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Novavax, Inc. (NVAX)

RSV Vaccine Candidate Phase II Top Line Results Conference

April 03, 2013 10:00 am ET


Frederick W. Driscoll - Chief Financial Officer, Principal Accounting Officer, Vice President and Treasurer

Stanley C. Erck - Chief Executive Officer, President , Director and Member of Finance Committee

Gregory M. Glenn - Chief Medical Officer and Senior Vice President

Pedro Piedra

Louis Fries - Vice President of Clinical and Medical Affairs


Gregory R. Wade - Wedbush Securities Inc., Research Division

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

Elemer Piros - Burrill & Company

George B. Zavoico - MLV & Co LLC, Research Division



Good day, ladies and gentlemen, and welcome to the Novavax RSV Vaccine Candidate Phase II Top Line Results Conference Call. My name is Karen, and I'll be your coordinator for today. [Operator Instructions] As a reminder, this conference is being recorded. Novavax, please proceed with your call.

Frederick W. Driscoll

Thank you, Karen, and good morning, everyone. This is Fred Driscoll, Chief Financial Officer of Novavax, and I thank you for joining us on today's conference call to discuss the top line results from Novavax's Phase II clinical trial of our RSV-F vaccine candidate in women of childbearing age. Both the press release from yesterday and an archive of this call can be found on the company's website at novavax.com.

On today's call are Novavax President and Chief Executive Officer, Stan Erck; our Senior Vice President and Chief Medical Officer, Dr. Gregory Glenn; and Dr. Louis Fries, our Vice President of Clinical and Medical Affairs; and Dr. Tony Piedra, Professor from the Department of Molecular Virology and Microbiology at Baylor College of Medicine.

Before we begin our prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference that could include financial, clinical or commercial projections. Statements relating to future financial or business performance, conditions or strategies and other financial and business matters, including clinical developments and anticipated milestones, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time. Further, information on the factors and risks that could affect Novavax's business, financial conditions and results of operations are contained in Novavax's filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this call, and Novavax assumes no duty to update such statements.

I'll now turn the call over to Novavax's President, Stan Erck.

Stanley C. Erck

Thanks, Fred, and good morning, everyone. So last night, we issued a press release announcing positive top line results from our Phase II study of our RSV-F vaccine candidate in women of childbearing age. We were very pleased that the vaccine achieved the trial's clinical protocol specified objectives. The primary objectives of the study were fourfold: first, to monitor safety; second, to measure the difference in anti-F IgG elicited across doses of 60 micrograms or 90 micrograms of our RSV antigen; third, to evaluate the use of 1 versus 2 immunizations; and finally, to evaluate the use of aluminum phosphate or alum as an adjuvant.

Overall, the results from this trial suggests that our RSV-F vaccine candidate has a potential to induce safe and clinically useful immunity for this important patient population. Significantly, immune responses in this study also equaled or exceeded those seen in our previous Phase I study.

The results from this study provide a compelling rationale for continued development of our RSV vaccine candidate. As you can imagine, these results will only increase our excitement regarding our RSV program. These data represent another key step in the development of our RSV vaccine candidate for use in the maternal immunization strategy.

With this trial, we have now expanded our safety database and have treated almost 500 subjects to date without a vaccine related serious adverse event. As you know, safety is paramount in the development of any vaccine, and we were pleased by the profile of our candidate.

As Greg will discuss shortly, the immunogenicity results from this Phase II trial confirm that the vaccine contains a potent antigen with the potential of inducing clinically meaningful immunity. This is very important as we move forward in the maternal immunization strategy, in which antibodies in vaccinated women can be expected to be naturally transferred to their infants in utero, potentially conferring protection at the earliest stage of life when these infants are extremely vulnerable to severe respiratory disease due to RSV. Maternal immunization is already commonly performed in the clinic to protect both the mother and infant from influenza, pertussis and tetanus.

Before I turn the call over to Greg to review the trial and then to Dr. Piedra to put the results in perspective, I want to first acknowledge and thank our partners at PATH. PATH is an international nonprofit organization that supports the development of health care initiatives for low resource countries. PATH is committed to the development of an RSV vaccine and to maternal immunization in order to protect vulnerable infants from RSV.

The collaboration with PATH provided approximately $2 million of non-dilutive initial funding to support this study. And as part of our agreement with PATH, they can elect to continue to collaborate on additional clinical phases to develop a vaccine for maternal immunization, potentially funding 50% of Novavax's external clinical development costs all the way through to licensure.

Read the rest of this transcript for free on seekingalpha.com