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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): November 12, 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
2.02 Results of Operations and Financial Condition.
On
November 12, 2026, Immix Biopharma, Inc., a Delaware corporation (the “Company”), issued a press release that included financial
information for its quarter ended September 30, 2026. A copy of the press release is attached as Exhibit 99.1 to this Current Report
on Form 8-K.
The
information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed
to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the
liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this
Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference
into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless
of any general incorporation language in such filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
The
following exhibits are furnished with this Current Report on Form 8-K:
Exhibit
Number |
|
Exhibit
Description |
| 99.1 |
|
Press Release, issued by Immix Biopharma, Inc. on November 12, 2026 |
| 104 |
|
Cover
Page Interactive Data File (the cover page XBRL tags are embedded within in 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:
November 12, 2026 |
/s/
Ilya Rachman |
| |
Ilya
Rachman, Ph.D., M.D. |
| |
Chief
Executive Officer |
Exhibit
99.1
Immix
Biopharma Reports Third Quarter 2026 Financial Results and Update on Corporate Progress
– Following positive NEXICART-2 clinical update, commercial launch preparation continues with commercial site activation activities, strengthened team, and provider and payer engagement –
–
Interim NEXICART-2 clinical trial results selected for oral presentation at ASH 2026 –
LOS
ANGELES, November 12, 2026 (GLOBE NEWSWIRE) – Immix Biopharma, Inc. (“Immix”, the “Company”, “we”
or “us”), a global leader in AL amyloidosis, today reported an update on corporate progress and financial results for the
quarter ended September 30, 2026.
Recent
NXC-201 Progress
| - | Positive
clinical data: 89% complete response rate was reported across all 45 NEXICART-2 patients,
with MRD-negativity indicating potential to reach up to 98% complete response rate in the
future. |
| - | Immix
continues to advance its AL Amyloidosis launch readiness activities across commercial site
activation, provider and payer engagement, manufacturing activities, and healthcare professional
education. |
Immix
plans for its BLA submission in mid-2027, and NEXICART-3 front line trial initiation in the first half of 2027.
Interim
NXC-201 NEXICART-2 Clinical Trial Results Selected for Oral Presentation at 68th American Society of Hematology (ASH) Annual
Meeting
On
Monday, December 14, 2026, NXC-201 NEXICART-2 interim clinical data will be presented at the 68th American Society of Hematology
(ASH) Annual Meeting in New Orleans, LA.
Commercial
Launch Preparation Continues with Strengthened Team
Immix
has appointed David He, MD, PhD as Senior Vice President, Head of Technical Operations. Dr. He has contributed in a senior role to two
approved BCMA CAR-Ts, CARVYKTI® and FUCASO®. Dr. He will lead chemistry, manufacturing, and controls at Immix, further accelerating
the Company’s planned path to commercialization. Prior to Immix, Dr. He served as the Chief Technology Officer from pre-BLA to
commercial-stage at IASO Biotherapeutics and as the Vice President, Technical Operations at Legend Biotech, as well as in a senior chemistry,
manufacturing, and controls positions at Boehringer Ingelheim, and other senior roles.
Immix
has appointed Karin McIntosh as Senior Vice President, Head of Regulatory Affairs. Karin has contributed to multiple FDA drug programs,
including JANUVIA® (FDA+EMA), EMFLAZA® (FDA), ELZONRIS® (FDA+EMA), and most recently, the approval of TREGZI® (FDA, 2026).
Karin will lead regulatory affairs at Immix in the United States and globally. Prior to Immix, Karin was Vice President, Head of Regulatory
Affairs at Orca Bio and held senior regulatory positions at Stemline Therapeutics, PTC Therapeutics, Merck, and Pfizer.
Additionally,
Immix has appointed additional key team members across its Commercial, Regulatory, Quality, Medical Affairs teams, and as Medical Science
Liaisons.
Upcoming
Events
| - | In
addition to NEXICART-2 interim clinical data being presented at ASH on Monday December 14,
2026, the Company will also present at the 45th Annual J.P. Morgan Healthcare
Conference being held in San Francisco from January 11 - 14, 2027. |
Financial
Results for the Third Quarter Ended September 30, 2026
| - | Immix
reported $340.9 million in cash, cash equivalents, and marketable securities as of September
30, 2026, which is expected to provide operating runway into mid-2028. |
| - | Immix
reported $15.9 million in operating expenses for the third quarter ended September 30, 2026. |
About
AL Amyloidosis
Amyloid
light-chain (AL) amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously
produces toxic light chains that build up in organs including the heart, kidney, and liver, causing organ failure and death.
AL
amyloidosis is the most common form of amyloidosis according to the National Institutes of Health. 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. (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 the potential of NXC-201
to reach up to a 98% complete response rate, the Company’s commercial launch readiness activities, the planned timing of the Company’s
BLA submission and the initiation of the NEXICART-3 front line trial, the presentation of NEXICART-2 interim clinical data at ASH, the
Company presenting at the 45th Annual J.P. Morgan Healthcare Conference, the contributions to be made by Dr. He, Karin McIntosh and other
new team members, including accelerating the planned path to commercialization, cash, cash equivalents, and marketable securities expected
to provide operating runway into mid-2028 and expected growth of the AL amyloidosis market. 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,
including the risk that MRD-negativity will not translate into higher complete response rates; (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) the risk that the Company may not submit its BLA
in mid-2027 or initiate the NEXICART-3 front line trial in the first half of 2027, or at all, and that any BLA submitted may not be accepted
or approved by the FDA on a timely basis or at all; (vii) the risk that the Company’s commercial launch readiness activities, including
commercial site activation, provider and payer engagement, manufacturing activities and healthcare professional education, will not be
successful or completed as planned; (viii) the risk that success in early phases of pre-clinical and clinicals trials do not ensure later
clinical trials will be successful; (ix) the risk that no drug product developed by the Company has received FDA pre-market approval
or otherwise been incorporated into a commercial drug product, (x) the risk that estimated expenses will be higher than anticipated,
cash, cash equivalents, and marketable securities will not provide operating runway into mid-2028 and 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; (xi) the risk that the new hires will not contribute as expected including accelerating
the planned path to commercialization; and (xii) those other risks disclosed in the section titled “Risk Factors” included
in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 25,
2026, as amended by that Form 10-K/A filed with the SEC on March 27, 2026, and other periodic or current reports subsequently filed with
the SEC. These reports are available at www.sec.gov. Immix cautions that the foregoing list of important factors is not complete. Immix
cautions readers not to place undue reliance on any forward-looking statements. Immix 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
IMMIX
BIOPHARMA, INC.
SELECTED
FINANCIAL DATA
(unaudited;
in US$ millions, except share and per share data)
| | |
Nine months ended September 30, 2026 | | |
Three months ended September 30, 2026 | |
| Statements of Cash Flows | |
| | | |
| | |
| | |
| | | |
| | |
| Cash flows provided by (used in) operating activities | |
| (33.9 | ) | |
| (12.3 | ) |
| Cash flows provided by (used in) investing activities | |
| (14.2 | ) | |
| (12.0 | ) |
| Cash flows provided by (used in) financing activities | |
| 274.4 | | |
| 119.2 | |
| | |
| | | |
| | |
| Statements of Operations and Comprehensive Loss | |
| | | |
| | |
| Total operating expenses | |
| (39.2 | ) | |
| (15.9 | ) |
| of which Research and Development costs | |
| (16.9 | ) | |
| (5.5 | ) |
| of which General and Administrative costs | |
| (22.3 | ) | |
| (10.4 | ) |
| Operating loss | |
| (39.2 | ) | |
| (15.9 | ) |
| Financial gain (loss) – interest income | |
| 3.6 | | |
| 2.0 | |
| Net loss before tax | |
| (35.6 | ) | |
| (13.9 | ) |
| Income tax | |
| (0.0 | ) | |
| — | |
| Net loss for the period | |
| (35.6 | ) | |
| (13.9 | ) |
| | |
As of Jun 30, 2026 | | |
As of Sep 30, 2026 | |
| Consolidated Balance Sheets | |
| | | |
| | |
| Cash, cash equivalents and marketable securities | |
| 234.1 | | |
| 340.9 | |
| Non-current assets | |
| 3.3 | | |
| 3.3 | |
| Other current assets | |
| 1.7 | | |
| 1.8 | |
| Total Assets | |
| 239.1 | | |
| 346.0 | |
| Total lease liabilities | |
| 1.0 | | |
| 1.0 | |
| Accounts payable and accrued expenses | |
| 9.2 | | |
| 9.9 | |
| Total Liabilities | |
| 10.2 | | |
| 10.9 | |
| Total Stockholders’ Equity | |
| 228.9 | | |
| 335.1 | |
| Total Liabilities and Stockholders’ Equity | |
| 239.1 | | |
| 346.0 | |
