Immix Biopharma will discuss CAR-T NXC-201 developments in AL Amyloidosis on a December 10 conference call.
Quiver AI Summary
Immix Biopharma, Inc. will hold a conference call on December 10, 2024, at 4:30 p.m. Eastern Time to discuss positive developments regarding their CAR-T therapy NXC-201 for relapsed/refractory AL Amyloidosis. The call will feature remarks from company management followed by a question-and-answer session. NXC-201 has shown promising clinical responses in a Phase 1b/2 study without neurotoxicity. The therapy has been granted Orphan Drug Designation by the FDA and EMA, and the market for AL Amyloidosis treatments is expected to grow significantly. Interested participants can join the call via Zoom.
Potential Positives
- Company management will provide a significant update on positive new developments regarding CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, indicating progress in their clinical program.
- NXC-201 has demonstrated robust clinical responses with no neurotoxicity in initial trials, which is a crucial positive indicator for the therapy's safety and effectiveness.
- The therapy has received Orphan Drug Designation (ODD) from both the US FDA and the EU EMA, which can enhance product development incentives and market exclusivity.
- The growing prevalence of relapsed/refractory AL Amyloidosis and the expanding market suggest a strong potential for future demand for NXC-201, positively impacting the company's market position.
Potential Negatives
- The press release heavily relies on forward-looking statements, indicating significant uncertainty regarding the future success of CAR-T NXC-201, which may undermine investor confidence.
- There is a risk that further data from ongoing clinical trials may not align with the initial positive results, raising concerns about the product's viability.
- The company has not received FDA pre-market approval for any drug product, which may hinder its credibility and marketability in a competitive biopharmaceutical landscape.
FAQ
What is the purpose of the conference call on December 10, 2024?
The conference call will update on positive developments regarding CAR-T NXC-201 for relapsed/refractory AL Amyloidosis.
How can I join the Immix Biopharma conference call?
Interested parties can attend via Zoom at the following link: https://zoom.us/j/94736340854?pwd=LTBtu2LuvwSb6S6ISuH5yKTDLsI2vt.1
What is CAR-T NXC-201 and its significance?
CAR-T NXC-201 is a chimeric antigen receptor T cell therapy targeting AL Amyloidosis, showing promising clinical responses in early studies.
What are the findings from the NEXICART-1 study?
Initial data from NEXICART-1 indicates robust clinical responses and no neurotoxicity in patients with relapsed/refractory AL Amyloidosis.
What is AL Amyloidosis and its impact?
AL Amyloidosis is caused by abnormal plasma proteins causing organ damage, leading to high mortality rates and significant health challenges.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
- Company management will provide an update on positive new developments regarding CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. Following management’s formal remarks, there will be a question-and-answer session.
- Conference Call to be held Tuesday, December 10, 2024 at 4:30 p.m. Eastern Time
- Interested parties can attend the conference call via Zoom using the following link:
https://zoom.us/j/94736340854?pwd=LTBtu2LuvwSb6S6ISuH5yKTDLsI2vt.1
LOS ANGELES, CA, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases, announced that it will hold a conference call for investors, analysts and members of the media on Tuesday, December 10, 2024 at 4:30 p.m. Eastern Time.
Company management will provide an update on positive new developments regarding CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. Following management’s formal remarks, there will be a question-and-answer session.
Interested parties can attend the conference call via Zoom using the following link:
https://zoom.us/j/94736340854?pwd=LTBtu2LuvwSb6S6ISuH5yKTDLsI2vt.1
About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. Initial data from Phase 1b/2 ex-U.S. study NEXICART-1 has demonstrated robust clinical responses with no neurotoxicity of any kind in relapsed/refractory 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 select immune-mediated diseases. The NXC-201 NEXICART-2 (NCT06097832) U.S. clinical trial builds on a robust clinical dataset. NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis by the US FDA and in the EU by the EMA.
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 developing cell therapies for AL Amyloidosis and select immune-mediated 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/2 trial NEXICART-2 (NCT06097832) as well as the ex-U.S. study NEXICART-1 (NCT04720313). NXC-201 has demonstrated no neurotoxicity of any kind in AL Amyloidosis and short duration of cytokine release syndrome (CRS), supporting expansion into select immune-mediated diseases. NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis by the US FDA and in the EU by the EMA. Learn more at www.immixbio.com and www.BeProactiveInAL.com.
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/2 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
[email protected]
Company Contact
[email protected]