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Damora Therapeutics, Inc.
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1 company response(s)
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Damora Therapeutics, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2021-11-10
Damora Therapeutics, Inc.
Filing - SEC Comment Letter to Damora Therapeutics, Inc.
UPLOAD · 2021-11-10
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Company responded
2021-11-10
Damora Therapeutics, Inc.
Filing - Correspondence from Damora Therapeutics, Inc.
CORRESP · 2021-11-10
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Damora Therapeutics, Inc.
Response Received
5 company response(s)
Medium - date proximity
Company responded
2020-10-13
Damora Therapeutics, Inc.
References: September 29, 2020
Filing - Correspondence from Damora Therapeutics, Inc.
CORRESP · 2020-10-13
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SEC wrote to company
2020-10-19
Damora Therapeutics, Inc.
Filing - SEC Comment Letter to Damora Therapeutics, Inc.
UPLOAD · 2020-10-19
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Company responded
2020-10-20
Damora Therapeutics, Inc.
References: September 29, 2020
Filing - Correspondence from Damora Therapeutics, Inc.
CORRESP · 2020-10-20
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Company responded
2020-10-23
Damora Therapeutics, Inc.
Filing - Correspondence from Damora Therapeutics, Inc.
CORRESP · 2020-10-23
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Company responded
2020-10-23
Damora Therapeutics, Inc.
Filing - Correspondence from Damora Therapeutics, Inc.
CORRESP · 2020-10-23
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Company responded
2020-10-26
Damora Therapeutics, Inc.
Filing - Correspondence from Damora Therapeutics, Inc.
CORRESP · 2020-10-26
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Damora Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2020-09-29
Damora Therapeutics, Inc.
Filing - SEC Comment Letter to Damora Therapeutics, Inc.
UPLOAD · 2020-09-29
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Company responded
2020-10-07
Damora Therapeutics, Inc.
References: September 29, 2020
Filing - Correspondence from Damora Therapeutics, Inc.
CORRESP · 2020-10-07
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-22 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-11-10 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-11-10 | SEC Comment Letter | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-26 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-23 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-23 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-20 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-19 | SEC Comment Letter | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-13 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-07 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-29 | SEC Comment Letter | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2021-11-10 | SEC Comment Letter | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-19 | SEC Comment Letter | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-29 | SEC Comment Letter | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-22 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-11-10 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-26 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-23 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-23 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-20 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-13 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-07 | Company Response | Damora Therapeutics, Inc. | DE | N/A | Read Filing View |
2025-12-22 - CORRESP - Damora Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Galecto, Inc. Ole Maaloes Vej 3 DK-2200 Copenhagen N Denmark 75 State Street Suite 100 Boston, MA 02109 (+45) 70 70 52 10 December 22, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Securities and Exchange Commission Washington, D.C. 20549 Attention: Tim Buchmiller Re: Galecto, Inc. Registration Statement on Form S-3 Filed on December 16, 2025 File No. 333-292175 (the “ Registration Statement ”) Request for Acceleration Dear Mr. Buchmiller, Pursuant to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the “ Commission ”) under the Securities Act of 1933, as amended, Galecto, Inc. (the “ Company ”) hereby respectfully requests acceleration of the effective date of the Registration Statement, so that it may become effective at 4:01 p.m., Eastern Time, on December 23, 2025, or as soon thereafter as practicable. The Company hereby authorizes each of Ryan A. Murr, Branden C. Berns, and Melanie E. Neary of Gibson, Dunn & Crutcher LLP, counsel to the Company, to make such request on its behalf. Once the Registration Statement is effective, please orally confirm the event with the Company’s counsel, Gibson, Dunn & Crutcher LLP by calling Melanie E. Neary at (415) 393-8243. The Company also respectfully requests that a copy of the written order from the Commission verifying the effective time and date of the Registration Statement be sent to mneary@gibsondunn.com. Should any member of the staff of the Commission have any questions or comments with respect to this request, please contact our counsel, Gibson, Dunn & Crutcher LLP, by calling Melanie E. Neary at (415) 393-8243. Very truly yours, GALECTO, INC. By: /s/ Hans T. Schambye, M.D., Ph.D. Hans T. Schambye, M.D., Ph.D. President, Chief Executive Officer and Director cc: Ryan A. Murr, Esq., Gibson, Dunn & Crutcher LLP Branden C. Berns, Esq., Gibson, Dunn & Crutcher LLP Melanie E. Neary, Esq., Gibson, Dunn & Crutcher LLP
2021-11-10 - CORRESP - Damora Therapeutics, Inc.
CORRESP 1 filename1.htm glto-corresp.htm GALECTO, INC. Ole Maaloes Vej 3 DK-2200 Copenhagen N Denmark November 10, 2021 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Galecto, Inc.: Registration Statement on Form S-3 filed November 4, 2021 (File No. 333-260778) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Galecto, Inc., a Delaware corporation (the “Company”), hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to November 12, 2021, at 4:01 pm Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. If you have any questions regarding this request, please contact William A. Magioncalda of Goodwin Procter LLP at (212) 459-7247. [Remainder of Page Intentionally Left Blank] Sincerely, GALECTO, INC. /s/ Jonathan Freve Name: Jonathan Freve Title: Chief Financial Officer cc: Edwin O’Connor, Esq., Goodwin Procter LLP William A. Magioncalda, Esq., Goodwin Procter LLP
2021-11-10 - UPLOAD - Damora Therapeutics, Inc.
United States securities and exchange commission logo
November 10, 2021
Jonathan Freve
Chief Financial Officer
Galecto, Inc.
75 State Street, Suite 100
Boston, Massachusetts, 02109
Re:Galecto, Inc.
Registration Statement on Form S-3
Filed November 4, 2021
File No. 333-260778
Dear Mr. Freve:
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 Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Edwin O'Connor, Esq.
2020-10-26 - CORRESP - Damora Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 620 8th Avenue New York, NY 10018 goodwinlaw.com +1 212 813 8800 October 26, 2020 VIA EDGAR Office of Life Sciences Division of Corporation Finance Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Donald Field Susan Block Kristin Lochhead Kate Tillan Re: Galecto, Inc. Erez Chimovits, Søren Lemonius, Chandra Leo and Karen Wagner Resignation Letters Dear Mr. Field: On behalf of Galecto, Inc. (the “Company”), we submit the enclosed resignation letters (the “Resignation Letters”) of Erez Chimovits, Søren Lemonius, Chandra Leo and Karen Wagner, each a member of the board of directors (the “Board”) of the Company. Each of the Resignation Letters was previously delivered to the Company to inform it that each of Mr. Chimovits, Mr. Lemonius, Dr. Leo and Dr. Wagner, respectively, will automatically resign as a member of the Board effective as of immediately prior to, and contingent upon, the effectiveness of the Company’s registration statement on Form S-1, and that Mr. Chimovits, Mr. Lemonius, Dr. Leo and Dr. Wagner, respectively, will not be responsible for any part of such registration statement. This letter is being furnished to the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission in accordance with Section 11(b)(1) of the Securities Act of 1933, as amended, to notify the Staff that Mr. Chimovits, Mr. Lemonius, Dr. Leo and Dr. Wagner, respectively, will not be responsible for the contents of the Company’s registration statement on Form S-1 (File No. 333-248719), including any amendments thereto. If you should have any questions regarding these matters, please contact the undersigned at (212) 813–8853. Sincerely, /s/ Edwin M. O’Connor Edwin M. O’Connor, Esq. cc: Hans Schambye, Chief Executive Officer, Galecto, Inc. October 24, 2020 Galecto, Inc. Ole Maaloes Vej 3, DK-2200 Copenhagen N Denmark Re: Resignation as a Director To the Board of Directors: I, Erez Chimovits, write to inform you that I hereby automatically resign from the board of directors (the “Board”) of Galecto, Inc. (the “Company”) and its subsidiaries, and all committees of the Board of the Company and its subsidiaries, effective as of immediately prior to, and contingent upon, the effectiveness of the Company’s registration statement on Form S-1 in connection with the Company’s initial public offering, and that I will not be responsible for any part of such registration statement. In the event that such registration is not effective prior to November 30, 2020, this letter of resignation shall be deemed withdrawn without having been given effect. Very truly yours, /s/ Erez Chimovits Erez Chimovits 89 Medinat Hayehudim St. Building E Herzliya 4614001 Israel October 24, 2020 Galecto, Inc. Ole Maaloes Vej 3, DK-2200 Copenhagen N Denmark Re: Resignation as a Director To the Board of Directors: I, Søren Lemonius, write to inform you that I hereby automatically resign from the board of directors (the “Board”) of Galecto, Inc. (the “Company”) and its subsidiaries, and all committees of the Board of the Company and its subsidiaries, effective as of immediately prior to, and contingent upon, the effectiveness of the Company’s registration statement on Form S-1 in connection with the Company’s initial public offering, and that I will not be responsible for any part of such registration statement. In the event that such registration is not effective prior to November 30, 2020, this letter of resignation shall be deemed withdrawn without having been given effect. Very truly yours, /s/ Søren Lemonius Søren Lemonius Store Strandstræde 18, DK-1255 Copenhagen, Denmark October 25, 2020 Galecto, Inc. Ole Maaloes Vej 3, DK-2200 Copenhagen N Denmark Re: Resignation as a Director To the Board of Directors: I, Chandra Leo, write to inform you that I hereby automatically resign from the board of directors (the “Board”) of Galecto, Inc. (the “Company”) and its subsidiaries, and all committees of the Board of the Company and its subsidiaries, effective as of immediately prior to, and contingent upon, the effectiveness of the Company’s registration statement on Form S-1 in connection with the Company’s initial public offering, and that I will not be responsible for any part of such registration statement. In the event that such registration is not effective prior to November 30, 2020, this letter of resignation shall be deemed withdrawn without having been given effect. Very truly yours, /s/ Chandra Leo Chandra Leo Suite 4-212-2, 23 Lime Tree Bay Ave. P.O. Box 30852 Grand Cayman, KY1-1204, Cayman Islands. October 24, 2020 Galecto, Inc. Ole Maaloes Vej 3, DK-2200 Copenhagen N Denmark Re: Resignation as a Director To the Board of Directors: I, Karen Wagner, write to inform you that I hereby automatically resign from the board of directors (the “Board”) of Galecto, Inc. (the “Company”) and its subsidiaries, and all committees of the Board of the Company and its subsidiaries, effective as of immediately prior to, and contingent upon, the effectiveness of the Company’s registration statement on Form S-1 in connection with the Company’s initial public offering, and that I will not be responsible for any part of such registration statement. In the event that such registration is not effective prior to November 30, 2020, this letter of resignation shall be deemed withdrawn without having been given effect. Very truly yours, /s/ Karen Wagner Karen Wagner Avenida de la Libertad, 25 4 A-B, 20004, San Sebastian, Spain
2020-10-23 - CORRESP - Damora Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR October 23, 2020 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Donald Field Susan Block Kristin Lochhead Kate Tillan Re: Galecto, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-249369 Requested Date: October 27, 2020 Requested Time: 4:00 p.m. Eastern Standard Time Dear Mr. Field: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Galecto, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to October 27, 2020, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling Kyra Ayo Caros at (617) 570-1603. We also respectfully request that a copy of the written order from the Securities and Exchange Commission (the “Commission”) verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Kyra Ayo Caros, by email at kayocaros@goodwinlaw.com. [Remainder of page left intentionally blank] If you have any questions regarding this request, please contact Kyra Ayo Caros of Goodwin Procter LLP at (617) 570-1603. Sincerely, GALECTO, INC. /s/ Hans T. Schambye Hans T. Schambye President and Chief Executive Officer cc: Jon Freve, Chief Financial Officer, Galecto, Inc. Edwin M. O’Connor, Esq., Goodwin Procter LLP
2020-10-23 - CORRESP - Damora Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP October 23, 2020 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Donald Field Susan Block Kristin Lochhead Kate Tillan Re: Galecto, Inc. Registration Statement on Form S-1, as amended (Registration No. 333-249369) Dear Mr. Field: In connection with the above-referenced Registration Statement, as amended, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we hereby join in the request of Galecto, Inc. that the effective date of the Registration Statement, as amended, be accelerated so that it will be declared effective at 4:00 p.m. Eastern Time on October 27, 2020, or as soon thereafter as practicable. Pursuant to Rule 460 under the Act, please be advised that we and the other prospective underwriters have distributed approximately 2,000 copies of the preliminary prospectus dated October 22, 2020 through the date hereof, to underwriters, dealers, institutions and others. In connection with the preliminary prospectus distribution for the above-referenced issue, the prospective underwriters have confirmed that they are complying with the 48-hour requirement in Rule 15c2-8(b) under the Securities Exchange Act of 1934, as amended. Very truly yours, BOFA SECURITIES, INC. SVB LEERINK LLC CREDIT SUISSE SECURITIES (USA) LLC As Representatives of the several underwriters [SIGNATURE PAGE FOLLOWS] BOFA SECURITIES, INC. By: /s/ Michele A.H. Allong Name: Michele A.H. Allong Title: Authorized Signatory SVB LEERINK LLC By: /s/ Gabriel Cavazos Name: Gabriel Cavazos Title: Managing Director CREDIT SUISSE SECURITIES (USA) LLC By: /s/ Rebecca Kotkin Name: Rebecca Kotkin Title: Director As representatives of the several underwriters. [Signature Page to Acceleration Request Letter]
2020-10-20 - CORRESP - Damora Therapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
October 20, 2020
Securities and Exchange Commission
Division of Corporation
Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Donald Field
Susan Block
Kristin Lochhead
Kate Tillan
Re: Galecto, Inc.
Registration Statement on Form S-1
Filed October 7, 2020
File No. 333-249369
Ladies and Gentleman:
This letter is submitted
on behalf of Galecto, Inc. (the “Company”) in response to comments of the staff of the Division of Corporation Finance, Office of Life Sciences (the “Staff”) of the U.S. Securities and Exchange Commission (the
“Commission”) with respect to the Company’s Registration Statement on Form S-1 filed on October 7, 2020 (the “Registration Statement”) as set forth in the
Staff’s letters dated September 29, 2020 and October 19, 2020 to Hans Schambye, Chief Executive Officer (the “Comment Letters”). The Company plans to file Amendment No. 1 to the Registration Statement on Form S-1, which will includes the changes excerpted below to be made in response to the Comment and certain other changes (the “Amended S-1”).
For reference purposes, the text of the relevant Comment Letter has been reproduced and italicized herein with responses below each numbered
comment.
Use of Proceeds, page 78
5.
We note your disclosure that you intend to use a portion of the net proceeds to fund the clinical
development of your programs in myelofibrosis, NASH and oncology. Please revise to specify how far in the clinical development of the associated product candidates you expect to reach with the net proceeds. In this regard, we note that you have a
number of clinical trials planned for the associated product candidates, namely GB1211 and GB2064.
Securities and Exchange Commission
October 20, 2020
Page 2
RESPONSE: The Company respectfully advises the Staff that it plans to revise its disclosure under the heading “Use of
Proceeds” regarding its expected use of proceeds from this offering and its cash and cash equivalents on hand to reflect the below.
“As of September 30, 2020, we had cash and cash equivalents of $85.5 million. We currently estimate that we will use the net
proceeds from this offering, together with our existing cash and cash equivalents, as follows:
•
approximately $95 million to fund the clinical development of our lead product candidate, GB0139, including
for conducting our Phase 3 clinical trial in IPF;
•
approximately $13 million to fund the clinical development of GB1211, including for conducting our Phase 2a
clinical trial in NASH;
•
approximately $11 million to fund the clinical development of GB1211, including for conducting our Phase 2a
clinical trial in oncology;
•
approximately $12 million to fund the clinical development of GB2064, including for conducting our Phase 2
clinical trial in myelofibrosis; and
•
the remainder, if any, for additional early-stage research and development activities, business development
activities, working capital and other general corporate purposes.
Based on our current plans, we believe our existing
cash and cash equivalents, together with the net proceeds from this offering, will be sufficient to fund our operating expenses and capital expenditure requirements into 2024.”
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Equity-Based Compensation, page 100
1.
We reference your response to prior comment 7 with regards to the valuation of the stock options issued on
June 24, 2020. We note that you used the April 30, 2020 option pricing method valuation to value the underlying shares. Please tell us how you considered updating the valuation for the period from April 30, 2020 through June 24,
2020, including what consideration you gave to any changes in your business or the economic environment during that time.
Securities and Exchange Commission
October 20, 2020
Page 3
RESPONSE: The Company’s Board of Directors considered the valuation of the underlying shares dated as of April 30, 2020,
together with other developments in the period from April 30, 2020 to June 24, 2020, for purposes of determining the valuation of stock options issued on June 24, 2020. The Company’s Board of Directors considered the following
developments in the economic environment and the Company’s business during the period from April 30, 2020 to June 24, 2020:
i. The U.S. economy and
financial markets experienced significant strain and turbulence as a result of the COVID-19 pandemic resulting in higher market volatility and investor uncertainty.
ii. Although the NASDAQ
biotechnology index increased 9.6% during this period, real gross domestic product (“GDP”) decreased at an annual rate of 31.7% in the second quarter of 2020, according to the “second” estimate released by the Bureau of
Economic Analysis.
iii. The
Company’s Phase 2b clinical trial in IPF patients, the only active clinical trial during this period, experienced patient enrollment delays due to the COVID-19 pandemic. These delays resulted in concerns
regarding the Company’s ability to complete the Phase 2b trial and ultimately required the expected completion date to be pushed back by at least six months. In addition, the Company was expected to initiate a second Phase 2 clinical trial in
fibrosis related to NASH in mid-2020 but, as a result of the COVID-19 pandemic, delayed the expected start date by at least six months. These delays were both unforeseen
and limited the clinical progress of the Company during the period in question.
iv. As of June 24, 2020,
the Company had yet to commence any formal steps towards an Initial Public Offering (“IPO”). The Company had neither engaged investment bankers, received any term sheets from prospective investors for new investment or scheduled an
organizational meeting related to the IPO efforts.
Based on the above factors, the Company’s Board of Directors determined there was
not a significant change in valuation of the Company’s underlying shares in the period from April 30, 2020 to June 24, 2020. Furthermore, based on the Company’s receipt of a crossover term sheet in late August 2020 and subsequent
closing of the Series D financing round in late September 2020, the increase in value from the Series C financing round that closed in October 2018 ($25.73 per share) to the Series D financing round that closed in September 2020 ($27.11 per share,
with substantially similar rights) was 5.4%. Therefore, no further adjustment to the value of the Company and its underlying shares was deemed necessary.
Securities and Exchange Commission
October 20, 2020
Page 4
The Company respectfully acknowledges the Staff’s request for disclosure regarding these considerations and will include the above
disclosure under “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates—Equity-based Compensation” in response to this
comment in the Amended S-1.
2.
Please disclose the methods that management used to determine the fair value of the company’s shares
and the nature of the material assumptions involved for the stock options issued in 2020 as noted in your response to prior comment 7.
RESPONSE: The Company respectfully acknowledges the Staff’s request for disclosure regarding the methods used to determine the fair
value of the common stock and the nature of the material assumptions involved in the stock options issued in 2020. The Company will include the following disclosure under “Management’s Discussion and Analysis of Financial Condition and
Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates—Equity-based Compensation” in response to this comment in the Amended S-1:
“For grants of options we made in 2020, we employed a market approach and utilized the
back-solve method for inferring the equity value predicated on the closing of the final tranche of our Series C convertible preferred shares in January 2020, and we allocated value among different classes of equity securities under a Black-Scholes
option pricing methodology. This method was selected as we concluded that the recent financing transaction was an arm’s-length transaction. Furthermore, as of the valuation date the development timelines
were long (the current Phase 2b clinical trial was expected to last up to 18 additional months) and future liquidity events were difficult to forecast. Application of the option pricing model back-solve method involves making assumptions for the
expected time to liquidity, volatility and risk- free rate and then solving for the value of equity such that the value for the most recent financing equals the amount paid. We assumed a 1.7-year estimated
term, 80% volatility rate and a risk-free rate of 0.19%. We then reflected a discount for lack of marketability of 33% derived from our then-current estimates of the time to a liquidity event. With the aid of the April 30, 2020 third-party
valuation and after consideration of macroeconomic and company-specific developments during the first half of 2020, our board of directors, with input from management, determined the fair market value of our common shares to be $5.07 per share for
the options granted on June 24, 2020.”
Securities and Exchange Commission
October 20, 2020
Page 5
* * * * *
Should you have any
further comments or questions with regard to the foregoing, please contact the undersigned at (212) 813-8853.
Sincerely,
/s/ Edwin O’Connor
GOODWIN PROCTER LLP
cc: Hans Schambye, Chief Executive
Officer, Galecto, Inc.
2020-10-19 - UPLOAD - Damora Therapeutics, Inc.
United States securities and exchange commission logo
October 19, 2020
Hans T. Schambye
Chief Executive Officer
Galecto, Inc.
Ole Maaloes Vej 3
DK-2200 Copenhagen N
Denmark
Re:Galecto, Inc.
Registration Statement on Form S-1
Filed October 7, 2020
File No. 333-249369
Dear Dr. Schambye:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Equity-Based Compensation, page 100
1.We reference your response to prior comment 7 with regard to the valuation of the stock
options issued on June 24, 2020. We note that you used the April 30, 2020 option pricing
method valuation to value the underlying shares. Please tell us how you considered
updating the valuation for the period from April 30, 2020 through June 24, 2020,
including what consideration you gave to any changes in your business or the economic
environment during that time.
FirstName LastNameHans T. Schambye
Comapany NameGalecto, Inc.
October 19, 2020 Page 2
FirstName LastName
Hans T. Schambye
Galecto, Inc.
October 19, 2020
Page 2
2.Please disclose the methods that management used to determine the fair value of the
company's shares and the nature of the material assumptions involved for the stock
options issued in 2020 as noted in your response to prior comment 7.
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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Kristin Lochhead at 202-551-3664 or Kate Tillan at 202-551-3604 if
you have questions regarding comments on the financial statements and related matters. Please
contact Donald Field at 202-551-3680 or Susan Block at 202-551-3210 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-10-13 - CORRESP - Damora Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP FOIA CONFIDENTIAL TREATMENT REQUEST The entity requesting confidential treatment is: Galecto, Inc. Ole Maaloes Vej 3 DK-2200 Copenhagen N Denmark Attn: Hans T. Schambye Chief Executive Officer (+45) 70 70 52 10 CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. OMITTED INFORMATION HAS BEEN REPLACED IN THIS LETTER AS FILED VIA EDGAR WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” October 13, 2020 By Electronic Submission Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Attention: Kristin Lochhead Kate Tillan Donald Field Susan Block Re: Galecto, Inc. Registration Statement on Form S-1 Filed October 7, 2020 File No. 333-249369 Ladies and Gentlemen: On behalf of Galecto, Inc. (the “Company”), set forth below is additional information to supplement the Company’s prior response to comment 7 of the letter dated September 29, 2020 from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) relating to the Company’s Confidential Draft Registration Statement on Form S-1 (File No. 377-03490), originally submitted by the Company to the Commission on September 2, 2020. Such Confidential Draft Registration Statement has been updated by the Company as reflected in the Registration Statement referenced above (File No. 333-249369), which was publicly CONFIDENTIAL TREATMENT REQUESTED BY GALECTO, INC. filed by the Company on October 7, 2020 (the “Registration Statement”). The supplemental response set forth below is based upon information provided to Goodwin Procter LLP by the Company. * * * For convenience of the Staff, we have recited the prior comment in italicized type and have followed the comment with the Company’s response. 7. We note from page F-24 that in June 2020, the board of directors granted 471,500 stock options. Once you have an estimated offering price or range, please explain to us how you determined the fair value of the common stock underlying your equity issuances and the reasons for any differences between the recent valuations of your common stock leading up to the initial public offering and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including stock compensation and beneficial conversion features. Summary of Recent Stock Option Grants and Valuations The Company presently anticipates that the estimated price range would be approximately $[***] to $[***] per share for the Company’s common stock (the “Preliminary IPO Price Range”) before giving effect to a stock split that the Company plans to implement prior to effectiveness of the Registration Statement. As stated in the Registration Statement, the Company has granted stock-based awards, consisting of stock options, to its employees and certain members of its board of directors. The Company measures stock-based compensation expense for stock options granted to its employees and directors on the date of grant and recognizes the corresponding compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. The Registration Statement describes the Company’s use of the Black-Scholes option-pricing model for the purpose of calculating the fair value of the stock options. In the twelve months preceding the filing of the Registration Statement, equity awards were granted and the Company’s board of directors, with input from management, determined the fair value of the Company’s common stock to be $[***] and $[***] per share (pre-stock split) as of June 24, 2020 and October 7, 2020, respectively, after considering valuation reports from an independent third-party valuation specialist as of April 30, 2020 and September 25, 2020, as well as the other objective and subjective factors described in the Registration Statement. Common share and option fair values discussed in this letter, including the Preliminary Assumed IPO Price, do not reflect any stock split the Company expects to effect prior to the offering. Set forth below in this letter is a discussion of each common stock valuation and the option grants in the preceding twelve months, along with a comparison of the fair value of the Company’s common stock from December 31, 2019 to the Preliminary Assumed IPO Price. CONFIDENTIAL TREATMENT REQUESTED BY GALECTO, INC. The following table presents a summary of equity awards in the preceding twelve months: Grant Date Number of shares subject to awards granted Per share exercise price Per share fair value of common stock on grant date Per share fair value of award on grant date June 2020 483,949 $[***] $[***] $[***] October 2020 365,500 $[***] $[***] $[***] The Company accounts for equity-based compensation in accordance with ASC 718, Compensation-Stock Compensation (“ASC 718”). In accordance with ASC 718, the Company measures compensation cost at estimated fair value and includes it as compensation expense over the vesting period during which service is provided in exchange for the award. The Company’s board of directors has estimated the fair value of the common shares at various grant dates, with input from management, considering the Company’s most recently available third-party valuations of the common shares and the board of directors’ assessment of additional objective and subjective factors that it believed were relevant to the estimated fair value. The Company used a Black-Scholes option pricing model to determine fair value of the stock options. The Black-Scholes option pricing model includes various assumptions, including the fair value of common shares, expected life of stock options, the expected volatility and the expected risk-free interest rate. The Company’s determinations of the fair value of the common shares were performed using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Guide”). In accordance with the Practice Guide, the Company considered the following methods for allocating the enterprise value across its classes and series of shares to determine the estimated fair value of its stock options at each valuation date. • Option Pricing Method (“OPM”). The OPM estimates the value of the common equity of the Company by treating the rights of the holders of common equity as equivalent to that of call options on any value of the enterprise above certain break points of value based upon the liquidation preferences of the holders of the Company’s preferred shares, as well as their rights to participation in a future financing. Thus, the value of the common shares can be determined by estimating the value of its portion of each of these call option rights. Consequently, the common share has value only if the funds available for distribution to shareholders exceed the value of the liquidation preference at the time of a liquidity event. • Probability-Weighted Expected Return Method (“PWERM”). The PWERM is a scenario-based analysis that estimates the value per share based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes considered by the Company, as well as the economic and control rights of each share class. • Hybrid Method. The Hybrid Method is a hybrid between the PWERM and OPM, estimating the probability-weighted value across multiple scenarios, but using the OPM to estimate the allocation of value within one or more of those scenarios. Weighting allocations are assigned to the OPM and PWERM methods factoring possible future liquidity events. CONFIDENTIAL TREATMENT REQUESTED BY GALECTO, INC. Additionally, as the stock options represent an option to purchase a security that is currently not marketable, an adjustment to the preliminary value estimates must be made to account for the lack of liquidity that a holder may experience. This adjustment is commonly referred to as a discount for lack of marketability (“DLOM”). December 31, 2019 Valuation In preparing the December 31, 2019 valuation of its common stock, the Company determined the enterprise value using the market approach with OPM based on the then-recently completed Series C preferred stock transaction. Management concluded that the use of the Series C preferred stock transaction supported this methodology since the willingness of existing investors to invest new money into the Company demonstrated that the transaction was indicative of enterprise value. The resulting estimated fair value of the Company’s common stock was $[***] per share (pre-stock split). Under the OPM, the Company used a back-solve method so that the enterprise value equaled the contemplated value of the Company determined by the Series C preferred stock financing transaction with both existing and new third-party investors which closed in December 2019. The DLOM of 30% applied was derived from the then-current estimates of the time to a liquidity event made by the Company’s senior management. April 30, 2020 Valuation In preparing the April 30, 2020 valuation of its common stock, the Company determined the enterprise value using the OPM based on the then-recently completed Series C preferred stock transaction. Management concluded that the use of the Series C preferred stock transaction supported this methodology since the willingness of existing investors to invest new money into the Company demonstrated that the transaction was indicative of enterprise value. The resulting estimated fair value of the Company’s common stock was $[***] per share (pre-stock split). Under the OPM, the Company used a back-solve method so that the enterprise value equaled the contemplated value of the Company determined by the Series C preferred stock financing transaction with both existing and new third-party investors which closed in December 2019. The DLOM of 33% applied was derived from the then-current estimates of the time to a liquidity event made by the Company’s senior management. During the period of March 1, 2020 through April 30, 2020, the U.S. economy and financial markets experienced significant strain and turbulence as a result of the coronavirus disease 2019 pandemic that caused higher market volatility and investor uncertainty, leading to an increase in the selected DLOM as of April 30, 2020. September 25, 2020 Valuation In preparing the September 25, 2020 valuation of its common stock, the Company determined the enterprise value using the Hybrid Method, estimating the probability-weighted value across multiple scenarios, including with the OPM backsolve based on the Company’s Series D preferred share transaction (recent transaction method) being weighted at 30% and the initial public offering (“IPO”) scenario being weighted at 70%. The relative probability weighting of the IPO increased from no probability of an IPO in the April 30, 2020 valuation because the Company confidentially submitted a draft registration statement on Form S-1 to the Commission on September 2, 2020, a substantial step CONFIDENTIAL TREATMENT REQUESTED BY GALECTO, INC. towards completing an IPO. The resulting estimated fair value of the Company’s common stock was $[***] per share (pre-stock split). For the IPO scenario, the future enterprise value at an expected IPO date was discounted to present value and allocated to each outstanding share class, on a fully diluted basis assuming all existing shareholders convert into common shares. The enterprise value was estimated using the guideline IPO transactions method and used an enterprise value between the 25th percentile and median of the 24 recent IPO transactions completed by issuers in a similar stage of development as the Company. The valuation estimated the time to a liquidity event at 0.27 years based on the Company’s plans and progress in pursuing an IPO, including the fact that it had confidentially submitted a draft registration statement on Form S-1. A discount rate of 25% was applied. The DLOM in this scenario was concluded to be 5.0%. The DLOMs used for both scenarios were derived from the then-current estimates of the time to the liquidity events made by the Company’s senior management. The fair value per common share in the IPO scenario was determined to be $[***] (pre-stock split). In the recent transaction scenario, the Company’s total enterprise value was estimated using the OPM backsolve method as the Company had closed its Series D preferred share financing in September 2020 for gross proceeds of $64.2 million. Based on the application of the OPM backsolve method, the valuation specialist estimated the breakpoints for the different classes of equity and applied the OPM to solve for the Series D transaction. The results from the OPM backsolve analysis determined the fair value of other classes of equity securities, including the common shares. The recent transactions method estimated the total enterprise value of the Company to be approximately $[***]. The valuation estimated the time to a liquidity event at 1.5 years based on consideration of the Company’s development status and the additional development time needed for its lead programs. The DLOM in this scenario was concluded to be 30.0%. The fair value per common share in the recent transaction scenario was determined to be $[***]. Estimated Initial Public Offering Price Range Rule 83 Confidential Treatment Request by Galecto, Inc. Request #1 To assist the Staff in its review, the Company advises the Staff that, although not yet reflected in the Registration Statement, based on discussions with the Company’s board of directors and reflecting input from the lead underwriters (the “Underwriters”) for the Company’s IPO, if the Company were to commence marketing of the transaction today, the Company presently anticipates that the estimated price range would be approximately $[***] to $[***] per share for the Company’s common stock before giving effect to a stock split that the Company plans to implement prior to effectiveness of the Registration Statement. The actual price range to be included in a subsequent amendment to the Registration Statement (which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) has not yet been determined and remains subject to adjustment based on factors outside of the Company’s control. However, the Company believes that the foregoing indicative price range will not be subject to significant change. CONFIDENTIAL TREATMENT REQUESTED BY GALECTO, INC. Galecto, Inc. respectfully requests that the information contained in the response be treated as confidential information and that the Commission provide timely notice to Hans T. Schambye, Chief Executive Officer, Galecto, Inc., Ole Maaloes Vej 3, DK-2200 Copenhagen N, Denmark (telephone (+45) 70 70 52 10), before it permits any disclosure of the double-underlined and highlighted information contained in Request #1. Prior to October 6, 2020, the Company and the Underwriters had not had any specific discussions regarding the Preliminary IPO Price Range. Among the factors that were considered in setting the Preliminary IPO Price Range were the following: • an analysis of the typical valuation ranges seen in recent IPOs of generally comparable companies in the biopharmaceutical industry; • the general condition of the securities markets and the recent market prices of, and the demand for, publicly traded common stock of generally comparable companies; • the recent performance of U.S. ini
2020-10-07 - CORRESP - Damora Therapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
October 7, 2020
Securities and Exchange Commission
Division of Corporation
Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Donald Field
Susan Block
Kristin Lochhead
Kate Tillan
Re:
Galecto, Inc.
Draft Registration Statement on Form S-1
Submitted September 2, 2020
CIK No. 0001800315
Ladies and
Gentleman:
This letter is submitted on behalf of Galecto, Inc. (the “Company”) in response to comments of the staff of
the Division of Corporation Finance, Office of Life Sciences (the “Staff”) of the U.S. Securities and Exchange Commission with respect to the Company’s Registration Statement on Form S-1
confidentially submitted on September 2, 2020 (the “Registration Statement”) as set forth in the Staff’s letter dated September 29, 2020 to Hans Schambye, Chief Executive Officer (the “Comment
Letter”).
For reference purposes, the text of the Comment Letter has been reproduced and italicized herein with responses below
each numbered comment.
Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1.
In one of the opening paragraphs, please include your net income and net loss for the most recent audited
period and any interim stub provided, as applicable. Please also disclose here that you have not had any products approved for sale and have not generated any product revenue, as you disclose on page 88.
RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on page 1 of the amended Registration Statement
(the “Amended Form S-1”) in response to the Staff’s comment.
Securities and Exchange Commission
October 7, 2020
Page
2
Recent Developments, page 3
2.
We note your disclosure that the “COVID-19 pandemic may
negatively impact [your] business, financial condition and results of operations by decreasing or delaying the enrollment of patients in [your] clinical trials or otherwise causing interruptions or delays in our programs and services.”
Please revise to discuss in greater detail if and how your clinical trials have been affected. Please also revise any associated risk factors to specifically discuss if and how COVID-19 has actually impacted
your clinical trials. In this regard, we note the last risk factors on pages 19 and 58 appear generic and do not specifically discuss if and how your clinical trials have been impacted.
RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on pages 19 and 60 of the Amended Form S-1 in response to the Staff’s comment.
Implications of Being an Emerging Growth Company and a Smaller
Reporting Company, page 5
3.
Please provide us with supplemental copies of all written communications, as defined in Rule 405 under the
Securities Act, that you, or anyone authorized to do so on your behalf, have presented or expect to present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not you retained, or intend to retain, copies of
those communications. Please contact the staff member associated with the review of this filing to discuss how to submit the materials, if any, to us for our review.
RESPONSE: The Company respectfully advises the Staff that it will provide the Staff, on a confidential basis under separate cover,
copies of all written communications presented to potential investors in reliance on Section 5(d) of the Securities Act and further advises the Staff that it will collect copies of any such materials from potential investors.
Cautionary Note Regarding Forward-Looking Statements, page 75
4.
We note your reference here to the Private Securities Litigation Reform Act of 1995. Please note that the
PSLRA safe harbor provisions do not apply to initial public offerings. Refer to Section 27A of the Securities Act of 1933. Please either delete any references to the Private Securities Litigation Reform Act or make clear that the safe harbor
does not apply to this offering.
RESPONSE: The Company respectfully advises the Staff that it has revised the
disclosure on page 77 of the Amended Form S-1 in response to the Staff’s comment.
Securities and Exchange Commission
October 7, 2020
Page
3
Use of Proceeds, page 78
5.
We note your disclosure that you intend to use a portion of the net proceeds to fund the clinical
development of our programs in myelofibrosis, NASH and oncology. Please revise to specify how far in the clinical development of the associated product candidates you expect to reach with the net proceeds. In this regard, we note that you have a
number of clinical trials planned for the associated product candidates, namely GB1211 and GB2064.
RESPONSE:
The Company respectfully advises the Staff that it will revise its disclosure regarding its expected use of proceeds from this offering and its cash and cash equivalents on hand substantially based on the current format included in the Registration
Statement, including with respect to a Phase 3 clinical trial for GB0139 and Phase 2 clinical trials for GB1211 and GB2064 once it has an estimate of the anticipated proceeds from the offering.
Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, Comparison of the Years Ended
December 31, 2019 and 2018, page 92
6.
As indicated in FRC 501.01, MD&A is intended to give an investor an opportunity to view a registrant
through the eyes of its management. Given the significance of your research and development costs, please consider including disaggregated disclosure of the nature of expenses incurred for each period.
RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on page 95 of the Amended Form S-1 in response to the Staff’s comment.
Critical Accounting Policies and Significant Judgments and Estimates
Equity-based Compensation, page 97
7.
We note from page F-24 that in June 2020, the board of directors
granted 471,500 stock options. Once you have an estimated offering price or range, please explain to us how you determined the fair value of the common stock underlying your equity issuances and the reasons for any differences between the recent
valuations of your common stock leading up to the initial public offering and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including stock compensation and beneficial
conversion features.
RESPONSE: The Company respectfully acknowledges the Staff’s request for an
explanation of how the Company determined the fair value of the common stock underlying its equity issuances and the reasons for any differences between the recent valuations of the Company’s common stock leading up to the IPO and the estimated
offering price, once available, and the Company will provide the requested information once it has an estimated offering price range.
Securities and Exchange Commission
October 7, 2020
Page
4
Narrative Disclosure to Summary Compensation Table, page 148
8.
Please file the Letter Agreements with Mr. Schambye and Mr. Pedersen as exhibits to your
registration statement or tell us why you believe this is not necessary.
RESPONSE: The Company respectfully
acknowledges the Staff’s comment and advises the Staff that the Letter Agreements with each of Mr. Schambye and Mr. Pedersen will be filed with the Amended Form S-1.
Principal Stockholders, page 156
9.
Please disclose in a footnote the natural person or persons that have voting and dispositive control of the
shares for the entities listed in the table as 5% or greater stockholders. Please also clarify which entities you are referring to in regards to Entities Affiliated with OrbiMed and Entities Affiliated with Bay City Capital, or advise.
RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on pages 163-166 of the Amended Form S-1 in response to the Staff’s comment.
Exclusive forum, page 163
10.
Please reconcile the disclosure in this section with the disclosure contained in the last risk factor on
page 73. In this regard, we note that your federal exclusive forum provision disclosure appears inconsistent, namely by identifying different federal jurisdictions for the adjudication of claims.
RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on page 172 of the Amended Form S-1 in response to the Staff’s comment.
Consolidated Financial Statements
Note 2. Summary of Significant Accounting Policies, page F-9
11.
Please disclose your accounting policy for cash equivalents. Refer to ASC 230-10-50-1.
RESPONSE: The Company respectfully advises the Staff that it has revised the disclosure on page
F-10 of the Amended Form S-1 in response to the Staff’s comment.
General
12.
Please provide us mockups of any pages that include any additional pictures or graphics to be presented,
including any accompanying captions. Please keep in mind, in scheduling your printing and distribution of the preliminary prospectus, that we may have comments after our review of these materials.
RESPONSE: The Company respectfully advises the Staff that the Amended Form S-1 contains all of
the graphic, visual or photographic material contemplated to be included in the printed prospectus. If, following the date of this letter, the Company determines to include additional graphic, visual or photographic material in the printed
prospectus, it will provide proofs of such material to the Staff prior to its use.
* * * * *
Securities and Exchange Commission
October 7, 2020
Page
5
Should you have any further comments or questions with regard to the foregoing, please
contact the undersigned at (212) 813-8853.
Sincerely,
/s/ Edwin O’Connor
GOODWIN PROCTER LLP
cc: Hans Schambye, Chief Executive Officer, Galecto, Inc.
2020-09-29 - UPLOAD - Damora Therapeutics, Inc.
United States securities and exchange commission logo
September 29, 2020
Hans T. Schambye
Chief Executive Officer
Galecto, Inc.
Ole Maaloes Vej 3
DK-2200 Copenhagen N
Denmark
Re:Galecto, Inc.
Draft Registration Statement on Form S-1
Submitted September 2, 2020
CIK No. 0001800315
Dear Dr. Schambye:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1.In one of the opening paragraphs, please include your net income and net loss for the most
recent audited period and any interim stub provided, as applicable. Please also disclose
here that you have not had any products approved for sale and have not generated any
product revenue, as you disclose on page 88.
Recent Developments, page 3
2.We note your disclosure that the "COVID-19 pandemic may negatively impact
[your] business, financial condition and results of operations by decreasing or delaying the
FirstName LastNameHans T. Schambye
Comapany NameGalecto, Inc.
September 29, 2020 Page 2
FirstName LastNameHans T. Schambye
Galecto, Inc.
September 29, 2020
Page 2
enrollment of patients in [your] clinical trials or otherwise causing interruptions or delays
in our programs and services." Please revise to discuss in greater detail if and how your
clinical trials have been affected. Please also revise any associated risk factors to
specifically discuss if and how COVID-19 has actually impacted your clinical trials. In
this regard, we note the last risk factors on pages 19 and 58 appear generic and do not
specifically discuss if and how your clinical trials have been impacted.
Implications of Being an Emerging Growth Company and a Smaller Reporting Company, page 5
3.Please provide us with supplemental copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
have presented or expect to present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain, copies of those
communications. Please contact the staff member associated with the review of this filing
to discuss how to submit the materials, if any, to us for our review.
Cautionary Note Regarding Forward-Looking Statements, page 75
4.We note your reference here to the Private Securities Litigation Reform Act of 1995.
Please note that the PSLRA safe harbor provisions do not apply to initial public offerings.
Refer to Section 27A of the Securities Act of 1933. Please either delete any references to
the Private Securities Litigation Reform Act or make clear that the safe harbor does not
apply to this offering.
Use of Proceeds, page 78
5.We note your disclosure that you intend to use a portion of the net proceeds to fund the
clinical development of our programs in myelofibrosis, NASH and oncology. Please
revise to specify how far in the clinical development of the associated product candidates
you expect to reach with the net proceeds. In this regard, we note that you have a number
of clinical trials planned for the associated product candidates, namely GB1211 and
GB2064.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, Comparison of the Years Ended December 31, 2019 and 2018, page 92
6.As indicated in FRC 501.01, MD&A is intended to give an investor an opportunity to
view a registrant through the eyes of its management. Given the significance of your
research and development costs, please consider including disaggregated disclosure of the
nature of expenses incurred for each period.
Critical Accounting Policies and Significant Judgments and Estimates
Equity-based Compensation, page 97
7.We note from page F-24 that in June 2020, the board of directors granted 471,500 stock
options. Once you have an estimated offering price or range, please explain to us how
FirstName LastNameHans T. Schambye
Comapany NameGalecto, Inc.
September 29, 2020 Page 3
FirstName LastName
Hans T. Schambye
Galecto, Inc.
September 29, 2020
Page 3
you determined the fair value of the common stock underlying your equity issuances and
the reasons for any differences between the recent valuations of your common stock
leading up to the initial public offering and the estimated offering price. This information
will help facilitate our review of your accounting for equity issuances including stock
compensation and beneficial conversion features.
Narrative Disclosure to Summary Compensation Table, page 148
8.Please file the Letter Agreements with Mr. Schambye and Mr. Pedersen as exhibits to
your registration statement or tell us why you believe this is not necessary.
Principal Stockholders, page 156
9.Please disclose in a footnote the natural person or persons that have voting and dispositive
control of the shares for the entities listed in the table as 5% or greater stockholders.
Please also clarify which entities you are referring to in regards to Entities Affiliated with
OrbiMed and Entities Affiliated with Bay City Capital, or advise.
Exclusive forum, page 163
10.Please reconcile the disclosure in this section with the disclosure contained in the last risk
factor on page 73. In this regard, we note that your federal exclusive forum provision
disclosure appears inconsistent, namely by identifying different federal jurisdictions for
the adjudication of claims.
Consolidated Financial Statements
Note 2. Summary of Significant Accounting Policies, page F-9
11.Please disclose your accounting policy for cash equivalents. Refer to ASC 230-10-50-1.
General
12.Please provide us mockups of any pages that include any additional pictures or graphics to
be presented, including any accompanying captions. Please keep in mind, in scheduling
your printing and distribution of the preliminary prospectus, that we may have comments
after our review of these materials.
You may contact Kristin Lochhead at 202-551-3664 or Kate Tillan at 202-551-3604 if
you have questions regarding comments on the financial statements and related matters. Please
contact Donald Field at 202-551-3680 or Susan Block at 202-551-3210 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
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