Prothena Expands Executive Team, Moves Forward With Drug Development

A quarter has passed since its spinoff from Elan(ELN), and Prothena(PRTA) continues to lumber forward with its development as an independent company.  Prothena issued two announcements last week. In the first, it announced the expansion of its management team, with the appointments of Dr. Martin Koller as Chief Medical Officer, and Tran Nguyen as Chief Financial Officer.

“Marty and Tran bring a wealth of biotech expertise to Prothena and will play pivotal roles as we advance our research and clinical pipeline. I am pleased to welcome them to our management team,” said Dr. Dale Schenk, President and Chief Executive Officer, Prothena. “Marty’s decades of clinical leadership will forge strong trial strategy and design in multiple indications. Tran’s financial strategy, planning and management experience with public life science companies will provide critical support for the advancement of our pipeline.”

Martin Koller, MD

Martin Koller, MD is a board-certified neurologist with more than 20 years of experience in the life sciences industry, developing small molecules and biologic therapeutics for a diverse array of indications. Prior to joining Prothena, Dr. Koller served as Chief Medical Officer at Sonexa Therapeutics. Previously, Dr. Koller held clinical development roles and leadership positions at life sciences companies including Athena Neurosciences, Elan Pharmaceuticals, Syntex Pharmaceuticals and Wyeth Pharmaceuticals. Dr. Koller has extensive expertise in clinical trial design, having been involved in the clinical development of numerous INDs and NDAs targeting a broad array of indications, including Alzheimer’s disease, multiple sclerosis, cervical dystonia, pain, epilepsy, migraine, stroke, anxiety, and depression. Dr. Koller has a BA from Franklin and Marshall College, an MPH with an emphasis in epidemiology from the University of Texas at Houston and his MD from the University of Maryland, Baltimore. Dr. Koller completed fellowship training in neuromuscular diseases at the University of Southern California.

Tran Nguyen

Tran Nguyen has 15 years of finance experience in the healthcare, banking and private equity industries. Prior to joining Prothena, he held management positions at Somaxon Pharmaceuticals, Inc., including Senior Vice President, Vice President, Chief Financial Officer, and Investor Relations, until its sale in 2013. Previously, Mr. Nguyen was Vice President, Chief Financial Officer and Investor Relations at Metabasis Therapeutics, Inc., until its sale in 2010. Before entering the biotech industry, Mr. Nguyen was a vice president in the Healthcare Investment Banking group at Citi Global Markets, Inc., and served in healthcare investment banking at Lehman Brothers, Inc. Mr. Nguyen has a BA from Claremont McKenna College and an MBA from UCLA Anderson School of Management.

The second announcement contained Prothena’s 2012 earnings and a forecast for 2013. Since the spinoff did not take effect until late December, and the company has no marketed products, the update on drug development and the forecast are of the most interest. The company has gained Orphan Drug Status for its first clinical candidate, NEOD001, as well as acceptance of its IND, and it plans to begin a phase I trial shortly. The firm has $125 million in cash and expects to complete 2013 with $88 million.

“Prothena targets proteins in novel ways to resolve unmet clinical need in patients. We achieved significant milestones in 2012; the FDA accepted our IND for NEOD001, and we established Prothena as an independent company. We expect to continue our positive momentum in 2013 by initiating a Phase 1 clinical trial for NEOD001 and advancing our research pipeline toward the clinic,” said Dale Schenk, PhD, President and Chief Executive Officer of Prothena.

“Our research and clinical progress has been supported by our success in building a seasoned board and solid management team,” continued Dr. Schenk. “We have a strong capital position to advance our lead assets further in clinical development including NEOD001 through Phase 2 proof of concept data, and PRX002 and PRX003 through Phase 1 clinical trials. We look forward to continued progress toward these goals in 2013.”

2012 Highlights

  • Completed separation from Elan and listing on Nasdaq as a public company; capitalized with $125 million in cash
  • NEOD001 was granted orphan drug designation for both AL and AA amyloidoses by U.S. Food and Drug Administration (FDA)
  • NEOD001 Investigational New Drug (IND) application for both AL and AA amyloidoses filed and accepted by FDA
  • PRX002 (formerly NEOD002) pre-clinical proof of concept and clinical supply manufacturing efforts progressed
  • PRX003 established pre-clinical proof of concept

Research and Development Pipeline Highlights

Prothena’s research and development pipeline includes three lead therapeutic antibody programs that the company plans to advance aggressively in 2013 and several discovery programs staged for future value.

NEOD001, a monoclonal antibody targeting AL and AA amyloid for the potential treatment of amyloidosis

  • Granted orphan designation by the European Medicines Agency for the treatment of AL amyloidosis
  • Phase 1 clinical trial in AL amyloidosis planned for early 2013

PRX002 (formerly NEOD002), a monoclonal antibody targeting synuclein for the potential treatment of Parkinson’s disease

  • IND enabling studies and pre-clinical safety testing planned for 2013
  • IND filing and Phase 1 trial in Parkinson’s disease patients planned for 2014

PRX003, a monoclonal antibody targeting MCAM (melanoma cell adhesion molecule) for the potential treatment of inflammatory disease and metastatic cancers

  • Selected lead candidate
  • IND filing and Phase 1 trial planned for 2015

2013 Financial Outlook

The Company expects a cash burn of $34 to $40 million for 2013, ending the year with approximately $88 million in cash. The 2013 cash burn is primarily driven by an estimated net loss of $36 to $42 million, which includes an estimated $2.5 million of depreciation and share-based compensation expense. The Company intends to use the anticipated 2013 spend to initiate and progress patient enrollment and dosing at multiple sites for its NEOD001 Phase 1 clinical trial, complete IND enabling toxicology studies for PRX002, select a first orphan indication for PRX003, and further advance its discovery programs.

Disclosure: The author holds no position in any stock mentioned