Risk Factors Update Summary
- Employee count increased from 17 full-time and 3 part-time to 24 full-time and 2 part-time.
- FDA issued a CRL requesting a PK/PD study for neffy compared to epinephrine, impacting approval timeline.
- Net losses decreased from approximately $54.4 million to $34.7 million for the year ended December 31, 2023.
- The FDA requested additional info on nitrosamine impurities for neffy, affecting regulatory process.
- Accumulated deficit increased from $76 million to $131 million as of December 31, 2023.
- Market research indicates 88% of former patients willing to return to neffy, potentially impacting market share.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1671858&owner=exclude
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