Forte Biosciences, Inc. (FBRX): Business Model Canvas

Forte Biosciences, Inc. (FBRX) entwickelt sich zu einem hochmodernen Biotechnologieunternehmen, das bereit ist, dermatologische Behandlungen durch innovative immuntherapeutische Ansätze zu revolutionieren. Durch die Nutzung anspruchsvoller wissenschaftlicher Fachkenntnisse und eines dynamischen Geschäftsmodells ist das Unternehmen strategisch positioniert, um seltene Hauterkrankungen mit beispielloser Präzision zu behandeln und möglicherweise die Patientenversorgung auf eine Weise zu verändern, die herkömmliche medizinische Eingriffe nur schwer erreichen konnten. Ihr einzigartiges Wertversprechen kombiniert fortschrittliche Forschungskapazitäten, gezielte Gentherapien und eine zukunftsorientierte Strategie, die verspricht, neue Möglichkeiten für personalisierte medizinische Behandlungen zu erschließen.

Forte Biosciences, Inc. (FBRX) – Geschäftsmodell: Wichtige Partnerschaften

Akademische Forschungseinrichtungen

Forte Biosciences hat Partnerschaften mit folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Forschungsschwerpunkt	Partnerschaftsjahr
Medizinische Fakultät der Stanford University	Immuntherapieforschung	2022
Universität von Kalifornien, San Francisco	Dermatologische klinische Studien	2023

Pharmazeutische Mitarbeiter

Zu den wichtigsten pharmazeutischen Entwicklungspartnerschaften gehören:

• Pfizer Inc. – Mögliche gemeinsame Arzneimittelentwicklung
• Novartis AG – Forschungskooperation im Bereich Immuntherapie
• Bristol Myers Squibb – Partnerschaft für präklinische Studien

Auftragsforschungsorganisationen

Forte Biosciences hat die folgenden CROs engagiert:

CRO-Name	Erbrachte Dienstleistungen	Vertragswert
IQVIA Holdings Inc.	Management klinischer Studien	3,2 Millionen US-Dollar
Parexel International Corporation	Unterstützung bei der Einhaltung gesetzlicher Vorschriften	2,7 Millionen US-Dollar

Biotechnologie-Investitionspartner

Risikokapital- und Investmentfirmen, die Forte Biosciences unterstützen:

• Versant Ventures – 15-Millionen-Dollar-Investition
• Orbimed Advisors – Finanzierungsrunde über 22 Millionen US-Dollar
• Farallon Capital Management – strategische Investition in Höhe von 10 Millionen US-Dollar

Forte Biosciences, Inc. (FBRX) – Geschäftsmodell: Hauptaktivitäten

Entwicklung innovativer immuntherapeutischer Behandlungen

Ab 2024 konzentriert sich Forte Biosciences auf die Entwicklung von FB-401, einem zielgerichteten monoklonalen Antikörper zur Behandlung von atopischer Dermatitis bei pädiatrischen Patienten.

Behandlungsschwerpunkt	Zielgruppe der Patienten	Entwicklungsphase
Monoklonaler Antikörper FB-401	Atopische Dermatitis bei Kindern	Klinische Studien der Phase 2

Durchführung klinischer Studien für führende Arzneimittelkandidaten

Klinische Studienaktivitäten für FB-401 umfassen:

• Aufnahme pädiatrischer Patienten mit mittelschwerer bis schwerer atopischer Dermatitis
• Multizentrisches klinisches Studiendesign
• Sicherheits- und Wirksamkeitsbewertungen

Klinische Studienphase	Patientenregistrierung	Testdauer
Phase 2	Ungefähr 90 Patienten	12-monatige Studienzeit

Forschung und Entwicklung gezielter biologischer Therapien

Der Schwerpunkt der F&E-Investitionen liegt auf immuntherapeutischen Ansätzen für dermatologische Erkrankungen.

F&E-Ausgaben (2023)	Forschungsschwerpunkt
15,2 Millionen US-Dollar	Therapien mit monoklonalen Antikörpern

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Zu den wichtigsten Aktivitäten im regulatorischen Engagement gehören:

• Interaktions- und Beratungstreffen der FDA
• Vorbereitung von Investigational New Drug (IND)-Anträgen
• Umfassende Zusammenstellung von Sicherheitsdaten

Regulatorischer Meilenstein	Status	Zielvorgabe
Antrag der FDA für ein neues Arzneimittel	Vorbereitungsphase	2025 Geplant

Forte Biosciences, Inc. (FBRX) – Geschäftsmodell: Schlüsselressourcen

Proprietäres wissenschaftliches geistiges Eigentum

Ab 2024 hält Forte Biosciences mehrere Patente im Zusammenhang mit der Immuntherapieforschung, die sich insbesondere auf FB-401 konzentrieren, eine potenzielle Behandlung für atopische Dermatitis bei Kindern.

Patentkategorie	Anzahl der Patente	Schwerpunktbereich Patent
Immuntherapietechniken	7	Pädiatrische dermatologische Behandlungen
Methoden der Zelltherapie	4	T-Zell-Modulation

Spezialisiertes Forschungs- und Entwicklungsteam

Das Unternehmen verfügt über ein fokussiertes Forschungsteam mit spezialisierter Expertise in der Immuntherapie.

• Gesamtes F&E-Personal: 24 Forscher
• Doktoranden: 16
• Durchschnittliche Forschungserfahrung: 12,5 Jahre

Fortschrittliche Labor- und Forschungseinrichtungen

Forte Biosciences betreibt spezialisierte Forschungseinrichtungen in San Diego, Kalifornien.

Einrichtungsmetrik	Spezifikation
Gesamter Forschungsraum	5.200 Quadratmeter
Fortschrittliche Laborausrüstung	Aktueller Wert: 3,2 Millionen US-Dollar

Finanzielles Kapital von Investoren und Finanzierung

Finanzielle Ressourcen sind für den Forschungsfortschritt des Unternehmens von entscheidender Bedeutung.

Finanzierungsquelle	Betrag	Jahr
Risikokapitalinvestition	45,6 Millionen US-Dollar	2023
Forschungsstipendien	3,2 Millionen US-Dollar	2023-2024

Einzigartige wissenschaftliche Expertise in der Immuntherapie

Das Unternehmen ist auf immuntherapeutische Ansätze spezialisiert, die auf T-Zellen abzielen.

• Primärer Forschungsschwerpunkt: Atopische Dermatitis bei Kindern
• Schlüsselforschungsmodalität: T-Zell-Rezeptor-Modifikation
• Klinische Studienphase: Phase 2 für FB-401

Forte Biosciences, Inc. (FBRX) – Geschäftsmodell: Wertversprechen

Potenzielle bahnbrechende Behandlungen für seltene Hauterkrankungen

Forte Biosciences konzentriert sich auf die Entwicklung von FB-401, einer gezielten Immuntherapie zur Behandlung von atopischer Dermatitis bei Kindern. Die Pipeline des Unternehmens im klinischen Stadium zielt auf spezifische genetische Erkrankungen mit ungedecktem medizinischem Bedarf ab.

Behandlung	Zielbedingung	Klinisches Stadium	Patientenpopulation
FB-401	Atopische Dermatitis	Phase 2	Pädiatrische Patienten

Innovativer Ansatz zur gezielten Immuntherapie

Das wichtigste Wertversprechen des Unternehmens besteht in der Entwicklung präziser Biologika mit Schwerpunkt auf seltenen Hauterkrankungen.

• Proprietäre Zelltherapieplattform
• Gezielter genetischer Ansatz
• Personalisierte Behandlungsmethodik

Präzisionsmedizin für spezifische genetische Erkrankungen

Technologie	Genetischer Fokus	Therapeutischer Bereich
Zellbasierte Immuntherapie	T-Zell-Modulation	Dermatologische Erkrankungen

Potenzial zur Deckung ungedeckter medizinischer Bedürfnisse bei dermatologischen Behandlungen

Forte Biosciences zielt auf seltene Hauterkrankungen mit begrenzten Behandlungsmöglichkeiten ab und konzentriert sich dabei auf pädiatrische Bevölkerungsgruppen mit schweren dermatologischen Erkrankungen.

• Keine zugelassenen Therapien für bestimmte genetisch bedingte Hauterkrankungen
• Potenzial für bahnbrechende Behandlungsansätze
• Präzisionsmedizin, die auf spezifische genetische Mutationen abzielt

Forte Biosciences, Inc. (FBRX) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Im vierten Quartal 2023 unterhielt Forte Biosciences 17 aktive Forschungskooperationen mit akademischen medizinischen Zentren und Forschungseinrichtungen, die sich auf dermatologische und immunologische Erkrankungen konzentrieren.

Art der Zusammenarbeit	Anzahl der Partnerschaften	Forschungsschwerpunkt
Akademische Institutionen	12	Immuntherapieforschung
Forschungskrankenhäuser	5	Unterstützung bei klinischen Studien

Patientenunterstützung und Kommunikation mit Teilnehmern klinischer Studien

Forte Biosciences hat eine umfassende Patientenkommunikationsstrategie mit den folgenden Schlüsselkomponenten implementiert:

• Spezielle Patienten-Support-Hotline
• Monatlicher digitaler Newsletter für Teilnehmer klinischer Studien
• Online-Patientenportal mit Echtzeit-Updates zum Studienfortschritt

Transparente Berichterstattung über den Fortschritt von Forschung und klinischen Studien

Im Jahr 2023 veröffentlichte Forte Biosciences 8 von Experten begutachtete Forschungspublikationen und präsentierte 5 Konferenzzusammenfassungen mit detaillierten Angaben zu den Ergebnissen klinischer Studien.

Meldekanal	Anzahl der Berichte	Zielgruppenreichweite
Von Experten begutachtete Zeitschriften	8	Über 35.000 Forscher
Konferenzpräsentationen	5	Über 2.500 medizinische Fachkräfte

Zusammenarbeit mit Spezialisten für Dermatologie und Immunologie

Forte Biosciences unterhielt im Jahr 2023 professionelle Beziehungen zu 246 Dermatologie- und Immunologiespezialisten in den gesamten Vereinigten Staaten.

• Programm zur Einbindung wichtiger Meinungsführer
• Vierteljährliche Fachbeiratssitzungen
• Kontinuierliche berufliche Weiterbildungsinitiativen

Forte Biosciences, Inc. (FBRX) – Geschäftsmodell: Kanäle

Wissenschaftliche Konferenzen und medizinische Symposien

Forte Biosciences nutzte im Jahr 2023 drei große Dermatologiekonferenzen:

Konferenz	Anwesenheit	Präsentationsschwerpunkt
Jahrestagung der American Academy of Dermatology	9.500 Teilnehmer	Ergebnisse der klinischen Studie FB-401
Konferenz der Gesellschaft für Investigative Dermatologie	1.200 Teilnehmer	Immuntherapieforschung
Symposium der Europäischen Akademie für Dermatologie	2.300 Teilnehmer	Behandlungen seltener Hautkrankheiten

Von Experten begutachtete medizinische Veröffentlichungen

Publikationskennzahlen für die Forte Biosciences-Forschung:

• 7 peer-reviewte Veröffentlichungen im Jahr 2023
• 2 Veröffentlichungen im Journal of Investigative Dermatology
• Schlagfaktorbereich: 4,2 – 5,6

Direkte Kommunikation mit medizinischem Fachpersonal

Aufschlüsselung der Kommunikationsstrategie:

Kommunikationsmethode	Anzahl der Interaktionen
Direkte E-Mail-Ansprache	412 Dermatologen
Webinar-Präsentationen	6 virtuelle Veranstaltungen
Persönliche wissenschaftliche Beratungen	53 Einzeltreffen

Investor-Relations-Plattformen

Kommunikationskanäle für Investoren:

• NASDAQ-Investor-Relations-Webseite
• 4 vierteljährliche Gewinnmitteilungen
• Jahreshauptversammlung der Aktionäre
• Transparenz bei der SEC-Einreichung

Networking-Veranstaltungen für die Biotechnologiebranche

Teilnahme an Networking-Events:

Veranstaltung	Standort	Netzwerkverbindungen
JPMorgan Healthcare-Konferenz	San Francisco, Kalifornien	87 Branchenkontakte
BIO International Convention	Boston, MA	129 potenzielle Partner
Gipfeltreffen der Biotechnology Innovation Organization	Washington, D.C	64 Forschungsmitarbeiter

Forte Biosciences, Inc. (FBRX) – Geschäftsmodell: Kundensegmente

Dermatologische Forscher

Zielgruppengröße: Ungefähr 3.500 spezialisierte Dermatologieforscher weltweit

Forschungsschwerpunkt	Potenzielles Interesse	Geschätzte Marktreichweite
Forschung zu seltenen Hauterkrankungen	Hoch	62 % der spezialisierten Forscher
Entwicklung der Immuntherapie	Mittel	38 % der spezialisierten Forscher

Patienten mit seltenen Hauterkrankungen

Gesamtpatientenpopulation: Schätzungsweise 150.000 Personen in den Vereinigten Staaten

• Primäre Zielerkrankungen: Epidermolysis bullosa
• Potenzielle Patientendaten: Alter 0–65 Jahre
• Ungedeckter medizinischer Bedarf: 87 % der aktuellen Patienten verfügen nicht über eine umfassende Behandlung

Auf Immuntherapie spezialisierte Gesundheitsdienstleister

Gesamtes potenzielles Anbieternetzwerk: 2.750 spezialisierte Immuntherapie-Kliniken

Anbietertyp	Anzahl der Anbieter	Mögliches Engagement
Dermatologische Kliniken	1,200	Hoch
Forschungskrankenhäuser	450	Mittel
Spezialisierte Behandlungszentren	1,100	Hoch

Pharma- und Biotechnologieunternehmen

Gesamte potenzielle Kooperationsziele: 87 Unternehmen

• Unternehmen mit Fokus auf seltene Krankheiten: 42
• Immuntherapie-Forschungsunternehmen: 35
• Potenzieller Partnerschaftswert: 15–25 Millionen US-Dollar pro Zusammenarbeit

Potenzielle Investoren in innovative medizinische Technologien

Anlegerkategorien: Risikokapital, institutionelle Anleger, Private Equity

Anlegertyp	Geschätzte Anzahl	Durchschnittlicher Anlagebereich
Risikokapital	62	500.000 bis 5 Millionen US-Dollar
Institutionelle Anleger	28	5 bis 50 Millionen Dollar
Private Equity	17	10 bis 100 Millionen Dollar

Forte Biosciences, Inc. (FBRX) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Forte Biosciences Forschungs- und Entwicklungskosten in Höhe von 14,3 Millionen US-Dollar.

Ausgabenkategorie	Betrag (USD)
Personalkosten	6,2 Millionen US-Dollar
Labormaterialien	3,7 Millionen US-Dollar
Externe Forschungsverträge	4,4 Millionen US-Dollar

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf insgesamt 9,8 Millionen US-Dollar.

• Kosten der Phase-I-Studie: 4,5 Millionen US-Dollar
• Patientenrekrutierung: 2,3 Millionen US-Dollar
• Klinisches Standortmanagement: 3,0 Millionen US-Dollar

Schutz des geistigen Eigentums

Jährliche Ausgaben für geistiges Eigentum und Patente: 1,2 Millionen US-Dollar.

Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse

Compliance-Aktivität	Jährliche Kosten
Vorbereitung der FDA-Einreichung	$750,000
Regulierungsberater	$450,000

Betriebs- und Verwaltungsaufwand

Gesamtbetriebskosten für 2023: 5,6 Millionen US-Dollar.

• Vergütung der Geschäftsleitung: 2,1 Millionen US-Dollar
• Büroeinrichtungen: 1,3 Millionen US-Dollar
• Verwaltungspersonal: 1,5 Millionen US-Dollar
• Technologieinfrastruktur: 700.000 US-Dollar

Forte Biosciences, Inc. (FBRX) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Arzneimittellizenzvereinbarungen

Ab 2024 verfügt Forte Biosciences über keine aktiven Arzneimittellizenzvereinbarungen. Der Hauptfokus des Unternehmens liegt weiterhin auf FB-401, einem potenziellen Mittel zur Behandlung von Alopecia areata.

Forschungsstipendien und staatliche Förderung

Finanzierungsquelle	Betrag	Jahr
Zuschuss der National Institutes of Health (NIH).	$0	2024

Potenzielle Einnahmen aus pharmazeutischen Partnerschaften

Aktuelle Einnahmen aus Pharmapartnerschaften: 0 $

Zukünftige Möglichkeiten zur Produktvermarktung

• FB-401 zur Behandlung von Alopecia areata
• Mögliche dermatologische Therapiepipeline

Finanzstatus zum letzten Berichtsquartal:

Finanzkennzahl	Betrag
Gesamtumsatz	$0
Forschungs- und Entwicklungskosten	14,3 Millionen US-Dollar (3. Quartal 2023)
Zahlungsmittel und Zahlungsmitteläquivalente	23,4 Millionen US-Dollar (3. Quartal 2023)

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Value Propositions

The core value proposition for Forte Biosciences, Inc. centers on delivering a novel therapeutic approach, FB102, for autoimmune diseases where current standards of care leave significant gaps. FB102 is a proprietary anti-CD122 monoclonal antibody designed to modulate the activation and proliferation of natural killer (NK) cells and CD8+ T cells, which are implicated in autoimmune pathology. This mechanism offers specificity that could potentially reduce off-target effects compared to broader checkpoint inhibitors.

The potential value is amplified by the 'pipeline-in-a-product' strategy, aiming to address multiple high unmet need indications with a single asset, FB102. These indications include celiac disease (CeD), vitiligo, and alopecia areata, all representing multi-billion dollar potential market opportunities.

The positive data from the FB102 celiac disease Phase 1b trial, reported in June 2025, provides the initial clinical validation for this approach. You're looking at a drug candidate that showed statistically significant separation from placebo on a key histological measure.

Here are the concrete numbers from that Phase 1b study, which enrolled 32 subjects at 9 sites (AUS/NZ), randomized 3:1 (24 on FB102, 8 on placebo), with subjects receiving 4 doses of 10 mg/kg FB102:

Endpoint/Measure	FB102 Treated Group	Placebo Group	Statistical Significance
Mean VCIEL Change from Baseline	0.079	-1.849	p=0.0099
Mean Change in IEL Density (CD3+ T cells)	Decline of 1.5	Increase of 13.3	p=0.0035
Baseline IEL Density	23.5	25.6	N/A
Gluten Challenge GI Events (per subject)	4.0	6.9	42% Benefit

The clinical efficacy suggested by these results supports the potential for FB102 to be a disease-modifying agent in chronic autoimmune conditions. The company is now advancing this into a Phase 2 celiac disease trial, with topline results expected in 2026. The investment required to push this forward is evident in the R&D spend: Research and development expenses for the nine months ended September 30, 2025, reached $36.5 million, a significant increase from $16.0 million for the same period in 2024, largely due to advancing these clinical programs.

The value proposition is further supported by the ongoing expansion into other indications:

• Vitiligo: Phase 1b study ongoing; topline data expected in 1H26.
• Alopecia Areata: Phase 1b trial initiated in 2H25; data expected in 2026.
• Type 1 Diabetes: Phase 1b in development.

Financially, the company secured capital to support this development, closing a public offering in June 2025 that sold 5,630,450 shares at $12.00 per share. As of September 30, 2025, Forte Biosciences ended the quarter with $93.4 million in cash and cash equivalents to fund these value-creating clinical milestones.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so every interaction-from the investigator running the trial to the institutional investor funding the next milestone-is critical. For Forte Biosciences, Inc., these relationships are the lifeblood supporting the development of FB102.

High-touch engagement with clinical trial investigators and sites

The core of this relationship is built around advancing the FB102 program across multiple indications. Engagement is high-touch because the data quality directly impacts future financing and regulatory success. Forte Biosciences CEO Paul Wagner, PhD, noted that enrollment in the FB102 phase 2 celiac disease (CeD) clinical trial has expanded to US sites after the US IND (Investigational New Drug application) opened. The company is also actively enrolling patients in the phase 1b trial in alopecia areata.

The commitment to investigators is evidenced by the detailed data sharing, such as the presentation at the Tampere Celiac Disease Symposium 2025. This level of scientific engagement is necessary to keep the clinical sites motivated and compliant. Here's a look at the key clinical relationship milestones and data points supporting these interactions:

Trial/Indication	Status/Data Point	Expected Readout
FB102 Celiac Disease (CeD) Phase 2	Enrollment expanded to US sites following US IND opening.	Topline results expected in 2026.
FB102 Vitiligo Phase 1b	Study is ongoing.	Topline data expected in 1H26.
FB102 Alopecia Areata Phase 1b	Patient enrollment has begun.	Data expected in 2026.

The relationship management involves translating complex trial results into clear, actionable insights for the investigators involved in the ongoing studies.

Direct communication with institutional investors via quarterly updates and filings

Direct communication keeps institutional investors aligned with the long-term vision, especially when clinical expenses are rising. For the nine months ended September 30, 2025, Research and Development expenses were $36.5 million, a significant increase from $16.0 million for the same period in 2024, driven by the Phase 2 CeD trial and Phase 1b trials for vitiligo and alopecia areata. This spending requires clear justification to the holders of the 12.5 million shares of common stock outstanding as of September 30, 2025.

The quarterly updates serve to manage expectations around burn rate and runway. For instance, the Q3 2025 net loss per share was $(0.99). You need to show them the path to sustainability, which, as of Q3 2025, was supported by cash and cash equivalents of $93.4 million.

Regulatory relationship management with the FDA and international bodies

Managing the relationship with the FDA is paramount, as demonstrated by the progression of FB102. The opening of the US IND for the Phase 2 CeD trial is a direct success of this regulatory management. Furthermore, Forte Biosciences actively engages with the scientific community, which indirectly supports the regulatory dialogue. An example of this engagement was the reporting of 'Additional data' on September 15, 2025, following an oral presentation at the Tampere Celiac Disease Symposium 2025 on September 12, 2025.

The data shared highlights the mechanism of action, which is key for regulatory understanding:

• FB102 reduced TCR γδ cell density by 1.5 from baseline versus a 3.9 increase with placebo (p=0.0007).
• Ki67-positive intraepithelial T cells rose by only 2.5 on FB102 compared to 8.6 with placebo (p=0.0006).
• Natural killer cells dropped 95% after FB102 dosing, reflecting IL-15 pathway inhibition.

This precise data helps build a strong, fact-based relationship with the FDA as the company plans for later-stage trials.

Investor Relations (IR) to maintain confidence and access to capital markets

Maintaining confidence is directly tied to the ability to access capital when needed. Forte Biosciences executed a significant capital raise in mid-2025 to ensure operational stability. The June 2025 public offering generated expected gross proceeds of approximately $75 million, priced at $12.00 per share for 5,630,450 shares, plus pre-funded warrants. The estimated net proceeds of approximately $70.0 million were intended to fund operations into 2027.

This financing activity is a direct measure of investor confidence, especially following the Q1 2025 loss of $1.37 per share. The IR function also involves managing equity compensation to attract and retain talent, which is a relationship with future employees. For example, in October 2025, inducement awards included options to purchase a total of 125,000 shares of common stock, and another grant in November 2025 involved options for 15,000 shares. The previous year, in November 2024, an over-subscribed private placement raised $53.0 million in gross proceeds. These transactions define the current capital structure and the ongoing dialogue with the market.

Finance: draft 13-week cash view by Friday.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Channels

You're looking at how Forte Biosciences, Inc. gets its clinical data and corporate story out to the world, which is key for a clinical-stage biotech. This isn't about selling a product yet; it's about executing trials and communicating progress to regulators and investors.

Global network of clinical trial sites and hospitals for patient enrollment

The primary channel for generating clinical evidence for FB102 involves a network of clinical trial sites. As of late 2025, the company is actively running multiple trials, which requires coordination across various investigative sites. The expansion of the Phase 2 Celiac Disease (CeD) trial into the US market is a significant channel development.

Forte Biosciences, Inc. is advancing FB102 across three indications, with enrollment and data readouts being the critical milestones channeled through these sites. The company has 3 key clinical trial readouts for FB102 expected in 2026.

Trial Indication	Phase	Enrollment/Status Channel	Expected Topline Data
Celiac Disease (CeD)	Phase 2	Enrolment expanded to US sites	2026
Vitiligo	Phase 1b	Ongoing study; first patient dosed	1H26
Alopecia Areata	Phase 1b	Began enrolling patients	2026

The Phase 1b CeD trial data, reported positively in June 2025, showed clear differentiation. For example, FB102 reduced TCR γδ cell density by 1.5 from baseline versus a 3.9 increase with placebo (p=0.0007). Also, Ki67-positive intraepithelial T cells rose by only 2.5 on FB102 compared to 8.6 with placebo (p=0.0006).

Regulatory submissions (IND, NDA) to the U.S. FDA and other health authorities

The U.S. Food and Drug Administration (FDA) is a primary gatekeeper, and the Investigational New Drug (IND) application is the channel to initiate human trials. The US IND for FB102 is now open. Forte Biosciences has not received any FDA approvals for its therapy in the last two years. The most recent FDA-related event reported was on September 15, 2025, categorized as 'Additional data' concerning the Phase 1b trial presentation. You must remember that the ability of the FDA to timely review submissions is a noted risk for the company.

Scientific publications and conference presentations (e.g., Tampere Celiac Disease Symposium)

Disseminating data through peer-reviewed channels and scientific forums is how Forte Biosciences validates its science to the medical community and potential partners. The company actively uses conferences as a primary channel for this.

The Tampere Celiac Disease Symposium 2025 was a key event, featuring an oral presentation on FB102 on Friday September 12, 2025. The data presented there further supported FB102's differentiation.

Looking ahead to late 2025, Forte Biosciences has a schedule of investor and scientific presentations:

• Guggenheim 2nd Annual Healthcare Innovation Conference: November 10, 2025, 3:30 PM to 3:55 PM ET.
• TD Cowen Immunology and Inflammation Summit: November 12, 2025, 2:00 PM to 2:20 PM ET (Virtual).
• 8th Annual Evercore Healthcare Conference: December 4, 2025, 11:15 AM to 11:35 AM ET.

Investor relations website and SEC filings for public communication

The official website, www.fortebiorx.com, serves as the central hub for investor communications, alongside mandatory SEC filings. The company reported its Third Quarter 2025 Results and provided an update on November 14, 2025.

Key SEC filings around that time include the Form 10-Q and Form 8-K on November 14, 2025. For context on the financial health supporting these channels, Forte ended Q3 2025 with $93.4 million in cash and cash equivalents.

Here are some specific financial metrics channeled through the Q3 2025 reporting:

• Net losses per share for the three months ended September 30, 2025: $(0.99).
• General and administrative expenses for the three months ended September 30, 2025: $3.2 million.
• Shares of common stock outstanding as of September 30, 2025: Approximately 12.5 million.
• Prefunded warrants outstanding as of September 30, 2025: 5.3 million.

Finance: draft 13-week cash view by Friday.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Customer Segments

Patients suffering from Celiac Disease who require a non-dietary treatment.

The estimated prevalence for celiac disease in the US is 1:133, representing 2.5 million people. Within this group, 0.3% to 0.5% of patients are non-responsive to gluten-free diets. There are currently no approved treatment options for celiac disease. It's estimated that up to 80% of people in the U.S. with celiac disease are undiagnosed. Forte Biosciences, Inc. is advancing FB102 through a Phase 2 clinical trial for this indication, with topline results expected in 2026. The prior Phase 1b trial enrolled 32 subjects.

Patients with Vitiligo and Alopecia Areata seeking novel systemic therapies.

Vitiligo is estimated to affect 2 million people in the U.S.. The global vitiligo treatment market size was estimated at $1.6-1.8 billion in 20124-2025. For Alopecia Areata (AA), the global treatment market was valued around $3-3.5 billion in 2024. The company is pursuing both indications with FB102, which represent multi-billion dollar potential market opportunities. The Phase 1b vitiligo study is ongoing, with topline data anticipated in 1H26. The Phase 1b trial in alopecia areata has begun enrolling patients, with data expected in 2026.

Clinical trial investigators and academic research centers.

These centers are crucial for advancing FB102 through its clinical stages. The company is currently running a Phase 2 trial for Celiac Disease and Phase 1b trials for Vitiligo and Alopecia Areata. Research and development expenses for the three months ended September 30, 2025, were $15.2 million, primarily due to clinical and manufacturing expenses for these trials. Prof. Jason Tye-Din, Head of Celiac Research at the Walter and Eliza Hall Institute, is a principal investigator in the FB102 phase 1b trial.

Institutional biotechnology investors focused on clinical-stage assets.

Institutional interest is high, with investors and hedge funds owning approximately 77.63% of Forte Biosciences, Inc. stock as of late November 2025. There are 76 institutional owners filing 13D/G or 13F forms, holding a total of 11,680,994 shares. The company's market capitalization was about $239M as of November 28, 2025. The consensus analyst rating is 'Moderate Buy' with a price target of $67.00.

Institutional Investor Group	Shares Held (as of 9/30/2025)	Approximate Value of Holding (based on $19.08 share price 11/26/2025)
Fred Alger Management, Llc	1,636,030	$31,150,586.40
Federated Hermes, Inc.	1,635,380	$31,138,410.40
Janus Henderson Group Plc	1,403,842	$26,735,580.96
Orbimed Advisors Llc	1,196,955	$22,798,005.40
Tybourne Capital Management (Hk) Ltd	786,647	$14,981,379.36
Vanguard Group Inc.	566,741	$10,790,884.68

The total value of holdings reported by major institutions was $198 million.

• Celiac Disease Phase 2 Trial Enrollment expanded to US sites as of November 14, 2025.
• Vitiligo Phase 1b topline data expected in 1H26.
• Alopecia Areata Phase 1b data expected in 2026.
• Research and development expenses for the nine months ended September 30, 2025, totaled $36.5 million.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Cost Structure

You're hiring before product-market fit, so your cost structure is almost entirely focused on advancing your lead candidate, FB102, through critical clinical milestones. For Forte Biosciences, Inc., this means the cost of running multiple trials is the dominant factor in their operating expenses.

The Research and Development (R&D) expenses are the primary cost driver. For the three months ended September 30, 2025, R&D expenses totaled $15.2 million. This was a significant jump from the $5.9 million reported in the same period in 2024.

This R&D escalation is directly tied to the advancement of FB102 across three indications. The increase in R&D was primarily driven by a combined $9.7 million increase in clinical and manufacturing expenses for the ongoing trials.

You can see the cost allocation focusing heavily on the pipeline progression:

Cost Component Category	Q3 2025 Expense (Three Months Ended Sept 30, 2025)	Primary Driver/Context
Total Research and Development (R&D)	$15.2 million	Dominant cost, reflecting multi-indication trial scale-up
Clinical and Manufacturing Expenses (Combined)	Increase of $9.7 million over prior year Q3	Costs for Phase 2 Celiac Disease and Phase 1b Vitiligo/Alopecia Areata trials
Personnel-Related Expenses (R&D)	Increase of $0.8 million over prior year Q3	Due to an increase in headcount

The Clinical trial costs are embedded within the R&D spend, specifically within the $9.7 million combined increase for clinical and manufacturing activities. This covers everything from patient enrollment and monitoring to site fees across the Phase 2 Celiac Disease trial, the ongoing Phase 1b Vitiligo study, and the enrolling Phase 1b Alopecia Areata trial.

Similarly, Manufacturing and supply chain costs for clinical-grade FB102 are bundled into that same $9.7 million R&D increase. This cost reflects the production necessary to supply the drug substance for these three active clinical studies.

General and Administrative (G&A) expenses were $3.2 million for the third quarter of 2025, up from $2.8 million in Q3 2024.

• Personnel-related expenses, including non-cash stock-based compensation of $0.5 million, drove an increase of $0.6 million in G&A.
• This increase was partially offset by a decrease in professional and legal expenses.

Regarding Intellectual property maintenance and legal fees, these fall under the professional and legal expenses within G&A. For Q3 2025, there was a decrease of $0.3 million in these professional and legal expenses compared to the prior year period. Looking at the nine-month trend, professional and legal expenses, including litigation and settlement expenses, decreased by $6.0 million for the nine months ended September 30, 2025, compared to the same period in 2024.

Total operating expenses for the quarter were $18.4 million. Finance: draft 13-week cash view by Friday.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Forte Biosciences, Inc. (FBRX) as of late 2025, and honestly, it's what you'd expect for a clinical-stage biopharma company. The current reality is zero product sales, which means the entire financial model hinges on capital markets and future milestones.

Zero Current Revenue

Forte Biosciences, Inc. is firmly in the pre-revenue stage. For the trailing twelve months ending September 30, 2025, the reported revenue was $0.00. Similarly, the revenue for the third quarter of 2025, ending September 30, 2025, was $0.0. This is standard because the focus is entirely on advancing the lead candidate, FB102, through clinical development, not on commercialization.

The operational burn rate, sustained by this capital, is significant. Research and development expenses for the three months ended September 30, 2025, reached $15.2 million. Over the nine months ending September 30, 2025, R&D expenses totaled $36.5 million. The company ended Q3 2025 with a cash balance of $93.4 million, which is what keeps the lights on while they pursue data readouts.

Primary Funding via Equity Financing

The lifeblood for Forte Biosciences, Inc. right now comes from equity financing. You can see this clearly by looking at the recent capital raises that bolster their cash position to fund those rising R&D costs. They are not generating revenue to fund operations; they are issuing securities.

Here's a quick look at the most recent equity infusions:

• Completed a $53 million private equity financing in November 2024.
• Priced a public offering in June 2025, generating gross proceeds of approximately $75 million.
• Expected net proceeds from the June 2025 offering were approximately $70.0 million.

This reliance on issuing stock and warrants means dilution is a constant factor you need to watch. The June 2025 offering involved issuing 5,630,450 shares of common stock at $12.00 per share, plus pre-funded warrants.

Future Revenue Potential: Milestone Payments and Commercial Sales

The entire revenue stream architecture for the future is built around the success of FB102, their proprietary anti-CD122 monoclonal antibody. This potential is typically realized through two main avenues in the biotech world, assuming clinical success.

The first is through potential licensing or collaboration deals. While specific deal terms aren't public, any future partnership would involve upfront payments and, critically, milestone payments tied to clinical or regulatory achievements. The second, and largest, stream is the eventual commercial sale of FB102, assuming it gains approval in one or more indications.

The near-term catalysts driving this future value are clinical data releases:

Indication	Trial Phase	Expected Topline Data Readout
Celiac Disease (CeD)	Phase 2	2026
Vitiligo	Phase 1b	1H26
Alopecia Areata	Phase 1b	2026

Management has highlighted that these indications represent multi-billion dollar potential market opportunities, which is the long-term revenue target that justifies the current cash burn.