What changed in this filing

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Item 1. Business

2026-03-25 compared with 2025-03-25 · 461 added, 532 removed, 606 unchanged (62% of the section changed)

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is a clinical-stage biopharmaceutical company focused on the application of chimeric antigen receptor cell therapy (“CAR-T”)

in light chain (AL) Amyloidosis and select immune-mediated diseases.

Our lead cell therapy candidate is FDA investigational new drug

(“IND”) cleared CAR-T NXC-201 (“NXC-201”), currently being evaluated in our ongoing United States Phase 1b/2

NEXICART-2 (NCT06097832) clinical trial and our ex-U.S.

phase 1b/2a NEXICART-1 (NCT04720313) clinical trial.

has been awarded Orphan Drug Designation (“ODD”) by both the FDA and European Commission (“EMA”) in AL Amyloidosis.

in light chain (AL) Amyloidosis and other serious diseases.

Our lead cell therapy candidate is CAR-T NXC-201 (“NXC-201”),

currently being evaluated in our ongoing United States Phase 1b/2 NEXICART-2 (NCT06097832) clinical trial and an ex-U.S.

NEXICART-1 (NCT04720313) clinical trial.

NEXICART-2 is expected to enroll 40 patients, with final readout and Biologics License Application

(“BLA”) submission planned thereafter.

has been awarded Regenerative Medicine Advanced Therapy (“RMAT”) Designation by the FDA, Orphan Drug Designation (“ODD”)

by both the FDA and European Commission (“EC”) in AL Amyloidosis and, most recently, in January 2026, Breakthrough Therapy

designation by the FDA for the treatment of relapsed/refractory AL amyloidosis.

mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures in

select immune-mediated diseases and other indications, as we believe patients are waiting.

AL Amyloidosis and other serious diseases, as we believe patients are waiting.

strategy is to:

our lead candidate NXC-201 in AL Amyloidosis and select immune-medicated diseases;

development of NXC-201 and additional cell therapy candidates in other applicable indications where CAR-T is not an approved therapy

N-GENIUS platform (discussed below) has produced our clinical-stage lead candidate NXC-201, a next-generation CAR-T for AL Amyloidosis

and select immune-mediated diseases.

ImmixBio Pipeline

is in clinical trials to treat relapsed/refractory AL Amyloidosis.

Develop our lead candidate

NXC-201 in AL Amyloidosis and other serious diseases;

Pursue development of NXC-201

and additional cell therapy candidates in other applicable indications where CAR-T is not an approved therapy today.

N-GENIUS platform (discussed below) has produced our clinical-stage lead candidate NXC-201, a next-generation CAR-T being designed to

treat AL Amyloidosis and other serious diseases.

Immix Pipeline

Clinical Trial Update

December 2025, we announced positive interim phase 2 safety and efficacy data from our Phase1/2 NEXICART-2 clinical trial, the first

trial of CAR-T in relapsed/refractory light chain (AL) amyloidosis, evaluating NXC-201.

The results were as of November 13, 2025

and were presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center in an oral presentation at the American Society of

Hematology’s ASH 2025 Annual Meeting.

Prior to NXC-201 treatment, all patients were exposed to an anti-CD38 antibody and a proteasome

Median prior lines of therapy were four (range:

All patients had baseline relapsed/refractory AL Amyloidosis organ

NXC-201 treatment, complete responses (“CRs”) were observed in 75% (at s/u IFE(-) level) (15 out of 20) patients as determined

by an independent review committee.

In four out of five pending patients, minimum residual disease (MRD) negativity in bone marrow suggests

a future complete response may be expected.

Downstream clinical improvement, including organ responses, were observed in 70% of evaluable

patients (7/10).

No neurotoxicity has been observed.

Grade 2 cytokine release syndrome was observed in four patients, Grade 1 cytokine

release syndrome was observed in 11 patients, with a median duration of one day.

December 7, 2025, we entered into an underwriting agreement (the “2025 Underwriting Agreement”) with Morgan Stanley &

LLC (“Morgan Stanley”), as representative of the several underwriters named in Schedule 1 thereto, relating to the issuance

and sale (the “2025 Offering”) of 19,117,646 shares (the “Shares”) of our common stock, and pre-funded warrants

to purchase up to 490,196 shares of our common stock (the “Pre-Funded Warrants”).

The Shares were sold at a price of $5.10

per share and the Pre-Funded Warrants were sold at a price of $5.09 per Pre-Funded Warrant, which represents the per share offering price

for the Shares minus the $0.01 per share exercise price for each Pre-Funded Warrant.

We raised gross proceeds of approximately $100.0

million in this offering.

2025 Securities Purchase Agreements

September 5, 2025 and September 11, 2025, we entered into Securities Purchase Agreements (the “September 2025 Securities Purchase

Agreements”) and Registration Rights Agreements with certain accredited investors (the “Purchasers”), pursuant to which

we sold to the Purchasers in a private placement transaction (the “Private Placement”) (i) an aggregate of 3,915,604 shares

of common stock and (ii) non-transferable warrants to purchase up to an aggregate of 2,936,709 shares of common stock (the “Warrants”).

The combined purchase price per share and Warrant was $2.37.

The Private Placement closed on September 5, 2025 and September 11, 2025

and aggregate gross proceeds from both closings were approximately $9.3 million, before deducting fees and expenses payable by us.

Warrants are exercisable over a ten-year period at an exercise price of $2.00 per share, subject to proportional adjustments in the event

of stock splits or combinations or similar events.

The Warrants are not transferable other than to affiliates of the Purchasers, and

are exercisable only for cash consideration.

Pursuant to the terms of the Registration Rights Agreements, we filed a resale registration

statement with the SEC on October 6, 2025 providing for the resale of the shares of common stock and the shares of common stock issuable

upon exercise of the Warrants by the Purchasers, which was declared effective by the SEC on December 1, 2025.

Pursuant to the terms of

the September 2025 Securities Purchase Agreements, effective September 8, 2025, our board of directors (the “Board”) appointed

Nancy Chang, Ph.D.

as a member of the Board.

is in a Phase 1b/2 clinical trial to treat relapsed/refractory AL Amyloidosis.

In June 2024, we began administering NXC-201 to patients

with relapsed/ refractory AL Amyloidosis in our open label, single arm, multi-site Phase 1b/2 clinical trial.

NEXICART-2 is expected

to enroll 40 patients, with final readout and BLA submission planned thereafter.

See “Recent Developments- Clinical

Update- NEXICART-2” above for information regarding trial results as of November 13, 2025.

amyloidosis is a life-threatening immunological disorder in which an abnormal protein called amyloid builds up in tissues and organs.

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Untreated patients with AL amyloidosis and cardiac involvement have a median survival

of less than 1 year, according to Quock, et al.

of less than one year, according to Quock, et al.

Journal of Comparative Effective Research, 2023.

The current market size for amyloidosis

therapies is estimated at $3.6 billion, expected to reach $6 billion in 2027, according to Grand View Research.

of March 11, 2025, we have disclosed treatment of 6 relapsed/refractory AL Amyloidosis patients in the United States in our ongoing Phase

1b/2 multi-site NEXICART-2 (NCT06097832) U.S.

clinical trial.

Memorial Sloan Kettering Cancer Center is the lead NEXICART-2 clinical

of March 11, 2025, we have disclosed treatment of 16 relapsed/refractory AL Amyloidosis patients in our ongoing Phase 1b/2a NEXICART-1

(NCT04720313) ex-U.S.

clinical trial.

global amyloidosis treatment market size was estimated at $5.80 billion in 2024 and is projected to reach $11.13 billion by 2033, growing

at a CAGR of 7.5% from 2025 to 2033, according to Grand View Research.

of March 2026, our ongoing Phase 1/2 multi-site NEXICART-2 (NCT06097832) U.S.

clinical trial is ongoing.

Memorial Sloan Kettering Cancer

Center is the lead NEXICART-2 clinical site.

September 2023, the FDA granted ODD to NXC-201 for the treatment of AL Amyloidosis.

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first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusive approval (or exclusivity),

which means that the FDA may not approve any other applications to market the same drug for the same indication for 7 years (except in

limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity).

November 2023, the FDA cleared an IND application for NXC-201 to enroll U.S.

patients into NXC-201 clinical trials.

which means that the FDA may not approve any other applications to market the same drug for the same indication for seven years (except

in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity).

November 2023, the FDA cleared an investigational new drug (“IND”) application for NXC-201 to enroll U.S.

patients into NXC-201

clinical trials.

December 2023, NXC-201 clinical data in relapsed/refractory AL Amyloidosis was presented in an oral presentation at the 65 th

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NXC-201, indicating an overall response rate of 100% (10/10) and a complete response rate of 70% (7/10).

February 2024, the European Commission (“EC”) granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis.

February 2024, the EC granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis.

Benefits of European ODD include:

10 years of market exclusivity once authorized in the EU;

Access to the EU centralized authorization

and reduced fees for EU protocol assistance, marketing authorization applications, inspections before authorization, applications

for changes to marketing authorizations made after approval, and reduced annual fees.

Access to the EU centralized authorization procedure;

and reduced fees for

EU protocol assistance, marketing authorization applications, inspections before authorization, applications for changes to marketing

authorizations made after approval, and reduced annual fees.

July 2024, we were awarded an $8 million grant from the California Institute for Regenerative Medicine (“CIRM”) to support

the clinical development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

December 2024, NXC-201 clinical data in relapsed/refractory AL Amyloidosis was presented in an oral presentation at the 66 th

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of 94% (15/16) and a complete response rate of 75% (12/16).

February 2025, the FDA granted Regenerative Medicine Advanced Therapy (“RMAT”) designation to sterically-optimized CAR-T

NXC-201 for the treatment of relapsed/refractory AL amyloidosis.

RMAT designation potentially streamlines the path to FDA approval by

allowing frequent interactions with FDA and routes to FDA Accelerated Approval and Priority Review.

As of June 2024 public information,

FDA approved less than half of RMAT applications submitted to the agency during the last eight years.

FDA RMAT designation requires that

a drug is an advanced regenerative medicine, targets a serious condition, with the potential to treat, modify, reverse, or cure, and

preliminary clinical evidence has indicated that the drug has the potential to address these unmet medical needs.

June 2025, NXC-201 clinical data in relapsed/refractory AL Amyloidosis was presented in an oral presentation at the 2025 American Society

of Clinical Oncology Annual Meeting (ASCO 2025), covering 10 relapsed/refractory AL Amyloidosis patients treated with NXC-201.

NXC-201 treatment, all patients normalized pathological disease markers As of the ASCO data cutoff, complete responses (CRs) were observed

in 70% (7 out of 10) of patients treated with NXC-201.

The remaining three patients were bone marrow minimum residual disease (MRD) negative

(10-6) at D+25, predicting future CR.

These patients were confirmed as CRs by Independent Review Committee following data cutoff.

clinical improvement, including cardiac and renal organ responses, were recorded.

There have been no relapses recorded and no safety

signals identified as of the date of this report.

Also, as of the date of this report, no neurotoxicity has been observed and only low-grade

cytokine release syndrome has been observed.

July 2025, we expanded the number of clinical trial sites to 18 in our relapsed/refractory AL Amyloidosis clinical trial NEXICART-2 with

a registrational design.

December 2025, we announced positive interim phase 2 NXC-201 results in an oral presentation at the American Society of Hematology’s

ASH 2025 Annual Meeting, presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center.

NXC-201 demonstrated a complete

response (CR) rate of 75% (at s/u IFE(-) level) (15/20) by independent review committee.

January 2026, the FDA granted Breakthrough Therapy designation to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory

AL amyloidosis.

Per FDA, Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat

a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available

therapy on a clinically significant endpoint.

Other Programs

other programs include NXC-201 for select immune-mediated diseases, a $25 billion combined annual market size according to Grand View

Research and Fortune Business Insights and other preclinical candidates.

inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development,

organizing and staffing our Company, business planning and raising capital.

We operate as one business segment and have incurred recurring

losses, the majority of which are attributable to research and development activities and negative cash flows from operations.

funded our operations primarily through the sale of equity securities and grant proceeds.

Currently, our primary use of cash is to fund

operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative

expenditures.

We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance our product

candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval.

In addition, if we obtain

regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing,

marketing, sales and distribution.

Furthermore, we incur costs associated with operating as a public company, including significant legal,

accounting, investor relations and other expenses.

Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year,

depending on the timing of our clinical trials and our expenses on other research and development activities.

other programs include NXC-201 for treatment of select other serious diseases and other preclinical candidates.

Platform and Technologies

believe our N-GENIUS platform has broad potential utility in hematologic and select immune-mediated diseases.

believe our N-GENIUS platform has broad potential utility in hematologic, neurologic, rheumatologic, vascular and other serious diseases.

in-licensed N-GENIUS platform, which has produced NXC-201, consists of three key elements:

(1) Purpose-Built Cell Therapy Evidence Capture

Engine + Relational Database, which relates ImmixBio internal data to external to accelerate therapy design, manufacture, and preclinical;

Engine + Relational Database, which relates Immix internal data to external to accelerate therapy design, manufacture, and preclinical;

(2) proprietary EXPAND technology, which is applied to multiple cell therapy indications, already utilized to create NXC-201;

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may apply to other products candidates produced by the N-GENIUS Platform.

Those 3 key characteristics are:

(a) high transduction efficiency

(supporting efficient manufacturing), (b) low tonic signaling (lower off-target toxicity may lead to lower toxicity), and (c) anti-exhaustion

capability (increased persistence may lead to activity over an extended period of time).

Those three key characteristics are:

(a) high transduction

efficiency (supporting efficient manufacturing), (b) low tonic signaling (lower off-target toxicity may lead to lower toxicity), and

Lead Program:

NXC-201 in relapsed/refractory AL Amyloidosis

first indication we intend to pursue for NXC-201 is relapsed/refractory AL Amyloidosis.

first indication we are pursuing for NXC-201 is relapsed/refractory AL Amyloidosis.

amyloidosis is a life-threatening immunological disorder in which an abnormal protein called amyloid builds up in tissues and organs.

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estimated to reach 38,500 patients in 2026.

AL amyloidosis has a one-year mortality rate of 47 percent, 76 percent of which is caused

by cardiac amyloidosis, according to Alexion.

The current market size for amyloidosis therapies is $3.6 billion, expected to reach $6

billion in 2027, according to Grand View Research.

AL amyloidosis has a one-year mortality rate of 47%, 76% of which is caused by cardiac amyloidosis,

according to Alexion.

The global amyloidosis treatment market size was estimated at $5.80 billion in 2024 and is projected to reach $11.13

billion by 2033, growing at a CAGR of 7.5% from 2025 to 2033, according to Grand View Research.

of March 2026, there are no FDA approved drugs for relapsed/refractory AL Amyloidosis.

NXC-201 “Blue Ocean Opportunity” in AL Amyloidosis

NXC-201 Addresses Sizable U.S.

Relapsed/Refractory AL Amyloidosis Patient Population

Composition and Mechanism of Action

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First CAR-T Generated by the N-GENIUS Platform

3 key characteristics of NXC-201 are:

three key characteristics of NXC-201 are:

(a) high transduction efficiency (supporting efficient manufacturing), (b) low tonic signaling

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Key Characteristics

has been designed with a proprietary, optimized C3ζγ for enhanced signal transduction, proprietary, optimized modified-stiffness

has been designed with a proprietary, optimized CD3ζγ for enhanced signal transduction, proprietary, optimized modified-stiffness

CD8 hinge, and proprietary, optimized COBRA binder for enhanced signal binding.

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the potential to allow for NXC-201 to deliver “digital” intracellular signaling, potentially eliminating neurotoxicity and

reducing CRS duration to 1 day.

minimizing cytokine release syndrome (“CRS”) duration.

N-GENIUS Platform – EXPAND Technology + COBRA Binder

was designed for high activity against disease-causing AL Amyloidosis LLPCs, which are also the source of immune-mediated diseases antibodies

in a variety of immune-mediated diseases.

Pre-clinical Data

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demonstrated high activity in the presence of AL Amyloidosis diseased plasma cells.

NXC-201 Targets Diseased AL Amyloidosis LLPCs in Patient Bone Marrow

NXC-201 Targets Diseased AL Amyloidosis LLPCs in One Patient’s Bone Marrow After 33 Days

Clinical Cancer Research, Kfir-Erenfeld,et al, 2022

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elimination of diseased AL Amyloidosis LLPCs was observed in relapsed/refractory AL Amyloidosis patients treated with NXC-201.

Clinical Data – Relapsed/refractory AL Amyloidosis

December 2024, NXC-201 clinical data in relapsed/refractory AL Amyloidosis was presented in an oral presentation at the 66 th

annual ASH meeting, covering 16 relapsed/refractory AL Amyloidosis patients treated with NXC-201.

This data represents the largest cohort

of AL patients treated with CAR T-based therapy reported in the literature thus far.

AL amyloidosis patients presented with organ involvement and were heavily pretreated with prior lines of therapy (median 4, range 3-10).

All patients had refractory, progressive disease.

No patients received bridging therapy.

characteristics:

(13/16) had cardiac involvement;

(6/16) had New York Heart Association (“NYHA”) stage 3 or 4 heart failure (3 stage 4, 3 stage 3);

(5/16) had Mayo stage 3 (1 stage 3b, 4 stage 3a) AL amyloidosis disease;

Relapsed/refractory

to a median 4 lines of prior therapy (range:

response rate of 94% (15/16);

response rate of 75% (12/16);

responder had a duration of response of 31.5 months as of December 9, 2024, with response ongoing;

were no immune effector cell-associated neurotoxicity syndrome (ICANS) events;

CRS duration was 2 days (range:

grade 4 CRS events;

experienced no CRS;

3 experienced grade 1 CRS;

8 Experienced grade 2 CRS;

and 3 experienced grade 3 CRS

Vitro Studies

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demonstrated by upregulation of the 4-1BB cell marker and increased secreted levels of inflammatory cytokines (interferon gamma:

tumour necrosis factor alpha:

tumor necrosis factor alpha:

TFNα), which was not seen in NT cells.

Furthermore, non-tumour bone marrow derived mononuclear cells

Furthermore, non-tumor bone marrow derived mononuclear cells

were not affected by co-culture with NXC-201, demonstrating the targeted effect of this therapy.

Development Strategy

our lead program, NXC-201 for relapsed/refractory AL Amyloidosis, we plan to enroll 40 patients in our open label, single-arm clinical

trial, and then submit a biologics license application (“BLA”) for FDA approval.

NXC-201 Clinical Development Plan Through FDA BLA Submissions

our lead program, NXC-201 for relapsed/refractory AL Amyloidosis, we are treating patients with relapsed/refractory AL Amyloidosis in

the Phase 2 portion of our Phase1/2 open label, single-arm clinical trial.

NEXICART-2 is expected to enroll 40 patients, and we plan

for a final data readout and, if positive, submission of a BLA for FDA approval thereafter.

See “Recent Developments- Clinical

Update- NEXICART-2” above for information regarding trial results as of November 13, 2025.

primary objectives in relapsed/refractory AL Amyloidosis are to study the safety and efficacy of NXC-201.

The efficacy endpoints are

to evaluate response rates according to consensus recommendations for AL amyloidosis treatment response criteria in AL (Palladini et

expected primary endpoints are complete response rate and overall response rate in our NXC-201 relapsed/refractory AL Amyloidosis clinical

primary endpoints in the NEXICART-2 trial are complete response rate and overall response rate in our NXC-201 relapsed/refractory AL

Amyloidosis clinical trial.

strategy is to pursue orphan drug indications in which open-label, single-arm clinical trials may lead to possible BLA submissions, or

indications with large populations with remaining unmet medical need.

Other Programs

are also pursuing development of NXC-201 in immune-mediated diseases, a $25 billion combined annual market size according to Grand View

Research and Fortune Business Insights.

Manufacturing

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and testing in the U.S.

In addition, we have already developed a scalable, reliable manufacturing process for our TSTx according

In addition, we have already developed a scalable, reliable manufacturing process for NXC-201 according

to current Good Manufacturing Practice (“cGMP”).

will continue to leverage our established technical, manufacturing, analytical, quality, cGMP, project management expertise and existing

relationships to contract with appropriate CMOs to manufacture our cell therapies and TSTx moving forward.

January 2024, the Company entered into a long-term operating lease agreement for biopharmaceutical research and development space located

in California.

To date, we have obtained active pharmaceutical ingredients (“API”) and drug product for our product candidates

from several third party contract manufacturers.

We are in the process of developing our supply chain for each of our product candidates

and have entered into agreements pursuant to which third-party contract manufacturers will provide us with necessary quantities of API

and drug product on a project-by-project basis based upon our needs.

We rely, and expect to continue to rely for the foreseeable future,

on FDA, EMA, or other jurisdiction-registered third-party contract manufacturing organizations to produce our product candidates for

pre-clinical and clinical testing, as well as for commercial manufacture if our product candidates receive marketing approval.

of the manufacture and design process for our product candidates, we rely on internal, scientific and manufacturing know-how and trade

secrets and the know-how and trade secrets of third-party manufacturers.

We also contract with additional third parties for the filling,

labeling, packaging, storage and distribution of investigational drug products.

We believe that this strategy allows us to maintain a

more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel while

also enabling us to focus our expertise and resources on the development of our product candidates.

We maintain agreements with our manufacturers

that include confidentiality and intellectual property, and quality provisions to protect our proprietary rights related to our product

candidates and satisfy regulatory requirements.

relationships to contract with appropriate CMOs to manufacture our cell therapies and NXC-201 moving forward.

January 2024, we entered into a long-term operating lease agreement for biopharmaceutical research and development space located in California.

To date, we have obtained active pharmaceutical ingredients (“API”) and drug product for our product candidates from several

third party contract manufacturers.

We are in the process of developing our supply chain for each of our product candidates and have

entered into agreements pursuant to which third-party contract manufacturers will provide us with necessary quantities of API and drug

product on a project-by-project basis based upon our needs.

We rely, and expect to continue to rely for the foreseeable future on third-party

CMOs to produce our product candidates for pre-clinical and clinical testing, as well as for commercial manufacture if our product candidates

receive marketing approval.

As part of the manufacture and design process for our product candidates, we rely on internal, scientific

and manufacturing know-how and trade secrets and the know-how and trade secrets of third-party manufacturers.

We will also contract with

additional third parties for the filling, labeling, packaging, storage and distribution of investigational drug products.

that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing

facilities, equipment and personnel while also enabling us to focus our expertise and resources on the development of our product candidates.

We maintain agreements with our manufacturers that include confidentiality and intellectual property, and quality provisions to protect

our proprietary rights related to our product candidates and satisfy regulatory requirements.

biotechnology industry is extremely competitive in the race to develop new products.

We currently face and will continue to face competition

for our development programs from groups that are developing therapies for oncology and inflammation.

The competition is likely to come

from multiple sources, including larger pharmaceutical companies, biotechnology companies, and academic institutions.

which have publicly disclosed developing therapies for AL amyloidosis include, but are not limited to, Prothena Corp, Caelum Biosciences

(Now Alexion/AstraZeneca), and Janssen/Johnson & Johnson.

which have publicly disclosed developing or that they intend to develop cell therapies for immune-mediated disease indications include,

but are not limited to:

Kyverna Therapeutics, Inc.;

Cabaletta Bio, Inc.;

Fate Therapeutics Inc.;

and Arcellx, Inc.

Our competitors include major multi-national pharmaceutical

companies and biotechnology companies developing both generic and proprietary therapies to treat serious diseases.

Many of these companies

are well-established and possess technical, human, research and development, financial, and sales and marketing resources significantly

greater than ours.

In addition, many of our potential competitors have formed strategic collaborations, partnerships and other types

of joint ventures with larger, well established industry competitors that afford these companies potential research and development and

commercialization advantages in the therapeutic areas we are currently pursuing.

Academic research centers, governmental agencies and

other public and private research organizations are also conducting and financing research activities which may produce products directly

competitive to those being developed by us.

In addition, many of these competitors may be able to obtain patent protection, obtain FDA

and other regulatory approvals and begin commercial sales of their products before us.

currently face and will continue to face competition for our development programs from groups that are developing therapies for oncology

and inflammation.

Companies which have publicly disclosed developing therapies for AL amyloidosis include, but are not limited to, Abbvie,

Caelum Biosciences (n/k/a Alexion/AstraZeneca), and Janssen/Johnson & Johnson.

success depends in part on our ability to obtain and maintain proprietary protection for our product candidates, technology and know-how,

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have substantial know-how and trade secrets relating to our technology and product candidates.

As of March 11, 2025, our patent portfolio includes 12 U.S.

and foreign granted patents, 16 pending U.S.

and foreign patent applications

related to our technology platform and our product candidates.

Of those, 2 patents have been granted in the U.S.

and 10 patents have been

granted in the following countries:

France, Germany, Ireland, Switzerland, and the United Kingdom.

Three non-provisional patent applications

are currently pending in the U.S.

and 9 foreign patent applications are currently pending in Australia, Brazil, Canada, Europe, Hong Kong,

Japan and Mexico.

Certain platform patents are expected to remain in force until 2033.

Other patents directed to platform technology could

remain in force until 2042.

below patents and patent applications comprise our patent portfolio.

All of the patents and patent applications listed below are owned

Application/Patent

Expected Expiration Date

Type of Patent Protection

United States

CANCER THERAPEUTICS

Methods of treatment

United States

METHODS AND RELATED COMPOSITIONS FOR THE TREATMENT OF CANCER

Compositions and methods of treatment

United States

METHODS AND RELATED COMPOSITIONS FOR THE TREATMENT OF CANCER

Compositions and methods of treatment

MICELLE COMPRISING AN INHIBITOR OF NF-KB

Compositions and methods of treatment

42021037058.1

MICELLE COMPRISING AN INHIBITOR OF NF-KB

Compositions and methods of treatment

GLUT-1 ZIELGERICHTETE UND MIT KURKUMIN BELADENE MIZELLEN

CANCER THERAPEUTICS

United Kingdom

GLUT-1 TARGETED AND CURCUMIN LOADED MICELLES

VERFAHREN UND VERWANDTE ZUSAMMENSETZUNGEN ZUR BEHANDLUNG VON KREBS

MÉTHODES ET COMPOSITIONS ASSOCIÉES POUR LE TRAITEMENT DU CANCER

United Kingdom

METHODS AND RELATED COMPOSITIONS FOR THE TREATMENT OF CANCER

NANOPARTICLES FOR CANCER TREATMENT

Compositions and methods of treatment

11 2024 000075 3

NANOPARTICLES FOR CANCER TREATMENT

Compositions and methods of treatment

NANOPARTICLES FOR CANCER TREATMENT

Compositions and methods of treatment

NANOPARTICLES FOR CANCER TREATMENT

Compositions and methods of treatment

NANOPARTICLES FOR CANCER TREATMENT

Compositions and methods of treatment

MX/a/2024/000302

NANOPARTICLES FOR CANCER TREATMENT

Compositions and methods of treatment

United States

NANOPARTICLES FOR CANCER TREATMENT

Compositions and methods of treatment

NANOPARTICLES FOR CANCER TREATMENT

Compositions and methods of treatment

NANOPARTICLES

FOR CANCER TREATMENT

and methods of treatment

NANOPARTICLES

FOR CANCER TREATMENT

and methods of treatment

NANOPARTICLES

FOR CANCER TREATMENT

and methods of treatment

MX/a/2024/003832

NANOPARTICLES

FOR CANCER TREATMENT

and methods of treatment

NANOPARTICLES

FOR CANCER TREATMENT

and methods of treatment

Any resulting patents in this family are expected to expire in 2033 (not including any patent term adjustment and patent term extension

in the United States and equivalents in foreign countries).

Any resulting patents in this family are expected to expire in 2042 (not including any patent term adjustment and patent term extension

in the United States and equivalents in foreign countries).

Additionally,

as of March 11, 2025, our subsidiary Nexcella, Inc.

has global exclusive rights to PCT Application No.

of March 2026, we have global exclusive rights to PCT Application No.

PCT/IL2023/050142 filed in 2023.

The application is directed to our N-GENIUS platform, EXPAND technology, and to our product candidates, including NXC-201.

The application

relates to a chimeric antigen receptor (CAR) molecule specific for B cell maturation antigen (BCMA), compositions and methods thereof

for the treatment of immune-related disorders.

The application is directed to

our N-GENIUS platform, EXPAND technology, and to our product candidates, including NXC-201.

The application relates to a chimeric antigen

receptor (CAR) molecule specific for B cell maturation antigen (BCMA), compositions and methods thereof for the treatment of immune-related

The PCT application has entered the national phase in the following countries:

States, Europe, Israel, United Arab Emirates, Australia, Brazil, Canada, China, Indonesia, Japan, Korea, Mexico, New Zealand, Philippines,

and Singapore.

United States, Europe, Israel, United Arab

Emirates, Australia, Brazil, Canada, China, Hong Kong, Indonesia, Japan, Korea, Mexico, New Zealand, Philippines, and Singapore (see

the below table).

Any resulting patents in this family are expected to expire in 2043 (not including any patent term adjustment and patent

term extension in the United States and equivalents in foreign countries).

Nexcella also has global exclusive rights to a patent family

directed to the Generation of “Naïve-like” CART cells.

This patent family has one U.S.

Provisional Patent Application

pending as of March 11, 2025.

Juris-diction

Expiration Date

IL2023/050142

CAR TO TARGET IMMUNE-RELATED DISORDERS, COMPOSITIONS AND METHOD THEREOF

112024016228-1

CAR TO TARGET IMMUNE-RELATED DISORDERS, COMPOSITIONS AND METHOD THEREOF

202380032400.8

CAR TO TARGET IMMUNE-RELATED DISORDERS, COMPOSITIONS AND METHOD THEREOF

62025108680.2

CAR TO TARGET IMMUNE-RELATED DISORDERS, COMPOSITIONS AND METHOD THEREOF

MX/a/2024/009763

CAR TO TARGET IMMUNE-RELATED DISORDERS, COMPOSITIONS AND METHOD THEREOF

1-2024-551906

CAR TO TARGET IMMUNE-RELATED DISORDERS, COMPOSITIONS AND METHOD THEREOF

10-2024-7030269

CAR TO TARGET IMMUNE-RELATED DISORDERS, COMPOSITIONS AND METHOD THEREOF

Arab Emirates

CAR TO TARGET IMMUNE-RELATED DISORDERS, COMPOSITIONS AND METHOD THEREOF

IL2025/050836

NOVEL PLATFORM FOR THE GENERATION OF “NAÏVE-LIKE” CART CELLS

also have global exclusive rights to PCT Application No.

PCT/IL2025/050836 filed in 2025 (see the above table).

This application is directed

to the Generation of “Naïve-like” CART cells.

Any resulting patents in this family are expected to expire in 2045 (not

including any patent term adjustment and patent term extension in the United States and equivalents in foreign countries).

generally pursue multilayered patent protection covering the composition of matter including the formulations of the product candidates,

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claims directed to methods of making, and methods of use of the product candidates.

License Agreement with Immix Biopharma Australia Pty Ltd.

January 23, 2017, we entered into an IP License Agreement (“License Agreement”) with Immix Biopharma Australia Pty Ltd.,

our wholly-owned subsidiary (“IBAPL”), pursuant to which we granted IBAPL a non-exclusive, non-transferable license to IMX-110

intellectual property that is necessary for the purpose of, among other things, conducting or facilitating the research, development

or clinical trials relating to such intellectual property in the Commonwealth of Australia.

Pursuant to the terms of the License Agreement,

during the term of the License Agreement, IBAPL shall pay us a royalty equal to a mid single digit percentage of Net Sales (as defined

in the License Agreement), subject to adjustment as set forth in the License Agreement.

The License Agreement may be terminated by either

party (i) upon 20 days prior written notice to the other party, (ii) if the other party breaches any provision of the License Agreement

and fails to remedy such breach within 10 business days after receiving written notice of such breach or (iii) if the other party is

the subject to an insolvency event as set forth in the License Agreement.

To date, we have not received any payments pursuant to the

License Agreement.

Master Services Agreement

December 22, 2014, we entered into a Master Service Agreement (“MSA”) with AxioMx, Inc.

(“AxioMx”) which is in

the business of developing and supplying custom affinity reagents.

We entered into the MSA to serve as a master agreement governing multiple

sets of projects as may be agreed upon us and AxioMx from time to time.

Pursuant to the MSA, we granted AxioMx a non-exclusive, royalty-free,

worldwide, non-transferable license to certain of our intellectual property to perform services pursuant to the MSA, and AxioMx granted

us an exclusive product assignment option which grants us an exclusive, royalty-bearing right, with the right to sublicense, under the

Deliverable (as defined in the MSA) to further research, develop, use, sell, offer for sale, import and export one or more assigned products

pursuant to the MSA.

We exercised the option in 2017.

Pursuant to the MSA, AxioMx is entitled to royalties on the sale of any Deliverable

that is used for diagnostic, prognostic or therapeutic purposes, in humans or animals, or for microbiology testing, including food safety

testing or environmental monitoring.

Specifically, we shall pay AxioMx a royalty of 3.5% of Net Sales (as defined in the MSA) of assigned

products for each Deliverable used in licensed products for therapeutic purposes.

In addition, we shall pay AxioMx a royalty of 1.5%

of Net Sales of assigned products for each Deliverable used in licensed products for diagnostic or prognostic purposes;

provided, however,

if three Deliverables are used in an assigned product for diagnostic or prognostic purposes, the royalty shall be 4.5%.

As of December

31, 2024, the MSA has expired and the Company does not intend to extend the MSA;

however, the royalty obligations described therein survived

the termination of the MSA.

of Nexcella Subsidiary

May 20, 2024, Nexcella, was merged (the “Merger”) with and into the Company, with the Company as the surviving corporation.

The Merger was effected pursuant to Section 253 of the Delaware General Corporation Law (“DGCL”) when the Company filed a

Certificate of Ownership and Merger (“Certificate of Merger”) with the Secretary of State of the State of Delaware.

prior to the Merger, the Company owned greater than 95% of the outstanding common stock on a fully diluted basis of Nexcella, par value

$0.0001 per share (the “Nexcella Shares”), and 100% of the outstanding shares of each other class of capital stock of Nexcella.

Under the DGCL, the only approval required was that of the Company’s Board of Directors for the Merger to become effective.

a result of the Merger, Nexcella ceased to exist and all assets, operations and other property and rights of Nexcella have been succeeded

to by the Company.

Pursuant to the terms of the Certificate of Merger, as a result of the Merger, each of the outstanding Nexcella Shares

(other than Nexcella Shares held by the Company) were converted, into common stock of the Company (“Company Merger Shares”).

In connection with the Merger, the Company issued 989,876 shares of its common stock of the Company to the former stockholders of Nexcella

(other than shares held by the Company) (including Company common stock issued to third-party cash investors in Nexcella) (the “Merger

In addition, the Company issued to the former participants in the Nexcella 2022 Equity Incentive Plan, 275,759 restricted

stock awards to receive common stock in the Company and options to purchase up to 595,676 shares of Company common stock at an exercise

price of $2.47 per share (the closing price on May 17, 2024), under the Company’s Amended and Restated 2021 Omnibus Equity Incentive

Inc., our former wholly-owned subsidiary, was merged with and into the Company in May 2024.

Subsequently, a wholly-owned

subsidiary Nexcella, Inc.

was created and continues to be wholly-owned.

and License Agreement with Hadasit and BIRAD

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license fee of $50,000.

Nexcella has agreed to pay royalties to the Licensors equal to 5% of Net Sales (as defined in the Agreement)

during the Royalty Period.

“Royalty Period” means for each Licensed Product, on a country-to-country basis, the period commencing

on December 8, 2022 and ending on the later of (a) the expiration of the last to expire Valid Claim (as defined in the Agreement) under

a Licensed Patent (as defined in the Agreement), if any, in such country, (b) the date of expiration of any other Exclusivity Right (as

defined in the Agreement) or data protection period granted by a regulatory or other governmental authority with respect to a Licensed

Product or (c) 15 years from the date of First Commercial Sale (as defined in the Agreement) of a Licensed Product in such country.

addition, Nexcella is required to pay milestone payments of up to $20 million upon the achievement of certain Net Sales milestones as

set forth in the Agreement and Nexcella has committed to funding NXC-201 clinical trials in Israel over 4 years for an estimated total

cost of approximately $13 million, spread on a quarterly basis over that period, which Nexcella believes will generate clinical trial

data owned by Nexcella.

The term of the Agreement commenced on December 8, 2022 and, unless earlier terminated pursuant to the terms

thereof, will continue in full force and effect until the later of the expiration of the last Valid Claim under a Licensed Patent or

a Joint Patent (as defined in the Agreement) or Exclusivity Right covering a Licensed Product or the expiration of a continuous period

of 15 years during which there shall not have been a First Commercial Sale of any Licensed Product in any country in the world.

may terminate the Agreement immediately if Nexcella or its affiliates or sublicensees commences an action in which it challenges the

validity, enforceability or scope of any of the Licensed Patents or Joint Patents.

Upon the merger of Nexcella with and into Immix, we assumed all of Nexcella’s rights and obligations pursuant

to the Agreement.

are required to pay royalties to the Licensors equal to 5% of Net Sales (as defined in the Agreement) during the Royalty Period.

Period” means for each Licensed Product, on a country-to-country basis, the period commencing on December 8, 2022 and ending on

the later of (a) the expiration of the last to expire Valid Claim (as defined in the Agreement) under a Licensed Patent (as defined in

the Agreement), if any, in such country, (b) the date of expiration of any other Exclusivity Right (as defined in the Agreement) or data

protection period granted by a regulatory or other governmental authority with respect to a Licensed Product or (c) 15 years from the

date of First Commercial Sale (as defined in the Agreement) of a Licensed Product in such country.

addition, we are required to pay milestone payments of up to $20 million upon the achievement of certain Net Sales milestones as set

forth in the Agreement.

Pursuant to the Agreement, Nexcella committed to funding NXC-201 clinical trials in Israel for a period of four

years for an estimated total cost of approximately $13 million, spread on a quarterly basis over that period, the payment of which has

been, and will be, paid by us since the merger in May 2024.

We expect that the clinical trial data generated by the NXC-201 clinical

trials in Israel will be owned by us.

The term of the Agreement commenced on December 8, 2022 and, unless earlier terminated pursuant

to the terms thereof, will continue in full force and effect until the later of the expiration of the last Valid Claim under a Licensed

Patent or a Joint Patent (as defined in the Agreement) or Exclusivity Right covering a Licensed Product or the expiration of a continuous

period of 15 years during which there shall not have been a First Commercial Sale of any Licensed Product in any country in the world.

Licensors may terminate the Agreement immediately if we or our affiliates or sublicensees commences an action in which the validity,

enforceability or scope of any of the Licensed Patents or Joint Patents is challenged.

In addition, either party may terminate the Agreement

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Additionally, Licensors may terminate

the Agreement if Nexcella becomes insolvent or files for bankruptcy.

license remains with the Company after the Nexcella Absorption.

December 16, 2024, Nexcella entered into the First Amendment to the Research and License Agreement (the “First Amendment”)

with the Licensors.

The First Amendment includes terms specific to new licensed products and requires an additional upfront license fee

of $1,500,000, payable no later than April 30, 2025, as well as development milestone payments of up to $4.5 million upon the Company’s

achievement of certain milestones.

2023 ATM Offering

July 14, 2023, we entered into an ATM Sales Agreement (the “July 2023 Sales Agreement”) with ThinkEquity LLC (the “Sales

Agent”) pursuant to which we may offer and sell, from time to time, through the Sales Agent, shares of our common stock, subject

to the terms and conditions set forth in the July 2023 Sales Agreement.

Initially, we are eligible to sell up to $4,200,000 worth of

shares of our common stock as the aggregate market value of our shares of common stock eligible for sale under the July 2023 Sales Agreement

is subject to the limitations of General Instruction I.B.6 of Form S-3 until such time that our public float equals or exceeds $75.0

In the event the aggregate market value of our outstanding common stock held by non-affiliates equals or exceeds $75.0 million,

then the one-third limitation on sales set forth in General Instruction I.B.6 of Form S-3 will not apply to additional sales made pursuant

to the July 2023 Sales Agreement.

We agreed to pay the Sales Agent a commission rate of 3.75% of the aggregate gross proceeds from the

sale of the shares of our common stock pursuant to the July 2023 Sales Agreement and paid an expense deposit of $15,000 to the Sales

Agent, which will be applied against the actual out-of-pocket accountable expenses.

In addition, we have agreed to reimburse the Sales

Agent for all expenses related to the offering including, without limitation, the fees and expenses of the Sales Agent’s legal

counsel up to $50,000, and to reimburse the Sales Agent, upon request, for such costs, fees and expenses in an amount not to exceed $7,500

on a quarterly basis for the first three fiscal quarters of each year and $10,000 for the fiscal fourth quarter of each year.

pursuant to the July 2023 Sales Agreement will terminate upon the earlier of (i) the sale of all of the shares of common stock subject

to the July 2023 Sales Agreement and (ii) termination of the July 2023 Sales Agreement as permitted therein.

We may terminate the July

2023 Sales Agreement in our sole discretion at any time by giving ten days’ prior notice to the Sales Agent.

The Sales Agent may

terminate the July 2023 Sales Agreement under the circumstances specified in the July 2023 Sales Agreement and in its sole discretion

at any time by giving ten days’ prior notice to us.

In addition, the July 2023 Sales Agreement may be terminated upon mutual agreement

by us and the Sales Agent.

July 14, 2023 through February 5, 2024, the Company sold 328,136 shares of common stock pursuant to the July 2023 Sales Agreement for

net proceeds of $1,091,887, after offering expenses.

On February 5, 2024, the Company suspended, and is not offering any shares of its

common stock pursuant to, the prospectus supplement dated July 14, 2023, relating to the July 2023 Sales Agreement by and between the

Company and the Sales Agent.

The Company will not make any sales of common stock pursuant to the July 2023 Sales Agreement unless and

until a new prospectus supplement is filed with the SEC;

however, the Sales Agreement remains in full force and effect.

February 5, 2024, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Titan Partners Group

LLC, a division of American Capital Partners, LLC (the “Underwriter”), relating to an underwritten offering (the “Offering”)

of 5,535,055 shares of common stock of the Company.

The public offering price was $2.71 per share of common stock and the Underwriter

agreed to purchase the common stock pursuant to the Underwriting Agreement at a price of $2.5203 per share.

On February 8, 2024, the

Company closed the offering and received net proceeds of $13,565,760, after deducting underwriting discounts and commissions and estimated

offering expenses.

Pursuant to the Agreement, the Company granted the Underwriter a 30-day over-allotment option to purchase up to an

additional 783,970 shares of common stock which was exercised in full on March 1, 2024 for net proceeds of $1,954,594, after deducting

underwriting discounts and offering expenses.

July 25, 2024, the Company was awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support

the clinical development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

The award is payable to the Company upon achievement of milestones that are primarily based on patient enrollment in the Company’s

clinical trials.

Additionally, if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions

of the grant, CIRM may suspend or permanently cease disbursements.

Funds received under this grant may only be used for allowable project

costs specifically identified with the CIRM-funded project.

Such costs can include, but are not limited to, salary for personnel, itemized

supplies, consultants, and itemized clinical study costs.

Under the terms of the grant, both CIRM and the Company will co-fund the research

project and the amount of the Company’s co-funding requirement is predetermined as a part of the award.

The Company signed the

grant agreement in November 2024 and begin receiving funds from the grant in November of 2024.

As of March 11, 2025, the Company has

received $3.6 million in grant reimbursements under the grant agreement.

February 10, 2025, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to sterically-optimized CAR-T NXC-201 for

the treatment of relapsed/refractory AL amyloidosis.

As of June 2024 public information, FDA approved less than half of RMAT applications

submitted to the agency during the last eight years.

FDA RMAT designation requires that a drug is an advanced regenerative medicine,

targets a serious condition, with the potential to treat, modify, reverse, or cure, and preliminary clinical evidence has indicated that

the drug has the potential to address these unmet medical needs.

the Agreement if we become insolvent or file for bankruptcy.

December 16, 2024, our wholly-owned subsidiary, Nexcella, Inc., entered into the First Amendment to the Research and License

Agreement (the “First Amendment”) with the Licensors.

The First Amendment includes terms specific to new licensed products

and requires an additional upfront license fee of $1.5 million, which has been paid in full as of December 31, 2025, as well as development

milestone payments of up to $4.5 million upon the Company’s achievement of certain milestones.

July 25, 2024, we were awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical

development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

payable to us upon achievement of milestones that are primarily based on patient enrollment in our clinical trials.

Additionally, if

CIRM determines, in its sole discretion, that we have not complied with the terms and conditions of the grant, CIRM may suspend or permanently

cease disbursements.

Funds received under this grant may only be used for allowable project costs specifically identified with the CIRM-funded

Such costs can include, but are not limited to, salary for personnel, itemized supplies, consultants, and itemized clinical

Under the terms of the grant, both CIRM and we will co-fund the research project and the amount of our co-funding requirement

is predetermined as a part of the award.

We signed the grant agreement in November 2024 and began receiving funds from the grant in November

As of March 20, 2026, we have received $6.2 million in grant reimbursements under the grant agreement.

States Regulation of Drugs and Biologics

expect that NXC-201 will be regulated by the FDA as a biologic by submitting a BLA.

We expect to pursue United States and global regulatory

designations, vouchers, conditional approvals and accelerated approvals where appropriate.

expect that NXC-201 will be regulated by the FDA as a biologic and plan to submit a BLA to the FDA after

the final readout from our NEXICART-2 trial.

We expect to pursue United States and global regulatory designations, vouchers, conditional

approvals and accelerated approvals where appropriate.

business activities are subject to various laws, rules and regulations of the United States as well as of foreign governments.

United States, the FDA regulates pharmaceutical and biological products under the Federal Food, Drug and Cosmetic Act, Public Health

Service Act, and implementing regulations.

Products are also subject to other federal, state and local statutes and regulations.

to comply with the applicable U.S.

requirements at any time during the product development process, approval process or after approval,

may subject an applicant to administrative or judicial sanctions.

FDA sanctions could include, among other actions, refusal to approve

pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals from the market, product

seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution,

disgorgement or civil or criminal penalties.

Any agency or judicial enforcement action could have a material adverse effect on us.

FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among

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process required by the FDA before drug candidates may be marketed in the United States generally involves the following:

of pre-clinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practice

(“GLP”) regulation;

to the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually or when significant

changes are made;

by an independent institutional review board (“IRB”), or ethics committee at each clinical site before the trial is commenced;

of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug candidate for its

intended purpose;

of and submission to the FDA of an NDA or BLA after completion of all pivotal clinical trials;

completion of an FDA Advisory Committee review, if applicable;

determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;

completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced

to assess compliance with cGMP, and of selected clinical investigation sites to assess compliance with current good clinical practice

review and approval of the NDA or BLA to permit commercial marketing of the product for particular indications for use in the United

completion of pre-clinical

laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practice (“GLP”)

submission to the FDA of

an IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are

approval by an independent

institutional review board (“IRB”), or ethics committee at each clinical site before the trial is commenced;

performance of adequate

and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug candidate for its intended purpose;

preparation of and submission

to the FDA of an NDA or BLA after completion of all pivotal clinical trials;

satisfactory completion

of an FDA Advisory Committee review, if applicable;

a determination by the

FDA within 60 days of its receipt of an NDA or BLA to file the application for review;

satisfactory completion

of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess

compliance with cGMP, and of selected clinical investigation sites to assess compliance with current good clinical practice (“cGCP”);

FDA review and approval

of the NDA or BLA to permit commercial marketing of the product for particular indications for use in the United States.

and Clinical Development

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purposes of NDA or BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

1— The investigational product is initially introduced into healthy human subjects or patients with the target disease or

These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational

product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

2— The investigational product is administered to a limited patient population with a specified disease or condition to

evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.

Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical

Some trials may combine aspects of Phase 1 and Phase 2 into a single clinical trial that can examine both safety in healthy

volunteers and safety and preliminary efficacy in patients with a specific disease.

3— The investigational product is administered to an expanded patient population to further evaluate dosage, to provide

statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed

clinical trial sites.

These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product

and to provide an adequate basis for product approval.

investigational product is initially introduced into healthy human subjects or patients with the target disease or condition.

studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product

in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary

efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.

Multiple Phase 2 clinical

trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

Some trials may

combine aspects of Phase 1 and Phase 2 into a single clinical trial that can examine both safety in healthy volunteers and safety

and preliminary efficacy in patients with a specific disease.

investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant

evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.

These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate

basis for product approval.

registrational trial is a clinical trial that adequately meets regulatory agency requirements for the evaluation of a drug candidate’s

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required user fees upon submission of the first section of the NDA or BLA.

In addition, the FDA may withdraw Fast Track designation if

it believes that the designation is no longer supported by data from the clinical trials.

Fast Track designation alone does not guarantee

qualification for the FDA’s priority review procedures.

Therapy Designation

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The designation includes all of the fast track program features,

as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the

development and review of the product, including involvement of senior managers.

including being eligible for rolling review, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and

an organizational commitment to expedite the development and review of the product, including involvement of senior managers.

event, the receipt of a Breakthrough Therapy designation for a product candidate may not result in a faster development process, review

or approval compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate approval by

January 2026, the FDA granted Breakthrough Therapy designation to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory

AL amyloidosis.

product is eligible for priority review if it has the potential to provide a significant improvement in the treatment, diagnosis or prevention

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A sponsor may choose

to request RPDD, but the designation process is entirely voluntary;

requesting designation is not a prerequisite to requesting or receiving

a priority review voucher.

In addition, sponsors who choose not to submit a RPDD request may nonetheless receive a priority review voucher

if they request such a voucher in their original marketing application and meet all of the eligibility criteria.

The Rare Pediatric Disease

Priority Review Voucher Program was extended as part of the 2021 Coronavirus Response and Relief Supplemental Consolidated Appropriations

Act in December 2020.

As part of this extension, after September 30, 2024, the FDA may only award a voucher for an approved rare pediatric

disease product application if the sponsor has a RPDD for the drug that was granted by September 30, 2024.

After September 30, 2026,

the FDA may not award any additional rare pediatric disease priority review vouchers.

to request rare pediatric disease designation (“RPDD”), but the designation process is entirely voluntary;

requesting designation

is not a prerequisite to requesting or receiving a priority review voucher.

In addition, sponsors who choose not to submit a RPDD request

may nonetheless receive a priority review voucher if they request such a voucher in their original marketing application and meet all

of the eligibility criteria.

The Rare Pediatric Disease Priority Review Voucher Program was extended as part of the 2021 Coronavirus

Response and Relief Supplemental Consolidated Appropriations Act in December 2020.

More recent legislative authorization for the Rare

Pediatric Disease Priority Review Voucher Program extended the program to enable award of priority review vouchers for approved products

until September 30, 2029.

Drug Designation

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Other potential consequences include, among other things:

on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls;

warning or untitled letters or holds on post-approval clinical trials;

of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product

seizure or detention, or refusal of the FDA to permit the import or export of products;

or the imposition of civil or criminal penalties.

restrictions on the marketing

or manufacturing of a product, complete withdrawal of the product from the market or product recalls;

fines, warning or untitled

letters or holds on post-approval clinical trials;

refusal of the FDA to approve

pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;

product seizure or detention,

or refusal of the FDA to permit the import or export of products;

injunctions or the imposition

of civil or criminal penalties.

FDA closely regulates the marketing, labeling, advertising and promotion of biologics and drugs.

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products can be marketed only if a marketing authorization from the competent regulatory agencies has been obtained.

to the United States, the various phases of preclinical and clinical research in the European Union are subject to significant regulatory

Although the EU Clinical Trials Directive 2001/20/EC has sought to harmonize the EU clinical trials regulatory framework, setting

out common rules for the control and authorization of clinical trials in the European Union, the EU Member States have transposed and

applied the provisions of the Directive differently.

This has led to significant variations in the Member State regimes.

Under the current

regime, before a clinical trial can be initiated it must be approved in each of the EU countries where the trial is to be conducted by

two distinct bodies:

the National Competent Authority (“NCA”), and one or more Ethics Committees (“ECs”).

the current regime all suspected unexpected serious adverse reactions to the investigated drug that occur during the clinical trial have

to be reported to the NCA and ECs of the Member State where they occurred.

EU clinical trials legislation currently is undergoing a transition process mainly aimed at harmonizing and streamlining clinical-trial

authorization, simplifying adverse-event reporting procedures, improving the supervision of clinical trials and increasing their transparency.

In April 2014, the EU adopted a new Clinical Trials Regulation (EU) No 536/2014, which is set to replace the current Clinical Trials

Directive 2001/20/EC.

It is expected that the new Clinical Trials Regulation (EU) No 536/2014 will apply following confirmation of full

functionality of the Clinical Trials Information System, the centralized EU portal and database for clinical trials foreseen by the Regulation,

through an independent audit, currently expected to occur in January 2022.

The new Regulation will be directly applicable in all Member

States (and so does not require national implementing legislation in each Member State), and aims at simplifying and streamlining the

approval of clinical studies in the EU, for instance by providing for a streamlined application procedure via a single point and strictly

defined deadlines for the assessment of clinical study applications.

development and commercialization of pharmaceutical products in the European Union (“EU”) is governed by a comprehensive

regulatory framework intended to ensure the safety, efficacy, and quality of medicinal products.

Drug development in the EU generally

follows a multi-stage process that includes non-clinical testing, clinical trials, regulatory review, and post-authorization monitoring.

trials conducted in the EU are subject to authorization by national competent authorities and ethics committees in the EU Member States

in which the trials are conducted.

Clinical trials are regulated under the EU Clinical Trials Regulation (EU) No.

536/2014, which is

intended to harmonize the assessment and supervision of clinical trials across the EU.

Sponsors are required to submit clinical trial

applications and related documentation through a centralized EU portal and database, and compliance with Good Clinical Practice (“GCP”)

standards is required.

Drug Review and Approval

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are two main types of MAs:

centralized MA is issued by the European Commission through the centralized procedure, based on the opinion of the Committee for

Medicinal Products for Human Use (“CHMP”), of the EMA, and is valid throughout the entire territory of the EEA.

The centralized

procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced-therapy

medicinal products (i.e.

gene-therapy, somatic cell-therapy or tissue-engineered medicines) and medicinal products containing a new

active substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune

dysfunctions and viral diseases.

The centralized procedure is optional for products containing a new active substance not yet authorized

in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest

of public health in the European Union.

The centralized MA is issued

by the European Commission through the centralized procedure, based on the opinion of the Committee for Medicinal Products for Human

Use (“CHMP”), of the EMA, and is valid throughout the entire territory of the EEA.

The centralized procedure is mandatory

for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced-therapy medicinal products

gene-therapy, somatic cell-therapy or tissue-engineered medicines) and medicinal products containing a new active substance

indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions

and viral diseases.

The centralized procedure is optional for products containing a new active substance not yet authorized in the

EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of

public health in the European Union.

Under the centralized procedure the maximum timeframe for the evaluation of an MA application

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to conduct an accelerated assessment.

MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are

available for products not falling within the mandatory scope of the centralized procedure.

Where a product has already been authorized

for marketing in a Member State of the EEA, this national MA can be recognized in other Member States through the mutual recognition

If the product has not received a national MA in any Member State at the time of application, it can be approved simultaneously

in various Member States through the decentralized procedure.

Under the decentralized procedure an identical dossier is submitted

to the competent authorities of each of the Member States in which the MA is sought, one of which is selected by the applicant as

the Reference Member State (“RMS”).

National MAs, which are

issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for

products not falling within the mandatory scope of the centralized procedure.

Where a product has already been authorized for marketing

in a Member State of the EEA, this national MA can be recognized in other Member States through the mutual recognition procedure.

If the product has not received a national MA in any Member State at the time of application, it can be approved simultaneously in

various Member States through the decentralized procedure.

Under the decentralized procedure an identical dossier is submitted to

the competent authorities of each of the Member States in which the MA is sought, one of which is selected by the applicant as the

Reference Member State (“RMS”).

The competent authority of the RMS prepares a draft assessment report, a draft summary

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that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions which either

affect no more than 5 in 10,000 persons in the European Union, or where it is unlikely that the marketing of the medicine would generate

affect no more than five in 10,000 persons in the European Union, or where it is unlikely that the marketing of the medicine would generate

sufficient return to justify the necessary investment in its development.

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CTN Scheme broadly involves:

of preclinical laboratory and animal testing;

to a HREC, of all material relating to the proposed clinical trial, including the trial protocol;

institution or organization at which the trial will be conducted, referred to as the “Approving Authority”, giving final

approval for the conduct of the trial at the site, having regard to the advice from the HREC;

investigator submitting a ‘Notification of Intent to Conduct a Clinical Trial’ form, or CTN Form, to the TGA.

form must be signed by the sponsor, the principal investigator, the chairman of the HREC and a person responsible from the Approving

The TGA does not review any data relating to the clinical trial however CTN trials cannot commence until the trial has

been notified to the TGA.

completion of preclinical

laboratory and animal testing;

submission to a HREC, of

all material relating to the proposed clinical trial, including the trial protocol;

the institution or organization

at which the trial will be conducted, referred to as the “Approving Authority”, giving final approval for the conduct

of the trial at the site, having regard to the advice from the HREC;

the investigator submitting

a ‘Notification of Intent to Conduct a Clinical Trial’ form, or CTN Form, to the TGA.

The CTN form must be signed by

the sponsor, the principal investigator, the chairman of the HREC and a person responsible from the Approving Authority.

does not review any data relating to the clinical trial however CTN trials cannot commence until the trial has been notified to the

the CTX Scheme:

sponsor submits an application to conduct a clinical trial to the TGA for evaluation and comment;

sponsor must forward any comments made by the TGA Delegate to the HREC(s) at the sites where the trial will be conducted.

a sponsor submits an application

to conduct a clinical trial to the TGA for evaluation and comment;

a sponsor must forward

any comments made by the TGA Delegate to the HREC(s) at the sites where the trial will be conducted.

sponsor cannot commence a trial under the CTX Scheme until written advice has been received from the TGA regarding the application and

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In order to obtain registration of the product on the ARTG, it is required

and well-controlled clinical trials demonstrate the quality, safety and efficacy of the therapeutic product;

is compiled which demonstrates that the manufacture of the therapeutic product complies with the principles of cGMP;

manufacturing

and clinical data is derived to submit to the Advisory Committee on Prescription Medicines, which makes recommendations to the TGA

as to whether or not to grant approval to include the therapeutic product in the ARTG;

ultimate decision is made by the TGA whether to include the therapeutic product in the ARTG.

adequate and well-controlled

clinical trials demonstrate the quality, safety and efficacy of the therapeutic product;

evidence is compiled which

demonstrates that the manufacture of the therapeutic product complies with the principles of cGMP;

manufacturing and clinical

data is derived to submit to the Advisory Committee on Prescription Medicines, which makes recommendations to the TGA as to whether

or not to grant approval to include the therapeutic product in the ARTG;

an ultimate decision is

made by the TGA whether to include the therapeutic product in the ARTG.

and Procedures Governing Approval of Products in Other Jurisdictions

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include the following:

federal Anti-Kickback Statute, a criminal statute, makes it illegal for any person or entity to knowingly and willfully, directly

or indirectly, solicit, receive, offer, or pay any remuneration that is in exchange for or to induce the referral of business, including

the purchase, order, lease of any good, facility, item or service for which payment may be made under a federal healthcare program,

such as Medicare or Medicaid.

The federal Anti-Kickback

Statute, a criminal statute, makes it illegal for any person or entity to knowingly and willfully, directly or indirectly, solicit,

receive, offer, or pay any remuneration that is in exchange for or to induce the referral of business, including the purchase, order,

lease of any good, facility, item or service for which payment may be made under a federal healthcare program, such as Medicare or

The term “remuneration” has been broadly interpreted to include anything of value.

Civil Monetary Penalties Law also contains a provision that prohibits the payment of anything of value in return for referrals and

provides for the imposition of civil penalties.

Omnibus Budget Reconciliation Act of 1993 (42 U.S.C.

§ 1395nn) (the “Stark Law”) prohibit referrals by a physician

of “designated health services” which are payable, in whole or in part, by Medicare or Medicaid, to an entity in which

the physician or the physician’s immediate family member has an investment interest or other financial relationship, subject

to several exceptions.

The Stark Law also prohibits billing for services rendered pursuant to a prohibited referral.

Several states

have enacted laws similar to the Stark Law.

The Civil Monetary Penalties

Law also contains a provision that prohibits the payment of anything of value in return for referrals and provides for the imposition

of civil penalties.

the Omnibus Budget Reconciliation

Act of 1993 (42 U.S.C.

§ 1395nn) (the “Stark Law”) prohibit referrals by a physician of “designated health

services” which are payable, in whole or in part, by Medicare or Medicaid, to an entity in which the physician or the physician’s

immediate family member has an investment interest or other financial relationship, subject to several exceptions.

The Stark Law

also prohibits billing for services rendered pursuant to a prohibited referral.

Several states have enacted laws similar to the Stark

These state laws may cover all (not just Medicare and Medicaid) patients.

the Stark Law in planning our products, marketing and other activities, and believe that our operations are in compliance with the

If we violate the Stark Law, our financial results and operations could be adversely affected.

Penalties for violations

include denial of payment for the services, significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs.

false claims and false statement laws, including the federal civil False Claims Act, prohibits, among other things, any person or

entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare

and Medicaid, claims for items or services, including drugs, that are false or fraudulent.

Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act

and their implementing regulations at 45 C.F.R.

Parts 160, 162 and 164, as amended (“HIPAA”) created additional federal

criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud

any healthcare benefit program, including private third-party payors or making any false, fictitious or fraudulent statement in connection

with the delivery of or payment for healthcare benefits, items or services.

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations,

imposes obligations on certain types of individuals and entities regarding the electronic exchange of information in common healthcare

transactions, as well as standards relating to the privacy and security of individually identifiable health information.

federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which

payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report

annually to the Centers for Medicare & Medicaid Services information related to payments or other transfers of value made to

physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

We consider the Stark Law in planning our products,

marketing and other activities, and believe that our operations are in compliance with the Stark Law.

If we violate the Stark Law,

our financial results and operations could be adversely affected.

Penalties for violations include denial of payment for the services,

significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs.

Federal false claims and

false statement laws, including the federal civil False Claims Act, prohibits, among other things, any person or entity from knowingly

presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims

for items or services, including drugs, that are false or fraudulent.

Health Insurance Portability

and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act and their implementing

regulations at 45 C.F.R.

Parts 160, 162 and 164, as amended (“HIPAA”) created additional federal criminal statutes that

prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit

program, including private third-party payors or making any false, fictitious or fraudulent statement in connection with the delivery

of or payment for healthcare benefits, items or services.

HIPAA, as amended by the

Health Information Technology for Economic and Clinical Health Act of 2009 and their implementing regulations, imposes obligations

on certain types of individuals and entities regarding the electronic exchange of information in common healthcare transactions,

as well as standards relating to the privacy and security of individually identifiable health information.

The federal Physician Payments

Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under

Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers

for Medicare & Medicaid Services information related to payments or other transfers of value made to physicians and teaching

hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope and may apply

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Additionally,

to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws.

of March 11, 2025, we had 21 employees, 18 of which are full-time employees.

to the extent that our product candidates, if approved, are sold in a foreign country, we may be subject to similar foreign laws.

of March 20, 2026, we had 21 employees, all of which are full-time employees.

Of such employees, 17 are engaged in research and development.

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were incorporated as a California limited liability company in 2012 and converted to a Delaware corporation in January 2014.

2016, we established a wholly-owned Australian subsidiary, Immix Biopharma Australia Pty Ltd., in order to conduct various pre-clinical

and clinical activities for the development of our product candidates.

In November 2022, we established a Delaware corporation, Nexcella,

Inc., in order to conduct various pre-clinical and clinical activities for the development of our product candidates.

On May 20, 2024,

Nexcella, was merged with and into the Company, with the Company continuing as the surviving corporation.

August 2016, we established a wholly-owned Australian subsidiary, Immix Biopharma Australia Pty Ltd., in order to conduct various

pre-clinical and clinical activities for the development of our product candidates.

In November 2022, we established a Delaware

corporation, Nexcella, Inc., in order to conduct various pre-clinical and clinical activities for the development of our product

On May 20, 2024, Nexcella Inc., our former wholly-owned subsidiary, was merged with and into the Company, with the

Company continuing as the surviving corporation.

Subsequently, a wholly-owned

subsidiary Nexcella, Inc.

was created and continues to be wholly-owned.

website address is www.immixbio.com .

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business