Introduction
Throughout our work on Renervate Therapeutics, entrepreneurial considerations have been central. Our Entrepreneurship work has entailed substantial research in a variety of areas, including on patents, intellectual property, marketing, pitching and commercialisation strategy . As evidenced by our in-depth business plan, our entrepreneurship research has culminated in an extensive business case and plan for the development and launch of our product into global markets, completed due to extensive research and entrepreneurial skill-set development.
Developing our Pitch Deck
As we planned to contact investors to corroborate the feasibility of launching Renervate Therapeutics as a start-up, we decided to create an ergonomic, digestible, and concise pitch deck. Ultimately, this is the first medium through which we contact potential stakeholders on behalf of the venture; it is vital to efficiently establish the reasons why Renervate Therapeutics would be worth capital raised through funding and grants. The average pitch is 5 - 10 minutes and this initial 5 - 10 minutes is what gives leeway to a more in-depth presentation with any individuals or organisations who are interested. In terms of the optimum number of slides for a pitch deck, this number ranges anywhere from 12 - 14 (with 19 being the upper limit) to guarantee that the attention of the audience is held entirely on delivery of our presentation.
To ensure cohesion of our pitch deck with general design aspects of Renervate Therapeutics, we have based the design off the centralised colour scheme. The motifs added onto the pitch deck are simple and sleek geometric shapes which align nicely with the countenance of our website. This pitch deck has undergone multiple iterations with help from Adrian Signell at The Creator Fund which will be elaborated on below.
Dragon's Biome
Figure 1: Dragon's Biome Event
As part of their project, KU Leuven organized an entrepreneurial meetup event where various iGEM teams could pitch their projects and receive expert feedback from their judges. The judges included Mathias Vissers (co-founder of Netic Health), Sofia-Sigal-Passeck (co-founder and CEO of UniPhage), Bram Perdu (an expert in life sciences) and Geoff Smith (manager of Geoff Smith Consulting Limited). Each of the pitches were timed to 6 minutes after which we were given feedback on our pitch deck. Following the pitch, we were advised to implement more scientific content into our pitch deck and to focus more heavily on the numerical values present throughout.This pitching opportunity was crucial for developing our final pitch deck which is available on our entrepreneurship page.
Discussions with Adrian Signell
Figure 2: Zoom call with Adrian Signell
We contacted Adrian Signell in August 2021 to discuss our entrepreneurship. Adrian Signell is an investment partner with The Creator Fund, a group dedicated to investing in university-led startups. We asked Adrian Signell for advice on our business model and to review the first draft of our business plan. Additionally, Adrian was one of the first individuals to see our pitch deck. Through talking with Adrian, we decided to look into collaborating and partnering with other biotech startups as an additional source of revenue.
As a result of our call with Adrian, we developed a two model business system; in one part of the model we would be selling our therapeutic to clinical organizations in the UK and abroad, using local supply chains to deliver our project to the patient. The second part of our business model focuses on partnerships and collaborations. This means that along with selling our therapeutic device, we can also sell components of our project such as the PCL scaffold, our PVFP-5 bioadhesive and our novel Chondroitinase ABC protein. The unique properties of each component have their own unique market value and, as such, we aim to capitalize on this in our business model. We have already made contact with groups such as NurExone Biologic, an Israeli-based group that is implementing exosome technology as a drug administration method for treating SCI. In particular, we have looked into using their exosome technology for the administration of our ChABC enzyme. We aim to engage in further biotech-related collaborations in the future as a means of revenue to continue funding our business.
Our Business Plan
The main aim Renervate Therapeutics is getting our combinatorial therapy from the lab into the market. In order to provide a detailed guide of the different aspects of our project, we created an in-depth business plan for Renervate Therapeutics, taking into account all of our stakeholders including SCI patients, the NHS, charities, and biomedical companies. Renervate Therapeutics’ business plan includes sections related to market analysis, intellectual property and funding routes, to ensure investors that we have developed a holistic and thorough analysis of the role our firm would play in the current SCI market.
We pitched our business plan to Adrian Signell, a student investor at venture capital firm ‘The Creator Fund’, who advised us on further ways to improve it. Taking into account this was student-led, he mentioned structural changes that would be required if we translated our research into a start-up.
Renervate Therapeutics' Business Plan
Our Patenting Strategy
We spoke to Dr Ceri Mathews - the IP & Licensing Manager at the Intellectual Property and Licensing Team at King's College London - who was able to give us a clearer view of what the patenting process would be like for an undergraduate team creating protectable intellectual property while participating in an open-source competition like iGEM. He explained to us how the intellectual property created under King’s College London would be dealt with in terms of ownership. Dr Mathews also provided examples of the types of situations where intellectual property would be owned by the College. From this, we were able to identify aspects from our team dynamic and development of any potential intellectual property to conclude that we would be able to negotiate ownership of our own intellectual property. Being a student-led team means we are not led by employees of the College, which is one such criterion for our IP becoming a KCL-owned IP. Moreover, he highlighted that only direct contributors to improvements of an invention from Phase I or Phase II could own the patent filed. This, therefore, alleviated any issue of third-party ownership of our intellectual property following Phase 2.
Additionally, Dr Mathews gave us insight into the pre- and post-patent applications considerations we would have to make. He outlined situations where - though not immediately obvious - our actions could lead to our novel ideas being classed as already publicly disclosed. Consequently, this would bar us from obtaining a patent for it. For example, by discussing or mentioning novel future improvements of an invention in a public setting(e.g. through a scientific paper or public conference), it would be classed as public disclosure and we would no longer be able to patent the novel improvement through the UK IP office.
Furthermore, Dr Mathews outlined the pros and cons of filing for multiple patents within a single project. As our project is multidisciplinary and a multicomponent therapeutic strategy, we inquired about whether we should push for the whole treatment to be patented as one or whether we should split it up into its constituents to result in multiple patents. He explained why both of these two options would be desirable, for example, the expenses for obtaining and protecting multiple patents would be higher but it would be harder to make a valid case to explain why our multiple novel ideas should be patented as one invention. He also emphasised that if we were applying for multiple patents, we would have to ensure they were all filed on the same day to ensure one patent does not expose another. Overall, Dr Mathews gave us a much clearer insight into intellectual property and its necessity for utmost protection to ensure that we are successful in obtaining patents for our prospective intellectual property.
Industry Outreach
Conversations with NurExone Biologic Ltd
We have approached NurExone Biologic - a company focused on treating SCI with exosomes containing PTEN siRNA loaded mesenchymal stem cells - for a potential partnership. Together, we discussed the benefits of incorporating their patented exosome delivery system to enhance the effectiveness of ChABC administration to our patient subset. As NurExone Biologic have been able to develop and test a non-invasive treatment for SCI, they remain one of our main competitors and partnering with them allows us to further the scope of our therapy. The incorporation of ChABC and exosomal delivery provides us with a unique selling point and will be of interest to potential investors and clinical partners. This, in turn, enables us to focus on the long term growth and expansion of our company through collaborative marketing and development strategies to eventually become the foremost treatment for SCI.
Figure 3: Zoom call with NurExone Biologics
Conversations with NeuroStimSpinal
We approached NeuroStimSpinal to understand and learn from their scientific and entrepreneurial journey of becoming a company aimed at treating spinal cord injuries. We recognised many parallels between both our projects; they, too, are planning to use a combinatorial approach involving the application of a scaffold in treating spinal cord lesions. However, their treatment involves a graphene scaffold and the use of electrostimulation to promote neuronal growth.
We spoke to Paula Marques, the Coordinator at NeuroStimSpinal. She informed us regarding the ethical approvals required for a therapeutic product which necessitate a certain level of technical readiness to enter clinical trials. This advice is crucial to our pre-clinical trial preparatory period where we would have to consider the legal work needed to guarantee that our project can be brought to market. Additionally, we must consider the treatment of animal models throughout in-vivo studies consequently highlighting the need for careful design and refinement of studies to reduce animal suffering. This is to ensure that we are keeping in line with government regulations. Ms Marques further highlighted the limitations of Brexit within the context of attaining different EU funding grants. Hence, we have decided to expand our fundraising plan and apply for non-EU grants. Ms Marques emphasized the importance of having conversations with the stakeholders e.g. neurosurgeons to incorporate clinical advice within our therapeutic product. Neurosurgeons will have a tendency to compare our scaffold approach to hydrogel treatments. As hydrogels are less invasive and injectable, this approach is favoured by many neurosurgeons. Nevertheless, we have identified that one of the strengths of our scaffold lies in the intricacy of the microarchitecture which mimics spinal cord tissue properties and provides structural support to growing axons - a unique advantage compared to hydrogel based competitors.
We pinpointed the unique selling point of NeuroStimSpinal’s project being the novel graphene based nature of their scaffold which is responsive to external electrical signalling. Together with their designed typography of the scaffold, they aim to promote neurite outgrowth and functional recovery. With the same aim and similar scaffold approach, we decided to include our unique selling point in our business plan to out compete other emerging therapeutic approaches like this. Renervate Therapeutics’ unique selling point is the MFP coating on the surface of our PCL scaffold, utilizing the underwater adhesiveness and non-immunogenic nature of MFP to adhere the scaffold in the lesion site and prevent inflammatory foreign body responses.
Figure 4: Zoom call with NeuroStimSpinal
