New Risk • Jul 02
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 37% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (37% increase in shares outstanding). Minor Risk Share price has been volatile over the past 3 months (9.2% average weekly change). New Risk • May 05
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 29% 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: Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding). Reported Earnings • May 02
First quarter 2026 earnings released: kr0.24 loss per share (vs kr0.17 loss in 1Q 2025) First quarter 2026 results: kr0.24 loss per share (further deteriorated from kr0.17 loss in 1Q 2025). Revenue: kr13.4m (up 5.5% from 1Q 2025). Net loss: kr94.5m (loss widened 50% from 1Q 2025). Revenue is forecast to grow 64% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Europe. Breakeven Date Change • Apr 30 The 4 analysts covering Egetis Therapeutics previously expected the company to break even in 2026. New consensus forecast suggests the company will make a profit of kr108.8m in 2026. Earnings growth of 38% is required to achieve expected profit on schedule.
New Risk • Apr 23
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 29% 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: Minor Risks Share price has been volatile over the past 3 months (9.7% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding). Board Change • Apr 15
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Behshad Sheldon was the last independent director to join the board, commencing their role in 2023. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Apr 15
Egetis Therapeutics AB (publ) Approves Board Appointments Egetis Therapeutics AB (publ) announced at its Annual General Meeting held on April 14, 2026, Jay Donovan Wu and Birgitte Volck were newly elected as members of the Board of Directors. New Risk • Apr 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 8.4% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr268m). Share price has been volatile over the past 3 months (8.4% average weekly change). Reported Earnings • Mar 30
Full year 2025 earnings released: kr0.93 loss per share (vs kr1.12 loss in FY 2024) Full year 2025 results: kr0.93 loss per share (improved from kr1.12 loss in FY 2024). Revenue: kr62.4m (up 35% from FY 2024). Net loss: kr342.5m (flat on FY 2024). Revenue is forecast to grow 54% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Europe. Reported Earnings • Feb 27
Full year 2025 earnings released: kr0.93 loss per share (vs kr1.12 loss in FY 2024) Full year 2025 results: kr0.93 loss per share (improved from kr1.12 loss in FY 2024). Revenue: kr62.4m (up 35% from FY 2024). Net loss: kr342.5m (flat on FY 2024). Revenue is forecast to grow 81% p.a. on average during the next 2 years, compared to a 14% growth forecast for the Biotechs industry in Europe. New Risk • Feb 27
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -kr268m This is considered a minor 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: Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr268m). Share price has been volatile over the past 3 months (8.2% average weekly change). Annuncio • Jan 02
Egetis Therapeutics AB (publ)(OM:EGTX) dropped from OMX Nordic Small Cap Index PledPharma AB has been removed from OMX Nordic Small Cap Index . Reported Earnings • Nov 26
Third quarter 2025 earnings released: kr0.23 loss per share (vs kr0.29 loss in 3Q 2024) Third quarter 2025 results: kr0.23 loss per share (improved from kr0.29 loss in 3Q 2024). Revenue: kr17.4m (up 85% from 3Q 2024). Net loss: kr82.4m (loss narrowed 4.4% from 3Q 2024). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Europe. Breakeven Date Change • Nov 26 The 4 analysts covering Egetis Therapeutics previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 6.6% to 2025. The company is expected to make a profit of kr113.6m in 2026. Average annual earnings growth of 79% is required to achieve expected profit on schedule.
Annuncio • Oct 11
Egetis Therapeutics AB (publ), Annual General Meeting, May 06, 2026 Egetis Therapeutics AB (publ), Annual General Meeting, May 06, 2026. Reported Earnings • Aug 25
Second quarter 2025 earnings released: kr0.22 loss per share (vs kr0.25 loss in 2Q 2024) Second quarter 2025 results: kr0.22 loss per share. Net loss: kr77.6m (loss widened 7.9% from 2Q 2024). Revenue is forecast to grow 84% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Europe. Annuncio • Aug 18
Egetis Therapeutics AB (publ) Reports Progress Towards US NDA Submission for Tiratricol Egetis Therapeutics AB (publ) announced that it has submitted a pre-NDA meeting (Type B) request to the US Food and Drug Administration (FDA) to discuss the contents and timing, including the role and position of the ReTRIACt study, of its New Drug Application (NDA) for tiratricol in the US, in light of the Breakthrough Therapy Designation (BTD) awarded on July 15, 2025, by the FDA. A BTD is awarded to programs that have shown preliminary evidence of clinical benefit that results in a meaningful improvement of key signs and symptoms compared to existing therapies. Egetis also provided an update on the recruitment status of the ReTRIACT study (clinicaltrials.gov identifier NCT05579327), evaluating withdrawal of tiratricol in patients with MCT8 deficiency. There are 15 evaluable patients in the trial. The Company plans to initiate the submission of the NDA to the FDA during 2025. The BTD was granted based on the Agency's review of Egetis' detailed analysis of the entire survival data set from the international real-world cohort study by the Erasmus University Medical Center (for preliminary results, see Abstract in Ref. 1), demonstrating a significant and substantial improvement in survival in tiratricol treated vs untreated patients. Receiving a BTD this late in a clinical development program is very encouraging for the forthcoming NDA process, as these designations are typically awarded at an early stage in development. On February 13, 2025, the European Commission approved Emcitate®? (tiratricol) as the first and only treatment for MCT8 deficiency in EU. Egetis launched Emcitate in the first country, Germany, on May 1, 2025. The Company's lead drug candidate Emcitate®? (Tiratricol) is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. After a dialogue with the FDA, Egetis is conducting a randomized, placebo-controlled pivotal study in at least 16 evaluable patients to verify the results on T3 levels seen in previous clinical trials and publications. As previously communicated, the Company will update the market as soon as recruitment closes, and at that time, the Company will also provide information on when to expect topline results and when the Company plans to submit the NDA application in 2025.iratricol holds FDA Breakthrough Therapy Designation and Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations.iratricol has been granted Rare Pediatric Disease Designation (RPDD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval. This voucher can be transferred or sold to another sponsor. The drug candidate Aladote®? (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed. The design of a pivotal Phase IIb study has been successfully completed. Annuncio • May 07
Egetis Therapeutics AB (Publ) Appoints Margarida Duarte as Members of the Board of Directors Egetis Therapeutics AB (publ) at its AGM held on May 6, 2025 appointed Margarida Duarte as members of the Board of Directors. Annuncio • May 05
Egetis Therapeutics AB (Publ) Confirms Launch of Emcitate® in Germany Egetis Therapeutics AB (publ) confirms the availability of its first approved product, Emcitate® (tiratricol) in Germany, as of May 1. This follows the European Commission's approval of Emcitate®? on February 13, 2025 for the treatment of MCT8 deficiency - a rare and serious condition. Emcitate® is the first and only approved treatment in the EU for MCT8 deficiency. The German launch marks a major step in Egetis' journey from an emerging biotech to a commercial-stage company. It is the first of several planned launches in EU with initial focus on the EU4 countries - Germany, France, Spain, and Italy - with pricing and reimbursement dossiers submitted in both Germany and France. Since acquiring the rights to Emcitate, Egetis has made significant scientific, clinical, and manufacturing investments, totaling over EUR 100 million, to advance Emcitate® from concept to commercialization. These include: Clinical Development: Sponsoring two key clinical trials to demonstrate efficacy and safety in patients with MCT8 deficiency and bioavailability /bioequivalence in healthy volunteers, alongside an ongoing pivotal trial supporting the upcoming New Drug Application (NDA) to the US FDA. Non-Clinical Studies: Execution of comprehensive in vivo and in vitro studies to satisfy safety requirements. Formulation Development: Development of a new patient-friendly tablet to meet regulatory requirements and current quality standards. The new tablet also offers greater delivery convenience for patients and caregivers. Manufacturing Upgrades: Major investments in manufacturing infrastructure to meet current Good Manufacturing Practice (GMP) and regulatory standards. Recent Insider Transactions • Jan 12
Chief Financial Officer recently sold €125k worth of stock On the 9th of January, Yilmaz Mahshid sold around 213k shares on-market at roughly €0.58 per share. This transaction amounted to 68% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Yilmaz has been a net seller over the last 12 months, reducing personal holdings by €121k. New Risk • Nov 09
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr216m 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 (-kr216m free cash flow). Shares are highly illiquid. Minor Risk Shareholders have been diluted in the past year (23% increase in shares outstanding). Reported Earnings • Nov 09
Third quarter 2024 earnings released: kr0.29 loss per share (vs kr0.34 loss in 3Q 2023) Third quarter 2024 results: kr0.29 loss per share (improved from kr0.34 loss in 3Q 2023). Revenue: kr9.40m (down 23% from 3Q 2023). Net loss: kr86.2m (flat on 3Q 2023). Revenue is forecast to grow 80% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Annuncio • Nov 01
Egetis Therapeutics AB (publ), Annual General Meeting, May 06, 2025 Egetis Therapeutics AB (publ), Annual General Meeting, May 06, 2025. Breakeven Date Change • Oct 24
Forecast breakeven date pushed back to 2026 The 5 analysts covering Egetis Therapeutics previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 57% per year to 2025. The company is expected to make a profit of kr127.7m in 2026. Average annual earnings growth of 90% is required to achieve expected profit on schedule. Annuncio • Oct 04
Egetis Therapeutics AB (Publ) Announces Resignation of Peder Walberg from the Board of Directors Egetis Therapeutics AB (publ) announced that Peder Walberg has decided to resign from the Board of Directors with immediate effect, to focus on his role as a major shareholder of the Company. Peder will continue to support the Company in his current operational role as a consultant to the Company. Annuncio • Sep 19
Egetis Submits A Patent Application to the United States Patent and Trademark Office for Processes of Preparation of Tiratricol Egetis Therapeutics AB (publ) announced that it has submitted a patent application tothe United States Patent and Trademark Office (USPTO) for "Processes of Preparation" of tiratricol. If granted, this would be a significant patent Egetis has obtained for the investigational drug tiratricol. Tiratricol is an endogenously available metabolite of thyroid hormone, with similar bioactive properties as the active thyroid hormone T3. Tiratricol enters the cell independently of the monocarboxylate transporter 8 (MCT8), bypassing the pathophysiologic defect in MCT8 deficiency. Clinical trials for the use of tiratricol for the treatment of MCT8 deficiency are ongoing and in October 2023 Egetis submitted a marketing authorisation application (MAA) in the EU. Accordingly, new and more efficient synthetic routes leading to tiratricol are needed. The processes and compounds described in the patent application help meet these and other needs. Egetis holds Orphan Drug Designation (ODD) for Emcitate® (tiratricol) for MCT8 deficiency in the US and the EU, which currently provides marketing exclusivities of 7 and 10 years, respectively, from the dates of regulatory approvals. Generally, the exclusivityterm of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Annuncio • Jun 20
Egetis Therapeutics AB (publ) Announces Topline Results of the Phase 2 Triac Trial II with Emcitate (Tiratricol) for MCT8 Deficiency Egetis announced topline results of the Phase 2 Triac Trial II with Emcitate (tiratricol) for MCT8 deficiency The numerical improvements versus baseline observed on the primary endpoints of neurocognitive development assessed by the GMFM-88 and BSID-III scales did not show a statistically significant improvement versus historical controls. The trial confirmed the significant and durable reduction of endogenous T3 concentrations in all patients and the well-tolerated safety profile of tiratricol seen in previous clinical studies, despite higher dosing per kg body weight compared to previous trials. The trial is complementary to the data already submitted and validated in the Marketing Authorisation Application for Emcitate (Tiratricol) for treatment of MCT8 deficiency, based on the benefit of normalization of thyrotoxicosis which has been demonstrated in patients of all ages, as agreed with the European Medicines Agency (EMA). Results from Triac Trial II will be included in the response to EMA 120-day list of questions in August 2024. The forthcoming New Drug Application in the USA will also be based on the already observed treatment effects on T3 concentrations and the manifestations of chronic thyrotoxicosis together with results from the ongoing ReTRIACt trial, as acknowledged by the US Food and Drug Administration (FDA). The timeline for regulatory review and approval in EU remain unchanged. For the US, as previously communicated, the Company will update the market with regards to timelines for NDA submission as soon as 16 evaluable patients have concluded the ongoing ReTRIACT trial. Another important feature of this disease is the high serum T3 concentrations in the blood. This results in thyrotoxicosis in tissues that are not dependent on MCT8 for their thyroid hormone supply. As a result, patients with MCT8 deficiency have clinical features of thyrotoxicosis such as low body weight, elevated heart rate and reduced muscle mass. Preclinical studies have shown that the T3 analogue tiratricol is transported into cells in an MCT8-independent manner. In animal models mimicking MCT8 deficiency, tiratricol has been shown to normalize brain development if administrated during early postnatal life. In previous studies (Triac Trial I and a long-term real-life study) has shown highly significant and clinically relevant results on Emcitate serum thyroid hormone T3 levels and secondary clinical endpoints. Emcitate submitted a marketing authorisation application (MAA) for Emcitate to the European Medicines Agency (MA) in October 2023. After a dialogue with the FDA, Egetis is conducting a randomized, placebo-controlled pivotal study in 16 evaluable patients to verify the results on T3 levels seen in previous clinical trials and publications. Egetis will update the market as soon as recruitment has been completed and at that point inform about the timing of availability of top-line results, and the expected timing of the subsequent NDA filing. Emcitate holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in the US and the EU. The drug candidate Aladote®? (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury. New Risk • Feb 25
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr278m 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 (-kr278m free cash flow). Shares are highly illiquid. Minor Risk Shareholders have been diluted in the past year (17% increase in shares outstanding). Reported Earnings • Feb 23
Full year 2023 earnings released: kr1.27 loss per share (vs kr1.00 loss in FY 2022) Full year 2023 results: kr1.27 loss per share (further deteriorated from kr1.00 loss in FY 2022). Revenue: kr57.6m (up 155% from FY 2022). Net loss: kr326.9m (loss widened 69% from FY 2022). Revenue is forecast to grow 69% p.a. on average during the next 3 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 14% per year but the company’s share price has fallen by 11% per year, which means it is significantly lagging earnings. Annuncio • Dec 13
Egetis Therapeutics AB (publ) Provides Update on Disease Awareness and the Expanded Access Program for Tiratricol (Emcitate) in the USA Egetis Therapeutics AB (publ) provided an update on disease awareness of MCT8 deficiency and the Expanded Access Program (EAP) for tiratricol (for eligible patients with MCT8 deficiency in the USA. MCT8 deficiency is an ultra-rare genetic condition that was described only in 2004 and Egetis is the first pharmaceutical company to develop a possible therapy for this disease. Consequently, the general understanding of the disease and its diagnosis is still very low, even among specialist physicians, and a large proportion of patients remain undiagnosed. The Company has focused its medical affairs activities on improving disease awareness and diagnosis, including participation and dialogues at scientific conferences, patient identification partnerships with genetic testing companies, Key Opinion Leader engagements, advisory boards and interactions with Patient Advocacy Groups. This has resulted in the identification of an additional 50 MCT8 deficiency patients in the USA, previously not diagnosed or known to the Company. Through broad implementation of Expanded Access Program for tiratricol in the USA the administrative burden for treating physicians will be reduced, should they wish to prescribe tiratricol to MCT8 patients under their care. The EAP is also important for patients who finish the ReTRIACt trial, to secure continued access to the treatment. MCT8 deficiency is a severely debilitating ultra-rare disease without any approved treatments and tiratricol has the opportunity to become the first approved treatment of MCT8 deficiency. The EAP was submitted to the US Food and Drug Administration (FDA) in October 2022, on request by the FDA. Healthcare professionals interested in making a request for access to the EAP or learning more about the criteria for the program can visit, study NCT05911399. According to the FDA rules for Early Access Programs, any patient enlisted in an EAP should first be evaluated for participation in ongoing clinical trials. About FDA's Expanded Access program. The Food and Drug Administration (F FDA) regulates the development and approval for marketing of medical products in the USA. Before regulatory approval, it is not normally possible to prescribe a pharmaceutical under development outside of clinical trials. However, in the case of a serious condition or disease for which there are no satisfactory alternatives, and where a clinical trial is not an option for a patient, a physician that wishes to prescribe an unapproved therapy may request permission through FDA's Expanded Access Program (E AP). EAPs are designed to give access to potential therapies before they are approved by the FDA and may include people not typically eligible for clinical trials. Additionally, FDA may ask a sponsor to consolidate expanded access for groups of patients under an existing IND when the agency has received a significant number of requests for individual patient expanded access to an investigational drug for the same use. The Company's lead drug candidate is under development for the treatment of patients with monocarboxylate Emcitate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In previous studies (Triac Trial I and a long-term real-life study) has shown highly significant and clinically relevant results on serum thyroid hormone T3 Emcitate levels and secondary clinical endpoints. Egetis submitted a marketing authorisation application (MAA) for to the Emcitate European Medicines Agency (EMA) in October 2023. After a dialogue with the FDA, Egetis is conducting a small randomized, placebo-controlled pivotal study in 16 patients to verify the results on T3 levels seen in previous clinical trials and publications. Egetis intends to submit a new drug application (NDA) in the US for in mid 2024 under the Fast-Track Designation granted by FDA. Emcitate. holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in Emcitate the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Emcitate has been granted Rare Pediatric Disease Designation (RPDD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval. This voucher can be transferred or sold to another sponsor. This voucher can be transferred and sold to another sponsor. The drug candidate is a first in the US, after approval". This voucher can be transferred or sell to another sponsor. This voucher will be transferred or sold to another sponsors. This voucher can be transferred to another sponsor. The drug candidates. The drug candidate is a priority to another sponsor. This voucher could be transferred to another sponsor. Annuncio • Nov 08
Egetis Therapeutics AB (publ) to Report Q1, 2024 Results on May 03, 2024 Egetis Therapeutics AB (publ) announced that they will report Q1, 2024 results on May 03, 2024 Annuncio • Nov 01
Egetis Therapeutics AB (publ), Annual General Meeting, May 06, 2024 Egetis Therapeutics AB (publ), Annual General Meeting, May 06, 2024. Annuncio • Oct 27
Egetis Therapeutics AB (publ) Announces Ema Validation of Marketing Authorisation Application for Emcitate for the Treatment of Mct8 Deficiency Egetis Therapeutics AB (publ) announced that its Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Emcitate (tiratricol) for the treatment of MCT8 deficiency has been validated. On October 9, 2023, Egetis announced the submission of the MAA. EMA performs a validation of the applications it receives. The objective is to make sure all essential regulatory elements required for scientific assessment are included in the application prior to the start of the review procedure. The Emcitate MAA is as of October 26, 2023, under review by the Committee for Medicinal Products for Human Use (CHMP). Annuncio • Oct 10
Egetis Therapeutics AB (publ) Submits Marketing Authorisation Application for Emcitate for Treatment of MCT8 Deficiency to the European Medicines Agency Egetis Therapeutics AB (publ) announced that the Company has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for Emcitate (tiratricol) for the treatment of MCT8 deficiency. This is an important step towards bringing the first approved treatment for MCT8 deficiency to patients and a transformative milestone for the Company. Emcitate has been granted Orphan Drug Designation by the EMA for MCT8 deficiency, and will following approval by the European Commission be eligible for 10 years of market exclusivity within the EU. The median review time for marketing authorisation applications in the EU is around 13-14 months. As agreed with the US FDA, Egetis is conducting a randomized, placebo-controlled pivotal study (ReTRIACt) in 16 evaluable patients to verify the results on thyroid hormone T3 levels seen in previous clinical trials and publications. The study started recruiting in July this year and patient recruitment is proceeding according to plan. Topline results are expected during the first half of 2024 and Egetis intends to submit a new drug application (NDA) in the USA for Emcitate in mid-2024 under the Fast-Track Designation granted by the FDA. In addition to the completed and ongoing clinical trials with Emcitate, more than 180 patients in over 25 countries, are currently being treated with Emcitate as part of the Company's Expanded Access/Named Patient Use/Compassionate Use programs. Annuncio • Aug 24
Egetis Therapeutics AB (publ) to Report Fiscal Year 2023 Results on Feb 24, 2024 Egetis Therapeutics AB (publ) announced that they will report fiscal year 2023 results on Feb 24, 2024 Annuncio • Jul 24
Egetis Therapeutics AB (Publ) Announces First Patient Included and Second Site Activated in the Pivotal Retriact Trial Egetis Therapeutics AB (publ) announced that the first patient has been included and a second site has been activated in the pivotal ReTRIACt clinical trial for the new drug application (NDA) in the USA for The trial will be conducted across three centers: at Erasmus Medical Center, Rotterdam, the Emcitate. Netherlands, Children's Hospital of Philadelphia, Philadelphia, PA, USA, and Addenbrooke's Hospital, Cambridge, UK. As previously reported, the Company expects topline results from the ReTRIACt study during the first half of 2024 and estimates a subsequent NDA submission in the USA in mid-2024, under the fast-track designation. Annuncio • May 25
Egetis Terminates Discussions Regarding Potential Acquisition Egetis Therapeutics AB (publ) (OM:EGTX) said on May 23, 2023 Egetis announced termination of discussions regarding potential acquisition of co. Discussions have now been terminated as board believes contemplated offer, terms, while providing premium to current share price, considerably undervalued long-term prospects of company. Annuncio • Jan 28
Egetis Therapeutics AB (Publ) Appoints Katayoun Welin-Berger as Vice President Operations, Effective from March 2023 Egetis Therapeutics AB (publ) announced the recruitment of Katayoun Welin-Berger, PhD, as Vice President Operations effective March 2023. Katayoun will be a member of the Company's leadership team. Katayoun has 30 years of experience in the pharmaceutical, probiotics and dietary supplements industries. She has a broad experience from roles of increasing responsibilities in areas including product development, CMC documentation, GMP manufacturing, procurement, outsourcing, supplier management, divestment, supply chain management and product life-cyclemanagement. Prior to joining Egetis, Katayoun was Vice President Operations at Calliditas Therapeutics with the responsibility of designing and managing the supply chains for development candidates and commercial products, and previously she held a similar role at BioGaia. Katayoun began her career in the pharmaceutical industry at AstraZeneca and held several positions within both R&D and Operations. She obtained a PhD in Pharmacy from Uppsala University. Annuncio • Dec 08
Egetis Therapeutics AB Submits Expanded Access Program for Emcitate® in the USA Egetis Therapeutics AB (publ) announced that the Company has submitted a protocol for an Expanded Access Program for Emcitate (tiratricol) in the USA, as requested by the Food and Drug Administration (FDA). Emcitate is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment, but does not yet hold regulatory approval anywhere in the world. Until now, physicians treating MCT8-deficiency patients in the USA, who are not part of an ongoing clinical trial with Emcitate, have been able to request authorization to treat patients by submitting individual Investigational New Drug (IND) requests to the FDA. As the number of diagnosed MCT8-deficiency patients has increased, with a concomitant increase in applications for individual INDs, Egetis has decided to implement an Expanded Access Program. Annuncio • Nov 29
Egetis Therapeutics AB (publ) to Report Fiscal Year 2022 Results on Feb 22, 2023 Egetis Therapeutics AB (publ) announced that they will report fiscal year 2022 results at 9:00 AM, Central European Standard Time on Feb 22, 2023 Annuncio • Jul 13
Egetis Therapeutics AB (publ) Receives Positive Opinion on Orphan Designation for Aladote® from the European Medicines Agency for the Prevention of Acute Liver Failure Egetis Therapeutics AB (publ) announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Aladote (calmangafodipir) for designation as orphan medicinal product for the Prevention of Acute Liver Failure, a life-threatening condition. Aladote is a first-in-class drug candidate developed for the treatment of paracetamol overdose in combination with N-acetylcysteine (NAC) to prevent acute liver failure. A proof-of-principle study has been successfully completed and the design of the upcoming pivotal Phase IIb/III study with the purpose of applying for market approval in the US and Europe for Aladote has been finalized after interactions with the US Food and Drug Administration (FDA), EMA and the UK Medicines and Healthcare products Regulatory agency (MHRA). Egetis expects to start this pivotal study for Aladote in 2022. The positive opinion adopted by the EMA on the application for orphan designation for the Prevention of Acute Liver Failure follows the Orphan Drug Designation for the Treatment of Acetaminophen Overdose granted by the US FDA in 2019. N-acetylcysteine (NAC) is the current standard of care antidote for paracetamol poisoning. It is most effective if given within eight hours of the overdose. Patients arriving later to the hospital, and for those with a severe overdose, there is a need for more efficacious treatment options. The scientific rationale as well as clinical results from a completed proof-of-principle study indicate that Aladote in combination with NAC has the potential to reduce liver damage in the specified patient population. Annuncio • Jun 21
Egetis Therapeutics AB (Publ) Appoints Sara Melton as President of North America Egetis Therapeutics AB (publ) announced the appointment of Sara Melton as President of North America. Ms. Melton will be part of the Company's leadership team and brings over 20 years of commercial leadership experience in biotechnology, pharmaceutical, and medical device companies, including rare disease. She will be responsible for establishing and maintaining a successful presence of Egetis and its products in the United States and Canada, including building the infrastructure for Egetis North America, developing relationships with key national stakeholders, and recruiting a highly effective team to support all initiatives necessary for the successful launch of Emcitate in 2024. Prior to joining Egetis Ms. Melton served as Vice President Commercial, Sales and Marketing Rare Disease at Mezzion Pharmaceuticals, Chicago, IL. Sara previously held various commercial leadership roles in biotechnology, pharmaceutical and medtech companies, including Astellas US LLC., Bristol-Myers Squibb, Arthrex Inc., and Achaogen Inc. Ms. Melton has an EMBA from Northwestern University, Kellogg School of Management. Breakeven Date Change • May 28
No longer forecast to breakeven The 2 analysts covering Egetis Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr170.0m in 2023. New consensus forecast suggests the company will make a loss of kr44.0m in 2023. Board Change • May 06
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Gunilla Osswald was the last independent director to join the board, commencing their role in 2017. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • May 06
Egetis Therapeutics AB (Publ) Announces Executive Changes Egetis Therapeutics AB (publ) announced three key appointments to medical affairs and the commercial team to deliver on activities to ensure successful launches after anticipated approvals of Emcitate in USA and Europe in 2024. Marianne Berrens-Peijnenburg joins as Global Head of Medical Affairs, Nadia Georges joins as Global Head of Market Access & Pricing, and Peter Verwaijen joins as Global Head of Marketing & Brand Strategy. Marianne Berrens-Peijnenburg has previously had international and senior roles at companies such as Santhera, Sanofi Genzyme and J&J. Marianne will be based in The Netherlands. Nadia Georges brings experience from global and international roles at companies such as Ferring, Takeda and Sanofi. Nadia will be based in Switzerland. Peter Verwaijen has previously had international and senior positions at companies such as Santhera, Roche and Actelion. Peter will be based in The Netherlands.