Oncology Venture — FDA OKs 505(b)(2) pathway for LiPlaCis in mBC

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Oncology Venture — FDA OKs 505(b)(2) pathway for LiPlaCis in mBC

Oncology Venture (OV) recently announced that the FDA agreed the 505(b)(2) pathway is an appropriate route for LiPlaCis in metastatic breast cancer (mbC) such that objective response rate (ORR) is a suitable primary endpoint for the study. OV is seeking approval for LiPlaCis via a single-arm pivotal study in ~100-200 patients with mBC. The company plans to update recruitment timelines following FDA approval of the IDE/IND application, which OV expects in H119.

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Healthcare

Oncology Venture

FDA OKs 505(b)(2) pathway for LiPlaCis in mBC

Clinical update

Pharma & biotech

21 December 2018

Price

SEK7.6

Market cap

SEK382m

US$0.16/DKK, US$0.11/SEK

Net debt (SEKm) at 30 September 2018

0.8

Shares in issue

50.3m

Free float

70%

Code

OV.ST

Primary exchange

NASDAQ First North Stockholm

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(7.8)

(43.7)

(37.7)

Rel (local)

(5.8)

(34.7)

(31.8)

52-week high/low

SEK15.0

SEK6.9

Business description

Oncology Venture is a Denmark-based biopharmaceutical company focused on oncology. Its patent-protected mRNA-based drug response predictor platform enables the identification of patients with gene expression highly likely to respond to treatment. To date, the company has in-licensed six drug candidates with the intent to conduct focused Phase II clinical trials and then out-license the revamped drugs.

Next events

Initiate 2X-121 Phase II in ovarian cancer

Q119

Phase II LiPlaCis trial top-line data

H119

Analysts

Nathaniel Calloway

+1 646 653 7036

Briana Warschun

+1 646 653 7031

Oncology Venture is a research client of Edison Investment Research Limited

Oncology Venture (OV) recently announced that the FDA agreed the 505(b)(2) pathway is an appropriate route for LiPlaCis in metastatic breast cancer (mbC) such that objective response rate (ORR) is a suitable primary endpoint for the study. OV is seeking approval for LiPlaCis via a single-arm pivotal study in ~100-200 patients with mBC. The company plans to update recruitment timelines following FDA approval of the IDE/IND application, which OV expects in H119.

Year end

Revenue (DKKm)

PBT*
(DKKm)

EPS*
(DKK)

DPS
(DKK)

P/E
(x)

Yield
(%)

12/17

5.1

(31.0)

(1.27)

0.0

N/A

N/A

12/18e

3.2

(29.2)

(0.57)

0.0

N/A

N/A

12/19e

1.9

(205.8)

(3.82)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

505(b)(2) pathway for LiPlaCis via ORR

In mid-December, OV announced that the FDA responded positively to its recently submitted pre-IDE/IND dossier detailing a potential application for LiPlaCis in mBC in the US. According to the company, the FDA agreed that the 505(b)(2) pathway is an acceptable course for LiPlaCis and that additional toxicology studies are not needed. The primary endpoint of the trial is ORR (ie partial responses plus complete responses); however, the FDA is also requesting supplementary characterisation of the patient sub-populations delineated by the drug response predictor (DRP) to be treated with LiPlaCis.

ORR is viable if granted ‘breakthrough’ designation

ORR is measured via single-arm studies in patients with refractory solid tumours where no alternative therapy exists. Therefore, ORR may serve as a viable endpoint for the LiPlaCis programme if the FDA grants ‘breakthrough therapy’ designation. In September 2017, the FDA approved Eli Lilly’s Verzenio (abemaciclib), a cyclin-dependent kinase (CDK) inhibitor, as a monotherapy for HR+, HER2- advanced or mBC with an ORR of 19.7% in a 132-patient trial.

Plans for the pivotal LiPlaCis trial

OV is seeking approval for LiPlaCis via a single-arm pivotal study in ~100–200 patients with mBC whereas the ongoing Phase II trial may serve as a bridge. The company expects to update recruitment timelines for the trial following FDA approval for the IDE/IND application, which OV expects in H119.

Valuation: SEK1,100.5m or SEK21.87 per share

Our valuation of OV remains unchanged at SEK1,100.5m or SEK21.87 per share (SEK20.52 per diluted share). The 505(b)(2) pathway enables drug approval with fewer patients in the clinical study and is consistent with our previous estimates for LiPlaCis of 200 patients needed for pivotal study. We expect to make further adjustments to our valuation in due course following feedback from the FDA regarding potential ‘Breakthrough Therapy’ designation for LiPlaCis.

Seeking LiPlaCis approval via 505(b)(2) pathway

On 18 December 2018, OV announced that the FDA provided positive feedback on its pre-IDE/IND dossier detailing a potential application for LiPlaCis in mBC in the US. According to the company, the FDA agreed the 505(b)(2) pathway is an appropriate registration route for LiPlaCis in combination with its unique DRP. Moreover, the FDA accepted ORR as the primary endpoint for the trial contingent on OV’s ability to provide additional characterisation of the patient sub-populations selected by the DRP to be treated with the drug. Several advantages to using ORR as a primary endpoint include assessment in single-arm studies and the opportunity to evaluate earlier and in smaller studies in comparison to survival studies.

ORR is a relatively common endpoint for both regular and accelerated approval in refractory solid tumours where no alternative therapy exists, specifically in mBC. It is important to note, however, that ORR is not a direct measure of comprehensive drug activity and is typically supplemented with response duration, tumour-related symptom relief and drug toxicity data for approval. In September 2017, the FDA approved Eli Lilly’s Verzenio (abemaciclib), a small molecule CDK 4 and 6 inhibitor, for HR+, HER2- advanced or mBC. Monotherapy approval was based on a single-arm, open-label multicentre trial in 132 women with HR+, HER2- advanced or mBC whose disease progressed on endocrine therapy, taxane therapy, and either one or two prior chemotherapy regimens. ORR was 19.7% with a median response duration of 8.6 months. Verzenio is also approved in combination with fulvestrant. Lilly reported Verzenio sales of $87.4m for the six months ending 30 June 2018.

OV is seeking approval for LiPlaCis, a liposomal version of cisplatin chemotherapy, via a single-arm pivotal study in ~100–200 patients with mBC whereas the ongoing Phase II trial may serve as a bridge. The DRP is used to classify tissue into three groups where the highly likely to respond (ie the top two groups) receive the drug and the less likely to respond (ie bottom one-third) do not receive treatment. More than 1,400 mBC patients have been evaluated for efficacy. As of 1 November 2018, five out of 10 patients (or 50%) in the top one-third of DRP selected patients and six out of 25 patients (or 24%) in the top two groups achieved partial remission or better, which is defined as a 30% or greater reduction in tumour size measured in one dimension in a CT-scan when treated with LiPlaCis. According to the company, this data may support obtaining ‘breakthrough therapy’ designation from the US FDA, which could expedite the development and review of the LiPlaCis programme if it demonstrates considerable improvement over existing therapies on clinically significant endpoints. OV plans to update recruitment timelines for the trial following FDA approval of the IDE/IND application, which the company expects in H119.

Valuation

The 505(b)(2) pathway enables drugs to be approved with fewer patients in the clinical study. These are consistent with our previous estimates for LiPlaCis of 200 patients needed for a pivotal study and therefore our valuation remains unchanged at SEK1,100.5m or SEK21.87 per share (SEK20.52 per diluted share). Adjustments to our valuation of the LiPlaCis programme are contingent on FDA feedback regarding ‘Breakthrough Therapy’ Designation. According to the company, its three highest priority assets include LiPlaCis, 2X-121 and dovitinib; and based on our estimates, we value these assets at SEK5.20, SEK3.09 and SEK5.10 per share, respectively. We expect to make further adjustments to our valuation of OV following feedback from the company’s six clinical programmes.

Exhibit 1: Valuation of OV

Development Program

Indication

Clinical stage

Prob. of success

Launch year

Launch pricing

Peak sales ($m)

rNPV (SEKm)

% owned by OV

OV rNPV (SEKm)

LiPlaCis

Metastatic breast cancer and metastatic prostate cancer

Phase II

25%

2023

$91,000

259.8

670.7

39

261.6

Irofulven

Metastatic prostate cancer

Phase Ib/II

20%

2023

$129,000

52.6

60.1

100

60.1

APO010

Multiple myeloma

Phase Ib/II

20%

2023

$143,000

80.9

98.1

100

98.1

2X-121

Metastatic breast cancer and ovarian cancer

Phase II

25%

2023

$132,000

116.4

168.9

92

155.4

2X-111

Glioblastoma and brain metastases from breast cancer

Phase Ib/II

25%

2024

$169,000

212.6

293.0

92

269.6

Dovitnib

Renal and liver cancer

Phase Ib/II

35%

2024

$145,000

152.0

466.4

55

256.5

Total

 

 

 

 

 

 

 

 

1,101.3

Net debt (at 30 September 2018) (SEKm)

(0.8)

Total firm value (SEKm)

1,100.5

Total shares (m)

50.3

Value per basic share (SEK)

21.87

Warrants and options (m)

3.3

Fully diluted shares in issue

53.6

Fully diluted value per share

20.52

Source: Edison Investment Research

Financials

Our financial forecasts and our financial requirements (DKK430m) for OV remain unchanged. We continue to expect these requirements to be significantly offset by the recent financing agreement with the European High Growth Opportunities Securitization Fund (EHGOSF) advised by Alpha Blue Ocean, announced on 30 November 2018. According to the agreement, OV may receive up to SEK200m in convertible notes and warrants over the next 24 months bearing 2% fixed interest, and potentially an additional SEK100m if all warrants are exercised. The pricing of the convertible notes and warrants will be determined once they are drawn (95% and 150% of the average of the last 15 trading days, respectively) and there is 50% warrant coverage in each tranche. The funding may be drawn down through the issuance of 20 tranches at SEK10m (note, the size of tranche can be decreased to SEK7.5m) and EHGOSF may ask for five of these. These capital requirements may be further offset by DKK20m remaining available to the company attributed to the flexible loan facility established with Trention.

Exhibit 2: Financial summary

DKK'000s

2017

2018e

2019e

Year end 31 December

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

5,145

3,192

1,876

Cost of Sales

0

0

0

Gross Profit

5,145

3,192

1,876

EBITDA

 

 

(23,848)

(38,438)

(204,616)

Operating Profit (before amort. and except.)

(23,848)

(37,589)

(203,767)

Intangible Amortisation

0

0

0

Exceptionals/Other

0

0

0

Operating Profit

(23,848)

(37,589)

(203,767)

Net Interest

(7,132)

8,358

(2,015)

Other (change in fair value of warrants)

0

0

0

Profit Before Tax (norm)

 

 

(30,980)

(29,231)

(205,782)

Profit Before Tax (IFRS)

 

 

(30,980)

(29,231)

(205,782)

Tax

590

557

3,914

Deferred tax

0

0

0

Profit After Tax (norm)

(30,390)

(28,674)

(201,868)

Profit After Tax (IFRS)

(30,390)

(28,674)

(201,868)

Average Number of Shares Outstanding (m)

24.3

50.3

52.8

EPS - normalised (ore)

 

 

(127.00)

(56.99)

(382.13)

EPS - IFRS (DKK)

 

 

(1.25)

(0.57)

(3.82)

Dividend per share (ore)

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

4,883

205,109

205,109

Intangible Assets

135

205,149

205,149

Tangible Assets

4,424

(40)

(40)

Other

324

0

0

Current Assets

 

 

8,102

29,463

63,138

Stocks

1,048

805

805

Debtors

3,048

5,758

20,222

Cash

3,326

5,797

21,093

Other

680

17,103

21,018

Current Liabilities

 

 

(10,540)

(6,019)

(29,314)

Creditors

(10,540)

(6,019)

(29,314)

Short term borrowings

0

0

0

Long Term Liabilities

 

 

0

(81,693)

(293,693)

Long term borrowings

0

(49,302)

(261,302)

Other long term liabilities

0

(32,391)

(32,391)

Net Assets

 

 

2,445

146,860

(54,760)

CASH FLOW

Operating Cash Flow

 

 

(10,702)

(58,158)

(195,855)

Net Interest

(170)

(252)

0

Tax

2,527

69

0

Capex

0

0

(849)

Acquisitions/disposals

(784)

14,457

0

Financing

7,478

177

0

Dividends

0

0

0

Other

(308)

(3,197)

0

Net Cash Flow

(1,959)

(46,904)

(196,704)

Opening net debt/(cash)

 

 

(5,488)

(3,326)

43,505

HP finance leases initiated

0

0

0

Exchange rate movements

(203)

(73)

0

Other

0

146

0

Closing net debt/(cash)

 

 

(3,326)

43,505

240,209

Source: Company reports, Edison Investment Research.

General disclaimer and copyright

This report has been commissioned by Oncology Venture and prepared and issued by Edison, in consideration of a fee payable by Oncology Venture. Edison Investment Research standard fees are £49,500 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 Edison analyst 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.

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Copyright: Copyright 2018 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2018. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

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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

Neither this document and associated email (together, the "Communication") constitutes or form part of any offer for sale or subscription of, or solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it form the basis of, or be relied on in connection with, any contract or commitment whatsoever. Any decision to purchase shares in the Company in the proposed placing should be made solely on the basis of the information to be contained in the admission document to be published in connection therewith.

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 (nor will such persons be able to purchase shares in the placing).

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The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. 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.

Frankfurt +49 (0)69 78 8076 960

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London +44 (0)20 3077 5700

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New York +1 646 653 7026

295 Madison Avenue, 18th Floor

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Sydney +61 (0)2 8249 8342

Level 12, Office 1205

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Oncology Venture and prepared and issued by Edison, in consideration of a fee payable by Oncology Venture. Edison Investment Research standard fees are £49,500 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 Edison analyst 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 2018 Edison Investment Research Limited (Edison). All rights reserved FTSE International Limited (“FTSE”) © FTSE 2018. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Myonlineadvisers Pty Ltd who holds an Australian Financial Services Licence (Number: 427484). 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

Neither this document and associated email (together, the "Communication") constitutes or form part of any offer for sale or subscription of, or solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it form the basis of, or be relied on in connection with, any contract or commitment whatsoever. Any decision to purchase shares in the Company in the proposed placing should be made solely on the basis of the information to be contained in the admission document to be published in connection therewith.

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 (nor will such persons be able to purchase shares in the placing).

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

The Investment Research is a publication distributed in the United States by Edison Investment Research, Inc. Edison Investment Research, Inc. is registered as an investment adviser with the Securities and Exchange Commission. 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.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

295 Madison Avenue, 18th Floor

10017, New York

US

Sydney +61 (0)2 8249 8342

Level 12, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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