IMMX Research: FDA Approval, SEC Filings and more!
Immix Biopharma is a clinical-stage biopharmaceutical company that has a focus on tissue-specific therapeutics in oncology and inflammation in the USA and in Australia.
Immix is currently developing IMX-110 (which was in clinical trials until it was accepted today (January 3 rd2022)) for treatment of soft-tissue sarcoma and solid tumors, IMX-111 for tissue-specific biologic treatment for colorectal cancer (cancer in the colon or rectum), and IMX-120 which is a tissue-specific treatment for ulcerative colitis and severe Crohn’s disease.
Immix was founded in 2012, has 2 full-time employees (lead by their CEO Chris Brown), and is headquartered in Los Angeles.
Today (January 3 rd, 2022) at 8:44am (EST) the news broke that the FDA approved their IMX-110 drug for the treatment of patients with Rhabdomyosarcoma (a rare form of pediatric cancer). As part of this approval (given the nature of their drug), Immix will also receive a priority review which they can use for another drug that they are developing (IMX-111, IMX-120, or another drug tat they may start developing). Alternatively, if immix does not choose to use it for one of their own drugs, they could sell the priority review (Priority Review Sale — PRV Sale) to another company for a profit.
The “priority review” guarantees that the FDA will act on a future drug application within 6 months of the applicants filing. Without the priority review applications can take up to 10 months to review. As you may have already thought, this can save pharmaceutical companies a lot of time and money that they would not have the chance to save otherwise (without the priority review).For more information about the FDA’s Priority Reviews, I have linked a page full of information on these reviews, published by the FDA, which can be found here. These vouchers can be re-sold to other biotech/pharmaceutical companies for a historic amount between $67M to $350M. This is huge for IMMX as their current market cap is $60M and the Review can sell for more than their current market cap if they choose to go the PRV Sale route. An article explaining a recent sale of a PRV and the ranges of historic sales can be found here).
Due to this good news, shares of IMMX gained as much as 50% in the 30 minutes following the announcement of this approval, before opening their trading (9:30am) and continuing to run upwards if 130% this morning.
Similar FDA Approval Case Study:
One similar case that I found was the case of Liminal BioSciences Inc. ($LMNL). Liminal got accepted for and FDA approval on June 4 th, 2021, and as part of this approval, they too received a Priority Review Voucher. The trading day following their approval, Liminal had a market cap of $155M (compared to IMMX’s of $67M today), and their shares rose 30% on the day (compared to IMMX of 100%+. Although this comparison is not fully accurate, they are comparable. However, the good news soon came crashing down for Liminal as they dropped 45% over the next 2 months. At this 2-month mark, Liminal announced their sale of the PRV (for $105M), which sent the stock soaring 28% on August 9 th2021. Since the sale of their voucher, Liminal has dropped another 70% over the past 5 months (totaling a drop of 80%+ since their original FDA announcement).
SEC Filings: FDA Approval (8-K):
Today (January 3 rd, 2022) Immix announced the FDA’s approval of their IMX-110 drug for the treatment of Rhabdomyosarcoma. As part of this acceptance, Immix received a PRV which they can either use on future drugs or sell to other drug developers (as discussed previously).
In Immix’s press release, they stated the following pertaining to the use of their drug:
“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 IPO Prospectus (424-B4): 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 drug designation (ODD) to IMX-110 for the treatment of soft tissue sarcoma.” Management Team:
On December 17 th, 2021, immix released their 424-B4 document, which outlined the necessary information pertaining to their IPO (which occurred on the same date). IMMX outlined that they would IPO at $5/share, with 4.2M shares to be outstanding. Additionally, immix have the underwriters the option to purchase an additional 630,000 shares of common stock within a 45 day period following the IPO transaction (at an exercise price of $6.25).
Dr. Ilya Rachman (MBA, MD, PHD): Dr. Rachman serves as Co-founder, Chairman, and CEO of Immix. Prior to Immix, Dr. Rachman served as a clinical investigator for drugs produced by the likes of GlaxoSmithKlein and Eli Lily.
Mr. Gabriel Morris (BA): Mr. Morris is the CFO and director of Immix. Mr. Morris has previously raised over $81M as the CFO of Zap Surgical Systems. Prior to this, Mr. Morris participated in over $50B in completed merger/acquisition transactions at Goldman Sachs, and other investment banks.
Mr. Graham Ross (FFPM, MD): Mr. Graham Ross is the Chief Medical Officer and Head of Clinical Development at Immix. Mr. Ross is an experienced pharmaceutical physician executive, garnering experience from the likes of Genentech, AstraZeneca, and GlaxoSmithKlein.
Originally published at https://utradea.com.