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United States securities and exchange commission logo
August 19, 2020
Kris Vaddi, Ph.D.
Chief Executive Officer
Prelude Therapeutics Incorporated
200 Powder Mill Road
Wilmington, DE 19803
Re: Prelude
Therapeutics Incorporated
Draft Registration
Statement on Form S-1
Submitted July 23,
2020
CIK No. 0001678660
Dear Dr. Vaddi:
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
Overview, page 2
1. Given the status of
your development of your product candidates, please tell us the basis
for your claims on page
1 and throughout the registration statement that your product
candidates are potent
and selective.
2. Please revise your
pipeline tables on pages 2 and 93 to include columns depicting each of
Phase 1, Phase 2, and
Phase 3 to ensure that all stages in the clinical trial process prior to
seeking FDA approval
are shown. In addition, please remove the "Pivotal" label, as it is
premature to suggest
that the completion of the Phase 1/2 clinical trials will lead to a
Kris Vaddi, Ph.D.
FirstName LastNameKris Vaddi, Ph.D.
Prelude Therapeutics Incorporated
Comapany
August 19, NamePrelude
2020 Therapeutics Incorporated
August
Page 2 19, 2020 Page 2
FirstName LastName
pivotal Phase 3 trial for the products listed. Note that the arrows
for each listed program
should be accurately drawn to show the precise phase of development
after the table has
been revised.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 5
3. Please 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.
Use of Proceeds, page 72
4. Please revise the discussion to identify the stage of clinical
development you expect to
achieve with the proceeds of the offering for PRT543, PRT811, and
PRT1419. To the
extent you expect to begin a particular stage of development but do
not expect to complete
it, please indicate that you will need to raise additional funding to
complete that stage of
development.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies
Stock-Based Compensation, page 88
5. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation and
beneficial conversion features.
Target Selection, page 99
6. We note your statements regarding your framework for optimizing your
drug discovery
and development efforts that you believe "increases the probability of
clinical and
regulatory success...." We also note your statements that you believe
your approach "will
result in better targeted and more effective cancer therapies" and
that you have observed
"promising clinical activity" to date. Please revise the prospectus to
remove any
statements, such as these, that imply forthcoming regulatory approval
of you product
candidates or the safety and efficacy of your candidates, as these
determinations are the
exclusive authority of the FDA or other regulators.
Our Product Candidates, page 101
7. Revise to explain briefly key measures you cite throughout your
Business section,
including terms such as complete response and stable disease.
Also, please ensure
that you provide a balanced presentation of clinical results. In this
regard, we note that
Kris Vaddi, Ph.D.
Prelude Therapeutics Incorporated
August 19, 2020
Page 3
your discussion of the interim and preliminary efficacy data for your
PRT543 Phase 1 trial
where you highlight a patient with a confirmed complete response but you
do not provide
interim data for the other 25 patients. Please revise or advise.
8. Please revise the discussion that accompanies Tables 2, 3, and 5 to
clarify how these
results demonstrate the relative inhibitory potency of your product
candidates and also
discuss why the levels achieved support continued clinical development.
Group A (Solid Tumors), page 111
9. Please revise your disclosure to briefly explain the parameters "Tmax"
and "AUC0-T"
listed in the tables on pages 111, 112 and 119.
Employment Arrangements with our Named Executive Officers, page 153
10. Please file your employment agreements with each of your executive
officers as exhibits
to the registration statement, as required by Item 601(b)(10) of
Regulation S-K.
Audited Financial Statemetns as of December 31, 2018 and 2019 and for the Years
then Ended
Note 1 Net Loss Per Share and Unaudited Pro Forma Net Loss Per Share, page F-11
11. Your pro forma net loss per share calculation appears to assume that the
8,823,529 shares
of Series B convertible preferred stock issued in May 2019 converted at
the beginning of
the period rather than at their date of issuance. Please refer to ASC
260-10-45-40(c) and
advise or revise your pro forma information accordingly. Also, once you
update your
financial statements for the six months ended June 30, 2020, please
address this comment
as it relates to the 8,823,529 shares of Series B convertible preferred
stock issued in
March 2020.
You may contact Rolf Sundwall at 202-551-3105 or Jeanne Baker at
202-551-3691 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Laura Crotty at 202-551-7614 with any
other
questions.
Sincerely,
FirstName LastNameKris Vaddi, Ph.D.
Division of
Corporation Finance
Comapany NamePrelude Therapeutics Incorporated
Office of Life
Sciences
August 19, 2020 Page 3
cc: Rob Freedman, Esq.
FirstName LastName