Last close As at 05/08/2026
USD9.54
▲ 0.21 (2.25%)
Market capitalisation
USD520m
Research: Healthcare
Immix Biopharma’s Q124 report reflected a period focused on its lead CAR-T asset, NXC-201, targeting amyloid light chain amyloidosis (ALA), which was recently bolstered by incremental NEXICART-1 data. The quarter saw a pick-up in preparatory activities in advance of the US NEXICART-2 trial initiation with the finalization of a manufacturing facility in California and selection of the lead clinical trial site. We await the first-patient dosing, expected in mid-2024. We also expect an update on the addition of the autoimmune indication for NXC-201 by year end. The Q1 operating loss of $5.6m was in line with our expectations, and Immix anticipates it will maintain a cash runway through Q225 ($29.3m cash at hand at end-Q124). Our valuation adjusts to $139.5m or $5.3/share, slightly changed from $142.2m or $5.4/share, previously, with the roll forward of our model and quarterly update.
Written by
Immix Biopharma |
All roads lead to NEXICART-2 |
Q124 results |
Pharma and biotech |
20 May 2024 |
Share price performance
Business description
Next events
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Immix Biopharma is a research client of Edison Investment Research Limited |
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Immix Biopharma’s Q124 report reflected a period focused on its lead CAR-T asset, NXC-201, targeting amyloid light chain amyloidosis (ALA), which was recently bolstered by incremental NEXICART-1 data. The quarter saw a pick-up in preparatory activities in advance of the US NEXICART-2 trial initiation with the finalization of a manufacturing facility in California and selection of the lead clinical trial site. We await the first-patient dosing, expected in mid-2024. We also expect an update on the addition of the autoimmune indication for NXC-201 by year end. The Q1 operating loss of $5.6m was in line with our expectations, and Immix anticipates it will maintain a cash runway through Q225 ($29.3m cash at hand at end-Q124). Our valuation adjusts to $139.5m or $5.3/share, slightly changed from $142.2m or $5.4/share, previously, with the roll forward of our model and quarterly update.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
0.0 |
(7.60) |
(0.55) |
0.0 |
N/A |
N/A |
12/23 |
0.0 |
(13.00) |
(0.75) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(21.44) |
(0.93) |
0.0 |
N/A |
N/A |
12/25e |
0.0 |
(26.55) |
(1.01) |
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 homing in on US trial launch
Recent business activities highlight Immix’s progress towards the NEXICART-2 trial, expected to commence in mid-2024. With the manufacturing facility established and lead trial site finalized, we believe the trial initiation remains on track. The US study (an open-label, single-arm, multi-site, dose-expansion Phase Ib trial) will evaluate the safety and efficacy of NXC-201 in c 40 ALA patients, aiming to reproduce the favorable efficacy data (including newly announced results) from the first 13 ALA patients treated in NEXICART-1. We note that management intends to file a Biologics License Application as early as 2025, if data continue to be supportive.
EU ODD: Opportunity remains in multiple myeloma
While we believe Immix’s strategic priority is ALA and autoimmune indications, the recent EU orphan drug designation (ODD) for NXC-201 in multiple myeloma (MM) is a reminder that opportunity remains in this indication. EU ODD provides up to 10 years of EU market exclusivity, subject to regulatory approval, and the recent FDA approval of Bristol Myers Squibb’s Abecma and J&J’s Carvykti in earlier-line treatment for MM indicates the market opportunity for novel CAR-T therapies. NXC-201 has demonstrated early efficacy in the NEXICART-1 trial (63 MM patients).
Valuation: Largely stable at $139.5m or $5.3/share
As Q124 results were in line with our expectations, we maintain both our near- and long-term estimates. Our valuation adjusts slightly from $142.2m or $5.4/share, previously, as we roll our model forward reflecting the quarterly results with a slightly lower cash position. Based on our projected burn rates, we continue to estimate the company is sufficiently funded into Q225.
New NEXICART-1 data strengthen ALA data package
Following the quarterly release, Immix reported the latest clinical data for NXC-201, its lead B-cell maturation antigen (BCMA) targeting CAR-T therapy, from NEXICART-1, at the American Society of Gene and Cell Therapy 27th Annual Meeting. This update included results for 13 ALA patients, all of whom were relapsed/refractory to standard-of-care Dara-CyBorD (daratumumab combined with cyclophosphamide, bortezomib and dexamethasone), and 12 of 13 patients had not been exposed to prior BCMA-targeted therapy. Of this population, there was a median of four prior lines of therapy that had failed to stop disease progression (range 3–10). Patients were infused with CAR-T cells at doses of: 150×106 (n=1); 450×106 (n=2); and 800×106 (n=10, the recommended Phase II dose). Key results were:
■
The overall response rate was 92% (12 of 13 patients).
■
The overall response rate for the patients not exposed to prior BCMA-targeted therapy was 100% (12 of 12 patients), consistent with the previously announced data from the first 10 patients.
•
The complete response rate for these patients was 75% (nine of 12 patients).
■
One patient was previously treated with a BCMA-targeted bispecific antibody therapy, and this patient did not respond to NXC-201.
■
As of 10 May 2024, the best responder had a duration of response of 28.0 months, and it was noted that the response is ongoing.
■
Zero cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.
■
The median cytokine release syndrome (CRS) duration was two days (range 1–5), a slight increase from the one-day CRS noted previously.
•
Zero cases of CRS events greater than grade 4 (which can include life-threatening symptoms and complications). Two patients experienced no CRS, three patients experienced grade 1 CRS, six patients experienced grade 2 CRS and two patients experienced grade 3 CRS.
Collectively, we believe these results support the potential of NXC-201 in this indication. We also note that the trial population included particularly fragile participants in an already tenuous patient population – 11 of 13 patients with cardiac involvement, five of 13 had New York Heart Association stage 3 or 4 heart failure, and five of 13 had Mayo stage 3 ALA. The positive ALA data seen to date from NEXICART-1 provide a strong foundation for the US NEXICART-2 trial, in our view.
Financials and valuation
Immix’s Q124 results were broadly in line, on an annualized basis, with our FY24 projections, signaling growing intensity in clinical activity for NXC-201 and preparatory work ahead of the initiation of the US-based NEXICART-2 trial, expected to commence in mid-2024. The operating loss more than doubled year-on-year to $5.6m (up from $2.5m in Q123) driven by material increases in both R&D and G&A expenses. R&D-related expenses increased nearly 1.5x y-o-y to $3.2m versus $1.3m in Q123 and reached the highest quarterly mark since listing. Expenses were primarily related to the ongoing CAR-T trials and the upcoming NEXICART-2 study in the US. We note that, in January 2024, Immix signed a lease for a 14,000 sqft biopharmaceutical manufacturing facility in California in preparation for the upcoming trial. G&A expenses ($2.3m) mirrored the previous two quarters, although higher than the Q123 figure of $1.2m. The increase in G&A expenses was largely attributed to an increase in professional services for investor relations and stock-based compensation (c $0.3m each during the quarter). Free cash flows reflected the increased opex of $4.1m versus $2.1m in Q123. We expect expenses during Q224 to be comparable to Q1, although R&D expenses may trend up in the second half of FY24 following the initiation of the US trials. We maintain our previously communicated estimates, including FY24e and FY25e operating losses of $22m and $26.2m, respectively.
Our long-term assumptions for Immix remain unchanged since our last update note. The immediate focus will remain the advancement of the US CAR-T trial in ALA, although we may see updates on MM as the ALA program progresses. We await more information on the additional autoimmune conditions the company intends to target, before incorporating these in our valuation. We also maintain our long-term estimates for the IMX-110 program but note that these are subject to revision based on further updates from management on the plans and clinical progress. Overall, our valuation for Immix remains largely unchanged at $139.5m, down slightly from $142.2m previously, reflecting the lower net cash position of $29.3m (compared to the previously used pro-forma figure of $33.5m), which offset the benefit from rolling forward our model. Our per share valuation adjusts slightly to $5.3, down from $5.4 previously, with the higher share count. Exhibit 1 presents a breakdown of our risk-adjusted net present valuation (rNPV) for Immix.
Exhibit 1: Immix Biopharma rNPV
Product |
Indication |
Launch |
Peak |
Peak sales (US$m) |
Value |
Probability |
rNPV |
rNPV/ |
NXC-201 |
Amyloid light chain amyloidosis |
2027 |
2033 |
370.6 |
193.1 |
25.0% |
45.4 |
1.7 |
NXC-201 |
Multiple myeloma |
2030 |
2035 |
288.7 |
131.8 |
17.5% |
30.0 |
1.1 |
IMX-110 |
Soft tissue sarcoma |
2029 |
2034 |
452.9 |
140.6 |
15.0% |
22.2 |
0.8 |
IMX-110 |
Solid tumors |
2029 |
2034 |
451.2 |
163.5 |
10.0% |
12.6 |
0.5 |
Net cash on 31 March 2024 |
|
|
|
29.3 |
100% |
29.3 |
1.1 |
|
Valuation |
|
|
|
|
658.3 |
|
139.5 |
5.3 |
Source: Edison Investment Research. Note: *The per share valuation uses the shares outstanding figure of 26.4m shares.
Immix ended Q124 with a net cash balance of $29.3m (compared to $17.5m at end FY23), which was supported by the equity raise net proceeds of $15.5m in February 2024 and $425.7k from the sale of shares under the July 2023 ATM facility (the facility was suspended in February 2024). Projected cash burn rates remain unchanged since our last update (with operating cash outflows of $21.5m and $26.4m in FY24e and FY25e, respectively), and we continue to see the company funded into Q225. We forecast the need to raise another $15m in 2025, prior to filing the Biologics License Application (BLA) for NXC-201 in ALA (provided data from the NEXICART studies are supportive).
For our model, we have included a licensing deal for NXC-201 worth $500m in 2026, with $50m in an upfront payment. However, should such a deal not materialize, we calculate the need to raise a further $15m in FY26, before breaking even in FY27 following the expected launch of NXC-201 in ALA. If Immix were to raise these funds (a total of $30m across FY25 and FY26) through equity issuance, it would have to issue 12.1m shares (assuming a conversion price of $2.47, based on the last closing price), and our valuation would decrease to $4.4/share (from $5.3/share currently), and the number of shares outstanding would increase to 38.6m from 26.4m currently.
Exhibit 2: Financial summary
Accounts: IFRS, year end 31 December, $000s |
2022 |
2023 |
2024e |
2025e |
PROFIT & LOSS |
|
|
|
|
Total revenues |
0 |
0 |
0 |
0 |
Cost of sales |
0 |
0 |
0 |
0 |
Gross profit |
0 |
0 |
0 |
0 |
Total operating expenses |
(8,219) |
(16,141) |
(21,963) |
(26,159) |
Research and development expenses |
(4,196) |
(8,735) |
(13,446) |
(16,790) |
SG&A |
(4,023) |
(7,406) |
(8,517) |
(9,369) |
EBITDA (normalized) |
(8,217) |
(16,136) |
(21,958) |
(26,013) |
Operating income (reported) |
(8,219) |
(16,141) |
(21,963) |
(26,159) |
Finance income/(expense) |
(0) |
572 |
525 |
(390) |
Exceptionals and adjustments |
0 |
0 |
0 |
0 |
Profit before tax (reported) |
(8,219) |
(15,569) |
(21,438) |
(26,549) |
Profit before tax (normalised) |
(7,595) |
(13,003) |
(21,438) |
(26,549) |
Income tax expense (includes exceptionals) |
(10) |
(26) |
(36) |
(45) |
Net income (reported) |
(8,230) |
(15,596) |
(21,474) |
(26,594) |
Net income (normalised) |
(7,606) |
(13,030) |
(21,474) |
(26,594) |
Basic average number of shares, m |
13.9 |
17.3 |
23.2 |
26.4 |
Basic EPS (US$) |
(0.59) |
(0.90) |
(0.93) |
(1.01) |
Adjusted EPS (US$) |
(0.55) |
(0.75) |
(0.93) |
(1.01) |
Dividend per share (US$) |
0.00 |
0.00 |
0.00 |
0.00 |
|
|
|
|
|
BALANCE SHEET |
|
|
|
|
Property, plant and equipment |
4 |
50 |
1,457 |
1,311 |
Other non current assets |
7 |
87 |
87 |
87 |
Total non-current assets |
10 |
137 |
1,544 |
1,399 |
Cash and equivalents |
13,437 |
17,510 |
11,990 |
541 |
Current tax receivables |
256 |
1,172 |
1,172 |
1,172 |
Other current assets |
1,205 |
1,106 |
1,106 |
1,106 |
Total current assets |
14,898 |
19,788 |
14,268 |
2,819 |
Other non-current liabilities |
475 |
0 |
1,412 |
1,412 |
Long term debt |
0 |
0 |
0 |
15,000 |
Total non-current liabilities |
475 |
0 |
1,412 |
16,412 |
Accounts payable |
1,273 |
3,722 |
3,722 |
3,722 |
Other current liabilities |
0 |
0 |
0 |
0 |
Total current liabilities |
1,273 |
3,722 |
3,722 |
3,722 |
Equity attributable to company |
13,160 |
16,203 |
10,678 |
(15,916) |
|
|
|
|
|
CASH FLOW STATEMENT |
|
|
|
|
Net Income |
(8,230) |
(15,596) |
(21,474) |
(26,594) |
Depreciation and amortisation |
2 |
5 |
5 |
146 |
Share based payments |
624 |
2,566 |
0 |
0 |
Other adjustments |
0 |
0 |
0 |
0 |
Movements in working capital |
195 |
1,653 |
0 |
0 |
Cash from operations (CFO) |
(7,408) |
(11,371) |
(21,469) |
(26,449) |
Capex |
0 |
(52) |
0 |
0 |
Acquisitions & disposals net |
0 |
0 |
0 |
0 |
Other investing activities |
0 |
0 |
0 |
0 |
Cash used in investing activities (CFIA) |
0 |
(52) |
0 |
0 |
Capital changes |
2,914 |
15,521 |
15,947 |
0 |
Debt Changes |
0 |
0 |
0 |
15,000 |
Other financing activities |
318 |
(57) |
2 |
0 |
Cash from financing activities (CFF) |
3,232 |
15,464 |
15,949 |
15,000 |
Cash and equivalents at beginning of period |
17,644 |
13,437 |
17,510 |
11,990 |
Increase/(decrease) in cash and equivalents |
(4,176) |
4,040 |
(5,520) |
(11,449) |
Effect of FX on cash and equivalents |
(32) |
33 |
0 |
0 |
Cash and equivalents at end of period |
13,437 |
17,510 |
11,990 |
541 |
Net (debt)/cash |
13,437 |
17,510 |
11,990 |
(14,459) |
Source: Company reports, Edison Investment Research
|
|
Research: Healthcare
Creo Medical’s FY23 results recapped strategic, regulatory and operational wins for its core electrosurgical device suite, including Speedboat’s approval for upper gastrointestinal (GI) procedures in Europe and launch of Speedboat UltraSlim. With MicroBlate and SpydrBlade nearing commercial launch and increased traction with partners Intuitive Surgical and CMR Surgical, we anticipate the product uptake curve to steepen in the medium term. FY23 was a solid year with 13.4% y-o-y revenue growth and Creo’s core portfolio more than doubled to £2.3m, with a c 120% increase of its user base. Q124 core revenues were c 14% higher compared to the FY23 quarterly average. Cost optimisation drove the narrowing of operating losses to £16.4m (FY22: £20.8m) and we continue to project topline growth and current cash at hand (gross cash of £17.4m at end-Q124) to support break-even in H126, slightly more conservative than management’s FY25 target. With minor adjustments to our estimates and rolling our model forward, we value Creo at £506m or 140p/share.