お知らせ • Jun 17
Oncopeptides AB (Publ) Announces Enrollment of First Patient in Oncopeptides' Glioblastoma Study Oncopeptides AB (publ) announced that the first patient has been enrolled in the clinical "Window-of-Opportunity" (WoO) study evaluating its proprietary Peptide Drug Conjugate (PDC) platform in glioblastoma. The WoO study, named OP-701 (INSULA), represents the first clinical evaluation of a PDC in glioblastoma, marking a major strategic milestone as Oncopeptides expands its core technology platform beyond multiple myeloma. The focused trial will enroll approximately 10 patients to provide initial human proof-of-concept to assess that the company's technology successfully penetrates the human blood-brain barrier (BBB) in glioblastoma patients and have cytotoxic (cell killing) activity in tumor cells. The BBB remains the primary clinical obstacle and causes most traditional oncological drugs to fail in this disease. By utilizing an approved drug from Oncopeptides' platform as a "clinical probe," the study employs an innovative and highly efficient design to capture drug activity directly within the tumor tissue from patients scheduled for surgery for recurrent disease. This approach aims to validate the underlying biological mechanism in a rapid, cost-efficient manner before advancing a PDC asset into formal dose-finding and potential further clinical trials. Glioblastoma is the most aggressive and devastating form of brain cancer, characterized by rapid tumor growth, invariable relapse, and a total lack of curative options, with a median survival rate of just 12–15 months. The global glioblastoma market represents a profound unmet medical need and is estimated to be worth more than 8 billion USD by 2035. Oncopeptides' PDC molecules are believed to be uniquely equipped to pass the blood-brain barrier due to their small size and lipophilicity, entering the target cancer cells freely to deliver their cytotoxic payload directly where it is needed. The trial is conducted at Oslo University Hospital in Norway. お知らせ • 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 19
Forecast to breakeven in 2028 The 2 analysts covering Oncopeptides expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 76% per year to 2027. The company is expected to make a profit of kr41.0m in 2028. Average annual earnings growth of 104% is required to achieve expected profit on schedule. Reported Earnings • May 15
First quarter 2026 earnings released First quarter 2026 results: Revenue: kr25.4m (up 91% from 1Q 2025). Net loss: kr32.2m (loss narrowed 47% from 1Q 2025). Revenue is forecast to grow 64% p.a. on average during the next 2 years, compared to a 11% decline forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has increased by 44% per year but the company’s share price has fallen by 41% per year, which means it is significantly lagging earnings. お知らせ • 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 New Risk • Apr 01
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 84% 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 (13% average weekly change). Negative equity (-kr59m). Shareholders have been substantially diluted in the past year (84% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr19m net loss in 2 years). Market cap is less than US$100m (kr573.2m market cap, or US$60.8m). 
