Progenza (allogenic adipose-derived mesenchymal stem cell therapy) / Regeneus - LARVOL DELTA

Kyocera pulls out of Regeneus deal for stem cell therapy Progenza for osteoarthritis (Bioworld) - "In a blow to Aussie regenerative medicine company Regeneus Ltd., Japan’s Kyocera Corp. has pulled out of a licensing deal for Regeneus’ lead mesenchymal stem cell (MSC) therapy, Progenza, for osteoarthritis of the knee for the Japan market. Osteoarthritis of the knee is the first indication for Progenza, an allogeneic off-the-shelf adipose-derived MSC therapy."

Licensing / partnership • CNS Disorders • Osteoarthritis • Pain

Regeneus Ltd (ASX:RGS) Receives Milestone Payment from Kyocera (Yahoo Finance) - "Regeneus Ltd...is pleased to announce that is has received a payment of 100M JPY (~A$1.3M) from Kyocera Corporation (Kyocera, TYO:6971) following the completion of execution of the agreement between the two companies for Kyocera to exclusively develop and commercialise Regeneus' lead stem cell platform technology Progenza for the treatment of Knee Osteoarthritis in Japan (refer to ASX announcement on 11 August)....Pursuant with the terms of the agreement, Regeneus is expected to receive a further US$4M from Kyocera in October 2020. The Company will notify the market once this payment has been received."

Financing • Osteoarthritis • Pain

Regeneus signs agreement with Kyocera for licensing of Progenza knee osteoarthritis drug to Japanese market (Small Caps) - "Clinical-stage regenerative medicine company Regeneus...has signed a licence and collaboration agreement with Kyocera Corporation to develop and commercialise its lead stem cell platform technology Progenza for the treatment of knee osteoarthritis in the Japanese market. Under the terms of the agreement, Kyocera will fund the manufacturing, development, and commercialisation costs for the mesenchymal stem cell and secretome-based drug in Japan."

Licensing / partnership • Osteoarthritis • Pain

Regeneus Ltd (ASX:RGS) Progenza OA Kyocera Negotiations Update (Yahoo Finance) - "Regeneus Ltd...today provides an update on its negotiations with Kyocera Corporation (TYO:6971) for a licence agreement to develop and commercialise Progenza for Knee Osteoarthritis (Progenza OA) in Japan...Both parties remain committed to the proposed commercial licence and the parties have agreed to extend the period of exclusivity, such that Kyocera will continue to have exclusive rights to negotiate the licence until 31 August 2020."

Licensing / partnership • CNS Disorders • Osteoarthritis • Pain

Regeneus Ltd (ASX:RGS) Kyocera completes Progenza due diligence (Yahoo Finance) - "Regeneus Ltd...today announced that it has received notification that Kyocera Corporation...has completed its due diligence process on its lead stem cell platform technology Progenza for treatment of Knee Osteoarthritis (Progenza OA)....Under the terms of the MOU, Kyocera now will have until the end of July 2020 for exclusive rights to negotiate a commercial license for Progenza OA in Japan."

Licensing / partnership • CNS Disorders • Gene Therapies • Osteoarthritis • Pain

Regeneus Ltd (ASX:RGS) receives a $1.6m milestone payment from Kyocera (Yahoo Finance) - "Regeneus Ltd...today received a non-refundable milestone payment of 100,000,000 JPY (approx. A$1.6M) from Kyocera Corporation (TYO:6971.T - News) as set out in the non-binding Memorandum of Understanding (MOU) signed on 2 March 2020. As announced to the market, the MOU gives Kyocera exclusive negotiation rights to Progenza for treatment of Knee Osteoarthritis (Progenza OA) in Japan."

Financing

Regeneus Ltd (asx:RGS) signs MOU with Kyocera Corporation (Market Watch) - "Regeneus...today announced it has signed a non-binding MOU with Kyocera Corporation....Under the MOU, Kyocera will conduct comprehensive due diligence related to Progenza before progressing to a conditional commercial agreement for the Company's lead technology. The agreement gives Kyocera exclusive negotiation rights to Progenza until 31 July 2020, outlines due diligence criteria, payment terms to access subset of research technology and process for a commercial agreement."

Licensing / partnership

Regeneus (ASX:RGS) receives $4M loan with Directors help (The Market Herald) - "Directors of regenerative medicine company Regeneus (RGS) have put in place a $4 million loan facility to help commercialise Progenza for knee osteoarthritis in Japan. Progenza is the company's lead therapy technology being developed for the treatment of osteoarthritis and other musculoskeletal disorders."

Financing

Regeneus Ltd appendix 4C - Quarterly (ABN Newswire) - "During the quarter, the Company and AGC terminated their exclusive manufacturing licence and joint venture agreement, a mutual decision which provides Regeneus with the flexibility to conclude commercial licence discussions with partners who intend to manufacture and commercialise Progenza OA in Japan."

Licensing / partnership

Regeneus Ltd (ASX:RGS) AGC agreement termination paves way for commercial partner (Yahoo Finance) - "Regeneus Ltd...has come to a mutual agreement with Japan-based manufacturer AGC Inc (AGC) to terminate their exclusive manufacturing licence and joint venture agreement...This clause was agreed to as a variation to the original agreement, as Regeneus anticipated potential commercial partners' desire to manufacture Progenza for Osteoarthritis (Progenza OA)....This change provides Regeneus with the necessary flexibility to conclude commercial licence discussions with partners who intend to manufacture and commercialize Progenza OA."

Licensing / partnership

Regeneus closer to Japan deal after take up of rights issue shortfall (The Market Herald) - "Regeneus (RGS), today announced a $755,029 share placement with a Japanese institutional investor as part of its funding to commercialise in Japan....A Phase 1 trials of Progenza for osteoarthritis was completed successfully and preparations are underway for a Phase 2 clinical trial in Japan; Regeneus plans to commercialise Progenza, a cell therapy technology that treats osteoarthritis, by 2023"

Financing • Launch • New P2 trial • Trial completion

Regeneus progressing well to commercialise Progenza in Japan by 2023; Undertakes strategic capital raising initiatives (Kalkine Media) - "The company is aiming to finalise a Phase 2 clinical study, commercialise Progenza for osteoarthritis with Japan product launch in 2023. Subsequently, Regeneus plans to bring Progenza for osteoarthritis to huge and potential European and US markets...The total funds raised via placement and Entitlement Offer will amount to $5.5 million...with sufficient funds to secure a commercial licensing deal for Progenza for osteoarthritis in Japan."

Commercial • Financing • Launch Japan • New P2 trial

Safety, tolerability and efficacy of intra-articular Progenza in knee osteoarthritis: a randomized double-blind placebo-controlled single ascending dose study. (PubMed, J Transl Med) - "When administered as a single intra-articular injection to patients with symptomatic knee OA, PRG was safe and well tolerated. Furthermore, measurable improvements in symptoms and knee structure outcomes warrant further studies on PRG's potential for disease modification in OA. Trial registration ANZCTR, ACTRN12615000439549. Date registered: 7th May 2015, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368355."

Clinical • Journal