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Development Plans
  • Stem Cell R&D: Reneurish focuses on advanced research and development of hiPSC-derived NPC therapies, optimising CRISPR-engineered iPSCs and enhancing BDNF expression through AAV vectors for improved stroke recovery outcomes. The pipeline is strategically designed for scalability and clinical efficacy, with potential expansion into other neurological conditions following successful proof of concept in stroke treatment.
  • Clinical Trials & Regulatory Compliance: Currently at Technology Readiness Level (TRL) 3, Reneurish prioritises completing in vitro studies to validate safety and efficacy. The company has consulted with the EMA, AEMPS, and Spanish Ministry of Health to understand regulatory requirements for Advanced Therapy Medicinal Products. These early-stage discussions prepare Reneurish for future Clinical Trial Applications and GMP compliance as they progress toward preclinical development.
  • Business Development & Strategic Partnerships: Establishing strategic partnerships is crucial for scaling operations and accelerating market entry. Reneurish aims to collaborate with pharmaceutical companies, academic institutions, and biotech firms to enhance IP development, co-development opportunities, and distribution capabilities, particularly after Phase 2 trials. This approach fosters synergistic relationships that enhance the overall value proposition of their technology.
  • Intellectual Property & Licensing: Securing IP protection for proprietary technologies is a top priority for Reneurish, focusing on patenting the universal iPSC line and novel BDNF expression system. The company is working with the Fundació Bosch i Gimpera to build a comprehensive patent portfolio. Once IP is secured, Reneurish plans to explore strategic licensing agreements with larger pharmaceutical companies specialising in regenerative medicine and neurotherapies, aligning with long-term goals for market entry and scalability.
  • Pharmaceutical Companies: Strategic alliances with major pharmaceutical firms are essential for co-development and global distribution efforts after Phase 2 clinical trials. These partnerships will accelerate market entry and scaling by leveraging established networks and resources.
  • Academic & Research Institutions: Collaborations with leading academic institutions provide access to cutting-edge research, advanced laboratory facilities, and preclinical study expertise. These partnerships enhance Reneurish's scientific and technological capabilities, driving continuous innovation.
  • Contract Research Organizations (CROs): Partnering with CROs will optimise clinical trial operations, ensuring regulatory compliance, efficient trial management, and the generation of high-quality clinical data. This collaboration strengthens Reneurish's applications to regulatory authorities.
  • Healthcare Providers: Close collaboration with hospitals and stroke rehabilitation centres positions these entities as clinical trial sites and key distribution partners post-market approval. This ensures that Reneurish's solution reaches those in need effectively.
  • R&D Expertise: Our team of leading scientists in regenerative medicine, cell biology, and genetic engineering is the foundation of our product innovation and clinical success, driving the development of cutting-edge therapies.
  • IP Portfolio: Our intellectual property encompasses patents for CRISPR-engineered iPSCs, universal donor NPCs, and our proprietary BDNF expression system, providing a robust competitive advantage in a rapidly evolving field.
  • Laboratory & GMP-compliant Manufacturing Facilities: Access to state-of-the-art laboratories and GMP-compliant manufacturing infrastructure will enable scalable production while adhering to stringent quality and regulatory standards, essential for fulfilling clinical trial requirements.
  • Clinical Trial Infrastructure: Establishing comprehensive clinical trial sites, patient recruitment pipelines, and robust data management systems are vital for the successful execution of our clinical programs, ensuring high-quality standards throughout the trial process.
  • Financial Capital: Securing funding from seed to Series A/B rounds is crucial to support clinical trials, product development, and the long-term growth trajectory of the company. Our funding strategy leverages diverse sources to meet these financial needs.

Reneurish’s stem cell-based therapy for stroke recovery combines CRISPR-engineered iPSC-derived neural progenitor cells (NPCs) with precisely regulated BDNF expression, offering a breakthrough in neural regeneration. Unlike current treatments that focus on minimising stroke damage, this therapy actively promotes neural recovery, enhancing motor and cognitive function. The scalable, off-the-shelf solution establishes Reneurish as a leader in regenerative neurology. The long-term strategy includes exploring mergers and acquisitions, providing pharmaceutical companies with a strategic entry into the expanding regenerative medicine market.

  • Pharmaceutical Companies: Targeting large pharmaceutical firms interested in licensing or acquiring our technology following Phase 2 trials, especially those seeking to diversify their portfolios into neuroregenerative medicine.
  • Hospitals & Stroke Centres: These institutions will administer our therapy to stroke patients and act as key distribution partners post-market approval, ensuring that our solution reaches those in need.
  • Neurologists & Clinicians: Medical professionals specialising in stroke care will play a vital role in prescribing and advocating for our therapy, enhancing patient access and adoption.
  • Stroke Patients: The ultimate beneficiaries of our therapy, stroke survivors, will experience significant improvements in recovery outcomes, positioning our solution as a life-enhancing intervention.
  • Direct Sales & Hospital Partnerships: We will forge direct sales relationships with hospitals and stroke centres to ensure widespread access to our therapy, while fostering long-term collaborations for ongoing treatment.
  • Biopharmaceutical Collaborations: Leveraging partnerships with established pharmaceutical companies will facilitate rapid global distribution post-Phase 2 trials, enabling swift market entry for our innovative therapy.
  • Medical & Industry Conferences: Presenting clinical data at key industry conferences will enhance our credibility, attract strategic investors, and generate interest from healthcare providers eager to adopt our solution.
  • Key Account Management (Pharma): We will cultivate long-term, strategic relationships with pharmaceutical companies through licensing, co-development agreements, and potential acquisition, ensuring mutual growth and sustainability.
  • Clinical Support for Providers: Offering comprehensive clinical support to hospitals and stroke centres will facilitate the seamless adoption of our therapy, providing training, resources, and ongoing assistance.
  • Patient Engagement & Education: By delivering education and support for stroke patients and caregivers, we aim to foster trust, enhance treatment compliance, and ultimately improve clinical outcomes, ensuring a positive reception of our therapy in the market.
  • R&D Expenses: A substantial portion of the budget is allocated to ongoing research and development, including cell therapy technology development, laboratory equipment, reagents, and bioreactors essential for high-quality product development.
  • Clinical Trial Costs: Conducting Phase 1 and 2 trials will incur significant expenses related to patient recruitment, trial management, regulatory compliance, and associated overheads.
  • Manufacturing Costs: As operations scale, costs associated with GMP-compliant production of iPSC-derived NPCs will increase, requiring investments in specialised equipment and facilities.
  • IP & Regulatory Fees: Securing patents and navigating complex regulatory pathways involves legal, administrative, and regulatory costs critical for compliance and protection of innovations.
  • Sales & Marketing: Following successful trials, investments will be made in marketing initiatives targeting healthcare providers and pharmaceutical companies, as well as participation in key industry events to drive adoption and awareness of the therapy.
  • Licensing & IP Agreements: We will generate revenue through licensing our proprietary technologies to pharmaceutical companies, securing upfront payments, milestone-based payments, and ongoing royalties, contributing to long-term sustainability.
  • Clinical Trial Sponsorship: Partnering with research institutions and biopharma for sponsored clinical trials will provide an additional revenue stream, helping to offset some of the costs associated with clinical research.
  • Direct Sales: Revenue will be generated from direct sales of our therapy to hospitals and stroke rehabilitation centres following regulatory approval, creating a consistent income stream.
  • Strategic M&A Exit: Our long-term exit strategy involves a potential acquisition by a large pharmaceutical company after successful Phase 2 trials, capitalising on the high demand for innovative neuroregenerative therapies and delivering substantial returns for our investors.


Roadmap

map with the incidence of ischemic stroke every 100.000 inhabitants

The following roadmap outlines the development plan for Reneurish, detailing the key milestones from 2024 to 2031. The process begins with in vitro validation, where we have already achieved proof of concept (POC) and secured €30k in funding. The next steps include preclinical studies, regulatory preparations for Phase 1 clinical trials, and progresses to Phase 2 with an exit strategy. Each phase includes critical actions such as securing additional funding, validating therapies, engaging with regulatory bodies, and ensuring GMP compliance. This roadmap highlights the strategic steps necessary to bring the therapy from early research stages to successful clinical trials and potential acquisition by pharmaceutical companies.




Intellectual property


"If it were your own money on the line, would you still choose to patent?" - Salvador Mena (Fundació Bosch and Gimpera).

Patents are crucial for IP protection, granting exclusive rights that prevent third parties from commercially exploiting an invention for a limited time (European Patent Office, EPO). This exclusivity is vital for protecting our therapies, but the patenting process can be lengthy and expensive. A key requirement for a European patent is that the invention must not be publicly disclosed before the application is filed.

We have proactively secured our IP by conducting a comprehensive patent search using platforms like Patentscope to identify similar existing technologies. While BDNF expression and cell therapies for stroke recovery have been studied (e.g., WO2019147036A1 and US 2013/0045189 A1), our innovative approach focuses on time-regulated gene expression of neurotrophic factors, reducing toxicity during critical therapeutic windows. Our use of CRISPR technology to develop universal donor cells further strengthens our IP portfolio.

To ensure a robust patent strategy, we consulted IP experts such as Sara Holland (Potter Clarkson), Jennifer O'Farrell (D Young & Co LLP), and Salvador Mena (Fundació Bosch i Gimpera). Their insights have been invaluable.

We are collaborating with the Fundació Bosch i Gimpera (FBG), the University of Barcelona's technology transfer office, to establish a comprehensive patent portfolio. If a UB personnel is co-inventor, FBG will cover patent costs. Our decision to patent is strategic; it focuses on creating value through licensing or building a company around the invention.

FBG will manage our IP, and if multiple co-inventors are involved, we must transfer rights to authorize FBG to represent us. This ensures protection and maintains our patent share if it becomes commercially viable. If a company is formed, FBG will transfer the patent upon incorporation and offer workspace for spin-offs at €600/month.

It’s important to note that IP protection begins with a patent; once patented, the invention can be made public without risk. If published before patenting, it cannot be protected. FBG emphasizes the need to assess whether the potential patent value justifies its cost. We aim to explore strategic licensing agreements with larger pharmaceutical companies specializing in neuroregenerative medicine.

In conclusion, we are now completing FBG's invention form to start the patent management process. After a thorough prior art search and confirmation of "freedom to operate," we can proceed with patenting. FBG also suggests gathering feedback from pharmaceutical companies to gauge interest in our therapy, which could lead to future licensing or acquisition. As FBG highlights, "Publishing is the currency of academia, but it can undermine tech transfer by limiting IP opportunities essential for commercialization." We must balance our scientific contributions with innovation protection.

We plan to file a patent for our expression system after the iGEM Jamboree, aligning with our PI's interest. We are confident that the system meets the essential patentability criteria: novelty, inventive step, and industrial application, particularly in stroke recovery. Furthermore, we have ensured that no critical information about our proprietary technology has been publicly disclosed, safeguarding the patent's approval. By securing robust patent protection, we aim to protect our IP and enhance the project's appeal to potential investors and strategic partners, maximizing its commercial potential and long-term success.



Risk assessment


Identifying, evaluating, and managing potential challenges that could arise throughout the development and clinical implementation of our therapy is a critical step. This process encompasses analysing scientific, clinical and patient-centred, regulatory, logistical, financial and operational risks.

map with the incidence of ischemic stroke every 100.000 inhabitants
map with the incidence of ischemic stroke every 100.000 inhabitants

By systematically evaluating these risks, Reneurish aims to develop mitigation strategies that will enable us to advance our stroke therapy while safeguarding patient safety and ensuring compliance with all regulatory standards.

For more detailed analysis, see the complete risk assessment.

In order to delve into Reneurish’s financial projections and understand why they are pivotal for our growth and sustainability, check out our section about cost analysis and funding strategy.



Cost analysis


The development and commercialization of our therapy is a complex and capital-intensive process, particularly as we advance from early R&D stages through clinical trials. The challenge arises from the use of advanced technologies, including hiPSC, CRISPR, AAV vectors, and complex gene expression systems. Below is a detailed breakdown of the costs involved and our strategic funding approach, focusing on developing an ATMP.


The development and commercialization of our therapy is a complex and capital-intensive process, particularly as we advance from early R&D stages through clinical trials. The challenge arises from the use of advanced technologies, including hiPSC, CRISPR, AAV vectors, and complex gene expression systems. Below is a detailed breakdown of the costs involved and our strategic funding approach, focusing on developing an ATMP.



Preclinical development


Preclinical development, which includes safety testing, pharmacodynamics, and pharmacokinetics studies, is estimated to cost between €1 million and €3 million. This phase also covers regulatory expenses necessary to secure approval from the EMA to progress to human trials.

The development of a cell-based therapy involves complex cell manufacturing processes, which can significantly drive up costs. The generation, characterization, and scalability of our cells for therapeutic use require strict compliance with GMP (Good Manufacturing Practice) standards, contributing to the higher preclinical expenditures. Previous research estimates preclinical costs can account for 9.6% to 42.9% of total capitalised R&D costs.



Phase I clinical trials


Phase I trials focus on testing safety and dosage in a small cohort of stroke patients, typically costing around €4 million. This phase is critical for establishing the safety profile of the therapy and understanding how the body responds to the treatment.

Costs during this phase are influenced by the need for customised manufacturing, patient-specific monitoring, and close regulatory oversight, all of which are typical for ATMPs.



Phase II clinical trials


As clinical trials expand to assess efficacy on a larger scale, the costs rise substantially. Phase II trials, involving a larger cohort of patients, can reach up to €10 million. This phase not only evaluates the therapy's effectiveness in treating stroke and continues safety monitoring, but also introduces additional logistical complexities. These include an increase in trial sites, stricter regulatory compliance, manufacturing scale-up for consistent product supply, advanced efficacy testing protocols, comprehensive data management systems, and intensified safety monitoring throughout the trial duration.



Total development costs


Beyond the early clinical phases, the total cost of developing a complex cell therapy for stroke could reach €100 million, which includes long-term studies and regulatory submissions. Once clinical success is established, scaling up manufacturing for wider patient use and commercialization is expected to cost an additional €50 million, bringing the overall cost to approximately €150 million.



Cost drivers specific to ATMPs

  • Cell Manufacturing: The creation of therapeutic-grade cells from hiPSCs requires specialised, highly regulated environments that adhere to GMP. This includes stringent quality control for cell differentiation, expansion, and storage.
  • Complex Logistics: Handling live cell therapies involves temperature-controlled environments, strict supply chain management, and personalised patient monitoring, all of which drive up trial and production costs.
  • Regulatory Compliance: ATMPs are subject to specific regulatory pathways within the EMA that require substantial documentation, long-term patient follow-up, and post-marketing surveillance, which further increases costs.

Funding strategy

Reneurish has developed a comprehensive funding strategy to support its development of an innovative stem cell-based therapy for stroke recovery. The strategy is divided into four key stages:

map with the incidence of ischemic stroke every 100.000 inhabitants
  1. Early-stage Funding (Idea to Proof of Concept): The company aims to secure €100,000 to €200,000 through friends, family, and fools (FFF), crowdfunding, university support, and initial grants. They will also leverage pre-seed funding and national R&D subsidies from the Fundació Bosch i Gimpera and regional Catalan biotech grants like CaixaResearch. Collaborations with strategic investors from the pharmaceutical sector are also planned. The goal is to attract early interest from large biotech firms for quick returns through licensing or early acquisition.
  2. Preclinical Development Funding: Reneurish targets €2 million to €5 million from venture capital, business angels, and European grants. Key funding programs include the European Innovation Council (EIC) Accelerator and Horizon Europe. The company plans to engage biotech-specialised investors like Invivo Partners, Ysios Capital, and Alta Life Sciences. Milestone-based investment structures aim to enhance valuation by 20% to 40% upon successful completion of preclinical studies. The goal is a potential acquisition by large pharmaceutical companies for €20 million to €50 million.
  3. Clinical Trial Funding: As the company progresses to Phase I/II trials, it will seek larger investments from venture capital firms specialising in biotechnology and ATMPs. An Initial Public Offering (IPO) to raise €50 million to €100 million is considered for Phase III trials. Licensing opportunities could generate €5 million to €15 million in non-dilutive capital. The goal is to position for an IPO with 2x to 5x returns for early investors or acquisition offers from pharmaceutical firms valued at €100 million or more.
  4. Long-term Funding and Commercialization: For Phase III and commercialization, Reneurish anticipates attracting €50 million to €100 million in private equity investments. Strategic partnerships with larger pharmaceutical companies will be explored. Additional funding sources include the EIC Accelerator, Horizon Europe, and CDTI grants and loans. The ultimate goal is acquisition by a large pharmaceutical company, potentially valued at €200 million or more.

Throughout all stages, Reneurish remains open to early acquisition opportunities (€5 million to €20 million valuation range) and considers an IPO for gradual exits. The company prioritises building relationships with pharmaceutical acquirers and focuses on strategic M&A deals that enable retention of royalties or milestones, aiming for ongoing annual returns of around €1 million post-sale.


Exit strategy

Our primary exit strategy is to secure a high-value acquisition by a major pharmaceutical or biotech company through a structured Mergers & Acquisitions process. This approach focuses on demonstrating clinical success with our therapy, making Reneurish an attractive acquisition target for companies that have the infrastructure and expertise to scale and commercialise our stroke recovery solution globally.


Key M&A targets:

  • Large Pharmaceutical Companies: Potential acquirers include industry leaders such as Roche, AstraZeneca, and Johnson & Johnson, all of which have extensive experience in neurology, regenerative medicine, and clinical trials, allowing fast commercialization of our therapy.
  • Specialised Biotech Firms: Companies in Spain like Cellerix and Histocell, which focus on cell therapy and advanced therapies, are also potential partners.

By merging with a larger pharmaceutical company or a specialised biotech firm, we can leverage their resources and regulatory expertise to scale effectively. This M&A strategy ensures momentum towards commercialization while maximising shareholder value. Additionally, if further clinical milestones are achieved, a second acquisition opportunity may present itself before final regulatory approval.