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Item 1. Business

2025-03-25 compared with 2024-03-29 · 368 added, 455 removed, 770 unchanged (52% of the section changed)

Immix Biopharma, Inc.

is a clinical-stage biopharmaceutical company focused

on the application of chimeric antigen receptor cell therapy (“CAR-T”) in light chain (AL) Amyloidosis and autoimmune disease.

Our lead cell therapy candidate is U.S.

Food and Drug Administration (“FDA”) investigational new drug (“IND”)

cleared CAR-T NXC-201, currently being evaluated in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313) clinical trial.

Based on early clinical

data, we believe NXC-201 has the potential to be the world’s first “Single-Day Cytokine Release Syndrome”, or “Single-Day

CRS” CAR-T (CRS median onset day 1, median duration 1 day), enabling the potential for a faster return home for patients.

has been awarded Orphan Drug Designation (“ODD”) by the FDA in both AL Amyloidosis and multiple myeloma, and ODD by the European

Commission (“EMA”) in AL Amyloidosis.

strategy is to:

● Develop our lead candidate CAR-T NXC-201 in AL Amyloidosis and other autoimmune

● Pursue development of NXC-201 and additional cell therapy candidates in

other applicable indications where CAR-T is not an approved therapy today

Biopharma, Inc.

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.

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

autoimmune and other indications, as we believe patients are waiting.

Select ImmixBio Possible Autoimmune Target Indications

N-GENIUS platform has produced our clinical-stage lead candidate NXC-201, a next-generation CAR-T for AL Amyloidosis and autoimmune disease,

complemented by emerging programs.

select immune-mediated diseases and other indications, 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.

of February 2024, we have treated 73 patients in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313), of which 63 were relapsed/refractory

multiple myeloma patients, and 10 were relapsed/refractory AL Amyloidosis patients.

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

This abnormal protein is produced by long-lived plasma cells (“LLPCs”), a type of immune B-cell.

The signs and symptoms of

AL amyloidosis vary among patients because build-up may occur in the heart (most frequent cause of mortality), liver, kidneys, intestines,

muscles, joints, nerves, or spleen, according to the National Institutes of Health (“NIH”).

Diagnosis is frequently delayed,

due to varied and non-specific symptoms including:

fatigue, weight loss, shortness of breath, dizziness, and numbness in hands and feet.

Upon diagnosis, many patients already have late-stage disease, and are not aware of available treatment options and clinical trials.

of March 11, 2025, there are no FDA approved drugs for relapsed/refractory AL Amyloidosis.

observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal

2021, estimated to reach 37,270 patients in 2025.

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

of less than 1 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.

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

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

November 2023, the U.S.

FDA cleared an IND application for NXC-201 to enroll U.S.

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

patients into NXC-201 clinical trials.

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

of European ODD include:

Benefits of European ODD include:

10 years of market exclusivity once authorized in the EU;

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.

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.

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, indicating an overall response rate

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

Other Programs

other programs include NXC-201 for autoimmune diseases, a $25 billion combined annual market size according to Grand View Research and

Fortune Business Insights;

NXC-201 for relapsed/refractory multiple myeloma, a $14 billion market size growing to $27 billion

according to Wilcock, et al, Nature Reviews;

IMX-110 for soft tissue sarcoma, a $3 billion market size according to Medgadget,

and in combination with anti-PD-1 for colorectal cancer, a $27 billion market size according to IndustryARC.

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.

Platform and Technologies

believe our N-GENIUS platform has broad potential utility in hematologic and autoimmune diseases.

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

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

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

and (3) Atomized, Novel Binding Scaffold Generation Engine, which allows for optimal molecule binding.

We believe key

characteristics of NXC-201 may apply to other products candidates produced by the N-GENIUS Platform.

Those 3 key characteristics

(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

Our Lead Program:

Engine + Relational Database, which relates ImmixBio 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;

Atomized, Novel Binding Scaffold Generation Engine, which allows for optimal molecule binding.

We believe key characteristics of NXC-201

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).

Lead Program:

NXC-201 in relapsed/refractory AL Amyloidosis

Market Opportunity

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

AL amyloidosis is a life-threatening immunological disorder in which an

abnormal protein called amyloid builds up in tissues and organs.

This abnormal protein is produced by long-lived plasma cells (“LLPCs”),

a type of immune B-cell.

The signs and symptoms of AL amyloidosis vary among patients because build-up may occur in the heart (most frequent

cause of mortality), liver, kidneys, intestines, muscles, joints, nerves, or spleen, according to the National Institutes of Health (“NIH”).

Diagnosis is frequently delayed, due to varied and non-specific symptoms including:

fatigue, weight loss, shortness of breath, dizziness,

and numbness in hands and feet.

Upon diagnosis, many patients already have late-stage disease, and are not aware of available treatment

options and clinical trials.

observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et

al Blood Cancer Journal, estimated to reach 29,712 patients in 2023.

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.

of February 2024, there are no FDA approved drugs for AL Amyloidosis.

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

This abnormal protein is produced by long-lived plasma cells (“LLPCs”), a type of immune B-cell.

The signs and symptoms of

AL amyloidosis vary among patients because build-up may occur in the heart (most frequent cause of mortality), liver, kidneys, intestines,

muscles, joints, nerves, or spleen, according to the National Institutes of Health (“NIH”).

Diagnosis is frequently delayed,

due to varied and non-specific symptoms including:

fatigue, weight loss, shortness of breath, dizziness, and numbness in hands and feet.

Upon diagnosis, many patients already have late-stage disease, and are not aware of available treatment options and clinical trials.

observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal,

estimated to reach 37,270 patients in 2025.

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.

of March 11, 2025, there are no FDA approved drugs for relapsed/refractory AL Amyloidosis.

NXC-201 “Blue Ocean Opportunity” in AL Amyloidosis

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What is CAR-T Cell Therapy?

Our N-GENIUS cell engineering platform with EXPAND technology has already

produced clinical-stage CAR-T NXC-201, targeting BCMA, which we believe is the first and only autologous CAR-T being developed to treat

light-chain (AL) Amyloidosis.

NXC-201 is currently being evaluated in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313) clinical trial.

N-GENIUS cell engineering platform with EXPAND technology has already produced clinical-stage CAR-T NXC-201, targeting BCMA, which we

believe is the first and only autologous CAR-T being developed to treat light-chain (AL) Amyloidosis.

NXC-201 is currently being evaluated

in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313) clinical trial.

First CAR-T Generated by the N-GENIUS Platform

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Key Characteristics

NXC-201 has been designed with a proprietary, optimized C3ζγ

for enhanced signal transduction, proprietary, optimized modified-stiffness CD8 hinge, and proprietary, optimized COBRA binder for enhanced

signal binding.

We believe the combination of these modifications has the potential to allow for NXC-201 to deliver “digital”

intracellular signaling, potentially eliminating neurotoxicity and reducing CRS duration to 1 day.

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

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

We believe the combination of these modifications has

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

reducing CRS duration to 1 day.

N-GENIUS Platform – EXPAND Technology + COBRA Binder

NXC-201 was designed for high activity against disease-causing AL Amyloidosis

LLPCs, which are also the source of autoimmune antibodies in a variety of autoimmune disorders.

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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Uneven BCMA expression across disease-causing LLPCs;

b) frail patient due to pre-existing organ (heart) damage.

frail patient due to pre-existing organ (heart) damage.

in Clinical Cancer Research in 2022, NXC-201 was tested preclinical and clinically in AL Amyloidosis.

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

These data represent the largest cohort

This data represents the largest cohort

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

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No patients received bridging therapy.

was administered at cell doses of either 150 × 10 6 , 450 × 10 6 , and 800 × 10 6 per patient.

characteristics:

(9/10) had high-risk cytogenetics

(13/16) had cardiac involvement;

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

(4/10) had t(11;14) translocation

Relapsed/refractory

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response rate of 94% (15/16);

response + very good partial response rate of 90% (9/10)

response rate of 70% (7/10) (6 out of 7 were minimum residual disease (“MRD”) 10 -5 )

response rate of 75% (12/16);

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

Median CRS duration was 1 day (range:

CRS duration was 2 days (range:

grade 4 CRS events;

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8 Experienced grade 2 CRS;

2 experienced grade 3 CRS

the 8 patients with cardiac involvement:

response rate of 100% (8/8)

response rate of 63% (5/8) (4 out of 5 were MRD 10 -5 )

response rate of 63% (5/8)

the 4 patients with t(11;14) disease:

response rate of 100% (4/4)

response rate of 75% (3/4) (MRD 10 -5 )

response rate of 50% (2/4)

and 3 experienced grade 3 CRS

Vitro Studies

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TFNα), which was not seen in NT cells.

Furthermore, non-tumour bone marrow derived mononuclear

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

NXC-201 Activation Following Overnight Co-culture with Amyloid Light Chain Amyloidosis Plasma Cells

65 th ASH NXC-201 presentation:

Rapid elimination of disease-causing amyloid chains by NXC-201 within ~30 days was

in Relapsed/refractory multiple myeloma

of February 2024, 63 patients with triple-refractory relapsed/refractory multiple myeloma with median 4 lines of prior therapy (range:

3-13) have been treated with NXC-201.

A 95% overall response rate to NXC-201 treatment was observed in relapsed/refractory multiple myeloma

patients not previously treated with BCMA-targeted therapy (98% overall response rate observed in relapsed/refractory multiple myeloma

patients without extra-medullary disease).

“Single-Day CRS” was demonstrated – median duration of CRS of 1 day, median

Multiple myeloma is a $14 billion market size growing to $27 billion according to Wilcock, et al, Nature Reviews.

Furthermore, non-tumour bone marrow derived mononuclear cells

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

Development Strategy

In 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 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

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

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

The expected primary endpoints

are complete response rate and overall response rate in our NXC-201 relapsed/refractory AL Amyloidosis clinical trial.

Our 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.

– Tissue-Specific Therapeutic TM with tissue micro environment

(“TME”) Normalization TM Technology

in Colorectal Cancer

first potential indication we intend to pursue for IMX-110 (in combination with anti-PD-1 antibody) is relapsed/refractory colorectal

cancer (“CRC”).

CRCs are cancers that arise from the colon and rectum.

According to American Cancer Society, there were roughly

153,020 new cases of colorectal cancer in the United States in 2023.

The five-year survival rate in the United States for all stages

of CRC is 65.1%, but this falls to 15.1% for patients with late-stage metastatic disease according to the National Cancer Institute (“NCI”).

CRC market is estimated to reach approximately $31.2 billion by 2025 from the estimated $26.3 billion in 2019 according to IndustryARC.

Drugs used to treat CRC include conventional irinotecan, oxaliplatin, 5-fluorouracil, pembrolizumab (marketed as Keytruda®, by Merck

& Co.), nivolumab (marketed as Opdivo®, by Bristol Meyers Squibb), bevacizumab (marketed as Avastin®, by Roche), ramucirumab

(marketed as Cyramza®, by Eli Lilly), and regorafenib (marketed as Stivarga® by Bayer).

$41.11 billion is the total publicly

disclosed combined annual sales of pembrolizumab (Keytruda®, Merck & Co.), nivolumab (Opdivo®), bevacizumab (Avastin®),

and ramucirumab (Cyramza®) according to 2023 available annual reports.

In relapsed/refractory proficient mismatch repair (pMMR) (microsatellite-stable

- MSS) relapsed/refractory mCRC, regorafenib (marketed as Stivarga® by Bayer) produced a median progression free survival (“mPFS”)

of 2.0 months according to the FDA approval label.

of February 2024, we continue to dose escalate IMX-110 + BeiGene anti-PD-1 Tislelizumab in our IMMINENT-01 (NCT05840835) study.

2023, we reported the following clinical data for IMX-110 + Tislelizumab in proficient mismatch repair (“pMMR”, or microsatellite-stable

– “MSS”) relapsed/refractory mCRC in IMMINENT-01:

Out of 4 relapsed/refractory metastatic colorectal cancer patients

treated with IMX-110 + tislelizumab:

3 out of 4 (75%) patients experienced tumor shrinkage at 2 months;

1 out of 4 (25%) patients experienced

tumor control at 2 months;

1 out of 4 patients remain on IMX-110 + tislelizumab therapy as of July 7, 2023;

Median progression-free survival

and overall survival not yet reached;

Patients received a median of 8 earlier anti-cancer treatments that failed to halt cancer growth

(lines of therapy) prior to receiving IMX-110 + tislelizumab.

in Soft Tissue Sarcoma (“STS”)

second potential indication we intend to pursue for IMX-110 is relapsed/refractory STS.

STSs are cancers that arise from muscle, fat,

nerves, fibrous tissues, blood vessels or deep skin tissues.

According to American Cancer Society, there were roughly 13,000 new cases

of soft tissue sarcomas in the United States during 2020 and about 13,400 new cases of soft tissue sarcomas in the United States are

anticipated in 2023.

Approximately 160,000 people live with soft tissue cancers in the United States.

The five-year survival rate for

all stages of STS is 65.4% in the United States, but this falls to 17.1% for patients with late-stage metastatic disease according the

The global soft tissue sarcoma market is estimated to reach approximately $6.5 billion by 2030 from the estimated $2.9 billion in

2019 according to Medgadget.

Drugs used to treat STS include conventional doxorubicin, eribulin (marketed as Halaven®, by Eisai Co,

Ltd), pazopanib (marketed as Votrient®, by Novartis), and trabectedin (marketed as Yondelis®, by Janssen/Johnson & Johnson).

response rates are increasingly considered as poor surrogates of clinical activity in STS.

Therefore, lack of progression, or progression

free survival (“PFS”), is used as the primary measure of treatment success in STS.

Conventional doxorubicin, in three separate

studies as a first-line therapy, produced a mPFS (meaning the time patients live without their cancer progressing) in STS patients of

2.5 months, 4.6 months, and 2.7 months according to Lorigan et al., 2007, Judson et al., 2014 and Chawla et al., 2015.

Eribulin (Halaven®),

was trialed in a study producing a mPFS in STS patients of 2.6 months according to Schöffski et al., 2016.

Pazopanib (Votrient®),

was trialed in a study producing a mPFS in STS patients of 4.6 months according to van der Graaf et al., 2012.

Trabectedin (Yondelis®)

was trialed in a study producing a mPFS in STS patients of 4.2 months according to Demetri et al., 2016.

of February 2024, we have treated 21 patients in our ongoing IMX-110 Phase 1b/2a clinical trial in the United States and Australia, of

which clinical analysis has been completed for the initial 14 patients.

Of those 14 patients, 8 patients completed a tumor measurement

after the enrollment measurement.

Of those 8 patients, a range of late-stage STSs were represented, including:

leiomyosarcoma, cholangiocarcinoma,

carcinosarcoma, and poorly differentiated sarcoma.

4 months was the mPFS observed in STS patients treated with IMX-110 in the United

States in our ongoing Phase 1b/2a clinical trial.

6 months of radiological PFS was observed in 50% of our STS patients treated with IMX-110.

100% of these patients received between 3 and 13 lines of therapy prior to IMX-110.

Zero drug-related serious adverse events and zero

dose interruptions due to toxicity have been observed in our 1b/2a clinical trial to-date.

Composition and Mechanism of Action

IMX-110, currently in Phase 1b/2a clinical trials, is a Tissue-Specific

Therapeutic TM with TME Normalization TM , a technology that we are developing initially for mCRC and STS.

is sustained by hypoxia (low oxygen concentration) and acidosis (an excessively acidic condition) which produce recurring waves of activation

of multiple kinases that upregulate NF-κB, STAT3 and other key transcriptional factors which cause recurrent inflammation.

inflammatory environment activates the TME to provide metabolic and structural support to the tumor and to recruit Treg T-cells (immune

cells suppressing immune response) to suppress anti-tumor immune response.

IMX-110’s poly-kinase inhibitor polyphenol curcuminoid

complex (“PCC”) halts this fundamental tumor-sustaining inflammation by blocking multiple kinases and interfering with NF-κB

and STAT3 activation, interrupting the positive feedback loop underlying the inflammatory cycle.

With tumor-sustaining inflammation halted,

IMX-110’s apoptosis inducer (Polyethylene glycol – phosphatidylethanolamine (“PEG-PE”)-doxorubicin complex) is

then able to induce tumor cell death where conventional therapies have been hampered by resistance caused by NF-κB and STAT3 activation.

IMX-110 Induces Apoptosis while Blocking Multiple Escape Pathways

Immunomodulation Effects

this pre-clinical study of IMX-110 monotherapy in the genetic Kras, p53, and Cre (“KPC”) pancreatic mouse cancer model, our histological analysis showed that

IMX-110 has the potential to transform “cold” tumors into “hot” tumors by eliminating immunosuppressive T-regulatory

immune cells (top), enabling cytotoxic T-lymphocytes to enter the tumor (middle), and eliminating tumor vascularization (bottom).

IMX-110 Tissue-Specific Therapeutic TM with TME Normalization TM Technology

Turns “Cold” Tumors “Hot” in Genetic (KPC) Pancreatic Cancer Pre-clinical Model

above paragraph for study description.

ImmixBio unpublished results.)

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

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

We are also pursuing development of NXC-201 in autoimmune diseases, a $25

billion combined annual market size according to Grand View Research and Fortune Business Insights.

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

have a strong track record of successful manufacturing.

We have already established a track record of producing NXC-201 for patient

dosing and testing in the U.S.

(73 patients dosed to-date).

In addition, we have already developed a scalable, reliable

manufacturing process for our TSTx according to current Good Manufacturing Practice (“cGMP”).

We have already established a track record of producing NXC-201 for patient dosing

and testing in the U.S.

In addition, we have already developed a scalable, reliable manufacturing process for our TSTx 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 manufacturing space located in

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.

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 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.

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.

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.

developing therapies for AL amyloidosis include, but are not limited to, Prothena Corp, Caelum Biosciences (Now Alexion/AstraZeneca),

and Janssen/Johnson & Johnson.

developing or intend to develop cell therapies for autoimmune indications include, but are not limited to:

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.;

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that are important to the development and implementation of our business.

Our patent portfolio is intended to cover our product candidates

and related components, their methods of use and processes for their manufacture, our proprietary reagents and assays, and any other

inventions that are commercially important to our business.

We also rely on trademarks as well as trade secret protection of our confidential

information and know-how relating to our proprietary technology platform, and product candidates.

We believe that we have substantial

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

of March 15, 2024, our patent portfolio includes 12 U.S.

We intend to build a patent portfolio to cover our product

candidates and related components, their methods of use and processes for their manufacture, our proprietary reagents and assays, and

any other inventions that are commercially important to our business.

We also rely on trademarks as well as trade secret protection of

our confidential information and know-how relating to our proprietary technology platform, and product candidates.

We believe that we

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, 2 pending international (PCT) patent applications related to our technology platform and our product candidates.

those, 2 patents has been granted in the U.S.

and 10 patents have been granted in the following countries:

France, Germany, Ireland,

Switzerland, and the United Kingdom.

Two 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.

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

Expiration Date

of Patent Protection

AND RELATED COMPOSITIONS FOR THE TREATMENT OF CANCER

and methods of treatment

AND RELATED COMPOSITIONS FOR THE TREATMENT OF CANCER

and methods of treatment

COMPRISING AN INHIBITOR OF NF-KB

and methods of treatment

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

COMPRISING AN INHIBITOR OF NF-KB

and methods of treatment

ZIELGERICHTETE UND MIT KURKUMIN BELADENE MIZELLEN

TARGETED AND CURCUMIN LOADED MICELLES

UND VERWANDTE ZUSAMMENSETZUNGEN ZUR BEHANDLUNG VON KREBS

ET COMPOSITIONS ASSOCIÉES POUR LE TRAITEMENT DU CANCER

AND RELATED COMPOSITIONS FOR THE TREATMENT OF CANCER

MX/a/2024/000302

NANOPARTICLES

FOR CANCER TREATMENT

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

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

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and methods of treatment

PCT/US2022/044948

MX/a/2024/003832

NANOPARTICLES

4 unchanged sentences

and methods of treatment

PCT/US2023/69537

NANOPARTICLES

FOR THE TREATMENT OF INFLAMMATORY DISEASES

Provided all maintenance and renewal fees are timely paid.

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,

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has global exclusive rights to PCT Application No.

PCT/IL2023/050142 filed in 20023 and claiming priority

Provisional Patent Application Nos.

63/308,277 and 63/368,002.

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.

We plan to enter the national phase of the PCT application in multiple countries.

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).

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 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.

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.

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

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

however, the royalty obligations described herein shall

survive the termination of 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

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 based on Net Sales (as defined in the Agreement)

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

during the Royalty Period.

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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 shall pay milestone payments of up to $20 million upon the achievement of certain Net Sales 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.

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

In addition, either party may terminate the Agreement if the other party materially breaches

the Agreement and fails to cure such breach within 30 days.

Additionally, Licensors may terminate the Agreement if Nexcella becomes insolvent

or files for bankruptcy.

with Nexcella

December 8, 2022, we entered a Founders Agreement with our subsidiary Nexcella (the “Nexcella Founders Agreement”).

to the Nexcella Founders Agreement, in consideration for the time and capital expended in the formation of Nexcella and the identification

of specific assets, the acquisition of which benefit Nexcella, we received 250,000 shares of Nexcella’s Class A Preferred Stock,

1,000,000 shares of Nexcella’s Class A Common Stock, and 5,000,000 shares of Nexcella’s common stock.

In addition, pursuant

to the Nexcella Founders Agreement, prior to a Qualified IPO (as defined in Nexcella’s Amended and Restated Certificate of Incorporation,

as amended (the “Nexcella COI”)) or Qualified Change in Control (as defined in the Nexcella COI), we shall provide funds

to Nexcella as requested by Nexcella, in good faith, to be evidenced by a senior unsecured promissory note.

The Nexcella Founders Agreement

has a term of 15 years, which, upon expiration, automatically renews for successive one-year periods unless terminated by us upon notice

at least six months prior to the end of the term or upon the occurrence of a Change of Control (as defined in the Nexcella Founders Agreement).

In exchange for the time and capital expended in the formation of Nexcella and the identification of specific assets, the acquisition

of which benefit Nexcella, on December 21, 2022, the Company loaned Nexcella approximately $2.1 million, evidenced by a senior unsecured

promissory note, which note matures on January 31, 2030, accrues interest at a rate of 7.875% per annum and is convertible into shares

of common stock of Nexcella at a conversion price of $2.00 per share, subject to adjustment;

provided, however, that such note shall

automatically convert into shares of Nexcella common stock immediately prior to certain conversion triggers set forth in the note.

may not prepay the note without our prior written consent .

Class A Preferred Stock is identical to the common stock other than as to conversion rights, the PIK Dividend right (as defined below)

and voting rights.

share of Class A Preferred Stock is convertible, at our option, into one share of Nexcella’s common stock, subject to certain adjustments.

As a holder of Nexcella’s Class A Preferred Stock, we will receive on each March 13 (each a “PIK Dividend Payment Date”)

until the date all outstanding Class A Preferred Stock is converted into Nexcella’s common stock or redeemed (and the purchase

price is paid in full), pro rata per share dividends paid in additional shares of Nexcella common stock (“PIK Dividends”)

such that the aggregate number of shares of common stock issued pursuant to such PIK Dividend is equal to 2.5% of Nexcella’s fully-diluted

outstanding capitalization on the date that is one business day prior to any PIK Dividend Payment Date.

In addition, as a holder of Class

A Preferred Stock, we shall be entitled to cast for each share of Class A Preferred Stock held as of the record date for determining

stockholders entitled to vote on matters presented to the stockholders of Nexcella, the number of votes that is equal to 1.1 times a

fraction, the numerator of which is the sum of (A) the shares of outstanding Nexcella common stock and (B) the whole shares of Nexcella

common stock into which the shares of outstanding Nexcella Class A Common Stock and the Class A Preferred Stock are convertible and the

denominator of which is number of shares of outstanding Nexcella Class A Preferred Stock.

share of Class A Common Stock is convertible, at our option, into one share of Nexcella’s common stock, subject to certain adjustments.

In addition, upon a Qualified IPO or Qualified Change in Control, the shares of Class A Common Stock, will automatically convert into

one share of Nexcella’s common stock;

provided however, if at that time, the Class A Common Stock is not then convertible into

a number of shares of Nexcella common stock (or such other capital stock or securities at the time issuable upon the conversion of the

Class A Common Stock) that have a value of:

(a) in the case of a Qualified IPO, at least $5,000,000 based on the initial offering price

in such offering, or (b) in the case of a Qualified Change in Control, at least $5,000,000 in cash or at least $5,000,000 of equity based

on the implied value of a share of Nexcella common stock resulting from the price paid upon the consummation of such Qualified Change

of Control, the Class A Common Stock will automatically convert into such number of shares of Nexcella common stock (or such other capital

stock or securities at the time issuable upon the conversion of the Class A Common Stock) that have a value of $5,000,000 based on the

initial offering price in such offering or the implied value of a share of Nexcella common stock resulting from the price paid upon the

consummation of such Qualified Change of Control (or if such Qualified Change of Control results in the Class A Shares being exchanged

solely for cash, then $5,000,000 in cash).

We shall be entitled to cast such number of votes equal to the number of whole shares of Nexcella

common stock into which our Class A Common Stock are convertible as of the record date for determining stockholders entitled to vote

on matters presented to the stockholders of Nexcella.

addition to the foregoing, we shall be entitled to one vote for each share of Nexcella common stock held by us.

Except as provided by

law or by the Nexcella COI, holders of Nexcella Class A Common Stock and Class A Preferred Stock shall vote together with the holders

of Nexcella common stock, as a single class.

additional consideration under the Nexcella Founders Agreement, Nexcella will also:

(i) pay an equity fee in shares of common stock,

payable within five business days of the closing of any equity or debt financing for Nexcella or any of its respective subsidiaries that

occurs after the effective date of the Nexcella Founders Agreement and ending on the date when we no longer have majority voting control

in Nexcella’s voting equity, equal to 2.5% of the gross amount of any such equity or debt financing;

and (ii) pay a cash fee equal

to 4.5% of Nexcella’s annual Net Sales (as defined in the Nexcella Founders Agreement), payable on an annual basis.

of a Change of Control, Nexcella will pay a one-time change in control fee equal to five times the product of (A) Net Sales for the 12

months immediately preceding the Change of Control and (B) 4.5%.

Services Agreement

as of December 8, 2022, we entered into a Management Services Agreement (the “Nexcella MSA”) with our subsidiary Nexcella.

Pursuant to the terms of the Nexcella MSA, we will render management, advisory and consulting services to Nexcella.

Services provided

under the Nexcella MSA may include, without limitation, (i) advice and assistance concerning any and all aspects of Nexcella’s

operations, clinical trials, financial planning and strategic transactions and financings and (ii) conducting relations on behalf of

Nexcella with accountants, attorneys, financial advisors and other professionals (collectively, the “Services”).

At our request,

Nexcella shall utilize clinical research services, medical education, communication and marketing services and investor relations/public

relation services of companies or individuals designated by us, provided those services are offered at market prices.

In consideration

for the Services, Nexcella will pay us an annual base management and consulting fee of $500,000 (the “Annual Consulting Fee”),

payable in advance in equal quarterly installments;

provided, however, that such Annual Consulting Fee shall be increased to $1.0 million

for each calendar year in which Nexcella has Net Assets (as defined in the Nexcella MSA) in excess of $100 million at the beginning of

the calendar year.

Notwithstanding the foregoing, the first Annual Consulting Fee payment shall be made on the first business day of

the calendar quarter immediately following the completion of the first equity financing for Nexcella that is in excess of $10 million

in gross proceeds.

The first payment shall include all amounts in arrears from the effective date of the Nexcella MSA through such payment

as well as the amounts in advance for such first quarterly payment.

Actual and direct out-of-pocket expenses reasonably incurred by us

in performing the Services shall be reimbursed to us by Nexcella.

The Nexcella MSA shall continue for a period of five years from the

effective date thereof and shall be automatically extended for additional five year periods unless we and Nexcella provide written notice

to not extend the term at least 90 days prior to the end of the term, unless the Nexcella MSA is terminated earlier by mutual agreement

between us and Nexcella.

February 2024, we conducted an underwritten public offering of 5,535,055 shares of common stock at the public offering price is $2.71

per shares, for the net proceeds, after underwriter discounts and offering expenses, of $13,566,697.

Pursuant to the underwriting

agreement, we granted the underwriter a 30-day over-allotment option to purchase up to an additional 783,970 shares of our common stock,

which was exercised in full on March 1, 2024 for the net proceeds, after underwiring discounts and offering expenses, of $1,954,594.

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

of European ODD include:

10 years of market exclusivity once authorized in the EU;

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.

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.

In addition, either party may terminate the Agreement

if the other party materially breaches the Agreement and fails to cure such breach within 30 days.

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.

States Regulation of Drugs and Biologics

expect that NXC-201 will be regulated by the FDA as a biologic by submitting a Biologic License Application (“BLA”).

that IMX-110 will be regulated by the FDA as a complex non-biologic by submitting a New Drug Application (“NDA”).

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 by submitting a BLA.

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.

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(“GLP”) regulation;

to the FDA of an Investigational New Drug (“IND”), which must become effective before clinical trials may begin and must

be updated annually or when significant changes are made;

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;

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Pediatric Disease Priority Review Voucher Program

enactment of the FDASIA in 2012, Congress authorized the FDA to award priority review vouchers to sponsors of certain rare pediatric

disease product applications that meet the criteria specified in the law.

This provision is designed to encourage development of new

drug and biological products for prevention and treatment of certain rare pediatric diseases.

Specifically, under this program, a sponsor

who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed

to receive a priority review of a subsequent marketing application for a different product.

The sponsor of a rare pediatric disease drug

product receiving a priority review voucher may transfer (including by sale) the voucher to another sponsor.

The voucher may be further

transferred any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application.

enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, Congress authorized the FDA to award priority

review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in the law.

provision is designed to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric

Specifically, under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease”

may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

The sponsor of a rare pediatric disease drug product receiving a priority review voucher may transfer (including by sale) the voucher

to another sponsor.

The voucher may be further transferred any number of times before the voucher is used, as long as the sponsor making

the transfer has not yet submitted the application.

the purposes of this program, a “rare pediatric disease” is a (a) serious or life-threatening disease in which the serious

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or imposition

of distribution restrictions or other restrictions under an REMS program.

of distribution restrictions or other restrictions under a REMS program.

Other potential consequences include, among other things:

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not regulate the behavior of physicians in their choice of treatments.

The FDA does, however, restrict manufacturer’s communications

The FDA does, however, restrict manufacturers’ communications

on the subject of off-label use of their products.

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of public health in the European Union.

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

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

by the EMA is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in

response to questions asked by the CHMP.

Clock stops may extend the timeframe of evaluation of a MA application considerably beyond

Clock stops may extend the timeframe of evaluation of an MA application considerably beyond

Where the CHMP gives a positive opinion, the EMA provides the opinion together with supporting documentation to the European

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Accelerated assessment might be granted by the CHMP in exceptional cases, when a medicinal product is expected to

be of a major public health interest, particularly from the point of view of therapeutic innovation.

be of major public health interest, particularly from the point of view of therapeutic innovation.

The timeframe for the evaluation

of a MA application under the accelerated assessment procedure is of 150 days, excluding stop-clocks, but it is possible that the

CHMP may revert to the standard time limit for the centralized procedure if it determines that the application is no longer appropriate

of an MA application under the accelerated assessment procedure is 150 days, excluding stop-clocks, but it is possible that the CHMP

may revert to the standard time limit for the centralized procedure if it determines that the application is no longer appropriate

to conduct an accelerated assessment.

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The PDCO can grant a deferral of the obligation to implement some or all of the measures of the PIP until

there are sufficient data to demonstrate the efficacy and safety of the product in adults.

there is sufficient data to demonstrate the efficacy and safety of the product in adults.

Further, the obligation to provide pediatric

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This pediatric reward is subject

to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

to specific conditions and is not automatically available when data in compliance with the PIP is developed and submitted.

March 2016, the EMA launched an initiative to facilitate development of product candidates in indications, often rare, for which few

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

Of such employees, 8 are engaged in research and

None of our employees are represented by a labor union or covered by a collective bargaining agreement, nor have we

experienced work stoppages.

Of such employees, 14 are engaged in research and development.

None of our employees are represented by a labor union or covered by a collective bargaining agreement, nor have we experienced work

We believe that relations with our employees are good.

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

ImmixBio currently

owns 95% of outstanding common stock on a fully diluted basis of Nexcella.

On May 20, 2024,

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

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