NEXICART-2 updates could be key catalysts

NEXICART-2 remains a priority, aiming to build on the previous positive results from the Israel-based NEXICART-1 trial. The most recent update showed that the first four patients had normalized disease markers within 30 days of treatment. Two patients showed complete responses while the other two were classified as measurable residual disease (MRD) negative. The next NEXICART-2 update, including data from additional patients at the higher of the two doses being tested, is expected in mid-2025, potentially representing an important catalyst. Following the recent RMAT designation, alongside receipt of orphan drug designation (ODD) from the FDA and EMA, we believe Immix is well positioned to progress NXC-201 through the clinic. NEXICART-2 is due to conclude from mid-2026, after which management plans to submit the regulatory package to the FDA for accelerated approval by the end of 2026.

Cash runway: Funded into Q425

Immix remains debt free and closed FY24 with net cash of $17.7m. This was supported by $15.5m in net proceeds from the Q124 equity raise and the receipt of $1.9m in grants from the California Institute for Regenerative Medicine (CIRM) in Q424. We expect the cash on hand and the remaining $6.1m in grant income (of which $1.6m has been received to date in FY25) to support operations into Q425, well past the interim readouts for NXC-201.

Valuation: $126.3m or $4.6 per share

We recently provided updated forecasts in our outlook note on Immix. For now, all our underlying assumptions are unchanged following the FY24 results. The minor benefits to the implied enterprise value from rolling our model forward are offset by a slightly lower net cash position, leaving our valuation broadly unchanged at $126.3m or $4.6 per share (from $125.8m or $4.6/share previously).

Patient-prioritized approach to CAR-Ts with an autoimmune focus

Immix’s pipeline is focused on its B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor T-cell therapy (CAR-T), NXC-201, in relapsed/refractory (r/r) amyloid light chain amyloidosis (ALA; Exhibit 1). To our knowledge, this is the only CAR-T therapy in clinical development for the indication and, taking into account its favorable safety profile to date (zero neurotoxicity reported in ALA patients; only manageable and short-duration cases of cytokine release syndrome reported), we believe it could translate into a sizable opportunity, with the potential to be more accessible compared to currently available CAR-Ts.

ALA is caused by the mutation of plasma cells in the bone marrow, which produce nonfunctional immunoglobulins that misfold to form amyloid light chains. These amyloid light chains then aggregate into amyloid fibrils that subsequently get deposited into organs, causing progressive organ dysfunction. As ALA is a rare disease (c 33,000 estimated cases in the US; annual incidence of c 4,000 cases), Immix has been granted ODD for NXC-201 in ALA by both the FDA and EMA. Key benefits of ODD include extended years of market exclusivity post approval (seven years in the US market; 10 years in the EU market), reduced development/regulatory fees and additional interaction with and support from the regulators. In January 2025, NXC-201 was also granted RMAT designation by the FDA, which may streamline the clinical development and subsequent approval process, offering many other operational and regulatory benefits such as regular consultations with the FDA through the development phases, flexibility in clinical trial designs and the potential for accelerated approval and priority review.

Beyond NXC-201 in r/r ALA, Immix’s management plans to report further clinical data to support the CAR-T’s application in other selected autoimmune indications from Q425, which may represent an inflection point for the company. If the data are supportive, it may open up avenues for additional clinical programs, with the potential to bolster the value proposition for the candidate and the company.

NEXICART-2 recap

The US-based NEXICART-2 trial (NCT06097832) is an open-label, single-arm, multi-site, dose escalation/expansion Phase Ib/II study to evaluate the safety and efficacy of NXC-201 in r/r ALA. The trial has been designed to assess two doses: 150m CAR-T cells and 450m CAR-T cells. We note that efficacy is being measured according to hematological response (in line with consensus recommendations in ALA). The study aims to recruit 40 r/r ALA patients, the majority of whom are intended to be enrolled in the Phase II portion. Eligibility criteria for NEXICART-2 include:

• Patients must have adequate cardiac function (patients with Mayo Stage IIIb ALA or New York Heart Association (NYHA) class III or IV heart failure may not be included).
• Patients must not have been treated with prior BCMA-targeted treatments.
• Patients must not have concomitant multiple myeloma.

NEXICART-2 differs from the preceding Israel-based NEXICART-1 trial, which did include patients with pre-existing severe cardiac involvement, those with prior BCMA-targeting therapy exposure and those with concomitant multiple myeloma. Furthermore, NEXICART-1 tested three doses of NXC-201: 150m CAR-T cells, 450m CAR-T cells and 800m CAR-T cells. Patient dosing for NEXICART-2 commenced in July 2024 and, following the successful six-patient safety run-in, based at the Memorial Sloan Kettering Cancer Center, Immix announced in January 2025 that it would be accelerating enrolment in the trial.

The latest from the clinic

The most recent clinical update from the NEXICART-2 trial was in December 2024, when Immix presented data from the first four patients involved in the study. The first three received NXC-201 at a dose of 150m cells, while the fourth received the 450m cell dose. These four patients had had a median of four prior lines of treatment (range: two to six), and two of the patients had received a prior autologous stem-cell transplant. In line with the NEXICART-2 protocol, disease markers were measured at enrolment: difference in free light chains (dFLC) was used for three of the patients, while M-spike was used for one who did not have elevated dFLC at enrolment. At the 14 November 2024 data cut-off, the median follow-up was 85 days (range: 29–141) and, at this stage, all patients showed normalized disease markers within 30 days of NXC-201 treatment. In addition, two patients were found to be in complete remission, with the other two patients classified as being MRD negative (no diseased cells were found on testing or verifying a million bone marrow cells). For the disease marker measures, significant reductions to <1mg/dL were observed for the three patients based on dFLC measures, and the patient measured by M-spike concentration showed a full resolution (Exhibit 2).

Furthermore, regarding the initial cardiac outcomes from this dataset, one of the patients improved their NYHA class from class II to class I within the first 14 days following treatment with NXC-201 (Exhibit 3).

In terms of safety, NXC-201 showed a favorable profile given the nature of CAR-T therapy treatment, in line with the previous NEXICART-1 trial. There were no reported cases of immune effector cell-associated neurotoxicity syndrome, an encouraging sign with potential to address some key limitations of currently available CAR-Ts. In terms of cytokine release syndrome (CRS), while two patients (both on the 150m dose) showed no CRS, only low-grade CRS was observed in the other two patients (one of which was grade 1 and the other was grade 2). Both of these were associated with an onset at day three and had a duration of less than 24 hours, which is generally considered manageable in this field. Hematologic adverse events included neutropenia (low neutrophil count) in the four patients (three of which were grade 3, one of which was grade 4), which is another common side effect of CAR-T therapy treatment. Importantly, there have been no cases of febrile neutropenia, treatment-related infections or cardiac toxicity, and no patient deaths.

We believe the latest clinical update represented a positive start to the NEXICART-2 trial. However, we acknowledge that it corresponded to a small patient population and additional data will be required to confirm and validate these initial findings. The next clinical data readout for NEXICART-2 is anticipated in mid-2025 and could represent an important catalyst for investor attention if the encouraging trend continues as more patients are dosed at 450m cells. Final top-line clinical data are expected from mid-2026, after which management has communicated that it intends to target an accelerated approval from the FDA within the same year.

For an in-depth overview, including a more detailed discussion of the CAR-T therapy treatment landscape, we direct readers to our recently published outlook note.

Financials

Immix reported operating expenses of $5.0m in Q424, down 7.2% y-o-y (Q423: $5.4m) and 32.6% q-o-q (Q324: $7.4m), although we note that this decline was primarily attributed to the $1.9m in grant income received from CIRM in November 2024. Adjusting for this, Q424 operating expenses would have risen by 28.6%. Underlying R&D expenses for the quarter were $3.3m, up 6.4% y-o-y, reflecting the increasing clinical activity related to the NEXICART-2 trial in the US. As noted above, this was offset by the $1.9m grant income from CIRM. This translated to net R&D expenses of $1.4m in Q424. SG&A expenses during the quarter were recorded at $3.6m, the highest quarterly figure to date, and up 58.8% from Q423 and 22.5% from Q324.

For the full year, Immix reported an operating loss of $22.7m (+40.5% y-o-y) driven by substantial increases in both R&D and SG&A expenses, attributed to the commencement of the US-focused study. This was broadly in line with our estimate of $23.6m in operating losses for FY24. We believe that the difference was due to our assumption regarding the CIRM grant in Q424 (we had reflected $1m in our model, versus the $1.9m received). SG&A expenses for the full year increased materially to $11.4m (up 53.7% y-o-y) and were primarily attributed to increased fees related to investor relations and professional services on price increases and scope expansion ($1.8m), higher compensation related to additional hiring (+$1.0m), stock-based compensation (+$450k) and other general expenses (+$675m). R&D expenses (adjusted for the CIRM grant) grew 51.3% y-o-y to $13.2m ($8.7m in FY23) and were related to contract research organization and other costs associated with the ongoing NEXICART-2, including site onboarding costs and licence fees (new sites opened in August 2024 in Cleveland Clinic, UC Davis and Sutter Health, in addition to the lead site at Memorial Sloan Kettering Cancer Center).

We recently presented our updated forecasts in an outlook note, and make only limited adjustments to our estimates based on the FY24 results. For FY25, we now include CIRM grant income of $6.1m (versus $7m previously), which remains pending following the receipt of $1.9m in Q424. We continue to assume underlying R&D expenses of $18m, but now reflect the grant income as an offset, rather than accounting for the receipts as income in our last update. This results in an FY25 net R&D estimate of $11.9m. We note that Immix has received another $1.7m grant from CIRM as of 11 March 2025 ($3.6m combined) and, although the remaining $4.4m will be contingent on certain predetermined milestones, for modelling purposes, we assume that the entire pending proceeds will be received in FY25. For SG&A, we increase our FY25 projection to $12.0m (versus $10.1m previously) to reflect the FY24 run rate. Overall, we now estimate an operating loss of $23.9m in FY25 (versus $21.1m previously). We also introduce FY26 forecasts, projecting an operating loss of $27.5m.

Immix ended FY24 with a net cash balance of $17.7m, supported by the $15.5m (net proceeds) equity raise in Q124 and $1.9m grant income from CIRM. Based on our projected cash burn rates and assuming all remaining proceeds from the CIRM grant will be received in FY25, we continue to see the company as funded into Q425. However, we note that this is more conservative than management’s guidance of a cash runway through Q126. We forecast that Immix will need to raise $5m in Q425 and another $25m in 2026, before signing a partnership deal for NXC-201 in 2027. Should a licensing deal not materialize, we estimate that the company would be required to raise another $15m in 2027, before turning cash flow positive in FY28 following the potential launch of NXC-201 in ALA. Our model reflects these capital raises as illustrative debt. Should the funds (a total of $45m across FY25–27) be raised through an equity issuance, Immix would need to issue 28.5m shares, which (at the last closing price of $1.58) would decrease our per-share valuation to $3.0/share from $4.6/share currently. The number of shares outstanding would increase to 52.0m from 27.5m currently.

Valuation

Following the FY24 results, our underlying assumptions remain unchanged, following the detailed review in our recent outlook note. We direct readers to our previous note for further details of our estimates and assumptions.

The minor benefits to the implied enterprise value from rolling our model forward have been offset by a slightly lower net cash position, leaving our valuation broadly unchanged at $126.3m or $4.6 per share (from $125.8m or $4.6/share previously).