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United States securities and exchange commission logo
November 24, 2021
Bihua Chen
Chief Executive Officer
Helix Acquisition Corp.
c/o Cormorant Asset Management, LP
200 Clarendon Street, 52nd Floor
Boston, MA 02116
Re: Helix Acquisition
Corp.
Preliminary Proxy
Statement on Schedule 14A
Filed October 29,
2021
File No. 001-39630
Dear Ms. Chen:
We have reviewed your filing 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 these comments within ten business days by
providing the requested
information or advise us as soon as possible when you will respond. If
you do not believe our
comments apply to your facts and circumstances, please tell us why in
your response.
After reviewing your
response to these comments, we may have additional comments.
Preliminary Proxy Statement on Schedule 14A
Interests of Certain Persons in the Business Combination, page 33
1. We note that the
initial shareholders agreed to waive their redemption rights. Please
describe any
consideration provided in exchange for this agreement.
2. We note that the Board
of Directors considered the potential conflicting interests of
Helix's Sponsor,
directors, and officers when evaluating the Business Combination. Please
clarify how the board
considered those conflicts in negotiating and recommending the
business combination.
Bihua Chen
FirstName LastNameBihua Chen
Helix Acquisition Corp.
Comapany 24,
November NameHelix
2021 Acquisition Corp.
November
Page 2 24, 2021 Page 2
FirstName LastName
Risk Factors Related to Helix and the Business Combination
Directors and officers of Helix have potential conflicts of interest in
recommending that Helix's
shareholders vote in favor of approval, page 76
3. Please highlight the risk that the sponsor may be incentivized to
complete an acquisition
of a less favorable target company or on terms less favorable to
shareholders rather than
liquidate given how much the sponsor stands to benefit from the
completion of a business
combination.
The Business Combination Proposal, page 110
4. We note that your disclosure of the Post-Business Combination
Ownership Structure on
page 112 assumes two redemption scenarios. Please revise to include a
sensitivity analysis
with a range of redemption scenarios, including minimum, maximum and
interim
redemption levels.
5. Please revise to disclose all possible sources and extent of dilution
that shareholders who
elect not to redeem their shares may experience in connection with the
business
combination. Provide disclosure of the impact of each significant
source of dilution,
including the amount of equity held by founders, convertible
securities, including warrants
retained by redeeming shareholders, at each of the redemption levels
detailed in your
sensitivity analysis, including any needed assumptions.
6. It appears that underwriting fees remain constant and are not adjusted
based on
redemptions. Revise your disclosure to disclose the effective
underwriting fee on a
percentage basis for shares at each redemption level presented in your
sensitivity analysis
related to dilution.
Background of the Business Combination
Negotiations with MoonLake, page 132
7. With reference to the disclosure on page 132, please revise to discuss
who introduced you
to MoonLake and the individuals and parties who were involved in the
initial
communications and negotiations.
8. We note your disclosure on page 132 that you conducted preliminary due
diligence on,
and held discussions with, 58 companies and only executed one letter
of intent, which was
with MoonLake. Please revise to disclose whether you entered into any
confidentiality
agreements with any potential target companies other than MoonLake,
and if so, how
many and the Board's reasons for terminating discussions with such
companies.
9. Please revise your disclosure in this section to further describe the
basis for the Helix
Board's belief that MoonLake had the ability to generate $1 billion in
revenue per year
within five to seven years given the inherent uncertainty of drug
development. Please
remove any reference to the ability to "de-risk" as such reference
implies that it is possible
to mitigate the risk associated with drug development and describe why
the Board valued
Bihua Chen
FirstName LastNameBihua Chen
Helix Acquisition Corp.
Comapany 24,
November NameHelix
2021 Acquisition Corp.
November
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comparisons to bimekizumab which has yet to be approved for
commercialization.
10. We note your disclosure that Helix sent an initial draft letter of
intent to MoonLake in
which it proposed the terms of a business combination. Please revise
to clarify how the
transaction structure and consideration evolved during the
negotiations, including the
proposals and counter- proposals made during the course of
negotiations, with respect to
the material terms of the merger, particularly as it relates to the
valuation of
MoonLake. Please be sure to indicate which party first presented a
valuation figure and
discuss each counterproposal so that investors can understand how this
term was
negotiated and whether the valuation moved materially during this
period. Discuss the
basis or bases presented in support of each valuation proposed and
what factors the Helix
Board considered that led to an increase in the valuation of $10
million.
11. Please clarify whether the financial models MoonLake provided Helix
management on
June 4, 2021 are materially the same as the MoonLake Forecasts
discussed on page 144. If
they are materially different, please tell us how they are different,
what changes were
made and why such changes were made.
MoonLake Valuation Analyses, page 140
12. With respect to the analyses where SVB Leerink selected certain
companies for purposes
of comparison, please disclose whether any companies meeting the
selection criteria were
excluded from the analyses, and if so, why they were excluded.
Certain Projected Financial Information, page 144
13. We note your disclosure that MoonLake provided its internally derived
estimated risk-
adjusted net revenues and unlevered free cash flow for the years
ending December 31,
2021 through 2040 to Helix in the second quarter of 2021 for use as a
component of its
overall evaluation of MoonLake and to SVB Leerink, which was
authorized and directed
by Helix to use and rely upon such information for purposes of
providing advice to the
Helix Board. We have the following comments regarding these forecasts:
Describe the process undertaken to formulate the forecasts and
the parties who
participated in the preparation of the forecasts. Clearly
identify the risk adjustments
in arriving at risk-adjusted revenue.
Disclose the material assumptions and estimates underlying the
forecasts, including
MoonLake's revenue growth rates, operating costs, product
pricing, gross margins,
etc. and the limitations of the forecasts. Provide investors with
sufficient information
to evaluate the forecasted financial information and its
reasonableness.
We note your disclosure that MoonLake provided the
risk-adjusted net revenues and
unlevered free cash flow information to Helix in the second
quarter of 2021 in
connection with its overall evaluation of MoonLake and to SVB
Leerink, among
other things. Please tell us what other information was provided
to Helix and SVB
Leerink at that time. If the other information provided included
additional projected
Bihua Chen
FirstName LastNameBihua Chen
Helix Acquisition Corp.
Comapany 24,
November NameHelix
2021 Acquisition Corp.
November
Page 4 24, 2021 Page 4
FirstName LastName
financial information, please disclose those projections or tell
us why they are not
material to investors.
Explain how you arrived at the probability of regulatory
approval and the nature of
such adjustment and whether you applied the same regulatory
success rates for each
of the pre-commercialization products, and if so, why.
Explain whether management prepared multiple forecast
scenarios, and if so, whether
the one presented in the document represents the average of the
scenarios or the most
likely scenario. Explain how you weighted the various scenarios.
Explain how management and the Board relied upon the forecasts
and how they
determined that they are reasonable, particularly in light of the
length of the forecasts
and since MoonLake is a clinical stage company with limited
operations and no
approved products. Specifically, address the reliability of the
projections related to
the later years presented.
Explain to us the extent that you have considered providing
separate forecasted
financial information for each product candidate based on its
stage of development.
Please quantify the adjustments that Helix management made to
the unlevered free
cash flow forecasts provided by MoonLake management and the
reasons for the
adjustments. Disclose projected operating and other expenses in
addition to
presenting an estimated net income (loss) amount.
Disclose the date you assume SLK will be granted regulatory
approval for each
indication for each significant market reflected in the forecast.
Revise to more clearly define for the reader the use of
gross-to-net and proportion of
days of treatment in estimating annual revenue per patient and
how management
arrived at 33% and 90%, respectively.
Business of MoonLake, page 181
14. You make several assertions regarding the safety and efficacy of your
product
candidates. Safety and efficacy determinations are solely within the
authority of the FDA
(or applicable foreign regulator) and are assessed throughout all
clinical trial phases. You
may present clinical trial end points and objective data resulting
from trials without
concluding efficacy and you may state that your product candidates
have been well
tolerated, if accurate. Please revise or remove these and similar
statements/inferences
throughout your prospectus:
Our novel tri-specific Nanobody, sonelokimab ( SLK , also
known as M1095/ALX
0761) is an IL-17A and IL-17F inhibitor that has clinically
demonstrated potential to
drive disease modification in dermatology and rheumatology
patients.
Specifically, dosages up to 120 mg showed rapid and significant
clinical benefit
compared with placebo.
In addition to these features, we believe that the strong
clinical results achieved to
date uniquely position SLK for success.
SLK showed notable therapeutic activity and a promising safety
profile.
We believe SLK has already demonstrated a leading therapeutic
advantage in
Bihua Chen
FirstName LastNameBihua Chen
Helix Acquisition Corp.
Comapany 24,
November NameHelix
2021 Acquisition Corp.
November
Page 5 24, 2021 Page 5
FirstName LastName
psoriasis as compared to the current standard of care provided by
IL-17A inhibitors.
SLK demonstrates potential in major inflammatory diseases
driven by IL-17A and
IL-17F, and clinical trials to date show high response levels
(PASI90 and PASI100
scores (Figure 4)) in psoriasis, with a favorable benefit-safety
profile.
We believe this data describes a benefit-risk profile that is
likely to be advantageous
to the current standard of care and bimekizumab.
Since inflammation in r-axSpA also impacts deep joint tissues,
we believe SLK has
the potential to demonstrate significant efficacy when compared
to other therapies,
considering the intrinsic characteristics of the Nanobody.
Considering its aforementioned benefit-safety profile and the
potential for tissue
penetration, we believe SLK could differentiate by elevating the
treatment goals to
HiSCR75 and beyond, significantly bettering the current standard
of care, as well as
other similar drugs targeting its mechanism of action.
SLK has demonstrated in a Phase 2 study safety and efficacy in
psoriasis.
Please revise your disclosure to eliminate any suggestion that your
product candidates
have been or will ultimately be determined to be safe or effective or
to have demonstrated
efficacy for purposes of granting marketing approval, including
comparisons to the
current standard of care. In your revised disclosure, please replace
all claims or
conclusions related to efficacy with a description of the objective
data resulting from the
trials.
15. We note your statement that you "are positioned to accelerate the
clinical development of
SLK." Please revise this disclosure and any similar disclosure
throughout the prospectus
to remove any implication that you will be successful in
commercializing your product
candidates in a rapid or accelerated manner as such statements are
speculative.
Our Solution: The Tri-Specific Nanobody Sonelokimab (SLK), page 183
16. We note your disclosure on page 185 stating that "SLK s Phase 2
clinical trial data in
psoriasis indicated that IL-17A/F inhibition provided by SLK is
potentially associated
with a safety profile that is consistent with current IL-17A
inhibitors and is more
favorable than bimekizumab, the other IL-17A/F product in
development." If you have not
conducted actual head-to-head trials, please revise your disclosure
here and elsewhere to
clearly state this fact and disclose why you believe these comparisons
are appropriate. If
you provide disclosure regarding results from other trials, expand
your disclosure to
provide additional information regarding these trials that would help
an investor make a
meaningful comparison (e.g., number of subjects, trial design,
statistical significance,
etc.).
Background opportunity in inflammatory diseases, page 186
17. Please disclose your basis or a source for the following
statementsmade in this section,
including the methodology and any material assumptions and limitations
underlying the
estimates:
Bihua Chen
FirstName LastNameBihua Chen
Helix Acquisition Corp.
Comapany 24,
November NameHelix
2021 Acquisition Corp.
November
Page 6 24, 2021 Page 6
FirstName LastName
"[The Psoriasis] market is projected to grow to over $25
billion by 2029."
" The global PsA therapeutics market was valued at $7.9 billion
in 2019 and is
expected to grow to approximately $10 billion by 2029."
"The global r-axSpA market was valued at around $4 billion in
2019 and is expected
to grow to closer to $5 billion in 2029"
"The global HS market was estimated to be approximately $1.0
billion in 2019 and is
expected to grow to over $3.0 billion by 2029"
Our Pipeline, page 188
18. Please revise to explain what you mean by SLK for the treatment of
psoriasis is "Phase 3-
ready." Please also shorten the lines in your pipeline table for all
four indications since
you have yet to initiate Phase 3 trials for psoriasis or Phase 2
trials for PsA, axSpA, and
HS.
Clinical Development of SLK, page 189
19. We note your disclosure regarding certain clinical trials in this
section. Please expand
your disclosure to discuss specific trial results for your product
candidate on which you
intend to rely, including the duration of the trial, the number of
subjects or patients in such
trials, how the product candidate was administered, who conducted the
trials, the dosage
used, any serious adverse events experienced, the primary and
secondary endpoints and
whether they were met. Also, please be sure to identify the year or
years when referenced
trials were conducted or commenced.
MoonLake Management's Discussion and Analysis of Financial Condition and
Results of
Operations
Liquidity and Capital Resources, page 214
20. We note on page F-31 that MoonLake's Report of Independent Registered
Public
Accounting Firm includes an explanatory paragraph regarding MoonLake's
ability to
continue as a going concern. Please revise this section, the risk
factors and the
Summary to address these going concern issues.
Helix Acquisition Corp.
Condensed Statements of Operations, page F-3
21. For the three months ended June 30, 2021, please revise here and on
page F-11 the Basic
and Diluted net loss per share, Non-Redeemable Ordinary Shares to
present a loss using
parentheticals, such as ($0.05).
22. Revise to update your financial statements for the period ended
September 30, 2021, and
clearly disclose the recent restatement.
Bihua Chen
Helix Acquisition Corp.
November 24, 2021
Page 7
MoonLake Immunotherapeutics AG
Statement of Operations, page F-33
23. Consistent with above, please revise your presentation of the Basic
and Diluted net loss
per common share to present a loss using parentheticals, such as
($47.80).
Notes to the Financial Statements
Note 13. Subsequent Events
Share-based compensation plan, page F-46
24. Please clarify if your BOD granted common shares or granted options to
acquire common
shares under the share based compensation plan. In addition, disclose
the price per share
these share-based awards were valued. If options to acquire common
shares were granted,
disclose the vesting requirements if applicable.
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.
You may contact Sasha Parikh at 202-551-3627 or Kevin Vaughn at
202-551-3494 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jordan Nimitz at 202-551-5831 or Ada D. Sarmento at 202-551-3798 with
any other
questions.
FirstName LastNameBihua Chen Sincerely,
Comapany NameHelix Acquisition Corp.
Division of
Corporation Finance
November 24, 2021 Page 7 Office of Life
Sciences
FirstName LastName