Immix Biopharma — A quarter of progress for both lead assets

Immix Biopharma (NASDAQ: IMMX)

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Research: Healthcare

Immix Biopharma — A quarter of progress for both lead assets

Throughout Q323, Immix shared encouraging updates for the clinical development of lead CAR-T asset NXC-201, including the announcement of orphan drug designation (ODD) in both multiple myeloma (MM) and amyloid light chain amyloidosis (ALA). In October 2023, the company shared positive efficacy and safety updates and we believe the data so far could support NXC-201 as the first outpatient CAR-T therapy, subject to regulatory approval, addressing the myriad of challenges associated with current CAR-Ts. In the quarter, Immix also shared positive interim data for its lead TSTx asset, IMX-110, and we anticipate further updates across Q423 to FY24. Net cash at the end of the period stood at $19.6m, which we estimate should provide an operating cash runway into Q424. As we adjust for our expense estimates based on year-to-date results, update net cash and roll our model forward, our valuation for Immix adjusts to $86.6m or $4.0 per share (from $90.7m or $4.2/share previously).

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Immix Biopharma

A quarter of progress for both lead assets

Q323 results

Pharma and biotech

17 November 2023

Price

US$4.45

Market cap

US$97m

Net cash (US$m) at 30 September 2023

19.6

Shares in issue (including 1.9m in unexercised pre-funded warrants)

21.8m

Free float

42%

Code

IMMX

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

49.8

151.4

283.6

Rel (local)

45.4

145.6

236.9

52-week high/low

US$4.56

US$1.05

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 for solid tumors in combination with tislelizumab. Immix’s subsidiary Nexcella (94% owned) is developing a CAR-T therapy, NXC-201, which is in the NEXICART-1 study for the treatment of multiple myeloma and AL amyloidosis.

Next events

NEXICART-1 (NXC-201) rolling data

Q423–FY24

Phase Ib/IIa (IMX-110) rolling data

Q423–FY24

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

Throughout Q323, Immix shared encouraging updates for the clinical development of lead CAR-T asset NXC-201, including the announcement of orphan drug designation (ODD) in both multiple myeloma (MM) and amyloid light chain amyloidosis (ALA). In October 2023, the company shared positive efficacy and safety updates and we believe the data so far could support NXC-201 as the first outpatient CAR-T therapy, subject to regulatory approval, addressing the myriad of challenges associated with current CAR-Ts. In the quarter, Immix also shared positive interim data for its lead TSTx asset, IMX-110, and we anticipate further updates across Q423 to FY24. Net cash at the end of the period stood at $19.6m, which we estimate should provide an operating cash runway into Q424. As we adjust for our expense estimates based on year-to-date results, update net cash and roll our model forward, our valuation for Immix adjusts to $86.6m or $4.0 per share (from $90.7m or $4.2/share previously).

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.

CAR-T program continues to drive newsflow

Key highlights from Q323 were announcements of the FDA granting ODD to NXC-201 for the treatment of MM and ALA. Importantly, a key benefit of ODD is seven years of US market exclusivity (if successful with regulatory approval). According to Evaluate Pharma, these indications have markets projected to be worth c $32bn and c $9bn by 2028, respectively. These potentially represent sizeable market opportunities for Immix, in our view, even if only a modest portion is captured.

Post-period, Immix shared positive updates from the NEXICART-1 trial. In MM, 63 patients have been treated to date, and for the 50 patients at the recommended Phase II dose (RP2D), the overall response rate (ORR) was 90% and complete or stringent complete responses (CR or sCR) were observed in 58% of patients. In ALA, for the nine patients treated at the RP2D, the ORR was 100% and the CR rate was 67%, demonstrating encouraging efficacy, in our view. Immix also recently announced that it had completed its third NXC-201 engineering batch at its US manufacturing site, demonstrating its CAR-T therapy manufacturing capabilities in this region and marking a positive step toward the company’s plans to expand the ongoing trial to the US. NEXICART-1 is operating in Israel and we are waiting additional updates from management on the launch of US trial sites.

Valuation: $86.6m or $4.0 per share

Our valuation for Immix adjusts to $86.6m or $4.0 per share (vs $90.7m or $4.2 per share previously), as the overall impact of our revised expense estimates and updated net cash balance more than offset the model roll-forward effect. Given our operating cash burn estimates, we continue estimate to a cash runway into Q424.

Immix’s pipeline progressing on all fronts

Immix remains focused on the clinical development of novel CAR-T therapies and Tissue Specific Therapeutics (TSTx) and the company has an active pipeline in both of these areas (Exhibit 1). The Phase Ib/IIa NEXICART-1 trial is assessing NXC-201, a B-cell maturation antigen (BCMA) targeting CAR-T therapy, for the treatment of MM and ALA; 72 patients have been enrolled to date. As a reminder, clinical development of NXC-201 is being independently financed by Immix’s subsidiary, Nexcella (of which Immix owns 94%).The Phase Ib/IIa IMMINENT-01 trial is assessing IMX-110 in combination with tislelizumab for the treatment of solid tumors (expected n=30). We anticipate clinical trial updates from both studies throughout Q423–FY24.

More to come with rolling CAR-T data

In the latest update for NEXICART-1, Immix reported data for a total of 63 MM patients. We note that this figure includes participants from the dose escalation portion of the trial: 150m cells (n=6), 450 cells (n=7) and the RP2D of 800m cells (n=50). As of the data cut-off point of 17 July 2023, the median follow-up duration was 11.9 months. It was found that of the patients at the RP2D without prior BCMA-targeted therapy (n=38), the ORR was 95%, associated with a median progression-free survival of 12.9 months. Of the patients at the RP2D with or without prior BCMA-targeted therapy (n=50), the ORR was 90%, with a CR or sCR rate of 58%. Of the MM patients treated to date, NXC-201 has shown notably low neurotoxicity rate of 4%.

For ALA, data have been reported for nine patients at the RP2D. At the cut-off point of 20 September 2023, the median follow-up duration was 7.3 months. For this patient population, the ORR was 100%, the CR rate was 67% and the organ response rate was 56%. There have been zero cases of neurotoxicity in ALA patients reported as part of this clinical trial.

In our view, the data reported so far represent an encouraging profile for NXC-201, both in terms of efficacy and safety. We note that currently approved CAR-T therapies are associated with safety concerns (neurotoxicity and cytokine release syndrome), limited accessibility (c 5% of US hospitals able to administer this type of treatment) and long hospital stays (c 14 days on average). As such, with Immix’s differentiated CAR-T therapy asset, we believe the company is well-positioned to address this unmet medical need and that this could translate into a potentially sizeable commercial opportunity, provided the company is successful with regulatory approval (further details can be found in our update note). We expect rolling updates for NXC-201 as the data become available. Management has stated that it plans to submit a Biologics License Application to the FDA for MM once 100 patients have been treated, and for ALA once 40 patients have been treated.

TSTx updates anticipated in Q423 and FY24

The latest update in TSTx was the interim data from IMMINENT-01 announced in July 2023. This clinical trial is a single-arm, dose-escalation (3+3) study designed to investigate the safety and tolerability of IMX-110 in combination with tislelizumab (expected n=30) in patients with relapsed/refractory solid tumors; the results will determine the maximum tolerated dose and the RP2D. At the data cut-off point of 7 July 2023, among the four metastatic colorectal cancer patients treated thus far, three (75%) have had tumor shrinkage. No severe adverse events have been reported to date. We highlight that all patients had stage IV relapsed/refractory metastatic colorectal cancer and had received a median eight lines of prior therapy. While we recognize that the data to date come from a small patient population, we view the early signs of efficacy and safety favorably. The trial is now enrolling the subsequent dose cohort of patients with solid tumors (including some with colorectal cancer) and we anticipate a steady flow of data readouts across Q423–FY24.

Exhibit 1: Immix’s clinical development pipeline

Source: Company website

Financials

As clinical activity continues to make steady progress, Immix’s operating performance in Q323 broadly mirrored the previous quarter, with cash outflow from operating activities reported at $3.1m versus $3.5m in Q223 (albeit materially higher than the $1.5m recorded in Q322). R&D-related expenses, which were primarily made up of clinical trial costs, came in at $2.1m, three times the figure reported in the comparable period ($0.7m in Q322). This increase is attributed to clinical costs associated with its ongoing clinical trials (NEXICART-1 clinical trial for CAR-T therapy NXC-201 and Phase Ib/IIa clinical trials for IMX-110). Note that clinical development of NXC-201 is being independently financed by Immix’s subsidiary, Nexcella (of which Immix owns 94%) and Nexcella’s operating expenses (including R&D costs) are consolidated within Immix’s reported financials. G&A expenses were also materially higher at $2.4m ($0.8m in Q322 and $1.5m in Q223) primarily due to costs related to professional services ($0.8m), stock-based compensation ($0.5m) and investor relations expenses ($0.4m). The Q323 net loss was $4.3m, up from $1.6m in Q322 and $3.6m in Q223.

Based on the nine-month operating performance and run rate, and expecting Immix to maintain a similar pace of clinical activity, we make certain adjustments to our FY23 and FY24 operating expense estimates. Our R&D expenses have been increased revised up to $7.4m and $10.1m in FY23 and FY24, respectively as compared to $6.9m and $9.8m in prior periods. Similarly, our G&A expense forecasts were increased to $6.9m ($5.7m previously) in FY23 and $7.7m ($6.4m previously) in FY24. These changes, coupled with some minor adjustments based on year-to-date results, translate into higher operating losses of $14.4m and $17.8m (versus $12.7m and $16.2m previously) in FY23 and FY24.

Valuation

Our valuation for Immix adjusts to $86.6m or $4.0 per share ($90.7m or $4.2 per share previously) as the aforementioned changes in our expense forecasts and updated net cash balance ($19.6m vs proforma net cash of $22.2m including August fund raise in our October note) more than offset the benefit from rolling forward our model by three months. Note that our per-share valuation assumes full conversion of the 1.9m prefunded warrants issued in August 2023 (as of the Q323 earnings release date, none of the prefunded warrants had been exercised). Based on our cash burn projections for FY23 and FY24, we continue to estimate operating cash runway for the company into Q424.

We continue to assume that Immix will need to raise a further $10m before end-FY24 before the projected global licensing deal in FY25. This $10m fund requirement has been accounted for as illustrative debt in our model. Alternatively, if the funding is instead realized through an equity issue (assumed at the current trading price of $4.25/share), Immix would have to issue 2.4m shares, which will have very minor impact on our per-share valuation so that it remains unchanged at $4.0 (the number of shares outstanding would increase from 21.8m to 24.1m).

Exhibit 2: Immix Biopharma rNPV

Product

Indication

Launch

Peak

Peak sales (US$m)

Value (US$m)

Probability

rNPV (US$m)

rNPV/ share (US$)

IMX-110

Soft tissue sarcoma

2028

2033

455.1

196.0

15.0%

29.5

1.4

IMX-110

Solid tumours

2029

2035

474.5

189.8

10.0%

12.0

0.5

NXC-201

MM

2030

2035

246.0

137.9

17.5%

18.8

0.9

NXC-201

ALA

2030

2035

143.7

78.0

17.5%

6.8

0.3

Net cash on 30 September 2023

 

 

 

 

19.6

100%

19.6

0.90

Valuation

 

 

 

 

621.3

 

86.6

4.0

Source: Edison Investment Research

Exhibit 3: Financial summary

Accounts: IFRS, Yr end: December 31, USD:000s

 

2021

2022

2023e

2024e

PROFIT & LOSS

 

 

 

 

 

Total revenues

 

0

0

0

0

Cost of sales

 

0

0

0

0

Gross profit

 

0

0

0

0

Total operating expenses

 

(1,352)

(8,219)

(14,360)

(17,779)

Research and development expenses

 

(127)

(4,196)

(7,433)

(10,113)

SG&A

 

(1,225)

(4,023)

(6,928)

(7,666)

EBITDA (normalized)

 

(1,350)

(8,217)

(14,358)

(17,767)

Operating income (reported)

 

(1,352)

(8,219)

(14,360)

(17,779)

Finance income/(expense)

 

(180)

(0)

378

0

Exceptionals and adjustments

 

(22,846)

0

0

0

Profit before tax (reported)

 

(24,378)

(8,219)

(13,983)

(17,779)

Profit before tax (normalised)

 

(1,313)

(7,695)

(11,963)

(17,379)

Income tax expense (includes exceptionals)

 

(6)

(10)

(21)

(27)

Net income (reported)

 

(24,384)

(8,230)

(14,004)

(17,806)

Net income (normalised)

 

(1,319)

(7,706)

(11,984)

(17,406)

Basic average number of shares, m

 

3.7

13.9

17.2

19.9

Basic EPS (US$)

 

(6.64)

(0.59)

(0.81)

(0.90)

Adjusted EPS (US$)

 

(0.36)

(0.55)

(0.70)

(0.88)

Dividend per share (US$)

 

0.00

0.00

0.00

0.00

 

 

 

 

 

 

BALANCE SHEET

 

 

 

 

 

Property, plant and equipment

 

6

4

40

30

Other non current assets

 

0

7

241

241

Total non-current assets

 

6

10

281

271

Cash and equivalents

 

17,644

13,437

16,034

8,638

Current tax receivables

 

26

256

652

652

Trade and other receivables

 

0

0

2

3

Other current assets

 

516

1,205

2,097

2,097

Total current assets

 

18,186

14,898

18,785

11,390

Non-current loans and borrowings

 

0

0

0

0

Non-current lease liabilities

 

0

0

0

0

Other non-current liabilities

 

0

475

0

0

Illustrative debt

 

0

0

0

10,000

Total non-current liabilities

 

0

475

0

10,000

Accounts payable

 

143

1,273

2,826

2,826

Current lease obligations

 

0

0

2

3

Other current liabilities

 

59

0

0

0

Total current liabilities

 

202

1,273

2,828

2,829

Equity attributable to company

 

17,990

13,160

16,239

(1,167)

 

 

0

0

(0)

(0)

CASH FLOW STATEMENT

 

 

 

 

 

Net Income

 

(24,384)

(8,230)

(14,004)

(17,806)

Depreciation and amortisation

 

2

2

3

12

Share based payments

 

219

524

2,020

400

Other adjustments

 

22,964

100

0

0

Movements in working capital

 

(391)

195

264

0

Cash from operations (CFO)

 

(1,589)

(7,408)

(11,717)

(17,394)

Capex

 

(1)

0

(39)

(2)

Acquisitions & disposals net

 

0

0

0

0

Other investing activities

 

0

0

0

0

Cash used in investing activities (CFIA)

 

(1)

0

(39)

(2)

Capital changes

 

18,849

2,914

14,413

0

Debt Changes

 

0

0

0

10,000

Other financing activities

 

0

318

(60)

0

Cash from financing activities (CFF)

 

18,849

3,232

14,353

10,000

Cash and equivalents at beginning of period

 

391

17,644

13,437

16,034

Increase/(decrease) in cash and equivalents

 

17,259

(4,176)

2,598

(7,396)

Effect of FX on cash and equivalents

 

(5)

(32)

0

0

Cash and equivalents at end of period

 

17,644

13,437

16,034

8,638

Net (debt)/cash

 

17,644

13,437

16,034

(1,362)

Source: Company reports, Edison Investment Research


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.

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Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

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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).

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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

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United Kingdom

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Thus far, FY23 has marked a year of successful advancement for Amoéba: (1) the development of its biocontrol plant is ongoing, poised to achieve production of 40 tonnes per annum of W. magna lysate; (2) a third scientific article has been published, which highlights the efficacy of its biocontrol product; and (3) the company has announced a potential further application for W. magna lysate in cosmetic skincare. The new application will not hinder advancement of the biological fungicide product. H123 saw the widening of EBIT losses by €1.0m y-o-y to €3.9m, primarily attributable to increased industrial deployment costs and financing fees; Amoéba plans to seek €45m financing to support its expansion and operations.

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