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United States securities and exchange commission logo
October 8, 2021
Errol De Souza
Executive Chairman
Bionomics Limited/FI
200 Greenhill Road
Eastwood SA 5063
Australia
Re: Bionomics Limited/
FI
Draft Registration
Statement on Form F-1
Submitted September
10, 2021
CIK No. 0001191070
Dear Mr. Souza:
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.
DRS Form F-1 filed September 10, 2021
Cover Page
1. We note your statement
that the closing price of your ordinary shares on the Australian
Securities Exchange was
A$ per ordinary share, equivalent to a price of US$
per ADS. You may use
the most recent home market trading price, converted to U.S.
dollars at the most
recent exchange rate, assuming the U.S. IPO price will be largely based
on the home market
trading price. If you expect that the U.S. IPO price will not be
substantially the same
as the home market trading price, please disclose on the cover page
of the preliminary
prospectus a bona fide price range of the offered securities.
Errol De Souza
FirstName
Bionomics LastNameErrol De Souza
Limited/FI
Comapany
October NameBionomics Limited/FI
8, 2021
October
Page 2 8, 2021 Page 2
FirstName LastName
BNC210, page 2
2. Please revise the summary to discuss briefly the federal and state
regulation of your
combination of BNC210 and EMP-01 as a controlled substance. Please
also include any
related risk in your bulleted risks listed on page 4.
3. We note that you received Fast Track designation from the FDA for your
PTSD program.
Please balance this with disclosure that such designation may not
result in a faster
development process and does not assure approval by the FDA.
Our Portfolio, page 2
4. We note the inclusion of undisclosed product candidates relating to
the treatment of pain
and cognition in your pipeline table. Given the limited amount of
disclosure related to
these programs, please explain why these programs are sufficiently
material to your
business to warrant inclusion in your pipeline table. If they are
material, please expand
your disclosure in your Business section to provide a more fulsome
discussion of these
programs, including a description of preclinical studies or
development activities
conducted. Alternatively, remove any programs that are not currently
material from your
pipeline table on pages 2 and 106. Please also identify the two
product candidates that are
in Phase 1 development under the Merck collaboration.
Legacy Oncology Programs, page 3
5. Please quantify the amount of payments you have received to date under
the license
agreement with Carina Biotech and the current stage of development of
BNC101 under
the agreement.
Our Early-Stage CNS Assets, page 3
6. We note your statement that your early stage programs are at a similar
stage to the stage at
which the a7 receptor PAM program was licensed under the 2014 Merck
License
Agreement. Please balance this disclosure with the fact that there is
no guarantee that
these programs will ever be licensed out.
a7 Receptor PAM Program with Merck, page 3
7. We note the statement that you are eligible to receive up to US$465
million in milestone
payments for achievement of certain development and commercial
milestones.
Please disclose that because Merck controls the clinical development
and worldwide
commercialization of any products developed from the collaboration,
you cannot predict
whether or when you might achieve any milestone payments under the
collaboration or
estimate the full amount of such payments, and that you may never
receive any such
payments. Additionally, please disclose you will not receive any
royalty payments from
Merck as a result of the contingent value right to be issued for the
sole benefit of your
existing shareholders. Please also explain the extent to which you
have access to
Errol De Souza
FirstName
Bionomics LastNameErrol De Souza
Limited/FI
Comapany
October NameBionomics Limited/FI
8, 2021
October
Page 3 8, 2021 Page 3
FirstName LastName
information related to clinical trial results, serious adverse events
and ongoing
communications with the FDA relating to these programs or the extent
to which Merck
is required to provide you with this information.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 5
8. 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.
Dilution, page 88
9. Please revise your definition of net tangible book value to more
clearly explain your
calculation of net tangible book value and per share information.
Licenses and Collaboration, page 94
10. We note your disclosure here and on page 127 that Merck is required to
make tiered
royalty payments on a product-by-product and country-by-country basis,
ranging from
mid single-digit to low double-digit percentage royalty rates. Please
refine your disclosure
to provide a more exact description of the high end of the range
(e.g., low teens) to ensure
that you have described the royalty rate within a ten percentage point
range.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 98
11. Please revise your discussion of other income on page 99 to quantify
the impact for each
of the factors you cited for the change in the amounts between the
years ended June 30,
2020 and June 30, 2021.
Business
Overview, page 106
12. 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). 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
statements/inferences throughout your prospectus that your product
candidates are safe
and/or effective. As a non-exhaustive list of illustrative examples
only, we note the
following:
On page 107, you state "BNC210 has...demonstrated anti-anxiety
and antidepressant
effects..."
Errol De Souza
Bionomics Limited/FI
October 8, 2021
Page 4
On page 107, you refer to an extensive safety database.
On page 107, you state "[W]e have observed three key
anxiety-reducing features
associated with BNC210:
o statistically significant reductions in hyperactivity in the
amygdala, the region of
the brain responsible for emotional control, when exposed
to fear-inducing triggers;
o in a head-to-head study, showed a statistically significant
reduction in the
intensity of defensive behavior, while lorazepam, a widely
prescribed benzodiazepine did not; and
o a statistically significant reduction in the intensity and
total number of panic
symptoms as well as more rapid recovery from the panic state
relative to placebo
On page 107, you state "a target blood exposure predicted to
show clinically
meaningful benefit for patients suffering from PTSD."
On page 109, you reference "favorable safety data" when
discussing BNC210.
On page 114, you state BNC210 has the potential for "similar
clinical efficacy
without many of the limiting side effects observed with
benzodiazepines, SSRIs and
SNRIs."
On page 125, you state "Representative molecules from each
series have been
observed to reverse pharmacologically induced cognitive deficits
in mouse and rat
models with equivalent efficacy to risperidone, an antipsychotic
drug used to treat
schizophrenia, used as the positive control."
On page 125, you state "Preclinical studies showed BNC101 was
able to target and
reduce the frequency of cancer stem cells derived from primary
patient colorectal
tumors both in vitro and in vivo."
Legacy Oncology Program, page 108
13. We note that you have a license agreement with Carina Biotech and a
collaboration
agreement with EmpathBio. Please provide the license and collaboration
agreements
as exhibits, and please revise the descriptions of these agreements to
disclose:
each parties' rights and obligations under the agreement;
quantify all payment made to date;
disclose separately the aggregate amount of all potential
development, regulatory and
commercial milestone payments;
disclose the amount of option fees for additional targets;
quantify the royalty rate, or a range no greater than 10 percentage
points per tier;
disclose when royalty provisions expire, if the expiration is based
on a number of
FirstName LastNameErrol
years following De Souza
commercialization, disclose the number of years;
Comapany NameBionomics
disclose Limited/FI
the expiration date; and
October 8, 2021
describe any
Page 4 termination provisions.
FirstName LastName
Errol De Souza
FirstName
Bionomics LastNameErrol De Souza
Limited/FI
Comapany
October NameBionomics Limited/FI
8, 2021
October
Page 5 8, 2021 Page 5
FirstName LastName
Our Strategy, page 109
14. We note your disclosure here and throughout your prospectus regarding
your goal of
developing and commercializing "novel, first-in-class" treatments.
Please remove
references to "first-in-class" as this statement implies an
expectation of regulatory
approval and is inappropriate given the length of time and uncertainty
with respect to
securing marketing approval. If your intention is to convey your
belief that your platform
or your programs utilize a novel technology or approach, you may
discuss how your
technology differs from technology used by competitors or that you are
not aware of
competing products that are further along in the development process.
Statements such as
these should be accompanied by cautionary language that the statements
are not intended
to give any indication that your technology or any potential product
candidates have been
proven effective or will receive regulatory approval.
15. We note your disclosure here and in the Summary that your strategy is
to
"rapidly progress" clinical development for your BNC210 product.
Please revise these
statements and any similar disclosure 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.
Potential Advantages of BNC210 for the Treatment of Anxiety and
Stressor-Related Disorders,
page 114
16. Please remove the table on page 115 regarding BNC210 vs. current
therapies. The
table implies an expectation of regulatory approval and is
inappropriate given the early
stage of development of BNC210.
Clinical Development of BNC210, page 115
17. Please revise your graphics throughout pages 119-122 so that they are
large enough to be
legible for investors.
18. Please provide p-values for the results of your trials or explain why
you are unable to
provide such values. At first use, please provide a brief explanation
of the disclosed p-
value and how it is used to measure statistical significance.
Intellectual Property, page 128
19. We note your statements that you have patented 1) two series of small
molecule inhibitors
with functional selectivity for Nav1.7 and Nav1.8 voltage gated sodium
channels for the
treatment of chronic pain and 2) two series of small molecule
Kv3.1/3.2 potassium
channel activators for the potential treatment of cognitive deficits
and negative symptoms
in schizophrenia and for the treatment of autism spectrum disorders.
Please expand your
Intellectual Property section to include descriptions of these
patents.
Errol De Souza
FirstName
Bionomics LastNameErrol De Souza
Limited/FI
Comapany
October NameBionomics Limited/FI
8, 2021
October
Page 6 8, 2021 Page 6
FirstName LastName
Principal Shareholders, page 162
20. Please identify the natural person or persons who directly or
indirectly exercise sole or
shared voting and/or dispositive power with respect to the common
stock held by BVF
Partners L.P. and Apeiron Investment Group Ltd.
Consolidated Financial Statements , page F-3
21. You disclose in Note 2(ii) that all amounts in the financial
statements are presented in
Australian dollars. Please state the currency on the face of the
financial statements as you
have done elsewhere in the filing and as required under Rule 3-20 of
Regulation S-X.
Notes to the Financial Statements
Note 2: Summary of Significant Accounting Policies
(iii) Application of New and Revised Accounting Standards , page F-9
22. You stated on page 6 that you are an Emerging Growth Company ("EGC")
and elected to
take advantage of an extended transition period for complying with new
or revised
accounting standard. We further note you adopted all the new and
revised Standards and
Interpretations issued by the IASB and effective for an accounting
period that begins on or
after July 2020. However, the EGC accounting deferral is not
applicable to IFRS filers.
Refer to the cover page of Form F-1, and please revise accordingly.
You may contact Christie Wong at 202-551-3684 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 202-551-6001 or Christopher Edwards at 202-551-6761
with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Nathan Ajiashvili, Esq.