Miromatrix Medical Inc. (NASDAQ:MIRO) is a pioneering life sciences company at the forefront of developing alternatives to human-donor organ transplants. The company's proprietary technology utilizes a scalable platform that employs a two-step method of decellularization and recellularization to remove porcine cells from organs obtained from pigs and replace them with unmodified human cells. This innovative approach holds the potential to revolutionize the field of organ transplantation and address the critical shortage of donor organs.
Business Overview
Miromatrix's initial focus is on bioengineering livers and kidneys, with the technology platform also applicable to other vital organs such as hearts, lungs, and pancreases. The company has established strategic collaborations with industry leaders like Baxter International Inc., CareDx, Inc., the Mayo Clinic, the Mount Sinai Health System, and the Texas Heart Institute, further strengthening its position in the market.Financials
Miromatrix's financial performance has been marked by significant investments in research and development as the company advances its innovative pipeline. For the fiscal year ended December 31, 2022, the company reported annual revenue of $953,470, a net loss of $30,007,832, and negative operating and free cash flows of $26,682,581 and $27,745,738, respectively. These figures reflect the company's commitment to driving its technology forward and building a robust product pipeline.Quarterly Highlights
In the latest quarter ended September 30, 2023, Miromatrix reported licensing revenue of $11,176, a gross loss of $113,824, and a net loss of $6,453,691. The company's research and development expenses for the quarter were $3,506,054, while regulatory and clinical expenses were $455,313, and general and administrative expenses were $2,143,421. These quarterly results underscore the company's ongoing focus on advancing its product development efforts.Liquidity
As of September 30, 2023, Miromatrix had cash and cash equivalents of $6,116,084 and short-term investments of $9,945,715, providing a total of $16,061,799 in available liquidity. The company has funded its operations primarily through equity and debt financings, as well as research grants. However, the company has expressed substantial doubt about its ability to continue as a going concern due to its limited financial resources and the need for additional capital to support its ongoing operations and product development activities.Regulatory Milestones and Product Pipeline
Miromatrix has made significant progress in its regulatory efforts. In the fourth quarter of 2022, the company filed an Investigational New Drug (IND) application with the FDA for its miroliver ELAP (External Liver Assist Product) designed to provide liver dialysis for acute liver failure patients. The company is currently addressing the FDA's clinical hold letter and plans to submit a complete response in the fourth quarter of 2023, with the goal of initiating a first-in-human, phase 1 clinical trial shortly thereafter.In addition to the miroliver ELAP, Miromatrix's product pipeline includes two other active programs: 1. miroliver: The company's fully implantable bioengineered liver intended to treat patients with acute and chronic liver failure. 2. mirokidney: The company's fully implantable bioengineered kidney designed to treat patients with end-stage renal disease.
The development of these innovative bioengineered organs represents Miromatrix's long-term vision to address the critical shortage of donor organs and transform the lives of patients in need.
Recent Developments
Pending Acquisition by United Therapeutics Corporation
On October 29, 2023, Miromatrix announced that it had entered into an Agreement and Plan of Merger with United Therapeutics Corporation (UTC), a publicly traded bioengineering company. Pursuant to the terms of the agreement, UTC will commence a tender offer to acquire Miromatrix for $3.25 per share in cash at closing, with an additional $1.75 per share in cash upon the first implantation of Miromatrix's mirokidney product into a living human patient by the end of 2025 in a clinical trial meeting specific requirements. The transaction is expected to close in December 2023, subject to the satisfaction of customary closing conditions, including the tender of a majority of Miromatrix's outstanding shares.