SecProbe.io

October 22, 2024
Nicholas Murphy
Chief Executive Officer and Managing Director
GenEmbryomics Limited
Level 14, Australia Square
264-278 George Street,
Sydney NSW 2000
Australia
Re:GenEmbryomics Limited
Draft Registration Statement on Form F-1
Submitted September 24, 2024
CIK No. 0002038033
Dear Nicholas Murphy:
            We have reviewed your draft registration statement and have the following comments.
            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 a comment applies 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 this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form F-1 submitted September 24, 2024
Cover Page
1.We note that this prospectus relates to both a primary offering and a secondary
offering. Please revise your cover page to clearly highlight at the forefront that the
secondary offering will not commence until after the closing of your initial public
offering and listing of the ordinary shares on the Nasdaq Capital Market, as you state
on page 45. Also revise to discuss the duration of the secondary offering, and clarify
whether the secondary offering is underwritten and the type of offering (firm
commitment or a best efforts offering). Refer to Item 501(b)(3) of Regulation S-K.

October 22, 2024
Page 2
Prospectus Summary, page 8
2.We note your disclosure on pages 27 and 75 that your products are currently
considered laboratory-developed tests (LDTs). Please include similar disclosure in
your prospectus summary accordingly.
3.We note your disclosure on page 9 that you "intend to progress the MoU with
Progenesis to a Heads of Agreement and have agreed with Progenesis to negotiate in
good faith to finalise the Heads of Agreement within 120 days from the MoU
execution date." We refer to your disclosure that the MoU was entered into on March
18, 2024. We also note your reference on page 59 to your "recently established
strategic partnership with Progenesis." Please revise your disclosure here and
throughout the prospectus to disclose the current status of the Heads of Agreement
with Progenesis and clarify, if true, that the proposed Heads of Agreement would be a
non-binding agreement. If you have entered into the Heads of Agreement with
Progenesis, please disclose the material terms of such agreement and file the
agreement as an exhibit to the registration statement or explain to us why you believe
you are not required to do so. Refer to Item 601(b)(10) of Regulation S-K. Please also
include appropriate risk factor disclosure to address any risks you may face if you fail
to enter into the Heads of Agreement and/or a binding agreement with Progenesis or
your two other potential partner IVF clinics, as applicable.
4.We note your disclosure in the Summary that the Early Adopter Agreements and
MoU with Progenesis constitute a “critical component of your strategy globally” and
“form the foundation for [y]our future commercial testing services.” Please balance
your disclosure with equally prominent disclosure concerning the challenges you face
in implementing your business strategy and gaining market acceptance. As examples
only, we note that you have not entered into binding agreements with partner IVF
clinics to date and also refer to your history of net losses and accumulated deficit.

5.Please revise your disclosure here and throughout the prospectus to clarify the
meaning and significance of scientific or technical terms the first time they are used in
the Summary and throughout the prospectus in order to ensure that lay readers will
understand the disclosure. For example only, fluorescence in situ hybridization, next-
generation sequencing, fertility-fraud, consanguinity, medelian and syndromic
diseases, and enterprise scale LIMS and EMS.
Implications of Being an "Emerging Growth Company", page 13
6.Please revise your disclosures here and on page 41 to clarify that you will be required
to conduct an evaluation of (y)our internal control over financial reporting beginning
with the filing of your second Form 10-K post effectiveness of this Form F-1.  Refer
to the guidance in Item 308(a) of Regulation S-K and the Instruction to Item 308 of
Regulation S-K.
Recent Developments, page 13
Please revise your presentation of the number of ordinary shares and any per share
data to reflect the share split of four and one half Ordinary Shares for every one 7.

October 22, 2024
Page 3
Ordinary Share throughout your disclosures in the Form F-1 along with clear
disclosure that you have adjusted all share and per share data to retroactively reflect
the share split for all periods presented.  As an example, we note your disclosure for
the Pre-IPO Raise of 39,119 Ordinary Shares, which does not appear to reflect the
share split.
The Offering, page 18
8.Please expand your disclosures regarding the number of Ordinary Shares outstanding
immediately after this offering to include the shares to be issued to the Promissory
Noteholders.
Uncertainty in the development and commercialization of our products, page 24
9.We note your disclosure on page 24 that “the launch of any new diagnostic test,
particularly those in the field of IVF and assisted fertility, will require the completion
of certain clinical validation studies to substantiate the utility of our technologies and
ensure their efficacy and safety in various demographic groups” and that “these trials
will involve the expenditure of substantial cash resources and may require large
numbers of patient specimens and, for certain products, large, prospective, and
controlled clinical trials.” Please expand your disclosure, where appropriate, relating
to the requirements to launch new diagnostic tests in the field of IVF and the types of
products that may require such clinical validation studies.
We continue to spend a significant amount of resources on research and development that
may not lead to successful products or the..., page 24
10.We note your disclosure here that "Panacea-GenomeScreen™ is not currently subject
to U.S. Food & Drug Administration (FDA) oversight." You also disclose on page 68
that you plan to enter your products into the European market in 2025. Please revise to
discuss whether your product is subject to oversight by similar regulatory agencies in
Europe. Please also clarify whether any of your other product candidates, including
the Couplet-GenomeScreen, Ova-GenomeScreen and Serendipity-GenomeScreen, are
subject to oversight by the FDA or similar regulatory agencies in Europe.
We rely on a limited number of suppliers, or in some cases, a single supplier, for some of our
test kits and materials and may not be..., page 28
11.We note your disclosure that you are dependent on a sole supplier for certain
components of your test kits.  Please revise to describe your source and the
availability for these components. Refer to Item 4.B.4 of Form 20-F.
Risk Factors
"We are an "emerging growth company" under the JOBS Act...", page 39
We note your disclosure that you intend to take advantage of the extended transition
period provided under Section 7(a)(2)(B) of the Securities Act for complying with
new or revised accounting standards.  Please revise your disclosure to clarify that this
option is not available to you, as your consolidated financial statements are prepared
in accordance with International Financial Reporting Standards (IFRS) as issued by
the International Accounting Standards Board (IASB), which does not provide for 12.

October 22, 2024
Page 4
extended transition periods for new or revised accounting standards.
Use of Proceeds, page 46
13.We refer to your disclosure on page 72 relating to the various products in your
development pipeline, including the Ova-GenomeScreen, Serendipity-GenomeScreen
and the Genome Sharing Platform. Please confirm whether you intend to use the
proceeds of this offering towards the development of these products, and if so, how
much you intend to allocate and how far the proceeds from the offering will allow you
to proceed with such products, as applicable. Refer to Item 3.C of Form 20-F, as
required by Item 4 of Form F-1.
Capitalization and Indebtedness, page 47
14.Please expand your tabular presentation to address the following:
•Include the use of proceeds from the IPO for the repayment of accrued interest
outstanding on the Promissory Notes.  Address this with the preparation of the
Dilution table.
•Include total capitalization line item, which is the sum of indebtedness and
shareholders’ equity/(deficit).
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 51
15.Please expand your disclosure to include an analysis of all of your operating expenses,
including employee benefits expense and share based payments.  As part of your
analysis, disclose the portion of the expenses that relates to general and administrative
activities, research and development activities and marketing activities for each period
presented.
16.Considering the significance of your research and development activities to your
business, please provide quantification of the nature of the material components of
your research and development expenses, including any compensation expense
recognized elsewhere, for each period presented.
Business, page 59
17.We refer to your disclosure on page 51 that you are “currently conducting clinical
trials in collaboration with leading IVF centers worldwide to validate the clinical
utility and cost-effectiveness of [y]our Panacea-GenomeScreen test.” Please expand
your disclosure, where appropriate, to discuss the scope and design of the clinical
trials, including the size of each trial and the parties who conducted the trials, the
primary endpoint, whether the trials are powered for statistical significance, and to
discuss the clinical observations.
Cost of Sequencing a Human Genome, page 61
We note your disclosures relating to the estimates for the total addressable market for
preimplantation genetic testing and the WGS market and have the following
comments:
 18.

October 22, 2024
Page 5
•We note your disclosure on page 61 that the global preimplantation genetic testing
market was estimated to be worth $0.7 billion and is expected to reach $1.2
billion by 2028 based on a CAGR of 11.4% from 2023 to 2028. Please revise to
provide the addressable market for the preimplantation genetic testing market in
the United States and discuss any material assumptions underlying these
projections; and
•We also refer to your disclosure that "[t]he global market size of WGS was valued
at US$5.5 billion in 2022 and is projected to reach US$30.l billion by 2032, with
a compound annual growth rate (CAGR) of 18.7% from 2023 to 2032." Please
provide a citation for and discuss the material assumptions underlying this
projection.

Key Relationships, page 67
19.We refer to your disclosure relating to the Master Services Agreement you entered
into with Cima Growth Solutions, LLC. Please revise to disclose the material terms of
the agreement, including the termination provision, and file such agreement as an
exhibit to the prospectus as required by Item 601(b)(10) of Regulation S-K or tell us
why you believe you are not required to do so.
20.We note your disclosure that you have partnered with Illumina Inc. to access
Illumina’s AI-powered system to assist with the analysis your raw WGS data. You
also disclose on page 50 that you are “currently licensing in partnership with Illumina
Inc.” Please revise your disclosure to clarify, if true, that you have entered into a
license agreement with Illumina. Please expand your disclosure to discuss the material
terms of such agreement, including without limitation, each party's rights and
obligations, the aggregate amounts paid to date (including any upfront, execution or
maintenance fees), the term of the agreement, the royalty term and royalty rate or
range, and the termination provisions, as applicable.
21.We note your disclosure in the Summary and elsewhere in the prospectus that you
entered into five letters of intent with potential partner IVF clinics in the year ended
June 30, 2023, which laid the groundwork for the three Early Adopter Agreements
you entered into in 2024, which subsequently led to the Memorandum of
Understanding with Progenesis. Please expand your disclosure to specify when you
entered into the five letters of intent and clarify your disclosure here and elsewhere in
the prospectus that Progenesis was identified as one of the three potential partner IVF
clinics. Please revise to provide a brief description of the material terms of the Early
Adopter Agreements and file such agreements as exhibits to the registration statement
or explain to us why you believe you are not required to do so. Refer to Item
601(b)(10) of Regulation S-K.
Development Pipeline, page 72
You disclose here and throughout the prospectus that you are working on several
additional products, such as Ova-GenomeScreen, Serendipity-GenomeScreen, and
Genome Sharing Platform. By way of example, we refer to your disclosure on page 72
that you expect to launch the Couplet-GenomeScreen genetic testing service in the 22.

October 22, 2024
Page 6
third quarter of the fiscal year ended June 30, 2025. Please expand your disclosure,
where appropriate, to describe in greater detail the timeline for the development of
each your products and software, including descriptions of any clinical trials, as
applicable. Please also address the following issues in your revised disclosure:

•With respect to your Couplet-GenomeScreen test, we note your disclosure that the
use of haplotype phased data provides a “more accurate depiction of an
individual’s genetic makeup”. Please expand your disclosure to discuss the type
of information haplotype unphased data provides, how Couplet-GenomeScreen
differs from current carrier testing methodologies, and whether current carrier
testing approaches utilizes haplotype phased and unphased data; and

•Please revise to provide additional detail relating to the technology and
methodologies used in your Ova-GenomeScreen product, including whether the
test utilizes Whole-Genome Sequencing analysis. Please clarify whether your
Serendipity-GenomeScreen test utilizes different technologies and/or
methodologies as your Couplet-GenomeScreen and Ova-GenomeScreen products,
if any.

Quality Control, page 73
23.We note your disclosure that you have adopted Qualio as your electronic quality
management system (eQMS) software and have partnered with Compliancy Group,
Inc. to ensure that your quality management system complies with regulatory
requirements. Please disclose if you have entered into any agreements with respect to
your Qualio eQMS software and with the Compliancy Group, and if so, please
provide a brief description of the material terms of the agreements and file such
agreements as exhibits to the registration statement or explain to us why you believe
you are not required to do so. Refer to Item 601(b)(10) of Regulation S-K.
IP Registrations and Applications, page 75
24.We note your disclosure on page 75 that your intellectual property portfolio “includes
a patent family that safeguards the proprietary technology and methods used in
Panacea-GenomeScreen.” Please clarify whether your intellectual property portfolio
currently includes any issued patents. For each material patent or patent application,
please revise your disclosure here to disclose:

•the specific product(s) or technology to which such patents or patent applications
relate;
•the type of patent protection (composition of matter, use or process);
•th