Comanche Biopharma Closes Oversubscribed $75 Million Series B Financing to Advance Mission to Develop and Make Globally Available the First Treatment Targeting a Root Cause of Preeclampsia

• Financing was led by New Enterprise Associates (NEA) and closed with additional new investor Atlas Venture and continued investment by GV and F-Prime Capital
  
• Significant investment by top-tier syndicate endorses Comanche's innovative science, notable clinical progress, and experienced team of siRNA and maternal health experts tackling the extraordinary unmet needs in preeclampsia
• Comanche's lead siRNA drug candidate, CBP-4888, targets an underlying cause of preeclampsia: over-production of the protein sFlt1 by the placenta, which leads to subsequent vascular damage to the mother and frequently prompts premature delivery of the baby
• By finally addressing a root cause of disease, Comanche aims to ameliorate maternal symptoms, avoid premature delivery, and enable the baby to continue safely maturing inside of the mother

CONCORD, Mass., Jan. 17, 2024 (GLOBE NEWSWIRE) -- Comanche Biopharma Corp. today announced the closing of an oversubscribed $75 million Series B financing to advance its mission to develop and make globally available the first treatment targeting a root cause of preeclampsia. Existing investors GV (Google Ventures), F-Prime Capital, Lilly Asia Ventures (LAV), and Longview Healthcare Ventures participated in the Series B round, joined by new investors New Enterprise Associates (NEA), who led the round, and Atlas Venture. Concurrent with the Series B raise, Scott Gottlieb, M.D., Partner on the NEA healthcare investment team and former Commissioner of the U.S. Food and Drug Administration, and David Grayzel, M.D., Partner at Atlas Venture, have joined Comanche's Board of Directors.

Preeclampsia is a prevalent and serious pregnancy complication that affects approximately 10 million women globally each year. It can lead to serious complications for both the mother and the baby, including multi-organ damage, seizures, and premature birth. Currently, delivery of the baby, often very prematurely, is the only available option for stopping the progression of preeclampsia.

Scott Johnson, M.D., Chief Executive Officer at Comanche Biopharma, commented, "We are thrilled to have the support and validation of this top-tier investor syndicate. Preeclampsia's detrimental impact extends well beyond the immediate health of mother and baby, affecting families, healthcare systems, and communities around the world. For the first time, we are able to target a root cause of this disease, potentially ameliorating its significant consequences and, in the process, take an important step toward improving the maternal health crisis, ensuring safer pregnancies, and delivering benefits that resonate across multiple facets of society globally."

Scott Gottlieb, M.D., a partner at New Enterprise Associates and newly appointed board member to Comanche Biopharma, said, "This medicine is the culmination of decades of scientific research that supports this novel approach to treating preeclampsia. The investment will enable us to advance the drug through a comprehensive series of clinical trials, aiming to determine its safety and effectiveness in addressing this serious and life-threatening pregnancy condition. Complications associated with pregnancy cause far too much suffering and death, and we believe this treatment could mitigate some of these tragic outcomes and, we hope, contribute to a broader and renewed effort in meeting these clinical challenges with innovative science, supported by new investment capital."

Comanche plans to use the proceeds from the Series B financing to initiate a clinical study of CBP-4888, its lead siRNA drug candidate, in pregnant preeclamptic patients later this year. The company recently completed a Phase 1 healthy volunteer study in women of child-bearing age.

Allison August, M.D., Chief Medical Officer at Comanche Biopharma and an obstetrician/gynecologist, added, "Tragically, millions of pregnancies are affected by preeclampsia, contributing to the escalating maternal mortality crisis. The only current effective intervention to initiate recovery from preeclampsia is premature delivery of the infant, a decision fraught with significant risk of short- and long-term complications for the baby. This stark reality, leading to over 500,000 infant fatalities annually worldwide, especially in regions with limited access to neonatal intensive care units, underscores the critical need for an effective treatment ? a need our team is acutely aware of and is fully committed to addressing. Our planned initiation of a clinical study in pregnant preeclamptic patients this year is a critical step toward advancing our mission."

Convergence of multiple factors propelled Comanche's focus on preeclampsia

Multiple factors have converged that motivated Comanche's focus on developing novel therapeutics that make pregnancies safer and specifically address preeclampsia:

• Maternal health crisis is escalating. The rising incidence of maternal deaths, with 80,000 annually worldwide due to preeclampsia, highlights an urgent need for action. Moreover, for survivors of preeclampsia, a diagnosis of this condition confers an immediate and lifelong 3 to 5-fold increased risk of a cardiovascular event such as a heart attack or stroke to the mother.

• A driving cause of preeclampsia is now unlocked. The cause of preeclampsia was previously a mystery. Comanche's founding researchers discovered that women with preeclampsia have dangerously high levels of a protein called sFlt1 in their bloodstream. When produced in excess by the placenta, this protein is toxic, severely damaging the mother's blood vessels and impairing the growth of new ones. This over-production of sFlt1 and subsequent vascular damage results in the common maternal signs and symptoms of preeclampsia.

• sFlt1-based predictive diagnostic is now available. In 2023, the FDA approved a blood test that can help predict severe preeclampsia prior to the onset of signs and symptoms. This diagnostic will serve as an important tool in the design of Comanche's CBP-4888 clinical studies, identifying only those pregnancies with elevated levels of the target protein and excluding those with other underlying diseases.

• siRNA technology has been validated with several approved drugs. Since 2018, six siRNA drugs have been approved based on the same Nobel prize-winning technology that underpins CBP-4888. This now mature approach can address indications ranging from orphan disease to population health, and its specificity makes it uniquely suited for targeting only the protein of interest.
  
  The siRNA technology in CBP-4888 instructs the body's own natural mechanisms to turn down sFlt1 production at its source in the placenta, thus lowering the toxic levels in the mother's blood and potentially giving physicians a meaningful therapeutic tool in the treatment of preeclampsia.

About Comanche Biopharma Corp.

Comanche Biopharma is a maternal and fetal medicine biopharmaceutical company working to make every pregnancy around the world safer. We are currently developing the world's first treatment for preeclampsia, which affects more than 10 million women globally every year.

Our mission is to develop the first definitive treatment for sFlt1-mediated preterm preeclampsia and facilitate its availability globally. Comanche Biopharma's founders have had successful careers discovering new medicines, building and selling companies, and taking on some of the hardest challenges in medicine. Ours is a new company with leaders who have established reputations for excellence, including scientific advisors Craig Mello, Nobel Laureate for the discovery of RNA interference, and Ananth Karumanchi who first identified the causal role of sFlt1 in preeclampsia. This discovery is the basis of the first diagnostic test which is currently standard of care in the European Union and United Kingdom for the management of patients suspected of having preeclampsia.

We are harnessing the power of these two recent scientific breakthroughs to bring an effective treatment for preeclampsia to the global marketplace. We are committed to the ethical representation of people of all colors and economic status globally in our clinical development programs. We plan to prioritize ensuring access to our solutions by those who need them most.

About CBP-4888

CBP-4888 is a fixed-dose combination of two small interfering ribonucleic acid (siRNAs) duplex oligonucleotides targeting soluble fms-like tyrosine kinase?1 (sFLT1) mRNA isoforms in the placenta.

About Preeclampsia

Preeclampsia is a prevalent and serious pregnancy complication that affects up to 8% of pregnancies worldwide. It can lead to a range of complications for both the mother and the baby, including multi-organ damage, seizures, and premature birth. Globally there are an estimated 80,000 maternal deaths and 500,000 fetal and newborn deaths annually due to this pregnancy complication. While preeclampsia can develop in any pregnancy, it disproportionately affects black individuals and those living in low resource settings. The signs and symptoms of preeclampsia can vary and include high blood pressure, acute kidney injury, swelling of the hands and face, severe headaches, vision changes, and abdominal pain. Currently, delivery of the baby, often very prematurely, is the only available option for stopping the progression of preeclampsia.

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