Forte Biosciences, Inc. Announces Second Quarter 2024 Results and Provides Business Update
Forte Biosciences (NASDAQ: FBRX) announced its Q2 2024 results and provided a business update. The company reported progress with FB102, its anti-CD122 monoclonal antibody therapeutic candidate. Key highlights include:
1. Successful completion of the SAD/MAD phase 1 healthy volunteer study for FB102.
2. Initiation of a patient study in celiac disease, with data expected by Q2 2025.
3. R&D expenses decreased to $5.7 million in Q2 2024 from $7.1 million in Q2 2023.
4. General and administrative expenses increased to $7.1 million in Q2 2024 from $1.9 million in Q2 2023.
5. Net loss per share was $(0.27) for Q2 2024.
6. Cash and cash equivalents stood at $24.5 million as of June 30, 2024.
Forte Biosciences (NASDAQ: FBRX) ha annunciato i risultati del secondo trimestre 2024 e fornito un aggiornamento aziendale. L'azienda ha segnalato progressi con FB102, il suo candidato terapeutico monoclonale anti-CD122. I punti salienti includono:
1. Completamento con successo dello studio di primo livello SAD/MAD su volontari sani per FB102.
2. Inizio di uno studio sui pazienti affetti da celiachia, con dati previsti per il secondo trimestre 2025.
3. Le spese di ricerca e sviluppo sono diminuite a 5,7 milioni di dollari nel secondo trimestre 2024, rispetto a 7,1 milioni di dollari nel secondo trimestre 2023.
4. Le spese generali e amministrative sono aumentate a 7,1 milioni di dollari nel secondo trimestre 2024, rispetto a 1,9 milioni di dollari nel secondo trimestre 2023.
5. La perdita netta per azione è stata di $(0,27) per il secondo trimestre 2024.
6. Oneri e disponibilità liquide ammontavano a 24,5 milioni di dollari al 30 giugno 2024.
Forte Biosciences (NASDAQ: FBRX) anunció los resultados del segundo trimestre de 2024 y proporcionó una actualización comercial. La compañía reportó avances con FB102, su candidato terapéutico monoclonal anti-CD122. Los aspectos más destacados incluyen:
1. Finalización exitosa del estudio de primer nivel SAD/MAD en voluntarios sanos para FB102.
2. Inicio de un estudio en pacientes con enfermedad celíaca, con datos esperados para el segundo trimestre de 2025.
3. Los gastos de I+D disminuyeron a 5,7 millones de dólares en el segundo trimestre de 2024 desde 7,1 millones de dólares en el segundo trimestre de 2023.
4. Los gastos generales y administrativos aumentaron a 7,1 millones de dólares en el segundo trimestre de 2024 desde 1,9 millones de dólares en el segundo trimestre de 2023.
5. La pérdida neta por acción fue de $(0,27) para el segundo trimestre de 2024.
6. El efectivo y equivalentes de efectivo se situaron en 24,5 millones de dólares a 30 de junio de 2024.
포르테 바이오사이언스(Forte Biosciences, NASDAQ: FBRX)가 2024년 2분기 실적을 발표하고 비즈니스 업데이트를 제공했습니다. 회사는 FB102, 항 CD122 단클론 항체 치료 후보에 대한 진전을 보고했습니다. 주요 사항은 다음과 같습니다:
1. FB102에 대한 건강한 자원봉사자를 대상으로 한 SAD/MAD 1단계 연구가 성공적으로 완료되었습니다.
2. 셀리악병 환자를 대상으로 한 연구가 시작되었으며, 데이터는 2025년 2분기에 예상됩니다.
3. 연구개발 비용이 2023년 2분기 710만 달러에서 2024년 2분기 570만 달러로 감소했습니다.
4. 일반 및 관리 비용이 2023년 2분기 190만 달러에서 2024년 2분기 710만 달러로 증가했습니다.
5. 2024년 2분기 주당 순손실은 $(0.27)였습니다.
6. 2024년 6월 30일 기준 현금 및 현금성 자산은 2450만 달러에 달했습니다.
Forte Biosciences (NASDAQ: FBRX) a annoncé ses résultats du deuxième trimestre 2024 et a fourni une mise à jour commerciale. La société a signalé des progrès avec FB102, son candidat thérapeutique monoclonal anti-CD122. Les points clés comprennent :
1. Achèvement réussi de l'étude de phase 1 SAD/MAD chez des volontaires sains pour FB102.
2. Lancement d'une étude sur des patients atteints de la maladie cœliaque, avec des données attendues d'ici le deuxième trimestre 2025.
3. Les dépenses de R&D ont diminué à 5,7 millions de dollars au deuxième trimestre 2024, contre 7,1 millions de dollars au deuxième trimestre 2023.
4. Les dépenses générales et administratives ont augmenté à 7,1 millions de dollars au deuxième trimestre 2024, contre 1,9 million de dollars au deuxième trimestre 2023.
5. La perte nette par action était de $(0,27) pour le deuxième trimestre 2024.
6. Les liquidités disponibles et équivalentes s'élevaient à 24,5 millions de dollars au 30 juin 2024.
Forte Biosciences (NASDAQ: FBRX) gab seine Ergebnisse für das zweite Quartal 2024 bekannt und lieferte ein Unternehmensupdate. Das Unternehmen berichtete über Fortschritte mit FB102, seinem therapeutischen Kandidaten gegen CD122. Zu den wichtigsten Punkten gehören:
1. Erfolgreicher Abschluss der SAD/MAD Phase-1-Studie mit gesunden Freiwilligen für FB102.
2. Beginn einer Patientenstudie bei Zöliakie, mit Daten, die für das zweite Quartal 2025 erwartet werden.
3. Die F&E-Ausgaben sanken im zweiten Quartal 2024 auf 5,7 Millionen US-Dollar, verglichen mit 7,1 Millionen US-Dollar im zweiten Quartal 2023.
4. Die allgemeinen und administrativen Ausgaben stiegen im zweiten Quartal 2024 auf 7,1 Millionen US-Dollar, verglichen mit 1,9 Millionen US-Dollar im zweiten Quartal 2023.
5. Der Nettoverlust pro Aktie betrug im zweiten Quartal 2024 $(0,27).
6. Die liquiden Mittel und Zahlungsmittel beliefen sich zum 30. Juni 2024 auf 24,5 Millionen US-Dollar.
- Successful completion of FB102 phase 1 healthy volunteer study with good safety profile
- Initiation of celiac disease patient study with FB102, addressing a significant unmet need
- Significant reduction in NK cell pharmacodynamic marker, demonstrating FB102's mechanism
- Decrease in R&D expenses from $7.1 million in Q2 2023 to $5.7 million in Q2 2024
- Increase in general and administrative expenses from $1.9 million in Q2 2023 to $7.1 million in Q2 2024
- Net loss per share of $(0.27) for Q2 2024
- Cash and cash equivalents decreased from $37.1 million at end of 2023 to $24.5 million as of June 30, 2024
Insights
Forte Biosciences' Q2 2024 results reveal a mixed financial picture. R&D expenses decreased to
The company's cash position of
The completion of FB102's phase 1 SAD/MAD study in healthy volunteers with a good safety profile is encouraging. The observed significant reduction in NK cell pharmacodynamic markers aligns with the drug's mechanism of action. The initiation of a celiac disease patient study, with data expected by Q2 2025, represents a critical milestone for Forte.
The in-vitro and non-human primate studies demonstrate FB102's potential selectivity in inhibiting intermediate vs. high affinity IL2 receptors. This could be advantageous in treating autoimmune diseases while potentially preserving regulatory T cell function. However, the true clinical significance of these findings remains to be determined in patient studies.
Second Quarter 2024 Business Highlights
“Forte continues to make excellent progress with FB102, our anti-CD122 monoclonal antibody therapeutic candidate. The SAD/MAD phase 1 healthy volunteer study has successfully completed and FB102 has demonstrated a good safety profile,” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. “Based on the successful completion of the phase 1 healthy volunteer cohorts, Forte is initiating a patient study in celiac disease with data expected by the second quarter of 2025. 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 Updates
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 was comparable to vehicle. These observations suggest that FB102 is demonstrating selectivity with respect to inhibiting the intermediate vs high affinity IL2 receptor.
The phase 1 healthy volunteer SAD/MAD cohorts have successfully completed. The FB102 phase 1 healthy volunteer study demonstrated a good safety profile. Of note, in this study FB102 reported a significant reduction in the NK cell pharmacodynamic marker of the FB102 mechanism. Based on these results, Forte is advancing clinical development of FB102 into a celiac disease patient study with first patient dosing expected in the third quarter of 2024. Top-line results of the study are expected by the second quarter of 2025.
Second Quarter 2024 Operating Results
Research and development expenses were
Research and development expenses were
General and administrative expenses were
General and administrative expenses were
Net losses per share were
Forte ended the second quarter 2024 with approximately
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands except share and par value data) |
||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ |
24,498 |
|
$ |
37,125 |
|
||
| Prepaid expenses and other current assets |
|
1,213 |
|
|
1,202 |
|
||
| Total current assets |
|
25,711 |
|
|
38,327 |
|
||
| Property and equipment, net |
|
96 |
|
|
109 |
|
||
| Other assets |
|
271 |
|
|
544 |
|
||
| Total assets | $ |
26,078 |
|
$ |
38,980 |
|
||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ |
5,275 |
|
$ |
1,424 |
|
||
| Accrued liabilities (including |
|
3,842 |
|
|
2,242 |
|
||
| Total current liabilities |
|
9,117 |
|
|
3,666 |
|
||
| Commitments and contingencies (Note 6) | ||||||||
| Stockholders’ equity | ||||||||
| Common stock, |
|
36 |
|
|
36 |
|
||
| Additional paid-in capital |
|
155,383 |
|
|
153,794 |
|
||
| Accumulated other comprehensive income (loss) |
|
(7 |
) |
|
4 |
|
||
| Accumulated deficit |
|
(138,451 |
) |
|
(118,520 |
) |
||
| Total stockholders’ equity |
|
16,961 |
|
|
35,314 |
|
||
| Total liabilities and stockholders’ equity | $ |
26,078 |
|
$ |
38,980 |
|
||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (in thousands, except share and per share amounts) |
||||||||||||||||
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ |
5,590 |
|
$ |
7,139 |
|
$ |
9,914 |
|
$ |
11,926 |
|
||||
| Research and development - related party |
|
150 |
|
$ |
- |
|
|
179 |
|
$ |
- |
|
||||
| General and administrative |
|
7,078 |
|
|
1,895 |
|
|
10,529 |
|
|
3,963 |
|
||||
| Total operating expenses |
|
12,818 |
|
|
9,034 |
|
|
20,622 |
|
|
15,889 |
|
||||
| Loss from operations |
|
(12,818 |
) |
|
(9,034 |
) |
|
(20,622 |
) |
|
(15,889 |
) |
||||
| Other income, net |
|
307 |
|
|
138 |
|
|
691 |
|
|
240 |
|
||||
| Net loss | $ |
(12,511 |
) |
$ |
(8,896 |
) |
$ |
(19,931 |
) |
$ |
(15,649 |
) |
||||
| Per share information: | ||||||||||||||||
| Net loss per share - basic and diluted | $ |
(0.27 |
) |
$ |
(0.42 |
) |
$ |
(0.43 |
) |
$ |
(0.74 |
) |
||||
| Weighted average shares and pre-funded warrants outstanding, basic and diluted |
|
46,131,151 |
|
|
21,046,831 |
|
|
46,107,006 |
|
|
21,026,866 |
|
||||
| Comprehensive Loss: | ||||||||||||||||
| Net loss | $ |
(12,511 |
) |
$ |
(8,896 |
) |
$ |
(19,931 |
) |
$ |
(15,649 |
) |
||||
| Unrealized (loss) gain on available-for-sale securities |
|
(5 |
) |
|
1 |
|
|
(11 |
) |
|
1 |
|
||||
| Comprehensive loss | $ |
(12,516 |
) |
$ |
(8,895 |
) |
$ |
(19,942 |
) |
$ |
(15,648 |
) |
||||
Additional details on Forte’s second quarter 2024 financial results can be found in Forte’s Form 10-Q as filed with the SEC on August 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 initiate a patient study in celiac disease with data expected by 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 commencement of the Company’s patient-based studies; the risk that results from preclinical and any interim result of our ongoing phase 1 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 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, in the Company’s subsequent Quarterly Report on Forms 10-Q filed on May 13, 2024 and August 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240814514202/en/
LifeSci Advisors
Mike Moyer, Managing Director
mmoyer@lifesciadvisors.com
Forte Biosciences, Inc.
Paul Wagner, CEO
investors@fortebiorx.com
Source: Forte Biosciences, Inc.
FAQ
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