On February 18, Homology Medicines Inc. (FIXX) disclosed notification of clinical hold of its pheNIX gene therapy trial of HMI-102 from the FDA. As a result, the stock plunged further deep in the after-hours on Friday.
In the regular trading session, the stock fluctuated between a high of $3.9200 and a low of $3.7450. FIXX stock closed the session in the red at $3.8600 with a slight decline of 0.26% at 315.36K shares. Following the announcement, the stock lost a further 37.31% or $1.44 in the after hours. Hence, the stock was trading at a value of $2.4200 per share in the after-hours on Friday.
The clinical-stage genetic medicine company, Homology Medicines Inc. was founded in 2015. Currently, the company has a market capitalization of $220.6 million with 57.15 million shares outstanding. FIXX stock stands at a year-to-date gain of 6.04% while it lost 67.97% last year.
HMI-102 Clinical Trial Hold
On Friday, the company announced that the FDA has notified the company about the clinical hold of the HMI-102 trial. Furthermore, an official clinical hold letter is expected within 30 days.
The reason for the clinical hold is the observations of elevated liver function tests. Thus, there is a need for the modification of risk mitigation measures in the study. FIXX will provide further updates about the trial after the FDA provides more details and clarity to the company.
FIXX’s Recent Presentations
Recently, the company presented at the 18th Annual WORLDSymposiumTM Meeting. During the event, the company presented data on HMI-203 gene therapy candidates for Hunter syndrome (MPS II). Currently, HMI-203 is being evaluated in juMPStart, which is a Phase 1 dose-escalation clinical trial. Moreover, data on FIXX’s AAVHSWC platform was also presented at the event.
FIXX’s Financial Overview
On November 15, the company declared its financial results for the third quarter of 2021.
In Q3 2021, FIXX incurred a net loss of $30.6 million, against $28.2 million in the year-ago period. Therefore, the net loss per basic and diluted share was $0.54 and $0.62 in Q3 of 2021 and 2020 respectively.
Additionally, the company has collaboration revenues of $1.7 million in Q3 2021, against $0.6 million in the prior-year period.
The company ended the quarter with cash, cash equivalents, and short-term investments of $187.6 million.
Conclusion
With the rise of certain observations in the clinical trial of HMI-102, the FDA placed a clinical hold on the trial. This announcement led to the stock’s downfall in the after-hours. Thus, the stock plunged deep in the after-market session when the news came out.
