Loading...
•
Mar 31, 2022
Tenaya Therapeutics Q1 2022 Earnings Report
Reported financial results for the first quarter ended March 31, 2022 and provided business and program updates.
Key Takeaways
Tenaya Therapeutics reported its first quarter 2022 financial results, with a net loss of $31.1 million, or $0.75 per share. The company's cash, cash equivalents and investments totaled $213.5 million as of March 31, 2022, expected to fund operations into the second half of 2023. Tenaya continues to advance its pipeline, including TN-201 which received Orphan Medicinal Product designation from the European Commission.
TN-201 received Orphan Medicinal Product designation from the European Commission for the treatment of HCM due to mutations in the MYBPC3 gene.
Preclinical data for TN-401 was presented at Heart Rhythm 2022, showing restoration of heart function and increased survival in a Pkp2 knockout mouse model.
IND-enabling efforts for TN-201 and TN-301 are on track, with IND applications expected to be submitted to the FDA in the second half of 2022.
Tenaya expects its cGMP manufacturing facility in Union City, California, to become operational in the first half of 2022.
Tenaya Therapeutics
Tenaya Therapeutics
Forward Guidance
Tenaya expects to submit IND applications for TN-201 and TN-301 to the FDA in the second half of 2022, and for TN-401 in 2023. The company also anticipates its cGMP manufacturing facility will become operational in the first half of 2022 and believes its current cash, cash equivalents and investments will be sufficient to fund operations at least into the second half of 2023.
Positive Outlook
- IND-enabling efforts for TN-201 and TN-301 are on track, with IND applications expected to be submitted to the FDA in the second half of 2022.
- Tenaya expects to submit an IND application for TN-401 to the FDA in 2023.
- Tenaya expects its state-of-the-art, modular cGMP manufacturing facility in Union City, California, will become operational in the first half of 2022.
- Current cash, cash equivalents and investments in marketable securities are expected to be sufficient to fund its current operating plan at least into the second half of 2023.
- TN-201 received Orphan Medicinal Product designation from the European Commission.
Challenges Ahead
- The process of discovering, developing and commercializing drugs involves risks and uncertainties.
- Tenaya's ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals for its product candidates is subject to risks.
- The timing, progress and results of preclinical studies for TN-201, TN-301, TN-401 and Tenaya’s other programs are subject to uncertainty.
- Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans is uncertain.
- The potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results exists.