Recce Pharmaceuticals Announces First-Quarter 2020 Financial Results and Provides Operational Highlights

Highlights:
Strong cash position with reserves of AUD $4.09MFormalized a Phase I Clinical trial agreement to conduct a first-in-human study of RECCE® 327Completed successful in-vivo toxicity study in animal models reinforcing indications of RECCE® 327’s wide therapeutic windowSYDNEY, Australia, April 29, 2020 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the company developing a new class of broad-spectrum synthetic antibiotics, today reported its March 2020 quarter results and operational highlights.Financial update
The Company ended the quarter with cash reserves of AUD $4.09 million.
Cash out-flows from operative activities were AUD $973,257. Research and development of RECCE® 327 was the main source of expenditure at AUD $817,255 during the period. The Company is debt free and believes it is well funded to obtain human clinical data as part of its recently announced Phase I clinical trial agreement.Clinical and Operational highlights
During the month of February, the Company announced successful in-vivo toxicity (safety) studies in small and large animal species; further reinforcing indications of RECCE® 327’s wide therapeutic window.The studies indicated a No Observed Adverse Effect Level (NOAEL) in either animal species tested at any time during or post study periods, when dosed at 500 mg/kg. Upon an independent, internationally renowned biotech experts’ further review, they echoed, “The NOAEL is 500mg/kg/24 hours for seven days while the NOAEL for one day is 4000mg/kg/24 hours in rats.”These results help position RECCE® 327 as a first-line therapy via a 24-hour intravenous infusion administration, with the aim to treat infection rapidly regardless of bacteria and their mutated superbug form.The Company reported more positive efficacy data with RECCE® antibiotics in a kidney and UTI infection animal model – an infection caused by Escherichia coli (E. Coli), which can often progress to sepsis. This indicates potential of RECCE® antibiotics to tackle infections at their earlier infection stage as part of investigating a ‘whole system’ therapeutic approach.First-in-human Clinical Trial/Self-Dosing treatment
Post quarter end, the Company announced it formalized a Phase I Clinical trial agreement to conduct a first-in-human study of its lead compound RECCE® 327 in 40 healthy patients at an Australian-based trial facility. The Phase I study will be conducted as an independent study and is not a clinical trial that is contingent on FDA approval.Parallel to the execution of the Phase I trial agreement, a respected physician at a leading teaching Australian hospital performed a self-dosing treatment that showed NOAEL. Blood samples were taken and results were found to be normal. The Company has ongoing productive discussions with a leading Australian teaching hospital to initiate an independent Phase I/II topical efficacy study in burn and skin infections.Looking Ahead
Whilst concerned for the societal and equity-market conditions brought on by COVID- 19, the board and management team believe the increasing global awareness of the threat of infectious diseases and the need for new antibiotics (anti-infectives as a whole) represents significant opportunities in the time ahead.We look forward to keeping shareholders updated and thank you for your continued support.
Dr John Prendergast
Non-Executive Chairman
Appendix 4CQuarterly cash flow report for entities subject to Listing Rule 4.7B





     Compliance statementThis statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.This statement gives a true and fair view of the matters disclosed.

NotesThis quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so.If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity.If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the [name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a disclosure committee, you can insert here: “By the Disclosure Committee”.If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained, that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively.