InMed Pharmaceuticals — INM-755 Phase I complete, on to Phase II

InMed Pharmaceuticals (US: INM)

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InMed Pharmaceuticals — INM-755 Phase I complete, on to Phase II

InMed Pharmaceuticals has now 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. Additionally, systemic drug concentrations were very low, which is desirable in a topical therapy.

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Healthcare

InMed Pharmaceuticals

INM-755 Phase I complete, on to Phase II

Development update

Pharma & biotech

11 January 2021

Price

US$4.87

Market cap

US$34m

C$0.79/US$

Net cash (C$m) at 30 September 2020 + offering

15.6

Shares in issue

7.0m

Free float

99.0%

Codes

INM (Nasdaq)
IN (TSX)

Primary exchange

Nasdaq

Secondary exchange

TSX

Share price performance

%

1m

3m

12m

Abs

52.2

47.4

(25.2)

Rel (local)

47.3

32.8

(36.4)

52-week high/low

US$9.70

US$2.98

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

755-102-HV trial results

Q1 CY21

Analysts

Maxim Jacobs

+1 646 653 7027

Nathaniel Calloway

+1 646 653 1036

InMed Pharmaceuticals is a research client of Edison Investment Research Limited

InMed Pharmaceuticals has now 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. Additionally, systemic drug concentrations were very low, which is desirable in a topical therapy.

Year end

Revenue (C$m)

PBT*
(C$m)

EPS*
(C$)

DPS
(C$)

P/E
(x)

Yield
(%)

06/19

0.0

(9.1)

(1.76)

0.00

N/A

N/A

06/20

0.0

(10.7)

(2.05)

0.00

N/A

N/A

06/21e

0.0

(11.0)

(1.66)

0.00

N/A

N/A

06/22e

0.0

(13.2)

(1.77)

0.00

N/A

N/A

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

INM-755 progressing into Phase II

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 epidermolysis bullosa (EB) patients with an anticipated treatment duration of 28 days. Regulatory applications are expected to be filed in several countries in H1 CY21.

BayMedica collaboration

InMed announced a research collaboration with BayMedica, which specializes in the design and manufacture of 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. Following the initial research phase, the companies may decide to license each other’s technology.

INM-088 formulation finalized

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. InMed licensed the delivery technology in December from EyeCRO, a contract research organization, for milestones, low single-digit royalties and a nominal amount of equity. IND-enabling studies are expected to begin in 2021.

Valuation: US$233m or US$33.34 per basic share

We have adjusted our valuation to US$233m (C$296m) or US$33.34 (C$42.35) per basic share from C$256m or C$1.49 per basic share. The total valuation rose due to increasing the probability of success for INM-755 to 10% from 7.5% following the positive Phase I data, rolling forward our NPVs and higher net cash following a Nasdaq offering. The per-share value increased following a one-for-33 share consolidation completed on 30 June.

Clinical update

InMed Pharmaceuticals recently announced the results of both its Phase I trials, 755-101-HV and 755-102-HV. In trial 755-101-HV, which 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. Additionally, this incidence did not occur in a dose dependent manner, which may indicate it was due to chance as the trial was small. Also, after application the cream was covered with a film dressing, which may have added to any skin irritation. 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.

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 H1 CY21.

Exhibit 1: Expected clinical trial program

Trial

Type of patients

Expected size

Treatment protocol

Purpose

Timing

Phase I
(755-101-HV)

Adult healthy volunteers with normal, intact skin

22

14 days on intact skin; two dosage strengths

Systemic and local safety/PK

Completed. Data indicated INM-755 cream was safe and well tolerated on intact skin.

Phase I
(755-102-HV)

Adult healthy volunteers with small wounds

8

14 days on small wounds; two dosage strengths

Local safety

Completed. Data indicated that INM-755 cream was safe and well tolerated on small wounds and the cream had no negative impact on wound healing.

Phase II (755-201-EB)

EB patients (first adults, then children)

Up to 20

28 days on intact skin and possibly wounds; two dosage strengths

Systemic and local safety and efficacy

IND/CTA filings in countries globally in H1 CY21. We currently expect a year for completion of the trial.

Source: InMed Pharmaceuticals

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. IND-enabling studies are expected to begin in 2021. 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

In June 2020, the company announced a change in approach to biosynthesis, the IntegraSyn manufacturing system. It will continue to focus on bacterial-based fermentation but with a goal of it being used in combination with other methods to increase yields and flexibility while reducing costs. InMed expects its process to be good manufacturing practice batch ready in Q1 CY21.

InMed also 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 to US$233m (C$296m) or US$33.34 (C$42.35) per basic share from C$256m or C$1.49 per basic share and from this point forward will be using US dollars as the base currency for the valuation of the company due to the listing on Nasdaq. The total valuation rose due to increasing the probability of success for INM-755 to 10% from 7.5% following the positive Phase I data, rolling forward our NPVs and higher net cash following a Nasdaq offering. The per-share value increased following a one-for-33 share consolidation completed on 30 June 2020.

Exhibit 2: InMed valuation table

Program

Stage

Probability of success

Launch year

Peak sales (C$m)

rNPV (C$m)

Biosynthesis (manufacturing)

Development

23%

2022

1,574

$251

INM-755

Phase I

10%

2026

345

$30

Total

$280.8

Net cash and equivalents (As of 30 September plus offering) (C$m)

$15.6

Total firm value (C$m)

$296.46

Total firm value (US$m)

$233.38

Total basic shares (as of 30 September 2020 + offering, m)

7.00

Value per basic share (US$)

$33.34

Options and warrants (as of 30 June 2020, m)

2.3

Total diluted shares (as of 30 June 2020, m)

9.3

Value per diluted share (US$)

$24.99

Source: Edison Investment Research

Financials

InMed reported a net loss of C$2.1m in Q121 (the period ending 30 September 2020), down from C$3.4m in the same period in the prior year due to lower operating expenses. R&D expenses were C$1.2m in the quarter compared to C$2.3m a year ago due to lower costs associated with external contractors and research supplies. G&A was $0.7m, down from $1.0m in Q120 due to lower accounting and legal expenses as well as decreased salaries and benefits. We have reduced FY21 R&D expenditure estimates from C$10.6m to C$5.9m but increased our SG&A estimates by C$1m as we expect greater legal and compliance costs due to being a Nasdaq-listed company. We are also introducing our FY22 estimates, which include C$6.8m in R&D spending and C$5.1m in SG&A.

InMed had C$6.1m in cash and marketable securities at 30 September and subsequently raised approximately US$8.0m in gross proceeds from a Nasdaq public offering through the issuance of 1.78m common shares at US$4.50 per share. Additionally, 1.78m warrants with a strike price of US$5.11 per share were issued. The warrants are immediately exercisable and expire in six years.

Based on the cash level following the offering, we believe InMed has funding into FY22. We forecast the company will raise C$12.5m in additional capital in FY22, which we model as illustrative long-term debt.

Exhibit 3: Financial summary

C$'000s

2019

2020

2021e

2022e

Year end 30 June

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

0

0

0

0

Cost of Sales

0

0

0

0

Gross Profit

0

0

0

0

Research and development

(5,639)

(7,105)

(5,886)

(6,769)

Selling, general & administrative

(3,798)

(3,533)

(4,904)

(5,100)

EBITDA

 

 

(9,436)

(10,638)

(10,790)

(11,869)

Operating Profit (before amort. and except.)

 

 

(9,561)

(10,859)

(11,029)

(12,108)

Intangible Amortisation

0

0

0

0

Exceptionals/Other

(4,128)

(1,144)

(732)

(761)

Operating Profit

(13,689)

(12,003)

(11,760)

(12,869)

Net Interest

434

147

26

(1,068)

Other (change in fair value of warrants)

0

0

0

0

Profit Before Tax (norm)

 

 

(9,127)

(10,713)

(11,002)

(13,175)

Profit Before Tax (IFRS)

 

 

(13,255)

(11,857)

(11,734)

(13,936)

Tax

0

0

0

0

Deferred tax

0

0

0

0

Profit After Tax (norm)

(9,127)

(10,713)

(11,002)

(13,175)

Profit After Tax (IFRS)

(13,255)

(11,857)

(11,734)

(13,936)

Average Number of Shares Outstanding (m)

5.2

5.2

6.6

7.4

EPS - normalised (C$)

 

 

(1.76)

(2.05)

(1.66)

(1.77)

EPS - IFRS (C$)

 

 

(2.56)

(2.27)

(1.77)

(1.87)

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

 

 

1,241

1,642

1,485

1,316

Intangible Assets

1,185

1,092

1,069

1,069

Tangible Assets

56

550

397

228

Other

0

0

19

19

Current Assets

 

 

18,548

8,603

7,318

6,593

Stocks

0

0

0

0

Debtors

0

0

0

0

Cash

18,039

7,970

6,550

5,825

Other

509

633

768

768

Current Liabilities

 

 

(1,563)

(2,284)

(2,500)

(2,500)

Creditors

(1,563)

(2,284)

(2,500)

(2,500)

Short term borrowings

0

0

0

0

Long Term Liabilities

 

 

0

(338)

(314)

(12,814)

Long term borrowings

0

0

0

(12,500)

Other long term liabilities

0

(338)

(314)

(314)

Net Assets

 

 

18,226

7,622

5,989

(7,405)

CASH FLOW

Operating Cash Flow

 

 

(8,769)

(9,767)

(10,829)

(13,156)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(35)

(57)

(63)

(69)

Acquisitions/disposals

0

0

0

0

Financing

273

(138)

9,472

0

Dividends

0

0

0

0

Other

0

1

0

0

Net Cash Flow

(8,532)

(9,962)

(1,420)

(13,225)

Opening net debt/(cash)

 

 

(26,477)

(18,039)

(7,970)

(6,550)

HP finance leases initiated

0

0

0

0

Exchange rate movements

0

0

0

0

Other

94

(107)

0

0

Closing net debt/(cash)

 

 

(18,039)

(7,970)

(6,550)

6,675

Source: Company accounts, 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.

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.

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1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

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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

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Research: Healthcare

Carmat — CE Mark achieved, launching in Q2

Carmat announced that it has received a CE Mark for its physiologic heart replacement therapy (PHRT) and that the product will be launched in Q221 under the brand name Aeson. The approved indication is a bridge to transplantation therapy (BTT), although over time we expect approval for Aeson as a destination therapy (DT), which will enable commercialisation to a larger number of patients. The initial commercial focus will be on France and Germany, which Carmat estimates to account for 55% of the EU mechanical circulatory support market.

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