Immix Biopharma — NXC-201 gains orphan drug designation in ALA

Immix Biopharma (NASDAQ: IMMX)

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USD2.12

−0.03 (−1.40%)

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Research: Healthcare

Immix Biopharma — NXC-201 gains orphan drug designation in ALA

Immix has announced that the FDA has granted orphan drug designation (ODD) to CAR-T asset NXC-201 for amyloid light chain amyloidosis (ALA). This occurred approximately a month after the announced ODD for multiple myeloma (MM), the other indication that Immix is pursuing with NXC-201. The benefits of ODD include seven years of US market exclusivity post approval, tax credits for qualified clinical trials and exemption from the Prescription Drug User Fee (c $3m for a new drug). ODD is issued to drugs/biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/conditions that affect fewer than 200k people in the US. Achieving ODD in both MM and ALA marks an important development for the progress of NXC-201, which has shown encouraging signs on both the clinical and regulatory fronts. We believe that the next readout (expected in September 2023) from the ongoing NEXICART-1 trial could be a significant catalyst for the company.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Immix Biopharma

NXC-201 gains orphan drug designation in ALA

Regulatory update

Pharma and biotech

22 September 2023

Price

US$3.45

Market cap

US$67m

Pro forma net cash (US$m) at 30 June 2023 (including US$9.6m fund raise in August)

22.2

Shares in issue (including shares issued for US$9.6m fund raise)

19.5m

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. Lead asset 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 has announced that the FDA has granted orphan drug designation (ODD) to CAR-T asset NXC-201 for amyloid light chain amyloidosis (ALA). This occurred approximately a month after the announced ODD for multiple myeloma (MM), the other indication that Immix is pursuing with NXC-201. The benefits of ODD include seven years of US market exclusivity post approval, tax credits for qualified clinical trials and exemption from the Prescription Drug User Fee (c $3m for a new drug). ODD is issued to drugs/biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/conditions that affect fewer than 200k people in the US. Achieving ODD in both MM and ALA marks an important development for the progress of NXC-201, which has shown encouraging signs on both the clinical and regulatory fronts. We believe that the next readout (expected in September 2023) from the ongoing NEXICART-1 trial could be a significant catalyst for the company.

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

(12.26)

(0.84)

0.0

N/A

N/A

12/24e

0.0

(15.83)

(0.97)

0.0

N/A

N/A

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

Immix has announced that the US FDA has granted ODD to NXC-201 as a potential treatment for ALA. NXC-201 now has ODD for both ALA and MM. The ODD qualifies NXC-201 for a minimum of seven years of US market exclusivity, provided it obtains FDA approval. According to EvaluatePharma, the amyloidosis market is projected to be worth c $8bn by 2028, which, alongside MM with a projected market value of c $33bn by 2028, represents a sizeable opportunity for Immix, even if only a modest portion of the total market is captured.

As a reminder, and as discussed in our prior note, NXC-201 is being developed by majority-owned subsidiary Nexcella. The recent readout in April 2023 from 58 patients in the Phase Ib/IIa NEXICART-1 trial showed encouraging overall response rates of 92% for MM (n=50) and 100% for ALA patients (n=8). Management plans to share updated MM clinical data at the 20th International Myeloma Society Annual Meeting on 27–30 September 2023, which could be an important catalyst for investor attention, in our view. We note that Immix completed a pre-IND meeting with the FDA in June for NXC-201 clinical trials and is now preparing to submit an IND application. It recently reported that it has completed its second NXC-201 engineering batch at its US manufacturing site.

Immix aims to differentiate NXC-201 against currently approved CAR-T therapies that are often associated with neurotoxicity and high-grade cytokine release syndrome (CRS). NXC-201 has shown a desirable safety profile to date with no reports of neurotoxicity or patient safety events greater than grade three CRS (those that occurred were associated with short onsets and durations). This may position it as the first out-patient CAR-T therapy, potentially allowing it to become more broadly accessible, which we believe may help from a regulatory point of view.

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 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

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