Molecure — Q323 report highlights clinical progress

Molecure (WSE: MOC)

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Research: Healthcare

Molecure — Q323 report highlights clinical progress

Molecure has released its Q323 report, providing an update on its clinical development activities, particularly around its oral, first-in-class inhibitor, OATD-01. Following the acceptance of the Investigational New Drug (IND) application in July 2023, the Phase II proof-of-concept study (KITE) for OATD-01 in pulmonary sarcoidosis remains on track with the first US patient expected to receive dosing in Q423. Additionally, we anticipate the company to obtain approval to commence recruitment for the KITE study in Europe in Q124, as the application was submitted to the EMA and MHRA in September 2023. Recruitment for Molecure’s second clinical-stage asset, OATD-02, in patients with advanced and/or metastatic solid tumours, is ongoing, and we now anticipate initial data in early 2024 (previously expected in Q423). As of 30 September 2023, Molecure had a gross cash position of PLN85m, which includes the PLN50m (c $12m) from the Q323 public offering. However, to support its strategic plans for 2023–25, the company will need to seek additional funding to fully cover its estimated capital expenditure requirement of PLN250m.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Molecure

Q323 report highlights clinical progress

Pharma and biotech

Spotlight Update

6 November 2023

Price

PLN16.9

Market cap

PLN284m

Share price graph

Share details

Code

MOC

Listing

Warsaw Stock Exchange

Shares in issue

16.8m

Cash at 29 September 2023

PLN85m

Business description

Molecure is a clinical-stage biotechnology company. It uses its medicinal chemistry and biology capabilities to discover and develop first-in-class small-molecule drug candidates designed to directly modulate underexplored protein targets and the function of RNA to treat multiple incurable diseases.

Bull

Two assets in clinical development (OATD-02 in Phase I; OATD-01 in preparation for Phase II).

OATD-01 has potential for disease-modifying action in interstitial lung disease.

Pipeline supported by preclinical assets and technology platform.

Bear

Delays or disruptions to timelines could affect management’s estimated cash runway.

Unvalidated mechanisms of action increase development risk.

Additional funding needed to complete Phase II development.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Zoe Karamanoli

+44 (0)20 3077 5700

Nidhi Singh

+44 (0)20 3077 5700

Molecure is a research client of Edison Investment Research Limited

Molecure has released its Q323 report, providing an update on its clinical development activities, particularly around its oral, first-in-class inhibitor, OATD-01. Following the acceptance of the Investigational New Drug (IND) application in July 2023, the Phase II proof-of-concept study (KITE) for OATD-01 in pulmonary sarcoidosis remains on track with the first US patient expected to receive dosing in Q423. Additionally, we anticipate the company to obtain approval to commence recruitment for the KITE study in Europe in Q124, as the application was submitted to the EMA and MHRA in September 2023. Recruitment for Molecure’s second clinical-stage asset, OATD-02, in patients with advanced and/or metastatic solid tumours, is ongoing, and we now anticipate initial data in early 2024 (previously expected in Q423). As of 30 September 2023, Molecure had a gross cash position of PLN85m, which includes the PLN50m (c $12m) from the Q323 public offering. However, to support its strategic plans for 2023–25, the company will need to seek additional funding to fully cover its estimated capital expenditure requirement of PLN250m.

Historical figures

Year
end

Revenue
(PLNm)

PBT
(PLNm)

EPS*
(PLN)

DPS
(PLN)

P/E
(x)

Yield
(%)

12/20

124.9

73.7

4.64

0.0

4.78

N/A

12/21

1.5

(13.6)

(0.98)

0.0

N/A

N/A

12/22

1.6

(15.3)

(1.09)

0.0

N/A

N/A

Source: Molecure accounts. Note: *Diluted EPS.

Phase II in OATD-01 on track to start in Q423

Molecure’s lead asset, OATD-01, is an oral, first-in-class inhibitor of CHIT1 (a human chitinase enzyme) that offers potential to be the first disease-modifying therapy for the treatment of sarcoidosis, an indication with substantial unmet medical need. The FDA accepted the IND application for the Phase II proof-of-concept trial (KITE) in July 2023, and the first patient in the US is expected to be dosed in Q423. Molecure anticipates receiving approval to initiate recruitment for the KITE study in Europe in Q124 given the application to the EMA and MHRA was submitted in September 2023. As a reminder, KITE is a global randomised, double-blind, placebo-controlled study (n=90), and the primary endpoint readout is expected by the company in mid-2025.

Cash position supported by recent equity funding

As of 30 September 2023, the company had a cash balance of PLN85m, taking into account the Q323 equity public offering of c PLN50m (c $12m) with the issuance of 2,776,000 series H shares at PLN18 per share. Based on the H123 cash position of PLN49.6m, we estimate a Q323 cash burn rate of around PLN15m (which included financing costs associated with the Q323 raise). We expect the company will need to seek additional funding to cover its estimated capital expenditure requirement of PLN250m (2023–25).

OATD-01: A first-in-class chitinase inhibitor in a Phase II proof-of-concept study

Molecure’s lead asset, OATD-01, is an oral, first-in-class inhibitor of CHIT1, a human chitinase enzyme that is implicated in the body’s immune response. Pathologically activated immune cells, such as macrophages and neutrophils, secrete CHIT1 as part of the body’s natural immune response. This may make CHIT1 an attractive therapeutic target for inflammatory and fibrotic diseases. The drug has already demonstrated a favourable safety profile in Phase I, and we note that the candidate has been granted Orphan Drug designation (ODD) for its use in sarcoidosis and idiopathic pulmonary fibrosis (IPF). Molecure is currently focused on the launch of its Phase II trial for OATD-01 in pulmonary sarcoidosis, but management believes OATD-01’s mechanism of action may also be applicable to the treatment of IPF, a progressive disease that leads to lung scarring and fibrosis that hampers the lungs’ ability to adequately transport oxygen.

No targeted or novel therapies are available to treat sarcoidosis

Sarcoidosis is a systemic inflammatory disorder of unknown origin, characterised by non-caseating granulomas in various organs, including the eyes, joints, heart, kidneys and lungs, among others. This condition can lead to irreversible organ damage and a reduced lifespan. It may result from factors such as HLA genes, epigenetic changes, other underlying diseases or exposure to unidentified antigens (eg observed in a high incidence among 9/11 firefighters). Diagnosis typically involves a combination of radiographic, clinical and histopathologic findings. Sarcoidosis has an overall prevalence of ~180,000 in the United States, although it exhibits regional variations, with a higher prevalence in the southern regions and a predilection for female and Black populations. Consequently, more cases are seen in places like Florida compared to Oregon. Sarcoidosis affects the lungs in about 90% of cases.

Despite several decades of research, treatment options are limited and often non-specific to the condition for treating sarcoidosis. The primary approach involves using corticosteroids as the first-line treatment, with NSAIDs and biologics considered as alternative options (according to sarcoidosis treatment guidelines). However, the use of steroids can lead to dependency and severe short- and long-term side effects.

The diagram below shows the current and investigational treatments for sarcoidosis based on pathogenesis. Given sarcoidosis is a disease that mainly affects the lungs, preserving or improving lung function is a crucial goal in managing the disease. Many of these drugs do not improve forced vital capacity (a measure of lung function), on an absolute basis or when compared to steroids, and have yielded mixed results. Also, many alternatives to steroids are associated with greater infection risks and malignancies.

Exhibit 1: Investigational treatments for sarcoidosis

Source: Alicia K Gerke, Treatment of Sarcoidosis: A multidisciplinary Approach, Nov 2020, Sec Inflammation

OATD-01 as a potential treatment for sarcoidosis

In preclinical studies OATD-01 reduced fibrosis (measured by the Ashcroft fibrosis score) in mice with induced lung fibrosis (through exposure to bleomycin). The drug has so far also demonstrated a good safety profile in Phase I studies and Molecure is progressing development into a Phase II study. In July 2023 the FDA accepted the company’s IND application and, in September 2023, the company submitted applications to the EMA and MHRA to conduct studies in Europe. The Phase II trial (KITE) is intended to be a multi-centre (20–30 sites in the US and Europe), randomised, double-blind, placebo-controlled study (expected total n=90). The primary endpoint will assess the efficacy of the drug in sarcoidosis patients after 12 weeks of administration, based on change from baseline in levels of granulomatous inflammation assessed by PET-CT imaging. The first patient for the KITE trial is scheduled to be dosed in the US in Q423. As this is the company’s flagship programme, the results for the study (expected by mid-2025) could represent a significant catalyst for investor attention, in our view

OATD-02: Potential immuno-oncology asset

The company’s second drug candidate is OATD-02, an oral, first-in-class inhibitor of ARG1/2, arginine-depleting enzymes associated with immunosuppressive tumour microenvironments. OATD-02 is currently being evaluated as a monotherapy in a Phase I clinical trial in patients with advanced and/or metastatic solid tumours. This is an open-label, multi-centre (three sites in Poland) study undergoing dose escalation, to assess the safety and tolerability of the drug. Additional objectives include preliminary efficacy (response and survival), pharmacokinetic and pharmacodynamic biomarker data, and establishing a maximum tolerated dose (MTD). Management has communicated that the trial will recruit 30 to a maximum of 40 patients, focusing on indications where checkpoint inhibitors have had low response rates, such as colorectal cancer, ovarian cancer, pancreatic cancer and renal cell carcinoma. The first patient was dosed in March 2023 with 2.5mg, and in April 2023 an independent committee recommended increasing the dose to 5mg, based on the a positive assessment of this first patient and a lack of tumour progression. Treatment of additional patients at 5mg is ongoing, and the committee has recommended that subsequent patients may be escalated to 10mg, as per the Bayesian optimal interval design. We anticipate updates on the progress of this trial early in 2024 (previously H223), and note that Molecure may explore combination studies with checkpoint inhibitors in the future to maximise the potential of OATD-02.

Molecure’s 2023–25 roadmap

As outlined in our prior note, Molecure recently shared its strategic objectives for 2023–25, which aim to enrich and diversify its clinical pipeline. These objectives include: 1) continuing the clinical development of OATD-01, aiming for therapeutic efficacy in a Phase II trial for pulmonary sarcoidosis by mid-2025 and exploring CHIT1 as a therapeutic target in additional indications; 2) advancing OATD-02’s Phase I trial in patients with solid tumours to determine safety and MTD, with potential expansion into haematological cancers and combination studies; 3) identifying lead compounds for unexplored protein targets in its preclinical portfolio; and 4) generating by the end of 2023 supportive data that could demonstrate small molecule binding to mRNA targets, and potentially lead to securing partnerships in 2024/25. Additionally, Molecure plans to enhance early-stage drug development efficiency through AI collaborations and reduce its validation to clinical candidate selection time and cost by 50% by 2025.

Financials

For the first nine months of FY23 (9M23), Molecure reported total revenue (including other operational revenue) of PLN1.3m, mainly comprising domestic research grants. Total operating expenses at PLN16.3m in 9M23 were PLN4.3m higher than the prior-year period, due to increased research costs associated with the advancement of the company’s clinical development pipeline, higher personnel expenses and enhanced costs of external research services. We estimate Q323 operating expenses were c PLN5.4m.

As a result, the net loss for the 9M23 period was PLN11.5m (vs PLN9.4m in 9M22) and c PLN4.1 in Q323. As of 30 September 2023, the company had a cash balance of PLN85m, which includes the equity raise in July of c PLN50m (c $12m). Based on the H123 cash position of PLN49.6m, we estimate a Q323 overall cash burn rate of around PLN15m (which we estimate was accentuated by offering costs associated with the Q323 financing). As part of its strategic plans for 2023–25, Molecure has expanded its development pipeline into several early-stage projects, hence, we expect increased clinical activity over the medium term. An initial indication of the costs incurred on research work on such early-stage projects is shown in the table below (Exhibit 2). We note that the company plans to oversee the advancement of these projects up to the early stages of clinical-stage development, and intends to then monetise and/or out-license the related programmes (ie it does not plan to continue funding the later stages of development required for regulatory approval and commercialisation).

Exhibit 2: Balance sheet value of capitalised projects

PLNm

As at 31 December 2022

As at 30 June 2023

Chitinase platform

14.54

21.33

Arginase platform

25.78

29.72

Deubiquitinase platform

8.19

10.92

Other

2.68

3.87

Total

51.19

65.85

Source: Molecure H123 report

At end Q323, the company’s cash balance stood at PLN85m, which includes the PLN50m fund-raise (gross value) by the issue of series H shares in Q323. However, Molecure estimates that the company might require about PLN250m to complete both its clinical trials and continue the development of its early-stage projects. Hence, the company may continue to seek more sources of funds in the form of upfront payments from license agreements, grants and subsidies, share issues and debt instruments. Exhibit 3 explains in detail the budgeting expectations previously disclosed by the company in its H123 report.

Exhibit 3: Capital expenditure estimates, 2023–25

PLNm

FY23–25

Clinical phase programmes

100

Discovery and pre-clinical development programmes (including AI tools)

75

mRNA platform (including AI tools)

25

General and administrative costs, including business development and IR

50

Total

250

PLNm

Clinical phase programmes

Discovery and pre-clinical development programmes (including AI tools)

mRNA platform (including AI tools)

General and administrative costs, including business development and IR

Total

FY23–25

100

75

25

50

250

Source: Molecure H123 report

General disclaimer and copyright

This report has been commissioned by Molecure and prepared and issued by Edison, in consideration of a fee payable by Molecure. 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.

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Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

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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.

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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.

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General disclaimer and copyright

This report has been commissioned by Molecure and prepared and issued by Edison, in consideration of a fee payable by Molecure. 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 2023 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

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Oryzon Genomics — Q323 recap ahead of key clinical stages

Oryzon’s Q323 results recapped the clinical progression across its drug development pipeline. The company continues to develop therapies that address unmet needs related to the central nervous system (CNS) and oncology. As noted previously, an important development was the positive safety data for the PORTICO trial, assessing vafidemstat in patients with borderline personality disorder (BPD). Oryzon continues to enrol patients for its lead oncology trial (FRIDA), investigating iadademstat as a potential treatment for acute myeloid leukaemia (AML) and an update is expected in Q224. Based on current visibility, we have adjusted our FY23 operating loss estimates to €5.4m (vs €3.8m previously). Top-line data from PORTICO and FRIDA are expected to be the next key catalysts. Gross cash at the end of Q323 stood at US$8.8m (€8.4m), down from US$14.6m in H123, which we anticipate should fund the company’s operations into Q124. We value Oryzon at €900.3m or €15.4/share (up from €874.1m or €15.6/share).

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