4TEEN4 Announces Publication in European Journal of Heart Failure Demonstrating First-in-Human Shock Reversal Evidence for Procizumab in Three Compassionate Use Cases

• Data from three terminally ill cardiogenic shock patients showcase potential of procizumab to safely reverse shock within 48 hours and provide promising first-in-human evidence on the translatability of preclinical efficacy to humans
• Procizumab is a first-in-class, monoclonal antibody neutralizing the activity of circulating dipeptidyl peptidase 3 (cDPP3), a key driver of cardiogenic shock
• Treatment with procizumab improved all clinical parameters assessed, and no adverse events were registered
• 4TEEN4’s Phase 2a clinical trial of procizumab in cardiogenic shock patients is set to initiate mid-2025 at 11 centers in Europe

Hennigsdorf/ Berlin, July 15, 2025 – 4TEEN4 Pharmaceuticals GmbH, today announced a publication on three terminally ill patients with cardiogenic shock and multi-organ failure, who received procizumab, the company’s proprietary anti-DPP3 antibody, in the European Journal of Heart Failure. The publication titled “Targeting Dipeptidyl Peptidase 3 (DPP3) in extreme-critically ill patients with refractory shock: First-in-human report on the safety and efficacy of an anti-DPP3 antibody” highlights that procizumab effectively blocked cDPP3 activity, without immediate adverse reactions or adverse reactions related to the administration of the antibody. All three patients who received procizumab under named-patient use reverted from shock within 48 hours.

“With procizumab, 4TEEN4 has a tremendous opportunity to establish a biomarker-driven treatment approach in shock, an indication with mortality rates of over 50%, which to date heavily relies on symptomatic care,” said Alexandre Mebaaza, MD, PhD, Professor of Medicine at Paris Cité University and lead investigator of 4TEEN4’s PROCARD Phase 2a study. “Approximately half of global shock cases show elevated levels of cDPP3. Procizumab’s highly specific mechanism of action has the potential to become the first treatment option to target the underlying pathological pathway of shock and address a substantial unmet medical need.”

Procizumab is a first-in-class monoclonal antibody blocking the activity of cDPP3, an enzyme involved in circulatory regulation through degradation of angiotensin II. This uncontrolled degradation disrupts the renin-angiotensin-aldosterone system (RAAS), potentially leading to cardiovascular collapse accompanied by organ failure and ultimately, death. Procizumab is designed to inhibit cDPP3 activity, resulting in restored control over the RAAS system, normalized cardiovascular function, and improved survival.

The three patients were terminally ill, in cardiogenic shock, and with multi-organ failure. An independent international patient selection board confirmed exhaustion of all conventional therapeutic options, with no further escalation of conventional therapy in the presence of a high chance of immediate mortality. A single dose of procizumab (at 10 mg/kg) was administered over a course of two hours. The mechanism of action, as observed in extensive pre-clinical studies, was confirmed by a strong reduction in DPP3 activity. This was accompanied by improvements across all clinical parameters assessed, including restoration of circulatory and respiratory function, reduced systemic inflammation, and normalization of kidney function, leading to shock reversal in all three patients within the 48-hour follow-up period. The treatment was well-tolerated with no adverse drug reactions.

“The results from these named-patient cases confirm the extensive body of data on the causality of elevated cDPP3 levels and increased mortality in this indication,” added Andreas Bergmann, PhD, Chief Executive Officer at 4TEEN4 Pharmaceuticals. “With the first in human data, our next goal is to rapidly establish an optimal dose of procizumab in a randomized, controlled setting with our PROCARD1 Phase 2a study, aiming to enroll the first patient in the coming months. Subsequently, we are preparing for the global pivotal Phase 2/3 study, set to initiate in the second half of 2026, to potentially deliver procizumab as a transformative treatment option to shock patients around the world.”

Procizumab’s safety has been previously demonstrated in a Phase 1 study involving healthy volunteers. The named-patient use represents the first application of procizumab in patients with cardiogenic shock, providing early, highly encouraging human efficacy signals that are consistent with the company’s extensive preclinical data in a range of disease models.

About Cardiogenic Shock
Cardiogenic shock is a severe and life-threatening condition in which the heart suddenly fails to pump enough blood to meet the body’s demands, leading to dangerously low blood pressure and insufficient oxygen delivery to vital organs. It is the second most common form of circulatory failure and is most often triggered by acute myocardial infarction (AMI) or acute decompensated heart failure (ADHF). Shock in general, which can result from sepsis, trauma, burns, or major surgery, is a leading cause of admission to intensive care units (ICUs) and affects approximately one in three ICU patients. Despite advances in supportive care, cardiogenic shock remains a largely unaddressed condition with no approved causal therapies and mortality rates exceeding 50%.

About Procizumab
Procizumab is a humanized monoclonal antibody designed to selectively target circulating dipeptidyl peptidase 3 (cDPP3). Under physiological conditions, DPP3 is an intracellular enzyme. However, when released into the circulation, typically as a result of cellular injury, it degrades angiotensin peptides, resulting in dysregulation of the renin-angiotensin-aldosterone system (RAAS). The loss of RAAS control can lead to shock, broad organ failure, and ultimately death. By inhibiting cDPP3, procizumab restores RAAS balance and stabilizes cardiovascular function. The therapeutic potential of procizumab has been demonstrated in three independent pre-clinical efficacy models, where it effectively normalized cardiovascular parameters, reversed organ dysfunction, and increased survival. Procizumab also exhibited a favorable safety and tolerability profile in a completed Phase 1 study in healthy volunteers.

About 4TEEN4
4TEEN4’s mission is to reverse life-threatening shock and restore organ function with procizumab. This highly specific, first-in-class antibody blocks circulating DPP3, the key pathological driver of mortality in shock. Based on highly encouraging results across preclinical models and initial use in patients, procizumab is now in a Phase 1b/2a study evaluating its potential as a treatment for shock caused by acute cardiovascular and septic events. By targeting the root cause, 4TEEN4 aims to move shock treatment beyond supportive care and improve survival in critically ill patients.

Investor & Media Contact:
Trophic Communications
Eva Mulder & Charlotte Spitz, PhD
+49 171 3512733
4TEEN4@trophic.eu

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