Immix Biopharma — 2023 recap with a preview of active year ahead

Immix Biopharma (NASDAQ: IMMX)

Last close As at 26/04/2024

USD2.10

−0.03 (−1.41%)

Market capitalisation

USD56m

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Research: Healthcare

Immix Biopharma — 2023 recap with a preview of active year ahead

Immix has shared a 12-month recap, capturing key clinical and regulatory events from 2023, setting the stage for an active 2024. Its lead CAR-T asset (NXC-201) is a B-cell maturation antigen (BCMA) targeting therapy for amyloid light chain amyloidosis (ALA) and multiple myeloma (MM). The latest clinical data (Phase Ib/IIa NEXICART-1 trial) showed an overall response rate (ORR) of 100% in ALA patients (n=10) and 90% in MM patients (n=50). On the regulatory front, NXC-201 received Orphan Drug designation (ODD) in February 2024 from the EMA for ALA, and in Q323 from the FDA for ALA and MM. The FDA also cleared Immix’s Investigational New Drug (IND) application in Q423, permitting NXC-201 dosing at US trial sites (NEXICART-2 trial for ALA patients). We believe this is an important development step for NXC-201, and we look forward to rolling data readouts after the start of NEXICART-2, most likely in H124.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Cancer cells low poly blue

Healthcare

Immix Biopharma

2023 recap with a preview of active year ahead

Company update

Pharma and biotech

27 February 2024

Price

US$3.04

Market cap

US$77m

Net cash (US$m) at 30 September 2023 (plus the c $15m to be raised from the February 2024 equity issue)

34.6

Shares in issue (following February 2024 equity raise)

25.4m

Free float

52%

Code

IMMX

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

Business description

Immix Biopharma is developing a new class of tissue-specific therapeutics targeting oncology and immune-dysregulated disease. IMX-110 is being investigated in a Phase Ib/IIa study for the treatment of soft tissue sarcoma and a Phase Ib/IIa trial in solid tumors in combination with tislelizumab. Immix’s subsidiary Nexcella (94% owned) is also developing a CAR-T therapy, NXC-201, which is in the NEXICART-1 study for the treatment of AL amyloidosis and multiple myeloma.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Immix Biopharma is a research client of Edison Investment Research Limited

Immix has shared a 12-month recap, capturing key clinical and regulatory events from 2023, setting the stage for an active 2024. Its lead CAR-T asset (NXC-201) is a B-cell maturation antigen (BCMA) targeting therapy for amyloid light chain amyloidosis (ALA) and multiple myeloma (MM). The latest clinical data (Phase Ib/IIa NEXICART-1 trial) showed an overall response rate (ORR) of 100% in ALA patients (n=10) and 90% in MM patients (n=50). On the regulatory front, NXC-201 received Orphan Drug designation (ODD) in February 2024 from the EMA for ALA, and in Q323 from the FDA for ALA and MM. The FDA also cleared Immix’s Investigational New Drug (IND) application in Q423, permitting NXC-201 dosing at US trial sites (NEXICART-2 trial for ALA patients). We believe this is an important development step for NXC-201, and we look forward to rolling data readouts after the start of NEXICART-2, most likely in H124.

Year end

Revenue
(US$m)

PBT*
(US$m)

EPS*
(US$)

DPS
(US$)

P/E
(x)

Yield
(%)

12/21

0.0

(1.31)

(0.36)

0.0

N/A

N/A

12/22

0.0

(7.70)

(0.55)

0.0

N/A

N/A

12/23e

0.0

(11.96)

(0.70)

0.0

N/A

N/A

12/24e

0.0

(17.38)

(0.88)**

0.0

N/A

N/A

Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments. **FY24e EPS has not been adjusted for increased share count following February 2024 equity raise.

Management shared an update describing its 2023 progress in the development of NXC-201, with long-term aspirations to be the first outpatient CAR-T therapy and address current challenges in the field (cost and access). NEXICART-1 is assessing Immix’s lead CAR-T asset for ALA and MM. In December 2023, Immix shared an encouraging update for 10 ALA patients, showing an ORR of 100%, a complete response (CR) rate of 70% and an organ response rate of 60%. The company also hosted a KOL event on ALA, describing how the NXC-201 data shows promise in this fragile patient population with limited treatment options. The latest update in MM was announced in October 2023, and of the 50 patients treated at the recommended Phase II dose, the ORR was 90%, with a CR or stringent CR rate of 58%. For patients not previously treated with BCMA-targeting therapies (n=38), the ORR was 95%. We note that Immix may expand into additional autoimmune indications, and management aims to finalize these plans within the next 12 months, targeting a market segment it estimates at $25bn (combined across all potential indications) with limited treatments available today.

Immix recently announced receipt of ODD from the EMA for ALA (February 2024), and from the FDA for ALA (September 2023) and MM (August 2023). Looking at the year ahead, we believe the move to the US (NEXICART-2) marks a key milestone, and expect that clinical data updates could represent key catalysts.

Although the FDA’s directive for black box warnings for secondary malignancies has been a head wind for CAR-T therapies, Immix attests that it has not seen such malignancies with NXC-201 in data to date. Despite the warnings, investors and big pharma show sustained interest in CAR-T therapies, with AstraZeneca’s acquisition of Gracell, and Kyverna Therapeutics’ IPO raising over $350m (gross).

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.

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Copyright: Copyright 2024 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

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United Kingdom

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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.

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Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

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London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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 2024 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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