Immix Biopharma — Marching towards US clinical trials for NXC-201

Immix Biopharma (NASDAQ: IMMX)

Last close As at 22/05/2024

USD2.30

−0.22 (−8.73%)

Market capitalisation

USD66m

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Research: Healthcare

Immix Biopharma — Marching towards US clinical trials for NXC-201

Immix Biopharma is closer to dosing its first US patient for lead CAR-T asset NXC-201, with the appointment of the Memorial Sloan Kettering Cancer Center as the main clinical site for the company’s US multi-site NEXICART-2 trial assessing NXC-201 in relapsed/refractory (r/r) amyloid light chain amyloidosis (ALA). NXC-201 targets B-cell maturation antigen (BCMA) and is differentiated by its low neurotoxicity and short cytokine release syndrome (CRS) duration to date, supporting Immix’s long-term aspiration to launch the first outpatient CAR-T therapy. The NEXICART-2 study will aim to reproduce the initial results from the Phase Ib/IIa NEXICART-1 study, which reported an overall response rate (ORR) of 100% for the first 10 patients treated. Top-line data from the first 40 patients in the NEXICART-2 trial are expected in 2025, which, if positive, will likely be followed by a biologic license application, a significant milestone for the Immix. The pipeline remains engaged, with IMX-110 in Phase Ib/IIa studies for solid tumors and NXC-201 also targeting multiple myeloma (MM) and, potentially, other autoimmune indications (starting H124).

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Immix Biopharma

Marching towards US clinical trials for NXC-201

Clinical trial update

Pharma and biotech

26 March 2024

Price

US$3.19

Market cap

US$81m

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

34.6

Shares in issue (following February 2024 equity raise)

25.5m

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

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Immix Biopharma is a research client of Edison Investment Research Limited

Immix Biopharma is closer to dosing its first US patient for lead CAR-T asset NXC-201, with the appointment of the Memorial Sloan Kettering Cancer Center as the main clinical site for the company’s US multi-site NEXICART-2 trial assessing NXC-201 in relapsed/refractory (r/r) amyloid light chain amyloidosis (ALA). NXC-201 targets B-cell maturation antigen (BCMA) and is differentiated by its low neurotoxicity and short cytokine release syndrome (CRS) duration to date, supporting Immix’s long-term aspiration to launch the first outpatient CAR-T therapy. The NEXICART-2 study will aim to reproduce the initial results from the Phase Ib/IIa NEXICART-1 study, which reported an overall response rate (ORR) of 100% for the first 10 patients treated. Top-line data from the first 40 patients in the NEXICART-2 trial are expected in 2025, which, if positive, will likely be followed by a biologic license application, a significant milestone for the Immix. The pipeline remains engaged, with IMX-110 in Phase Ib/IIa studies for solid tumors and NXC-201 also targeting multiple myeloma (MM) and, potentially, other autoimmune indications (starting 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.

The US trial (NEXICART-2) will be a Phase Ib open-label, single-arm, multi-site dose expansion trial, aiming to recruit c 40 patients (starting H124) with r/r ALA. The study will evaluate both the safety and efficacy of the treatment. Following the selection of the Memorial Sloan Kettering Cancer Center as the first trial site, we expect patient enrollment to commence imminently. Management anticipates that the trial will be fully enrolled within 18 months, which may lead to a possible data readout as early as late 2025. Immix received investigational new drug approval from the FDA in November 2023 and NXC-201 holds the orphan drug designation for ALA in both the US and Europe. Given the drug’s favorable safety profile to date and short duration of CRS (one day vs four-to-seven days for currently approved CAR-Ts, based on available Phase I data), management asserts that the drug holds the potential to become the first outpatient CAR-T. This also builds the case for the drug to be explored in other autoimmune conditions, which Immix plans to pursue beginning in H124.

In addition to ALA (currently the primary focus for Immix), NXC-201 is also being evaluated in patients with MM (NEXICART-1). The most recently reported study data delivers an ORR of 90% for the 50 patients treated at the recommended Phase II dose of 800m cells (total study size: 100). The company’s second asset, IMX-110, utilizes Immix’s tissue-specific therapeutics (TSTx) and is involved in two Phase Ib/IIa clinical programs, one for the treatment of soft tissue sarcomas (STS) and the other for solid tumors. The Phase I monotherapy arm in STS is expected to conclude in 2024, with readouts expected through the year. Following the recent $15m equity raise, we estimate the company to be funded through FY25, past key data readouts for NXC-201 in ALA and potentially MM.

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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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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