Andrea Patricelli Malizia is the CEO of IAMA Therapeutics, a preclinical-stage pharmaceutical company focused on the discovery, development, and commercialisation of novel medicines to make a difference in the lives of individuals suffering from brain disorders.
Before IAMA Therapeutics, Andrea worked as Director of Strategy and Operations at IMT School for Advanced Studies Lucca, Italy, and as Director of Corporate Strategy at QStat Consulting in Boston, Massachusetts, USA. Andrea was also the Scientific Founder of BeRNA Therapeutics, a company developing novel biological drugs to cure chronic pain transcutaneously based in Boston.
Andrea holds a Degree in Molecular Biology from Università degli Studi di Siena, a PhD in Translational Medicine from University College Dublin, and an MBA from Northeastern University in Boston.
You have an extensive experience in the biotech industry at the international level, and recently you joined IAMA Therapeutics as CEO. What led you to this decision? What convinced you to join the startup world?
Andrea: I have a long and diversified experience in the pharmaceutical and biotech industry. I started my career as a research fellow at the University College of Dublin in Ireland, then at Harvard University and Biogen, a large pharmaceutical company in Cambridge, in the Greater Boston Area, before launching BeRNA Therapeutics.
Immediately after this experience, I worked serving companies of different sizes in the life science sector in corporate strategy. It always amazed me with the dynamicity and desire to disrupt the status quo in the startup world.
Back in Italy, I was looking forward to investing my expertise in business and life science, a multidisciplinary experience essential to drive the responsibilities of a leader in the biotech and pharmaceutical startup field.
There are very successful examples of large and medium pharmaceutical companies in Italy, with many micro-companies holding and advancing very promising ideas but with scarce access to private capital. When I met Laura Cancedda and Marco De Vivo, the two scientific founders of IAMA Therapeutics, I was fascinated by their desire to advance their research to a higher level in clinical development, which had already attracted the interest of Claris Ventures and CDP Venture Capital.
They fascinated me with their idea, energy and desire to create opportunities for individuals with cognitive and neurodevelopmental disorders. The idea published in high top rank and peer-reviewed journals was very welcomed by the scientific community and proved to be reliable in several experimental conditions. In addition, Annalisa Savardi and Marco Borgogno, research fellows who have investigated the efficacy of the candidate drugs at the Istituto Italiano di Tecnologia (IIT), have considerable know-how and a long-standing experience has joined IAMA Therapeutics to support further its research and translation in drug discovery and neuropharmacology. The synergy of the expertise of all the team is already designing an amazing business path for the future of this company.
IAMA Therapeutics is an Italian biotech company focused on discovering, developing, and commercialising novel medicines to make a difference in the lives of individuals suffering from brain disorders. The company was created thanks to a project of Istituto Italiano di Tecnologia (IIT). Can you tell us more about the business model of the company?
Andrea: In the pharma industry, R&D expenses are a significant burden on the cash flow. This is because liabilities and risks are so high at this level that the rate of success in moving forward to the later clinical developmental stages is meagre. For example, the advanced preclinical stage is the “death valley” of translational research before starting the first in human studies. And, moving forward, the probability of the candidate drugs to succeed becomes thinner, with just 5-10% of success for small molecules in the neurology area.
There are different strategies for the potential business model of IAMA Therapeutics, with an initial private investment primarily invested in R&D. Our business model relies explicitly on assessing R&D spending and profitability, valuing specific business development activities as partnering and licensing. This approach focuses on reducing the R&D expenses while hedging the risk of the company’s pipeline.
We have secured external partnerships in discovery and advanced preclinical development with renowned CROs and academic groups. At the same time, we have licensed a new class of selective inhibitors, as you mentioned from Istituto Italiano di Tecnologia (IIT). In the near future, we will secure other valuable IPs that will be out-licensed in later developmental stages if confirmed as promising assets in our research.
These are tremendous strategies to strengthen the organic growth of IAMA Therapeutics and expand its current pipeline, which has already provided significant results.
What results have you achieved until now?
Andrea: We have closed the first round of funding, the series A, raising € 8 million to start with the operating capital necessary to advance the clinical study in subjects with autism. We are looking forward to the next round by the end of next year to license and develop other programs. We in-licensed a new class of selective NKCC1- inhibitors from IIT.
NKCC1 is a cotransporter of the chloride in the brain, consistently reported in the literature, and linked to several neurodevelopmental and cognitive disorders. Thus, we look forward to exploring the plethora of diversified and potential therapeutics opportunities soon.
In addition, we also signed a sponsored research agreement with IIT to identify and select other candidate drugs targeting rare orphan diseases as secondary forms of autism and epilepsy, the latter in collaboration with a world-renowned research laboratory in Boston, Massachusetts, USA.
So, IAMA Therapeutics raised € 8 million from a pool of investors, including CDP Venture Capital and Claris Ventures. What are the development plans of the company?
Andrea: Our mission is to create opportunities for people with cognitive and neurodevelopmental disorders, especially children suffering from autism, epilepsy, or other neuropsychiatric forms.
Although our primary goal as a pharmaceutical company is to foster science in the lab, we intend to engage patients and organisations in the future development phases. It is our responsibility toward the people who need it the most.
I am laying the ground to enforce a strong sense of social responsibility and create awareness as many parents, and caregivers express to us every day their interest in our candidate drugs. Our first duty is to be committed to individuals with autism or other neurodevelopmental disorders.
In addition, I am bringing a more agile mindset while maximising the efforts in what we do as we strive to advance all the programs to the regulatory approval. And I believe we can do it together with international and renowned experts in the field, as per our Scientific Advisory Board constituted by the top clinicians and leaders in drug discovery.
Our mission is to create opportunities for the people who want to live their lives to the fullest. As scientists, we can provide these opportunities only through collaboration and a great sense of social responsibility in our development plans.
What are the main challenges you think you will experience in growing IAMA Therapeutics? What advice would you give to startup CEOs?
Andrea: The challenges could be intrinsic to the company and its assets and extrinsic threats.
As said earlier, any pitfall might happen in the drug development process in discovery or at a later stage in preclinical and clinical studies. Another possibility could be excessive spending for a low-profitable candidate drug if licensed. The latter, or threats, offer a different scenario in which the challenges could be based, for example, on competition, a lack of interest by licensors and investors, or poor coverage by health insurance if launched in the US market.
Thus, as you see, as a CEO, you always navigate in uncharted waters. Still, you constantly must assess potential risks, ponder any possible consequences on the business, and act accordingly to prevent any challenges. However, it is never a one-man-show, but teamwork in which passion for what is done is the only purpose that drives the team’s motivation.
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For more info on IAMA Therapeutics, visit: https://iamatherapeutics.com/