On January 04, Annexon Inc. (ANNX) shared the interim data from its Phase 2 trial of ANX005 for Huntington’s disease (HD). Following the announcement, the company’s stock nose-dived in the after hours.
During the regular session, ANNX stock lost 7.79% at its closing value of $11.01 on Tuesday. While it was already in a downtrend, the stock plunged deep in the after-hours to lose 22.80%. Consequently, the stock was trading at $8.50 per share in the after hours.
The clinical-stage biopharmaceutical company, Annexon Inc. (ANNX) has a market capitalization of $458.2 million. Currently, the company has 38.37 million shares outstanding in the market.
ANNX’s Phase 2 Interim Data
The company has been conducting an open-label Phase 2 clinical trial of ANX005 in Huntington’s disease patients. HD is a rare and fatal disease that causes progressive degeneration of nerves in the brain. It mostly results in movement, cognitive and psychiatric disorders. Moreover, ANX005 is the company’s lead monoclonal antibody candidate for various complement-mediated disorders that includes HD. It is designed to stop the start of damaging complement activation, hence disrupting the course of the disease.
On Tuesday, ANNX disclosed the interim data from the ongoing Phase 2 trial. According to the interim safety and target engagement data:
- ANX005 showed general well-tolerability in the study.
- The most common adverse events (AEs) included first dose infusion-related reactions.
- Five patients discontinued the treatment; three due to drug-related AE, two due to serious adverse events. Both the patients stabilized after discontinuation.
- ANX005 treatment resulted in full target engagement of C1q in evaluable patients.
Moreover, according to the interim efficacy and biomarker data:
- The evaluable patients showed improvements in clinical measures as per cUHDRS (Composite Unified Huntington’s Disease Rating Scale).
- After six months of treatment, 56% of the patients demonstrated improvement from baseline.
- 75% of patients with excess baseline complement activity showed a statistical improvement in cUHDRS over six months against 36% with low activity.
- Mean plasma and CSF NfL levels were generally consistent and comparable to HD patients’ published natural history.
Furthermore, the trial is still ongoing and ANNX expects to report complete data from the trial and follow-up period in Q2 of 2022.
Q3 Financial Highlights
In the third quarter of 2021, ANNX suffered from a net loss of $35.6 million ($0.93/share), against $15.6 million ($0.77/share) in Q3 of 2020.
In addition, the company ended the quarter with cash, cash equivalents, and short-term investments of $271.4 million.
