Annuncio • Jul 20
Medivir Receives Notice of Allowance for Fostrox Plus Lenvatinib Combination Patent in the Usa Medivir AB announced that it has received a Notice of Allowance by the United States Patent and Trademark Office (USPTO) for the company's patent application covering claims for the combination of fostroxacitabine bralpamide (fostrox) with lenvatinib for the treatment of hepatocellular carcinoma (HCC) and cancer metastases to the liver. This adds to the previous approvals in EU, Japan, Australia and Canada. The Notice of Allowance indicates that the USPTO intends to grant the application once standard procedural steps have been completed. The fostrox plus lenvatinib combination patent provides protection and market exclusivity until at least April 2041. Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling a chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel inactive to the liver where activation and release takes place locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with primary liver cancer and liver metastases from other tumor types. A phase 1b monotherapy study with fostrox has previously been conducted that established clinical proof-of-concept. A phase 1b/2a combination study with fostrox in combination with Lenvima in advanced HCC was completed in November 2024, where data showed encouraging anti-cancer efficacy with a good safety and tolerability profile. Board Change • May 21
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. No experienced directors. 1 highly experienced director. Director Uli Hacksell is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Annuncio • Mar 07
Medivir AB Appoints Patrik Norgren as Chief Financial Officer, Effective March 23, 2026 Medivir AB has appointed Patrik Norgren as Chief Financial Officer. He will assume his role on March 23, 2026. Norgren most recently served as CFO of the Swedish pharmaceutical company Cinclus Pharma. He brings over 20 years of extensive experience in CFO and senior financial leadership roles across both private and publicly listed companies. Annuncio • Feb 18
Medivir AB (publ) to Report Nine Months, 2026 Results on Nov 05, 2026 Medivir AB (publ) announced that they will report nine months, 2026 results on Nov 05, 2026 Annuncio • Feb 10
Medivir AB (publ) announced that it has received SEK 45 million in funding from Carl Bennet AB On February 9, 2026, Medivir AB (publ) closed the transaction. Annuncio • Jan 29
Medivir AB (publ), Annual General Meeting, May 07, 2026 Medivir AB (publ), Annual General Meeting, May 07, 2026. Annuncio • Jan 15
Medivir AB (Publ) Appoints Anders Hallberg as Ordinary Board Member and Chairman of the Board Medivir AB held an extraordinary general meeting on January 14, 2026. The extraordinary general meeting resolved that the board shall consist of four ordinary board members without deputies. Anders Hallberg was elected as ordinary board member for the period until the next annual general meeting, with Anders Hallberg as chairman of the board. Annuncio • Oct 09
Medivir AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 151.426537 million. Medivir AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 151.426537 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 336,503,415
Price\Range: SEK 0.45
Transaction Features: Rights Offering Annuncio • Jul 10
Medivir AB Receives Notice of Allowance for Fostrox Plus Lenvatinib Combination Patent by Japan Patent Office Medivir AB announced that it has received a Notice of Allowance by the Japan Patent Office (JPO) for the company's patent application covering claims for the combination of fostroxacitabine bralpamide (fostrox) with lenvatinib (L envima) for the treatment of hepatocellular carcinoma (HCC) and cancer metastases to the liver. This adds to the recent approval by the Australian Patent Office (IP Australia) and the previously communicated European Unitary patent approval. The Notice of Allowance indicates that the JPO intends to grant the application once standard procedural steps have been completed. The fostrox plus Lenvima combination patent provides protection and market exclusivity until April 2041. Annuncio • Mar 28
Medivir AB (publ), Annual General Meeting, May 07, 2025 Medivir AB (publ), Annual General Meeting, May 07, 2025, at 14:00 W. Europe Standard Time. Location: at 7a odenplan, norrtullsgatan 6, stockholm Sweden Annuncio • Feb 18
Medivir AB (publ) to Report Nine Months, 2025 Results on Nov 06, 2025 Medivir AB (publ) announced that they will report nine months, 2025 results on Nov 06, 2025 Annuncio • Dec 16
Medivir AB Obtains IND Approval for Fostrox - the Firstoral, Liver-Targeted Treatment for Advanced Liver Cancer Medivir AB announced the approval of the US Investigational New Drug application (IND) for evaluating fostrox + Lenvima vs Lenvima alone in a phase 2b study in 2nd line advanced HCC. The randomized phase 2b study will evaluate the combination of fostrox + Lenvima vs Lenvima alone in second-line advanced HCC patients who have previously been treated with an immunotherapy combination. The primary endpoint is Objective Response Rate with secondary endpoints including duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and Quality of Life. Principal Investigator of the study is Prof. Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona in Spain, and one of the most renowned global experts in the field of liver cancer. Annuncio • Nov 28
Medivir AB Announces Finalisation of the Phase 1B/2A Study of fostroxacitabine bralpamide Medivir AB announced that the phase 1b/2a study of fostroxacitabine bralpamide (fostrox) + Lenvima® in 2nd or 3rd line advanced liver cancer (HCC), closed on November 26th. The 3 remaining patients in the study have been transferred to compassionate use, allowing continued benefit from the treatment. At the ESMO congress in Barcelona in September, the company presented positive, mature data showing an encouraging tolerability profile and improved outcomes beyond what can be expected from current alternatives in second-line advanced HCC. Patients in the study showed extended duration of benefit, resulting in longer than expected treatment time, as evidenced by a median Time to Progression of 10.9 months. This is substantially longer than previously seen in second-line HCC. With the study now closed, the company plans to present end-of-treatment data at an upcoming scientific congress. The objectives of the phase 1b/2a study, evaluating safety and preliminary efficacy of fostrox in combination with Lenvima, were met. Mature data presented at ESMO this year showed that the combination is safe and tolerable with encouraging anti-tumor activity. These results indicate improved outcomes beyond current second-line alternatives in advanced HCC and with a compassionate use program in place, the remaining patients can continue benefitting from the treatment. Reported Earnings • Nov 07
Third quarter 2024 earnings released: kr0.30 loss per share (vs kr0.42 loss in 3Q 2023) Third quarter 2024 results: kr0.30 loss per share. Net loss: kr34.6m (loss widened 47% from 3Q 2023). Revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe. Annuncio • Oct 23
Medivir AB (Publ) Appoints Nomination Committee Medivir AB (publ) announced that the composition of its Nomination Committee is now completed, and this year’s Nomination Committee consists of:
Karl Tobieson, appointed by Linc AB; Richard Torgerson, appointed by Nordea Funds AB; Anders Hallberg, appointed by Hallberg Management AB; Uli Hacksell, Chairman of the Board, Medivir AB. Annuncio • Sep 16
Medivir Presents Positive, Mature Data from its Ongoing Phase 1b / 2a Study of fostroxacitabine bralpamide (fostrox) + Lenvima in Advanced Liver Cancer (hepatocellular carcinoma/HCC) at the European Society of Medical Oncology Congress Medivir AB (publ) presented positive, mature data from its ongoing phase 1b /2a study of fostroxacitabine bralpamide (fostrox) + Lenvima® in advanced liver cancer (hepatocellular carcinoma/HCC) at the ESMO (European Society of Medical Oncology) Congress in Barcelona, Spain. On September 16, 2024’s ESMO update, poster number 986P, presented by Dr. Hong Jae Chon on September 16, shows promising duration of benefit with 19% of patients continuing treatment for more than a year and the longest running patient remaining on treatment for over 2 years, with sustained partial response. The patients in the study had disease control on fostrox + Lenvima independent if they benefitted from previous line of therapy, showing potential for all second-line patients to benefit from the combination. The safety and tolerability profile continues to be encouraging with no unexpected adverse events. While hematological adverse events were common, they were temporary in nature. Decreases in neutrophil & platelet counts showed a cyclic pattern with recovery before next cycle of treatment, enabling patients to remain on treatment long-term. Importantly, no patient experienced febrile neutropenia or low platelet count with bleeding and there were no fostrox-related serious adverse events. Results come despite very poor prognosis for most second-line HCC patients on September 16, 2024, with just 5% - 10% responding to current standard of care treatment, and a typical TTP of only 3 - 4 months. The data are from Medivir's ongoing phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study, evaluating the safety and efficacy of fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. Annuncio • Sep 12
Medivir AB to Present Mature Clinical Data for Fostrox + Lenvima at ESMO Conference Medivir AB has previously announced that detailed and mature data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) will be presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 16, 2024. The abstract, titled "Fostrox (fostroxac itabine bralpamide) plus lenvatinib in patients with locally advanced unresectable or metastatic hepatocellular carcinoma ("HCC") progressed on immunotherapy combinations. Results from a multi-center phase 1b/2a studies." will be presented by Dr. Hong Jae Chon, CHA Bundang Medical Center in Korea. After the presentation Medivir will also host a webcast where Dr. Chon and Dr. Pia Baumann, Chief Medical Officer at Medivir, will present the data and answer questions. In addition to the presentation of phase 1b/2a data, Dr. Chon with his experience of treating liver cancer patients, will provide additional context to the data by comparing with what can be expected with current clinical practice in second-line. Reported Earnings • Aug 23
Second quarter 2024 earnings released: kr0.32 loss per share (vs kr0.48 loss in 2Q 2023) Second quarter 2024 results: kr0.32 loss per share. Net loss: kr36.0m (loss widened 35% from 2Q 2023). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Annuncio • Jul 18
Medivir AB to Present Updated Clinical Data for Fostrox + Lenvima in Hepatocellular Cancer At ESMO Conference in September Stockholm Medivir AB announce that updated data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 13-17, 2024. Updated clinical data from the ongoing phase 1b/2a study with fostrox in combination with Lenvima. will be presented. As patients are able to stay on treatment long-term, it enables a detailed update on the safety and tolerability profile and how it evolves over time. The presentation will also include additional updates on efficacy endpoints. New Risk • Jul 01
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: -kr79m 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 (-kr79m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Shareholders have been substantially diluted in the past year (101% increase in shares outstanding). Revenue is less than US$1m (kr7.7m revenue, or US$732k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr139m net loss in 3 years). Market cap is less than US$100m (€30.3m market cap, or US$32.6m). Annuncio • Jun 27
Medivir AB Presents Positive New Data from Its Ongoing Phase Ib / IIa Study of Fostroxacitabine Bralpamide (Fostrox) + Lenvima® in Advanced Hepatocellular Carcinoma (HCC) Medivir AB presented positive new data from its ongoing phase Ib /IIa study of fostroxacitabine bralpamide (fostrox) + Lenvima® in advanced hepatocellular carcinoma (HCC) at the ESMO GI (European Society of Medical Oncology, Gastrointestinal Cancers Congress in Munich, Germany. ESMO GI update, poster number 176P, is being presented by Dr Hong Jae Chon on June 27, shows: An overall response rate (ORR) of 24%, with a disease control rate (DCR) of 81%, while the median TTP is now 10.8 months, with 25% of patients still on treatment; One patient remains on treatment after 22 months, benefiting from a sustained partial response; Biopsies confirm selective DNA damage to tumor cells, while there is no impact on normal liver function as measured by ALT/AST levels and stable ALBI score over time. The lack of impact on normal liver function supports the previously reported encouraging safety and tolerability profile, where only 5% of patients had to discontinue due to adverse events and the need for dose modification was lower than expected. The data are from Medivir's ongoing phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study, evaluating the safety and efficacy of fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. HCC is the most common type of liver cancer, accounting for more than 80% of cases worldwide. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20%. Annuncio • Jun 19
Medivir Selects Global CRO Partner for Upcoming Phase 2B Study in HCC with fostrox + Lenvima and Initiates Study Feasibility Medivir AB announced that it has selected a global CRO partner for the planned phase 2b study evaluating fostroxacitabine bralpamide (fostrox) + Lenvima®? vs Lenvima alone in second line HCC. In the next phase of development, Medivir is planning for a global, randomized phase 2b study aligned with its recent supportive Type C interaction with the FDA. The objective is to evaluate the combination of fostrox + Lenvima in second line advanced HCC with the aim of becoming the first, approved treatment alternative after current first line treatment. The study is planned to enroll patients broadly in the US, EU and Asia, building on countries and sites participating in currently ongoing phase 1b/2a, which will ensure that recruitment requirements for a potential accelerated or conditional approval are fulfilled. A key next step is to initiate study feasibility to identify optimal sites and investigators to enable study start in early 2025. Already now, the company have received high level of interest from experts in HCC regarding potential participation in the study. Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing harmful effects on normal livercells. This is achieved by coupling a chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in advanced HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile. Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the USA. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. The unmet medical need is especially high in second line where there are no approved treatments post first line standard of care. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20%. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need. Annuncio • May 08
Medivir Aktiebolag (publ) Approves Board Appointments Medivir Aktiebolag (publ) at its annual general meeting held on 7 May 2024, approved to elect Angelica Loskog and Anna Törner as new members of the board of directors. Reported Earnings • May 02
First quarter 2024 earnings released: kr0.23 loss per share (vs kr0.34 loss in 1Q 2023) First quarter 2024 results: kr0.23 loss per share. Net loss: kr26.1m (loss widened 38% from 1Q 2023). Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Reported Earnings • Feb 16
Full year 2023 earnings released: kr1.22 loss per share (vs kr1.59 loss in FY 2022) Full year 2023 results: kr1.22 loss per share. Net loss: kr89.3m (flat on FY 2022). Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Annuncio • Feb 15
Medivir AB (publ) to Report Q3, 2024 Results on Nov 06, 2024 Medivir AB (publ) announced that they will report Q3, 2024 results on Nov 06, 2024 Annuncio • Jan 26
Medivir AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 20.000001 million. Medivir AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 20.000001 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 7,547,170
Price\Range: SEK 2.65
Transaction Features: Subsequent Direct Listing New Risk • Jan 24
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 89% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (30% average weekly change). Share price has been highly volatile over the past 3 months (30% average weekly change). Shareholders have been substantially diluted in the past year (89% increase in shares outstanding). Revenue is less than US$1m (kr5.5m revenue, or US$528k). Revenue is less than US$1m (kr5.5m revenue, or US$528k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr188m net loss in 3 years). Currently unprofitable and not forecast to become profitable over next 3 years (kr188m net loss in 3 years). Market cap is less than US$100m (€26.8m market cap, or US$29.2m). Market cap is less than US$100m (€26.8m market cap, or US$29.2m). Annuncio • Jan 23
Medivir AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 20.000001 million. Medivir AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 20.000001 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 7,547,170
Price\Range: SEK 2.65
Transaction Features: Subsequent Direct Listing Annuncio • Jan 19
Medivir Presents the First Clinical Data with Fostrox + Lenvima At the Asco GI Scientific Congress Medivir presents the first clinical data with fostrox + Lenvima at the ASCO GI scientific congress, showing further improved clinical benefit vs previous interim updates from the ongoing phase Ib/IIa study in advanced hepatocellular carcinoma. According to the company, the data supports the planning for a pivotal phase IIb study in 2024. BioStock reached out to Pia Baumann, Medivir's CMO, to learn more about the new data. Annuncio • Jan 17
Medivir AB Announces Further Improved Clinical Benefit with Fostrox + Lenvima as Data from the Ongoing Phase 1B/2A Study in Advanced Hepatocellular Cancer Medivir AB announced further improved clinical benefit with fostrox + Lenvima®? as data from the ongoing phase 1b/2a study in advanced hepatocellular carcinoma (HCC) will be presented at the ASCO (American Society of Clinical Oncology) GI (Gastrointestinal Cancers) Symposium in San Francisco on January 19. The updated data further supports accelerating the fostrox development program to initiate a registrational phase 2b study in second-line HCC in 2024. The data is from a phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study evaluating the safety and efficacy with fostroxacitabine bralpamide (fostrox) in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. With a high and durable disease control rate of 61% at 18 weeks, the majority of patients in this study have continuous clinical benefit. "Hepatocellular cancer is a particularly complex disease," says Dr. Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona in Spain, and investigator in the fostrox + Lenvima study. "A clear unmet need remains for safe and effective combination treatments. These data show that fostrox + Lenvima have encouraging results related to clinical outcome in patients with second-line advanced HCC without jeopardizing safety. I look forward to further explore the efficacy of fostrox added to Lenvima in a randomized, controlled trial". The results from the phase 1b/2a trial will be presented by Dr Maria Reig, poster number 476P, at ASCO GI on January 19. Medivir will host a conference call to provide additional details from the study, comments on the data and the plans moving forward with fostrox, at 14.00 CET on January 23, 2024. The prodrug design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b/2a, is a Phase 1b/2a study will be presented by Dr. Maria Reig, poster number 3,000P, at ASCO GI. Annuncio • Dec 23
Medivir AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 128.961315 million. Medivir AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 128.961315 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 48,664,647
Price\Range: SEK 2.65
Transaction Features: Rights Offering Annuncio • Dec 20
Medivir AB Announces Data from Ongoing Phase 1B/2A Study in Advanced Hepatocellular Cancers Medivir AB announced improved durable clinical benefit in maturing data from the ongoing phase 1b/2a study in advanced hepatocellular carcinoma (HCC), measured by local review. These data, where all patients have had minimum 12 weeks follow-up, further supports accelerating the fostrox development program to initiate a registrational phase 2b study in second-line HCC in 2024. The data is from a phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study evaluating the safety and efficacy with fostroxacitabine bralpamide (fostrox) in combination with Lenvima®? in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. The study is ongoing with ~50% of patients still on treatment and all patients have had minimum12 weeks follow-up. The combination remains tolerable with no unexpected new safety events and lower need for dose reductions than expected. Additional data from the ongoing phase 1ss/2a study will be presented at the ASCO Gastrointestinal Cancers Symposium, January 18-20, 2024 in San Francisco, USA. The abstract, titled "First safety and efficacy data from phase Ib/IIa study of fostroxacitabine Bralpamide (fost approx, MIV-818) in combination with lenvatinib in patients with hepatocellular carcinoma ("HCC)" will be presented by Dr. Maria Reig, Director of the Barcelona Clinic Liver Cancer (BCLC) and the Liver Oncology Unit at the Hospital Clinic of Barcelona in Spain on January 19th. Annuncio • Nov 29
Medivir AB Announces Updated Formulation of Fostrox Critical to Support Planned Study with Accelerated Approval Intent in Second Line HCC Medivir AB announced that it has finalized the development of an updated formulation of fostrox, suitable for commercial manufacture. HCC is a potentially life-threatening form of liver cancer and the third leading cause of cancer-related death worldwide. The need for new treatments is high and the development of an updated commercial formulation is an additional step towards fostrox becoming a treatment option for HCC patients. The development efforts have been carried out by Quotient Sciences, Medivir's partner for formulation development and manufacture of drug product. Fostrox is currently being evaluated in an ongoing phase 1b/2a study in combination with Lenvima, a tyrosine kinase inhibitor. It is an open-label, multicenter study and includes patients with HCC for whom current first- or second-line treatment has proven ineffective or is not tolerable. It has the potential to provide HCC patients, who have progressed on current first line standard of care, with an alternative option where no other treatments are approved. With the study fully recruited and 50% of patients still on treatment, interim data indicates clinical benefit without compromising safety, when fostrox is added to Lenvima in second-line HCC. Based on these promising data, together with the lack of approved medical treatments after tumor progression on first line standard of care, the company has communicated the plan to initiate phase 2b study with accelerated approval intent. A formulation suitable for commercial manufacture is a critical component in clinical studies with regulatory intent. With the formulation development program successfully finalized, the next step is to manufacture three different strengths of fostrox together with placebo to ensure momentum in the fostrox development program and enable a timely start of the planned phase 2b study. Annuncio • Nov 09
Medivir AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 147.979713 million. Medivir AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 147.979713 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 55,841,401
Price\Range: SEK 2.65
Transaction Features: Rights Offering Reported Earnings • Oct 30
Third quarter 2023 earnings released: kr0.42 loss per share (vs kr0.27 loss in 3Q 2022) Third quarter 2023 results: kr0.42 loss per share (further deteriorated from kr0.27 loss in 3Q 2022). Net loss: kr23.6m (loss widened 60% from 3Q 2022). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 16% 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 20% per year, which means it is significantly lagging earnings. Annuncio • Oct 28
Medivir AB (publ) to Report First Half, 2024 Results on Aug 22, 2024 Medivir AB (publ) announced that they will report first half, 2024 results on Aug 22, 2024 Annuncio • Oct 21
Medivir AB (Publ) Announces Resignation of Anette Lindqvist as Director Medivir AB (publ) announced that the company's board member Anette Lindqvist has informed the board of directors that she is leaving her position as director due to personal reasons. Annuncio • Oct 06
Medivir AB Announces All Patients in the Ongoing Phase 2A Study in Advanced Hepatocellular Car Car Car Carcinoma Has Now Dosed At Least Two Treatment Cycle Medivir AB announced that all patients in the ongoing phase 2a study in advanced hepatocellular carcinoma (HCC) has now dosed at least two treatment cycles and the treatment continues to show very promising clinical benefit. The study evaluates safety and efficacy with the candidate drug fostrox in combination with Lenvima®? in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. The study, which is an open-label, multi-center, dose-escalation and dose-expansion study, continues to show early and durable clinical benefit across the cohort, as measured by local review. Of the 13 patients with sustained tumor control at 3 months, 3 patients achieved Partial Response and 10 patients Stable Disease, providing 17% Overall Response Rate (ORR) and 72% Disease Control Rate (DCR). The patient who has benefited the longer remains on treatment after 13.5 months, with sustained partial response. The combination remains tolerable with no unexpected new safety events and adverse events are transient and manage. continued lower need for dose reductions or interruptions than expected. The observed tolerability is of outmost importance as patients with HCC often have an increased sensitivity to drugs in general due to impaired liver function. "Overall, the consistent early and durable signals of clinical benefit and the favorable safety profile are very encouraging. The overall response rate of 17% already at 2nd scan is very encouraging and indicates a higher share of responders than historically seen in second line treatment of HCC. Medivir plans to provide an update in connection with the company's upcoming quarterly results presentation on October 27. This will include a more comprehensive update of local review data as most of the patients will have had the opportunity to have at least three scans, with each scan scheduled to take place every 6 weeks. In addition to the data update, the company will also provide further context what these more mature data could mean for future clinical practice in second line HCC, a patient population for whom there are no approved medical treatments. Annuncio • Sep 05
Medivir AB Reports Promising Interim Data, Including A First Complete Response in Phase 1B/2A Hcc Study with Fostrox in Combination with Lenvima Medivir AB announced promising interim safety and efficacy data from its ongoing phase 1b/2a study of first-in-class candidate drug fostrox in combination with Lenvima®? in advanced hepatocellular carcinoma (HCC) patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. The interim results confirmed the previously announced favorable safety and tolerability profile. No new or unexpected safety events and the combination continues to be tolerable. The phase 2a dose expansion part of the study is ongoing and is now fully recruited. Data from phase 1b/2a is planned to be presented at an upcoming scientific congress. Board Change • Sep 01
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 3 experienced directors. No highly experienced directors. Independent Director Bengt Westermark is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Reported Earnings • Aug 20
Second quarter 2023 earnings released: kr0.48 loss per share (vs kr0.41 loss in 2Q 2022) Second quarter 2023 results: kr0.48 loss per share (further deteriorated from kr0.41 loss in 2Q 2022). Net loss: kr26.6m (loss widened 15% from 2Q 2022). Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 25% per year, which means it is significantly lagging earnings. Annuncio • Aug 14
Medivir AB Announces 15th Patient with Advanced Liver Cancer Has Been Included in the Ongoing Phase 2A Study Medivir AB announced that the 15th patient with advanced hepatocellular carcinoma (HCC) has been included in the ongoing phase 2a study. The study evaluates safety and efficacy with the candidate drug fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable. The preliminary results from the initial phase 1b part were positive with a good safety and tolerability profile. The study, which is an open-label, multi-center, dose-escalation and dose-expansion study, continues to show encouraging clinical results as the disease has been stabilized in the majority of patients and they remain on treatment. The interest in including patients in the ongoing phase 2a Study with fostrox + Lenvima has been great among both investigators and patients. The combination remains tolerable and only one patient has discontinued treatment due to side effects related to fostrox. Furthermore, the need for dose reductions has been lower than expected. The observed tolerability is of outmost importance as patients with HCC often have an increased sensitivity to drugs in general due to impaired liver function. The promising observations in the phase 1b/2a study mean that Medivir, together with its Scientific Advisory Council, is intensifying preparations for the next phase in the clinical development of fostrox. Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing. Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20%. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with immediate and advanced HCC, results in a large unmet medical need. Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a pro-drug designed to actively treat liver cancer and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Birinapant, a SMAC mimetic, is exclusively outlicensed to IGM Biosciences to be developed in combination with IGM-antibodies for the treatment of solid tumors. Annuncio • Aug 08
Medivir AB Announces Formation of A Scientific Advisory Council Medivir AB announced the formation of a Scientific Advisory Council as the company intensifies its plans for next phase of development. The members of Medivir'sScientific Advisory Council: Dr. Jeff Evans is a Professor of Translational Cancer Research in the School of Cancer Sciences, University of Glasgow, and Honorary Consultant in Medical Oncology at the Beatson West of Scotland Cancer Centre, Glasgow, UK. He is the Lead of the Glasgow Experimental Cancer Medicine Centre (ECMC) and National Clinical Lead of the NHS Scotland Cancer Research Network. He is an investigator in the fostrox clinical development program. Dr. Richard Finn is a Professor of Medicine at the Geffen School of Medicine at UCLA Department of Medicine, Division of Hematology/Oncology. Dr. Finn splits his time between patient care and directing the Translational Research Laboratory in the Division of Hematology/Oncology. His research interests are focused on the development of targeted therapeutics for solid tumors across histologies. Dr. Finn has been the primary investigator of several, ground-breaking studies in HCC, including the ground-breaking ImBrave 150 study. Dr. Jeong Heo is a Professor of Internal Medicine at Pusan National University School of Medicine and Director of Gastroenterology and Hepatology at Pusan National University Hospital. During his career, Professor Heo has held a number of academic positions, university and hospital appointments and has been principal investigator in many clinical trials for phase I-IV of hepatitis B, C and hepatocellular carcinoma. He is an investigator in the fostrox clinical program. Dr. Maria Reig is the Head of the BCLC and Liver Oncology Unit at Hospital Clinic of Barcelona in Spain. Her expertise and area of interest is the development of prognostic models for patients with liver cancer and evaluation of treatment options with special emphasis in systemic therapy as well as new research about immune modulation and cancer emergence after antiviral treatment. She is an investigator in the fostrox clinical program. Dr. Arndt Vogel is managing senior consultant and Professor in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School. He is also head of the GI-Cancer Center and of the Center for Personalized Medicine at Medical School Hannover. His scientific focus is the translational and clinical research in gastrointestinal cancer. Professor Vogel is member and chairman of Hepatobiliary Cancer Study Group of the AIO, a collaborative group in clinical oncology in Germany. Within ESMO, he is member of the ESMO Guidelines Steering Committee. Furthermore, Professor Vogel has responsibilities in the establishment of the national guideline and is the coordinator of the ESMO clinical practice guideline on the management of hepatocellular carcinoma and biliary tract cancer. Annuncio • Jun 20
Medivir AB Announces Patent Application for Fostrox Approval in China Medivir AB announced that the company's patent application, covering both substance claims for fostroxacitabine bralpamide (fostrox) and its use for liver cancer treatment, has recently been approved by the Chinese patent authority. Corresponding patents have already been granted in the USA, the EU, Japan and a large number of other countries, mainly in Asia. The patent is valid until 2035 with extensions of up to 5 years expected in key markets. Primary liver cancer (HCC) is one of the most common forms of cancer with over 800,0001) new patients globally per year. More than 50% of these are estimated to be in China. Annuncio • Jun 02
Medivir AB Completes the Dose Escalation Part (Phase 1B) of the 1B/2A Study in Hcc and Focus on the Combination of Fostrox and Lenvima Medivir AB announced that a safe dose has been established for treatment with the drug candidate fostroxacitabine bralpamide (fostrox) in combination with Keytruda®? in the initial dose escalation part (phase 1b) of the company's 1b/2a study in hepatocellular carcinoma (HCC). In the ongoing expansion part of the study (phase 2a) Medivir is focusing on the fostrox and Lenvima combination and intends to explore the possibility of fostrox in a triple combination together with immunotherapy in earlier lines. The absolute majority of first-line HCC patients are currently treated with Tecentriq®? (anti-PD-L1) plus Avastin®?. Lenvima®? is a targeted therapy and there is a clear rationale for using a different mechanism of action in second line- than in first line treatment, to overcome the development of resistance. This makes fostrox + Lenvima®? the most relevant combination to explore further in the second line setting. With immunotherapy as the standard treatment in first line, the chance, at progression, of responding to further immunotherapy in the following lines is limited, which is why fostrox plus Keytruda®? will not be studied further as a second-line therapy at the moment. With a safe dose established for the fostrox + Keytruda®? arm, the intention is instead to explore the possibility of fost approx as a triple combination partner in earlier lines of immunotherapy combinations. In the two dose arms of the study, fostrox has been combined with Keytruda®?, an anti-PD-1 checkpoint inhibitor, or Lenvima®?, a tyrosine kinase inhibitor, in patients with HCC for whom first-line treatment has been effective or not tolerated. The aim of the study is to evaluate safety, tolerability and also to get an indication of the effect of fostrox in combination with two already existing drugs. Medivir announced in February that the dose arm with fostrox + Lenvima™? showed a safe dose and proceeded to the expansion phase (phase 2a), where the first 11 patients have been dosed in a short time. The study is being conducted at 15 clinics in the UK, Spain and South Korea. Reported Earnings • Apr 09
Full year 2022 earnings released: kr1.59 loss per share (vs kr1.20 loss in FY 2021) Full year 2022 results: kr1.59 loss per share (further deteriorated from kr1.20 loss in FY 2021). Net loss: kr88.8m (loss widened 41% from FY 2021). Products in clinical trials Phase I: 2 Phase II: 5 Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 45% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings. Breakeven Date Change • Feb 16
Forecast to breakeven in 2024 The 3 analysts covering Medivir expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 19% to 2023. The company is expected to make a profit of kr18.4m in 2024. Board Change • Feb 12
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 Lennart Hansson was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Dec 12
Medivir Completes A Successful Pre-IND Meeting with the FDA Medivir AB announced that the company has completed a pre-IND meeting with the US Food and Drug Administration and has received positive feedback on the development plan in preparation for an IND for its candidate drug fostroxacitabine bralpamide (fostrox). This is a significant step towards an application to include American study centers in future clinical trials (Investigational New Drug Application, IND). Fostrox is an orally administered liver-targeted pro-drug currently undergoing phase 1/2a clinical trial in advanced hepatocellular carcinoma, in combination with pembrolizumab or lenvatinib. The main purpose of the pre-IND meeting was to discuss the overall development plan in preparation for an IND for fostrox and identify any need for further data prior to submitting the IND application. Based on the meeting with the FDA and its recommendations, Medivir assesses that it can now proceed with the next step in the process towards an IND application. The company plans to submit an IND application to the US authority in 2023. An approved IND application is a prerequisite for conducting clinical studies with a new candidate drug in the United States. Annuncio • Nov 21
Medivir AB (Publ) Appoints Pia Baumann as New Chief Medical Officer Medivir AB (publ) announced that Pia Baumann has been recruited as its new Chief Medical Officer (CMO). Her role includes overall responsibility for the continued clinical development of the candidate drug fostroxacitabine bralpamide (fostrox). She will be part of the company's management team and will take up her position on February 20, 2023. Pia Baumann, who is an MD specialized in oncology and earned her Ph.D. at Karolinska Institute, has substantial experience in drug development in the cancer field. Her experience comes from many years of clinical work at Karolinska Hospital and larger pharmaceutical companies as well as smaller biotech companies where she has developed global product strategies as well as designed and conducted clinical studies in close collaboration with leading clinics. Pia most recently held a position at AstraZeneca as Vice President Medical with global responsibility for the company's Tagrisso and Lung Cancer franchise. Before that, she held leading, global positions in cancer drug development at Takeda, Incyte and ARIAD Pharmaceuticals. Annuncio • Jun 18
Medivir AB (publ) to Report Q2, 2023 Results on Aug 18, 2023 Medivir AB (publ) announced that they will report Q2, 2023 results on Aug 18, 2023 Annuncio • May 06
Medivir Aktiebolag (Publ) Announces Board Changes Medivir Aktiebolag (publ) announced at annual general meeting held on May 5, 2022, the shareholders elected Anette Lindqvist as members of the board. An van Es Johansson resigned from the board after having declined re-election. Annuncio • Apr 06
Medivir AB (publ) to Report Fiscal Year 2021 Final Results on Apr 05, 2022 Medivir AB (publ) announced that they will report fiscal year 2021 final results on Apr 05, 2022 Annuncio • Mar 01
Medivir AB (Publ) Announces Phase II Study of Miv-711 for Osteoarthritis Shows Statistically Significant Reduction in Oa Pain Medivir AB (publ) announces that an article entitled "Symptomatic and structural benefit of cathepsin K inhibition by MIV-711 in a subgroup with unilateral pain: post-hoc analysis of a randomised phase 2a clinical trial" by Bihlet, A.R. et al has been published in Clinical and Experimental Rheumatology 2022. Extensive pain in one knee, other than the target-knee for which pain is measured, may confound osteoarthritis (OA) pain outcomes. This exploratory analysis focused on a subgroup of patients in the MIV-711 phase IIa trial with pain predominantly in one knee (unilateral pain). In a subgroup with predominantly unilateral knee pain, a statistically significant reduction in OA pain by MIV-711 treatment was found, with concurrent beneficial structural effects. Annuncio • Sep 14
Medivir AB (publ) Announces Abstract for MIV-818 phase 1b monotherapy for ESMO Congress published Medivir AB announced that the Abstract entitled 'Phase 1 study of the novel prodrug MIV-818 in patients with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCCA) or liver metastases (LM)' has been released on the European Society for Medical Oncology (ESMO) website. MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. MIV-818 has completed a phase 1b monotherapy study, and a combination study in HCC is now planned to be initiated during the second half of 2021. Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is. 11% HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need. Annuncio • Aug 13
Medivir AB Announces Positive Data from the Remetinostat Phase II Study in Basal Cell Carcinoma Published in Clinical Cancer Research Medivir AB announced that positive data from the investigator-initiated study evaluating the effects of remetinostat in basal cell carcinoma (BCC) patients has been published in Clinical Cancer Research (online first doi: 10.1158/1078-0432.CCR-21-0560). This clinical study was conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr. Kavita Sarin. Results of the open-label clinical trial of the topical HDAC inhibitor, remetinostat, as neoadjuvant treatment for BCC were reported. Thirty-three per-protocol tumors from 25 participants were included in the analysis. The overall response rate (ORR), defined as the proportion of tumors achieving more than 30% decrease in the longest diameter from baseline to week 8, was 69.7% [90% confidence interval (CI), 54%-82.5%]. On pathologic examination, 54.8% of tumors demonstrated complete resolution. No systemic adverse events were reported. Annuncio • May 25
Medivir Announces the Design of its Upcoming MIV-818 Combination Study Medivir AB announced the details of its upcoming phase 1/2a combination study with the company's leading candidate drug, MIV-818, against liver cancer. The unique mechanism of action of MIV-818 makes it attractive to be combined with a multitude of other targeted and non-targeted drugs for the treatment of hepatocellular carcinoma. In the upcoming combination study, MIV-818 will be administered in two combinations, either with lenvatinib, a tyrosine kinase inhibitor or pembrolizumab, an anti-PD-1 check-point inhibitor. The planned trial will be an open-label, multi-center phase 1/2a study starting with a dose escalation part to establish the recommended phase 2 dose (RP2D). This is followed by the expansion study (phase 2a) with an initial evaluation of the safety and efficacy of the combination of MIV-818 with lenvatinib or pembrolizumab. The study will include patients with hepatocellular carcinoma (HCC) who have progressed on, or are intolerant of, first line standard therapy. The study is planned to have two parallel dose-escalation streams. Once the RP2D has been established for the combinations, further cohorts of up to 30 patients with HCC will be enrolled in the phase 2a part of the study. The first patient is expected to be enrolled in the second half of 2021. Annuncio • May 21
Medivir AB Announces Positive Results from Investigator-Initiated Phase II Clinical Study of Remetinostat in Patients with Squamous Cell Carcinoma Medivir AB announced that results for the investigator-initiated phase II clinical study in patients with squamous cell carcinoma (SCC). The primary objective of the study was to assess the effects of topical remetinostat on biopsy-proven SCC and SCC in situ tumors. This clinical study was conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Kavita Sarin. The company is providing remetinostat drug supply for this study, and has full access to, and the rights to use, all clinical data after the study is complete. Four patients with five cutaneous SCCs were included in this case series and treated with remetinostat gel 1%. All five tumours, including a range of histological subtypes, demonstrated complete clinical and pathological resolution after up to 8 weeks of treatment. All patients experienced a localized cutaneous reaction in response to the treatment, which required one patient to discontinue therapy. No systemic adverse events were reported. Annuncio • Feb 17
Medivir AB (publ), Annual General Meeting, May 05, 2021 Medivir AB (publ), Annual General Meeting, May 05, 2021. Annuncio • Feb 13
Medivir AB Announces Delisting of Paid Subscription Shares Medivir AB (publ) announced delisting of paid subscription shares. Last trading day for MVIR BTA B will be on February 15, 2021. Annuncio • Feb 11
Medivir AB Enters into Licensing Agreement with Ubiquigent Limited for Preclinical Program USP7 Medivir AB announced at it had entered into a license agreement witith Ubiquigent Limited (Ubiquigent) for Medivir's preclinical USP7 research program. Under the terms of the agreement, Medivir has granted Ubiquigent an exclusive
worldwide license to develop and commercialize the program including all associated compounds across any therapeutic indication(s) in return for agreed revenue share upon successful development or commercialization by
Ubiquigent. Ubiquitin specific peptidase 7 (USP7) is a deubiquitylating (DUB) enzyme that has been linked to cancer due to its ability to deubiquitylate substrates that regulate key oncogenic, DNA-damage response and tumor initiating pathways. Inhibitors of USP7 therefore represent an exciting opportunity to be effective treatments in targeted patient populations in oncology either as a monotherapy or in combination therapies. Ubiquigent has established itself as a respected partner in the DUB field with a strong track record in the development of small molecule DUB inhibitors both through supporting the drug discovery efforts of its partners and by the strengthening of its own portfolio of novel DUB inhibitors. This latest agreement builds upon an existing long-term relationship between the parties and directly supports Ubiquigent's strategy to build and commercialize a strong IP portfolio of novel DUB
inhibitors. Is New 90 Day High Low • Jan 27
New 90-day low: €0.79 The company is down 40% from its price of €1.32 on 29 October 2020. The German market is up 21% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 17% over the same period. Annuncio • Jan 12
IGM Biosciences Enters into Exclusive Licensing Agreement with Medivir AB for Birinapant IGM Biosciences Inc. announced that it has entered into an exclusive license agreement with Medivir AB, through which IGM will receive global, exclusive development and commercialization rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells. The combination of IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) being developed by IGM, and birinapant has been shown to enhance anti-tumor activity preclinically. Under terms of the agreement, Medivir will receive an upfront payment of $1 million upon signing the agreement, followed by an additional $1.5 million when birinapant is included by IGM in clinical Phase I studies. The terms of the agreement also entitle Medivir, should birinapant be successfully developed and approved, to receive milestone payments up to a total of approximately $350 million, plus tiered royalties from the mid-single digits up to mid-teens on net sales. In addition to its apoptotic activity, birinapant augments anti-tumor immune system activity. Through this double action, on both tumor cells and cells of the immune system, birinapant has the potential to improve the treatment of several types of cancer when used in combination with other drugs. IGM-8444 is currently being tested in a Phase 1 dose escalation study in patients with solid and hematologic malignancies. DR5 is a member of the tumor necrosis factor receptor superfamily (TNFrSF) and is often expressed on the surface of cancer cells. Subject to regulatory review, IGM plans to begin the clinical testing of birinapant in combination with IGM-8444 for the treatment of solid tumors later this year. Is New 90 Day High Low • Dec 24
New 90-day low: €0.80 The company is down 38% from its price of €1.29 on 25 September 2020. The German market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 6.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annuncio • Dec 13
Medivir AB (Publ) Renegotiates its agreement with TetraLogic Pharmaceuticals Corporation Medivir AB has renegotiated its agreement with TetraLogic Pharmaceuticals Corporation (TetraLogic) regarding financial obligations for birinapant, a SMAC mimetic, for the treatment of solid cancer tumors. The purpose of the new agreement is to create improved business development opportunities. The original agreement between Medivir and TetraLogic included milestone payments with predetermined amounts as well as royalty obligations to TetraLogic if and when Medivir develops, markets or out-licenses birinapant further. The original agreement has been dissolved and renegotiated so that the compensation Medivir is obliged to pay in a potential future transaction is now based solely on the distribution of actual future revenues to Medivir. Is New 90 Day High Low • Dec 09
New 90-day low: €1.10 The company is down 20% from its price of €1.37 on 10 September 2020. The German market is up 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Nov 14
New 90-day low: €1.24 The company is down 14% from its price of €1.44 on 14 August 2020. The German market is up 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Reported Earnings • Nov 11
Third quarter 2020 earnings released: EPS kr0.19 Third quarter 2020 results: Net income: kr4.60m (up kr27.7m from 3Q 2019). Over the last 3 years on average, earnings per share has increased by 49% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings. Is New 90 Day High Low • Oct 22
New 90-day low: €1.27 The company is down 12% from its price of €1.44 on 24 July 2020. The German market is down 3.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 15% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annuncio • Oct 05
Medivir AB (Publ) Appoints Tom Morris as Interim Chief Medical Officer Medivir AB announced that it has appointed Dr. Tom Morris as interim Chief Medical Officer effective October 5, 2020. Dr. Morris will report to CEO Yilmaz Mahshid and join the Medivir Executive Team. Tom Morris has more than 20 years of experience within drug development, mostly in oncology. Previously employed at Medeval Ltd. and more recently at AstraZeneca. He has overseen the clinical development of several global drug programs, interacting with regulatory agencies, external clinical experts and academic groups worldwide. Annuncio • Sep 22
Medivir AB (publ) to Report Q2, 2020 Results on Aug 20, 2020 Medivir AB (publ) announced that they will report Q2, 2020 results on Aug 20, 2020 Annuncio • Aug 21
Medivir AB (publ) to Report Fiscal Year 2020 Results on Feb 15, 2021 Medivir AB (publ) announced that they will report fiscal year 2020 results on Feb 15, 2021 Annuncio • Aug 18
Medivir AB (Publ) Announces CEO Changes Medivir AB announced that Dr. Yilmaz Mahshid will assume his position as CEO on September 14, 2020. Uli Hacksell, who has been CEO since October 2018, will remain as a Board Member of Medivir. Yilmaz Mahshid joins Medivir from his recent position as CFO at PledPharma. He was prior to that Investment Manager at Industrifonden.