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Forte Biosciences, Inc. Announces Third Quarter 2024 Results and Provides Business Update

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Forte Biosciences (NASDAQ: FBRX) reported Q3 2024 results and provided updates on FB102 development. The company has begun dosing patients in a celiac disease clinical trial, with topline data expected in Q2 2025. Q3 financial results showed R&D expenses of $5.9M (down from $6.4M in Q3 2023) and G&A expenses of $2.8M (down from $3.8M). The company reported a net loss of $(4.54) per share and ended the quarter with $16.4M in cash. In August 2024, Forte implemented a 1:25 reverse split, resulting in 1.46M shares outstanding.

Forte Biosciences (NASDAQ: FBRX) ha riportato i risultati del terzo trimestre 2024 e fornito aggiornamenti sullo sviluppo di FB102. La società ha iniziato a somministrare trattamento ai pazienti in uno studio clinico sulla celiachia, con dati preliminari attesi nel secondo trimestre del 2025. I risultati finanziari del terzo trimestre hanno mostrato spese per R&S di 5,9 milioni di dollari (in calo rispetto ai 6,4 milioni di dollari del terzo trimestre 2023) e spese generali e amministrative di 2,8 milioni di dollari (in calo rispetto ai 3,8 milioni). L'azienda ha registrato una perdita netta di $(4,54) per azione e ha chiuso il trimestre con 16,4 milioni di dollari in contante. A agosto 2024, Forte ha implementato uno split inverso 1:25, portando a 1,46 milioni di azioni in circolazione.

Forte Biosciences (NASDAQ: FBRX) informó sobre los resultados del tercer trimestre de 2024 y proporcionó actualizaciones sobre el desarrollo de FB102. La compañía ha comenzado a dosificar pacientes en un ensayo clínico para la enfermedad celíaca, con datos preliminares esperados para el segundo trimestre de 2025. Los resultados financieros del tercer trimestre mostraron gastos de I+D de $5.9 millones (en comparación con $6.4 millones en el tercer trimestre de 2023) y gastos generales y administrativos de $2.8 millones (en comparación con $3.8 millones). La empresa reportó una pérdida neta de $(4.54) por acción y finalizó el trimestre con $16.4 millones en efectivo. En agosto de 2024, Forte implementó un split inverso 1:25, lo que resultó en 1.46 millones de acciones en circulación.

포르테 바이오사이언스 (NASDAQ: FBRX)는 2024년 3분기 실적을 보고하고 FB102 개발에 대한 업데이트를 제공했습니다. 회사는 셀리악병 임상 시험에서 환자에게 약물을 투여하기 시작했으며, 2025년 2분기에 주요 데이터가 예상됩니다. 3분기 재무 결과에서는 연구개발 비용이 590만 달러(2023년 3분기 640만 달러에서 감소)와 일반 및 관리비가 280만 달러(380만 달러에서 감소)로 나타났습니다. 회사는 주당 $(4.54)의 순손실을 보고했으며, 분기를 1,640만 달러의 현금을 보유한 상태로 마감했습니다. 2024년 8월, 포르테는 1:25 비율의 역분할을 시행하여 총 146만 주의 유통 주식을 기록했습니다.

Forte Biosciences (NASDAQ: FBRX) a annoncé les résultats du troisième trimestre 2024 et a fourni des mises à jour sur le développement de FB102. La société a commencé à administrer un traitement aux patients dans un essai clinique sur la maladie cœliaque, avec des données clés attendues au deuxième trimestre de 2025. Les résultats financiers du troisième trimestre ont montré des dépenses de R&D de 5,9 M$ (en baisse par rapport à 6,4 M$ au troisième trimestre 2023) et des dépenses générales et administratives de 2,8 M$ (en baisse par rapport à 3,8 M$). L'entreprise a enregistré une perte nette de $(4,54) par action et a terminé le trimestre avec 16,4 M$ en liquidités. En août 2024, Forte a mis en œuvre un reverse split de 1:25, ce qui a abouti à 1,46 million d'actions en circulation.

Forte Biosciences (NASDAQ: FBRX) hat die Ergebnisse des dritten Quartals 2024 veröffentlicht und Updates zur Entwicklung von FB102 bereitgestellt. Das Unternehmen hat mit der Dosisverabreichung an Patienten in einer klinischen Studie zur Zöliakie begonnen, wobei die ersten Ergebnisse im zweiten Quartal 2025 erwartet werden. Die finanziellen Ergebnisse des dritten Quartals zeigten F&E-Ausgaben von 5,9 Millionen USD (rückläufig von 6,4 Millionen USD im dritten Quartal 2023) und allgemeine und Verwaltungskosten von 2,8 Millionen USD (rückläufig von 3,8 Millionen USD). Das Unternehmen berichtete von einem Nettoverlust von $(4,54) pro Aktie und beendete das Quartal mit 16,4 Millionen USD an Barmitteln. Im August 2024 führte Forte einen 1:25-Rücksplit durch, was zu 1,46 Millionen ausstehenden Aktien führte.

Positive
  • FB102 demonstrated significant inhibition of T and NK cell proliferation in mechanistic studies
  • Phase 1 healthy volunteer trial showed good safety profile
  • R&D expenses decreased by $0.5M compared to Q3 2023
  • G&A expenses decreased by $1M compared to Q3 2023
Negative
  • Net loss of $(4.54) per share in Q3 2024
  • Cash position decreased to $16.4M from $37.1M at end of 2023
  • 1:25 reverse stock split implemented in August 2024
  • Accumulated deficit increased to $(146.8M)

Insights

The Q3 results reveal concerning financial metrics for this clinical-stage biotech. $16.4 million cash position represents a significant decline from $37.1 million at year-end 2023, with a quarterly burn rate of approximately $8.4 million. At the current pace, without additional funding, the runway extends only through mid-2024.

The FB102 celiac disease trial progression is notable, but investors should watch the increasing liabilities, with current liabilities jumping to $8.58 million from $3.67 million. The widening net loss of $28.3 million for the nine months, despite reduced R&D expenses, signals operational challenges.

While the FB102 preclinical data shows promise in NK cell modulation and Treg maintenance, the Q2 2025 timeline for topline data creates a significant gap between current cash reserves and clinical milestones, suggesting likely near-term financing needs.

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.

LifeSci Advisors

Mike Moyer, Managing Director

mmoyer@lifesciadvisors.com

Forte Biosciences, Inc.

Paul Wagner, CEO

investors@fortebiorx.com

Source: Forte Biosciences, Inc.

FAQ

What were Forte Biosciences (FBRX) Q3 2024 financial results?

Forte Biosciences reported R&D expenses of $5.9M, G&A expenses of $2.8M, and a net loss of $(4.54) per share for Q3 2024. The company ended the quarter with $16.4M in cash.

When will Forte Biosciences (FBRX) report FB102 celiac disease trial results?

Forte Biosciences expects to report topline data from the FB102 celiac disease trial in the second quarter of 2025.

What was the ratio of Forte Biosciences (FBRX) reverse stock split in 2024?

Forte Biosciences implemented a 1:25 reverse stock split in August 2024, resulting in 1.46 million shares outstanding.

Forte Biosciences, Inc.

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