Core Viewpoint - PCI Biotech Holding ASA has decided to discontinue the development of its photochemical lysis (PCL) technology for viral vector manufacturing due to insufficient progress towards its 2025 goals [1][3] Group 1: Development Progress - The company aimed to demonstrate improved yield in mini benchtop bioreactors by 2025, but efforts have not yielded convincing results [1][2] - Additional initiatives were undertaken following the preliminary 2024 Interim Report and the Annual Report 2024, but these did not lead to satisfactory outcomes [2] Group 2: Project Risks and Financial Position - Insufficient progress has extended project timelines and increased resource requirements, raising the overall project risk to an unacceptable level [3] - As of June 2025, PCI Biotech's cash position was NOK 13.6 million, which is expected to sustain operations into Q4 2025, but there is uncertainty regarding the ability to secure additional financing [4] - The company is evaluating its future, considering options such as a potential sale, merger, or complete wind-down of operations [4]

Core Insights - The focus is on sustainable wealth growth through investments in R&D biotech [1] - The author expresses a personal beneficial long position in QURE shares, indicating confidence in the company's potential [1] Company and Industry Summary - The article emphasizes the importance of research and development in the biotechnology sector as a means to achieve sustainable investment returns [1] - The author highlights the relevance of their academic background in Cell Physiology and Bio-organic Chemistry to their investment strategy in biotech [1]

Financial Data and Key Metrics Changes - Total operating expenses for Q4 2024 were $20.0 million, roughly equal to Q4 2023 and $0.9 million above the previous quarter [35] - Net loss for Q4 2024 was $17.6 million compared to $17.0 million in the prior-year period [36] - For fiscal year 2024, net loss was $70.8 million, an increase of 11% year-over-year from $63.7 million in fiscal year 2023 [37] Business Line Data and Key Metrics Changes - Research and development expenses in Q4 2024 were $12.8 million compared to $12.5 million in the prior-year period, while general and administrative expenses were $7.2 million in Q4 2024 compared to $7.5 million in the prior-year period [36] - Operating expenses for fiscal year 2024 were $81.5 million, an increase of 7% from $76.2 million in fiscal year 2023 [37] Market Data and Key Metrics Changes - The company ended the year with approximately $206 million in cash, cash equivalents, and investments compared to $264 million at the end of the previous year [39] Company Strategy and Development Direction - The company now expects the launch of its proteome analysis platform to occur in late 2026, focusing on reducing technical risk and maximizing performance [29][33] - The company plans to engage in significant partnerships to explore tau proteoform landscapes and aims to provide leading researchers access to its platform for tau proteoform-related studies in 2025 [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to deliver a game-changing product to the market, emphasizing the importance of rigorous financial discipline and operational adjustments to extend the cash runway through 2027 [33][41] - The company anticipates that 2025 will be a pivotal year for applying the platform's capabilities to important questions about tau proteoforms in Alzheimer's disease [30] Other Important Information - The company reduced its headcount by approximately 16% to align resources with development goals and extend its cash runway [33][38] - The company is focused on optimizing assay configurations and surface chemistry to enhance the performance of its platform [29][55] Q&A Session Summary Question: Could you elaborate on your plan to modify the assay configuration and surface chemistry? - Management explained that the modifications aim to enhance specific binding of affinity reagents to proteins and differentiate non-specific binding, addressing issues related to probe labeling and surface chemistry [48][49][52] Question: Does the planned change impact the cost structure of the platform? - Management indicated that the changes may have a positive impact on the consumable side and that the previously mentioned pricing of approximately $1 million for the instrument remains valid [54][55] Question: What are the key milestones and timing over 2025 and into 2026? - Management outlined milestones including providing access to the platform for tau proteoform studies, signing partnerships, and decoding a significant number of proteins from complex samples [82][84] Question: How does your platform's performance compare to other tau protein platforms? - Management highlighted that their platform uniquely measures proteoforms in high throughput and sensitivity, allowing for detailed insights into Alzheimer's disease [89][92] Question: Is the late 2026 launch for both broadscale discovery and targeted platforms? - Management clarified that both modalities are heading to market with different strategies, with broadscale discovery launching commercially in late 2026 while proteoform capabilities will be introduced through partnerships [95][100]

Financial Data and Key Metrics Changes - The company ended Q4 2024 with $562 million in cash and no bank debt, significantly exceeding its original cost-cutting target for 2024 [10][48] - Total company adjusted EBITDA in Q4 was negative $57 million, an improvement from negative $101 million in Q4 2023 [30] - Cash burn in Q4 2024 was $55 million, down from $114 million in Q3 2024, reflecting successful restructuring efforts [32][33] Business Line Data and Key Metrics Changes - Cell Engineering revenue for Q4 2024 was $35 million, up 29% year-over-year, driven by growth with large biopharma customers [15] - Biosecurity revenue in Q4 2024 was $9 million, with a full-year revenue of $53 million, down 51% from $108 million in 2023 due to the end of K-12 COVID testing contracts [23][24] - The company supported 138 active programs across 85 customers on the Cell Engineering platform in Q4 2024, a 5% increase in active programs year-over-year [17] Market Data and Key Metrics Changes - The government segment has been a source of growth, but uncertainties in this area are factored into the low end of revenue guidance for 2025 [38] - The company expects Cell Engineering revenue for 2025 to be in the range of $110 million to $130 million, with Biosecurity revenue guidance at least $50 million [39][40] Company Strategy and Development Direction - The company aims to reach adjusted EBITDA breakeven while maintaining a cash margin of safety, focusing on cost reduction and revenue expansion [10][12] - Ginkgo is expanding into life science tools and services, responding to market trends in biopharma for more data for AI models [44][46] - The company has achieved a $190 million annualized run rate reduction in spending through Q4 2024, exceeding initial targets [47] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the uncertain macro environment but is encouraged by early traction in tools offerings and the restructuring progress [42][43] - The company is optimistic about its competitive position in the biotech industry and plans to continue reducing cash burn while expanding revenue sources [48][50] - Management emphasizes the importance of maintaining a cash margin of safety to avoid dilutive fundraising [11][48] Other Important Information - The company has remediated its SOX material weakness, indicating improved financial reporting processes [43] - Ginkgo is leading an international consortium for a project worth up to EUR 24 million focused on point-of-care sequencing and metagenomic NGS [83][84] Q&A Session Summary Question: What are the ideal customer personas Ginkgo needs to close for new client acquisition - The ideal customer persona varies by product; for solutions deals, it is typically the head of R&D in large biopharma or the CEO in small biotech [89] - For data points, the target is usually a lead for a drug program, which allows for a wider engagement [90] - For automation, the focus is on automation leads responsible for building out new work cells [91]