View ValuationSaniona 향후 성장Future 기준 점검 0/6Saniona의 수익이 연간 14.4%로 감소할 것으로 예상됨입니다.핵심 정보n/a이익 성장률n/aEPS 성장률Biotechs 이익 성장23.7%매출 성장률-14.4%향후 자기자본이익률n/a애널리스트 커버리지Low마지막 업데이트28 May 2026최근 향후 성장 업데이트업데이트 없음모든 업데이트 보기Recent updatesReported Earnings • May 26First quarter 2026 earnings released: kr0.33 loss per share (vs kr0.17 profit in 1Q 2025)First quarter 2026 results: kr0.33 loss per share (down from kr0.17 profit in 1Q 2025). Revenue: kr4.69m (down 52% from 1Q 2025). Net loss: kr46.2m (down 344% from profit in 1Q 2025). Revenue is expected to decline by 4.8% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Europe are expected to grow by 15%. Over the last 3 years on average, earnings per share has increased by 98% per year but the company’s share price has only increased by 33% per year, which means it is significantly lagging earnings growth.공고 • Nov 27+ 3 more updatesSaniona AB (publ) to Report Q3, 2026 Results on Nov 26, 2026Saniona AB (publ) announced that they will report Q3, 2026 results at 8:00 AM, Central European Standard Time on Nov 26, 2026공고 • Nov 07Saniona AB (publ), Annual General Meeting, May 27, 2026Saniona AB (publ), Annual General Meeting, May 27, 2026. Location: malmo Sweden공고 • May 29Saniona AB (Publ) Announces Board ChangesSaniona AB (publ) announced that at its AGM held on May 28, 2025 approved John Haurum was elected as new chairman of the board and Jørgen Drejer was elected as new deputy chairman of the board. The previous board member Pierandrea Muglia was not available for re-election.공고 • Mar 12Saniona AB (Publ) Appoints Pierandrea Muglia as Chief Medical OfficerSaniona AB (publ) has appointed Pierandrea Muglia, M.D., as Chief Medical Officer, bringing over three decades of expertise from large international pharmaceutical companies, biotech and neuroscience research. A board member since 2023, Muglia has seen Saniona's pipeline grow and its partnerships, like the $610 million deal with Acadia Pharmaceuticals, thrive. Now, he'll steer the company's clinical and regulatory efforts as it prepares three candidates for phase II trials.공고 • Mar 03Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly San711) Phase 1 StudyAcadia Pharmaceuticals Inc. and Saniona announced the successful completion of the two originally planned cohorts in their Phase 1 multiple-ascending-dose MAD study (EUCT: 2024-514514-12-00) of ACP-711, formerly SAN711, in healthy volunteers. In the study, ACP-711 was safe and generally well tolerated across all dosing cohorts. There were no serious adverse events, and all participants completed the study. Most adverse events were mild. No safety laboratory concerns, cardiovascular concerns, or abnormal neurological findings were observed. Given the favorable safety and tolerability profile and the prioritization of essential tremor as the lead indication, Acadia Pharmaceuticals and Saniona are seeking regulatory approval to evaluate ACP-711 in elderly healthy volunteers and to test higher repeated doses. To enable this extension, the study has been temporarily paused until regulatory approval.공고 • Jan 11Saniona AB (publ), Annual General Meeting, May 28, 2025Saniona AB (publ), Annual General Meeting, May 28, 2025.공고 • Nov 28+ 4 more updatesSaniona AB (publ) to Report Q2, 2025 Results on Aug 28, 2025Saniona AB (publ) announced that they will report Q2, 2025 results at 8:00 AM, Central European Standard Time on Aug 28, 2025공고 • Oct 07Saniona Initiates SAN711 Biomarker StudySaniona announced that it has dosed the first subjects with SAN711 in a Phase 1 multiple ascending dose (MAD)/biomarker study. This marks a significant milestone that put the foundation for launching a clinical proof-of-concept study in children with absence seizures, scheduled for 2025. Topline data from the Phase 1 study is anticipated by the end of 2024. This Phase 1 MAD/biomarker study will investigate three critical aspects to inform future clinical trials: the effect of food intake on SAN711 dosing, the safety and tolerability as well as the potential benefits of higher doses using clinically relevant pharmacodynamic biomarkers. These insights will refine the dosing strategy for future patient studies as the Phase 1 MAD/biomarker study will assess the safety, tolerability, and pharmacokinetics of SAN711 in higher doses than those used in the previous Phase 1 study, while gathering data on food interactions and the drug's pharmacodynamic effects on EEG during both awake and sleep states in healthy volunteers. Saniona’s earlier Phase 1 study demonstrated excellent tolerability and indicated potential therapeutic benefit at relevant clinical plasma concentrations. The current study builds on these findings by exploring whether higher doses can offer even greater potential without compromising safety. Additionally, preclinical data suggests that SAN711 selective pharmacology modulates certain brain circuits, which can be detected via EEG measurements during both awake and sleep states. This not only serves as a functional biomarker of SAN711’s activity in the brain but may also indicate potential benefits for patients in future studies. The study is being conducted in collaboration with Evotec at the Clinical Research Centre (CRC) of the University Hospital in Verona, Italy. Both Evotec and CRC bring extensive expertise in neurological and psychiatric clinical research, which will support the successful execution of the study.공고 • Sep 18Saniona Receives Regulatory Approval for San711 Biomarker StudySaniona announced that it has been granted approval to begin a Phase 1 multiple ascending dose (MAD)/biomarker study in adults for SAN711. This study is a key step towards launching a clinical proof-of-concept study in children with absence seizures, scheduled for 2025. The Phase 1 MAD/biomarker study will assess the safety, tolerability, and pharmacokinetics of higher SAN711 doses in a multiple-dose setting. It will also gather data on food interactions and the drug's pharmacodynamic effects on EEG during both awake and sleep states in healthy volunteers. The biomarker data can provide evidence of SAN711's central pharmacological activity, aiding in defining the dosing strategy for future patient studies. This information, combined with receptor occupancy data from a prior PET study, will guide the next steps. Saniona is conducting this study in collaboration with Evotec at the Clinical Research Centre of the University Hospital in Verona, Italy. Evotec and CRC bring extensive experience in neurological and psychiatric clinical research, enhancing the study's execution. Additionally, Saniona is conducting a preclinical juvenile toxicity study and physiologically based pharmacokinetic modeling to translate adult Phase 1 data into appropriate dosing for children.New Risk • Sep 02New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr76m 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 (-kr76m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (73% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (kr34m net loss next year). Revenue is less than US$5m (kr25m revenue, or US$2.4m). Market cap is less than US$100m (€41.9m market cap, or US$46.4m).Reported Earnings • Sep 01Second quarter 2024 earnings released: kr0.18 loss per share (vs kr0.34 loss in 2Q 2023)Second quarter 2024 results: kr0.18 loss per share (improved from kr0.34 loss in 2Q 2023). Revenue: kr8.02m (up 108% from 2Q 2023). Net loss: kr19.7m (loss narrowed 7.1% from 2Q 2023). Revenue is forecast to grow 36% p.a. on average during the next 2 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 58% per year but the company’s share price has fallen by 41% per year, which means it is significantly lagging earnings.New Risk • Jun 07New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Shareholders have been substantially diluted in the past year (78% increase in shares outstanding). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr80m). Currently unprofitable and not forecast to become profitable next year (kr38m net loss next year). Revenue is less than US$5m (kr21m revenue, or US$2.0m). Market cap is less than US$100m (€29.9m market cap, or US$32.4m).Reported Earnings • May 30First quarter 2024 earnings released: kr0.08 loss per share (vs kr0.35 loss in 1Q 2023)First quarter 2024 results: kr0.08 loss per share (improved from kr0.35 loss in 1Q 2023). Revenue: kr6.03m (up 179% from 1Q 2023). Net loss: kr9.24m (loss narrowed 57% from 1Q 2023). Revenue is forecast to grow 41% p.a. on average during the next 2 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 44% per year but the company’s share price has fallen by 57% per year, which means it is significantly lagging earnings.공고 • Mar 01Saniona AB (publ) to Report Fiscal Year 2023 Results on Apr 30, 2024Saniona AB (publ) announced that they will report fiscal year 2023 results at 9:00 AM, Central European Standard Time on Apr 30, 2024New Risk • Mar 01New major risk - Negative shareholders equityThe company has negative equity. Total equity: -kr22m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Negative equity (-kr22m). Shareholders have been substantially diluted in the past year (78% increase in shares outstanding). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr86m). Currently unprofitable and not forecast to become profitable over next 2 years (kr60m net loss in 2 years). Revenue is less than US$5m (kr17m revenue, or US$1.6m). Market cap is less than US$100m (€19.9m market cap, or US$21.5m).Reported Earnings • Mar 01Full year 2023 earnings released: kr1.49 loss per share (vs kr3.93 loss in FY 2022)Full year 2023 results: kr1.49 loss per share (improved from kr3.93 loss in FY 2022). Revenue: kr16.8m (up 10% from FY 2022). Net loss: kr95.8m (loss narrowed 61% from FY 2022). Revenue is forecast to grow 22% p.a. on average during the next 2 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 25% per year but the company’s share price has fallen by 56% per year, which means it is significantly lagging earnings.공고 • Jan 02Saniona Announces the Selection of Its Proprietary GABAA A5 Negative Allosteric Modulator (NAM) Lead Compound, San2465Saniona announced the selection of its proprietary GABAA a5 Negative Allosteric Modulator (NAM) lead compound, SAN2465, as a clinical candidate for major depressive disorder. This decision follows encouraging results obtained from a rodent model, specifically the chronic mild stress model of depression. SAN2465 demonstrated rapid and sustained reversal of chronic stress-induced depressive-like symptoms, including anhedonia, anxiety, and cognitive impairment. This positions SAN2465 as an innovative and rapid-acting approach to treating major depressive disorder and its associated comorbidities. Originally discovered through collaboration with Boehringer Ingelheim for schizophrenia, SAN2465 is a highly potent and selective negative allosteric modulator of GABAA a5. Saniona holds exclusive global rights to the program following the termination of the collaboration with BoehringerIngelheim in November 2020. SAN2465 is now poised for pre-clinical development as a rapid-acting antidepressant for collaboration with a partner. SAN2465 was rigorously tested in the chronic mild stress model of Depression in the laboratory of Professor Mariusz Papp, Maj Institute of Pharmacology, Polish Academy of sciences, Krakow, Poland. The chronic mild stress model is widely acknowledged as the most valid animal model of depression with translational potential to human disease. Results indicate that a single oral treatment of SAN2465, administered 24 and 48 hours before testing, effectively reversed depressive-like symptoms, as assessed by stress-induced reduction of sucrose intake. Furthermore, SAN2465 reversed the anxiogenic-like behaviors and cognitive impairments induced by stress after a single oral treatment administered 48 hours and 72 hours before testing, respectively. Importantly, the onset and robustness of the effect are comparable to the NMDA antagonist ketamine, suggesting a potential new mechanism of action with a differentiated side effect profile. The rapid antidepressant effect of esketamine is believed to stem from fast onset neuroplastic changes in molecular signaling cascades in relevant brain regions. Similar changes have been observed through pharmacological negative allosteric modulation of the GABAA a5 receptors in rodent studies suggesting that this mechanism could have a comparable rapid antidepressant effect in humans. Importantly, unlike NMDA receptor blockade with esketamine, negative modulation of GABAA a5 receptors is not anticipated to lead to significant adverse effects, as the expression of these receptors is more localized and mainly restricted to limbic areas. Use of esketamine is restricted by a Risk Evaluation and Mitigation Strategy (REMS) Program.공고 • Dec 27Saniona AB (publ) Strengthens Epilepsy Pipeline with Selection of SAN2355 as Clinical CandidateSaniona AB (publ) announced that it marks a significant epilepsy pipeline milestone by selecting SAN2355 as the first clinical candidate from its Kv7 epilepsy program. SAN2355, a subtype-selective activator of Kv7.2/Kv7.3 channels, represents a promising new generation of effective and well-tolerated epilepsy medicines. Having successfully passed critical candidate selection steps and secured a favorable opinion from the European Patent Office (EPO), Saniona is poised to advance SAN2355 into the preclinical development phase. Epilepsy, a brain disorder characterized by recurrent seizures, affects millions of people worldwide. Approximately 30% of patients are unresponsive to current medicines, emphasizing a substantial unmet need in the field. Kv7 channels play a crucial role in mediating potassium ion transport across the cell membrane of neurons, reducing the likelihood of generating uncontrolled bursts of nerve impulses. The Kv7 channel family comprises five subtypes, with channels consisting of Kv7.2 and Kv7.3 subunits selectively expressed in the brain. Activators of Kv7.2 and Kv7.3 channels effectively dampen overactive neurons, aiding in the prevention of epileptic seizures. Mutations in the Kv7.2 and Kv7.3 subunits are the second most common cause of inherited, severe childhood epilepsies, underscoring the importance of Kv7.2/Kv7.3 channels in controlling nerve cell activity. The non-selective Kv7 activator retigabine has provided clinical and commercial proof-of-concept for treating patients with resistant focal onset seizures. However, it has been withdrawn from the market due to compound-specific and non-target-related side effects.Reported Earnings • Dec 01Third quarter 2023 earnings released: kr0.38 loss per share (vs kr0.28 profit in 3Q 2022)Third quarter 2023 results: kr0.38 loss per share (down from kr0.28 profit in 3Q 2022). Revenue: kr5.45m (up 128% from 3Q 2022). Net loss: kr24.1m (down 238% from profit in 3Q 2022). Revenue is forecast to grow 60% p.a. on average during the next 2 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 37% per year, which means it is significantly lagging earnings.공고 • Nov 30+ 4 more updatesSaniona AB (publ) to Report Fiscal Year 2024 Results on Feb 27, 2025Saniona AB (publ) announced that they will report fiscal year 2024 results at 8:00 AM, Central European Standard Time on Feb 27, 2025공고 • Nov 29Saniona AB (publ) Announces Composition of Nomination CommitteeSaniona AB (publ) announced the composition of the Nomination Committee for the Annual General Meeting 2024. Pursuant to the instruction and charter for the Nomination Committee adopted by the general meeting, the Nomination Committee shall comprise of three members, which shall be the Chairman of the Board of Directors and two members appointed by the two larger shareholders as of last September. On September 30, 2023, the two larger shareholders, who desired to appoint a representative to the Nomination Committee, were Jørgen Drejer and Dan Peters. Each such shareholder has appointed a representative, as shown below, who together with the Chairman of the Board of Directors will form Saniona AB’s Nomination Committee. The Nomination Committee’s members are: John Haurum, professional board member for life science companies and former CEO of F-star Biotechnology Limited, Cambridge, UK, appointed by Jørgen Drejer; Søren Skjærbæk, Partner at Ursus law firm, Vejle, Denmark, appointed by Dan Peters; Jørgen Drejer, Chairman of Saniona AB’s Board. Søren Skjærbæk has been appointed as Chairman of the Nomination Committee. The Nomination Committee shall prepare and submit proposals to the Annual General Meeting 2024.공고 • Nov 22Saniona Promotes Kv7 Epilepsy Compound to Candidate Selection PhaseSaniona AB (publ) announced that it has initiated the candidate selection phase with a proprietary subtype selective frontrunner molecule from the Kv7 lead optimization program for epilepsy. The compound has a unique selectivity profile and represents a potential new generation of effective and well tolerated epilepsy medicines. Epilepsy, a brain disorder characterized by recurrent seizures, affects millions of people worldwide. There is considerable unmet need since about 30% of the patients are unresponsive to current medicines. Kv7 channels mediate potassium ion transport across the cell membrane of neurons, which decreases the likelihood of generating uncontrolled nerve impulses. Activators of Kv7 channels are therefore very effective in dampening overactive neurons and thus prevent the generation of epileptic seizures. Mutations in Kv7 channels containing the Kv7.2 and Kv7.3 subunits are the second most common cause of inherited severe childhood epilepsies, which demonstrate their importance in controlling nerve cell activity. The non-selective Kv7 activator retigabine has provided both clinical and commercial proof-of-concept for treatment of patients with resistant focal onset seizures. Retigabine has also shown anti-epileptic effect and developmental improvement in smaller investigator-driven studies with children with loss-of-function mutations in Kv7.2. However, retigabine has been withdrawn from the market due to compound specific and non-target related side-effects. The Kv7 channel family comprise five subtypes, of which channels consisting of Kv7.2 and Kv7.3 subunits are selectively expressed in the brain. The Saniona program focuses on development of subtype selective Kv7.2/Kv7.3 activators, thus avoiding retigabine´s troublesome side effects on the CNS and urinary system, which caused a high drop-out rate in the clinical studies and eventually resulted in quite low adherence to the drug despite good efficacy.New Risk • Sep 01New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 13% 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 Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr101m). Currently unprofitable and not forecast to become profitable over next 2 years (kr54m net loss in 2 years). Shareholders have been diluted in the past year (2.8% increase in shares outstanding). Revenue is less than US$5m (kr12m revenue, or US$1.1m). Market cap is less than US$100m (€42.2m market cap, or US$45.6m).Reported Earnings • Sep 01Second quarter 2023 earnings released: kr0.34 loss per share (vs kr1.42 loss in 2Q 2022)Second quarter 2023 results: kr0.34 loss per share (improved from kr1.42 loss in 2Q 2022). Revenue: kr3.85m (up 30% from 2Q 2022). Net loss: kr21.2m (loss narrowed 76% from 2Q 2022). Revenue is expected to decline by 6.2% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 15%. Over the last 3 years on average, earnings per share has fallen by 18% per year but the company’s share price has fallen by 39% per year, which means it is performing significantly worse than earnings.New Risk • Aug 20New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.8% This is considered a minor 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 (12% average weekly change). Revenue is less than US$1m (kr11m revenue, or US$985k). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr212m). Currently unprofitable and not forecast to become profitable over next 2 years (kr42m net loss in 2 years). Shareholders have been diluted in the past year (2.8% increase in shares outstanding). Market cap is less than US$100m (€38.0m market cap, or US$41.3m).Reported Earnings • May 26First quarter 2023 earnings released: kr0.35 loss per share (vs kr2.14 loss in 1Q 2022)First quarter 2023 results: kr0.35 loss per share (improved from kr2.14 loss in 1Q 2022). Revenue: kr2.16m (down 67% from 1Q 2022). Net loss: kr21.7m (loss narrowed 84% from 1Q 2022). Revenue is forecast to grow 74% p.a. on average during the next 2 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 43% per year whereas the company’s share price has fallen by 41% per year.Reported Earnings • Feb 24Full year 2022 earnings released: kr3.93 loss per share (vs kr6.59 loss in FY 2021)Full year 2022 results: kr3.93 loss per share (improved from kr6.59 loss in FY 2021). Revenue: kr15.3m (up 46% from FY 2021). Net loss: kr245.4m (loss narrowed 40% from FY 2021). Over the last 3 years on average, earnings per share has fallen by 53% per year whereas the company’s share price has fallen by 51% per year.공고 • Nov 26Saniona AB Appoints Nomination Committee for the Annual General Meeting 2023Saniona AB announced the composition of the Nomination Committee for the Annual General Meeting 2023. Pursuant to the instruction and charter for the Nomination Committee adopted by the general meeting, the Nomination Committee shall comprise of three members, which shall be the Chairman of the Board of Directors and two members appointed by the two largest shareholders as of last September. On September 30, 2022, the two largest shareholders, who desired to appoint a representative to the Nomination Committee, were Jørgen Drejer and Dan Peters. Each such shareholder has appointed a representative, as shown below, who together with the Chairman of the Board of Directors will form Saniona AB’s Nomination Committee. The Nomination Committee’s members are: John Haurum, professional board member for life science companies and former CEO of F-star Biotechnology Limited, Cambridge, UK, appointed by Jørgen Drejer Søren Skjærbæk, Partner at Ursus law firm, Vejle, Denmark, appointed by Dan Peters, Jørgen Drejer, Chairman of Saniona AB’s Board.Reported Earnings • Nov 18Third quarter 2022 earnings released: EPS: kr0.28 (vs kr1.50 loss in 3Q 2021)Third quarter 2022 results: EPS: kr0.28 (up from kr1.50 loss in 3Q 2021). Revenue: kr2.39m (up 5.5% from 3Q 2021). Net income: kr17.5m (up kr111.2m from 3Q 2021). Over the last 3 years on average, earnings per share has fallen by 52% per year whereas the company’s share price has fallen by 50% per year.공고 • Nov 17+ 3 more updatesSaniona AB (publ) to Report Q1, 2023 Results on May 25, 2023Saniona AB (publ) announced that they will report Q1, 2023 results at 8:00 AM, Central European Standard Time on May 25, 2023Board Change • Nov 16Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 1 highly experienced director. Independent Director Anna Ljung was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.공고 • Nov 03Saniona AB (publ) Announces Anti-Inflammatory and Anti-Fibrotic Candidate SAN903 Is Ready for Clinical StudiesSaniona AB (publ) announced that SAN903 is ready to start the regulatory process for entering Phase 1 clinical trials either by Saniona alone or together with a partner following successful completion of preclinical development.SAN903 is a novel, potential first-in-class medicine based on inhibition of the calcium-activated potassium ion channel, KCa3.1. This ion channel is found on several types of immune cells, where it participates in the control of the cellular pathways that maintain pathogenic activation and inflammation in chronic diseases. The KCa3.1 channel is also expressed on fibroblasts, especially on myofibroblasts, where it supports the overproduction of connective tissue that can lead to fibrosis. Prevention of fibrotic complications is an aspect of the disease, which is poorly treated by current standard-of-care IBD medicines, and progressed fibrosis often requires surgical intervention to resolve potentially life-threatening gut obstructions. SAN903 dampens inflammation and fibrosis by preventing cell division and cell migration of activated immune cells and fibroblast and by impeding cytokine release and collagen secretion of the respective cell types. Palle Christophersen, EVP Research, commented: I am incredibly happy that SAN903 – which is the result of a long and challenging drug discovery phase – has now successfully completed the preclinical development package and is ready for entering the clinical stages. Inflammatory bowel disease is a complex disease with a rather low initial responder rate and poorly controlled disease progression. Due to its new mode-of-action, I anticipate that the entry indication for SAN903 can be newly diagnosed, mild-to-moderate colitis patients that are failing first-line treatment with standard-of-care medicine. Due to the actions on both inflammatory and fibrotic processes, I hope that SAN903 can become the first maintenance drug, which effectively prevents development of intestinal fibrosis in patients suffering from inflammatory bowel disease.Reported Earnings • Aug 26Second quarter 2022 earnings released: kr1.42 loss per share (vs kr1.67 loss in 2Q 2021)Second quarter 2022 results: kr1.42 loss per share (up from kr1.67 loss in 2Q 2021). Net loss: kr88.6m (loss narrowed 15% from 2Q 2021). Over the last 3 years on average, earnings per share has fallen by 55% per year but the company’s share price has only fallen by 37% per year, which means it has not declined as severely as earnings.공고 • Aug 17Saniona Progresses Its Kv7 Epilepsy Program into Lead OptimizationSaniona announced that it has progressed its promising Kv7 epilepsy program into the Lead Optimization Phase, which is the last drug discovery phase before potential selection of a clinical candidate. Epilepsy, characterized by recurrent seizures, currently affects millions of people worldwide. There is a significant medical need as approximately 30% of patients are insensitive to treatment by conventional epilepsy medicines. Furthermore, anti-seizure therepy may cause disabling side effects and often require careful dose adjustment to minimize these. Kv7 ion channels are voltage-activated potassium channels that play a critical role by dampening of repetitive firing of neurons, which potentially can lead to seizure activity. The special importance of the Kv7.2/Kv7.3 heteromeric channel within epilepsy is clearly illustrated by the increasing numbers of mutations in Kv7.2 andKv7.3 that are found to be associated with severe inherited forms of epilepsy. Thus, small molecule drugs that facilitate the opening of Kv7.2/Kv7.3 ion channels have potential to treat epilepsy as well as other neuronal hyperexcitability disorders. There is proof of concept for the use of Kv7 modulators for treatment of epilepsy as a relatively recently approved non- selective Kv7 anti-seizure drug, ezogabine (retigabine), has demonstrated strong anti-epilepticactivity. Unfortunately, this drug had to be withdrawn from the market due to serious adverse effects including skin discoloration, retinal changes, and increased risk of urinary retention, a potentially life-threatening condition. The skin discoloration and retinal changes are caused by ezogabine’s chemical instability and not by the compound’s mode-of-action, whereas the increased risk of urinary retention is believed to be due to the non-selective profile of ezogabine leading to unintentional activation of Kv7 subtypes expressed in the bladder. Several companies and academic groups have over the past decade worked on developing a next generation drugcandidate avoiding the limitations and tolerability issues with ezogabine. Saniona scientists have been active in the Kv7 drug discovery field for more than a decade and have worked in previous Kv7 Pharma partnership programs. Saniona has now managed to progress into lead optimization stage with a new chemical series that circumvent limitations with first generation drug candidates. The main features of these new Kv7 activators are improved chemical stability as well as differentiation in selectivity and mechanism-of-action, which can eliminate relaxation of bladder tissue. The objective of the lead optimization program is thus to develop a second generation Kv7 medicine without the side effects that led to the withdrawal of exogabine from the market.공고 • Jul 01Saniona Reports Positive Top Line Results from the SAN711 Phase 1 Clinical TrialSaniona announced that it has successfully completed its Phase 1 clinical trial of SAN711, which is positioned for the treatment of neuropathic pain disorders. Data from the trial demonstrated that SAN711 was safe and well tolerated across all dosing cohorts with a favorable absorption and distribution profile. There were no serious adverse events, and all subjects completed the study. Long term dosing with SAN711 at a well tolerated dose of 0.8 mg twice a day resulted in 24- hour receptor occupancy ranging between 50% and 72% assessed to lead to desired pharmacological effects. The results of this Phase 1 clinical trial open the path for continued clinical development of SAN711. The Phase 1 clinical trial was conducted in 66 healthy volunteers. The primary objective of the study was to determine the safety and tolerability of SAN711, which was evaluated through single ascending dose and multiple ascending dose phases of the study. The secondary objective was to measure binding to target receptors, which was assessed during a positron emission tomography (PET) evaluation phase of the study. The clinical trial was conducted in the United Kingdom (U.K.) under the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA). SAN711 was safe and well tolerated across all dosing cohorts. There were no serious adverse events, and all subjects completed the study. Adverse events were mostly mild, and the few adverse events of moderate intensity were, apart from two, assessed to be non-related to drug administration. There were no safety laboratory concerns, cardiovascular concerns, and no abnormal neurological examinations, including Mini Mental State Examinations. SAN711 was absorbed rapidly following single oral doses of 0.1 to 2.25 mg/kg (mean T max of 0.75 h - 2.08 h). Linear pharmacokinetics was observed and the mean half-life for elimination (T½) ranged between 7.4 and 12.3 h over all dose levels. Maximum plasma levels of SAN711 reached up to 1577 ng/ml corresponding to 84% occupancy of all target receptors. PET results confirmed the hypothesis that a pharmacologically active receptor occupancy may be achieved at well-tolerated doses of SAN711. In the multiple ascending dose phase, a well tolerated dose of 0.8 mg/kg twice daily led to plasma levels consistent with 24-hour receptor occupancy ranging from 50% to 72%. Based on pre-clinical data, this exposure level is predicted to result in desired therapeutic effects.Board Change • Jun 29Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 1 highly experienced director. Independent Director Anna Ljung was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.공고 • Jun 25Saniona’S Preclinical Candidate San903 Shows Robust Dampening of Fibrosis in Chronic Kidney Disease ModelSaniona announced that professor Helle Prætorius, Univ. of Aarhus, Denmark, made a presentation at the ECM conference,2022, which shows that SAN903 protects against fibrosisin a chronic kindneydease model. Chronic kidney disease (CKD) is a devastating, progressive deterioration of renal function that significantly impacts the quality of life for the individual and represents a substantial cost for the society. Regardless of the cause of CKD, renal fibrosis is a major component of the disease and is the best predictor of progression to CKD-associated renal failure. Saniona’s collaborator professor Helle Prætorius, MD-PhD, Univ. of Århus, Denmark demonstrated in her presentation that Saniona’s KCa3.1 inhibitor SAN903 dampened renal fibrosis in a mouse model of CKD. When SAN903 was administrated daily during unilateral urinary obstruction the total fibrotic area was reduced by up to 43% (p>0.0001). SAN903 was well tolerated at all doses. SAN903 is a novel, potential first-in-class medicine based on inhibition of the calcium-activated potassium ion channel, KCa3.1. This ion channel is found in immune cells and fibroblasts where it participates in the control of cell proliferation and migration as well as cytokine and collagen production. Previous studies have indicated that KCa3.1 inhibition may reduce inflammation and fibrosis in various diseases. Saniona expects to complete regulatory preclinical development mid 2022 and to initiate Phase 1 clinical trials end 2022 or early 2023.공고 • May 21Saniona Provides Update on Ongoing Review of Tesofensine in MexicoSaniona announced that the Mexican regulatory authority Comisión Federal para la Protección contra RiesgosSanitarios (COFEPRIS) has published on Twitter that its technical committee on new molecules (El Comité de MoléculasNuevas) was unable to provide a favorable opinion on tesofensine following a meeting held on May 18, 2022. The statement on Twitter does not provide any details or explanation for the position taken. As part of the ongoing review process, the tesofensine application was reviewed by a COFEPRIS technical committee on new molecules on May 18, 2022. Saniona’s partner Productos Medix, S. A de S.V, (Medix) has not received any official statement from COFEPRIS yet. Therefore, Medix is not able to comment on this statement and the possible implication for pursuing the process of seeking approval for tesofensine in Mexico.공고 • Apr 26+ 2 more updatesSaniona Appoints Anita Milland as Chief Financial Officer, Effective April 30, 2022Saniona announced that it will refocus its strategy on ion channel research and development (R&D) and, as a result, further streamline its operations. Effective April 30, 2022, Anita Milland will become the Chief Financial Officer (CFO). Anita Milland is currently VP Finance & Adminstration at Saniona and served as interim CFO at Saniona during 2020.공고 • Mar 31+ 1 more updateSaniona Announces Voluntary Pause of Phase 2B Clinical Trials of Tesomet for Hypothalamic Obesity and Prader-Willi SyndromeThe board of Saniona has resolved to implement multiple actions including a voluntary pause of the Phase 2b clinical trials of Tesomet for hypothalamic obesity (HO) and Prader-Willi syndrome (PWS) and a workforce reduction of approximately 30%. The decision to voluntarily pause the Phase 2b clinical trials of Tesomet is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The decision to voluntarily pause the Phase 2b clinical trials of Tesomet for HO and PWS is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The Tesomet programs previously achieved highly encouraging results in initial Phase 2 trials, and the international Phase 2b trials were by far the largest expenditure for the company. Saniona will continue its ongoing Phase 1 clinical trial of SAN711, which is expected to deliver data by the end of the first half of 2022. The company will also continue to invest in its ion channel drug discovery engine, including SAN903, which is expected to enter Phase 1 clinical trials in the second half of 2022, and discovery research efforts, which are expected to result in a new ion channel modulator advancing into the preclinical pipeline in 2022. Saniona will also continue to pursue strategic financing options and expand its business development efforts to include opportunities that could allow Tesomet to advance.Reported Earnings • Feb 25Full year 2021 earnings: EPS in line with expectations, revenues disappointFull year 2021 results: kr6.59 loss per share (down from kr1.79 loss in FY 2020). Net loss: kr410.9m (loss widened 460% from FY 2020). Revenue missed analyst estimates by 46%. Over the last 3 years on average, earnings per share has fallen by 41% per year whereas the company’s share price has fallen by 39% per year.공고 • Feb 25Saniona AB (publ) to Report Fiscal Year 2021 Final Results on Apr 29, 2022Saniona AB (publ) announced that they will report fiscal year 2021 final results at 8:00 AM, Central European Standard Time on Apr 29, 2022공고 • Feb 11Saniona Initiates Multiple Ascending Dose Stage of SAN711 Phase 1 Clinical TrialSaniona provided an update on progress in its Phase 1 clinical trial of SAN711. The company reported that it has now also initiated the multiple ascending dose stage of the trial. The study is placebo-controlled, and the data remain blinded. Saniona continues to expect data from the trialby the end of the first half of 2022. The Phase 1 clinical trial is a randomized, placebo-controlled study being conducted in approximately 80 healthy volunteers. The primary objective of the study is to determine the tolerability and the maximum tolerated dose of SAN711, as evaluated through the single ascending dose and multiple ascending dose phases of the study. The secondary objective is to measure binding to target receptors, as assessed during a positron emission tomography (PET) evaluation phase of the study. SAN711 is an investigational, potential first-in-class positive allosteric modulator of GABA-A a3 receptors and may be applicable in the treatment of rare neuropathic disorders. It is the first novel molecule derived from Saniona’s proprietary ion channel drug discovery engine to be advanced into internal clinical trials.공고 • Dec 29Saniona Initiates Phase 2b Clinical Trial of Tesomet for Prader-Willi SyndromeSaniona announced the initiation of a Phase 2b clinical trial of Tesomet in patients with Prader-Willi syndrome (PWS). Tesomet is an investigational fixed-dose combination therapy of tesofensine, a triple monoamine reuptake inhibitor, and metoprolol, a beta-1 selective blocker. Data from the trial are expected in the first half of 2023. The Phase 2b clinical trial in PWS includes a randomized, double-blind, placebo-controlled 16-week treatment period followed by a 36-week open-label extension period. The trial is expected to enroll approximately 120 patients with genetically-confirmed PWS. Initially, the trial will enroll adults (18 to 65 years of age) and then, following confirmation by the data monitoring committee and by the FDA, the trial is planned to expand into adolescents (13 to 17 years of age). During the 16-week double-blind period, participants will be randomized to receive daily dosing with Tesomet at one of three dose levels or a placebo. During the 36-week open-label extension period, participants who wish to continue treatment, including those who originally received placebo, will receive the highest tolerated dose of Tesomet as established during the double-blind period. The primary objective of the study will be change in hyperphagia at week 16 as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), a caregiver-reported survey that evaluates food-seeking behavior, such as frequency of sneaking food or time spent talking about food, and which has been used as the primary outcome measure for most PWS clinical trials. Secondary endpoints include change in body weight, change in caregiver impression of hyperphagia, change in clinician impression of overall disease severity, and change in clinician impression of overall clinical status. The clinical trial is being conducted at multiple sites around the world including in the United States, New Zealand, Australia, and in multiple countries in Europe including the United Kingdom, Sweden, Italy, Spain and others.Reported Earnings • Nov 19Third quarter 2021 earnings released: kr1.50 loss per share (vs kr1.24 loss in 3Q 2020)Third quarter 2021 results: Net loss: kr93.7m (loss widened 78% from 3Q 2020).Reported Earnings • Aug 27Second quarter 2021 earnings released: kr1.67 loss per share (vs kr1.24 loss in 2Q 2020)Second quarter 2021 results: Net loss: kr103.9m (loss widened 185% from 2Q 2020).공고 • Jul 01Saniona Initiates Phase 1 Clinical Trial of SAN711Saniona announced that it has dosed the first patientin a Phase 1 clinical trial of SAN711, a novel molecule derived from Saniona’s proprietary ion channel drug discovery engine. SAN711 is a first-in-class positive allosteric modulator of GABA-A a3 receptors and may be applicable in the treatment of rare neuropathic disorders. Data from the trial are expected in the first half of 2022. The Phase 1 clinical trial will be conducted in approximately 80 healthy volunteers. The primary objective of the study is to determine the tolerability and the maximum tolerated dose of SAN711, which will be evaluated through single ascending dose and multiple ascending dose phases of the study. The secondary objective is to measure binding to target receptors, which will be assessed during a positron emission tomography (PET) evaluation phase of the study. The clinical trial is being conducted in the United Kingdom (U.K.) under the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA). After completion of the Phase 1 clinical trial, Saniona intends to select a lead indication and file an Investigational New Drug (IND) application with the United States Food & Drug Administration (U.S. FDA) to support Phase 2 studies for SAN711 in the U.S.공고 • Jun 09Saniona to Present Preclinical Data on SAN711 at the 7th Congress of the European Academy of NeurologySaniona announced it will present preclinical data on SAN711 in a model of facial neuropathic painat the 7thCongress of the European Academy of Neurology (EAN), which is being held virtually June 19 - 22, 2021. SAN711 is a first-in-class positive allosteric modulator of GABA-A a3 that was designed using Saniona’s ion channel drug discovery engine. While existing molecules target all GABA-A receptors indiscriminately, SAN711 selectively enhances the effects of GABA-A on a3 containing receptors. Preclinical studies have indicated that this selectivity may allow SAN711 to provide pain relief and other benefits in the central nervous system while avoiding the typical adverse effects associated with non-selective GABA-A activation such as sedation, motor instability, cognitive impairment, abuse liability and physical dependence.Reported Earnings • May 28First quarter 2021 earnings released: kr1.34 loss per share (vs kr1.47 profit in 1Q 2020)First quarter 2021 results: Net loss: kr83.4m (down 293% from profit in 1Q 2020).Reported Earnings • Mar 18Full year 2020 earnings released: kr1.79 loss per share (vs kr2.95 loss in FY 2019)Full year 2020 results: Net loss: kr73.4m (loss narrowed 3.1% from FY 2019).공고 • Mar 09Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic ObesitySaniona announced it received feedback from the U.S. Food and Drug Administration (FDA) providing further clarity on a regulatory path for Tesomet in the treatment of hypothalamic obesity (HO). Based on this feedback, Saniona is proceeding with plans to initiate a Phase 2b study in HO in the first half of this year. Saniona previously announced that the FDA had highlighted the potential for off-label use of Tesomet in the general obese population. As a result, Saniona submitted a response proposing a Risk Evaluation and Mitigation Strategy (REMS), which is often used to restrict commercial distribution to the appropriate patients suffering from an unmet medical need. The FDA indicated overall agreement with this proposal and stated Saniona should demonstrate that HO fulfills the criteria for an unmet medical need. Saniona further proposed including 24-hour ambulatory blood pressure monitoring (ABPM) and Holter (electrocardiogram) monitoring as part of the HO program. The agency stated that robust data from these analyses could be useful in determining the level of cardiovascular assessment needed in Phase 3. The agency also acknowledged the challenge of conducting 24-hour monitoring in HO patients and said the analyses could be conducted in a separate study in general obese people.공고 • Mar 04Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi SyndromeSaniona announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Tesomet for the treatment of Prader-Willi syndrome (PWS). Saniona is preparing to initiate a Phase 2b study of Tesomet in PWS in the first half of this year. Orphan drug designation is a special status granted by the FDA to medicines and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. The number of patients with PWS is estimated to be between 11,000 and 34,000 in the U.S. and between 17,000 and 50,000 in Europe. Receiving orphan designation qualifies Saniona for certain development benefits, including tax credits, elimination of certain FDA license application fees, and seven years of market exclusivity in the U.S. following approval.Is New 90 Day High Low • Feb 11New 90-day low: €1.81The company is down 23% from its price of €2.35 on 13 November 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 10.0% over the same period.공고 • Jan 26Novartis AG (SWX:NOVN) completed the acquisition of Cadent Therapeutics, Inc. from a group of sellers.Novartis AG (SWX:NOVN) reached a definitive agreement to acquire Cadent Therapeutics, Inc. from a group of sellers for approximately $770 million on December 17, 2020. Upon closing of the agreement, Cadent will receive $210 million upfront payment and will be eligible for up to $560 million in milestone payments. The acquisition will give Novartis full rights to Cadent’s neuroscience portfolio, including its NMDAr program, which consists of two clinical programs CAD-9303, a NMDAr positive allosteric modulator and MIJ-821, a NMDAr negative allosteric modulator, which was licensed to Novartis in 2015. Additionally, Novartis will gain full rights to CAD-1883, a clinical stage SK channel positive allosteric modulator in development for movement disorders. The transaction is subject to customary closing conditions, including antitrust review pursuant to the Hart-Scott-Rodino premerger notification program. The transaction has been approved by the Board of Directors and stockholders of Cadent Therapeutics. The transaction is expected to be completed during first quarter of 2021. Novartis AG (SWX:NOVN) completed the acquisition of Cadent Therapeutics, Inc. from a group of sellers on January 25, 2021. Saniona AB (publ) (OM:SANION) sold approximately 3% stake in Cadent Therapeutics and received approximately $2.9 million (SEK 24.2 million) in an upfront payment.Is New 90 Day High Low • Jan 15New 90-day low: €1.97The company is down 19% from its price of €2.42 on 16 October 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period.공고 • Dec 23+ 1 more updateSaniona Announces Management AppointmentsSaniona AB (publ) announced the further expansion of its executive team with the appointments of Denelle Waynick as Chief Legal Officer and Kyle Haraldsen as Chief Technical Operations Officer. The positions will be based in the U.S. and will support Saniona's advancement of clinical trials for Tesomet and SAN711 as well as the company's growing U.S. presence. Denelle Waynick, Chief Legal Officer, has nearly 30 years of experience advising domestic and international companies in the healthcare and life sciences industries. Most recently, Waynick served as Chief Legal Officer and Corporate Secretary at MyoKardia, where she provided strategic and practical counsel to C-suite executives in legal matters, as well as issues impacted by the regulatory and policy environment. Kyle Haraldsen, Chief Technical Operations Officer, has nearly 20 years of technical operations and manufacturing experience in the biopharmaceutical industry, including in support of U.S. and E.U. product approvals. Most recently, he served as the Vice President of Technical Operations and Project Management at AMAG Pharmaceuticals, where he led the process and analytical development, manufacturing, supply chain and project management functions. Waynick and Haraldsen will serve on Saniona's executive committee and will report to President and CEO Rami Levin. Both positions will be based in Saniona's office in the Boston, Massachusetts-area, U.S. Waynick and Haraldsen will start in January 2021.Recent Insider Transactions • Dec 06Co-Founder recently bought €11k worth of stockOn the 30th of November, Jørgen Drejer bought around 5k shares on-market at roughly €2.25 per share. This was the largest purchase by an insider in the last 3 months. This was Jørgen's only on-market trade for the last 12 months.Is New 90 Day High Low • Dec 05New 90-day low: €2.07The company is down 18% from its price of €2.52 on 04 September 2020. The German market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 8.0% over the same period.Reported Earnings • Dec 03Third quarter 2020 earnings released: kr1.24 loss per shareThird quarter 2020 results: Net loss: kr52.7m (loss widened 90% from 3Q 2019).Reported Earnings • Dec 01Third quarter 2020 earnings released: kr1.24 loss per shareThird quarter 2020 results: Net loss: kr52.7m (loss widened 90% from 3Q 2019).공고 • Nov 30+ 3 more updatesSaniona AB (publ) to Report Fiscal Year 2021 Results on Feb 24, 2022Saniona AB (publ) announced that they will report fiscal year 2021 results at 8:00 AM, Central European Standard Time on Feb 24, 2022공고 • Nov 27+ 1 more updateSaniona AB (publ) Appoints Nomination Committee MembersSaniona AB (publ) announced that together with the Chairman of the Board of Directors will form Saniona AB’s Nomination Committee, the Nomination Committee’s members are: Søren Skjærbæk, Partner at Ursus law firm, Vejle, Denmark, appointed by Jørgen Drejer and John Haurum, professional board member for life science companies and former CEO of F-star Biotechnology Limited, Cambridge, UK, appointed by New Leaf Venture Partners.공고 • Nov 25Saniona Reports Positive Topline Results from Tesomet Phase 2 Open-Label Extension Study in Hypothalamic ObesitySaniona announced positive top-line results from the Phase 2 open-label extension study of Tesomet in patients with hypothalamic obesity (HO). Patients treated with Tesomet for nearly one year (24 week double-blind [DB] followed by 24 week open label extension [OLE]) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control. No clinically meaningful differences in heart rate or blood pressure were observed over the course of the trial. Highlights from top-line open-label extension study data include: Safety: The primary endpoint of the study was the overall safety and tolerability of Tesomet in patients with HO. Tesomet was shown to be well-tolerated. Side effects observed in the open-label extension (OLE) period of the study were generally mild and consistent with those observed in the double-blind (DB) period. The most common adverse events included dry mouth, joint pain, headache and dizziness. There were three events of palpitations in the placebo patients who were switched to Tesomet, and none in the group that received Tesomet for the full 48 weeks. There was one serious adverse event related to abdominal pain which spontaneously resolved. There were no clinically meaningful differences in heart rate or blood pressure observed over the nearly year-long study. All 18 patients who entered the OLE study completed it. Bodyweight: As previously reported, treatment with Tesomet led to a statistically significant 6.28% average reduction in bodyweight compared to placebo (p=0.0169) in the 24-week DB period of the study. This reduction was maintained through the 24-week OLE period, with these patients demonstrating a statistically significant 5.96% average reduction in bodyweight at Week 48 (p=0.008 vs baseline). Additionally, patients who received placebo during the DB period and were switched to Tesomet at Week 24 for the OLE period demonstrated a clinically meaningful 4.95% average reduction in bodyweight from baseline to Week 48. Waist circumference: As previously reported, treatment with Tesomet led to a 5.04% reduction in waist circumference compared to placebo (p=0.0519) in the DB period. This reduction was maintained during the OLE period, with these patients demonstrating a 5.07% reduction in waist circumference at Week 48 (p=0.003). Additionally, patients who received placebo during DB period and were switched to Tesomet at Week 24 for the OLE period demonstrated a 2.24% average reduction in waist circumference from baseline to Week 48. Glycemic control: As previously reported, there were two diabetic (T2D) patients who received Tesomet during the DB period, and they showed marked reduction of HbA1c levels (48.8% at Week 24), while no change was seen in normoglycemic patients. These two diabetic patients continued to receive Tesomet during the OLE period, and the reduction in HbA1c was maintained (46.17% at Week 48). Saniona intends to present and/or publish additional data from this study in an appropriate future peer-reviewed, scientific forum. Additionally, Saniona intends to provide these data to the FDA as part of ongoing communications around plans to ensure that only appropriate patients would receive Tesomet, if approved. Pending this alignment with the FDA, Saniona intends to initiate a Phase 2b study in HO in the first half of 2021.Is New 90 Day High Low • Oct 21New 90-day low: €2.37The company is down 20% from its price of €2.96 on 22 July 2020. The German market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 12% over the same period.공고 • Oct 10Saniona Receives Pre-IND Feedback from FDA on Regulatory Path for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO)Saniona announced that it received written feedback from the U.S. Food and Drug Administration (FDA) regarding pre-Investigational New Drug (IND) submissions for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO). Regarding PWS, the FDA's Division of Psychiatry within the Office of Neuroscience provided additional feedback on conducting a supportive Phase 2b study evaluating multiple doses of Tesomet in adult and adolescent PWS patients. Saniona expects to begin this Phase 2b study in the first half of 2021. As part of its ongoing discussions with the FDA, Saniona inquired if the planned Phase 2b study could serve as a single pivotal trial supporting approval of Tesomet in PWS. The FDA considered this request and, as Tesomet is a new molecular entity, the agency recommended that Saniona conduct a supportive Phase 2b study prior to initiating a Phase 3 study to confirm the safety and efficacy of the doses intended for commercialization. In addition, in recognition of the significant unmet need within the PWS pediatric population, the FDA recommended that Saniona plan to evaluate Tesomet in children younger than age 12. Regarding HO, the FDA's Division of Diabetes, Lipid Disorders and Obesity within the Office of Cardiology, Hematology, Endocrinology, and Nephrology agreed that the 505(b)(2) pathway is an appropriate development pathway for Tesomet. The agency recommended that the clinical development program for Tesomet in HO include a supportive Phase 2b study followed by a Phase 3 study. The agency expressed concerns about potential off-label use in the general obese population and suggested this needs to be evaluated, such as through a cardiovascular outcomes study, or that Saniona would need to clarify how it would restrict distribution of Tesomet exclusively to the rare HO population. Saniona is seeking additional guidance from the FDA in order to clarify the path forward for Tesomet in HO.공고 • Aug 12Saniona AB (publ) has completed a Follow-on Equity Offering in the amount of $64.999993 million.Saniona AB (publ) has completed a Follow-on Equity Offering in the amount of $64.999993 million. Security Name: Shares Security Type: Common Stock Securities Offered: 30,660,374 Price\Range: $2.12 Transaction Features: Subsequent Direct Listing공고 • Jul 30An unknown buyer acquired 3.96% stake in Scandion Oncology A/S (NGM:SCOL) from Saniona AB (publ) (OM:SANION) for for $2.3 million.An unknown buyer acquired 3.96% stake in Scandion Oncology A/S (NGM:SCOL) from Saniona AB (publ) (OM:SANION) for $2.3 million on June 22, 2020. As part of the acquisition, Saniona sold 0.75 million shares of Scandion Oncology. The sale of shares brings Saniona’s ownership stake in Scandion Oncology below 15%. Proceeds from sales of shares will be used to continue Saniona's advancement of their pipeline, including mid/late-stage clinical trials with Tesomet. An unknown buyer completed the acquisition of 3.96% stake in Scandion Oncology A/S (NGM:SCOL) from Saniona AB (publ) (OM:SANION) on June 22, 2020.이익 및 매출 성장 예측DB:30S - 애널리스트 향후 추정치 및 과거 재무 데이터 (SEK Millions)날짜매출이익자유현금흐름영업현금흐름평균 애널리스트 수12/31/2028236N/AN/AN/A112/31/2027388N/AN/AN/A112/31/2026267N/AN/AN/A13/31/2026429220181256N/A12/31/2025434285200274N/A9/30/2025743573571644N/A6/30/2025340214188261N/A3/31/2025338217234234N/A12/31/2024335189248248N/A9/30/202427-87-54-53N/A6/30/202425-82-60-60N/A3/31/202421-83-65-65N/A12/31/202317-96-73-73N/A9/30/202315-74-84-84N/A6/30/202312-33-101-100N/A3/31/202311-100-212-211N/A12/31/202215-212-283-282N/A9/30/202215-334-331-331N/A6/30/202215-445-383-382N/A3/31/202214-461-325-324N/A12/31/202110-411-347-345N/A9/30/20219-326-326-323N/A6/30/20219-280-296-291N/A3/31/20219-200-244-239N/A12/31/20208-73-179-174N/A9/30/202011-25-153-145N/A6/30/20209-5-124-119N/A3/31/20208-1-132-127N/A12/31/20197-69N/A-99N/A9/30/20195-96N/A-89N/A6/30/201949-53N/A-42N/A3/31/201952-52N/A-30N/A12/31/201855-41N/A-23N/A9/30/201857-32N/A-33N/A6/30/201817-61N/A-71N/A3/31/201817-56N/A-62N/A12/31/201721-49N/A-57N/A9/30/201721-47N/A-50N/A6/30/201768-6N/A-3N/A3/31/201767-2N/A-5N/A12/31/2016752N/A8N/A9/30/20167110N/A3N/A6/30/201623-25N/A-32N/A3/31/201625-21N/A-25N/A12/31/201514-23N/A-29N/A9/30/201516-23N/A-18N/A더 보기애널리스트 향후 성장 전망수입 대 저축률: 30S 의 예상 수익 증가율이 절약률(1.9%)보다 높은지 판단하기에는 데이터가 부족합니다.수익 vs 시장: 30S 의 수익이 German 시장보다 빠르게 성장할 것으로 예상되는지 판단하기에는 데이터가 부족합니다.고성장 수익: 30S 의 수익이 향후 3년 동안 상당히 증가할 것으로 예상되는지 판단하기에는 데이터가 부족합니다.수익 대 시장: 30S 의 수익은 향후 3년간 감소할 것으로 예상됩니다(연간 -14.4%).고성장 매출: 30S 의 수익은 향후 3년 동안 감소할 것으로 예상됩니다(연간 -14.4%).주당순이익 성장 예측향후 자기자본이익률미래 ROE: 30S의 자본 수익률이 3년 후 높을 것으로 예상되는지 판단하기에 데이터가 부족합니다.성장 기업 찾아보기7D1Y7D1Y7D1YPharmaceuticals-biotech 산업의 고성장 기업.View Past Performance기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/07/22 20:46종가2026/07/22 00:00수익2026/03/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델의 세부 정보는 당사의 GitHub 페이지에서 확인하실 수 있습니다. 또한 보고서 사용 방법에 대한 가이드와 YouTube 튜토리얼도 제공하고 있습니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Saniona AB (publ)는 3명의 분석가가 다루고 있습니다. 이 중 1명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Michael NovodNordea MarketsJesper IlsoeNordea MarketsFredrik ThorRedeye
Reported Earnings • May 26First quarter 2026 earnings released: kr0.33 loss per share (vs kr0.17 profit in 1Q 2025)First quarter 2026 results: kr0.33 loss per share (down from kr0.17 profit in 1Q 2025). Revenue: kr4.69m (down 52% from 1Q 2025). Net loss: kr46.2m (down 344% from profit in 1Q 2025). Revenue is expected to decline by 4.8% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Europe are expected to grow by 15%. Over the last 3 years on average, earnings per share has increased by 98% per year but the company’s share price has only increased by 33% per year, which means it is significantly lagging earnings growth.
공고 • Nov 27+ 3 more updatesSaniona AB (publ) to Report Q3, 2026 Results on Nov 26, 2026Saniona AB (publ) announced that they will report Q3, 2026 results at 8:00 AM, Central European Standard Time on Nov 26, 2026
공고 • Nov 07Saniona AB (publ), Annual General Meeting, May 27, 2026Saniona AB (publ), Annual General Meeting, May 27, 2026. Location: malmo Sweden
공고 • May 29Saniona AB (Publ) Announces Board ChangesSaniona AB (publ) announced that at its AGM held on May 28, 2025 approved John Haurum was elected as new chairman of the board and Jørgen Drejer was elected as new deputy chairman of the board. The previous board member Pierandrea Muglia was not available for re-election.
공고 • Mar 12Saniona AB (Publ) Appoints Pierandrea Muglia as Chief Medical OfficerSaniona AB (publ) has appointed Pierandrea Muglia, M.D., as Chief Medical Officer, bringing over three decades of expertise from large international pharmaceutical companies, biotech and neuroscience research. A board member since 2023, Muglia has seen Saniona's pipeline grow and its partnerships, like the $610 million deal with Acadia Pharmaceuticals, thrive. Now, he'll steer the company's clinical and regulatory efforts as it prepares three candidates for phase II trials.
공고 • Mar 03Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly San711) Phase 1 StudyAcadia Pharmaceuticals Inc. and Saniona announced the successful completion of the two originally planned cohorts in their Phase 1 multiple-ascending-dose MAD study (EUCT: 2024-514514-12-00) of ACP-711, formerly SAN711, in healthy volunteers. In the study, ACP-711 was safe and generally well tolerated across all dosing cohorts. There were no serious adverse events, and all participants completed the study. Most adverse events were mild. No safety laboratory concerns, cardiovascular concerns, or abnormal neurological findings were observed. Given the favorable safety and tolerability profile and the prioritization of essential tremor as the lead indication, Acadia Pharmaceuticals and Saniona are seeking regulatory approval to evaluate ACP-711 in elderly healthy volunteers and to test higher repeated doses. To enable this extension, the study has been temporarily paused until regulatory approval.
공고 • Jan 11Saniona AB (publ), Annual General Meeting, May 28, 2025Saniona AB (publ), Annual General Meeting, May 28, 2025.
공고 • Nov 28+ 4 more updatesSaniona AB (publ) to Report Q2, 2025 Results on Aug 28, 2025Saniona AB (publ) announced that they will report Q2, 2025 results at 8:00 AM, Central European Standard Time on Aug 28, 2025
공고 • Oct 07Saniona Initiates SAN711 Biomarker StudySaniona announced that it has dosed the first subjects with SAN711 in a Phase 1 multiple ascending dose (MAD)/biomarker study. This marks a significant milestone that put the foundation for launching a clinical proof-of-concept study in children with absence seizures, scheduled for 2025. Topline data from the Phase 1 study is anticipated by the end of 2024. This Phase 1 MAD/biomarker study will investigate three critical aspects to inform future clinical trials: the effect of food intake on SAN711 dosing, the safety and tolerability as well as the potential benefits of higher doses using clinically relevant pharmacodynamic biomarkers. These insights will refine the dosing strategy for future patient studies as the Phase 1 MAD/biomarker study will assess the safety, tolerability, and pharmacokinetics of SAN711 in higher doses than those used in the previous Phase 1 study, while gathering data on food interactions and the drug's pharmacodynamic effects on EEG during both awake and sleep states in healthy volunteers. Saniona’s earlier Phase 1 study demonstrated excellent tolerability and indicated potential therapeutic benefit at relevant clinical plasma concentrations. The current study builds on these findings by exploring whether higher doses can offer even greater potential without compromising safety. Additionally, preclinical data suggests that SAN711 selective pharmacology modulates certain brain circuits, which can be detected via EEG measurements during both awake and sleep states. This not only serves as a functional biomarker of SAN711’s activity in the brain but may also indicate potential benefits for patients in future studies. The study is being conducted in collaboration with Evotec at the Clinical Research Centre (CRC) of the University Hospital in Verona, Italy. Both Evotec and CRC bring extensive expertise in neurological and psychiatric clinical research, which will support the successful execution of the study.
공고 • Sep 18Saniona Receives Regulatory Approval for San711 Biomarker StudySaniona announced that it has been granted approval to begin a Phase 1 multiple ascending dose (MAD)/biomarker study in adults for SAN711. This study is a key step towards launching a clinical proof-of-concept study in children with absence seizures, scheduled for 2025. The Phase 1 MAD/biomarker study will assess the safety, tolerability, and pharmacokinetics of higher SAN711 doses in a multiple-dose setting. It will also gather data on food interactions and the drug's pharmacodynamic effects on EEG during both awake and sleep states in healthy volunteers. The biomarker data can provide evidence of SAN711's central pharmacological activity, aiding in defining the dosing strategy for future patient studies. This information, combined with receptor occupancy data from a prior PET study, will guide the next steps. Saniona is conducting this study in collaboration with Evotec at the Clinical Research Centre of the University Hospital in Verona, Italy. Evotec and CRC bring extensive experience in neurological and psychiatric clinical research, enhancing the study's execution. Additionally, Saniona is conducting a preclinical juvenile toxicity study and physiologically based pharmacokinetic modeling to translate adult Phase 1 data into appropriate dosing for children.
New Risk • Sep 02New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr76m 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 (-kr76m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (73% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (kr34m net loss next year). Revenue is less than US$5m (kr25m revenue, or US$2.4m). Market cap is less than US$100m (€41.9m market cap, or US$46.4m).
Reported Earnings • Sep 01Second quarter 2024 earnings released: kr0.18 loss per share (vs kr0.34 loss in 2Q 2023)Second quarter 2024 results: kr0.18 loss per share (improved from kr0.34 loss in 2Q 2023). Revenue: kr8.02m (up 108% from 2Q 2023). Net loss: kr19.7m (loss narrowed 7.1% from 2Q 2023). Revenue is forecast to grow 36% p.a. on average during the next 2 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 58% per year but the company’s share price has fallen by 41% per year, which means it is significantly lagging earnings.
New Risk • Jun 07New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Shareholders have been substantially diluted in the past year (78% increase in shares outstanding). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr80m). Currently unprofitable and not forecast to become profitable next year (kr38m net loss next year). Revenue is less than US$5m (kr21m revenue, or US$2.0m). Market cap is less than US$100m (€29.9m market cap, or US$32.4m).
Reported Earnings • May 30First quarter 2024 earnings released: kr0.08 loss per share (vs kr0.35 loss in 1Q 2023)First quarter 2024 results: kr0.08 loss per share (improved from kr0.35 loss in 1Q 2023). Revenue: kr6.03m (up 179% from 1Q 2023). Net loss: kr9.24m (loss narrowed 57% from 1Q 2023). Revenue is forecast to grow 41% p.a. on average during the next 2 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 44% per year but the company’s share price has fallen by 57% per year, which means it is significantly lagging earnings.
공고 • Mar 01Saniona AB (publ) to Report Fiscal Year 2023 Results on Apr 30, 2024Saniona AB (publ) announced that they will report fiscal year 2023 results at 9:00 AM, Central European Standard Time on Apr 30, 2024
New Risk • Mar 01New major risk - Negative shareholders equityThe company has negative equity. Total equity: -kr22m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Negative equity (-kr22m). Shareholders have been substantially diluted in the past year (78% increase in shares outstanding). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr86m). Currently unprofitable and not forecast to become profitable over next 2 years (kr60m net loss in 2 years). Revenue is less than US$5m (kr17m revenue, or US$1.6m). Market cap is less than US$100m (€19.9m market cap, or US$21.5m).
Reported Earnings • Mar 01Full year 2023 earnings released: kr1.49 loss per share (vs kr3.93 loss in FY 2022)Full year 2023 results: kr1.49 loss per share (improved from kr3.93 loss in FY 2022). Revenue: kr16.8m (up 10% from FY 2022). Net loss: kr95.8m (loss narrowed 61% from FY 2022). Revenue is forecast to grow 22% p.a. on average during the next 2 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 25% per year but the company’s share price has fallen by 56% per year, which means it is significantly lagging earnings.
공고 • Jan 02Saniona Announces the Selection of Its Proprietary GABAA A5 Negative Allosteric Modulator (NAM) Lead Compound, San2465Saniona announced the selection of its proprietary GABAA a5 Negative Allosteric Modulator (NAM) lead compound, SAN2465, as a clinical candidate for major depressive disorder. This decision follows encouraging results obtained from a rodent model, specifically the chronic mild stress model of depression. SAN2465 demonstrated rapid and sustained reversal of chronic stress-induced depressive-like symptoms, including anhedonia, anxiety, and cognitive impairment. This positions SAN2465 as an innovative and rapid-acting approach to treating major depressive disorder and its associated comorbidities. Originally discovered through collaboration with Boehringer Ingelheim for schizophrenia, SAN2465 is a highly potent and selective negative allosteric modulator of GABAA a5. Saniona holds exclusive global rights to the program following the termination of the collaboration with BoehringerIngelheim in November 2020. SAN2465 is now poised for pre-clinical development as a rapid-acting antidepressant for collaboration with a partner. SAN2465 was rigorously tested in the chronic mild stress model of Depression in the laboratory of Professor Mariusz Papp, Maj Institute of Pharmacology, Polish Academy of sciences, Krakow, Poland. The chronic mild stress model is widely acknowledged as the most valid animal model of depression with translational potential to human disease. Results indicate that a single oral treatment of SAN2465, administered 24 and 48 hours before testing, effectively reversed depressive-like symptoms, as assessed by stress-induced reduction of sucrose intake. Furthermore, SAN2465 reversed the anxiogenic-like behaviors and cognitive impairments induced by stress after a single oral treatment administered 48 hours and 72 hours before testing, respectively. Importantly, the onset and robustness of the effect are comparable to the NMDA antagonist ketamine, suggesting a potential new mechanism of action with a differentiated side effect profile. The rapid antidepressant effect of esketamine is believed to stem from fast onset neuroplastic changes in molecular signaling cascades in relevant brain regions. Similar changes have been observed through pharmacological negative allosteric modulation of the GABAA a5 receptors in rodent studies suggesting that this mechanism could have a comparable rapid antidepressant effect in humans. Importantly, unlike NMDA receptor blockade with esketamine, negative modulation of GABAA a5 receptors is not anticipated to lead to significant adverse effects, as the expression of these receptors is more localized and mainly restricted to limbic areas. Use of esketamine is restricted by a Risk Evaluation and Mitigation Strategy (REMS) Program.
공고 • Dec 27Saniona AB (publ) Strengthens Epilepsy Pipeline with Selection of SAN2355 as Clinical CandidateSaniona AB (publ) announced that it marks a significant epilepsy pipeline milestone by selecting SAN2355 as the first clinical candidate from its Kv7 epilepsy program. SAN2355, a subtype-selective activator of Kv7.2/Kv7.3 channels, represents a promising new generation of effective and well-tolerated epilepsy medicines. Having successfully passed critical candidate selection steps and secured a favorable opinion from the European Patent Office (EPO), Saniona is poised to advance SAN2355 into the preclinical development phase. Epilepsy, a brain disorder characterized by recurrent seizures, affects millions of people worldwide. Approximately 30% of patients are unresponsive to current medicines, emphasizing a substantial unmet need in the field. Kv7 channels play a crucial role in mediating potassium ion transport across the cell membrane of neurons, reducing the likelihood of generating uncontrolled bursts of nerve impulses. The Kv7 channel family comprises five subtypes, with channels consisting of Kv7.2 and Kv7.3 subunits selectively expressed in the brain. Activators of Kv7.2 and Kv7.3 channels effectively dampen overactive neurons, aiding in the prevention of epileptic seizures. Mutations in the Kv7.2 and Kv7.3 subunits are the second most common cause of inherited, severe childhood epilepsies, underscoring the importance of Kv7.2/Kv7.3 channels in controlling nerve cell activity. The non-selective Kv7 activator retigabine has provided clinical and commercial proof-of-concept for treating patients with resistant focal onset seizures. However, it has been withdrawn from the market due to compound-specific and non-target-related side effects.
Reported Earnings • Dec 01Third quarter 2023 earnings released: kr0.38 loss per share (vs kr0.28 profit in 3Q 2022)Third quarter 2023 results: kr0.38 loss per share (down from kr0.28 profit in 3Q 2022). Revenue: kr5.45m (up 128% from 3Q 2022). Net loss: kr24.1m (down 238% from profit in 3Q 2022). Revenue is forecast to grow 60% p.a. on average during the next 2 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 37% per year, which means it is significantly lagging earnings.
공고 • Nov 30+ 4 more updatesSaniona AB (publ) to Report Fiscal Year 2024 Results on Feb 27, 2025Saniona AB (publ) announced that they will report fiscal year 2024 results at 8:00 AM, Central European Standard Time on Feb 27, 2025
공고 • Nov 29Saniona AB (publ) Announces Composition of Nomination CommitteeSaniona AB (publ) announced the composition of the Nomination Committee for the Annual General Meeting 2024. Pursuant to the instruction and charter for the Nomination Committee adopted by the general meeting, the Nomination Committee shall comprise of three members, which shall be the Chairman of the Board of Directors and two members appointed by the two larger shareholders as of last September. On September 30, 2023, the two larger shareholders, who desired to appoint a representative to the Nomination Committee, were Jørgen Drejer and Dan Peters. Each such shareholder has appointed a representative, as shown below, who together with the Chairman of the Board of Directors will form Saniona AB’s Nomination Committee. The Nomination Committee’s members are: John Haurum, professional board member for life science companies and former CEO of F-star Biotechnology Limited, Cambridge, UK, appointed by Jørgen Drejer; Søren Skjærbæk, Partner at Ursus law firm, Vejle, Denmark, appointed by Dan Peters; Jørgen Drejer, Chairman of Saniona AB’s Board. Søren Skjærbæk has been appointed as Chairman of the Nomination Committee. The Nomination Committee shall prepare and submit proposals to the Annual General Meeting 2024.
공고 • Nov 22Saniona Promotes Kv7 Epilepsy Compound to Candidate Selection PhaseSaniona AB (publ) announced that it has initiated the candidate selection phase with a proprietary subtype selective frontrunner molecule from the Kv7 lead optimization program for epilepsy. The compound has a unique selectivity profile and represents a potential new generation of effective and well tolerated epilepsy medicines. Epilepsy, a brain disorder characterized by recurrent seizures, affects millions of people worldwide. There is considerable unmet need since about 30% of the patients are unresponsive to current medicines. Kv7 channels mediate potassium ion transport across the cell membrane of neurons, which decreases the likelihood of generating uncontrolled nerve impulses. Activators of Kv7 channels are therefore very effective in dampening overactive neurons and thus prevent the generation of epileptic seizures. Mutations in Kv7 channels containing the Kv7.2 and Kv7.3 subunits are the second most common cause of inherited severe childhood epilepsies, which demonstrate their importance in controlling nerve cell activity. The non-selective Kv7 activator retigabine has provided both clinical and commercial proof-of-concept for treatment of patients with resistant focal onset seizures. Retigabine has also shown anti-epileptic effect and developmental improvement in smaller investigator-driven studies with children with loss-of-function mutations in Kv7.2. However, retigabine has been withdrawn from the market due to compound specific and non-target related side-effects. The Kv7 channel family comprise five subtypes, of which channels consisting of Kv7.2 and Kv7.3 subunits are selectively expressed in the brain. The Saniona program focuses on development of subtype selective Kv7.2/Kv7.3 activators, thus avoiding retigabine´s troublesome side effects on the CNS and urinary system, which caused a high drop-out rate in the clinical studies and eventually resulted in quite low adherence to the drug despite good efficacy.
New Risk • Sep 01New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 13% 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 Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr101m). Currently unprofitable and not forecast to become profitable over next 2 years (kr54m net loss in 2 years). Shareholders have been diluted in the past year (2.8% increase in shares outstanding). Revenue is less than US$5m (kr12m revenue, or US$1.1m). Market cap is less than US$100m (€42.2m market cap, or US$45.6m).
Reported Earnings • Sep 01Second quarter 2023 earnings released: kr0.34 loss per share (vs kr1.42 loss in 2Q 2022)Second quarter 2023 results: kr0.34 loss per share (improved from kr1.42 loss in 2Q 2022). Revenue: kr3.85m (up 30% from 2Q 2022). Net loss: kr21.2m (loss narrowed 76% from 2Q 2022). Revenue is expected to decline by 6.2% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 15%. Over the last 3 years on average, earnings per share has fallen by 18% per year but the company’s share price has fallen by 39% per year, which means it is performing significantly worse than earnings.
New Risk • Aug 20New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.8% This is considered a minor 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 (12% average weekly change). Revenue is less than US$1m (kr11m revenue, or US$985k). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr212m). Currently unprofitable and not forecast to become profitable over next 2 years (kr42m net loss in 2 years). Shareholders have been diluted in the past year (2.8% increase in shares outstanding). Market cap is less than US$100m (€38.0m market cap, or US$41.3m).
Reported Earnings • May 26First quarter 2023 earnings released: kr0.35 loss per share (vs kr2.14 loss in 1Q 2022)First quarter 2023 results: kr0.35 loss per share (improved from kr2.14 loss in 1Q 2022). Revenue: kr2.16m (down 67% from 1Q 2022). Net loss: kr21.7m (loss narrowed 84% from 1Q 2022). Revenue is forecast to grow 74% p.a. on average during the next 2 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has fallen by 43% per year whereas the company’s share price has fallen by 41% per year.
Reported Earnings • Feb 24Full year 2022 earnings released: kr3.93 loss per share (vs kr6.59 loss in FY 2021)Full year 2022 results: kr3.93 loss per share (improved from kr6.59 loss in FY 2021). Revenue: kr15.3m (up 46% from FY 2021). Net loss: kr245.4m (loss narrowed 40% from FY 2021). Over the last 3 years on average, earnings per share has fallen by 53% per year whereas the company’s share price has fallen by 51% per year.
공고 • Nov 26Saniona AB Appoints Nomination Committee for the Annual General Meeting 2023Saniona AB announced the composition of the Nomination Committee for the Annual General Meeting 2023. Pursuant to the instruction and charter for the Nomination Committee adopted by the general meeting, the Nomination Committee shall comprise of three members, which shall be the Chairman of the Board of Directors and two members appointed by the two largest shareholders as of last September. On September 30, 2022, the two largest shareholders, who desired to appoint a representative to the Nomination Committee, were Jørgen Drejer and Dan Peters. Each such shareholder has appointed a representative, as shown below, who together with the Chairman of the Board of Directors will form Saniona AB’s Nomination Committee. The Nomination Committee’s members are: John Haurum, professional board member for life science companies and former CEO of F-star Biotechnology Limited, Cambridge, UK, appointed by Jørgen Drejer Søren Skjærbæk, Partner at Ursus law firm, Vejle, Denmark, appointed by Dan Peters, Jørgen Drejer, Chairman of Saniona AB’s Board.
Reported Earnings • Nov 18Third quarter 2022 earnings released: EPS: kr0.28 (vs kr1.50 loss in 3Q 2021)Third quarter 2022 results: EPS: kr0.28 (up from kr1.50 loss in 3Q 2021). Revenue: kr2.39m (up 5.5% from 3Q 2021). Net income: kr17.5m (up kr111.2m from 3Q 2021). Over the last 3 years on average, earnings per share has fallen by 52% per year whereas the company’s share price has fallen by 50% per year.
공고 • Nov 17+ 3 more updatesSaniona AB (publ) to Report Q1, 2023 Results on May 25, 2023Saniona AB (publ) announced that they will report Q1, 2023 results at 8:00 AM, Central European Standard Time on May 25, 2023
Board Change • Nov 16Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 1 highly experienced director. Independent Director Anna Ljung was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
공고 • Nov 03Saniona AB (publ) Announces Anti-Inflammatory and Anti-Fibrotic Candidate SAN903 Is Ready for Clinical StudiesSaniona AB (publ) announced that SAN903 is ready to start the regulatory process for entering Phase 1 clinical trials either by Saniona alone or together with a partner following successful completion of preclinical development.SAN903 is a novel, potential first-in-class medicine based on inhibition of the calcium-activated potassium ion channel, KCa3.1. This ion channel is found on several types of immune cells, where it participates in the control of the cellular pathways that maintain pathogenic activation and inflammation in chronic diseases. The KCa3.1 channel is also expressed on fibroblasts, especially on myofibroblasts, where it supports the overproduction of connective tissue that can lead to fibrosis. Prevention of fibrotic complications is an aspect of the disease, which is poorly treated by current standard-of-care IBD medicines, and progressed fibrosis often requires surgical intervention to resolve potentially life-threatening gut obstructions. SAN903 dampens inflammation and fibrosis by preventing cell division and cell migration of activated immune cells and fibroblast and by impeding cytokine release and collagen secretion of the respective cell types. Palle Christophersen, EVP Research, commented: I am incredibly happy that SAN903 – which is the result of a long and challenging drug discovery phase – has now successfully completed the preclinical development package and is ready for entering the clinical stages. Inflammatory bowel disease is a complex disease with a rather low initial responder rate and poorly controlled disease progression. Due to its new mode-of-action, I anticipate that the entry indication for SAN903 can be newly diagnosed, mild-to-moderate colitis patients that are failing first-line treatment with standard-of-care medicine. Due to the actions on both inflammatory and fibrotic processes, I hope that SAN903 can become the first maintenance drug, which effectively prevents development of intestinal fibrosis in patients suffering from inflammatory bowel disease.
Reported Earnings • Aug 26Second quarter 2022 earnings released: kr1.42 loss per share (vs kr1.67 loss in 2Q 2021)Second quarter 2022 results: kr1.42 loss per share (up from kr1.67 loss in 2Q 2021). Net loss: kr88.6m (loss narrowed 15% from 2Q 2021). Over the last 3 years on average, earnings per share has fallen by 55% per year but the company’s share price has only fallen by 37% per year, which means it has not declined as severely as earnings.
공고 • Aug 17Saniona Progresses Its Kv7 Epilepsy Program into Lead OptimizationSaniona announced that it has progressed its promising Kv7 epilepsy program into the Lead Optimization Phase, which is the last drug discovery phase before potential selection of a clinical candidate. Epilepsy, characterized by recurrent seizures, currently affects millions of people worldwide. There is a significant medical need as approximately 30% of patients are insensitive to treatment by conventional epilepsy medicines. Furthermore, anti-seizure therepy may cause disabling side effects and often require careful dose adjustment to minimize these. Kv7 ion channels are voltage-activated potassium channels that play a critical role by dampening of repetitive firing of neurons, which potentially can lead to seizure activity. The special importance of the Kv7.2/Kv7.3 heteromeric channel within epilepsy is clearly illustrated by the increasing numbers of mutations in Kv7.2 andKv7.3 that are found to be associated with severe inherited forms of epilepsy. Thus, small molecule drugs that facilitate the opening of Kv7.2/Kv7.3 ion channels have potential to treat epilepsy as well as other neuronal hyperexcitability disorders. There is proof of concept for the use of Kv7 modulators for treatment of epilepsy as a relatively recently approved non- selective Kv7 anti-seizure drug, ezogabine (retigabine), has demonstrated strong anti-epilepticactivity. Unfortunately, this drug had to be withdrawn from the market due to serious adverse effects including skin discoloration, retinal changes, and increased risk of urinary retention, a potentially life-threatening condition. The skin discoloration and retinal changes are caused by ezogabine’s chemical instability and not by the compound’s mode-of-action, whereas the increased risk of urinary retention is believed to be due to the non-selective profile of ezogabine leading to unintentional activation of Kv7 subtypes expressed in the bladder. Several companies and academic groups have over the past decade worked on developing a next generation drugcandidate avoiding the limitations and tolerability issues with ezogabine. Saniona scientists have been active in the Kv7 drug discovery field for more than a decade and have worked in previous Kv7 Pharma partnership programs. Saniona has now managed to progress into lead optimization stage with a new chemical series that circumvent limitations with first generation drug candidates. The main features of these new Kv7 activators are improved chemical stability as well as differentiation in selectivity and mechanism-of-action, which can eliminate relaxation of bladder tissue. The objective of the lead optimization program is thus to develop a second generation Kv7 medicine without the side effects that led to the withdrawal of exogabine from the market.
공고 • Jul 01Saniona Reports Positive Top Line Results from the SAN711 Phase 1 Clinical TrialSaniona announced that it has successfully completed its Phase 1 clinical trial of SAN711, which is positioned for the treatment of neuropathic pain disorders. Data from the trial demonstrated that SAN711 was safe and well tolerated across all dosing cohorts with a favorable absorption and distribution profile. There were no serious adverse events, and all subjects completed the study. Long term dosing with SAN711 at a well tolerated dose of 0.8 mg twice a day resulted in 24- hour receptor occupancy ranging between 50% and 72% assessed to lead to desired pharmacological effects. The results of this Phase 1 clinical trial open the path for continued clinical development of SAN711. The Phase 1 clinical trial was conducted in 66 healthy volunteers. The primary objective of the study was to determine the safety and tolerability of SAN711, which was evaluated through single ascending dose and multiple ascending dose phases of the study. The secondary objective was to measure binding to target receptors, which was assessed during a positron emission tomography (PET) evaluation phase of the study. The clinical trial was conducted in the United Kingdom (U.K.) under the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA). SAN711 was safe and well tolerated across all dosing cohorts. There were no serious adverse events, and all subjects completed the study. Adverse events were mostly mild, and the few adverse events of moderate intensity were, apart from two, assessed to be non-related to drug administration. There were no safety laboratory concerns, cardiovascular concerns, and no abnormal neurological examinations, including Mini Mental State Examinations. SAN711 was absorbed rapidly following single oral doses of 0.1 to 2.25 mg/kg (mean T max of 0.75 h - 2.08 h). Linear pharmacokinetics was observed and the mean half-life for elimination (T½) ranged between 7.4 and 12.3 h over all dose levels. Maximum plasma levels of SAN711 reached up to 1577 ng/ml corresponding to 84% occupancy of all target receptors. PET results confirmed the hypothesis that a pharmacologically active receptor occupancy may be achieved at well-tolerated doses of SAN711. In the multiple ascending dose phase, a well tolerated dose of 0.8 mg/kg twice daily led to plasma levels consistent with 24-hour receptor occupancy ranging from 50% to 72%. Based on pre-clinical data, this exposure level is predicted to result in desired therapeutic effects.
Board Change • Jun 29Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 1 highly experienced director. Independent Director Anna Ljung was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
공고 • Jun 25Saniona’S Preclinical Candidate San903 Shows Robust Dampening of Fibrosis in Chronic Kidney Disease ModelSaniona announced that professor Helle Prætorius, Univ. of Aarhus, Denmark, made a presentation at the ECM conference,2022, which shows that SAN903 protects against fibrosisin a chronic kindneydease model. Chronic kidney disease (CKD) is a devastating, progressive deterioration of renal function that significantly impacts the quality of life for the individual and represents a substantial cost for the society. Regardless of the cause of CKD, renal fibrosis is a major component of the disease and is the best predictor of progression to CKD-associated renal failure. Saniona’s collaborator professor Helle Prætorius, MD-PhD, Univ. of Århus, Denmark demonstrated in her presentation that Saniona’s KCa3.1 inhibitor SAN903 dampened renal fibrosis in a mouse model of CKD. When SAN903 was administrated daily during unilateral urinary obstruction the total fibrotic area was reduced by up to 43% (p>0.0001). SAN903 was well tolerated at all doses. SAN903 is a novel, potential first-in-class medicine based on inhibition of the calcium-activated potassium ion channel, KCa3.1. This ion channel is found in immune cells and fibroblasts where it participates in the control of cell proliferation and migration as well as cytokine and collagen production. Previous studies have indicated that KCa3.1 inhibition may reduce inflammation and fibrosis in various diseases. Saniona expects to complete regulatory preclinical development mid 2022 and to initiate Phase 1 clinical trials end 2022 or early 2023.
공고 • May 21Saniona Provides Update on Ongoing Review of Tesofensine in MexicoSaniona announced that the Mexican regulatory authority Comisión Federal para la Protección contra RiesgosSanitarios (COFEPRIS) has published on Twitter that its technical committee on new molecules (El Comité de MoléculasNuevas) was unable to provide a favorable opinion on tesofensine following a meeting held on May 18, 2022. The statement on Twitter does not provide any details or explanation for the position taken. As part of the ongoing review process, the tesofensine application was reviewed by a COFEPRIS technical committee on new molecules on May 18, 2022. Saniona’s partner Productos Medix, S. A de S.V, (Medix) has not received any official statement from COFEPRIS yet. Therefore, Medix is not able to comment on this statement and the possible implication for pursuing the process of seeking approval for tesofensine in Mexico.
공고 • Apr 26+ 2 more updatesSaniona Appoints Anita Milland as Chief Financial Officer, Effective April 30, 2022Saniona announced that it will refocus its strategy on ion channel research and development (R&D) and, as a result, further streamline its operations. Effective April 30, 2022, Anita Milland will become the Chief Financial Officer (CFO). Anita Milland is currently VP Finance & Adminstration at Saniona and served as interim CFO at Saniona during 2020.
공고 • Mar 31+ 1 more updateSaniona Announces Voluntary Pause of Phase 2B Clinical Trials of Tesomet for Hypothalamic Obesity and Prader-Willi SyndromeThe board of Saniona has resolved to implement multiple actions including a voluntary pause of the Phase 2b clinical trials of Tesomet for hypothalamic obesity (HO) and Prader-Willi syndrome (PWS) and a workforce reduction of approximately 30%. The decision to voluntarily pause the Phase 2b clinical trials of Tesomet is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The decision to voluntarily pause the Phase 2b clinical trials of Tesomet for HO and PWS is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The Tesomet programs previously achieved highly encouraging results in initial Phase 2 trials, and the international Phase 2b trials were by far the largest expenditure for the company. Saniona will continue its ongoing Phase 1 clinical trial of SAN711, which is expected to deliver data by the end of the first half of 2022. The company will also continue to invest in its ion channel drug discovery engine, including SAN903, which is expected to enter Phase 1 clinical trials in the second half of 2022, and discovery research efforts, which are expected to result in a new ion channel modulator advancing into the preclinical pipeline in 2022. Saniona will also continue to pursue strategic financing options and expand its business development efforts to include opportunities that could allow Tesomet to advance.
Reported Earnings • Feb 25Full year 2021 earnings: EPS in line with expectations, revenues disappointFull year 2021 results: kr6.59 loss per share (down from kr1.79 loss in FY 2020). Net loss: kr410.9m (loss widened 460% from FY 2020). Revenue missed analyst estimates by 46%. Over the last 3 years on average, earnings per share has fallen by 41% per year whereas the company’s share price has fallen by 39% per year.
공고 • Feb 25Saniona AB (publ) to Report Fiscal Year 2021 Final Results on Apr 29, 2022Saniona AB (publ) announced that they will report fiscal year 2021 final results at 8:00 AM, Central European Standard Time on Apr 29, 2022
공고 • Feb 11Saniona Initiates Multiple Ascending Dose Stage of SAN711 Phase 1 Clinical TrialSaniona provided an update on progress in its Phase 1 clinical trial of SAN711. The company reported that it has now also initiated the multiple ascending dose stage of the trial. The study is placebo-controlled, and the data remain blinded. Saniona continues to expect data from the trialby the end of the first half of 2022. The Phase 1 clinical trial is a randomized, placebo-controlled study being conducted in approximately 80 healthy volunteers. The primary objective of the study is to determine the tolerability and the maximum tolerated dose of SAN711, as evaluated through the single ascending dose and multiple ascending dose phases of the study. The secondary objective is to measure binding to target receptors, as assessed during a positron emission tomography (PET) evaluation phase of the study. SAN711 is an investigational, potential first-in-class positive allosteric modulator of GABA-A a3 receptors and may be applicable in the treatment of rare neuropathic disorders. It is the first novel molecule derived from Saniona’s proprietary ion channel drug discovery engine to be advanced into internal clinical trials.
공고 • Dec 29Saniona Initiates Phase 2b Clinical Trial of Tesomet for Prader-Willi SyndromeSaniona announced the initiation of a Phase 2b clinical trial of Tesomet in patients with Prader-Willi syndrome (PWS). Tesomet is an investigational fixed-dose combination therapy of tesofensine, a triple monoamine reuptake inhibitor, and metoprolol, a beta-1 selective blocker. Data from the trial are expected in the first half of 2023. The Phase 2b clinical trial in PWS includes a randomized, double-blind, placebo-controlled 16-week treatment period followed by a 36-week open-label extension period. The trial is expected to enroll approximately 120 patients with genetically-confirmed PWS. Initially, the trial will enroll adults (18 to 65 years of age) and then, following confirmation by the data monitoring committee and by the FDA, the trial is planned to expand into adolescents (13 to 17 years of age). During the 16-week double-blind period, participants will be randomized to receive daily dosing with Tesomet at one of three dose levels or a placebo. During the 36-week open-label extension period, participants who wish to continue treatment, including those who originally received placebo, will receive the highest tolerated dose of Tesomet as established during the double-blind period. The primary objective of the study will be change in hyperphagia at week 16 as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), a caregiver-reported survey that evaluates food-seeking behavior, such as frequency of sneaking food or time spent talking about food, and which has been used as the primary outcome measure for most PWS clinical trials. Secondary endpoints include change in body weight, change in caregiver impression of hyperphagia, change in clinician impression of overall disease severity, and change in clinician impression of overall clinical status. The clinical trial is being conducted at multiple sites around the world including in the United States, New Zealand, Australia, and in multiple countries in Europe including the United Kingdom, Sweden, Italy, Spain and others.
Reported Earnings • Nov 19Third quarter 2021 earnings released: kr1.50 loss per share (vs kr1.24 loss in 3Q 2020)Third quarter 2021 results: Net loss: kr93.7m (loss widened 78% from 3Q 2020).
Reported Earnings • Aug 27Second quarter 2021 earnings released: kr1.67 loss per share (vs kr1.24 loss in 2Q 2020)Second quarter 2021 results: Net loss: kr103.9m (loss widened 185% from 2Q 2020).
공고 • Jul 01Saniona Initiates Phase 1 Clinical Trial of SAN711Saniona announced that it has dosed the first patientin a Phase 1 clinical trial of SAN711, a novel molecule derived from Saniona’s proprietary ion channel drug discovery engine. SAN711 is a first-in-class positive allosteric modulator of GABA-A a3 receptors and may be applicable in the treatment of rare neuropathic disorders. Data from the trial are expected in the first half of 2022. The Phase 1 clinical trial will be conducted in approximately 80 healthy volunteers. The primary objective of the study is to determine the tolerability and the maximum tolerated dose of SAN711, which will be evaluated through single ascending dose and multiple ascending dose phases of the study. The secondary objective is to measure binding to target receptors, which will be assessed during a positron emission tomography (PET) evaluation phase of the study. The clinical trial is being conducted in the United Kingdom (U.K.) under the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA). After completion of the Phase 1 clinical trial, Saniona intends to select a lead indication and file an Investigational New Drug (IND) application with the United States Food & Drug Administration (U.S. FDA) to support Phase 2 studies for SAN711 in the U.S.
공고 • Jun 09Saniona to Present Preclinical Data on SAN711 at the 7th Congress of the European Academy of NeurologySaniona announced it will present preclinical data on SAN711 in a model of facial neuropathic painat the 7thCongress of the European Academy of Neurology (EAN), which is being held virtually June 19 - 22, 2021. SAN711 is a first-in-class positive allosteric modulator of GABA-A a3 that was designed using Saniona’s ion channel drug discovery engine. While existing molecules target all GABA-A receptors indiscriminately, SAN711 selectively enhances the effects of GABA-A on a3 containing receptors. Preclinical studies have indicated that this selectivity may allow SAN711 to provide pain relief and other benefits in the central nervous system while avoiding the typical adverse effects associated with non-selective GABA-A activation such as sedation, motor instability, cognitive impairment, abuse liability and physical dependence.
Reported Earnings • May 28First quarter 2021 earnings released: kr1.34 loss per share (vs kr1.47 profit in 1Q 2020)First quarter 2021 results: Net loss: kr83.4m (down 293% from profit in 1Q 2020).
Reported Earnings • Mar 18Full year 2020 earnings released: kr1.79 loss per share (vs kr2.95 loss in FY 2019)Full year 2020 results: Net loss: kr73.4m (loss narrowed 3.1% from FY 2019).
공고 • Mar 09Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic ObesitySaniona announced it received feedback from the U.S. Food and Drug Administration (FDA) providing further clarity on a regulatory path for Tesomet in the treatment of hypothalamic obesity (HO). Based on this feedback, Saniona is proceeding with plans to initiate a Phase 2b study in HO in the first half of this year. Saniona previously announced that the FDA had highlighted the potential for off-label use of Tesomet in the general obese population. As a result, Saniona submitted a response proposing a Risk Evaluation and Mitigation Strategy (REMS), which is often used to restrict commercial distribution to the appropriate patients suffering from an unmet medical need. The FDA indicated overall agreement with this proposal and stated Saniona should demonstrate that HO fulfills the criteria for an unmet medical need. Saniona further proposed including 24-hour ambulatory blood pressure monitoring (ABPM) and Holter (electrocardiogram) monitoring as part of the HO program. The agency stated that robust data from these analyses could be useful in determining the level of cardiovascular assessment needed in Phase 3. The agency also acknowledged the challenge of conducting 24-hour monitoring in HO patients and said the analyses could be conducted in a separate study in general obese people.
공고 • Mar 04Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi SyndromeSaniona announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Tesomet for the treatment of Prader-Willi syndrome (PWS). Saniona is preparing to initiate a Phase 2b study of Tesomet in PWS in the first half of this year. Orphan drug designation is a special status granted by the FDA to medicines and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. The number of patients with PWS is estimated to be between 11,000 and 34,000 in the U.S. and between 17,000 and 50,000 in Europe. Receiving orphan designation qualifies Saniona for certain development benefits, including tax credits, elimination of certain FDA license application fees, and seven years of market exclusivity in the U.S. following approval.
Is New 90 Day High Low • Feb 11New 90-day low: €1.81The company is down 23% from its price of €2.35 on 13 November 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 10.0% over the same period.
공고 • Jan 26Novartis AG (SWX:NOVN) completed the acquisition of Cadent Therapeutics, Inc. from a group of sellers.Novartis AG (SWX:NOVN) reached a definitive agreement to acquire Cadent Therapeutics, Inc. from a group of sellers for approximately $770 million on December 17, 2020. Upon closing of the agreement, Cadent will receive $210 million upfront payment and will be eligible for up to $560 million in milestone payments. The acquisition will give Novartis full rights to Cadent’s neuroscience portfolio, including its NMDAr program, which consists of two clinical programs CAD-9303, a NMDAr positive allosteric modulator and MIJ-821, a NMDAr negative allosteric modulator, which was licensed to Novartis in 2015. Additionally, Novartis will gain full rights to CAD-1883, a clinical stage SK channel positive allosteric modulator in development for movement disorders. The transaction is subject to customary closing conditions, including antitrust review pursuant to the Hart-Scott-Rodino premerger notification program. The transaction has been approved by the Board of Directors and stockholders of Cadent Therapeutics. The transaction is expected to be completed during first quarter of 2021. Novartis AG (SWX:NOVN) completed the acquisition of Cadent Therapeutics, Inc. from a group of sellers on January 25, 2021. Saniona AB (publ) (OM:SANION) sold approximately 3% stake in Cadent Therapeutics and received approximately $2.9 million (SEK 24.2 million) in an upfront payment.
Is New 90 Day High Low • Jan 15New 90-day low: €1.97The company is down 19% from its price of €2.42 on 16 October 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period.
공고 • Dec 23+ 1 more updateSaniona Announces Management AppointmentsSaniona AB (publ) announced the further expansion of its executive team with the appointments of Denelle Waynick as Chief Legal Officer and Kyle Haraldsen as Chief Technical Operations Officer. The positions will be based in the U.S. and will support Saniona's advancement of clinical trials for Tesomet and SAN711 as well as the company's growing U.S. presence. Denelle Waynick, Chief Legal Officer, has nearly 30 years of experience advising domestic and international companies in the healthcare and life sciences industries. Most recently, Waynick served as Chief Legal Officer and Corporate Secretary at MyoKardia, where she provided strategic and practical counsel to C-suite executives in legal matters, as well as issues impacted by the regulatory and policy environment. Kyle Haraldsen, Chief Technical Operations Officer, has nearly 20 years of technical operations and manufacturing experience in the biopharmaceutical industry, including in support of U.S. and E.U. product approvals. Most recently, he served as the Vice President of Technical Operations and Project Management at AMAG Pharmaceuticals, where he led the process and analytical development, manufacturing, supply chain and project management functions. Waynick and Haraldsen will serve on Saniona's executive committee and will report to President and CEO Rami Levin. Both positions will be based in Saniona's office in the Boston, Massachusetts-area, U.S. Waynick and Haraldsen will start in January 2021.
Recent Insider Transactions • Dec 06Co-Founder recently bought €11k worth of stockOn the 30th of November, Jørgen Drejer bought around 5k shares on-market at roughly €2.25 per share. This was the largest purchase by an insider in the last 3 months. This was Jørgen's only on-market trade for the last 12 months.
Is New 90 Day High Low • Dec 05New 90-day low: €2.07The company is down 18% from its price of €2.52 on 04 September 2020. The German market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 8.0% over the same period.
Reported Earnings • Dec 03Third quarter 2020 earnings released: kr1.24 loss per shareThird quarter 2020 results: Net loss: kr52.7m (loss widened 90% from 3Q 2019).
Reported Earnings • Dec 01Third quarter 2020 earnings released: kr1.24 loss per shareThird quarter 2020 results: Net loss: kr52.7m (loss widened 90% from 3Q 2019).
공고 • Nov 30+ 3 more updatesSaniona AB (publ) to Report Fiscal Year 2021 Results on Feb 24, 2022Saniona AB (publ) announced that they will report fiscal year 2021 results at 8:00 AM, Central European Standard Time on Feb 24, 2022
공고 • Nov 27+ 1 more updateSaniona AB (publ) Appoints Nomination Committee MembersSaniona AB (publ) announced that together with the Chairman of the Board of Directors will form Saniona AB’s Nomination Committee, the Nomination Committee’s members are: Søren Skjærbæk, Partner at Ursus law firm, Vejle, Denmark, appointed by Jørgen Drejer and John Haurum, professional board member for life science companies and former CEO of F-star Biotechnology Limited, Cambridge, UK, appointed by New Leaf Venture Partners.
공고 • Nov 25Saniona Reports Positive Topline Results from Tesomet Phase 2 Open-Label Extension Study in Hypothalamic ObesitySaniona announced positive top-line results from the Phase 2 open-label extension study of Tesomet in patients with hypothalamic obesity (HO). Patients treated with Tesomet for nearly one year (24 week double-blind [DB] followed by 24 week open label extension [OLE]) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control. No clinically meaningful differences in heart rate or blood pressure were observed over the course of the trial. Highlights from top-line open-label extension study data include: Safety: The primary endpoint of the study was the overall safety and tolerability of Tesomet in patients with HO. Tesomet was shown to be well-tolerated. Side effects observed in the open-label extension (OLE) period of the study were generally mild and consistent with those observed in the double-blind (DB) period. The most common adverse events included dry mouth, joint pain, headache and dizziness. There were three events of palpitations in the placebo patients who were switched to Tesomet, and none in the group that received Tesomet for the full 48 weeks. There was one serious adverse event related to abdominal pain which spontaneously resolved. There were no clinically meaningful differences in heart rate or blood pressure observed over the nearly year-long study. All 18 patients who entered the OLE study completed it. Bodyweight: As previously reported, treatment with Tesomet led to a statistically significant 6.28% average reduction in bodyweight compared to placebo (p=0.0169) in the 24-week DB period of the study. This reduction was maintained through the 24-week OLE period, with these patients demonstrating a statistically significant 5.96% average reduction in bodyweight at Week 48 (p=0.008 vs baseline). Additionally, patients who received placebo during the DB period and were switched to Tesomet at Week 24 for the OLE period demonstrated a clinically meaningful 4.95% average reduction in bodyweight from baseline to Week 48. Waist circumference: As previously reported, treatment with Tesomet led to a 5.04% reduction in waist circumference compared to placebo (p=0.0519) in the DB period. This reduction was maintained during the OLE period, with these patients demonstrating a 5.07% reduction in waist circumference at Week 48 (p=0.003). Additionally, patients who received placebo during DB period and were switched to Tesomet at Week 24 for the OLE period demonstrated a 2.24% average reduction in waist circumference from baseline to Week 48. Glycemic control: As previously reported, there were two diabetic (T2D) patients who received Tesomet during the DB period, and they showed marked reduction of HbA1c levels (48.8% at Week 24), while no change was seen in normoglycemic patients. These two diabetic patients continued to receive Tesomet during the OLE period, and the reduction in HbA1c was maintained (46.17% at Week 48). Saniona intends to present and/or publish additional data from this study in an appropriate future peer-reviewed, scientific forum. Additionally, Saniona intends to provide these data to the FDA as part of ongoing communications around plans to ensure that only appropriate patients would receive Tesomet, if approved. Pending this alignment with the FDA, Saniona intends to initiate a Phase 2b study in HO in the first half of 2021.
Is New 90 Day High Low • Oct 21New 90-day low: €2.37The company is down 20% from its price of €2.96 on 22 July 2020. The German market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 12% over the same period.
공고 • Oct 10Saniona Receives Pre-IND Feedback from FDA on Regulatory Path for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO)Saniona announced that it received written feedback from the U.S. Food and Drug Administration (FDA) regarding pre-Investigational New Drug (IND) submissions for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO). Regarding PWS, the FDA's Division of Psychiatry within the Office of Neuroscience provided additional feedback on conducting a supportive Phase 2b study evaluating multiple doses of Tesomet in adult and adolescent PWS patients. Saniona expects to begin this Phase 2b study in the first half of 2021. As part of its ongoing discussions with the FDA, Saniona inquired if the planned Phase 2b study could serve as a single pivotal trial supporting approval of Tesomet in PWS. The FDA considered this request and, as Tesomet is a new molecular entity, the agency recommended that Saniona conduct a supportive Phase 2b study prior to initiating a Phase 3 study to confirm the safety and efficacy of the doses intended for commercialization. In addition, in recognition of the significant unmet need within the PWS pediatric population, the FDA recommended that Saniona plan to evaluate Tesomet in children younger than age 12. Regarding HO, the FDA's Division of Diabetes, Lipid Disorders and Obesity within the Office of Cardiology, Hematology, Endocrinology, and Nephrology agreed that the 505(b)(2) pathway is an appropriate development pathway for Tesomet. The agency recommended that the clinical development program for Tesomet in HO include a supportive Phase 2b study followed by a Phase 3 study. The agency expressed concerns about potential off-label use in the general obese population and suggested this needs to be evaluated, such as through a cardiovascular outcomes study, or that Saniona would need to clarify how it would restrict distribution of Tesomet exclusively to the rare HO population. Saniona is seeking additional guidance from the FDA in order to clarify the path forward for Tesomet in HO.
공고 • Aug 12Saniona AB (publ) has completed a Follow-on Equity Offering in the amount of $64.999993 million.Saniona AB (publ) has completed a Follow-on Equity Offering in the amount of $64.999993 million. Security Name: Shares Security Type: Common Stock Securities Offered: 30,660,374 Price\Range: $2.12 Transaction Features: Subsequent Direct Listing
공고 • Jul 30An unknown buyer acquired 3.96% stake in Scandion Oncology A/S (NGM:SCOL) from Saniona AB (publ) (OM:SANION) for for $2.3 million.An unknown buyer acquired 3.96% stake in Scandion Oncology A/S (NGM:SCOL) from Saniona AB (publ) (OM:SANION) for $2.3 million on June 22, 2020. As part of the acquisition, Saniona sold 0.75 million shares of Scandion Oncology. The sale of shares brings Saniona’s ownership stake in Scandion Oncology below 15%. Proceeds from sales of shares will be used to continue Saniona's advancement of their pipeline, including mid/late-stage clinical trials with Tesomet. An unknown buyer completed the acquisition of 3.96% stake in Scandion Oncology A/S (NGM:SCOL) from Saniona AB (publ) (OM:SANION) on June 22, 2020.