A new generation of biotechnology companies is beginning to rethink the foundations of drug discovery. At the intersection of population genomics, biomarker-driven trials, and artificial intelligence, Halia Therapeutics is exploring a different approach: studying the biological mechanisms that allow certain individuals to remain healthy despite strong genetic risk factors. In conversation, CEO David Bearss explains how this concept of genetic resilience could open a new frontier for early intervention and preventive medicine.
What professional experiences shaped your journey into biotechnology and ultimately led you to Halia Therapeutics?
I am a scientist by training and, even today, I still think of myself as someone in a white coat working in the laboratory, even if I no longer spend as much time there as I once did. Early in my career I trained under Dr Daniel Von Hoff, widely regarded as one of the pioneers of translational oncology and early-phase clinical trials. Working with him first as a postdoctoral fellow and later as junior faculty exposed me to the realities of moving scientific discoveries from the laboratory into clinical development. That experience shaped my entire professional focus, which has always centred on translating biological insights into therapies that can meaningfully improve patients’ lives.
Since then I have founded several biotechnology companies, many of which were later acquired by larger organisations. My motivation has remained consistent: identifying discoveries made in the laboratory and finding ways to bring them into the clinic. Over the course of my career I have helped move 18 drug candidates from discovery into human studies, and several programmes I worked on eventually became approved medicines. Seeing the impact of those therapies on patients is deeply motivating. When you realise that people are alive today because of discoveries you helped advance, it reinforces the importance of continuing to pursue new approaches that could expand that impact.
At the same time, those experiences also highlight the challenges of drug development. Translating laboratory discoveries into successful therapies is rarely straightforward. It is a complex and often unpredictable process, and attrition remains high across the industry. One question that increasingly concerned me was why success rates appear to be declining despite the extraordinary advances in technology and the increasing resources devoted to biomedical research. Historically, around 15 percent of drugs entering clinical development were eventually approved. Today that number is closer to seven percent, suggesting that we are still missing something fundamental in how we connect laboratory discoveries to patient outcomes.
Part of that reflection relates to the expectations surrounding the Human Genome Project. Completed in 2003, it was widely believed that decoding the human genome would transform medicine by revealing the genetic basis of disease. In many ways it did transform biology, enabling advances in genomics, molecular diagnostics, and precision medicine. However, while our understanding of genetics improved dramatically, the translation of those insights into effective therapies has been slower than many expected.
What excites me now is that we finally have access to population-scale genomic data that allow us to ask entirely different questions about human biology. These datasets make it possible to study not only disease risk but also why some individuals remain healthy despite strong genetic predispositions. Abu Dhabi, through its ambitious national genomics initiatives and integrated health data infrastructure, offers an environment where such questions can be explored at scale. Establishing a presence in the Middle East is not the typical path for an early-stage biotechnology company, but the data and the scientific opportunity make it the right place to test what could be a new paradigm in drug discovery.
What vision underpins Halia Therapeutics, and how does your approach seek to reshape the way new therapies are discovered and developed?
The idea behind Halia Therapeutics began with a fairly simple question about how we approach drug discovery. For decades, most biomedical research has focused on studying disease itself. We examine what goes wrong in conditions such as cancer, cardiovascular disease, or Alzheimer’s and then attempt to design therapies that correct those failures. Genomics has helped us identify many of the genetic risk factors associated with these diseases, yet one consistent observation is that most of those risk factors are not fully penetrant. In other words, many individuals who carry a high-risk genetic profile never actually develop the disease.
That observation led us to ask whether we might learn more by studying the opposite side of the equation. Instead of focusing only on patients who become ill, what if we examined people who remain healthy despite carrying significant genetic risks? Nature often reveals powerful biological mechanisms through these kinds of exceptions. Historically, however, it has been difficult to identify such individuals because healthy people rarely appear in clinical settings in the same way that patients do. The emergence of large-scale population genomics programmes, combined with linked health data, is beginning to change that dynamic and allows researchers to study resilience in a systematic way.
One example that shaped our thinking involves Alzheimer’s disease and the APOE4 variant, which is one of the strongest common genetic risk factors for late-onset Alzheimer’s. Individuals who carry one copy of APOE4 have a significantly higher risk of developing the disease, while those with two copies face an even greater probability. Yet even among people with this high-risk genotype, some individuals remain cognitively healthy well into older age. Understanding why that happens became a central question for us.
To explore this, we studied an extended family in Utah where APOE4 was prevalent and ultimately identified 275 family members who were willing to undergo whole genome sequencing. Rather than focusing on those who developed Alzheimer’s, we concentrated on individuals who carried two copies of APOE4 but remained cognitively healthy beyond the age of seventy. Through that analysis we identified a second genetic variant that appeared to counteract the risk associated with APOE4. Further work revealed that this protective effect was linked to a biological pathway involved in inflammation.
That discovery became the starting point for Halia Therapeutics. By studying genetic resilience rather than disease alone, we identified a pathway that could potentially be targeted therapeutically. We have since developed a drug designed to modulate that inflammatory pathway and are preparing to test it in individuals who carry APOE4 and show early biological signals associated with Alzheimer’s risk. Abu Dhabi provides a unique setting for this work because population-scale genomic data, combined with integrated health records, make it possible to identify these high-risk individuals and conduct biomarker-driven clinical studies that would be very difficult to run elsewhere.
When do you expect the clinical programme to begin, and what milestones will determine whether the therapy proves effective?
The programme has now reached the point where most of the critical components required to launch the study are in place, although bringing them together has involved considerable coordination. Because this initiative combines genomic information, biomarker screening, and early clinical intervention, we worked closely with the Department of Health to establish a framework that protects patient privacy while allowing individuals to participate. Outreach to potential participants is therefore handled through government channels rather than directly by us. Individuals identified through genomic data will be invited to undergo a blood-based biomarker test designed to detect early biological signals associated with Alzheimer’s disease.
At the same time, the operational infrastructure for the trial has been established locally. We have partnered with laboratories capable of conducting the biomarker testing and are working with IROS, the contract research organisation within the M42 ecosystem, to coordinate the study in Abu Dhabi. Clinical sites across the emirate have been contracted, the investigational drug has been imported, and regulatory and safety reviews have been completed. With those pieces now aligned, we expect to begin the first stage of the programme in the coming weeks, starting with the identification and enrolment of eligible participants.
The study will focus on individuals who both carry the APOE4 genetic risk factor and test positive for the biomarker that signals early disease activity. Once participants consent to join the trial, they will begin treatment and will be monitored over the course of a year, with regular blood tests used to track changes in the biomarker. The central objective is to determine whether the therapy can shift that signal from positive to negative, which would indicate that we are altering the biological processes associated with the early stages of the disease. As in any clinical programme, the results will take time to emerge, but the coming year should provide a clear indication of whether this approach can influence the trajectory of the condition.
Beyond the immediate trial, our ambition is to demonstrate that the concept can be applied more broadly. There are hundreds of known genetic risk factors linked to different diseases, yet historically we have not acted on many of them because identifying risk did not translate into meaningful intervention. If this strategy proves effective, it could change that equation by enabling earlier, targeted treatment for individuals at high risk. In parallel, we are developing artificial intelligence tools trained on genomic datasets, including newly available access to Genomics England data, to help identify additional resilience mechanisms more rapidly. The goal is to shorten the discovery process and apply this model repeatedly across multiple diseases.
How is Halia Therapeutics financing its development strategy, and what are the next steps in supporting the company’s growth?
Financing is one of the constant challenges in biotechnology because every stage of development requires substantial capital. Advancing programmes through discovery, clinical trials, and regulatory processes is inherently expensive, particularly when you aim to use the best available technologies. As a private biotech, we have raised around USD 78 million from private investors so far, which has allowed us to build the organisation, develop the science behind our genetic resilience platform, and move several programmes into clinical development. We are now in the process of raising a new financing round, with the intention of bringing in additional institutional investors who could support the next phase of growth and potentially position the company for a public offering in the future.
Alongside the Alzheimer’s programme, we are also advancing a second clinical effort in a rare haematological disorder known as myelodysplastic syndrome, or MDS. This disease is partly driven by inflammation in the bone marrow, which disrupts the body’s ability to produce healthy blood cells and often leaves patients dependent on regular transfusions. Building on our earlier discovery work around inflammatory pathways, we developed a therapy targeting the NEK7/NLRP3 inflammasome pathway and recently completed a Phase 2 clinical trial in patients with lower-risk MDS. The results showed encouraging outcomes, including improvements in haemoglobin levels and reductions in transfusion dependence for many participants. Data like this is particularly important for a company at our stage because strong clinical signals provide the foundation for attracting new investment and supporting the broader ambition of exploring genetic resilience across multiple diseases.
How are you building the team behind Halia Therapeutics, and what capabilities are guiding the organisation as it expands internationally?
As our activities in the region have developed, we have begun establishing a team on the ground in Abu Dhabi to support the operational and strategic requirements of the programme. Conducting a clinical trial of this nature involves constant coordination across multiple stakeholders, including hospital systems, clinical investigators, regulators, diagnostic partners, and research collaborators. Managing that complexity requires strong project management as well as specialised expertise in areas such as regulatory affairs, clinical operations, and external partnerships. Having people locally who can engage directly with these stakeholders is therefore essential, and we are building a team capable of supporting the trial while ensuring effective collaboration with our partners across the ecosystem.
At the same time, our ambition extends beyond the immediate needs of the clinical programme. If we are going to build a long-term partnership around genomic data and precision medicine, it makes sense to gradually bring more of the scientific and analytical capabilities closer to where those resources exist. This includes exploring how artificial intelligence can be integrated across the drug discovery process, from identifying resilience mechanisms in genomic datasets to helping prioritise therapeutic targets and accelerate development. Working closely with partners such as M42 and the Department of Health, we see the opportunity to develop a broader ecosystem that connects genomic insight, clinical research, and advanced analytics, supported by a team that can translate those capabilities into new therapeutic programmes.
What excites you most about the future of this field, and what message would you share with the international life sciences community?
What excites me most is that we are still at the very early stages of understanding what artificial intelligence can contribute to drug discovery and development. When these tools are combined with large-scale genomic data and deeper biological insight, they create opportunities to identify mechanisms and therapeutic targets in ways that were simply not possible before. Over the next five years I expect we will begin to see meaningful advances as these capabilities mature and start to influence how the industry approaches the discovery of new medicines.
