These findings provide further support for the unique pharmacological profile of PN6047 and strengthen the scientific rationale for evaluating the candidate across additional indications. While our primary focus remains the ongoing clinical development programme in neuropathic pain, the new data contribute valuable insights into the broader therapeutic potential of PN6047

We have reached an important milestone with the development of PN6047 by manufacturing the drug product for the Phase IIa study, planned to start in Q4 2026. PN6047 offers new hope for the future of neuropathic pain management, with the potential to enable a fundamental shift towards safer non-addictive treatments.

PharmNovo has built a strong foundation, with its lead candidate PN6047 now approaching Phase II. The Board will support the company when entering the next stage of development and work closely with management to maintain a clear, focused path forward, including constructive dialogue with potential partners.

We have reached an important milestone with the company’s development and I am very proud of the PharmNovo team for their excellent work leading to the CTA approval in Spain. PN6047 offers new hope for the future of neuropathic pain management by enabling a fundamental shift towards safer non-addictive treatments that can redefine standards of care

The FDA had no critical comments on the CMC information or the non-clinical data and gave valuable guidance for the future CMC and non-clinical development program. They also gave clear guidance on the design of the “proof of concept” study (the Phase II a study). This now provides us with a clear and straightforward pathway towards the initiation of the phase IIa study with PN6047.

Securing the maximum funding available under the EIC Accelerator program highlights the innovative potential of PN6047. We are deeply thankful for GAEU Consulting’s professional assistance. Their expertise was invaluable, and the support from Horizon Europe will be crucial in advancing our clinical trials and bringing this much-needed pain relief solution to patients.

Without the adverse effects common to conventional opioids, PN6047 redefines what an opioid can be. Its unique action, being highly selective for the delta opioid receptor and not interacting with the mu-opioid receptor–the main source of adverse effects in conventional opioids–underscores a safer approach to pain management. This positions PN6047 as a potential pivotal treatment in neuropathic pain, ready to advance to the next stages of development.

PN6047 is completely different from traditional opioid drugs. As a highly selective and biased DORA, it offers a new perspective on pain management and opioid withdrawal treatment. We are encouraged by the interest from NIDA, which not only recognises the potential of PN6047 to provide relief but also validates its no abuse potential.

Our collaboration with Worldwide Clinical Trials is a significant step in our dedication to addressing the complex challenges of neuropathic pain. Their expertise was instrumental in our decision to partner together. With early promising results from PN6047, we are optimistic about its potential to make a difference. As we prepare for the phase IIa study, scheduled to launch in 2024, our mission is clear: to deepen our understanding and move forward toward a solution that truly enhances the quality of life for those affected.

We have reached a remarkable milestone with our phase I study, and I am very proud of my team. Our mission to transform neuropathic pain treatment is steadily progressing. Our drug candidate has demonstrated robust tolerability and pharmacokinetics and, most importantly, avoids the common pitfalls associated with conventional opioids. We are on a path to improve lives, and this marks just the beginning of our journey.

Our mission has always been clear—to redefine pain management and offer safe and effective solutions. We are excited about these outcomes in the animal studies that underscore our dedication to providing effective pain relief with minimal risk of addiction and other unwanted and potentially life-threatening side effects.

We are thrilled to welcome Alexander Dahlquist to the PharmNovo team. His extensive experience in international finance and business management, along with his expertise in business control and process development, will play an important role in realising our vision to enhance the quality of life for people suffering from neuropathic pain.

Jesper Kjerulff has demonstrated a high level of strategic proficiency, business acumen, and possesses a solid background. With Jesper's deep understanding of the PN6047 project, we consider it a privilege to have him back on our team at PharmNovo as we continue the journey with our candidate compound PN6047.

We are pleased to welcome Inge Tarnow and Thomas Eskildsen, who will be a great contributioon to the team and the development of PN6047.

Their knowledge and experience are tailor-made to strengthen the positive development of PharmNovo as we now take the step from preclinical to clinical development.

We are extremely proud and happy to have achieved a milestone we have worked to reach for a very long time. Our vision is to improve the quality of life for people suffering from chronic pain. Going from preclinical to clinical development is a significant achievement for everyone involved. I want to take this opportunity to thank and congratulate our team; everyone has worked hard and been totally committed to achieving this.

We are delighted with this successful share issue, which means we are now well equipped and ready to take our drug candidate into clinical trials. Thanks to Sciety and their extensive investor syndicate, which includes significant venture capital firms, we have strengthened our ownership base with Karolinska Development AB. In addition to the capital, they add deep know-how and an extensive international contact network.

With great pleasure and satisfaction, we can announce that our first clinical trial application has been submitted. The application results from many years of dedicated preclinical work and marks an essential milestone in developing our candidate for the treatment of neuropathic pain. I thank the team whose hard work and commitment have made it possible to achieve this. We await information from the authorities and look forward to starting the clinical trial in 2022.