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Jade Biosciences, Inc.
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Jade Biosciences, Inc.
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SEC wrote to company
2025-02-18
Jade Biosciences, Inc.
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2025-02-24
Jade Biosciences, Inc.
References: February 18, 2025
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2025-03-14
Jade Biosciences, Inc.
References: March 11, 2025
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2025-03-24
Jade Biosciences, Inc.
References: March 21, 2025
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2025-03-24
Jade Biosciences, Inc.
References: March 21, 2025
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Jade Biosciences, Inc.
Awaiting Response
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Jade Biosciences, Inc.
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Jade Biosciences, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2022-08-18
Jade Biosciences, Inc.
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2022-08-19
Jade Biosciences, Inc.
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Jade Biosciences, Inc.
Response Received
3 company response(s)
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SEC wrote to company
2021-06-21
Jade Biosciences, Inc.
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2021-06-24
Jade Biosciences, Inc.
References: June 21, 2021
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2021-06-25
Jade Biosciences, Inc.
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2021-06-25
Jade Biosciences, Inc.
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Jade Biosciences, Inc.
Response Received
1 company response(s)
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SEC wrote to company
2021-06-02
Jade Biosciences, Inc.
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2021-06-09
Jade Biosciences, Inc.
References: June 2, 2020
Summary
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-23 | SEC Comment Letter | Jade Biosciences, Inc. | DE | 333-292369 | Read Filing View |
| 2025-12-23 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-03-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-03-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-03-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-03-21 | SEC Comment Letter | Jade Biosciences, Inc. | DE | 333-283562 | Read Filing View |
| 2025-03-14 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-03-11 | SEC Comment Letter | Jade Biosciences, Inc. | DE | 333-283562 | Read Filing View |
| 2025-02-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-02-18 | SEC Comment Letter | Jade Biosciences, Inc. | DE | 333-283562 | Read Filing View |
| 2022-08-19 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2022-08-18 | SEC Comment Letter | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-21 | SEC Comment Letter | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-09 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-02 | SEC Comment Letter | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-23 | SEC Comment Letter | Jade Biosciences, Inc. | DE | 333-292369 | Read Filing View |
| 2025-03-21 | SEC Comment Letter | Jade Biosciences, Inc. | DE | 333-283562 | Read Filing View |
| 2025-03-11 | SEC Comment Letter | Jade Biosciences, Inc. | DE | 333-283562 | Read Filing View |
| 2025-02-18 | SEC Comment Letter | Jade Biosciences, Inc. | DE | 333-283562 | Read Filing View |
| 2022-08-18 | SEC Comment Letter | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-21 | SEC Comment Letter | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-02 | SEC Comment Letter | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-23 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-03-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-03-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-03-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-03-14 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2025-02-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2022-08-19 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-25 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-24 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
| 2021-06-09 | Company Response | Jade Biosciences, Inc. | DE | N/A | Read Filing View |
2025-12-23 - UPLOAD - Jade Biosciences, Inc. File: 333-292369
December 23, 2025 Tom Frohlich Chief Executive Officer Jade Biosciences, Inc. 221 Crescent St., Building 23 Suite 105 Waltham, MA 02453 Re:Jade Biosciences, Inc. Registration Statement on Form S-1 Filed December 22, 2025 File No. 333-292369 Dear Tom Frohlich: 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:Anthony Gostanian, Esq.
2025-12-23 - CORRESP - Jade Biosciences, Inc.
CORRESP 1 filename1.htm CORRESP Jade Biosciences, Inc. 221 Crescent Street, Building 23, Suite 105 Waltham, Massachusetts 02453 December 23, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-6010 Attn: Mr. Jimmy McNamara Re: Jade Biosciences, Inc. Registration Statement on Form S-1 File No. 333-292369 Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (the “Registration Statement”) of Jade Biosciences, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m. Eastern Time on December 30, 2025, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Matt Bush at (858) 523-3962. Thank you for your assistance in this matter. Very truly yours, JADE BIOSCIENCES, INC. By: /s/ Bradford Dahms Bradford Dahms Chief Financial Officer cc: Tom Frohlich, Jade Biosciences, Inc. Elizabeth Balta, Jade Biosciences, Inc. Cheston Larson, Latham & Watkins LLP Matthew T. Bush, Latham & Watkins LLP Anthony Gostanian, Latham & Watkins LLP
2025-03-24 - CORRESP - Jade Biosciences, Inc.
CORRESP 1 filename1.htm Goodwin Procter llp The New York Times Building 620 Eighth Avenue New York, NY 10018 goodwinlaw.com +1 212 813 8800 Via EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Jessica Dickerson, Chris Edwards, Tara Harkins and Sasha Parikh Re: Aerovate Therapeutics, Inc. Amendment No. 3 to Registration Statement on Form S-4 Filed March 14, 2025 File No. 333-283562 Ladies and Gentlemen, On behalf of Aerovate Therapeutics, Inc. (the " Company "), we are submitting this letter to the Securities and Exchange Commission (the " SEC ") via EDGAR in response to the comment letter from the staff of the SEC (the " Staff "), dated March 21, 2025 (the " Comment Letter "), pertaining to the Company's above-referenced Amendment No. 3 to Registration Statement on Form S-4/A (the " Third Amended Registration Statement "). In connection with such responses, the Company is concurrently filing Amendment No. 4 to the Registration Statement (the " Fourth Amended Registration Statement "). For your convenience, the Staff's comments are summarized in this letter, and each comment is followed by the applicable responses on behalf of the Company. Unless otherwise indicated, page references in the responses correspond to the page numbers in the Fourth Amended Registration Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Fourth Amended Registration Statement. Amendment No. 3 to Registration Statement on Form S-4 Jade Management's Discussion and Analysis of Financial Condition and Results of Operations Stock-Based Compensation, page 346 1. Please address the following regarding the stock options and restricted stock units granted by Jade: · Revise to provide a tabular presentation or revise your table on pages 186-187 to provide the grant date, number of options or restricted stock units granted, exercise price, valuation of common stock used, compensation expense recognized for all options and restricted stock units granted. Securities and Exchange Commission March 24, 2025 Page 2 · Tell us and revise your disclosure to explain how the valuation used compares to the exchange ratio of the merger. · Tell us and revise your disclosure to address how the valuation process considered the common control nature of the relationship between Jade and Paragon at the time of the grant. Further, explain how the valuation considered eventual conclusion of the overall plan of licensing of JADE-001, JADE-002 and JADE- 003 between related parties. Response : The Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised the disclosure on pages 346–349 of the Fourth Amended Registration Statement in response to the Staff's comment. ***** Please contact the undersigned at (212) 813-8800 or via email at eoconnor@goodwinlaw.com if you have any questions with respect to the foregoing. Very truly yours, /s/ Edwin M. O'Connor Edwin M. O'Connor, Esq. Goodwin Procter LLP cc: Timothy Noyes, Aerovate Therapeutics, Inc. George Eldridge, Aerovate Therapeutics, Inc. Tevia K. Pollard, Esq., Goodwin Procter LLP Alicia M. Tschirhart, Esq . , Goodwin Procter LLP Ryan A. Murr, Gibson, Dunn & Crutcher LLP Branden C. Berns, Gibson, Dunn & Crutcher LLP
2025-03-24 - CORRESP - Jade Biosciences, Inc.
CORRESP
1
filename1.htm
CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR
HAVE BEEN OMITTED AND PROVIDED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY AEROVATE
THERAPEUTICS, INC. 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 [***].
March 24, 2025
VIA EDGAR AND OVERNIGHT
DELIVERY
CONFIDENTIAL
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Jessica Dickerson
Chris Edwards
Tara Harkins
Sasha Parikh
Re: Aerovate Therapeutics, Inc.
Amendment No. 3 to Registration Statement on Form S-4
Filed March 14, 2025
File No. 333-283562
Ladies and Gentlemen:
On behalf of Aerovate Therapeutics, Inc.
(the " Aerovate ") and Jade Biosciences, Inc. (" Jade "), we submit this supplemental letter in
response to a comment from the staff (the " Staff ") of the U.S. Securities and Exchange Commission (the " Commission ")
received by letter dated March 21, 2025 (the " Comment Letter ") relating to Aerovate's Registration Statement
on Form S-4, originally filed with the Commission on December 2, 2024 and amended on January 22, 2025, February 24,
2025 and March 14, 2025 (the " Registration Statement ").
Because of the commercially sensitive nature of
certain information contained herein, this supplemental letter is accompanied by Aerovate's request for confidential treatment
for selected portions of this supplemental letter. Aerovate has filed separate correspondence with the Office of Freedom of Information
and Privacy Act Operations in connection with its confidential treatment request, pursuant to Rule 83 of the Commission's
Rules on Information and Requests, 17 C.F.R. §200.83. For the Staff's reference, we have enclosed a copy of Aerovate's
correspondence to the Office of Freedom of Information and Privacy Act Operations, as well as an unredacted copy of this supplemental
letter, marked to show the portions redacted from the version filed via EDGAR and for which Aerovate is requesting confidential treatment.
For the convenience of the Staff, we have recited
the comment from the Comment Letter in italicized type and have followed the comment with Jade's response.
U.S. Securities and Exchange Commission
March 24, 2025
CONFIDENTIAL TREATMENT REQUESTED BY AEROVATE THERAPEUTICS, INC.
1. Please
address the following regarding the stock options and restricted stock units granted by Jade:
· Revise
to provide a tabular presentation or revise your table on pages 186-187 to provide the
grant date, number of options or restricted stock units granted, exercise price, valuation
of common stock used, compensation expense recognized for all options and restricted stock
units granted.
· Tell
us and revise your disclosure to explain how the valuation used compares to the exchange
ratio of the merger.
· Tell
us and revise your disclosure to address how the valuation process considered the common
control nature of the relationship between Jade and Paragon at the time of grant. Further,
explain how the valuation considered eventual conclusion of the overall plan of licensing
of JADE-001, JADE-002 and JADE-003 between related parties.
Jade submits the below additional information
to assist the Staff in its review of Jade's position with respect to its determination of the fair value of its restricted stock
and stock option awards.
Preliminary Valuation
Aerovate has complied with this request and
provided updated tabular disclosure in Amendment No. 4 to the Registration Statement, which is filed concurrently herewith.
Additionally, Jade advises the Staff that the exchange ratio that is reflected in the documentation for the reverse merger with
Aerovate (the " Merger ") and the purchase price per share that is reflected in the documentation for the
pre-closing financing (the " Jade Pre-Closing Financing "), each reference a pre-money valuation of Jade of $175
million (the " Jade Merger Valuation "). The Jade Merger Valuation did not take into account the then-current lack
of liquidity for Jade's common stock and assumed a successful reverse merger, with no weighting attributed to any other
outcome for Jade's business, such as remaining as a privately held company or becoming a public company through an initial
public offering (an " IPO ").
As is typical in reverse mergers, the Jade Merger
Valuation was determined (a) through arm's length negotiations with Aerovate's board of directors (the " Aerovate
Board ") as discussed on pages 113-123 of the Registration Statement and (b) through arm's length negotiations
with leading investors in the life sciences industry with respect to their investment participation in the Jade Pre-Closing Financing.
The factors considered by the Aerovate Board in evaluating the Merger are set forth on pages 123-126 of the Registration Statement.
Among the factors that were considered in estimating the Jade Merger Valuation with respect to the Jade Pre-Closing Financing were the
following:
· Jade's
financial position and prospects;
2
U.S. Securities and Exchange Commission
March 24, 2025
CONFIDENTIAL TREATMENT REQUESTED BY AEROVATE THERAPEUTICS, INC.
· Jade's
stage of operations and development of JADE-001;
· the
general conditions of the securities market and the recent market prices of, and the demand
for, publicly traded common stock of comparable companies;
· the
expected timeframe for completion of the Merger;
· the
probability of receiving approval of the Merger by Aerovate's stockholders; and
· the
probability of successfully closing the Merger and the Jade Pre-Closing Financing.
Prior to the signing of the Agreement and
Plan of Merger on October 30, 2024 (the " Merger Agreement "), Jade intended to complete an IPO. Prior to
beginning the IPO process in August 2024, Jade's valuation was determined through discussions by and among Jade's
board of Directors (the " Jade Board "), members of Jade's senior management and through arm's length
negotiations with leading investors in the life sciences industry with respect to their investment in convertible notes of Jade in
July 2024. In addition to Fairmount Funds Management LLC ("Fairmount"), which invested $20 million of the $95
million raised in the convertible notes financing (the " Convertible Notes Financing "), other investors included Venrock Healthcare Capital Partners, Deep Track
Biotechnology Fund, Driehaus Life Sciences, Braidwell and Frazier Life Sciences. As is typical in a company's preparation for
an IPO, Jade's valuation thereafter until the time of the signing of the Merger Agreement was not derived using a formal
determination of fair value, but was determined through discussions among the Jade Board, members of Jade's senior management
and representatives of the underwriters. Among the additional factors that were considered in estimating Jade's value at the
time of the future IPO were the following:
· Jade's
financial position and prospects;
· an
analysis of the typical valuation ranges seen in recent IPOs for comparable companies in
Jade's industry;
· the
general conditions of the securities market and the recent market prices of, and the demand
for, publicly traded common stock of comparable companies; and
· the
recent performance of IPOs of companies in the industry in which Jade operates.
Grants of Restricted Stock
On
June 18, 2024, the date of Jade's inception (the " Inception Date "), three individuals purchased an
aggregate of 819,672 shares of Jade restricted stock. Such shares were purchased at the par value, $0.0001 per share. Jade
determined this value based on the early stage of the company, the fact that it had no operations or assets and the uncertain nature
and probability of any potential financing that would enable Jade to acquire operations or assets (which financing would require the participation of a number of other funds beyond affiliated entities). With respect to the
Staff's question of how the valuation process at such time considered the common control nature of the relationship
between Jade and Paragon Therapeutics, Inc. (" Paragon ") at the time of this grant, Jade considered the
possibility that Fairmount, a common controlling entity of Jade and Paragon, may in the future support Jade's acquisition of
certain assets in the form of rights to intellectual property related to Jade's anticipated anti-APRIL program,
JADE-001, from Paragon, an affiliate of Fairmount; however, at the time of such grant, such a possibility of support was too
premature and speculative to have resulted in any valuation impact at Jade. Furthermore, at such time, the intellectual property
assets owned by Paragon that ultimately became the subject of the option agreement with Jade were at a very early stage and several
months away from even producing a potential discovery candidate for JADE-001, while JADE-002 and JADE-003 were not yet contemplated at all. In addition, the net value of any assets after accounting for the
associated spend and financing that would have been required to support such programs was negligible or negative. Finally, other
than Jade's chief scientific officer, Jade had not hired adequate management members in order to execute on its development
plan.
3
U.S. Securities and Exchange Commission
March 24, 2025
CONFIDENTIAL TREATMENT REQUESTED BY AEROVATE THERAPEUTICS, INC.
Summary of Option Awards
From the Inception Date
to March 24, 2025, Jade has issued the following stock option awards to its employees, consultants and members of the Jade Board:
Grant Date
Number of shares of common stock underlying equity awards
Exercise price per share of common stock
Grant
Date Fair Value
per Stock Option (1)
September 4, 2024
198,633
$ 0.31
$ 0.24
October 12, 2024
2,673,437
$ 0.96
$ 0.76
October 29, 2024
765,908
$ 1.46
$ 1.15
December 29, 2024
153,441
$ 3.75
$ 2.96
January 23, 2025
8,820,790
$ 3.80
$ 3.00
(1) Calculated in accordance with
Financial Accounting Standards Board Topic 718.
Historical Determinations of Fair Value of Common Stock
As there has been no public market for the
shares of common stock underlying Jade's equity awards, for all periods prior to the Merger, the fair value of the shares of
common stock underlying the equity awards was estimated on each grant date by the Jade Board. In order to determine the fair value
of shares of the Jade's common stock, the Jade Board considered, among other things, 409A valuations performed by third party
valuation firms, valuations reflected in the Convertible Notes Financing in July and September 2024, and the
valuation reflected in the sale of Jade common stock to third party investors in the Jade Pre-Closing Financing. In light of the
absence of public market valuation data, the Jade Board considered various objective and subjective factors to determine the fair
value of the shares of Jade's common stock as of each grant date, including:
· the
prices at which Jade sold its convertible notes to third parties and existing investors;
4
U.S. Securities and Exchange Commission
March 24, 2025
CONFIDENTIAL TREATMENT REQUESTED BY AEROVATE THERAPEUTICS, INC.
· the
continued build-out of Jade's management team;
· external
market conditions affecting, and the trends within, the pharmaceutical and biotechnology
sectors;
· Jade's
financial position, including cash on hand, and its historical and forecasted performance
and operating results;
· Jade's
negative cash flows and its need for additional financing;
· the
lack of an active public market for Jade's common stock;
· the
likelihood of achieving a liquidity event, such as an IPO or a M&A transaction, in light
of prevailing market conditions; and
· the
market performance of similar public companies in the pharmaceutical and biotechnology sectors
following their listing as a public company.
Jade's most recent third-party 409A
valuations, which were relied upon by management in determining the fair value of its common stock, were prepared as of
July 24, 2024, September 30, 2024, October 22, 2024, October 31, 2024 and December 31, 2024. These
third-party 409A valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public
Accountants' Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as
Compensation.
Jade considered the following methods for allocating
enterprise value to determine the estimated fair value of its common stock:
Option
Pricing Method (" OPM "): The OPM treats common stock and preferred stock as call options on the total equity
value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company's
securities changes. Under this method, the common stock 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, and assumes the company has funds available to make a liquidation
preference meaningful and collectible by the shareholders. The OPM requires the input of subjective assumptions, including the expected
term of the award, the expected volatility, risk-free interest rates, and the dividend yield. The expected life of the awards granted
during the period was determined based on an expected time to the liquidation event.
Hybrid
Method . The hybrid method is a probability-weighted expected return method (" PWERM "), where the equity
value is allocated in one or more of the scenarios using an OPM. The PWERM is a scenario-based methodology that estimates the fair value
of each share based upon an analysis of future values, assuming various outcomes. The value of the common stock is based on the probability-weighted
value across the scenarios, considering the OPM to estimate the value within certain scenarios given the rights of each class of stock.
5
U.S. Securities and Exchange Commission
March 24, 2025
CONFIDENTIAL TREATMENT REQUESTED BY AEROVATE THERAPEUTICS, INC.
Additionally, a discount for lack of marketability
(" DLOM ") of the common stock is then applied to arrive at an indication of fair value for the common stock.
Jade's independent third-party
valuations were used, in part, by the Jade Board to determine the price per share of common stock and by management to determine the
estimated fair value of the common stock. These 409A valuations utilized the Hybrid Method to value the common stock as of
July 24, 2024 (the " July 24, 2024 Valuation "), September 30, 2024 (the
" September 30, 2024 Valuation "), October 22, 2024 (the " October 22, 2024
Valuation "), and included both IPO and future M&A scenarios. Following the signing of the Merger Agreement, these 409A
valuations also utilized the Hybrid Method to value the common stock as of October 31, 2024 (the " October 31,
2024 Valuation ") and December 31, 2024 (the " December 31, 2024 Valuation "); however, such
409A valuations instead included both reverse merger and future M&A scenarios.
July 24, 2024 Valuation
An independent third-party 409A valuation of
Jade determined that the July 24, 2024 Valuation as of July 24, 2024 was $0.31 per share. The fair value of Jade's
common stock was estimated using a Hybrid Method. This approach was determined to be the most appropriate method because
Jade's early stage of development, with no revenue projections available and no historically priced round of equity financing
from third party investors made income-based and market approaches inappropriate. The implied probability-weighted total equity
value was calculated by considering the likelihood of the two potential exit scenarios. The IPO scenario was weighted at
2025-03-24 - CORRESP - Jade Biosciences, Inc.
CORRESP 1 filename1.htm Aerovate Therapeutics, Inc. 930 Winter Street, Suite M-500 Waltham, MA 02451 March 24, 2025 VIA EDGAR Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street NE Washington, DC 20549 Attention: Ms. Jessica Dickerson Mr. Chris Edwards Ms. Tara Harkins Ms. Sasha Parikh Re: Aerovate Therapeutics, Inc. Acceleration Request for Registration Statement on Form S-4 File No. 333-283562 Requested Date: March 25, 2025 Requested Time: 4:15 p.m. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Aerovate Therapeutics, Inc. (the " Company ") hereby requests that the effective date of the above-referenced registration statement (the " Registration Statement ") be accelerated to March 25, 2025, at 4:15 p.m., Eastern Time, or as soon thereafter as practicable, unless the Company requests by telephone that such Registration Statement be declared effective at some other time. The Company hereby authorizes each of Edwin O'Connor, Tevia K. Pollard and Alicia Tschirhart of Goodwin Procter 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, Goodwin Procter LLP by calling Edwin O'Connor at (212) 813-8853. The Company also respectfully requests that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to the Company's counsel, Goodwin Procter LLP, Attention: Edwin O'Connor, by email to eoconnor@goodwinlaw.com . If you have any questions regarding this request, please contact Edwin O'Connor of Goodwin Procter LLP at (212) 813-8853. * * * Sincerely, Aerovate Therapeutics, Inc. By: /s/ Timothy Noyes Timothy Noyes Chief Executive Officer cc: Edwin O'Connor, Goodwin Procter LLP Tevia K. Pollard, Goodwin Procter LLP Alicia Tschirhart, Goodwin Procter LLP George Eldridge, Aerovate Therapeutics, Inc. Ryan A. Murr, Gibson, Dunn & Crutcher LLP Branden C. Berns, Gibson, Dunn & Crutcher LLP
2025-03-21 - UPLOAD - Jade Biosciences, Inc. File: 333-283562
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 21, 2025 Timothy Noyes Chief Executive Officer Aerovate Therapeutics, Inc. 930 Winter Street, Suite M-500 Waltham, MA 02451 Re: Aerovate Therapeutics, Inc. Amendment No. 3 to Registration Statement on Form S-4 Filed March 14, 2025 File No. 333-283562 Dear Timothy Noyes: We have reviewed your amended registration statement and have the following comment. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe a comment applies 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 this letter, we may have additional comments. Amendment No. 3 to Registration Statement on Form S-4 Jade Management's Discussion and Analysis of Financial Condition and Results of Operations Stock-Based Compensation, page 346 1. Please address the following regarding the stock options and restricted stock units granted by Jade: Revise to provide a tabular presentation or revise your table on pages 186-187 to provide the grant date, number of options or restricted stock units granted, exercise price, valuation of common stock used, compensation expense recognized for all options and restricted stock units granted. Tell us and revise your disclosure to explain how the valuation used compares to the exchange ratio of the merger. March 21, 2025 Page 2 Tell us and revise your disclosure to address how the valuation process considered the common control nature of the relationship between Jade and Paragon at the time of the grant. Further, explain how the valuation considered eventual conclusion of the overall plan of licensing of JADE-001, JADE-002 and JADE- 003 between related parties. Please contact Tara Harkins at 202-551-3639 or Sasha Parikh at 202-551-3627 if you have questions regarding comments on the financial statements and related matters. Please contact Jessica Dickerson at 202-551-8013 or Chris Edwards at 202-551-6761 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Edwin M. O'Connor, Esq. </TEXT> </DOCUMENT>
2025-03-14 - CORRESP - Jade Biosciences, Inc.
CORRESP 1 filename1.htm Goodwin Procter llp The New York Times Building 620 Eighth Avenue New York, NY 10018 goodwinlaw.com +1 212 813 8800 Via EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Jessica Dickerson, Chris Edwards, Tara Harkins and Sasha Parikh Re: Aerovate Therapeutics, Inc. Amendment No. 2 to Registration Statement on Form S-4 Filed February 24, 2025 File No. 333-283562 Ladies and Gentlemen, On behalf of Aerovate Therapeutics, Inc. (the " Company "), we are submitting this letter to the Securities and Exchange Commission (the " SEC ") via EDGAR in response to the comment letter from the staff of the SEC (the " Staff "), dated March 11, 2025 (the " Comment Letter "), pertaining to the Company's above-referenced Amendment No. 2 to Registration Statement on Form S-4/A (the " Second Amended Registration Statement "). In connection with such responses, the Company is concurrently filing Amendment No. 3 to the Registration Statement (the " Third Amended Registration Statement "). For your convenience, the Staff's comments are summarized in this letter, and each comment is followed by the applicable responses on behalf of the Company. Unless otherwise indicated, page references in the responses correspond to the page numbers in the Third Amended Registration Statement. Capitalized terms used in this letter but otherwise not defined herein shall have the meanings set forth in the Third Amended Registration Statement. Amendment No. 2 to Registration Statement on Form S-4 Questions and Answers about the Merger Why am I receiving this proxy statement/prospectus?, page 2 1. We note your response to prior comment 3. Specifically, we note the statement in your response that the issuance of the Aerovate pre-funded warrants and Aerovate Series A Preferred Stock are being registered as part of the registration statement. However, the disclosure in this section and in the added explanatory note on page 1 states only that the prospectus is used to offer shares of Aerovate common stock. Please revise your disclosures as appropriate to clarify, consistent with your response, that the prospectus also is used to offer the Aerovate pre-funded warrants and Aerovate Series A Preferred Stock. Response : The Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised the disclosure on pages i and 129 of the Third Amended Registration Statement in response to the Staff's comment. The Company also respectfully advises the Staff that it has revised footnote (1) to the filing fee table filed as Exhibit 107 to the Third Amended Registration Statement to clarify that the securities being registered include the Aerovate pre-funded warrants and Aerovate Series A Preferred Stock. Securities and Exchange Commission March 14, 2025 Page 2 The Special Meeting in Lieu of Annual Meeting of Aerovate Stockholders Solicitation of Proxies, page 100 2. We note your added disclosure that you have retained Innisfree M&A as your proxy solicitor. Please revise your disclosure to state the material features of any contract or arrangement for such solicitation and the cost or anticipated cost thereof. Refer to Item 4(a)(3) of Schedule 14A. Response : The Company respectfully acknowledges the Staff's comment and advises the Staff that it has revised the disclosure on pages 10 and 112 of the Third Amended Registration Statement in response to the Staff's comment. Opinion of Aerovate's Financial Advisor, page 117 3. We note your response to prior comment 13. Specifically, although we note your response that Lucid did not review any pro forma financial effects of the merger, as well as your deletion of the corresponding statement on page 118, the Lucid Opinion filed as Annex G states that Lucid "[r]eviewed certain pro forma financial effects of the Merger." Please tell us how to reconcile this apparent inconsistency or otherwise advise. In addition, we do not see disclosure of the "cash burn model" referenced both on page 118 and in the Lucid Opinion. Please direct us to this disclosure or, as previously requested, provide us with your analysis as to whether such model is material. In your analysis, tell us whether the projections presented in this model were used or relied upon by your board of directors or Lucid in reaching the fairness determination, whether they effected the merger consideration, exchange ratio or other materials terms of the transaction during negotiations, and how the projections related to the merger consideration. Alternatively, revise your discussion to disclose the projections. Response : The Company respectfully acknowledges the Staff's comment and advises the Staff that while the Lucid Opinion implies that Lucid reviewed pro forma financial effects of the Merger and a Jade cash burn model, no projections regarding Jade's operating forecast were reviewed or considered by Lucid when rendering the Lucid Opinion. The only pro forma financial effects of the Merger or cash burn projection provided by Jade to the Company or Lucid were (i) a pro forma ownership structure of the Combined Company and (ii) an estimate of the period through which Jade believed that the expected net proceeds from the Merger and the Jade pre-closing financing, together with Jade's existing cash, would enable Jade to fund its operating expenses, both of which are disclosed in the Third Amended Registration Statement in the section titled "Principal Stockholders of the Combined Company" and on pages 131, 333 and 340, respectively. Securities and Exchange Commission March 14, 2025 Page 3 U.S. Federal Income Tax Considerations of the Merger, page 133 4. We note your response to prior comment 15, including the forms of legal opinion filed as Exhibits 8.1 and 8.2 to the registration statement. Please tell us when counsel expects to deliver these tax opinions. Refer to Sections III.D.2 and III.D.3 of Staff Legal Bulletin No. 19. In addition, if you intend the exhibits to constitute short-form opinions, please revise your registration statement to clearly state that the disclosure under U.S. Federal Income Tax Considerations of the Merger is the opinion of counsel and clearly identify and articulate the opinion being rendered. Refer to Section III.B.2 of Staff Legal Bulletin No. 19. Response : The Company respectfully acknowledges the Staff's comment and advises the Staff that, in accordance with Section III of Staff Legal Bulletin No. 19, the Third Amended Registration Statement includes the opinions of counsel from the Company and Jade to be executed prior to the effectiveness of the Third Amended Registration Statement covering the material tax consequences of the merger as Exhibit 8.1 and Exhibit 8.2, and that the Company has revised the applicable disclosures in the Third Amended Registration Statement on pages 147 and 148. Securities and Exchange Commission March 14, 2025 Page 4 ***** Please contact the undersigned at (212) 813-8800 or via email at eoconnor@goodwinlaw.com if you have any questions with respect to the foregoing. Very truly yours, /s/ Edwin M. O'Connor Edwin M. O'Connor, Esq. Goodwin Procter LLP cc: Timothy Noyes, Aerovate Therapeutics, Inc. George Eldridge, Aerovate Therapeutics, Inc. Tevia K. Pollard, Esq., Goodwin Procter LLP Alicia M. Tschirhart, Esq . , Goodwin Procter LLP Ryan A. Murr, Gibson, Dunn & Crutcher LLP Branden C. Berns, Gibson, Dunn & Crutcher LLP
2025-03-11 - UPLOAD - Jade Biosciences, Inc. File: 333-283562
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 11, 2025 Timothy Noyes Chief Executive Officer Aerovate Therapeutics, Inc. 930 Winter Street, Suite M-500 Waltham, MA 02451 Re: Aerovate Therapeutics, Inc. Amendment No. 2 to Registration Statement on Form S-4 Filed February 24, 2025 File No. 333-283562 Dear Timothy Noyes: We have reviewed your amended registration statement and have the following comments. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe a comment applies 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 this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our February 18, 2025 letter. Amendment No. 2 to Registration Statement on Form S-4 Questions and Answers about the Merger Why am I receiving this proxy statement/prospectus?, page 2 1. We note your response to prior comment 3. Specifically, we note the statement in your response that the issuance of the Aerovate pre-funded warrants and Aerovate Series A Preferred Stock are being registered as part of the registration statement. However, the disclosure in this section and in the added explanatory note on page 1 states only that the prospectus is used to offer shares of Aerovate common stock. Please revise your disclosures as appropriate to clarify, consistent with your response, that the prospectus also is used to offer the Aerovate pre-funded warrants and Aerovate Series A Preferred Stock. March 11, 2025 Page 2 The Special Meeting in Lieu of Annual Meeting of Aerovate Stockholders Solicitation of Proxies, page 100 2. We note your added disclosure that you have retained Innisfree M&A as your proxy solicitor. Please revise your disclosure to state the material features of any contract or arrangement for such solicitation and the cost or anticipated cost thereof. Refer to Item 4(a)(3) of Schedule 14A. Opinion of Aerovate's Financial Advisor, page 117 3. We note your response to prior comment 13. Specifically, although we note your response that Lucid did not review any pro forma financial effects of the merger, as well as your deletion of the corresponding statement on page 118, the Lucid Opinion filed as Annex G states that Lucid "[r]eviewed certain pro forma financial effects of the Merger." Please tell us how to reconcile this apparent inconsistency or otherwise advise. In addition, we do not see disclosure of the "cash burn model" referenced both on page 118 and in the Lucid Opinion. Please direct us to this disclosure or, as previously requested, provide us with your analysis as to whether such model is material. In your analysis, tell us whether the projections presented in this model were used or relied upon by your board of directors or Lucid in reaching the fairness determination, whether they effected the merger consideration, exchange ratio or other materials terms of the transaction during negotiations, and how the projections related to the merger consideration. Alternatively, revise your discussion to disclose the projections. U.S. Federal Income Tax Considerations of the Merger, page 133 4. We note your response to prior comment 15, including the forms of legal opinion filed as Exhibits 8.1 and 8.2 to the registration statement. Please tell us when counsel expects to deliver these tax opinions. Refer to Sections III.D.2 and III.D.3 of Staff Legal Bulletin No. 19. In addition, if you intend the exhibits to constitute short-form opinions, please revise your registration statement to clearly state that the disclosure under U.S. Federal Income Tax Considerations of the Merger is the opinion of counsel and clearly identify and articulate the opinion being rendered. Refer to Section III.B.2 of Staff Legal Bulletin No. 19. Please contact Tara Harkins at 202-551-3639 or Sasha Parikh at 202-551-3627 if you have questions regarding comments on the financial statements and related matters. Please contact Jessica Dickerson at 202-551-8013 or Chris Edwards at 202-551-6761 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Edwin M. O'Connor, Esq. </TEXT> </DOCUMENT>
2025-02-24 - CORRESP - Jade Biosciences, Inc.
CORRESP
1
filename1.htm
Goodwin Procter llp
The New York Times Building
620 Eighth Avenue
New York, NY 10018
goodwinlaw.com
+1 212 813 8800
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3628
Attention: Jessica Dickerson, Chris Edwards, Tara Harkins and Sasha
Parikh
Re:
Aerovate Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed January 22, 2025
File No. 333-283562
Ladies and Gentlemen,
On behalf of Aerovate Therapeutics, Inc.
(the “Company”), we are submitting this letter to the Securities and Exchange Commission (the “SEC”)
via EDGAR in response to the comment letter from the staff of the SEC (the “Staff”), dated February 18, 2025 (the
“Comment Letter”), pertaining to the Company’s above-referenced Amendment No. 1 to Registration Statement
on Form S-4/A (the “First Amended Registration Statement”). In connection with such responses, the Company is
concurrently filing Amendment No. 2 to the Registration Statement (the “Second Amended Registration Statement”).
For your convenience, the Staff’s comments
are summarized in this letter, and each comment is followed by the applicable responses on behalf of the Company. Unless otherwise indicated,
page references in the responses correspond to the page numbers in the Second Amended Registration Statement. Capitalized terms
used in this letter but otherwise not defined herein shall have the meanings set forth in the Second Amended Registration Statement.
Amendment No. 1 to Registration Statement
on Form S-4
Cover Page
1. In the second paragraph on the prospectus cover page, you disclose what will happen to each share
of Jade common stock (including the shares to be issued in the Jade Pre-Closing Financing) and each share of Jade Series Seed Convertible
Preferred Stock upon consummation of the merger. Please also disclose what will happen to the Jade pre-funded warrants to be issued in
the Jade Pre-Closing Financing. In this regard, we note your disclosure on page 5 that the Jade pre-funded warrants will be exchanged
for Aerovate pre-funded warrants.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on the Cover
Page of the Second Amended Registration Statement in response to the Staff’s comment.
Securities and Exchange
Commission
February 24, 2025
Page 2
2. The description of Proposal 1 appears to contemplate the approval of two different actions. Specifically,
it appears to contemplate (i) approval of the issuance of shares and (ii) approval of the change of control. Please revise the
description of the proposal to clarify, if true, that Proposal 1 covers one action (i.e., the issuance of shares), which will (i) represent
more than 20% of the shares of your common stock outstanding immediately prior to the Merger and (ii) result in a change of control.
Please make similar revisions throughout the proxy statement prospectus as appropriate. Alternatively, tell us why you do not believe
these revisions are appropriate.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on the Cover
Page, in the Notice of Special Meeting of Stockholders In Lieu of an Annual Meeting of Stockholders, and on pages 3, 108 and 195
of the Second Amended Registration Statement in response to the Staff’s comment.
Questions and Answers about the Merger
Why am I receiving this proxy statement/prospectus?,
page 2
3. In the second bullet point, you state that the proxy statement/prospectus serves as a prospectus
of Aerovate used to offer shares of Aerovate common stock, including shares issuable upon the exercise of Aerovate pre-funded warrants
and shares issuable upon the conversion of Aerovate Series A Preferred Stock, which will be issued in exchange for Jade pre-funded
warrants and Jade Preferred Stock, respectively. Please tell us whether the prospectus also is being used to offer the Aerovate pre-funded
warrants and the Aerovate Series A Preferred Stock or whether the issuance of such securities will be made in reliance on an exemption
from registration. If the latter, please explain and provide us with your analysis as to the appropriateness of registering the primary
issuance of the shares underlying such securities.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that the proxy statement/prospectus included in
the Second Amended Registration Statement is being used to offer shares of Aerovate common stock, including those issuable upon the exercise
of Aerovate pre-funded warrants and the conversion of Aerovate Series A Preferred Stock. The issuance of Aerovate pre-funded warrants
and Aerovate Series A Preferred Stock will not be made in reliance on an exemption from registration. Instead, these securities are
being registered under the Securities Act as part of the Form S-4 registration statement. In accordance with the SEC Division of
Corporation Finance, Compliance and Disclosure Interpretations, Section 139. 2 Securities Act Section 5, Q. 139.01 (Aug. 14,
2009), the underlying securities must (emphasis added) be registered at the time of the offer and sale of convertible securities
or warrants if such securities are convertible or exercisable within one year. The Aerovate pre-funded warrants and Aerovate Series A
Preferred Stock are exercisable or convertible within one year, respectively. Therefore, the shares of Aerovate common stock issuable
upon the exercise of the pre-funded warrants and the conversion of the Series A Preferred Stock are being registered concurrently
with the offer and sale of these securities.
Securities and Exchange
Commission
February 24, 2025
Page 3
In addition, the Company respectfully
advises the Staff that it has revised the disclosure on pages i, 3 and 129 of the Second Amended Registration Statement in response
to the Staff’s comment. The Company also respectfully advises the Staff that it has revised footnote (1) to the filing fee
table filed as Exhibit 107 to the Second Amended Registration Statement to clarify that the securities being registered include the
shares of Aerovate common stock underlying the Aerovate pre-funded warrants and Aerovate Series A Preferred Stock.
What is the Jade Pre-Closing Financing?,
page 2
4. Please revise this section to disclose the conversion price for the convertible notes and the amount
of the Jade Pre-Closing Financing that will be represented by the shares issued upon conversion of the convertible notes.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 3 of
the Second Amended Registration Statement in response to the Staff’s comment regarding the conversion price for the convertible
notes. The Company respectfully acknowledges the Staff’s comment regarding amount of the Jade Pre-Closing Financing that will be
represented by the shares issued upon conversion of the convertible notes and advises the Staff that the requested disclosure was previously
included on page 2 of the Amended Registration Statement. The Company respectfully directs the Staff to the language set forth on page
3 of the Second Amended Registration Statement, which is as follows (emphasis added):
On October 30, 2024, concurrently
with the execution and delivery of the Merger Agreement, Jade entered into the Securities Purchase Agreement with certain investors named
therein, including, among others, Fairmount, Venrock Healthcare Capital Partners, and a large investment firm, with participation from
Deep Track Capital, Braidwell LP, Driehaus Capital Management, Frazier Life Sciences, RA Capital Management, Great Point Partners, Soleus
Capital, Avidity Partners, Blackstone Multi-Asset Investing, Logos Capital, Deerfield Management, OrbiMed, and Samsara BioCapital, pursuant
to which such investors agreed to purchase shares of Jade common stock and pre-funded warrants to purchase shares of Jade common stock
at an estimated purchase price of $5.9407 per share and $5.9406 per pre-funded warrant for an aggregate purchase price of approximately
$300.0 million (which reflects the conversion of the previously issued $95 million of convertible notes).
Why is Aerovate seeking stockholder approval
to issue shares..., page 4
5. You state that you expect to issue approximately 1.06 million shares of your common stock, excluding
shares underlying the Aerovate pre-funded warrants and the Aerovate Series A Preferred Stock to be issued in connection with the
merger. To the extent known, please also disclose the number of shares of your common stock you expect to underly such securities or otherwise
advise. In this regard, we note your disclosure regarding the Jade Pre-Closing Financing on page 310.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 5 of
the Second Amended Registration Statement in response to the Staff’s comment.
Will the common stock of the Combined Company
trade on an exchange?, page 5
6. Given that the Nasdaq listing condition is waivable, please revise your disclosure to indicate whether
recirculation or resolicitation of stockholders will occur prior to the vote if the listing application is not approved but the condition
is waived. If stockholders will not have certainty regarding the listing of the combined company's shares at the time they are asked to
vote, please clarify this fact. Please also provide risk factor disclosure that addresses the potential consequences of the parties waiving
the condition and the closing occurring without the Nasdaq listing, including but not limited to the liquidity implications thereof.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on the Cover
Page and pages 6 and 29 of the Second Amended Registration Statement in response to the Staff’s comment.
Securities and Exchange
Commission
February 24, 2025
Page 4
What happens if I do not return a proxy
card..., page 7
7. You state that the failure to return a proxy card or otherwise vote or provide proxy instructions
will reduce the aggregate number of votes required to approve Proposal Nos. 1, 5, 6 and 7 and will have the effect of a vote “AGAINST”
Proposal Nos. 2, 3 and 4. Please revise your disclosure to clarify how proxies will vote shares represented by a validly signed and returned
proxy card that is not completed. In this regard, we note your disclosures in your discussions of the proposals that, unless otherwise
instructed, it is the intention of the proxies to vote shares represented by properly executed proxy cards "FOR" each of the
proposals.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 8–9
of the Second Amended Registration Statement in response to the Staff’s comment.
May I attend the Aerovate Special Meeting
and vote in person?, page 7
8. To the extent applicable, please disclose how stockholders who hold their shares in "street
name" may attend the special meeting and vote in person.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 9
of the Second Amended Registration Statement in response to the Staff’s comment.
What are the material U.S. federal income
tax considerations of the Merger..., page 8
9. You state that there will be no U.S. federal income tax considerations to your stockholders as a
result of the merger. To the extent applicable, please briefly address any U.S. federal income tax considerations to your stockholders
resulting from the cash payments to be made to your stockholders for the Aerovate ITM Options to be cancelled in connection with the merger.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 10
and 149 of the Second Amended Registration Statement in response to the Staff’s comment.
Securities and Exchange
Commission
February 24, 2025
Page 5
Prospectus Summary
The Companies, page 10
10. We note your discussion of JADE-001 on pages 10 and 11. Similar to your disclosure on page 235,
please disclose here that you were founded by Fairmount Funds Management LLC in 2024 and launched to research and develop antibody candidates
licensed from Paragon Therapeutics, Inc., an antibody discovery engine founded by Fairmount. In addition, your revised disclosure
should:
· specifically disclose that you license JADE-001 from Paragon and that you have an unexercised option
to license JADE-002 and JADE-003 from Paragon;
· identify Fairmount and Paragon as related parties; and
· include a cross reference to a more fulsome discussion of your relationship, and the nature of these
arrangements, with Paragon.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 12–13
of the Second Amended Registration Statement in response to the Staff’s comment.
The Special Meeting of Aerovate Stockholders
Required Vote, page 98
11. In the second sentence, you state that abstentions and broker non-votes will be counted towards
a quorum. However, in the second paragraph, you state that abstentions and broker non-votes will not be treated as shares present for
the purpose of a quorum for the transaction of business at the special meeting. Please revise your disclosures to reconcile this apparent
inconsistency or otherwise advise.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 111-112
of the Second Amended Registration Statement in response to the Staff’s comment.
The Merger
Aerovate's Reasons for the Merger, page 108
12. We note that one of the factors considered by your board of directors in support of its decision
to approve the merger agreement included the board’s conclusion that the merger would provide your existing stockholders a "significant
opportunity" to participate in the potential growth of the combined company following the merger. Please revise your disclosure to
clarify what you mean by "significant opportunity." In this regard, we note that your existing stockholders will in the aggregate
hold approximately 1.6% of the fully-diluted shares of your common stock immediately following the merger, a substantially smaller percentage
than proposed by the other counterparties discussed in the "Background of the Transaction."
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on pages 14
and 124 of the Second Amended Registration Statement in response to the Staff’s comment.
Securities and Exchange
Commission
February 24, 2025
Page 6
Opinion of Aerovate's Financial Advisor,
page 114
13. We note your statement on page 115 that, in connection with the Lucid Opinion, Lucid (i) reviewed
certain pro forma financial effects of the merger and (ii) reviewed and analyzed certain internal financial analyses, including the
cash burn model over the next year and whether concurrent capital raised would sufficiently cover select programs, reports, and other
information concerning Jade provided by Jade. However, we do not see disclosure of these projections in the discussion regarding the Lucid
Opinion. Please provide us with your analysis as to whether these projections are material. In your analysis, tell us whether these projections
were used or relied upon by your board of directors or Lucid in
2025-02-18 - UPLOAD - Jade Biosciences, Inc. File: 333-283562
February 18, 2025
Timothy Noyes
Chief Executive Officer
Aerovate Therapeutics, Inc.
930 Winter Street, Suite M-500
Waltham, MA 02451
Re:Aerovate Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed January 22, 2025
File No. 333-283562
Dear Timothy Noyes:
We have reviewed your registration statement and have the following comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.
Amendment No. 1 to Registration Statement on Form S-4
Cover Page
1.In the second paragraph on the prospectus cover page, you disclose what will happen
to each share of Jade common stock (including the shares to be issued in the Jade Pre-
Closing Financing) and each share of Jade Series Seed Convertible Preferred Stock
upon consummation of the merger. Please also disclose what will happen to the Jade
pre-funded warrants to be issued in the Jade Pre-Closing Financing. In this regard, we
note your disclosure on page 5 that the Jade pre-funded warrants will be exchanged
for Aerovate pre-funded warrants.
The description of Proposal 1 appears to contemplate the approval of two different
actions. Specifically, it appears to contemplate (i) approval of the issuance of shares
and (ii) approval of the change of control. Please revise the description of the proposal
to clarify, if true, that Proposal 1 covers one action (i.e., the issuance of shares), which
will (i) represent more than 20% of the shares of your common stock outstanding 2.
February 18, 2025
Page 2
immediately prior to the Merger and (ii) result in a change of control. Please make
similar revisions throughout the proxy statement prospectus as appropriate.
Alternatively, tell us why you do not believe these revisions are appropriate.
Questions and Answers about the Merger
Why am I receiving this proxy statement/prospectus?, page 2
3.In the second bullet point, you state that the proxy statement/prospectus serves as a
prospectus of Aerovate used to offer shares of Aerovate common stock, including
shares issuable upon the exercise of Aerovate pre-funded warrants and shares issuable
upon the conversion of Aerovate Series A Preferred Stock, which will be issued in
exchange for Jade pre-funded warrants and Jade Preferred Stock, respectively. Please
tell us whether the prospectus also is being used to offer the Aerovate pre-funded
warrants and the Aerovate Series A Preferred Stock or whether the issuance of such
securities will be made in reliance on an exemption from registration. If the latter,
please explain and provide us with your analysis as to the appropriateness of
registering the primary issuance of the shares underlying such securities.
What is the Jade Pre-Closing Financing?, page 2
4.Please revise this section to disclose the conversion price for the convertible notes and
the amount of the Jade Pre-Closing Financing that will be represented by the shares
issued upon conversion of the convertible notes.
Why is Aerovate seeking stockholder approval to issue shares..., page 4
5.You state that you expect to issue approximately 1.06 million shares of your common
stock, excluding shares underlying the Aerovate pre-funded warrants and the
Aerovate Series A Preferred Stock to be issued in connection with the merger. To the
extent known, please also disclose the number of shares of your common stock you
expect to underly such securities or otherwise advise. In this regard, we note your
disclosure regarding the Jade Pre-Closing Financing on page 310.
Will the common stock of the Combined Company trade on an exchange?, page 5
6.Given that the Nasdaq listing condition is waivable, please revise your disclosure to
indicate whether recirculation or resolicitation of stockholders will occur prior to the
vote if the listing application is not approved but the condition is waived. If
stockholders will not have certainty regarding the listing of the combined company's
shares at the time they are asked to vote, please clarify this fact. Please also provide
risk factor disclosure that addresses the potential consequences of the parties waiving
the condition and the closing occurring without the Nasdaq listing, including but not
limited to the liquidity implications thereof.
What happens if I do not return a proxy card..., page 7
You state that the failure to return a proxy card or otherwise vote or provide proxy
instructions will reduce the aggregate number of votes required to approve Proposal
Nos. 1, 5, 6 and 7 and will have the effect of a vote “AGAINST” Proposal Nos. 2, 3
and 4. Please revise your disclosure to clarify how proxies will vote shares
represented by a validly signed and returned proxy card that is not completed. In this 7.
February 18, 2025
Page 3
regard, we note your disclosures in your discussions of the proposals that, unless
otherwise instructed, it is the intention of the proxies to vote shares represented by
properly executed proxy cards "FOR" each of the proposals.
May I attend the Aerovate Special Meeting and vote in person?, page 7
8.To the extent applicable, please disclose how stockholders who hold their shares in
"street name" may attend the special meeting and vote in person.
What are the material U.S. federal income tax considerations of the Merger..., page 8
9.You state that there will be no U.S. federal income tax considerations to your
stockholders as a result of the merger. To the extent applicable, please briefly address
any U.S. federal income tax considerations to your stockholders resulting from the
cash payments to be made to your stockholders for the Aerovate ITM Options to be
cancelled in connection with the merger.
Prospectus Summary
The Companies, page 10
10.We note your discussion of JADE-001 on pages 10 and 11. Similar to your disclosure
on page 235, please disclose here that you were founded by Fairmount Funds
Management LLC in 2024 and launched to research and develop antibody candidates
licensed from Paragon Therapeutics, Inc., an antibody discovery engine founded by
Fairmount. In addition, your revised disclosure should:
•specifically disclose that you license JADE-001 from Paragon and that you have
an unexercised option to license JADE-002 and JADE-003 from Paragon;
•identify Fairmount and Paragon as related parties; and
•include a cross reference to a more fulsome discussion of your relationship, and
the nature of these arrangements, with Paragon.
The Special Meeting of Aerovate Stockholders
Required Vote, page 98
11.In the second sentence, you state that abstentions and broker non-votes will be
counted towards a quorum. However, in the second paragraph, you state that
abstentions and broker non-votes will not be treated as shares present for the purpose
of a quorum for the transaction of business at the special meeting. Please revise your
disclosures to reconcile this apparent inconsistency or otherwise advise.
The Merger
Aerovate's Reasons for the Merger, page 108
We note that one of the factors considered by your board of directors in support of its
decision to approve the merger agreement included the board’s conclusion that the
merger would provide your existing stockholders a "significant opportunity" to
participate in the potential growth of the combined company following the merger.
Please revise your disclosure to clarify what you mean by "significant opportunity." In
this regard, we note that your existing stockholders will in the aggregate hold
approximately 1.6% of the fully-diluted shares of your common stock immediately 12.
February 18, 2025
Page 4
following the merger, a substantially smaller percentage than proposed by the other
counterparties discussed in the "Background of the Transaction."
Opinion of Aerovate's Financial Advisor, page 114
13.We note your statement on page 115 that, in connection with the Lucid Opinion,
Lucid (i) reviewed certain pro forma financial effects of the merger and (ii) reviewed
and analyzed certain internal financial analyses, including the cash burn model over
the next year and whether concurrent capital raised would sufficiently cover select
programs, reports, and other information concerning Jade provided by Jade. However,
we do not see disclosure of these projections in the discussion regarding the Lucid
Opinion. Please provide us with your analysis as to whether these projections are
material. In your analysis, tell us whether these projections were used or relied upon
by your board of directors or Lucid in reaching the fairness determination, whether
they affected the merger consideration, exchange ratio or other material terms of the
transaction during negotiations, and how the projections relate to the merger
consideration. Alternatively, revise your discussion to disclose the projections.
Interests of Jade Directors and Executive Officers in the Merger
Frohlich and King Anti-Dilution Provisions, page 127
14.We note your disclosure regarding the anti-dilution rights held by Tom Frohlich and
Andrew King, including that the rights are applicable until Jade has raised an
aggregate of $200 million in financing. Please disclose whether the Jade Pre-Closing
Financing will trigger and/or extinguish these rights. If the Jade Pre-Closing
Financing will trigger these rights, disclose the approximate number of options, and
any applicable terms thereof, expected to be issued to Tom Frohlich and Andrew King
pursuant to these rights.
U.S. Federal Income Tax Considerations of the Merger, page 130
15.We note your disclosure that each of Jade and Aerovate "intends" that the merger
qualifies as a "reorganization" within the meaning of Section 368(a) of the Code.
Please revise to clearly state whether the transaction will qualify as a reorganization,
include an opinion of counsel covering the material tax consequences of the merger
and state that the disclosure in this section represents the opinion of counsel. If there is
uncertainty regarding the tax treatment of the transactions, counsel may (1) issue a
"should" or "more likely than not" opinion to make clear that the opinion is subject to
a degree of uncertainty and (2) explain why it cannot give a firm opinion. Refer to
Section III.C of Staff Legal Bulletin No. 19. Please also remove language assuming
certain consequences (e.g., assuming that the merger constitutes a reorganization).
For further guidance, refer to Item 601(b)(8) of Regulation S-K and Staff Legal
Bulletin No. 19.
Agreements Related to the Merger
Subscription Agreement, page 153
To the extent not already described in this section, please revise your disclosure to
briefly describe the material terms of the pre-funded warrants to be issued in
16.
February 18, 2025
Page 5
connection with the merger transactions, including, for example, the exercise period
and duration of the warrants.
Proposal No. 2 - The Reverse Stock Split Proposal, page 169
17.In the second paragraph under "General" on page 169, you state that your board of
directors may determine to effect the reverse stock split, if approved, even if the other
proposals to be acted upon at the meeting are not approved, including the issuance of
your common stock pursuant to the Merger Agreement. However, in the second two
paragraphs under "Required Vote" on page 174, you indicate that the reverse stock
split cannot and will not be effected unless the Nasdaq Stock Issuance Proposal and
the Authorized Share Increase Proposal are approved and the merger is consummated.
Please revise your disclosures as appropriate to reconcile this apparent inconsistency.
In addition, if the reverse stock split may be effected without consummation of the
merger, clarify whether the Jade board of directors will still have input regarding the
split ratio and in determining whether to effect the reverse stock split.
Proposal No. 4 - The Redomestication Proposal
Interest of Certain Persons, page 199
18.You state that others may allege, and stockholders should be aware, that the combined
company’s directors and executive officers may be considered to have interests in the
Nevada Redomestication that are different form, or in addition to, the interests of the
stockholders generally. Please revise your disclosure to briefly describe these
interests.
Jade's Business
Overview, page 233
19.On page 234, you state that Jade benefits from the availability of researchers, drug
developers, and manufacturers with experience in monoclonal antibodies that it can
access to support its efforts, subject to any restrictions related to intellectual property.
Please revise your disclosures to clarify the nature of this "access," and describe how
restrictions related to intellectual property may impact such access.
20.We note your references on page 235 to "accelerated approval." Please revise your
disclosures where you discuss qualifying for accelerated approval to include balancing
disclosure that an accelerated approval pathway may not lead to a faster development
or regulatory review or approval process and does not increase the likelihood that a
product candidate will receive marketing approval.
21.Please balance the statement that JADE-001 has the potential to capture a sizable
portion of what it estimates to be the $10 billion IgAN market with the fact that you
have not begun clinical development of JADE-001 and that it will be several years
before you will be able to commercialize JADE-001 if you are able to successfully
complete clinical trials.
Jade's Strategy, page 236
We note your disclosure in the second bullet point that Jade has commenced
preclinical discovery with respect to its JADE-002 and JADE-003 programs. Given 22.
February 18, 2025
Page 6
that Jade has not yet exercised its options to license the JADE-002 and JADE-003
targets from Paragon, please revise your disclosure as appropriate to clarify the nature
and extent of these preclinical discovery activities, including to clarify Paragon’s
involvement, if any, in such activities. For example, if true, disclose that, pursuant to
the terms of the Paragon Option Agreement and a related Research Plan, Paragon is
performing the preclinical discovery activities.
Jade's Collaboration, License and Services Agreements
Paragon Option Agreement, page 251
23.We note your disclosures regarding the Paragon Option Agreement. Please revise
your disclosures about the Paragon Option Agreement to clarify:
•when the separate license agreement is pre-negotiated (e.g., when selecting a
target or prior thereto or thereafter, before exercising an option, etc.); and
•which multispecific antibodies and products are covered by the right of first
negotiation described on pages 252 and 254.
JADE-001 License Agreement, page 253
24.Please disclose whether the key terms of the License Agreement described in this
section were "pre-negotiated," as suggested on pages 252, 296, and 311. If yes, clarify
whether you expect the "pre-negotiated" terms to be consistent across all options
under the Paragon Option Agreement, particularly JADE-002 and JADE-003.
25.In the first paragraph, you state that the License Agreement gives Jade an "exclusive
and sublicensable license" for "certain antibodies and products targeting APRIL."
However, your disclosures throughout the proxy statement/prospectus indicate that
Jade exercised an option, and entered into a license agreement, for JADE-001, which
you identify as Jade’s initial product candidate. To the extent applicable, please revise
your disclosures to clarify whether the exercised option extends beyond JADE-001
and/or a specific product candidate. If only the License Agreement extends beyond
JADE-001 and/or a specific product candidate, please briefly descri
2022-08-19 - CORRESP - Jade Biosciences, Inc.
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VIA
EDGAR
August
19, 2022
United
States Securities and Exchange Commission
Office
of Life Sciences
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Aerovate Therapeutics, Inc.
Acceleration Request for Registration Statement on Form S-3
File No. 333-266883
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Aerovate Therapeutics, Inc. (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to August 23, 2022, at 4:01 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 Alicia Tschirhart
at (415) 733-6156. If you have any questions regarding this request, please contact Alicia Tschirhart of Goodwin Procter LLP at (415)
733-6156.
Sincerely,
AEROVATE THERAPEUTICS, INC.
/s/ George
A. Eldridge
George A. Eldridge
Chief Financial Officer
cc: Timothy
P. Noyes, Aerovate Therapeutics, Inc.
Edwin
M. O’Connor, Goodwin Procter LLP
Alicia
M. Tschirhart, Goodwin Procter LLP
2022-08-18 - UPLOAD - Jade Biosciences, Inc.
United States securities and exchange commission logo
August 18, 2022
Timothy P. Noyes
Chief Executive Officer
Aerovate Therapeutics, Inc.
930 Winter Street, Suite M-500
Waltham, MA 02451
Re:Aerovate Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 15, 2022
File No. 333-266883
Dear Mr. Noyes:
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 Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Alicia M. Tschirhart, Esq.
2021-06-25 - CORRESP - Jade Biosciences, Inc.
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1
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VIA EDGAR
June 25, 2021
Office of Life Sciences
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Kasey Robinson and Christopher
Edwards
Re: Aerovate Therapeutics, Inc.
Acceleration Request for Registration Statement on Form S-1
File No. 333-256949
Ladies and Gentlemen,
Pursuant to Rule 461 under
the Securities Act of 1933, as amended (the “Act”), Aerovate Therapeutics, Inc. (the “Company”)
hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”)
be accelerated to June 29, 2021, at 4:30 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 Edwin M. O’Connor at (212)
813-8853. We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective
time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Edwin M. O’Connor, by facsimile
to (212) 937-3476.
If you have any questions
regarding this request, please contact Edwin M. O’Connor of Goodwin Procter LLP at (212) 813-8853.
Sincerely,
AEROVATE THERAPEUTICS, INC.
/s/ Timothy P.
Noyes
Timothy P. Noyes
Chief Executive Officer
cc: George A. Eldridge, Aerovate Therapeutics, Inc.
Edwin M. O’Connor, Goodwin Procter
LLP
Alicia M. Tschirhart, Goodwin Procter LLP
2021-06-25 - CORRESP - Jade Biosciences, Inc.
CORRESP
1
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VIA EDGAR
June 25, 2021
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Kasey Robinson
Christopher Edwards
Re:
Aerovate Therapeutics, Inc.
Acceleration Request for Registration Statement
on Form S-1
File No. 333-256949
Requested Date:
June 29, 2021
Requested Time:
4:30 p.m. Eastern Standard
Time
Dear Ms. Robinson and Mr. Edwards:
In accordance with Rule 461 under the Securities
Act of 1933, as amended (the “Act”), Jefferies LLC, Cowen and Company, LLC and Evercore Group L.L.C., as representatives
of the several underwriters, hereby join Aerovate Therapeutics, Inc. in requesting that the effective date of the above-referenced registration
statement (the “Registration Statement”) be accelerated to June 29, 2021, at 4:30 p.m., Eastern Time, or as soon thereafter
as practicable.
Pursuant to Rule 460 under the Act, please be advised
that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions
and others, prior to the requested effective time of the Registration Statement.
We have been informed by the participating underwriters
that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable.
[Signature Page Follows]
Very truly yours,
As representatives of the several underwriters
JEFFERIES LLC
By:
/s/ Matthew Kim
Name:Matthew Kim
Title:Managing Director, Joint Head of US Biotechnology
COWEN AND COMPANY, LLC
By:
/s/ Bill Follis
Name:Bill Follis
Title:Managing Director
EVERCORE GROUP L.L.C.
By:
/s/ Maren Winnick
Name:Maren Winnick
Title:Senior Managing Director, Advisory
2021-06-24 - CORRESP - Jade Biosciences, Inc.
CORRESP
1
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Goodwin Procter LLP
100 Northern Avenue
Boston, MA 02210
goodwinlaw.com
+1 617 570 1000
June 24, 2021
VIA EDGAR
United States Securities and
Exchange Commission
Division of Corporation Finance
Office of Life Sciences
Mail Stop 4561
100 F Street, N.E.
Washington, D.C. 20549
Attention: Kasey Robinson and
Christopher Edwards
Re: Aerovate Therapeutics, Inc.
Registration Statement on Form S-1
Submitted June 9, 2021
File No. 333-256949
Ladies and Gentlemen:
On behalf of our client, Aerovate Therapeutics, Inc.
(the “Company”), we are responding to the comments from the Staff (the “Staff”) of the Securities
and Exchange Commission (the “Commission”) relating to the Company’s Registration Statement on Form S-1
(the “Registration Statement”) contained in the Staff’s letter dated June 21, 2021 (the “Comment
Letter”). In response to the comments set forth in the Comment Letter, the Company has revised the Registration Statement
and is submitting a revised Amendment No. 2 to the Registration Statement (the “Amendment No. 2 Registration Statement”),
together with this response letter. The Amendment No. 2 Registration Statement also contains certain additional updates and
revisions. We are also sending, under separate cover, a copy of the Amendment No. 2 Registration Statement (including exhibits)
and a marked copy of the Amendment No. 2 Registration Statement showing the changes to the Registration Statement.
Set forth below are the Company’s responses
to the Staff’s comments in the Comment Letter. The responses and information below are based on information provided to us
by the Company. For convenience, the Staff’s comments are repeated below in italics, followed by the Company’s response
to the comments as well as a summary of the responsive actions taken. We have included page numbers to refer to the location
in the Amendment No. 2 Registration Statement submitted herewith where the revised language addressing a particular comment appears.
Capitalized terms used but not defined herein are used herein as defined in the Amendment No. 2 Registration Statement.
Registration Statement on Form S-1 Filed June 9, 2021
Prospectus Summary
Overview, page 1
1. We note your response to comment 3. Please revise your disclosure to describe the serious adverse events that were observed during
the Phase 3 trial conducted by Novartis.
RESPONSE:
The Company respectfully advises the Staff that it has revised its disclosure on pages 1 and 79 of the Amendment No. 2 Registration
Statement in response to the Staff’s comment. In addition, the Company respectfully directs the Staff to its disclosure on pages 88-89 of the Amendment No. 2 Registration Statement
regarding the adverse events and serious adverse events observed during the Phase 3 IMPRES trial conducted by Novartis.
If you should have any questions regarding the
enclosed matters, please contact the undersigned at (212) 813-8853
Sincerely,
/s/
Edwin M. O’Connor
Edwin
M. O’Connor, Esq.
cc:
Timothy P. Noyes, Chief Executive Officer
George Eldridge, Chief Financial Officer
Aerovate Therapeutics, Inc.
Alicia M. Tschirhart, Esq.
Goodwin Procter LLP
Peter N. Handrinos. Esq.
Wesley C. Holmes, Esq.
Latham & Watkins LLP
2021-06-21 - UPLOAD - Jade Biosciences, Inc.
United States securities and exchange commission logo
June 21, 2021
Timothy Noyes
Chief Executive Officer
Aerovate Therapeutics, Inc.
200 Berkeley Street, Floor 18
Boston, MA 02116
Re:Aerovate Therapeutics, Inc.
Registration Statement on Form S-1
Filed June 9, 2021
File No. 333-256949
Dear Mr. Noyes:
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. Unless we note
otherwise, our references to prior comments are to comments in our June 2, 2021 letter.
Registration Statement on Form S-1 Filed June 9, 2021
Prospectus Summary
Overview, page 1
1.We note your response to comment 3. Please revise your disclosure to describe the
serious adverse events that were observed during the Phase 3 trial conducted by Novartis.
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.
FirstName LastNameTimothy Noyes
Comapany NameAerovate Therapeutics, Inc.
June 21, 2021 Page 2
FirstName LastName
Timothy Noyes
Aerovate Therapeutics, Inc.
June 21, 2021
Page 2
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 Michael Fay at 202-551-3812 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Kasey Robinson at 202-551-5880 or Christopher Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Edwin O’Connor, Esq.
2021-06-09 - CORRESP - Jade Biosciences, Inc.
CORRESP 1 filename1.htm Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 June 9, 2021 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Kasey Robinson and Christopher Edwards Re: Aerovate Therapeutics, Inc. Draft Registration Statement on Form S-1 Submitted May 6, 2021 CIK No. 0001798749 Ladies and Gentlemen: On behalf of our client, Aerovate Therapeutics, Inc. (the “Company”), we are responding to the comments 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 (the “Draft Registration Statement”) contained in the Staff’s letter dated June 2, 2020 (the “Comment Letter”). In response to the comments set forth in the Comment Letter, the Company has revised the Draft Registration Statement and is publicly submitting a revised Registration Statement (the “Registration Statement”), together with this response letter. The Registration Statement also contains certain additional updates and revisions. We are also sending, under separate cover, a copy of the Registration Statement (including exhibits) and a marked copy of the Registration Statement showing the changes to the Draft Registration Statement. Set forth below are the Company’s responses to the Staff’s comments in the Comment Letter. The responses and information below are based on information provided to us by the Company. For convenience, the Staff’s comments are repeated below in italics, followed by the Company’s response to the comments as well as a summary of the responsive actions taken. We have included page numbers to refer to the location in the Registration Statement submitted herewith where the revised language addressing a particular comment appears. Capitalized terms used but not defined herein are used herein as defined in the Registration Statement. Draft Registration Statement on Form S-1, filed May 6, 2021 Prospectus Summary Overview, page 1 1. We note your statement that “oral imatinib also demonstrated statistically significant and clinically meaningful benefit in PAH patients in an international Phase 3 trial conducted by Novartis” and similar statements throughout the registration statement. Since findings of safety or efficacy are solely within the authority of the FDA or similar foreign regulators, and oral imatinib has not been approved for the treatment of PAH, please revise to remove any statements that suggest the safety and efficacy of this product candidate. Where you deem appropriate, you may present objective data without including your conclusions related to safety or efficacy. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 1, 17, 67, 79-81 and 94 of the Registration Statement in response to the Staff’s comment. 2. We note your comparison of the results of your Phase 1 trial of AV-101 to the results observed in the Phase 3 IMPRES clinical trial of oral imatinib. Given that it appears you have not conducted head-to-head trials, and the significant variables across clinical trials, please tell us why you believe it is appropriate to include this comparison. Include in your response whether you expect to be able to rely on this data to support an application for marketing approval from the FDA or comparable regulatory body for commercialization of AV-101. RESPONSE: The Company acknowledges the Staff’s comment and respectfully advises the Staff that it believes the comparison is appropriate because the Company’s Phase 1 clinical trial included multiple doses of AV-101 and a 400 mg dose of oral imatinib as a comparator. All doses of AV-101 resulted in lower systemic plasma levels of imatinib compared to those for 400 mg of oral imatinib. The Company reviewed these data with the FDA as an important element of its plan to follow a 505(b)(2) regulatory pathway, and based on that discussion the Company expects to be able to rely on these data to support an application for marketing approval from the FDA in the United States for the commercialization of AV-101. 3. Please describe the “systemic” adverse events that were observed during the Phase 3 trial conducted by Novartis and whether these were categorized as serious adverse events. RESPONSE: The Company respectfully advises the Staff that systemic adverse events observed in the Phase 3 IMPRES trial conducted by Novartis included anemia, dyspnea, peripheral edema, presyncope and subdural hematoma. All of these were categorized as serious adverse events. For avoidance of doubt, the Company has revised its disclosure on pages 1, 21, 67 and 79 of the Registration Statement in response to the Staff’s comment to remove references to "systemic" when referring to the adverse events that were observed during the Phase 3 IMPRES trial. 4. We note your use of the term “high unmet medical need” here and elsewhere in the document. Such a term might imply that your products are eligible for fast track designation or priority review granted by the FDA for products that treat certain serious unmet medical needs. Please remove your use of this term throughout or otherwise please explain why you believe use of this term is appropriate. RESPONSE: The Company respectfully advises the Staff that based on discussions with the FDA, the Company’s clinical trial design and market precedent with another antiproliferative drug that has completed a Phase 2 trial, the Company believes AV-101 is eligible for Breakthrough Therapy Designation and priority review following the successful completion of the Phase 2b trial. For avoidance of doubt, the Company has revised its disclosure on pages 1 and 79 of the Registration Statement in response to the Staff’s comment to remove references to "high" when referring to the unmet medical need of PAH patients. 5. We note your statement that you have received regulatory guidance from the FDA that your clinical program could support a NDA submission. Please revise to provide context for such statement and balance your disclosure by stating that the process of clinical development is inherently uncertain and there can be no guarantee that you will obtain marketing approval. We also note your statements that your “focus on developing AV- 101 is driven by promising historical results from the Phase 3 IMPRES clinical trial of oral imatinib,” that you are “pursuing an efficient clinical development program utilizing established endpoints for development and approval of previous PAH drugs” and similar statements throughout the registration statement. These statements could imply that the FDA has approved, or will more easily approve, your product candidate. As your drug is distinct from prior drugs that have been approved by the FDA, please revise your disclosure to remove any implication that your product candidate is more likely to receive FDA approval than others. Additionally, revise your statements on page 79 that you intend to pursue a “rapid development path” that “employs a seamless adaptive design to streamline the development timeline to a potential NDA filing” and similar disclosure throughout the prospectus to remove any implication that you will be successful in obtaining regulatory approval or commercializing your product candidate in a rapid or accelerated manner as such statements are speculative. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 1-2 and 79-81 in response to the Staff’s comment. The Company respectfully advises the Staff that during the end of Phase 1 meeting with the FDA, the Company received regulatory guidance that the Phase 2b/3 clinical trial could, if successful, support an NDA. Such discussion is documented in the FDA’s meeting minutes provided to the Company, which the Company can provide the Staff on a confidential basis under separate cover upon request. Risks Associated with Our Business, page 3 6. Please revise this section as follows: · Add a bullet point highlighting that your patent portfolio is pending and that you do not own any issued patents with respect to AV-101. In this regard, we note your disclosure on page 30. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 4 and 30 of the Registration Statement in response to the Staff’s comment. · Add a bullet point highlighting the risks related to the concentration of ownership of your common stock, as discussed on page 49. Please include in this bullet and in the corresponding risk factor on page 49 a discussion of the number of your executive officers and directors who are affiliated with your principal stockholders. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on page 4 of the Registration Statement in response to the Staff’s comment. · Expand your disclosure in the ninth bullet point or add a new bullet point to highlight that you plan to conduct clinical trials for AV-101 outside the United States and that if the FDA, EMA, or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional trials, as discussed on page 38. Please also revise the disclosure in your prospectus summary to discuss that you plan to conduct your clinical trials outside the United States and clarify where you conducted your Phase 1 trial. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 2 and 4 of the Registration Statement in response to the Staff’s comment. Use of Proceeds, page 60 7. Please revise your disclosure that you expect to use net proceeds from this offering to fund further development of AV101, including the global Phase 2b/3 clinical trial, to provide an estimate of how far in the clinical development process for AV101 the allocated proceeds of the offering will enable you to reach. For example, if you will not complete the Phase 2b or Phase 3 portion of the trial, please revise to so state. If any material amounts of other funds are necessary to complete your clinical trials for this candidate, please revise your disclosure to state the amounts and the sources of such other funds. Refer to Instruction 3 of Item 504 of Regulation S-K. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 6 and 60 of the Registration Statement in response to the Staff’s comment. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Common Stock Valuations, page 74 8. Please disclose the fair value of your common stock for each grant date of stock-based awards, as determined by your board of directors, as well as the significant actual factors considered by them in their determination of fair value. As part of the revised disclosure, identify the reasons for grant date-over-grant date changes in fair value. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 77-78 of the Registration Statement in response to the Staff’s comment to include the fair value of the Company’s common stock (“Common Stock”) for each grant date of stock based awards as well as the significant factors considered by the Company’s board of directors in their determination of fair value. In addition, the Company respectfully advises the Staff as follows with respect to the changes in valuation from grant date to grant date. December 31, 2019 Valuation and February 14, 2020, May 1, 2020 and May 19, 2020 Stock Option Grants For the December 31, 2019 valuation (the “December Valuation”), the Company utilized the invested capital method to determine the enterprise value and the OPM as the primary allocation methodology. The invested capital method and OPM was used as there had not been any recent third-party financings and the Company was wholly owned by RA Capital. Additionally, the invested capital method considered the Company’s preclinical stage of development as well as prospects and related valuations for future third party financings. The concluded Common Stock value was $0.95 per share at the non-marketable, minority level of value. The Company granted options to purchase a total of 250,000 shares of Common Stock at an exercise price of $0.95 per share from February 14, 2020 to May 19, 2020. The Company’s board of directors determined the estimated fair value of the Common Stock at the time of the grants was $0.95 per share based on a number of factors, including the December Valuation by an independent third party as well expected valuations associated with an anticipated preferred stock financing. August 5, 2020 Valuation and September 4, 2020 and November 24, 2020 Stock Option Grants For the August 5, 2020 valuation (the “August Valuation”), the Company utilized the OPM methodology, which was based in large part on the August 5, 2020 pricing of the Series A redeemable convertible preferred stock financing (the “Series A Financing”), to derive the implied equity value for the Company. Within the OPM framework, the back solver method for inferring equity value implied by a recent financing transaction involves making assumptions for the expected time to liquidity, volatility, and risk-free rate and then solving for the value of the equity such that the implied value for the most recent financing equals the amount paid. This method was selected as the Company concluded that the contemporaneous Series A Financing was an arm’s length transaction. The Series A Financing was structured as a tranched transaction, affording the initial investors in the Series A Financing the right or obligation, depending on certain outcomes, to participate in three additional tranches of the Series A Financing. The OPM back solve model was designed to take into account these features of the three subsequent milestone closings. The concluded Common Stock value was $0.56 at the non-marketable, minority level of value. On September 4, 2020, the Company modified the 250,000 previously granted stock options at a per share exercise price of $0.95 to a per share exercise price of $0.56, and, as a result of the modification, recorded incremental stock-based compensation expense for the change in fair value of the modified awards. In addition to the 250,000 modified stock option grants, the Company granted options to purchase a total of 441,645 shares of Common Stock at an exercise price of $0.56 per share from September 4, 2020 to November 24, 2020. The Company’s board of directors determined the estimated fair value of the Common Stock at the time of the grants was $0.56 per share based on a number of factors, including the August Valuation by an independent third party. February 1, 2021 Valuation and April 2, 2021 Stock Option Grants On February 1, 2021, the Company completed the first of three milestone closings (the “First Milestone Closing”) under the Series A Preferred Stock Purchase Agreement and sold 4,224,274 shares of Series A redeemable convertible preferred stock at $1.893 per share for aggregate gross proceeds of $8.0 million. As of the beginning of February 2021, the Company had completed certain preclinical experiments and received the results from its Phase 1 study demonstrating safety and tolerability of doses that were to be carried forward to a Phase 2b/3 trial. As a result of the Company completing the First Milestone Closing, a valuation was performed as of February 1, 2021 (the “February Valuation”). For the February Valuation, the Company used a hybrid of the PWERM and the OPM. The hybrid method applied the PWERM utilizing the probability of going public or exiting through an acquisition transact
2021-06-02 - UPLOAD - Jade Biosciences, Inc.
United States securities and exchange commission logo
June 2, 2021
Timothy Noyes
Chief Executive Officer
Aerovate Therapeutics, Inc.
200 Berkeley Street, Floor 18
Boston, MA 02116
Re:Aerovate Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted May 6, 2021
CIK No. 0001798749
Dear Mr. Noyes:
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
Overview, page 1
1.We note your statement that "oral imatinib also demonstrated statistically significant and
clinically meaningful benefit in PAH patients in an international Phase 3 trial conducted
by Novartis" and similar statements throughout the registration statement. Since findings
of safety or efficacy are solely within the authority of the FDA or similar foreign
regulators, and oral imatinib has not been approved for the treatment of PAH, please
revise to remove any statements that suggest the safety and efficacy of this product
candidate. Where you deem appropriate, you may present objective data without
including your conclusions related to safety or efficacy.
FirstName LastNameTimothy Noyes
Comapany NameAerovate Therapeutics, Inc.
June 2, 2021 Page 2
FirstName LastNameTimothy Noyes
Aerovate Therapeutics, Inc.
June 2, 2021
Page 2
2.We note your comparison of the results of your Phase 1 trial of AV-101 to the results
observed in the Phase 3 IMPRES clinical trial of oral imatinib. Given that it appears you
have not conducted head-to-head trials, and the significant variables across clinical
trials, please tell us why you believe it is appropriate to include this comparison. Include
in your response whether you expect to be able to rely on this data to support an
application for marketing approval from the FDA or comparable regulatory body for
commercialization of AV-101.
3.Please describe the “systemic" adverse events that were observed during the Phase 3 trial
conducted by Novartis and whether these were categorized as serious adverse events.
4.We note your use of the term “high unmet medical need” here and elsewhere in the
document. Such a term might imply that your products are eligible for fast track
designation or priority review granted by the FDA for products that treat certain serious
unmet medical needs. Please remove your use of this term throughout or otherwise please
explain why you believe use of this term is appropriate.
5.We note your statement that you have received regulatory guidance from the FDA that
your clinical program could support a NDA submission. Please revise to provide context
for such statement and balance your disclosure by stating that the process of clinical
development is inherently uncertain and there can be no guarantee that you will obtain
marketing approval. We also note your statements that your "focus on developing AV-
101 is driven by promising historical results from the Phase 3 IMPRES clinical trial of
oral imatinib," that you are "pursuing an efficient clinical development program utilizing
established endpoints for development and approval of previous PAH drugs" and similar
statements throughout the registration statement. These statements could imply that the
FDA has approved, or will more easily approve, your product candidate. As your drug is
distinct from prior drugs that have been approved by the FDA, please revise your
disclosure to remove any implication that your product candidate is more likely to receive
FDA approval than others. Additionally, revise your statements on page 79 that you
intend to pursue a "rapid development path" that "employs a seamless adaptive design to
streamline the development timeline to a potential NDA filing" and similar disclosure
throughout the prospectus to remove any implication that you will be successful in
obtaining regulatory approval or commercializing your product candidate in a rapid or
accelerated manner as such statements are speculative.
Risks Associated with Our Business, page 3
6.Please revise this section as follows:
•Add a bullet point highlighting that your patent portfolio is pending and that you do
not own any issued patents with respect to AV-101. In this regard, we note your
disclosure on page 30.
•Add a bullet point highlighting the risks related to the concentration of ownership of
your common stock, as discussed on page 49. Please include in this bullet and in the
FirstName LastNameTimothy Noyes
Comapany NameAerovate Therapeutics, Inc.
June 2, 2021 Page 3
FirstName LastNameTimothy Noyes
Aerovate Therapeutics, Inc.
June 2, 2021
Page 3
corresponding risk factor on page 49 a discussion of the number of your executive
officers and directors who are affiliated with your principal stockholders.
•Expand your disclosure in the ninth bullet point or add a new bullet point to highlight
that you plan to conduct clinical trials for AV-101 outside the United States and that
if the FDA, EMA, or any applicable foreign regulatory authority does not accept such
data, it would result in the need for additional trials, as discussed on page 38. Please
also revise the disclosure in your prospectus summary to discuss that you plan to
conduct your clinical trials outside the United States and clarify where you conducted
your Phase 1 trial.
Use of Proceeds, page 60
7.Please revise your disclosure that you expect to use net proceeds from this offering to fund
further development of AV101, including the global Phase 2b/3 clinical trial, to provide
an estimate of how far in the clinical development process for AV101 the allocated
proceeds of the offering will enable you to reach. For example, if you will not complete
the Phase 2b or Phase 3 portion of the trial, please revise to so state. If any material
amounts of other funds are necessary to complete your clinical trials for this candidate,
please revise your disclosure to state the amounts and the sources of such other funds.
Refer to Instruction 3 of Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Common Stock Valuations, page 74
8.Please disclose the fair value of your common stock for each grant date of stock-based
awards, as determined by your board of directors, as well as the significant actual factors
considered by them in their determination of fair value. As part of the revised disclosure,
identify the reasons for grant date-over-grant date changes in fair value.
Business
Intellectual Property, page 93
9.Please revise your intellectual property disclosure to disclose for each material patent
application the specific products or technologies to which such patent applications relate.
Also clearly describe on an individual basis the type of patent protection sought for each
product or technology (composition of matter, use, or process), the expected expiration of
each patent, and the jurisdiction, including any foreign jurisdiction, of each pending
patent. In this regard, it may be useful to provide this disclosure in tabular form to support
the narrative already included.
Competition, page 95
10.We note your statement that AV-101 is a "potentially first-in-class inhaled medication"
targeting certain PAH patients. Given the stage of development, and your
FirstName LastNameTimothy Noyes
Comapany NameAerovate Therapeutics, Inc.
June 2, 2021 Page 4
FirstName LastName
Timothy Noyes
Aerovate Therapeutics, Inc.
June 2, 2021
Page 4
acknowledgement that obtaining FDA approval is inherently uncertain, this statement
would appear to be premature. Please revise this statement as appropriate.
Employment Arrangements with Our Named Executive Officers, page 122
11.We note your disclosure on page 122 that you have entered into offer letter agreements
with certain of your named executive officers. We also note your disclosure on page 126
regarding the Senior Executive Cash Incentive Bonus Plan. Please file such
offer letter agreements and the Senior Executive Cash Incentive Bonus Plan as exhibits
pursuant to Item 601(b)(10) of Regulation S-K.
General
12.Please confirm that you will update your disclosure for any shares you become obligated
to issue under the Stock Purchase Agreement prior to the completion of the initial public
offering.
13.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
You may contact Michael Fay at 202-551-3812 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Kasey Robinson at 202-551-5880 or Christopher Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Edwin O’Connor, Esq.