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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): July 25, 2024
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)
N/A
(Former
name or former address, if changed since last report)
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
8.01 Other Events.
On
July 25, 2024, Immix Biopharma, Inc. (the “Company”) filed a press release announcing that Nexcella, Inc., its wholly-owned
subsidiary, has been awarded a $8 million grant from the California Institute for Regenerative Medicine. A copy of the press release
is included herewith as Exhibit 99.1 and the information in the press release is incorporated by reference into this Item 8.01
in its entirety by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURE
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:
July 26, 2024 |
/s/ Ilya
Rachman |
| |
Ilya Rachman |
| |
Chief Executive Officer |
Exhibit
99.1
California
Institute for Regenerative Medicine Awards Funding for
CAR-T
NXC-201 U.S. AL Amyloidosis Clinical Trial (NEXICART-2)
| |
● |
$8
million grant funds development of NXC-201 in relapsed/refractory AL Amyloidosis |
LOS
ANGELES, July 25, 2024 (GLOBE NEWSWIRE) – Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We”
or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL
Amyloidosis and autoimmune disease, today announced that the California Institute for Regenerative Medicine (CIRM) has awarded Immix
Biopharma cell therapy division Nexcella an $8 million CLIN2 grant award to support clinical development of chimeric antigen receptor
T-cell (CAR-T) therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.
“AL
amyloidosis is an unmet medical need, and current approved therapies for this rare disease are mostly not well tolerated and have not
led to sustained remissions,” said Dr. Abla Creasey, PhD, Vice President of Therapeutics Development at CIRM. “This one-time
therapy would be an innovative treatment for patients with AL Amyloidosis, and the preliminary data are encouraging.”
“We
are grateful for the recognition from CIRM of the importance of NXC-201 in relapsed/refractory AL Amyloidosis, for which there are no
FDA approved drugs today,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial
Officer of Immix Biopharma, added: “We are excited to join California’s thriving CIRM biotechnology innovation ecosystem
as we proceed on-plan with NEXICART-2.”
The
NEXICART-2 U.S. study is intended to evaluate the safety and efficacy of NXC-201 in relapsed/refractory AL Amyloidosis patients with
adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study builds on positive data from the initial
ex-U.S. study, NEXICART-1, presented at the 27th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT 2024)
which showed a 92% overall response rate in relapsed/refractory AL Amyloidosis patients (12/13). The best responder experienced a 28.0
month duration of response (as reported May 10, 2024, with ongoing follow-up).
NXC-201
is the only CAR-T therapy currently in development in AL Amyloidosis, mentioned in a review article entitled “Systemic Light
Chain Amyloidosis” published in June, 2024 New England Journal of Medicine .
About
the California Institute for Regenerative Medicine (CIRM)
At
CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical
needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced
professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development
of today’s most promising stem cell technologies.
With
$5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions
dedicated to helping people by bringing the future of cellular medicine closer to reality.
About
NEXICART-2
NEXICART-2
(NCT06097832) is an open-label, single-arm, multi-site U.S. Phase 1b/2 dose expansion clinical trial of CAR-T NXC-201 in relapsed/refractory
AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function who have not been exposed to prior BCMA-targeted
therapy. The study is designed with a standard 6 patient safety-run in to evaluate two doses (three patients each at 150 million CAR+T
cells and 450 million CAR+T cells), with the potential for further escalation to 800 million CAR+T cells (all 3 dose levels were evaluated
in the NEXICART-1 study and have produced complete responses in relapsed/refractory AL Amyloidosis patients). The study aims to evaluate
the safety and efficacy of NXC-201 in this patient population. Primary endpoints are complete response rate and overall response rate,
according to consensus recommendations (Palladini et al. 2012).
About
NEXICART-1
NEXICART-1
(NCT04720313) is an open-label, ex-U.S. Phase 1b/2a clinical trial of NXC-201 (formerly HBI0101) in patients with relapsed/refractory
multiple myeloma and relapsed/refractory AL amyloidosis (including AL Amyloidosis patients with impaired cardiac function and including
AL Amyloidosis patients exposed to prior BCMA-targeted therapy). The primary objective of the study is to characterize the safety and
efficacy, as well as confirm the recommended Phase 2 dose (RP2D) of NXC-201 (which has already been confirmed). NEXICART-1 clinical results,
most recently from ASGCT 2024, are available at https://immixbio.com/pipeline/#publications.
About
NXC-201
NXC-201
is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. Initial data from Phase 1b/2a ex-U.S. study
NEXICART-1 has demonstrated short duration of cytokine release syndrome (CRS) and no grade 3 or delayed neurotoxicity in high-volume
disease, as well as short duration CRS and no neurotoxicity of any kind in AL Amyloidosis.
NXC-201
is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis,
with the potential to expand into autoimmune indications. The NXC-201 NEXICART-2 U.S. clinical trial builds on a robust clinical dataset.
NXC-201 has been awarded Orphan Drug Designation (ODD) in the US by the FDA and in the EU by the EMA in AL Amyloidosis.
About
AL Amyloidosis
AL
amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart,
kidney, liver, and other organs. This build-up causes progressive and widespread damage to multiple organs, including heart failure,
and leads to high mortality rates.
The
U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al
Blood Cancer Journal, to approximately 33,277 patients in 2024.
The
Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.
About
Immix Biopharma, Inc.
Immix
Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis
and autoimmune diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.
NXC-201 is being evaluated in the U.S. Phase 1b/2a trial NEXICART-2 (NCT06097832) as well as the ex-U.S. study NEXICART-1 (NCT04720313).
NXC-201 has demonstrated short duration of cytokine release syndrome (CRS) and no grade 3 or delayed neurotoxicity in high-volume disease,
as well as short duration CRS and no neurotoxicity of any kind in AL Amyloidosis, supporting expansion into autoimmune indications. NXC-201
has been awarded Orphan Drug Designation (ODD) in the US by the FDA and in the EU by the EMA in AL Amyloidosis. Learn more at www.immixbio.com
and www.BeProactiveInAL.com.
About
Nexcella, Inc.
As
of May 2024, Nexcella, Inc. is a wholly-owned subsidiary of, and the cell therapy division of, Immix Biopharma, Inc. (ImmixBio) (Nasdaq:
IMMX).
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, the receipt of, timing of receipt, finalization
of the terms of, and allocation of funds in connection with, the grant discussed above and potential benefits of our product candidate
CAR-T NXC-201. 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 further data from the ongoing Phase 1b/2a clinical trials for CAR-T
NXC-201 will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able
to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iii) that success in early phases of pre-clinical
and clinicals trials do not ensure later clinical trials will be successful; (iv) that no drug product developed by the Company has received
FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) 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 (vii) 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 29, 2024 and other periodic 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
v3.24.2
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