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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
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
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”).
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 (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.
On
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 |
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
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 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
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
