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Dec 31, 2019
89Bio Q4 2019 Earnings Report
89bio reported financial results for Q4 and full year 2019, highlighting progress with BIO89-100 clinical trials and a successful IPO.
Key Takeaways
89bio reported its Q4 and full year 2019 financial results, noting the initiation of the Phase 1b/2a clinical trial for BIO89-100 in NASH, planned initiation of Phase 2 study in SHTG, and the completion of an upsized initial public offering.
Initiated dosing in Phase 1b/2a clinical trial evaluating BIO89-100 in patients with NASH or NAFLD.
Phase 2 clinical trial evaluating BIO89-100 in patients with SHTG is on track for initiation in the first half of 2020.
Completed an upsized IPO on November 13, 2019, with gross proceeds of approximately $97.6 million.
Cash and cash equivalents were $93.4 million as of December 31, 2019, including net proceeds from the IPO.
89Bio
89Bio
Forward Guidance
89bio expects 2020 to be a transformative year with topline data from the Phase 1b/2a NASH study expected in the second half of 2020 and planned initiation of the Phase 2 study in SHTG in the first half of 2020.
Positive Outlook
- Topline data from Phase 1b/2a NASH study expected in 2H20.
- Planned initiation of Phase 2 SHTG study in 1H20.
- BIO89-100 demonstrated consistent beneficial effects in preclinical studies.
- BIO89-100 demonstrated a favorable tolerability profile and dose-proportional pharmacokinetics in Phase 1a clinical trial.
- Statistically significant improvements in key lipid parameters were observed for two weeks after a single dose of BIO89-100.
Challenges Ahead
- Expectations regarding the enrollment, completion and outcome of 89bio’s proof of concept Phase 1b/2a clinical trial evaluating BIO89-100 in patients with NASH or patients with NAFLD and a high risk of NASH.
- Expectations regarding the timing, completion and outcome of 89bio’s proof of concept Phase 2 clinical trial evaluating BIO89-100 in patients with SHTG.
- The unpredictable relationship between preclinical study results and clinical study results.
- Liquidity and capital resources.
- Other risks and uncertainties identified in 89bio’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed December 18, 2019 with the SEC and other subsequent disclosure documents filed with the SEC.