Major Estimate Revision • Jun 26
Consensus revenue estimates fall by 16% The consensus outlook for revenues in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from kr169.0m to kr141.3m. Forecast losses increased from -kr0.405 to -kr0.465 per share. Biotechs industry in Sweden expected to see average net income growth of 14% next year. Consensus price target of kr2.50 unchanged from last update. Share price was steady at kr1.65 over the past week. 공시 • 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. 공시 • 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. New Risk • May 19
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr221m Forecast net loss in 2 years: kr325k This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. 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 (75% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr325k net loss in 2 years). Market cap is less than US$100m (kr676.7m market cap, or US$72.1m). 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.