We are an innovative regenerative medicine and cellular therapy company targeting autoimmune diseases and inflammatory disorders. (Incorporated in Nevada)

We generate revenue from our other technologies through a number of other activities, including through the sale of our stem cell products and cell lines. These products include native mesenchymal stem cells, several lines of Cancer-Associated Fibroblasts and native fibroblasts that are used by these institutions for stem cell research and the development of advanced immunotherapy of cancer. Additionally, we sell cosmeceuticals through InfiniVive MD, LLC (“InfiniVive MD”), our wholly owned subsidiary, to plastic surgeons, cosmetic surgeons, aestheticians and consumers in the United States and internationally, which helps to alleviate our capital expenses.

Through our proprietary platform, AlloRx Stem Cell therapy, we are developing novel cellular therapeutic candidates that are derived from culture-expanded MSCs sourced from the Wharton’s jelly of umbilical cords (“UCs”) donated by healthy volunteers following childbirth. In the United States, we are authorized to conduct two clinical trials under two U.S. Food and Drug Administration Investigational New Drug applications to assess the safety and efficacy of AlloRx Stem Cell therapy in Pitt Hopkins syndrome and post-acute sequelae to SARs-CoV-2 (“PASC”), or long COVID (“Long COVID”), and expect to commence those trials in the second half of 2024. As of March 31, 2024, over 537 subjects have received treatment with our AlloRx Stem Cells, primarily in foreign clinical studies conducted by third parties. Our lead clinical program is expected to focus on PTHS, a rare neurogenetic disorder primarily affecting children that is characterized by global developmental delays including autistic features, language delays, intellectual disability, neuro-irritability and significant behavioral concerns.

Our pipeline includes five core development programs:

Phase 1/2a clinical trial in Pitt Hopkins syndrome. According to the Pitt Hopkins Research Foundation, PTHS impacts between 1 in 34,000 and 1 in 41,000 individuals according to some estimates. Although the exact incidence of PTHS is unknown, we believe it would meet the prevalence requirements for an Orphan Drug Designation from the FDA if the other designation requirements are met, although any determination as to whether PTHS qualifies as a “rare disease or condition” will be made by FDA.

Phase 1/2a clinical trial in PASC/Long COVID. Long COVID is a newly recognized condition following the onset of the COVID-19 pandemic, which is characterized by persistent and prolonged symptoms or long-term complications four weeks or more after first being infected with the SARs-CoV-2 virus. Long COVID results from COVID-19 infection and produces prolonged symptoms of fatigue, cognitive impairment and various additional symptoms that can be debilitating. According to the Centers for Disease Control and Prevention, a recent study found that approximately two-thirds of respondents who had tested positive for COVID-19 experienced long-term symptoms often associated with SARs-CoV-2 infection. Given the emerging nature of COVID-19 and new virus variants resulting from mutations, we believe the incidence of Long COVID will continue to increase. A report published in March 2022 by the Science, Technology Assessment, and Analytics team of the U.S. Government Accountability Office found that Long COVID has potentially affected up to 23 million Americans, pushing an estimated 1 million people out of work.

We intend to initiate our FDA-cleared clinical trials for PTHS and Long COVID in the second half of 2024 pending institutional review board approval of clinical trial agreements or other agreements with contemplated collaborators and clinical trial sites.

In addition, we are also currently focused on our pre-clinical development programs for multiple sclerosis, lupus/systemic lupus erythematosus and Alzheimer’s disease. We plan to submit two additional IND applications to FDA to initiate Phase 1/2a clinical trials to assess the safety and efficacy of AlloRx Stem Cell therapy in adults with lupus (SLE) sometime in 2024 and in adults with MS in late 2024, which will be subject to FDA clearance prior to the initiation of any clinical trials for these indications.

We are also advancing and actively pursuing pre-clinical research and development activities of AlloRx Stem Cell therapy for the potential treatment of Alzheimer’s disease with the goal of progressing towards a potential IND filing for this indication in the future.

Note: Net loss and revenue are for the 12 months that ended April 30, 2024. 

(Note: Vitro Biopharma plans to offer 1.0 million shares at a price range of $5.00 to $6.00 to raise $5.5 million in its IPO. This is an NYSE – American Exchange listing. Background: Vitro Bioipharma disclosed the terms for its IPO – 1.82 million shares (1,818,181 shares) at a price range of  $5.00 to $6.00 to raise $10.0 million – with a market cap of $37 million – in an S-1/A filing on June 29, 2023; ThinkEquity was the sole book-runner. At that time, Vitro Biopharma planned to list its stock on the NASDAQ. Vitro Biopharma initially filed to go public – with its S-1 dated Sept. 9,  2022 – and plans to raise up to $17.0 million.)