Recce Pharmaceuticals — BPOM clearance to start Phase III R327G study
Recce Pharma

Recce Pharmaceuticals (ASX: RCE)

Last close As at 17/12/2024

AUD0.47

−0.03 (−5.05%)

Market capitalisation

AUD109m

More on this equity

Research: Healthcare

Recce Pharmaceuticals — BPOM clearance to start Phase III R327G study

Recce received approval from the Indonesian Drug and Food Regulatory Authority, Badan POM (BPOM), to start its registrational Phase III study in Indonesia of RECCE® 327 topical gel (R327G) in diabetic foot infections (DFIs). This was the final hurdle that needed to be overcome before study enrolment can proceed, which is expected to start before the end of 2024. Top-line data from the 300-patient double-blinded Phase III study (with 200 patients in the R327 arm and 100 on placebo) are anticipated in late 2025. If positive, we expect Recce would be able to launch R327G in South-East Asia in H2 CY26, potentially marking the company’s transition to a commercial stage.

Written by

Pooya Hemami

Analyst - Healthcare

Healthcare

Recce Pharmaceuticals

BPOM clearance to start Phase III R327G study

Clinical trial clearance

Pharma and biotech

17 December 2024

Price

A$0.47

Market cap

A$109m

US$0.65/A$

Estimated net debt (A$m) at 30 September 2024

3.5

Shares in issue

231.9m

Free float

90%

Code

RCE

Primary exchange

ASX

Secondary exchange

Frankfurt: R9Q,
OTC: RECEF

Share price performance

Business description

Recce Pharmaceuticals is an Australian company developing its novel, broad-spectrum synthetic polymer anti-infective drugs for the treatment of several infectious diseases, including sepsis, acute bacterial skin and skin structure infections, burn wound infections and urinary tract infections.

Analyst

Pooya Hemami, OD MBA CFA

+1 643 653 7026

Recce Pharmaceuticals is a research client of Edison Investment Research Limited.

Recce received approval from the Indonesian Drug and Food Regulatory Authority, Badan POM (BPOM), to start its registrational Phase III study in Indonesia of RECCE® 327 topical gel (R327G) in diabetic foot infections (DFIs). This was the final hurdle that needed to be overcome before study enrolment can proceed, which is expected to start before the end of 2024. Top-line data from the 300-patient double-blinded Phase III study (with 200 patients in the R327 arm and 100 on placebo) are anticipated in late 2025. If positive, we expect Recce would be able to launch R327G in South-East Asia in H2 CY26, potentially marking the company’s transition to a commercial stage.

Year end

Revenue**
(A$m)

PBT*
(A$m)

EPS*
(A$)

DPS
(A$)

P/E
(x)

Yield
(%)

06/23

4.3

(13.1)

(0.08)

0.0

N/A

N/A

06/24

4.9

(17.8)

(0.10)

0.0

N/A

N/A

06/25e

10.1

(16.2)

(0.07)

0.0

N/A

N/A

06/26e

6.0

(71.9)

(0.31)

0.0

N/A

N/A

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

DFIs are a frequent complication in patients who have diabetes mellitus that is not adequately controlled and are the most common complication from diabetes requiring hospitalisation. About 2–4% of patients with diabetes will experience foot ulceration each year, of which 50–60% will result in DFIs. We believe the prevalence of diabetes in ASEAN countries is c 47 million people, marking a c A$50m (annual) DFI revenue opportunity for Recce, as summarised in our prior note.

Recce is receiving significant funding and infrastructure support from key Indonesian stakeholders, including the Indonesian Ministry of Health, for the registrational Phase III DFI programme as well as from its previously announced strategic collaboration and memorandum of understanding in South-East Asia with Indonesian biomedical company PT Etana Biotechnologies. Consequently, Recce expects its total cost to complete the study will be US$2m, not including the effects from the 43.5% R&D rebate scheme under the company’s advanced overseas finding status with the Australian government. Hence, the net cost to Recce may only be c US$1.2m.

Recce also reiterated that it is on track to complete its open-label Phase II study assessing R327G as a treatment for acute bacterial skin and skin structure infections (ABSSSI) before the end of 2024. It reported in November 2024 that it has dosed 20 patients out of an expected total enrolment target of 30 and that all patients dosed to date (excluding one patient withdrawal) had met the primary endpoint of either a complete cure of their presenting condition or a significant improvement following treatment with R327G. Recce reiterated that it expects to start a Phase III ABSSSI study in Australia and New Zealand in H1 CY25. We anticipate potential commercialisation for R327G in ABSSSI in CY28. Altogether, we believe the company’s near-term focus on advancing the ABSSSI and DFI indications for R327G are providing a clear path to future revenues.

General disclaimer and copyright

This report has been commissioned by Recce Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by Recce Pharmaceuticals. Edison Investment Research standard fees are £60,000 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 2024 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.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

General disclaimer and copyright

This report has been commissioned by Recce Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by Recce Pharmaceuticals. Edison Investment Research standard fees are £60,000 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 2024 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.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

More on Recce Pharmaceuticals

View All

Latest from the Healthcare sector

View All Healthcare content

Research: Healthcare

Newron Pharmaceuticals — Evenamide licence agreement in Japan

Newron has entered into a licence agreement with EA Pharma, a subsidiary of Eisai, to develop, manufacture and commercialise evenamide, Newron’s proprietary modulator of the excessive release of glutamate for the treatment of schizophrenia. The transaction covers Japan and other designated Asian territories, meeting management’s target of securing a deal in Q424. Newron will receive an upfront payment of €44m, up to €73m in contributions to development and milestones, and will be eligible to tiered royalties up to a double-digit percentage of net sales for evenamide in the covered regions. We expect the upfront payment to extend Newron’s operating cash runway, enabling it to maintain operations through 2026 at a minimum (versus through H125 previously). We place our estimates under review as we update our model to reflect the terms of the announcement.

Continue Reading

Subscribe to Edison

Get access to the very latest content matched to your personal investment style.

Sign up for free