Immix Biopharma — US CAR-T trial commences patient dosing

Immix Biopharma (NASDAQ: IMMX)

Last close As at 19/07/2024

USD2.05

−0.13 (−5.96%)

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Research: Healthcare

Immix Biopharma — US CAR-T trial commences patient dosing

Immix has announced that the first patient has been dosed in its Phase Ib NEXICART-2 trial of lead CAR-T asset NXC-201, which took place at lead study site, the Memorial Sloan Kettering Cancer Center. This US-based study will evaluate the safety and efficacy of NXC-201 in approximately 40 patients with relapsed/refractory amyloid light chain amyloidosis (r/r ALA). Management expects the trial to be fully enrolled within 18 months, implying that top-line results could be available in H126. In the near term, we anticipate rolling data readouts as seen with the prior NEXICART-1 trial. We also expect more details for the expansion of NXC-201 into additional autoimmune indications by the end of 2024.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Immix Biopharma

US CAR-T trial commences patient dosing

Clinical update

Pharma and biotech

10 July 2024

Price

US$2.20

Market cap

US$58m

Net cash (US$m) at 31 March 2024

29.3

Shares in issue

26.4m

Free float

42%

Code

IMMX

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

Business description

Immix Biopharma is a clinical-stage biopharma developing personalized therapies for oncology and immunology. Lead asset NXC-201 is a BCMA-targeting CAR-T asset, being evaluated for amyloid light chain amyloidosis and multiple myeloma with plans to expand to autoimmune indications. Legacy asset IMX-110 is being investigated in a Phase Ib/IIa trial in soft tissue sarcoma and a Phase Ib/IIa trial for solid tumors in combination with tislelizumab.

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 announced that the first patient has been dosed in its Phase Ib NEXICART-2 trial of lead CAR-T asset NXC-201, which took place at lead study site, the Memorial Sloan Kettering Cancer Center. This US-based study will evaluate the safety and efficacy of NXC-201 in approximately 40 patients with relapsed/refractory amyloid light chain amyloidosis (r/r ALA). Management expects the trial to be fully enrolled within 18 months, implying that top-line results could be available in H126. In the near term, we anticipate rolling data readouts as seen with the prior NEXICART-1 trial. We also expect more details for the expansion of NXC-201 into additional autoimmune indications by the end of 2024.

Year end

Revenue
(US$m)

PBT*
(US$m)

EPS*
(US$)

DPS
(US$)

P/E
(x)

Yield
(%)

12/22

0.0

(7.60)

(0.55)

0.0

N/A

N/A

12/23

0.0

(13.00)

(0.75)

0.0

N/A

N/A

12/24e

0.0

(21.44)

(0.93)

0.0

N/A

N/A

12/25e

0.0

(26.55)

(1.01)

0.0

N/A

N/A

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

The US-based NEXICART-2 trial is a Phase Ib open-label, single-arm, multi-site dose escalation/dose expansion study, which will test the safety and efficacy of NXC-201, a B-cell maturation antigen (BCMA) targeting CAR-T therapy. The target population for the trial is patients with r/r ALA with adequate cardiac function who have not had prior BCMA-targeted treatments. The dose escalation part of the study will evaluate two doses (150m CAR-T cells and 450m CAR-T cells) across two three-patient cohorts, with the potential to increase dosing to 800m CAR-T cells in the expansion phase, should initial doses be deemed safe. We note that these doses were tested successfully in the previous NEXICART-1 trial (conducted in Israel). The study will determine the maximum tolerated and recommended Phase II dose, while also evaluating efficacy signals (complete response rate and overall response rate). We believe the launch of NEXICART-2 marks a key milestone for Immix and note that the timing of the first patient dosing is consistent with management’s guidance of mid-2024. The trial is expected to complete patient recruitment by late-2025/early-2026. If data are supportive, we expect Immix to follow this up by filing a Biologics License Application with the FDA.

In our view, all eyes will be on whether NXC-201 can replicate the encouraging results seen in the NEXICART-1 trial. Key data from the 13 ALA patients (reported in May 2024) included an overall response rate of 92% (12/13 patients) and a best responder duration of 28.0 months (as of 10 May 2024), with the response ongoing. No cases of neurotoxicity were reported and cases of cytokine release syndrome had a low median duration of two days, showing promise in addressing the limitations of current approved CAR-T therapies and positioning NXC-201 as a potential out-patient treatment, which could save healthcare systems significant hospitalization costs. We also note that, to our knowledge, NXC-201 is the only CAR-T therapy in development for ALA and, given that alternative treatment options for this fragile patient population are limited, we believe there is sizeable opportunity for Immix in this space.

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.

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London │ New York │ Frankfurt

20 Red Lion Street

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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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