Phase II enrolment to begin in second half

InMed Pharmaceuticals 22 February 2021 Update
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InMed Pharmaceuticals

Phase II enrolment to begin in second half

Financial update

Pharma & biotech

22 February 2021

Price

US$4.37

Market cap

US$35m

Net cash (US$m) at 31 December 2020 + offering

14.1

Shares in issue

8.1m

Free float

74.1%

Code

INM

Primary exchange

Nasdaq

Secondary exchange

TSX

Share price performance

%

1m

3m

12m

Abs

0.7

27.4

(47.6)

Rel (local)

(2.1)

16.8

(54.6)

52-week high/low

US$10

US$3

Business description

InMed Pharmaceuticals is a Canada-based biopharmaceutical company focused on manufacturing and developing cannabinoids. Its biosynthesis platform may be able to produce cannabinoids for less cost and with improved purity compared to currently used methods. The company is also developing a proprietary pipeline, including INM-755 for epidermolysis bullosa, a serious, debilitating orphan indication.

Next events

INM-755 Phase II initiation

H2 CY21

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 7036

InMed Pharmaceuticals is a research client of Edison Investment Research Limited

Following the safety and tolerability data from the two Phase I trials in healthy volunteers, INM-755 is moving forward into a Phase II (755-201-EB) trial in up to 20 epidermolysis bullosa (EB) patients with an anticipated treatment duration of 28 days. Regulatory applications are expected to be filed in several countries in Q2 CY21 with enrolment to begin in the second half of the calendar year. Also, the formulation for INM-088 has been finalized with IND-enabling toxicology studies expected to begin in CY21 and filings for human clinical trials to begin in H1 CY22.

Year end

Revenue (US$m)

PBT*
(US$m)

EPS*
(US$)

DPS
(US$)

P/E
(x)

Yield
(%)

06/19

0.0

(9.2)

(1.77)

0.00

N/A

N/A

06/20

0.0

(9.0)

(1.73)

0.00

N/A

N/A

06/21e

0.0

(9.1)

(1.33)

0.00

N/A

N/A

06/22e

0.0

(10.5)

(1.24)

0.00

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortization of acquired intangibles, exceptional items and share-based payments.

INM-755 safe and well tolerated

InMed previously announced top-line results from both the 755-101-HV and 755-102-HV Phase I trials. Trial 755-101-HV was conducted in 22 healthy adult volunteers with intact skin, while 755-102-HV was conducted in eight healthy volunteers with small wounds. Both trials indicated that INM-755 was safe and well tolerated. There were no systemic or serious adverse effects, nor were there any adverse event-related withdrawals.

INM-088 moving forward

A formulation of INM-088 for glaucoma has been finalized and has demonstrated the ability to deliver sustained levels of cannabinol (CBN) to the eye in an animal model through a stable and comfortable eyedrop formulation. The delivery technology was licensed (covering global commercial rights to all cannabinoids and analogs) from EyeCRO, a contract research organization. Scale-up of manufacturing for the final formulation is in process. IND-enabling studies are expected to begin in 2021 with filings for human clinical trials expected in H1 CY22.

BayMedica collaboration initiating

In November, InMed announced a research collaboration with BayMedica, which specializes in rare natural cannabinoids and analogs. As part of the agreement, BayMedica will receive access to aspects of InMed’s IntegraSyn biosynthesis platform, while InMed will explore the therapeutic potential of some of BayMedica’s cannabinoid analogs in neuroprotection.

Valuation: US$236m or US$29.27 per basic share

We have adjusted our valuation from US$233m or US$33.34 per basic share to US$236m or US$29.27 per basic share. The total valuation rose due to higher net cash following a financing, while the per-share value decreased due to a higher number of shares outstanding.

Clinical update

Following the safety and tolerability data from the Phase I program, INM-755 will be moving forward into a Phase II (755-201-EB) trial in up to 20 EB patients with an anticipated treatment duration of 28 days. Regulatory applications are expected to be filed in several countries in Q2 CY21 with enrollment to begin in the second half of the calendar year.

InMed Pharmaceuticals recently announced the results of both its Phase I trials, 755-101-HV and 755-102-HV. Trial 755-101-HV studied the systemic and local safety, tolerability and pharmacokinetics (PK) of two dosage strengths of INM-755 cream in 22 healthy adult volunteers. Importantly, there were no systemic or serious side effects. There was a slightly higher incidence and intensity of redness, swelling, scaling and burning in the treatment group, but none of these was serious and no subjects dropped out of the trial because of them nor were these side effects dose dependent. Systemic exposure of the drug was very low and no systemic adverse effects were caused by exposure to INM-755, which is important in a topical therapy, especially a cannabinoid.

Similar results were seen in trial 755-102-HV, which studied the impact of INM-755 in eight healthy volunteers with small wounds. The small blister wounds were created at the clinical site to largely mimic the types of wounds typically seen in EB simplex patients. The study compared two dosage strengths of INM-755 cream versus vehicle alone as well as no treatment (in other words, four treatment conditions). Erythema and scaling were seen across all treatment groups, including those receiving vehicle or no treatment. There were a few mild cases of stinging/burning but these were only seen in the vehicle and low-concentration cream treated wounds and not the high-concentration treated or untreated wounds. As with 755-101-HV, no systemic adverse events were reported. Importantly, the INM-755 creams did not introduce any delay in wound healing.

For INM-088 for glaucoma, the company is moving forward with a final formulation, one that has demonstrated the ability to deliver sustained levels of CBN to the eye in an animal model through a stable and comfortable eyedrop formulation. InMed licensed the delivery technology in December 2020 from EyeCRO, a contract research organization, for milestones, low single-digit royalties and a nominal amount of equity. Scale-up of manufacturing for the final formulation is in process. IND-enabling studies are expected to begin in 2021 with filings for human clinical trials expected in H1 CY22. Preclinical data so far have indicated a neuroprotective effect in ocular disease and INM-088 may also have the potential to reduce intraocular pressure (IOP) through improvement in the aqueous humor outflow. Importantly, some of the safety studies for INM-755 can be used for INM-088 for glaucoma as both products have the same active ingredient (CBN).

Biosynthesis platform

InMed recently announced a research collaboration with BayMedica, which specializes in the design and manufacture of rare natural cannabinoids and analogs through biosynthesis and pharmaceutical chemistry. As part of the reciprocal agreement, BayMedica will receive access to one or more of InMed’s high-efficiency enzyme gene sequences to assess their ability to improve on the manufacturing process for cannabinoids in BayMedica’s library. In return, BayMedica will provide InMed with access to BayMedica’s library of proprietary cannabinoid analogs (as these are novel, they have the potential to be protected by composition of matter patents unlike naturally occurring cannabinoids). InMed will conduct preclinical research on numerous therapeutic compounds to explore their potential in selected disease models related to neuroprotection. Following the initial research phase, the companies may license each other’s technology if desired.

Valuation

We have adjusted our valuation from US$233m or US$33.34 per basic share to US$236m or US$29.27 per basic share. The total valuation rose due to higher net cash following a February 2021 financing (US$4.5m gross, or US$4.0m net), while the per-share value decreased due to a higher number of shares outstanding. Note that we have completely converted our model into US dollars as the company is now reporting in that currency and is using US GAAP.

Exhibit 1: InMed valuation

Program

Stage

Probability of success

Launch year

Peak sales (US$m)

rNPV
(US$m)

Biosynthesis (manufacturing)

Development

23%

2022

1,243

$198

INM-755

Phase I

10%

2026

313

$24

Total

$221.8

Pro-forma net cash and equivalents (as of 31 December plus offering) (US$m)

$14.1

Total firm value (US$m)

$235.91

Total basic shares (as of 31 December 2020 + offering, m)

8.06

Value per basic share (US$)

$29.27

Options and warrants (as of 31 December 2020 + offering, m)

3.4

Total diluted shares (as of 31 December 2020 + offering, m)

11.4

Value per diluted share (US$)

$20.63

Source: Edison Investment Research

Financials

InMed reported a net loss of US$2.2m in Q221 (the period ending 31 December 2020), down from US$2.5m in the same period in the prior year due to lower R&D expenses. R&D expenses were US$0.9m in the quarter compared to US$1.6m a year ago thanks to lower spending on the biosynthesis program as well as the completion of the Phase I program during the period. G&A was US$1.0m, up slightly from US$0.9m in Q220. We have converted our financial model to US dollars and US GAAP as the company is now reporting in both. Prior periods have been adjusted as well. Our R&D estimates for FY21 and FY22 are now US$4.3m and US$5.0m, respectively (as compared to C$5.9m and C$6.8m previously). SG&A estimates are now US$4.3m and US$4.5m for FY21 and FY22, respectively, compared to C$4.9m and C$5.1m previously.

InMed had US$10.1m in cash and marketable securities at 31 December and subsequently (February 2021) raised approximately US$4m in net proceeds from a private placement, priced at US$4.25 per unit, with a unit including a common share and 0.66 of a warrant (the warrants have an exercise price of US$4.85 per share, are exercisable six months after issuance and have a term of five and a half years).

Based on the cash level following the offering, we believe InMed has funding through much of FY22. We forecast the company will raise US$10m in additional capital in FY22, which we model as illustrative long-term debt.

Exhibit 2: Financial summary

US$'000s

2019

2020

2021e

2022e

Year end 30 June

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

Revenue

 

 

0

0

0

0

Cost of Sales

0

0

0

0

Gross Profit

0

0

0

0

Research and development

(5,126)

(5,811)

(4,337)

(4,987)

Selling, general & administrative

(4,297)

(3,227)

(4,325)

(4,498)

EBITDA

 

 

(9,423)

(9,038)

(8,661)

(9,485)

Operating Profit (before amort. and except.)

 

 

(9,542)

(9,151)

(8,800)

(9,623)

Intangible Amortisation

0

0

0

0

Exceptionals/Other

(34)

82

104

108

Operating Profit

(9,576)

(9,069)

(8,696)

(9,515)

Net Interest and financial expense

328

130

(347)

(854)

Other (change in fair value of warrants)

0

0

0

0

Profit Before Tax (norm)

 

 

(9,215)

(9,021)

(9,147)

(10,477)

Profit Before Tax (IFRS)

 

 

(9,248)

(8,939)

(9,043)

(10,369)

Tax

0

0

0

0

Deferred tax

0

0

0

0

Profit After Tax (norm)

(9,215)

(9,021)

(9,147)

(10,477)

Profit After Tax (IFRS)

(9,248)

(8,939)

(9,043)

(10,369)

Average Number of Shares Outstanding (m)

5.2

5.2

6.9

8.5

EPS - normalised (US$)

 

 

(1.77)

(1.73)

(1.33)

(1.24)

EPS - GAAP (US$)

 

 

(1.78)

(1.71)

(1.31)

(1.22)

Dividend per share (c)

0.0

0.0

0.0

0.0

Gross Margin (%)

N/A

N/A

N/A

N/A

EBITDA Margin (%)

N/A

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

1,264

1,490

1,466

1,374

Intangible Assets

1,221

1,087

1,110

1,110

Tangible Assets

43

403

342

250

Other

0

0

15

15

Current Assets

 

 

14,173

6,312

9,275

9,388

Stocks

0

0

0

0

Debtors

65

45

155

155

Cash

13,784

5,848

9,091

9,205

Other

324

419

28

28

Current Liabilities

 

 

(1,194)

(1,676)

(2,154)

(2,154)

Creditors

(1,194)

(1,676)

(2,154)

(2,154)

Short term borrowings

0

0

0

0

Long Term Liabilities

 

 

0

(248)

(2,003)

(12,003)

Long term borrowings

0

0

0

(10,000)

Other long term liabilities

0

(248)

(2,003)

(2,003)

Net Assets

 

 

14,243

5,878

6,584

(3,394)

CASH FLOW

Operating Cash Flow

 

 

(6,624)

(7,375)

(8,106)

(9,840)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(27)

(43)

(42)

(46)

Acquisitions/disposals

0

0

0

0

Financing

205

(31)

10,893

0

Dividends

0

0

0

0

Other

0

1

0

0

Net Cash Flow

(6,446)

(7,448)

2,745

(9,887)

Opening net debt/(cash)

 

 

(20,179)

(13,784)

(5,848)

(9,091)

HP finance leases initiated

0

0

0

0

Exchange rate movements

(17)

416

(495)

0

Other

69

(905)

993

0

Closing net debt/(cash)

 

 

(13,784)

(5,848)

(9,091)

795

Source: company reports, Edison Investment Research

General disclaimer and copyright

This report has been commissioned by InMed Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by InMed Pharmaceuticals. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

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Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2021 Edison Investment Research Limited (Edison).

Australia

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New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

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Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

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Germany

London +44 (0)20 3077 5700

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United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

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United States of America

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by InMed Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by InMed Pharmaceuticals. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2021 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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