Houston, Texas — (June 30, 2023) — GreenJay Therapeutics, Inc. (“GreenJay” or the “Company”), a drug formulation company focused on developing safer, more soluble and more efficacious therapies for patients with leukemia and other blood disorders, announced today that the Company has completed its seed round of financing.
“We are very pleased with our success in raising significant capital that allows further development of our novel formulation of IV busulfan,” said Michael Redman, President and Chief Executive Officer of GreenJay. “Reaching this important milestone provides us with the ability to perform activities necessary to submit for FDA registration through the 505(b)(2) regulatory pathway.”
The 505(b)(2) New Drug Application (NDA) is a streamlined process in which the applicant relies on one or more investigations conducted by a company other than the applicant and for which the applicant has not obtained right of reference. This pathway enables investigators and/or manufacturers to apply for approval without the need to repeat all the drug development work performed for an innovator drug.
The novel formulation, called BulantaTM, differs from other IV busulfan formulations in that Bulanta does not contain dimethyl acetamide (DMA), which has been deemed by regulatory authorities as a toxic solvent. DMA is currently being dosed at a level up to 1000 times the daily permitted exposure when used in current IV busulfan formulations and is associated with neurotoxicity side effects.
About GreenJay
GreenJay Therapeutics, Inc. is a drug formulation company focused on developing drug products with greater drug solubility, improved safety profiles and greater efficacy. The Company’s lead product candidate, BULANTA (IV busulfan), is being developed as an alternative to other IV formulations of busulfan that contain the toxic DMA solvent. For more information, please visit the Company’s web site at www.greenjaytherapeutics.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of GreenJay’s product candidates, alone and in combination with other therapies, on leukemia and other blood diseases, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of BULANTA and our other potential product candidates including whether we receive fast track or similar regulatory designations; and costs associated with developing our product candidates.
All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
GreenJay Therapeutics, Inc.
mredman@greenjaytherapeutics.com