FB-102

DALLAS--( BUSINESS WIRE )--Forte Biosciences, Inc. ( www.fortebiorx.com ) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced an oversubscribed $53 million equity financing to support the continuing clinical advancement of FB102. “We are appreciative of the support from new and existing investors including OrbiMed, Janus Henderson Investors, Tybourne Capital Management, Alger, Ikarian Capital, LLC, BVF Partners LP, and The Red Hook Fund LP. This financing by high quality institutional investors is transformative for Forte and highlights the meaningful potential for FB102. As a result of the financing, Forte is well capitalized to continue advancing FB102 across autoimmune indications. As we have previously indicated, the healthy volunteer study has completed and a celiac disease trial is underway with a topline readout projected in the second quarter of 2025. We expect to advance FB102 into additional indications over the next 12 months. 2025 could be an exciting year of clinical milestones for FB102,” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. Forte Biosciences will be hosting an R&D Day on December 3 rd with additional details forthcoming. TD Cowen acted as the lead placement agent for the financing. Guggenheim Securities provided Capital Markets Advisory services to Forte Biosciences. Chardan, Rodman & Renshaw and Brookline Capital Markets acted as co-placement managers for the financing. About Forte Forte Biosciences, Inc. is a clinical-stage biopharmaceutical company that is advancing FB102, which is a proprietary anti-CD122 monoclonal antibody therapeutic candidate with potentially broad autoimmune and autoimmune-related indications. Financing Disclosures The securities to be sold in this financing have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction's securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. Pursuant to the securities purchase agreement, Forte Biosciences has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) to register the resale by the investors of the securities sold in the private placement. Any offering of the Forte Biosciences’ Common Stock under the resale registration statement will only be made by means of a prospectus. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any security of Forte Biosciences, nor shall there be any offer, solicitation, or sale of any security of Forte Biosciences in any jurisdiction in which such offer, solicitation or sale would be unlawful. 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 in this press release include statements regarding the use of proceeds of the offering; the satisfaction of the closing conditions set forth in the securities purchase agreement; Forte’s plans to advance FB-102 into clinical trials and the expected timelines related thereto; the timing of a readout from the celiac disease trial; Forte’s 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 Quarterly Report on Form 10-Q filed on November 14, 2024, and in its other filings with the SEC. 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.

DALLAS--( BUSINESS WIRE )--Forte Biosciences, Inc. ( www.fortebiorx.com ) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced third quarter 2024 results and provided a business update. Third Quarter 2024 Business Highlights “We continue to make excellent progress with FB102 and have begun dosing patients in a celiac disease clinical trial. In addition to safety and tolerability, we will be assessing the histological impact as well as a variety of other activity parameters. The topline data is expected to readout in the second quarter of 2025,” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. “Based on the biology of celiac disease and the mechanism of action of FB102, we are excited about the potential in celiac disease, an indication with a significant unmet need. We believe the data to date supports the significant potential for FB102 across a variety of autoimmune and autoimmune-related diseases with large addressable markets and we look forward to pursuing these opportunities as we continue to advance the FB102 program.” R&D and Clinical Development Summary In FB102 mechanistic in-vitro studies, human donor T and NK cells were stimulated with either IL2 or IL15 in the presence or absence of FB102. FB102 significantly inhibited proliferation and activation at levels comparable to unstimulated cells. Human donor regulatory T cell (Treg) studies stimulated with IL2 demonstrated comparable proliferation both in the presence and absence of FB102. In the 4- and 13-week nonhuman primate (NHP) studies, after a single dose, FB102 demonstrated significant reductions in the NK cell pharmacodynamic marker. Additionally, after multiple doses at exposures comparable to human therapeutic doses, Treg levels in the FB102 dosing arm were comparable to vehicle. These observations suggest that FB102 is demonstrating selectivity with respect to inhibiting the intermediate versus high affinity IL2 receptor. The phase 1 healthy volunteer SAD/MAD cohorts have completed successfully. The FB102 phase 1 healthy volunteer trial demonstrated a good safety profile. Of note, this trial reported a significant reduction in the NK cell pharmacodynamic marker of the FB102 mechanism. Based on these results, Forte has advanced clinical development of FB102 into a celiac disease patient trial. Top-line results of the study are expected in the second quarter of 2025. Third Quarter 2024 Operating Results Research and development expenses were $5.9 million for the three months ended September 30, 2024, compared to $6.4 million for the same period in 2023. The decrease was primarily due to a decrease of $3.0 million in manufacturing costs partially offset by an increase of $2.5 million in clinical and other expenses. Research and development expenses were $16.0 million for the nine months ended September 30, 2024, compared to $18.3 million for the same period in 2023. The decrease was primarily due to a decrease of $7.5 million in manufacturing costs partially offset by an increase of $4.0 million in clinical and other expenses as we advanced our FB102 program through clinical trials, and a net increase of $1.2 million in payroll and related expenses due to an increase in our average headcount and related costs. General and administrative expenses were $2.8 million for the three months ended September 30, 2024 compared to $3.8 million for the same period in 2023. The decrease was primarily due to decreases in legal and professional expenses. General and administrative expenses were $13.3 million for the nine months ended September 30, 2024, compared to $7.8 million for the same period in 2023. The increase was primarily due to increases in legal and professional expenses. Net losses per share were $(4.54) and $(6.57) for the three months ended September 30, 2024 and 2023, and $(15.35) and $(23.97) for the nine months ended September 30, 2024 and 2023, respectively. Forte ended the third quarter 2024 with $16.4 million in cash and cash equivalents. In August 2024, Forte effected a 1:25 reverse split and has 1.46 million shares of common stock outstanding on a post-split basis as of September 30, 2024. FORTE BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and par value data) September 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 16,363 $ 37,125 Prepaid expenses and other current assets 1,305 1,202 Total current assets 17,668 38,327 Property and equipment, net 86 109 Other assets 192 544 Total assets $ 17,946 $ 38,980 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 5,159 $ 1,424 Accrued liabilities 3,421 2,242 Total current liabilities 8,580 3,666 Commitments and contingencies (Note 6) Stockholders’ equity Common stock, $0.001 par value: 200,000,000 shares authorized as of September 30, 2024 (unaudited) and December 31, 2023; 1,460,007 and 1,453,402 shares issued and outstanding as of September 30, 2024 (unaudited) and December 31, 2023, respectively 1 1 Additional paid-in capital 156,207 153,829 Accumulated other comprehensive income 1 4 Accumulated deficit (146,843 ) (118,520 ) Total stockholders’ equity 9,366 35,314 Total liabilities and stockholders’ equity $ 17,946 $ 38,980 FORTE BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) (in thousands, except share and per share amounts) For the Three Months Ended September 30, For the Nine Months Ended September 30, 2024 2023 2024 2023 Operating expenses: Research and development $ 5,720 $ 6,369 $ 15,634 $ 18,295 Research and development - related party 150 - 329 - General and administrative 2,759 3,847 13,288 7,810 Total operating expenses 8,629 10,216 29,251 26,105 Loss from operations (8,629 ) (10,216 ) (29,251 ) (26,105 ) Other income, net 237 261 928 501 Net loss $ (8,392 ) $ (9,955 ) $ (28,323 ) $ (25,604 ) Per share information: Net loss per share - basic and diluted $ (4.54 ) $ (6.57 ) $ (15.35 ) $ (23.97 ) Weighted average shares and pre-funded warrants outstanding, basic and diluted 1,847,644 1,514,509 1,845,407 1,068,019 Comprehensive Loss: Net loss $ (8,392 ) $ (9,955 ) $ (28,323 ) $ (25,604 ) Unrealized gain (loss) on available-for-sale securities, net 8 (6 ) (3 ) (5 ) Comprehensive loss $ (8,384 ) $ (9,961 ) $ (28,326 ) $ (25,609 ) Additional details on Forte’s third quarter 2024 financial results can be found in Forte’s Form 10-Q as filed with the SEC on November 14, 2024. You can also find more information in the investor relations section of Forte’s website at www.fortebiorx.com . About Forte Forte Biosciences, Inc. is a clinical-stage biopharmaceutical company that is advancing FB102, which is a proprietary anti-CD122 monoclonal antibody therapeutic candidate with potentially broad autoimmune and autoimmune-related indications. 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 Company’s beliefs, goals, intentions and expectations regarding its product candidate, FB102 and the therapeutic and commercial market potential of FB102, and Forte’s plans to continue a patient trial in celiac disease with data expected in the second quarter of 2025. 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 related to Forte’s ability to obtain sufficient additional capital to continue to advance Forte’s product candidate, FB102; uncertainties associated with the clinical development and regulatory approval of Forte’s product candidate, FB102, including potential delays in the commencement, enrollment and completion of clinical trials, including the timing of the completion of the Company’s patient-based trials; the risk that results from preclinical and any interim result of our ongoing clinical trials may not be predictive of future results from clinical trials; risks associated with the failure to realize any value from FB102 in light of inherent risks, expense and difficulties involved in successfully bringing product candidates to market; and additional risks, uncertainties, and other information affecting Forte’s business and operating results is contained in Forte’s Quarterly Report on Forms 10-Q filed on November 14, 2024, 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.