SecProbe.io

January 27, 2025
Iris Bincovich
Chief Executive Officer
Innocan Pharma Corporation
1015, 926 - 5 Avenue SW
Calgary, Alberta T2P 0N7
Canada
Re:Innocan Pharma Corporation
Draft Registration Statement on Form F-1
Submitted December 31, 2024
CIK No. 0001889791
Dear Iris Bincovich:
            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
Prospectus Summary
Overview, page 1
1.We note your disclosure that your "synthetic Cannabidiol-loaded Liposome injection
Platform (LPT-CBD) facilitates exact dosing and the prolonged and controlled release
of Synthetic CBD into the blood stream without the risk of addiction, tolerance and
dependency that is typical in opioids." Since you have not completed clinical trials
that have established these results, please revise your disclosure with appropriate
cautionary language, including to clarify that this is your expectation and that you are
in the pre-clinical stage for human and animal use with respect to this product
candidate.

January 27, 2025
Page 2
2.Briefly indicate the reason for using synthetic CBD in your LPT-CBD product
candidate. Briefly indicate what is proprietary about your LPT-CBD product
candidate and disclose whether you are seeking composition of matter patent
protection for the synthetic CBD molecule and for the liposomal formulation. Include
appropriate risk factor disclosure if you are not.
3.We note your disclosure that you have "initiated" the FDA regulatory review process
for LPT-CBD as a non-opioid alternative for chronic pain management in humans.
Please revise your disclosure to clarify here, as applicable, that you have not yet
submitted an IND or commenced clinical trials for the product candidate.
4.We note your disclosure that, in the Consumer Wellness segment, you have
established a joint venture, B.I. Sky Global Ltd., or B.I. Sky, your subsidiary. We also
note your disclosure on page 123 that you, together with Brandzon Co. Ltd., a private
company founded by Roni Kamhi, your Chief Operating Officer and a Director,
established B.I. Sky where you hold 60% and Brandzon holds 40% of B.I. Sky. Please
disclose here, and elsewhere as appropriate, your percentage ownership in B.I. Sky
and the related-party interest of Roni Kamhi. In addition, if an investment in your
company represents an ownership of 60% of the operations conducted in your
Consumer Wellness segment, please make that clear.
5.We note your disclosure that through B.I. Sky you develop and market high-
performance personal care and beauty products in the United States. However, we
note from your disclosure on pages F-9 and F-47 that your Consumer Wellness
segment sells products mainly in the European market, whereas your disclosure under
"Geographical analysis of revenue" on page F-30 indicates you have derived most of
your revenue in the United States for the last two fiscal years. Please indicate where
your Consumer Wellness products are sold and clarify the extent of your current
activities in the United States and European markets.
6.Please briefly describe the products from which you derive material revenues in the
Consumer Wellness segment. In this regard, we note your disclosure on page 36 that
"some of [y]our wellness products are formulated with plant derived cannabinoids
such as hemp derived CBD." In your description of your material products in the
Consumer Wellness segment, please make clear whether those products contain CBD,
derived from hemp or otherwise, and indicate the legal status of those products under
the laws of the United States and of the various states that you currently generate or
intend to generate revenue.
7.We note your disclosure that your patent portfolio includes 29 published patents
granted and pending across 7 families. We also note your disclosure under
"Intellectual Property" starting on page 105. Please clarify, if true, that your granted
patents relate to pain-relieving topical compositions sold in your Consumer Wellness
segment and that your patent applications related to your liposomal cannabinoids and
uses thereof are pending at this time.
Our Strengths, page 1
We note your reference to an advisory board. Please include disclosure in an
appropriate location that describes the role or function of your advisory board,
identifies each member, and indicates whether there are any rules or procedures 8.

January 27, 2025
Page 3
governing this board. Please also disclose how members of the advisory board are
compensated. If the function of your advisory board is not sufficiently material to an
investment decision, please consider whether it is appropriate to include related
disclosure in your prospectus summary.
9.We note your disclosure that you are pursuing FDA pathways designed to accelerate
the review and approval process for your therapies. Please revise to include balancing
disclosure that any accelerated approval pathways may not lead to a faster
development or regulatory review or approval process and does not increase the
likelihood that your product candidate will receive marketing approval. We note your
similar disclosure in the last bullet point on page 98. Please include balancing
disclosure for that disclosure as well.
10.Please briefly disclose the basis for your belief that securing a sponsor fee waiver
from the FDA's Center for Veterinary Medicine (CVM) for the development of LPT-
CBD for animal health is sufficiently material to highlight in your prospectus
summary. For example, indicate the basis for the fee waiver and how that impacts
your INAD application and the approval process.
Our Strategy, page 2
11.You disclose that the FDA acknowledged that LPT-CBD can be submitted under the
505(b)(2) abbreviated pathway pending a scientific bridge to the listed drug and that
the FDA has also agreed on your Phase I clinical study design which is essential for
filing an IND application for LPT-CBD. Please revise briefly here, and elsewhere
with sufficient detail as appropriate, to identify the "listed drug" and to address the
following:
•Convey more clearly to investors if the 505(b)(2) abbreviated pathway and the
filing of an IND are separate approval pathways, clarifying which pathway you
intend to pursue. For example, it is not sufficiently clear if these are separate
pathways, if you would need to conduct three phases of clinical trials for the
505(b)(2) abbreviated pathway, if you could just rely on the scientific bridge for
new drug approval or whether the scientific bridge would simplify your clinical
trial process. We also note your reference to Phase 1, Phase 2 and Phase 3 trials
on page 108.
•Disclose the status of your plans, if any, for establishing a scientific bridge to the
listed drug, and clarify whether there are any other material requirements you
must satisfy in pursuing the 505(b)(2) abbreviated pathway.
•If you expect to submit an application for an IND to study LPT-CBD in humans,
please disclose when you expect to do so.
Further to your discussion of the 505(b)(2) abbreviated pathway, we note your
disclosure on page 109 that the 505(b)(2) regulatory pathway that you may pursue for
LPT-CBD approval involves the FDA approving the new product candidate for all or
some of the labeled indications for which the referenced product has been approved,
as well as for any new indications sought by the 505(b)(2) applicant. Please disclose
the approved indications for the referenced product, or the "listed drug" as referred to
in this section, and any specific new indications that you will seek to have approved
for your LPT-CBD candidate. In this regard, we note your disclosure on page 1 12.

January 27, 2025
Page 4
regarding the regulatory review of LPT-CBD as a non-opioid alternative for chronic
pain management, as well as your disclosure on page 12 that any revenue earned on
approved product candidates will be dependent in part upon the breadth of the product
label. Also, expand your disclosure under "Competition" on page 103 to indicate how
the referenced product for purposes of your 505(b)(2) application will factor into your
competitive position.
13.We also note your disclosure that the CVM issued an Investigational New Animal
Drug, or INAD, number to facilitate your LPT-CBD development for animal health
applications. Clarify here and in your "Business" section whether you have submitted
an INAD application, or, if you have not, disclose when you anticipate submitting
your INAD application, and disclose whether you will need approval from the CVM
of your INAD application prior to commencing clinical activities for your LPT-CBD
product candidate in animals.
Summary Risk Factors, page 3
14.Revise your summary risk factors to also address your history of net losses,
accumulated deficit and the opinion of your auditor regarding the substantial doubt
about your ability to continue as a going concern.
15.We note the disclosure in the last bullet point on page 4 that you "may become subject
to U.S. federal and state forfeiture laws, negatively impacting our operations." Please
further expand this disclosure to indicate, as you have done at the bottom of page 45,
that investors located in jurisdictions where any of your product candidates remain
illegal may be at risk of prosecution under conspiracy, aiding and abetting, and money
laundering statutes, and may be at further risk of losing their investments or proceeds
under forfeiture statutes. Also identify the jurisdictions of concern.
16.Your disclosure in the third bullet point and in the related risk factor indicates that
your topical product lines are part of your "Pharmaceuticals" segment. However, other
disclosures throughout the prospectus indicate that your topical product lines are part
of your "Consumer Wellness" segment. Please revise your disclosures as appropriate
to reconcile this apparent inconsistency. In addition, clarify whether any of your
topical or other existing products have received or otherwise require regulatory
approval.
Summary Financial Data, page 9
17.We note you refer investors in this section, and in the Capitalization section on page
57, to a section titled "Selected Financial Data." Please revise to clarify what section
of your prospectus you are referring to by "Selected Financial Data."
We are an emerging growth company . . ., page 63
18.Your state here that you have elected to delay adoption of new or revised accounting
standards which is inconsistent with your disclosure on page 6 and 85 where you state
that you will not be able to avail yourself of this extended transition period. Please
revise.

January 27, 2025
Page 5
Use of Proceeds, page 73
19.We note that you intend to use the proceeds from this offering for multiple purposes,
including for "research and development of new technologies as well as existing
products, including human and veterinary applications pursuant to our LPT-CBD
project" and "for marketing and sales efforts of our products in new and existing
territories." Please revise to disclose:
•the amount of proceeds from this offering that you intend to use for your LPT-
CBD injectable technology for human use and for animal use;
•the amount of proceeds from this offering that you intend to use for "new
technologies" and clarify what new technologies, to the extent material, you
intend to pursue at this time;
•how far in the development and regulatory approval process for LPT-CBD you
anticipate the proceeds from this offering will enable you to reach for the human
market and for the animal market;
•the new and existing territories where you intend to use proceeds from this
offering for the marketing and sales efforts related to your products (in this
regard, we note your disclosure beginning on page 35 that there may be regulatory
restrictions on marketing your products in certain countries); and
•state the anticipated amount and sources of other funds, if any, that may be
necessary to accomplish the specific purposes for which the proceeds are to be
obtained.
If the anticipated proceeds from this offering will not be sufficient to fund all the
proposed purposes, the order of priority of such purposes should be given, as well as
the amount and sources of other funds needed.
Management's Discussion and Analysis of Financial Condition and Results of Operations,
page 79
20.We note from your disclosure on page 80 that sales in your Pharmaceuticals segment
are "made through business-to-business." In an appropriate location in your
prospectus, please describe how you are deriving revenues from this segment for the
periods presented given your disclosure that your pharmaceutical product candidates
are in preclinical development. Where you discuss and analyze revenues for the
periods presented in this section, include a quantitative and qualitative description of
the reasons underlying the material changes in the revenues from the Pharmaceuticals
segment.
Components of Operating Results
Revenue, page 80
21.Your state here that revenue is recognized on a cash basis once payments are
received for your Consumer Wellness segment which is inconsistent with your stated
policy on page F-13. Please revise.
22.On pages 100 and 101, you note loyalty programs and subscription agreements
have contributed to sales growth. Please provide disclosure regarding these programs
and your accounting under each of these programs.

January 27, 2025
Page 6
Results of Operations
Revenues, page 82
23.For each of the periods presented, you noted that the increase in revenues are mainly
attributed to the increase in revenues from on-line sales platforms of B.I. Sky due to
the addition of new products. Please list the new products made available for sale in
each period and quantify the impact the new products generated in revenues for each
of the periods presented.
Business
Overview, page 90
24.We note your disclosure that the FDA has agreed on your Phase I clinical study
design for LPT-CBD in humans. In an appropriate location, revise to discuss the trial
design, including number of participants to be enrolled in the study, the primary and
secondary endpoints, and what adverse events you will evaluate. Also indicate the
regulatory jurisdictions in which you anticipate conducting clinicals trials for both
your animal and human indications.
Our Products, page 92
25.As safety and efficacy determinations are solely within the authority of the FDA and
comparable foreign regulators, please remove or revise any statements throughout
your prospectus that state or imply that your product candidates are safe or effective.
We note the following disclosures as examples:
•"The liposomes remain safely under the skin", and LPT-CBD is an innovative and
"effective delivery platform" (page 92);
•"The effectiveness of LPT (Liposome Technology) ensures high bioavailability of
cannabidiol…" (page 93);
•The headings "Anti-Inflammatory Efficacy in Mice" (page 94), "Efficacy -
Osteoarthritis Related Pain Relief in Clinical Dogs" (page 95), and "Basic Safety
in Clinical Dogs" (page 96);
•"safe performance" (page 95);
•"[W]e successfully demonstrated the efficacy and safety of our liposomal delivery
technology…" (page 97);
•"Over the past year, repeated administration of LPT-CBD in dogs and other
animals demonstrated … efficacy…" (page 98);
•"effective therapeutic solution" (page 103);
•"effective pain management" (page 104);
•"ensures solutions that are not