LOS ANGELES - Immix Biopharma, Inc. (NASDAQ:IMMX), a clinical-stage biopharmaceutical company, announced today the addition of three new clinical trial sites for its U.S. Phase 1b/2 study of CAR-T therapy NXC-201 in patients with relapsed/refractory AL Amyloidosis. The expansion includes prestigious institutions such as Cleveland Clinic, UC Davis, and Sutter Health, with Memorial Sloan Kettering Cancer Center continuing as the lead site.
The NEXICART-2 trial aims to evaluate the safety and efficacy of NXC-201 in patients who have not previously received BCMA-targeted therapy and have adequate cardiac function. This follows promising results from the ex-U.S. study NEXICART-1, which showed a 92% overall response rate in a similar patient group.
Ilya Rachman, M.D., Ph.D., CEO of Immix Biopharma, expressed pride in broadening the trial's reach to more patients across the nation. CFO Gabriel Morris highlighted the importance of these additional sites for the upcoming interim and final readouts of the NEXICART-2 study.
NXC-201 is currently the sole CAR-T therapy under development for AL Amyloidosis and has been recognized in medical literature, including a June 2024 review in the New England Journal of Medicine. The NEXICART-2 trial is set to enroll 40 patients, with a safety-run in to evaluate two doses of CAR+T cells, and the potential for further dose escalation.
AL Amyloidosis is a condition where misfolded amyloid proteins accumulate in organs, leading to organ failure and high mortality. The U.S. observed prevalence of the disease is increasing, with an estimated 33,277 patients in 2024. The market for Amyloidosis treatments is expected to grow from $3.6 billion in 2017 to $6 billion in 2025.
The information in this article is based on a press release statement from Immix Biopharma, Inc.
In other recent news, Immix Biopharma has made significant strides with two key developments. The company recently announced a change in its independent registered public accounting firm, appointing Crowe LLP to replace KMJ Corbin & Company LLP. The Audit Committee approved this change, which was made official with no disagreements or reportable events noted between Immix Biopharma and the previous firm.
Simultaneously, Immix Biopharma has received an orphan drug designation from the European Commission for its therapy NXC-201, targeted at treating multiple myeloma, a type of blood cancer. This designation grants the company a decade of market exclusivity upon authorization in the European Union.
Switching focus to RenovoRx, the company has appointed Ryan Witt as Senior Vice President, Head of Corporate Strategy and Partnerships. This move aims to advance clinical and commercial development opportunities, particularly for its Phase III investigational product, RenovoGem™. Witt's appointment is expected to aid in expanding treatment opportunities and fostering new business development prospects.
These are recent developments for both Immix Biopharma and RenovoRx, as they continue their endeavors in the biopharmaceutical industry, focusing on clinical trials and expanding their presence in the oncology sector.
InvestingPro Insights
In light of Immix Biopharma, Inc.'s (NASDAQ:IMMX) recent clinical trial expansions, investors and industry observers are closely monitoring the company's financial health and market position. According to InvestingPro data, Immix Biopharma holds a market capitalization of approximately $59.84 million. This valuation reflects the investor confidence in the potential of its CAR-T therapy, despite the company facing financial challenges, as indicated by a negative P/E ratio of -2.7, and an adjusted P/E ratio for the last twelve months as of Q2 2024 at -3.15.
InvestingPro Tips reveal a mixed financial picture for Immix Biopharma. On the positive side, the company holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations, suggesting a degree of financial stability in the near term. However, the company is quickly burning through cash and has been flagged for weak gross profit margins. Analysts also do not anticipate Immix Biopharma will be profitable this year, which is consistent with the company not being profitable over the last twelve months. Additionally, the company does not pay a dividend to shareholders, which may influence investment decisions for those seeking regular income.
With the company's next earnings date scheduled for August 28, 2024, stakeholders will be keen to see how these financial metrics evolve in the context of the company's operational progress. For investors seeking more in-depth analysis, there are additional InvestingPro Tips available on the company's profile page (https://www.investing.com/pro/IMMX), providing further insights into Immix Biopharma's financials and market performance.
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