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RCE - Recce Pharmaceuticals

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Recce has expertise in research and development of pharmaceutical drugs that kill germs. It has synthesised and patented RECCE antibiotics. The Company plans to undertake both the development of a production 'model', and the pre-clinical regulatory requirements of RECCE antibiotics designed for human use.

It is anticipated that RCE will list on the ASX during October 2015.

http://www.recce.com.au
 
Recce Limited has fired up today. Up around 38% in the first half an hour of trading. I haven't gone through the Investor Presentation released on Friday afternoon in any detail but assume that someone was impressed by it.
 
Recce Limited comes back down to Earth today after announcing a share purchase plan at 17.5c.

Currently down 20% to 18c, presumably as some shareholders sell some of their holdings to buy into the SPP at a discount.
 
Anyone keen on hearing directly from the company, here's Executive Director Michele Dilizia a few months ago on the positive results from RECCE 327. Quick 90 second video, but very informative
 
RCE has FDA QIDP designation which gives the company fast track regulatory review plus 10 years of market exclusivity.
RCE ... is involved drug discovery and development business commercialising a new class of synthetic antibiotics with broad spectrum activity designed to address the global health challenge of antibiotic resistant superbugs. Its patented lead candidate known as RECCE 327 has been developed for the treatment of blood infections and sepsis.
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After raising money in Oct, RCE considers the company well funded. Also the business received further funds from the Australian Government under the Australian R&D incentive scheme.

RCE keeps coming out with *Positive Data* announcements - Burns wound infection 27/11, Antibiotic Safety Studies 10/02, Kidney UTI infections 14/02, Influenza A 20/04, MRSA Superbug 23/04, Neisseria Gonorrhea 04/05 - but what do these really mean?

SP has the usual Covid dip and part recovery, but where's it going?
 
- and a pop likely today (above $1.00??)


RECCE® Compounds Selected by CSIRO/Doherty Institute in Priority 1 Candidate Group for SARS-CoV-2 Antiviral Screening Program
Highlights:
• RECCE® 327 and New RECCE® 529 compounds were selected for their unique mechanism of actions against hyper-mutation, as indicated on bacteria and viruses (respectively)
• Testing program will be conducted by CSIRO & University of Melbourne at the Doherty Institute
• Therapeutic antiviral treatment focus of RECCE® 327 and RECCE® 529 may see added potential benefit against secondary bacterial infections

Priority 1 status is defined as “highest or strong likelihood of antiviral or antiseptic efficacy – Compounds in this grouping will be eligible for stage 1 laboratory screening trials”.
 
Recce chairman John Prendergast said under the agreement, the company would retain all intellectual property rights. He added that Recce would fund the first stage of the program’s development, which is expected to cost $35,000.

Dr Prendergast said if testing progresses, costs will increase at each stage.
“The company will make (an) announcement in relation to progress to any further stage, and will detail any material associated costs.” “We are very pleased to have been selected by the CSIRO, one of the largest and most diverse scientific research organisations in the world, to investigate the efficacy of two of our promising compounds against SARS-CoV-2. “The compounds’ unique, universal mechanisms of action indicate the potential to attack a broad range of viruses and as well, overcome the threat of viruses’ typical hyper-mutation into new and deadly pathogens.”
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It comes after CSIRO researchers last week found that lab-grown cells from the upper layer of the airway to the lungs — the human bronchial epithelium — reliably mimic a live person’s airway’s response to viruses. CSIRO research scientist Elizabeth Pharo said the airway model could potentially be used to screen up to 100 antiviral compounds within three months, and CSIRO is exploring ways to further accelerate screening including the use of robotic technology.
“For many respiratory diseases, such as COVID-19, the airways act as the ‘first responders’ to inhaled pathogens,” Dr Pharo said. “When we infected our airway epithelial cultures with the 2009 pandemic H1N1 influenza virus, the cells had the same innate immune response as in a live person’s airway. “It’s hoped this work will help improve our understanding of how COVID-19 may affect people with pre-existing lung conditions.”
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and a 50% kick on today's news. Clearly the $35K spend is early money, a seat at the table.

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and another hop on pop. Now $1.45

RCE has entered into an agreement with Path BioAnalytics Inc, a precision medicine company based in Durham, North Carolina, USA, for the study of RECCE® 327 and RECCE® 529 against SARS-CoV-2.

Researchers at PBA will evaluate RECCE® 327 and RECCE® 529 against SARS-CoV-2 (the virus causing the disease ‘Coronavirus’ or ‘COVID-19’) in an ex vivo respiratory organoid model system. The study will be conducted in the state-of-the-art Biosafety Level 3 containment laboratories of a leading US research university, where the infection of the organoids with SARS-CoV-2 will take place.

The purpose of the study is to evaluate both compound therapies for the prevention and/or mitigation of SARS-CoV-2 infections in an ex-vivo respiratory model system with preliminary data anticipated September 2020.
 
pushing to new highs

For executive director James Graham, medical technology is just one of many potential winners for Australia that will transition the economy away from rocks and crops in the 21st century.
"Importantly, we are in a place that supports innovation and right now, we are an infectious disease company in the midst of a global infectious disease crisis. We could choose anywhere to be but there is nowhere we would rather want to be than Australia and we always will be here," he says."Moreover, we have an extraordinarily valuable R&D rebate scheme in Australia where we get 43.5 per cent back on every $1 we spend. So if we spend $5 million on R&D applicable research, that is about $7 million of true cash runway. That incentivises us to stay local, to build local know-how and advance the technology for intended sale in international markets," he says.
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As well as the Covid work with CSIRO and Doherty Institute, the company is a potential world leader in something much larger in the long term: helping combat our growing resistance to antibiotics. the company is the only one in the world that has a qualified infectious disease designation awarded by the US Food and Drugs Administration for sepsis.
This designation provides us 10 years of market exclusivity above and beyond a patent position. So that i's a government backed 10 year market exclusivity only from time of approval," Graham says. "And while that is incredibly unique, we also have a pending human application for dosing on wounds in a West Australian hospital in a burns department led by a very prominent burn specialist."
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It has taken a while but What a difference a week can make for RCE



ASX Announcement Recce Pharmaceuticals Dual Lists on Frankfurt Stock Exchange Highlights: • Shares now trading on major German Trading Exchanges • Shares trade under code: R9Q • No related capital raising - trade of existing securities with trade volume to increase on ASX • Expected to broaden institutional and retail investor base across EU, in-line with increasing activity in the region Sydney Australia, 8 March 2021: Recce Pharmaceuticals Ltd (ASX:RCE), is pleased to announce the Company’s shares are now Dual Listed on the Frankfurt Stock Exchange (FSE), with trading commencing Monday 8 March at 8:00am (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.”

And



ASX Announcement Positive Sinusitis Patient Update - Special Access Scheme Highlights: • RECCE® 327 (R327) delivers positive human clinical response against multidrugresistant, Gram-negative P. aeruginosa sinusitis infection, in a single patient use pursuant to the TGA Special Access Scheme Category A (SAS - Category A) • The patient outcome follows positive results from animal study in sinusitis with Gram-positive bacteria and supports broad spectrum potential of Recce’s antiinfective compounds against life-threatening bacteria Sydney Australia, 7 April 2021: Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (Company), the Company developing New Classes of Synthetic Anti-Infectives, is pleased to announce that a Special Access Scheme (SAS) Category A notification has been made to the Therapeutic Goods Administration (TGA) by a medical practitioner following the successful treatment of a patient with RECCE® 327 (R327), via nasal passage, against multidrug-resistant Pseudomonas aeruginosa (P. aeruginosa) sinusitis infection. While the Company is pleased with the apparent success of the application of R327, it is important to note that only a single patient has been treated pursuant to the Special Access Scheme, which is a notification pathway which can be accessed by health practitioners on behalf of a prescribing medical practitioner for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment, and does not constitute a clinical trial. R327 is not approved for use in humans and significant further clinical testing is required to evaluate the quality, safety and efficacy of R327. Patient outcome (P. aeruginosa sinusitis) – Special Access Scheme Category A As stated above, R327 was not applied as part of a clinical trial. Results must therefore be considered anecdotal, however, the Company is encouraged by them. A 59-year-old male was categorised as suffering multidrug-resistant P. aeruginosa sinusitis infection. Clinical samples of R327 were released under strict medical oversight having been determined to meet TGA SAS-A criteria, including: ‘seriously ill, where death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.’ 1 The patient has suffered from sinusitis infections all of their adult life, which had advanced to a multidrug-resistant Gram-negative P. aeruginosa sinusitis infection in their upper nasal eustachian tube. This infection was unresponsive to previous surgeries, all antibiotic treatments attempted including ciproflaxin (negative side effects), Septrim Forte (twice daily) and Doxylin, including last-resort peripherally inserted central catheter (PICC Line) methods of administration in some instances. Patient X (for reasons of patient confidentiality) dosed according to a strict, dose-escalating protocol applying 5 -10 drops per 20 millilitres of R327 in saline solution, three times a day into the infected area. Using a rubber bulb, Patient X pushed the mixture up into both the left and right nasal passages, toward the ears. Upon applying R327 in the infected area, Patient X noted a minor stinging sensation as the solution reached the area of infection in both nasal passages, subsiding after approximately three minutes. Within 90 minutes, Patient X recorded their sinuses began to feel clearer, less inflamed and reported less discharge. As Patient X continued their dosing program, it was recorded the stinging sensation subsided over time. Over a three-day period of applying R327 topically via spray to the infected areas in the sinus', Patient X reported a substantial reduction in infected discharge, termination of sweating and a return to normal sleeping patterns with no side effects. Post-dosing program, blood samples were taken and tested. These samples showed no detectable signs of P. aeruginosa infection and no abnormalities. Not long after the dosing program, the patient reported feeling a return of the initial infection. Following a sinus biopsy, an opportunistic ‘common bacterium’ had taken residence where the P. aeruginosa was previously. Having advanced from a life-threating infection status, it was agreed that the new, unrelated bacterial infection was early in its growth. A course of Septrim Forte cleared the opportunistic bacteria and the initial drug resistant P. aeruginosa 1 https://www.tga.gov.au/book-page/information-health-practitioners remained undetected. The Company is encouraged by the nasally administrated response of this patient and the formal submission to the TGA of the Special Access Scheme treatment, following its completion. The Company will continue with its clinical trials to assess the safety or efficacy of R327 and/or any related compounds. James Graham, Chief Executive Officer of Recce Pharmaceuticals said, “We are thrilled by this positive indication for this patient with a terribly, debilitating condition that has been driven over many years by this recalcitrant pathogen.”
 

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