Forte Biosciences, Inc. Announces 4Q and Full Year 2020 Results and Provides a General Business Update
Forte Biosciences, Inc. (NASDAQ: FBRX) announced its fourth quarter and full year 2020 results on March 24, 2021. The company completed enrollment of 154 subjects in its clinical trial for FB-401, which received FDA Fast Track designation. Additionally, Forte raised $46 million through a public offering in November. As of December 31, 2020, the company's cash and cash equivalents totaled $58.8 million, sufficient for operations for at least 12 months. R&D expenses surged to $10 million, driven by clinical development costs, while 2020 losses per share were reported at $6.32.
- Completed enrollment of 154 subjects in the FB-401 clinical trial for atopic dermatitis.
- FDA granted Fast Track designation to FB-401, highlighting the drug's potential.
- Successfully raised $46 million in a public offering.
- Ended 2020 with $58.8 million in cash, ensuring operational funding for the next year.
- Incurred a significant loss per share of $6.32 for 2020, up from $1.93 in 2019.
- R&D expenses increased dramatically to $10 million, indicating rising operational costs.
Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company announces fourth quarter and full year 2020 results and provides a general business update on March 24, 2021.
“Forte made significant progress in the fourth quarter of 2020. In September, we initiated a randomized trial of FB-401 in atopic dermatitis patients, including adults and children 2 years of age and older. We are very pleased to announce that patient enrollment is now complete. This is a significant milestone that represents the culmination of the entire team’s effort and is particularly impressive in the context of the many challenges associated with the current pandemic. Another notable milestone was the granting of Fast Track designation to FB-401 by the FDA in recognition of the unmet need and seriousness of the disease. Additionally, we strengthened our balance sheet with a successful public offering in November,” said Paul Wagner, Ph.D., CEO of Forte Biosciences. “Following the close of the quarter, two additional patents were issued, further bolstering our robust IP protection and bringing the total U.S. patent portfolio to nine.”
Fourth Quarter and Full Year 2020 Results
Fourth Quarter Business Highlights
In September 2020, Forte initiated a multi-center, placebo-controlled clinical trial of its lead product candidate, FB-401 which was expected to enroll approximately 124 pediatric, adolescent and adult atopic dermatitis subjects aged 2 years of age and older. Enrollment is now complete with 154 subjects. Additional information about our Phase 2 trial can be found at ClinicalTrials.gov using the identifier NCT04504279.
In October 2020, the U.S. Food and Drug Administration (“FDA”) granted Fast Track Designation to FB-401 for the treatment of atopic dermatitis.
On November 2, 2020, Forte completed a public offering of 1,614,035 shares of its common stock at
Forte ended the year 2020 with approximately
Fourth Quarter and Full Year 2020 Operating Results
Research and development expenses were
General and administrative expenses were
In the second quarter of 2020, Forte recognized a charge of
Losses per share were
Balance Sheet Data
| Forte Biosciences, Inc. | ||||
| Consolidated Balance Sheets | ||||
| (in thousands, except share and par value data) | ||||
| December 31, 2020 | December 31, 2019 | |||
| Assets | ||||
| Current assets: | ||||
| Cash and cash equivalents |
|
|
||
| Prepaid expenses and other current assets | 1,133 |
567 |
||
| Total current assets | 59,898 |
7,506 |
||
{
"@context": "https://schema.org",
"@type": "FAQPage",
"name": "Forte Biosciences, Inc. Announces 4Q and Full Year 2020 Results and Provides a General Business Update FAQs",
"mainEntity": [
{
"@type": "Question",
"name": "What were Forte Biosciences' Q4 2020 results?",
"acceptedAnswer": {
"@type": "Answer",
"text": "Forte reported a loss per share of $0.37 and increased R&D expenses totaling $3.0 million."
}
},
{
"@type": "Question",
"name": "How much cash did Forte Biosciences have at the end of 2020?",
"acceptedAnswer": {
"@type": "Answer",
"text": "Forte ended 2020 with approximately $58.8 million in cash and cash equivalents."
}
},
{
"@type": "Question",
"name": "What is FB-401 and its status?",
"acceptedAnswer": {
"@type": "Answer",
"text": "FB-401 is Forte's lead product candidate for atopic dermatitis, which completed enrollment in its clinical trial and received FDA Fast Track designation."
}
},
{
"@type": "Question",
"name": "What was the outcome of Forte's public offering?",
"acceptedAnswer": {
"@type": "Answer",
"text": "Forte raised $46 million by offering 1,614,035 shares at $28.50 per share, including an over-allotment."
}
},
{
"@type": "Question",
"name": "What were the key highlights from Forte's business update?",
"acceptedAnswer": {
"@type": "Answer",
"text": "Key highlights include successful subject enrollment for FB-401, Fast Track designation, and strengthening of the balance sheet."
}
}
]
}
FAQ
What were Forte Biosciences' Q4 2020 results?
Forte reported a loss per share of $0.37 and increased R&D expenses totaling $3.0 million.
How much cash did Forte Biosciences have at the end of 2020?
Forte ended 2020 with approximately $58.8 million in cash and cash equivalents.
What is FB-401 and its status?
FB-401 is Forte's lead product candidate for atopic dermatitis, which completed enrollment in its clinical trial and received FDA Fast Track designation.
What was the outcome of Forte's public offering?
Forte raised $46 million by offering 1,614,035 shares at $28.50 per share, including an over-allotment.
What were the key highlights from Forte's business update?
Key highlights include successful subject enrollment for FB-401, Fast Track designation, and strengthening of the balance sheet.
Forte Biosciences, Inc.
NASDAQ:FBRXFBRX RankingsFBRX Latest NewsFBRX Stock Data
17.39M
1.21M
10.94%
54.05%
0.07%
Biotechnology
Pharmaceutical Preparations
United States of America
DALLAS
| ||||