Regenicin, Inc.

The Company continues to evaluate the impact of the COVID-19 virus on the our industry. It is reasonable to assume that the virus had a negative effect on the Company’s financial condition and results of the operations. However, the COVID-19 virus had a significant impact on our efforts to secure additional funding. Governmental agencies and many investors redirected most grants, investments and efforts in the healthcare sector exclusively to COVID-19 vaccines, PEP, COVID testing, and related equipment. 

^{As reported, in our previous filings in 2019, the risk of introducing pathogens when using materials from animals to produce drugs, devices, and biologics has increased awareness of the safety issues. Covid 19 has now clearly demonstrated the dire consequences when pathogens from animals are introduced into humans. The pandemic has also exposed the weaknesses in our healthcare system and its dependence on foreign supply chain. NovaDerm® and future Regenicin products will be the first and only products that use domestic closed herd animal sourced materials like collagen to produce the life-saving products. We have been working with our collagen supplier and the FDA to ensure we are meeting the expectations for traceability and purity of the FDA for NovaDerm®} production.

Our major objective for 2021 remains to secure funding to finalize some additional requirements of the IND application and begin the clinical trials. It is estimated that the direct costs to finalize the IND will be approximately $1.9 million, and the cost to complete Phase 1/2 of the clinical trial will be approximately $5.0 million. As previously reported, our goal in obtaining this funding has been to minimize shareholders' dilution as much as possible. Consequently, we are continuing to primarily pursuing financing through the issuance of a debt instrument, international licensing agreements and government grants. 

Operating expenses, consisting solely of general and administrative expenses, amount to $376,554 and $225,736 for the six and three months ended March 31, 2021, compared with $335,208 and $162,858 for the six and three months ended March 31, 2020. The increases were primarily result of an increased accrued auditor’s and accounting fees.

Other income (expenses) totaled ($16,628) and ($25,440) for the six and three months ended March 31, 2021 as compared to ($31,426) and ($25,790) for the six and three months ended March 31, 2020. Other income (expenses) consisted primarily of interest expense. The increase in interest expense related primarily to interest charged on a convertible note issued to John Weber, the Company’s chief financial officer, on March 31, 2020.