Correspondence 0001104659-23-109965 from TriSalus Life Sciences, Inc. (TLSI)
TriSalus Life Sciences, Inc.
Date: Oct. 18, 2023 · CIK: 0001826667 · Accession: 0001104659-23-109965
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-274292
Referenced dates: September 27, 2023
Letter
Carlos Ramirez
T: +1 858 550 6157
cramirez@cooley.com
October 18, 2023
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Manufacturing
100 F Street, NE
Washington, D.C. 20549
Attention:
Nicholas O’Leary
Abby Adams
Re: TriSalus Life Sciences, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 1, 2023
File No. 333-274292
Ladies and Gentlemen:
On behalf of TriSalus Life Sciences, Inc. (the “Company”), we are providing this letter in response to comments (the “Comments”) received from the staff of the U.S. Securities and Exchange Commission’s Division of Corporation Finance (the “Staff”) by letter dated September 27, 2023 with respect to the Company’s Amendment No. 1 to Registration Statement on Form S-1, as filed on September 1, 2023. Concurrently with the submission of this letter, the Company is filling its second amendment to the registration statement on Form S-1 (the “Amendment No. 2”) and certain exhibits via EDGAR to the Commission.
The Staff’s comments are repeated below in bold, followed by the Company’s responses to the comments. We have included page numbers to refer to the location in Amendment No. 2 where the disclosure addressing a particular comment appears. Defined terms used but not otherwise defined herein shall have the respective meanings ascribed thereto in Amendment No. 2.
Amendment No. 1 to Form S-1 filed September 1,
Cover Page
1. We note your disclosure of the purchase price for certain securities being registered for resale. For each of the securities being registered for resale, disclose the price that the selling securityholders paid for such securities.
In response to the Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure on the cover page and pages 5 and 60 of Amendment No. 2.
Cooley LLP 10265 Science Center Drive San Diego, CA 92121-1117
t: +1 858 550 6000 f: +1 858 550-6420 cooley.com
U.S. Securities and Exchange Commission
October 18, 2023
Page Two
Prospectus Summary, page 1
2. Here and in your risk factors, use of proceeds and management's discussion and analysis, and elsewhere where you address your recent trading prices as compared to the warrant exercise price, please revise to clarify that your warrants are out of the money and it is unlikely that warrant holders would exercise your warrants while the trading price is below the warrant exercise price. In addition, we note that your disclosure does not present a clear view of your liquidity expectations. We note, for example:
• Disclosure in the liquidity discussion on pages 76-77, wherein you state, "We believe that the proceeds from the Business Combination and [the July 2023] exercise of warrants should be sufficient to fund our operations through key data read-outs expected in mid-2024. However, unless we are able to raise additional capital, we do not currently expect that our existing cash and cash equivalents, including cash received in connection with the Business Combination will be sufficient to fund our projected liquidity requirements for the next 12 months, creating substantial doubt about our ability to continue as a going concern."
• The liquidity discussion refers to the section addressing "Funding Requirements," wherein you state, "We will likely require additional capital in the near term in order to continue to fund our operations through equity or debt financings, partnerships, collaborations, or other sources which may not be available on a timely basis, on favorable terms, or at all, and such capital, if obtained, may not be sufficient to enable us to continue to implement our long-term business strategy."
Please revise your cover page, summary, risk factors, use of proceeds, and MD&A to clarify the ability of your company to fund your operations on a prospective basis with your current cash on hand.
In response to the Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure on the cover page and pages 4, 61–62, 66, 81–82 and 85–86 of Amendment No. 2.
3. Revise your prospectus to disclose the price that each selling securityholder paid for the securities being registered for resale. To the extent you have not done so, highlight any differences in the current trading price, the prices that the Sponsor, PIPE investors and other selling securityholders acquired their shares and warrants, and the price that the public securityholders acquired their shares and warrants. Disclose that while the Sponsor, PIPE investors and other selling securityholders may experience a positive rate of return based on the current trading price, the public securityholders may not experience a similar rate of return on the securities they purchased due to differences in the purchase prices and the current trading price. Please also disclose the potential profit the selling securityholders will earn based on the current trading price. Lastly, please include appropriate risk factor disclosure.
In response to the Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure on the cover page and pages 5 and 60 of Amendment No. 2.
Cooley LLP 10265 Science Center Drive San Diego, CA 92121-1117
t: +1 858 550 6000 f: +1 858 550-6420 cooley.com
U.S. Securities and Exchange Commission
October 18, 2023
Page Three
Risk Factors
Sales of our Common Stock and/or Warrants or the perception of such sales, by us or the selling securityholders pursuant to this prospectus, page 57
4. We note the risk factor on page 59 addressing the potential negative pressure potential sales by the selling securityholders may have on your security prices. Please revise the risk factor to state the purchase price the various selling security holders paid for their securities being registered for resale, in addition to the price paid originally for the Founder Shares.
In response to the Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure on pages 60–61 of Amendment No. 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations, page 66
5. We note that the projected revenues for 2023 were $19.2 million, as set forth in the unaudited prospective financial information management prepared and provided to the Board, the company’s financial advisors and the SPAC in connection with the evaluation of the Business Combination. We also note that your actual revenues for the six months ended June 30, 2023 was approximately $7.6 million. It appears that you will miss your 2023 revenue projection. Please update your disclosure in Liquidity and Capital Resources, and elsewhere, to provide updated information about the company’s financial position and further risks to the business operations and liquidity in light of these circumstances.
In response to the Staff’s comment, the Company respectfully informs the Staff that there are no changes to its 2023 revenue projection. In addition, the Company respectfully advises the Staff that it has revised the disclosure on pages 80–81 of Amendment No. 2.
Liquidity and Capital Resources, page 75
6. In light of the significant number of redemptions and the unlikelihood that the company will receive significant proceeds from exercises of the warrants because of the disparity between the exercise price of the warrants and the current trading price of the common stock, expand your discussion of capital resources to address any changes in the company’s liquidity position since the business combination.
In response to the Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure on pages 81–82 of Amendment No. 2.
7. We note your disclosure that this offering involves the potential sale of a substantial portion of shares for resale and that such sales could impact the market price of the company’s common stock. Please expand your disclosure to highlight the fact that a number of beneficial owners of more than 5% will be able to sell all of their shares for so long as the registration statement of which this prospectus forms a part is available for use. In providing this disclosure, please include the number of beneficial owners of more than 5% of your shares that are participating in the offering.
In response to the Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure on page 82 of Amendment No. 2.
Cooley LLP 10265 Science Center Drive San Diego, CA 92121-1117
t: +1 858 550 6000 f: +1 858 550-6420 cooley.com
U.S. Securities and Exchange Commission
October 18, 2023
Page Four
General
8. Please revise to update your disclosures throughout the filing and address areas that appear to need updating or that present inconsistencies. Non-exclusive examples of areas where disclosure should be updated are as follows:
• To the extent applicable, revise the risk factors and other areas of the document to clarify the current stage of clinical development for your product candidates, and whether you have made any determination with respect to seeking expedited approval pathways or orphan drug status (pages 13, 29-31, 96 and 98-103). We note the product pipeline in the investor presentation submitted with your Form 8-K filed September 1, 2023, does not correspond with the disclosure on page 98;
• Update the disclosure regarding the CARES Act, and the status of related legislation (pages 35-36);
• Update the status of your patents and patent applications, which currently are stated as of July 16, 2023, and your progress in notifying certain foreign patent offices of your ownership of foreign patent rights related to SD-101 (pages 44-45 and 48 and 110-113);
• Update the disclosure regarding the impact of new tax laws and management's remediation plans regarding the material weaknesses in your internal controls (page 55);
• Update the risk factors related to the market for your securities and price volatility (page 56);
• Revise to clarify that your warrants are exercisable (page 59);
• Revise the risk factors to clarify that your current charter contains an exclusive forum provision, rather than it "will provide" that federal district courts will be the sole and exclusive forum (page 62);
• Update the recent developments on page 68; and
• Please update the status of the transactions described in "Certain Relationships and Related Party Transactions," beginning on page 155, to the extent the transactions do not reflect the effects of the business combination.
In response to the Staff’s comment, the Company respectfully advises the Staff that it has revised the disclosure on pages 7–8, 10, 13, 19, 22, 32, 37, 42, 45–46, 55–59, 62–64, 72, 94, 99, 103, 105–108, 111, 113, 115–117 and 161–163 of Amendment No. 2. The Company also respectfully advises the Staff that there have not been any changes to its determinations with respect to seeking expedited approval pathways or orphan drug status.
9. Please revise the first paragraph on the cover page, and the prospectus generally, to remove the registration of these private placement shares:
• "up to 4,933,333 shares of Common Stock that are issuable upon the exercise of 4,933,333 warrants (the “Private Placement Warrants”) held by MedTech Acquisition Sponsor LLC, a Delaware limited liability company (the “Sponsor”), originally issued in a private placement in connection with the initial public offering of MedTech Acquisition Corporation (“MTAC”)," and
• "up to 1,000,000 shares of Common Stock that are issuable upon the exercise of 1,000,000 conversion warrants issuable upon the conversion of the promissory note issued by MTAC to the Sponsor for working capital requirements and payment of certain expenses in connection with a potential
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CORRESP
1
filename1.htm
Carlos Ramirez
T: +1 858 550 6157
cramirez@cooley.com
October 18, 2023
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Manufacturing
100 F Street, NE
Washington, D.C. 20549
Attention:
Nicholas O’Leary
Abby Adams
Re: TriSalus Life Sciences, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 1, 2023
File No. 333-274292
Ladies and Gentlemen:
On behalf of TriSalus Life Sciences, Inc.
(the “Company”), we are providing this letter in response to comments (the “Comments”)
received from the staff of the U.S. Securities and Exchange Commission’s Division of Corporation Finance (the “Staff”)
by letter dated September 27, 2023 with respect to the Company’s Amendment No. 1 to Registration Statement on Form S-1,
as filed on September 1, 2023. Concurrently with the submission of this letter, the Company is filling its second amendment to the
registration statement on Form S-1 (the “Amendment No. 2”) and certain exhibits via EDGAR to the
Commission.
The Staff’s comments are repeated below
in bold, followed by the Company’s responses to the comments. We have included page numbers to refer to the location in Amendment
No. 2 where the disclosure addressing a particular comment appears. Defined terms used but not otherwise defined herein shall have
the respective meanings ascribed thereto in Amendment No. 2.
Amendment No. 1 to Form S-1 filed September 1,
2023
Cover Page
1. We note your disclosure of
the purchase price for certain securities being registered for resale. For each of the securities
being registered for resale, disclose the price that the selling securityholders paid for
such securities.
In response to the Staff’s comment,
the Company respectfully advises the Staff that it has revised the disclosure on the cover page and pages 5 and 60 of Amendment
No. 2.
Cooley LLP 10265 Science Center Drive San Diego,
CA 92121-1117
t: +1 858 550 6000 f: +1 858 550-6420 cooley.com
U.S. Securities and Exchange Commission
October 18, 2023
Page Two
Prospectus Summary, page 1
2. Here and in your risk factors,
use of proceeds and management's discussion and analysis, and elsewhere where you address
your recent trading prices as compared to the warrant exercise price, please revise to clarify
that your warrants are out of the money and it is unlikely that warrant holders would exercise
your warrants while the trading price is below the warrant exercise price. In addition, we
note that your disclosure does not present a clear view of your liquidity expectations. We
note, for example:
• Disclosure
in the liquidity discussion on pages 76-77, wherein you state, "We believe that
the proceeds from the Business Combination and [the July 2023] exercise of warrants
should be sufficient to fund our operations through key data read-outs expected in mid-2024.
However, unless we are able to raise additional capital, we do not currently expect that
our existing cash and cash equivalents, including cash received in connection with the Business
Combination will be sufficient to fund our projected liquidity requirements for the next
12 months, creating substantial doubt about our ability to continue as a going concern."
• The
liquidity discussion refers to the section addressing "Funding Requirements," wherein
you state, "We will likely require additional capital in the near term in order to continue
to fund our operations through equity or debt financings, partnerships, collaborations, or
other sources which may not be available on a timely basis, on favorable terms, or at all,
and such capital, if obtained, may not be sufficient to enable us to continue to implement
our long-term business strategy."
Please revise your cover page, summary,
risk factors, use of proceeds, and MD&A to clarify the ability of your company to fund your operations on a prospective basis with
your current cash on hand.
In response to the Staff’s comment,
the Company respectfully advises the Staff that it has revised the disclosure on the cover page and pages 4, 61–62, 66,
81–82 and 85–86 of Amendment No. 2.
3. Revise your prospectus to disclose
the price that each selling securityholder paid for the securities being registered for resale.
To the extent you have not done so, highlight any differences in the current trading price,
the prices that the Sponsor, PIPE investors and other selling securityholders acquired their
shares and warrants, and the price that the public securityholders acquired their shares
and warrants. Disclose that while the Sponsor, PIPE investors and other selling securityholders
may experience a positive rate of return based on the current trading price, the public securityholders
may not experience a similar rate of return on the securities they purchased due to differences
in the purchase prices and the current trading price. Please also disclose the potential
profit the selling securityholders will earn based on the current trading price. Lastly,
please include appropriate risk factor disclosure.
In response to the Staff’s comment,
the Company respectfully advises the Staff that it has revised the disclosure on the cover page and pages 5 and 60 of Amendment
No. 2.
Cooley LLP 10265 Science Center Drive San Diego,
CA 92121-1117
t: +1 858 550 6000 f: +1 858 550-6420 cooley.com
U.S. Securities and Exchange Commission
October 18, 2023
Page Three
Risk Factors
Sales of our Common Stock and/or Warrants or the perception
of such sales, by us or the selling securityholders pursuant to this prospectus, page 57
4. We note the risk factor on
page 59 addressing the potential negative pressure potential sales by the selling securityholders
may have on your security prices. Please revise the risk factor to state the purchase price
the various selling security holders paid for their securities being registered for resale,
in addition to the price paid originally for the Founder Shares.
In response to the Staff’s comment,
the Company respectfully advises the Staff that it has revised the disclosure on pages 60–61 of Amendment No. 2.
Management's Discussion and Analysis of Financial Condition
and Results of Operations, page 66
5. We note that the projected
revenues for 2023 were $19.2 million, as set forth in the unaudited prospective financial
information management prepared and provided to the Board, the company’s financial
advisors and the SPAC in connection with the evaluation of the Business Combination. We also
note that your actual revenues for the six months ended June 30, 2023 was approximately
$7.6 million. It appears that you will miss your 2023 revenue projection. Please update your
disclosure in Liquidity and Capital Resources, and elsewhere, to provide updated information
about the company’s financial position and further risks to the business operations
and liquidity in light of these circumstances.
In response to the Staff’s comment,
the Company respectfully informs the Staff that there are no changes to its 2023 revenue projection. In addition, the Company respectfully
advises the Staff that it has revised the disclosure on pages 80–81 of Amendment No. 2.
Liquidity and Capital Resources, page 75
6. In light of the significant
number of redemptions and the unlikelihood that the company will receive significant proceeds
from exercises of the warrants because of the disparity between the exercise price of the
warrants and the current trading price of the common stock, expand your discussion of capital
resources to address any changes in the company’s liquidity position since the business
combination.
In response to the Staff’s comment,
the Company respectfully advises the Staff that it has revised the disclosure on pages 81–82 of Amendment No. 2.
7. We note your disclosure that
this offering involves the potential sale of a substantial portion of shares for resale and
that such sales could impact the market price of the company’s common stock. Please
expand your disclosure to highlight the fact that a number of beneficial owners of more than
5% will be able to sell all of their shares for so long as the registration statement of
which this prospectus forms a part is available for use. In providing this disclosure, please
include the number of beneficial owners of more than 5% of your shares that are participating
in the offering.
In response to the Staff’s comment,
the Company respectfully advises the Staff that it has revised the disclosure on page 82 of Amendment No. 2.
Cooley LLP 10265 Science Center Drive San Diego,
CA 92121-1117
t: +1 858 550 6000 f: +1 858 550-6420 cooley.com
U.S. Securities and Exchange Commission
October 18, 2023
Page Four
General
8. Please revise to update your
disclosures throughout the filing and address areas that appear to need updating or that
present inconsistencies. Non-exclusive examples of areas where disclosure should be updated
are as follows:
• To
the extent applicable, revise the risk factors and other areas of the document to clarify
the current stage of clinical development for your product candidates, and whether you have
made any determination with respect to seeking expedited approval pathways or orphan drug
status (pages 13, 29-31, 96 and 98-103). We note the product pipeline in the investor
presentation submitted with your Form 8-K filed September 1, 2023, does not correspond
with the disclosure on page 98;
• Update
the disclosure regarding the CARES Act, and the status of related legislation (pages 35-36);
• Update
the status of your patents and patent applications, which currently are stated as of July 16,
2023, and your progress in notifying certain foreign patent offices of your ownership of
foreign patent rights related to SD-101 (pages 44-45 and 48 and 110-113);
• Update
the disclosure regarding the impact of new tax laws and management's remediation plans regarding
the material weaknesses in your internal controls (page 55);
• Update
the risk factors related to the market for your securities and price volatility (page 56);
• Revise
to clarify that your warrants are exercisable (page 59);
• Revise
the risk factors to clarify that your current charter contains an exclusive forum provision,
rather than it "will provide" that federal district courts will be the sole and
exclusive forum (page 62);
• Update
the recent developments on page 68; and
• Please
update the status of the transactions described in "Certain Relationships and Related
Party Transactions," beginning on page 155, to the extent the transactions do not
reflect the effects of the business combination.
In response to the Staff’s comment,
the Company respectfully advises the Staff that it has revised the disclosure on pages 7–8, 10, 13, 19, 22, 32, 37, 42, 45–46,
55–59, 62–64, 72, 94, 99, 103, 105–108, 111, 113, 115–117 and 161–163 of Amendment No. 2. The Company
also respectfully advises the Staff that there have not been any changes to its determinations with respect to seeking expedited approval
pathways or orphan drug status.
9. Please revise the first paragraph
on the cover page, and the prospectus generally, to remove the registration of these private
placement shares:
• "up
to 4,933,333 shares of Common Stock that are issuable upon the exercise of 4,933,333 warrants
(the “Private Placement Warrants”) held by MedTech Acquisition Sponsor LLC, a
Delaware limited liability company (the “Sponsor”), originally issued in a private
placement in connection with the initial public offering of MedTech Acquisition Corporation
(“MTAC”)," and
• "up
to 1,000,000 shares of Common Stock that are issuable upon the exercise of 1,000,000 conversion
warrants issuable upon the conversion of the promissory note issued by MTAC to the Sponsor
for working capital requirements and payment of certain expenses in connection with a potential