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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): March 30, 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,
March 30, 2026, Immix Biopharma, Inc., a Delaware corporation (the “Company”), issued a press release announcing that the
enrollment for its NEXICART-2 clinical trial of NXC-201 is complete, with topline results expected in Q3 2026. A copy of the press release
is furnished as Exhibit 99.1 to this Current Report on Form 8-K
The
information in this Item 7.01 and Exhibit 99.1 attached hereto are furnished and shall not be deemed to be “filed” with the
Securities and Exchange Commission for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”) or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into
any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in
such filing.
Item
8.01. Other Events.
On
March 30, 2026, the Company issued a press release announcing that the enrollment for its NEXICART-2 clinical trial of NXC-201 is complete,
with topline results expected in Q3 2026.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release issued by Immix Biopharma, Inc., dated March 30, 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: March 30, 2026 |
/s/ Ilya
Rachman |
| |
Ilya Rachman, Ph.D., M.D. |
| |
Chief Executive Officer |
Exhibit
99.1
Immix
Biopharma Announces Enrollment Completion of BLA-Enabling Relapsed/Refractory AL Amyloidosis Trial NEXICART-2, and Upcoming Milestones
–
Full enrollment of BLA-enabling trial complete, per prior guidance –
–
Topline NEXICART-2 Results Expected Q3 2026, followed by BLA submission and planned commercial launch –
–
Onboarded Chief Medical Officer, formerly of Merck and Johnson & Johnson for BLA submission –
LOS
ANGELES, March 30, 2026 (GLOBE NEWSWIRE) – Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We”
or “Us” or “IMMX”), the global leader in relapsed/refractory AL Amyloidosis, today announced that NEXICART-2
enrollment is complete, meeting Company guidance, with topline results expected in Q3 2026, followed by BLA submission and planned commercial
launch.
“In
AL Amyloidosis, the immune system produces toxic light chains that clog up the heart, kidney and liver, causing organ failure and death.
In our trials, we have seen that one-and-done NXC-201 eliminates the source of these toxic light chains. If approved, NXC-201 would be
the first FDA approved treatment for relapsed/refractory AL Amyloidosis,” said Ilya Rachman, MD, PhD, Chief Executive Officer of
Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We are grateful to patients, families, caregivers,
investigators, and credit our team’s tireless efforts. Building on our positive interim readout at ASH 2025, topline NEXICART-2
results are expected in Q3, driving BLA submission and planned commercial launch.”
In
addition to meeting guidance for NEXICART-2 enrollment completion and announcing topline NEXICART-2 results expected Q3 2026, Immix has
onboarded a commercial-experienced Chief Medical Officer, Richard Graydon, MD, PhD. Dr. Graydon is a board-certified hematologist-oncologist
with over 20 years of experience in clinical development, most recently at Merck & Co. and Johnson & Johnson, where he led new
and supplemental new drug applications and biologics license applications for 7 approved drugs including DARZALEX, CARVYKTI, KEYTRUDA,
and IMBRUVICA. Dr. Graydon received his MD and PhD from Stanford University and trained at Harvard’s Massachusetts General Hospital.
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 40-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.
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 the global leader in relapsed/refractory 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 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 topline NEXICART-2 results
expected Q3 2026, followed by BLA submission and planned commercial launch; NXC-201 being the possible first FDA approved treatment for
relapsed/refractory AL Amyloidosis; 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, ivi) 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 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
