Company Overview

Company Description

Acesis Holdings Corporation together with its wholly-owned subsidiaries, Acesis Biomed Limited, a company incorporated in England and Wales (“Acesis UK”), and Acesis Biomed US, Inc., a Colorado corporation (“ABI”), is an emerging, pre-phase 1 (first-in-man “FIM”) clinical, biotechnology company focused on men’s health. Since the incorporation of ABI in the State of Colorado on March 11, 2015, we have been developing novel treatments for low testosterone levels in males (“Low–T”) known as T-deficiency or male hypogonadism. Our business model is to develop non-steroid innovative proprietary product candidates that transform the treatment of men with Low-T. Our product candidate pipeline is based on the discoveries of our co-founder Dr. Papadopoulos, a recognized expert in the steroid biochemistry field. Dr. Papadopoulos is currently the Dean of the University of Southern California (“USC”) School of Pharmacy, John Stauffer Dean’s Chair in Pharmaceutical Sciences & Professor of Pharmacology and Pharmaceutical Sciences.

The Company’s mission is to transform the treatment of Low–T in males (also known as hypogonadism) using non-hormonal, orally administered peptide therapeutics and thereby expanding the therapeutic choices that health care providers and patients have in a market currently dominated by non-oral options. The aim is to develop a more targeted, effective and potentially safer alternative compared to conventional marketed treatments. These marketed products contain as their core medical ingredient synthetic steroid testosterone discovered in the 1930s and are administered in the form of injections, gels, creams, patches and more recently pills. The Company’s point of differentiation, compared to its competitors, is that its drug pipeline (peptides) is not a steroid or a hormone, but is intended to induce the body (specifically, the testes, which is the major natural site of T synthesis in men) to produce its own testosterone. The Company’s lead ACE-167 peptide has been designed to target a molecular mechanism to induce the Leydig cells (testosterone-producing cells located in the interstitium of the testes defined as the space between the seminiferous tubules in the testes) to synthesize T. Our pre-clinical work with relevant rat models has not indicated any side effects attributable to the use of our lead peptide (ACE-167) in restoring endogenous T, leading us to postulate that we may have a product candidate without the side effects of the current exogenous formulations. Nonetheless, the safety profile of our peptide product candidate as compared to current testosterone replacement therapies (“TRTs”) remains subject to verification through clinical trials.

The Company’s lead peptide, ACE-167, has been designed to act through a novel molecular mechanism to induce the Leydig cells of the testis to synthesize testosterone thereby restoring endogenous T production. The unique attributes of ACE-167, including its novel mechanism of action and non-steroidal composition, and its ability to induce endogenous levels of T production will need to be proven by the completion of clinical trials and regulatory review. It is our goal to prove that product candidate ACE-167 does not confer the adverse effects in the body as reported for the marketed T formulations.

For example, it is well established that exogenous formulations of T exert negative feedback on the hypothalamus and pituitary, reducing levels of luteinizing hormone (“LH”, a hormone secreted by the anterior pituitary gland that stimulates the synthesis of androgen in males and reducing endogenous intratesticular testosterone production which impairs spermatogenesis resulting to infertility (Fertil Steril Rev., Vol. 2, No. 1, January 2021 2666-5719: Exogenous testosterone replacement therapy versus raising endogenous testosterone levels: current and future prospects). Extensive pre-clinical work using relevant rat models of hypogonadism has not indicated any effects of ACE-167 (RdVTQ) on circulating LH levels. In fact, the absence of no changes in LH levels was one of the main criteria used for selecting our pipeline and our lead candidate ACE-167.

The Company notes that, although we have preliminary evidence in animals that ACE-167 due to its novel mechanism of action may restore endogenous levels of T without altering other parameters affected by exogenous T (e.g. LH and cortisol), we cannot a priori assert that ACE-167 will have an overall better or improved safety profile over currently marketed T products without first gathering additional data and having successfully completed the IND animal studies in two species, clinical trials in men and rigorous regulatory scrutiny and approvals.

The Company is at the pre-IND and IND stage of development for the treatment of primary and secondary male hypogonadism. We expect to use approximately $3,000,000 of the proceeds derived from this offering to complete these development stages so that ACE-167 can transition to FIM phase 1 clinical trials within 24 months from the completion of this offering. The Company estimates that it will require an additional $2.5 million from other sources to obtain clinical supplies and to run the phase 1 clinical trial. Furthermore, the Company will use approximately $600,000 of offering proceeds in the next 18 months to fund a parallel pre-clinical program evaluating the use of our lead peptide, ACE-167, in Klinefelter Syndrome, NAFLD and type 2 diabetes indications. There is clinical evidence linking Low–T in such indications. Accordingly, we will be evaluating in this program the use of the ACE-167 peptide to treat Low–T in these diseases with animal studies and models through the lab of Dr. Papadopoulos at USC under a research collaboration agreement.

We were incorporated on October 3, 2022, in Nevada. Our principal executive offices are located at 9233 Park Meadows Dr., Ste 108, Lone Tree, CO 80124 and our telephone number is 720-389-0650. Our website address is www.acesisbio.com.