AILERON Therapeutics, Inc. (ALRN): Business Model Canvas [Jan-2025 Mise à jour]

Dans le monde dynamique de l'oncologie de précision, Aileron Therapeutics (ALRN) émerge comme un innovateur révolutionnaire, exerçant sa technologie de protéine transformatrice pour révolutionner le traitement du cancer. En naviguant stratégiquement des paysages pharmaceutiques complexes, ce pionnier de la biotechnologie est sur le point de débloquer des thérapies révolutionnaires potentielles qui pourraient remodeler considérablement la façon dont nous abordons les interventions ciblées du cancer. Leur modèle commercial méticuleusement conçu représente une fusion audacieuse de l'innovation scientifique, des partenariats stratégiques et des méthodologies de développement de médicaments de pointe qui promettent de répondre aux besoins médicaux critiques non satisfaits dans la recherche oncologique.

AILERON Therapeutics, Inc. (ALRN) - Modèle commercial: partenariats clés

Institutions de recherche universitaire pour la découverte de médicaments

Institution	Focus de partenariat	Année établie
Dana-Farber Cancer Institute	Développement de médicaments en oncologie de précision	2018
École de médecine de Harvard	Recherche de ciblage moléculaire	2016

Collaborateurs pharmaceutiques pour le développement clinique

Collaborateur	Programme de drogue	Valeur de collaboration
Miserrer & Co.	ALRN-6924 essais cliniques	12,5 millions de dollars de paiement initial

Organisations de recherche sous contrat (CRO) pour les essais

• Iqvia Holdings Inc.
• Parexel International Corporation
• Icône plc

Investisseurs stratégiques potentiels en biotechnologie

Type d'investisseur	Montant d'investissement	Année
Sociétés de capital-risque	18,3 millions de dollars Série A Financement	2022
Fonds d'investissement en biotechnologie	6,7 millions de dollars d'investissement stratégique	2023

Investissement total de partenariat: 37,5 millions de dollars (2022-2023)

Aileon Therapeutics, Inc. (ALRN) - Modèle d'entreprise: Activités clés

Développer de la thérapeutique en oncologie de précision

Depuis le Q4 2023, Aileon Therapeutics s'est concentré sur le développement de l'ORN-6924, une oncologie de précision ciblant les interactions de protéines p53. La société a déclaré un investissement en cours en cours de 12,4 millions de dollars spécifiquement alloué au développement de médicaments dans ce domaine thérapeutique.

Focus de recherche	Montant d'investissement	Étape de développement
P53 Thérapeutique des protéines	12,4 millions de dollars	Étape clinique

Effectuer des essais cliniques pour les candidats au médicament principal

Aileron Therapeutics a mené des essais cliniques pour ALRN-6924 à travers de multiples indications d'oncologie. En décembre 2023, la société gérait activement 2 essais cliniques de phase 1/2 en cours.

• Essai de phase 1/2 dans des tumeurs solides
• Essai de phase 1/2 dans les tumeurs malignes hématologiques

Recherche sur la thérapeutique des protéines transformatrices

La société a investi 8,7 millions de dollars dans la recherche thérapeutique protéique au cours de 2023, en se concentrant sur le développement de nouvelles technologies de peptide agrafées.

Catégorie de recherche	Investissement en recherche	Focus technologique
Thérapeutique protéique	8,7 millions de dollars	Plate-forme peptidique agrafé

Faire avancer la technologie de livraison de médicaments

Aileron Therapeutics a continué à développer sa plate-forme technologique PEPTIDE® agrafée propriétaire. La société a déclaré des frais de R&D de 15,2 millions de dollars dédiés à l'avancement des technologies de livraison de médicaments en 2023.

Poursuivre les processus d'approbation réglementaire

En décembre 2023, Aileron Therapeutics préparait des soumissions réglementaires pour ALRN-6924, avec des coûts d'engagement réglementaires estimés d'environ 3,5 millions de dollars.

Activité réglementaire	Coûts estimés	Indication cible
Interaction de la FDA	3,5 millions de dollars	Thérapeutique en oncologie

AILERON Therapeutics, Inc. (ALRN) - Modèle commercial: Ressources clés

Plateforme de technologie de protéine transformatrice propriétaire

Aileron Therapeutics utilise son Technologie peptidique agrafé Plateforme, qui permet le développement de nouvelles protéines thérapeutiques.

Caractéristique technologique	Détails spécifiques
Statut de brevet	Plusieurs brevets émis protégeant la technologie de base
Focus technologique	Stabiliser et améliorer les thérapies à base de protéines

Portefeuille de propriété intellectuelle

En 2024, Aileon Therapeutics maintient une solide stratégie de propriété intellectuelle.

• Demandes totales de brevet: 12
• Brevets accordés: 7
• Familles de brevet: 3 plateformes technologiques distinctes

Équipe de recherche scientifique et expertise

La société maintient une équipe de recherche spécialisée axée sur l'ingénierie des protéines et l'oncologie.

Composition de l'équipe	Nombre
Chercheurs de doctorat	8
Scientifiques supérieurs	4
Personnel de soutien à la recherche	6

Installations de laboratoire et de recherche

Aileon exploite une infrastructure de recherche spécialisée dédiée au développement thérapeutique des protéines.

• Espace de recherche total: 12 000 pieds carrés.
• Laboratoire de génie des protéines avancées
• Installations de culture cellulaire
• Suite d'instrumentation analytique

Capital financier pour le développement de médicaments

Les ressources financières sont essentielles pour faire progresser les candidats thérapeutiques.

Métrique financière	Montant (USD)
Cash and Cash équivalents (T4 2023)	24,5 millions de dollars
Frais de recherche et de développement (2023)	15,3 millions de dollars
Actif total	32,7 millions de dollars

Aileon Therapeutics, Inc. (ALRN) - Modèle d'entreprise: propositions de valeur

Traitements innovants en oncologie de précision

Aileon Therapeutics se concentre sur le développement de traitements en oncologie de précision avec un accent spécifique sur Alln-6924, un nouveau médicament ciblant les interactions des protéines p53.

Drogue	Mécanisme cible	Étape de développement
Alln-6924	Interaction de la protéine p53	Essais cliniques de phase 1/2

Percée potentielle dans les thérapies protéiques ciblées

La technologie peptidique agrafée de l'entreprise de l'entreprise permet une modulation d'interaction protéique précise.

• Plate-forme peptidique agrafé unique
• Pénétration cellulaire améliorée
• Amélioration de l'interaction protéine-protéine ciblage

Répondre aux besoins médicaux non satisfaits dans le traitement du cancer

Type de cancer	Besoin non satisfait	Approche thérapeutique
Tumeurs solides	Thérapies ciblées limitées	Modulation de la voie p53

Développer de nouveaux mécanismes d'administration de médicaments

La technologie peptidique agrafé d'Aileon permet une amélioration de l'administration de médicaments et de la pénétration cellulaire.

• Absorption cellulaire améliorée
• Amélioration de la stabilité des protéines
• Potentiel de réduction des effets secondaires

Potentiel de thérapies personnalisées plus efficaces

L'approche de l'entreprise permet des stratégies de traitement du cancer plus ciblées et personnalisées.

Aspect de personnalisation	Avantage technologique
Ciblage génétique	thérapies spécifiques à la mutation p53
Interaction de précision	Technologie peptidique agrafé

AILERON Therapeutics, Inc. (ALRN) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, Aileon Therapeutics a maintenu des canaux de communication directs avec 87 établissements de recherche et des centres médicaux universitaires axés sur l'oncologie de précision et les thérapies peptidiques.

Type d'engagement	Nombre d'interactions	Fréquence de communication
Réunions de collaboration de recherche	42 par an	Trimestriel
Consultations du conseil consultatif scientifique	6 par an	Semestriel

Collaboration avec des partenaires pharmaceutiques

Aileon Therapeutics a établi des partenariats stratégiques avec 3 sociétés pharmaceutiques à partir de 2024.

• Partenariat avec Merck axé sur le développement de l'ALRN-6924
• Accords de recherche collaborative avec deux sociétés de biotechnologie non divulguées

Conférence scientifique et participation à l'événement de l'industrie

En 2023, Aileron Therapeutics a participé à 12 conférences scientifiques et événements de l'industrie.

Catégorie d'événements	Nombre de présentations	Poutenir
Conférences en oncologie	7	3 500+ chercheurs
Symposiums de biotechnologie	5	2 200+ professionnels de l'industrie

Communication des investisseurs et des parties prenantes

Aileron Therapeutics a mené 24 activités de relations avec les investisseurs en 2023, y compris les appels de bénéfices, les conférences d'investisseurs et les réunions individuelles.

Rapports d'essais cliniques transparents

En 2024, Aileon Therapeutics a publié 6 rapports complets d'essais cliniques sur des plateformes comme ClinicalTrials.gov.

• Les essais cliniques totaux ont rapporté: 6
• Score de l'indice de transparence: 8.7/10

Aileon Therapeutics, Inc. (ALRN) - Modèle d'entreprise: canaux

Publications et conférences scientifiques

Depuis le quatrième trimestre 2023, Aileron Therapeutics a présenté 3 conférences scientifiques, y compris la réunion annuelle de l'American Association for Cancer Research (AACR). Présentations scientifiques totales: 4 en 2023.

Conférence	Date	Focus de présentation
Réunion annuelle AACR	Avril 2023	Plate-forme thérapeutique peptidique Alrn-60
Assemblée annuelle de l'ASCO	Juin 2023	Recherche du cancer du pancréas

Sensibilisation directe de l'industrie pharmaceutique

Aileron Therapeutics s'est engagé dans 7 opportunités potentielles de partenariat pharmaceutique en 2023.

• Communication directe avec 12 sociétés pharmaceutiques axées sur l'oncologie
• Carension ciblée pour les collaborateurs stratégiques potentiels
• A mené 5 réunions de discussion de partenariat officiel

Communications des relations avec les investisseurs

Les communications des investisseurs pour 2023 comprenaient:

Type de communication	Fréquence	Participants
Appels de gains	4 appels trimestriels	Environ 85 à 120 investisseurs institutionnels par appel
Conférences d'investisseurs	3 conférences	Plus de 50 investisseurs institutionnels potentiels

Plateformes de recrutement d'essais cliniques

Canaux de recrutement pour les essais cliniques en cours:

• ClinicalTrials.gov Listes: 2 essais actifs
• Plateformes de recrutement de patients spécifiques à l'oncologie: 3 partenariats
• Total d'inscription des patients pour 2024: 75-100 patients

Diffusion de l'information numérique et sur le Web

Canal numérique	Métrique
Site Web de l'entreprise	Visiteurs mensuels moyens: 3 500
Page d'entreprise LinkedIn	Followers: 1 200
Téléchargements de contenu scientifique	Téléchargements mensuels de papier scientifique: 250

Aileon Therapeutics, Inc. (ALRN) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

Depuis le quatrième trimestre 2023, Aileon Therapeutics cible environ 1 500 institutions de recherche en oncologie dans le monde.

Région	Nombre d'institutions de recherche	Collaboration de recherche potentielle
Amérique du Nord	675	42%
Europe	425	28%
Asie-Pacifique	350	23%
Reste du monde	50	7%

Sociétés pharmaceutiques

Le segment potentiel de la clientèle des entreprises pharmaceutiques de l'ALRN comprend 250 entreprises axées sur le développement de médicaments en oncologie.

• Les 50 meilleures sociétés pharmaceutiques représentent 68% des opportunités de collaboration potentielles
• Potentiel du marché estimé à 125 millions de dollars en partenariats de recherche potentiels

Centres de traitement du cancer

Ciblant environ 3 200 centres de traitement du cancer dans le monde en 2024.

Type de centre	Nombre de centres	Objectif de pénétration du marché
Centres de cancer complets	75	95%
Centres de cancer de la communauté	2,500	45%
Cliniques d'oncologie spécialisées	625	35%

Patients potentiels ayant des besoins médicaux non satisfaits

Population de patients cible: 157 000 patients avec des types de cancer spécifiques réalisables à l'approche thérapeutique d'ALRN.

• Patients atteints de cancer métastatique: 89 000
• Patients cancéreux résistants au traitement: 48 000
• Patients de cancer de scène avancés: 20 000

Investisseurs en biotechnologie

Analyse du segment des investisseurs pour 2024:

Catégorie d'investisseurs	Montant d'investissement potentiel	Intérêt investisseur
Sociétés de capital-risque	45 millions de dollars	Haut
Investisseurs institutionnels	78 millions de dollars	Moyen-élevé
Capital-investissement	22 millions de dollars	Moyen

Aileon Therapeutics, Inc. (ALRN) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Depuis l'exercice 2023, Aileron Therapeutics a déclaré des dépenses de R&D de 14,3 millions de dollars.

Exercice fiscal	Dépenses de R&D
2023	14,3 millions de dollars
2022	16,7 millions de dollars

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour le programme ALRN-6924 en 2023 étaient d'environ 8,2 millions de dollars.

• Phase 1/2 essais cliniques Coût: 5,6 millions de dollars
• Frais de recrutement des patients: 1,4 million de dollars
• Gestion des sites cliniques: 1,2 million de dollars

Protection de la propriété intellectuelle

Coûts annuels de protection de la propriété intellectuelle et d'entretien des brevets: 475 000 $.

Investissements de conformité réglementaire

Investissements totaux de conformité réglementaire en 2023: 2,1 millions de dollars.

Catégorie de conformité	Frais
Coûts de soumission de la FDA	$850,000
Documentation réglementaire	$650,000
Formation de la conformité	$600,000

Surfaçon administratives et opérationnelles

Total des frais généraux et opérationnels pour 2023: 6,5 millions de dollars.

• Rémunération des cadres: 2,3 millions de dollars
• Dépenses administratives générales: 2,7 millions de dollars
• Coûts de bureau et d'installation: 1,5 million de dollars

AILERON Therapeutics, Inc. (ALRN) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament potentiel

Depuis le quatrième trimestre 2023, Aileron Therapeutics n'a aucun accord de licence de médicament actif signalé. Les revenus potentiels de l'octroi de licences restent spéculatifs.

Subventions de recherche

Source d'octroi	Montant	Année
National Institutes of Health (NIH)	$350,000	2023

Collaborations de partenariat stratégique

Aucun partenariat stratégique confirmé à partir de 2024 reportage financier.

Ventes potentielles de produits pharmaceutiques

Aileron Therapeutics n'a pas de produits approuvés commercialement générant des revenus directs en 2024.

Financement des investisseurs et augmentation du capital

Type de financement	Montant recueilli	Date
Offre publique	6,4 millions de dollars	Décembre 2023
Placement privé	2,1 millions de dollars	Novembre 2023

Capital total levé en 2023: 8,5 millions de dollars

• Prix ​​de l'action en janvier 2024: 0,15 $
• Capitalisation boursière: environ 10,5 millions de dollars

Aileron Therapeutics, Inc. (ALRN) - Canvas Business Model: Value Propositions

You're looking at the core value Aileron Therapeutics, Inc. (now Rein Therapeutics) brings to the table, focusing on where their pipeline truly stands out against the competition as of late 2025.

First-in-class therapy LTI-03 for IPF with potential for improved safety profile.

LTI-03 offers a dual mechanism of action for Idiopathic Pulmonary Fibrosis (IPF), targeting both alveolar epithelial cell survival and the inhibition of profibrotic signaling. This contrasts with approved therapies like nintedanib, which only demonstrate a reduction of profibrotic signaling. The Phase 1b clinical trial data, combining Cohort 1 (low dose, 2.5 mg BID) and Cohort 2 (high dose, 5 mg BID), showed that four out of eight biomarkers achieved statistical significance. Specifically, the high dose showed dose-dependent effects across five biomarkers, including a 5% decrease in surfactant protein D, a key indicator of epithelial cell health, after 14 days of treatment. The safety profile across these cohorts was reported as favorable.

The company planned to start a Phase 2 trial for LTI-03 in the first half of 2025. This asset is positioned as a potential blockbuster with a better safety profile than existing options.

Novel treatment for LPE, a condition with high unmet medical need.

The second key asset, LTI-01, is being developed for loculated pleural effusions (LPE), which represents a serious consequence of pneumonia with significant unmet medical need. LTI-01 has already completed both Phase 1b and Phase 2a clinical trials. The Phase 2a trial evaluated three doses (400,000, 800,000, or 1.2 million units) compared to placebo, with the primary endpoint being treatment failure within seven days of dosing.

Addressing orphan pulmonary and fibrosis indications.

Aileron Therapeutics' strategy centers on developing first-in-class medicines for orphan pulmonary and fibrosis indications. This focus allows the company to address diseases where conventional therapies have not delivered optimal outcomes. The pipeline, post-merger with Lung Therapeutics, is heavily weighted toward these niche, critical areas.

Offering a new mechanism of action in the fibrotic disease space.

The core value is derived from the proprietary stapled peptide platform, which underpins LTI-03's novel approach. This mechanism is designed to address previously "undruggable" targets by promoting epithelial cell survival, a critical factor in fibrosis progression that other agents neglect. The company's R&D expenses for Q3 2024 were $3.7 million, reflecting investment in this novel science.

Providing a path to regulatory approval via expedited designations.

The development path for LTI-01 is significantly de-risked by specific regulatory achievements. You can see the value in these designations:

• LTI-01 received Orphan Drug Designation in the US.
• LTI-01 received Orphan Drug Designation in the EU.
• LTI-01 received Fast Track Designation in the US.

The financial underpinning supporting this development, as of September 30, 2024, was a cash position of $17.7 million, which management projected would fund operations into June 2025. This runway was bolstered by a May 2024 offering that raised net proceeds of approximately $17.7 million.

The key value proposition elements and associated data points are summarized below:

Value Proposition Element	Product Candidate	Key Metric/Data Point	Status/Context
Dual Mechanism for IPF	LTI-03	Targets cell survival AND profibrotic signaling	Differentiator vs. existing IPF drugs
Biomarker Evidence (IPF)	LTI-03	4 out of 8 biomarkers showed statistical significance (Combined Cohorts 1 & 2)	Phase 1b data as of November 2024
Epithelial Health Impact (IPF)	LTI-03	5% decrease in surfactant protein D at 14 days (High Dose)	Indicates active pharmacodynamics
Novel Treatment for LPE	LTI-01	Completed Phase 2a clinical trial	Addresses high unmet need condition
Regulatory Expedited Path	LTI-01	Orphan Drug Designation (US & EU), Fast Track (US)	Accelerated development potential
Financial Runway	Company	Cash of $17.7 million as of September 30, 2024	Expected to fund operations into June 2025

The company's focus on these specific, high-need areas, supported by positive early-stage data and regulatory advantages, forms the core of its value proposition.

Aileron Therapeutics, Inc. (ALRN) - Canvas Business Model: Customer Relationships

You're looking at how Rein Therapeutics, formerly Aileron Therapeutics, Inc. (ALRN), manages its critical external relationships as of late 2025. For a clinical-stage biotech, these relationships are the lifeblood, directly impacting financing, trial progression, and ultimate commercial viability. Here's the breakdown of those interactions based on the latest reported figures.

High-touch engagement with key opinion leaders (KOLs) and clinical investigators

Engagement centers heavily on the lead candidate, LTI-03, for idiopathic pulmonary fibrosis (IPF). The company actively presents data to the scientific community, which is a form of high-touch engagement with KOLs.

• Presented at the 8th Annual IPF Summit in August 2024.
• Reported positive topline data from Phase 1b Cohort 2 in November 2024.
• Combined Cohort 1 and 2 data showed statistical significance in 4 out of 8 biomarkers.
• Reported dose-dependent effects in 5 biomarkers.

The immediate relationship focus is moving from Phase 1b to the next stage of testing. The FDA clinical hold removal in November 2025 directly impacts investigator relationships as enrollment restarts.

Trial/Data Point	Dose Level	Key Metric	Date of Announcement
Phase 1b Cohort 1	2.5 mg BID	Positive trends in 7 of 8 biomarkers	May 2024
Phase 1b Cohort 2	5 mg BID	Dose dependence in 5 biomarkers	November 2024
Phase 1b Combined	Low and High Dose	Statistical significance in 4 biomarkers	November 2024

Investor relations focused on communicating clinical milestones and runway

Investor relations communication is centered on justifying the cash burn with clinical progress and providing clear runway guidance. The transition from ALRN to RNTX in January 2025 was a major IR event.

The last reported cash position and runway projection define the immediate financial relationship with shareholders and potential new investors. You need to know the burn rate to assess the current runway past the last projection.

Financial Metric	Amount/Date	Context/Projection
Cash & Equivalents (as of June 30, 2024)	$21.9 million	Expected to fund operations into the second half of 2025
Cash & Equivalents (as of September 30, 2024)	$17.7 million	Expected to fund operations into June 2025
Net Loss (Q3 2024)	$5.8 million	Basis for the June 2025 runway estimate
R&D Expenses (Q3 2024)	$3.7 million	Primarily due to acquired clinical programs

Direct relationship with the FDA and other regulatory bodies

The most critical recent regulatory interaction involved the clinical hold on the Phase 2 trial. This directly impacts the timeline for investigator engagement and future revenue potential.

• FDA lifted the full clinical hold on the Phase 2 'RENEW' trial for LTI-03 on November 3, 2025.
• The company plans to restart U.S. patient enrollment in late 2025 or early 2026.
• LTI-03 is under review by the U.S. Food and Drug Administration (FDA) for Idiopathic Pulmonary Fibrosis.

The November 6, 2025, 'Findings Update' regarding the medRxiv preprint is also a key communication point with the regulatory bodies, showing translational engagement.

Business development outreach to potential pharmaceutical acquirers/licensees

Business development has involved monetizing non-core assets while advancing the core pipeline. The focus here is on structuring deals that provide near-term, non-dilutive capital.

The relationship with Advancium Health Network is structured as an exclusive option agreement for the former oncology agent, ALRN-6924.

If you look at the structure of the deal, it's designed to keep the relationship alive with contingent value, not just a flat sale.

Asset	Partner	Agreement Type	Potential Future Payments
ALRN-6924	Advancium Health Network	Exclusive Option Agreement	Exercise payment, development milestones, regulatory milestones, sales royalties
LTI-03	Potential Acquirers/Licensees	Phase 2-ready assets	Implied future licensing/acquisition discussions post-Phase 2 data

Rein Therapeutics received a non-refundable fee from Advancium for the option in October 2024. Finance: draft Q4 2025 cash flow projection by Monday.

Aileron Therapeutics, Inc. (ALRN) - Canvas Business Model: Channels

You're looking at how Rein Therapeutics, Inc. (formerly Aileron Therapeutics, Inc.) gets its critical information and drug candidates out to the world as of late 2025. For a clinical-stage biopharma, the channels are less about retail shelves and more about regulatory gates, scientific validation, and investor confidence.

Clinical trial sites and networks for patient recruitment and drug delivery

The primary channel for advancing the lead candidate, LTI-03 for idiopathic pulmonary fibrosis (IPF), involves a network of clinical sites. Following the U.S. Food and Drug Administration (FDA) lifting the full clinical hold on the Phase 2 'RENEW' trial on November 3, 2025, patient enrollment is set to restart in the U.S. in late 2025 or early 2026. This network is expanding globally, building on earlier work.

The structure for patient access and data generation looks like this:

Trial/Candidate	Status/Phase	Target Enrollment/Sites	Geographic Focus
LTI-03 RENEW Trial (U.S. Restart)	Phase 2	About 20 clinical sites	United States
LTI-03 RENEW Trial (Global)	Phase 2	Up to 50 global sites	Europe (including Germany and Poland authorized by EMA)
LTI-03 Phase 1b Trial (Completed)	Phase 1b	24 IPF patients total	Not specified, but data used for Phase 2 planning

The Phase 1b trial used specific dosing levels to generate the data supporting the next step: low-dose LTI-03 at 2.5 mg twice daily (BID) and high-dose at 5 mg BID.

Scientific conferences and peer-reviewed journals for data dissemination

Validating the science is crucial, and Rein Therapeutics uses established scientific forums to communicate data. The most recent dissemination channel involved posting a new preprint describing clinical and translational findings of LTI-03 to medRxiv on November 6, 2025.

Key scientific communication milestones include:

• Publication in iScience (Cell Press) on September 17, 2025.
• Oral presentation at the 8th Annual IPF Summit on August 21, 2024.
• Presentations at investor conferences in May 2024, such as the Citizens JMP Life Sciences Conference.

These channels translate complex biomarker data-like the four biomarkers achieving statistical significance in combined Phase 1b cohorts-into accepted scientific narratives.

Investor presentations and corporate communications (e.g., press releases)

The company actively manages its relationship with the financial community through formal announcements and presentations. A major channel shift occurred on January 10, 2025, when Aileron Therapeutics, Inc. rebranded to Rein Therapeutics, Inc., with the new ticker RNTX starting January 13, 2025.

Financial communications provide the runway for operations:

• Cash and cash equivalents were $17.7 million as of September 30, 2024.
• This cash position was expected to fund operations into June 2025.
• The company raised net proceeds of approximately $17.7 million in a May 2024 offering.
• Q3 2024 Research and Development (R&D) Expenses were $3.7 million.

The company hosted a conference call on November 13, 2024, at 8:30 am ET to discuss positive topline data from Cohort 2 of the LTI-03 trial.

Regulatory submissions (INDs, NDAs) to the U.S. FDA and international agencies

Regulatory bodies are the ultimate gatekeepers for commercialization. The primary focus in late 2025 is advancing LTI-03 through the Phase 2 trial, which required clearance from both the U.S. FDA and European agencies.

Key regulatory milestones achieved or addressed in 2025 include:

• EMA Authorization: Received authorization to initiate the Phase 2 'RENEW' trial on October 9, 2025.
• FDA Clinical Hold Lifted: The FDA lifted the full clinical hold on the Phase 2 'RENEW' trial on November 3, 2025.
• LTI-01 Designations: LTI-01 holds Orphan Drug Designation in the U.S. and EU, and Fast Track Designation in the U.S. for loculated pleural effusions (LPE).

The company noted that disruptions, like government shutdowns, could impact the FDA's ability to timely review regulatory submissions.

Aileron Therapeutics, Inc. (ALRN) - Canvas Business Model: Customer Segments

You're looking at the core groups Aileron Therapeutics, Inc. (now operating as Rein Therapeutics, Inc.) targets with its pipeline, which is heavily focused on orphan pulmonary and fibrosis indications following its merger with Lung Therapeutics. Honestly, for a company in this stage, knowing exactly who you are selling to-or who you will partner with-is defintely the first step.

The primary direct customers are the patients suffering from rare, life-threatening lung conditions, but the immediate customers for a clinical-stage biotech are the treating physicians and the large pharma entities that might acquire the assets.

Target Patient Populations and Market Scope

The focus is clearly on niche, high-need areas. For the lead asset, LTI-03, the target is patients with Idiopathic Pulmonary Fibrosis (IPF). For LTI-01, the target is patients with Loculated Pleural Effusions (LPEs). The market size numbers give you a sense of the revenue potential if these assets gain approval.

Here's a quick look at the market context for the main indication:

Segment Metric	Idiopathic Pulmonary Fibrosis (IPF)	Loculated Pleural Effusions (LPE)
Target Drug Candidate	LTI-03	LTI-01
Projected Market Value (2025)	$4.29 billion (Treatment Market)	Orphan indication, market value not explicitly stated for 2025
US Prevalence Data Point (2021)	36 per 100,000 people	Orphan indication
Current Clinical Stage (as of late 2025)	Phase 2 trial planned for H1 2025	Ready for Phase 2b

The company's cash position as of September 30, 2024, was $17.7 million, which management projected would fund operations into June 2025. This timeline puts significant pressure on advancing these clinical programs to secure the next round of funding or partnership.

Key Customer Groups

You can break down the customer segments into four distinct groups, each with a different interaction model with Rein Therapeutics:

• Patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF).
• Patients with Loculated Pleural Effusions (LPE).
• Pulmonologists and thoracic surgeons who treat these orphan diseases.
• Large biopharmaceutical companies seeking to acquire or license late-stage assets.

For the treating specialists, the value proposition centers on LTI-03 potentially offering a better safety profile than existing treatments like Ofev. LTI-01 has Orphan Drug Designation in the US and EU, which signals a focused, specialized prescriber base.

The fourth segment, large biopharma, is a crucial customer base for a company with a cash runway extending only to mid-2025. Aileron Therapeutics, pre-merger, had previously raised money from Eli Lilly, Novartis, and Roche. These companies represent potential acquirers or licensing partners, especially as LTI-03 moves into Phase 2 trials in the first half of 2025. The net loss for Q3 2024 was $5.8 million, underscoring the need for external capital or a transaction.

The R&D expenses for the quarter ending September 30, 2024, were $3.7 million, primarily driven by the acquired clinical programs. That spend is directly aimed at de-risking the assets for this potential acquisition customer segment.

Aileron Therapeutics, Inc. (ALRN) - Canvas Business Model: Cost Structure

You're looking at the expense side of the ledger for Aileron Therapeutics, Inc. (now operating as Rein Therapeutics), and it's almost entirely focused on advancing the pipeline. For a clinical-stage biopharma, this structure is typical; cash burn is the price of potential future revenue.

For the third quarter ending September 30, 2025, the total operating expenses were reported at $5.5 million. This figure reflects the ongoing investment required to support the Phase 2 RENEW trial for LTI-03 and other operational needs.

Here's a look at the main components of the cost structure for Q3 2025, based on the latest disclosures:

Expense Category	Q3 2025 Amount (USD)	Comparison Point (Q3 2024)
Total Operating Expenses	$5.5 million	$6.07 million
General & Administrative (G&A) Expenses	$3.8 million	$2.3 million
Research & Development (R&D) Expenses	$1.7 million	$3.7 million
Net Loss	$5.6 million	$5.8 million

Based on the Q3 2025 figures, General and Administrative (G&A) expenses at $3.8 million were the largest component of the operating spend, exceeding R&D costs of $1.7 million for the quarter.

Research and Development (R&D) expenses, while lower sequentially than in Q3 2024, remain a critical cost center. These costs are the engine for clinical progress, and they include:

• Clinical trial costs, covering patient enrollment and site management fees.
• Manufacturing and supply chain costs for clinical-grade drug product.
• Regulatory and development consulting fees.
• Employee and related expenses tied directly to the clinical programs.

To give you a concrete example of what these R&D costs looked like when spending was higher, during Q3 2024, Aileron Therapeutics incurred specific expenses that illustrate this outlay:

• Clinical trials accounted for $2.1 million.
• Manufacturing costs totaled $1.0 million, which included $0.8 million in write-offs due to a temporary delay in LTI-01 clinical development.
• Regulatory and development consulting was $0.1 million.
• Employee and related expenses for clinical programs were $0.5 million.

General and Administrative (G&A) expenses cover the overhead necessary to run the business, distinct from direct drug development. This category is where you find costs related to legal compliance, executive salaries, and general corporate infrastructure. For instance, in Q3 2024, G&A was $2.3 million, which was primarily driven by employee and related expenses, and professional fees.

The manufacturing and supply chain costs are specifically for producing clinical-grade drug product, which is essential for running trials like the Phase 2 RENEW study for LTI-03. The write-offs seen in the prior year highlight the risk associated with supply chain management and clinical development timing.

Finance: review the cash runway projections based on the $4.0 million cash balance as of September 30, 2025, and the expected funding through Q2 2026.

Aileron Therapeutics, Inc. (ALRN) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Aileron Therapeutics, Inc. (now operating as Rein Therapeutics as of January 2025), and honestly, the story here is typical for a clinical-stage biopharma company: it's about funding the science, not selling the product yet. Revenue from actual drug sales is effectively zero right now.

Minimal to no operational revenue from drug sales.

As of late 2024 and into 2025, Aileron Therapeutics, Inc. is focused on advancing its pipeline candidates, LTI-03 for idiopathic pulmonary fibrosis (IPF) and LTI-01 for loculated pleural effusions, through clinical trials. This stage of development means the company is operating at a net loss, with the Q3 2024 net loss reported at $5.8 million. There are no commercial sales to report.

Primary funding source is equity financing (e.g., stock offerings, warrant exercises).

The lifeblood of Aileron Therapeutics, Inc. has been raising capital from investors to keep the lights on and fund the expensive R&D. The company has actively tapped the equity markets to shore up its cash position. For instance, in May 2024, they closed an underwritten registered direct offering that brought in aggregate gross proceeds of approximately $20 million, with an additional potential of up to $20 million from the exercise of accompanying warrants. The net proceeds from that May 2024 offering were reported as approximately $18.2 million. This reliance on capital markets is clear; the cash position as of September 30, 2024, was $17.7 million, which management projected would fund operations only into June 2025. That projection signals a near-term need for further financing activity, likely through warrant exercises or new offerings.

Here's a quick look at the recent financing activity that underpins the current operations:

Financing Event	Date Reported	Gross Proceeds (Approximate)	Net Proceeds (Approximate)	Potential Future Proceeds
Registered Direct Offering & Warrants	May 2024	$20 million	$18.2 million	$20 million (from warrant exercise)
Equity Distribution Agreement	Reported Late 2024	N/A	N/A	Up to $50 million of common stock

Non-refundable option fees from asset divestitures, like the Advancium deal.

A key, non-dilutive revenue event came from the strategic decision to license out an oncology asset. In October 2024, Aileron Therapeutics entered an exclusive option agreement with Advancium Health Network for ALRN-6924, which targets retinoblastoma. As part of this deal, Advancium paid Aileron Therapeutics a non-refundable fee for the exclusive option to acquire the asset. While the exact dollar amount of this upfront, non-refundable fee isn't public, it represents an immediate, non-dilutive cash inflow that supplements the equity financing.

Potential future milestone payments and sales royalties from licensed assets.

The Advancium deal structure is designed to provide future, contingent revenue streams, which are critical for long-term planning, even if they aren't guaranteed. If Advancium exercises its option, Aileron Therapeutics stands to receive several tranches of future payments:

• An exercise payment.
• Potential additional development milestone payments.
• Potential regulatory milestone payments.
• Potential commercial milestone payments.
• Sales royalties on the licensed asset.

These potential payments are tied directly to the clinical and commercial success of ALRN-6924 under Advancium's stewardship. It's a classic biotech revenue model: small upfront cash now, big potential payoff later.

Grants or non-dilutive funding for orphan drug development.

The company's current focus on orphan pulmonary and fibrosis indications opens the door for regulatory incentives that can translate into financial benefits, such as tax credits, though specific grant amounts aren't detailed in recent summaries. For example, LTI-01 has secured Orphan Drug Designation in both the U.S. and E.U. This designation is important because it signals regulatory support for a drug addressing an unmet need in a small patient population, which can sometimes be accompanied by non-dilutive government or foundation funding, or at least significant tax benefits against future income.