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f8k_060215.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

 
FORM 8-K
CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  June 1, 2015

Proteon Therapeutics, Inc.
(Exact name of registrant as specified in its charter)

Delaware
001-36694
20-4580525
(State or other jurisdiction
(Commission
(IRS Employer
of incorporation)
File Number)
Identification No.)

 
200 West Street
Waltham, MA
02451
(Address of principal executive offices)
(Zip Code)

 
Registrant’s telephone number, including area code:  (781) 890-0102

N/A
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 
 
Introductory Comment
 
Throughout this Current Report on Form 8-K, the terms “we,” “us,” “our”, “Company” and “Proteon” refer to Proteon Therapeutics, Inc.
 
Item 5.02.       Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

On June 2, 2015, Proteon announced the appointment of Scott Toner as Senior Vice President of Marketing, effective June 1, 2015. A copy of the press release announcing Mr. Toner’s appointment is filed as Exhibit 99.1 to this Current Report on Form 8-K.

Prior to joining Proteon, from 2014 to 2015, Mr. Toner, age 60, served as the VP Marketing and Sales of OPKO Health’s Renal Division. From 2012 to 2014, he served as a consultant to companies in the biotechnology industry and from 2011 to 2012 served as Senior Director, Marketing of Reata Pharmaceuticals. Prior to that, from 2007 to 2010, Mr. Toner served as Executive Director of Marketing with AMAG Pharmaceuticals. From 1985 to 2007, Mr. Toner held various roles within the domestic and international divisions of Abbott Laboratories, concentrating primarily on the nephrology and critical care therapeutic spaces. Mr. Toner serves as a member of the Board of the American Association of Kidney Disease Patients (AAKP).

There are no agreements or understandings between Mr. Toner and any other person pursuant to which he was appointed as an executive officer of the Company, there are no family relationships between Mr. Toner and any director or executive officer of the Company, and he has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

On April 19, 2015, the Company entered into a letter agreement with Mr. Toner outlining the terms of his employment (the “Employment Agreement”). In accordance with the terms of the Employment Agreement, Mr. Toner became our Senior Vice President of Marketing effective as of June 1, 2015. Under the Employment Agreement, Mr. Toner’s base salary will be equal to $245,000 per year, subject to increases by the Compensation Committee of the Company’s Board of Directors (the “Board”) (the “Committee”) at any time in its sole discretion. Mr. Toner is also eligible to receive an annual discretionary bonus, not to exceed 30% of his base salary, if certain performance goals are met in the discretion of the Committee. In addition, Mr. Toner will receive a signing bonus of $5,000 in the Company’s next payroll period.

On June 2, 2015, the Board granted Mr. Toner options to purchase 50,000 shares of the Company’s common stock (the “Option Grant”) subject to the terms and conditions of the Company’s stock plans. The Option Grant will vest as to 12,500 options on the first anniversary of his hire date, and the remaining 37,500 options will vest in twelve equal quarterly installments from September 30, 2016 through June 30, 2019, conditioned upon Mr. Toner’s continued employment.

Under the Employment Agreement, Mr. Toner will be entitled to cash severance payments if the Company terminates his employment without Cause (as defined in the Employment Agreement) or if Mr. Toner resigns his employment by reason of Constructive Termination (as defined in the Employment Agreement).

In connection with the execution of the Employment Agreement, Mr. Toner agreed to maintain Company confidential information and trade secrets and also to adhere to certain covenants of non-competition.
 
The foregoing summary description of the Employment Agreement with Mr. Toner does not purport to be complete and is qualified in its entirety by reference to the Employment Agreement, which is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference in its entirety.
 
 
 
 
Item 9.01.      Financial Statements and Exhibits
 
(d) Exhibits
 
Exhibit No.
Description
 
99.1
Press Release, dated June 2, 2015, issued by Proteon Therapeutics, Inc.
 
99.2
Employment Agreement, dated April 19, 2015, by and between Proteon Therapeutics, Inc. and Scott Toner
 
 

 

 
 
 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
Date:  June 2, 2015
PROTEON THERAPEUTICS, INC.
  
 
(Registrant)
  
 
 
    
 
By:
/s/ Timothy P. Noyes
  
 
Name:  Timothy P. Noyes
  
 
Title:     President & Chief Executive Officer
  

 
 
 

 
 
 
 
EXHIBIT INDEX
 
 
Exhibit No.
Description
 
99.1
Press Release, dated June 2, 2015, issued by Proteon Therapeutics, Inc.
 
99.2
Employment Agreement, dated April 19, 2015, by and between Proteon Therapeutics, Inc. and Scott Toner
 

 
Proteon Therapeutics Appoints Scott Toner as Senior Vice President of Marketing

EXHIBIT 99.1

Proteon Therapeutics Appoints Scott Toner as Senior Vice President of Marketing

WALTHAM, Mass., June 2, 2015 (GLOBE NEWSWIRE) -- Proteon Therapeutics Inc. (Nasdaq: PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced the addition of Scott Toner as Senior Vice President of Marketing. In this position, Scott will oversee development of the strategy around the potential commercialization of Proteon's investigational drug, vonapanitase. He brings over 25 years of experience developing and implementing effective commercial strategies for new drugs and critical care products and has worked for nearly 15 years specifically on drugs to treat the complications of chronic kidney disease (CKD).

"Scott's leadership and experience successfully commercializing therapies for CKD patients are an ideal fit for Proteon as we progress through Phase 3 trials and prepare the strategy around the potential commercialization of vonapanitase," said Timothy Noyes, President and Chief Executive Officer. "We are delighted to welcome Scott to Proteon's senior management team and look forward to his contributions as we develop vonapanitase to improve arteriovenous fistula patency for CKD patients undergoing hemodialysis."

Most recently, Scott served as Vice President, U.S. Marketing and Sales, at OPKO Health, where he led the commercial planning for the launch of an investigational treatment for secondary hyperparathyroidism (SHPT). Previously, Scott served as a senior marketing executive at Reata Pharmaceuticals, where he led development of the global marketing strategy for an investigational therapy for CKD in patients with type 2 diabetes. Scott was also the Executive Director of Marketing at AMAG Pharmaceuticals, where he led the launch of Feraheme®, an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with CKD. Scott worked for 20 years at Abbott Laboratories in progressive sales, sales training, sales management and domestic and international marketing roles. While head of marketing at Abbott Renal, he led the launch of Zemplar® Injection, which became the most commercially successful vitamin D therapy in the United States for the prevention and treatment of SHPT associated with CKD Stage 5. Scott serves as a member of the Board of the American Association of Kidney Disease Patients (AAKP).

"Although arteriovenous fistulas are the preferred form of hemodialysis vascular access, they are at risk of patency loss, which results in additional corrective procedures and reduced fistula survival," remarked Scott. "Proteon is currently evaluating in clinical trials whether vonapanitase can prolong fistula patency, an unmet medical need for which there are no approved therapies currently available. I am excited to join the Proteon team and work together developing this novel and potentially innovative treatment for CKD patients undergoing hemodialysis."

Proteon is currently enrolling patients in a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical study of vonapanitase in CKD patients undergoing surgical creation of a radiocephalic AVF for hemodialysis. The Company expects to complete enrollment by the end of 2015 and is anticipating initiating enrollment in a second Phase 3 clinical study in the second quarter of 2015. Proteon is also conducting an ongoing Phase 1 clinical study of vonapanitase in patients with symptomatic peripheral artery disease (PAD).

About Proteon Therapeutics

Proteon Therapeutics is committed to improving the health of patients with kidney and vascular diseases through the development of novel, first-in-class therapeutics. Proteon's lead product candidate, vonapanitase (formerly PRT-201), is designed to improve arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis. Proteon is currently evaluating vonapanitase in a Phase 3 clinical trial in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic AVF for hemodialysis and a Phase 1 clinical trial in patients with symptomatic peripheral artery disease (PAD). For more information, please visit www.proteontherapeutics.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are, or may be deemed to be, "forward-looking statements." In some cases these forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately," "potential," or, in each case, their negatives or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements, including those regarding the potential surgical and endovascular applications for vonapanitase, the potential use of vonapanitase for patients with renal and vascular diseases, the effect of vonapanitase in patients with CKD, timing to complete enrollment for the Phase 3 trial, timing for initiation of enrollment for the second Phase 3 trial, and those relating to future events or our future financial performance or condition, involve substantial known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors, including whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements for the period anticipated; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether vonapanitase will advance through the clinical trial process on the anticipated timeline and warrant submission for regulatory approval; whether such a submission would receive approval from the Food and Drug Administration or equivalent foreign regulatory agencies on a timely basis or at all; and whether we can successfully commercialize and market our product candidates, are described more fully in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, as filed with the Securities and Exchange Commission on May 13, 2015, and our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on March 20, 2015, and our Current Reports on Form 8-K, as filed with the SEC, particularly in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations." In light of the significant uncertainties in our forward-looking statements, you should not place undue reliance on these statements or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements contained in this press release represent our estimates and assumptions only as of the date of this press release and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

Investor Relations Contact
George Eldridge, Proteon Therapeutics, Senior Vice President and Chief Financial Officer
781-890-0102
geldridge@proteontherapeutics.com
 
Media Contact
Chris Erdman or Lynnea Olivarez, MacDougall Biomedical Communications
781-235-3060
proteon@macbiocom.com
exh_992.htm
EXHIBIT 99.2