Immix Biopharma — A quarter focusing on a CAR-T strategy

Immix Biopharma (NASDAQ: IMMX)

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Research: Healthcare

Immix Biopharma — A quarter focusing on a CAR-T strategy

Following recent updates regarding Immix’s CAR-T therapy (NXC-201) and Q123 results, we have adjusted our financial estimates. Quarterly R&D expenses of $1.3m were lower than expected, largely due to lower clinical development costs. Roughly 48% of these expenses were related to quarterly payments made to the licensors of Nexcella’s (Immix’s majority-owned, 94%, subsidiary) CAR-T therapy, NXC-201. Based on the quarterly R&D spend run rate, we have revised our FY23 R&D expenses to $6.1m, down from $11.7m previously. The resulting operating loss of $10.9m is down from $15.8m previously. Immix ended the quarter with a net-cash position of $11.5m and raised a further $2.5m post quarter end through the company’s ATM facility, which we anticipate will provide an operating cash runway into Q224, a slight extension from Q423 previously. Our valuation of Immix has been adjusted due to the higher pro-forma cash position of $14m, rolling our model forward and our revised R&D estimates. We value Immix at $83.3m or $5.5 per share (previously $77.1m or $5.5/share).

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Immix Biopharma

A quarter focusing on a CAR-T strategy

Q123 results

Pharma and biotech

23 May 2023

Price

US$1.75

Market cap

US$26m

Net cash (US$m) at 31 March 2023

11.5

Shares in issue

15.0m

Free float

42%

Code

IMMX

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(6.4)

(24.6)

(17.5)

Rel (local)

(7.7)

(28.2)

(23.2)

52-week high/low

US$3.14

US$0.75

Business description

Immix Biopharma is developing a new class of tissue-specific therapeutics targeting oncology and immune-dysregulated disease. Its lead asset, IMX-110, is being investigated in a Phase Ib/IIa study for the treatment of soft tissue sarcoma and a Phase Ib trial in advanced solid tumours in combination with the ICI tislelizumab. Immix’s Nexcella subsidiary is also developing a CAR-T therapy, NXC-201, which is in the Phase Ib/IIa NEXICART study for the treatment of multiple myeloma and AL amyloidosis.

Next events

NEXICART-1 (NXC-201) 50-patient ongoing data

CY23

Phase Ib/IIa (IMX-110) rolling data

H123

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Dr Adam McCarter

+44 (0)20 3077 5700

Immix Biopharma is a research client of Edison Investment Research Limited

Following recent updates regarding Immix’s CAR-T therapy (NXC-201) and Q123 results, we have adjusted our financial estimates. Quarterly R&D expenses of $1.3m were lower than expected, largely due to lower clinical development costs. Roughly 48% of these expenses were related to quarterly payments made to the licensors of Nexcella’s (Immix’s majority-owned, 94%, subsidiary) CAR-T therapy, NXC-201. Based on the quarterly R&D spend run rate, we have revised our FY23 R&D expenses to $6.1m, down from $11.7m previously. The resulting operating loss of $10.9m is down from $15.8m previously. Immix ended the quarter with a net-cash position of $11.5m and raised a further $2.5m post quarter end through the company’s ATM facility, which we anticipate will provide an operating cash runway into Q224, a slight extension from Q423 previously. Our valuation of Immix has been adjusted due to the higher pro-forma cash position of $14m, rolling our model forward and our revised R&D estimates. We value Immix at $83.3m or $5.5 per share (previously $77.1m or $5.5/share).

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

(10.50)

(0.72)

0.0

N/A

N/A

12/24e

0.0

(14.01)

(0.93)

0.0

N/A

N/A

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

NXC-201 newsflow leads the way in Q123

Immix continues to generate positive newsflow from its NEXICART-1 trial investigating NXC-201, a CAR-T therapy, for the treatment of multiple myeloma (MM) and Amyloid light chain (AL) amyloidosis . The latest readouts from the study reported positive results for the 58 patients enrolled so far, with an overall response rate (ORR) of 92% for patients with MM, and an ORR of 100% for patients with ALA. Immix believes that if NEXICART-1 reaches patient enrollment of 100 it could potentially serve as a registrational study, provided results continue to be positive. We note that the FDA approval of Carvykti (J&J CAR-T) was based on the outcome of the CARTITUDE-1 trial (n=97), a similarly designed open-label, single-arm study.

Cash runway into Q224

Immix reported net cash of $11.5m at end-Q123. With the lower-than-expected costs associated with the clinical development of NXC-201, we anticipate a slight extension of the company’s cash runway into Q224 (from Q423, previously). We estimate Immix will need to raise c $20m to fund operations into FY25, at which point we assume Immix will secure a full global licensing deal for IMX-110.

Valuation: $83.3m or $5.5 per share

We value Immix at $83.3m or $5.5 per share (versus $77.1m or $5.5/share previously). While the total rNPV has increased as we rolled forward our estimates, updated for net cash and lowered R&D cost expectations, our per-share valuation is unchanged due to the higher share count, which has increased from 13.9m to 15.0m following the company’s equity raise through its newly established ATM facility.

Clinical results impress in AL amyloidosis

Amyloid light chain (AL) amyloidosis is a rare disease characterized by the abnormal buildup of toxic light chain (LC) proteins called amyloid fibrils. These deposits are found to gather in critical organs such as the heart, kidney and liver, leading to progressive organ damage and ultimately organ failure. It is estimated that c 4,000 new cases of AL amyloidosis will be recorded in the United States each year. The current first line standard of care (SoC) for AL amyloidosis is a four-drug combination of subcutaneous Darzalex (Daratumumab) with bortezomib, cyclophosphamide and dexamethasone. The major goal of treatment is to achieve a hematological response (HR) by reducing the levels of circulating LC proteins, which should translate into an organ response, an improvement in organ function to prolong patient survival. However, limited therapeutic options currently exist in the relapse/refractory AL amyloidosis setting. Hematological ORRs of 55% have been reported although this figure is comprised of patients (n=31) treated with various protocols including re-treatment with Darzalex combinations, venetoclax and proteasome inhibitor (bortezomib) based regimes. Additionally, organ response rates in relapsed/refractory (r/r) AL amyloidosis continue to be relatively low, sitting at only 29%.

As part of its ongoing NEXICART-1 study, Immix is investigating the application of its BCMA targeting autologous (patient-derived) CAR-T therapy, NXC-201, for the treatment of r/r MM or r/r AL amyloidosis. Immix reported the most recent clinical data from the study at the 26th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT), which reflected eight r/r AL amyloidosis patients who had disease progression following Darzalex based treatment and were subsequently treated with NXC-201. A hematologic ORR of 100% was observed, consisting of five complete responses (63%), two very good partial responses (25%) and one partial response (12%), Exhibit 1.

Exhibit 1: NXC-201 clinical data in AL amyloidosis and comparator studies

Source: Immix Biopharma corporate presentation

This hematologic ORR translated into an organ response rate of 71%, a significant improvement over the previously reported organ response rate of 29%.

In our view, a notable feature of the NXC-201 data in r/r AL amyloidosis patients is the positive safety profile the treatment has demonstrated, to date. While we caveat that the current clinical data only represents a smaller patient population (n=8), the initial results appear encouraging. In seven out of eight (87%) evaluated patients, the pathology of their AL amyloidosis has progressed into the heart with patients having previously received a median of six prior lines of therapy. Of these, five patients had New York Heart Association (NYHA) functional classifications of grade III or IV and could be considered a highly compromised patient cohort whose cardiac function may be extremely sensitive to further treatment exposure. Additionally, one of the most reported and toxic side effects of CAR-T therapy is inflammatory cytokine release syndrome (CRS), a response that can potentially trigger orthostatic hypotension and, depending on the severity of the response, may require patients to receive an antihypotensive (vasopressor) agent. The risks of CAR-T related CRS are further heightened in patients with already weakened cardiac function where the sudden onset of hypotension could potentially be fatal. As such, many AL amyloidosis patients with NYHA ≥ grade 3 are often excluded from clinical studies due to the potential dangers associated with further treatment. However, to date, no serious adverse events have been reported from the AL amyloidosis patients enrolled in NEXICART-1. The most severely cardiac compromised patients in the study (n=3) with an NYHA grade of 4 did not experience a CRS grade >2 and did not need to receive any vasopressor treatments. Additionally, each of these NYHA grade 4 patients saw a reduction in NYHA stage, with one patient reporting a reduction to NYHA grade 2.

Patient recruitment for the NEXICART-1 study is currently ongoing in Israel; however, Immix intends to expand the study and to activate the first trials sites in the United States in Q423. Management has also communicated it plans to submit a biological license application (BLA) for FDA approval in AL amyloidosis once 30–40 patients are treated with NXC-201 in the NEXICART-1 study.

Financials and valuation

Based on the lower than anticipated R&D run rate in the Q123 results, we have revised our financial estimates. We anticipate an FY23 operating loss of $10.9m (previously $15.8m), with net cash outflows from operating activities of $10.4m (previously $15.6m). Q123 operating expenses continued to be split c 50% between R&D ($1.3m) and SG&A ($1.2m). We note that of the Q123 R&D expenses, c $0.63m (53%) were attributed to the in-licensing of NXC-201 where, under the terms of the agreement, Immix’s subsidiary Nexcella (of which Immix owns 94%) is required to make quarterly payments amounting to a total of c $13m, along with an annual license fee of $50k, through to September 2026 to the licensors (Hadasit Medical Research Services & Development and BIRAD).

While the size of the payments may vary from quarter to quarter across the licensing period, for the purposes of our model we have forecast R&D expenses associated with NXC-201 of c $865k/quarter or $3.5m/year. The $13m associated with the licensing fee will be used to fund clinical trials in Israel over four years. According to its annual filings (10-K) Immix is currently planning to extend the NEXICART-I study to clinical trial sites in the United States and expects to activate the first site by end Q423. We therefore anticipate a steady quarterly burn rate in FY23 associated with the NEXICART-1 Israel trial costs before the impact of the trial expansion into the United States on operating expenses is realized in FY24. Immix believes that the NEXICART-I Phase Ib/IIa study will cost c $20m, which we estimate corresponds to c $13m to support Israel trial costs and c $7m for the US trial site expansion. A summary of the changes to our estimates is shown in Exhibit 1.

Exhibit 2: Key changes to forecasts

FY23e

FY24e

US$m

Old

New

Change (%)

Old

New

Change (%)

Operating expenses

(15.8)

(10.9)

-31.0%

(16.4)

(14.4)

-12.1%

– R&D

(11.7)

(6.1)

-47.9%

(12.2)

(9.5)

-22.1%

– G&A

(4.1)

(4.8)

17.1%

(4.2)

(4.9)

16.7%

EBIT

(15.8)

(10.9)

-31.0%

(16.4)

(14.4)

-12.1%

Operating cash outflow

(15.6)

(10.4)

-33.3%

(16.1)

(14.0)

-13.0%

Source: Edison Investment Research

In March 2023 Immix entered into an at-the-market (ATM) sales agreement with ThinkEquity (the sales agent), which will allow Immix to issue and sell up to $5m of the company’s common stock in sales deemed to be ‘at-the-market’ offerings. In Q123 Immix reported that it raised c $0.1m from the sale of common shares under the ATM facility. As of May 2023, the company reported that (post-period) it has raised net proceeds of $2.5m under the ATM facility. With Immix’s net cash position of $11.5m at end-March 2023, we estimate the company is funded into Q224, in line with management guidance.

We estimate that Immix and Nexcella together will need to raise $20m in FY24 before the company secures a global licensing deal in FY25, following trial readouts of IMX-110 in soft tissue sarcoma (STS), which the company expects by end FY24. We assume Immix receives licensing milestones associated with STS and NXC-201 in FY26 and FY27. We account for this $20m funding requirement as illustrative debt in our model. Alternatively, if funding is realized through an equity issue instead (assumed at the current trading price of $1.75/share), Immix would have to issue 9.7m shares, resulting in our per-share valuation decreasing to $3.5 from $5.5 currently (the number of shares outstanding would increase from 15.0m to 24.7m). However, we do not expect Immix to be fully revenue generating and self-sustaining until the commercial launch of its first product (IMX-110), which we estimate will be in FY28.

We value Immix at $83.3m or $5.5 per share (versus $77.1m or $5.5 per share previously), based on a risk-adjusted net present value (NPV) for IMX-110 in STS and solid tumor indications, NXC-201 in MM and ALA and a pro-forma net cash position of $14.0m. Our valuation has been adjusted due to the company’s higher pro-forma cash position of $14.0m, rolling our model forward and lower estimated total R&D expenses for the development of NXC-201. Our per share valuation is slightly offset by the increased share count (15.0m from 13.9m). A breakdown of our rNPV assumptions is displayed in Exhibit 3.

Exhibit 3: Immix Biopharma rNPV

Product

Launch

Peak

Peak sales
(US$m)

Value
(US$m)

Probability

rNPV
(US$m)

rNPV/share (US$)

IMX-110 (STS)

2028

2033

455.1

184.8

15.0%

29.5

2.0

NXC-201 (MM)

2030

2035

246.0*

130.0**

17.5%

19.0

1.2

IMX-110 (solid tumors)

2029

2035

474.5

178.5

10.0%

13.1

0.9

NXC-201 (ALA)

2030

2035

143.7

74.2**

17.5%

7.8

0.5

Pro forma net cash post period 31 March 2023

 

 

 

14.0

100%

14.0

0.9

Valuation

 

 

 

581.4

 

83.3

5.5

Source: Edison Investment Research. Note: *Assumed licensing milestone payments value and overall deal value higher for NXC-201 than IMX-110. We have modelled a deal value of $210m for IMX-110 versus $450m for NXC-201. **Weighted by Immix’s 94% ownership of the asset in Nexcella.

Exhibit 4: Financial summary

Accounts: IFRS; year end 31 December; US$000s

 

2020

2021

2022

2023e

2024e

PROFIT & LOSS

 

 

 

 

 

 

Total revenues

 

0

0

0

0

0

Cost of sales

 

0

0

0

0

0

Gross profit

 

0

0

0

0

0

Total operating expenses

 

(454)

(1,352)

(8,219)

(10,898)

(14,413)

Research and development expenses

 

(248)

(127)

(4,196)

(6,070)

(9,489)

SG&A

 

(206)

(1,225)

(4,023)

(4,828)

(4,924)

EBITDA (normalized)

 

(452)

(1,350)

(8,217)

(10,896)

(14,412)

Operating income (reported)

 

(454)

(1,352)

(8,219)

(10,898)

(14,413)

Finance income/(expense)

 

(102)

(180)

(0)

0

0

Exceptionals and adjustments

 

(574)

(22,846)

0

0

0

Profit before tax (reported)

 

(1,130)

(24,378)

(8,219)

(10,898)

(14,413)

Profit before tax (normalised)

 

(555)

(1,313)

(7,695)

(10,498)

(14,013)

Income tax expense (includes exceptionals)

 

(18)

(6)

(10)

(12)

(16)

Net income (reported)

 

(1,148)

(24,384)

(8,230)

(10,910)

(14,430)

Net income (normalised)

 

(572)

(1,319)

(7,706)

(10,510)

(14,030)

Basic average number of shares, m

 

1.1

3.7

13.9

14.6

15.0

Basic EPS (US$)

 

(1.02)

(6.64)

(0.59)

(0.75)

(0.96)

Adjusted EPS (US$)

 

(0.51)

(0.36)

(0.55)

(0.72)

(0.93)

Dividend per share (US$)

 

0.00

0.00

0.00

0.00

0.00

 

 

 

 

 

 

 

BALANCE SHEET

 

 

 

 

 

 

Property, plant and equipment

 

7

6

4

4

4

Other non current assets

 

0

0

7

167

167

Total non-current assets

 

7

6

10

171

171

Cash and equivalents

 

391

17,644

13,437

5,578

11,548

Current tax receivables

 

127

26

256

322

322

Trade and other receivables

 

0

0

0

2

3

Other current assets

 

14

516

1,205

1,205

1,205

Total current assets

 

532

18,186

14,898

7,108

13,079

Non-current loans and borrowings

 

0

0

0

0

0

Non-current lease liabilities

 

0

0

0

0

0

Other non-current liabilities

 

0

0

475

0

0

Illustrative debt

 

4,050

0

0

0

20,000

Total non-current liabilities

 

4,050

0

475

0

20,000

Accounts payable

 

252

143

1,273

1,473

1,473

Current lease obligations

 

0

0

0

2

3

Other current liabilities

 

968

59

0

0

0

Total current liabilities

 

1,220

202

1,273

1,475

1,476

Equity attributable to company

 

(4,731)

17,990

13,160

5,804

(8,226)

 

 

0

0

0

0

0

CASH FLOW STATEMENT

 

 

 

 

 

 

Net Income

 

(1,148)

(24,384)

(8,230)

(10,910)

(14,430)

Depreciation and amortisation

 

2

2

2

2

2

Share based payments

 

0

219

524

400

400

Other adjustments

 

575

22,964

100

0

0

Movements in working capital

 

166

(391)

195

133

0

Cash from operations (CFO)

 

(405)

(1,589)

(7,408)

(10,376)

(14,028)

Capex

 

0

(1)

0

(2)

(2)

Acquisitions & disposals net

 

0

0

0

0

0

Other investing activities

 

0

0

0

0

0

Cash used in investing activities (CFIA)

 

0

(1)

0

(2)

(2)

Capital changes

 

0

18,849

2,914

2,504

0

Debt Changes

 

0

0

0

0

20,000

Other financing activities

 

0

0

318

15

20,000

Cash from financing activities (CFF)

 

0

18,849

3,232

2,519

40,000

Cash and equivalents at beginning of period

 

734

391

17,644

13,437

5,578

Increase/(decrease) in cash and equivalents

 

(405)

17,259

(4,176)

(7,859)

25,970

Effect of FX on cash and equivalents

 

62

(5)

(32)

0

0

Cash and equivalents at end of period

 

391

17,644

13,437

5,578

31,548

Net (debt)/cash

 

(3,659)

17,644

13,437

5,578

(8,452)

Source: company accounts, Edison Investment Research

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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

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United Kingdom

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