Form 8-K

8-K — Immix Biopharma, Inc.

Accession: 0001493152-26-051402

Filed: 2026-11-12

Period: 2026-11-12

CIK: 0001873835

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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EX-99.1 (ex99-1.htm)

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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

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 ☒

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.

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

EX-99.1

Filename: ex99-1.htm · Sequence: 2

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

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.

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

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

Other current assets

1.7

1.8

Total Assets

239.1

346.0

Total lease liabilities

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

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