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EF: What opportunities do you see next year, and what are you most excited about?
MS: The buzzword will be AI in the upcoming year, especially in Silicon Valley. Conversations there revolve around how AI can revolutionize the industry. Recent reports by McKinsey and others show how the industry is investing in AI and how it could significantly speed up drug discovery, cut costs, and reduce attrition rates. Over the past year, we have been working on this, and we are ready to implement solutions. Success stories exist of companies that are utilizing AI modules to support drug discovery.
We are also diving deeper into an exciting approach of targeting human mRNA directly with small molecules instead of focusing just on proteins. While it is more technically challenging, mRNA offers more targets for small molecules, with the potential to treat many incurable diseases. We use small molecules to change mRNA function, by altering mRNA translation into pathological proteins. In this approach, we are using mRNA fragments as a novel biological target rather than a therapeutic modality as has been the case in the case of COVID or cancer vaccines. This approach offers an order of magnitude more biological targets than proteins. We try to prevent the creation of undesired proteins rather than tackling them once they are present in advanced diseases. Before the end of 2023, we are eager to show our proof of concept in our mRNA discovery platform. We have secured non-dilutive financing and anticipate collaborations with larger pharmaceutical and biotech companies.
At Molecure we are currently running a phase 2 proof of concept trial, aiming to demonstrate the therapeutic effectiveness of our clinical candidate OATD-01, which blocks the activity of CHIT1, a protein driving various inflammatory and fibrotic diseases. While we have seen promising results in rodents, we are still unable to prove the efficacy of OATD-01 in curing patients. We are proud to be the first Polish company to receive FDA approval to start a phase 2 clinical trial in the US.
EF: What is the role of Molecure in the market?
MS: Our primary mission is to introduce the first innovative Polish drug for unmet medical needs worldwide. That is the core purpose behind our company's creation, and it drives everything we do. Regarding our role in the Polish biotech sector, we are among the pioneers shaping this sector's growth. Ryvu was the first Polish innovative biotech company founded in 2007. Since then, over 20 companies have emerged, significantly increasing the market cap of the sector. About a decade ago, Ryvu's value was below $50 million, representing a significant part of the innovative Polish biotech sector's worth. Fast forward ten years, and as a sector, we have grown more than tenfold. Presently, the sector's value, driven mainly by listed companies, is estimated between $1.5 – 3.5 billion USD. While these figures are still far from more established biotech countries, the growth trajectory is impressive.
We are on a high-growth trajectory, but we have room for improvement. Several companies are actively engaging in global partnerships. While neither RYVU, Molecure, nor other biotech might be directly bringing these drugs to market, we anticipate the possibility of the first Polish drugs entering the global market within the next two to five years through partnering with global pharma companies.
EF: What trends do you see in the therapeutic areas you are focusing on currently?
MS: Our Company has a diverse pipeline of projects, most focusing on modifying the function of human immune cells. Our mRNA discovery platform stands apart—like a startup within a mature company. Our sector recognizes more and more the potential of altering immune cells to impact various diseases. Across our projects, we have three that focus on inflammation and fibrosis. We are looking at immune cells such as macrophages transforming them with the use of our compound from a pro-inflammatory and pro-fibrotic state to a more restorative one. Our global target, OATD-01, now in phase 2 trials in the US, aims to reverse this transformation. We hope that this approach can address diseases driven by chronic inflammation.
In the oncology realm, our focus is on immuno-oncology. Our OATD-02 project aims to modify T-cells, empowering the immune system to identify and eliminate cancer cells. We are taking a different route than direct cytotoxic therapies. Modifying immune cells is a common thread in most of our programs, and we are excited about their potential. While checkpoint inhibitors have changed cancer therapies significantly, our R&D drug, particularly in combination with checkpoints such as PD-1 or PDL-1, shows promise in making cancer treatments much more effective. We are navigating the space where mRNA and smaller molecules intersect, mostly within oncology, but the potential exists for other targets, too.
Sarcoidosis, an orphan disease with no approved drugs, affects many patients, particularly impacting the lungs in 90% of cases. Our choice of this indication in light of no approved drugs (unlike IPF, where there are two approved drugs) allows us to test our potential disease-modifying treatment options against placebo.
Furthermore, sarcoidosis is an orphan disease where tissue remodelling is not as advanced as in the case of pulmonary fibrosis. This allows for shorter dosing to see the therapeutic effect. Last but not least, access to patients is much easier not only because of the larger patient population worldwide but also because there are many fewer trials conducted than in IPF.
We are excited about utilizing a very novel PET/CT imaging endpoint, which was accepted by the FDA during our IND procedure, which will allow us to quantitatively show reduced inflammation and decreased clusters of immune cells (so-called granulomas) affecting lung function. One of our leading KOLs referred to OATD-01 as a “granuloma buster”. While Sarcoidosis is our initial therapeutic focus, success here could pave the way for exploring other conditions such as IPF, NASH or even IBD, where our compound has shown promise in preclinical models of those diseases. This trial serves as clinical validation of both: our new target (CHIT1) and the compound itself, marking a significant step into the treatment of patients with other incurable inflammatory and fibrotic diseases.
EF: As the first Polish company to reach phase 2 trials in the US, what strategies have you put into play to innovate and bring Poland to the forefront as an innovative hub for biotech?
MS: Poland might not be the biotech center of the world, but we have a wealth of talent, especially in early-stage drug discovery and development. Compared to places like California or the East Coast around the Boston area, where the biotech scene is thriving, we might have fewer companies, but we are not short on brilliant minds. We attract top graduates due to less competition. At one point, we had up to a few hundred applicants for a senior biologist role. Our innovations mostly stem from in-house research rather than licensing compounds from renowned universities.
Our pipeline's diversity comes from starting new programs based on top-level biology research validating new, first-in-class targets and progressing them into clinical development. Our advantage lies in lower R&D costs, enabling us to get compounds to clinical development at a fraction of the cost of Western European or US companies. This means more opportunities for success. We might take more shots, but it increases our chances of hitting the mark. While our team may be less experienced in late-stage drug development, having multiple shots on goal gives us an added advantage. We focus on pioneering technologies and targets yet to be explored, taking calculated risks for potentially higher payoffs. It is riskier than established programs, but success could mean significant breakthroughs.
EF: How are you innovating in Poland, and how can Poland become a biotech hub?
MS: We are currently running one clinical trial in Poland, and another globally. The price-to-quality ratio for clinical trials in Poland is impressive. Even though countries further to the east or southeast might offer more competitive prices, quality is the most important factor. Historically, our strength was in late-stage clinical trials. Now, we are seeing more phase 1 and 2 trials emerging, integrating the entire process from early drug discovery to effective participation in late-stage clinical development. While we must go global to reach a diverse population, Poland can be a strong hub for progress.
Another factor supporting the sector is access to substantial funding. While we lack specialized biotech funds and struggle to attract foreign capital, utilizing available funds effectively could significantly boost the industry. Non-dilutive funds are crucial due to the absence of specialized funds and the industry being relatively unfamiliar to generalist investors. Growing the sector can open doors to foreign capital, but in the meantime, non-dilutive funds are critical for support of R&D.
Poland's success in the gaming industry is rooted in our strong education system for IT programming, boasting some of the world's best programmers. This led to the creation of multibillion-dollar gaming companies that expanded globally. While creating a game like The Witcher differs greatly in timescale from developing drugs for patients, the life science and biotech sectors have similar potential to gaming. We have a pool of highly skilled graduates with top-notch education, offering immense value to these industries. With this talent, even at a slower pace, we can drive the biotech sector similarly to how IT professionals shaped the gaming industry.
EF: How do your risk-taking strategy and long-term goals differentiate Molecure from other biotech companies?
MS: In comparing ourselves to other companies pursuing similar goals, we have consciously focused on therapies with breakthrough potential that can change how several diseases are treated. Our approach differs somewhat from companies like Ryvu, which historically developed drugs for clinically validated targets with a more specific focus on oncology. What we are doing involves new, unproven targets. It is like professional gambling with higher stakes; we need more attempts and sometimes more investment, but hitting the jackpot could revolutionize treating a disease globally. We are taking calculated risks for potentially game-changing outcomes. Comparatively, companies like Captor, working on a very novel protein degradation technology, are still in the preclinical stage. We have moved beyond that. We are a fully integrated biotech with two clinical-stage programs showing great potential. We combine innovation and risk-taking with clinical development experience to diversify our risks.
EF: What strategy do you use to attract investment and investors into Poland?
MS: Getting our valuation back over $200 million, where it was three years ago, is an important goal. We need to increase our valuation to have any impact on various fund managers’ portfolios; otherwise, it will not catch their attention, even if the return is significant in relative terms. We considered reverse mergers, looking at a potential transition to NASDAQ from the Warsaw Stock Exchange. Unfortunately, it is immensely complex due to different legal frameworks. This situation and our early listing on the Warsaw Stock Exchange (WSE) limit our VC and private equity funding options.
Using non-dilutive funding could reduce risk for international investors eyeing Poland’s capital-intensive and high-risk biotech sector. There’s potential in mechanisms like the Polish Development Fund (PFR), balancing public and private financing to attract international investors. A combination of factors, including increased visibility and international appeal, is vital to draw biotech specialist investors. Despite successful high-value transactions with global partners, attracting specialized biotech investors remains challenging.
EF: If you had to advise people trying to enter the biotech sector in the Polish industry, what advice would you give, and what pillars would it be founded on?
MS: For entrepreneurs, finding a niche with unique and well-defined advantages is crucial for growth and internationalization. I have experienced this firsthand, starting a MedTech company with a PhD student, which became the third best-selling cardiac telemetry diagnostic technology in the US, worth over a billion PLN at its peak on the Warsaw Stock Exchange. Aim high, dream big, stay focused, and be stubborn in your strategic goals as an entrepreneur. Never give up, never surrender.
Regarding investments, Poland has bright scientists and an entrepreneurial spirit that would benefit from more ambitious and risk-tolerant investors. Funders coming in can discover many opportunities, but ambition and capital are essential for them to flourish. Poland might not match the readiness of the US or some Western European countries to finance risky ventures with sufficient capital, crucial in the time-sensitive MedTech space. Poland has shown high-return opportunities in life sciences, and investors should look for strong teams with unique technology and the drive to internationalize rapidly. The right team and unique technology are the winning formula for outside investors.
EF: Where did you see the company in 10 years, and what achievements do you want to see in the next ten years ten years?
MS: In 10 years, I envision having a drug on the market, successfully treating patients with incurable diseases. I aim for our biotech sector to be among the fastest growing in Europe, specializing in unique autoimmune and neoplastic disorders, focusing on developing new therapeutic opportunities and globally commercializing them.
