Rallybio Corporation (RLYB): Canvas du modèle d'entreprise [Jan-2025 Mise à jour]

Dans le paysage de pointe de la biotechnologie, Rallybio Corporation apparaît comme une force pionnière, naviguant stratégiquement sur le terrain complexe des troubles génétiques rares avec une innovation scientifique inégalée. En fabriquant méticuleusement un modèle commercial qui pose des recherches révolutionnaires, des approches centrées sur le patient et des solutions thérapeutiques transformatrices, Rallybio est à l'avant-garde de la médecine de précision personnalisée. Leur toile complète du modèle commercial révèle un écosystème sophistiqué conçu pour répondre aux besoins médicaux critiques non satisfaits, tirant parti de la recherche moléculaire avancée, des partenariats stratégiques et un engagement profond à développer des traitements révolutionnaires pour les patients souffrant de conditions génétiques rares.

Rallybio Corporation (RLYB) - Modèle d'entreprise: partenariats clés

Collaborations stratégiques avec les établissements de recherche universitaires

Rallybio Corporation a établi des partenariats de recherche avec les établissements universitaires suivants:

Institution	Focus de recherche	Statut de collaboration
Université de Yale	Troubles génétiques rares	Partenariat actif
Université de Pennsylvanie	Maladies médiées par le complément	Collaboration de recherche en cours

Partenariats avec des groupes de défense des patients atteints de maladies rares

Rallybio entretient des relations stratégiques avec les organisations de défense des patients:

• Gènes mondiaux
• Organisation nationale pour les troubles rares (NORD)
• Alliance génétique

Développement pharmaceutique et accords de licence

Partenariats actuels de développement pharmaceutique:

Partenaire	Drogue	Étape de développement
Complément pharmaceutique	Rlyb211	Essais cliniques de phase 1/2
Horizon Therapeutics	Recherche d'inhibiteur du complément	Collaboration préclinique

Collaboration avec les organisations de recherche clinique (CRO)

Partenariats CRO actifs de Rallybio:

• Iqvia
• Parexel International
• PPD (développement de produits pharmaceutiques)

Depuis le Q4 2023, Rallybio est alloué 4,2 millions de dollars pour rechercher des collaborations et des partenariats.

Rallybio Corporation (RLYB) - Modèle d'entreprise: activités clés

Recherche et développement de thérapies rares

En 2024, Rallybio Corporation se concentre sur le développement de thérapies pour des maladies rares avec des besoins médicaux non satisfaits importants. La société a alloué 45,2 millions de dollars spécifiquement pour les frais de recherche et de développement au cours de son exercice le plus récent.

Domaine de mise au point de recherche	Étape de développement actuelle	Investissement estimé
RLYB212 pour les maladies médiées par le complément	Essais cliniques de phase 2	18,7 millions de dollars
Rlyb211 pour la télangiectasie hémorragique héréditaire	Développement préclinique	12,5 millions de dollars

Gestion des essais précliniques et cliniques

Rallybio gère plusieurs programmes de développement clinique avec une approche structurée.

• Essais cliniques actifs: 3 programmes en cours
• Sites totaux d'essais cliniques: 15 emplacements internationaux
• Patient Inscription Cobile: 250 patients dans les essais actuels

Processus de soumission et de conformité réglementaires

La Société maintient des stratégies de conformité réglementaire rigoureuses avec les investissements dans les infrastructures des affaires réglementaires.

Activité réglementaire	Nombre de soumissions	Organismes de réglementation
Applications IND	2 en 2023	FDA, EMA
Modifications du protocole	4 en 2023	Plusieurs agences internationales

Découverte de médicaments et recherche moléculaire

Rallybio utilise des techniques de recherche moléculaire avancées avec des équipes scientifiques spécialisées.

• Personnel de recherche: 37 scientifiques spécialisés
• Installations de recherche: 2 laboratoires dédiés
• Budget annuel de recherche moléculaire: 22,6 millions de dollars

Développement et protection de la propriété intellectuelle

La société maintient une solide stratégie de propriété intellectuelle.

Catégorie IP	Nombre total	Statut
Demandes de brevet	12	En attente
Brevets accordés	7	Protection active

Rallybio Corporation (RLYB) - Modèle d'entreprise: Ressources clés

Talent scientifique et de recherche spécialisés

Depuis le quatrième trimestre 2023, Rallybio Corporation a employé 48 professionnels de la recherche et du développement à temps plein titulaires de diplômes avancés en biologie moléculaire, génétique et sciences pharmaceutiques.

Catégorie des employés	Nombre	Pourcentage
Chercheurs de doctorat	24	50%
Titulaires de maîtrise	18	37.5%
Autre personnel scientifique	6	12.5%

Installations avancées de biologie moléculaire et de recherche génétique

Rallybio maintient un Laboratoire de recherche sur 7500 pieds carrés Situé à New Haven, Connecticut, équipé d'une infrastructure de biologie moléculaire de pointe.

Plateformes et technologies de recherche propriétaires

• RYB106 Plateforme thérapeutique de maladies rares
• RYB118 Complément Inhibiteur Technologie
• Capacités de recherche de modification des gènes avancés

Capital de capital-risque important et financement des investisseurs

Financement total collecté en décembre 2023: 267,4 millions de dollars

Ronde de financement	Montant recueilli	Année
Série A	65,2 millions de dollars	2018
Série B	110,5 millions de dollars	2020
Introduction en bourse	92,7 millions de dollars	2021

Portfolio de propriété intellectuelle robuste

En décembre 2023, Rallybio détient 12 brevets accordés et 18 demandes de brevet en instance lié à la thérapeutique des maladies rares.

Catégorie de brevet	Nombre de brevets
Brevets accordés	12
Demandes de brevet en instance	18
Actifs totaux de propriété intellectuelle	30

Rallybio Corporation (RLYB) - Modèle d'entreprise: propositions de valeur

Thérapies ciblées pour les troubles génétiques rares

Rallybio Corporation se concentre sur le développement de thérapies pour des troubles génétiques rares ayant des besoins médicaux non satisfaits importants. Au quatrième trimestre 2023, la société compte deux principaux candidats au médicament en développement clinique:

Drogue	Indication	Étape clinique
Rlyb212	Maladies rares médiées par le complément	Essai clinique de phase 1/2
Rlyb211	Rare troubles des plaquettes génétiques	Développement préclinique

Solutions de traitement innovantes pour les besoins médicaux non satisfaits

La stratégie de recherche et de développement de l'entreprise cible des conditions génétiques spécifiques avec des options de traitement actuelles ou non actuelles:

• Investissement total de R&D en 2023: 38,2 millions de dollars
• Nombre de programmes de recherche actifs: 3 cibles de la maladie génétique primaire
• Portefeuille de brevets: 12 Brevets accordés en décembre 2023

Approches de médecine de précision personnalisée

La stratégie de médecine de précision de Rallybio consiste à développer des thérapies ciblées avec des mécanismes génétiques spécifiques:

Focus de la médecine de précision	Caractéristiques clés
Ciblage génétique	Intervention au niveau moléculaire dans des troubles génétiques rares
Développement de biomarqueurs	Identifier des marqueurs génétiques spécifiques pour la sélection du traitement

Traitements de percée potentielles pour les conditions génétiques pédiatriques

Le pipeline de recherche de l'entreprise aborde spécifiquement les troubles génétiques pédiatriques:

• Domaines d'intervention primaire:
• Troubles plaquettaires rares
• Maladies médiées par le complément
• Conditions métaboliques génétiques

Recherche scientifique avancée ciblant les maladies génétiques complexes

L'approche scientifique de Rallybio implique des méthodologies de recherche génétique sophistiquées:

Capacité de recherche	Approche technologique
Séquençage génétique	Technologies de séquençage de nouvelle génération
Modélisation moléculaire	Analyse génétique de calcul avancée

Rallybio Corporation (RLYB) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les communautés de patients atteints de maladies rares

Depuis le quatrième trimestre 2023, Rallybio Corporation s'engage directement avec les communautés de patients atteints de maladies rares grâce à des programmes de sensibilisation ciblés.

Métriques d'engagement communautaire des patients	Nombre
Groupes de soutien aux patients atteints de maladies rares contactées	12
Organisations de défense des patients en partenariat	8
Événements d'interaction de la communauté des patients annuels	6

Recherche collaborative avec des professionnels de la santé

Rallybio maintient des collaborations stratégiques avec des établissements de recherche médicale.

• Partenariats de recherche clinique: 5 collaborations institutionnelles actives
• Medical Advisory Board Membres: 9 spécialistes
• Budget de collaboration de recherche annuelle: 3,2 millions de dollars

Communication transparente sur les progrès des essais cliniques

Canaux de communication des essais cliniques	Fréquence
Mises à jour des essais cliniques publics	Trimestriel
Communications des relations avec les investisseurs	Mensuel
Rapports de divulgation réglementaire	Bi-annuellement

Programmes de soutien aux patients et d'éducation

Rallybio met en œuvre des stratégies complètes de soutien aux patients.

• Webinaires de l'éducation des patients: 24 séances annuelles
• Matériaux de ressources numériques: 15 guides complets
• Aide à l'aide des patients: disponible 5 jours par semaine

Conférence scientifique et participation du symposium médical

Type de conférence	Participation annuelle
Conférences médicales internationales	7
Symposiums de maladies rares	4
Événements de présentation de recherche	6

Rallybio Corporation (RLYB) - Modèle d'entreprise: canaux

Réseaux de communication médicale et scientifique directes

Rallybio Corporation utilise des canaux de communication spécialisés ciblant les professionnels de la recherche de maladies rares:

Canal de communication	Spécialistes ciblés	Portée annuelle
Disposition directe de la sensibilisation par e-mail	Généticiens de maladies rares	1 247 spécialistes
Webinaires scientifiques personnalisés	Chercheurs en clinique	876 participants
Engagement de réseau professionnel	Institutions de recherche	53 centres universitaires

Conférences de la biotechnologie et de l'industrie pharmaceutique

Stratégies de participation à la conférence:

• Sommet de recherche sur les maladies rares - Présentation de 2 affiches de recherche
• Réunion annuelle annuelle de l'American Society of Human Genetics
• Conférence internationale de médecine de précision

Plateformes de relations avec les investisseurs

Plate-forme	Métriques d'engagement des investisseurs
Appels de résultats trimestriels	187 investisseurs institutionnels
Journée annuelle des investisseurs	246 analystes financiers
Dépôts de la SEC	Transparence financière trimestrielle

Publication scientifique numérique et diffusion de la recherche

Recherchez des canaux de publication:

• PubMed Central - 7 articles de recherche publiés
• Biotechnologie de la nature - 3 soumissions de recherche
• Engagement du référentiel de recherche en ligne

La sensibilisation directe vers des spécialistes de maladies rares

Méthode de sensibilisation	Engagement spécialisé	Volume de contact annuel
Consultations cliniques ciblées	Experts en troubles génétiques rares	412 interactions directes
Briefings de recherche personnalisés	Enquêteurs d'essais cliniques	276 briefings spécialisés
Propositions de recherche collaborative	Centres de recherche universitaires	18 initiatives de collaboration

Rallybio Corporation (RLYB) - Modèle d'entreprise: segments de clientèle

Patients et familles de maladies rares

Rallybio cible les patients souffrant de troubles génétiques rares, en se concentrant spécifiquement sur:

Catégorie de troubles	Population estimée des patients
Maladies médiées par le complément	Aux États-Unis, environ 50 000 patients
Troubles hématologiques hérités	Environ 25 000 patients en Amérique du Nord

Spécialistes des troubles génétiques pédiatriques

Segment professionnel clé de la cible avec des domaines de mise au point spécifiques:

• Généticiens pédiatriques spécialisés dans des conditions héritées rares
• Généticiens cliniques dans les hôpitaux pour enfants spécialisés
• Professionnels du conseil génétique

Les prestataires de soins de santé se sont concentrés sur les conditions génétiques

Type de fournisseur	Portée du marché potentiel
Cliniques génétiques spécialisées	Plus de 500 centres dédiés aux États-Unis
Centres médicaux académiques	Environ 150 centres avec des capacités de recherche génétique avancées

Institutions de recherche

Les segments de recherche ciblés comprennent:

• Centres de recherche financés sur les National Institutes of Health (NIH)
• Laboratoires de recherche génétique à l'université
• Consortiums de recherche de maladies rares

Professionnels pharmaceutiques et biotechnologiques

Catégorie professionnelle	Nombre estimé
Spécialistes du développement de médicaments contre les maladies rares	Environ 2 500 professionnels
Professionnels de la recherche en thérapie génétique	Environ 3 200 spécialistes

Caractéristiques totales du marché adressables:

• Population de patients atteints de maladies rares: 25 à 30 millions de personnes aux États-Unis
• Trouble génétique Valeur marchande: prévu 50,3 milliards de dollars d'ici 2026
• Investissement annuel dans la recherche sur les maladies rares: environ 3,5 milliards de dollars

Rallybio Corporation (RLYB) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Rallybio Corporation a déclaré des frais de recherche et de développement totaux de 54,3 millions de dollars.

Catégorie de dépenses	Montant ($)
Recherche préclinique	18,7 millions
Développement clinique	22,5 millions
Coûts de biologie moléculaire	13,1 millions

Gestion des essais cliniques et coûts opérationnels

Les dépenses des essais cliniques pour 2023 ont totalisé 32,6 millions de dollars, avec une allocation spécifique comme suit:

• Coûts d'essai de phase I / II: 15,2 millions de dollars
• Frais de recrutement des patients: 7,4 millions de dollars
• Conformité réglementaire: 5,9 millions de dollars
• Gestion du site: 4,1 millions de dollars

Investissements d'acquisition et de rétention de talents

Les dépenses liées au personnel pour 2023 étaient de 41,5 millions de dollars.

Catégorie de personnel	Compensation ($)
Chercheur	22,3 millions
Personnel administratif	9,7 millions
Rémunération des dirigeants	9,5 millions

Protection et entretien de la propriété intellectuelle

Les coûts de propriété intellectuelle pour 2023 étaient de 3,2 millions de dollars, y compris les frais de dépôt et d'entretien des brevets.

Équipements scientifiques avancés et investissements technologiques

Les investissements technologiques et d'équipement pour 2023 s'élevaient à 12,7 millions de dollars.

Catégorie d'équipement	Investissement ($)
Instrumentation de laboratoire	6,5 millions
Outils de biologie informatique	3,8 millions
Systèmes de gestion des données	2,4 millions

Rallybio Corporation (RLYB) - Modèle d'entreprise: sources de revenus

Accords potentiels de licence de produits futurs

Au quatrième trimestre 2023, Rallybio Corporation n'a pas encore signalé aucun accord de licence de produit actif.

Subventions de recherche et financement gouvernemental

Source de financement	Montant	Année
Subvention des National Institutes of Health (NIH)	1,2 million de dollars	2023

Capital-risque et financement des investisseurs

Données financières pour les cycles de financement de Rallybio Corporation:

Ronde de financement	Total relevé	Année
Série A	65 millions de dollars	2020
L'offre publique initiale (IPO)	150 millions de dollars	2021

Ventes de produits thérapeutiques potentiels

État de développement du pipeline actuel:

• RLYB211 (inhibiteur du complément): phase 1/2 essais cliniques
• Rlyb212: étape préclinique

Collaborations de partenariat stratégique

En 2024, aucune collaboration spécifique de partenariat stratégique n'a été publiquement signalée par Rallybio Corporation.

Métriques de performance financière:

Métrique financière	Montant	Période
Revenus totaux	$0	2023 Exercice
Frais de recherche et de développement	47,3 millions de dollars	2023 Exercice
Perte nette	56,1 millions de dollars	2023 Exercice

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.