此前於2025年美國血液學會年會（ASH 2025）公佈的4名MRD陰性（微小殘留病變陰性）患者，現已全部轉為完全緩解（CR）。

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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

 of
 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 ☒

 

If
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.

 

On
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”).

 

In
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.

 

On
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