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

Highlights:

• Strong cash balance of A$25.68 million after successful capital raising
• Phase I human clinical trial to evaluate RECCE^® 327 (I.V.) in healthy subjects at leading clinical research organization, Adelaide’s CMAX
• SARS-CoV-2 domestic and international studies on-track
• Presented positive oral data on New RECCE^® 435 against H. pylori, without toxicity
• H. pylori study agreement with Murdoch Children’s Research Institute
• Secured AusIndustry Grant $37,508 + GST with $50,000 more upon milestones
  
  
• Expanded management and advisory teams with CEO, Board of Directors,
• Clinical Advisory Committee and Chief Scientific Officer appointments

SYDNEY, Australia, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing new classes of synthetic anti-infectives, today reported its 30 September 2020 quarter results and operational highlights.

Financial Update

The Company ended the quarter with cash reserves of A$25,687,906 after a well supported placement of A$1.30 per share. Cash out-flows from operations were A$3.3 million with investment in research and development ($2.5m) the main source of expenditure during the period; $0.370m to related parties (executive & director fees). The Company is well funded to advance its clinical and commercial programs.

The Company also received a A$37,508 grant as part of the Entrepreneurs’ Program run by the Department of Industry, Science, Energy and Resources. The funds will be go towards costs associated with the RECCE^® 327 in the SARS-CoV-2 antiviral screening program with a further A$50,000 to be paid on achieving development milestones.

Operational Highlights

Phase I Clinical Trial Update

The Phase I clinical study of its lead compound, RECCE^® 327 is being conducted at South Australia’s CMAX Clinical Research. The trial is progressing as planned with significant volumes of RECCE^® 327 and placebo produced to specification for the study at the Company’s manufacturing facility in Macquarie Park Sydney.

Photos accompanying this announcement are available at:

The Phase I study will assess the safety and tolerability of RECCE^® 327 through intravenous infusion in healthy subjects as a single ascending dose.

SARS-CoV-2 International Studies

University of Tennessee researchers evaluated RECCE^® 327 and RECCE^® 529 compounds in an in-vitro respiratory organoid model. RECCE^® 327 and RECCE^® 529 showed concentration-dependent reductions in the SARS-CoV-2 virus. In a separate but related study, concentrations of RECCE^® 327 and RECCE^® 529 were tested and further indicated an excellent toxicity profile (<0.25%) on Vero (monkey) cells. U.S. researchers recommended advancing research of both compounds, prompting the Company to secure testing in a gold-standard in-vivo COVID-19 infection study in animals (ferrets) with data on-track within the calendar year.

CSIRO/Doherty Institute SARS-CoV-2 Australian studies

A study of RECCE^® 327 against SARS-CoV-2 (COVID-19) has been completed according to protocol. Results are expected to be reported in November.

New oral formulation – RECCE^® 435

RECCE^® 435 is a broad spectrum synthetic polymer antibiotic formulated for oral use. In a recent study, RECCE^® 435 showed dose-dependent and efficacy against Helicobacter pylori (H. pylori) bacteria isolated from a patient with a duodenal ulcer compared to control vehicle in independent study model in rats. In a separate and independent oral dosing study, RECCE^® 435 yielded no observed toxicity with favourable weight gain throughout.

Murdoch Children’s Research Institute (MCRI) has since entered agreement with the Company to conduct a range of preclinical studies assessing the potential of RECCE^® 435 for the treatment of H. pylori infections. The program is led by Professor Phil Sutton and carried out by the Mucosal Immunology Group at the MCRI, Royal Children’s Hospital.

Board and Management

During the reporting period, the Company strengthened its management and advisory teams with a number of important appointments.

Dr. Alan W. Dunton (M.D.) – Non-Executive Director

Dr. Dunton joined the Board as an independent Non-Executive Director and member of the Company’s Audit & Risk/Remuneration & Nomination Committees.

Dr. Dunton has led clinical research development efforts and advanced drug candidates including a number of blockbuster antibiotics, through regulatory review and commercialization at Fortune 500 companies including Johnson & Johnson and Roche.

Professor Phillip Sutton – Clinical Advisory Committee & Head of Helicobacter pylori program

Professor Sutton joined as Head of the Helicobacter pylori stomach development program.

Professor Sutton leads the Mucosal Immunology Group at the Murdoch Children’s Research Institute in Victoria, Australia and has more than 30 years of research and industry experience having served as the former Head of Immunology at CSL Limited in Melbourne.

Recce Appointments

The Company further appointed James Graham as Chief Executive Officer and Michele Dilizia as Chief Scientific Officer. Both have been with the Company since inception and will continue their roles as members of the Board. Michele will continue her significant contribution to advancing our important research, clinical collaborations and in-house research programs.

The Board and management remain focused and are moving as quickly as possible to take full advantage of our leadership in the global race to develop new therapies and create long-term shareholder value.

About Recce Pharmaceuticals Ltd



Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialization of New Classes of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens.

Recce’s anti-infective pipeline is unique and comprised of broad-spectrum synthetic polymer antibiotics RECCE^® 327 and RECCE^® 435, and RECCE^® 529 for viral infections with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively.

Patented lead candidate RECCE^® 327 has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms. Recce’s new antibiotic compound, RECCE^® 435, has been formulated for oral use.

The FDA has awarded RECCE^® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labeling it for Fast Track Designation, plus 10 years of market exclusivity post approval.

Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE^® technologies targeting synergistic, unmet medical needs.

Corporate Contact

James Graham

Recce Pharmaceuticals Ltd

+61 (02) 8075 4585

Media and Investor Relations (AU)

Andrew Geddes

CityPR

+61 (02) 9267 4511

Media and Investor Relations (USA)

Meredith Sosulski, Ph.D.

LifeSci Communications