Alveron Pharma Announces Close of €5M Seed Extension Financing, led by Broadview Ventures, to Accelerate Breakthrough Therapy for Intracranial Haemorrhage

Nijmegen, The Netherlands, December 6, 2024 – Alveron Pharma is pleased to announce today the closing of a €5.0 million Series Seed extension financing to advance the development of its innovative drug, OKL-1111, for the treatment of intracranial haemorrhage (ICH). The syndicate is led by Broadview Ventures and includes the participation of all existing investors including Sanquin (the Dutch Blood Foundation), Thuja Capital, Waterman Ventures and Oost NL.

Founded in 2019, Alveron Pharma is developing a synthetic anticoagulant and platelet inhibitor reversal agent to prevent haematoma expansion and improve clinical outcomes in patients with ICH. Current therapies for treating ICH patients on anticoagulants have cumbersome regimens, resulting in excessive door to needle times, often exceeding two hours, which exacerbate poor outcomes for these patients. OKL-1111 has a universal mode of action by binding to a downstream clotting factor and a unique product profile, enabling administration within 10 minutes of a diagnosing CT scan. In addition, the drug reverses the effects of clopidogrel, a major platelet inhibitor, for which there is currently no antidote. The capital provided from this new financing enables Alveron to accelerate important development activities that support OKL-1111’s readiness for further clinical studies to demonstrate safety and proof-of-concept efficacy in patients.

“With the support from our syndicate of specialist life science investors, alongside the expertise of our Scientific Advisory Board, we are eager to advance our innovative therapeutic approach and improve patient outcomes,” said Ben Nichols, CEO of Alveron Pharma.

Benjamin Kreitman, Principal at Broadview Ventures, Inc. commented, "Intracranial haemorrhage remains a severe unmet medical need, and the development of novel treatments to reverse both anticoagulants and platelet inhibitors could deliver a meaningful improvement in the long-term outcomes of ICH patients. As Broadview's investment strategy is focused on the improvement of human health in the areas of cardiovascular disease and stroke, we are delighted to accelerate this highly innovative approach in this indication of significant unmet need."

About Alveron Pharma. Alveron is a clinical-stage company developing OKL-1111 as a first-line intravenously-administered therapy to treat intracranial haemorrhage (ICH) associated with anticoagulant and/or platelet inhibitor use. OKL-1111’s novel mechanism of action and product profile could enable a significant reduction in the time required to halt bleeding as compared to other reversal approaches, to limit haematoma expansion and improve clinical outcomes including mortality and morbidity. www.alveron.com

About Broadview Ventures. Broadview Ventures is a mission-driven investment organization that makes targeted investments in early-stage companies to accelerate the development of innovative therapeutics, devices, and diagnostics for cardiovascular disease and stroke. Broadview is funded by the Leducq Charitable Trust. www.broadviewventures.org

About Thuja Capital. Thuja Capital Management (Thuja) manages several venture capital funds aimed at building and scaling companies in the fields of (bio)pharmaceuticals, MedTech and digital health. In addition to generating a financial return for its investors, Thuja’s investments positively impact the health and well-being of patients. Thuja serves physicians and patients worldwide by providing capital to daring entrepreneurs with ground-breaking product concepts locally. For more information visit www.thujacapital.com

About Waterman Ventures. Waterman Ventures is a technology investor with over 30 years of experience in turning promising innovations into flourishing companies. Through the years, Waterman has collected a wealth of experience and lessons learned in building teams, finding product-market fit, scaling production and growing revenues. It is itsheartfelt ambition to keep engaging this experience to support the leading companies of the next generation. For more information visit www.watermanventures.nl

About Oost NL. (East Netherlands Development Agency) is an agency that focuses its activities and projects on strengthening and stimulating the economy of the provinces of Gelderland and Overijssel, the Netherlands. Oost NL supports starting and growth-phase SMEs. We do this partly with risk capital from various revolving innovation funds, and partly through our knowledge, networks and personal contacts. Through the revolving funds we provide direct as well as indirect investment in private funds and, if required, we also provide fund management in other national public instruments we help deploy. www.oostnl.nl

About Sanquinnovate (SQI).  SQI is dedicated to transforming Sanquin's unique knowledge and expertise into tangible solutions that enhance the healthcare and quality of life for patients and donors. We achieve our mission by supporting the valorization process, founding participation, and securing licensing agreements. This allows us to translate knowledge from the laboratory into real-world applications, creating value for society, patients and donors. For more information visit www.sanquin.org/nl/partnering/over-sanquinnovate

Alveron Pharma completes successful first-in-human trial of OKL-1111

2nd October 2023 Nijmegen, The Netherlands

Alveron Pharma announces that it has completed a Phase 1 clinical study for OKL-1111, a new drug for the rapid treatment of Intracranial Haemorrhage (ICH) and other life-threatening bleeds associated with the use of anticoagulants or platelet inhibitors. The study was conducted at Hammersmith Medicines Research in London. OKL-1111 was well-tolerated in the trial with healthy human volunteers and showed no more adverse events above those in the placebo groups. Volunteers also received an anticoagulant and a pharmacodynamic effect was observed with OKL-1111 administration. In the prior non-clinical program, the drug reduced bleeding in a clinically relevant intracranial haemorrhage model using high doses of an anticoagulant. Furthermore, a broad-spectrum mode of action was demonstrated against all classes of anticoagulant and one platelet inhibitor to date in a standard haemostasis model.

The company also announced a further round of investment from current shareholders, in preparation for a major Series A investment or corporate partnership.

Alveron’s drug OKL-1111 is positioned as a rapid, first-line therapy for ICH

ICH is a devastating condition with a 30-50% mortality rate and is responsible for approximately 50% of disability associated with stroke as a whole. The use of anticoagulants or platelet inhibitors greatly increases the probability and severity of ICH - with an aging population this is a growing problem. One of the major reasons for poor outcomes in ICH is that patients are simply treated too late with reversal agents and median “door to needle” times of around 2 hours are reported. Current treatment regimen require the identity of the anticoagulant; consultation with an expert; dose calculation; patient weight and reconstitution of multiple vials of powder into solution. Combined with a CT scan this cumbersome process takes too long.

Alveron’s drug, OKL-1111, is positioned as a rapid, first-line therapy, given its universal mode of action that does not require anticoagulant or antiplatelet identification. The drug is also being developed as a ready-to-use solution for injection, reducing preparation time. Lastly, in the pre-clinical and Phase I trials there were no indications of thrombotic overshoot, reducing the need for expert risk/benefit evaluation prior to use. OKL-1111 has therefore the potential for rapid administration with greatly improved outcomes.

Introduction of portable stroke diagnostics and telemedicine will herald a new era in ultra-rapid treatment

Exciting new developments in portable assays, computerized tissue temnography, and telemedicine will enable ICH to be detected in an ambulance. OKL-1111’s profile is suited to this environment and the administration of a reversal agent pre-hospital will have a dramatic impact on mortality and disability.

Alveron’s CEO, Ben Nichols commented, “This is good progress towards a treatment that could really impact outcomes for this devastating condition. With the increased use of anticoagulants and platelet inhibitors worldwide, it is a timely development.

Michel Briejer of Thuja Capital, Alveron’s lead investor, commented “With the successful completion of the Phase 1 trial for OKL-1111, Alveron Pharma is one step closer to bringing their revolutionary universal reversal agent to patients suffering from intracranial haemorrhage, one that brings the promise of swifter response and improved outcomes.”

Background Information

Alveron Pharma is based in the Netherlands and UK and is backed by venture capital managers Thuja Capital (thujacapital.com); Waterman Ventures (watermanventures.nl); Oost NL (oostnl.nl); Zwiers Pharma BV; and Sanquin Innovatie BV (sanquin.org/partnering). The company has also received an Innovation Credit loan from the Dutch government. The drug, OKL-1111, originates from a joint research project between OKKLO BV and Sanquin, the Dutch blood foundation. Alveron acquired the rights to OKL-1111 and is led by an experienced management team. For further information contact: Ben.nichols@alveron.com; michel.briejer@thujacapital.com

Alveron Pharma starts the first clinical trial of new drug for treatment of intracranial haemorrhage

20th March 2023 Nijmegen, The Netherlands

Alveron Pharma announces that it has commenced a Phase 1 clinical study for OKL-1111, a new drug for the treatment of Intracranial Haemorrhage (ICH) and other life-threatening bleeds associated with the use of anticoagulants or platelet inhibitors. The clinical trial is taking place in the UK and will investigate safety, pharmacokinetics and pharmacodynamics in man.

ICH is a devastating condition with a 30-50% mortality rate and is also responsible for approximately 50% of disability associated with stroke as a whole. The use of anticoagulants or platelet inhibitors greatly increases the probability and severity of ICH, and with an aging population this is a growing problem. One of the major reasons for poor outcomes in ICH is that patients are simply treated too late with reversal agents. Current mainstream therapies require the identity of the anticoagulant; consultation with an expert; dose calculations with some requiring patient weight and reconstitution of multiple vials of powder into solution. This process can take over one hour.

Alveron’s drug OKL-1111 is positioned as a rapid, first line therapy as it has a truly universal mode of action, not requiring anticoagulant identification. OKL-1111 is being developed as a ready-to-use solution for injection also eliminating a very time-consuming preparation step. The pre-clinical safety data indicates a very low risk of thrombotic overshoot, reducing the need for expert risk/benefit evaluation prior to use. OKL-1111 has therefore the potential for rapid administration with greatly improved outcomes.

OKL-1111’s product profile is also potentially suitable for use in ambulances which may become feasible with the introduction of mobile diagnostic technologies. This would further reduce the time to treatment, radically improving outcomes.

Alveron’s CEO, Ben Nichols commented “this is the first step towards a treatment that could really impact on outcomes for this devastating condition and with the increased use of anticoagulants and platelet inhibitors worldwide, it is timely”.

Michel Briejer of Thuja Capital, Alveron’s lead investor, commented “it is exciting to see this drug now move into clinical testing, after having generated an extensive preclinical data package suggestive of good safety and universal reversal of anticoagulants”.

Background Information

Alveron Pharma is based in the Netherlands and UK and is backed by venture capital managers Thuja Capital (thujacapital.com); Waterman Ventures (watermanventures.nl); Oost NL (oostnl.nl); Zwiers Pharma BV and Sanquin Innovatie BV (sanquin.org/partnering). . The company has also received an IK loan from the Dutch government.

The drug OKL-1111 originates from a joint research project between OKKLO BV and Sanquin, the Dutch blood foundation. Alveron acquired the rights to OKL-1111 and is led by an experienced management team.

For further information contact:

Ben.nichols@alveron.com

michel.briejer@thujacapital.com