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United States securities and exchange commission logo
August 13, 2020
Megan Baldwin, Ph.D.
Chief Executive Officer and Managing Director
Opthea Limited
Level 4
650 Chapel Street
South Yarra, Victoria 3141
Australia
Re: Opthea Limited
Draft Registration
Statement on Form F-1
Submitted July 17,
2020
CIK No. 0001815620
Dear Dr. Baldwin:
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 F-1 submitted July 17, 2020
COVER PAGE
1. We note your disclosure
that the last reported sale price of your ordinary shares on the
Australian Securities
Exchange was A$ _____ per ordinary share and that the final
offering price will be
determined through negotiations with the underwriters and will take
into account market
conditions and other factors. However, your statements on page 187
indicate that your
underwriters propose to offer the shares at the price set forth on the
cover page. Please
revise your cover page to provide a bona fide range for the ADSs, or
alternatively, you may
use the most recent home market trading price, converted to US
Megan Baldwin, Ph.D.
FirstName LastNameMegan Baldwin, Ph.D.
Opthea Limited
Comapany
August 13, NameOpthea
2020 Limited
August
Page 2 13, 2020 Page 2
FirstName LastName
dollars at the most recent exchange rate, if the U.S. IPO price will
be substantially similar
to the home market trading price.
2. Please revise your third paragraph to disclose that there is currently
no established public
trading market in the U.S. for the offered securities.
PROSPECTUS SUMMARY
Overview, page 1
3. Please revise to limit the discussion of clinical trial results in
your prospectus summary to
the endpoints of the trial and whether they were met. Also balance
your disclosure by
adding a discussion of serious adverse events, which you discuss in
the Business section,
and that you do not have any data for OPT-302 for longer than 24
weeks.
4. We note your statement that there is a significant and expanding
market opportunity in
wet AMD. Please quantify the current market size. It is not clear from
the disclosure
whether the current market size is equal to the worldwide sales of
ranibizumab and
aflibercept or some other figure.
5. The pipeline tables on pages 3 and 97 appears to present two separate
programs for Wet
AMD. Please remove the second arrow, otherwise revise to clarify, or
advise.
Implications of Being an Emerging Growth Company, page 5
6. 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.
RISK FACTORS
We have received tax incentives under the Research and Development Tax
Incentive scheme in
Australia. . ., page 35
7. Revise to quantify the amount of cash incentives at issue.
As a foreign private issuer, we are permitted to adopt certain home country
practices..., page 66
8. We note your disclosure on page 66 and throughout the prospectus that
you intend to
follow home country corporate governance practices. Please revise to
provide a concise
summary of all material differences between corporate governance
practices in Australia
and required by Nasdaq for domestic companies.
USE OF PROCEEDS, page 72
9. Please revise to identify the stage of development you expect to
achieve for your product
candidate in the wet AMD indication with the proceeds of the offering.
If the anticipated
proceeds will not be sufficient to fund all the proposed purposes,
please disclose the order
Megan Baldwin, Ph.D.
Opthea Limited
August 13, 2020
Page 3
of priority of such purposes. To the extent material amounts of other
funds are necessary
to accomplish the specified purposes, state the amounts and sources of
such other funds
needed for each specified purpose. Refer to Item 3.C.1 of Form 20-F.
10. To the extent that a material amount of proceeds remain after the
allocation to OPT-302
for wet AMD, please revise your disclosure to include the estimated
amount of proceeds
you plan to allocate for each of the uses identified in the second
bullet point.
BUSINESS
Phase 1/2a Clinical Trial Results in Wet AMD, page 103
11. We refer to the comparison in the second full paragraph on page 104 of
your Phase
1/2a data to historical results from the pivotal Phase 3 ranibizumab
monotherapy trial.
Please remove this comparison as it is not based on a head-to-head
study. We note that
your discussion of your Phase 2b results includes a comparison of the
results from the 2.0
mg OPT-302 combination therapy group with those from the ranibizumab
monotherapy
group.
Phase 2b Clinical Trial Results in Wet AMD, page 105
12. Please provide a textual discussion of the statistical analysis
performed on the data
presented on pages 107-114. Also add an explanation of how statistical
significance
relates to the approval process of the FDA and other regulators.
13. Please revise the first sentence of the penultimate paragraph on page
113 to explain the
significance of these observations.
Phase 2a Clinical Trial of OPT-302 in DME, page 118
14. We refer to your statement on page 122 that you have extensive dosing
experience
demonstrating a "favorable safety profile." Safety determinations are
within the authority
of the FDA and comparable regulatory authorities, and such statements
are not
appropriate. Please revise to remove this statement.
Board of Directors, page 144
15. Please clarify the paragraph on page 144 to explain, if true, that
retiring directors are
eligible for re-election.
MANAGEMENT
Employment Agreements with
FirstName LastNameMegan Senior Management,
Baldwin, Ph.D. page 150
Comapany
16. PleaseNameOpthea Limited agreements with each of your executive
officers as exhibits
file your employment
Augustto13,
the2020
registration
Page 3 statement. See Instruction 4 to Exhibits on Form 20-F.
FirstName LastName
Megan Baldwin, Ph.D.
FirstName LastNameMegan Baldwin, Ph.D.
Opthea Limited
Comapany
August 13, NameOpthea
2020 Limited
August
Page 4 13, 2020 Page 4
FirstName LastName
PRINCIPAL SHAREHOLDERS, page 155
17. Please identify the natural persons who are the beneficial owners of
the shares held by the
5% or greater shareholders identified in your table.
DESCRIPTION OF AMERICAN DEPOSITARY SHARES
Governing Law/Waiver of Jury Trial, page 173
18. We note your disclosure regarding the waiver of jury trial provision
on page 173. Please
include a risk factor to highlight the material risks related to this
provision, including the
possibility of less favorable outcomes, uncertainty regarding its
enforceability, the
potential for increased costs to bring a claim, whether it may
discourage or limit suits
against you or the depositary and whether the provision applies to
purchasers in secondary
transactions. Also disclose whether this provision would apply if the
ADS holder were to
withdraw the ordinary shares.
You may contact Nudrat Salik at 202-551-3692 or Brian Cascio at
202-551-3676 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Dorrie Yale at 202-551-8776 with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Ferish Patel, Esq.