Tillkännagivande • Apr 25
Circio Holding ASA has withdrawn its Follow-on Equity Offering in the amount of NOK 82.49999 million. Circio Holding ASA has withdrawn its Follow-on Equity Offering in the amount of NOK 82.49999 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 7,638,888
Price\Range: NOK 10.8
Transaction Features: Rights Offering Tillkännagivande • Apr 08
Circio Holding ASA has filed a Follow-on Equity Offering in the amount of NOK 82.49999 million. Circio Holding ASA has filed a Follow-on Equity Offering in the amount of NOK 82.49999 million.
Security Name: Share
Security Type: Common Stock
Securities Offered: 7,638,888
Price\Range: NOK 10.8
Transaction Features: Rights Offering Tillkännagivande • Jan 30
Circio Holding ASA has completed a Follow-on Equity Offering in the amount of NOK 50 million. Circio Holding ASA has completed a Follow-on Equity Offering in the amount of NOK 50 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 48,200,000
Price\Range: NOK 1
Security Features: Attached Warrants
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,800,000
Price\Range: NOK 1
Security Features: Attached Warrants
Transaction Features: Regulation S; Rights Offering Tillkännagivande • Dec 09
Circio Holding ASA has filed a Follow-on Equity Offering in the amount of NOK 50 million. Circio Holding ASA has filed a Follow-on Equity Offering in the amount of NOK 50 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 50,000,000
Price\Range: NOK 1
Security Features: Attached Warrants
Transaction Features: Rights Offering Buy Or Sell Opportunity • Nov 02
Now 98% undervalued after recent price drop Over the last 90 days, the stock has fallen 100% to €0.0006. The fair value is estimated to be €0.029, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 44% over the last 3 years. Meanwhile, the company has become profitable. Revenue is forecast to grow by 82,630% in 2 years. Earnings are forecast to grow by 301% in the next 2 years. Tillkännagivande • Oct 24
Circio Holding ASA Presents Circvec Circular RNA in Vivo Expression Proof-Of-Concept Data At ESGCT 2024 Annual Meeting Circio Holding ASA announced the publication of new, strong and statistically significant circVec circular RNA in vivo expression proof-of-concept data, presented both in the form of a poster and oral presentation by CTO, Dr. Thomas B Hansen, at the European Society of Cell and Gene Therapy (ESGCT) annual meeting 2024. In the ESGCT presentation, Circio showed the evolution and improvements of the circVec platform from the initial circVec 1.0 design to the current generation 2.1. Long-term in vivo experiments have now demonstrated that circVec 2.1 robustly outperforms classical mRNA-based expression over time, offering enhanced durability that reaches up to 15-fold higher reporter signals in mouse models. Additionally, a machine-learning approach to codon optimization has generated a novel circVec 2.2 design, delivering a further 2-4-fold increase in protein yield. Circio is currently testing the performance of circVec 2.1 and 2.2 in both viral and DNA vector systems in multiple tissues and disease settings in vivo. These data will guide future development and partnering strategy for the circVec platform. New Risk • Sep 30
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 128% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Debt is not well covered by operating cash flow (currently running at an operating cash loss). Share price has been highly volatile over the past 3 months (1,200% average daily change). Negative equity (-kr43m). Earnings are forecast to decline by an average of 128% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (242% increase in shares outstanding). Revenue is less than US$1m (kr123k revenue, or US$12k). Market cap is less than US$10m (€1.46m market cap, or US$1.63m). New Risk • Aug 30
New major risk - Financial position The company's debt is not well covered by operating cash flow. Currently running at an operating cash loss. This is considered a major risk. If the company's operating cash flows are too small relative to the size of their debt, it increases their balance sheet risk. The company has less cash from operations to cover its expenses from servicing large debt and it increases the risk of liquidity issues. It also extends the time it would take for the company to pay back the debt in full, meaning it may not be able to easily pay it all off in a distress scenario. Currently, the following risks have been identified for the company: Major Risks Debt is not well covered by operating cash flow (currently running at an operating cash loss). Share price has been highly volatile over the past 3 months (42% average weekly change). Negative equity (-kr43m). Shareholders have been substantially diluted in the past year (264% increase in shares outstanding). Revenue is less than US$1m (kr123k revenue, or US$12k). Market cap is less than US$10m (€2.83m market cap, or US$3.13m). Tillkännagivande • Jun 18
Circio Announces Strengthened in Vivo Data and Enhanced Circvec 2.2 Design Circio Holding ASA announced updated in vivo data. This new data demonstrates a substantial durability advantage of Circio's circVec technology over conventional mRNA expression. In addition, Circio has undertaken sequence optimization resulting in a new and enhanced circVec 2.2 design. In parallel to the in vivo characterization, Circio has tested and incorporated further features into the circVec platform. A dual-function `remove-&-replace' concept has been designed and validated in vitro for Alpha-1-antitrypsin deficiency (AATD). This concept has the ability to both replace functional AAT protein and remove the disease variant. AATD is a genetic disease that causes severe symptoms in the lung and liver. There are currently no satisfactory therapeutic options available, and AATD represents a major unmet medical need with over 200,000 patients affected in the USA and EU. New Risk • Jun 12
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 66% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (73% average weekly change). Negative equity (-kr96m). Shareholders have been substantially diluted in the past year (66% increase in shares outstanding). Revenue is less than US$1m (kr123k revenue, or US$11k). Market cap is less than US$10m (€2.37m market cap, or US$2.55m). Tillkännagivande • Apr 18
Circio Holding ASA has filed a Follow-on Equity Offering in the amount of NOK 60 million. Circio Holding ASA has filed a Follow-on Equity Offering in the amount of NOK 60 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: Rights Offering Tillkännagivande • Apr 17
Circio Announces in Vivo Proof-Of-Concept for Its circVec circular RNA Platform Technology and Reinforced Gene Therapy Focus Circio Holding ASA announces that it has established technical in vivo proof-of-concept for its proprietary circVec circular RNA platform by demonstrating statistically significant improvement in durability over mRNA-based expression. The circVec technology has broad potential, particularly to enhance the potency and reduce cost of current gold-standard gene therapy, and the R&D strategy is centered on this rapidly expanding therapeutic area. In parallel to the in vivo characterization, Circio has tested and incorporated further features into the circVec platform. A dual-function 'remove-&-replace' concept has been designed and validated in vitro for Alpha-1-antitrypsin deficiency (AATD), with the ability to both replace functional AAT protein and remove the disease variant. This genetic disease causes severe symptoms in the lung and liver, and there are currently no satisfactory therapeutic options available. AATD represents a major unmet medical need and there are over 200,000 patients affected in the USA and EU. To Circio´s knowledge, circVec 2.1 far exceeds other known intra-cellular circRNA-based expression systems, both in terms of circRNA biogenesis efficiency and protein yield. The platform still has further potential, and Circio is continuously improving the technology towards circVec 3.0 and beyond. The platform is protected by deep internal expertise and know-how, with three patents protecting the core technological features filed to date, and additional applications in progress. Breakeven Date Change • Apr 05
Forecast breakeven date pushed back to 2026 The 2 analysts covering Circio Holding previously expected the company to break even in 2024. New consensus forecast suggests the company will make a profit of kr198.0m in 2026. Average annual earnings growth of 88% is required to achieve expected profit on schedule. New Risk • Mar 11
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr115m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-kr72m). Revenue is less than US$1m (kr10m revenue, or US$958k). Market cap is less than US$10m (€3.91m market cap, or US$4.28m). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (21% increase in shares outstanding). Tillkännagivande • Feb 01
Circio Holding ASA Announces Dosing of First Patient in the Collaborative Phase 2 Trial Sponsored by Georgetown University Circio Holding ASA announced 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. The study will enroll 54 KRAS-mutated patients in total, 27 immunotherapy-naive PDAC patients and 27 NSCLC patients who have progressed on prior anti-PD1 therapy. Tillkännagivande • Dec 12
IOVaxis Therapeutics Files Updated TG01 Investigational New Drug Application with the Chinese National Medical Products Administration Circio Holding ASA announced 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. Within two weeks of TG01 IND approval by the NMPA, IOVaxis may exercise its exclusive license option and trigger a USD 3 million milestone payment to Circio. 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 the exclusive license option for TG01 and TG02 within 14 days. Tillkännagivande • Dec 07
Circio Holding ASA Announces Completion of Planned Safety Review and Opening for Full Enrollment of TG01 Study At Oslo University Hospital Circio Holding ASA announced that mutant RAS cancer vaccine TG01 adjuvanted by QS-21 STIMULON has passed the planned safety cohort review without any concerns in the multiple myeloma trial at Oslo University Hospital (OUS). The study has now opened for full enrollment of twenty patients in total. In this phase 1 clinical trial, TG01 is being tested as a monotherapy in multiple myeloma in a clinical collaboration between OUS and Circio. The study is led by multiple myeloma expert Dr. Fredrik Schjesvold with OUS as the study sponsor. Circio provides TG01 drug supply, scientific support and a financial contribution. New Risk • Oct 18
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr115m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr115m free cash flow). Share price has been highly volatile over the past 3 months (35% average weekly change). Negative equity (-kr72m). Revenue is less than US$1m (kr10m revenue, or US$913k). Market cap is less than US$10m (€5.91m market cap, or US$6.25m). Minor Risk Shareholders have been diluted in the past year (14% increase in shares outstanding). Breakeven Date Change • Aug 25 The 2 analysts covering Circio Holding previously expected the company to break even in 2024. New consensus forecast suggests losses will reduce by 76% to 2023. The company is expected to make a profit of kr74.7m in 2024.
Breakeven Date Change • Apr 18
Forecast to breakeven in 2024 The analyst covering Targovax expects the company to break even for the first time. New forecast suggests losses will reduce by 70% to 2023. The company is expected to make a profit of kr74.7m in 2024. Average annual earnings growth of 94% is required to achieve expected profit on schedule. Breakeven Date Change • Mar 09
Forecast to breakeven in 2024 The analyst covering Targovax expects the company to break even for the first time. New forecast suggests the company will make a profit of kr75.0m in 2024. Average annual earnings growth of 48% is required to achieve expected profit on schedule. Tillkännagivande • Dec 23
Targovax Announces That the TG01 Study in Multiple Myeloma At Oslo University Hospital Has Received Regulatory Approvals to Proceed Targovax ASA announced that the planned clinical trial with mutant RAS cancer vaccine TG01 in multiple myeloma has received regulatory approval to proceed from NOMA and REK. The trial is a collaboration between OUS and Targovax and will test TG01 vaccination as a monotherapy in 20 KRAS or NRAS mutated multiple myeloma patients who continue to have measurable disease after completion of standard of care treatment. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can enhance the clinical response. The trial will be sponsored by OUS and led by Dr. Fredrik Schjesvold, an international leader in the field and founder of the Oslo Myeloma Center, the larger Myeloma center in the Nordics. Targovax will provide TG01 drug supply, scientific support and a financial contribution through grants awarded from Innovation Norway and the Norwegian Research Council. Board Change • Nov 21
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Director Thomas Falck was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Oct 21
Targovax ASA Completes ONCOS-102 Phase 1b Study in PD-1 CPI Resistant Advanced Melanoma Has Been Published in the Oncology Journal Clinical Cancer Research Targovax ASA announced that the completed ONCOS-102 phase 1b study in PD-1 CPI resistant advanced melanoma has been published in the oncology journal Clinical Cancer Research, published by the American Association for Cancer Research (AACR). PD-1 CPI resistant advanced melanoma is a major unmet medical need affecting up to 25,000 patients per year in the major markets. The diagnosis is associated with a poor prognosis and there are currently no approved treatment options available. In this phase 1b trial, ONCOS-102 was given intra-tumorally to 21 PD-1 CPI resistant melanoma patients, followed by re-treatment with the PD-1 CPI Keytruda. It is anticipated that local injection of ONCOS-102 will induce an inflammatory immune response in the tumor microenvironment and drive systemic T -cell activation, which in turn can re-sensitize the patient to PD-1 CPI therapy. As expected, ONCOS-102 generated strong and durable immune activation in the treated patients, which translated into a promising objective response rate (ORR) of 35%. Importantly, the clinical efficacy was associated with continuous replication of ONCOS-102 within the tumor, statistically significant increase in T-cell infiltration, and broad and persistent upregulation of immunological pathways in responding patients.Titel: Pilot Study of ONCOS-102 and Pembrolizumab: Remodeling of the Tumor Microenvironment and Clinical Outcomes in Anti-PD-1-Resistant Advanced Melanoma. Tillkännagivande • Sep 28
Targovax ASA Receives Approval to Proceed with the Oncos-102 Phase 2 Melanoma Study from the US FDA Targovax ASA announces that the FDA has accepted the protocol and given the formal go -ahead to proceed with the planned ONCOS-102 phase 2 trial in melanoma. Study initiation activities are proceeding according to the communicated timeline, with the aim to start enrolling patients in late 2022 or early 2023. PD-1 CPI refractory advanced melanoma is a major unmet medical need affecting up to 25,000 patients per year globally in the major markets. The diagnosis has poor prognosis and there are currently no approved treatment options available. In a recently reported phase 1 trial, ONCOS-102 demonstrated a highly competitive response rate (ORR) of 35% in this patient population in combination with a PD-1 CPI. Importantly, the strong ORR outcome was corroborated by biomarker data showing significant increase in T-cell infiltration and broad and persistent activation of immune-related gene signatures in responding patients. Based on these promising early clinical results, Targovax is planning to conduct a larger, phase 2 multi-cohort study to further explore and validate the benefit of ONCOS-102 in PD-1 CPI refractory melanoma. This phase 2 study will be run in collaboration with Targovax's partner Agenus, who will provide their Fc-enhanced CTLA-4 (botensilimab) and PD-1 (balstilimab) CPIs for combination with ONCOS-102. In the first part of the study, two groups will evaluate the safety and efficacy of (1) a higher dose of ONCOS-102 to be tested as a monotherapy and (2) the low and new higher dose of ONCOS-102 in combination with the PD-1 CPI balstilimab. Following confirmation of the safety of the increased ONCOS-102 dose, the study will proceed into its second part adding two more groups. In group (3) ONCOS-102 will for the first time be combined with a CTLA-4 CPI (botensilimab) and, ultimately, in (4) the triple combination of ONCOS-102, balstilimab and botensilimab will be tested. Breakeven Date Change • Aug 22
Forecast to breakeven in 2024 The 2 analysts covering Targovax expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr14.7m in 2024. Average annual earnings growth of 38% is required to achieve expected profit on schedule. Tillkännagivande • Jun 24
Targovax ASA Announces that the FDA Grant Authorization to Initiate Clinical Trials with the Enhanced TG01 RAS Vaccine in the USA Targovax ASA announced that the US FDA has approved an IND application for TG01 combined with QS-21 STIMULON, which allows the preparations to initiate clinical trials in the USA to proceed. In May, an IND application for the enhanced TG01 mutant RAS cancer vaccine, with QS-21 STIMULON as adjuvant, was filed with the US FDA. The FDA has now approved this IND application, which means that the new and improved TG01 version has been authorized to proceed with clinical studies in the USA. Targovax has previously demonstrated promising clinical data for an earlier version of TG01 in KRAS mutant pancreatic cancer. For technical and commercial reasons, Targovax has made significant improvements in TG01 to strengthen immune activation and simplify handling at the hospital and improve patient convenience. In this new format, TG01 will be co-administered with the FDA approved adjuvant QS-21 STIMULON, provided by collaboration partner Agenus. QS-21 STIMULON is expected to enhance TG01 efficacy by driving stronger and broader mutant RAS immune responses. TG01 and QS-21 STIMULON will be mixed and dosed as a single injection, rather than two separate injections as in prior trials. Moreover, the injection will be given sub-cutaneously instead of intra-dermally. These modifications will make the administration of TG01 more patient friendly and simpler to manage for healthcare personnel. Board Change • Apr 29
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Director Thomas Falck was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Apr 21
Targovax ASA Announces Board Changes Targovax ASA announced that the Genel Meeting has elected Dr. Raphael Clynes and Mr. Thomas Falck as new members of its Board of Directors. Dr.Clynes is an internationally recognized cellular immunologist and medical oncologist. Dr. Clynes was on the faculty at the Columbia University where he developed several novel therapeutic approaches in cancer and autoimmunity. Since joining industry in 2014, Dr. Clynes has led clinical immunotherapy development, including checkpoint inhibtors and novel CD3 bispecifics, at Bristol Myers Squibb (BMS) and at Xencor, where he is currently VP Translational Biology. Mr. Falck is an experienced CEO, CFO, Board Chair and Non-Executive Director, Venture Capitalist & Growth Investor with demonstrated success in defining and delivering profitable growth while undertaking strategic and organizational change. He has broad experience with Private Equity, Venture Capital, Stock Listed, Family and Government owned entities. Raphael Clynes and Thomas Falck are replacing Per Samuelsson and Johan Christenson. Breakeven Date Change • Mar 12
Forecast to breakeven in 2024 The 2 analysts covering Targovax expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr14.7m in 2024. Average annual earnings growth of 20% is required to achieve expected profit on schedule. Tillkännagivande • Feb 28
Targovax ASA Appoints Lubor Gaal as Chief Financial Officer, Effective March 7, 2022 Targovax ASA announced that it has appointed Dr. Lubor Gaal as Chief Financial Officer (CFO), effective as of 7 March 2022. Most recently, he served as Managing Director and Head of Europe at Locust Walk. Before Locust Walk, he was Head of External Innovation and Licensing and a member of the R&D Management Committee at Almirall and Head of Europe Search and Evaluation for oncology at Bristol-Myers Squibb. Breakeven Date Change • Feb 19
Forecast to breakeven in 2024 The 2 analysts covering Targovax expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr15.0m in 2024. Average annual earnings growth of 11% is required to achieve expected profit on schedule. Tillkännagivande • Dec 20
Targovax ASA Announces ONCOS-102 Achieves 25.0 Months Median Overall Survival in First Line Mesothelioma Targovax ASA announced mOS of 25.0 months for treatment with ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in malignant pleural mesothelioma (MPM) in the subgroup of patients receiving therapy in the first-line setting. The study is an open-label, exploratory phase 1/2 trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first and later line MPM to assess safety, immune activation and clinical efficacy compared with SoC alone. A total of 31 patients were enrolled in the trial, with 20 patients in the treatment group receiving ONCOS-102 plus SoC chemotherapy, and 11 patients in the control group receiving SoC only. The 30-month follow-up has now been completed. At the 30-month follow-up, mOS was 25.0 months for the subgroup of randomized, first-line ONCOS-102-treated patients (n=8). This is a clear improvement over the mOS of 13.5 months observed in the first-line SoC-only control group (n=6). Previous phase 3 clinical trials in MPM have reported mOS in the range of 12-16 months for patients receiving the same SoC chemotherapy treatment in the first-line setting1. The combination of Opdivo/Yervoy double checkpoint inhibition was recently approved as a first-line treatment option for MPM based on a phase 3 trial showing 18.1 months mOS. Objective response rate (ORR), progression free survival (PFS) and mOS have been previously reported, and remain unchanged. The 30-month follow-up analysis completes the mOS data set for all subgroups in the trial. Immune activation was assessed in tumor biopsies pre- and post-ONCOS-102 treatment (Day 0 and Day 36). The tumor tissue analyses revealed powerful and consistent ONCOS-102-induced remodeling of the tumor microenvironment with increased T-cell infiltration and a shift towards pro-inflammatory immune cells, far beyond what was observed for the SoC-only control group. This immune activation is associated with tumor responses and is most pronounced in patients with better survival outcomes, indicating that the immune activating capacity of ONCOS-102 is driving the clinical benefit for patients. Executive Departure • Oct 07
Chief Financial Officer Torbjørn Furuseth has left the company On the 30th of September, Torbjørn Furuseth's tenure as Chief Financial Officer ended after 3.0 years in the role. As of June 2021, Torbjørn still personally held only 15.00k shares (€12k worth at the time). Torbjørn is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 3.08 years. Tillkännagivande • Jun 23
Targovax Receives Fast Track Designation for Oncos-102 in Melanoma Targovax ASA announces that its lead clinical candidate ONCOS-102 has received Fast Track designation in PD-1-refractory advanced melanoma from the US FDA. The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses. Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma. This Fast Track approval comes in addition to ONCOS-102´s existing Fast Track designation in malignant pleural mesothelioma. The FDA Fast Track designation is awarded to therapies with potential to address unmet medical needs in serious medical conditions and allows for more frequent interactions with the FDA to expedite clinical development, as well as the regulatory review processes. Fast Track products have high likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application for rolling review to shorten the approval timeline. Tillkännagivande • Jun 17
Targovax Announces Completed Enrollment in the Phase 1/2 Trial with ONCOS-102 in Combination with Durvalumab in Patients with Advanced Colorectal Cancer with Peritoneal Malignancies Targovax ASA announced that the ONCOS-102 and durvalumab trial in patients with advanced peritoneal malignancies has completed enrollment in the colorectal cancer cohort. This phase 1/2 trial investigates the safety, biologic and anti-tumor activity of ONCOS-102 in combination with Imfinzi (durvalumab, anti-PD-L1) in patients with advanced peritoneal malignancies who have failed prior standard chemotherapy and have histologically confirmed platinum-resistant or refractory epithelial ovarian or colorectal cancer. In October 2020, the pre-defined disease control efficacy threshold in part 1 in the colorectal cancer cohort was met, and this expansion cohort was opened for recruitment of the part 2 patients. The clinical and immune activation data are expected to be available first half of 2022. Tillkännagivande • Jun 11
Targovax ASA's ONCOS-102 Mesothelioma 24-Month Data Shows Class-Leading Median Overall Survival Targovax ASA announced MoS between 21.9 and 25.0 months from the randomized phase 1/2 trial of ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM). The study is an open-label, exploratory phase 1/2 trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (or later) line MPM to assess safety, immune activation and clinical efficacy compared with SoC alone. A total of 31 patients were enrolled in the trial, with 20 patients in the treatment group receiving ONCOS-102 plus SoC chemotherapy, and 11 patients in the control group receiving SoC only. The trial has now completed the 24-month follow-up. At the 24-month follow-up, it was determined that the final mOS will be in the range of 21.9 to 25.0 months for first-line ONCOS-102-treated patients in the randomized group (n=8). This is a clear improvement over the MoS of 13.5 months observed in the first-line SoC-only control group (n=6). Previous MPM clinical trials have reported mOS in the range of 12–16 months for patients receiving the same SoC chemotherapy treatment. Immune activation was assessed in tumor biopsies pre- and post-ONCOS-102 treatment (Day 36). The tumor tissue analyses revealed broad and powerful ONCOS-102-induced remodeling of the tumor microenvironment with increased T-cell infiltration and a shift towards pro-inflammatory immune cells, far beyond what was observed for the SoC-only control group. Notably, this activity was associated with both tumor responses and survival outcomes, indicating that the immune activation generated by ONCOS-102 is driving the clinical benefit for patients. Recently, the double checkpoint inhibitor (CPI) combination of Opdivo and Yervoy (nivolumab and ipilimumab) was approved by the U.S. Food and Drug Administration (October 2020) and the European Medicines Agency (April 2021) for the first-line treatment of MPM, based on a phase 3 trial showing mOS of 18.1 months compared with 14.1 months in the SoC control group (pemetrexed/cisplatin). The Opdivo/Yervoy combination is seeing rapid uptake among clinicians in both the USA and Europe and is becoming the new preferred first-line Standard of Care. Given the class-leading activity ONCOS-102 has demonstrated in CPI-refractory melanoma, Targovax believes there is a strong scientific rationale for testing ONCOS-102 in the CPI-refractory setting also in MPM. This opportunity is now being discussed with key opinion leaders. Tillkännagivande • Mar 18
Targovax ASA Announces Board Changes Targovax ASA announced that the General meeting has elected seasoned industry expert Sonia Quaratino MD PhD as new member of the Board of Directors. Dr. Quaratino is an R&D executive with over 20 years' experience in clinical development and immunology research. She is Chief Medical Officer at Kymab. She is also the Chair of the Scientific and Clinical Advisory Board for STipe Therapeutics. Dr. Quaratino is replacing Dr. Wheeler. Tillkännagivande • Mar 09
Targovax Granted US Patent for Oncos-102 in Combination with Checkpoint Inhibitors Targovax ASA announced that the US Patent Office has granted US Patent no 10,940,203. The patent covers the use of ONCOS-102 in combination with checkpoint inhibitors. In December 2020 Targovax announced that the combination of ONCOS-102 and checkpoint inhibitor pembrolizumab (Keytruda) demonstrated 35% best objective response rate (ORR) in anti-PD1 refractory malignant melanoma patients. Systemic effects were also observed in multiple patients, including two examples where a non-injected lesion completely regressed. In this open label phase 1 trial the combination of ONCOS-102 and the anti-PD1 checkpoint inhibitor pembrolizumab has been tested in patients with advanced, unresectable melanoma who have had disease progression despite treatment with anti-PD1 checkpoint inhibitor. This is a particularly challenging patient population, which is refractory to approved immunotherapies and has few treatment alternatives available. Targovax's lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system. On the back of very encouraging data in several indications, in monotherapy and in multiple combination, the planned development steps for ONCOS-102 is a registrational-directed trial in checkpoint inhibitor refractory melanoma. Tillkännagivande • Feb 24
Continued Survival Benefit in Targovax's ONCOS-102 Trial in Mesothelioma At the 21-Month Follow-Up Targovax ASA announced 21-month follow-up data from the randomized phase I/II trial of ONCOS-102 in combination with standard of care chemotherapy in malignant pleural mesothelioma (MPM). The trial is an open label, exploratory phase I/II trial adding ONCOS-102 to standard of care (SoC) chemotherapy (pemetrexed/cisplatin) in first and second (and later) line MPM to assess safety, immune activation and clinical efficacy vs SoC only. In total, 31 patients have been treated in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and chemotherapy combination, and 11 patients in a control group receiving chemotherapy only. The 31 patients have now completed the 21-month follow-up. Immunological data and 12-month survival rate were reported in June 2020. and 18-month survival follow-up in November 2020. At the 21-month follow-up, half of the patients in the first-line ONCOS-102-treated group of the randomized part of the trial were still alive, and mOS was not yet reached. Based on current survival data mOS will be 20.5 months or longer. For the first-line SoC-only control group mOS is 13.5 months, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment. Analyst Estimate Surprise Post Earnings • Feb 20
Revenue misses expectations Revenue missed analyst estimates by 87%. Over the next year, revenue is forecast to grow 958%, compared to a 50% growth forecast for the Biotechs industry in Germany. Tillkännagivande • Feb 16
Targovax ASA Receives Fast-Track Designation for ONCOS-102 Targovax ASA announced that its lead clinical candidate ONCOS-102 has received Fast-Track designation in malignant pleural mesothelioma from the US FDA. The US FDA granted Fast-Track designation to ONCOS-102 based on encouraging pre-clinical and clinical efficacy associated with broad immune activation observed to date. Receiving this designation is an endorsement by the US FDA of the strength of the ONCOS-102 data package. The FDA Fast Track-designation is awarded to therapies with potential to address unmet medical needs in serious medical conditions and allows for more frequent interactions with the FDA to expedite clinical development, as well as the regulatory review processes. Fast-Track products have improved likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application early to shorten review time. The Fast-Track approval comes in addition to ONCOS-102´s existing Orphan Drug Designation (ODD) with both the US FDA and European EMA in the mesothelioma indication, which provides ONCOS-102 market exclusivity for 7 and 10 years in the USA and EU, respectively, from the date of BLA grant. Tillkännagivande • Jan 06
Targovax grants IOVaxis 3 months extension to the exclusive license option for TG mutant RAS vaccines in Greater China and Singapore Targovax ASA announced that it has granted an extension of 3 months to the exclusive option agreement with IOVaxis Therapeutics of Nantong, China, for clinical development and licensing of the Targovax mutant RAS vaccines TG01 and TG02 in China, Hong Kong, Macau and Singapore. On 8 January 2020 Targovax and IOVaxis announced that they had entered into an exclusive option agreement with 12-month validity for the development and commercialization of Targovax's TG vaccines in Greater China and Singapore. Is New 90 Day High Low • Dec 29
New 90-day high: €1.02 The company is up 42% from its price of €0.72 on 30 September 2020. The German market is up 9.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 6.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Dec 04
New 90-day high: €0.86 The company is up 39% from its price of €0.62 on 04 September 2020. The German market is up 4.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Tillkännagivande • Nov 26
Targovax ASA Demonstrates Encouraging Survival Data for Oncos-102 in Mesothelioma Targovax ASA releases 18-month follow-up data from the randomized phase I/II trial of ONCOS-102 in combination with standard-of-care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM). The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. In total, 31 patients have been included in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and SoC combination (8 randomized in first-line), and 11 patients in the control group receiving SoC only (6 in first-line). At the 18-month follow-up, more than half of the patients in the first-line ONCOS-102-treated group were still alive, and the mOS was not yet reached. Based on current survival data the mOS will be 18.2 months or longer. For the first -line SoC-only control group, less than half of the patients were alive, and mOS will be 14.2 months or less, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment. An analysis of all the first-line patients, including 3 experimental safety lead-in patients, shows similar results as the randomized first-line patients. The next survival analysis is planned in first half of 2021. In June, it was reported that ONCOS-102 treatment induces broad and powerful immune activation in MPM, far beyond what is achieved with SoC alone. Importantly, this immune activation is associated with better survival outcomes at the 18-month analysis, indicating that the immunological activity of ONCOS -102 drives the observed clinical benefit. Analyst Estimate Surprise Post Earnings • Nov 07
Revenue in line with expectations Revenue was in line with analyst estimates. Over the next year, revenue is forecast to grow 116%, compared to a 321% growth forecast for the Biotechs industry in Germany. Tillkännagivande • Oct 29
Targovax Announces Formation of New Scientific Advisory Board Targovax ASA announced the formation of a new Scientific Advisory Board (SAB). The SAB consists of a group of world-renowned experts in immuno-oncology research and drug development carefully selected to act as advisors to guide the Targovax R&D strategy. The SAB will be comprised of the following members: Raphael Clynes, MD, PhD. Dmitriy Zamarin, MD, PhD: Dr. Zamarin is an Assistant Attending Physician and Translational Research Director in the Gynecologic Medical Oncology Service at the Memorial Sloan Kettering Cancer Center. Dean A. Fennell, FRCP, PhD. Is New 90 Day High Low • Oct 22
New 90-day low: €0.57 The company is down 2.0% from its price of €0.58 on 24 July 2020. The German market is down 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 15% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Tillkännagivande • Oct 16
Targovax ASA has completed a Follow-on Equity Offering in the amount of NOK 75.000003 million. Targovax ASA has completed a Follow-on Equity Offering in the amount of NOK 75.000003 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 10,344,828
Price\Range: NOK 7.25 Tillkännagivande • Oct 13
Targovax ASA Announces ONCOS-102 and Durvalumab Trial Successfully Completes Part 1 in Colorectal Cancer Targovax ASA announced that the colorectal cancer cohort in part 1 of the ONCOS-102 and durvalumab trial in colorectal and platinum-resistant ovarian cancer that has spread to the peritoneum has met the pre-defined efficacy threshold of patients without progression at the end of week 24. The second part of the colorectal expansion cohort is now open for recruitment. The study is an open label, exploratory phase I/II trial assessing the combination of intra-peritoneally delivered ONCOS-102 in combination with systemically administered durvalumab, an anti-PD-L1 checkpoint inhibitor, in patients with colorectal (CRC) or platinum-resistant ovarian (OC) cancers that have metastasized to the peritoneal cavity. The trial is designed with a dose-escalation phase assessing three different dosing levels, followed by an expansion phase split into separate CRC and OC cohorts. The expansion phase is divided into two parts, where the second part is opened only if a pre-defined efficacy threshold is met in the first part. The efficacy threshold in the CRC cohort is 1 out of 13 patients and 5 out of 18 patients in the OC cohort without progression at week 24. Ludwig Cancer Research, the trial sponsor, and the investigators have reviewed the available data in part 1 of the expansion phase and concluded that the threshold has been met in the CRC cohort. The second part of the CRC cohort has therefore been opened for recruitment with the aim of enrolling 14 additional patients. For OC, threshold was not met, and this cohort has been closed for further recruitment. Dr. Dmitriy Zamarin, Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSK), Investigator at the Ludwig Center at MSK and Principal Investigator of the study, said: Chemotherapy-resistant microsatellite-stable colorectal cancer is a challenging disease to treat, with a response rate to immune checkpoint inhibitor monotherapy of less than 5%. They are hopeful that the immune activation by ONCOS-102 in peritoneal cavity may sensitize these tumors to immune checkpoint inhibition and improve this response rate. Is New 90 Day High Low • Sep 24
New 90-day high: €0.72 The company is up 9.0% from its price of €0.66 on 26 June 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. 
