Vitiligo

DALLAS--(BUSINESS WIRE)-- Forte Biosciences, Inc. ( ) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its 2023 results and provided a business update. 2023 Business Highlights “Forte achieved a major milestone by advancing FB-102 into the clinic and beating the timelines we targeted in our third quarter business update. The single ascending dose (SAD) portion of the FB-102 phase 1 trial was successfully completed and dosing has begun in the multiple ascending dose (MAD) cohorts.” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. “I am deeply appreciative of the talented Forte team that made this achievement possible. I also want to thank our investors who believe in the potential of FB-102 and in the Forte team as we continue to advance this exciting program. We look forward to providing more clinical updates on FB-102 over the course of this year.” 2023 Operating Results Research and development expenses were $21.9 million for the year ended December 31, 2023, compared to $5.6 million during the same period in 2022. The increase of $16.3 million was primarily due to a net increase of approximately $9.9 million in manufacturing expense, a net increase of approximately $6.0 million in preclinical and clinical expenses as our FB-102 program entered the clinic, and a net increase in payroll and related expenses of approximately $0.4 million primarily due to an increase in headcount. General and administrative expenses were $10.6 million for the year ended December 31, 2023, compared to $8.3 million for the same period in 2022. The increase of $2.3 million was primarily due to an increase in professional and legal expenses of $2.6 million, an increase in other expenses of $0.4 million, including rent and personnel expenses, partially offset by a reduction in stock-based compensation expense of $0.7 million. Net losses per share were ($1.00) and ($0.80) for the years ended December 31, 2023 and 2022, respectively. Forte ended 2023 with approximately $37.1 million in cash and cash equivalents. Forte had approximately 36.3 million shares of common stock outstanding as of December 31, 2023. CONSOLIDATED BALANCE SHEETS (in thousands except share and par value data) December 31, 2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $ 37,125 $ 41,100 Prepaid expenses and other current assets 1,202 411 Total current assets 38,327 41,511 Property and equipment, net 109 — Other assets 544 486 Total assets $ 38,980 $ 41,997 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,424 $ 1,153 Accrued liabilities 2,242 2,026 Total current liabilities 3,666 3,179 Commitments and contingencies (Note 6) Stockholders’ equity: Common stock, $0.001 par value: 200,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 36,335,105 and 21,000,069 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively 36 21 Additional paid-in capital 153,794 125,841 Accumulated other comprehensive income 4 — Accumulated deficit (118,520 ) (87,044 ) Total stockholders’ equity 35,314 38,818 Total liabilities and stockholders’ equity $ 38,980 $ 41,997 CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts) Year Ended December 31, 2023 2022 Operating expenses: Research and development $ 21,862 $ 5,594 General and administrative 10,624 8,302 Total operating expenses 32,486 13,896 Loss from operations (32,486 ) (13,896 ) Interest income 1,124 162 Other expense, net (114 ) (145 ) Net loss $ (31,476 ) $ (13,879 ) Per share information: Net loss per share - basic and diluted $ (1.00 ) $ (0.80 ) Weighted average shares and pre-funded warrants outstanding, basic and diluted 31,571,039 17,383,531 Comprehensive Loss: Net loss $ (31,476 ) $ (13,879 ) Unrealized gain on available-for-sale securities 4 — Comprehensive loss $ (31,472 ) $ (13,879 ) Additional details on our 2023 financial results can be found in Forte’s Form 10-K as filed with the SEC on March 18, 2024. You can also find more information in the investor relations section of our website at . About Forte Forte Biosciences, Inc. is a clinical-stage biopharmaceutical company that is advancing its product candidate, FB-102, which is a proprietary molecule with potentially broad autoimmune and autoimmune-related 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 Company’s beliefs, goals, intentions and expectations regarding its product candidate, FB-102 and the therapeutic potential of 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 related to Forte’s ability to obtain sufficient additional capital to continue to advance Forte’s product candidate, FB-102; uncertainties associated with the clinical development and regulatory approval of Forte’s product candidate, FB-102, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that results from preclinical studies may not be predictive of results from clinical trials; risks associated with the failure to realize any value from FB-102 in light of inherent risks 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 Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission on March 18, 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.

Opzelura is a cream version of Incyte's blockbuster Jakafi. After a pair of approvals in recent years and as its sales continue to climb, Incyte's topical JAK inhibitor Opzelura is adding to its clinical case with trial results that demonstrate its benefits in patients with mild to moderate hidradenitis suppurativa (HS). In a phase 2 study testing twice-daily Opzelura cream in patients with mild to moderate HS, investigators noted a “significantly greater” reduction in patients’ abscesses and inflammatory nodule (AN) count after 16 weeks compared with patients who received a control cream. The disease is characterized by painful nodules and abscesses that can cause irreversible tissue destruction and scarring.  The results, which the company shared in a presentation at this year’s American Academy of Dermatology meeting, show “great potential” for patients with milder HS, Incyte's vice president of inflammation and autoimmunity, Jim Lee, M.D., Ph.D., said in a release. “Despite its daily impact on the lives of patients, there are currently no approved therapies for mild-to-moderate HS and the current standard of care is often inadequate,” Lee added. “Today’s data represent an important step in progressing research for HS with the goal of being able to provide patients with an effective option to better manage their condition.” The drug reduced total AN count by 50% or more in roughly 79% of patients, while more than 20% of patients who received the drug achieved complete clearance. Plus, the majority of Opzelura patients met the criteria for Hidradenitis Suppurativa Clinical Response, a measure that includes a 50% or greater reduction in AN count without an increase in abscesses or draining fistulas. Two patients did discontinue their participation in the study, but no serious treatment-emergent adverse events were reported, Incyte said. Opzelura is a cream version of Incyte’s blockbuster Jakafi and scored its original approval in 2021 for atopic dermatitis, adding on an indication for vitiligo the following year. The med is currently the only topical JAK inhibitor on the U.S. market, but Leo Pharma and its contender delgocitinib stand to put pressure on Incyte’s dominance. Recently, the company has been steadily reporting positive phase 3 studies of its JAK inhibitor cream in chronic hand eczema. Elsewhere in Incyte’s JAK inhibitor arsenal is its oral povorcitinib, which just showed significant improvements in itch and disease severity in a phase 2 study in prurigo nodularis. Opzelura is also being tested in prurigo nodularis and is proving to be a rising star for Incyte. The drug brought in $338 million in 2023 sales as “one of the best recent dermatology launches,” the company's North American general manager Barry Flannelly said on the company’s fourth-quarter and full-year earnings conference call.

Incyte recently revealed positive outcomes from its phase 2 trial of povorcitinib, an oral JAK1 inhibitor, in treating prurigo nodularis (PN), a chronic skin condition characterized by intense itching and the formation of nodules. The findings, presented at the American Academy of Dermatology Annual Meeting, demonstrated that povorcitinib significantly improved itch relief across various dosage groups compared to a placebo, meeting both primary and secondary study endpoints. Notably, patients treated with the drug showed a marked improvement in itch reduction and skin condition after just four weeks of treatment, signaling a potential breakthrough for individuals grappling with the persistent and often debilitating symptoms of PN. Povorcitinib is also being tested in advanced phase 3 trials for skin conditions hidradenitis suppurativa and vitiligo and is in ongoing phase 2 trials for PN, asthma, and a type of hives known as chronic spontaneous urticaria. Two years ago, the FDA approved Incyte’s JAK inhibitor cream, Opzelura, for the topical treatment of nonsegmental vitiligo in patients aged 12 and older. This drug became the first and only FDA-approved product for repigmentation in patients with this condition.