Immix Biopharma — Pipeline momentum continues in FY23

Immix Biopharma (NASDAQ: IMMX)

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Research: Healthcare

Immix Biopharma — Pipeline momentum continues in FY23

Immix Biopharma’s FY22 results reflected a busy period as management ramped up clinical activity across multiple programs. In a major development, Immix expanded its portfolio with the in-licensing of NXC-201, an autologous CAR-T therapy being investigated for the treatment of multiple myeloma (MM) and AL amyloidosis (ALA) currently in the ongoing Phase I/II NEXICART-1 study. With the increase in R&D activity primarily associated with in-licensing NXC-201, Immix reported an operating loss of $8.2m in FY22 (FY21: $1.4m) and we estimate that its net cash position of $13.4m at end-December 2022 provides a cash runway into Q423. Given the company’s increased disclosure of its arrangement with the licensors and of future NEXICART-I study costs, as well as its communicated strategy to expand clinical studies in the US, we now include NXC-201 in our valuation. We value Immix at $77.1m or $5.5 per share (previously $61.5m or $4.4 per share).

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Immix Biopharma

Pipeline momentum continues in FY23

FY22 results

Pharma and biotech

5 April 2023

Price

US$1.95

Market cap

US$27m

Net cash (US$m) at 31 December 2022

13.4

Shares in issue

13.9m

Free float

42%

Code

IMMX

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(17.1)

(26.0)

(32.8)

Rel (local)

(18.3)

(30.4)

(24.9)

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

Immix Biopharma’s FY22 results reflected a busy period as management ramped up clinical activity across multiple programs. In a major development, Immix expanded its portfolio with the in-licensing of NXC-201, an autologous CAR-T therapy being investigated for the treatment of multiple myeloma (MM) and AL amyloidosis (ALA) currently in the ongoing Phase I/II NEXICART-1 study. With the increase in R&D activity primarily associated with in-licensing NXC-201, Immix reported an operating loss of $8.2m in FY22 (FY21: $1.4m) and we estimate that its net cash position of $13.4m at end-December 2022 provides a cash runway into Q423. Given the company’s increased disclosure of its arrangement with the licensors and of future NEXICART-I study costs, as well as its communicated strategy to expand clinical studies in the US, we now include NXC-201 in our valuation. We value Immix at $77.1m or $5.5 per share (previously $61.5m or $4.4 per 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

(15.44)

(1.11)

0.0

N/A

N/A

12/24e

0.0

(16.03)

(1.15)

0.0

N/A

N/A

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

Recent deals put MM CAR-T therapies in spotlight

Immix’s expansion into the CAR-T market could not have been more timely, as it coincides with some notable transactions for B-cell maturation antigen (BCMA) targeting CAR-T therapies in MM. In December 2022, Gilead announced a licensing deal with Arcellx for its lead CAR-T asset, CART-ddBCMA, consisting of an upfront payment of $225m. In our view, this transaction provides an encouraging signal for big pharma’s continued interest in CAR-T technology. Additionally, if NXC-201 can differentiate itself in the market through improved safety in MM patients with ALA and outpatient CAR-T potential, this would maximize the value of NXC-201 to potential partners/licensors, in our view.

Cash runway into Q423 with costs expected to rise

Immix reported a net cash position of $13.4m at end-FY22, which we forecast will provide a cash runway for the company into Q423. Management expects R&D costs to rise as development activities expand and we estimate Immix will need to raise $20m by Q423 to fund operations into FY25, at which point we assume Immix will secure a full global licensing deal for IMX-110.

Valuation: $77.1m or $5.5 per share

We value Immix at $77.1m or $5.5 per share (versus $61.5m or $4.4 per share previously). The valuation has risen due to adding an rNPV model assessing NXC-201’s potential in MM where we assume a licensing deal for NXC-201 will be achieved in 2026, worth up to $450m based on precedent deals for Phase I/II MM assets.

Financials

In FY22 Immix reported operating losses amounting to $8.2m, a significant increase from FY21’s operating losses of $1.4m. FY22 operating expenses were split c 50% between R&D ($4.2m) and SG&A ($4.0m). R&D expenses were primarily related to contract research organization and patient costs associated with the ongoing Phase I/II study of IMX-110 in solid tumors, while SG&A expenses included patent maintenance costs and consulting expenses. Overall, operating losses were significantly higher than our FY22 estimates ($6.2m). However, we note that c 46% of total FY22 operating expenses were incurred in Q422, attributed to the in-licensing of NXC-201 in December 2022. A $1.5m upfront licence fee was included in Immix’s consolidated accounts under R&D expenses (c 35% of total R&D expenses for FY22). In addition, under the terms of the agreement, Immix’s subsidiary Nexcella (of which Immix owns 98%) is required to make quarterly payments amounting to c $13m through to September 2026 (c $865k/quarter, $3.5m/year) to the licensors (Hadasit Medical Research Services & Development and BIRAD) to fund clinical trials in Israel over four years, as well as an annual licence fee of $50k. Further terms of the deal include future royalty payments of 5% on net sales of licensed products together with potential future commercial milestone payments amounting to $20m for net sales exceeding $700m.

Management has stated that it expects Nexcella to become an independently financed company and absorb future costs associated with the clinical development of NXC-201. To date, Nexcella has raised c $650k in gross proceeds following a private placement in January 2023. It has communicated that the NEXICART-I Phase Ib/IIa study will cost c $20m as it intends to extend the ongoing trial to the United States ($13m to support Israel trial costs and $7m for US trial site expansion). However, for forecasting purposes, we now model that Nexcella’s activities will be financed by Immix. As such, we assume that Nexcella and Immix together will need to raise $20m by end Q423 to support the ongoing NEXICART-I trial and development of IMX-110. We note that if Nexcella obtains independent financing for its activities in the future, this could dilute Immix’s ownership interest in the subsidiary. We had previously forecast a $10m funding need for IMX-110 alone but, due to the addition of NXC-201 costs, we expect Immix and Nexcella combined will require $20m by end 2023 to fund the ongoing NEXICART-I study as well as our existing IMX-110 development assumptions.

We have now included licensing fee costs and expected future costs of funding the NEXICART study for NXC-201 in our estimates and, with the continued development of IMX-110 in two ongoing studies, we estimate R&D expenses to increase to $11.7m and $12.2m in FY23 and FY24, respectively. Operating cash outflows for FY22 amounted to $7.4m and Immix ended 2022 with a net cash position of $13.4m, which we estimate should fund operations into Q423. We estimate operating cash outflows of $15.6m in FY23, increasing to $16.1m in FY24. We had previously forecast that Immix would be required to raise $10m in FY24 to fund the development of IMX-110. However, with the inclusion of the NXC-201 program, we estimate that Immix and Nexcella together will need to raise $20m in Q423 before the company secures a global licensing deal in FY25 following trial readouts of IMX-110 in soft tissue sarcoma (STS), expected 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 $1.82/share), Immix would have to issue 10.9m shares, resulting in our per-share valuation decreasing to $3.2 from $5.5 currently (the number of shares outstanding would increase from 13.9m to 24.8m). 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.

Valuation

We value Immix at $77.1m or $5.5 per share (versus $61.5m or $4.4 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 net cash position of $13.4m at end-December 2022. Our model applies a discount rate of 12.5%. The valuation has increased as we have now included NXC-201; given the company’s increased disclosure of its arrangement with the licensors and of future NEXICART-I study costs, as well as its communicated strategy to expand clinical studies in the US, we are now including NXC-201 in our valuation. Based on previous deals for Phase I/II MM assets, we assume that Immix will secure a licensing deal by end FY26 worth up to $450m and have modelled an upfront payment of $45m and additional clinical, regulatory and commercial milestone payments of $405m. We have split the deal economics across both MM and ALA. In our view, Immix may be able to secure competitive licensing terms due to NXC-201’s differentiating safety profile in MM and ALA patients as well as the therapy’s potential application as an outpatient treatment which, if demonstrated, may increase the scale of treatment adoption. For more details on NXC-201’s clinical utility, please see our recent note. We assume a partner will absorb all subsequent R&D and commercialization expenses. The assumptions used for NXC-201 in our valuation are presented in Exhibit 1.

Exhibit 1: rNPV assumptions

Asset

Indication

Assumptions

NXC-201

Multiple myeloma and amyloidosis

Target market: we assume 100% of MM cases express BCMA differentiation and that 15% of patients will progress onto fourth-line treatment. While existing CAR-Ts in MM are approved as fifth-line treatment options, ongoing studies are attempting to position CAR-T therapies in earlier lines of treatment (3rd-4th line), a strategy that Nexcella is also looking to pursue. We therefore assume NXC-201 will be positioned as a fourth-line treatment option in MM with a conservative peak market penetration of 5% given the competitive nature of the BCMA-targeting MM therapy market.

We assume NXC-201 will be positioned as a dual treatment for MM patients who develop ALA (c 15% of MM patients). Management attests that existing CAR-T treatments are currently too toxic to treat such patients and, assuming NXC-201 demonstrates a beneficial safety profile, we assign a peak penetration of 20% within the ALA sub-population.

Pricing & licensing: we assume pricing of $442k per patient per year in the US with a 50% discount in the EU. Our price is based on the average price of the two marketed MM CAR-T therapies, Abecma ($420k) and Carvykti ($465k). We assume that Immix will secure a licensing deal in 2026, which we have based on our assessment of past licensing deals for Phase II MM assets and CAR-T treatments. We assume an upfront payment of $45m with a further $415m in regulatory, clinical and commercial milestones and low double-digit royalties on net sales, where deal economics are split across both MM and ALA.

Trial timelines and R&D cost: we assign R&D-related costs of $20m, which we assume will be required to fund the completion of the NEXICART study as it expands into the US. The study is expected to be completed by FY25. We assume a licensing deal in 2026, at which point a partner would assume all future developmental costs. We anticipate commercial launches for NXC-201 in MM and ALA in 2030.

Probability of success: we assume a probability of approval of 17.5% based on historical clinical phase transition success rates of 30% from Phase II to Phase III, 60% from Phase III to NDA and 95% from NDA to approval in hematological malignancies in oncology.*

Source: Edison Investment Research. Note: *Clinical phase transition success rates are based on 2021 Clinical Development Success Rates l Pharma Intelligence (informa.com) as well objective analysis of data reported from the clinical program.

Additionally, we assume a cumulative probability of success of 17.5%, based on historical clinical transition success rates of oncology studies in hematological malignancies. Our valuation for Immix comprises 37% for IMX-110 in STS, 23% for NXC-201 in MM, 14% for IMX-110 in solid tumors, 9% for NXC-201 in ALA and 17% in cash.

Exhibit 2: 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

183.1

15.0%

27.7

2.0

NXC-201 (MM)

2030

2035

246.0*

129.1**

17.5%

17.9

1.3

IMX-110 (solid tumors)

2029

2035

474.5

176.7

10.0%

11.3

0.8

NXC-201 (ALA)

2030

2035

143.7

73.4**

17.5%

6.7

0.5

Net cash on 31 December 2022

 

 

 

13.4

100%

13.4

0.97

Valuation

 

 

 

575.8

 

77.1

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 98% ownership of the asset in Nexcella.

Exhibit 3: 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)

(15,841)

(16,425)

Research and development expenses

 

(248)

(127)

(4,196)

(11,737)

(12,239)

SG&A

 

(206)

(1,225)

(4,023)

(4,104)

(4,186)

EBITDA (normalized)

 

(452)

(1,350)

(8,217)

(15,839)

(16,423)

Operating income (reported)

 

(454)

(1,352)

(8,219)

(15,841)

(16,425)

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)

(15,841)

(16,425)

Profit before tax (normalised)

 

(555)

(1,313)

(7,695)

(15,441)

(16,025)

Income tax expense (includes exceptionals)

 

(18)

(6)

(10)

(18)

(19)

Net income (reported)

 

(1,148)

(24,384)

(8,230)

(15,859)

(16,443)

Net income (normalised)

 

(572)

(1,319)

(7,706)

(15,459)

(16,043)

Basic average number of shares, m

 

1.1

3.7

13.9

13.9

13.9

Basic EPS (US$)

 

(1.02)

(6.64)

(0.59)

(1.14)

(1.18)

Adjusted EPS (US$)

 

(0.51)

(0.36)

(0.55)

(1.11)

(1.15)

Dividend per share (US$)

 

0.00

0.00

0.00

0.00

0.00

BALANCE SHEET

 

 

 

 

 

 

Property, plant and equipment

 

7

6

4

4

5

Other non-current assets

 

0

0

7

7

7

Total non-current assets

 

7

6

10

11

12

Cash and equivalents

 

391

17,644

13,437

17,877

1,733

Current tax receivables

 

127

26

256

356

456

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

19,441

3,397

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

475

475

Total non-current liabilities

 

0

0

475

475

475

Accounts payable

 

252

143

1,273

1,273

1,273

Illustrative debt

 

4,050

0

0

20,000

20,000

Current lease obligations

 

0

0

0

2

3

Other current liabilities

 

968

59

0

0

0

Total current liabilities

 

5,270

202

1,273

21,275

21,276

Equity attributable to company

 

(4,731)

17,990

13,160

(2,299)

(18,342)

CASH FLOW STATEMENT

 

 

 

 

 

 

Net Income

 

(1,148)

(24,384)

(8,230)

(15,859)

(16,443)

Depreciation and amortisation

 

2

2

2

1

1

Share based payments

 

0

219

524

400

400

Other adjustments

 

575

22,964

100

0

0

Movements in working capital

 

166

(391)

195

(100)

(100)

Cash from operations (CFO)

 

(405)

(1,589)

(7,408)

(15,557)

(16,142)

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

0

0

Debt Changes

 

0

0

0

20,000

0

Other financing activities

 

0

0

318

0

0

Cash from financing activities (CFF)

 

0

18,849

3,232

20,000

0

Cash and equivalents at beginning of period

 

734

391

17,644

13,437

17,877

Increase/(decrease) in cash and equivalents

 

(405)

17,259

(4,176)

4,441

(16,144)

Effect of FX on cash and equivalents

 

62

(5)

(32)

0

0

Cash and equivalents at end of period

 

391

17,644

13,437

17,877

1,733

Net (debt)/cash

 

(3,659)

17,644

13,437

(2,123)

(18,267)

Source: Edison Investment Research, Immix Company Accounts

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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.

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.

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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.

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Molecure — Clinical progression ahead in FY23

Molecure is entering FY23 with two active clinical programmes. OATD-01, the company’s lead proprietary asset, is in development for the treatment of sarcoidosis, but management expects to expand into new indications if the data are supportive. The first patient is due to be dosed in the Phase II trial for this asset in H223. Molecure also recently reported the first dosing in the Phase I trial for OATD-02, a novel drug for the treatment of solid tumours; an update for this study is expected in Q423. The company reported a 22.3% y-o-y increase in operating expenses for FY22, due to higher costs of external services and personnel expenses during the year. With a net cash position of PLN54.0m at end FY22, management anticipates a cash runway into early FY24 (at least 12 months).

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