Amplyx Pharmaceuticals today announced the company has closed on a $40.5 million Series B financing. The round was led by RiverVest Venture Partners, and included investments by New Enterprise Associates, BioMed Ventures and individual investors. Amplyx will use the funding to advance the clinical development of APX001, the company's broad-spectrum antifungal agent to treat life threatening fungal infections.

The company plans to initiate Phase 1 clinical trials of APX001 in 2016 to support a Phase 2 program in candidiasis, invasive aspergillosis and rare molds. APX001 has a novel mechanism of action and has shown broad-spectrum activity in animal models of infection by common species of Candida and Aspergillus, as well as high potency against rare molds. Amplyx is developing both intravenous and oral formulations of APX001 to address the need for hospital-based administration, as well as continued convenient administration after hospital discharge.

'There is an urgent unmet need for new treatments for fungal infections which increasingly impact immuno-compromised patients who are at high risk of contracting these difficult-to-treat, and often deadly, infections,' said Mike Grey, president and CEO of Amplyx Pharmaceuticals. 'There hasn't been a new class of antifungal drug approved since 2001, and many existing antifungal agents are difficult to use, often poorly tolerated or ineffective due to the rise of drug resistant strains.'

In association with the financing, Niall O'Donnell, Ph.D., managing director, RiverVest Venture Partners, and Ed Mathers, partner, New Enterprise Associates, were named to Amplyx's board of directors.

The following management team has been retained to lead the company, and will join Amplyx founder and chief scientific officer, Mitchell Mutz, Ph.D., as well as a number of experienced antifungal/drug development experts:

Mike Grey, president and CEO, is a venture partner with Pappas Ventures. He was previously president and CEO of Lumena Pharmaceuticals, acquired by Shire in 2014.
Ciara Kennedy, Ph.D., chief operating officer, joins Amplyx from Shire where she was vice president, head of cholestatic liver disease. Dr. Kennedy previously led the clinical development programs she initiated as chief operating officer, Lumena Pharmaceuticals.
Susan Dube, vice president, business development and administration, was previously vice president of corporate development at Lumena Pharmaceuticals before its acquisition by Shire.
'Several members of Amplyx's management team have worked together previously on a number of successful ventures and have the vital experience necessary to execute the clinical development of APX001, including leadership in obtaining multiple drug approvals,' said Dr. O'Donnell. 'The combination of this seasoned management team with great working relationships and a promising asset in a space with significant unmet need makes Amplyx a highly attractive company.'

The company will be eligible to pursue an accelerated regulatory pathway for APX001 under the Generating Antibiotics Incentives Now (GAIN) Act, which provides Fast-Track and priority FDA review of a qualified infectious disease product, as well as potential market authorization in the U.S. with a limited clinical trial database. The GAIN Act also extends the period of regulatory exclusivity by five years during which antifungals that treat serious or life-threatening infections can be sold without generic competition.

'APX001 has the potential to transform the antifungal treatment landscape by providing a much needed tool to address some of the most deadly and hard-to-treat fungal infections which impact more than 600,000 patients worldwide each year,' said Mr. Mathers. 'The combination of a potentially transformational therapy with a winning team that has previously successfully executed is a recipe for a great potential return on our investment.'

About RiverVest
RiverVest Venture Partners focuses exclusively on innovations in life sciences, a field in which our team has significant research, clinical, operational and investment expertise. Established in 2000, RiverVest has funded 34 innovative life science companies resulting in 21 exits, and currently has assets under management of more than $290 million. www.rivervest.com

About New Enterprise Associates
New Enterprise Associates, Inc. (NEA) is a global venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors and geographies. With nearly $17 billion in cumulative committed capital since inception, NEA invests in technology and healthcare companies at all stages in a company's lifecycle, from seed stage through IPO. The firm's long track record of successful investing includes more than 200 portfolio company IPOs and more than 320 acquisitions. www.nea.com.

About BioMed Ventures
BioMed Ventures is the investment arm of BioMed Realty - the leading provider of real estate to the life science industry. Launched in 2011, we invest in top-tier life science companies and equity funds to advance innovation throughout the sector and achieve superior risk-adjusted investment returns. biomedventures@biomedrealty.com

About Amplyx Pharmaceuticals
Amplyx Pharmaceuticals is developing novel, broad-spectrum antifungal agents for the treatment of life-threatening fungal infections. The company's lead compound, APX001, will enter clinical development in 2016 and has shown broad-spectrum activity in animal models of invasive fungal infection by common species of Candida and Aspergillus, as well as high potency against rare, difficult-to-treat molds. Amplyx has raised $42.5 million in venture capital and received more than $10 million in grants from the National Institutes of Health to supports its drug discovery and development efforts. The company's research operations are located at Johnson & Johnson Innovation, JLABS in San Diego, Calif.