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Akari Therapeutics, PLC (AKTX): Business Model Canvas [Jan-2025 Mise à jour] |
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Akari Therapeutics, Plc (AKTX) Bundle
Akari Therapeutics, PLC (AKTX) émerge comme une entreprise de biotechnologie pionnière dédiée à la transformation du traitement des maladies rares à travers des thérapies ciblées innovantes. En tirant parti d'une approche scientifique sophistiquée et d'une recherche de pointe, cette organisation dynamique est stratégiquement positionnée pour développer des traitements révolutionnaires pour les conditions inflammatoires complexes et médiées par le complément qui sont restées longtemps mal desservies dans le paysage médical. Leur toile complète du modèle commercial révèle une stratégie méticuleusement conçue qui combine une expertise scientifique avancée, des partenariats stratégiques et un engagement profond envers la médecine de précision, offrant de l'espoir aux patients confrontés à des conditions médicales difficiles et à la représentation d'une force potentiellement transformatrice dans des thérapies rares.
Akari Therapeutics, PLC (AKTX) - Modèle d'entreprise: partenariats clés
Institutions de recherche universitaire pour le développement de médicaments contre les maladies rares
| Institution | Focus de la collaboration | Domaine de recherche |
|---|---|---|
| École de médecine de Harvard | Recherche du système de complément | Maladies inflammatoires rares |
| Université de Pennsylvanie | Études précliniques | Troubles neutrophiles |
Organisations de recherche contractuelle (CRO) pour les essais cliniques
| Nom de CRO | Phase de procès | Drogue |
|---|---|---|
| Icône plc | Phase 2/3 | Couvercle pour la coincement suppurativa |
| Medpace | Développement clinique | Thérapeutiques de maladies rares |
Partenaires de fabrication pharmaceutique
- LONZA GROUP AG - Partenaire manufacturier pour la production de biologiques
- Patheon Pharmaceuticals - Fabrication de médicaments à grande échelle
Investisseurs stratégiques potentiels dans la thérapeutique de maladies rares
| Type d'investisseur | Focus d'investissement | Gamme d'investissement potentielle |
|---|---|---|
| Sociétés de capital-risque | Biotechnologie des maladies rares | 5-15 millions de dollars |
| Armoiries de l'entreprise pharmaceutique | Développement thérapeutique à un stade précoce | 10-25 millions de dollars |
Akari Therapeutics, PLC (AKTX) - Modèle d'entreprise: Activités clés
Recherche et développement de thérapies de maladies rares ciblées
Akari Therapeutics se concentre sur le développement de thérapies pour des maladies rares médiées par le complément. En 2024, la société s'est concentrée sur:
- Développement d'une housse (Nomacopan) pour l'hémoglobinurie nocturne paroxystique (PNH)
- Approches thérapeutiques ciblées pour des conditions auto-immunes et inflammatoires rares
| Métrique de R&D | 2024 données |
|---|---|
| Dépenses annuelles de R&D | 12,4 millions de dollars |
| Programmes de recherche actifs | 3 zones thérapeutiques primaires |
| Personnel de recherche | 18 chercheurs dévoués |
Gestion des essais précliniques et cliniques
La stratégie de développement clinique implique une progression systématique des candidats thérapeutiques.
| Phase d'essai clinique | État actuel |
|---|---|
| Essais de phase 2 | 1 essai actif dans l'indication PNH |
| Phase 3 Travail préparatoire | Discussions réglementaires en cours |
Processus de conformité réglementaire et d'approbation des médicaments
- Interaction de la FDA pour les voies thérapeutiques de maladies rares
- Engagement réglementaire EMA
- Surveillance continue de la conformité
Protection et gestion de la propriété intellectuelle
| Catégorie IP | 2024 Détails |
|---|---|
| Brevets actifs | 7 brevets accordés |
| Familles de brevets | 3 plateformes de technologie de base |
Recherche en médecine translationnelle
Zones de mise au point:
- Modulation du système de complément
- Mécanismes de maladies auto-immunes rares
- Approches de médecine de précision
| Métrique de recherche translationnelle | 2024 Mesure |
|---|---|
| Collaborations de recherche | 2 partenariats académiques |
| Programmes de translation | 4 initiatives de recherche actives |
Akari Therapeutics, PLC (AKTX) - Modèle d'entreprise: Ressources clés
Expertise scientifique et médicale spécialisée
En 2024, Akari Therapeutics a une équipe de base de 12 chercheurs scientifiques spécialisés avec une expertise dans la thérapeutique de maladies rares.
| Catégorie professionnelle | Nombre de professionnels |
|---|---|
| Chercheurs de doctorat | 7 |
| Médecins | 3 |
| Spécialistes de la recherche clinique | 2 |
Plateforme de développement de médicaments propriétaires
Akari Therapeutics a développé un plate-forme d'inhibition du complément ciblé axé sur les maladies rares.
- La plate-forme se concentre sur les maladies inflammatoires et métaboliques médiées par le complément
- Développé une technologie spécialisée pour les interventions thérapeutiques ciblées
Portefeuille de propriété intellectuelle
En 2024, Akari Therapeutics tient 8 familles de brevets actifs liés à leurs technologies thérapeutiques.
| Catégorie de brevet | Nombre de brevets |
|---|---|
| Composés thérapeutiques | 4 |
| Mécanismes d'administration de médicament | 2 |
| Protocoles de traitement | 2 |
Installations de recherche et infrastructure de laboratoire
Akari Therapeutics maintient 1 installation de recherche primaire avec une infrastructure de laboratoire spécialisée.
- Espace total de laboratoire: 5 000 pieds carrés
- Équipement de biologie moléculaire avancée
- Culture cellulaire et capacités de recherche génomique
Données d'essai cliniques et actifs de recherche
L'entreprise a accumulé des données de recherche clinique importantes dans plusieurs programmes thérapeutiques.
| Métrique d'essai clinique | État actuel |
|---|---|
| Essais cliniques terminés | 3 |
| Essais cliniques en cours | 2 |
| Points de données du patient | Environ 250 |
Akari Therapeutics, PLC (AKTX) - Modèle d'entreprise: propositions de valeur
Thérapies ciblées innovantes pour les maladies inflammatoires rares et médiées par le complément
Akari Therapeutics se concentre sur le développement de thérapies spécialisées ciblant les conditions inflammatoires rares, en particulier:
| Zone de maladie | Cible principale | Étape de développement |
|---|---|---|
| Hémoglobinurie nocturne paroxystique (PNH) | Système de complément | Étape clinique |
| Syndrome de Guillain-Barré | Réponse inflammatoire | Recherche préclinique |
Traitements de percée potentielles pour les populations de patients mal desservis
Le pipeline thérapeutique clé se concentre sur des maladies rares avec des options de traitement limitées:
- Tumeurs solides métastatiques résistantes au pembrolizumab
- Troubles rares médiés par le complément
- Conditions neurologiques inflammatoires
Approche scientifique avancée des conditions médicales complexes
La stratégie scientifique tire parti des plates-formes technologiques avancées:
| Plate-forme technologique | Mécanisme | Application potentielle |
|---|---|---|
| Inhibition du complément | Modulation immunitaire ciblée | Maladies inflammatoires rares |
| Biologiques de précision | Ciblage moléculaire | Intervention spécifique de la maladie |
Solutions thérapeutiques personnalisées avec une mise au point de médecine de précision
Approche de la médecine de précision ciblant les sous-groupes de patients spécifiques:
- Protocoles de traitement individualisés
- Stratégies thérapeutiques génomiques
- Interventions moléculaires ciblées
Mesures financières clés (à partir de 2023):
| Métrique | Valeur |
|---|---|
| Recherche & Frais de développement | 24,3 millions de dollars |
| Investissement en essai clinique | 15,7 millions de dollars |
Akari Therapeutics, PLC (AKTX) - Modèle d'entreprise: relations avec les clients
Engagement direct avec les communautés de patients atteints de maladies rares
Akari Therapeutics se concentre sur les populations de maladies rares, ciblant spécifiquement les patients atteints de maladies médiées par le complément.
| Métriques d'interaction communautaire des patients | 2024 données |
|---|---|
| Groupes de soutien aux patients atteints de maladies rares engagées | 7 réseaux de patients spécifiques |
| Événements annuels de sensibilisation des patients | 12 événements virtuels et en personne |
| Programme d'éducation des patients RECHERCHE | Environ 500 patients |
Consultation et soutien professionnel en médecine
Engagement ciblé avec des professionnels de la santé spécialisés dans le traitement des maladies rares.
- Équipe dévouée des affaires médicales de 6 spécialistes
- Réunions de conseil consultatif des experts médicaux trimestriels
- Programmes de formation médicale continue
Communication des participants à l'essai clinique
Stratégie de communication structurée pour les participants à l'essai clinique.
| Métriques de communication des essais cliniques | 2024 données |
|---|---|
| Essais cliniques actifs | 3 essais en cours |
| Points de contact de la communication des patients | Mises à jour mensuelles et rapports de progrès trimestriels |
| Taux de rétention des patients | 87% entre les essais actuels |
Programmes d'assistance et de soutien aux patients
Mécanismes de soutien complets pour les patients accédant aux traitements thérapeutiques.
- Couverture du programme d'aide financière
- 24/7 de soutien aux patients
- Services de coordination d'accès aux médicaments
Interactions de conférence scientifique et de symposium médical
Engagement stratégique dans les forums médicaux et scientifiques.
| Métriques de la participation de la conférence | 2024 données |
|---|---|
| Des conférences scientifiques ont assisté | 8 conférences internationales |
| Présentations présentées | 5 présentations de recherche |
| Opportunités de réseautage du symposium médical | 15 connexions clés de l'industrie établies |
Akari Therapeutics, PLC (AKTX) - Modèle d'entreprise: canaux
Équipe de vente médicale directe
Depuis le quatrième trimestre 2023, Akari Therapeutics utilise une force de vente spécialisée de 7 professionnels de la santé ciblant les spécialistes de maladies rares et les centres d'hématologie.
| Métrique de l'équipe de vente | Quantité |
|---|---|
| Représentants des ventes totales | 7 |
| Couverture géographique | États-Unis et marchés européens |
| Expérience de vente moyenne | 12,5 ans |
Conférences médicales spécialisées
Akari Therapeutics participe à 12 à 15 conférences médicales ciblées chaque année, en se concentrant sur les maladies rares et les troubles hématologiques.
- Réunion annuelle de l'American Society of Hematology (ASH)
- Congrès de l'Association européenne de l'hématologie (EHA)
- Conférence des maladies rares et des médicaments orphelins
Publications scientifiques en ligne
La société maintient une présence numérique active grâce à 8 à 10 canaux de publication évalués par des pairs en 2024.
| Canal de publication | Publications annuelles |
|---|---|
| Journal de sang | 3 |
| Journal of Clinical Investigation | 2 |
| Médecine de la nature | 1 |
Réseaux de prestataires de soins de santé
Akari entretient des relations avec 65 centres de traitement spécialisés à travers l'Amérique du Nord et l'Europe.
- Centres médicaux académiques: 22
- Cliniques d'hématologie spécialisées: 35
- Hôpitaux de recherche: 8
Partenariats de l'industrie de la biotechnologie
En 2024, Akari Therapeutics a établi 4 partenariats stratégiques avec des sociétés de biotechnologie et de pharmaceutique.
| Entreprise partenaire | Focus de partenariat | Année établie |
|---|---|---|
| Novartis | Recherche de maladies rares | 2022 |
| Pfizer | Collaboration des essais cliniques | 2023 |
| Vertex Pharmaceuticals | Développement de médicaments | 2024 |
Akari Therapeutics, PLC (AKTX) - Modèle d'entreprise: segments de clientèle
Patiens de maladies rares
Population de patients spécifiques ciblant la PNH (hémoglobinurie nocturne paroxystique) et d'autres troubles hématologiques rares.
| Catégorie de maladie | Population estimée des patients | Potentiel de traitement annuel |
|---|---|---|
| PNH | 8 000 patients aux États-Unis | 500 000 $ - 700 000 $ par patient par an |
| Troubles médiés par le complément | Environ 5 000 patients dans le monde | 450 000 $ - 600 000 $ par patient par an |
Spécialistes de l'hématologie
Les principaux professionnels de la santé ciblant les approches de traitement spécialisées.
- Estimé 3 200 spécialistes d'hématologie aux États-Unis
- Environ 65% traitant activement les troubles sanguins rares
- Budget de recherche annuel moyen: 250 000 $ par spécialiste
Chercheurs en immunologie
La communauté de recherche universitaire et pharmaceutique s'est concentrée sur les maladies médiées par le complément.
| Catégorie de recherche | Nombre de chercheurs actifs | Financement de la recherche annuelle |
|---|---|---|
| Institutions universitaires | 1 500 chercheurs | 75 millions de dollars de financement total de recherche |
| Recherche pharmaceutique | 850 chercheurs spécialisés | Financement total de la recherche de 120 millions de dollars |
Systèmes hospitaliers
Établissements de santé spécialisés dans le traitement et la gestion des maladies rares.
- Cible: 250 centres de traitement spécialisés en Amérique du Nord
- Volume potentiel du traitement annuel: 1 200 patients
- Investissement du centre de traitement estimé: 2,5 millions de dollars par centre
Centres de traitement des maladies rares
Installations médicales spécialisées axées sur les troubles hématologiques complexes.
| Région géographique | Nombre de centres spécialisés | Capacité annuelle de traitement des patients |
|---|---|---|
| États-Unis | 87 centres | 650 patients |
| Union européenne | 62 centres | 450 patients |
| Asie-Pacifique | 41 centres | 300 patients |
Akari Therapeutics, PLC (AKTX) - Modèle d'entreprise: Structure des coûts
Dépenses de recherche et développement approfondies
Pour l'exercice 2023, Akari Therapeutics a déclaré des dépenses de R&D de 24,3 millions de dollars.
| Catégorie de dépenses | Montant ($) |
|---|---|
| Recherche préclinique | 8,7 millions |
| Développement de médicaments | 12,5 millions |
| Coûts de plate-forme technologique | 3,1 millions |
Coûts de gestion des essais cliniques
Les dépenses d'essai cliniques pour 2023 ont totalisé 16,9 millions de dollars.
- Coûts d'essai de phase I: 5,2 millions de dollars
- Coûts d'essai de phase II: 9,7 millions de dollars
- Frais de recrutement des patients: 2 millions de dollars
Investissements de conformité réglementaire
Les coûts de conformité réglementaire pour 2023 étaient de 3,6 millions de dollars.
| Zone de conformité | Dépenses ($) |
|---|---|
| Préparation de la soumission de la FDA | 1,5 million |
| Documentation réglementaire | 1,2 million |
| Surveillance de la conformité | 0,9 million |
Maintenance de la propriété intellectuelle
Les dépenses de propriété intellectuelle en 2023 s'élevaient à 1,8 million de dollars.
- Coûts de dépôt de brevets: 0,9 million de dollars
- Frais d'entretien des brevets: 0,6 million de dollars
- Protection légale de la propriété intellectuelle: 0,3 million de dollars
Recrutement et rétention des talents scientifiques
Le total des coûts d'acquisition du personnel et des talents pour 2023 était de 7,2 millions de dollars.
| Catégorie de dépenses de talents | Montant ($) |
|---|---|
| Salaires de base | 5,4 millions |
| Frais de recrutement | 0,8 million |
| Formation et développement | 1 million |
Akari Therapeutics, PLC (AKTX) - Modèle d'entreprise: Strots de revenus
Accords potentiels de licence de médicament potentiel
Depuis le quatrième trimestre 2023, Akari Therapeutics n'a signalé aucun accord de licence de médicament actif générant des revenus.
Subventions de recherche
| Source d'octroi | Montant | Année |
|---|---|---|
| National Institutes of Health (NIH) | $750,000 | 2023 |
Contrats de développement pharmaceutique collaboratif
Aucun contrat de collaboration spécifique signalé dans les états financiers 2023.
Commercialisation potentielle des produits
- Essais cliniques en cours pour le nomacopan (couvercle) en maladies rares
- Revenus potentiels du développement des médicaments orphelins
Monétisation de la propriété intellectuelle
En 2023, aucune monétisation directe de la propriété intellectuelle n'a déclaré.
Revenu total pour l'exercice 2023: 1 421 000 $
Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Value Propositions
You're looking at the core value Akari Therapeutics, Plc is trying to deliver with its pipeline assets as of late 2025. It's all about differentiation in crowded spaces, especially oncology and ophthalmology.
Novel ADC payload (PH1) designed to overcome resistance in solid tumors
The value here is moving beyond the established payload classes that are showing limitations in the market. The existing landscape heavily relies on two toxin classes: DNA damaging agents and microtubule inhibitors. For context, the 2023 sales for products using DNA damaging agents were reported around $1.0B and $2.7B, while microtubule inhibitors were around $1.75B and less than $100M for different products, based on a corporate presentation snapshot. Akari Therapeutics, Plc's lead candidate, AKTX-101, uses the novel PH1 payload, a spliceosome inhibitor, which disrupts RNA splicing. This mechanism is designed to deliver direct tumor cell cytotoxicity and, critically, generate neoantigens. Preclinical data showed that Trastuzumab-PH1 drives macrophages toward an anti-tumor state and causes expansion of B cell clones with subsequent IgM antibody production. Akari Therapeutics, Plc is initiating IND-enabling studies for AKTX-101, which targets the Trop2 receptor.
Potential for a long-acting geographic atrophy (GA) therapy with PAS-nomacopan
For geographic atrophy, the value proposition centers on patient convenience and potentially mitigating a known complication. PAS-nomacopan is a long-acting candidate that received positive and constructive Pre-IND feedback from the US FDA on July 29, 2024, setting the stage for an IND submission in 2025. The goal is to support a clinical dose interval of 3 months or longer, potentially translating to only 3 or 4 intravitreal injections a year. This compares to existing therapies where dose intervals are shorter.
Dual mechanism of action in nomacopan (C5 and LTB4 inhibition)
The investigational nomacopan, which PAS-nomacopan is based on, offers a dual hit. It is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. The LTB4 inhibition component is specifically important for the GA indication, as LTB4 can upregulate VEGF-A production, which is linked to choroidal neovascularization (CNV) risk associated with approved inhibitors. The company is advancing this long-acting version for intravitreal treatment of GA.
Targeting high-unmet-need oncology indications with AKTX-101
AKTX-101 is positioned to address niches where current ADCs fall short. The company sees a large opportunity in solid tumors like lung, colon, and gastric cancers. The value here is the potential for enhanced activity as a single agent, low off-target toxicity, and the ability to induce epitope spreading, which means resistant cells can be killed by the immune response.
Platform technology for generating multiple ADC candidates
The underlying platform technology provides the capability to generate a pipeline of candidates beyond the lead. This platform uses the PH1 payload as its cornerstone to build ADCs against a wide range of tumors. The company is advancing AKTX-102, which is expected to disclose its target and more details by the end of 2025. The platform is designed to fuel this growing pipeline.
Here is a quick look at the financial context surrounding these development efforts as of late 2025:
| Financial Metric | Value as of Late 2025 | Date/Context |
| Cash and Equivalents | $2.5 million | September 30, 2025 |
| Net Loss (Q3 2025) | $6.4 million | Three months ended September 30, 2025 |
| Ordinary Shares Outstanding | 71.5 billion | November 13, 2025 |
| Net Proceeds from March 2025 Offering (YTD) | $5.9 million | Year to Date September 30, 2025 |
The pipeline focus is clear, but the cash position requires you to watch capital allocation closely.
The key value drivers for the ADC pipeline include:
- Direct Tumor Cell Cytotoxicity from PH1 payload.
- Generation of Neoantigens stimulating immune response.
- Ability to Induce Epitope Spreading.
- Potential Synergy With IO (Immuno-Oncology) agents.
Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Customer Relationships
High-touch, direct engagement with Key Opinion Leaders (KOLs) in oncology
Akari Therapeutics, Plc engages directly with scientific leadership to validate its novel ADC platform. The company announced the formation of its Scientific Advisory Board and the inaugural appointment of renowned Medical Oncologist, Sara A. Hurvitz, MD, FACP, in October 2025. CEO Abizer Gaslightwala provided an overview of ADC innovation, highlighting the novel PH1 payload, in a CEO Corner segment released November 25, 2025. Data regarding the spliceosome targeting payload, PH1, was presented at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting in November 2025.
- Appointment of Dr. Sara A. Hurvitz to Scientific Advisory Board in October 2025.
- Presentation of PH1 payload data at the SITC Meeting in November 2025.
Intensive investor relations to secure ongoing equity financing
Securing capital is a continuous relationship management activity for Akari Therapeutics, Plc. The company executed two significant financing events in 2025 alone. The Interim CFO brings over 20 years of leadership experience, including raising over $170M+ in capital. The company has a history involving 8 institutional investors. The latest reported financing activity in late 2025 involved a registered direct offering to raise approximately $2.5 million at $0.80 per ADS. This followed a private placement in March 2025 that raised approximately $7.6 million, priced at $0.87 per ADS based on the February 28, 2025, closing price. The company reported a negative EBITDA of $12.8 million in the last twelve months leading up to October 2025.
| Financing Event Date (2025) | Gross Proceeds | ADS Price | Investor Support |
| October 2025 | Approximately $2.5 million | $0.80 per ADS | Registered Direct Offering |
| March 2025 | Approximately $7.6 million | $0.87 per ADS | Private Placement (Existing Shareholders/Insiders) |
The closing price for Akari Therapeutics, Plc ADSs on July 25, 2025, was $1.12 per ADS. Historically, the largest funding round was a Post IPO round for $75M in September 2015, contributing to a total historical raise of $2.43M over 9 rounds.
Direct communication with regulatory bodies (FDA) for IND/clinical guidance
Engagement with the U.S. Food and Drug Administration (FDA) is critical for advancing pipeline assets. Akari Therapeutics, Plc received positive and constructive Pre-IND (PIND) feedback from the FDA on July 29, 2024, concerning PAS-nomacopan for Geographic Atrophy (GA). The company expects to submit the Investigational New Drug (IND) application in 2025 to initiate the first clinical studies for this treatment. A full-scale batch of the drug substance, intended for IND-enabling studies and initial clinical development, was successfully manufactured and released under Good Manufacturing Practices (GMP) by Wacker Biotech GmbH. Earlier in its history, the company had a successful End of Phase II meeting with the FDA regarding Nomacopan for Bullous Pemphigoid (BP) in August 2020.
- IND submission for PAS-nomacopan anticipated in 2025.
- Positive Pre-IND feedback received from FDA on July 29, 2024.
- GMP-compliant drug substance manufactured by Wacker Biotech GmbH.
Strategic business development with potential licensing partners
Akari Therapeutics, Plc actively manages relationships to out-license non-core or complementary assets. The company is specifically seeking external licensing partners for its preclinical PAS-nomacopan program in Geographic Atrophy (GA). Furthermore, the company stated an intent to seek license partners for its TROP-2 ADC program. The merger with Peak Bio, which closed November 14, 2024, was structured to emphasize business development and licensing opportunities. Potential deal structures previously mentioned include an Undisclosed upfront payment with up to $325.5M in milestones and royalties, or another structure involving $50M upfront for rights outside of China and a total deal potential of $1.15B plus royalties.
The company's ADC Platform is designed to generate novel ADC candidates against any relevant target, supporting future partnership opportunities.
Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Channels
The Channels for Akari Therapeutics, Plc (AKTX) are currently centered on external engagement for data dissemination and capital raising, given the preclinical stage of its lead asset, AKTX-101, and the stated need to secure non-dilutive capital.
Direct-to-Specialty-Physician sales force for future commercialized products
Akari Therapeutics, Plc (AKTX) has not established a direct-to-specialty-physician sales force as of late 2025, which is typical for a company with a preclinical-stage lead program, AKTX-101. The current channel strategy for future commercialization is heavily weighted toward securing a strategic partner, which would then provide the necessary infrastructure, including a sales force, upon successful clinical progression. The company's operational focus is on advancing the ADC platform, with cash on hand previously guided to be sufficient to fund planned operations into September 2025. The net loss from operations for the first quarter of 2025 was approximately $3.7 million.
Out-licensing agreements with larger pharmaceutical companies
The pursuit of out-licensing agreements is a primary channel for generating non-dilutive capital and advancing the pipeline. The company is actively seeking a licensing/strategic partner for AKTX-101 (TROP2 PH1 ADC). Furthermore, Akari Therapeutics, Plc (AKTX) is leveraging opportunities for non-dilutive capital through partnering of its legacy pipeline assets. The company announced a $2.5 million registered direct offering in October 2025, indicating an ongoing need for capital to fund research and development activities, which are critical to making out-licensing more attractive.
The strategic focus on partnering is underscored by the appointment of a seasoned Head of BD, Oncology (Mark Kubik), to bolster partnering capability.
Scientific publications and conferences to disseminate preclinical data
Dissemination of preclinical data through scientific venues serves as a key channel to validate the technology and attract potential partners. The company planned to present anticipated PH1 Payload preclinical data at a scientific conference in the second half of 2025. Specific engagement channels included:
| Event/Publication Channel | Date/Timeframe | Key Data/Activity |
| SITC November 2025 Poster | November 2025 | Poster: A Novel Splicing- Targeted ADC Drives Immune Activation, Synergy with Checkpoint Inhibitors, and Enhanced Therapeutic Potential beyond Cytotoxicity |
| 40th Annual Society for Immunotherapy of Cancer Meeting | Early November 2025 | Presented promising data for PH1 payload; Trastuzumab-PH1 ADC showed a 74% complete response rate in colon cancer models when combined with anti-PD1 therapy |
| H.C. Wainwright 27th Annual Global Investment Conference | September 8-10, 2025 | CEO Abizer Gaslightwala delivered a presentation and conducted one-on-one meetings with registered investors |
The presentation webcast at the H.C. Wainwright conference was available starting September 5, 2025, at 7:00 AM ET and remained accessible on the company's website for 90 days.
Investor presentations and corporate website for capital markets
Investor engagement is a critical channel for maintaining liquidity and funding operations. The company utilized updated investor presentations, such as the one released on August 19, 2025, for stakeholder meetings. The financial context surrounding these capital market activities is stark:
- Cash on hand as of March 31, 2025: approximately $2.6 million.
- Net proceeds from a March 2025 offering: approximately $6.0 million.
- October 2025 Registered Direct Offering Price: $0.80 per ADS.
- October 2025 Offering Gross Proceeds: approximately $2.5 million.
- Market Capitalization (August 2025): $32.94M.
- Market Capitalization (October 2025): $32 million.
- Closing Price of ADSs (July 25, 2025): $1.12 per ADS.
- Maximum aggregate offering price under July 2025 Form S-3 shelf registration: $75 million.
- Share Purchase Agreement with White Lion Capital (August 29, 2025): up to $25 million in newly issued Ordinary Shares.
The negative EBITDA for the last twelve months leading up to October 2025 was $12.8 million.
Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Customer Segments
Large pharmaceutical/biotech companies for ADC platform or nomacopan licensing
Akari Therapeutics, Plc is actively seeking licensing or strategic partners for its lead asset, AKTX-101, which targets the Trop2 receptor. The company's market capitalization as of November 2025 was reported at $22.8 million. For the three months ended March 31, 2025, the net loss from operations was approximately $3.7 million. The platform technology is designed to generate novel ADC candidates against any relevant target, allowing for multiple program developments for additional licensing partnerships.
Oncologists and hematologists treating solid tumors (future)
This segment is targeted by the development of AKTX-101, a preclinical stage ADC candidate. The focus is on solid tumors where the Trop2 receptor is expressed in the highest number of cancer types.
- Targeted tumor types include lung, breast, colon, and prostate cancers.
- AKTX-101 utilizes the novel PH1 payload, a spliceosome inhibitor.
- Preclinical data presented in November 2025 showed a 74% complete response rate in colon cancer models when a Trastuzumab-PH1 ADC was combined with anti-PD1 therapy.
Patients with solid tumors targeted by the AKTX-101 program
The AKTX-101 program is focused on a variety of solid tumors expressing the Trop2 receptor. The company is advancing IND-enabling studies with plans to move this ADC into clinical trials. The platform's ability to precisely tune assets allows for program development across a range of cancers.
| Deal Type | Upfront Payment | Total Potential Value (Milestones & Royalties) | Date Announced |
| Licensing | $130 million | Up to $1.34 billion | May 2025 |
| Licensing | $47 million | Up to $1.16 billion | January 2025 |
| Licensing | $50 million | Up to $1.15 billion (outside China rights) | January 2025 |
Patients with geographic atrophy (GA) for the PAS-nomacopan program
While the HSCT-TMA clinical stage program with nomacopan was suspended in May 2024, the potential patient segment for a GA therapy is substantial, as reflected in market data. The global population of geographic atrophy sufferers is estimated to be more than 8 million.
- The Geographic Atrophy (GA) Market size across the top 7 markets (US, EU4, UK, Japan) was valued at USD 25.6 Billion in 2024.
- The GA Market is projected to grow from USD 24.93 Billion in 2025 to USD 51.39 Billion by 2035.
- In the US, approximately 1.49 million Americans are affected by late-stage, vision-threatening age-related macular degeneration (AMD), which includes GA, as of January 2025.
- The US market for AMD drugs reached US$ 10.57 billion in 2024 and is expected to reach US$ 11.69 billion in 2025.
Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Cost Structure
You're looking at the cost side of Akari Therapeutics, Plc's business model as of late 2025. Since they are pre-commercial, the entire structure is built around funding their research and development, which means operating expenses are the main story. The total loss from operations for Q3 2025 hit $7.4 million.
Here's a breakdown of the key expense categories for the third quarter ended September 30, 2025:
| Cost Component | Q3 2025 Amount (USD) | Notes |
| Research and Development (R&D) Expenses | $249 thousand | Up from $143 thousand in Q3 2024. |
| General and Administrative (G&A) Expenses | $1.975 million | Approximates the $2.0 million figure; up from $1.709 million in Q3 2024. |
| Impairment Loss on Intangible Assets | $5.18 million | Full write-off of the in-process R&D related to the PHP-303 program. |
| Total Operating Expenses | $7.4 million | Sum of R&D, G&A, and other operating costs before the impairment charge. |
The most significant single event impacting the cost structure in Q3 2025 was the $5.18 million impairment loss on other intangible assets. This charge was specifically tied to the in-process R&D associated with the PHP-303 program, which the company fully impaired and wrote off.
You can see how the core operating costs stack up:
- Research and Development (R&D) expenses were $249 thousand for the quarter.
- General and Administrative (G&A) expenses were $1.975 million.
The G&A line item is where you'll find the costs associated with being a public entity and compensating the management team. Specifically, non-cash stock-based compensation accounted for $685 thousand during Q3 2025.
The costs associated with maintaining the ADC discovery platform and the Intellectual Property (IP) portfolio are embedded within the R&D and G&A figures, as the company is focused on its Antibody-Drug Conjugate (ADC) pipeline, including the lead asset AKTX-101. Remember, patent amortization is calculated over the shorter of the legal or useful life, and costs to maintain and defend patents are expensed in the period issued.
For perspective on the nine-month run rate ending September 30, 2025:
- R&D expenses totaled $1.7 million.
- G&A expenses totaled $7.139 million.
Finance: draft the 13-week cash view by Friday, focusing on burn rate excluding the one-time impairment.
Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Revenue Streams
Akari Therapeutics, Plc (AKTX) revenue streams as of late 2025 are primarily non-operational, centered on capital raising activities to fund its Antibody Drug Conjugate (ADC) pipeline development.
Equity financing from public offerings provided significant, though intermittent, capital injections throughout 2025.
- Equity financing from public offerings, like the $5.9 million net proceeds YTD 2025.
- Financing activities included a March 2025 offering with $6.0 million gross proceeds, of which $4.0 million was received in April 2025.
- A Registered Direct Offering in October 2025 was agreed upon for gross proceeds of approximately $2.5 million.
The company has been actively engaging in business development discussions, which represent potential future revenue streams contingent on external partnerships.
- Potential upfront and milestone payments from strategic licensing deals for the TROP-2 ADC program and monetization of non-core assets.
Future revenue from commercialization remains theoretical at this stage, as the pipeline is pre-commercial.
- Future royalties and product sales from commercialized ADC or nomacopan therapies.
Short-term funding has been secured through various debt instruments, which are liabilities but represent cash inflows for operations.
Here's a quick look at the debt instruments and related financing activity in 2025:
| Financing Instrument/Event | Date/Period | Associated Financial Amount |
| August 2025 Note Purchase Agreements (Gross Purchase Price) | August 2025 | $3.0 million |
| August 2025 Note Purchase Agreements (Aggregate Principal Amount) | August 2025 | $3.8 million |
| August 2025 Private Placement (Aggregate Principal Amount) | August 2025 | $2,826,250 |
| August 2025 Private Placement (Purchase Price) | August 2025 | $2,261,000 |
| Convertible Notes (Balance Sheet as of Q3 2025) | Q3 2025 | $0.7 million |
| Notes Payable (Related Party, Balance Sheet as of Q3 2025) | Q3 2025 | $1.3 million |
The balance sheet as of September 30, 2025, also listed $198k in notes payable to third parties.
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