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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 |
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
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
AL
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
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
