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.…
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.
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Item 7.01Item 7.01 - Regulation FD Disclosure
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 8.01Item 8.01 - Other Events
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.
Filed exhibits (1)
EX-99.1 (by filename) ex99-1.htm
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
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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)
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To-date, all patients achieving MRD-negativity reached CR within one year of treatment -
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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)
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No relapses observed for any patient who reached CR or MRD-negativity to-date -
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No neurotoxicity or enterocolitis has been observed to-date -
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NEXICART-2 final readout and BLA submission planned mid-2027 -
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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. (“ImmixB…