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Item 1. Business

2023-03-27 compared with 2022-03-28 · 676 added, 203 removed, 1137 unchanged (44% of the section changed)

Biopharma, Inc.

has the following two business units:

ImmixBio is focused on developing Tissue Specific Therapeutics targeting solid tumors and immune-dysregulated diseases.

As of February

2023, 19 patients with advanced solid tumors were treated with IMX-110, ImmixBio’s lead candidate.

Our majority-owned subsidiary, Nexcella, Inc.

(formerly known as Immix Biopharma Cell Therapy, Inc.), is engaged in the discovery and development of novel cell therapies for hematologic

malignancies (blood cancers) and other indications.

As of February 2023, 42 patients with relapsed/refractory multiple myeloma (90%

overall response rate at therapeutic dose) and 5 relapsed/refractory light chain (AL) amyloidosis patients (100% organ response,

100% complete response rate) have been treated with next-generation CAR-T NXC-201.

– TISSUE SPECIFIC THERAPEUTICS FOR SOLID TUMORS

are a clinical-stage biopharmaceutical company developing a novel class of Tissue-Specific Therapeutics (“TSTx”) TM in

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therapies have been hampered by resistance caused by NF-κB and STAT3 activation.

of March 2022, we have treated 14 patients in our ongoing Phase 1b/2a clinical trial in the United States and Australia.

of February 2023, we have treated the first 2 patients in our ongoing Phase 1b/2a clinical trial of IMX-110 + Novartis/BeiGene anti-PD-1

Tislelizumab.

of February 2023, we have treated 17 patients in our ongoing Phase 1b/2a clinical trial in the United States and Australia.

100% of these

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final clinical study report and (ii) the date of termination of the trial.

In addition, either party may terminate the agreement

(i) upon 30 days prior written notice to the other party if, in the case of our Company, we cease the development of IMX-110 or, in the

case of BeiGene, it ceases the development, marketing and sale of Tislelizumab, (ii) upon written notice to the other party if there

have been one or more serious adverse events indicating a patient safety issue with continuing the trial, (iii) upon written notice to

the other party if a regulatory authority withdraws approval of IMX-110 or Tislelizumab, as applicable, and/or the trial, (iv) upon 60

days notice to the other party with or without reason, (v) immediately upon written notice to the other party if such other party consummates

In addition, either party may terminate the agreement (i)

upon 30 days prior written notice to the other party if, in the case of our Company, we cease the development of IMX-110 or, in the case

of BeiGene, it ceases the development, marketing and sale of Tislelizumab, (ii) upon written notice to the other party if there have

been one or more serious adverse events indicating a patient safety issue with continuing the trial, (iii) upon written notice to the

other party if a regulatory authority withdraws approval of IMX-110 or Tislelizumab, as applicable, and/or the trial, (iv) upon 60 days’

notice to the other party with or without reason, (v) immediately upon written notice to the other party if such other party consummates

a Change of Control Transaction (as defined in the agreement) and/or (vi) upon written notice to the other party in the event such other

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

January 2022, the FDA granted Rare Pediatric Disease Designation (“RPDD”) to IMX-110 for the treatment of rhabdomyosarcoma,

a life-threatening pediatric cancer in children.

RPDD qualifies us to receive fast track review and a priority review voucher (“PRV”)

at the time of marketing approval of IMX-110.

Other Product Candidates

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Building on the well-tolerated profile of our lead candidate from our ongoing

clinical trial, we believe IMX-111 is the first cancer therapeutic to be developed that takes advantage of GLUT1 overexpression

clinical trial, we believe IMX-111 is the first cancer therapeutic to be developed that takes advantage of GLUT1 overexpression in cancer.

is a Tissue-Specific Biologic TM built on our Immune Normalization Technology TM for inflammatory bowel disease with

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(component of a drug) for these overactive immune cells, allowing for tissue-specific delivery of IMX-120.

than IMX-110, the FDA has not given any indication as to whether any of our other product candidates will receive ODD.

ImmixBio SMAR x T Tissue-Specific TM Platform – Summary Rendering

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

tissue sarcomas in the United States during 2020.

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

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

five-year survival rate for all stages of STS is 65.0% in the United States, but this falls to 16.0% for patients with late-stage metastatic

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.

global soft tissue sarcoma market is estimated to reach approximately $6.5 billion by 2030 from the estimated $2.9 billion in 2019.

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

million is the total publicly disclosed combined

annual sales of eribulin (Halaven®), pazopanib (Votrient®), and trabectedin (Yondelis®) according to the most recent available

annual reports.

million is the total publicly disclosed combined annual sales of eribulin (Halaven®), pazopanib (Votrient®), and trabectedin

(Yondelis®) according to the most recent available annual reports.

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

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months was the mPFS observed in STS patients treated with IMX-110 in the United States in our ongoing Phase 1b/2a clinical trial.

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

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

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ImmixBio has evaluable data for 8 patients as of March 2022 (out of n=17, the remaining 9 did not complete any

tumor measurements after enrollment scan).

All 8 evaluable patients have discontinued treatment.

“Heavily Pretreated” refers

to 3-13 lines of therapy.

tumor measurements after enrollment scan, of which 2 due to being dosed in December 2022).

All 8 evaluable patients have discontinued

“Heavily Pretreated” refers to 3-13 lines of therapy.

Dose expressed in mg/m 2 .

Our employees were involved in the design of this study and the results

are unpublished.)

Our employees were involved

in the design of this study and the results are unpublished.)

addition to IMX-110 STS data, a colorectal cancer patient originally considered for hospice, was subsequently treated with IMX-110 for

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Adapted from Sarisozen, et al., 2016)

observed that IMX-110 of statistically significantly increased apoptosis in 3D spheroid U87MG glioblastoma model as measured by increase

observed that IMX-110 has statistically significantly increased apoptosis in 3D spheroid U87MG glioblastoma model as measured by increase

in caspase 3/7 activity after 24 hours versus groups treated with:

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including genetic KPC pancreatic mouse model, xenograft mouse models of various cancers, and in vitro with various cancer cell

observed that IMX-110 statistically significantly inhibited tumor growth in a pre-clinical study that we funded and was conducted on

an industry sponsored research basis in a HCT-116 colon cancer xenograft mouse model (which is poorly sensitive to doxorubicin).

primary endpoint of the study was tumor growth inhibition as measured by tumor volume, with the secondary endpoint being overall survival.

Female nude (NU/NU) mice bearing 250mm 3 HCT-116 tumors were treated every 2 days starting at day 0 (7 total tail vein injections,

arrows correspond to injection days) at a dose of 4 mg/kg CUR and 0.4 mg/kg DOX (six mice per dosing group).

Survival was determined

when the tumor reached 1000mm 3 .

Our employees were involved in the design of this study and Ilya Rachman, our Chief Executive

Officer and Chairman of our board of directors, was a co-author of the results published in 2013.

No adverse side effects of IMX-110

were observed as measured by lack of weight loss.

observed that IMX-110 has statistically significantly inhibited tumor growth in a pre-clinical study that we funded and was

conducted on an industry sponsored research basis in a HCT-116 colon cancer xenograft mouse model (which is poorly sensitive to

doxorubicin).

The primary endpoint of the study was tumor growth inhibition as measured by tumor volume, with the secondary endpoint

being overall survival.

Female nude (NU/NU) mice bearing 250mm 3 HCT-116 tumors were treated every 2 days starting at day

0 (7 total tail vein injections, arrows correspond to injection days) at a dose of 4 mg/kg CUR and 0.4 mg/kg DOX (six mice per

dosing group).

Survival was determined when the tumor reached 1000mm 3 .

Our employees were involved in the design of this

study and Ilya Rachman, our Chief Executive Officer and Chairman of our board of directors, was a co-author of the results published

No adverse side effects of IMX-110 were observed as measured by lack of weight loss.

IMX-110 Tissue-Specific Therapeutic TM with TME Normalization TM Technology Statistically Significantly Inhibited

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of low-dose IMX-110 were alive while all control animals were dead.

observed that IMX-110 monotherapy statistically significantly inhibited tumor growth in a pre-clinical study that we funded and was conducted

in a genetic pancreatic cancer (KPC) mouse model.

The primary endpoint of the study was tumor growth inhibition as measured by tumor

volume and weight.

Transgenic mice (Pdx1-Cre) were treated every day starting at day 0 (5 total tail vein injections, arrows correspond

to injection days) at a dose of 6 mg/kg CUR and 1.4 mg/kg DOX (at least six mice per dosing group).

Survival was determined when the

tumor reached 1500mm 3 .

Surviving animals were euthanized after the last blood collection prior to Day 30, tumors were excised,

measured, weighted, photographed and sectioned for histological analysis.

Our employees were involved in the design of this study and

the results are unpublished.

No adverse side effects of IMX-110 were observed as measured by lack of weight loss.

observed that IMX-110 monotherapy has statistically significantly inhibited tumor growth in a pre-clinical study that we funded and

was conducted in a genetic pancreatic cancer (KPC) mouse model.

The primary endpoint of the study was tumor growth inhibition as

measured by tumor volume and weight.

Transgenic mice (Pdx1-Cre) were treated every day starting at day 0 (5 total tail vein

injections, arrows correspond to injection days) at a dose of 6 mg/kg CUR and 1.4 mg/kg DOX (at least six mice per dosing group).

Survival was determined when the tumor reached 1500mm 3 .

Surviving animals were euthanized after the last blood collection

prior to Day 30, tumors were excised, measured, weighted, photographed and sectioned for histological analysis.

Our employees were

involved in the design of this study and the results are unpublished.

No adverse side effects of IMX-110 were observed as measured

by lack of weight loss.

IMX-110 Tissue-Specific Therapeutic TM with TME Normalization TM Technology Monotherapy Statistically Significantly

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According to American Cancer Society, there were roughly 153,020 new cases of colorectal cancer in the United

Globally, there are roughly 1,930,000 new cases of colorectal cancer each year, of which 519,500 are in Europe, 148,500 are in

Japan, 20,500 are in Australia and New Zealand, and 555,000 are in China.

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

of CRC is 64.7%, but this falls to 14.7% for patients with late-stage metastatic disease.

States in 2023.

Globally, there are roughly 1,930,000 new cases of colorectal cancer each year, of which 519,500 are in Europe, 148,500

are in Japan, 20,500 are in Australia and New Zealand, and 555,000 are in China.

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.

colorectal cancer market is estimated to reach approximately $31.2 billion by 2025 from the estimated $26.3 billion in 2019.

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as Cyramza®, by Eli Lilly).

billion is the total publicly disclosed combined

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

(Cyramza®) according to the most recent available annual reports.

billion is the total publicly disclosed combined annual sales of pembrolizumab (Keytruda®, Merck & Co.), nivolumab (Opdivo®),

bevacizumab (Avastin®), and ramucirumab (Cyramza®) according to the most recent available annual reports.

these therapies are either approved in combination with chemotherapies, or in a small subset of colorectal cancer patients.

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xenograft mouse models of various cancers, and in vitro with various cancer cell lines.

observed that IMX-111 statistically significantly inhibited tumor growth in a pre-clinical study that we funded and was conducted on

an industry sponsored research basis in a HCT-116 colon cancer xenograft mouse model (which is poorly sensitive to doxorubicin).

primary endpoint of the study was tumor growth inhibition as measured by tumor volume, with the secondary endpoint being overall survival.

Female nude (NU/NU) mice bearing 250mm 3 HCT-116 tumors were treated every 2 days starting at day 0 (7 total tail vein injections,

arrows correspond to injection days) at a dose of 4 mg/kg CUR and 0.4 mg/kg DOX (six mice per dosing group).

Survival was determined

when the tumor reached 1000mm 3 .

Our employees were involved in the design of this study and Ilya Rachman, our Chief Executive

Officer and Chairman of our board of directors, was a co-author of the results published in 2013.

No adverse side effects of IMX-111

were observed as measured by lack of weight loss.

observed that IMX-111 has statistically significantly inhibited tumor growth in a pre-clinical study that we funded and was

conducted on an industry sponsored research basis in a HCT-116 colon cancer xenograft mouse model (which is poorly sensitive to

doxorubicin).

The primary endpoint of the study was tumor growth inhibition as measured by tumor volume, with the secondary endpoint

being overall survival.

Female nude (NU/NU) mice bearing 250mm 3 HCT-116 tumors were treated every 2 days starting at day

0 (7 total tail vein injections, arrows correspond to injection days) at a dose of 4 mg/kg CUR and 0.4 mg/kg DOX (six mice per

dosing group).

Survival was determined when the tumor reached 1000mm 3 .

Our employees were involved in the design of this

study and Ilya Rachman, our Chief Executive Officer and Chairman of our board of directors, was a co-author of the results published

No adverse side effects of IMX-111 were observed as measured by lack of weight loss.

IMX-111 Tissue-Specific Biologic TM with TME Normalization TM Technology Statistically Significantly Inhibited

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of low-dose IMX-111 were alive while all control animals were dead.

observed that IMX-111 statistically significantly inhibited tumor growth in a pre-clinical study that we funded and was conducted on

an industry sponsored research basis in a MDA-MB-231 triple-negative breast cancer xenograft mouse model (which is poorly sensitive to

doxorubicin).

The primary endpoint of the study was tumor growth inhibition as measured by tumor volume, with the secondary endpoint

being overall survival.

Female nude (NU/NU) mice bearing 150mm 3 MDA-MB-231 tumors were treated every 2 days starting at day

20 except last injection administered at day 33 (7 total IV injections) at a dose of 6 mg/kg CUR and 1 mg/kg DOX (at least six mice per

dosing group).

observed that IMX-111 has statistically significantly inhibited tumor growth in a pre-clinical study that we funded and was

conducted on an industry sponsored research basis in a MDA-MB-231 triple-negative breast cancer xenograft mouse model (which is

poorly sensitive to doxorubicin).

The primary endpoint of the study was tumor growth inhibition as measured by tumor volume, with

the secondary endpoint being overall survival.

Female nude (NU/NU) mice bearing 150mm 3 MDA-MB-231 tumors were treated

every 2 days starting at day 20 except last injection administered at day 33 (7 total IV injections) at a dose of 6 mg/kg CUR and 1

mg/kg DOX (at least six mice per dosing group).

Survival was determined when the tumor reached 1000mm 3 .

Our employees were involved in the design of this study

and Ilya Rachman, our Chief Executive Officer and Chairman of our board of directors, was a co-author of the results published in 2014.

No adverse side effects of IMX-111 were observed as measured by lack of weight loss.

Our employees

were involved in the design of this study and Ilya Rachman, our Chief Executive Officer and Chairman of our board of directors, was

a co-author of the results published in 2014.

No adverse side effects of IMX-111 were observed as measured by lack of weight

IMX-111 Tissue-Specific Biologic TM with TME Normalization TM Technology Statistically Significantly Inhibited

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Development Strategy

plan to conduct IND-enabling studies for IMX-111 by mid-2022, pursuing advanced colorectal cancer as the initial indication.

We anticipate

filing an IND for IMX-111 in 2023.

We plan to initiate a Phase 1b/2a study with IMX-111 in solid tumors in the United States and Australia,

with the first patient anticipated to be dosed in 2023.

We plan for IMX-111 to pursue advanced colorectal cancer as its initial indication.

plan to conduct IND-enabling studies for IMX-111 in 2023 (completing in in the first half 2024), pursuing advanced colorectal cancer

as the initial indication.

We anticipate filing an IND for IMX-111 in in the first half 2024.

We plan to initiate a Phase 1b/2a study

with IMX-111 in solid tumors in the United States and Australia, with the first patient anticipated to be dosed in 2024.

IMX-111 to pursue advanced colorectal cancer as its initial indication.

Tissue-Specific Biologic TM with Immune Normalization Technology TM for inflammatory bowel disease

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& Johnson), and vedolizumab (marketed as Entyvio®, by Takeda).

billion is the total publicly disclosed combined

annual sales of adalimumab (Humira®), ustekinumab (Stelara®), and vedolizumab (Entyvio®, Takeda) according to the most recent

available annual reports.

billion is the total publicly disclosed combined annual sales of adalimumab (Humira®), ustekinumab (Stelara®), and vedolizumab

(Entyvio®, Takeda) according to the most recent available annual reports.

for clinical trials in IBD are measured in terms of remission rates at 4-8 weeks post treatment.

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Development Strategy

plan to conduct IND-enabling studies for IMX-120 by mid-2022, pursuing ulcerative colitis and severe Crohn’s disease indications.

We anticipate filing an IND for IMX-120 in 2023.

We plan to initiate a Phase 1b/2a study with IMX-120 in IBD in the United States and

Australia with the first patient anticipated to be dosed in 2023.

We plan for IMX-120 to pursue UC and severe CD indications.

plan to conduct IND-enabling studies for IMX-120 in 2023 (completing in the first half of 2024), pursuing ulcerative colitis and severe

Crohn’s disease indications.

We anticipate filing an IND for IMX-120 in the first half of 2024.

We plan to initiate a Phase 1b/2a

study with IMX-120 in IBD in the United States and Australia with the first patient anticipated to be dosed in 2024.

We plan for IMX-120

to pursue UC and severe CD indications.

– CELL THERAPIES FOR HEMATOLOGIC MALIGNANCIES

Inc, our majority-owned subsidiary, is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell

therapies for oncology and other indications.

We believe cell therapies are one of the forward pillars of medicine, and our mission is

to harness the power of cell therapies to rapidly engineer safe, effective, accessible treatments to improve patient outcomes in oncology

and other indications.

Our N-GENIUS cell engineering platform with EXPAND technology has already produced clinical-stage NXC-201, which

we believe is the first outpatient autologous chimeric antigen receptor T-cell therapy (“CAR-T”).

Autologous cells refer

to the patient’s own cells (versus allogeneic, which refers to another person’s cells).

NXC-201 targets B-cell maturation

antigen (“BCMA”) for multiple myeloma (“MM”) and AL amyloidosis (“ALA”).

Though CAR-T cell therapies

have shown benefits to date, they have historically faced barriers to adoption due to prolonged hospitalization with frequent intensive

care unit (“ICU”) stays due to unpredictable onset and duration of immune effector cell-associated neurotoxicity syndrome

(“ICANS”) neurotoxicity and grade 3 and 4 cytokine release syndrome (“CRS”), leading to a 15-day median hospital

stay for CAR-T treatments today.

NXC-201 has already demonstrated class-leading 90% overall response rates, 59% complete response rates,

and favorable tolerability in MM (exemplified by no ICANS neurotoxicity over 42 multiple myeloma patients).

According to the National

Cancer Institute, “overall response” refers to “the percentage of patients whose cancer shrinks or disappears after

treatment” and “complete response” refers to “the disappearance of all signs of cancer in response to treatment.”

Additionally, 8 ALA patients have also been treated by NXC-201 to-date with a 100% hematologic complete response rate, of which 5 published patients demonstrated 100% hematologic complete response

rate and 100% cardiac,

liver, and renal organ system response rate.

Based on NXC-201 short (median onset day 1, median duration 2 day) low-grade CRS, we believe

NXC-201 could require only a 2-3 day hospital stay, potentially reducing hospital stay costs by 80-87% and make NXC-201 the first and

only potential outpatient CAR-T in development.

Additionally, outpatient treatment could create a much larger accessible market/wider

access for NXC-201 (99% of CAR-T today is administered in large academic medical centers, which account for only 5% of medical centers

by count today in the US).

estimate the current market size for multiple myeloma therapies is $18 billion, expected to reach $29 billion in 2027, according to Wilcock,

Nature Reviews .

The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025.

We believe our N-GENIUS platform with EXPAND

technology will allow us to treat additional BCMA-positive indications such as chronic lymphocytic leukemia (“CLL”), follicular

lymphoma (“FL”), Waldenstrom’s macroglobulinemia, and B-cell lymphoma with NXC-201.

We believe our platform will also

accelerate the development of CAR-T NXC-301 for acute lymphoblastic leukemia (“ALL”), large B-Cell lymphoma (“LBCL”)

and mantle cell lymphoma (“MCL”), as well as NXC-401 for Acute myeloid leukemia (“AML”).

We plan to treat oncology

and other indications.

Lead Product Candidate (Nexcella)

currently in Phase 1b/2a clinical trials for relapsed or refractory (“r/r”) MM and relapsed or refractory (r/r) ALA, is a next generation

autologous CAR-T targeting BCMA.

BCMA is a highly expressed protein in a number of hematologic malignancies including MM.

When an antigen

such as BCMA is expressed on cancer cells, NXC-201 is able to target and kill those cancer cells, sparing healthy tissue.

BCMA has been

shown to be over-expressed on MM, LBCL, CLL, ALA and other plasma cell dyscrasia diseased cells.

Multiple Myeloma Clinical Data To-Date

in Haematologica in 2022 and presented at the 5th European CAR T-cell Meeting, we recently announced positive interim results

for the 42 patients enrolled in our ongoing NEXTIVATE-1 (NCT04720313) Phase 1b/2a clinical trial of NXC-201, our lead product candidate,

for the treatment of patients with relapsed or refractory (r/r) MM.

As of the October 23, 2022 data cutoff date, based on median follow-up

of 146 days (range, 18-314), clinical data is presented below.

These data comprised the dose escalation cohorts for the first dose level

(DL1) (150 million CAR+ T cells, n=6), the second dose level (DL2) (450 million CAR+ T cells, n=7), and the third, therapeutic dose level

(DL3) (800 million CAR+ T cells, n=29).

highlights from the MM data presented are as follows:

overall response rate (“ORR”) was observed in 29 multiple myeloma patients receiving

the therapeutic dose of NXC-201

of 29 (59%) of patients receiving the therapeutic dose reached complete response (“CR”)

or stringent complete response (“sCR”)

was manageable and no neurotoxicity was observed

therapeutic dose of NXC-201 (800 million CAR+T cells) has been established as the recommended

Phase 2 dose (“RP2D”)

supports investigating NXC-201 as the first potential outpatient CAR-T cell therapy

patients in the clinical trial experienced Grade 4 CRS

1 patient in the clinical trial experienced Grade 3 CRS

longest response in the clinical trial so far was over 11 months

42 patients treated as of the October 23, 2022 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome

inhibitor and 1 anti-CD38 antibody).

AL Amyloidosis Clinical Data To-Date

ALA patients have been treated by NXC-201 to-date with a 100% hematologic complete response rate, of which, 4 were Published in Clinical

Cancer Research in 2022 and presented at the 5th European CAR T-cell Meeting.

We recently published positive interim results for the

first 5 patients enrolled in our ongoing clinical trial of NXC-201, our lead product candidate, for the treatment of patients with ALA.

of the October 23, 2022 cutoff for 5 patients treated with NXC-201 with r/r ALA:

100% organ response rate:

organ response rate (cardiac)

organ response rate (renal)

organ response rate (kidney)

100% complete responses (MRD negativity 10 -5 ) were produced by NXC-201.

data comprised the dose escalation cohorts for the first dose level (DL1) (150 million CAR+ T cells, n=1), the second dose level (DL2)

(450 million CAR+ T cells, n=2), and the third, therapeutic dose level (DL3) (800 million CAR+ T cells, n=2).

information is available in our Clinical Cancer Research publication for the first 4 ALA patients treated with NXC-201.

the February 26, 2022 publication date, based on median follow-up of 5.2 months, key highlights are as follows:

100% organ response rate:

organ response rate (cardiac)

organ response rate (renal)

organ response rate (kidney)

100% achieved CR (MRD negativity 10 -5 )

2-stage improvement in New York Heart Association (“NYHA”) Heart Failure Stage was observed with NXC-201

Mean 65% reduction (2,656pg/mL) in NT-proBNP from baseline

No patients experienced ICANS neurotoxicity

No patients experienced Grade 4 CRS

the 4 patients in the ongoing AL amyloidosis clinical trial as of the February 26, 2022 publication date, of the patients with NYHA stage

> 2, 1 was stage 4, and 2 were stage 3.

After treatment with NXC-201, the stage 4 patient improved to stage 2, and both of the stage

3 patients also improved to stage 2.

Pre-treatment

Post-treatment

NXC-201 Treatment Effect

NYHA Stage Reduction

the ongoing AL amyloidosis clinical trial, N-terminal (NT)-pro hormone BNP (NT proBNP) (pg/mL) levels were reported.

the Cleveland Clinic, for patients above 50 years of age, >900 NT proBNP (pg/mL) could mean heart function is unstable.

patients in the ongoing AL amyloidosis ALA clinical trial as of the February 26, 2022 publication date, 3 had pre-treatment NT

proBNP levels of 7,500, 2,800 and 2,773, respectively, which were reduced to 2,700 (4,800 point reduction), 1,505 (1,295 point

reduction) and 901 (1,872 point reduction) (units:

pg/mL), respectively, after treatment with NXC-201.

Pre-treatment

ProBNP (pg/mL)

Post-treatment

ProBNP (pg/mL)

Treatment Effect

ProBNP absolute reduction (pg/mL)

Treatment Effect

ProBNP percentage reduction (pg/mL)

our ongoing AL amyloidosis clinical trial, N-terminal (NT)-pro hormone BNP (NT proBNP) (pg/mL) levels were reported.

According to the

Cleveland Clinic, for patients above 50 years of age, NT proBNP >900 (pg/mL) could mean heart function is unstable.

Of the 4 patients

in the ongoing AL amyloidosis clinical trial as of the February 26, 2022 publication date, 3 had pre-treatment NT proBNP levels of 7,500,

2,800 and 2,773, respectively, which were reduced to 2,700 (4,800 point reduction), 1,505 (1,295 point reduction) and 901 (1,872 point

reduction) (units:

pg/mL), respectively, after treatment with NXC-201.

Potentially The First Outpatient CAR-T

believe NXC-201 is the first and only potential next-generation CAR-T treatment that could be delivered as an outpatient

Outpatient therapy may enable NXC-201

to address a much larger accessible market/wider access to NXC-201 CAR-T therapy (99% of CAR-T today is administered in large academic

medical centers, which account for only 5% of medical centers by count today in the US).

Additionally, NXC-201 treatment may result in

an 80-87% reduction in hospital stay costs (2-3 day hospital stay NXC-201 vs.

15-day CAR-T standard).

multiple myeloma, as of the October 23, 2022 data cutoff, low-grade CRS duration of median 2 days at therapeutic dose (range:

(n=42) points to NXC-201 potentially becoming the first and only out-patient CAR-T for Multiple Myeloma and other BCMA-positive malignancies.

AL amyloidosis, as of the October 23, 2022 publication date, no grade 4 CRS was observed, and CRS duration of median 4 days at therapeutic

1-5 days) (n=5) points to NXC-201 potentially becoming the first and only out-patient CAR-T for AL Amyloidosis.

Market Opportunity (Nexcella)

hematologic cancer market size is $60 billion today, growing to $120 billion in 2028.

– Multiple Myeloma

estimate the current market size for multiple myeloma therapies is $18 billion, expected to reach $29 billion in 2027, according to Wilcock,

Nature Reviews .

myeloma (“MM”) is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive

proliferation of these cells.

Despite initial remission, unfortunately, most patients are likely to relapse.

There are 34,470 patients

in the United States diagnosed with MM each year.

Prognosis for patients who do not respond to or relapse after treatment with standard

therapies, including protease inhibitors and immunomodulatory agents remains poor.

is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological

cancer cases, 20% of deaths due to hematological malignancies and impacting over 100,000 patients globally each year.

The Surveillance,

Epidemiology, and End Results (“SEER”) Program database projects that approximately 35,000 new cases of MM in the United States and over

35,000 new cases in six select markets within Europe and Asia.

2021, the FDA approved idecabtagene vicleucel (marketed as ABECMA® by Bristol Myers Squibb), at the time the only BCMA-targeted CAR-T

for multiple myeloma.

ABECMA® was approved based on a 100-patient, open-label MM study which resulted in a complete response rate

of 28% and >= Grade 3 neurotoxicity of 8% at the therapeutic dose, according to the ABECMA® FDA approval label.

December 2022, Gilead paid $225 million upfront and invested $100 million in Arcellx, Inc.

in exchange to equally share profits of CART-ddBCMA,

a BCMA-targeted CAR-T for multiple myeloma.

CART-ddBCMA was evaluated in a clinical trial in which 19 patients were treated at the therapeutic

dose, which resulted in a complete response rate of 71%, and >= Grade 3 neurotoxicity of 4%, according to Arcellx, Inc.

– AL amyloidosis

estimate the current market size for amyloidosis therapies is $3.6 billion, expected to reach $6 billion in 2027.

is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow.

Misfolded amyloid proteins produced by plasma

cells cause buildup in and around tissues, nerves and organs, gradually affecting their function.

This can cause progressive and widespread

organ damage, and high mortality rates.

affects roughly 30,000 – 40,000 patients in total throughout the U.S.

and Europe, and it is estimated that there are approximately

3,000 – 4,000 new cases of AL amyloidosis annually in the U.S., though actual incidence is likely higher as a result of under-diagnosis.

Amyloidosis has a one-year mortality rate of 47 percent, 76 percent of which is caused by cardiac amyloidosis.

ALA remains a high unmet need disease with just one FDA approved therapy

in the last two decades - daratumumab.

2021, the FDA approved daratumumab (marketed as DARZALEX® by Janssen/Johnson & Johnson), which is the only FDA approved therapy

for AL amyloidosis.

Daratumumab (DARZALEX®) was trialed in an ALA study where daratumumab was combined with cyclophosphamide + bortezomib

+ dexamethasone in a 4-drug combination, which produced a 53% hematologic complete response rate with a 42% organ response rate (cardiac)

according to Kastritis, et al., 2021.

● We are leveraging market CAR-T experience so far—manufacturing consistency,

automation technology, efficacy, tolerability.

for MM CAR-Ts continues to exceed supply – there are currently only 2 MM CAR-Ts on

common with approved CAR-Ts:

High grade Cytokine Release Syndrome (> grade 3) and neurotoxicity

side-effects.

● Bi-specifics/Allogeneic

CAR-Ts still work in progress.

Pipeline (Nexcella)

are building a broad and scalable pipeline that has positioned us to capitalize on the potential of our proprietary platform technologies

and achieve long-term growth and sustainability within the field of cell therapy.

We believe our N-GENIUS platform and EXPAND technology

will enable us to target a range of hematologic malignancies.

have worldwide rights to all of our programs and have summarized our preclinical and clinical programs in the pipeline chart below:

are in the process of extending our ongoing NEXICART-I (NCT04720313) Phase 1b/2a clinical trial to the United States, which could cause

NEXICART-I to be a registrational clinical trial, generating clinical data that could be included in a Biologics License Application

(BLA) to the U.S.

Food and Drug Administration (FDA).

Based on our current regulatory pathway, we believe that results from our NEXICART-I

trial, if positive, together with clinical results from our United States studies could be sufficient to support the filing of a BLA.

Platform and Technologies (Nexcella)

N-GENIUS platform has broad potential utility in hematologic and autoimmune disease.

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

(1) Purpose-Built Cell Therapy Evidence Capture Engine + Relational Database, which relates Nexcella 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, to potentially increase efficacy and tolerability;

and (3) Atomized, Novel Binding Scaffold Generation

Engine, which allows us to make the correct binding for every molecule.

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 (lower dose may lead to

lower toxicity), (b) low tonic signaling (lower off-target toxicity may lead to lower toxicity), and (c) anti-exhaustion capability (increased

persistence may lead to efficacy over an extended period of time).

Clinical Development Plan and Milestones (Nexcella)

are in the process of extending our ongoing NEXICART-I (NCT04720313) Phase 1b/2a clinical trial to the United States, which could cause

NEXICART-I to be a registrational clinical trial, generating clinical data that could be included in a Biologics License Application

(BLA) to the U.S.

Food and Drug Administration (FDA).

We also intend to rapidly pursue clinical development of NXC-201 in AL Amyloidosis,

in earlier lines of multiple myeloma therapy, and other BCMA-positive hematologic malignancies on an outpatient basis.

MM, we plan to enroll approximately 100 patients in our ongoing open-label study at the recommended phase 2 dose, then submit a BLA for

approval to the FDA.

ALA, we plan to enroll approximately 30-40 patients in an open-label study at the recommended phase 2 dose, then submit a BLA for approval

2023, we plan to continue to report interim data results from our ongoing phase 1b/2a NXC-201 clinical trial, complete a pre-IND meeting

with the FDA, file an IND for US phase 2 trial for NXC-201, and open a US clinical trial for NXC-201.

plan to submit our first NXC-201 BLA to the FDA in the first half of 2025.

believe that the foundation of our competitive advantage is our proprietary technology, clinical evidence, track record of execution,

manufacturing success, and assembly of a proven management team.

We believe these advantages may position us to achieve significant market

share in a large and attractive market and to ultimately transform the cell therapy market, contributing to a significant advancement

Manufacturing

have already established a track record of producing 4 batches of our Tissue-Specific Therapeutics (TSTx) TM according to

current Good Manufacturing Practice (“cGMP”), and have treated 14 patients so-far in our ongoing Phase 1b/2a clinical trial

as of March 2022.

have already established a track record of producing 7 batches of our TSTx according to current Good Manufacturing Practice (“cGMP”),

and have treated 17 patients so-far in our ongoing Phase 1b/2a clinical trial as of February 2023.

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

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Inc., Landos Biopharma Inc., and Seres Therapeutics Inc.

developing CAR-Ts targeting multiple myeloma include, but are not limited to, Janssen/Johnson & Johnson, Bristol Myers Squibb, and

Arcellx, Inc.

Companies developing therapies for AL amyloidosis include, but are not limited to, Prothena Corp, Caelum Biosciences (Now

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

– Soft Tissue Sarcoma

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Pembrolizumab monotherapy produced a mPFS in sarcoma of 4.2 months, according to Tawbi et al., 2017.

addition to the above, companies with approved therapies and that are developing therapies for soft tissue sarcoma include, but are not

limited to, BioAtla Inc., Epizyme Inc., Nanobiotix SA, C4 Therapeutics, Inc., Adaptimmune Therapeutics plc, Eisai, Novartis, and Janssen/Johnson

addition to the above, companies with approved therapies and that are developing therapies for soft tissue sarcoma include, but are

not limited to, BioAtla Inc., Epizyme Inc., Nanobiotix SA, C4 Therapeutics, Inc., Adaptimmune Therapeutics plc, Eisai, Novartis,

Mirati Therapeutics, Inc., 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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of March 17, 2023, our patent portfolio includes 11 U.S.

and foreign patents, 4 pending U.S.

and foreign patent applications,

and 3 pending U.S.

provisional patent applications related to our technology platform and our product candidates.

Of those, 1 patent

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.

One non-provisional patent application is currently pending in the U.S.

and 3 foreign patent applications are currently

pending before the European Patent Office, and in China and Hong Kong.

and foreign granted patents, 3 pending U.S.

and foreign patent

applications, 2 pending international (PCT) patent applications, and 1 pending U.S.

provisional patent application related to our

technology platform and our product candidates.

Of those, 1 patent 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.

One non-provisional patent application is

currently pending in the U.S.

and 2 foreign patent applications are currently pending before the European Patent Office and Hong Kong.

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

Other patents directed to platform technology are expected to remain in force until 2036.

Other patents directed to platform

technology are expected to remain in force until 2036.

below patents and patent applications comprise our patent portfolio.

All of the patents and patent applications listed below are owned

and related compositions for the treatment of cancer

and methods of treatment

Nanoparticles

for the treatment of inflammatory diseases

and methods of treatment

Nanoparticles

for cancer treatment

and methods of treatment

Expected Expiration Date

Type of Patent Protection

United States

Nanoparticles

for cancer treatment

Cancer therapeutics

Methods of treatment

United States

Methods and related compositions for the treatment of cancer

Compositions and methods of treatment

ciblant le Glut-1 et comprenant de la curcumine (Glut-1 targeted and curcumin loaded micelles)

zielgerichtete und mit Kurkumin beladene Mizellen (Glut-1 targeted and curcumin loaded micelles)

targeted and curcumin loaded micelles

zielgerichtete und mit Kurkumin beladene Mizellen (Glut-1 targeted and curcumin loaded micelles)

targeted and curcumin loaded micelles

Patent Office

comprising an inhibitor of NF-KB

42021037058.1

201680069854.2

United States

Nanoparticles for the treatment of inflammatory diseases

Compositions and methods of treatment

PCT/US2022/036419

Nanoparticles for cancer treatment

Compositions and methods of treatment

PCT/US22/44948

Nanoparticles for cancer treatment

Compositions and methods of treatment

Micelles ciblant le Glut-1 et comprenant de la curcumine (Glut-1 targeted and curcumin loaded micelles)

Glut-1 zielgerichtete und mit Kurkumin beladene Mizellen (Glut-1 targeted and curcumin loaded micelles)

Glut-1 targeted and curcumin loaded micelles

Glut-1 zielgerichtete und mit Kurkumin beladene Mizellen (Glut-1 targeted and curcumin loaded micelles)

United Kingdom

Glut-1 targeted and curcumin loaded micelles

European Patent Office

Micelle comprising an inhibitor of NF-KB

42021037058.1

(Methods and related compositions for the treatment of cancer)

Compositions,

methods and use

Micelle comprising an inhibitor of NF-kB

et compositions associées pour le traitement du cancer (methods and related compositions for the treatment of cancer)

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and related compositions for the treatment of cancer

Additionally,

as of March 17, 2022, Nexcella, Inc.

has global exclusive rights to patents #63/308,277, #63/368,002, PCT/IL2023/050142 which are directed to our N-GENIUS platform,

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

The patents include one pending PCT application (PCT

Application No.

PCT/IL2023/050142), filed in 2023.

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.

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

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

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

Subject to certain

exceptions, the MSA shall continue for a period of five years from the effective date, unless extended by us and AxioMx.

be terminated by either party upon a material breach of the MSA, which breach remains uncured for 30 days after written notice thereof.

In addition, we may also terminate the MSA at any time upon 30 days prior written notice to AxioMx.

The MSA has not been amended or extended,

however, the royalty obligations described in this paragraph survive the termination of the MSA.

January 5, 2022, we sold 630,000 shares of our common stock in connection with our initial public offering pursuant to the underwriter’s

option to purchase additional shares to cover over-allotments for a purchase price of $5.00 per share.

We received net proceeds of approximately

$2.9 million, after deducting underwriting discounts and commissions and offering expenses borne by us.

As of December

31, 2022, 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.

and License Agreement with Hadasit and BIRAD

December 8, 2022, Nexcella entered into a Research and License Agreement (the “Agreement”) with Hadasit Medical Research Services

& Development, Ltd.

and BIRAD – Research and Development Company Ltd.

(collectively, the “Licensors”) pursuant to

which the Licensors granted to Nexcella an exclusive, worldwide, royalty-bearing license throughout the world, except Israel, Cyprus and

other countries in the Middle East (the “Territory”), to an invention entitled “Anti-BCMA CAR-T cells to target plasma

cell” to develop, manufacture, have manufactured, use, market, offer for sale, sell, have sold, export and import the Licensed Product

(as defined in the Agreement).

Pursuant to the Agreement, Nexcella shall paid the

Licensors an upfront fee of $1,500,000 in December 2022 .

Additional quarterly payments totaling approximately $13.0 million are due through September 2026 along with an annual license fee of

Nexcella has agreed to pay royalties to the Licensors equal to 5% of based on 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.

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.

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 Nexcella (the “Nexcella Founders Agreement”).

Pursuant 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 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.

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.

On December 8, 2022,

we issued an aggregate of 350,000 shares of Nexcella restricted common stock to our officers for services to be performed, which shares

vest in 48 equal monthly installments.

12, 2023, Nexcella entered into share purchase agreements with certain accredited investors for their purchase of an aggregate 100,152

shares of Nexcella’s common stock at a purchase price of $6.49 per share, for gross proceeds of approximately $650,000.

our Chief Executive Officer and Chief Financial Officer collectively purchased 23,112 shares of Nexcella’s common stock for an aggregate

purchase price of $150,000.

As a result of the foregoing offering, as of January 12, 2023, we owned 98% of Nexcella.

22, 2023, we entered into an ATM Sales Agreement (the “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 having an aggregate offering

price of up to $5,000,000, subject to the terms and conditions set forth in the Sales Agreement.

We will pay the Sales Agent a fixed commission

rate of 3.75% of the aggregate gross proceeds from the sale of the shares of our common stock pursuant to the Sales Agreement.

paid an expense deposit of $15,000 to the Sales Agent, which will be applied against the actual out-of-pocket accountable expenses.

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 shall 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.

The offering pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all of the shares

of common stock subject to the Sales Agreement, and (ii) termination of the Sales Agreement as permitted therein.

We may terminate

the 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 Sales Agreement under the circumstances specified in the Sales Agreement and in its sole discretion at any time by giving

ten days’ prior notice to us.

In addition, the Sales Agreement may be terminated upon mutual agreement by us and the Sales Agent.

States Regulation of Drugs and Biologics

expect that IMX-110 will be regulated by the FDA as a complex non-biologic, and will require submission of a New Drug Application

(“NDA”) to the FDA.

We expect that IMX-111 and IMX-120 will be regulated by the FDA as a biological product, or biologic,

which will require submission of a Biologics License Application (“BLA”) to the FDA.

We expect to pursue United States

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

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

We expect that IMX-111 and IMX-120 will be regulated by the FDA as a biological product, or biologic, by submitting a Biologics License

Application (“BLA”) to the FDA.

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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Development and Review Programs

Fast Track Designation

FDA offers several expedited development and review programs for qualifying product candidates.

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

Breakthrough Therapy Designation

product intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation

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

Priority Review

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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approval, pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

Medicine Advanced Therapy Designation

passage of the Cures Act in December 2016, Congress authorized the FDA to accelerate review and approval of products designated as

regenerative medicine advanced therapies.

A product is eligible for RMAT designation if it is a regenerative medicine therapy that

is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and preliminary clinical evidence

indicates that the product has the potential to address unmet medical needs for such disease or condition.

Regenerative medicine

therapies include cell therapy, therapeutic tissue engineering product, human cell and tissue products and combination products that

use such products.

The benefits of a regenerative medicine advanced therapy designation include early interactions with FDA to

expedite development and review, benefits available to breakthrough therapies, potential eligibility for priority review, and

accelerated approval based on surrogate or intermediate endpoints.

RMAT designation may be rescinded if a product no longer meets

the qualifying criteria.

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.

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

or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates,

infants, children, and adolescents;

and (b) rare disease or conditions within the meaning of the Orphan Drug Act.

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.

Drug Designation

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

warning letters or holds on post-approval clinical trials;

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

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The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential

civil and criminal penalties.

Physicians may prescribe legally available products for uses that are not described in the product’s

labeling and that differ from those tested by us and approved by the FDA.

Such off-label uses are common across medical specialties.

comply with these requirements can result in, among other things, adverse publicity, warning or untitled letters, corrective advertising

and potential civil and criminal penalties.

Physicians may prescribe legally available products for uses that are not described in the

product’s labeling and that differ from those tested by us and approved by the FDA.

Such off-label uses are common across medical

Physicians may believe that such off-label uses are the best treatment for patients in varied circumstances.

The FDA does not regulate

the behavior of physicians in their choice of treatments.

The FDA does, however, restrict manufacturer’s communications on the

subject of off-label use of their products.

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

The FDA does, however, restrict manufacturer’s communications

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

Drug Development

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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 (“CTR”), which replaced the

current Clinical Trials Directive 2001/20/EC.

The CTR became applicable on January 31, 2022.

There is a three-year transition period,

where entities that set up clinical trials will have time to transition ongoing trials to the new CTR.

By January 31, 2025,

all clinical trials must be transitioned to the CTR.

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, by providing, for example a streamlined application procedure via a single point and strictly

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.

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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 (for indications other than those identified above), 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 a 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.

may extend the timeframe of evaluation of a MA application considerably beyond 210 days.

Where the CHMP gives a positive opinion,

the EMA provides the opinion together with supporting documentation to the European Commission, who make the final decision to grant

a marketing authorization, which is issued within 67 days of receipt of the EMA’s recommendation.

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.

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 to conduct an accelerated assessment.

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.

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

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

Commission, who make the final decision to grant a marketing authorization, which is issued within 67 days of receipt of the EMA’s

recommendation.

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.

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

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

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The ICH guidelines must

be followed across all areas of clinical research, including those related to pharmaceutical quality, nonclinical and clinical

be complied with across all fields of clinical research, including those related to pharmaceutical quality, nonclinical and clinical

data requirements and trial designs.

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approval for the conduct of the trial has been obtained from an ethics committee and the institution at which the trial will be conducted.

Therapeutic Goods Act 1989 (the Act) requires

that medical products, including pharmaceuticals, imported into, supplied in, or exported from Australia be included

in the Australian Register of Therapeutic Goods (“ARTG”).

In order to obtain registration of the product on the

must provide a product application containing adequate nonclinical data as well as data from

adequate and well-controlled clinical trials that demonstrate the safety and efficacy of the therapeutic product;

also must provide information demonstrating that the manufacture and quality of the therapeutic product complies with the principles

then evaluates the application data, taking into account recommendations from an advisory committee, such as the Advisory Committee

on Medicines, which makes recommendations to the TGA as to whether or not to grant approval to include the therapeutic product in

TGA must decide to include the

therapeutic product on the ARTG.

for inclusion in the Australian Register of Therapeutic Goods (“ARTG”) is required before a pharmaceutical product may be

marketed (or imported, exported or manufactured) in Australia.

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.

and Procedures Governing Approval of Products in Other Jurisdictions

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provides for the imposition of civil penalties.

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

(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.

These state laws may cover all (not just Medicare

and Medicaid) patients.

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.

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

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

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

of March 23, 2022, we had two full-time employees, no part-time employees and seven consultants.

We are not a party

to any collective bargaining agreements.

We believe that we maintain good relations with our employees.

of March 17, 2023, we had 11 employees, 9 of which are full-time employees.

Of such employees, 7 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.

Corporate History

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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.

ImmixBio currently

owns 98% of Nexcella.

website address is www.immixbio.com .

The contents of, or information accessible through, our website are not part of this Annual

Report on Form 10-K, and our website address is included in this document as an inactive textual reference only.

The contents of, or information accessible through, our website are not part of this

Annual Report on Form 10-K, and our website address is included in this document as an inactive textual reference only.

We make our filings

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The address of the SEC’s website is www.sec.gov .

The information contained in the SEC’s website is not

intended to be a part of this filing.

The information contained in the SEC’s website

is not intended to be a part of this filing.

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