<SEC-DOCUMENT>0000000000-21-013712.txt : 20220114
<SEC-HEADER>0000000000-21-013712.hdr.sgml : 20220114
<ACCEPTANCE-DATETIME>20211112103003
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-21-013712
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20211112

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			BIONOMICS LIMITED/FI
		CENTRAL INDEX KEY:			0001191070
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			C3

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		31 DALGLEISH STREET
		CITY:			THEBARTON
		STATE:			C3
		ZIP:			5031
		BUSINESS PHONE:		61 8 8354 6107

	MAIL ADDRESS:	
		STREET 1:		31 DALGLEISH STREET
		CITY:			THEBARTON
		STATE:			C3
		ZIP:			5031
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
United States securities and exchange commission logo





                              November 12, 2021

       Errol De Souza
       Executive Chairman
       Bionomics Limited/FI
       200 Greenhill Road
       Eastwood SA 5063
       Australia

                                                        Re: Bionomics Limited/
FI
                                                            Amendment No. 1 to
                                                            Draft Registration
Statement on Form F-1
                                                            Submitted October
28, 2021
                                                            CIK No. 0001191070

       Dear Mr. Souza:

             We have reviewed your amended 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.

       Amendment No. 1 to Draft Form F-1 filed October 28, 2021

       BNC201, page 2

   1.                                                   We note your revisions
in response to our prior comment 2 and reissue in part.
                                                        Please include in your
summary risk factors on page 4 the risk related to federal and state
                                                        regulation of your
combination of BNC210 and EMP-01 as a controlled substance.
       Our Portfolio, page 2

   2.                                                   We note your response
to prior comment 4. Please delete references to the undisclosed
                                                        programs. Since these
programs are in clinical development, they should be disclosed.
 Errol De Souza
FirstName
Bionomics LastNameErrol  De Souza
          Limited/FI
Comapany 12,
November  NameBionomics
              2021        Limited/FI
November
Page  2   12, 2021 Page 2
FirstName LastName
a7 Receptor PAM Program with Merck, page 3

3.       We note your response to our prior comment 7 and reissue in part.
Please disclose that 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 control the clinical development process, whether
you have access to
         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.

Potential Advantages of BNC210 for the Treatment of Anxiety and
Stressor-Related Disorders,
page 114

4.       We note your response to our prior comment 16 and reissue. Dividing
the previous
         table into two separate tables does not resolve the implied
expectation of regulatory
         approval, which is still inappropriate given the early stage of
BNC210's development.
         Please remove the tables on page 115.
Legacy Oncology Programs, page 125

5.       We note your response to our prior comment 12 and reissue in part.
Please revise the
         below statements to disclose your objective observations from the
trials without
         concluding that the product candidate was effective or had an impact
on the observed
         results. Any conclusions regarding efficacy are within the sole
authority of the FDA. For
         example, we would not object to a statement such as "In preclinical
studies, BNC101 was
         associated with a reduction in the frequency of cancer stem cells..."

                On page 125, "Representative molecules from each series have
been observed to
              reverse pharmacologically induced cognitive deficits in mouse and
rat models with
              equivalent activity to risperidone, an antipsychotic drug used to
treat schizophrenia,
              used as the positive control."
                On page 125, "In preclinical studies, BNC101 targeted and
reduced the frequency of
              cancer stem cells derived from primary patient colorectal tumors
both in vitro and in
              vivo."
6.       We note your response to our prior comment 13. To the extent the
product
         candidate relating to your memorandum of understanding with EmpathBio
is material, the
         memorandum supporting the development of this product candidate is
material and should
         be fully described and filed as an exhibit pursuant to Item 601(b)(10)
of Regulation S-K,
         or provide an analysis as to why you do not believe filing is
required. If you do not
         consider the agreement material, please remove the collaboration from
the table.

       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
 Errol De Souza
Bionomics Limited/FI
November 12, 2021
Page 3

contact Jordan Nimitz at 202-551-5831 or Christopher Edwards at 202-551-6761
with any other
questions.



                                                         Sincerely,
FirstName LastNameErrol De Souza
                                                         Division of
Corporation Finance
Comapany NameBionomics Limited/FI
                                                         Office of Life
Sciences
November 12, 2021 Page 3
cc:       Nathan Ajiashvili, Esq.
FirstName LastName
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
