Ultimovacs — UV1 ODD a sign of positive things to come

Ultimovacs (OSE: ULTI)

Last close As at 01/11/2024

NOK7.55

0.06 (0.80%)

Market capitalisation

260m

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Research: Healthcare

Ultimovacs — UV1 ODD a sign of positive things to come

Ultimovacs has announced that the US FDA has granted orphan drug designation (ODD) to its cancer vaccine, UV1, for the treatment of mesothelioma. This is a positive development as the orphan designation is based on initial clinical data from the investigator-led Phase II NIPU clinical trial, which did not meet its primary end point of progression-free survival (PFS) in June 2023; however, it indicated a positive trend in overall survival (OS) in the UV1 arm. While the company is gearing up to share updated dataset (especially OS data) for NIPU at the upcoming ESMO Congress from 20–24 October, we believe the ODD indicates UV1’s potential in mesothelioma and might be helpful in further discussions with the US FDA. In our view, the upcoming readouts from the ongoing Phase II trials, including the next INITIUM (malignant melanoma) top-line results in H124, represent major catalysts for the company.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Ultimovacs_resized

Healthcare

Ultimovacs

UV1 ODD a sign of positive things to come

Regulatory update

Pharma and biotech

10 October 2023

Price

NOK106.4

Market cap

NOK3,661m

NOK10.58/US$

Net cash (NOKm) at end-June 2023

(excluding leases)

344.1

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 (hTERT), 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

Nidhi Singh

+44 (0)20 3077 5700

Ultimovacs is a research client of Edison Investment Research Limited

Ultimovacs has announced that the US FDA has granted orphan drug designation (ODD) to its cancer vaccine, UV1, for the treatment of mesothelioma. This is a positive development as the orphan designation is based on initial clinical data from the investigator-led Phase II NIPU clinical trial, which did not meet its primary end point of progression-free survival (PFS) in June 2023; however, it indicated a positive trend in overall survival (OS) in the UV1 arm. While the company is gearing up to share updated dataset (especially OS data) for NIPU at the upcoming ESMO Congress from 20–24 October, we believe the ODD indicates UV1’s potential in mesothelioma and might be helpful in further discussions with the US FDA. In our view, the upcoming readouts from the ongoing Phase II trials, including the next INITIUM (malignant melanoma) top-line results in H124, represent major catalysts for the company.

Year end

Revenue
(NOKm)

PBT*

(NOKm)

EPS**
(NOK)

DPS
(NOK)

P/E
(x)

Yield
(%)

12/21

0.0

(164.7)

(5.09)

0.0

N/A

N/A

12/22

0.0

(167.8)

(4.89)

0.0

N/A

N/A

12/23e

0.0

(214.8)

(6.24)

0.0

N/A

N/A

12/24e

0.0

(227.9)

(8.08)

0.0

N/A

N/A

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

The latest ODD for UV1 for mesothelioma is encouraging given the top-line results for the NIPU trial (mesothelioma; n=118) in June were initially received negatively. It also broadens the scope of the existing ODD for UV1 in malignant melanoma, received in December 2021. Ultimovacs reported initial clinical data from the Phase II NIPU study investigating the company’s cancer vaccine, UV1, as a second-line treatment of malignant pleural mesothelioma (MPM) in June 2023. We note that the NIPU study is sponsored by Oslo University Hospital with support from BristolMyers Squibb and Ultimovacs. While the study did not meet its primary endpoint of PFS following assessment conducted by a central independent review committee, local assessments at the study hospitals performed by specialist radiographers measured a statistically significant improvement in PFS. Importantly, a positive trend in overall survival was observed in the UV1 arm of the NIPU study.

We expect Ultimovacs to present more mature and updated overall survival (OS) data at the upcoming European Society for Medical Oncology Congress in late October, which, if favourable, might further confirm the OS benefit in the UV1 arm. We emphasise that NIPU study assesses UV1 in second-line treatment for MPM, where standard-of-care is not yet established, with fewer treatment options, mainly related to palliative care. Hence, it represents an important therapeutic opportunity for the company.

Apart from NIPU trial, Ultimovacs is conducting additional Phase II studies in patients with malignant melanoma (INTIUM), head and neck cancer (FOCUS), ovarian cancer (DOVACC) and non-small cell lung cancer (LUNGVAC). The topline data from the malignant melanoma and head and neck cancer trials are anticipated within a year’s timeframe and represent the next key catalysts for the company.

General disclaimer and copyright

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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 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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