Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced third quarter 2023 results and provided a business update.

Third Quarter 2023 Business Highlights

“The third quarter of 2023 was defined by continued solid progress on FB-102,” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. “Based on our preclinical data, we continue to believe that FB-102 is a best-in-class anti-CD122 antibody with broad therapeutic potential. Given the support of our new investors, we are in a strong position to advance FB-102 into human clinical trials by early 2024 and look forward to providing substantive clinical updates on FB-102 over the course of the year.”

Third Quarter 2023 Operating Results

On July 31, 2023, Forte issued 15,166,957 shares of common stock and 9,689,293 pre-funded warrants as a part of a private placement that raised approximately $25.0 million in gross proceeds and before issuance costs of $272,000.

Research and development expenses were $6.4 million for the three months ended September 30, 2023, compared to $1.4 million for the same period in 2022. Research and development expenses were $18.3 million for the nine months ended September 30, 2023, compared to $3.1 million for the same period in 2022. The increases were primarily due to manufacturing and development expenses of our FB-102 program as it advances towards the clinic.

General and administrative expenses were $3.8 million for the three months ended September 30, 2023, compared to $2.0 million for the same period in 2022. General and administrative expenses were $7.8 million for the nine months ended September 30, 2023 compared to $5.9 million for the same period in 2022.

Net losses per share were ($0.26) and ($0.18) for the three months ended September 30, 2023 and 2022, and ($0.96) and ($0.56) for the nine months ended September 30, 2023 and 2022, respectively.

Forte ended the third quarter 2023 with approximately $46.2 million in cash and cash equivalents. Forte had approximately 36.3 million shares of common stock outstanding as of September 30, 2023.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands except share and par value data)

 
September 30, 2023December 31, 2022
(unaudited)
Assets
Current assets:
Cash and cash equivalents

$

46,185

 

$

41,100

 

Prepaid expenses and other current assets

 

917

 

 

411

 

Total current assets

 

47,102

 

 

41,511

 

 
Property and equipment, net

 

98

 

 

—

 

Other assets

 

679

 

 

486

 

Total assets

$

47,879

 

$

41,997

 

 
Liabilities and stockholders' equity
Current liabilities:
Accounts payable

$

5,354

 

$

1,153

 

Accrued liabilities

 

2,117

 

 

2,026

 

Total current liabilities

 

7,471

 

 

3,179

 

 
Commitments and contingencies (Note 6)
Stockholders’ equity
Common stock, $0.001 par value: 200,000,000 shares authorized as of September 30, 2023 (unaudited) and December 31, 2022; 36,281,772 and 21,000,069 shares issued and outstanding as of September 30, 2023 (unaudited) and December 31, 2022, respectively

 

36

 

 

21

 

Additional paid-in capital

 

153,025

 

 

125,841

 

Accumulated other comprehensive income

 

(5

)

 

—

 

Accumulated deficit

 

(112,648

)

 

(87,044

)

Total stockholders’ equity

 

40,408

 

 

38,818

 

Total liabilities and stockholders’ equity

$

47,879

 

$

41,997

 

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

 

For the Three Months Ended

September 30,

For the Nine Months Ended

September 30,

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:
Research and development

$

6,369

 

$

1,379

 

$

18,295

 

$

3,106

 

General and administrative

 

3,847

 

 

2,044

 

 

7,810

 

 

5,851

 

Total operating expenses

 

10,216

 

 

3,423

 

 

26,105

 

 

8,957

 

Loss from operations

 

(10,216

)

 

(3,423

)

 

(26,105

)

 

(8,957

)

Other income (expense), net

 

261

 

 

23

 

 

501

 

 

(45

)

Net loss

$

(9,955

)

$

(3,400

)

$

(25,604

)

$

(9,002

)

Per share information:
Net loss per share - basic and diluted

$

(0.26

)

$

(0.18

)

$

(0.96

)

$

(0.56

)

 
Weighted average shares and pre-funded warrants outstanding, basic and diluted

 

37,862,772

 

 

18,927,446

 

 

26,700,505

 

 

16,164,770

 

 
Comprehensive Loss:
Net loss

$

(9,955

)

$

(3,400

)

$

(25,604

)

$

(9,002

)

Unrealized loss on available-for-sale securities

 

(6

)

 

—

 

 

(5

)

 

—

 

Comprehensive loss

$

(9,961

)

$

(3,400

)

$

(25,609

)

$

(9,002

)

Additional details on our financial results for the third quarter of 2023 can be found in Forte’s Form 10-Q as filed with the SEC on November 13, 2023. You can also find more information in the investor relations section of our website at www.fortebiorx.com.

About Forte

Forte Biosciences, Inc. is a biopharmaceutical company that is advancing its product candidate, FB-102, which is a proprietary molecule with potentially broad autoimmune applications including in such indications as graft-versus-host disease, vitiligo and alopecia areata.

Forward-Looking Statements

Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. Forward looking statements include statements regarding the use of proceeds of the offering; our plans to advance FB-102 into clinical trials and the expected timelines related thereto; our projections regarding the market size for FB-102; the therapeutic potential of FB-102; and Forte’s plans to develop and potentially commercialize its product candidates, including FB-102. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: risks associated with market conditions; risks related to the Company’s estimates regarding future expenses, capital requirements and need for additional financing; uncertainties associated with the clinical development and regulatory approval of Forte’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that results from early preclinical studies may not be predictive of results from later-stage studies or clinical trials; Forte’s ability to successfully enter into collaborations, and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of Forte’s product candidates; Forte’s commercialization, marketing and manufacturing capabilities and strategy; developments and projections relating to Forte’s competitors and its industry; the impact of government laws and regulations; Forte’s ability to protect its intellectual property position; Forte’s estimates regarding future revenue, expenses, capital requirements and need for additional financing; and the impact of global events on the Company, the Company’s industry or the economy generally. Information on these and additional risks, uncertainties, and other information affecting Forte’s business and operating results is contained in Forte’s Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the Securities and Exchange Commission on March 31, 2023, in the Company’s subsequent Quarterly Report on Form 10-Q filed on November 13, 2023, and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Source: Forte Biosciences, Inc.