Immix Biopharma — Encouraging stream of ALA data newsflow

Immix Biopharma (NASDAQ: IMMX)

Last close As at 26/02/2024

USD3.04

−0.02 (−0.65%)

Market capitalisation

USD77m

More on this equity

Research: Healthcare

Immix Biopharma — Encouraging stream of ALA data newsflow

Immix presented encouraging new data at the American Society of Hematology (ASH) 2023 meeting for its Nexcella subsidiary’s lead CAR-T asset, NXC-201, in amyloid light chain amyloidosis (ALA) patients. The update corresponds to 10 ALA patients treated with NXC-201, for which the overall response rate (ORR) stands at 100% (10/10). NXC-201 also maintains its competitive safety profile among this group, including no cases of neurotoxicity and only low-grade cytokine release syndrome associated with short onset and duration. The results to date are supportive of NXC-201 potentially becoming the first outpatient CAR-T therapy, in our view, offering a potentially desirable treatment option for a fragile patient population. While the current data come from the NEXICART-1 trial based in Israel, with the Investigational New Drug (IND) application in ALA patients recently accepted by the FDA, we believe the enrolment of patients at US trial sites (NEXICART-2) will be a key milestone for the clinical progression of NXC-201. Management has communicated that it intends to submit a Biologics License Application to the FDA once 30–40 ALA patients have been treated.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Cancer cells low poly blue

Healthcare

Immix Biopharma

Encouraging stream of ALA data newsflow

Clinical update

Pharma and biotech

12 December 2023

Price

US$4.63

Market cap

US$101m

Net cash (US$m) at 30 September 2023

19.6

Shares in issue (including 1.9m in unexercised prefunded warrants)

21.8m

Free float

42%

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 multiple myeloma and AL amyloidosis.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Immix Biopharma is a research client of Edison Investment Research Limited

Immix presented encouraging new data at the American Society of Hematology (ASH) 2023 meeting for its Nexcella subsidiary’s lead CAR-T asset, NXC-201, in amyloid light chain amyloidosis (ALA) patients. The update corresponds to 10 ALA patients treated with NXC-201, for which the overall response rate (ORR) stands at 100% (10/10). NXC-201 also maintains its competitive safety profile among this group, including no cases of neurotoxicity and only low-grade cytokine release syndrome associated with short onset and duration. The results to date are supportive of NXC-201 potentially becoming the first outpatient CAR-T therapy, in our view, offering a potentially desirable treatment option for a fragile patient population. While the current data come from the NEXICART-1 trial based in Israel, with the Investigational New Drug (IND) application in ALA patients recently accepted by the FDA, we believe the enrolment of patients at US trial sites (NEXICART-2) will be a key milestone for the clinical progression of NXC-201. Management has communicated that it intends to submit a Biologics License Application to the FDA once 30–40 ALA patients have been treated.

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.

At ASH 2023, Immix has shared an update on the NEXICART-1 trial, which includes one new relapsed/refractory ALA patient. As of the data cut-off of 10 December 2023, the data show an ORR of 100%, a complete response (CR) rate of 70% (7/10) and an organ response rate of 60% (6/10). The best responder duration has been reported as 23.7 months, and it was stated that this response is ongoing. In our view, these results mark positive progress from the last data update, the details of which are discussed here. We highlight that the NEXICART-1 trial involves a frail and heavily pre-treated patient population (median of six lines of prior therapy) with significant organ involvement. This includes 8/10 patients with cardiac involvement, for which, the CR and the organ response rates were both 63% (5/8). The group also includes 4/10 patients with t(11;14) disease, for which the CR rate was 75% (3/4) and the organ response rate was 50% (2/4).

ALA is a rare but serious multisystem disease affecting the kidneys, heart, liver, intestine and nervous system, with approximately 4k new cases diagnosed in the US each year, and at present there are limited treatment options. We therefore believe that there is significant opportunity for Immix to address this unmet need. The company has already received Orphan Drug designation from the FDA, and with the recent clearance of its IND application, we expect the coming months will see new patients enrolled to US trial sites (this portion of the trial is being referred to as NEXICART-2). We believe this will mark a step toward NXC-201 potentially becoming the first outpatient CAR-T therapy; we continue to expect rolling updates from Immix as the information becomes available.

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 2023 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

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 2023 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

More on Immix Biopharma

View All

Latest from the Healthcare sector

View All Healthcare content

Research: Financials

Record — Underlying growth and pipeline are attractive

In H124, Record posted steady management fee growth of 3% y-o-y to £19.6m as the company benefited from a higher assets under management equivalent (AUME) base. Total revenues, however, were down 3% as performance fees in H123 outweighed those earned in H124. Profit before tax was down 17% y-o-y to £6.3m as Record incurred costs related to its expansion and modernisation initiatives. In line with its progressive dividend policy, Record increased its dividend by 5% y-o-y to 2.15p per share. After four years as CEO, Leslie Hill announced her retirement and will be succeeded by Dr Jan Witte (CEO of the subsidiary Record Currency Management) at the end of FY24 in March. He has also been appointed to the board as executive director with effect from 1 January 2024. Leslie will maintain her share ownership in Record and will assist senior management in Record’s transition phase.

Continue Reading
Record_resized

Subscribe to Edison

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

Sign up for free