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Flushed With Cash, Moderna Expands Space, Went on Hiring Spree and Launches at Least Two Clinical Trials

7/26/2016 5:52:24 AM

Flushed With Cash, Moderna Expands Space, Went on Hiring Spree and Launches At Least Two Clinical Trials July 26, 2016
By Mark Terry, Breaking News Staff

Moderna Therapeutics, headquartered in Cambridge, Massachusetts, provided a mid-year update on its scientific progress today.

To top off the list, Moderna and AstraZeneca (AZN) announced they had filed a Clinical Trial Application (CTA) for a Phase I study of AZD8601 in Europe. Moderna also indicated it had eight more mRNA development candidates that it is advancing through programs for investigational new drug (IND) applications. All eight are from internally led programs and partnered programs. Several are expected to begin clinical evaluations this year.

Flushed With Cash, Moderna Expands Space, Went on Hiring Spree and Launches at Least Two Clinical Trials

“In the first half of 2016, our team continued to make significant strides to advance our goal to deliver a new generation of transformative medicines for patients across a broad spectrum of diseases,” said Stephane Bancel, Moderna’s chief executive officer, in a statement. “In the five years since Moderna’s founding, we have initiated two clinical trials, filed a CTA for a third program and moved another eight development candidates into IND-enabling studies.”

And impressively, the company has more than 90 discovery programs across its ecosystem of internal and external partners. Therapeutics areas include infectious diseases, rare diseases, oncology, immuno-oncology and cardiovascular diseases.

Currently the company has two compounds in clinical trials, with a possible four more by year end.

Flushed With Cash, Moderna Expands Space, Went on Hiring Spree and Launches at Least Two Clinical Trials

Moderna also has a very strong financial position, with about $1 billion in cash, primarily from payments related to its collaborations with Merck & Co. (MRK) and Vertex (VRTX). The Vertex deal is fairly recent, inked on July 6. It is a three-year collaboration and will focus on using mRNA therapies to help lung cells manufacture functional copies of the cystic fibrosis transmembrane conductance regulatory (CFTR) protein, which malfunctions in CF patients. Vertex paid Moderna $20 million in an upfront payment, and invested another $20 million in a convertible note that will convert to equity. It also has an additional possible $275 million in developmental and regulatory milestones.

The Merck deal was also in early July, late June, and is focused on personalized cancer vaccines. That deal is valued at $200 million. Other deals with AstraZeneca for cardiovascular diseases and cancer, and Alexion Pharmaceuticals (ALXN) for rare diseases, are worth $240 million and $125 million, respectively.
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Moderna also has a Global Health Partnership with the Bill & Melinda Gates Foundation to develop an mRNA-based antibody against HIV.

The company reports GAAP revenues of $36 million, cash income of about $80 million from various milestone payments and reimbursements, and another $135 million from investments.

In addition, Moderna has created a wholly owned and validated manufacturing facility in Cambridge, Massachusetts, and expanded its lab, office and manufacturing facilities from 115,000 square feet to 200,000 square feet. And it also hired 120 people in the first half of the year, employing 440, up from 320.

Saqib Islam, formerly executive vice president and chief strategy and portfolio officer of Alexion Pharmaceuticals (ALXN), joined the company as chief business officer. And Michael Watson, formerly global head of Vaccination Policy and Advocacy at Sanofi Pasteur (SASY.PA) stepped in as president of Valera, a Moderna venture company that focuses on infectious diseases.

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