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DALLAS, March 31, 2025--(BUSINESS WIRE)--Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced full year 2024 results and provides a clinical update.
"2024 was a very productive year with significant progress on the development of FB102, including the completion of the healthy volunteer study and the initiation of celiac patient trial," said Forte Biosciences CEO Paul Wagner, Ph.D.
"The celiac patient trial is progressing very well. Nearly half of the patients have completed both FB102 dosing and the gluten challenge. FB102 continues to be well-tolerated and there have been no dropouts to date. We are looking forward to reading out the topline results of the trial in the second quarter of 2025. Additionally, we are expecting to dose the first patient in the FB102 vitiligo trial shortly. 2025 is shaping up to be a very eventful year which we believe will further validate the potential for FB102."
2024 Operating Results
Research and development expenses were $21.2 million for the year ended December 31, 2024, compared to $21.9 million during the same period in 2023. The decrease of $0.7 million was primarily due to a decrease of $7.0 million in manufacturing expenses primarily offset by increases of $5.5 million in preclinical and clinical expenses as our FB102 program entered the clinic, and a net increase in payroll and related expenses of $1.3 million primarily due to an increase in headcount.
General and administrative expenses were $15.4 million for the year ended December 31, 2024 compared to $10.6 million for the same period in 2023. The increase of $4.8 million was primarily due to an increase in professional and legal expenses.
Net losses per share were $(12.17) and $(24.92) for the years ended December 31, 2024 and 2023, respectively.
Forte ended 2024 with $58.4 million in cash, cash equivalents and short-term investments. In August 2024, Forte effected a 1:25 reverse stock split. In November 2024, Forte raised $53.0 million in gross proceeds from an over-subscribed private placement. There are 6.4 million shares of common stock and 5.0 million prefunded warrants outstanding as of December 31, 2024.
| Forte Biosciences, Inc. Consolidated Balance Sheets (in thousands, except share and par value data) | ||||||||
| December 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,244 | $ | 37,125 | ||||
| Short-term investments | 36,121 | - | ||||||
| Prepaid expenses and other current assets | 2,981 | 1,202 | ||||||
| Total current assets | 61,346 | 38,327 | ||||||
| Property and equipment, net | 77 | 109 | ||||||
| Other assets | 138 | 544 | ||||||
| Total assets | $ | 61,561 | $ | 38,980 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,879 | $ | 1,424 | ||||
| Accrued liabilities | 4,202 | 2,242 | ||||||
| Total current liabilities | 9,081 | 3,666 | ||||||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.001 par value: 200,000,000 shares authorized as of December 31, 2024 and December 31, 2023; 6,393,323 and 1,453,402 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively | 6 | 1 | ||||||
| Additional paid-in capital | 206,461 | 153,829 | ||||||
| Accumulated other comprehensive income | 11 | 4 | ||||||
| Accumulated deficit | (153,998 | ) | (118,520 | ) | ||||
| Total stockholders’ equity | 52,480 | 35,314 | ||||||
| Total liabilities and stockholders’ equity | $ | 61,561 | $ | 38,980 | ||||
| Forte Biosciences, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) | ||||||||
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 20,714 | $ | 21,862 | ||||
| Research and development - related party | 479 | - | ||||||
| General and administrative | 15,409 | 10,624 | ||||||
| Total operating expenses | 36,602 | 32,486 | ||||||
| Loss from operations | (36,602 | ) | (32,486 | ) | ||||
| Interest income | 1,314 | 1,124 | ||||||
| Other expense, net | (190 | ) | (114 | ) | ||||
| Net loss | $ | (35,478 | ) | $ | (31,476 | ) | ||
| Per share information: | ||||||||
| Net loss per share - basic and diluted | $ | (12.17 | ) | $ | (24.92 | ) | ||
| Weighted average shares and pre-funded warrants outstanding, basic and diluted | 2,915,894 | 1,262,840 | ||||||
| Comprehensive Loss: | ||||||||
| Net loss | $ | (35,478 | ) | $ | (31,476 | ) | ||
| Unrealized gain on available-for-sale securities | 7 | 4 | ||||||
| Comprehensive loss | $ | (35,471 | ) | $ | (31,472 | ) | ||
Additional details on Forte’s full year 2024 financial results can be found in Forte’s Form 10-K as filed with the SEC on March 28, 2025. You can also find more information in the investor relations section of Forte’s website at www.fortebiorx.com.