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November 16, 2017

Form S-4 Filed with SEC

After announcing on October 17, 2017 that Neothetics, Inc. (NASDAQ:NEOT) and Evofem Biosciences, Inc. have entered into a definitive agreement under which privately-held Evofem Biosciences will merge with a wholly-owned subsidiary of Neothetics in an all-stock transaction, Neothetics, Inc. filed on November 15, 2017 a Form S-4 to the SEC.   https://www.sec.gov/Archives/edgar/data/1618835/000119312517344290/0001193125-17-344290-index.htm    

After announcing on October 17, 2017 that Neothetics, Inc. (NASDAQ:NEOT) and Evofem Biosciences, Inc. have entered into a…

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October 17, 2017

Neothetics, Inc. and Evofem Biosciences, Inc. Announce Merger Agreement to Create Women’s Health Company

SAN DIEGO, CA, October 17, 2017 — Neothetics, Inc. (NASDAQ: NEOT) and Evofem Biosciences, Inc. today announced they have entered into a definitive agreement under which privately-held Evofem Biosciences will merge with a wholly-owned subsidiary of Neothetics in an all-stock transaction. The merger will position the combined company with an opportunity to become a leading women’s health company that develops and commercializes novel products. Upon closing of the transaction, Neothetics will be renamed Evofem Biosciences, Inc., and will be under the leadership of Evofem Biosciences’ Chief Executive Officer, Saundra Pelletier. An affiliate of an existing Evofem Biosciences’ investor, Invesco Asset Management Ltd., has entered into a securities purchase agreement to acquire an additional $20 million of common stock in the combined company immediately following the completion of the merger. “Following an extensive and thorough review of strategic alternatives, we believe the proposed merger with Evofem Biosciences provides the best opportunity to maximize value for Neothetics’ shareholders,” said Martha Demski, a member of Neothetics Strategic Transaction Committee and Board of Directors.  “We believe the strength of the leadership team, coupled with the completion of its pregnancy prevention trial, will enable Amphora® to reach significant value inflection points in the near term.” “This merger and concurrent financing provides continued funding for Evofem Biosciences’ ongoing Phase III study of Amphora® as a vaginal contraceptive – AMPOWER.  We expect to close the study database and file for FDA review in the second quarter of 2019,” said Saundra Pelletier, Chief Executive Officer of Evofem Biosciences.…

SAN DIEGO, CA, October 17, 2017 — Neothetics, Inc. (NASDAQ: NEOT) and Evofem Biosciences, Inc.…

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June 29, 2017

AMPHORA® (L-lactic Acid, citric acid, and potassium bitartrate) Receives "Qualified Infectious Disease Product" (QIDP) Designation from the FDA

Designation includes two separate indications and provides eligibility for priority review and additional exclusivity

San Diego, CA - Evofem Biosciences, a biotechnology company focused on the development and commercialization of women’s health products, today announced that its drug candidate, AMPHORA, being studied for contraception and treating Sexually Transmitted Infections (STI) has been designated as a "Qualified Infectious Disease Product" (QIDP) by the U.S. Food & Drug Administration (FDA) for two separate indications: the prevention of urogenital gonorrhea infection in women, and to reduce the recurrent episodes of bacterial vaginosis (BV). QIDP designation is intended to encourage development of new drugs for the treatment of serious or life-threatening infections.  The threat level of drug-resistant gonorrhea is characterized as “urgent” in that it has an immediate public health threat that requires urgent and aggressive action.  The threat level of vancomycin-resistant BV microorganisms is characterized as “serious” which means these bacteria are a serious concern and require prompt and sustained action to ensure the problem does not grow. “BV is the most common vaginal infection among women of childbearing age and gonorrhea is the second most commonly reported infectious disease,” said Kelly Culwell, MD, Chief Medical Officer for Evofem Biosciences.  “According to the Centers for Disease Control (CDC), gonorrhea has developed resistance to nearly all the antibiotics used for treatment, and the recommended treatment for BV is currently only effective in 60% of all cases, with 30-40% recurrence rates.” A drug that receives QIDP designation may qualify for an additional five years of marketing exclusivity and is eligible for the FDA’s fast-track program, intended to facilitate development and expedite review of…

San Diego, CA - Evofem Biosciences, a biotechnology company focused on the development and commercialization…

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December 16, 2016

Evofem Biosciences Appoints Dr. David Friend as Chief Scientific Officer

SAN DIEGO, CA — Evofem Biosciences announces that Dr. David Friend has been named Chief Scientific Officer effective immediately. In this role, Dr. Friend will be responsible for providing oversight and responsibility for scientific leadership covering the entire R&D program and product lifestyle management initiatives reporting to Saundra Pelletier, CEO. Prior to this appointment, Dr. Friend served as Director of Product Development at CONRAD, an organization that works to expand contraceptive choices and prevent sexually transmitted infections. Before CONRAD, Dr. Friend was Vice President, Research at Vyteris, Inc, a company that develops novel transdermal delivery systems. He has developed oral dosage forms for delivery of drugs and he holds several patents for novel dosage forms.  His previous professional experience includes work at a number of pharmaceutical companies, including Delsys Pharmaceutical, a division of Elan Corporation, Vascular Therapeutics, CIBUS Pharmaceuticals and SRI International. Dr. Friend has published more than 60 research articles and is currently on the editorial board of the Drug Delivery and Translational Research, Antiviral Research and Pharmaceutical Development and Technology Journals. Additionally, Dr. Friend sits on three scientific advisory boards in the areas of microbicide development and the prevention of HIV transmission. He earned his Bachelor of Science in biochemistry from the University of California, Davis, and his PhD in chemistry from the University of California, Berkeley.    About Evofem Biosciences  Evofem Biosciences develops and commercializes innovative products that support and promote women as the primary healthcare consumer. Evofem Biosciences is currently identifying and developing new and novel…

SAN DIEGO, CA — Evofem Biosciences announces that Dr. David Friend has been named Chief…

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August 29, 2016

Evofem Biosciences Appoints Russell Barrans as Chief Commercial Officer

SAN DIEGO, CA — Evofem Biosciences announces that Russell Barrans has been named Chief Commercial Officer effective immediately. In this role, Mr. Barrans will have responsibility for all global commercial activities including: marketing, sales, public relationships, analytics, KOL engagement, and life cycle management of the Evofem Biosciences product portfolio. He will report directly to Saundra Pelletier, CEO. “We are excited to have Russell join the Evofem executive team in this important role.  His deep experience in the women’s healthcare industry and his US and global launch experience will allow him to have immediate impact on the business,” said Pelletier.  Prior to joining the Evofem executve team, Mr. Barrans was the Sr. Vice-President for Marketing and Sales for the organization. In his previous role Mr. Barrans was part of the TEVA Pharmaceuticals leadership team as the Director of Women’s Healthcare Marketing .  He also held senior level positions at global and domestic companies including Bayer and led his own strategic consulting firm servicing biotech and pharmaceutical brands. Mr. Barrans has worked in many aspects of the women’s healthcare pharmaceutical industry and has overseen the launch of numerous innovative contraceptive brands including Mirena®, and Plan B One-Step® OTC. Mr. Barrans graduated from California Coast University with a Bachelor’s of Science in Business Administration and holds an MBA from California Coast University.    About Evofem Biosciences  Evofem Biosciences develops and commercializes innovative products that support and promote women as the primary healthcare consumer. Evofem Biosciences is currently identifying and developing new and novel products that…

SAN DIEGO, CA — Evofem Biosciences announces that Russell Barrans has been named Chief Commercial…

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August 17, 2016

Evofem Biosciences Announces First Patient Enrolled in a Clinical Trial to Determine the Effect and Duration of Amphora Gel on Vaginal pH

SAN DIEGO, August 17, 2016 – Evofem Biosciences, a biotechnology company focused on the development and commercialization of women’s health products, has announced that patient enrollment has begun in their clinical study that will evaluate the effect and duration of Evofem Biosciences’ proprietary vaginal gel, Amphora for Bacterial Vaginosis (BV), on vaginal pH. BV is an infection caused by an imbalance of bacteria in the vagina and is the most common vaginal infection in women ages 15-44..1 The etiology and pathogenesis of BV are not completely understood, and it is unclear whether the rise in vaginal pH that accompanies BV is a cause or effect of the microbial imbalance.2 Treatment of BV with antiobiotics often fails to correct the micro flora imbalance, therefore recurrence of BV is common.3,4  Current research suggests that Amphora for BV works through a novel mechanism of action with potential efficacy in helping to restore and maintain the proper balance of beneficial bacteria in the vagina. “This proprietary vaginal gel is an acidity-maintaining gel which lowers the vaginal pH. With the first patient enrolled in the trial, we will be collecting data to determine the duration of its effect and the impact on the vaginal microbiome which will inform the design of future clinical trials,” said Dr. David Friend, PhD., Senior Vice President of Research and Development and Technical Operations of Evofem Biosciences. “Millions of women suffer from the recurrence of bacterial vaginosis,” said Saundra Pelletier, Evofem Biosciences CEO. “Our innovative vaginal gel has the potential…

SAN DIEGO, August 17, 2016 – Evofem Biosciences, a biotechnology company focused on the development…

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August 4, 2016

Evofem secures $25 million in Series D funding

Women’s reproductive healthcare leader intends to use funds to advance it’s pipeline of novel contraceptive options

EVOFEM SECURES $25.0 MILLION IN SERIES D FUNDING Women’s Reproductive Healthcare Leader Intends to Use Funds to Advance its Pipeline of Novel Contraceptive Options SAN DIEGO, CA – AUGUST 4, 2016 – Evofem, a biotechnology company focused on developing and commercializing innovative contraceptive options in women’s reproductive health, announced today that they have closed on a Series D Preferred Stock financing of up to $25.0 million from Woodford Investment Management, a UK-based asset management company headed by Neil Woodford. Evofem will utilize  the funds to enhance  the clinical and commercialization infrastructure and add to the current pipeline of innovative contraceptive technologies. “We are pleased that Woodford Investment Management recognizes the potential of our contraceptive technology which offers a meaningful alternative to women who desire non-hormonal contraception,” said Saundra Pelletier, Evofem CEO. “Empowering women with access to innovative contraceptive options is the core of our business. We understand that women have changing needs regarding their reproductive choices and we want to offer non-hormonal, woman-controlled solutions.”   About Evofem Evofem Holdings, Inc. seeks to address a growing global contraceptive market, while delivering effective, woman-controlled products with global distribution. Evofem has two lead product candidates: Amphora®, a vaginal contraceptive gel, and the Nestorone® Ring, a one-year contraceptive vaginal ring, both of which have completed Phase III clinical studies. For more information visit www.evofem.com.   About Woodford Investment Management Woodford Investment Management is a fast-growing asset management company built on a founding philosophy of transparency and simplicity.  Launched in May 2014, the company has more…

EVOFEM SECURES $25.0 MILLION IN SERIES D FUNDING Women’s Reproductive Healthcare Leader Intends to Use…

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June 15, 2016

Evofem to Address the Cavendish Global Health Impact Forum at Biocom on Innovations in Reproductive Health Care around the globe.

SAN DIEGO – June 15, 2016 — Evofem, a biotechnology company focused on the development and commercialization of women’s health products, announced today it has been selected to present at the upcoming Cavendish Global Health Impact Forum co-hosted with Biocom, June 20-23, 2016, in San Diego. Cavendish Global Forums assist family offices and foundations in developing and implementing their individual pro-social impact investing, grant-giving and philanthropy programs within health and the life sciences. In accomplishing this, the Forums showcase presentations and panel discussions by leading family offices, foundations, research institutions and private-sector companies engaged in developing innovations with the potential for transformational impact on disease prevention, diagnosis and treatment. A unique gathering of family offices, Cavendish Impact Forums are hosted by leading institutions around the world and take place three times each year. The theme of the upcoming Forum is Innovation, Philanthropy and Investing Inspired for Impact. As one of the companies selected to participate and present at this years Forum in San Diego, Saundra Pelletier, CEO of WomanCare Global and Evofem will present the unique innovations being developed by Evofem and WomanCare Global to meet the contraceptive needs of women across the globe.  “Our team is working diligently to develop innovative treatments to meet the unmet reproductive health care needs of women,” said Saundra Pelletier, Chief Executive Officer of Evofem. “There are approximately 225 million women who have a need for modern contraception globally. We look forward to meeting with accomplished entrepreneurs, thought-leaders and philanthropists who echo our mission…

SAN DIEGO – June 15, 2016 — Evofem, a biotechnology company focused on the development…

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May 16, 2016

Evofem and WomanCare Global to Attend Women Deliver 2016

Largest conference on health, rights, and wellbeing of girls and women with focus on solutions SAN DIEGO and Copenhagen, Denmark -­‐-­‐ May 16, 2016 – Evofem and WomanCare Global will join leading experts on women’s global health and rights in Copenhagen, Denmark, May 16-­‐19, 2016, for Women Deliver 2016. Saundra Pelletier, the organizations’ CEO, will join more than 5,000 global leaders, including Melinda Gates, Dr. Jim Yong Kim, the President of World Bank, as well as policymakers, donors, activists, and journalists from around the globe to share their expertise, and call for a better future for girls and women everywhere. With more than 225 million girls and women globally who say they would like to plan their next pregnancy but don’t have access to services, supplies or information, access and education around women’s reproductive health is a top global issue that will be addressed at the conference. “It is critical for women to be able to decide if, how and when they will have children,” said Saundra Pelletier, Evofem’s CEO and WomanCare Global’s Founding CEO. “Women being able to make the best choices for themselves and their families is predicated on access to information and resources. Investing in women and girls is absolutely critical to the success of humanity.” WCG and Evofem will exhibit in booth C4-­‐37-­‐38 and here is a list of activities taking place during the week at Women Deliver. For those unable to join us at Women Deliver, the conference is offering Women Deliver Live with exclusive…

Largest conference on health, rights, and wellbeing of girls and women with focus on solutions…

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March 31, 2016

Evofem Files IND for Evaluation of Prevention of Recurrence of Bacterial Vaginosis

SAN DIEGO – March 31, 2016 — Evofem, a biotechnology company focused on the development and commercialization of women’s health products, announced today that it filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) requesting clearance to begin human clinical trials for its lead product in development, a proprietary vaginal gel, to be evaluated for the prevention of recurrence of bacterial vaginosis (BV).   BV is an infection caused by an imbalance of bacteria in the vagina and is the most common vaginal infection in women ages 15-44. (Centers for Disease Control, 2014). Because the etiology and pathogenesis of BV are not completely understood, treatment for BV is not always effective, resulting in high recurrence rates (Sobel, 2009). Recurrent BV is generally defined as three or more episodes of BV per year, and one study found that 6-month recurrence rates were as high as 80 percent (Marrazzo J, 2010). Given the treatment challenges and the fact that BV is the most common vaginal infection for women of reproductive age, the condition causes considerable frustration for both patients and providers (Swidsinski A, 2008).   Current research suggests Evofem’s proprietary vaginal gel works through a novel mechanism of action with potential efficacy in helping restore and maintain the proper balance of beneficial bacteria. The study Evofem will conduct is a randomized, placebo controlled study in a group of 100 women and will provide information on dose and dosing frequency for a subsequent Phase II prevention trial. The Company expects to…

SAN DIEGO – March 31, 2016 — Evofem, a biotechnology company focused on the development…

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February 9, 2016

Evofem and DKT to Develop Coated Condom

SAN DIEGO – Evofem Holdings, Inc., a biotechnology company focused on the development and commercialization of women’s health products, and DKT, one of the largest private providers of family planning and reproductive health products and services in the developing world, today announced they have signed a memorandum of understanding (MOU) to develop a coated condom prototype with lubricating, contraceptive and anti-infective properties. Condoms, when used properly, are an effective and affordable method of contraception. Condoms can also reduce the risk of sexually transmitted infections (STIs) including HIV, gonorrhea, chlamydia, and trichomoniasis¹. Condoms coated with spermicides were marketed as further reducing the risk of pregnancy and reducing the risk of STI contraction, but began to be phased out when a 2001 study suggested that certain surfactant-based spermicides could actually cause genital irritation and increase the risk of HIV transmission². Most condoms are now coated with silicone, which has lubricating properties, but no contraceptive or anti-STI properties. “We believe there is a gap in the market now for a condom that can provide additional protection beyond the barrier of the condom itself. If successful, this product could offer more choices for protection from pregnancy and sexually transmitted infections, it could be an important new product in the condom marketplace,” said Christopher Purdy, President and CEO of DKT. Evofem is studying its proprietary vaginal gel for potential use as a condom coating. Under the terms of the MOU, Evofem will direct and fund the development by DKT International of a coated condom from prototype…

SAN DIEGO – Evofem Holdings, Inc., a biotechnology company focused on the development and commercialization of…

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January 11, 2016

Evofem Holdings, Inc. Announces Successful Completion of Pre-IND Meeting for Amphora®

SAN DIEGO – Evofem, a biotechnology company focused on the development and commercialization of women’s health products, announced today that it met with representatives of the U.S. Food and Drug Administration (“FDA”) in a Pre-IND (Investigational New Drug) meeting for its lead product, Amphora to be evaluated for the prevention of recurrence of Bacterial Vaginosis (BV). Research suggests Amphora, a vaginally delivered topical gel, works through a novel mechanism of action against several bacterial and viral organisms. As a result of this meeting, Evofem will be developing a formal research protocol to begin clinical studies. Saundra Pelletier, Chief Executive Officer of Evofem, said, “I am pleased with the guidance we received and the clarification of the work necessary to file an Investigational New Drug Application. This area of development is consistent with our platform of finding and developing promising healthcare solutions that address unmet needs for women worldwide.” A New Drug Application for Amphora as a non-hormonal, vaginal gel contraceptive was accepted by the United States Food and Drug Administration (FDA) in July of 2015. About Evofem Evofem Holdings, Inc. seeks to address a growing global contraceptive market, while delivering effective, woman-controlled products with global distribution. Evofem Holdings, Inc. has two lead product candidates: Amphora, a non-hormonal contraceptive gel, and the Nestorone Ring, a one-year contraceptive vaginal ring, both of which have completed Phase III clinical studies. For further information on the Company, please visit: www.evofem.com About Amphora Amphora is a non-hormonal vaginal gel. In addition to the regulatory filing…

SAN DIEGO – Evofem, a biotechnology company focused on the development and commercialization of women’s…

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January 6, 2016

Evofem, Inc. Expands Management Team

SAN DIEGO — Evofem, Inc. announced today that Brandi Howard has been named Vice President of Global Medical Affairs and Nicole Beckstrand has been named Vice President of Public Relations & Communications, effective immediately. Howard will manage all global medical affairs initiatives and reports to Evofem Chief Medical Officer, Dr. Kelly Culwell. Beckstrand is responsible for internal and external communication and public relations strategy for the company, and reports to Evofem CEO, Saundra Pelletier. “Brandi’s and Nicole’s extensive industry experience offers a unique blend of skills that will be an asset for  Evofem as we continue to grow and deliver on our mission to develop reliable, safe, and convenient reproductive care for women worldwide,” said Pelletier. “I am pleased to add two highly qualified women with strong track records of success, extensive experience and industry knowledge to our team.” Prior to joining Evofem, Howard was the Senior Director and Head of U.S. Field Medical Affairs at Teva Pharmaceuticals, leading teams across eight therapeutic areas and managed care. She has held medical affairs roles in the United States and globally, and has led numerous medical launch teams for various women’s health products. Howard earned her doctorate from the University of Pennsylvania where her area of research focused on adolescent sexual risk behaviors and contraceptive use. She has published widely in journals, including Contraception and Fertility & Sterility. Beckstrand brings more than 17 years of communications expertise in the health care, science and technology industries to Evofem. Prior to joining Evofem, Beckstrand…

SAN DIEGO — Evofem, Inc. announced today that Brandi Howard has been named Vice President…

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September 22, 2015

Evofem, Inc. Announces FDA Acceptance of New Drug Application for Amphora™ as a Contraceptive

San Diego, CA — Evofem, Inc. today announced that a New Drug Application for Amphora has been accepted for filing by the United States Food and Drug Administration (FDA).  The NDA requests FDA approval for Amphora as a non-hormonal, vaginal gel contraceptive. “We are delighted that the FDA has accepted this filing for Amphora,” said Evofem CEO Saundra Pelletier.  “We believe that the data from our phase III trial with over 3,000 patients demonstrates that Amphora has the potential to be an important hormone-free contraceptive option for women.” The application is supported by a large, multicenter, open-label, randomized, phase III trial that examined the repeated use of Amphora gel compared to a vaginal gel containing Nonoxynol-9 as the primary method of contraception over seven cycles of use.  The FDA has also conditionally accepted the company’s proposed trade name of Amphora, a decision that would be finalized upon approval of the NDA. About Amphora Amphora is a non-hormonal vaginal gel. In addition to the regulatory filing for approval as a contraceptive, Amphora is being investigated for microbicidal properties to develop a potential multipurpose prevention technology.  Amphora works by restoring the vaginal pH levels to those consistent with a healthy vaginal environment. A healthy vaginal environment acts against both sperm, as well as, viral and bacterial pathogens. About Evofem, Inc. Evofem, Inc. is a privately held biotechnology company that discovers, develops and commercializes prescription and over-the-counter products in the areas of feminine health and hygiene and for the prevention of sexually transmitted…

San Diego, CA — Evofem, Inc. today announced that a New Drug Application for Amphora…

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July 30, 2015

Evofem, Inc. Appoints Russell Barrans as Vice President of Sales and Marketing for North America

SAN DIEGO, CA — Evofem, Inc. announces that Russell Barrans has been named Vice President of Sales and Marketing for North America effective immediately. In this role, Mr. Barrans will be responsible for the commercial launch and lifecycle management of the Evofem product portfolio.  He will report to Evofem COO, John Fair. “We are excited to have Russell join the Evofem team in this important role.  His deep experience in the women’s healthcare industry and his US and global launch experience will allow him to have immediate impact on the business,” said Fair. Prior to joining Evofem, Mr. Barrans was the Director of Women’s Healthcare Marketing for TEVA Pharmaceuticals.  He also held senior level positions at global and domestic companies including Bayer and led his own strategic consulting firm servicing biotech and pharmaceutical brands. Mr. Barrans has worked in many aspects of the women’s healthcare pharmaceutical industry and has overseen the launch of numerous innovative contraceptive brands including Mirena®, and Plan B One-Step® OTC. Mr. Barrans graduated from California Coast University with a Bachelor’s of Science in Business Administration and holds an MBA from California Coast University.   About Evofem, Inc. Evofem, Inc. is a privately held biotechnology company that discovers, develops and commercializes prescription and over-the-counter products in the areas of feminine care, contraception, and the prevention of sexually transmitted infections.  Evofem, Inc. is committed to delivering effective, woman-controlled, rapidly reversible forms of contraception to women globally.   Media Inquiries Ellen Thomas +1.718.490.3248 [email protected]

SAN DIEGO, CA — Evofem, Inc. announces that Russell Barrans has been named Vice President…

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July 6, 2015

Evofem, Inc. Submits New Drug Application to U.S. FDA for Amphora™ as a Contraceptive

San Diego, CA – Evofem, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Amphora as a contraceptive vaginal gel for women.  The submission is based on the results of a large, multicenter, open-label, randomized, phase III trial that examined the repeated use of Amphora gel compared to a vaginal gel containing Nonoxynol-9 as the primary method of contraception over seven cycles of use. “Evofem is committed to our mission of empowering women by providing new innovations in women’s health and more ways for women to manage their fertility,” said Saundra Pelletier, Chief Executive Officer of Evofem, Inc.  “Based on the results of the phase III trial, we believe Amphora can become an important and exciting new product for women and address a large unmet need in the market because it is woman-controlled, pericoital and hormone-free.” About Amphora Amphora is a non-hormonal vaginal gel. In addition to submission for approval as a contraceptive, Amphora is being investigated for microbicidal properties to develop a potential multipurpose prevention technology.  Amphora works by restoring the vaginal pH levels to those consistent with a healthy vaginal environment which acts against both semen as well as viral and bacterial pathogens. About Evofem, Inc. Evofem, Inc. is a privately held biotechnology company that discovers, develops and commercializes prescription and over-the-counter products in the areas of feminine care, contraception, and the prevention of sexually transmitted infections.  Evofem, Inc. is committed to delivering effective,…

San Diego, CA – Evofem, Inc. announced today that it has submitted a New Drug…

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July 1, 2015

Evofem, Inc. Appoints Dr. Kelly Culwell as Chief Medical Officer

SAN DIEGO, CA — Evofem, Inc. announces that Dr. Kelly Culwell has been named Chief Medical Officer, effective immediately. In this role, Dr. Culwell will provide medical oversight, expertise and leadership to ensure the delivery of quality healthcare products.  She will report to Evofem CEO, Saundra Pelletier. “Kelly’s knowledge, enthusiasm and work in developing global guidelines for clinical practice in women’s health will make her an asset to the Evofem team,” said Pelletier. In addition to her duties as CMO, Dr. Culwell is a Volunteer Clinical Professor in the Department of Obstetrics and Gynecology at the University of California, San Diego and Davis campuses. Prior to Evofem, Dr. Culwell served as Medical Director of the Planned Parenthood of the Pacific Southwest.   Her previous experience includes Medical Advisor to the International Planned Parenthood Federation and Medical Officer with the World Health Organization. Dr. Culwell has published widely in journals including Contraception, the International Journal of Gynecology and Obstetrics, and Obstetrics & Gynecology.  She completed her medical training and residency at the University of California, Davis and University of California, San Diego, respectively. She earned a Master of Public Health from Northwestern University, where she also completed a fellowship in family planning and contraception. About Evofem, Inc. Evofem, Inc. is a privately held biotechnology company that discovers, develops and commercializes prescription and over-the-counter products in the areas of feminine care, contraception, and the prevention of sexually transmitted infections.  Evofem, Inc. is committed to delivering effective, woman-controlled, rapidly reversible forms of contraception to…

SAN DIEGO, CA — Evofem, Inc. announces that Dr. Kelly Culwell has been named Chief…

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April 14, 2015

Woman Care Global & Evofem CEO Saundra Pelletier Announced as Speaker for UVA Darden School of Business’ Leadership Speaker Series

San Diego, CA—Saundra Pelletier, CEO of Woman Care Global and Evofem Inc., will be the final speaker for the Spring 2015 Leadership Speaker Series at the University of Virginia’s Darden School of Business.   The Darden Leadership Speaker Series features the world’s thought leaders sharing their stories, expertise and advice with Darden students, faculty and staff. Ms. Pelletier has dedicated her life and career to empowering women, and she has been a major force in bringing attention to the need for women globally to access reproductive health supplies.  She has grown Woman Care Global’s reach to over 100 countries while also leading Evofem Inc., a privately held biotechnology company that develops innovative prescription and consumer products. “I’m excited to share my experiences building a global, public/private partnership at Darden where a focus on purpose, people and profit is valued”, said Pelletier. “Our organization strives to use smart business strategy to build socially sound and sustainable programs that make it easier for women to get access to the reproductive healthcare products they deserve.” Ms. Pelletier will speak on Wednesday, April 15, 2015 from 1:30pm-2:30pm at the University of Virginia’s Darden School of Business in Charlottesville, VA.    About Woman Care Global Woman Care Global is a global non-profit healthcare company whose mission is to provide reproductive health solutions for women and girls around the world. Leveraging our medical, social and commercial expertise, we have built a sustainable value chain that enables us to reliably deliver high-quality products and point of care services,…

San Diego, CA—Saundra Pelletier, CEO of Woman Care Global and Evofem Inc., will be the…

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April 1, 2015

Evofem, Inc. Appoints Dr. David Friend as Senior Vice President of Product Development

SAN DIEGO, CA — Evofem, Inc. announces that Dr. David Friend has been named Senior Vice President of Product Development, effective immediately. In this role, Dr. Friend will be responsible for providing scientific leadership and managing product development from initial concept to final product.  He will report to Evofem’s Chief Medical Officer. “David brings an extensive scientific background coupled with global experience in women’s health,” said Evofem’s COO, John Fair. “We look forward to his contributions to our team.” Prior to joining Evofem, Dr. Friend served as Director of Product Development at CONRAD, an organization that works to expand contraceptive choices and prevent sexually transmitted infections. Before CONRAD, Dr. Friend was Vice President, Research at Vyteris, Inc, a company that develops novel transdermal delivery systems. He has developed oral dosage forms for delivery of drugs and he holds several patents for novel dosage forms.  His previous professional experience includes work at a number of pharmaceutical companies, including Delsys Pharmaceutical, a division of Elan Corporation, Vascular Therapeutics, CIBUS Pharmaceuticals and SRI International. Dr. Friend has published more than 60 research articles and is currently on the editorial board of the Drug Delivery and Translational Research, Antiviral Research and Pharmaceutical Development and Technology Journals. Additionally, Dr. Friend sits on three scientific advisory boards in the areas of microbicide development and the prevention of HIV transmission. He earned his Bachelor of Science in biochemistry from the University of California, Davis, and his PhD in chemistry from the University of California, Berkeley. About Evofem,…

SAN DIEGO, CA — Evofem, Inc. announces that Dr. David Friend has been named Senior…

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January 13, 2015

Evofem, Inc. Announces Pre-NDA Meeting With FDA for Amphora™

SAN DIEGO, CA —Evofem, Inc., a biotechnology company focused on the discovery and development of women’s health products, announced today that it concluded its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding Amphora. “We are encouraged and confident that we have received appropriate guidance as we prepare for the NDA submission of Amphora,” said Saundra Pelletier, CEO of Evofem, Inc. “This is an important first step in the lifecycle management of Amphora.” The meeting was held on December 9, 2014 and meeting minutes have been received. The outcome of the pre-NDA meeting allows Evofem, Inc. to maintain expectations of an NDA filing for Amphora in mid-to-late 2015, as planned. Amphora, a non-hormonal vaginal gel, recently completed a large, multicenter, open-label, randomized, phase III trial that examined the repeated use of Amphora gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over seven cycles of use. The primary endpoint was rate of pregnancy. About Evofem, Inc. Evofem, Inc. is a privately held biotechnology company that discovers, develops and commercializes prescription and over-the-counter products in the areas of feminine care, contraception, and the prevention of sexually transmitted infections.  Evofem, Inc. is committed to delivering effective, woman-controlled, rapidly reversible forms of contraception to women globally. Media Contact Ellen Thomas [email protected] +1.718.490.3248

SAN DIEGO, CA —Evofem, Inc., a biotechnology company focused on the discovery and development of…

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June 26, 2014

Evofem Announces the Completion of a Phase III Contraceptive Clinical Trial

San Diego, California – Evofem announced the completion of a Phase III contraceptive clinical trial examining the efficacy of its contraceptive vaginal gel Amphora™. The clinical trial compared Amphora to Conceptrol®, the brand name of Nonoxynol-9, and the only spermicidal vaginal gel currently approved by the FDA. The 3,386-subject trial tested the efficacy of Amphora in preventing pregnancy as compared to Conceptrol. “We are excited to have reached this important milestone in the development of Amphora,” said Saundra Pelletier, CEO of Evofem Inc. “We really believe Amphora has tremendous potential to impact the lives of millions of women, globally.” Health Decisions, a leading clinical research organization (CRO) conducted the Amphora clinical trial. “We are pleased to announce early completion on a 3,386-subject global study of a potentially important new contraceptive alternative for women worldwide,” said Health Decisions CEO Michael Rosenberg, MD, MPH. “A combination of intensive study management based on streaming information and progressive subject-by-subject closeout enabled this important early step toward regulatory approval for a non-hormonal alternative to existing contraceptives.” About Evofem, Inc. Evofem, Inc. is a privately held biotechnology company that discovers, develops and commercializes prescription and over-the-counter products in the areas of feminine care, contraception, and the prevention of sexually transmitted infections.  Evofem, Inc. is committed to delivering effective, woman-controlled, rapidly reversible forms of contraception to women globally. Media Inquiries Ellen Thomas +1.718.490.3248 [email protected]

San Diego, California – Evofem announced the completion of a Phase III contraceptive clinical trial…

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