extent that the 20% threshold will be crossed, but
it will have no bearing on the approval of the transaction pursuant to the Securities Purchase Agreement, in which the Warrants were purchased,
and (ii) with respect to issuance of the Consideration Shares, the relevant information of such scenario is properly disclosed in the
Company's Proxy Statement. Therefore, the Company determined and continues to believe that the proposal to authorize additional
common shares does not "involve" the acquisition.
Item 11, 13 and 14
Item 11 states that "If action is to be
taken with respect to the authorization or issuance of any securities otherwise than for exchange for outstanding securities of the registrant",
then the registrant should furnish specific information. The Company believes that such information, as required by Item 11 of Schedule
14A and the relevant regulations, is already properly included in the Proxy Statement.
In addition, Instruction 1 to Item 13 of Schedule
14A states that "any or all of the information required by paragraph (a) of this Item not material for the exercise of prudent judgment
in regard to the matter to be acted upon may be omitted," and "In the usual case… the information is not deemed material
where the matter to be acted upon is the authorization or issuance of common stock, otherwise than in an exchange, merger, consolidation,
acquisition or similar transaction..." Given the nature of the Transactions disclosed above, the Company does not believe that the
information required by Item 13(a) is material for the exercise of Warrants and issuance of the Conversion Shares, because shareholders'
approval is required only for purposes of the Nasdaq 20% Rule, and not for the approval of the Transactions, which the Company and its
Board had full authority, without shareholders' approval, to consummate.
Finally, Item 14(a) of Schedule 14A, "Applicability,"
lists the matters for which the subsequent Item 14(b) transaction information is to be provided. These matters are, exclusively, (1) a
merger or consolidation; (2) an acquisition of securities of another person; (3) an acquisition of any other going business
or the assets of a going business; (4) a sale or other transfer of all or any substantial part of assets; or (5) a liquidation
or dissolution
The approval of Proposal No. 6, as detailed in
the Proxy Statement, does not fall within any of the above actions, as the shareholder approval is only required with respect of the exercise
of Warrants and issuance of Consideration Shares pursuant to the Nasdaq 20% Rule, and the Transactions were not contingent upon, nor subject
to, shareholders' approval. The Company respectfully submits that the inclusion of information required by Item 14 of Schedule 14A
may, in fact, cause confusion regarding the nature of the required shareholders' vote and mislead shareholders by suggesting that
the Company is asking for their vote, in part, to approve the consummation of the Transactions.
In light of the foregoing, the Company respectfully
submits that the information required by Items 13 and 14 of Schedule 14A is inapplicable to the decision to be made by the Company's
shareholders under Proposal No. 6 with respect to the exercise of Warrants and issuance of Conversion Shares. Such information, if included
in the Proxy Statement, may in fact cause confusion regarding the nature of the required shareholders' vote and mislead shareholders
into believing that, by voting against, they are voting against the consummation of the Transactions.
We thank you for your prompt attention to this
letter and look forward to hearing from you at your earliest convenience. If you have any questions or require additional information,
please contact our attorneys Ron Ben-Bassat, Esq. at (212) 660-5003, or Howard Berkenblit, Esq. at (617) 338 2979, each of Sullivan &
Worcester LLP.
Sincerely,
pluri INC .
By:
/s/ Liat Zalts
Chief Financial Officer
3
2025-03-26 - UPLOAD - Pluri Inc. File: 001-31392
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 26, 2025 Liat Zalts Chief Financial Officer Pluri Inc. Matam Advanced Technology Park Building No.5 Haifa, Israel, 3508409 Re: Pluri Inc. Preliminary Proxy Statement on Schedule 14A Filed March 14, 2025 File No. 001-31392 Dear Liat Zalts: We have reviewed your filing and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Preliminary Proxy Statement on Schedule 14A Proposal No. 6 - Private Placement Proposal, page 14 1. We note that Proposal No. 6 seeks shareholders of Pluri Inc. to approve the exercise of the Warrants and the issuance of the Consideration Shares in connection with the acquisition of a majority of the equity interests in Kokomodo Ltd. Insofar as your shareholders will not have a separate opportunity to vote on that transaction, please revise your disclosure to include the information required pursuant to Note A of Schedule 14A, including the information set forth in Items 11, 13, and 14 of Schedule 14A. Refer to Question and Answer 151.02 of the Compliance and Disclosure Interpretations for Proxy Rules and Schedules 14A/14C available on our website. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. March 26, 2025 Page 2 Please contact Doris Stacey Gama at 202-551-3188 or Tim Buchmiller at 202-551- 3635 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Ron Ben-Bassat, Esq. </TEXT> </DOCUMENT>
2023-09-19 - CORRESP - Pluri Inc.
CORRESP
1
filename1.htm
Pluri Inc.
MATAM Advanced Technology Park
Building No. 5
Haifa, Israel 3508409
September 19, 2023
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, D.C. 20549
Attn: Doris Stacey Gama
Re:
Pluri Inc.
Registration Statement on Form S-3
Filed July 20, 2023
File No. 333-273347
Ladies and Gentlemen:
Pluri
Inc. (the “Company”) hereby requests acceleration of the effectiveness of the above-referenced registration statement
pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective
on September 21, 2023, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The
Company understands that the Commission will consider this request for acceleration of the effective date of the above-referenced registration
statement as a confirmation of the fact that the Company is aware of its responsibilities under the Securities Act and the Securities
Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the above-referenced
registration statement.
Very truly yours,
PLURI INC.
By:
/s/
Chen Franco-Yehuda
Chen Franco-Yehuda
Chief Financial Officer
cc:
Oded Har-Even, Esq.
Howard E. Berkenblit, Esq.
Ron Ben-Bassat, Esq.
2023-07-25 - UPLOAD - Pluri Inc.
United States securities and exchange commission logo
July 25, 2023
Chen Franco-Yehuda
Chief Financial Officer and Treasurer
Pluri Inc.
MATAM Advanced Technology Park
Building No. 5, Haifa L3 31905 Israel
Re:Pluri Inc.
Registration Statement on Form S-3
Filed July 20, 2023
File No. 333-273347
Dear Chen Franco-Yehuda:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Oded Har-Even, Esq.
2023-06-06 - CORRESP - Pluri Inc.
CORRESP
1
filename1.htm
Pluri Inc.
MATAM Advanced Technology Park
Building No. 5
Haifa, Israel 3508409
June 6, 2023
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, D.C. 20549
Attn: Tim Buchmiller
Re:
Pluri Inc.
Registration Statement on Form S-3
Filed June 1, 2023
File No. 333-272330
Ladies and Gentlemen:
Pluri Inc. (the “Company”)
hereby requests acceleration of the effectiveness of the above-referenced registration statement pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Securities Act”), so that it may become effective on June 8, 2023, at 4:00 p.m., Eastern
Time, or as soon thereafter as is practicable.
The Company understands
that the Commission will consider this request for acceleration of the effective date of the above-referenced registration statement as
a confirmation of the fact that the Company is aware of its responsibilities under the Securities Act and the Securities Exchange Act
of 1934, as amended, as they relate to the proposed public offering of the securities specified in the above-referenced registration statement.
Very truly yours,
PLURI INC.
By:
/s/ Chen Franco-Yehuda
Chen Franco-Yehuda
Chief Financial Officer
cc:
Oded Har-Even, Esq.
Howard E. Berkenblit, Esq.
Ron Ben-Bassat, Esq.
2023-06-05 - UPLOAD - Pluri Inc.
United States securities and exchange commission logo
June 5, 2023
Chen Franco-Yehuda
Chief Financial Officer
Pluri Inc.
MATAM Advanced Technology Park,
Building No. 5, Haifa, Israel 3508409
Re:Pluri Inc.
Registration Statement on Form S-3
Filed June 1, 2023
File No. 333-272330
Dear Chen Franco-Yehuda:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Oded Har-Even, Esq.
2020-07-22 - UPLOAD - Pluri Inc.
United States securities and exchange commission logo
July 21, 2020
Chen Franco-Yehuda
Chief Financial Officer
PLURISTEM THERAPEUTICS INC
MATAM Advanced Technology Park
Building No. 5
Haifa L3 31905 Israel
Re:PLURISTEM THERAPEUTICS INC
Registration Statement on Form S-3
Filed July 16, 2020
File No. 333-239890
Dear Mr. Franco-Yehuda:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Laura Crotty at (202) 551- 7614 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Howard Berkenblit
2020-07-22 - CORRESP - Pluri Inc.
CORRESP
1
filename1.htm
Pluristem Therapeutics Inc.
MATAM Advanced Technology Park,
Building No. 5
Haifa L3 31905 Israel
July 22, 2020
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, D.C. 20549
Attn: Laura Crotty
Re:
Pluristem Therapeutics Inc.
Registration Statement on Form S-3
Filed July 16, 2020
File No. 333-239890
Ladies and Gentlemen:
Pluristem Therapeutics
Inc. (the “Company”) hereby requests acceleration of the effectiveness of the above-referenced registration
statement pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that
it may become effective on July 23, 2020, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Company understands
that the Commission will consider this request for acceleration of the effective date of the above-referenced registration statement
as a confirmation of the fact that the Company is aware of its responsibilities under the Securities Act and the Securities Exchange
Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the above-referenced registration
statement.
Very truly yours,
PLURISTEM THERAPEUTICS INC.
By:
/s/ Chen Franco-Yehuda
Chen Franco-Yehuda
Chief Financial Officer
cc:
Oded Har-Even, Esq.
Howard E. Berkenblit, Esq.
2020-05-21 - UPLOAD - Pluri Inc.
United States securities and exchange commission logo
May 21, 2020
Chen Franco-Yehuda
Chief Financial Officer
Pluristem Therapeutics Inc.
Matam Advanced Technology Park
Building No. 5
Haifa, Israel, 3508409
Re:Pluristem Therapeutics Inc.
Preliminary Proxy Statement on Schedule 14A
Filed April 30, 2020
File No. 001-31392
Dear Ms. Franco-Yehuda:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ron Ben-Bassat
2020-05-18 - CORRESP - Pluri Inc.
CORRESP
1
filename1.htm
Pluristem Therapeutics Inc.
Matam Advanced Technology Park
Building No. 5
Haifa, Israel, 31905
May 18, 2020
Division of Corporation Finance, Office of Life Sciences
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549-6010
Attention: Chris Edwards
Re: Pluristem Therapeutics Inc. (the “Company”)
Preliminary Proxy Statement
on Schedule 14A (the “Preliminary Proxy”)
Filed April 30, 2020
File No. 001-31392
Dear Mr. Edwards:
The purpose of this letter
is to respond to your letter of May 14, 2020, with respect to the above-captioned filing. For ease of reference, the Company’s
response is keyed to your comments.
Preliminary Proxy Statement on Schedule
14A
Proposal No. 3 – Increase the Number of Authorized Shares of Common Stock, page 9
1. Please revise the proxy statement to indicate whether you currently have any plans, arrangements or understandings, written
or oral, to issue any of the authorized but unissued shares that would become available as a result of the amendment to the Articles
of Incorporation.
Response to Comment: We have revised
the disclosure in the Preliminary Proxy to confirm that the Company has no current plans, arrangements or understandings, written
or oral, to issue any of the authorized but unissued shares that would become available as a result of the amendment to the Articles
of Incorporation.
2. Please expand the disclosure regarding the potential sale of equity securities in order to utilize funds that may be loaned
by the European Investment Bank. Please discuss whether you have cash on hand to satisfy your funding obligations under the Finance
Contract or if you will need to raise capital through equity sales, and, if capital raises are necessary, at what times and amounts
and through what types of offerings.
Response to Comment: We have expanded
the disclosure in the Preliminary Proxy to confirm that the Company has sufficient capital to satisfy its funding obligations under
the Finance Contract but that it may elect to conduct capital raises. We have further expanded the disclosure in the Proxy Statement
to provide for the potential types of capital raises, and the times and amounts of such raises.
Division of Corporation Finance, Office of Life Sciences
United States Securities and Exchange Commission
Page 2
May 18, 2020
Please contact Ron Ben-Bassat at (212)
660-5003, attorney at Sullivan & Worcester LLP, the Company's U.S. counsel, if you have any questions or require additional
information.
Respectfully,
Pluristem Therapeutics Inc.
By:
/s/ Chen Franco-Yehuda
Chen Franco-Yehuda
Chief Financial Officer
cc: Ron Ben-Bassat, Esq.
2020-05-14 - UPLOAD - Pluri Inc.
United States securities and exchange commission logo
May 14, 2020
Chen Franco-Yehuda
Chief Financial Officer
Pluristem Therapeutics Inc.
Matam Advanced Technology Park
Building No. 5
Haifa, Israel, 3508409
Re:Pluristem Therapeutics Inc.
Preliminary Proxy Statement on Schedule 14A
Filed April 30, 2020
File No. 001-31392
Dear Ms. Franco-Yehuda:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Preliminary Proxy Statement on Schedule 14A
Proposal No. 3 - Increase the Number of Authorized Shares of Common Stock, page 9
1.Please revise the proxy statement to indicate whether you currently have any
plans, arrangements or understandings, written or oral, to issue any of the authorized
but unissued shares that would become available as a result of the amendment to the
Articles of Incorporation.
2.Please expand the disclosure regarding the potential sale of equity securities in order to
utilize funds that may be loaned by the European Investment Bank. Please discuss
whether you have cash on hand to satisfy your funding obligations under the Finance
Contract or if you will need to raise capital through equity sales, and, if capital raises are
necessary, at what times and amounts and through what types of offerings.
FirstName LastNameChen Franco-Yehuda
Comapany NamePluristem Therapeutics Inc.
May 14, 2020 Page 2
FirstName LastName
Chen Franco-Yehuda
Pluristem Therapeutics Inc.
May 14, 2020
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Please contact Chris Edwards at (202) 551-6761 or Joe McCann at (202) 551-6262 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ron Ben-Bassat
2017-06-28 - CORRESP - Pluri Inc.
CORRESP 1 filename1.htm Pluristem Therapeutics Inc. MATAM Advanced Technology Park, Building No. 5 Haifa L3 31905 Israel June 28, 2017 Via EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, D.C. 20549 Attn: Christine Westbrook Re: Pluristem Therapeutics Inc. Registration Statement on Form S-3 Filed June 23, 2017 File No. 333-218916 Ladies and Gentlemen: Pluristem Therapeutics Inc. (the “Company”) hereby requests acceleration of the effectiveness of the above-referenced registration statement pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective on June 30, 2017, at 2:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Company understands that the Commission will consider this request for acceleration of the effective date of the above-referenced registration statement as a confirmation of the fact that the Company is aware of its responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the above-referenced registration statement. Very truly yours, PLURISTEM THERAPEUTICS INC. By: /s/ Erez Egozi Erez Egozi Chief Financial Officer cc: Oded Har-Even, Esq. Howard E. Berkenblit, Esq.
2017-06-28 - UPLOAD - Pluri Inc.
June 28, 2017
Zami Aberman
Chairman and Co-Chief Executive Officer
Pluristem Therapeutics Inc.
MATAM Advanced Technology Park
Buidling No. 5
Haifa L3 31905 Israel
Pluristem Therapeutics Inc.
Registration Statement on Form S-3
Filed June 23, 2017
File No. 333-218916Re:
Dear Mr. Aberman:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Christine Westbrook at (202) 551-5019 with any questions.
Division of Corporation Finance
Office of Healthcare and
Insurance
cc: Oded Har-Even, Esq.
2017-04-06 - UPLOAD - Pluri Inc.
Mail Stop 4546 April 6, 2017 Erez Egozi Chief Financial Officer Pluristem Therapeutics Inc. Matam Advanced Technology Park Building No. 5 Haifa, Israel, 31905 Re: Pluristem Therapeutics Inc. Form 10-K for the Fiscal Year Ended June 30, 2016 Filed September 7, 2016 File No. 001-31392 Dear Mr. Egozi : We have completed our review of your filing . We remind you that the company and its management are responsible for the accuracy and adequacy of the ir disclosure s, notwithstanding any review, comments, action or absence of action by the staff . Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance Cc: Oded Har -Even, Esq. Zysman, Aharoni, Gayer and Sullivan & Worcester LLP
2017-04-04 - CORRESP - Pluri Inc.
CORRESP 1 filename1.htm Pluristem Therapeutics Inc. Matam Advanced Technology Park Building No. 5 Haifa, Israel, 31905 April 4, 2017 Suzanne Hayes, Assistant Director Office of Healthcare and Insurance United States Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549-6010 Re: Pluristem Therapeutics Inc. (the “Company”) Form 10-K for the Fiscal Year ended June 30, 2016 Filed September 7, 2016 File No. 001-31392 Dear Ms. Hayes: The purpose of this letter is to respond to your letter of February 27, 2017, and received by the Company on March 27, 2017, with respect to the above-captioned filing. For ease of reference, the Company’s response is keyed to your comment (inserted in italicized font). General 1. In future filings, please include all material terms for your material collaboration and license agreements. Please also file these agreements as exhibits to your next Exchange Act report. We note, for example, your collaborative research agreement with the Berlin-Brandenburg Center for Regenerative Therapies at Charité, your license agreement with TES Holdings Co., Ltd., and your collaboration with Fukushima Medical University. Please ensure that your disclosure includes all material terms including, as appropriate, the duration of the agreement, termination provisions, material payment provisions, future milestone payments to be paid or received, and royalty rates and royalty terms. In the alternative, please tell us why you do not believe these agreements are material. Response to Comment: For the reasons set forth more fully below, the Company does not believe that its collaborative research agreement (the “Research Agreement”) with the Berlin-Brandenburg Center for Regenerative Therapies at Charité (“Charité”), its license agreement with TES Holdings Co., Ltd. (the “License Agreement”) and its collaboration with Fukushima Medical University (“Fukushima”) pursuant to a memorandum of understanding (the “Memorandum of Understanding”) constitute material agreements that require such agreements to be filed with the Company’s reports (the “Reports”) filed pursuant to Securities Exchange Act of 1934, as amended. The Company does not believe the Research Agreement to be material primarily due to the fact that the agreement relates solely to clinical research studies in Germany. While the Company does view the Research Agreement as important to the Company’s progress in Germany, it does not view such agreement as being material to the Company’s business prospects as a whole. In addition, the Company disclosed in its Annual Report on Form 10-K for the fiscal year ended June 30, 2016 (the “Annual Report”) that Charité will receive between 1% to 2% royalties from new developments that have been achieved during the joint development, an amount which even if received the Company does not expect to be material. Notwithstanding the foregoing, the Company has provided disclosures relating to the material terms of the Research Agreement in its Annual Report and will continue to do so in its future Reports to the extent the Research Agreement is discussed. Ms. Pamela A. Long Page 2 April 4, 2017 With respect to the License Agreement, while the Company acknowledges that such agreement provides for the license of certain Japanese patents relating to ischemic diseases with placental cell therapy in Japan and provides for the payment of certain royalties, the percentage of royalties to be paid thereunder are in the single low-digits, as reported in the Annual Report, an amount which even if paid the Company does not expect to be material. Furthermore, the obligation with respect to payment of royalties pursuant to the License Agreement is limited to sales from a single Company product – the PLX-PAD – in a single clinical indication of critical limb ischemia and solely for sales that occur in Japan. Furthermore, such royalty payments expire upon the expiration of the patent in 2023. As such, even if the Company is able to commercialize its products in the near term, the period of time in which it would be required to pay any such royalties would be limited, and therefore the amounts in question would not be material in the aggregate. Notwithstanding the foregoing, the Company has provided disclosures relating to the material terms of the License Agreement in its Annual Report and will continue to do so in its future Reports to the extent the License Agreement is discussed. Finally, with respect to the Memorandum of Understanding, the Company does not view the agreement as material, based on the fact that it is a non-exclusive arrangement relating solely to the research collaboration efforts of the Company’s PLX-R18 cells for the treatment of acute radiation syndrome and for morbidities following radiotherapy treatment in cancer patients. In that regard, the Company is not required to continue its collaboration efforts with Fukushima, and the Memorandum of Understanding does not contain any commercial terms requiring the payments of royalties or milestone payments. Notwithstanding the foregoing, the Company intends to provide a description of the material terms of the Memorandum of Understanding as it relates to its duration, in its future Reports to the extent the Memorandum of Understanding is discussed. Based on the foregoing, the Company believes its prior disclosures relating to the Research Agreement, License Agreement and Memorandum of Understanding are sufficient due to the fact that such agreements are not material to the Company’s business, nor constitute agreements to which the Company is substantially dependent, and the Company does not currently intend to file such agreements with its future Reports. Notwithstanding the foregoing, the Company currently plans to continue to provide disclosures of the material terms of the Research Agreement and License Agreement and to provide a description of the material terms of the Memorandum of Understanding in its future Reports to the extent such agreements are otherwise discussed. Please contact Oded Har-Even at (212) 660-5002, attorney at Zysman, Aharoni, Gayer and Sullivan & Worcester LLP, the Company's U.S. counsel, if you have any questions or require additional information. Respectfully, Pluristem Therapeutics Inc. By: /s/ Erez Egozi Erez Egozi Chief Financial Officer cc: Oded Har-Even, Esq.
2017-02-27 - UPLOAD - Pluri Inc.
Mail Stop 4546 February 27, 2017 Yaky Yanay Chief Financial Officer, Chief Operating Officer and President Pluristem Therapeutics Inc. Matam Advanced Technology Park Building No. 5 Haifa, Israel, 31905 Re: Pluristem Therapeutics Inc. Form 10-K for the Fiscal Year Ended June 30, 2016 Filed September 7, 2016 File No. 001-31392 Dear Mr. Aberman : We have reviewed your filing an d have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to these comments within ten busine ss days by providing the requested information or advis e us as soon as possible when you will respond. If you do not believe our comments apply to your facts and circumstances , please tell us why in your response. After reviewing your response to these comments, we may have additional comments. General 1. In future filings, please include all material terms for your material collaboration and license agreements. Please also file these agreements as exhibits to your next Exchange Act report. We note, for example, your collaborative research agreement with the Berlin - Brandenburg Center for Regenerative Therapies at Charité, your license agreement with TES Holdings Co., Ltd., and your collaboration with Fukushima Medical University. Please ensure that your disclosure includes all material terms including, as appropriate, the duration of the agreement, termination provisions, material payment provi sions, future milestone payments to be paid or received, and royalty rates and royalty terms. In the alternative, please tell us why you do not believe these agreements are material. We remind you that the company and its management are responsible for t he accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Yaky Yanay Pluristem Therapeutics Inc. February 27, 2017 Page 2 Please contact Chris Edwards at (202) 551 -6761 or Erin Jaskot at (202) 551 -3442 with any questions. Sincerely, /s/ Erin K. Jaskot Suzanne Hayes Assistant Director Office of Healthcare and Insurance
2014-04-03 - UPLOAD - Pluri Inc.
April 3 , 2014 Via E -mail Yaky Yanay Executive Vice President, Chief Financial Officer and Secretary Pluristem Therapeutics, Inc. MATAM Advanced Technology Park Building No. 5 Haifa, Israel 31905 Re: Pluristem Therapeutics, Inc. Form 10 -K for t he Fiscal year Ended June 30, 2013 Filed September 11 , 2013 File No. 001 -31392 Dear Mr. Yanay : We have completed our review of your filing. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person u nder the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing include the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director
2014-03-31 - CORRESP - Pluri Inc.
CORRESP
1
filename1.htm
zk1414693.htm
March 31, 2014
Jeffrey P. Riedler, Assistant Director
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, DC 20549-6010
Re:
Pluristem Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2013 (the "Filing")
Filed September 11, 2013
File No. 001-31392
Dear Mr. Riedler:
The purpose of this letter is to respond to your letter of March 19, 2014, with respect to the above-captioned Filing. For ease of reference, our response is keyed to your comment (inserted in italicized font).
Form 10-K for the Fiscal Year Ended June 30, 2013
Item 1. Business
Ongoing Research and Development Plans, page 6
1.
We note your response to our comment 1 and your position that the royalty rate represents confidential information. However, you should still disclose the royalty rate within a range of 10%, e.g. single digits, teens, etc. This is true even if the exact percentage rate has been redacted pursuant to a grant of confidential treatment. Additionally, please note that under the confidential treatment rule, we have the authority to reconsider our action in the future with respect to grants of confidential treatment. Please include your proposed disclosure in a supplemental response that also includes the full proposed disclosure from your letter dated February 19, 2014 in response to comment 1.
Response to Comment 1:
In its next annual report on Form 10-K, the Company plans to revise and supplement its current disclosure about its agreement with United Therapeutics Corporation (the "United Agreement" and "United," respectively) to address the Staff's comment, by adding the following phrase:
"…(v) following commercialization of the product, royalties at a mid-single digit percent…"
Mr. Jeffrey P. Riedler
Page 2
March 31, 2014
Accordingly, the full proposed disclosure regarding the United Agreement shall be substantially in the form below:
'On June 19, 2011, the Company entered into an exclusive license agreement (the "United Agreement") with United for the use of the Company's PLX cells to develop and commercialize a cell-based product for the treatment of Pulmonary Hypertension ("PAH"). The United Agreement provides that United will receive exclusive worldwide license rights for the development and commercialization of the Company's PLX cell-based product to treat PAH. The United Agreement further provides for the following consideration payable to the Company: (i) an upfront payment of $7 million paid in August 2011, which includes a $5 million non-refundable upfront payment and a $2 million advance payment on the development; (ii) up to $37.5 million upon reaching certain regulatory milestones with respect to the development of a product to treat PAH; (iii) reimbursement of up to $10 million of certain of the Company's expenses if the Company establishes a GMP manufacturing facility in North America; (iv) reimbursement of certain costs in connection with the development of the product; and (v) following commercialization of the product, royalties at a mid-single digit percent and the purchase of commercial supplies of the developed product from the Company at a specified margin over the Company’s cost.
The United Agreement became effective on August 2, 2011, and will continue until the later of a few events, including termination of all patents relating to the collaboration, upon certain government action or if the parties do not develop any product under the United Agreement. United may unilaterally terminate the United Agreement at any time and without cause. In such event, United shall pay the Company certain costs and expenses of winding down any non-cancellable commitments made by the Company prior to the date of termination and cease all development activities in connection with the United Agreement.'
* * *
We acknowledge and understand the following:
·
the Company is responsible for the adequacy and accuracy of the disclosure in the Filing;
·
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the Filing; and
·
the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Please contact the undersigned at +972-74-710-8759, or Shy S. Baranov at (617) 338-2932 or Howard E. Berkenblit at (617) 338-2979, both attorneys at Z.A.G/S&W LLP, the Company's U.S. counsel, if you have any questions or require additional information.
Respectfully,
Pluristem Therapeutics, Inc.
By:
/s/ Boaz Gur-Lavie
cc:
Shy S. Baranov, Esq.
Howard E. Berkenblit, Esq.
2014-03-20 - UPLOAD - Pluri Inc.
March 19 , 2014 Via E -mail Yaky Yanay Executive Vice President, Chief Financial Officer and Secretary Pluristem Therapeutics, Inc. MATAM Advanced Technology Park Building No. 5 Haifa, Israel 31905 Re: Pluristem Therapeutics, Inc. Form 10 -K for t he Fiscal year Ended June 30, 2013 Filed September 11 , 2013 Response dated February 19, 2014 File No. 001 -31392 Dear Mr. Yanay : We have reviewed your February 19, 2014 response to our February 4, 2014 comment letter and have t he following additional comment . Please respond to this letter within ten business days by providing the requested infor mation or by advising us when you will provide the requested response . If you do not believe our comment applies to your facts and circu mstances , please tell us why in your response. After revie wing the infor mation you provide in response to this comment, we may have additio nal co mments. Item 1. Business Ongoing Research and Development Plans, pag e 6 1. We note your response to our prior comment 1 and your position that the royalty rate represents confidential information. However, you should still disclose the royalty rate within a range of 10%, e.g., single digits, teens, etc. This is true even i f the exact percentage rate has been redacted pursuant to a grant of confidential treatment. Additionally, please note that under the confidential treatment rule, we have the authority to reconsider our action in the future with respect to grants of confi dential treatment. Please include your proposed disclosure in a supplemental response that also includes the full proposed disclosure from your letter dated February 19, 2014 in response to comment 1. Yaky Yanay Pluristem Therapeutics, Inc. March 19 , 2014 Page 2 We urge all persons who are respons ible for the accuracy and adequacy of the disclosure in the filings to be certain that the filings include the in formation the Securities E xchange Act of 1934 and all applicable Exchange Act rules require. Since the compa ny and its man agement are in poss ession of all facts relating to a compa ny’s disclosur e, they are responsible for the accuracy and adequacy of the disclosur es they have made. In responding to our comment , please provide a written statement from the company acknowledging that : the company is responsible for the adequacy and accuracy of the disclosure in the filing ; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing ; and the company may not assert staff comment s as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States . Please contact Austin Stephenson at (202) 551 -3192, John Krug at (202) 551 -3862 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director
2014-02-19 - CORRESP - Pluri Inc.
CORRESP
1
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zk1414461.htm
February 19, 2014
Jim B. Rosenberg, Senior Assistant Chief Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, DC 20549-6010
Re:
Pluristem Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2013 (the "Filing")
Filed September 11, 2013
File No. 001-31392
Dear Mr. Rosenberg:
The purpose of this letter is to respond to your letter of February 4, 2014, with respect to the above-captioned Filing. For ease of reference, our responses are keyed to your comments (inserted in italicized font).
Form 10-K for the Fiscal Year Ended June 30, 2013
Item 1. Business
Ongoing Research and Development Plans, page 6
1.
We note your disclosure regarding the collaboration agreements with United Therapeutics and CHA Bio&Diostech in this section. Please disclose all duration and termination provisions applicable to each agreement as well as the applicable royalty rates within a ten percent range, e.g. single digits, teens, etc. Finally, we note your reference to other research institutions in the second paragraph of this page with whom you have collaborated in the past. Please expand the disclosure to state whether there are any current obligations or ongoing collaboration activities relating to these entities.
Response to Comment 1:
In its next annual report on Form 10-K, the Company plans to revise and supplement its current disclosure about its agreement with United Therapeutics Corporation ("United") to address the Staff's comment, substantially in the form below:
'On June 19, 2011, the Company entered into an exclusive license agreement (the "United Agreement") with United for the use of the Company's PLX cells to develop and commercialize a cell-based product for the treatment of Pulmonary Hypertension ("PAH"). The United Agreement provides that United will receive exclusive worldwide license rights for the development and commercialization of the Company's PLX cell-based product to treat PAH. The United Agreement further provides for the following consideration payable to the Company: (i) an upfront payment of $7 million paid in August 2011, which includes a $5 million non-refundable upfront payment and a $2 million advance payment on the development ; (ii) up to $37.5 million upon reaching certain regulatory milestones with respect to the development of a product to treat PAH; (iii) reimbursement of up to $10 million of certain of the Company's expenses if the Company establishes a GMP manufacturing facility in North America; (iv) reimbursement of certain costs in connection with the development of the product; and (v) following commercialization of the product, royalties and the purchase of commercial supplies of the developed product from the Company at a specified margin over the Company’s cost.
Mr. Jim B. Rosenberg
Page 2
February 19, 2014
The United Agreement became effective on August 2, 2011, and will continue until the later of a few events, including termination of all patents relating to the collaboration, upon certain government action or if the parties do not develop any product under the United Agreement. United may unilaterally terminate the United Agreement at any time and without cause. In such event, United shall pay the Company certain costs and expenses of winding down any non-cancellable commitments made by the Company prior to the date of termination and cease all development activities in connection with the United Agreement.'
The Company would like to draw the Staff's attention to the fact that the United Agreement contains an additional termination provision (the "Remaining Termination Provision") which has been kept confidential per an Order Granting Confidential Treatment under the Securities Exchange Act of 1934 issued by the SEC on October 5, 2011. Such order further provides that the royalty rates under the United Agreement may be kept confidential (the "Royalty Rate"). The Company continues to believe that disclosure of the Remaining Termination Provision or the Royalty Rate might be used in the future by potential licensing partners or competitors to the disadvantage of the Company which could adversely affect the Company’s negotiations of future transactions of a similar nature. Therefore the Company is of the opinion that the Remaining Termination Provision as well as the range of the Royalty Rate should not be disclosed.
In its next annual report on Form 10-K, the Company plans to revise and supplement its current disclosure about the agreement with CHA Bio&Diostech ("CHA") to address the Staff comments, substantially in the form below:
'On June 26, 2013, the Company entered into an exclusive out-license and commercialization agreement (the "CHA Agreement") with CHA, for conducting clinical trials and commercialization of its PLX-PAD product in South Korea in connection with two indications: the treatment of Critical Limb Ischemia, and Intermediate Claudication. Under the terms of this agreement, CHA will bear the costs of conducting the clinical trials for the agreed upon indications, and the Company will continue to retain rights to its proprietary manufacturing technology and cell-related intellectual property.
In the event that the Company's products receive regulatory approvals in South Korea for marketing as treatment for the specified indications, the parties will form an equally owned joint venture in order to sell, distribute and market such products in South Korea. In addition, and as contemplated by the CHA Agreement, the Company issued to CHA 2,500,000 shares of its common stock in consideration for the issuance to the Company of 1,011,504 shares of CHA, which reflect total consideration, to each of the Company and CHA, of approximately $10 million (based on average closing price of CHA common shares over the last 30 trading days preceding the date of the CHA Agreement). The CHA Agreement does not provide for royalty payments by either CHA or the Company.
Mr. Jim B. Rosenberg
Page 3
February 19, 2014
The term of the CHA Agreement extends from June 24, 2013, until the later of the expiration, lapse, cancellation, abandonment or invalidation of the last valid patent claim covering the development of the product indications. The CHA Agreement contains customary termination provisions, including in the event the parties do not reach an agreement upon development plan for conducting the clinical trials.
Upon termination of this CHA Agreement, the license granted thereunder will terminate and all rights included therein will revert to the Company, whereupon the Company will be free to enter into agreements with any other third parties for the granting of a license in or outside South Korea or to deal in any other manner with such rights as it shall see fit at its sole discretion.'
In its next annual report on Form 10-K, the Company plans to revise and supplement its current disclosure about the other collaborations to address the Staff comments, substantially in the form below:
'In recent years we have also engaged in research and development projects with other leading research institutions such as the Hadassah University Medical Center ("Hadassah") in Jerusalem, Israel and the Texas AM Health Science Center ("Texas A&M") in Round Rock, Texas.
The Company used the services of Texas A&M for conducting a pre-clinical trial with PLX cells in a mice model of pre-eclampsia. The period of this collaboration extends from January 1, 2013, until August 31, 2014. The Company has no current or ongoing obligations to Texas A&M.
The Company used the services of Hadassah to conduct pre-clinical trials from 2011 through 2013, mainly in the field of radiation. The Company has no current or ongoing obligations to Hadassah.'
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
Liquidity and Capital Resources, page 26
2.
We note your disclosure on this page relating to grants received from the Office of the Chief Scientist and related restrictions described in the risk factor on page 15. Any agreement relating to these grants appears to be material to your operations. Please promptly file any such agreement as an exhibit to your annual report pursuant to Item 601(b)(10) of Regulation S-K. In addition, to the extent applicable, please disclose any duration and termination provisions relating to the most recent grant award.
Response to Comment 2:
As noted, the Company has received grants for its research and development expenses from the Office of the Chief Scientist in Israel (the "OCS") under letters of approval (the "Letter of Approval"). The Company’s position is that the Letters of Approval (or other documentation relating to the OCS grants) are not material and are not required to be filed under Item 601(b)(10) of Regulation S-K for the following reasons:
Mr. Jim B. Rosenberg
Page 4
February 19, 2014
First, the operative document in the case of an OCS grant is a letter of approval (the "Letter of Approval"). The Letter of Approval sets forth various conditions dictated by the Israeli Encouragement of Industrial Research and Development Law, 5744-1984, and related regulations (the "Research Law"). The Company views the Letter of Approval as a unilateral government action rather than a bilateral contract.
Further, the Company has reviewed filings of peer companies that received OCS grants and who are subject to the reporting requirements of the Securities Exchange Act of 1934, and based on such review believes that the prevailing approach with the vast majority of such companies is not to file Letters of Approval (or other documentation relating to such grants).
While the Company believes no filing is required under the circumstances, the Company is nonetheless willing to file the Letters of Approval in light of the Staff’s comment, as well as a practice by a minority of peer companies of filing such Letters of Approval. The Company therefore plans to file the Letters of Approval in its next annual report on Form 10-K.
In addition, the Company hereby advises the Staff that the Letter of Approval for the most recent grant award, for the year ended December 31, 2013, was received in August 2013. The Letter of Approval incorporates, or references, the requirements and restrictions dictated by the Research Law, the main elements of which are summarized in the following sentences. In return for the OCS's participation, the Company is committed to pay royalties at a rate of 3%-5% of sales of the products and services derived from a technology developed using these grants until 100% of the dollar-linked grant is repaid. In addition, the OCS may impose certain conditions on any arrangement under which the OCS permits the Company to transfer technology or development out of Israel or outsource manufacturing out of Israel. While the grant is given to the Company over a certain period of time (usually a year), the requirements and restrictions under the Research Law continue and do not have a set expiration period, except for the royalties, which requirement to pay them expires after payment in full.
Application of Critical Accounting Policies
Research and Development Expenses, Net, page 29
3.
We believe your disclosure could provide more insight into research and development expenses for each year presented showing the amount incurred:
·
for each of these: clinical trials expenses, salaries, lab materials expenses and consultants and subcontractor expenses; and
·
for each key research development project.
Reconcile the totals for each analysis to total research and development expense. Consider providing us proposed disclosure to be included in future periodic reports to improve your disclosure.
Response to Comment 3:
The Company’s management has taken a holistic approach with respect to its research and development expenses and sees the development of its PLX product for different indications as one project. Therefore, the Company’s management does not monitor such expenses on a per project basis. The main reason for this approach is that the Company’s various research and development activities are either interconnected or using the same resources, and analyzing them per project would be challenging and the Company does not believe this level of analysis would be helpful to understanding the nature of the Company’s business. In other words, in all current clinical studies the Company uses the same PLX cells and relies on the same resources, such as the PLX manufacturing facility and PLX properties research. In addition, the vast majority of the Company’s expenses are related to the product development, manufacturing and characterization. Therefore the Company accumulates all costs under one project, namely, the PLX development.
Mr. Jim B. Rosenberg
Page 5
February 19, 2014
In its next annual report on Form 10-K, the Company plans to revise and supplement its current disclosure about the research and development activities to address the Staff comment, substantially in the form below:
‘The Company’s research and development expenses consist primarily of clinical trials expenses, consultant and subcontractor expenses, payroll and related expenses, lab material expenses, stock based compensation expenses, rent and maintenance expenses and patent expenses. The following table provides a breakdown of the related costs for fiscal years 2011 through 2013 (US Dollars in thousands):
Year ended June 30,
2011
2012
2013
Clinical trials expenses
$
509
$
779
$
1,900
Consultants and subcontractor expenses
924
2,224
3,562
Payroll and related expenses
2,689
3,927
5,672
Lab materials expenses
1,490
2,665
3,824
Stock based compensation expenses
1,352
1,402
993
Depreciation expenses
284
402
955
Rent and maintenance expenses
475
628
1,362
Patent expenses
254
335
673
Other R&D expenses
334
323
965
Total expenses
8,311
12,685
19,906
Less: OCS and others participation
(1,682
)
(3,527
)
(2,673
)
Research and Development Expenses, Net
$
6,629
$
9,158
$
17,233
We invest heavily in research and development. Research and development expenses, net, were our major operating expenses, representing between 58% - 75% of the total operating expenses for each of our fiscal years 2011, 2012 and 2013. We expect that in the upcoming years our research and development expenses, net, will continue to be our major operating expense.’
Item 8. Financial Statements and Supplementary Data
Note 2. Significant Accounting Policies
i. Revenue Recognition from the license Agreement with United Therapeutics, page F-16
4.
Please provide us your analysis that supports accounting for amounts received for achievement of milestones under your Untied Therapeutics license agreement in accordance with ASC 450-30-25. In your analysis explain how your accounting treatment would differ from the milestone method under ASC 605-28-25. Also, tell us why you do not provide information about each milestone. In this regard, ASC 605-28-50-2 would require additional information. Consider providing us revised proposed disclosure to be included in future periodic reports, if and as applicable.
Mr. Jim B. Rosenberg
Page 6
February 19, 2014
Response to Comment 4:
According to the United Agreement, United will pay the Company, among other things, future potential payments of up to $37.5 million upon reaching certain regulatory milestones. To date, we have not received any milestone payments.
Our accounting analysis for the above mentioned regulatory milestones payments initially followed the guidance of ASC 605-28, Milestone Method. ASC 605-28-20 defines "Milestone" as an event having all of the following characteristics:
a.
There is substantive uncertainty at the date the arrangement is entered into that the event will be achieved. A vendor’s
2014-02-04 - UPLOAD - Pluri Inc.
February 4, 2014 Via E -mail Yaky Yanay Executive Vice President, Chief F inancial Officer and Secretary Pluristem Therapeutics, Inc. MATAM Advanced Technology Park Building No. 5 Haifa, Israel 31 905 Re: Pluristem Therapeutics, Inc. Form 10-K for the Fi scal Year Ended June 30, 2013 Filed September 11, 2013 File No. 001-31392 Dear M r. Yanay : We have reviewed your filing and have the following comment s. In our comment s, we ask you to provide us with information so we may better understand your disclosure s. Please respond to this letter within 10 business days by providing us the requested information or by advising us when you will provide the requested response. If you do not believe a comment appl ies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that key s your response s to our comment s. After reviewing the information provide d, we may raise additional comments and/or request that you amend your filing . Item 1. Business Ongoing Research and Development Plans, page 6 1. We note your disclosure regarding the collaboration agreements with United Therapeutics and CHA Bio&D iostech in this section. Please disclose all duration and termination provisions applicable to each agreement as well as the applicable royalty rates within a ten percent range, e.g. single digits, teens, etc. Finally, we note your reference to other res earch institutions in the second paragraph of this page with whom you have collaborated in the past. Please expand the disclosure to state whether there are any current obligations or ongoing collaboration activities relating to these entities. Yakay Yanay Pluristem Therapeutics , Inc. February 4, 2014 Page 2 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources, page 26 2. We note your disclosure on this page relating to grants received from the Office of the Chief Scientist and related restrictions described in the risk factor on page 15. Any agreement relating to these grants appears to be material to your operations. Please promptly file any such agreement as an exhibit to your annual report pursuant to Item 601(b)(10) of Regulation S -K. In addition, to the extent applicable, please disclose any duration and termination provisions relating to the most recent grant award . Application of Critical Accounting Policies Research and Development Expenses, Net, page 29 3. We believe your disclosure could provide more insight into research and development expenses incurred. Please provide us an analysis of your research and de velopment expenses for each year presented showing the amount incurred : for each of these: clinical trials expenses, salaries, lab materials expenses and consultants and subcontractor expenses ; and for each key research and development project. Reconcile the totals for each analysis to total research and development expense. Consider providing us proposed disclosure to be included in future periodic reports to improve your disclosure. Item 8. Financial Statements and Supplementary Data Note 2: - Significant Accounting Policies i. Revenue Recognition from the license Agreement with United Therapeutics , page F -16 4. Please provide us your analysis that supports account ing for amounts received for the achievement of milestone s under your United Therapeutics license agreement in accordance with ASC 450 -30-25. In your analysis explain how your accounting treatment would differ from the milestone method under ASC 605 -28-25. Also, tell us why you do not provide information about each milestone . In this regard, ASC 605 -28-50-2 would require additional information. Consider providing us revised proposed disclosure to be included in future periodic reports, if and as applicable. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Yakay Yanay Pluristem Therapeutics , Inc. February 4, 2014 Page 3 In respond ing to our comment s, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initia ted by the Commission or any person under the federal securities laws of the United States. You may contact Scott Wuenschell , Staff Accountant, at (202) 551 -3467 or Joel Parker , Accounting Branch Chief, at (202) 551 -3651 if you have questions regarding the processing of your response as well as any questions regarding comments on the financial st atements and related matters. You may contact Austin Stephenson , Staff Attorney, at (202) 551 -3192 or John Krug , Senior Counsel, at (202) 551 -3862 with questions on any of the other comments. In this regard, do not hesitate to contact me at (202) 551 -3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2011-10-18 - CORRESP - Pluri Inc.
CORRESP
1
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October 18, 2011
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, DC 20549
Attn: Jeffrey Riedler, Assistant Director
RE: Pluristem Therapeutics Inc.
Registration Statement on Form S-3 Filed on September 26, 2011
File No. 333-177009
Ladies and Gentlemen:
Pluristem Therapeutics Inc. (“Pluristem”) hereby requests acceleration of the effectiveness of the above-referenced registration statement pursuant to Rule 460 and Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective on October 20, 2011, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
Pluristem acknowledges that:
·
should the Commission or the staff, acting pursuant to delegated authority, declare the above-referenced registration statement effective, it does not foreclose the Commission from taking any action with respect to the above-referenced registration statement;
·
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the above-referenced registration statement effective, does not relieve Pluristem from its full responsibility for the adequacy and accuracy of the disclosure in the above-referenced registration statement; and
Securities and Exchange Commission
October 18, 2011
Page 2
·
Pluristem may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Pluristem understands that the Commission will consider this request for acceleration of the effective date of this above-referenced registration statement as a confirmation of the fact that Pluristem is aware of its respective responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the referenced above registration statement.
Very truly yours,
/s/ Yaky Yanay
Yaky Yanay
Chief Financial Officer
Cc: Edwin L. Miller, Esq.
Shy S. Baranov, Esq.
2011-10-17 - CORRESP - Pluri Inc.
CORRESP
1
filename1.htm
zk1110529.htm
October 17, 2011
Via Edgar
Jeffrey Riedler
Assistant Director
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Pluristem Therapeutics Inc.
Registration Statement on Form S-3
Filed September 26, 2011
File No. 333-177009
Dear Mr. Riedler:
This letter responds to the letter dated October 6, 2011 (the “Comment Letter”) containing a comment from the staff of the Division of Corporation Finance of the Securities and Exchange Commission resulting from the staff’s review of the filing identified above (the “Filing”) of Pluristem Therapeutics Inc. (“Company”). Our response is set out below following the text of the comment in the Comment Letter.
Comment
We note that you do not appear eligible to conduct a primary offering under General Instruction I.B.1. to Form S-3. Please advise us as to your eligibility to conduct a primary offering on Form S-3 under General Instruction I.B.6. in light of the securities offered in the previous 12 months pursuant to your prospectus dated January 11, 2011 (File No. 333-171334). Your analysis should include the calculation of your current non-affiliate public float, calculated in accordance with Instruction 1 to General Instruction I.B.6., and the value of all take-down offerings made pursuant to the January 11, 2011 prospectus.
Response:
The Company believes that it is eligible to conduct primary offerings under General Instruction I.B.1. to Form S-3 because the value of the shares of Common Stock held by non-affiliates of the Company (the “Public Float”) was more than $75 million, as of a date within 60 days prior to the date of the Filing.
On September 25, 2011, the day before the date of Filing, the Company had 42,936,719 shares of Common Stock outstanding, of which 1,784,265 were held by affiliates of the Company. The balance of the shares, i.e., 41,152,454, is the number of the Company’s shares of Common Stock held by non-affiliates. On September 25, 2011, the price at which the Company’s shares of Common Stock were last sold was $2.13 per share. Therefore, on September 25, 2011, the Public Float was $87,654,727, which exceeds the $75 million threshold amount for purposes of the eligibility requirement of Item I.B.1.
United States Securities and Exchange Commission
Page 2
October 17, 2011
It should be noted that the Public Float exceeded the $75 million threshold amount on all days during the 60 day period prior to the date of the Filing. For instance, on July 29, 2011, the price at which the Company’s shares of Common Stock were last sold was $3.43 per share. On such date 41,152,454 shares of the Company’s Common Stock were held by non-affiliates. Therefore, on July 29, 2011, the Public Float was $141,152,917, which significantly exceeds the $75 million threshold amount for purposes of the eligibility requirement of Item I.B.1.
* * *
The Company acknowledges the following:
·
Should the Commission or the staff, acting pursuant to delegated authority, declare the Filing effective, it does not foreclose the Commission from taking any action with respect to the Filing;
·
The action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Filing; and
·
The Company may not assert staff comments as a defense in any proceeding initiated by the Securities and Exchange Commission or any person under the federal securities laws of the United States.
We appreciate your comment and welcome the opportunity to discuss with you our response provided above. Please call me at (972) 74-710-7107, or Shy S. Baranov, Esq. at (617) 338-2932, or Edwin L. Miller, Esq. at (617) 338-2447, both attorneys at Zysman Aharoni Gayer and Sullivan & Worcester LLP, if you have any questions or require additional information.
Respectfully,
PLURISTEM THERAPEUTICS INC.
By:
/s/ Yaky Yanay
Yaky Yanay
Chief Executive Officer
cc:
Edwin L. Miller, Esq.
Shy S. Baranov, Esq.
2011-10-06 - UPLOAD - Pluri Inc.
October 6, 2011 Via E-mail Zami Aberman Chief Executive Officer Pluristem Therapeutics Inc. MATAM Advanced Technology Park Building No. 20 Haifa 31905 Israel Re: Pluristem Therapeutics Inc. Registration Statement on Form S-3 Filed September 26, 2011 File No. 333-177009 Dear Mr. Aberman: We have limited our review of your registrati on statement to the issue we have addressed in our comment below. Please respond to this letter by providing the requested information. Where you do not believe our comment applies to your facts a nd circumstances, please tell us why in your response. After reviewing the information you provide in response to our comment, we may have additional comments. We note that you do not appear eligible to conduct a primary offering under General Instruction I.B.1. to Form S-3. Please advise us as to your eligibility to conduct a primary offering on Form S-3 under General Instruction I.B .6. in light of the securities offered in the previous 12 months pursuant to your prosp ectus dated January 11, 2011 (File No. 333-171334). Your analysis should include the calculation of your current non-a ffiliate public float, calculated in accordance with Instruction 1 to General In struction I.B.6., and the value of all take-down offerings made pursuant to th e January 11, 2011 prospectus. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing incl udes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disc losure, they are responsible for the accuracy and adequacy of the disclosures they have made. Zami Aberman Pluristem Therapeutics Inc. October 6, 2011 Page 2 Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please pr ovide a written statement from the company acknowledging that: should the Commission or the staff, acting purs uant to delegated authority, declare the filing effective, it does not foreclose the Co mmission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments a nd the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding re quests for acceleration. We will consider a written request for acceleration of the effective date of the regi stration statement as confirmation of the fact that those reques ting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Excha nge Act of 1934 as they relate to the proposed public offering of the securities specified in th e above registration stat ement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Karen Ubell at (202) 551-3873 or me at (202) 551-3715 with any questions. Sincerely, /s/ Jeffrey Riedler Jeffrey Riedler Assistant Director
2011-05-12 - UPLOAD - Pluri Inc.
May 11, 2011 Yaky Yanay Chief Financial Officer (Principal Financial and Accounting Officer) Pluristem Therapeutics, Inc. MATAM Advanced Technology Park Building No. 20 Haifa, Israel 31905 Re: Pluristem Therapeutics, Inc Form 10-K for Fiscal Year Ended June 30, 2010 Filed September 21, 2010 File No. 001-31392 Dear Mr. Yanay: We have completed our review of your f iling. We remind you that our comments or changes to disclosure in res ponse to our comments do not fore close the Commission from taking any action with respect to the company or th e filing and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, Joel Parker Accounting Branch Chief
2011-03-31 - CORRESP - Pluri Inc.
CORRESP
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March 31, 2011
Via Edgar and Fax
Jim B. Rosenberg
Senior Assistant Chief Accountant
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Pluristem Therapeutics Inc.
Form 10-K for the Fiscal Year Ended June 30, 2010
Filed September 21, 2010 (the “Filing”)
File No. 001-31392
Dear Mr. Rosenberg:
This letter responds to the letter dated March 10, 2011 (the “Comment Letter”) containing comments from the staff of the Division of Corporation Finance of the Securities and Exchange Commission resulting from the staff’s review of the Filing of Pluristem Therapeutics Inc. (“Pluristem” or the “Company”) identified above. Our responses are set out below following the text of the Comment Letter to which each response relates. Unless the context otherwise requires, references in this letter to “we,” “us,” and “our” refer to Pluristem Therapeutics Inc. as required by the context.
Intellectual Property, page 7
1.
Please provide proposed draft disclosure for inclusion in future filings detailing additional information about your material patents including the number of pending and issued patents you own and the range of expiration dates for the patents.
Response:
We propose to include the following discussion in future filings, as applicable, subject to updates after the date hereof:
Our intellectual property portfolio is focused on developing a three-dimensional model of the human cell expansion process, mimicking the natural environment of their expansion in the human body. We understand that our success will depend on maintaining our intellectual property superiority over competition and therefore we are committed to protecting our technology and product candidates via patents and other methods described below.
United States Securities and Exchange Commission
Page 2
March 31, 2011
As of today, Pluristem is the full owner of 15 granted patents and of 60 pending patent applications in the U.S. and Europe as well as in additional countries worldwide, including in the Far East and South America.
Based on the well established understanding that the characteristics and therapeutic potential of a cell product are largely determined by the source of the cells and by the methods and conditions used during their manufacturing process, our portfolio includes multilayered claims on the various unique aspects of Adherent Stromal Cells, or ASCs.
Our portfolio includes claims on:
·
Our propriety 3D Stromal Cells expansion method;
·
Composition of matter claims on the cells;
·
The therapeutic use of PLX cells for the treatment of a large variety of medical conditions; and
·
Selection criteria for determination of cells suitable for administration.
Through our experience with ASC-based product development, we have developed expertise and know-how in this field. We have built the ability to manufacture clinical grade ASCs in-house. Most aspects of the technology are covered by patents and patent applications. In addition, specific aspects are kept as know-how, protected by Pluristem’s confidentiality agreement policies with our employees, consultants, contractors, manufacturers and advisors. These agreements generally provide for protection of confidential information, restrictions on the use of materials and assignment of inventions conceived during the course of performance of services for us.
Pluristem is the full and sole owner of its intellectual property and we have no obligations to pay royalties to any third party, except for royalties to the Israeli Office of Chief Scientist, or the OCS (see note 6D in our audited consolidated financial statements for fiscal 2010 included elsewhere in this Form 10-K).
The intellectual property coverage of Pluristem’s technology and biologic drug candidates is multilayered and relies on multiple patents in combination. The following table provides a description of our key patents and patent applications and is not intended to represent an assessment of claims limitations or scope. The expiration dates of these patents, based on filing dates, range from 2019 to 2026. Actual expiration dates will be determined according to extensions received based on the Hatch-Waxman Act.
Patent
Jurisdiction
Subject Matter
Related Product(s)
Method And Apparatus For Maintenance And Expansion Of Hemopoietic Stem Cells And/Or Progenitor Cells
United States
Japan, Europe, Mexico, Australia, South Africa, Israel, Russia, New Zealand, India, China Hong Kong, Canada
Process and methods
PLX
Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy
United States
Japan, Europe, Mexico, Australia, South Africa, Israel, Russia, New Zealand, India, China Hong Kong, Canada, Brazil, Korea, Singapore
Process and methods, Composition of matter, Method of treating
PLX
Adherent Cells from Adipose or Placenta Tissues and Use Thereof in Therapy
United States
Japan, Europe, Mexico, Australia, South Africa, Israel, Russia, New Zealand, India, China Hong Kong, Canada, Brazil, Korea, Singapore
Composition of matter, Method of treating
PLX
United States Securities and Exchange Commission
Page 3
March 31, 2011
Business Experience, page 27
2.
Please provide proposed draft disclosure for inclusion in future filings discussing the specific experience, qualifications, attributes or skills that led to the conclusion that each director should serve on your company’s board, as required by Item 401(e)(1) of Regulation S-K.
Response:
We propose to include the following discussion in future filings, as applicable, subject to updates after the date hereof:
The following is a summary of the education and business experience of each director during at least the past five years, indicating each person’s principal occupation during the period, and the name and principal business of the organization by which they were employed. In addition, following each such summary are the reasons why we concluded that each director should serve on our Board of Directors.
Zami Aberman
Mr. Aberman became our Chief Executive Officer and President in September 2005 and a director of the Company in November 2005. Mr. Aberman has served as our Chairman of the Board since April 2006, and between May 2007 and February 2009 he was Co-Chairman with Mr. Mark Germain. He has 25 years of experience in marketing and management in the high technology industry. Mr. Aberman has held positions of Chief Executive Officer and Chairman in Israel, the United States, Europe, Japan and Korea. He has operated within high-tech global companies in the fields of automatic optical inspection, network security, video over IP, software, chip design and robotics. Mr. Aberman serves as the Chairman of Rose Hitech Ltd., a private investment company. He has served in the past as the Chairman of VLScom Ltd., a private company specializing in video compression for HDTV and video over IP and as a director of Ori Software Ltd., a company involved in data management. Prior to that, Mr. Aberman served as the President and CEO of Elbit Vision System Ltd. (EVSNF.OB), a company engaged in automatic optical inspection. Prior to his service with the Company, Mr. Aberman has served as President and CEO of Netect Ltd., specializing in the field of internet security software and was the Co-Founder, President and CEO of Associative Computing Ltd., which developed an associative parallel processor for real-time video processing. He has also served as Chairman of Display Inspection Systems Inc., specializing in laser based inspection machines and as President and CEO of Robomatix Technologies Ltd. In 1992, Mr. Aberman was awarded the Rothschild Prize for excellence in his field from the President of the State of Israel. Mr. Aberman holds a B.Sc. in Mechanical Engineering from Ben Gurion University in Israel.
We believe that Mr. Aberman’s qualifications to sit on our Board of Directors include his years of experience in the financial markets in Israel and globally, as well as his experience in serving as the CEO of publicly traded entities.
United States Securities and Exchange Commission
Page 4
March 31, 2011
Nachum Rosman
Mr. Rosman became a director of the Company in October 2007. In 1999, Mr. Rosman founded Talecity Ltd., a movie production company, and has since been serving as its Chief Financial Officer. In addition he provides management and consulting services to startup companies in the financial, organizational and human resource aspects of their operations. Mr. Rosman also serves as a director at several privately held companies. Throughout his career, Mr. Rosman held Chief Executive Officer and Chief Financial Officer positions in Israel, the United States and England. In these positions he was responsible, among other things, for finance management, fund raising, acquisitions and technology sales.
Mr. Rosman holds a B.Sc. in Management Engineering and an M.Sc. in Operations Research from the Technion, Haifa, Israel. Mr. Rosman also participated in a Ph.D. program in Investments and Financing at the Tel Aviv University, Israel.
We believe that Mr. Rosman’s qualifications to sit on our Board of Directors include his years of experience in the high-tech industry, as well as his knowledge and familiarity with corporate finance.
Doron Shorrer
Mr. Shorrer became a director of the Company in October 2003. Mr. Shorrer also serves as a director of other companies: AIG Israel Insurance Company Ltd., Omer Insurance Mutual Fund, Massad Bank, Provident Fund of employees of the Israel Electric Company Ltd., Gold Bond Logistic Group and B. Yair - a construction company, the last two companies that are trading at the Tel-Aviv Stock Exchange. Between 2002 and 2004 he was Chairman of the Boards of Phoenix Insurance Company, one of the largest insurance companies in Israel, and of Mivtachim Pension Benefit Group, the largest pension fund in Israel. Prior to serving in these positions, Mr. Shorrer held senior positions that included Arbitrator at the Claims Resolution Tribunal for Dormant Accounts in Switzerland; Economic and Financial Advisor, Commissioner of Insurance and Capital Markets for the State of Israel; Member of the board of directors of “Nechasim” of the State of Israel; Member Committee for the Examination of Structural Changes in the Capital Market (The Brodet Committee); General Director of the Ministry of Transport; Co-Founder and director of an accounting firm with offices in Jerusalem, Tel-Aviv and Haifa; Member of the Lecture Staff of the Amal School Chain; Chairman of a Public Committee for Telecommunications; and Economic Consultant to the Ministry of Energy. Among many areas of expertise, Mr. Shorrer formulates, implements and administers business planning in the private and institutional sector in addition to consulting on economic, accounting and taxation issues to a large audience ranging from private concerns to government ministries. Mr. Shorrer holds a B.A. in Economics and Accounting and an M.A. in Business Administration (specialization in finance and banking) from the Hebrew University of Jerusalem and is a Certified Public Accountant (ISR).
We believe that Mr Shorrer’s qualifications to sit on our Board of Directors include his years of experience in the high-tech industry, his vast skill and expertise in accounting and economics, as well as his knowledge and familiarity with corporate finance.
United States Securities and Exchange Commission
Page 5
March 31, 2011
Hava Meretzki
Ms. Meretzki became a director of the Company in October 2003. Ms. Meretzki is an attorney and since 2009 has been a partner in the law firm of Meretzki - Tavor in Haifa, Israel. Ms. Meretzki specializes in civil, trade and labor law and is presently Vice-Chairman for the National Council of the Israel Bar Association. In addition, Ms. Meretzki was nominated to be a member of the committee that nominates legal advisers for Israeli governmental companies.
Ms. Meretzki received a Bachelors Degree in Law from the Hebrew University in 1991 and was admitted to the Israel Bar Association in 1993.
We believe that Ms. Meretzki’s qualifications to sit on our Board of Directors include her years of experience with legal and corporate governance matters.
Isaac Braun
Mr. Braun became a director of the Company in July 2005. Mr. Braun is a business veteran with entrepreneurial, industrial and manufacturing experience. He is a co-founder and has been a board member of several hi-tech start-ups in the areas of e-commerce, security, messaging, search engines and biotechnology. Mr. Braun is involved with advising private companies on raising capital and business development.
We believe that Mr. Braun’s qualifications to sit on our Board of Directors include his years of experience in the high-tech industry, as well as his knowledge and familiarity with corporate finance.
Israel Ben-Yoram
Mr. Ben-Yoram became a director of the Company in January 2005. He has been a director and partner in the accounting firm of Mor, Ben-Yoram and Partners in Israel since 1985. In addition, since 1992, Mr. Ben-Yoram has been a shareholder and has served as the head director of Mor, Ben-Yoram Ltd., a private company in Israel in parallel to the operation of Mor, Ben-Yoram and Partners. This company provides management services, economic consulting services and other professional services to businesses. Furthermore, Mr. Ben-Yoram is the CEO of Eshed Dash Ltd. and Zonbit Ltd. During 2003-2004 Mr. Ben-Yoram served as a director of Brainstorm Cell Therapeutics Inc. (BCLI) and Smart Energy solutions, Inc. (SMGY), both of which were traded on the NASDAQ.
Mr. Ben-Yoram received a B.A. in accounting from the University of Tel Aviv, an M.A. in Economics from the Hebrew University of Jerusalem, an LL.B. and an MBA from Tel Aviv University and an LL.M. from Bar Ilan University. In addition, Mr. Ben-Yoram is qualified in arbitration and in mediation.
We believe that Mr. Ben-Yoram’s qualifications to sit on our Board of Directors include his years of experience in the high-tech industry, his experience serving as a director of NASDAQ companies, as well as his knowledge and familiarity with corporate finance and accounting.
Mark Germain
Mr. Germain became a director of the Company in May 2007. Between May 2007 and February 2009, Mr. Germain served as Co-Chairman of our Board. For more than five years, Mr. Germain has been a merchant banker serving primarily the biotech and life sciences industries. He has been involved as a founder, director, chairman of the board of, and/or investor in, over twenty companies in the biotech field, and assisted many of them in arranging corporate partnerships, acquiring technology, entering into mergers and acquisitions, and executing financings and going public transactions. He graduated from New York University School of Law in 1975, Order of the Coif, and was a partner in a New York law firm practicing corporate and securities law before leaving in 1986. Since then, and until he entered the biotech field in 1991, he served in senior executive capacities, including as president of a public company, which was sold in 1991. In addition to being Co-Chairman of the Company, Mr. Germain is a director of the following publicly traded companies: Stem Cell Innovations, Inc., ChromaDex, Inc., Omnimmune Corp. and Collexis Holdings, Inc. He is also a co-founder and director of a number of private companies in the biotechnology field.
We believe that Mr. Germain’s qualifications to sit on our Board of Directors include his years of experience in the biotech industry, his experience serving as a director of public companies, as well as his knowledge and familiarity with corporate finance.
United States Securities and Exchange Commission
Page 6
March 31, 2011
Shai Pines
Mr. Pines became a director of the Comp
2011-03-21 - CORRESP - Pluri Inc.
CORRESP
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Correspondence
PLURISTEM THERAPEUTICS, INC.
MATAM Advanced Technology Park, Building No. 20, Haifa, Israel 31905
March 21, 2011
VIA EDGAR AND FAX
Jim B. Rosenberg
Senior Assistant Chief Accountant
U.S. Securities and Exchange Commission
Division of Corporation Finance
Washington, DC 20549
Re:
Pluristem Therapeutics, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2010
Filed September 21, 2010
File No. 001-31392
Dear Mr. Rosenberg:
We have received your letter dated March 10, 2011 and are in the process of preparing responses to your comments. As discussed with Ms. Tabatha Akins, we do not expect to be able to respond within 10 business days of your letter. However, we anticipate that we should be able to respond to your comments by March 31, 2011.
Sincerely,
/s/ Yaky Yanay
Yaky Yanay
Chief Executive Officer
2011-03-18 - UPLOAD - Pluri Inc.
March 10, 2011 Yaky Yanay Chief Financial Officer (Principal Financial and Accounting Officer) Pluristem Therapeutics, Inc. MATAM Advanced Technology Park Building No. 20 Haifa, Israel 31905 Re: Pluristem Therapeutics, Inc Form 10-K for Fiscal Year Ended June 30, 2010 Filed September 21, 2010 File No. 001-31392 Dear Mr. Yanay: We have reviewed your filing and have the following comments. In some of our comments, we ask you to provide us with in formation so we may better understand your disclosure. Please respond to this letter within te n business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circ umstances, please tell us why in your response. Please furnish us a letter on EDGAR under the fo rm type label CORRESP that keys your responses to our comments. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. Intellectual Property, page 7 1. Please provide proposed draft disclosure fo r inclusion in future filings detailing additional information about your material patents includi ng the number of pending and issued patents you own and the range of expiration dates for the patents. Business Experience, page 27 2. Please provide proposed draft disclosure for inclusion in future filings discussing the specific experience, qualifications, attributes or skills that led to the conclusion that each director should serve on your company’ s board, as required by Item 401(e)(1) of Regulation S-K. Yaky Yanay Pluristem Therapeutics, Inc. March 10, 2011 Page 2 Notes to Consolidated Financial Statements Note 7: - Share Capital a nd Stock Options, page F-29 3. The warrant agreements for certain of your wa rrant issuances indicate that the exercise prices are subject to adjustment in the event that you issue eq uity at a price per share less than the volume weighted averag e price at the record date. Please explain to us why you have not apparently reclassified these warra nts to liabilities eff ective July 1, 2009 under FASB ASC 815-40-15 with tran sition guidance at FASB AS C 815-10-65-3. In addition, it appears that some of the warrants were issued in conne ction with registered unit offerings. Please confirm that t hose warrants have been classifi ed as liabilities or tell us why liability classification is not required. Item 9A. Controls and Procedures Management’s Report on Internal Cont rol Over Financial Reporting, page 26 4. We note that you conduct substantially all of your operations outside of the United States. In order to enhance our understanding of how you prepare your financial statements and assess your internal control over financial reporting, we ask that you provide us with information that will help us answer the following questions. • How do you evaluate and assess internal control over financial reporting? o In connection with your process to determine whether your internal control over financial reporting was effective, please describe whether and how you considered controls to address financial reporting risks that are relevant to all locations where you have operations. o If you have an internal audit function, please describe it and explain how, if at all, that function impacted your evaluation of your internal control over financial reporting. • How do you maintain your books and records and prepare your financial statements? o If you maintain your books and records in accordance with U.S. GAAP, describe the controls you maintain to ensure that the activities you conduct and the transactions you consummate are recorded in accordance with U.S. GAAP. o If you do not maintain your books and records in accordance with U.S. GAAP, tell us what basis of accounting you use a nd describe the process you go through to convert your books and records to U.S. GAAP for SEC reporting. Describe the controls you maintain to ensure that you have made all necessary and appropriate adjustments in your conversions and disclosures. • What is the background of the people involved in your financial reporting? o We would like to understand more about the background of the people who are primarily responsible for preparing and supervising the preparation of your financial statements and evaluating the effectiveness of your internal control over financial reporting and their knowledge of U.S. GAAP and SEC rules and regulations. Do not identify people by name, but for each person, please tell us: • what role he or she takes in preparing your financial statements and evaluating the effectiveness of your internal control; • what relevant education and ongoing training he or she has had relating to U.S. GAAP; Yaky Yanay Pluristem Therapeutics, Inc. March 10, 2011 Page 3 • the nature of his or her contractual or other relationship to you; • whether he or she holds and maintains any professional designations such as Certified Public Accountant (U.S.) or Certified Management Accountant; and • about his or her professional experience, including experience in preparing and/or auditing financial statements prepared in accordance with U.S. GAAP and evaluating effectiveness of internal control over financial reporting. o If you retain an accounting firm or other similar organization to prepare your financial statements or evaluate your internal control over financial reporting, please tell us: • the name and address of the accounting firm or organization; • the qualifications of their employees who perform the services for your company; • how and why they are qualified to prepare your financial statements or evaluate your internal control over financial reporting; • how many hours they spent last year performing these services for you; and • the total amount of fees you paid to each accounting firm or organization in connection with the preparation of your financial statements and in connection with the evaluation of internal control over financial reporting for the most recent fiscal year end. o If you retain individuals who are not your employees and are not employed by an accounting firm or other similar organization to prepare your financial statements or evaluate your internal control over financial reporting, do not provide us with their names, but please tell us: • why you believe they are qualified to prepare your financial statements or evaluate your internal control over financial reporting; • how many hours they spent last year performing these services for you; and • the total amount of fees you paid to each individual in connection with the preparation of your financial statements and in connection with the evaluation of internal control over financial reporting for the most recent fiscal year end. • Please describe your audit committee financial expert’s qualifications, including the extent of his or her knowledge of U.S. GAAP and internal control over financial reporting. You may contact Tabatha Akin s, Staff Accountant (202) 551 -3658 or Mary Mast, Senior Staff Accountant at (202) 551-3613 if you have a ny questions regarding th e processing of your response as well as any questions regarding co mments on the financial statements and related matters. Please contact Michae l Rosenthall, Attorney Advisor at (202) 551-3674 or Sebastian Gomez Abero, Attorney Advisor at (202) 551- 3578 with questions on any of the other comments. In this regard, do not hesita te to contact me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant