Form 8-K

8-K — Immix Biopharma, Inc.

Accession: 0001493152-26-044761

Filed: 2026-09-29

Period: 2026-09-29

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): September 29, 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.

September 29, 2026,

Immix Biopharma, Inc. (the “Company”) issued a press release announcing that across all forty-five relapsed/refractory light

chain (“AL”) Amyloidosis patients enrolled in the Phase 2 NEXICART-2 clinical trial, NXC-201 has produced an 89% (40/45)

complete response (“CR”) rate. 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 (the “Securities Act”), 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.

September 29, 2026, the Company announced an update from the Phase 2 NEXICART-2 clinical trial, including positive results of an 89%

(40/45) complete response (“CR”) rate across all forty-five relapsed/refractory AL Amyloidosis patients enrolled in the

trial, as assessed by an independent review committee. Additionally, all twenty-five of the new relapsed/refractory AL Amyloidosis

patients are either in CR or already minimum residual disease (“MRD”)- negative. To-date, all patients achieving

MRD-negativity reached CR within one year of treatment. In four pending patients that are already MRD-negative, MRD-negativity

in bone marrow predicts future CR, potentially increasing future CR rate up to 98% (44/45). No relapses have been observed to date for patients who reached CR or

MRD-negativity. No neurotoxicity or enterocolitis has been observed to date. Safety data through August 4, 2026 has been generally

consistent with previous safety data observed and reported in NEXICART-2 trial. NEXICART-2 is a fully enrolled, 45-patient

multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in patients with relapsed/refractory AL Amyloidosis,

with a registrational design. The NEXICART-2 final readout and BLA submission are planned in mid-2027.

Cautionary

Note Regarding Forward-Looking Statements

This

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

“safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements

relating to the MRD-negativity potentially increasing the future CR rate up to 98% ; NEXICART-2 final readout and BLA submission

planned in 2027; the potential

benefits of our product candidate NXC-201 and the timing and results related to clinical trials. 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 September 29, 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:

September 29, 2026

/s/

Ilya Rachman

Ilya

Rachman, Ph.D., M.D.

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Immix

Biopharma Announces 89% Complete Response Rate at Interim Update Across All NEXICART-2 Patients, with MRD-Negativity Indicating Potential

to Reach up to 98% Complete Response Rate, Supporting Potential Best-in-Class Therapy for Relapsed/Refractory AL Amyloidosis

–

100% (25/25) of new patients are either in complete response (CR) or MRD-negative (21/25 are in CR; remaining 4/25 are MRD-negative)

–

To-date, all patients achieving MRD-negativity reached CR within one year of treatment –

–

Across all forty-five patients, NXC-201 produced an 89% (40/45) CR rate as assessed by independent review committee –

– In four pending patients

that are already MRD-negative, MRD-negativity in bone marrow predicts future CR, potentially increasing future CR rate up to 98% (44/45)

–

No relapses observed for any patient who reached CR or MRD-negativity to-date –

–

No neurotoxicity or enterocolitis has been observed to-date –

–

NEXICART-2 final readout and BLA submission planned mid-2027 –

–

Virtual investor event today Sep 29 at 8:00am ET: https://events.q4inc.com/attendee/484851283/ –

LOS

ANGELES, Sep 29, 2026 (GLOBE NEWSWIRE) – Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We”

or “Us” or “IMMX”), a global leader in relapsed/refractory AL Amyloidosis, today announced positive results of

an 89% (40/45) complete response (CR) rate in an interim update across all forty-five NEXICART-2 patients, advancing NXC-201 as a potential

best-in-class therapy for AL Amyloidosis. All twenty-five new relapsed/refractory AL Amyloidosis patients are either in complete response

(CR) or already minimum residual disease (MRD)-negative. To-date, all patients achieving MRD-negativity reached CR within one year of

treatment. Across all forty-five patients, NXC-201 produced an 89% (40/45) CR rate as assessed by independent review committee. In

four pending patients that are already MRD-negative, MRD-negativity in bone marrow predicts future CR, potentially increasing future

CR rate up to 98% (44/45). No relapses to date have been observed for any patient who reached CR or MRD-negativity to-date.

No neurotoxicity or enterocolitis has been observed to-date. NEXICART-2 final readout and BLA submission are planned in 2027.

“Today,

patients with AL Amyloidosis face years of burdensome, continuous treatment. As a potential one-and-done treatment option, NXC-201 could

liberate patients from that burden,” said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma, adding: “We

are thrilled with NXC-201’s magnitude of effect across a broad range of relapsed/refractory AL Amyloidosis patients in NEXICART-2.”

Gabriel Morris, President of Immix Biopharma, added, “NXC-201’s complete response rate continues to increase over time, even

as reported patient counts have now more than doubled. We look forward to final readout, BLA submission and potentially making NXC-201

available to relapsed/refractory AL Amyloidosis patients at commercial launch.”

Investor

Webcast and Conference Call Information

The

Company will host a conference call to discuss these data at 8:00 a.m. ET today, Sep 29, 2026. The live webcast can be accessed at https://events.q4inc.com/attendee/484851283/

or under “Events & Presentations” in the Investors section of the company’s website at www.immixbio.com. The webcast

will be available for replay on the company website. Analysts who wish to join the teleconference and participate in Q&A should register

at the link above.

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 30,506 patients in 2026.

The

Amyloidosis market was $6.2 billion in 2025, and is expected to reach $6.6 billion in 2026, according to Grand View Research.

About

NXC-201

is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a proprietary CD3ζ, CD8 hinge and

binder “digital filter” 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 proprietary CD3ζ, CD8 hinge and binder “digital filter” 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 NEXICART-2 final readout

and BLA submission planned in mid-2027; making NXC-201 available to patients at commercial launch, if approved; the size of the AL Amyloidosis

market; the potential benefits of our product candidate 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 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 later 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 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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