Ultimovacs — Another ODD boosts the off-the-shelf, universal UV1

Ultimovacs (OSE: ULTI)

Last close As at 24/04/2024

NOK7.58

−0.28 (−3.56%)

Market capitalisation

NOK261m

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Research: Healthcare

Ultimovacs — Another ODD boosts the off-the-shelf, universal UV1

Ultimovacs has been granted Orphan Drug designation (ODD) from the European Medicines Agency (EMA) for UV1 in mesothelioma, marking another step forward for the clinical development of its lead universal, off-the-shelf cancer vaccine. This encouraging regulatory designation follows on the heels of the FDA ODD (October 2023) and Fast Track designation (February 2024) for UV1 in this same indication, which helps set the foundation for a potential Phase III programme. A key benefit of EU ODD is the potential for 10-year market exclusivity, provided UV1 achieves regulatory approval. The EMA decision was based on the recent positive data from the Phase II NIPU trial (reported October 2023) demonstrating a 27% reduction in risk of death with UV1 treatment compared to the standard of care in patients with malignant pleural mesothelioma (MPM). We await the results from the Phase II INITIUM trial in malignant melanoma (MM), the company’s lead indication, in March 2024, which is likely the next catalyst for the company.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Ultimovacs

Another ODD boosts the off-the-shelf, universal UV1

Regulatory update

Pharma and biotech

20 February 2024

Price

NOK147.0

Market cap

NOK5,058m

NOK10.50/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

Ultimovacs has been granted Orphan Drug designation (ODD) from the European Medicines Agency (EMA) for UV1 in mesothelioma, marking another step forward for the clinical development of its lead universal, off-the-shelf cancer vaccine. This encouraging regulatory designation follows on the heels of the FDA ODD (October 2023) and Fast Track designation (February 2024) for UV1 in this same indication, which helps set the foundation for a potential Phase III programme. A key benefit of EU ODD is the potential for 10-year market exclusivity, provided UV1 achieves regulatory approval. The EMA decision was based on the recent positive data from the Phase II NIPU trial (reported October 2023) demonstrating a 27% reduction in risk of death with UV1 treatment compared to the standard of care in patients with malignant pleural mesothelioma (MPM). We await the results from the Phase II INITIUM trial in malignant melanoma (MM), the company’s lead indication, in March 2024, which is likely the next catalyst for the company.

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

12/24e

0.0

(225.8)

(6.56)

0.0

N/A

N/A

12/25e

1,212.3

1,080.7

31.41

0.0

4.68

N/A

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

Ultimovacs has announced that the EMA has granted ODD to UV1 for the treatment of mesothelioma. The benefits of EU ODD include up to 10 years of market exclusivity (post-approval), clinical protocol assistance and reduced regulatory fees. The EMA grants ODD to investigational therapies intended to treat a seriously debilitating or life-threatening condition affecting fewer than five in 10,000 people in the EU. As mesothelioma is an aggressive type of cancer with high mortality and limited treatment options, we believe UV1 has the potential to offer an effective solution, and the receipt of EU ODD marks a noteworthy recognition of UV1’s potential efficacy.

As a reminder, the latest clinical data were the detailed results from NIPU (n=118), which evaluated UV1 in combination with ipilimumab and nivolumab (IPI-NIVO) in MPM patients, compared to IPI-NIVO alone (standard of care). Importantly, overall survival (OS) was 15.4 months in the UV1 treatment arm versus 11.1 months for the control arm, which we view as a highly encouraging result given that OS is widely considered the gold standard of endpoints in oncology trials. UV1 treatment also showed comparable safety/tolerability to IPI-NIVO alone. We note that the US FDA has previously granted ODD to UV1 for the treatment of patients with mesothelioma, as well as Fast Track designation in the same indication.

We continue to believe that the upcoming Phase II INITIUM readouts in MM (expected March 2024) could represent the next most significant catalyst for Ultimovacs. The FDA granted Fast Track designation to UV1 as an add-on therapy to checkpoint inhibitors for the treatment of unresectable or metastatic melanoma in October 2021 and ODD for the treatment of stage IIB–IV melanoma in December 2021. Ultimovacs recently recapped an active FY23, and a detailed discussion (including INITIUM) can be found in our prior update note.

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.

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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

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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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