Cynata Therapeutics Limited (CYP.AX)
| Previous close | 0.7200 |
| Open | 0.7200 |
| Bid | 0.7100 x 0 |
| Ask | 0.6700 x 0 |
| Day's range | 0.7000 - 0.7200 |
| 52-week range | 0.5800 - 1.2800 |
| Volume | 245,327 |
| Avg. volume | 252,184 |
| Market cap | 103.925M |
| Beta (5Y monthly) | 0.42 |
| PE ratio (TTM) | N/A |
| EPS (TTM) | -0.0350 |
| Earnings date | 20 Aug 2018 - 24 Aug 2018 |
| Forward dividend & yield | N/A (N/A) |
| Ex-dividend date | N/A |
| 1y target est | 2.25 |
- GlobeNewswire
Cynata Secures $15m Placement Led By $10m from Healthcare Investor BioScience Managers to Expand Development Pipeline
MELBOURNE, Australia, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce a successful $15 million placement (“Placement”), led by a $10m investment from experienced healthcare investor BioScience Managers through the BioScience Managers Translation Fund I (BMTFI). BMTFI has a mandate to invest in Australian based innovative healthcare technology and this investment will allow Cynata to significantly expand its clinical development pipeline and scale their operations in Australia. The Placement is being undertaken at an offer price of $0.70 for each new share and will be followed by a 1 for 15 non-renounceable entitlement offer at the same offer price as the Placement. The Company’s Cymerus™ mesenchymal stem cells (MSCs) will be developed for three new, additional indications; idiopathic pulmonary fibrosis (IPF), renal transplantation and diabetic foot ulcers (DFU). Further information on Cynata’s clinical development pipeline, new indications and the Capital Raising are set out in the company’s Investor Presentation.Key highlights: * Preparations underway to expand Cynata’s clinical development pipeline to include idiopathic pulmonary fibrosis, renal transplantation and diabetic foot ulcers * Additional clinical trials to build on solid foundation from studies in relevant pre-clinical disease models and driven by significant unmet medical needs and promising commercial opportunities * A$15m institutional placement to existing and new investors at $0.70 per new share, led by A$10m from healthcare investor BioScience Managers via the BMTFI * A 1 for 15 non-renounceable pro-rata entitlement offer to eligible shareholders to raise up to approximately A$5.5m will follow the Placement * Proceeds raised to primarily fund the expansion of Cynata’s clinical development pipeline, enhance process development and progress regulatory strategy for commercialisation Dr. Ross Macdonald, Cynata’s CEO and MD, said: “The endorsement from BioScience Managers, an experienced and highly successful healthcare investor, in Cynata’s core Cymerus™ technology and the broad potential of our clinical pipeline provides great validation of our platform. The capital secured will enable a logical and significant expansion of our clinical development into new indications, essentially doubling the size of our clinical pipeline. The additional indications of IPF, renal transplantation and DFU were chosen based on the promising results of multiple pre-clinical studies and highly attractive opportunities, in which our Cymerus MSCs have the potential to significantly improve patient outcomes and to provide new standards of care in these challenging settings. We are encouraged by the confidence in our strategy demonstrated by BioScience Managers, existing shareholders and new investors. Additionally, we are pleased to provide an entitlement offer to eligible shareholders on the same terms as the institutional and sophisticated investors. We look forward to initiating the planned studies in the near term and building on the significant progress made to date with the development of our Cymerus platform technology.”Expanding the clinical development pipeline Cynata has carefully selected additional target indications for further clinical development, following a comprehensive scientific, clinical and commercial review. The target indications, including IPF, renal transplantation and DFU, represent a combined market opportunity in excess of A$20bn p.a.1,2,3. Key preparation activities are now underway to advance clinical programs in these high priority target indications including (but not limited to): trial design, regulatory consultation, endpoint selection, key opinion leader engagements and clinical site selection. The Company will continue to develop its existing clinical product pipeline in addition to these new targets and will continue to drive its partnering strategy. Further background information on the new target indications is provided below. Idiopathic Pulmonary Fibrosis (IPF)IPF is an incurable disease of unknown cause, which results in extensive scarring (or fibrosis) of the lungs. When first diagnosed, lung damage is often advanced and invariably progresses to respiratory failure with only 20% to 30% of patients surviving five years after diagnosis4. Treatment of IPF represents a significant unmet medical need, with existing therapies having limited effects on disease progression and survival rates. Studies conducted in preclinical rodent models of IPF demonstrated efficacy of Cymerus MSCs, based on statistically significant improvements in multiple clinically relevant outcome measures, including levels of fibrosis, inflammation, dynamic lung compliance and airway resistance.Renal TransplantationRenal transplantation is a common treatment for end-stage kidney disease, where the kidneys are no longer able to function and a transplant is required to eliminate patients’ reliance on dialysis. Following a kidney transplant, the body may recognise the transplanted kidney as foreign tissue and attempt to protect the patient by attacking it. In preclinical studies, Cymerus MSC treatment demonstrated effects expected to minimise or prevent organ transplant rejection.Diabetic Foot Ulcer (DFU)DFUs are sores on the feet of patients with diabetes and are among the most common complications occurring in 15% to 25% of patients sometime during their lifetime5. Severe ulcers can lead to hospitalisation and lower limb amputation if not treated in a timely manner. Cymerus MSCs have achieved encouraging efficacy results in a preclinical model of diabetic foot ulcers. This provides strong support for the inclusion of this new indication to Cynata’s clinical development pipeline.Capital RaisingThe capital raising consists of an institutional placement (Placement) and a 1 for 15 non-renounceable entitlement offer (Entitlement Offer) (together, the Capital Raising). The offer price for the Capital Raising is A$0.70 per new share (Offer Price). The Offer Price represents a 9.6% discount to the 5-day VWAP as of 8 December 2020 of $0.774 (the last day of trading of CYP shares prior to announcement of the Capital Raising).All shares issued under the Capital Raising will be fully paid ordinary shares ranking equally with existing Cynata shares on issue (New Shares). Vesparum Capital is acting as the Independent Capital Markets Advisor for Cynata. Funds raised via the Placement and Entitlement Offer will be used to: * Expand clinical product development pipeline: pursue additional clinical trials in attractive indications. High priority targets include IPF, renal transplantation and DFU * Process development and commercialisation: Optimise and expand manufacturing capabilities to enhance scale-up efficiencies and progress Cynata’s US regulatory strategy, to place the Company in a strong position to commercialise its MSC products * Additional headcount, general working capital and corporate costs PlacementThe Placement to institutions, sophisticated and professional investors will raise $15m, before transaction-related costs. The Placement comprises the issue of 21.43m New Shares at the Offer Price. The Placement attracted strong support from existing shareholders and new investors, including the A$10m commitment from Phillip Asset Management Limited as trustee for BMTFI.The Placement will be undertaken in a single tranche within the Company’s existing placement capacity under ASX Listing Rule 7.1 and 7.1A – therefore no shareholder approval is required for the Placement. New Shares subscribed for under the Placement are expected to settle on 18 December 2020 and commence trading on the ASX on 21 December 2020.Entitlement OfferIn addition to the Placement, the Company is undertaking a 1 for 15 non-renounceable entitlement offer to existing shareholders, to raise up to approximately $5.5m. Eligible shareholders at the Record Date of Wednesday, 16 December 2020 with a registered address in Australia or New Zealand will be invited to participate in the Entitlement Offer, at the Offer Price (being the same price as the Placement). The Entitlement Offer will open on Monday, 21 December 2020 and close on Wednesday, 13 January 2021. The Entitlement Offer is non-renounceable and entitlements will not be tradable or otherwise transferable.Eligible shareholders who take up their entitlement in full can also apply for additional New Shares in excess of their entitlement under a top-up facility. Allocations for additional New Shares above pro-rata entitlements will be determined at Cynata’s absolute discretion and are not guaranteed. The Company reserves the right to allot and issue any shortfall shares in the Entitlement Offer at its discretion.The terms and conditions and further details of how to participate in the Entitlement Offer will be set out in the Offer Booklet to be sent to eligible shareholders on Monday, 21 December 2020. The Offer Booklet will include a personalised entitlement and acceptance form. Copies of the Offer Booklet will also be available on the ASX and Cynata’s website.Indicative Capital Raising timetable6EventDate ASX Announcement and Company resumes tradingFriday, 11 December 2020 Record date for Entitlement OfferWednesday, 16 December 2020 Settlement of PlacementFriday, 18 December 2020 Allotment and commencement of trading of New Shares under the PlacementMonday, 21 December 2020 Despatch of Offer Booklet and Entitlement Offer opensMonday, 21 December 2020 Entitlement Offer closesWednesday, 13 January 2021 Announcement of Entitlement Offer resultsMonday, 18 January 2021 New Shares issued under the Entitlement OfferWednesday, 20 January 2021 Allotment and commencement of trading of New Shares under the Entitlement OfferThursday, 21 January 2021 Authorised for release by Dr Ross Macdonald, Managing Director & CEO CONTACTS: Dr Ross Macdonald, CEO, Cynata Therapeutics, +61 (0)412 119343, ross.macdonald@cynata.com Claire LaCagnina, U.S. Media Contact, +1 315.765.1462, clacagnina@6degreespr.comAbout Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.Cynata’s lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Cynata has active clinical trials, using its Cymerus™ MSCs for a Phase 3 trial is osteoarthritis and a Phase 2 trial in severe complications arising from COVID-19. Cynata plans to advance into trials for GvHD (through licensee Fujifilm) and critical limb ischemia. Cynata is planning for additional clinical programs in further indications (including idiopathic pulmonary fibrosis, renal transplantation, and diabetic foot ulcers), following encouraging pre-clinical data. In addition, Cynata has demonstrated utility of its Cymerus™ MSC technology in preclinical models of asthma, diabetic wounds, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.1 iHealthcareAnalyst Inc, 2019 (represents global market by 2025) 2 Organ Transplant Immunosuppressant Drugs Market in 2026, Grand View Research, Inc.,2019 3 Transparency Market Research, 2020 (Reflect global DFU treatment market by 2027 4 Ley B, et al. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Repsir Crit Care Med. 2011;183(4):431-40. https://www.ihealthcareanalyst.com/report/idiopathic-pulmonary-fibrosis-treatment-market 5 Mutluoglu M, Uzun G, Turhan V, Gorenek L, Ay H, Lipsky BA. How reliable are cultures of specimens from superficial swabs compared with those of deep tissue in patients with diabetic foot ulcers? J Diabetes Complications. 2012 May-Jun;26(3):225-9 6 This timetable is indicative only and subject to change. The Company reserves the right to amend the dates at its discretion and without notice, subject to the ASX Listing Rules and the Corporations Act 2001 (Cth). All times are AEDT
- GlobeNewswire
Phase 3 Osteoarthritis Clinical Trial Commences
MELBOURNE, Australia, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that the Phase 3 SCUlpTOR (“Stem Cells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis”) Trial of CYP-004, Cynata’s Cymerus™ mesenchymal stem cell (MSC) product for osteoarthritis, has now commenced. This trial is sponsored by the University of Sydney and funded by an Australian Government National Health and Medical Research Council (NHMRC) competitive Project Grant. The trial will take place at study centres in Sydney and Tasmania and subject treatment will commence with an initial four patients from the University’s volunteers' database, who will be assessed for four weeks, before the study opens for enrolment more widely. As no additional volunteers are being sought at this time, patients who are interested in participating in the trial should wait until wider enrolment commences before contacting study centres, which is expected to happen early in 2021. The aim of the trial is to assess the effect of Cymerus MSCs compared to placebo on clinical outcomes and knee joint structure over a two-year period, in 440 patients with osteoarthritis of the knee.Professor David Hunter, Principal Investigator, said: “There is no cure for osteoarthritis and current treatment options largely focus on alleviating pain, rather than modifying the course of the underlying disease. We are delighted to commence this trial, which is designed to evaluate the disease modifying potential of Cymerus MSCs. We believe that it will be the largest randomised controlled trial of MSCs conducted in patients with osteoarthritis worldwide. Consequently, we anticipate that it will be an enormously influential trial, with the potential to inform clinical practice guidelines globally.” Dr. Kilian Kelly, Cynata’s Chief Operating Officer, said: “The commencement of the SCUlpTOR Trial is a very important achievement. This clinical trial aims to determine whether Cynata’s proprietary Cymerus MSC technology, which has been evaluated in a wide range of disease targets, including graft-versus-host disease (GvHD), sepsis, and respiratory diseases such as acute respiratory distress syndrome (ARDS), is active in the setting of knee osteoarthritis. Our Cymerus technology uniquely enables the scalable manufacture of robust MSCs, without the substantial functional inconsistency that has been observed between MSC batches manufactured using conventional methods. We look forward to advancing this clinical trial to investigate the potential benefits our MSCs could have to treat osteoarthritis patients with this common and debilitating disease.”A presentation is attached to this announcement and provides an overview of osteoarthritis including the opportunity, preclinical research and the clinical trial plans.Phase 3 osteoarthritis trial sponsored by the University of SydneyThe trial is led by Professor David Hunter, who is the Florance and Cope Chair of Rheumatology and Professor of Medicine at the University of Sydney and has been Chief Investigator of numerous clinical trials in osteoarthritis. He has more than 500 publications in high-impact journals, including the New England Journal of Medicine, Journal of the American Medical Association and British Medical Journal.The research team also includes Professor Changhai Ding (University of Tasmania), Professor Stefan Lohmander (Lund University, Sweden), Dr Rachel O'Connell (University of Sydney) and Dr Xia Wang (University of Sydney), as well as numerous associate investigators.Authorised for release by Dr Ross Macdonald, Managing Director & CEOCONTACTS:Dr Ross Macdonald, CEO, Cynata Therapeutics, +61 (0)412 119343, ross.macdonald@cynata.com Claire LaCagnina, U.S. Media Contact, +1 315.765.1462, clacagnina@6degreespr.com About the Phase 3 Clinical Trial in Osteoarthritis (The SCUlpTOR trial) The clinical trial, entitled Stem Cells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis: a randomised placebo-controlled trial, is funded by an Australian Government NHMRC Project Grant, in addition to in-kind contributions from participating institutions. Cynata will supply Cymerus™ MSCs for use in the trial and will not be required to contribute any cash to fund the project.The trial will be a randomised, double-blind placebo-controlled trial. Subject to satisfactory completion of an initial phase of the study in four subjects who will be assessed for a period of four weeks (two who will receive placebo and two who will receive Cymerus MSCs), the trial will seek to enrol 440 patients with osteoarthritis of the knee. Participants will receive intra-articular injections of Cymerus MSCs or placebo on three occasions over a period of 1 year, and will be followed up for a total of two years from enrolment. The co-primary endpoints are: (i) the proportion of participants achieving patient-acceptable symptom state (PASS) for knee pain at 24 months; and (ii) central medial femorotibial (cMFT) cartilage loss from baseline to 24 months. Secondary outcome measures will include assessments of pain, other symptoms, physical function, quality of life.About Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.Cynata’s lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Cynata plans to advance its Cymerus™ MSCs into Phase 2 trials for severe complications arising from COVID-19, GvHD and critical limb ischemia and a Phase 3 trial in osteoarthritis. In addition, Cynata has demonstrated utility of its Cymerus™ MSC technology in preclinical models of asthma, diabetic wounds, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.
- GlobeNewswire
Cymerus MSCs Demonstrate Efficacy in Preclinical Lung Disease Study
MELBOURNE, Australia, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, has today announced positive efficacy data from a study of its induced pluripotent stem cell (iPSC)-derived Cymerus™ mesenchymal stem cells (MSCs) in a preclinical rodent model of idiopathic pulmonary fibrosis (IPF). Key highlights: * Efficacy demonstrated in preclinical rodent model of IPF, a disease which causes severe lung damage and leads to respiratory failure * Existing treatments for IPF have limited efficacy * Treatment with Cynata’s Cymerus MSCs led to statistically significant improvements in multiple harmful effects of IPF, including interstitial fibrosis, dynamic lung compliance and airway resistanceDr. Kilian Kelly, Cynata’s Chief Operating Officer, said: “These latest results with Cymerus MSCs add to the large body of evidence on the potency of these cells and their potential utility in treating a wide range of devastating diseases. IPF represents an enormous unmet medical need, as existing treatment options have only modest effects on disease progression and survival rates. We will continue to work with Professor Samuel and our other advisors to determine the next steps for this important program.”IPF is a currently incurable disease of unknown cause, which results in extensive scarring or fibrosis of the lungs. Lung damage is often advanced by the time the condition is initially diagnosed, and existing treatment options have very limited efficacy. It invariably progresses to respiratory failure, with only 20-30% of patients surviving 5 years from the time of diagnosis.1 The value of the global IPF market is expected to reach around US$5.9b by 2025 with an annual growth of 13%.2It is notable that fibrosis is observed in the lungs of COVID-19 patients with severe disease and may become an important factor in the longer-term effects in such surviving patients. It also occurs in surviving patients of acute respiratory distress syndrome (ARDS) from other causes. As previously announced, Cynata are conducting a Phase 2 clinical trial in patients with respiratory distress associated with COVID‑19.The effect of Cymerus MSCs is being studied in the widely used and clinically relevant bleomycin-induced IPF model, which is the gold-standard preclinical model of this condition. Compared to placebo, Cymerus MSC treatment led to statistically significant improvements in: * Dynamic lung compliance (the lung's ability to stretch and expand) * Airway resistance (a measure of the airway’s opposition to airflow into the lungs) * Interstitial lung inflammation (swelling in the tissue surrounding the airways) * Interstitial lung fibrosis (fibrosis in the tissue surrounding the airways) * Epithelial and subepithelial thickness (additional signs of fibrosis)The initial phase of the IPF preclinical study found that control animals suffered a 40% loss of dynamic lung compliance after bleomycin administration, as expected in this model. However, when Cymerus MSC treatment was administered in a single dose 3 weeks later, or as a double dose at 3 and 4 weeks later, the loss of dynamic lung compliance was just 15%. Similarly, while bleomycin administration led to profound interstitial inflammation and fibrosis, as well as increases in airway resistance, epithelial thickness and subepithelial thickness, Cymerus MSC treatment dramatically reduced each of these harmful effects.The study is led by Professor Chrishan Samuel, Department of Pharmacology at Monash University, Melbourne, and follows on from his previous studies which demonstrated that Cymerus MSCs significantly reduce fibrosis and inflammation in a model of asthma.3,4Professor Samuel commented: “These results are extremely encouraging. While they are very consistent with our previous studies of these cells in a model of asthma, it was important to confirm that the potent anti-inflammatory and anti-fibrotic effects of Cymerus MSCs would be replicated in IPF, which is a disease with very different underlying pathophysiology. We look forward to publishing our results in a peer-reviewed journal in due course.”Authorised for release by Dr Ross Macdonald, Managing Director & CEOCONTACTS:Cynata Therapeutics, +61 (0)412 119343, ross.macdonald@cynata.com Claire LaCagnina, U.S. Media Contact, +1 315.765.1462, clacagnina@6degreespr.com About Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.Cynata’s lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Cynata plans to advance its Cymerus™ MSCs into Phase 2 trials for severe complications arising from COVID-19, GvHD and critical limb ischemia and a Phase 3 trial in osteoarthritis. In addition, Cynata has demonstrated utility of its Cymerus™ MSC technology in preclinical models of asthma, diabetic wounds, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome. ________________________________________________________________________________________________________________________________________________ 1 Ley B, et al. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011;183(4):431-40. 2 https://www.ihealthcareanalyst.com/report/idiopathic-pulmonary-fibrosis-treatment-market/ 3 Royce SG, et al. iPSC- and mesenchymoangioblast-derived mesenchymal stem cells provide greater protection against experimental chronic allergic airways disease compared with a clinically used corticosteroid. FASEB J. 2019;33(5):6402-11 4 Royce SG, et al. Intranasal administration of mesenchymoangioblast-derived mesenchymal stem cells abrogates airway fibrosis and airway hyperresponsiveness associated with chronic allergic airways disease. FASEB J. 2017;31(9):4168-78
