Rallybio Corporation (RLYB): Business Model Canvas

In der hochmodernen Biotechnologielandschaft erweist sich die Rallybio Corporation als Pionierkraft, die das komplexe Terrain seltener genetischer Erkrankungen mit beispielloser wissenschaftlicher Innovation strategisch bewältigt. Durch die sorgfältige Ausarbeitung eines Geschäftsmodells, das bahnbrechende Forschung, patientenzentrierte Ansätze und transformative therapeutische Lösungen verbindet, steht Rallybio an der Spitze der personalisierten Präzisionsmedizin. Ihr umfassender Business Model Canvas offenbart ein hochentwickeltes Ökosystem, das darauf ausgelegt ist, kritische ungedeckte medizinische Bedürfnisse zu erfüllen und fortschrittliche molekulare Forschung, strategische Partnerschaften und ein starkes Engagement für die Entwicklung bahnbrechender Behandlungen für Patienten mit seltenen genetischen Erkrankungen zu nutzen.

Rallybio Corporation (RLYB) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Kooperationen mit akademischen Forschungseinrichtungen

Rallybio Corporation hat Forschungspartnerschaften mit den folgenden akademischen Institutionen aufgebaut:

Institution	Forschungsschwerpunkt	Kooperationsstatus
Yale-Universität	Seltene genetische Störungen	Aktive Partnerschaft
Universität von Pennsylvania	Komplementvermittelte Erkrankungen	Laufende Forschungskooperation

Partnerschaften mit Interessengruppen für Patienten mit seltenen Krankheiten

Rallybio unterhält strategische Beziehungen zu Patientenvertretungsorganisationen:

• Globale Gene
• Nationale Organisation für seltene Erkrankungen (NORD)
• Genetische Allianz

Pharmazeutische Entwicklungs- und Lizenzvereinbarungen

Aktuelle pharmazeutische Entwicklungspartnerschaften:

Partner	Arzneimittelkandidat	Entwicklungsphase
Komplementarzneimittel	RLYB211	Klinische Studien der Phase 1/2
Horizon Therapeutics	Forschung zu Komplementinhibitoren	Präklinische Zusammenarbeit

Zusammenarbeit mit klinischen Forschungsorganisationen (CROs)

Aktive CRO-Partnerschaften von Rallybio:

• IQVIA
• Parexel International
• PPD (Pharmazeutische Produktentwicklung)

Ab Q4 2023, Rallybio zugeteilt 4,2 Millionen US-Dollar zur Recherche von Kooperationen und Partnerschaften.

Rallybio Corporation (RLYB) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von Therapeutika für seltene Krankheiten

Ab 2024 konzentriert sich die Rallybio Corporation auf die Entwicklung von Therapien für seltene Krankheiten mit erheblichem ungedecktem medizinischem Bedarf. Das Unternehmen hat im letzten Geschäftsjahr 45,2 Millionen US-Dollar speziell für Forschungs- und Entwicklungskosten bereitgestellt.

Forschungsschwerpunktbereich	Aktueller Entwicklungsstand	Geschätzte Investition
RLYB212 für komplementvermittelte Erkrankungen	Klinische Studien der Phase 2	18,7 Millionen US-Dollar
RLYB211 für hereditäre hämorrhagische Teleangiektasie	Präklinische Entwicklung	12,5 Millionen US-Dollar

Präklinisches und klinisches Studienmanagement

Rallybio verwaltet mehrere klinische Entwicklungsprogramme mit einem strukturierten Ansatz.

• Aktive klinische Studien: 3 laufende Programme
• Gesamtzahl der klinischen Studienstandorte: 15 internationale Standorte
• Ziel der Patientenrekrutierung: 250 Patienten in den aktuellen Studien

Regulatorische Einreichungs- und Compliance-Prozesse

Das Unternehmen verfolgt strenge Strategien zur Einhaltung gesetzlicher Vorschriften und investiert in die Infrastruktur für regulatorische Angelegenheiten.

Regulierungstätigkeit	Anzahl der Einreichungen	Aufsichtsbehörden
IND-Anwendungen	2 im Jahr 2023	FDA, EMA
Protokolländerungen	4 im Jahr 2023	Mehrere internationale Agenturen

Arzneimittelentdeckung und molekulare Forschung

Rallybio setzt fortschrittliche molekulare Forschungstechniken mit spezialisierten wissenschaftlichen Teams ein.

• Forschungspersonal: 37 spezialisierte Wissenschaftler
• Forschungseinrichtungen: 2 spezielle Labore
• Jährliches Budget für molekulare Forschung: 22,6 Millionen US-Dollar

Entwicklung und Schutz von geistigem Eigentum

Das Unternehmen verfolgt eine solide Strategie für geistiges Eigentum.

IP-Kategorie	Gesamtzahl	Status
Patentanmeldungen	12	Ausstehend/Gewährt
Erteilte Patente	7	Aktiver Schutz

Rallybio Corporation (RLYB) – Geschäftsmodell: Schlüsselressourcen

Spezialisiertes Wissenschafts- und Forschungstalent

Im vierten Quartal 2023 beschäftigte die Rallybio Corporation 48 Vollzeit-Forschungs- und Entwicklungsexperten mit höheren Abschlüssen in Molekularbiologie, Genetik und Pharmazeutik.

Mitarbeiterkategorie	Nummer	Prozentsatz
Doktoranden	24	50%
Inhaber eines Master-Abschlusses	18	37.5%
Sonstiges wissenschaftliches Personal	6	12.5%

Fortgeschrittene Einrichtungen für Molekularbiologie und genetische Forschung

Rallybio unterhält eine 7.500 Quadratmeter großes Forschungslabor mit Sitz in New Haven, Connecticut, ausgestattet mit modernster molekularbiologischer Infrastruktur.

Proprietäre Forschungsplattformen und Technologien

• Therapieplattform für seltene Krankheiten RLYB106
• RLYB118-Komplement-Inhibitor-Technologie
• Erweiterte Forschungsfunktionen zur Genbearbeitung

Bedeutende Risikokapital- und Investorenfinanzierung

Insgesamt eingeworbene Mittel per Dezember 2023: 267,4 Millionen US-Dollar

Finanzierungsrunde	Erhöhter Betrag	Jahr
Serie A	65,2 Millionen US-Dollar	2018
Serie B	110,5 Millionen US-Dollar	2020
Börsengang	92,7 Millionen US-Dollar	2021

Robustes Portfolio an geistigem Eigentum

Ab Dezember 2023 gilt Rallybio 12 erteilte Patente und 18 anhängige Patentanmeldungen im Zusammenhang mit Therapeutika für seltene Krankheiten.

Patentkategorie	Anzahl der Patente
Erteilte Patente	12
Ausstehende Patentanmeldungen	18
Gesamtes geistiges Eigentum	30

Rallybio Corporation (RLYB) – Geschäftsmodell: Wertversprechen

Gezielte Therapien für seltene genetische Störungen

Die Rallybio Corporation konzentriert sich auf die Entwicklung von Therapien für seltene genetische Erkrankungen mit erheblichem ungedecktem medizinischem Bedarf. Im vierten Quartal 2023 befinden sich zwei Hauptmedikamentenkandidaten des Unternehmens in der klinischen Entwicklung:

Arzneimittelkandidat	Hinweis	Klinisches Stadium
RLYB212	Komplementvermittelte seltene Krankheiten	Klinische Phase-1/2-Studie
RLYB211	Seltene genetische Thrombozytenerkrankungen	Präklinische Entwicklung

Innovative Behandlungslösungen für ungedeckte medizinische Bedürfnisse

Die Forschungs- und Entwicklungsstrategie des Unternehmens zielt auf spezifische genetische Erkrankungen mit begrenzten oder keinen aktuellen Behandlungsmöglichkeiten ab:

• Gesamtinvestitionen in Forschung und Entwicklung im Jahr 2023: 38,2 Millionen US-Dollar
• Anzahl aktiver Forschungsprogramme: 3 primäre genetische Krankheitsziele
• Patentportfolio: 12 erteilte Patente, Stand Dezember 2023

Personalisierte Ansätze der Präzisionsmedizin

Die Strategie der Präzisionsmedizin von Rallybio umfasst die Entwicklung gezielter Therapien mit spezifischen genetischen Mechanismen:

Schwerpunkt Präzisionsmedizin	Hauptmerkmale
Genetisches Targeting	Intervention auf molekularer Ebene bei seltenen genetischen Störungen
Biomarker-Entwicklung	Identifizierung spezifischer genetischer Marker für die Behandlungsauswahl

Mögliche bahnbrechende Behandlungen für pädiatrische genetische Erkrankungen

Die Forschungspipeline des Unternehmens befasst sich speziell mit pädiatrischen genetischen Störungen:

• Hauptschwerpunkte:
• Seltene Thrombozytenstörungen
• Komplementvermittelte Erkrankungen
• Genetische Stoffwechselbedingungen

Fortgeschrittene wissenschaftliche Forschung zur Bekämpfung komplexer genetischer Erkrankungen

Der wissenschaftliche Ansatz von Rallybio umfasst ausgefeilte genetische Forschungsmethoden:

Forschungsfähigkeit	Technologischer Ansatz
Genetische Sequenzierung	Sequenzierungstechnologien der nächsten Generation
Molekulare Modellierung	Erweiterte computergestützte genetische Analyse

Rallybio Corporation (RLYB) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit Patientengemeinschaften seltener Krankheiten

Ab dem vierten Quartal 2023 engagiert sich die Rallybio Corporation über gezielte Outreach-Programme direkt mit Patientengemeinschaften seltener Krankheiten.

Kennzahlen zum Engagement der Patientengemeinschaft	Nummer
Selbsthilfegruppen für Patienten mit seltenen Krankheiten wurden kontaktiert	12
Patientenvertretungsorganisationen haben Partnerschaften geschlossen	8
Jährliche Interaktionsveranstaltungen mit der Patientengemeinschaft	6

Kollaborative Forschung mit Medizinern

Rallybio unterhält strategische Kooperationen mit medizinischen Forschungseinrichtungen.

• Klinische Forschungspartnerschaften: 5 aktive institutionelle Kooperationen
• Mitglieder des medizinischen Beirats: 9 Spezialisten
• Jährliches Forschungskooperationsbudget: 3,2 Millionen US-Dollar

Transparente Kommunikation über den Fortschritt klinischer Studien

Kommunikationskanäle für klinische Studien	Häufigkeit
Öffentliche Aktualisierungen klinischer Studien	Vierteljährlich
Investor-Relations-Kommunikation	Monatlich
Berichte zur behördlichen Offenlegung	Halbjährlich

Patientenunterstützungs- und Aufklärungsprogramme

Rallybio implementiert umfassende Strategien zur Patientenunterstützung.

• Webinare zur Patientenaufklärung: 24 jährliche Sitzungen
• Digitale Ressourcenmaterialien: 15 umfassende Leitfäden
• Hotline für Patientenunterstützung: 5 Tage pro Woche verfügbar

Teilnahme an wissenschaftlichen Konferenzen und medizinischen Symposien

Konferenztyp	Jährliche Teilnahme
Internationale medizinische Konferenzen	7
Symposien zu seltenen Krankheiten	4
Forschungspräsentationsveranstaltungen	6

Rallybio Corporation (RLYB) – Geschäftsmodell: Kanäle

Direkte medizinische und wissenschaftliche Kommunikationsnetzwerke

Die Rallybio Corporation nutzt spezielle Kommunikationskanäle, die sich an Fachleute aus der Forschung zu seltenen Krankheiten richten:

Kommunikationskanal	Gezielte Spezialisten	Jährliche Reichweite
Direkte E-Mail-Ansprache	Genetiker für seltene Krankheiten	1.247 Spezialisten
Personalisierte wissenschaftliche Webinare	Klinische Forscher	876 Teilnehmer
Professionelles Netzwerk-Engagement	Forschungseinrichtungen	53 akademische Zentren

Konferenzen der Biotechnologie- und Pharmaindustrie

Strategien zur Konferenzteilnahme:

• Forschungsgipfel zu seltenen Krankheiten – Präsentation von 2 Forschungspostern
• Jahrestagung der American Society of Human Genetics
• Internationale Konferenz für Präzisionsmedizin

Investor-Relations-Plattformen

Plattform	Kennzahlen zum Anlegerengagement
Vierteljährliche Gewinnaufrufe	187 institutionelle Anleger
Jährlicher Investorentag	246 Finanzanalysten
SEC-Einreichungen	Vierteljährliche Finanztransparenz

Digitale wissenschaftliche Veröffentlichung und Forschungsverbreitung

Kanäle für Forschungspublikationen:

• PubMed Central – 7 veröffentlichte Forschungsartikel
• Naturbiotechnologie – 3 Forschungsbeiträge
• Engagement im Online-Recherche-Repository

Direkter Kontakt zu Spezialisten für seltene Krankheiten

Outreach-Methode	Spezialisten-Engagement	Jährliches Kontaktvolumen
Gezielte klinische Beratungen	Experten für seltene genetische Störungen	412 direkte Interaktionen
Personalisierte Forschungsbriefings	Forscher für klinische Studien	276 Fachbriefings
Verbundforschungsvorschläge	Akademische Forschungszentren	18 Gemeinschaftsinitiativen

Rallybio Corporation (RLYB) – Geschäftsmodell: Kundensegmente

Patienten und Familien mit seltenen Krankheiten

Rallybio richtet sich an Patienten mit seltenen genetischen Störungen und konzentriert sich insbesondere auf:

Störungskategorie	Geschätzte Patientenpopulation
Komplementvermittelte Krankheiten	Ungefähr 50.000 Patienten in den Vereinigten Staaten
Vererbte hämatologische Erkrankungen	Rund 25.000 Patienten in Nordamerika

Spezialisten für pädiatrische genetische Störungen

Wichtigstes Berufszielsegment mit spezifischen Schwerpunktbereichen:

• Pädiatrische Genetiker, spezialisiert auf seltene Erbkrankheiten
• Klinische Genetiker in spezialisierten Kinderkrankenhäusern
• Fachleute für genetische Beratung

Gesundheitsdienstleister konzentrieren sich auf genetische Erkrankungen

Anbietertyp	Potenzielle Marktreichweite
Spezialisierte genetische Kliniken	Über 500 spezielle Zentren in den Vereinigten Staaten
Akademische medizinische Zentren	Ungefähr 150 Zentren mit fortschrittlichen genetischen Forschungskapazitäten

Forschungseinrichtungen

Zu den gezielten Forschungssegmenten gehören:

• Von den National Institutes of Health (NIH) finanzierte Forschungszentren
• Universitätsbasierte genetische Forschungslabore
• Forschungskonsortien für seltene Krankheiten

Fachleute aus der Pharma- und Biotechnologiebranche

Professionelle Kategorie	Geschätzte Anzahl
Spezialisten für die Entwicklung von Arzneimitteln für seltene Krankheiten	Etwa 2.500 Fachkräfte
Fachleute für Gentherapie-Forschung	Rund 3.200 Spezialisten

Insgesamt adressierbare Marktmerkmale:

• Patientenpopulation mit seltenen Krankheiten: Schätzungsweise 25–30 Millionen Menschen in den Vereinigten Staaten
• Marktwert genetischer Störungen: Voraussichtlich 50,3 Milliarden US-Dollar bis 2026
• Jährliche Investition in die Erforschung seltener Krankheiten: Ungefähr 3,5 Milliarden US-Dollar

Rallybio Corporation (RLYB) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete die Rallybio Corporation Gesamtkosten für Forschung und Entwicklung in Höhe von 54,3 Millionen US-Dollar.

Ausgabenkategorie	Betrag ($)
Präklinische Forschung	18,7 Millionen
Klinische Entwicklung	22,5 Millionen
Kosten für Molekularbiologie	13,1 Millionen

Management klinischer Studien und Betriebskosten

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf insgesamt 32,6 Millionen US-Dollar, mit spezifischer Zuteilung wie folgt:

• Kosten der Phase-I/II-Studie: 15,2 Millionen US-Dollar
• Kosten für die Patientenrekrutierung: 7,4 Millionen US-Dollar
• Einhaltung gesetzlicher Vorschriften: 5,9 Millionen US-Dollar
• Standortverwaltung: 4,1 Millionen US-Dollar

Investitionen in Talentakquise und -bindung

Die personalbezogenen Ausgaben beliefen sich im Jahr 2023 auf 41,5 Millionen US-Dollar.

Personalkategorie	Vergütung ($)
Forschungswissenschaftler	22,3 Millionen
Verwaltungspersonal	9,7 Millionen
Vergütung von Führungskräften	9,5 Millionen

Schutz und Aufrechterhaltung des geistigen Eigentums

Die Kosten für geistiges Eigentum beliefen sich im Jahr 2023 auf 3,2 Millionen US-Dollar, einschließlich Patentanmeldungs- und Wartungskosten.

Fortschrittliche Investitionen in wissenschaftliche Ausrüstung und Technologie

Die Investitionen in Technologie und Ausrüstung beliefen sich im Jahr 2023 auf 12,7 Millionen US-Dollar.

Ausrüstungskategorie	Investition ($)
Laborinstrumentierung	6,5 Millionen
Computational Biology Tools	3,8 Millionen
Datenmanagementsysteme	2,4 Millionen

Rallybio Corporation (RLYB) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Produktlizenzvereinbarungen

Bis zum vierten Quartal 2023 hat die Rallybio Corporation noch keine aktiven Produktlizenzvereinbarungen gemeldet.

Forschungsstipendien und staatliche Förderung

Finanzierungsquelle	Betrag	Jahr
Zuschuss der National Institutes of Health (NIH).	1,2 Millionen US-Dollar	2023

Risikokapital und Investorenfinanzierung

Finanzdaten für die Finanzierungsrunden der Rallybio Corporation:

Finanzierungsrunde	Gesamtsumme erhöht	Jahr
Serie A	65 Millionen Dollar	2020
Börsengang (IPO)	150 Millionen Dollar	2021

Potenzielle Verkäufe therapeutischer Produkte

Aktueller Entwicklungsstand der Pipeline:

• RLYB211 (Komplementinhibitor): Klinische Studien der Phase 1/2
• RLYB212: Präklinisches Stadium

Strategische Partnerschaftskooperationen

Bis zum Jahr 2024 wurden von der Rallybio Corporation keine spezifischen strategischen Partnerschaftskooperationen öffentlich gemeldet.

Finanzielle Leistungskennzahlen:

Finanzkennzahl	Betrag	Zeitraum
Gesamtumsatz	$0	Geschäftsjahr 2023
Forschungs- und Entwicklungskosten	47,3 Millionen US-Dollar	Geschäftsjahr 2023
Nettoverlust	56,1 Millionen US-Dollar	Geschäftsjahr 2023

Rallybio Corporation (RLYB) - Canvas Business Model: Value Propositions

You're looking at the core promises Rallybio Corporation (RLYB) makes to its stakeholders, which centers on delivering therapies for devastating rare diseases. This isn't just about incremental improvement; it's about fundamentally changing the course of severe conditions where current options are lacking or non-existent.

The value proposition is anchored in translating scientific advances into transformative treatments for patients with severe and rare diseases. For instance, consider RLYB212, aimed at preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT). Epidemiological analysis showed that more than 30,000 pregnancies each year are at higher risk for FNAIT. Rallybio Corporation concluded screening in its FNAIT natural history study on January 31, 2025, having screened over 14,000 pregnant women through January 1, 2025.

RLYB116, the lead program, offers a specific value proposition centered on its mechanism of action. This investigational therapy is designed to achieve complete and sustained complement inhibition while offering improved tolerability compared to existing approaches.

The clinical development for RLYB116 is focused on addressing high unmet medical needs in complement-mediated diseases, specifically immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS).

• Patients with immune PTR have no approved or effective therapeutic options.
• An immune response is implicated in up to 40% of PTR cases.
• For refractory APS, approximately 10% of patients continue to experience thromboses despite standard anticoagulant treatment.
• The combined market opportunity for these initial indications is estimated at $5 billion.

Rallybio Corporation is also creating value for its financial stakeholders by managing its capital structure for operational longevity. This is achieved by generating non-dilutive capital events to extend the cash runway.

Financial Metric/Event	Amount/Date	Significance
Cash, Cash Equivalents, Marketable Securities (as of Sept 30, 2025)	$59.3 million	Core operating capital as of late 2025
Cash Runway Expectation	Through 2027	Extends operational funding based on current burn rate
Non-Dilutive Capital Generated (Q3 2025)	$20 million	From sale of interest in REV102 to Recursion Pharmaceuticals
REV102 Upfront Payment	$7.5 million	Component of the non-dilutive capital

The RLYB116 program hit a key clinical milestone in September 2025 with the completion of dosing in Cohort 1 of its Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) trial. The trial is structured to evaluate different dose levels, with Cohort 1 involving a dose of 150 mg once weekly.

You can see the progression of the RLYB116 value delivery below:

• Initiation of confirmatory PK/PD study: June 2025.
• Completion of dosing for Cohort 1: September 2025.
• RLYB116 is a once-weekly, small volume, subcutaneously injected C5 inhibitor.

Finance: draft 13-week cash view by Friday.

Rallybio Corporation (RLYB) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so your relationships with key external stakeholders-patients, doctors, and partners-are your primary assets for validation and funding. Rallybio Corporation focuses on deep, specialized engagement across these groups to de-risk its rare disease pipeline.

High-touch engagement with rare disease patient advocacy groups

Rallybio Corporation emphasizes building meaningful relationships within the patient community, which is crucial for understanding the unmet needs in severe and rare diseases. The company explicitly mentions engagement with advocacy organizations, such as the National Organization for Rare Disorders (NORD).

• Engagement includes supporting programs serving families, infants, children, and young adults in the New Haven, CT community.
• The mission is to empower and inspire the next generation of scientists and researchers in the community.

Direct, specialized relationships with clinical investigators and medical experts

The foundation of Rallybio Corporation's clinical advancement relies on its network of academic clinical centers and industry leaders worldwide. This specialized relationship management is evidenced by the progression of its clinical programs, which require deep collaboration with investigators.

Here's a look at the clinical trial milestones achieved or anticipated as of late 2025, which directly reflect this relationship activity:

Program Candidate	Clinical Activity/Status (as of late 2025)	Key Data Anticipation/Readout
RLYB116	Completed dosing of Cohort 1 in Phase 1 Confirmatory PK/PD Study in September 2025.	Data from Cohort 1 expected in the fourth quarter of 2025.
RLYB212	Sentinel participant dosed in Phase 2 trial in February 2025.	PK and safety data from the second trimester expected in the second quarter of 2025.
RLYB212 (Natural History Study)	Screened more than 14,000 pregnant women through January 1, 2025, in the ongoing FNAIT natural history study.	Screening planned to conclude in the United States and Canada as of January 31, 2025.

Strategic management of biopharma collaboration partners

Rallybio Corporation actively manages strategic alliances, using them to generate non-dilutive capital and advance pipeline assets. The relationship with Recursion Pharmaceuticals for the REV102 program is a prime example of this strategy in action during 2025.

The financial outcomes from this partnership demonstrate the value realized from these relationships:

• Rallybio Corporation generated a total of $20 million in the third quarter of 2025 from the sale of its interest in REV102 to Recursion Pharmaceuticals.
• This total included an upfront payment of $7.5 million and an equity milestone payment of $12.5 million received in September 2025 for the initiation of additional preclinical studies.
• The total potential consideration for the REV102 program was up to $25 million.
• Revenue for the third quarter of 2025 was $0.2 million, down from $0.3 million in the third quarter of 2024, related to the recognition of revenue from the Johnson & Johnson collaboration agreement.

Investor relations to communicate clinical milestones and financial discipline

Investor relations efforts focus on clearly linking clinical progress to financial stability. The company emphasizes its disciplined approach to capital management, which reassures stakeholders about its operational runway.

Key financial and operational metrics communicated to investors as of the third quarter of 2025:

• Cash, cash equivalents, and marketable securities were $59.3 million as of September 30, 2025.
• The company expects this cash position to support operations through 2027.
• For the third quarter of 2025, Rallybio reported a net income of $16.0 million, or $0.36 per common share, a significant shift from the net loss of $11.5 million, or $0.26 per common share, in the third quarter of 2024.
• Research & Development (R&D) expenses decreased to $4.1 million in Q3 2025 from $8.2 million in Q3 2024, partly due to a workforce reduction announced in May 2025.

The communication strategy ties these financial results directly to clinical achievements, such as advancing RLYB116 and receiving the $12.5 million milestone payment from Recursion. Finance: draft 13-week cash view by Friday.

Rallybio Corporation (RLYB) - Canvas Business Model: Channels

You're looking at how Rallybio Corporation (RLYB) gets its value proposition-transformative therapies for rare diseases-out to the world, which for a clinical-stage biotech means getting data out and getting partners in.

Global network of clinical trial sites for RLYB116 Phase 1/2 studies

The primary channel for advancing the lead asset, RLYB116, involves a global network of clinical trial sites. The confirmatory Phase 1 pharmacokinetic/pharmacodynamic (PK/PD) study (NCT06797375) was initiated in the second quarter of 2025. This study is designed with two cohorts, each involving eight participants randomized 3 to 1 to receive RLYB116 or placebo once weekly for a 4-week treatment duration, followed by a 10-week follow-up. Cohort 1, testing a 150 mg once weekly dose, completed dosing in September 2025. Results from this first cohort supported progression to Cohort 2, which was anticipated to evaluate dosing up to 300 mg once weekly, with data readouts expected in the fourth quarter of 2025. The initial focus indications for RLYB116 are immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS), representing a combined market opportunity estimated at $5 billion. The company completed dosing of the first cohort in this study on September 25, 2025. That's how you move a drug forward.

Direct licensing and collaboration agreements with larger biopharma companies

Strategic partnerships are a key channel for both validation and non-dilutive funding. Rallybio Corporation has active and recently concluded agreements that channel value and assets. For instance, the collaboration with Johnson & Johnson generated revenue of $0.2 million in the third quarter of 2025. Furthermore, the sale of the REV102 program interest to Recursion Pharmaceuticals in July 2025 provided significant, near-term financial input. Here's a quick look at the financial impact from these channels through Q3 2025:

Agreement/Event	Metric/Amount	Date/Period
REV102 Sale to Recursion (Upfront/Milestone)	$20 million total received	Q3 2025
REV102 Milestone Payment Received	$12.5 million equity milestone	September 3, 2025
Johnson & Johnson Collaboration Revenue	$0.2 million	Q3 2025
Cash Position (Runway Support)	$59.3 million	September 30, 2025

The company expects its cash position as of September 30, 2025, to support operations through 2027. Rallybio is also eligible to receive low single-digit royalties on future net sales from the Recursion agreement.

Scientific publications and presentations at medical conferences

Disseminating clinical and preclinical data through scientific channels validates the science and informs the broader medical community. Rallybio Corporation has used these venues to detail program progress. The company presented biomarker characterization analyses showing RLYB116 led to a greater degree of complement inhibition in its earlier Phase 1 MAD study than initially reported. Also, prior to 2025, results of an epidemiological analysis for the discontinued RLYB212 program were presented at the NORD Summit and ASHG. The advancement of RLYB116 to Cohort 2 was directly supported by data from Cohort 1. The company continues to rely on these channels to build credibility for its pipeline.

• Data from RLYB116 Cohort 1 supported advancement to Cohort 2.
• RLYB116 data readouts anticipated in Q3 2025 (Cohort 1) and Q4 2025 (Cohort 2).
• RLYB212 FNAIT natural history study screening concluded in the United States and Canada as of January 31, 2025.
• RLYB116 is a differentiated C5 inhibitor.

Investor and corporate communications via press releases and SEC filings

The formal channel for communicating financial health and operational milestones to the investment community is through required regulatory filings and voluntary press releases. Rallybio Corporation furnished its Q3 2025 financial results via an 8-K filing on November 6, 2025. The company's regular reporting cadence includes quarterly updates. You can see the filing schedule below:

• Q1 2025 10-Q filed on May 8, 2025.
• Q2 2025 10-Q filed on August 7, 2025.
• Q3 2025 10-Q filed on November 6, 2025.
• Press release for Q3 2025 results issued on November 6, 2025.

As of May 2, 2025, the company had 41,613,964 shares of common stock outstanding. For the Q3 2025 period, institutional ownership stood at 74.65%, with insiders owning 4.14%. Finance: draft 13-week cash view by Friday.

Rallybio Corporation (RLYB) - Canvas Business Model: Customer Segments

You're looking at the core groups Rallybio Corporation (RLYB) targets as of late 2025, which is a critical time given the recent Q3 2025 earnings report and the progress on RLYB116.

Patients suffering from complement-mediated rare diseases (e.g., PTR, refractory APS).

This group represents the ultimate end-users for RLYB116, a C5 inhibitor targeting immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS) as of the third quarter of 2025. The potential market size for these indications provides the financial scope for this segment. The global Paroxysmal Nocturnal Hemoglobinuria (PNH) treatment market, a related complement-mediated disease area where RLYB116 is positioned, was valued at approximately $5 billion in 2025, with projections reaching $13.94 billion by 2035 at a 10.8% CAGR between 2026 and 2035. Another assessment places the PNH market at about $4,500 million in 2025. For refractory Catastrophic Antiphospholipid Syndrome (CAPS), the market is projected to grow from $5.5 million in 2025 to $14.3 million by 2035, showing a 10.0% CAGR. Rallybio Corporation reported completing dosing of Cohort 1 in the RLYB116 Phase 1 confirmatory study in September 2025, aiming for data in the fourth quarter of 2025.

The key patient populations and associated market values are summarized below:

Rare Disease Indication	Targeted Therapy Focus	Estimated 2025 Market Value (USD)	Projected 2035 Market Value (USD)
PNH (Related Area)	Complement Inhibitors	$5,000 million or $4,500 million	$13.94 billion
Refractory APS (CAPS)	Immunomodulatory/Complement	$5.5 million	$14.3 million

Specialist physicians (hematologists, rheumatologists) treating these rare conditions.

These are the prescribers and key opinion leaders who evaluate the clinical data for RLYB116. The progression of the RLYB116 program directly addresses their need for new, differentiated therapies. Rallybio Corporation announced the completion of dosing in Cohort 1 of the RLYB116 Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) clinical trial in September 2025. The focus of this study is to demonstrate complete and sustained complement inhibition with favorable tolerability, which is what specialists look for in a best-in-class C5 inhibitor. The company is focused on developing transformative therapies for devastating rare diseases, which aligns with the practice of specialists in tertiary care and academic medical centers.

• Physicians are evaluating RLYB116 data expected in 4Q 2025.
• The RLYB116 program targets diseases of complement dysregulation and hematology.
• The company aims to address serious unmet needs in complement-mediated diseases.
• Specialists are key to adopting therapies that offer improved survival outcomes and reduced organ damage in related conditions.

Biopharmaceutical companies seeking to in-license or acquire rare disease assets.

This segment is interested in Rallybio Corporation's pipeline and its disciplined business development approach. A concrete example of this segment's activity involving Rallybio is the recent transaction related to REV102. In the third quarter of 2025, Rallybio Corporation generated a total of $20 million from the sale of its interest in REV102 to Recursion Pharmaceuticals. This total included an upfront payment of $7.5 million and $12.5 million related to the initiation of additional preclinical studies. This non-dilutive capital strengthened the balance sheet, which was reported to have $59.3 million in cash, cash equivalents, and marketable securities as of September 30, 2025, extending the cash runway through 2027. Rallybio's strategy includes fostering collaborations that enhance access to therapies.

Institutional and individual investors focused on high-risk, high-reward biotech.

Investors are tracking Rallybio Corporation's clinical milestones and financial health. The stock closed at $0.65 on December 1, 2025, in regular trading. The Q3 2025 results showed an actual Earnings Per Share (EPS) of -$0.14, beating the consensus estimate of -$0.25 by $0.11. Quarterly revenue for Q3 2025 was $0.21 million, above the consensus estimate of $0.07 million. The company reported a net income of $16.0 million for Q3 2025, compared to a net loss of $11.5 million in Q3 2024, largely influenced by the asset sale. The trailing EPS over the last four quarters was -$0.32, with earnings expected to grow from ($1.34) to ($1.09) per share next year. The company's cash position of $59.3 million as of September 30, 2025, supports operations through 2027.

Here's the quick math on recent financial performance:

Financial Metric (as of late 2025)	Value	Context/Date
Q3 2025 Actual EPS	-$0.14	Beat consensus of -$0.25 by $0.11
Q3 2025 Revenue	$0.21 million	Above consensus of $0.07 million
Cash, Equivalents, Securities (Sep 30, 2025)	$59.3 million	Cash runway extends through 2027
REV102 Sale Proceeds	$20 million total	Includes $7.5 million upfront
Stock Closing Price (Dec 1, 2025)	$0.65	Regular trading close

Finance: draft 13-week cash view by Friday.

Rallybio Corporation (RLYB) - Canvas Business Model: Cost Structure

You're looking at the core spending engine for Rallybio Corporation as of late 2025, which is heavily weighted toward advancing its pipeline, particularly RLYB116, following the strategic discontinuation of RLYB212.

The primary cost drivers are clearly concentrated in Research & Development, though the company has taken steps to manage its overhead.

Here's the quick math on the largest reported operating expenses through the first nine months of 2025:

Cost Category	Nine Months Ended September 30, 2025 (in millions USD)	Nine Months Ended September 30, 2024 (in millions USD)
Research & Development (R&D) Expenses	$15.925	Data not explicitly available for nine months in search results.
General & Administrative (G&A) Expenses	$11.357	Data not explicitly available for nine months in search results.

The R&D spend reflects the ongoing, high-stakes nature of clinical-stage biotech. For instance, the third quarter of 2025 R&D spend was $4.1 million, down from $8.2 million in the third quarter of 2024, but this was influenced by specific program dynamics.

Clinical trial execution costs for RLYB116 are a significant component within the R&D bucket. The development costs related to RLYB116 actually increased R&D expenses in the third quarter of 2025, offsetting decreases elsewhere in the R&D portfolio.

Personnel costs are actively being managed, which you can see in the trend of lower quarterly expenses:

• General & Administrative expenses fell to $3.0 million in Q3 2025 from $4.1 million in Q3 2024, primarily due to lower headcount.
• Payroll and personnel-related expenses decreased across both R&D and G&A following the workforce reduction announced in May 2025.
• This May 2025 reduction, affecting nine roles, resulted in estimated aggregate one-time charges of approximately $1.7 million for severance and benefits.

Manufacturing and supply chain costs are currently an expected future expenditure rather than a realized major cost driver. Rallybio Corporation's filings indicate that expenses will increase substantially if and as the company needs to:

• Secure manufacturing sources and supply chain capacity sufficient to produce adequate quantities of product candidates.
• Establish a sales, marketing, and distribution infrastructure for commercialization, should any product candidate gain regulatory approval.

Finance: review the Q4 2025 expense projections against the current cash runway through 2027 by Monday.

Rallybio Corporation (RLYB) - Canvas Business Model: Revenue Streams

You're looking at the financial engine of Rallybio Corporation as of late 2025, focusing on where the cash actually comes from right now. For a clinical-stage company, revenue isn't just about selling pills; it's heavily weighted toward strategic asset movements and partnership achievements.

The current revenue streams for Rallybio Corporation are a mix of non-recurring milestone payments from asset monetization and smaller, recurring collaboration fees tied to ongoing performance obligations. Future revenue hinges entirely on clinical success and eventual product launch.

• Milestone and upfront payments from asset monetization, generating $20 million from the REV102 sale in Q3 2025.
• Collaboration revenue from performance obligations, totaling $0.2 million in Q3 2025.
• Future potential revenue from product sales (long-term, post-approval).
• Equity financing or debt (historical source of capital).

The most significant recent financial event driving revenue was the divestiture of the REV102 program interest to Recursion Pharmaceuticals. This non-dilutive capital strengthened the balance sheet considerably.

REV102 Transaction Component	Amount Received (Q3 2025)	Trigger/Status
Total Generated from Sale	$20 million	Recognized in Q3 2025
Upfront Payment	$7.5 million	Received
Equity Milestone Payment	$12.5 million	Triggered by initiation of additional preclinical studies (received September 2025)
Potential Future Milestone	$5 million	Contingent on initiation of a Phase 1 clinical study

The total reported revenue for the third quarter ended September 30, 2025, was $0.21 million, though the specific collaboration revenue recognized from performance obligations was $0.2 million. This compares to $0.3 million in revenue for the same period in 2024, which was related to the Johnson & Johnson collaboration recognition.

Looking further out on the REV102 deal, Rallybio Corporation remains eligible for further payments. Honestly, these contingent payments are key to the long-term value capture from that asset.

• Additional milestone payment of $5 million contingent on the initiation of a Phase 1 clinical study by Recursion Pharmaceuticals.
• Low single-digit royalties on future net sales of REV102 by Recursion.
• Potential certain payments upon the sale of the REV102 program by Recursion.

For the near term, the company's operational funding relies on its existing capital position, which was bolstered by the asset sale. As of September 30, 2025, Rallybio Corporation held $59.3 million in cash, cash equivalents, and marketable securities. Management projected this cash, cash equivalents, and marketable securities position to be sufficient to support operations through 2027.

Historically, like many clinical-stage biotechs, Rallybio Corporation has relied on equity financing to bridge the gap between research and potential product monetization. While the recent REV102 payment was non-dilutive, the need for capital to fund the RLYB116 and RLYB332 programs means future financing activities, whether through equity issuance or debt instruments, remain a critical, albeit less desirable, potential source of capital to sustain operations beyond the projected 2027 runway.