Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Crinetics Pharmaceuticals Inc (CRNX, Financial) has submitted its first NDA for paltusotine, a next-generation therapy for acromegaly, and anticipates FDA filing notification in December.
- The company is preparing for the anticipated launch of paltusotine by building commercial capabilities and engaging with payers for formulary placement.
- Crinetics Pharmaceuticals Inc (CRNX) has a strong financial position with approximately $1.4 billion in cash and investments, projected to fund operations into 2029.
- The company is advancing a robust pipeline with multiple candidates, including CRN 9,682, a novel nonpeptide drug conjugate for cancer treatment.
- Positive results from a phase two study for carcinoid syndrome were reported, with plans to start a phase three trial on schedule.
Negative Points
- There were no revenues for the quarter ended September 30, 2024, compared to $0.3 million for the same period in 2023.
- Research and development expenses increased to $61.9 million for the quarter, up from $43.8 million in the same period in 2023, driven by higher personnel costs and manufacturing activities.
- General and administrative expenses rose to $25.9 million for the quarter, compared to $15.5 million in the same period in 2023, due to higher personnel costs and commercial planning activities.
- Net loss for the quarter was $76.8 million, compared to a net loss of $57.5 million for the same period in 2023.
- The company anticipates increased R&D and SG&A expenses as it prepares for the potential launch of paltusotine and initiates multiple phase three studies.
Q & A Highlights
Q: Can you provide more details about the NDC program, CRN 9,682, and its advantages over ADCs or radiotherapies?
A: The NDC platform is an extension of ideas from radio nets, offering advantages over ADCs by targeting GPCRs, which are difficult for antibodies. NDCs allow for selective internalization and intracellular cleavage, offering simpler synthesis and potential advantages in pharmacokinetics. We aim to learn more about these advantages in real-world settings, particularly with neuroendocrine tumors. - Dr. Scott Struthers, CEO
Q: With several products entering the clinic next year, when can we expect Phase 1 data, and how did you choose the MMAE toxin for CRN 9,682?
A: We anticipate a flow of information over the next year but won't provide precise timelines. CRN 9,682 is not a direct homologue of paltusotine; it was optimized for selective binding and internalization. MMAE was chosen due to its established use in ADCs, but we are exploring alternative payloads. - Dr. Scott Struthers, CEO
Q: How are you approaching candidate selection for obesity indications in 2025, given the competitive landscape?
A: We focus on selecting candidates that can be easily manufactured and have good tolerability. We aim for a best-in-class profile for small molecule GLP-1 agonists, ensuring they meet high standards before advancing. - Dr. Scott Struthers, CEO
Q: What are the potential advantages of non-peptide compounds in the obesity space compared to other assets?
A: Non-peptide compounds offer advantages in manufacturing and allow exploration of broader chemical space and delivery methods. This flexibility helps optimize pharmacokinetic activities and clinical profiles, addressing one of the biggest public health challenges. - Dr. Scott Struthers, CEO
Q: Can you discuss the common toxicities associated with MMAE ADCs and your confidence in balancing efficacy and tolerability?
A: We are aware of MMAE's common toxicities and have designed CRN 9,682 to minimize circulating free MMAE, ensuring good preclinical safety margins. The conjugates clear rapidly from systemic circulation, while cleaved MMAE accumulates in tumor cells. - Dr. Scott Struthers, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
