Check out the full company presentation here.
Right now, IMMX has several potential catalysts that could fuel this profile towards a vertical move near term. And none may be more important than this one...
IMMX No 1. Potential Catalyst - U.S. FDA Grants (RPD) Designation For IMX-110
U.S. Food and Dr-ug Administration Approves Immix Biopharma Rare Pediatric Disease Designation for IMX-110 as a Treatment for Life-Threatening Pediatric Cancer in Children
- Rare Pediatric Disease Designation (“RPDD”) qualifies Immix Biopharma to receive fast track review, and a priority review voucher (“PRV”) at the time of marketing approval of IMX-110.
- PRV holders can benefit from an expedited six-month review of a new dr-ug application for any disease by the FDA.
- While their future value is uncertain, PRVs are transferable to other companies and have historically sold for $67 to $350Mn according to a January 2020 report on dr-ug development by the Government Accountability Office.
LOS ANGELES, Jan. 03, 2022 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, announced today that the U.S. Food and Dr-ug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for IMX-110 for the treatment of a life-threatening form of pediatric cancer in children, rhabdomyosarcoma. IMX-110, an investigational product, is currently being evaluated in a Phase 1b/2a clinical trial.
The FDA grants Rare Pediatric Disease designation for serious and life-threatening diseases that primarily affect children aged 18 years or younger and impact fewer than 200,000 people in the United States.
If a New Dr-ug Application in the United States for IMX-110 is approved, ImmixBio may be eligible to receive a Priority Review Voucher (PRV) from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application, or may be sold or transferred.
“We are pleased by FDA’s acknowledgment of the urgent need for a safe and effective treatment for children with this devastating disease,” stated ImmixBio’s Chief Executive Officer Ilya Rachman, M.D., PhD. “We are encouraged by our Phase 1b/2a clinical data in soft tissue sarcoma. IMX-110 is a tissue-specific therapeutic that simultaneously attacks all 3 components of the tumor micro-environment, severing the critical lifelines between the tumor and its metabolic and structural support. We believe our SMARxT platform generating Tissue-Specific Therapeutics represents a distinct alternative to the traditional ‘single target, single mutation’ development model.”
Rhabdomyosarcoma (“RMS”) is a high-grade, malignant neoplasm, the most common soft tissue sarcoma in pediatric and adolescent populations and which rarely occurs in adults. The prevalence of RMS in the United States is approximately 20,000 children of all ages. The five-year survival rate ranges from 20% to 30% for children in the high-risk group where cancer spreads widely in the body.
IMX-110 is the first clinical-stage product of ImmixBio’s SMARxT Tissue-Specific™ Platform, which produces Tissue-Specific Therapeutics that accumulate at intended therapeutic sites at 3 to 5 times the rate of conventional medicines. The FDA has already granted orphan dr-ug designation (ODD) to IMX-110 for the treatment of soft tissue sarcoma.
ImmixBio recently shared clinical data across multiple soft tissue sarcoma subtypes in several heavily pretreated patients demonstrating median progression-free survival (PFS) of 4 months with zero dr-ug-related severe adverse events and zero dose interruptions due to toxicity.
Read the full article here.
IMMX No 2. Potential Catalyst - A Crazy Low Float
According to the Yahoo Finance website, IMMX has a tiny float.
The website reports this profile to have approximately 1.29Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility.
With so few shares available for trading, other potential catalysts could help spark a vertical move in the short-term.
IMMX No 3. Potential Catalyst - Positive Results Thrill CEO
ImmixBio IMX-110 Produced 50% Positive Response Rate in First-Line-Therapy-Resistant Cancer, Surpassing the Standard of Care in Mice Study
- IMX-110 produced a 50% response rate after 1 cycle of treatment as a monotherapy in first-line-therapy-resistant cancer - soft tissue sarcoma (STS) mice study
- IMX-110 response rate surpassed standard of care doxorubicin’s response rate of 0% after 1 cycle of treatment in the same study
- IMX-110 is in clinical development for STS, a $3Bn market expected to grow to $6.5Bn by 2030
LOS ANGELES, Jan. 12, 2022 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, today announced study data showing that ImmixBio’s lead candidate IMX-110 produced a 50% response rate in a first-line-therapy-resistant cancer - soft tissue sarcoma (STS) mouse study, surpassing the STS standard of care doxorubicin’s 0% response rate in the same mouse study. The responses were assessed by RECIST 1.1 criteria applied to mice, with progression assessed after one cycle of treatment in a study funded by ImmixBio and conducted by a major STS oncology treatment center.
“We strive to test our dr-ug candidates in the most realistic, challenging animal models available,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “We are thrilled to see that in this first-line-therapy resistant STS model that IMX-110 showed significant activity. We believe this study is a preview of what our SMARxT Platform generating Tissue-Specific Therapeutics can do, a distinct alternative to the traditional ‘single target, single mutation’ development model.”
Read the full article here.
IMMX No 4. Potential Catalyst - IPO And Joining The NasdaqCM
Immix Biopharma, Inc. Announces Closing of Initial Public Offering
LOS ANGELES, CA, Dec. 20, 2021 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the “Company”), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, today announced the closing of its initial public offering of 4,200,000 shares of its common st-ock at a public offering price of $5.00 per share, for gross proceeds of $21Mn, before deducting underwriting discounts, commissions and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 630,000 shares of common st-ock at the initial public offering price, less the underwriting discount, to cover over-allotments.
The shares began trading on the Nasdaq Capital Market on December 16, 2021 under the ticker symbol “IMMX.”
ThinkEquity acted as sole book-running manager for the offering.
The Company intends to use the net proceeds from the offering to fund a planned IMX-110 Phase 2a clinical trial in soft tissue sarcoma and IMX-110 + tislelizumab Phase 1b combination trial, for IND-enabling studies for IMX-111 (colorectal cancer) and IMX-120 (inflammatory bowel disease), and for working capital and other general corporate purposes.
Read the full article here.
IMMX Complete Recap - 4 Potential Catalysts Lead The Way
No 1. - U.S. FDA Grants (RPD) Designation For IMX-110
No 2. - A Crazy Low Float
No 3. - Positive Results Thrill CEO
No 4. - IPO And Joining The NasdaqCM
Coverage is officially initiated on IMMX. When you have time later, do this: