Ultimovacs — UV1 by no means out after NIPU readout

Ultimovacs (OSE: ULTI)

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Research: Healthcare

Ultimovacs — UV1 by no means out after NIPU readout

Ultimovacs has reported initial clinical data from the Phase II investigator-sponsored NIPU study investigating the company’s cancer vaccine, UV1, for the treatment of relapsed/refractory (r/r) malignant pleural mesothelioma (MPM). While the study did not meet its primary endpoint of progression-free survival (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. However, it is likely these assessments are not totally blinded. Importantly, a positive trend in overall survival (OS) was observed in the UV1 arm of the NIPU study; however, the clinical data needs longer to mature before definitive conclusions can be drawn from this trend. We stress that the latest results from NIPU should not be used as definitive predictors of efficacy in any of the ongoing Phase II studies for UV1. We have adjusted our valuation of Ultimovacs to reflect the latest NIPU readouts to NOK7.4bn or NOK216/share (previously NOK8.0bn or NOK234/share).

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Ultimovacs

UV1 by no means out after NIPU readout

NIPU study results

Pharma and biotech

12 June 2023

Price

NOK78.7

Market cap

NOK2,707m

NOK10.59/US$

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

405.5

Shares in issue

34.4m

Free float

53%

Code

ULTI

Primary exchange

Oslo Stock Exchange

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(37.6)

(29.9)

6.6

Rel (local)

(38.2)

(27.3)

15.3

52-week high/low

NOK136

NOK60

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% of all cancer types. UV1 therefore has broad potential in a variety of different settings and combinations.

Next events

Phase II INITIUM top-line data

H223

Phase I TENDU initial data

H223

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Adam McCarter

+44 (0)20 3077 5700

Ultimovacs is a research client of Edison Investment Research Limited

Ultimovacs has reported initial clinical data from the Phase II investigator-sponsored NIPU study investigating the company’s cancer vaccine, UV1, for the treatment of relapsed/refractory (r/r) malignant pleural mesothelioma (MPM). While the study did not meet its primary endpoint of progression-free survival (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. However, it is likely these assessments are not totally blinded. Importantly, a positive trend in overall survival (OS) was observed in the UV1 arm of the NIPU study; however, the clinical data needs longer to mature before definitive conclusions can be drawn from this trend. We stress that the latest results from NIPU should not be used as definitive predictors of efficacy in any of the ongoing Phase II studies for UV1. We have adjusted our valuation of Ultimovacs to reflect the latest NIPU readouts to NOK7.4bn or NOK216/share (previously NOK8.0bn or NOK234/share).

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

(210.8)

(6.13)

0.0

N/A

N/A

12/24e

0.0

(277.9)

(8.08)

0.0

N/A

N/A

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

NIPU should not detract from INITIUM

It is important to note that while the PFS endpoint was not met in the NIPU trial, r/r MPM is regarded as an extremely challenging indication with little evidence, to date, demonstrating the effectiveness of immunotherapy in the second-line treatment setting. Additionally, the NIPU study was an investigator-initiated trial and, in our view, MPM is not a key indication in the company’s pipeline. The Phase II INITIUM study in advanced melanoma is fully funded by Ultimovacs and could be considered as the company’s strategic priority. Due to the significant difference in cancer biology between MPM and melanoma as well as in the established standard of care, we believe there is very little read-across between the results of NIPU and INITIUM.

Proof-of-concept data exists in melanoma

Melanoma is considered one of the most immunogenic tumour types and, unlike in MPM, UV1 has already demonstrated encouraging long-term survival data in combination with pembrolizumab (Keytruda) in first-line unresectable melanoma. The Phase I (UV-103) trial reported PFS of 18.9 months, an improvement on the PFS of 8.4 months reported from a separate study (KEYNOTE-006) for pembrolizumab. Additionally, one- and two-year OS rates from the study were reported to be 87% (26/30) and 73% (22/30) respectively.

Valuation: NOK7.4bn or NOK216/share

Our valuation has been affected the adjustment in our probability of success for UV1 in MPM to 10% (25% previously) and in ovarian cancer (OC) to 15% (25% previously), an indication where immunotherapy has also had limited success.

Valuation

The most recent results of the NIPU study have shown some signals for UV1 efficacy in MPM. Additionally, we note that the results from the CheckMate-743 trial subsequently led to the approval of nivolumab and ipilimumab in first-line MPM and a PFS of 6.8 months was reported for the combination compared to 7.2 months in chemotherapy alone. However, OS for the combination arm was 18.1 months versus 14.1 months with chemotherapy.

Yet, considering the NIPU trial did not meet its primary endpoint we have adjusted the probability of success for UV1 in MPM down to 10% compared to 25% previously, reducing our rNPV valuation in this indication from NOK22.1/share to NOK10.5/share. We have also adjusted the probability of success of UV1 in OC to 15% (previously 25%) due to the fact the investigator-sponsored DOVACC study is not investigating UV1 with any of the OC FDA approved immune checkpoint inhibitors (pembrolizumab and dostarlimab). While the study is assessing UV1 in combination with Olaparib (PARP inhibitor) and durvalumab (PD-L1 inhibitor), the latter is not currently approved in OC and, historically, immunotherapy has struggled in the treatment of OC.

With these changes we value Ultimovacs at NOK7.4bn or NOK216/share (previously NOK8.0bn or NOK234/share), with the company’s value primarily derived from larger oncology indications. Our valuation for Ultimovacs is composed of 22% malignant melanoma, 5% MPM, 8% OC, 22% head and neck cancer, 38% non-small cell lung cancer and 5% cash. A breakdown of our rNPV calculations can be seen in Exhibit 1.

Exhibit 1: Valuation of Ultimovacs

Product

Launch

Peak sales
($m)

NPV (NOKm)

NPV/share (NOK/share)

Probability

rNPV (NOKm)

rNPV/share (NOK/share)

UV1 – malignant melanoma

2028

1,270

6,059.0

176.2

25.0%

1,648.5

47.9

UV1 – mesothelioma

2028

570

2,836.2

82.5

10.0%

361.0

10.5

UV1 – ovarian cancer

2029

787

3,234.2

94.0

15.0%

599.7

17.4

UV1 – head and neck cancer

2029

1,370

5,866.8

170.6

25.0%

1,609.5

46.8

UV1 – NSCLC

2030

2,683

10,347.2

300.8

25.0%

2,803.4

81.5

Net cash, last reported

 

 

405.5

11.8

100.0%

405.5

11.8

Valuation

 

 

28,749.0

835.8

7,427.6

215.9

Source: Edison Investment Research

Exhibit 2: Financial summary

Accounts: IFRS; year end 31 December; NOKm

 

2019

2020

2021

2022

2023e

2024e

Income statement

 

 

 

 

 

 

 

Total revenues

 

0.00

0.00

0.00

0.00

0.00

0.00

Cost of sales

 

0.00

0.00

0.00

0.00

0.00

0.00

Gross profit

 

0.00

0.00

0.00

0.00

0.00

0.00

SG&A (expenses)

 

(20.16)

(50.99)

(61.92)

(71.47)

(85.76)

(102.91)

R&D costs

 

(35.53)

(64.66)

(96.74)

(95.18)

(109.52)

(136.90)

Other income/(expense)

 

(8.47)

(5.78)

(2.48)

(14.34)

(27.38)

(34.22)

Exceptionals and adjustments

 

0.00

0.00

0.00

0.00

0.00

0.00

Reported EBITDA

 

(64.15)

(121.43)

(161.13)

(180.98)

(222.65)

(274.03)

Depreciation and amortisation

 

(2.06)

(2.72)

(2.70)

(2.65)

(2.44)

(2.38)

Reported Operating Profit/(loss)

 

(66.22)

(124.15)

(163.83)

(183.63)

(225.09)

(276.41)

Finance income/(expense)

 

5.05

3.59

(0.89)

15.84

14.30

(1.50)

Other income/(expense)

 

0.00

0.00

0.00

0.00

0.00

0.00

Exceptionals and adjustments

 

0.00

0.00

0.00

0.00

0.00

0.00

Reported PBT

 

(61.17)

(120.55)

(164.72)

(167.79)

(210.79)

(277.91)

Income tax expense

 

0.00

0.00

0.00

0.00

0.00

0.00

Reported net income

 

(61.17)

(120.55)

(164.72)

(167.79)

(210.79)

(277.91)

 

 

 

 

 

 

 

 

Basic average number of shares, m

 

22.93

30.26

32.37

34.31

34.40

34.40

Basic EPS (NOK)

 

(2.67)

(3.98)

(5.09)

(4.89)

(6.13)

(8.08)

Diluted EPS (NOK)

 

(2.67)

(3.98)

(5.09)

(4.89)

(6.13)

(8.08)

 

 

 

 

 

 

 

 

Balance sheet

 

 

 

 

 

 

 

Property, plant and equipment

 

0.536

0.377

0.212

0.220

0.125

0.007

Intangible assets

 

66.370

76.346

71.119

68.429

66.280

64.211

Other non-current assets

 

3.523

3.630

1.951

5.444

5.444

5.444

Total non-current assets

 

70.429

80.353

73.282

74.093

71.849

69.662

Cash and equivalents

 

399.607

440.925

574.168

425.309

226.907

111.739

Trade and other receivables

 

0.000

0.000

0.000

0.000

0.000

0.000

Other current assets

 

8.004

8.438

8.087

10.270

10.270

10.270

Total current assets

 

407.611

449.363

582.255

435.579

237.177

122.009

Non-current loans and borrowings

 

2.301

2.075

0.457

3.713

3.713

153.713

Deferred tax liabilities

 

10.851

11.795

11.031

10.701

10.701

10.701

Total non-current liabilities

 

13.152

13.870

11.488

14.414

14.414

164.414

Trade and other payables

 

11.768

8.611

22.555

7.655

9.383

11.523

Other current liabilities

 

8.489

18.856

28.342

38.252

38.252

38.252

Total current liabilities

 

20.257

27.467

50.897

45.907

47.635

49.775

Equity attributable to company

 

444.632

488.380

593.152

449.351

246.977

(22.518)

 

 

 

 

 

 

 

 

Cash flow statement

 

 

 

 

 

 

 

Operating Profit/(loss)

 

(66.217)

(124.146)

(163.833)

(183.630)

(225.093)

(276.412)

Depreciation and amortisation

 

2.063

2.720

2.703

2.648

2.439

2.382

Other adjustments

 

(2.023)

3.215

12.331

4.437

(6.367)

2.747

Movements in working capital

 

(1.862)

6.395

23.860

(6.988)

1.728

2.139

Interest paid / received

 

0.000

0.000

0.000

0.000

0.000

0.000

Income taxes paid

 

0.000

0.000

0.000

0.000

0.000

0.000

Cash from operations (CFO)

 

(62.988)

(108.223)

(125.828)

(167.694)

(212.994)

(270.646)

Capex

 

(0.172)

(0.282)

(0.085)

(0.195)

(0.195)

(0.195)

Acquisitions & disposals net

 

0.000

0.000

0.000

0.000

0.000

0.000

Other investing activities

 

4.490

(0.455)

3.062

8.887

14.787

5.673

Cash used in investing activities (CFIA)

 

4.318

(0.737)

2.977

8.692

14.592

5.478

Net proceeds from issue of shares

 

344.582

152.933

261.852

5.484

0.000

0.000

Movements in debt

 

0.000

0.000

0.000

0.000

0.000

150.000

Other financing activities

 

(1.579)

(1.916)

(1.895)

(1.907)

0.000

0.000

Cash flow from financing activities

 

343.003

151.017

259.957

3.577

0.000

150.000

Increase/(decrease) in cash and equivalents

 

284.333

42.057

137.106

(155.425)

(198.402)

(115.168)

Cash and equivalents at beginning of period

 

115.540

399.607

440.925

574.168

425.309

226.907

Cash and equivalents at end of period

 

399.608

440.925

574.168

425.310

226.907

111.739

Net (debt) cash (including lease liabilities)

 

395.982

437.143

572.083

419.830

221.427

(43.741)

Source: Edison Investment Research, Ultimovacs company accounts

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

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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