Ultimovacs — Steadfast commitment to UV1 progression

Ultimovacs (OSE: ULTI)

Last close As at 30/04/2024

NOK6.98

0.02 (0.29%)

Market capitalisation

NOK241m

More on this equity

Research: Healthcare

Ultimovacs — Steadfast commitment to UV1 progression

Despite the recent setback with the INITIUM trial (first-line treatment of patients with unresectable or metastatic malignant melanoma), Ultimovacs has reinstated its commitment to press on with its clinical development of its cancer vaccine, UV1, across other target indications. The principal near-term focus will be on the anticipated results of Phase II FOCUS (head and neck cancer) and DOVACC (ovarian cancer) trials in Q324 and H125, respectively, and will inform its subsequent strategic direction. To remain funded to these milestones, the company has enforced stringent cost control measures, including activity level adjustments, reprioritisation of operations and a 40% workforce reduction, to support runway extension to Q425 (the company estimates its cash burn will be NOK15m/quarter).

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Ultimovacs

Steadfast commitment to UV1 progression

Strategy update

Pharma and biotech

18 April 2024

Price

NOK10.1

Market cap

NOK347m

NOK10.98/US$

Net cash (NOKm) at end-December 2023 (excluding leases)

266.6

Shares in issue

34.4m

Free float

60%

Code

ULTI

Primary exchange

Oslo Stock Exchange

Secondary exchange

N/A

Share price performance

Business description

Ultimovacs is developing novel immunotherapies against cancer. Its lead product candidate, UV1, is a peptide-based vaccine against the universal cancer antigen telomerase, which is expressed in c 85–90% of all cancer types. UV1 therefore has broad potential in a variety of different settings and combinations.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Ultimovacs is a research client of Edison Investment Research Limited

Despite the recent setback with the INITIUM trial (first-line treatment of patients with unresectable or metastatic malignant melanoma), Ultimovacs has reinstated its commitment to press on with its clinical development of its cancer vaccine, UV1, across other target indications. The principal near-term focus will be on the anticipated results of Phase II FOCUS (head and neck cancer) and DOVACC (ovarian cancer) trials in Q324 and H125, respectively, and will inform its subsequent strategic direction. To remain funded to these milestones, the company has enforced stringent cost control measures, including activity level adjustments, reprioritisation of operations and a 40% workforce reduction, to support runway extension to Q425 (the company estimates its cash burn will be NOK15m/quarter).

Year
end

Revenue (NOKm)

PBT*
(NOKm)

EPS**
(NOK)

DPS
(NOK)

P/E
(x)

Yield
(%)

12/22

0.0

(167.8)

(4.90)

0.0

N/A

N/A

12/23

0.0

(189.2)

(5.50)

0.0

N/A

N/A

Note: *PBT is reported. **EPS is fully diluted.

As per the announcement, Ultimovacs has implemented austerity measures to support the clinical progression of UV1, its cancer vaccine. Measures include a notable decrease in its workforce and activity level, which should extend the company’s cash runway to Q425, based on the company’s estimated quarterly cash burn rate of NOK15m. We view these as necessary adjustments, in light of the INITIUM trial (initially announced in March 2024) results and subsequent equity value erosion. As a reminder, median progression-free survival was not reached in either the control arm (ipilimumab and nivolumab, IPI-NIVO) or the experimental arm (UV1 plus IPI-NIVO), and the experimental arm was found to have no added benefit to IPI-NIVO alone in terms of either overall survival or objective response rate. The company has decided not to undertake any further development work for this indication.

We maintain, however, that opportunity remains for the other cancer indications being explored, and we remind readers that melanoma is just one of five indications being explored in Ultimovacs’ broad Phase II programme for UV1. For example the results for NIPU in mesothelioma demonstrated a reduced risk of death by 27% with UV1 plus IPI-NIVO compared to IPI-NIVO alone and continues to hold future potential for the company. We believe this highlights the importance of the company’s broad data-driven clinical development plans, as trial results are expected to differ across different cancer indications, and potentially with different combinations of immunotherapies (for example, the FOCUS trial will test UV1 with pembrolizumab vs IPI-NIVO in the INITIUM and NIPU trials).

Looking ahead, we believe that the results from FOCUS (Q324) and DOVACC (H125) could potentially represent significant inflection points and sentiment boosters for Ultimovacs. Further on the horizon is the LUNGVAC trial in non-small cell lung cancer, although we note that clinical study progression in this indication may be contingent on the company raising additional funds (given that topline readouts were guided for H126). While patient enrolment has been completed for FOCUS, we expect an update on patient enrolment for DOVACC and LUNGVAC with the company’s Q124 report (expected 7 May 2024).

General disclaimer and copyright

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

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Copyright: Copyright 2024 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.

New Zealand

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United Kingdom

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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.

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 Ultimovacs and prepared and issued by Edison, in consideration of a fee payable by Ultimovacs. 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

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