Immix Biopharma — IMX-110 clinical expansion on the horizon

Immix Biopharma (NASDAQ: IMMX)

Currency in USD

Last close As at 02/02/2023

USD2.62

−0.02 (−0.57%)

Market capitalisation

USD37m

Research: Healthcare

Immix Biopharma — IMX-110 clinical expansion on the horizon

Immix Biopharma’s 9M22 financial results were consistent with our full year estimates. The company reported operating losses of US$4.4m, up from US$0.8m in 9M21, due to the increased costs associated with the clinical development activities for the company’s lead asset, IMX-110. With a net cash position of US$16.9m at end Q322, and based on our projected cash burn rates, we estimate Immix’s operations are funded into Q424, past rolling clinical readouts from its Phase IIa study in soft tissue sarcoma (STS) and its Phase Ib in advanced solid tumours in FY23. Our valuation of Immix Biopharma is largely unchanged at US$55.4m or US$4.0 per share.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Immix Biopharma

IMX-110 clinical expansion on the horizon

Q322 update

Pharma and biotech

14 November 2022

Price

US$0.88

Market cap

US$12m

Net cash ($m) at 30 September 2022

16.9

Shares in issue

13.9m

Free float

42%

Code

IMMX

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(28.3)

(64.4)

N/A

Rel (local)

(35.5)

(62.5)

N/A

52-week high/low

$6.75

$0.75

Business description

Immix Biopharma is developing a new class of tissue-specific therapeutics targeting oncology and immune-dysregulated disease. In Q422, the company’s lead clinical asset, IMX-110, is expected to begin a Phase IIa study for the treatment of STS and a Phase Ib trial in advanced solid tumours in combination with the ICI tislelizumab. The company also has a preclinical pipeline based on the TSTx technology.

Next events

Phase IIa expansion trial STS initiation

Q422

Phase Ib IMX-110 combination trial initiation

Q422

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Adam McCarter

+44 (0)20 3077 5700

Dr Harry Shrives

+44 (0)20 3077 5700

Immix Biopharma is a research client of Edison Investment Research Limited

Immix Biopharma’s 9M22 financial results were consistent with our full year estimates. The company reported operating losses of US$4.4m, up from US$0.8m in 9M21, due to the increased costs associated with the clinical development activities for the company’s lead asset, IMX-110. With a net cash position of US$16.9m at end Q322, and based on our projected cash burn rates, we estimate Immix’s operations are funded into Q424, past rolling clinical readouts from its Phase IIa study in soft tissue sarcoma (STS) and its Phase Ib in advanced solid tumours in FY23. Our valuation of Immix Biopharma is largely unchanged at US$55.4m or US$4.0 per share.

Year end

Revenue (US$m)

PBT*
(US$m)

EPS*
(US$)

DPS
(US$)

P/E
(x)

Yield
(%)

12/20

0.0

(0.56)

(0.51)

0.0

N/A

N/A

12/21

0.0

(1.31)

(0.36)

0.0

N/A

N/A

12/22e

0.0

(6.09)

(0.44)

0.0

N/A

N/A

12/23e

0.0

(8.78)

(0.63)

0.0

N/A

N/A

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

On track for trial starts by end FY22

Q422 is expected to be a period of significant activity for Immix with the initiation of its key phase IIa expansion study investigating IMX-110 in first-line STS as well as a Phase Ib basket combination trial in advanced solid tumours. The Phase Ib study will assess IMX-110 in combination with Beigene/Novartis’ immune checkpoint inhibitor (ICI), tislelizumab. Management expects to provide rolling data readouts from both studies throughout FY23, with top-line data from each expected by end FY24. We see the timely initiation of both studies as the next major milestone for the company. For more details on IMX-110’s clinical development strategy please see our recent initiation.

Costs expected to rise in FY23

With the expected ramp in clinical activities, and the simultaneous running of two trials, we anticipate that total operating expenses will increase significantly from FY22e (US$6.2m) into FY23e (US$8.8m), largely driven by increased R&D expenditure. We estimate R&D expenses for FY22 to be US$3.0m, rising to US$5.5m in FY23. We base our R&D costs on estimated expenses incurred by the company in previous clinical trials and management’s communicated budget of c US$11m for the Phase Ib and Phase IIa IMX-110 studies.

Valuation: US$55.4m or US$4.0 per share

Our valuation of Immix Biopharma remains largely unchanged at US$55.4m or US$4.0 per share (US$56.7m or US$4.1 per share previously). The slight value change comes as a result of the company’s lower net cash position at end-Q322 of US$16.9m. Considering Q322 results, our financial estimates remain broadly unchanged and our underlying long-term assumptions are unchanged.

Approval for paediatric patient enrolment

In addition to the financial update Immix has also received approval from the Institutional Review Board (IRB) to recruit paediatric patients suffering from rhabdomyosarcoma, a rare soft tissue cancer in children into its upcoming Phase IIa expansion trial. Immix had previously been awarded rare paediatric disease designation (RPDD) by the US FDA for IMX-110 in the treatment of rhabdomyosarcoma. An RPDD qualifies Immix Biopharma to receive fast track review and a priority review voucher (PRV), upon marketing approval of IMX-110. A PRV would entitle Immix to obtain a six-month priority review for any subsequent new drug application for IMX-110 into any new indication. Notably, PRVs are tradable assets that regularly fetch upwards of US$100m in value. A prerequisite to FDA approval of a PRV is the enrolment of paediatric patients in a clinical trial, so we see the IRB’s decision as a positive step for IMX-110’s clinical development strategy.

Exhibit 1: Financial summary

Accounts: IFRS, Yr end: December 31, USD:000s

 

2019

2020

2021

2022e

2023e

PROFIT & LOSS

 

 

 

 

 

 

Total revenues

 

0

0

0

0

0

Cost of sales

 

0

0

0

0

0

Gross profit

 

0

0

0

0

0

Total operating expenses

 

(842)

(454)

(1,352)

(6,206)

(8,770)

Research and development expenses

 

(583)

(248)

(127)

(3,020)

(5,520)

SG&A

 

(259)

(206)

(1,225)

(3,186)

(3,250)

EBITDA (normalized)

 

(841)

(452)

(1,350)

(6,205)

(8,769)

Operating income (reported)

 

(842)

(454)

(1,352)

(6,206)

(8,770)

Finance income/(expense)

 

(110)

(102)

(180)

(0)

0

Exceptionals and adjustments

 

0

(574)

(22,846)

0

0

Profit before tax (reported)

 

(952)

(1,130)

(24,378)

(6,207)

(8,770)

Profit before tax (normalised)

 

(952)

(555)

(1,313)

(5,913)

(8,770)

Income tax expense (includes exceptionals)

 

(21)

(18)

(6)

(7)

(10)

Net income (reported)

 

(973)

(1,148)

(24,384)

(6,214)

(8,780)

Net income (normalised)

 

(973)

(572)

(1,319)

(5,920)

(8,780)

Basic average number of shares, m

 

1.1

1.1

3.7

13.9

13.9

Basic EPS (US$)

 

(0.86)

(1.02)

(6.64)

(0.45)

(0.63)

Adjusted EPS (US$)

 

(0.86)

(0.51)

(0.36)

(0.43)

(0.63)

Dividend per share (US$)

 

0.00

0.00

0.00

0.00

0.00

 

 

 

 

 

 

 

BALANCE SHEET

 

 

 

 

 

 

Property, plant and equipment

 

10

7

6

4

3

Total non-current assets

 

10

7

6

4

3

Cash and equivalents

 

734

391

17,644

15,096

6,317

Current tax receivables

 

176

127

26

182

182

Trade and other receivables

 

0

0

0

0

0

Other current assets

 

24

14

516

292

292

Total current assets

 

933

532

18,186

15,571

6,792

Non-current loans and borrowings

 

0

0

0

0

0

Non-current lease liabilities

 

0

0

0

0

0

Other non-current liabilities

 

0

0

0

0

0

Total non-current liabilities

 

0

0

0

0

0

Accounts payable

 

248

252

143

646

646

Illustrative debt

 

0

4,050

0

0

0

Current lease obligations

 

0

0

0

0

0

Other current liabilities

 

4,342

968

59

0

0

Total current liabilities

 

4,589

5,270

202

646

646

Equity attributable to company

 

(3,646)

(4,731)

17,990

14,928

6,148

 

 

0

0

0

0

0

CASH FLOW STATEMENT

 

 

 

 

 

 

Net Income

 

(973)

(1,148)

(24,384)

(6,214)

(8,780)

Depreciation and amortisation

 

1

2

2

2

1

Share based payments

 

0

0

219

294

0

Other adjustments

 

0

575

22,964

0

0

Movements in working capital

 

182

166

(391)

562

0

Cash from operations (CFO)

 

(790)

(405)

(1,589)

(5,356)

(8,779)

Capex

 

(7)

0

(1)

0

0

Acquisitions & disposals net

 

0

0

0

0

0

Other investing activities

 

0

0

0

0

0

Cash used in investing activities (CFIA)

 

(7)

0

(1)

0

0

Capital changes

 

1,050

0

18,849

2,914

0

Debt Changes

 

0

0

0

0

0

Other financing activities

 

0

0

0

(106)

0

Cash from financing activities (CFF)

 

1,050

0

18,849

2,808

0

Cash and equivalents at beginning of period

 

462

734

391

17,644

15,096

Increase/(decrease) in cash and equivalents

 

253

(405)

17,259

(2,548)

(8,779)

Effect of FX on cash and equivalents

 

19

62

(5)

0

0

Cash and equivalents at end of period

 

734

391

17,644

15,096

6,317

Net (debt)/cash

 

734

(3,659)

17,644

15,096

6,317

Source: Immix Biopharma company accounts, Edison Investment Research

General disclaimer and copyright

This report has been commissioned by Immix Biopharma and prepared and issued by Edison, in consideration of a fee payable by Immix Biopharma. 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 2022 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

General disclaimer and copyright

This report has been commissioned by Immix Biopharma and prepared and issued by Edison, in consideration of a fee payable by Immix Biopharma. 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 2022 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

More on Immix Biopharma

View All

Latest from the Healthcare sector

View All Healthcare content

Research: Healthcare

OpGen — Guidance revision triggered by softer Q322

OpGen’s Q322 revenues of $0.4m missed consensus estimates (following a strong Q222 performance), with management attributing the softness to longer than expected sales cycles for ARES and lower Unyvero A50 sales in international markets. Encouragingly though, the quarter was marked by business advancements – signing a second Acuitas AMR Gene Panel commercial contract, completing the UTI test panel patient enrollment in the US, launching ARES sequencing services in the US and announcing collaborations with FIND and BioVersys – which all present monetization opportunities to potentially support revenue uplift starting in FY23. The Q322 miss, however, has triggered a guidance downgrade, with FY22 revenue expected to be $2.5–3.0m (previously 25% y-o-y growth; c $4.5m in revenue). In light of these developments, we withdraw our estimates and valuation while we await further clarity on the installed base, revenue mix and margins.

Continue Reading

Subscribe to Edison

Get access to the very latest content matched to your personal investment style.

Sign up for free