Oslo, 27 March 2024: Reference is made to the stock exchange announcement by Circio Holding ASA (OSE:CRNA) ("CIRCIO" or the "Company") on 21 March 2024, regarding the requested conversion of convertible bonds by Atlas Special Opportunities, LLC.
The share capital increase has now been registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret). The Company's new share capital is NOK 4,865,976.00 divided into 8,109,960 shares, each with a nominal value of NOK 0.60.
]]>Reference is made to Circio Holding ASA's (the "Company") stock exchange announcement on 9 March 2023, in which the Company announced that it had requested Atlas Special Opportunities, LLC ("Atlas") to subscribe and pay for the first tranche of convertible bonds under the Investment Agreement entered into between Atlas and the Company, consisting of 75 convertible bonds.
Atlas has, by a notice of conversion, requested conversion of convertible bonds with a nominal value of NOK 1,000,000 which, pursuant to the bond terms, are convertible into 171,065 new shares in the Company at a conversion price of NOK 5.8457.
The Company's share capital will accordingly be increased by NOK 102,639.00 by the issuance of 171,065 new shares upon completion of the conversion by registration of the share capital increase in the Norwegian Register of Business Enterprises (Nw.: Foretaksregisteret). Following the conversion, the Company's total share capital will be NOK 4,865,976.00, divided into 8,109,960 shares, each with a nominal value of NOK 0.60.
]]>· The option exercise grants IOVaxis an exclusive license to develop and commercialize mutant RAS vaccines TG01/TG02 in Greater China and Singapore
Oslo, Norway 19 March 2024 - Circio Holding ASA (OSE: CRNA) announces that following approval of the investigational new drug (IND) application by the Chinese National Medical Products Administration (NMPA) on 1 March 2024, IOVaxis Therapeutics of Nantong, China, has on 15 March 2024 exercised its option to license mutant RAS cancer vaccines TG01 and TG02. The license grants IOVaxis exclusive rights to develop and commercialize the TG vaccines in Greater China and Singapore.
Under the license agreement between the parties, Circio is entitled to receive a milestone payment of USD 3m following the exercise of the license option. The total deal includes up to USD 10m in clinical development milestones, as well as royalties and commercial milestones on future sales.
Due to an ongoing process by IOVaxis to secure capital to cover both the milestone payments and the planned phase 1/2 TG01 clinical program and a re-evaluation around the TG01 intellectual property and data protection rights in China, IOVaxis has requested a six-month payment extension of the option fee and a discussion around certain commercial terms. The parties have agreed that IOVaxis will pay USD 300.000 of the option fee to Circio immediately, and that the remaining balance will be due on 15 September 2024. If the payments are not made by the agreed dates, the exclusive license will expire on 15 September 2024.
Dr. John Wang, CEO of IOVaxis Therapeutics, said: "Our substantially expanded IND-package has now been approved by the NMPA, and we are very eager to bring TG01 into the clinic as rapidly as possible to provide a much-needed targeted therapeutic option to patients in China with RAS-mutated pancreatic cancer. The IND-approval was also a critical milestone for our ongoing investor dialogues to secure the required capital for the planned TG01 development program in China and Singapore, and we are very grateful for the flexibility shown by the Circio team to grant an extension to allow further discussions between the parties and with our investors to take place".
Dr. Erik Digman Wiklund, CEO of Circio Holding ASA, added: "The partnership with IOVaxis is an important component of our aim to bring TG01 development forward through strategic collaborations in multiple settings and geographies. Dr. Wang and his team have shown strong commitment to get the IND approved, which required a substantial investment of time and resources by IOVaxis to develop a broad additional pre-clinical data package. We are very pleased to have such a dedicated partner and expect that the IND approval will make their fundraising successful. We look forward to taking our partnership to the next stage and initiate clinical development in China, which will be the first time TG01 is tested in an Asian patient population".
]]>Oslo, 13 March 2024: Reference is made to the stock exchange announcement by Circio Holding ASA (OSE:CRNA) ("CIRCIO" or the "Company") on 4 and 5 March 2024, regarding the requested conversion of convertible bonds by Atlas Special Opportunities, LLC.
The share capital increase has now been registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret). The Company's new share capital is NOK 4,763,337.00 divided into 7,938,895 shares, each with a nominal value of NOK 0.60.
]]>Oslo, Norway, 8 March 2024: Reference is made to the stock exchange announcement published by Circio Holding ASA (the "Company") on 28 September 2023 regarding the approval of a registration document (the "Registration Document") which was prepared to be used as a base prospectus for the purpose of listing new shares in the Company related to the convertible bond facility with Atlas Special Opportunities LLC ("Atlas").
Further reference is made to the stock exchange announcements published by the Company on 4 and 5 March 2024, announcing that Atlas had by notice of conversion, requested conversion of convertible bonds into a total of 171,154 new shares in the Company. A total of 99,548 of the new shares (the "New Shares") were issued at a separate ISIN pending publication of a prospectus.
The Financial Supervisory Authority of Norway (Nw.: Finanstilsynet) has today approved a securities note, a supplement to the Registration Document and a summary (together with the Registration Document, referred to as the "Prospectus") prepared for the listing of the New Shares.
The Prospectus is available at the Company's website https://www.circio.com/en/section/investors/prospectus/.
***
]]>Reference is made to Circio Holding ASA's (the "Company") stock exchange announcement on 9 March 2023, in which the Company announced that it had requested Atlas Special Opportunities, LLC ("Atlas") to subscribe and pay for the first tranche of convertible bonds under the Investment Agreement entered into between Atlas and the Company, consisting of 75 convertible bonds.
Atlas has, by a notice of conversion, requested conversion of convertible bonds with a nominal value of NOK 500,000 which, pursuant to the bond terms, are convertible into 85,877 new shares in the Company at a conversion price of NOK 5.8222.
The Company's share capital will accordingly be increased by NOK 51,526.20 by the issuance of 85,877 new shares upon completion of the conversion by registration of the share capital increase in the Norwegian Register of Business Enterprises (Nw.: Foretaksregisteret). Following the conversion, the Company's total share capital will be NOK 4,763,337.00, divided into 7,938,895 shares, each with a nominal value of NOK 0.60.
]]>· The IND application filed by partner IOVaxis Therapeutics to initiate TG01 clinical development in China was approved by the Chinese NMPA on 1 March 2024
Oslo, Norway 4 March 2024 - Circio Holding ASA (OSE: CRNA) announces that the TG01 investigational new drug (IND) application filed by partner IOVaxis Therapeutics of Nantong, China, has been approved by the Chinese National Medical Products Administration (NMPA). Following this acceptance by the NMPA, IOVaxis has the necessary regulatory approval to initiate TG01 clinical development in China.
Under the parties' agreement, IOVaxis has an exclusive option to license mutant RAS cancer vaccines TG01 and TG02 for China, Hong Kong, Macau, and Singapore, see link to the partnership announcement here (https://www.circio.com/en/targovax-and-iovaxis-therapeutics-enters-option-agreement-for-tg-mutant-ras-vaccine-license-and-clinical-development-in-china/) and the IND-filing here (https://www.circio.com/en/tg01-ind-application-filed-in-china-by-circios-partner-iovaxis-therapeutics/). Within two weeks of the TG01 IND approval by the NMPA, IOVaxis may elect to exercise its license option and trigger a USD 3m milestone payment to Circio.
]]>Reference is made to Circio Holding ASA's (the "Company") stock exchange announcement on 9 March 2023, in which the Company announced that it had requested Atlas Special Opportunities, LLC ("Atlas") to subscribe and pay for the first tranche of convertible bonds under the Investment Agreement entered into between Atlas and the Company, consisting of 75 convertible bonds.
Atlas has, by a notice of conversion, requested conversion of convertible bonds with a nominal value of NOK 500,000 which, pursuant to the bond terms, are convertible into 85,877 new shares in the Company at a conversion price of NOK 5.8222.
The Company's share capital will accordingly be increased by NOK 51,526.20 by the issuance of 85,877 new shares upon completion of the conversion by registration of the share capital increase in the Norwegian Register of Business Enterprises (Nw.: Foretaksregisteret). Following the conversion, the Company's total share capital will be NOK 4,711,810.80, divided into 7,853,018 shares, each with a nominal value of NOK 0.60.
]]>Oslo, Norway, 27 February 2024 - Circio Holding ASA (OSE: CRNA) announces that CFO Lubor Gaal is invited as a panel discussant at the 17th Annual European Life Sciences CEO Forum
Dr Lubor Gaal will participate in the conference discussion panel on gene therapy in rare disease:
17th Annual European Life Sciences CEO Forum, Zurich, Switzerland
Panel: Rare & Orphan Therapies Panel: Gene Therapy & Other Modalities
Presenter: Lubor Gaal, CFO
Date: 28 February 2024
Time: 11:50 CET
***
]]>Oslo, 7 February 2024: Reference is made to the stock exchange announcement by Circio Holding ASA (OSE:CRNA) ("CIRCIO" or the "Company") on 5 February 2024, regarding the requested conversion of convertible bonds by Atlas Special Opportunities, LLC.
The share capital increase has now been registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret). The Company's new share capital is NOK 4,660,284.60 divided into 7,767,141 shares, each with a nominal value of NOK 0.60.
]]>Reference is made to Circio Holding ASA's (the "Company") stock exchange announcement on 9 March 2023, in which the Company announced that it had requested Atlas Special Opportunities, LLC ("Atlas") to subscribe and pay for the first tranche of convertible bonds under the Investment Agreement entered into between Atlas and the Company, consisting of 75 convertible bonds.
Atlas has, by a notice of conversion issued to Nordic Trustee AS, requested conversion of convertible bonds with a nominal value of NOK 1,000,000 which, pursuant to the bond terms, are convertible into 152,895 new shares in the Company at a conversion price of NOK 6.5404.
The Company's share capital will accordingly be increased by NOK 91,737.00 by the issuance of 152,895 new shares upon completion of the conversion by registration of the share capital increase in the Norwegian Register of Business Enterprises (Nw.: Foretaksregisteret). Following the conversion, the Company's total share capital will be NOK 4,660,284.60, divided into 7,767,141 shares, each with a nominal value of NOK 0.60.
]]>Oslo, Norway, 1 February 2024 - Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA and immunotherapy medicines, today announces that the first patient has been dosed in the collaborative phase 2 trial sponsored by Georgetown University. In this study, mutant RAS cancer vaccine TG01 is being tested in combination with daratumumab (anti-CD38, Janssen) and nivolumab (anti-PD1, BMS) in patients with RAS-mutated pancreatic cancer (PDAC) and patients with non-small cell lung cancer (NSCLC).
Mutations in the RAS-family of genes are a major cause of cancer and found in over 90% of PDAC and 30% of NSCLC cancer patients. RAS-mutated cancers typically have poor prognosis with few targeted treatment alternatives, and the medical need for novel therapeutic options remains high.
To further study this unmet medical need, a phase 2 trial has been initiated to test the combination of daratumumab (Janssen), nivolumab (BMS) and TG01 in advanced PDAC and anti-PD1 resistant NSCLC (see announcement Nov 16 2023 (https://www.circio.com/en/circio-joins-collaboration-to-test-the-combination-of-tg01-vaccination-with-daratumumab-and-nivolumab-in-immunotherapy-resistant-patients-with-mutant-ras-cancers/)). The study will enroll 54 KRAS-mutated patients in total, 27 immunotherapy-naïve PDAC patients and 27 NSCLC patients who have progressed on prior anti-PD1 therapy.
Ola Melin, Head of the TG program at Circio, said: "The externally sponsored clinical program with our enhanced TG01 cancer vaccine is progressing well. The Georgetown study is now the third active clinical trial with patients on treatment, and comes in addition to the multiple myeloma study at Oslo University Hospital and the pancreatic cancer study at Kansas University. Collaborations are the core of the TG01 development strategy, and we are continuing to execute on the plan to advance our KRAS program through external development in multiple settings and geographies."
]]>Oslo, Norway 18 January 2024 - Circio Holding ASA (OSE: CRNA) today announces that Business Finland has approved Circio's application for a waiver in full of three R&D loans totalling EUR 6.2m granted towards the development of ONCOS-102. As a result, Circio's equity will be increased by a corresponding amount.
Business Finland is a public agency that provides funding towards R&D activities for companies in Finland. Targovax Oy, a wholly owned Finnish subsidiary of Circio Holding ASA, received three loans from Business Finland for the development and commercialization of ONCOS-102 in 2010, 2012 and 2013, totalling EUR 6 209 888. The loans were repayable over a ten-year period from 2021-2031 with an interest rate of currently 1.25% p.a.
In 2023, Circio made the strategic decision to prioritize and accelerate pre-clinical development of its innovative circular RNA (circRNA) platform and discontinue the ONCOS-102 program. Following this decision, Circio applied for a waiver of the three ONCOS-102 loans. On 15 January 2024, Business Finland approved the application and granted a waiver in full of the outstanding principal amount and future interest of the three loans. The waiver is subject to the termination of the ONCOS-102 program and its related IP and the liquidation of Targovax Oy, which is ongoing with the relevant authorities in Finland.
Dr. Lubor Gaal, CFO of Circio Holding ASA, said: "The Business Finland loans were granted to Oncos Therapeutics Oy more than ten years ago, and assumed by the Targovax group following the acquisition of Oncos Therapeutics in 2015. We greatly appreciate the goodwill and flexibility shown by Business Finland in waiving these loans, thereby enabling us to fully dedicate our resources towards development of our groundbreaking circVec platform, which has the potential to disrupt the genetic medicine and vaccine fields".
About Business Finland
Business Finland is the government organization for innovation funding and trade, travel, and investment promotion in Finland. More information: https://www.businessfinland.fi/en/for-finnish-customers/home.
Oslo, 12 January 2024: Reference is made to the stock exchange announcement by Circio Holding ASA (OSE:CRNA) ("CIRCIO" or the "Company") on 10 January 2024, regarding the requested conversion of convertible bonds by Atlas Special Opportunities, LLC.
The share capital increase has now been registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret). The Company's new share capital is NOK 4,568,547.60 divided into 7,614,246 shares, each with a nominal value of NOK 0.60.
]]>Reference is made to Circio Holding ASA's (the "Company") stock exchange announcement on 9 March 2023, in which the Company announced that it had requested Atlas Special Opportunities, LLC ("Atlas") to subscribe and pay for the first tranche of convertible bonds under the Investment Agreement entered into between Atlas and the Company, consisting of 75 convertible bonds.
Atlas has, by a notice of conversion issued to Nordic Trustee AS, requested conversion of convertible bonds with a nominal value of NOK 1,000,000 which, pursuant to the bond terms, are convertible into 140,435 new shares in the Company at a conversion price of NOK 7.1207.
The Company's share capital will accordingly be increased by NOK 84,261.00 by the issuance of 140,435 new shares upon completion of the conversion by registration of the share capital increase in the Norwegian Register of Business Enterprises (Nw.: Foretaksregisteret). Following the conversion, the Company's total share capital will be NOK 4,568,547.60, divided into 7,614,246 shares, each with a nominal value of NOK 0.60.
]]>Oslo, 4 January 2024: Reference is made to the stock exchange announcement by Circio Holding ASA (OSE:CRNA) ("CIRCIO" or the "Company") on 28 December 2023, regarding the requested conversion of convertible bonds by Atlas Special Opportunities, LLC.
The share capital increase has now been registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret). The Company's new share capital is NOK 4,484,286.60 divided into 7,473,811 shares, each with a nominal value of NOK 0.60.
]]>Reference is made to Circio Holding ASA's (the "Company") stock exchange announcement on 9 March 2023, in which the Company announced that it had requested Atlas Special Opportunities, LLC ("Atlas") to subscribe and pay for the first tranche of convertible bonds under the Investment Agreement entered into between Atlas and the Company, consisting of 75 convertible bonds.
Atlas has, by a notice of conversion issued to Nordic Trustee AS, requested conversion of convertible bonds with a nominal value of NOK 500,000 which, pursuant to the bond terms, are convertible into 77,097 new shares in the Company at a conversion price of NOK 6.4853.
The Company's share capital will accordingly be increased by NOK 46,258.20 by the issuance of 77,097 new shares upon completion of the conversion by registration of the share capital increase in the Norwegian Register of Business Enterprises (Nw.: Foretaksregisteret). Following the conversion, the Company's total share capital will be NOK 4,484,286.60, divided into 7,473,811 shares, each with a nominal value of NOK 0.60.
]]>Oslo, 22 December 2023: Reference is made to the stock exchange announcement by Circio Holding ASA (OSE:CRNA) ("CIRCIO" or the "Company") on 19 December 2023, regarding the requested conversion of convertible bonds by Atlas Special Opportunities, LLC.
The share capital increase has now been registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret). The Company's new share capital is NOK 4,438,028.40 divided into 7,396,714 shares, each with a nominal value of NOK 0.60.
]]>Oslo, 19 December 2023: Reference is made to the stock exchange announcement by Circio Holding ASA (OSE:CRNA) ("CIRCIO" or the "Company") on 13 December 2023, regarding the requested conversion of convertible bonds by Atlas Special Opportunities, LLC.
The share capital increase has now been registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret). The Company's new share capital is NOK 4,391,770.20 divided into 7,319,617 shares, each with a nominal value of NOK 0.60.
]]>Reference is made to Circio Holding ASA's (the "Company") stock exchange announcement on 9 March 2023, in which the Company announced that it had requested Atlas Special Opportunities, LLC ("Atlas") to subscribe and pay for the first tranche of convertible bonds under the Investment Agreement entered into between Atlas and the Company, consisting of 75 convertible bonds.
Atlas has, by a notice of conversion issued to Nordic Trustee AS, requested conversion of convertible bonds with a nominal value of NOK 500,000 which, pursuant to the bond terms, are convertible into 77,097 new shares in the Company at a conversion price of NOK 6.4853.
The Company's share capital will accordingly be increased by NOK 46,258.20 by the issuance of 77,097 new shares upon completion of the conversion by registration of the share capital increase in the Norwegian Register of Business Enterprises (Nw.: Foretaksregisteret). Following the conversion, the Company's total share capital will be NOK 4,438,028.40, divided into 7,396,714 shares, each with a nominal value of NOK 0.60.
]]>Reference is made to Circio Holding ASA's (the "Company") stock exchange announcement on 9 March 2023, in which the Company announced that it had requested Atlas Special Opportunities, LLC ("Atlas") to subscribe and pay for the first tranche of convertible bonds under the Investment Agreement entered into between Atlas and the Company, consisting of 75 convertible bonds.
Atlas has today, by a notice of conversion issued to Nordic Trustee AS, requested conversion of convertible bonds with a nominal value of NOK 500,000 which, pursuant to the bond terms, are convertible into 77,097 new shares in the Company at a conversion price of NOK 6.4853.
The Company's share capital will accordingly be increased by NOK 46,258.20 by the issuance of 77,097 new shares upon completion of the conversion by registration of the share capital increase in the Norwegian Register of Business Enterprises (Nw.: Foretaksregisteret). Following the conversion, the Company's total share capital will be NOK 4,391,770.20, divided into 7,319,617 shares, each with a nominal value of NOK 0.60.
]]>Oslo, Norway 12 December 2023 - Circio Holding ASA (OSE: CRNA) announces that partner IOVaxis Therapeutics of Nantong, China, has filed the updated TG01 investigational new drug (IND) application with the Chinese National Medical Products Administration (NMPA), with an expected review period of sixty days.
IOVaxis has an exclusive option agreement to license mutant RAS cancer vaccines TG01 and TG02 for China, Hong Kong, Macau, and Singapore, see link to press release here (https://www.circio.com/en/targovax-and-iovaxis-therapeutics-enters-option-agreement-for-tg-mutant-ras-vaccine-license-and-clinical-development-in-china/). Within two weeks of TG01 IND approval by the NMPA, IOVaxis may exercise its exclusive license option and trigger a USD 3m milestone payment to Circio.
Dr. John Wang, CEO of IOVaxis Therapeutics, said: "Following broad additional pre-clinical characterization of the TG01 product, we have now filed a substantially expanded IND-package, which we are confident meets the requirements of the NMPA. We have been impressed by previous clinical data for TG01 and are eager to bring this innovative mutant RAS immunotherapy to patients in China. Once we have the IND approval, we intend to initiate a phase 1 study in pancreatic cancer as soon as possible, and then rapidly expand to other KRAS indications and combinations."
The NMPA requested additional pre-clinical characterization of TG01 following review of the initial TG01 IND filing in 2021. The requested studies have now been performed and included in the resubmitted IND-package. The expected response time is sixty days from the submission date. Following IND-approval, IOVaxis may exercise its exclusive license option for TG01 and TG02 within 14 days.
Dr. Erik Digman Wiklund, CEO of Circio Holding ASA, added: "This partnership with IOVaxis is an important component of our aim to bring TG01 development forward through strategic collaborations in multiple settings and geographies. Dr. Wang and his team have shown strong commitment to meet the requirements of the Chinese regulatory authorities and generated a substantial pre-clinical data package to support the filing. We are very pleased to have such a dedicated partner and expect that the IND will now be accepted in China, as it has already been in Europe and the USA."
]]>