Startups, Venture

Amplyx grabs $67M to fund a pivotal drive to the FDA with an anti-fungal aimed at a lethal threat

Amplyx Plarmaceuticals is prepping a move into a pivotal Phase II program for its anti-fungal drug with a sizable $67 million round in hand to pay for the two-year effort ahead. And it’s tackling a dangerous fungus with its broad-spectrum therapy that the CDC has characterized as a “catastrophic threat.”

Ciara Kennedy

Amplyx CEO Ciara Kennedy says that the San Diego-based biotech more than doubled its total raise before this round after finishing up the Phase I program. As the government has steadily upped the incentives it’s using to encourage development of drug-resistant infection fighters, lawmakers moved the goal post for her company up to Phase II — making this a “really interesting and exciting time.”

It’s a big round for Amplyx, which has 19 staffers. But in addition to the pair of Phase II trials they’re readying to launch — which will take a couple of years to wrap — the biotech also has to complete its manufacturing prep work, tox studies and so on to ready a move into the market if they get a green light.

Kennedy was part of the ex-Lumena gang that founded Amplyx. Initially the COO, Mike Grey had helmed the company at first, then stepped up to executive chairman at the beginning of this year as Kennedy moved into the CEO role. Shire bought out Lumena in a $260 million-plus deal in 2014, leaving the experienced group free to do a startup.

That background suggests another sale could be in the offing, if the data look good. But Kennedy isn’t about to get boxed in to one fate like that. Phase II biotechs like to have choices.

“Could we commercialize this ourselves?” she tells me. “Absolutely.”

The product is aimed at high volume hospitals and is intended to fill the role of a preferred anti-infective. Fighting drug-resistant cases — singling out the lethal Candida aurus — will be important to its quick success. But Kennedy sees this as a front-line drug with a new mechanism of action; a first choice rather than a last chance. It’s something a dedicated sales team could field.

But she isn’t ruling a sale out either. Either way, now isn’t the right time for a deal.

Says Kennedy: “I think the companies that are commercially active in the anti-infective world tend to be the kind of company that pay more later for a de-risked product.” So at or near the regulatory finish line works best on timing.

In the meantime, Amplyx has a growing and dedicated venture crowd happy to bear the risk and wait for the rewards.

Sofinnova Venture Partners led the Series C, joined by new investors Lundbeckfonden Ventures, Arix Bioscience and Pappas Capital. Existing investors New Enterprise Associates, RiverVest Venture Partners, 3×5 RiverVest II and BioMed Ventures also participated in the financing. Anand Mehra, M.D., managing partner at Sofinnova Ventures, and Johan Kördel, Ph.D., senior partner at Lundbeckfonden Ventures, will join the Amplyxboard of directors.


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RAPS Regulatory Convergence 2017