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Forte Biosciences, Inc. Announces 4Q and Full Year 2020 Results and Provides a General Business Update

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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 $28.50 per share, which includes the over-allotment option exercised by underwriters to purchase an additional 210,526 shares for gross proceeds of $46.0 million.

Forte ended the year 2020 with approximately $58.8 million in cash and cash equivalents which Forte believes is sufficient to fund operations for at least the next 12 months. Cash burn for the fourth quarter 2020 was $4.1 million. Forte had approximately 12.8 million shares of common stock outstanding as of December 31, 2020. In February 2021, Forte issued 673,463 shares of its common stock pursuant to cashless exercises by certain warrant holders.

Fourth Quarter and Full Year 2020 Operating Results

Research and development expenses were $3.0 million and $1.2 million for the three months ended December 31, 2020 and 2019, respectively, and $10.0 million and $2.7 million for the years ended December 31, 2020 and 2019, respectively. The increases in 2020 were primarily due to manufacturing and clinical development costs as Forte continues to advance FB-401 through Phase 2 clinical trials.

General and administrative expenses were $1.5 million and $0.4 million for the three months ended December 31, 2020 and 2019, respectively, and $4.2 million and $1.4 million for the years ended December 31, 2020 and 2019, respectively. The increases in 2020 were primarily due to professional fees for legal, auditing, tax and business consulting services, and personnel expenses as Forte transitioned to being a public company.

In the second quarter of 2020, Forte recognized a charge of $32.1 million for acquired in-process research and development related to the reverse merger with Tocagen which closed on June 15th, 2020.

Losses per share were $0.37 and $0.74 for the three months ended December 31, 2020 and 2019, respectively, and $6.32 and $1.93 for the years ended December 31, 2020 and 2019, respectively.

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

$ 58,765

$ 6,939

Prepaid expenses and other current assets

1,133

567

Total current assets

59,898

7,506

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Forte Biosciences, Inc.

NASDAQ:FBRX

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About FBRX

we are driven by a vision to end cancer mortality. our company was founded on this vision in 2007. tocagen’s mission is to become a leading biopharmaceutical company for the treatment of cancer using cancer-selective gene therapy products based on our retroviral gene therapy platforms to increase lifespan, initially for patients with advanced local and metastatic cancer. our broadly applicable product candidates are designed to activate a patient’s immune system against their cancer from within. at the core of our approach is a novel gene therapy platform that utilizes retroviral replicating vectors (rrvs), which are designed to selectively deliver therapeutic genes into the dna of cancer cells. our proprietary platform is designed to fight cancer through a combination of mechanisms of action without the autoimmune toxicities that patients commonly experience with other treatments. in other words, our technology is designed to combat cancer with fewer side effects, keeping patients’ he