ASX Share rice
Sat 15 May 2021 - 02:06:am (Sydney)

RCE Share Price

RECCE PHARMACEUTICALS LTDRCEPharmaceuticals, Biotechnology & Life Sciences

RCE Company Information

Name:

Recce Pharmaceuticals Ltd

Sector:

Healthcare

Industry:

Biotechnology

GIC Industry:

Pharmaceuticals

GIC Sub Industry:

Pharmaceuticals

Address:

Gateway Tower Sydney NSW Australia 2000

Phone:

61 2 8075 4585

CEO & MD:

Mr. James Hamilton-Bray Graham

Chief Scientific Director & Exec. Director:

Ms. Michele Keryn Dilizia

Principal Quality Chemist & Exec. Director:

Dr. Justin Ward

Principal Engineer & Head of Manufacturing:

Mr. Arthur Kollaras

Chief Financial Officer:

Mr. Justin Reynolds

Marketing Mang.:

Mr. Daniel Astudillo B.A., B.Com., M.B.A.

Member of Clinical Advisory Committee & Head of Helicobacter Pylori Devel. Program:

Prof. Philip Sutton

Company Sec.:

Mr. Alistair McKeough BA, LLB, LLM

Company Overview:

Recce Pharmaceuticals Ltd, a biotechnology company, engages in the research, development, and commercialization of synthetic antibiotics in Australia, the United States, and the United Kingdom. The company's lead candidate is RECCE 327 to treat blood infections and sepsis derived from E. coli and S. aureus bacteria, including their superbug forms. It also develops RECCE 529, a synthetic anti-infective for viral infections; and RECCE 435, a synthetic polymer antibiotics. The company was formerly known as Recce Limited and changed its name to Recce Pharmaceuticals Ltd in November 2017. Recce Pharmaceuticals Ltd was incorporated in 2007 and is headquartered in Sydney, Australia.

RCE Share Price Information

Shares Issued:

173.78M

Market Capitalisation:

$190.29M

Revenue (TTM):

$690.05K

Revenue Per Share (TTM):

$0.01

Earnings per Share:

$-0.03

Operating Margin (TTM):

$-19.24

Return On Assets (TTM):

$-0.55

Return On Equity (TTM):

$-0.94

Quarterly Revenue Growth (YOY):

-0.403

Gross Profit(TTM):

$-977,344

Diluted Earnings Per Share (TTM):

$-0.098

RCE CashFlow Statement

CashFlow Date:

2020-06-30

Investments:

$-5,944

Change To Liabilities:

$177.83K

Total Cashflow From Investing Activities:

$-5,944

Net Borrowings:

$-887,514

Net Income:

$-4,316,737

Total Cash From Operating Activities:

$-3,807,450

Depreciation:

$200.82K

Change To Account Receivables:

$-4,847

Sale Purchase Of Stock:

$6.98M

Capital Expenditures:

$5.94K

RCE Income Statement

Income Date:

2020-06-30

Income Before Tax:

$-4,316,740

Net Income:

$-4,316,740

Operating Income:

$-4,260,290

Other Operating Expenses:

$1.36M

Interest Expense:

$45.85K

Total Revenue:

$1.15M

RCE Balance Sheet

Balance Sheet Date:

2020-06-30

Total Liabilities:

$0.93M

Total Stockholder Equity:

$2.31M

Other Current Liabilities:

$234.07K

Total Assets:

$3.24M

Common Stock:

$18.47M

Other Current Assets:

$15.85K

Retained Earnings:

$-17,958,259

Other Liabilities:

$46.30K

Cash:

$2.68M

Total Current Liabilities:

$885.23K

Property - Plant & Equipment:

$504.70K

Net Tangible Assets:

$2.31M

Total Current Assets:

$2.74M

Net Receivables:

$41.36K

Short-Term Investments:

$504.70K

Accounts Payable:

$159.49K

Non Currrent Assets (Other):

$-1

Short-Term Investments:

$504.70

Non Current Liabilities Total:

$46.30K

RCE Share Price History

RCE News

04 May, 2021
ESKAPE Pathogens: Standardised and Drug Resistant Broad Efficacious Dosing Range Figure 1 Minimum inhibitory concentration (ppm) of RECCE® 327 against ESKAPE pathogens. Figure 2 Time-kill curves of R327 at various concentrations against strains of ESKAPE pathogens. Highlights: More than 99.9% effective against full suite of ESKAPE pathogens, within hours of exposure to RECCE® 327 (R327) in independent bacterial efficacy studiesR327 remains effective against hypermutated ESKAPE superbugs, including multi-drug resistant (MDR) forms, a current market challenge of all existing antibiotics On-track to be the only company developing an efficacious anti-infective against ESKAPE pathogens globally SYDNEY, Australia, May 04, 2021 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE) (FSE:R9Q) (Company), the Company developing new classes of synthetic anti-infectives, is pleased to announce RECCE® 327 (R327) has demonstrated bactericidal activity against all six antibiotic resistant ESKAPE pathogens, including drug resistant mutations (superbugs) as well as two additional World Health Organization (WHO) priority pathogens list. “We are encouraged by the data from this study and will continue to explore the potential of RECCE® 327 to treat hospital-acquired infections,” said Recce Pharmaceuticals CEO James Graham. “Antimicrobial resistance is one of the most urgent threats to global public health with the suite of ESKAPE pathogens posing a significant threat due to their virulence and rapid development of drug-resistance. Additionally, with R327 effective against two more priority pathogens listed by the WHO, we believe this reinforces the potential of R327 to treat some of the greatest threats to human health.” These antibiotic resistant bacteria acronymically dubbed 'ESKAPE' due to their propensity of 'escaping' the biocidal action of antibiotics, are collectively responsible for over 720,000 hospital acquired (nosocomial) infections in the United States alone each year.1 The ESKAPE pathogens include both Gram-positive and Gram-negative bacteria; Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species. The study was conducted by an independent contract research organization to assess the in-vitro efficacy of R327 against all ESKAPE pathogen bacterial strains. R327 is a broad-spectrum synthetic anti-infective that has potential to address the urgent global health threat posed by antibiotic resistant superbugs and emerging viral pathogens. Graphics accompanying this announcement are available athttps://www.globenewswire.com/NewsRoom/AttachmentNg/a3b15bb1-79c7-44fd-b457-734d4e2fa7d0 https://www.globenewswire.com/NewsRoom/AttachmentNg/a695f826-f4e3-4061-bea3-d0ae89a8d31f ESKAPE pathogens are responsible for 42.2% of blood infections,2 around 50 million infections each year, resulting in one in five deaths in the community or one in three deaths in hospitals3 and are associated with higher lengths of stay, cost of care, and mortality compared with non-ESKAPE pathogens.2 The dilution method of R327 used in these studies slightly increased the minimum inhibitory concentration (MIC) across the wide range of Gram-positive, Gram-negative and superbug forms of bacteria. The slight variation (+/-) between one experiment to the next is likely due to small variance in the sensitivity of the instruments used in detection. The dilution of R327 that showed efficacy against K. pneumonia (CRE) is higher than previous findings though still well within the therapeutic window dosing range. Additionally, R327 was shown to be effective against the WHO global priority pathogens carbapenem-resistant Escherichia coli (E. coli CRE) and multi-drug resistant Neisseria gonorrhoeae4 (N. gonorrhea MDR). These bacteria are listed on the WHO’s list of priority pathogens as those for which new antibiotics are urgently needed in addition to ESKAPE pathogens. A graphic accompanying this announcement is available athttps://www.globenewswire.com/NewsRoom/AttachmentNg/08edf798-57a0-4634-8bb3-593db59a0b48 The minimum inhibitory concentration (MIC), or the lowest concentration of a drug that prevents visible growth of a bacterium or bacteria, was first determined to define the test concentrations for the time-kill study. The time-kill study was performed to determine the bacterial killing effect of R327 at a total of five concentrations, ranging from 0.5X to 8X the MIC and to measure killing kinetics of treatment with R327 against each strain. Time-kill curves of R327 at various concentrations against strains of ESKAPE pathogens. In the time kill assay, each R327 dilution was tested in duplicate with the average plot shown. The bactericidal activity of R327 demonstrated a three-log or 99.9% reduction in the number of colony forming units (CFUs) over 24 hours against all six strains at various concentrations and times. Additional time kill concentration studies are underway with drug-resistant bacterial and are expected to be in-line with existing MIC/Time Kill. Data is expected in around a month and as pivotal inclusion in a Whitepaper/Abstract for presentation at the World Microbe Forum (20-24 June 2021) 5. About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation 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, 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 – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate in development. 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. Chief Executive OfficerJames GrahamRecce Pharmaceuticals Ltd+61 (02) 9256 2571james.graham@recce.com.au Media and Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media and Investor Relations (USA)Meredith Sosulski, PhDLifeSci Communications+1 929 469 3851msosulski@lifescicomms.com 1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4871955/#:~:text=The%20ESKAPE%20pathogens%20(Enterococcus%20faecium,nosocomial%20infections%20throughout%20the%20world. 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902016/ 3 https://www.sensium.co.uk/news/lancet-publication-finds-one-in-five-deaths-due-to-sepsis/ 4 https://www.pharmacologydiscoveryservices.com/catalogmanagement/viewitem/Neisseria-gonorrhoeae-MDR-WHO-L-CCUG-57598-MIC/612505 5 https://www.worldmicrobeforum.org/
19 Apr, 2021
We can readily understand why investors are attracted to unprofitable companies. Indeed, Recce Pharmaceuticals...
01 Apr, 2021
Efficacy of Recce Anti-Infectives in Acute Bacterial Rhinosinusitis Efficacy Acute Bacterial Rhinosinusitis Histology of Sinuses in Acute Bacterial Rhinosinusitis Animal Model Early Infection Control Highlights: Positive sinusitis infection data indicated in animal study Study supports broad spectrum potential of Recce’s anti-infective compounds against Streptococcus pneumoniae (S. pneumoniae) for both nasal and intravenous administration RECCE® 327 (R327) and experimental RECCE® 111 (R111) tested against marketed therapeutic alternative in-vivo in sinusitis study; independent study agreement anticipated SYDNEY, Australia, April 01, 2021 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (Company), the Company developing New Classes of Synthetic Anti-Infectives, is pleased to announce animal study data showing positive efficacy of a new anti-infective formulation RECCE® 111 (R111) against Streptococcus pneumoniae (S. pneumoniae) bacterial sinusitis in mice. RECCE® 111 is a non-descript title for an experimental compound, developed in-house, building upon the unique mechanisms of action of RECCE® 327. “We’re continually excited by the potential of Recce’s anti-infective compounds and are encouraged by these positive indications,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “Moreover, this further enhances the breadth of Recce’s synthetic polymer platform.” The study was conducted by an independent Contract Research Organization, to assess the dose-dependency of R327 and R1111 in-vivo antibacterial activity against S. pneumoniae in a mouse model of acute bacterial rhinosinusitis infection. Efficacy of Recce Anti-infectives in Acute Bacterial Rhinosinusitis Treatment TableGroupTreatmentClinical Observation1Early infection control (day1 post infection)NAD2Infection vehicle control, twice daily, oral, 5 daysNAD3Positive Control (Azithromycin, oral, 200 mg/kg, twice daily, 5 days)NAD4RECCE® 327 (Low dose, Nasal, 50 mg/kg, Twice daily, 5 days)NAD5RECCE® 327 (Mid dose, Nasal, 100 mg/kg, Twice daily, 5 days)NAD6RECCE® 327 (High dose, Nasal, 500 mg/kg, Twice daily, 5 days)NAD7RECCE® 327 (Low dose, IV, 100 mg/kg, Twice daily, 5 days)NAD8RECCE® 327 (Mid dose, IV, 500 mg/kg, Twice daily, 5 days)NAD9RECCE® 327 (High dose, IV, 1000 mg/kg, Twice daily, 5 days)NAD10RECCE® 111 (Low dose, IV, 50 mg/kg, Twice daily, 5 days)NAD11RECCE® 111 (Mid dose, IV, 100 mg/kg, Twice daily, 5 days)NAD12RECCE® 111 (High dose, IV, 250 mg/kg, Twice daily, 5 days)NADEfficacy Acute Bacterial RhinosinusitisNAD: No abnormality detected This bacterium was chosen due to its immediate availability as a recognized sinusitis model. Streptococcus pneumoniae, a Gram-positive bacterium, is a leading cause of bacterial pneumonia and meningitis in the United States, and a common cause of bloodstream infections, also known as sepsis, ear and sinus infections.2 A total of 12 groups of 10 mice each were assessed to determine the effectiveness of R327 and R111 against S. pneumoniae. Three groups were treated with varying intranasal doses twice daily of R327 (50, 100, 500 mg/kg) and showed a significant dose-dependent antibacterial effect when compared to early infection and vehicle control (p
15 Mar, 2021
Filter Drugs By Development Phase and Type RECCE® 327 (R327) has been added to The Pew Charitable Trusts’ annual list of Non-traditional Products in Development to Combat Bacterial Infections identifying new antibiotic treatments in development worldwide. Highlights: RECCE® 327 included in The Pew Charitable Trusts’ annual assessment of non-traditional antibiotic treatment in clinical developmentRECCE® 327 is the only synthetic polymer drug candidate for treating sepsis currently in developmentNew “outside-the-box” drugs are critically needed, with conventional antibiotic pipeline extremely thin SYDNEY Australia, March 15, 2021 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE) (FSE:R9Q), is pleased to announce its lead compound RECCE® 327 (R327) has been added to The Pew Charitable Trusts’ annual list of Non-traditional Products in Development to Combat Bacterial Infections identifying new antibiotic treatments in development worldwide. “We welcome inclusion of our lead compound in this important annual global record of efforts underway to address the urgent unmet medical need to develop new antibiotic treatments,” said Recce Pharmaceuticals Chief Executive Officer James Graham. “May this bring light to those at risk or suffering from sepsis, an infection for which no specific treatments exist, at this time.” The Non-traditional Products in Development to Combat Bacterial Infections register is a key part of the respected independent non-profit organization’s efforts to help health and medical researchers better understand bacterial infections and address antibiotic resistance. The Pew Charitable Trusts’ stated mission is to serve the public interest by improving public policy, informing the public, and invigorating civic life. The register of non-traditional treatments shows 36 candidates which are in clinical development as of March 2021. It includes new approaches ranging from well-known medical interventions, such as vaccines and immunotherapies, to new therapies which have never been approved for use in human medicine. The list identifies each product and its manufacturer, type of approach, potential indications, target or mechanism of action, and stage in the clinical development process. About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation 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, 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 – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the only synthetic polymer drug candidate for treating sepsis currently in development. 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 ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 8075 4585James.graham@recce.com.au Media and Investor Relations (AU)Andrew Geddes CityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media and Investor Relations (USA)Meredith Sosulski, Ph.D.LifeSci Communications+1 929 469 3851msosulski@lifescicomms.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8bb30e6b-7b85-4dc4-bd97-a69a6c04c405 Image Source: The Pew Charitable Trusts 2021
09 Mar, 2021
Shares now trading on major German Trading Exchanges Shares trade under code: R9QNo related capital raising - trade of existing securities with trade volume to increase on Australian Stock Exchange (ASX)Expected to broaden institutional and retail investor base across EU, in-line with increasing activity in the region SYDNEY, Australia, March 09, 2021 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE) (Company), the Company developing new classes of synthetic anti-infectives is pleased to announce the Company’s shares are now Dual Listed on the Frankfurt Stock Exchange (FSE).Trading commenced Monday, March 8 at 8:00 a.m. (CET) under the code R9Q. The dual listing sees trading of the Company’s securities on German Trading Exchanges: Frankfurt, Tradegate, Munich, Stuttgart and Gettex. The dual listing was possible without many of the primary listing procedures, seeing a widening of investor reach with minimal cost. There is no associated capital raising due to the Company’s strong existing financial position and sees no issuance of new securities due to the Company being listed and market-makable via the ASX. Dr. John Prendergast, Chairman of Recce Pharmaceuticals Ltd said, “Dual-listing on the Frankfurt Stock Exchange is a wonderful new chapter in our global strategy. As the third largest stock exchange in the world, it sees the connection of EU biotech and overseas capital with the Company’s new classes of synthetic anti-Infectives development program.” Mr. Stefan Müller, CEO of DGWA, said, “DGWA are thrilled to be working with Recce in Europe. Investor interest in quality biotechnology companies is significant and increasing with the global anti-infective market expected to grow at a compound rate of over 30% to 2030 and anticipate this German listing will provide EU investors an opportunity to participate in that growth. We are confident Recce will be warmly welcomed among the European investment community and look forward to supporting their activity in the region over the time ahead.” About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation 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, 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 – labelling 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 ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 8075 4585James.graham@recce.com.au Media and Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media and Investor Relations (USA)Meredith Sosulski, Ph.D.LifeSci Communications+1 929 469 3851msosulski@lifescicomms.com
24 Feb, 2021
Highlights: Broadens institutional and retail investor base across EU and enables access to additional capital markets No related capital raising - trade of existing securities with trade volume to increase on ASX On-the-ground investor relations firm to further support intended research programs in EU SYDNEY, Australia, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE) (Company), the Company developing new classes of synthetic anti-infectives is pleased to announce it has commenced the application process to dual list its stock on the Frankfurt Stock Exhange (FSE). “Dual-listing on FSE enables Recce to broaden its exposure to European investors,” said Dr. John Prendergast, Non-Executive Chairman of Recce Pharmaceuticals Ltd. “The Company considers that it meets the requirements necessary to dual-list on FSE and will provide updates on its application progress.” Dual listing on the FSE will see the Company increase exposure to a large base of retail and institutional investors in the European Union (EU) through German Trading Exchanges (Frankfurt, Tradegate, Berlin, Stuttgart). The Frankfurt Stock Exchange is the third largest in Europe and tenth largest in the world. Recce Pharmaceuticals has appointed Deutsche Gesellschaft Für Wertpapieranalyse GMBH (DGWA) as its investor and corporate relations advisor in Europe. DGWA will facilitate engagement with prospective investors in the German speaking DACH region (Germany, Austria and Switzerland) while driving awareness of Recce’s novel synthetic anti-infective compounds. Mr. Stefan Müller, the CEO of DGWA added, “We are excited to support Recce in engagement with European investors and opportunities to expand its infectious disease programs.” The Company will provide the market further updates on its listing process on material developments, with expectation the process will be completed in upcoming weeks. About Recce Pharmaceuticals LtdRecce 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, 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 – labelling 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 ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 8075 4585James.graham@recce.com.au Media and Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media and Investor Relations (USA)Meredith Sosulski, Ph.D.LifeSci Communications+1 929 469 3851msosulski@lifescicomms.com
16 Feb, 2021
RECCE® 327 RT-PCR and Cell Viability Data RECCE® 327 RT-PCR and Cell Viability Data Highlights: RECCE® 327, a synthetic anti-infective 99.9% efficacious in confirmatory in-vitro screening assay against SARS-CoV-2 virusSARS-CoV-2 virus no longer detectable by virus titration at 4,000 ppm – minimal toxicity to Vero cellsNo toxicity identifiable at 1,333 ppm or less U.S. in-vivo studies in parallel expanded to include new UK & South African COVID-19 causing strains SYDNEY, Australia, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing new classes of synthetic anti-infectives, today announced results of RECCE® 327 (R327) demonstrating encouraging virucidal activity against the SARS-CoV-2 virus with a positive safety profile. “We continue to be encouraged by the results from the antiviral SARS-CoV-2 screening program as it reinforces our belief in the potential of R327 against COVID-19 including emerging variant strains,” said Non-Executive Chairman Dr. John Prendergast. “We would like to thank the Doherty Institute for performing the experiments and look forward to coming studies.” The finding is based on independent tests conducted by the CSIRO/Doherty Institute as part of its SARS-CoV-2 Anti-viral Screening Program. R327 showed a reduction in SARS-CoV-2 viral genome numbers at 4,000 parts per million (ppm) and virus was no longer detectable by viral titration; the RT-PCR detected the three-log drop in viral genome copies (99.9% reduction). PCR is a highly sensitive technique for viral detection and quantitation – the first choice in COVID swab testing in humans and animals.1 Antiviral testing was conducted in triplicate with a very small variance bar above the 4,000 ppm data point. Minimal toxicity was observed at 4,000 ppm of R327; there was no cytotoxicity at or below 1,333 ppm. Further testing will be required at higher dose levels to establish the IC 50 and cytotoxicity which will then allow the Company to decide whether to pursue R327 as an anti SARS-CoV2 inhibitor candidate. Statistical signficance was not relevent in this study. All intellectual property rights are retained by the Company with data to be reported as becomes available. In parallel to the testing at CSIRO/Doherty Institute in Australia, a leading contract research organisation in the United States is expanding its in-vivo studies of RECCE compounds against SARS-CoV-2 in ferrets to include emerging UK and South African variant strains of the virus. These studies continue to progress well with results on-track within the present quarter. Whilst Recce is delighted by the results, further testing must be completed before R327 is confirmed as being active against the SARS-CoV-2 virus. 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 antibiotics are unique – their potency does not diminish even with repeated use, a common failure associated with existing antibiotics and their propensity to rapidly succumb to resistant superbugs. Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms. The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling 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. 1 https://pubmed.ncbi.nlm.nih.gov/21819328/ Chief Executive OfficerJames GrahamRecce Pharmaceuticals Ltd+61 (02) 9256 2571James.graham@recce.com.au Media and Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media and Investor Relations (USA)Meredith Sosulski, PhDLifeSci Communications+1 929 469 3851msosulski@lifescicomms.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e8623e3f-66ef-4446-bfa8-c0647d01c775.
Highlights: Phase I/II trial agreement with Fiona Stanley Hospital (Burns Unit) in Perth Western AustraliaStudy led by world leading burn treatment specialistsStudy will assess safety and efficacy of RECCE® 327 against a broad range of infectious disease on chronic burn wounds in up to 30 patients RECCE® 327 formulated as new spray-on antibiotic for chronic burn wounds First patients to be dosed in present quarter SYDNEY, Australia, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE), the Company developing new classes of synthetic anti-infectives, today announced it has formalized an agreement with Fiona Stanley Hospital for a Phase 1/2 clinical trial to assess the potential of RECCE® 327’s new spray-on, broad-spectrum antibiotic for the treatment of topical burn wound infections. “We look forward to working with the world-leading team at Fiona Stanley Hospital in advancing new treatment options for burns victims at increased risk of infection from multidrug resistant organisms,” said Recce Pharmaceuticals Non-Executive Chairman Dr. John Prendergast. “Based on promising results from preclinical studies, we believe RECCE® 327 has potential to make a significant impact in treating infections, which continue to pose a challenge to the long-term survival of patients in burns units.” The trial investigators are Dr. Edward Raby, Clinical Microbiologist and Infectious Diseases expert at Royal Perth and Fiona Stanley Hospitals, Dr. Chris Heath, Head of Infectious Diseases at Fiona Stanley Hospital, and Professor Fiona Wood, Director of State Adult Burns Unit at Fiona Stanley Hospital, internationally renowned burns surgeon, known for pioneering the development of ‘spray-on skin.’ Dr. Raby said, “Antibiotic resistant infection is a major issue after burns injuries. Our team is keen to identify and add new treatments with the potential to overcome antibiotic resistance and improve patient’s lives. We look forward to evaluating this new spray-on antibiotic.” The Phase 1/2 topical study will enroll up to 30 patients and be conducted at Fiona Stanley Hospital Burns Unit in Perth Western Australia. The study will assess the safety and efficacy of RECCE® 327 as a broad spectrum spray-on antibiotic for patients with Gram-positive and Gram-negative bacterial burn wound infections expanding to a comparative effectiveness study based on the data. Over 14 days, 10 patients will receive RECCE® 327 daily, while 20 patients will receive treatment three times per week. The first patients are expected to be dosed in the present quarter. Burn wound specialists will oversee delivery of RECCE® 327 in a spray-on formulation, specifically developed for the study. The product has been produced at the Company’s manufacturing facility to the same human clinical study standards as the previously announced Phase 1 intravenous clinical trial. It is anticipated the two studies will run in parallel, demonstrating the broad administration capabilities of RECCE® 327. 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 antibiotics are unique – their potency does not diminish even with repeated use, a common failure associated with existing antibiotics and their propensity to rapidly succumb to resistant superbugs. Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms. The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling 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 ContactJames GrahamRecce Pharmaceuticals Ltd+61 (02) 8075 4585James.graham@recce.com.au Media and Investor Relations (AU)Andrew GeddesCityPR+61 (02) 9267 4511ageddes@citypublicrelations.com.au Media and Investor Relations (USA)Meredith Sosulski, Ph.D.LifeSci Communications+1 929 469 3851msosulski@lifescicomms.com
18 Jan, 2021
A look at the shareholders of Recce Pharmaceuticals Ltd ( ASX:RCE ) can tell us which group is most powerful. Large...
23 Dec, 2020
Nasal Wash Viral Titres in Hamsters Nasal Wash Viral Titres in HamstersHighlights: * RECCE® 327 and RECCE® 529 demonstrated dose-dependent activity in-vivo against SARS-CoV-2 virus in Syrian golden hamsters, a well-accepted model of infection * Intranasal administration of both compounds supports multiple potential modes of administration against SARS-CoV-2 * Company committed to its COVID-19 activities as part of its infectious disease portfolio SYDNEY, Australia, Dec. 23, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing new classes of synthetic anti-infectives, today announced results from its international SARS-CoV-2 in-vivo studies, demonstrating positive activity of RECCE® 327 (R327) and RECCE® 529 (R529) against the SARS-CoV-2 virus in Syrian golden hamsters.Non-Executive Chairman Dr. John Prendergast said, “We are certainly encouraged by these in-vivo results and will continue to investigate the potential of Recce’s anti-infectives in larger animal models. We look forward to continuing our international studies which demonstrate the potential of our compounds to be effective against SARS-CoV-2.”The study consisted of five groups of eight hamsters, each receiving a different treatment – placebo control of saline nasal wash, low dose of R327 (200mg/kg), high dose of R327 (400mg/kg), low dose of R529 (100mg/kg), and high dose of R529 (200mg/kg). All animals were infected with SARS CoV-2 on Day 0 with treatments administered twice daily on Days 1-5 and viral titres measured directly on Days 2, 4 and 6 via qPCR. In this model, the viral titres typically peak between Days 2 and 4.The results, in both R327 and R529, demonstrated a positive reduction in COVID-19 viral load compared to the placebo group. The data that statistical significance has not been assessed, conveyed a mean log reduction within groups on Day 4 where the low R529 dose achieved a log reduction in the order of 1.5 logs and a high dose of R327 achieved a log reduction of 1.25 logs. Two of the five hamsters with COVID-19 infection on Day 6 indicated adverse clinical symptoms in the high dose R529 group and were excluded from the study. The Company considers a study specific anomaly since R529 was routinely well tolerated at considerably higher intravascularly infused doses in-vivo. The weight of the hamsters across all groups at the start and the end of the study remained approximately the same.This hamster study is the first indication of the potential for nasal administration of Recce’s anti-infective compounds, specifically when used against viruses. A gold-standard ferret COVID-19 study is underway in the United States seeking to build upon this method of administration, including higher dose concentrations and two other forms of administration, only possible in larger species. These data are expected in early 2021.Whilst Recce is delighted by the results, further testing must be completed before R327 or R529 are confirmed as being safe or effective against the SARS-CoV-2 virus. The Company would like to thank IITRI for performing the experiments. IITRI is a “DOD-secure” facility; both the physical security of IITRI laboratories and our facility security program are regularly reviewed by inspectors from the United States Department of Defence1.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 antibiotics are unique – their potency does not diminish even with repeated use, a common failure associated with existing antibiotics and their propensity to rapidly succumb to resistant superbugs.Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms.The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling 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.* * *1 https://iitri.org/iitri-advantage/Corporate Contact James Graham Recce Pharmaceuticals Ltd +61 (02) 8075 4585 James.graham@recce.com.auMedia and Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.auMedia and Investor Relations (USA) Meredith Sosulski, Ph.D. LifeSci Communications +1 929 469 3851 msosulski@lifescicomms.comAn infographic accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2dc0c5c2-c07e-4452-987f-9ea8b86dbea8
21 Dec, 2020
SYDNEY, Australia, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE), the Company developing new classes of synthetic anti-infectives, is pleased to provide an update on its clinical programs. Topical Phase I/II Human Clinical Trial Submission Topical Phase I/II human clinical study is on track and progressing well. The Company recently announced it has received Human Research Ethics Approval for its Phase I/II human topical clinical trial in infected burn wounds and is closely working with South Metropolitan Health Service (Department of WA Health) on operational specifics with first patient treatment anticipated Q1 2021.Intravenous Phase I Human Clinical Trial Phase I clinical trial is progressing well with onsite audits this week and patient screening expected to take place in Q1 of 2021. The Company’s lead product RECCE® 327 (R327) has been dispatched to clinical research facility CMAX in Adelaide, who have 30,000 registered patient volunteers on file.Murdoch Children’s Research Institute Independent animal ethics commitee has approved the first preclinical animal studies to assess potential of RECCE® 435 (R435) administered orally for the treatment of Helicobacter pylori (H. pylori) gastric infection, at Murdoch Children’s Research Institute (MCRI). Samples of R435 have been received by MCRI, and the work being led by world H. pylori expert Professor Phil Sutton, Head of Mucosal Immunology at MCRI,, is on track for first data to be reported in Q1 2021.SARS-CoV-2 (COVID-19) Studies During the current quarter, the Company received encouraging results from SARS-CoV-2 studies in both Australia and the United States, with each advancing to their respective next stages. In the United States, both R327 and RECCE® 529 (R529) compounds are in advanced stages of in vivo testing completion according to international COVID-19 study 1 protocols in leading testing species of hamsters and ferrets.1 The two gold-standard studies in COVID-19 testing allows for the assessment of various modes of administration to combat the disease.The first of the hamster data via intranasal administration is expected within the next two weeks, with ferret animal data via other modes of administration expected to follow soon after.Looking ahead The Company’s continues to manage a strong balance sheet in excess of $23 million AUD (ex anticipated R&D in-flow) in support of its infectious disease activities and looks forward to updating investors over the time ahead.1 https://www.nature.com/articles/s41586-020-2787-6About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation 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 – labelling 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 James.graham@recce.com.auMedia and Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.auMedia and Investor Relations (USA) Meredith Sosulski, Ph.D. LifeSci Communications +1 929 469 3851 msosulski@lifescicomms.com
23 Nov, 2020
SYDNEY, Australia, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE), the Company developing new classes of synthetic anti-infectives, is pleased to announce the Japan Patent Office (JPO) has granted Patent Family 3 titled “Anti-virus Agent and Method for Treatment of Viral Infection”, furthering marketing and manufacturing monopolies to February 2037. “Recce’s intellectual property portfolio continues to grow in-line with our business strategy and the unprecedented global infectious disease crisis before us,” said Chief Executive Officer, James Graham. “At now 31 granted patents across three wholly-owned patent families, our market-monopolies reinforce our unique opportunity among a significant-range of both bacterial and viral pathogens.”Japan Patent Office granted claims relate to RECCE® 327 (R327) and new anti-viral formulation RECCE® 529 (R529), most notably: * Composition/method of manufacture of RECCE® anti-infectives * Use of R327 or R529 for the treatment of viruses having a lipid envelope or coat, examples being SARS-CoV-2 and coronaviruses, influenza viruses, HIV, hepatitis, Ross River and Herpes viruses * Administration of R327 or R529 by oral, injection, inhalation and transdermal dose applications Japan is the second largest pharmaceutical market in the world1 with the unmet medical need from infections caused by lipid enveloped or coated viruses representing millions of potential patients Japan country alone. Patent Family 3 applications in other major pharmaceutical markets around the world are in their advanced stages of independent patent reviews.__________________________________1 https://www.worldatlas.com/articles/countries-with-the-biggest-global-pharmaceutical-markets-in-the-world.html 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 – labelling 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 James.graham@recce.com.auMedia and Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.auMedia and Investor Relations (USA) Meredith Sosulski, Ph.D. LifeSci Communications +1 929 469 3851 msosulski@lifescicomms.com
11 Nov, 2020
Virus Titers IC50 of test compound excluding the three lowest data points: 109.8 PPM. Data as extracted from Doherty Institute ReportHighlights: * RECCE® 327, a synthetic anti-infective showed encouraging efficacy in an in-vitro screening assay against SARS-CoV-2 virus * RECCE® 327 showed encouraging inhibition and is advancing to Stage 1b (confirmatory in-vitro testing and a cytotoxicity assessment), underway in near weeks * U.S. in-vivo studies running in parallel are on track for data YE 2020SYDNEY, Australia, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing new classes of synthetic anti-infectives, today announced encouraging results from the CSIRO/The Peter Doherty Institute for Infection and Immunology (‘Doherty Institute’) Antiviral SARS-CoV-2 Screening Program showing RECCE® 327 (R327) had encouraging inhibition of the SARS-CoV-2 virus.“We’re highly encouraged by the results from this study, which indicate anti-viral activity of R327 and, in particular, highlight the potential potency of our lead candidate against SARS-CoV-2,” said Non-Executive Chairman Dr. John Prendergast. “We are interested in seeing the next stage and look forward to continuing research on the effectiveness of R327 with the team at the Doherty Institute.”Half maximal inhibitory concentration (IC50) of 109.8 ppm was identified in the screen. The compound concentration is expressed in parts per million (ppm) as the synthetic polymers in RECCE® 327 have a range of molecular weights. IC50 is used as a measure of potency and indicates how much of a particular drug is needed to inhibit, in vitro, viral infection by 50%. This is seen in the virus titers or viral count as achieved. Preliminary indications of potential toxicity were observed in the two highest concentration tested (4000 ppm and 2000 ppm) only- indicating an 10-20-fold safety window (2000ppm/100ppm). The positive control in this study was the investigational compound, beta-d-N4 hydroxycytidine (NHC), recognized as a highly active anti-viral compound against SARS-CoV-2 in-vitro but not approved for human use.1Stage 1b (confirmation and cytotoxicity) is expected to begin in near-weeks at the Doherty Institute in Melbourne. All intellectual property rights are retained by the Company with study expected to take some months.In parallel to the CSIRO/Doherty Institute studies in Australia, a contract research organization in the United States is advancing in their in-vivo studies of RECCE compounds against SARS-CoV-2 in ferrets. The Company does not consider that the engagement of this organization in the United States is material, however, if there are any material results from the studies, the Company will update the market accordingly. These studies continue to progress well with results on-track for year-end 2020.Whilst Recce is delighted by the results, they are preliminary and further testing must be completed before R327 is confirmed as being active against the SARS-CoV-2 virus. The Company would like to thank the Doherty Institute for performing the experiments.1 https://go.drugbank.com/drugs/DB15660About Recce Pharmaceuticals LtdRecce 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 antibiotics are unique – their potency does not diminish even with repeated use, a common failure associated with existing antibiotics and their propensity to rapidly succumb to resistant superbugs.Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms.The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling 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 James.graham@recce.com.auMedia and Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.auMedia and Investor Relations (USA) Meredith Sosulski, Ph.D. LifeSci Communications +1 929 469 3851 msosulski@lifescicomms.comA photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8041078b-012a-44b0-85c0-391c33097c49.
21 Oct, 2020
Photo 1: RECCE 327 and Placebo Samples for the Phase 1 Study RECCE 327 and Placebo Samples for the Phase 1 Study Photo 2: RECCE 327 and Placebo Samples for the Phase 1 Study RECCE 327 and Placebo Samples for the Phase 1 StudyHighlights: * 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:https://www.globenewswire.com/NewsRoom/AttachmentNg/97d6fa8b-4a41-4963-b23b-a6d930ea303dhttps://www.globenewswire.com/NewsRoom/AttachmentNg/ab0c74d5-2ace-40a6-9d84-667497c4f9a5The 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 (
19 Oct, 2020
Highlights: * Study will assess safety and efficacy of RECCE® 327 against a broad range of infectious bacteria on chronic burn wounds in up to 30 patients over two week period * Study anticipated to be sponsored by South Metropolitan Health Service, Department of Health, Government of Western Australia (WA) * Fiona Stanley Hospital (Burns Unit) in Perth Western Australia identified as study site SYDNEY, Australia, Oct. 19, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE), the Company developing new classes of synthetic anti-infectives, today announced it has received Human Research Ethics Committee (HREC) approval to start a Phase I/II clinical trial of its broad-spectrum antibiotic RECCE® 327 on patients with infected burn wounds.“Human ethics approval is another milestone for Recce and the clinicians seeking effective treatments to combat the scourge of antibiotic resistant bacteria,” said Recce Pharmaceuticals Chairman Dr. John Prendergast. “Achieving this goal speaks to the dedication of our clinical and research team as we continue to build on our clinical and commercial potential.”The clinical study is anticipated to be sponsored by the South Metropolitan Health Service, Department of Health, Government of Western Australia. The Fiona Stanley Hospital has been nominated as the study site and a separate trial agreement will be finalized in due course.The Phase I/II topical study will assess RECCE® 327 as a broad-spectrum antibiotic for patients with Gram-positive and Gram-negative bacterial burn wound infections.The trial will involve up to 30 patients to assess safety and efficacy of RECCE® 327 before expanding to a comparative effectiveness study based on the data. Over 14 days, 10 patients will receive RECCE® 327 daily while a further 20 receive treatment three times per week.Investigators will review the study data for clinical efficacy and toxicity before deciding to expand the trial to assess the compound’s efficacy against the current best standards of care.Burn wounds specialists will oversee delivery of RECCE® 327 via a spray-on formulation, specially developed for the study. The product has been produced at the Company’s manufacturing facilty to the same human clinical study standards as the previously announced Phase I intravenous clinical trial. It is anticipated the two studies will run in parallel, demonstrating broad administration capabilities of RECCE® 327.This ethics approval is confirmation Recce has completed the necessary pre-clinical safety and efficacy testing of RECCE® 327 required to commence human clinical trials.About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation 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 – labelling 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 James.graham@recce.com.auMedia and Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.auMedia and Investor Relations (USA) Meredith Sosulski, Ph.D. LifeSci Communications +1 929 469 3851 msosulski@lifescicomms.com
14 Oct, 2020
SYDNEY, Australia, Oct. 14, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE), the Company developing New Classes of Synthetic Anti-Infectives, is pleased to announce the Board of Directors has unanimously appointed Michele Dilizia to the role of Chief Scientific Officer. Ms. Dilizia will also continue her role as Executive Director and as a member of the Board of Directors. “As co-inventor of Recce’s Synthetic Anti-Infectives, Michele’s significant contributions to the Company reflects her strong scientific acumen and deep expertise in synthetic anti-infectives,” said Recce Pharmaceuticals Non-Executive Chairman Dr. John Prendergast. “Michele has demonstrated leadership and expertise that has been instrumental to the development of RECCE® compounds. As Michele takes on her new role, the Board is confident in her ability to continue advancing the Company’s clinical initiatives.”Ms. Dilizia’s specialization is in medical microbiology and regulatory affairs. Michele successfully co-led the research and development of Recce’s suite of anti-infective compounds, resulting in a portfolio of granted patents across the globe, including a Qualified Infectious Disease Product designation with the U.S. Food and Drug Administration (FDA).Chief Scientific Officer Michele Dilizia said, “I am delighted to have been appointed to this role by the Board and it has been my privilege to contribute to the development of a unique technology like RECCE® Anti-Infectives. I look forward to continue working with the research team to build on the Company’s anti-infective pipeline to unlock the full clinical potential of our technology in the time ahead.”Ms. Dilizia recently delivered the Opening R&D Address at the World Anti-Microbial Resistant (AMR) Congress. In her talk entitled, “Synthetic Antibiotics: The New Approach the World Needs,” she provided an overview of Recce’s anti-infective pipeline which may be viewed here.About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation 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 – labelling 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 James.graham@recce.com.auMedia and Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.auMedia and Investor Relations (USA) Meredith Sosulski, Ph.D. LifeSci Communications +1 929 469 3851 msosulski@lifescicomms.com
30 Sep, 2020
Highlights: * Murdoch Children’s Research Institute to evaluate the in-vivo antimicrobial activity of RECCE® 435 oral formulation against Helicobacter pylori (H. pylori) in preclinical studies program * Studies led by H. pylori infectious disease expert Professor Philip Sutton * Multiple world-first data opportunities over 12 months study program – anticipated human clinical trial beyond SYDNEY, Australia, Sept. 30, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE), the Company developing New Classes of Synthetic Anti-Infectives, today announced it has entered into an agreement with the Murdoch Children’s Research Institute (MCRI) to conduct preclinical studies assessing the potential of RECCE® 435 (R435) for the treatment of Helicobacter pylori (H. pylori) infections. “Antibiotic-resistant forms of H. pylori are on the rise,” stated Recce Pharmaceuticals Non-Executive Chairman, Dr. John Prendergast. “This is worrisome because more than four billion worldwide are infected with H. pylori,1 which is the leading cause of peptic ulcers and stomach cancer. We are excited to collaborate with Professor Sutton and MCRI in investigating the potential of our oral antibiotic RECCE® 435 as what could be the first non-combination treatment for H. pylori infection, including those caused by drug resistant forms of the pathogen.”The research program will be carried out by the Mucosal Immunology Group at the MCRI, Royal Children’s Hospital. The MCRI is the largest child health research institute in Australia and one of the top three worldwide for research quality and impact.2Researchers will evaluate the antimicrobial activity of RECCE® 435 against H. pylori across a range of internationally recognized in-vitro and in-vivo study models. The studies will be led by Professor Philip Sutton, Head of MCRI Mucosal Immunology Group in Victoria, Australia. Professor Sutton recently joined Recce’s clinical advisory committee as Head of the H. pylori program with a world leading background in the biology of H. pylori and the subsequent infections linked to stomach ulcers and gastric cancer.There is a global unmet medical need for the treatment of H. pylori with no first-line therapy curative in all patients.3 Today, the most commonly used treatment is triple therapy, which includes the use of a proton-pump inhibitor (PPI) in combination with multiple antibiotics (amoxicillin, metronidazole and/or clarithromycin).4 The existing treatment duration is 7 to 14 days; however, the eradication rate of standard triple therapy has fallen below 80% due to the increasing prevalence of antibiotic resistant strains worldwide.2Recce and MCRI will work together on the oral antibiotic dosing program with a particular focus on optimal dosing and the effect of RECCE® 435\. The agreement is in place until 31 December 2022; however, the Company anticipates completion in approximately 12 months, at which time it will pursue a human clinical trial. The Company is well funded to support the study program following its recent successful capital raise. All intellectual property rights are retained by the Company.The World Health Organization (WHO) lists H. pylori as a priority pathogen on its list of antibiotic-resistant bacteria that pose the greatest threat to human health. An expert led panel at the WHO identified that there is an urgent need to develop new antibiotics against H. pylori, which remains a significant cause of morbidity and mortality worldwide. As a result, the U.S. Food and Drug Administration have included H. pylori as a bacterium qualifying for their Qualified Infectious Disease Product (QIDP) program. The estimated direct and indirect costs related to H. pylori and peptic ulcer disease is nearly $6 billion annually.5About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation 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 – labelling 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 James.graham@recce.com.auMedia and Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.auMedia and Investor Relations (USA) Meredith Sosulski, Ph.D. LifeSci Communications +1 929 469 3851 msosulski@lifescicomms.com__________________________________ 1 https://www.gastrojournal.org/article/S0016-5085(17)35531-2/pdf 2 https://www.mcri.edu.au/about 3 https://www.racgp.org.au/afp/2014/may/helicobacter-pylori-eradication/ 4 https://clinicaltrials.gov/ct2/show/NCT03832465 5 https://www.cdc.gov/mmwr/preview/mmwrhtml/00049679.htm
23 Sep, 2020
Highlights: * Commitments received for a placement of A$27,950,000 at $1.30 per share * Significant participation from overseas and Australian blue-chip institutional investors * This capital raising will serve to fast track current activities and sees Company well funded for human clinical trials SYDNEY, Australia, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE), the Company developing new classes of synthetic anti-infectives, is pleased to announce it has raised A$27,950,000 (before costs) in a placement to institutional, professional and sophisticated investors that will result in 21,500,000 full paid ordinary shares being issued at A$1.30 per share (Placement).The Placement was strongly supported from local and overseas institutional, sophisticated and professional investors participating in the offer.“We greatly appreciate the support shown by both our existing investors and new institutional investors,” said Recce Pharmaceuticals Chief Executive Officer James Graham. “Their financial support comes at a transformative time for Recce as we prepare to advance human clinical trials. We welcome all new investors and look forward to updating the market as our pivotal trials progress in the coming months.”At $1.30 per share, the Placement represents a 400% premium to the Company’s October capital raise in 2019 when priced at a 20.5% discount to the close of $1.635 on 18 September 2020 and a 16% discount to the 20 day volume weighted average price of $1.549.Proceeds will be used to advance Recce’s synthetic anti-infective pipeline comprised of RECCE® 327, RECCE® 435 and RECCE® 529 to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens. Additional support by the Australian Government’s 43.5% R&D rebate on R&D applicable activities, ensures the Company is fully funded to complete its Phase I human clinical trial, SARS- CoV-2 (COVID-19) pre-clinical program, Helicobacter pylori preclinical program, and the anticipated Phase I/II topical study at a leading teaching Australian hospital. Funds will also be used to support regulatory submissions and general corporate purposes.The Placement utilizes the Company’s existing capacity to issue securities under ASX Listing Rules 7.1 (10,650,156) and 7.1A (14,599,844), including the options detailed below. Seeking to support some of the excess demand above the Placement, former Executive Chairman Dr. Graham Melrose has agreed to sell 1,576,923 shares on the same terms as the Placement for consideration of $2.05m. This managed sale has served to provide capacity for additional shareholders to join the register of the Company using a portion of the oversubscriptions.Shaw and Partners Limited acted as Sole Lead Manager. Fees payable to Shaws in relation to the Placement include a cash payment of 6% of the total amount raised and the issue of 3.75m unlisted options with an exercise price at a $1.56 and an expiry date three years from the date of issue.The Company anticipates that the Placement shares and fee options will be issued on or around Wednesday, 30 September 2020.About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation 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 – labelling 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 James.graham@recce.com.auMedia and Investor Relations (AU) Andrew Geddes CityPR +61 (02) 9267 4511 ageddes@citypublicrelations.com.auMedia and Investor Relations (USA) Meredith Sosulski, Ph.D. LifeSci Communications +1 929 469 3851 msosulski@lifescicomms.com
10 Sep, 2020
Concentration-Dependent Reductions in Viral Infection Relative Change Over Baseline vs Control - 48 Hours Figure 2 R529 Percent of Max Cytotoxicity Figure 3 R327 Percent Max of CytotoxicityHighlights * RECCE® 327 (R327) & RECCE® 529 (R529) compounds have shown concentration-dependent reductions in the SARS-CoV-2 (COVID-19) virus in an in-vitro study using organoids made from human airway epithelial cells * Concentrations of R327 and R529 tested, further indicated an excellent toxicity profile (
01 Sep, 2020
* Recce awarded grant of A$37,508 plus GST by the Australian Government Department of Industry, Science, Energy and Resources as part of the Entrepreneurs’ Programme. * The grant will be directed towards project costs associated with assessing RECCE® 327 in the SARS-CoV-2 Antiviral Screening Program and is subject to performance based milestones. * The Company will receive a follow up grant of a maximum of $50,000 upon successful completion of milestones. SYDNEY, Australia, Sept. 01, 2020 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE) (Company), the Company developing new classes of synthetic anti-infectives, today announced it has received an Innovation Connections grant of A$37,508 plus Goods and Services Tax (GST), under the Australian Government’s Entreprenuers’ Programme. RECCE® 327 was recently accepted into the SARS-CoV-2 Antiviral Screening Program, a fee- for-service research program being conducted at the Doherty Institute (a joint venture partnership between the University of Melbourne and The Royal Melbourne Hospital) and CSIRO’s Australian Centre for Disease Preparedness (ACDP). Innovation Connections, assists businesses in establishing research priorities, locating researchers, and providing access to funding to enable R&D projects. All intellectual property rights are retained by the Company, with the full program expected to take some months and updates to be made available on material developments as the program advances. Non-Executive Chairman Dr. John Prendergast said, “We are very pleased to receive this funding from the Australian Government Entrepreneurs’ Programme to study the efficacy of RECCE® 327 against SARS-CoV-2. The funds will go towards testing of our lead compound and enable us to advance a new class of anti-infectives with a unique mechanism of action against hyper-mutation to address the growing threat posed by resistant superbugs and viruses.”This announcement has been approved for release by Recce Pharmaceuticals Board 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 antibiotics are unique – their potency does not diminish even with repeated use, a common failure associated with existing antibiotics and their propensity to rapidly succumb to resistant superbugs. Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms. The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling 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.Executive DirectorMedia & Investor Relations (AU) Media & Investor Relations (USA) James GrahamAndrew GeddesMeredith Sosulski, PhD Recce Pharmaceuticals, Ltd.CityPRLifeSci Communications +61 (02) 8075 4585+61 (02) 9267 4511+1 929 469 3851 james.graham@recce.com.auageddes@citypublicrelations.com.aumsosulski@lifescicomms.com