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01/10 17:31
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call highlights significant financial risks, including a steep decline in cash reserves, raising concerns about operational funding. The delay in NDA submission and regulatory uncertainties further contribute to a negative sentiment. Despite cost-cutting measures, the market competition and lack of clear strategic direction in the Q&A section suggest challenges ahead. These factors, combined with the absence of strong positive catalysts, imply a likely negative stock price reaction.
Cash and Cash Equivalents $13,900,000 (decreased from $23,300,000 as of 12/31/2024) - The decrease is attributed to operational expenditures.
Research and Development Expenses $3,400,000 (decreased from $7,100,000 for the same period in 2024) - The decrease is largely driven by reduced patient follow-up activities for the Clover WM Phase two clinical study and a reduction in personnel costs.
General and Administrative Expenses $3,000,000 (decreased from $4,900,000 for the same period in 2024) - The decrease was primarily due to a reduction in pre-commercialization and personnel costs.
Net Loss $6,600,000 or $0.14 per share (decreased from $26,600,000 or $0.91 per share during the same period in 2024) - The significant reduction in net loss reflects the overall decrease in operational expenses.
New Product Development: SelectR is advancing its clinical development pipeline of radiopharmaceuticals, particularly focusing on iapoficine I-131 for the treatment of Waldenstrom’s macroglobulinemia (WM). The Phase II CLOVER WM clinical trial has shown promising efficacy and safety results. SelectR is also progressing its solid tumor-focused radioisotope programs, including an alpha emitter for pancreatic cancer and an OG emitter for triple negative breast cancer.
Market Expansion: SelectR is seeking guidance from the EMA for conditional approval of iapoficine I-131 in Europe, aiming for a faster market entry for this critical treatment. The company anticipates a meeting with the EMA in the third quarter of 2025 to discuss the regulatory pathway for conditional approval.
Operational Efficiency: Research and development expenses decreased to approximately $3.4 million for Q1 2025 from $7.1 million in Q1 2024, primarily due to reduced patient follow-up activities and personnel costs. General and administrative expenses also decreased to $3 million in Q1 2025 from $4.9 million in Q1 2024, driven by lower pre-commercialization and personnel costs.
Strategic Shift: SelectR has engaged Oppenheimer as an exclusive financial advisor to explore strategic alternatives, including mergers, acquisitions, partnerships, and licensing arrangements.
Regulatory Risks: SelectR is navigating the regulatory landscape with the FDA and EMA for the approval of iapoficine I-131. The company is seeking guidance for accelerated approval, which involves uncertainties regarding the acceptance of their proposed study designs and data.
Financial Risks: SelectR's cash reserves decreased from $23.3 million to $13.9 million, raising concerns about funding operations into late 2025. The company is exploring strategic alternatives, which may include mergers or partnerships, indicating potential financial instability.
Market Competition: The company faces competitive pressures in the relapsed-refractory market, particularly against established therapies like rituximab, which has a higher response rate in earlier lines of therapy. This could impact the market potential for iapoficine I-131.
Clinical Development Risks: The initiation and timing of clinical trials for SelectR's pipeline products are contingent on obtaining necessary funding, which poses a risk to their development timelines and market entry.
Economic Factors: The pricing environment in Europe is different from the U.S., which may affect the commercial opportunity for their products. The company must navigate these economic factors while seeking conditional approval from the EMA.
Strategic Alternatives Exploration: SelectR has engaged Oppenheimer as an exclusive financial advisor to explore strategic alternatives, which may include mergers, acquisitions, partnerships, joint ventures, licensing arrangements, or other non-dilutive transactions.
Regulatory Pathway for Iapopacine I-131: SelectR is finalizing requirements from the FDA and EMA for Iapopacine I-131 for the treatment of Waldenstrom’s macroglobulinemia, aiming for accelerated approval in the U.S. and conditional approval in Europe.
Clinical Development Pipeline: SelectR is progressing its clinical development pipeline, including solid tumor-focused radioisotope programs for pancreatic cancer and triple-negative breast cancer.
Cash Position: SelectR ended the quarter with cash and cash equivalents of $13.9 million, expected to fund operations into Q4 2025.
Research and Development Expenses: R&D expenses for Q1 2025 were approximately $3.4 million, down from $7.1 million in Q1 2024.
Net Loss: Net loss for Q1 2025 was $6.6 million, or $0.14 per share, compared to $26.6 million, or $0.91 per share in Q1 2024.
Conditional Approval Timeline: SelectR expects to hear from the EMA regarding conditional approval in Q3 2025.
Cash and Cash Equivalents: $13,900,000 as of 03/31/2025, down from $23,300,000 as of 12/31/2024.
Net Loss: $6,600,000 or $0.14 per share for the three months ended 03/31/2025, compared to $26,600,000 or $0.91 per share for the same period in 2024.
Research and Development Expenses: $3,400,000 for the three months ended 03/31/2025, down from $7,100,000 for the same period in 2024.
General and Administrative Expenses: $3,000,000 for the three months ended 03/31/2025, compared to $4,900,000 for the same period in 2024.
Shareholder Value Maximization: Engaged Oppenheimer as an exclusive financial advisor to explore strategic alternatives to maximize shareholder value.
The earnings call presents a mixed outlook. While there are positive developments such as decreased expenses and strong partnership momentum, significant risks persist, including reliance on rare isotopes and funding needs for trials. The Q&A reveals cautious optimism but lacks concrete guidance and pricing details, which may concern investors. Given the balanced nature of positive and negative factors, a neutral stock price reaction is expected.
While there are positive aspects, such as reduced R&D expenses and a strategic plan for accelerated approval, significant risks are present. Funding challenges and regulatory uncertainties are major concerns, as the company's plans hinge on securing additional capital. The Q&A reveals management's lack of clarity on critical timelines, further increasing uncertainty. The decrease in cash reserves and increased net loss also contribute to a negative outlook. Without a market cap, we assume mid-cap, leading to a likely stock price decrease of -2% to -8%.
The earnings call reveals multiple concerns: a significant decrease in cash reserves, ongoing regulatory and financial risks, and competitive market challenges. While cost reductions have improved net loss, the delay in NDA submission and reliance on strategic alternatives indicate uncertainty. The Q&A section highlights management's lack of clarity on critical trial decisions. Despite positive strides in cost management, the overall sentiment is negative, especially given the financial and operational risks. Without a market cap, the reaction is predicted as negative due to these uncertainties and challenges.
The earnings call highlights significant financial risks, including a steep decline in cash reserves, raising concerns about operational funding. The delay in NDA submission and regulatory uncertainties further contribute to a negative sentiment. Despite cost-cutting measures, the market competition and lack of clear strategic direction in the Q&A section suggest challenges ahead. These factors, combined with the absence of strong positive catalysts, imply a likely negative stock price reaction.
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