Chimeric Therapeutics — Acquiring an exciting new NK cell technology

Chimeric Therapeutics (AU: CHM)

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Research: Healthcare

Chimeric Therapeutics — Acquiring an exciting new NK cell technology

Chimeric has announced that it has entered into an exclusive option agreement to license the clinically validated, off the shelf, robust, enhanced natural killer (CORE-NK) cell platform from Case Western Reserve University for the treatment of cancer. The CORE-NK platform was designed to overcome the hurdles associated with NK cell development and enables the production of large numbers of highly active universal donor NK cells that are active in the body. The company expects to rapidly move to complete full licensing of the platform.

Analyst avatar placeholder

Written by

Maxim Jacobs

Healthcare

Chimeric Therapeutics

Acquiring an exciting new NK cell technology

Development update

Pharma & biotech

6 December 2021

Price

A$0.27

Market cap

A$90m

A$1.40/US$

Net cash (A$m) at 30 June 2021

17.4

Shares in issue

333.4m

Free float

39.2%

Code

CHM

Primary exchange

ASX

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(13.3)

(24.6)

N/A

Rel (local)

(11.4)

(21.8)

N/A

52-week high/low

A$0.39

A$0.24

Business description

Chimeric Therapeutics is an oncology-focused Australian-based company that recently went public on the ASX. The lead programme is CHM 1101, currently in Phase I for the treatment of GBM. Beyond GBM, the technology may have applicability for other tumours such as melanoma. The company recently in-licensed a CDH17 CAR T for use in solid tumours and the CORE-NK platform, which may have broad applicability in cancer.

Next events

Updated CHM 1101 data

CY22

CHM 2101 Phase I initiation

CY22

Analysts

Maxim Jacobs

+1 646 653 7027

Jyoti Prakash

+91 981 880 393

Chimeric Therapeutics is a research client of Edison Investment Research Limited

Chimeric has announced that it has entered into an exclusive option agreement to license the clinically validated, off the shelf, robust, enhanced natural killer (CORE-NK) cell platform from Case Western Reserve University for the treatment of cancer. The CORE-NK platform was designed to overcome the hurdles associated with NK cell development and enables the production of large numbers of highly active universal donor NK cells that are active in the body. The company expects to rapidly move to complete full licensing of the platform.

Year end

Revenue (A$m)

PBT*
(A$m)

EPS*
(A$)

DPS
(A$)

P/E
(x)

Yield
(%)

06/20

0.0

(0.1)

(62.01)

0.0

N/A

N/A

06/21

0.0

(14.9)

(0.08)

0.0

N/A

N/A

06/22e

0.0

(14.0)

(0.04)

0.0

N/A

N/A

06/23e

0.0

(14.5)

(0.04)

0.0

N/A

N/A

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

Improving NK cells

NK cells are naturally found within the body and are able to recognise and kill cancer cells, but efficacy when used in a therapeutic setting is often limited due to challenges in manufacturing enough of them to halt the growth of many cancers. CORE-NK cells are made by activating and expanding NK cells to make them more active and robust in large numbers.

Enabling an expansion of the pipeline

Besides using CORE-NK cells to target cancer directly, this licensure would allow for the creation of CAR-NK programs to augment the current CLTX CAR T and CDH17 CAR T programmes that are focused on solid tumours. Four new pipeline programmes are expected to be started in 2023 following the anticipated acquisition of the CORE-NK platform.

Positive low dose CHM 1101 data from Phase I

Data from the low dose cohort of four patients from the Phase I trial of CHM 1101 (CLTX CAR T) was presented in November at the Society for Neuro-Oncology (SNO) annual meeting. Three out of four patients achieved stable disease that was durable for five to eight weeks. In one patient, there was no evidence of progression in the part of the brain in which CHM 1101 was infused intratumourally and progression was only seen in an area of the brain where it was not infused intertumourally.

Valuation: A$322m or $0.97 per share

We have adjusted our valuation from A$327m or A$0.99 per share to A$322m or A$0.97 per basic share, mainly due to lower net cash. Because the CORE-NK platform is not fully licensed and its associated products are not yet in the clinic, we are not including them in our valuation yet, in accordance with Edison methodology. Once included, they may have a meaningful impact upon the valuation due to the size of the markets targeted by the company.

The CORE-NK platform

Chimeric has announced that it has entered into an exclusive option agreement to license the CORE-NK platform from Case Western Reserve University. NK cells are found in the body naturally and are able to recognise and kill cancer cells without affecting healthy cells. They are also able to produce cytokines that use the immune system to mount an additional response to kill tumours. However, efficacy when used in a therapeutic setting is often limited due to challenges in manufacturing enough of them to halt the growth of many cancers. Through the platform, CORE-NK cells are made by activating and expanding NK cells to make them more active and robust in large numbers.1 The company expects to rapidly move to complete full licensing of the platform. Financial terms are likely to include development milestones, industry standard royalties (likely single digit in our view) and an upfront payment.

  Ojo et al., Membrane bound IL-21 based NK cell feeder cells drive robust expansion and metabolic activation of NK cells. Scientific Reports 2019 Oct 17;9(1):14916.

The anticipated licensure would enable a significant expansion of the product pipeline past CHM 1101 and CHM 2101, the CLTX and CDH17 CAR T therapies, respectively, currently in development. The company plans to develop CAR NK versions of both those programmes, develop therapies using the current and next generation CORE-NK platform and an additional CAR NK with an undisclosed target. CAR NK products would be made by inserting CARs into the CORE-NK platform cells. Adding the CARs improves the delivery of the NK cells to specific antigen-expressing tumours.

Exhibit 1: Planned Chimeric pipeline post-CORE-NK licensure

Programme

Construct

Type

Indication focus

Status

CHM 1101

CLTX CAR T

Autologous

Glioblastoma multiforme (GBM), melanoma, colorectal, prostate

Phase I ongoing in GBM, second trial in another indication planned for 2022

CHM 2101

CDH17 CAR T

Autologous

Neuroendocrine, colorectal, pancreatic, gastric

Phase I expected 2022

CHM 0201

CORE -NK Platform

Allogeneic

Both hematologic and solid tumours

Phase I complete (9 patients completed all three dose levels with data expected in 2022), further technological enhancements planned for development as combination therapy

CHM 0301

Next Generation CORE-NK platform

Allogeneic

Hematologic tumours

Phase I planned 2023

CHM 1301

CLTX CAR -NK

Allogeneic

Glioblastoma multiforme (GBM), melanoma, colorectal, prostate

Phase I planned 2023

CHM 2301

CDH17 CAR-NK

Allogeneic

Neuroendocrine, colorectal, pancreatic, gastric

Phase I planned 2023

CHM 3301

Undisclosed CAR-NK

Allogeneic

Undisclosed

Phase I planned 2023

Source: Chimeric Therapeutics

As NK cells are not thought to cause graft-versus-host-disease (GVHD), all these CORE-NK based therapies have the potential to be allogeneic, where cells from a single donor could be used to treat multiple patients. This is in contrast to autologous therapies where treatments are based on a patient’s own cells. Allogeneic therapies hold the promise of starting with healthier material, lowering manufacturing costs and being rapidly available to patients (the bespoke nature of autologous treatments can delay treatment for weeks).

Besides these announced programmes, Chimeric will be seeking additional collaboration and licensing opportunities for the platform.

CHM 1101 data from the low-dose cohort

At the SNO conference in November, data from the CHM 1101 Phase I was presented. The data focused the four patients who were enrolled at the lowest dose level of 44m CLTX CAR T cells (which were injected intratumourally in a single injection). Stable disease was achieved in three out of the four patients with durability of five to eight weeks. Importantly, in one patient, there was no observed tumour recurrence in the left frontal lobe where the CLTX CAR T cells were administered. Tumour progression in that patient occurred in the left temporal lobe, which did not receive the infusion. Also, with regards to safety, therapy was generally well tolerated and there were no cytokine release syndrome (CRS) events due to therapy.

Dose escalation is planned across four dose levels up to 440m cells through dual intratumoural and intraventricular routes of administration (intraventricular administration only starts at the 88m cell dose level).

Valuation

We have adjusted our valuation from A$327m or A$0.99 per share to A$322m or A$0.97 per basic share, mainly due to lower net cash. Because the CORE-NK platform is not fully licensed and its associated products are not yet in the clinic, we are not including them in our valuation yet, in accordance with Edison methodology. Once included, they may have a meaningful impact upon the valuation due to the size of the markets targeted by the company.

Exhibit 2: Chimeric valuation table

Product

Main indication

Status

Probability of successful commercialisation

Approval year

Peak sales (A$m)

Economics

rNPV
(A$m)

CLTX-CAR T

GBM

Phase I

10%

2027

3,210

100% less single-digit royalty to COH

305.0

Total

 

 

 

 

 

 

305.0

Net cash (as of 30 September 2021)

17.4

Total firm value (A$)

322.42

Total basic shares (m)

333.4

Value per basic share (A$)

0.97

Options (m)

32.1

Total number of shares (m)

365.6

Diluted value per share (A$)

0.88

Source: Edison Investment Research. Note: COH is the City of Hope cancer center

Financials

In the quarterly cash flow report for the first quarter of FY22 (the period ending 30 September 2021), Chimeric reported A$17.4m in cash at Q122. In FY21 the company had an operating loss of A$15.1m. We have not made any meaningful changes to our financial model following these results and have introduced FY23 estimates, which feature A$14.5m in operating expenses. We may increase our R&D expense estimates once we have more clarity on the clinical programme post the closure of the licensing of the CORE-NK platform. We continue to project a financing need of A$80m through 2026, with A$20m expected to be raised in FY22 and modelled as illustrative debt.

Exhibit 3: Financial summary

A$'000s

2020

2021

2022e

2023e

Year end 30 June

AIFRS

AIFRS

AIFRS

AIFRS

PROFIT & LOSS

Revenue

 

 

0

0

0

0

Cost of Sales

0

0

0

0

Gross Profit

0

0

0

0

Sales, General and Administrative Expenses

(64)

(11,068)

(4,007)

(4,167)

Research and Development Expense

0

(3,778)

(9,975)

(10,374)

EBITDA

 

 

(64)

(14,847)

(13,982)

(14,541)

Operating Profit (before amort. and except.)

 

 

(64)

(14,847)

(13,982)

(14,541)

Intangible Amortisation

0

0

0

0

Other

0

0

0

0

Exceptionals

0

(264)

0

0

Operating Profit

(64)

(15,110)

(13,982)

(14,541)

Net Interest

0

(3)

(3)

(3)

Other

0

0

0

0

Profit Before Tax (norm)

 

 

(64)

(14,850)

(13,985)

(14,545)

Profit Before Tax (FRS 3)

 

 

(64)

(15,114)

(13,985)

(14,545)

Tax

0

0

0

0

Deferred tax

(0)

(0)

(0)

(0)

Profit After Tax (norm)

(64)

(14,850)

(13,985)

(14,545)

Profit After Tax (FRS 3)

(64)

(15,114)

(13,985)

(14,545)

Average Number of Shares Outstanding (m)

0.0

181.9

333.4

336.7

EPS - normalised (A$)

 

 

(62.01)

(0.08)

(0.04)

(0.04)

EPS - Reported (A$)

 

 

(63.02)

(0.08)

(0.04)

(0.04)

Dividend per share (c)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

0

13,840

17,072

20,338

Intangible Assets

0

13,826

16,244

18,661

Tangible Assets

0

14

829

1,677

Other

0

0

0

0

Current Assets

 

 

(0)

22,665

28,662

29,154

Stocks

0

0

0

0

Debtors

0

24

0

0

Cash

(0)

22,410

28,063

28,187

Other

0

231

599

967

Current Liabilities

 

 

(64)

(7,355)

(7,355)

(7,355)

Creditors

(30)

(7,355)

(7,355)

(7,355)

Short term borrowings

(34)

0

0

0

Long Term Liabilities

 

 

0

(4,019)

(24,019)

(39,019)

Long term borrowings

0

0

(20,000)

(35,000)

Other long-term liabilities

0

(4,019)

(4,019)

(4,019)

Net Assets

 

 

(64)

25,131

14,360

3,118

CASH FLOW

Operating Cash Flow

 

 

(34)

(8,835)

(10,928)

(11,424)

Net Interest

0

0

0

0

Tax

0

0

0

0

Capex

0

(5,307)

(3,419)

(3,452)

Acquisitions/disposals

0

0

0

0

Financing

0

36,585

0

0

Dividends

0

0

0

0

Other

0

0

0

0

Net Cash Flow

(34)

22,443

(14,347)

(14,876)

Opening net debt/(cash)

 

 

0

34

(22,410)

(8,063)

HP finance leases initiated

0

0

0

0

Exchange rate movements

0

(9)

0

0

Other

0

10

0

0

Closing net debt/(cash)

 

 

34

(22,410)

(8,063)

6,813

Source: company reports, Edison Investment Research


General disclaimer and copyright

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

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Copyright: Copyright 2021 Edison Investment Research Limited (Edison).

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New Zealand

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United Kingdom

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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

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1185 Avenue of the Americas

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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

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

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