Flagship Pioneering Announces Ohana Biosciences

Industry-first sperm biology platform drives understanding of how differences in sperm can impact the most important aspects of the reproductive journey

Novel products could dramatically improve fertility rates, reduce pregnancy complications, inherited disease, and developmental disorders, and deliver non-hormonal contraception

Disruptive approach to reproductive health challenges could drive down health care costs

CAMBRIDGE, Mass., Jan. 27, 2020 /PRNewswire/ -- Flagship Pioneering, a unique life sciences innovation enterprise, today announced a first-in-category reproductive health company, Ohana Biosciences. Ohana is embarking on a fresh approach to the field of reproductive medicine with the creation of the industry's first sperm biology platform, a major shift from the traditional path of focusing on egg biology. Since Ohana's founding in 2016, its platform has yielded product opportunities in fundamental areas of reproductive health based on insights into sperm biology. Those opportunities include improving fertility rates, reducing pregnancy complications, inherited disease, and developmental disorders, and delivering non-hormonal contraception. Ohana—the word means "family" in Hawaiian—is led by CEO Amber Salzman, Ph.D., and is based in Cambridge, Massachusetts.

"As parental age increases and demographics shift, we face a growing global crisis in reproductive health, and there's an urgent need to advance science that can tackle growing rates of infertility, inherited disease, and pregnancy complications," said Noubar Afeyan, Ph.D., Co-founder of Ohana and CEO of Flagship Pioneering. "We specifically recruited Dr. Salzman to lead Ohana because of her deep scientific expertise, clinical development experience, and tireless advocacy for innovative approaches to help patients. Her extensive experience at GlaxoSmithKline as part of the R&D executive team, previous CEO roles, and her renowned leadership in rare disease—born out of her personal journey to find a cure for her son's rare disease—put her in a powerful position to lead Ohana's mission to reshape reproductive health for people around the world."

Novel approach using sperm biology could yield improved health outcomes
Ohana is focused on transforming global reproductive health to help at the most important points in the reproductive journey. The company seeks out disruptive advancements and treatments with its sperm biology platform to:

• Enhance fertility through innovative treatments and expanded access. Ohana's products will potentially increase fertility rates for those undergoing assisted reproductive technology, such as in vitro fertilization (IVF). These patent-protected, ex vivo sperm enhancement treatments could reduce the number of cycles required to achieve successful pregnancy and birth, helping to alleviate the emotional, physical, and financial toll that many people face going through assisted reproduction.
  
  
• Improve reproductive health outcomes for mothers and children by reducing pregnancy complications, transmission of inherited disease, and developmental disorders. Ohana's advances in sperm biology enable the profiling of sperm to offer the best health outcomes. For mothers, this has the potential to reduce pregnancy complications such as miscarriage, premature birth, pre-eclampsia, and gestational diabetes. For children, this may improve health outcomes by reducing inherited disease and developmental disorders.
  
  
• Provide non-hormonal birth control for men and women. Ohana's investigational non-hormonal, reversible, long-lasting birth control has the potential to reduce near- and long-term side effects for women while promoting shared responsibility for planning procreation, redefining contraception for billions of people.

"Infertility continues to rise," said John Mendlein, Ph.D., Executive Partner at Flagship Pioneering. "Seven million couples in the U.S. alone are infertile, with less than 10% being treated. Parental health and environmental factors continue to increase the risk of pregnancy complications, inherited diseases, and developmental disorders, creating significant burdens for individuals as well as the entire health care system. Additionally, few choices for contraception exist, most of which are hormone-based and associated with near- and long-term health impacts for women. Flagship Pioneering founded Ohana as a pioneering effort to scientifically interrogate sperm biology to provide insights in how to solve reproductive health challenges. Rather than limiting solutions to egg biology, our sperm-based approach creates new therapeutic horizons in reproductive health for women, men, and children."

Ohana is currently conducting a randomized control trial in patients undergoing IVF at six of the leading fertility centers in the U.S. to study the impact of the company's product to enhance sperm for more effective IVF procedures, with a launch slated for 2021. This will lay the groundwork for Ohana's next-generation products in multiple therapeutic areas across its pipeline. Ohana is also planning to conduct Investigational New Drug – enabling studies for its non-hormonal contraception product this year.

"At Ohana, our work is deeply personal. Many have struggled with infertility, pregnancy complications, or the risk of having our children inherit disease. Despite the prevalence of these challenges, the field of reproductive medicine still leaves the vast majority of people untreated," said CEO Amber Salzman. "I was attracted by Ohana's bold vision to pursue the untapped area of sperm biology as a source of products for people with reproductive health challenges. Our scientists have developed the world's largest database of sequenced sperm to understand sperm biology and intervention points that can impact fertility and fertilization, as well as health outcomes for moms and children. We aim to address the biggest challenges in reproductive health today, enabling millions of people to build a healthy family with less cost to our health care systems."

To learn more about Ohana, please visit the company's new website at www.OhanaBio.com.

Forward-Looking Statements Disclaimer
This press release contains forward-looking statements regarding future events (within the meaning of the Private Securities Litigation Reform Act of 1995). Any forward-looking statements in this press release are based on current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. Any forward-looking statements contained in this press release represent Ohana's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date, and Ohana explicitly disclaims any obligation to update any forward-looking statements.

About Ohana Biosciences
At Ohana Biosciences, we are pioneering a reproductive health revolution through our industry-first platform of sperm-based technologies. We began with a vision to reimagine global reproductive health and help all people create the healthy family they dream of – when they are ready. Today, we believe our unprecedented understanding of sperm biology coupled with our pioneering research will turn our vision into a reality. Our research in sperm biology has led to breakthrough discoveries that impact reproductive health outcomes, and these proprietary findings have been translated into a holistic sperm-biology-based reproductive medicine platform. Through our platform, we are addressing fundamental components of reproductive health: fertility, pregnancy complications, inherited disease, developmental disorders, and contraception. By offering advancements in fertility treatments, new technologies to reduce pregnancy complications, disease transmission, and developmental disorders, and enabling non-hormonal contraception, Ohana is dedicated to becoming a leader in reproductive health and offering life-changing options for people. Ohana, which means "family" in Hawaiian, was founded in 2016 by Flagship Pioneering Partners Noubar Afeyan, Ph.D., and David Berry, M.D., Ph.D., and is based in Cambridge, Mass. Please visit our website, www.OhanaBio.com, to learn more.

About Flagship Pioneering
Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $30 billion in aggregate value. To date, Flagship is backed by more than $3.3 billion of aggregate capital commitments, of which over $1.9 billion has been deployed toward the founding and growth of its pioneering companies alongside more than $10 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 39 transformative companies, including Axcella Health (NASDAQ: AXLA), Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics, Indigo Agriculture, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Seres Therapeutics (NASDAQ: MCRB), and Syros Pharmaceuticals (NASDAQ: SYRS).