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Introduction & Market Context
Nykode Therapeutics ASA (NASDAQ:NYKD) presented its first quarter 2025 results on May 28, revealing significant improvements in its financial position despite reporting no revenue for the period. The company’s stock traded at $1.92, down 1.09% on the day of the presentation, as investors digested the mixed results that showed operational progress amid ongoing restructuring efforts.
The immunotherapy company, which focuses on cancer vaccines and immune tolerance applications, has been implementing organizational streamlining measures that appear to be yielding financial benefits, even as it continues to advance its clinical pipeline.
Quarterly Performance Highlights
Nykode reported no revenue from contracts with customers in Q1 2025, compared to $827,000 in the same period last year and $6.9 million in Q4 2024. Despite the revenue decline, the company significantly narrowed its operating loss to $7.54 million from $15.6 million in Q1 2024, reflecting successful cost-cutting measures.
Most notably, the company reduced its net loss to just $1.44 million, a substantial improvement from the $14.94 million loss reported in Q1 2024. Employee benefit expenses were cut by more than half, dropping to $3.71 million from $8.82 million in the prior-year quarter.
As shown in the following income statement, these financial improvements demonstrate the impact of the company’s organizational streamlining:
The company maintained a strong cash position of $106.2 million as of March 31, 2025, providing runway for its ongoing clinical programs. Nykode also reported a robust equity ratio of 91%, indicating a solid financial foundation.
Clinical Program Updates
Nykode highlighted several recent achievements across its clinical portfolio. The company published Phase 2 data from its VB-C-02 trial in the BMJ Journal for ImmunoTherapy of Cancer, demonstrating favorable safety and efficacy results for VB10.16 in combination with atezolizumab for HPV16-positive cervical cancer.
The published data showed a median overall survival of 24.7 months, confirming durable efficacy of the treatment approach, as illustrated in the following publication highlight:
At ASCO 2025, Nykode presented additional data from the VB-C-02 trial showing that VB10.16 combined with atezolizumab induced durable clinical responses in HPV16+ cervical cancer. The company noted that stronger HPV16-specific T cell responses were associated with reduced systemic immunosuppression.
The company also reported progress with its VB-C-03 trial, which is evaluating VB10.16 and pembrolizumab in first-line HPV16+, PD-L1+ R/M HNSCC. Accrual for the highest dose (9 mg) has been completed, with safety data expected in Q2 2025 and the first interim analysis anticipated in the second half of 2025.
For its personalized neoantigen vaccine program, VB10.NEO, Nykode presented promising data at ASCO 2025. The VB-N-02 trial showed neoantigen-specific immune responses in all patients, with de novo immune responses in 85% and durable T cell clone expansion in 82% of patients. The treatment demonstrated a favorable safety profile in these heavily pre-treated patients.
Immune Tolerance Program Advances
Nykode’s immune tolerance program showed encouraging preclinical results, with data demonstrating durable efficacy in disease models even when treatment was initiated after disease onset. This finding is particularly significant for potential applications in autoimmune diseases, allergies, and organ transplant rejection.
As shown in the following graph, the company’s targeted vaccine demonstrated sustained efficacy over time compared to control:
The company also highlighted a new method enabling regulatory T cell analysis, which demonstrated strong induction of antigen-specific regulatory T cells:
Additionally, Nykode presented the first proof of its treatment reducing auto-antibodies, a critical marker for autoimmune conditions:
Strategic Initiatives
Nykode completed its organizational streamlining in Q1 2025 and elected Susanne Stuffers as the new Chair of the Board on April 23, 2025. The company approved a cash dividend of NOK 1.00 per share on May 26, 2025, signaling confidence in its financial position despite ongoing R&D investments.
The company outlined its 2025 organizational priorities across its three main programs:
1. For VB10.16: Present new clinical data, advance the C-03 trial, prepare for the C-03 readout, and update the VB10.16 strategy.
2. For VB10.NEO: Present new clinical data and update the strategic approach.
3. For Immune Tolerance: Present additional data and update the immune tolerance strategy.
Nykode plans to provide a comprehensive update on its corporate strategy in connection with its second quarter 2025 results.
Forward-Looking Statements
Nykode emphasized its continued focus on cost discipline, with the full effect of restructuring expected by Q3 2025. The company plans to provide updated cash runway guidance with its Q2 2025 report and stated it is on track for a sustainable cost base.
CEO Michael Engsig, who previously targeted "a cost base of approximately US$20 million dollars per year," continues to lead the company’s financial discipline efforts while advancing key clinical programs.
With multiple data readouts expected throughout 2025, including safety data from the VB-C-03 trial in Q2 and the first interim analysis in H2, Nykode is positioning itself for potential strategic partnerships while maintaining its streamlined operations and strong cash position.
Full presentation:
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