SEC Comment Letter 0000000000-23-010715 to CARGO Therapeutics, Inc. (CRGX) (CIK 0001966494)
CARGO Therapeutics, Inc. (CRGX) (CIK 0001966494)
Date: Sept. 28, 2023 · CIK: 0001966494 · Accession: 0000000000-23-010715
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United States securities and exchange commission logo
September 28, 2023
Halley Gilbert
Chief Legal Officer
CARGO Therapeutics, Inc.
1900 Alameda De Las Pulgas, Suite 350
San Mateo, CA 94403
Re:CARGO Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted September 1, 2023
CIK No. 0001966494
Dear Halley Gilbert:
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.Please disclose whether Stanford’s Phase 1 clinical trial was powered for statistical
significance, and whether any SAEs were observed. Please also disclose whether
Stanford is a licensor, or otherwise advise.
2.We note your disclosure on page 2 that Stanford received Breakthrough Therapy
Designation from the FDA. Please balance this disclosure with the statement on page 45
that a Breakthrough Therapy Designation may not lead to a faster development or
regulatory review or approval process, and does not increase the likelihood that a product
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candidate will receive FDA approval. Please also clarify whether your product candidate,
CRG-022, has been designated by the FDA as a breakthrough therapy for the purposes of
your IND application.
3.With regard to your disclosure that CRG-022 is being studied by Stanford in a Phase 1
clinical trial, please clarify, if known, whether Stanford plans to pursue additional clinical
trials beyond its current Phase 1 clinical trial with a goal of receiving regulatory approval
and how your and their trials will work in tandem, if at all.
4.We note your references to "breakthrough" and "encouraging" results here, and
elsewhere. Please refrain from describing preliminary data from clinical trials as
"breakthrough" or "encouraging" as this may create an inference that a product candidate
is more likely to be found to be safe and effective and limit the discussion to the objective
clinical data, such as the endpoints and whether they were met.
5.We note your disclosure on page 3 regarding “demonstrating” comparability of the final
drug product to that produced by the process used in the Stanford Phase 1 clinical trial.
Please balance this disclosure with the statements on page 45 and elsewhere that you
cannot assure that the FDA will agree with your claim of comparability and the
sufficiency of the data to support it, or agree with your ability to reference the preclinical,
manufacturing or clinical data generated by the Stanford clinical trial even if you obtain a
right of reference from Stanford.
6.Please revise your prospectus summary to explain briefly at first use each of the scientific
or technical terms. By way of example only, we note the following terms:
•Autologous
•Chimeric antigen receptor
•High Complete Response
•Cognate ligands
•Immune escape
•Payload capacity
•Lentiviral vector
Our solution: next generation of CAR T-cell therapies, page 3
7.We note your disclosure on page 4 that your team will implement manufacturing
processes that are highly reliable and readily transferrable to expand capacity, reduce
turnaround time and minimize costs of goods. Please balance this disclosure with the
statements on page 25 that you may experience delays in developing a sustainable,
reproducible and scalable manufacturing and page 55 that you do not own or operate your
own manufacturing facilities, and rely on third-parties, which can result in increased costs
that could delay, prevent, or impair development or commercialization efforts.
Our history, team and investors, page 6
8.We note your disclosure that your team has progressed products from research to clinical
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trials, and ultimately to regulatory approval and commercialization. Please balance this
disclosure with the statement on page 25 that novel products, such as yours, can be more
complex and consequently more expensive and take longer than for other, better known or
extensively studied pharmaceutical or other product candidates.
9.Please limit the disclosure of specific investors to those identified in the beneficial
ownership table on page 194. Additionally, indicate that prospective investors should not
rely on the named investors’ investment decisions, that these investors may have different
risk tolerances and that the shares purchased in the referenced financings may have been
conducted at a significant discount to the IPO price, if true.
Risk Factors Summary, page 7
10.We note your disclosure that you have experienced “rapid growth” since your inception,
and that you “expect” to continue to grow in the future. Please specify the type of
“growth” you are referencing in this disclosure. In this regard, we note your disclosure on
page 22 appears to reference employee and operational growth.
Summary financial data, page 12
11.You disclose on page F-23 that the preferred stock will automatically be converted into
common stock upon the IPO provided that the offering price per share is not less than
$5.00 (as adjusted for stock dividend, stock split, combination or other similar
recapitalization) and the aggregate gross proceeds to the Company are not less than $75.0
million, or at the date and time, or occurrence, of an event specified in a vote or written
consent of the holders of the majority of the outstanding shares of convertible preferred
stock. Tell us why it is appropriate to include the conversion in the pro forma column on
page 14. If you believe the preferred stock will convert upon the IPO, please revise the
disclosure to clarify the conditions in which the conversion will occur and tell us why you
believe the conditions will be met.
Critical Accounting Policies and Significant Judgments and Estimates
Common Stock Valuations, page 120
12.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the awards 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-based compensation. Please discuss
with the staff how to submit your response.
Business
Our lead program, CRG-022, page 125
13.Please revise to clearly disclose the primary and secondary endpoints, if any, of the
Stanford Phase 1 clinical trial and whether they were achieved. In addition, please
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disclose any observed serious adverse events.
Our tri-specific program, CRG-023, page 127
14.Please identify the referenced study published in June 2023.
Establishment of a commercial manufacturing process for CRG-022, page 138
15.We note your disclosure that the manufacturing process for CRG-022 builds upon the
process used to manufacture CRG-022 used by Stanford. If your manufacturing process
uses technology developed by Stanford, please indicate in an appropriate location whether
such technology is in-licensed under the Stanford Agreement.
Competition, page 145
16.With respect to your disclosures regarding competitors, please explain the difference
between “autologous” and “allogenic” CAR T therapies.
Intellectual Property, page 147
17.Please specify the foreign jurisdictions in which you have pending applications, licensed
patents or licensed pending patents.
License Agreements, page 149
18.Please revise your Stanford Agreement and National Cancer Institute license agreement
disclosures relating to "double-digit percentage" of milestone payments applicable to
product covered by licensed patent rights on non-patented products, "low double-digit
percentage" of non-royalty revenue in the event you choose to exercise your right to
sublicense, and "low single-digit to a low double-digit percentage" to specify a percentage
rate or range that does not exceed ten percentage points.
Notes to the Financial Statements for the year ended December 31, 2022
11. License and research and development agreements
Oxford license and supply agreement, page F-27
19.Please disaggregate the $9.3 million milestone payments you may be required to pay into
development, regulatory and commercial milestones.
General
20.Please ensure the writing is legible in the visual depictions throughout your draft
registration statement. For example only, your visual under “Pre STASH technology” on
page 145 contains illegible text.
21.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
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not they retain copies of the communications.
You may contact Christine Torney at 202-551-3652 or Mary Mast at 202-551-3613 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jimmy McNamara at 202-551-7349 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Benjamin A. Potter, Esq.