Arovella Therapeutics — Acquiring DKK1 rights

Arovella Therapeutics (ASX: ALA)

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Research: Healthcare

Arovella Therapeutics — Acquiring DKK1 rights

Arovella Therapeutics (formerly SUDA Pharmaceuticals) has announced it has in-licensed the rights to a novel monoclonal antibody that targets the Dickkopf-1 (DKK1) peptide from MD Anderson Cancer Center (for undisclosed upfront and development milestones as well as single digit royalties). DKK1 has been shown to promote tumour metastasis across a variety of tumour types. The company plans to combine the DKK1 targeting technology with its recently acquired invariant natural killer T (iNKT) cell therapy platform and test DKK1-CAR-iNKT cells (under programme name ALA-104) in cancer models in 2022.

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Healthcare

Arovella Therapeutics

Acquiring DKK1 rights

Development update

Pharma & biotech

21 December 2021

Price

A$0.04

Market cap

A$17m

A$1.39/US$

Net cash (A$m) at 30 September 2021

5.1

Shares in issue

480.9m

Free float

86.8%

Code

ALA

Primary exchange

ASX

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(18.2)

(26.5)

(5.3)

Rel (local)

(16.8)

(27.2)

(13.7)

52-week high/low

A$0.07

A$0.03

Business description

Arovella Therapeutics (formerly SUDA Pharmaceuticals) has historically been a drug delivery company focusing on developing oro-mucosal spray versions of established medicines. It has ex-North America rights to ZolpiMist, the spray version of Ambien for insomnia. It recently acquired a CAR-iNKT programme for haematological malignancies and a DKK1 antibody, which has potential in multiple myeloma and solid tumours.

Next events

Progress on iNKT development

2022

Analysts

Maxim Jacobs

+1 646 653 7027

Jyoti Prakash

+91 981 880 393

Arovella Therapeutics is a research client of Edison Investment Research Limited

Arovella Therapeutics (formerly SUDA Pharmaceuticals) has announced it has in-licensed the rights to a novel monoclonal antibody that targets the Dickkopf-1 (DKK1) peptide from MD Anderson Cancer Center (for undisclosed upfront and development milestones as well as single digit royalties). DKK1 has been shown to promote tumour metastasis across a variety of tumour types. The company plans to combine the DKK1 targeting technology with its recently acquired invariant natural killer T (iNKT) cell therapy platform and test DKK1-CAR-iNKT cells (under programme name ALA-104) in cancer models in 2022.

Year end

Revenue (A$m)

PBT*
(A$m)

EPS*
(A$)

DPS
(A$)

P/E
(x)

Yield
(%)

06/20

0.5

(4.0)

(0.03)

0.0

N/A

N/A

06/21

0.3

(3.8)

(0.01)

0.0

N/A

N/A

06/22e

0.5

(7.1)

(0.01)

0.0

N/A

N/A

06/23e

2.5

(6.0)

(0.01)

0.0

N/A

N/A

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

DKK1 shows promise across tumour types

DKK1 has been shown to promote tumour metastasis across multiple solid tumours including, lung, breast, liver, oesophageal, gastric, pancreatic, cervical and bladder cancers. DKK1 also appears to be overexpressed on multiple myeloma cells and DKK1-CAR-T cells have shown promising efficacy results in multiple myeloma mouse models while sparing healthy tissue.

ALA-104 next steps

Over the next 12 months, Arovella will seek to confirm that DKK1 does not target healthy cells and that it can combine with the iNKT cell therapy platform. It plans to initiate preclinical studies across relevant tumour types and develop/initiate a manufacturing strategy.

ALA-101 update

ALA-101 (CAR19-iNKT) is being developed as an off-the-shelf treatment for blood cancers and so far has shown strong preclinical activity against CD19-expressing cancers. The company is developing the clinical plan for ALA-101 and, following selection of the manufacturer, expects to commence manufacturing of the lentiviral vector shortly.

Valuation: A$25m or A$0.05 per basic share

We have adjusted our Arovella valuation from A$26m or A$0.05 per basic share (A$0.05 per diluted share), to A$25m or A$0.05 per basic share (A$0.04 per diluted share) mainly due to slightly lower cash levels. We are not yet including either of the CAR-iNKT programmes in our valuation but intend to do so when they enter the clinic. Given the sales of similar products and recent acquisition activity in this space, the resulting changes to our valuation could be meaningful.

Continuing to build the pipeline

Arovella has announced it has in-licensed the rights to a novel monoclonal antibody that targets the DKK1 peptide from the MD Anderson Cancer Center for undisclosed upfront and development milestones as well as single-digit royalties. DKK1 has been shown to promote tumour metastasis across a variety of solid tumour types including, lung, breast, liver, oesophageal, gastric, pancreatic, cervical and bladder cancers.1 DKK1 also appears to be overexpressed on multiple myeloma cells.2 DKK1-CAR-T cells have shown promising efficacy results in multiple myeloma mouse models in which all treated mice were alive at 50–60 days while untreated mice succumbed to cancer at 30–40 days (see Exhibit 1). Importantly, healthy cells were spared and no weight loss was seen. The company has also indicated that DKK1-CAR-T cells also showed promise in pancreatic, lung and triple-negative breast cancer models.

  Zhu et al., Expression and Role of Dickkopf-1 (Dkk1) in Tumors: From the cells to the patients. Cancer Management and Research 2021:13 659–675

  Qian et al., Dickkopf-1 (DKK1) is a widely expressed and potent tumor-associated antigen in multiple myeloma. Blood 2007 Sep 1; 110(5): 1587–1594.

Exhibit 1: DKK1-CAR-T cells in multiple myeloma mouse model

Source: Arovella Therapeutics

Over the next 12 months, the company will seek to confirm DKK1 does not target healthy cells, that it can combine with the iNKT cell therapy platform (which may enable an off-the shelf product), initiate preclinical studies across relevant tumour types and develop/initiate a manufacturing strategy.

Exhibit 2: Updated Arovella Therapeutics pipeline

Programme

Indications

Status

Partner

Cell therapy

ALA-101 (CAR19-iNKT)

CD19 expression lymphomas

Preclinical

ALA-102

Undisclosed

Discovery

ALA-103

Undisclosed

Discovery

ALA-104 (DKK1-CAR-iNKT)

Multiple myeloma and solid tumours

Preclinical

OroMist platform

ZolpiMist

Short-term insomnia

Registered

Teva, STADA

ALA-001 (Sumatriptan)

Migraine

Preclinical

Strides

ALA-018 (Anagrelide)

Solid tumours and thrombocytosis

Reformulation

ALA-021 (pharmaceutical grade cannabis)

Multiple

Reformulation

Cann Pharma Australia

ALA-023

Undisclosed

Preclinical

Sanofi

Source: Arovella Therapeutics

ZolpiMist updates

In August, Mitsubishi Tanabe Korea announced its intention not to proceed with the licence and supply agreement for ZolpiMist in South Korea. However, the next day Arovella announced that STADA Pharmaceuticals Australia entered into a licence and distribution agreement for Australia (where ZolpiMist was approved on 29 July 2020). Arovella received an upfront payment of A$170,000 and will receive a A$40,000 milestone payment on regulatory approval of an enhancement of the spray unit (which will incorporate a user-friendly, child-resistant lock). Additionally, Arovella will receive a 10% royalty on sales. Commercial sales are expected to start in Q3 CY22.

Valuation

We have decreased our Arovella valuation from A$26m or A$0.05 per basic share (A$0.05 per diluted share), to A$25m or A$0.05 per basic share (A$0.04 per diluted share) mainly due to slightly lower cash levels. We are not yet including either of the CAR-iNKT programmes in our valuation but intend to do so when they enter the clinic. Given the sales of similar products (US$563m in sales in 2020 for Yescarta, the CAR-T from Gilead) and recent acquisition activity (such as Kuur, an iNKT company purchased by Athenex for US$70m upfront and US$115m in potential milestones) in this space, the resulting change to our valuation could be meaningful. We have not made meaningful changes to our ZolpiMist valuation after the partnership changes as our Mitsubishi Tanabe Korea estimates were conservative and the STADA Australia agreement may offer similar returns.

Exhibit 3: Arovella valuation

Product

Main indication

Status

Probability of successful commercialisation

Approval year

Peak sales (A$m)

Economics

rNPV
(A$m)

ZolpiMist

Insomnia

Registered (Australia), pre-registration (other regions)

70%

2020

17.3

Double-digit royalties

19.6

Total

 

 

 

 

 

 

19.6

Net cash (as of 30 September 2021)

5.1

Total firm value (A$m)

24.7

Total basic shares (m)

480.9

Value per basic share (A$)

0.05

Options (m)

76.0

Total number of shares (m)

556.9

Diluted value per share (A$)

0.04

Source: Edison Investment Research

Financials

The company reported A$5.1m in cash at 30 September 2021 with operating cash burn of A$1.6m during Q1 FY22. This was an acceleration from the A$0.9m burn seen in Q4 FY21 due to the upfront costs associated with the iNKT licensure. Note that in FY21, the company reported A$3.5m in operating cash burn for the year and had A$0.5m in investing cash outflows. In June, Arovella raised A$3.65m through the issuance of 96.2m shares at A$0.038 per share to help fund development of the iNKT cell therapy platform. We have made minor changes to our FY22 estimates, including a reduction of expected revenues by A$0.5m as we had expected some royalties from Mitsubishi Tanabe Korea in that year and STADA Australia sales likely will not start until FY23. We have also increased SG&A expense estimates by A$0.3m. Additionally, in November, Arovella announced the receipt of an Australian R&D tax incentive of A$0.5m, which we have booked for FY22 in other income.

We have introduced FY23 forecasts, which feature A$2.4m in revenues (with royalties from Teva and STADA territories) and A$5.4m in operating cash burn. We continue to forecast an additional A$12.5m in financing through FY23 (modelled as illustrative debt). Financing needs will likely accelerate as the pipeline programmes mature and enter the clinic and we will update our estimates accordingly.

Exhibit 4: Financial summary

A$'000s

2020

2021

2022e

2023e

Year end 30 June

AIFRS

AIFRS

AIFRS

AIFRS

PROFIT & LOSS

Revenue

 

 

533

257

520

2,447

Cost of Sales

(201)

(223)

(267)

(321)

Gross Profit

332

35

253

2,126

Sales, General and Administrative Expenses

(4,543)

(4,070)

(4,233)

(4,402)

Research and Development Expense

0

0

(3,000)

(3,120)

EBITDA

 

 

(3,413)

(3,129)

(6,456)

(5,396)

Operating Profit (before amort. and except.)

 

 

(3,985)

(3,781)

(7,108)

(6,049)

Intangible Amortisation

0

0

0

0

Other

799

907

524

0

Exceptionals

(5,973)

(1,239)

0

0

Operating Profit

(9,958)

(5,021)

(7,108)

(6,049)

Net Interest

22

(27)

(28)

(29)

Other

0

0

0

0

Profit Before Tax (norm)

 

 

(3,963)

(3,808)

(7,136)

(6,077)

Profit Before Tax (FRS 3)

 

 

(9,936)

(5,047)

(7,136)

(6,077)

Tax

0

0

0

0

Deferred tax

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(3,963)

(3,808)

(7,136)

(6,077)

Profit After Tax (FRS 3)

(9,936)

(5,047)

(7,136)

(6,078)

Average Number of Shares Outstanding (m)

142.3

330.9

481.0

485.8

EPS - normalised (A$)

 

 

(0.03)

(0.01)

(0.01)

(0.01)

EPS - Reported (A$)

 

 

(0.07)

(0.02)

(0.01)

(0.01)

Dividend per share (c)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

4,673

3,344

3,722

4,106

Intangible Assets

4,251

2,911

3,129

3,347

Tangible Assets

365

381

541

707

Other

57

52

52

52

Current Assets

 

 

2,035

7,343

7,877

6,964

Stocks

22

0

0

0

Debtors

869

534

534

534

Cash

977

6,717

7,251

6,338

Other

166

92

92

92

Current Liabilities

 

 

(2,022)

(1,695)

(1,689)

(1,689)

Creditors

(2,010)

(1,689)

(1,689)

(1,689)

Short term borrowings

(12)

(6)

0

0

Long Term Liabilities

 

 

(550)

(11)

(7,511)

(12,511)

Long term borrowings

(4)

(3)

(7,503)

(12,503)

Other long term liabilities

(545)

(8)

(8)

(8)

Net Assets

 

 

4,135

8,982

2,399

(3,130)

CASH FLOW

Operating Cash Flow

 

 

(2,884)

(3,545)

(6,445)

(5,385)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

(388)

(515)

(521)

(528)

Acquisitions/disposals

0

0

0

0

Financing

0

9,856

0

0

Dividends

0

0

0

0

Other

0

0

0

0

Net Cash Flow

(3,272)

5,797

(6,966)

(5,913)

Opening net debt/(cash)

 

 

(4,260)

(961)

(6,709)

252

HP finance leases initiated

0

0

0

0

Exchange rate movements

0

0

0

0

Other

(27)

(50)

6

0

Closing net debt/(cash)

 

 

(961)

(6,709)

252

6,165

Source: Company reports, Edison Investment Research. Note: The company does not separately disclose R&D expenses but we have provided a forecast for future years. Also, FY20 results have been restated by the company.

General disclaimer and copyright

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

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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 2021 Edison Investment Research Limited (Edison).

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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

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.

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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

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

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NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Arovella Therapeutics and prepared and issued by Edison, in consideration of a fee payable by Arovella Therapeutics. 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 2021 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.

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

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, 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

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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