Arcturus Therapeutics Holdings Inc. Common StockARCT
Scheduled
Arcturus Therapeutics Holdings Inc. Common Stock CG 46th Annual Growth Conference
Review the key takeaways and the transcript of this earnings call.
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Key takeaways
- Arcturus has an approved Covid vaccine in 32 countries and uses its vaccine enterprise to fund its therapeutics franchise.
- The company is developing two flagship mRNA programs: ARCT032, an inhaled mRNA therapy for class one cystic fibrosis (CF), and ARCT810, an injectable mRNA therapeutic for ornithine transcarbamylase (OTC) deficiency, a rare liver disease.
- ARCT032 delivers mRNA via the proprietary Lunar lipid nanoparticle technology to bronchial epithelial cells to produce new CFTR protein, targeting patients with class one CF who currently have no approved treatments.
- The phase two study for ARCT032 is enrolling up to 20 subjects across the US, Turkey, and Israel, with data expected to support a decision to proceed to phase three in Q4 2024.
- Arcturus is collecting multiple efficacy endpoints for ARCT032 including FEV, lung clearance index, quality of life surveys, and high-resolution CT scans, and will compare results to a normative study conducted by the CF Foundation.
- The decision to proceed to phase three for ARCT032 will trigger up to $40 million in funding from Thermo Fisher, which holds commercial manufacturing rights under a unique deal that does not involve equity dilution or royalty sales.
- ARCT810 targets OTC deficiency by delivering mRNA to the liver to produce functional ornithine transcarbamylase enzyme, aiming to normalize ammonia and glutamine levels in patients.
- Phase two dosing and enrollment for ARCT810 are complete in Europe and the US, with a data readout and regulatory path update expected before September 30, 2024.
- The OTC program has three key biomarkers: ammonia, glutamine, and urea, with a focus on pediatric patients who have high unmet medical need.
- Arcturus estimates approximately 10,000 class one CF patients and 10,000 OTC patients in the US and Europe, with orphan drug pricing potential around $1.2 million for OTC therapies.
- The company reported cash and cash equivalents of $191 million plus $12 million from a partner, providing a runway through the second half of 2028.
- Arcturus plans to develop both rare disease programs independently but may seek a partner for the OTC program to fund the CF phase three study.
- The regained 100% control of their Covid vaccine rights is seen as a significant commercial opportunity, with the vaccine approved in 32 countries and a partner distributing in Japan for the current season.
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