Annonce • May 22
Oncopeptides AB Announces Publication of Phase 2 Bridge Study Results for Pepaxti in Relapsed Refractory Multiple Myeloma Patients with Renal Impairment Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, announced the publication of the results from the Phase 2 BRIDGE (OP-107) clinical study in the peer-reviewed journal Clinical Lymphoma, Myeloma and Leukemia. The prospective, open-label study evaluated the pharmacokinetics (PK), safety, and efficacy of Pepaxti (melflufen) plus dexamethasone in relapsed, refractory multiple myeloma (RRMM) patients with moderate-to-severe renal impairment (RI). Patients with renal insufficiency represent roughly half of all myeloma diagnoses and typically suffer from poorer long-term outcomes and limited clinical options. The final analyses demonstrate that while systemic exposure to the active metabolite melphalan varies based on baseline kidney function, a reduced melflufen starting dose of 30 mg in patients with moderate renal impairment delivers a consistent safety profile, treatment responses, and survival measures aligned with prior trials conducted in less selected populations. Furthermore, exploratory data gathered across the treatment cycles showed that renal function remained stable or slightly improved during therapy, suggesting that Pepaxti does not adversely impact the kidneys at the studied doses. Validated dose optimization: The PK data directly validate the clinical use and efficacy of a 30 mg Pepaxti starting dose for patients with moderate renal impairment (eGFR =30 to <45 mL/min/1.73 m²). Sustained efficacy in fragile populations: Patients with moderate renal impairment achieved an Overall Response Rate (ORR) of 47.6% in Cohort 1a (40 mg starting dose) and 70.0% in Cohort 1b (30 mg starting dose), with a median progression-free survival (PFS) of 8.6 months and 7.7 months, respectively. No new safety signals: Despite advanced renal impairment and high treatment exposure, the safety profile was well-characterized and manageable. The most frequently reported treatment-emergent adverse events were hematological (thrombocytopenia, anemia, and neutropenia), which is consistent with previous clinical trials. The full article, titled "BRIDGE (OP-107): A Phase 2 Pharmacokinetic Study of Melflufen Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma and Impaired Renal Function," is available online via Clinical Lymphoma, Myeloma and Leukemia. Pepaxti (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. Breakeven Date Change • May 20
Forecast to breakeven in 2028 The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 62% per year to 2027. The company is expected to make a profit of kr4.50m in 2028. Average annual earnings growth of 87% is required to achieve expected profit on schedule. Annonce • Apr 16
Oncopeptides AB (publ), Annual General Meeting, May 21, 2026 Oncopeptides AB (publ), Annual General Meeting, May 21, 2026, at 14:00 W. Europe Standard Time. Location: tandstickspalatset, vastra, tradgardsgatan 15, stockholm Sweden Annonce • Mar 18
Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million. Oncopeptides AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 200.389791 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 129,283,736
Price\Range: SEK 1.55
Transaction Features: Rights Offering Annonce • Jan 17
Oncopeptides AB (Publ) Provides Sales Guidance for the Fourth Quarter and Full Year 2025 Oncopeptides AB (publ) provided sales guidance for the fourth quarter and full year 2025. For the quarter company expects net sales for the second quarter to amount to SEK 18.6 million an increase of 88% versus Fourth Quarter 2024.
For the full year, the company expects net sales to amount to 71.2 million SEK, an increase of 125% versus 2024. Annonce • Jan 16
Oncopeptides AB (publ) to Report Fiscal Year 2025 Results on Feb 19, 2026 Oncopeptides AB (publ) announced that they will report fiscal year 2025 results on Feb 19, 2026 Annonce • Sep 01
Oncopeptides AB (publ) Announces the Publication of Two Real-World Evidence (RWE) Abstracts on Pepaxti At the International Myeloma Society Annual Meeting Oncopeptides AB (publ) announced the publication of two real-world evidence (RWE) abstracts on Pepaxti at the International Myeloma Society (IMS) Annual Meeting, September 17-20 in Toronto, Canada. As previously communicated, the data were generated through treatment outcomes in real world settings from centers in Valencia, Spain and Bologna, Italy and underscore the growing interest in real-world clinical use of Pepaxti. The Italian study reports an overall response rate (ORR) of 47% in a heavily pretreated patient population with relapsed or refractory multiple myeloma, confirming the efficacy previously demonstrated in the HORIZON trial with a similar safety profile. Importantly, the study demonstrated efficacy in patients treated with novel immunotherapies, underscoring the robust effectiveness of Pepaxti in daily clinical practice. The Spanish study confirms the efficacy of Pepaxti in an even more heavily pretreated patient population where the majority of patients had been exposed to either anti-BCMA or anti-GPRC5D immunotherapy, generating data highly relevant to clinicians seeking guidance for treatment decisions. Both studies confirm Pepaxti's favorable tolerability profile in real-world settings - a key consideration in multiple myeloma where safety challenges are common. Annonce • Aug 22
Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 150.232109 million. Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 150.232109 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 46,947,534
Price\Range: SEK 3.2
Transaction Features: Rights Offering Annonce • Jul 23
Oncopeptides AB (publ) Announces Acceptance of Spanish and Italian Real-World Data at IMS Annual Meeting Oncopeptides AB (publ) announced that two real-world evidence (RWE) posters have been accepted for presentation at the upcoming International Myeloma Society (IMS) Annual Meeting, taking place in Toronto, Canada on September 17-20. The data were generated through treatment outcomes in real world settings from centers in Valencia, Spain and Bologna, Italy and underscore the growing interest in real-world clinical use of Pepaxti. The accepted posters focus on real-world outcomes in heavily pretreated patients with relapsed or refractory multiple myeloma. While specific results will be shared at the congress, the inclusion of these patient cases reflects the increasing importance of RWE to guide treatment decisions in clinical practice. For a medicine with limited awareness and use to date, real-world data play a key role in building physician confidence and informing market access. The inclusion of these two posters at IMS follows a growing body of independent research that reflects clinical experiences across Europe. Annonce • May 22
Oncopeptides AB (publ) Approves Election of Christine Rankin as Board Member The Annual General Meeting in Oncopeptides AB (publ) was held on 22 May 2025, approved election of Christine Rankin as board members. Annonce • May 06
Oncopeptides AB's Ordinary Shares to be Deleted from OTC Equity Oncopeptides AB (publ) Ordinary Shares will be deleted from OTC Equity effective May 06, 2025, due to inactive security. Annonce • Apr 17
Oncopeptides AB (publ), Annual General Meeting, May 22, 2025 Oncopeptides AB (publ), Annual General Meeting, May 22, 2025, at 10:00 W. Europe Standard Time. Location: at tandstickspalatset, vastra tradgardsgatan 15, stockholm Sweden Annonce • Apr 16
Oncopeptides AB (publ) Announces the Publication of New Real-World Data That Further Support the Effectiveness and Tolerability of Melflufen, Refractory Multiple Myeloma Oncopeptides AB (publ) announced the publication of new real-world data that further support the effectiveness and tolerability of melflufen, branded in Europe as Pepaxti, in patients with relapsed, refractory multiple myeloma (RRMM). The data were presented in an abstract from the University of Catania, Italy. It highlights treatment outcomes in a single-center real-world setting. The retrospective analysis included eight triple-class refractory RRMM patients who had received a median of 3.5 prior lines of therapy. Notably, several patients presented with high-risk features, including extramedullary disease. Despite this, treatment with Pepaxti in combination with dexamethasone showed an overall response rate (ORR) of 37.5%, with partial responses seen even among patients with advanced disease manifestations. The data underline Pepaxti's role as a viable treatment option for patients with advanced RRMM for patients who have received at least three prior lines of therapy and whose disease has progressed on or after the last therapy. Annonce • Mar 03
Oncopeptides AB (publ) to Report Q1, 2025 Results on May 15, 2025 Oncopeptides AB (publ) announced that they will report Q1, 2025 results on May 15, 2025 Annonce • Feb 20
Oncopeptides AB (publ) to Report Q4, 2024 Results on Feb 27, 2025 Oncopeptides AB (publ) announced that they will report Q4, 2024 results at 8:00 AM, Central European Standard Time on Feb 27, 2025 Annonce • Feb 06
Jarl Ulf Jungnelius Resigns from Oncopeptides AB (publ) Board of Directors Oncopeptides AB (publ) announced that Jarl Ulf Jungnelius has informed the Board of Directors of his decision to step down from the Bord of Directors of Oncopeptides in which he has served since 2011. This due to personal reasons related to a change of domicile from Sweden. Annonce • Jan 27
Oncopeptides' Pepaxti Formally Approves for Full Reimbursement in Italy Oncopeptides AB (publ) announced that the positive reimbursement decision for its drug Pepaxti (melflufen) has been published in the Italian Official Journal ("IOJ", It.: Gazetta Ufficiale). This marks the final regulatory step for the drug's upcoming commercialization in Italy, confirming Oncopeptides' expectation of first sales during first half, 2025. With the IOJ publication, Oncopeptides can now initiate the regional access process to bring Pepaxti to patients. The company's goal is to make the treatment available to eligible Italian patients with relapsed and refractory multiple myeloma over the coming months. Italy reports an annual incidence of approximately 6,000 new cases of multiple myeloma, and with about 1,800 patients falling within Pepaxti's target population. 79 patients across 10 Italian hospitals during the clinical development of Pepaxti and 86 treated patients in the Early Access Program (EAP) underscores the clinical experience in the country and high unmet need for the drug. The Early Access program have been closed following the reimbursement. As previously communicated, Oncopeptides is currently in the process of strengthening its presence in Italy by expanding its team and investing in initiatives to raise awareness about Pepaxti and its benefits. Board Change • Dec 30
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 09
Third quarter 2024 earnings released: kr0.29 loss per share (vs kr0.45 loss in 3Q 2023) Third quarter 2024 results: kr0.29 loss per share. Revenue: kr8.51m (up 203% from 3Q 2023). Net loss: kr60.2m (loss widened 49% from 3Q 2023). Revenue is forecast to grow 92% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. New Risk • Oct 01
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Shareholders have been substantially diluted in the past year (127% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr134m net loss in 2 years). Revenue is less than US$5m (kr21m revenue, or US$2.1m). Market cap is less than US$100m (€40.1m market cap, or US$44.4m). Reported Earnings • Aug 19
Second quarter 2024 earnings released: kr0.48 loss per share (vs kr0.60 loss in 2Q 2023) Second quarter 2024 results: kr0.48 loss per share. Net loss: kr73.2m (loss widened 30% from 2Q 2023). Revenue is forecast to grow 78% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Annonce • Jul 04
An undisclosed buyer acquired an 9.166336% stake in Oncopeptides AB (publ) (OM:ONCO) from Industrifonden for SEK 22.4 million. An undisclosed buyer acquired an 9.166336% stake in Oncopeptides AB (publ) (OM:ONCO) from Industrifonden for SEK 22.4 million on July 2, 2024. Industrifonden Foundation has divested its entire stake in Oncopeptides.
An undisclosed buyer completed the acquisition of 9.166336% stake in Oncopeptides AB (publ) (OM:ONCO) from Industrifonden on July 2, 2024. New Risk • Jun 04
New major risk - Negative shareholders equity The company has negative equity. Total equity: -kr8.4m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (69% average daily change). Negative equity (-kr8.4m). Shareholders have been substantially diluted in the past year (128% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr145m net loss in 2 years). Revenue is less than US$5m (kr39m revenue, or US$3.7m). Market cap is less than US$100m (€60.3m market cap, or US$65.5m). Reported Earnings • Jun 04
First quarter 2024 earnings released: kr0.75 loss per share (vs kr0.75 loss in 1Q 2023) First quarter 2024 results: kr0.75 loss per share (improved from kr0.75 loss in 1Q 2023). Revenue: kr5.07m (up 351% from 1Q 2023). Net loss: kr67.7m (loss narrowed 4.7% from 1Q 2023). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Annonce • May 17
Oncopeptides AB (publ) Presents New Data Highlighting Treatment Benefits of Pepaxti in High-Risk Multiple Myeloma Patients at the COMy Congress Oncopeptides AB (publ) announced that new scientific data on melflufen, branded in Europe as Pepaxti, has been accepted at the 10th annual World Congress on Cont Cont Cont Controversies in Multiple Myeloma (COMy), to be held on May 23-26. The study, published by a team from institutions across Europe, including the University of Wurzburg and the Institute for Molecular Medicine Finland, focuses on the effectiveness of melflufen and shows promising results for the drug when treating patients with a particularly challenging form of multiple myeloma. The study will be presented to congress attendees through an online oral presentation on May 26. The presentation will be given by Caroline Heckman, from the Institute for Molecular Medicine Finland. Multiple myeloma can be especially difficult to treat in patients who have specific genetic mutations or deletions, such as del(17p) and/or mutations in the TP53 gene. These genetic characteristics are associated with a poorer prognosis and shorter survival rates. The research findings indicate that melflufen is more effective than traditional alkylating agents causing DNA damage and promoting the death of cancer cells lacking a functional so-called p53 protein, which is a common issue in high-risk multiple myeloma cases. The study also highlighted significant changes in gene expression that enhance the drug's impact on cancer cells. Furthermore, patients with the del(17p) genetic abnormality treated with melflufen and dexamethasone showed a longer progression-free survival and higher overall response rate compared to those treated with pomalidomide and dexamethasone in the OP-103 OCEAN trial. New Risk • May 08
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 133% 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 (47% average daily change). Shareholders have been substantially diluted in the past year (133% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr66m net loss in 3 years). Revenue is less than US$5m (kr35m revenue, or US$3.2m). Market cap is less than US$100m (€54.4m market cap, or US$58.4m). Buy Or Sell Opportunity • May 08
Now 81% undervalued after recent price drop Over the last 90 days, the stock has fallen 91% to €0.051. The fair value is estimated to be €0.27, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 32% over the last 3 years. Earnings per share has grown by 67%. For the next 3 years, revenue is forecast to grow by 58% per annum. Earnings are also forecast to grow by 32% per annum over the same time period. Buy Or Sell Opportunity • Apr 24
Now 79% undervalued after recent price drop Over the last 90 days, the stock has fallen 87% to €0.076. The fair value is estimated to be €0.37, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 32% over the last 3 years. Earnings per share has grown by 67%. For the next 3 years, revenue is forecast to grow by 52% per annum. Earnings are also forecast to grow by 40% per annum over the same time period. New Risk • Apr 08
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 4.7% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (18% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr50m net loss in 3 years). Shareholders have been diluted in the past year (4.7% increase in shares outstanding). Revenue is less than US$5m (kr35m revenue, or US$3.3m). Market cap is less than US$100m (€44.6m market cap, or US$48.4m). Annonce • Apr 05
Oncopeptides AB (Publ) Provides Sales Guidance for the First Quarter of 2024 Oncopeptides AB (publ) provided sales guidance for the first quarter of 2024. The company expected net sales to amount to SEK 5.1 million (SEK 1.1 million). Annonce • Mar 13
Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 300 million. Oncopeptides AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 300 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: Rights Offering New Risk • Feb 28
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: -kr279m 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 Risk Less than 1 year of cash runway based on free cash flow trend (-kr279m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr50m net loss in 3 years). Share price has been volatile over the past 3 months (7.9% average weekly change). Revenue is less than US$5m (kr35m revenue, or US$3.4m). Market cap is less than US$100m (€43.6m market cap, or US$47.2m). Annonce • Feb 24
Oncopeptides AB (publ), Annual General Meeting, May 22, 2024 Oncopeptides AB (publ), Annual General Meeting, May 22, 2024. Annonce • Dec 16
Oncopeptides Announces European Commission Decides to Formally Approve its Application to EMA for Extended Indication for Pepaxti into Earlier Lines Oncopeptides announced that the European Commission has decided to formally approve the company’s application to the European Medicines Agency (EMA) for an extended indication for Pepaxti into earlier lines. The previously communicated decision by Oncopeptides to opt out of the process to extend the indication remains. Oncopeptides has submitted an application to adjust the indication of Pepaxti to the originally approved indication, a process that is expected to be finalized in early 2024. During this time, Oncopeptides will work together with the European Commission, EMA as well as local stakeholders to ensure an efficient removal process for the extended indication. Annonce • Nov 18
Oncopeptides AB (publ) to Report Q3, 2024 Results on Nov 07, 2024 Oncopeptides AB (publ) announced that they will report Q3, 2024 results on Nov 07, 2024 Annonce • Nov 15
Oncopeptides Selects to Present Additional Data from Ocean Study Oncopeptides AB (publ) announced that long-term outcomes from its Phase 3 OCEAN study has been accepted as a poster and will be presented at the 65th annual American Society of Hematology (ASH) Meeting and Exposition. The conference takes place in San Diego between December 9-12. ASH is the world's professional hematologic society serving both clinicians and scientists around the world who are working to conquer blood diseases. The phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies. 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: -kr304m 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 (-kr304m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr147m net loss in 2 years). Revenue is less than US$5m (kr29m revenue, or US$2.7m). Market cap is less than US$100m (€56.9m market cap, or US$61.0m). Annonce • Oct 27
Oncopeptides AB (publ) to Report Q2, 2024 Results on Aug 14, 2024 Oncopeptides AB (publ) announced that they will report Q2, 2024 results at 8:00 AM, Central European Standard Time on Aug 14, 2024 Annonce • Oct 21
Oncopeptides AB (publ) Announces the Nomination Committee Oncopeptides AB (publ) announces that the composition of the Nomination Committee has been established. According to the principles for the appointment of the Nomination Committee in Oncopeptides AB (publ), the Nomination Committee for the annual general meeting 2024 shall be composed of members appointed by the three largest shareholders in terms of voting rights as of the end of the third quarter 2023 who are willing to participate in the Nomination Committee, along with the Chairman of the Board of Directors. The Nomination Committee in respect of the annual general meeting 2024 consists of the following persons who together represent approximately 29 percent of the number of shares and votes in the company based on the shareholder information at end of September 2023. Staffan Lindstrand, appointed by HealthCap VI L.P., Patrik Sobocki, appointed by Stiftelsen Industrifonden, Caroline Mebius, appointed by Handelsbanken funds, and Per Wold-Olsen, the Chairman of the Board. Annonce • Oct 12
Oncopeptides AB (publ) to Report Q1, 2024 Results on May 03, 2024 Oncopeptides AB (publ) announced that they will report Q1, 2024 results on May 03, 2024 Annonce • Oct 02
Oncopeptides AB (publ) to Report Fiscal Year 2023 Final Results on Apr 22, 2024 Oncopeptides AB (publ) announced that they will report fiscal year 2023 final results on Apr 22, 2024 Annonce • Sep 21
Oncopeptides AB (publ) to Report Fiscal Year 2023 Results on Feb 27, 2024 Oncopeptides AB (publ) announced that they will report fiscal year 2023 results on Feb 27, 2024 Annonce • Sep 15
Oncopeptides AB (Publ) Announces Positive Opinion on Type II Variation to Extend the Therapeutic Indication of Pepaxti Based on Ocean Trial Results Oncopeptides AB (publ) announced that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), has, following their scientific assessment, adopted a positive opinion on Oncopeptides' application for earlier lines of treatment for patients with relapsed, refractory multiple myeloma (RRMM). The opinion from the CHMP will now be sent to the European Commission for a final decision. Based on findings from its OCEAN trial, Oncopeptides submitted, on 28 Nov. 2022, an application to extend the therapeutic indication of Pepaxti to the treatment of adult patients with multiple myeloma who have received at least two prior lines of therapies, whose disease is refractory to lenalidomide and the last line of therapy. With their opinion, CHMP recommends that the use of Pepaxti could be expanded to earlier lines of treatment and also peripheral administration, meaning delivery of treatment through peripheral rather than central veins, a less invasive way of administration. Oncopeptides will as a next step assess the current market dynamics of the rapidly evolving multiple myeloma landscape, including the competition in different lines of treatment and the effect that extending Pepaxti into earlier lines of treatment would have on Oncopeptides's ability to receive a reimbursed price that reflects its innovation. Annonce • Aug 10
Oncopeptides AB (publ) Appoints Henrik Bergentoft as Chief Financial Officer Oncopeptides AB (publ) announced that the company has appointed Henrik Bergentoft as Chief Financial Officer, CFO. Henrik was most recently CFO at RaySearch Laboratories and brings 20+ years of experience from leading finance roles at both medical and non-medical, publicly listed organizations. He will assume his new position during the fourth quarter, replacing Holger Lembrér. Annonce • Jun 14
Holger Lembrér Will Leave Oncopeptides as Chief Financial Officer Oncopeptides AB (publ) announced that Holger Lembrér, Chief Financial Officer (CFO) has decided to leave Oncopeptides to pursue a new role in another company. Holger was appointed CFO in January 2023. He will continue in his current role until December or until a new CFO takes office. A recruitment process will be initiated immediately. Breakeven Date Change • May 08
No longer forecast to breakeven The 2 analysts covering Oncopeptides no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr45.0m in 2025. New consensus forecast suggests the company will make a loss of kr43.0m in 2025. Reported Earnings • Feb 17
Full year 2022 earnings released: kr4.11 loss per share (vs kr19.00 loss in FY 2021) Full year 2022 results: kr4.11 loss per share (improved from kr19.00 loss in FY 2021). Net loss: kr338.0m (loss narrowed 76% from FY 2021). Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has fallen by 59% per year, which means it is significantly lagging earnings. Breakeven Date Change • Feb 12
Forecast to breakeven in 2024 The 2 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 63% per year to 2023. The company is expected to make a profit of kr53.4m in 2024. Average annual earnings growth of 79% is required to achieve expected profit on schedule. Annonce • Jan 12
Oncopeptides AB (Publ) Announces Chief Financial Officer Changes Oncopeptides AB (publ.) announced that the company has appointed Holger Lembrer as Chief Financial Officer, CFO. Prior to joining the company, Holger Lembrer was Business Unit CFO at Assa Abloy, and before that Investor Relations Officer, and Financial Controller. He has also been a Senior Auditor at Ernst & Young. Holger Lembrer will assume his new position before the end of February 2023 and will replace Annika Muskantor who has been interim CFO since November 1, 2021. Annonce • Jan 05
Oncopeptides AB (publ) Announces Jakob Lindberg Assumes Chief Scientific Officer Oncopeptides AB (publ) announced that the Board of Directors has appointed Dr. Monica Shaw as Chief Executive Officer, CEO, of Oncopeptides. She replaces Jakob Lindberg, who has been the CEO since November 15, 2021. Lindberg assumes his previous position as Chief Scientific Officer. Annonce • Jan 04
Oncopeptides AB (Publ) Announces Executive Changes Oncopeptides AB (publ.) announced that the board of directors has appointed Dr. Monica Shaw as chief executive officer of the company. She replaces Jakob Lindberg, who has been the CEO since November 15, 2021. Lindberg assumes his previous position as Chief Scientific Officer. These changes are effective immediately. Dr. Monica Shaw brings a wealth of executive leadership skills from the pharmaceutical industry, e.g., GSK and LEO Pharma, and has a strong track record from bringing more than 15 products through phase III to successful commercialization, globally and across many geographies. She has a broad therapeutic area knowledge from previous positions as a physician and within industry, including Immunology, Oncology, Virology, Neurology and Rare Diseases. Annonce • Dec 23
Oncopeptides AB (publ) Announces Nomination Committee Appointments According to the principles for the appointment of the Nomination Committee in Oncopeptides AB (publ), the Nomination Committee for the annual general meeting 2023 shall be composed of members appointed by the three largest shareholders in terms of voting rights as of September 30 who are willing to participate in the Nomination Committee, along with the Chairman of the Board of Directors. The composition of the Nomination Committee has now been established, and Oncopeptides announced that the Nomination Committee in respect of the annual general meeting 2023 consists of the following persons who together represent approximately 29% of the number of shares and votes in the company based on the shareholder information at end of September. Staffan Lindstrand, appointed by HealthCap VI L.P. Patrik Sobocki, appointed by Stiftelsen Industrifonden, Caroline Mebius, appointed by Handelsbanken funds, Per Wold-Olsen, the Chairman of the Board. Annonce • Dec 15
Oncopeptides AB (publ) to Report Fiscal Year 2022 Final Results on Apr 25, 2023 Oncopeptides AB (publ) announced that they will report fiscal year 2022 final results at 9:00 AM, Central European Standard Time on Apr 25, 2023 Annonce • Dec 08
Oncopeptides Provides Update on Pepaxto US Marketing Authorization Oncopeptides AB (publ) announced that theUS Food and Drug Administration, FDA, has requested a withdrawal of the US marketing authorization for Pepaxto® (melphalan flufenamide, also called melflufen). The request is based on the outcome of the confirmatory phase 3 OCEAN study, which demonstrated an ITT overall survival HR of 1.1, but with significant survival result differences for both melflufen and the comparator drug pomalidomide for large relevant patient groups. Pepaxtowas granted accelerated approval in the U.S., on February 26,2021, and is indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. At the FDA's request, Oncopeptides stopped marketing Pepaxto in the US on October 22, 2021, and Pepaxto is currently not commercially available for US patients. The commercialization of Pepaxti® in Europe is ongoing. Pepaxti has a full approval from the European Medicines Agency, EMA, since August 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the UK on November 11, 2022. Both approvals take the large OCEAN study overall survival differences across relevant patient groups into account. Pepaxti is indicated in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. The Company is developing its preclinical pipeline, including the next generation of drug candidates from the PDC platform, as well as an NK-cell engager, built on the technology platform of "Small Polypeptide based Killer Engagers", SPiKEs. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annonce • Nov 12
Oncopeptides AB (Publ) Announces Pepaxti Has Been Granted Marketing Authorization in the Uk Oncopeptides AB (publ) announced that Pepaxti® (melphalan flufenamide, also called melflufen) has been granted marketing authorization in combination with dexamethasone, by the Medicines & Healthcare products Regulatory Agency, MHRA, in UK. The marketing authorization in the UK is based on data from the phase 2 HORIZON study and is supported by data from the randomized controlled phase 3 OCEAN study as a confirmatory study. The clinical benefit of melflufen in multiple myeloma patients with a treatment history with no stem-cell transplant or a successful prior stem-cell transplant has recently gained additional support with data from the phase 3 LIGHTHOUSE study. Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. On August 18, Pepaxti was granted marketing authorization by the European Commission in EU and in the EEA-countries Iceland, Lichtenstein, and Norway. Annonce • Nov 11
Oncopeptides AB (Publ) Announces the Market Potential for Pepaxti in Europe Oncopeptides AB (publ) announced the estimated market potential for Pepaxti® in Europe. The potential assumes that the Company´s pending type 2 variation submission to the European Medicines Agency based on OCEAN data, will be approved by the agency, and enable patients with relapsed refractory multiple myeloma access to the drug in an earlier treatment line.Furthermore, the market potential assumes that price negotiations will reflect the degree of innovation of the drug and the clinical benefit to the patients. The European Commission has granted Pepaxti, in combination with dexamethasone, Marketing Authorization in the European Union and countries in the European Economic Area, for the treatment of adult patients withmultiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. Breakeven Date Change • Nov 10
Forecast to breakeven in 2024 The 3 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 63% per year to 2023. The company is expected to make a profit of kr73.4m in 2024. Average annual earnings growth of 87% is required to achieve expected profit on schedule. Annonce • Nov 09
Oncopeptides AB (publ), Annual General Meeting, May 25, 2023 Oncopeptides AB (publ), Annual General Meeting, May 25, 2023. Annonce • Oct 26
Oncopeptides AB (publ) Announces Data from the Phase 3 Lighthouse Study Oncopeptides AB (publ) announced data from the phase 3 LIGHTHOUSE study that further confirms the clinical benefit of melflufen in patients with relapsed refractory multiple myeloma (RRMM). The LIGHTHOUSE study investigated the efficacy and safety of the combination of melflufen plus daratumumab subcutaneous (sc) plus dexamethasone in comparison with daratumumab sc. (with supportive dexamethasone) in patients who were refractory to at least an immunomodulatory agent and a proteasome inhibitor or have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent. LIGHTHOUSE is a randomized, open label phase 3 trial, designed as a confirmatory study in addition to the phase 3 OCEAN study. The primary endpoint was progression free survival (PFS). The study started in December 2020 and was planned to include 240 patients. In July 2021, the US Food and Drug Administration (FDA) requested a partial clinical hold of all studies with melflufen. Consequently, patient recruitment in LIGHTHOUSE was halted after 54 patients had been randomized. The clinical study was prematurely terminated in February 2022. Twenty-seven patients were randomized to each treatment arm. Patient characteristics were balanced between the two study arms. The observed efficacy and safety profile for the daratumumab sc. control arm in LIGHTHOUSE was in line with the approval labels in EU and USA with numerically higher PFS and Overall Response Rate (ORR). Despite the small number of patients enrolled in LIGHTHOUSE at the time of study termination (n=54), the PFS in the ITT population was superior for the melflufen treatment arm in comparison with the control arm with a hazard-ratio (HR) of 0.18 and a nominal p-value of 0.0032. The ITT ORR was superior with a nominal p-value of 0.030, and the ITT Overall Survival (OS) HR was 0.47 with a nominal p-value of 0.37. In the patient population where the European Medicines Agency (EMA) confirmed melflufen clinical benefit based on the OCEAN trial, the LIGHTHOUSE study (n=29) demonstrated superior PFS with a HR of 0.062 with a nominal p-value of 0.0005, superior ORR with a nominal p-value of 0.0051, and superior OS with a HR of 0.00 with a nominal p-value of 0.037. This patient population excludes patients with post-ASCT time-to-progression <36 months. The safety profile of the melflufen and daratumumab sc combination was in line with what was observed in the phase 1/2 ANCHOR study, with predominantly clinically manageable cytopenias. The ANCHOR study was evaluating safety and efficacy of melflufen plus dexamethasone in combination with either daratumumab sc or bortezomib in patients with RRMM. Annonce • Oct 04
Oncopeptides AB (publ) Starts Commercialization of Pepaxti in Europe - Germany First Market Oncopeptides AB (publ) announced that the Company has submitted the AMNOG dossier to "The Federal Joint Committee" (G-BA) in Germany. This initiates the commercial launch of Pepaxti and thus Germany will be the first market in Europe where the drug is launched. On August 18, the European Commission granted Pepaxti, in combination with dexamethasone, Marketing Authorization in the European Union and countries in the European Economic Area, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. Oncopeptides will launch Pepaxti with a focused and lean organization, dedicated to providing patient access for the drug in Germany and Austria. The ex-manufacturer price amounts to 5.450 E per vial, concluding an average price of 10.900 E per cycle/month. The price reflects the clinical benefit for patients in the approved indication. The price is valid for one year and will be subject to negotiations with the National Association of Statutory Health Insurance Funds to set a reimbursed price for German sick funds. According to data from more than 60 sick funds in Germany in 2020, the prevalence of multiple myeloma is estimated to 59.000 patients and the annual incidence of diagnosed patients is approximately 9.200 cases. The indicated population for Pepaxti in Germany amounts to around 2.500 patients. Annonce • Sep 23
Oncopeptides AB (publ) Provides Update from Meeting with Advisory Committee ODAC Oncopeptides AB (publ) announced that the Oncologic Drugs Advisory Committee (ODAC), of the US Food and Drug Administration (FDA), has finalized the discussion on the benefit-risk profile of Pepaxto® (melphalan flufenamide, also called melflufen). A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population. Pepaxto is indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. In the light of the outcome of the OCEAN trial, the FDA has asked the ODAC panel to vote on the following question: “Given the potential detriment in overall survival (OS), failure to demonstrate a progression-free survival (PFS) benefit, and lack of an appropriate dose, is the benefit risk profile of melphalan flufenamide favorable for the currently indicated patient population?” In a 14 to 2 vote, the ODAC answered no to the question. The FDA will not issue a final determination on the issues discussed until input from the advisory committee process has been considered and all reviews have been finalized. Annonce • Sep 08
Oncopeptides AB (Publ) Receives SEK 5 Million Grant for Nk-Cell Engager Project in Multiple Myeloma Oncopeptides AB (publ) has received a research grant of SEK 5 Million from Sweden's Innovation Agency, to develop preclinical proof of concept (PoC) for a novel synthetic small polypeptide for the treatment of multiple myeloma. The compound is a Natural Killer (NK) cell engaging immunotherapy, with superior tissue penetration and immune cell activation. The NK ENGAGE project has been qualified as a Eurostars program and will be driven by a research consortium including the department of Cancer Immunology at Oslo University Hospital, Norway, Pharmatest Services Ltd. in Turku, Finland, and Oncopeptides, together with its collaborator the Royal Institute of Technology in Stockholm, KTH, where the technology originally stems from. The project is supported by a research grant from Sweden'sInnovation Agency. By project completion, the efficacy of the lead compound will be validated in a novel preclinical model. The data package generated in NK Engage, enables Oncopeptides to enter final preclinical studies including IND enabling studies, and subsequently start clinical development. Following a successful phase 1 trial, a strong data package will be generated to support further development of the candidate drug. The project is expected to start on October 1, 2022 and will continue for 36 months. Annonce • Aug 19
European Commission Approves Oncopeptides' Pepaxti for the Treatment of Patients with Relapsed Refractory Multiple Myeloma Oncopeptides AB (publ) announced that the European Commission has granted Pepaxti® (melphalan flufenamide, also called melflufen) marketing authorization in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. The marketing authorization is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Lichtenstein, and Norway. The marketing authorization is based on data from the phase 2 HORIZON study and is supported by data from the randomized controlled phase 3 OCEAN study as confirmatory study. Oncopeptides intends to submit a type II variation in fourth quarter 2022 to enable access to earlier lines of treatment for patients with relapsed refractory multiple myeloma (RRMM). Oncopeptides will now advance market access activities to pave the way for a successful launch of Pepaxti in Germany in fourth quarter, 2022. The Company is dedicated to making the drug available for patients across Europe and is actively considering various options to commercialize the product. Breakeven Date Change • Aug 13
Forecast to breakeven in 2024 The 2 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 68% per year to 2023. The company is expected to make a profit of kr200.2m in 2024. Average annual earnings growth of 30% is required to achieve expected profit on schedule. Annonce • Jun 25
Oncopeptides AB (Publ) Issues A Positive Opinion Recommending Full Approval of Oncopeptides Peti in Eu for Patients with Tr Triple Class Refractory Multiple Myeloma Oncopeptides AB (publ) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), has unanimously adopted a positive opinion recommending a full marketing authorization approval (MAA) of Pepaxti (melphalan flufenamide, also called melflufen) in EU. The European Commission (EC) will make a legally binding decision based on the EMA recommendation within 60 days. Once granted by EC, the marketing authorization is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Lichtenstein, and Norway. The positive opinion is based on data from the phase 2 HORIZON study andis supported by data from the randomized controlled phase 3 OCEAN study which was utilized as confirmatory study. No specific post-marketing commitments were issued. Oncopeptides intends to submit a type II variation in Fourth Quarter 2022 to enable access to earlier lines of treatment for patients with relapsed refractory multiple myeloma (RRMM). Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti -CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. Annonce • Jun 24
Oncopeptides AB (Publ) Announces That the European Medicines Agency´S Committee for Medicinal Products for Human Use Oncopeptides AB (publ) announced that the European Medicines Agency´s (EMA) Committee for Medicinal Products for Human Use (CHMP), has unanimously adopted a positive opinion recommending a full marketing authorization approval (MAA) of Pepaxti® (melphalan flufenamide, also called melflufen) in EU. The European Commission (EC) will make a legally binding decision based on the EMA recommendation within 60 days. Once granted by EC, the marketing authorization is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Lichtenstein, and Norway. The positive opinion is based on data from the phase 2 HORIZON study and is supported by data from the randomized controlled phase 3 OCEAN study which was utilized as confirmatory study. No specific post-marketing commitments were issued. Oncopeptides intends to submit a type II variation in Fourth Quarter 2022 to enable access to earlier lines of treatment for patients with relapsed refractory multiple myeloma (RRMM). Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least oneproteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem celltransplantation, the time to progression should be at least 3 years from transplantation. As previously disclosed, Oncopeptides has an EIB loan facility. Oncopeptides and EIB are currently in negotiations,to update tranche definitions to reflect the current regulatory situation. In addition, the Company is considering additional financing options to capture the opportunities with the upcoming EU-approval. This may include new share issues and other public or private financing options. Oncopeptides will advance market access activities after an approval by the European Commission, to pave the way for a successful launch of Pepaxti in Germany in fourth quarter of 2022. The Company is actively considering various options to commercialize the drug, making it available for patients across Europe, and maximizing shareholder value. Reported Earnings • May 06
First quarter 2022 earnings released: kr1.31 loss per share (vs kr3.45 loss in 1Q 2021) First quarter 2022 results: kr1.31 loss per share (up from kr3.45 loss in 1Q 2021). Revenue: kr0 (down 100% from 1Q 2021). Net loss: kr98.6m (loss narrowed 58% from 1Q 2021). Profit margin: (up from net loss in 1Q 2021). The move to profitability was driven by lower revenue. Over the next year, revenue is expected to shrink by 54% compared to a 28% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has fallen by 59% per year, which means it is performing significantly worse than earnings. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions • Feb 20
Chief Executive Officer recently bought €188k worth of stock On the 18th of February, Jakob Lindberg bought around 215k shares on-market at roughly €0.87 per share. This was the largest purchase by an insider in the last 3 months. Despite this recent buy, Jakob has been a net seller over the last 12 months, reducing personal holdings by €1.4m. Annonce • Feb 18
Oncopeptides AB (publ) to Report Fiscal Year 2022 Results on Feb 16, 2023 Oncopeptides AB (publ) announced that they will report fiscal year 2022 results at 8:00 AM, Central European Standard Time on Feb 16, 2023 Breakeven Date Change • Feb 17
No longer forecast to breakeven The 4 analysts covering Oncopeptides no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr212.5m in 2024. New consensus forecast suggests the company will make a loss of kr48.0m in 2024. Annonce • Jan 22
Oncopeptides Rescinds Voluntary Withdrawal of Pepaxto in the US – No Intent to Market in the US at This Time Oncopeptides AB (publ) announced that the Company has contacted the US Food and Drug Administration and rescinded the October 22, 2021, letter requesting voluntary withdrawal of the NDA of Pepaxto® (INN melphalan flufenamide, also called melflufen) in the US. Further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials have led the Company to reconsider its previous voluntary withdrawal request. Oncopeptides has discontinued the marketing of Pepaxto in the US and does not intend to market Pepaxto in the US at this time. The company has initiated a dialogue with the FDA to review the new data. Recent Insider Transactions • Jan 14
Independent Chairman of the Board recently bought €138k worth of stock On the 12th of January, Per Wold-Olsen bought around 186k shares on-market at roughly €0.74 per share. This was the largest purchase by an insider in the last 3 months. Per has been a buyer over the last 12 months, purchasing a net total of €187k worth in shares. Annonce • Jan 13
Oncopeptides AB (Publ) Announces Data from Phase 3 Ocean Study Published in the Lancet Haematology Oncopeptides AB (publ) announced that the data from the randomized head-to-head phase 3 OCEAN study, evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in lenalidomide refractory patients with relapsed refractory multiple myeloma (RRMM) that have received 2-4 prior lines of therapy, have been published in the Lancet Hematology. The OCEAN study was initiated in 2017 and includes 495 patients from 108 hospitals in 21 countries across Europe, North America, and Asia. In the intention to treat population (ITT) melflufen met the primary endpoint of superior Progression Free Survival (PFS) as assessed by the Independent Review Committee, with a median PFS of 6.8 months, compared to 4.9 months for pomalidomide with a Hazard Ratio (HR) of 0.79 (p-value 0.03). PFS was defined as the time from randomization to confirmed disease progression or death. Key secondary endpoints were Overall Response Rate (ORR), Overall Survival (OS) and safety. The ORR, the proportion of patients with a complete or partial response, was 33 % in the melflufen group and 27 % in the pomalidomide group (non-statistically different). The ITT OS HR was 1.10 (non-statistically different). The study showed a highly heterogenous OS HR result with significant statistical interactions between the OS HR result and patient characteristics such as Autologous Stem Cell Transplant (ASCT) and gender. Further analyses of the result and their potential implications are ongoing. Safety endpoints were treatment duration, frequency and grade of adverse events, frequency of events leading to dose modifications, and time to dose modifications. The safety and tolerability of melflufen plus dexamethasone, were consistent with previous reports. Hematological treatment emergent adverse events were most common, and generally clinically manageable with dose modifications. Despite higher frequencies of grade 3 or 4 thrombocytopenia and neutropenia with melflufen compared to pomalidomide, the number of concurrent grade 3 or 4 bleeding with thrombocytopenia and infection events with neutropenia were low. Most patients continued therapy after dose reduction and few adverse events resulted in discontinuation of treatment. Board Change • Jan 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Jennifer Jackson was the last director to join the board, commencing their role in 2018. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Executive Departure • Nov 28
Chief Executive Officer Martin Duvall has left the company On the 15th of November, Martin Duvall was replaced as CEO by Jakob Lindberg after 1.4 years in the role. As of September 2021, Martin still personally held only 8.80k shares (€36k worth at the time). Martin is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.63 years, which is considered inexperienced in the Simply Wall St Risk Model. Under Martin's leadership, the company delivered a total shareholder return of -96%. Executive Departure • Nov 28
Chief Executive Officer Martin Duvall has left the company On the 15th of November, Martin Duvall was replaced as CEO by Jakob Lindberg after 1.4 years in the role. As of September 2021, Martin still personally held only 8.80k shares (€36k worth at the time). Martin is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.63 years, which is considered inexperienced in the Simply Wall St Risk Model. Under Martin's leadership, the company delivered a total shareholder return of -96%. Executive Departure • Nov 28
Chief Executive Officer Martin Duvall has left the company On the 15th of November, Martin Duvall was replaced as CEO by Jakob Lindberg after 1.4 years in the role. As of September 2021, Martin still personally held only 8.80k shares (€36k worth at the time). Martin is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.63 years, which is considered inexperienced in the Simply Wall St Risk Model. Under Martin's leadership, the company delivered a total shareholder return of -96%. Executive Departure • Nov 28
Chief Executive Officer Martin Duvall has left the company On the 15th of November, Martin Duvall was replaced as CEO by Jakob Lindberg after 1.4 years in the role. As of September 2021, Martin still personally held only 8.80k shares (€36k worth at the time). Martin is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.63 years, which is considered inexperienced in the Simply Wall St Risk Model. Under Martin's leadership, the company delivered a total shareholder return of -96%. Executive Departure • Nov 28
Chief Executive Officer Martin Duvall has left the company On the 15th of November, Martin Duvall was replaced as CEO by Jakob Lindberg after 1.4 years in the role. As of September 2021, Martin still personally held only 8.80k shares (€36k worth at the time). Martin is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.63 years, which is considered inexperienced in the Simply Wall St Risk Model. Under Martin's leadership, the company delivered a total shareholder return of -96%. Executive Departure • Nov 28
Chief Executive Officer Martin Duvall has left the company On the 15th of November, Martin Duvall was replaced as CEO by Jakob Lindberg after 1.4 years in the role. As of September 2021, Martin still personally held only 8.80k shares (€36k worth at the time). Martin is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.63 years, which is considered inexperienced in the Simply Wall St Risk Model. Under Martin's leadership, the company delivered a total shareholder return of -96%. Executive Departure • Nov 28
Chief Executive Officer Martin Duvall has left the company On the 15th of November, Martin Duvall was replaced as CEO by Jakob Lindberg after 1.4 years in the role. As of September 2021, Martin still personally held only 8.80k shares (€36k worth at the time). Martin is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.63 years, which is considered inexperienced in the Simply Wall St Risk Model. Under Martin's leadership, the company delivered a total shareholder return of -96%. Executive Departure • Nov 28
Chief Executive Officer Martin Duvall has left the company On the 15th of November, Martin Duvall was replaced as CEO by Jakob Lindberg after 1.4 years in the role. As of September 2021, Martin still personally held only 8.80k shares (€36k worth at the time). Martin is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.63 years, which is considered inexperienced in the Simply Wall St Risk Model. Under Martin's leadership, the company delivered a total shareholder return of -96%.