Form 8-K

8-K — Immix Biopharma, Inc.

Accession: 0001493152-26-024707

Filed: 2026-05-21

Period: 2026-05-21

CIK: 0001873835

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

DC 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of

the

Securities Exchange Act of 1934

Date

of report (Date of earliest event reported): May 21, 2026

IMMIX

BIOPHARMA, INC.

(Exact

Name of Registrant as Specified in Its Charter)

Delaware

001-41159

45-4869378

(State

or Other Jurisdiction

Incorporation)

(Commission

File

Number)

(I.R.S.

Employer

Identification

Number)

11400

West Olympic Blvd., Suite 200

Los

Angeles, CA 90064

(Address

of principal executive offices)

(310)

651-8041

(Registrant’s

telephone number, including area code)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under

any of the following provisions.

☐

Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14d-2(b)

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)

Securities

registered pursuant to Section 12(b)of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock, par value of $0.0001 per share

IMMX

The

Nasdaq Stock Market LLC

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ☒

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

7.01 Regulation FD Disclosure.

May 21, 2026, Immix Biopharma, Inc. (the “Company”) issued a press release announcing that all four MRD-negative relapsed/refractory

light chain (“AL”) Amyloidosis patients announced by the Company at the American Society of Hematology 2025 Annual Meeting

(“ASH 2025”) held in Orlando, Florida in December have converted to complete response (“CR”). A copy of the press

release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”).

accordance with General Instruction B.2 of Form 8-K, the information in Item 7.01 of this Current Report and Exhibit 99.1 attached hereto

shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange

Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration

statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set

forth by specific reference in such filing. In addition, the information set forth under this Item 7.01, including Exhibit 99.1, shall

not be deemed an admission as to the materiality of any information in this Current Report.

Item

8.01 Other Events.

May 21, 2026, the Company announced an update from the Phase 2 NEXICART-2 NXC-201

clinical trial, including that all four MRD-negative relapsed/refractory AL Amyloidosis

patients announced by the Company at the ASH 2025 have converted to CR. Of the first 20 patients in NEXICART-2, all MRD-negative

patients have converted to CR, increasing the CR rate to 95% (19/20). No relapses have been observed to date for patients who have

reached CR, and all CRs were reached within one year of follow-up post-dosing. Additionally, MRD-negativity 10-5 was

achieved within 30 days for all MRD-negative patients. As of May 14, 2025, 17 of 20 patients in

NEXICART-2 showed rapid normalization of diseased light chains in patients with a median time to initial response of 7 days. Safety

data through May 14, 2026 has been generally consistent with previous safety data observed and reported in NEXICART-2 trial. The

next NEXICART-2 update is expected in late September 2026. NEXICART-2

is a fully enrolled 45-patient multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory

AL Amyloidosis, with a potentially registrational design. A multi-center, randomized, Phase 3

trial of NXC-201 in newly diagnosed AL Amyloidosis patients is planned to be initiated in the first half of 2027.

Risk

Factors

The

risk factor listed below should be read in conjunction with the risk factors disclosed in the Company’s Annual Report on Form 10-K

for the year ended December 31, 2025.

Interim

data from clinical trials are subject to various risks, including that final results may be materially different than those reflected

in any interim data and that third parties, including regulatory agencies may disagree with the analysis used to interpret the interim

data.

Interim

data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as more data on existing

patients become available. When a clinical trial is ongoing, the final results from the trial may be materially different from those

reflected in any interim data the Company reports.

Further,

others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses

or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability

or commercialization of the particular product candidate or product and the value of the Company in general. In addition, the information

the Company chooses to publicly disclose regarding a particular study or clinical trial is typically a summary of extensive information,

and you or others may not agree with what the Company determines is the material or otherwise appropriate information to include in its

disclosure. Any information the Company determines not to disclose may ultimately be deemed significant with respect to future decisions,

conclusions, views, activities or otherwise regarding a particular product, product candidate or its business. If the interim data that

the Company reports differs from actual results, or if others, including regulatory authorities, disagree with the conclusions reached,

the Company’s ability to obtain approval for, and commercialize, its product candidates, including NXC-201, may be harmed.

Cautionary

Note Regarding Forward-Looking Statements

This

Current Report contains “forward-looking” statements within the meaning of the Securities Act, the Securities Exchange

Act of 1934, as amended, and of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995,

including, but not limited to statements regarding the expected timing of the next NEXICART-2 update and the Company’s plans

to initiate a multi-center, randomized, Phase 3 trial of NXC-201 in newly diagnosed AL Amyloidosis

patients, including the timing thereof. All statements other than statements of historical fact are statements that could be deemed

forward-looking statements. The words “believes,” “anticipates,” “estimates,”

“plans,” “expects,” “intends,” “may,” “could,” “should,”

“potential,” “likely,” “projects,” “continue,” “will,”

“schedule,” and “would” and similar expressions are intended to identify forward-looking statements,

although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based

on the Company’s current expectations and projections about future events and various assumptions, including without

limitation regarding the timing and results of the Company’s clinical trials, and the regulatory landscape. Forward-looking

statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ

significantly from those expressed in any forward-looking statement, including risks and uncertainties described herein, under the

heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, its

Quarterly Reports on Form 10-Q and other documents that the Company files from time to time with the SEC. The forward-looking

statements in this Current Report speak only as of the date hereof, the Company undertakes no obligation to revise or update any

forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law.

Item

9.01 Financial Statements and Exhibits.

The

following exhibits are furnished with this Current Report on Form 8-K:

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press

Release, dated May 21, 2026.

104

Cover

Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

Immix

Biopharma, Inc.

Dated:

May 21, 2026

/s/

Ilya Rachman

Ilya

Rachman, M.D., Ph.D.,

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Immix

Biopharma Announces 95% complete response rate in interim update from relapsed/refractory AL Amyloidosis Clinical Trial

NEXICART-2

–

Of first 20 patients, all four MRD-negative patients have converted to complete response (CR) –

– CR rate now 95% (19 of 20 patients) –

–

All CRs reached within 1 year of follow-up post-dosing –

–

No relapses to-date observed for patients who have reached CR –

–

All subsequently enrolled patients for whom MRD results are available are MRD-negative at one month –

–

Next NEXICART-2 Update Expected Late September, 2026 –

LOS

ANGELES, May 21, 2026 (GLOBE NEWSWIRE) – Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We”

or “Us” or “IMMX”), a global leader in AL Amyloidosis, today announced that all four relapsed/refractory AL Amyloidosis

MRD-negative patients presented at ASH 2025 have converted to complete response (CR). The NEXICART-2 CR rate is now 95% (19 out

of 20 patients). All CRs were reached within 1 year of follow-up post-dosing. No relapses have been observed as of today for patients

who have reached CR. All subsequently enrolled patients for whom MRD results are available are MRD-negative at one month. The next NEXICART-2

update is expected late September 2026.

These

results support the Company’s plan to initiate a multi-center, randomized Phase 3 trial in newly diagnosed AL Amyloidosis patients.

“Even

in a heavily pretreated population of median 4 prior lines of therapy, we are pleased that NXC-201, as a 5th line of therapy,

drives MRD-negativity, converting to durable CRs to-date, indicating that NXC-201 can eliminate the source of toxic light chains

that clog up the heart, kidney and liver, causing organ failure and death in relapsed/refractory AL Amyloidosis. As a potential frontline

therapy in AL Amyloidosis, we believe there’s potential to transform a usual 2-year treatment, into a one-and-done: NXC-201.”

Gabriel Morris, President, Chief Financial Officer of Immix Biopharma, added, “We have observed the NEXICART-2 CR rate improving

over time. In September 2026 we plan to present updated data from our ongoing NEXICART-2 trial. By end of March 2027, we expect to

present 1-year follow-up data of enrolled patients, which we expect will drive BLA submission and commercial launch.”

About

NEXICART-2

(NCT06097832) is a multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis,

with a registrational design. NEXICART-2 is a 45-patient study.

About

AL Amyloidosis

Amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces

toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.

The

number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron,

et al Blood Cancer Journal, to approximately 38,500 patients in 2026.

The

Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research as of 2023.

About

NXC-201

is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a “digital filter” that is

designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic

light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the

FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

About

Immix Biopharma, Inc.

Immix

Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune

system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ

failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201

with a “digital filter” that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize

and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory

AL Amyloidosis NEXICART-2 (NCT06097832), with a potentially registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the

US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.

Forward

Looking Statements

This

press release contains forward-looking statements regarding Immix Biopharma, Inc., its results of operations, prospects, future business

plans and operations and the matters discussed above, including, but not limited to, statements relating to upcoming NEXICART-2 results

and our expectations surrounding the durability of clinical response, timing and expectations relating to our planned BLA submission

and commercial launch thereafter, if approved; the size of the AL Amyloidosis market; the potential benefits of our product candidate

CAR-T NXC-201 and the timing and results related to clinical trials. These statements involve risks and uncertainties, and actual results

may differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements also

include, but are not limited to, our plans, objectives, expectations and intentions and other statements that contain words such as “expects”,

“contemplates”, “anticipates”, “plans”, “intends”, “believes”, “estimates”,

“potential”, and variations of such words or similar expressions that convey the uncertainty of future events or outcomes,

or that do not relate to historical matters. Those forward-looking statements involve known and unknown risks, uncertainties and other

factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the estimates for the number

of patients in the U.S. with relapsed/refractory AL Amyloidosis and the market size reaching not being accurate; (ii) the risk that Breakthrough

Therapy designation will not expedite the development of NXC-201; (iii) the risk that further data from the ongoing Phase 1/2

clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date; (iv) the risk that the Company

may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (v) the risk that the Company may not be able to

advance to registration-enabling studies for CAR-T NXC-201 or other product candidates; (vi) that success in early phases of

pre-clinical and clinicals trials do not ensure data from such clinical trials, or subsequent clinical trials will be successful; (vii)

that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug

product; (viii) the risk that the Company may not be able to obtain additional working capital with which to continue the clinical

trials for CAR-T NXC-201, or advance to the initiation of registration-enabling studies, for such product candidates as and when needed

and (ix) those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form

10-K filed with the SEC on March 25, 2026, and other periodic or current reports subsequently filed with the Securities and Exchange

Commission. These reports are available at www.sec.gov. Immix Biopharma cautions that the foregoing list of important factors is not

complete. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake,

and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as

they occur, except as required by law. If we update one or more forward-looking statements, no inference should be drawn that we will

make additional updates with respect to those or other forward-looking statements.

Contacts

Mike

Moyer

LifeSci

Advisors

mmoyer@lifesciadvisors.com

Company

Contact

irteam@immixbio.com

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