UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): October 22, 2013
KaloBios Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-35798 | 77-0557236 | ||
| (State or other Jurisdiction of Incorporation) |
(Commission File No.) |
(IRS Employer Identification No.) |
260 East Grand Avenue
South San Francisco, CA 94080
(Address of principal executive offices, including zip code)
(650) 243-3100
(Registrant’s telephone number, including area code)
(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):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
The Board of Directors (the “Board”) of KaloBios Pharmaceuticals, Inc. (the “Company”) appointed Herb C. Cross to the role of the Company’s Chief Financial Officer as of October 14, 2013 and as the principal financial and accounting officer effective October 22, 2013, replacing Jeffrey H. Cooper who previously indicated his intention to retire to spend more time with family and pursue other personal interests. Mr. Cross joined the Company on September 23, 2013 (the “Hire Date”) and has transitioned into the Chief Financial Officer role in coordination with Mr. Cooper.
There are no family relationships among Mr. Cross and any of our directors or executive officers and, other than as set forth herein, there are no arrangements or understandings between Mr. Cross and any other persons pursuant to which Mr. Cross was appointed as an executive officer of the Company. There have been no transactions or proposed transactions regarding Mr. Cross that are required to be disclosed pursuant to Item 404(a) of Regulation S-K.
In connection with his appointment as Chief Financial Officer, Mr. Cross was granted an option to purchase 150,000 shares of the Company’s common stock (the “Cross Option Award”) with an exercise price equal to $4.15 per share, which was the closing price of the Company’s common stock on the date of grant. The Cross Option Award was granted under the Company’s 2012 Equity Incentive Plan. Twenty-five percent (25%) of the shares subject to the Cross Option Award will vest upon the completion of twelve continuous months of service from the Hire Date, and the remaining seventy-five percent (75%) of shares subject to the Cross Option Award will vest in equal monthly installments over the following thirty-six months of continuous service.
On October 22, 2013, the Board appointed Laurie Smaldone Alsup, M.D. to serve as a director of the Company, effective as of the close of business on October 22, 2013. The Board also appointed Dr. Smaldone Alsup to serve on the Compensation Committee of the Board (the “Compensation Committee”), effective as of the close of business on October 22, 2013. Dr. Smaldone Alsup has served as President of PharmApprove, a scientific, medical and regulatory communications consulting company, since August 2011. From April 2008 to May 2011, Dr. Smaldone Alsup served as President and Chief Executive Officer of Phytomedics, Inc., an early stage life sciences company. Dr. Smaldone Alsup served in multiple senior roles, including Vice President of Corporate Strategy and Business Risk Management from 2004 to 2007 and Senior Vice President of Global Regulatory Science & Affairs from 1998 to 2004, at Bristol-Myers Squibb Company.
In connection with her appointment to the Board, Dr. Smaldone Alsup will receive compensation consistent with the Company’s current compensation arrangements for non-employee directors, including cash compensation in the amount of $40,000 per year payable quarterly. Dr. Smaldone Alsup will also receive cash compensation in the amount of $6,000 per year payable quarterly in connection with her service on the Compensation Committee. Dr. Smaldone Alsup was granted an option to purchase 20,000 shares of the Company’s common stock (the “Smaldone Alsup Option Award”) with an exercise price equal to $4.15 per share, which was the closing price of the Company’s common stock on the date of grant. The Smaldone Alsup Option Award was granted under the Company’s 2012 Equity Incentive Plan. The shares subject to the Smaldone Alsup Option Award will vest in equal monthly installments over thirty-six months of continuous service after October 22, 2013.
On October 23, 2013, the Company announced that Dennis Henner, Ph.D. resigned from his position as a director of the Company, effective as of the close of business on October 22, 2013. Dr. Henner has stated that his resignation is not because of a disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
A copy of the press release announcing Dr. Henner’s resignation and Dr. Smaldone Alsup’s appointment is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press release issued by KaloBios Pharmaceuticals, Inc. on October 23, 2013. | |
SIGNATURES
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.
| KaloBios Pharmaceuticals, Inc. | ||
| By: | /s/ David W. Pritchard | |
| David W. Pritchard | ||
| President and Chief Executive Officer | ||
Dated: October 23, 2013
Exhibit 99.1
KaloBios Elects Laurie Smaldone Alsup, M.D. to Board
SOUTH SAN FRANCISCO, CA (October 23, 2013): KaloBios Pharmaceuticals, Inc. (Nasdaq:KBIO) today announced the election of Laurie Smaldone Alsup, M.D. to KaloBios’ Board of Directors.
“Dr. Smaldone Alsup brings to the Board extensive experience in leading teams through the review and approval process of the U.S. Food and Drug Administration, European Medicines Agency and other health authorities,” said David W. Pritchard, KaloBios’ President and Chief Executive Officer. “Moreover, as a clinician she has led the overall development and commercialization of drugs for a broad range of disease indications including oncology, infectious disease, and inflammatory/ immune-based conditions that are directly relevant to our own portfolio.”
“Dr. Smaldone Alsup replaces Dr. Dennis Henner, whom we thank for his valuable service to KaloBios during an important phase of our company’s development and growth,” added Mr. Pritchard.
Laurie Smaldone Alsup has over 25 years of global leadership experience in the pharmaceutical and biotechnology industries. Currently, Dr. Smaldone Alsup is President and Chief Scientific Officer of PharmApprove, a regulatory communications consultancy firm. Dr. Smaldone Alsup previously served in clinical and regulatory roles of increasing responsibility and scope while at Bristol Myers Squibb, including Senior Vice President of Global Regulatory Science, Vice President of Infectious Diseases Clinical Research, and also as Director of Cancer Clinical Research. In addition, she served as CEO of Phytomedics, an early stage biopharmaceutical company focused on arthritis and inflammation. Dr. Smaldone Alsup received her M.D. degree at Yale University, where she completed her residency in Internal Medicine and fellowship in Medical Oncology.
About KaloBios
KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies designed to treat severe life-threatening or debilitating diseases for which there is an unmet medical need, with a clinical focus on severe respiratory diseases and cancer.
Currently, KaloBios has three drug development programs:
| • | KB003, an anti-GM-CSF mAb with potential to treat inflammatory diseases, is being developed for the treatment of severe asthma. Enrollment of 160 patients has been completed in a Phase 2 study in the United States, Europe and Australia. |
| • | KB001-A, an anti-PcrV mAb fragment, is partnered exclusively with Sanofi and is being developed for the prevention and treatment of Pseudomonas aeruginosa (Pa) infection. KaloBios has retained rights for the cystic fibrosis (CF) indication and has initiated a 180 patient Phase 2 study in CF subjects with chronic Pa lung infection in the United States. KaloBios received Orphan Drug designation from the European Commission for KB001-A for the treatment of Pa lung infection in CF. Sanofi is pursuing a ventilator-associated pneumonia prevention indication in the intensive care setting, an indication which has received U.S. FDA Fast Track Designation. |
| • | KB004, an anti-EphA3 mAb, has potential in treating hematologic malignancies and solid tumors. KaloBios is currently testing this drug in a Phase 1 study in subjects with hematologic malignancies. |
All of the company’s antibodies were generated using its proprietary Humaneered® technology, a method that converts nonhuman antibodies (typically mouse) into recombinant antibodies that have a high binding affinity to their target and are designed for chronic therapeutic use. The company believes that antibodies produced using its Humaneered® technology offer important clinical and economic advantages over antibodies generated by other methods in terms of high binding affinity, high manufacturing yields, and minimal to no immunogenicity (inappropriate immune response) upon repeat administration in humans.
For more information on KaloBios Pharmaceuticals, please visit our web site at http://www.kalobios.com.
Forward Looking Statements
This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the company’s clinical development of KB001-A, KB003 and KB004. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company’s limited cash reserves and its ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that the company has initiated or plans to initiate; the company’s dependence on Sanofi Pasteur for the development and commercialization of KB001-A; the company’s ability to successfully complete further development of its programs; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the company’s ability to protect the company’s intellectual property; competition; changes in the regulatory landscape or the imposition of regulations that affect the company’s products; and other factors listed under “Risk Factors” in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 1, 2013, the quarterly reports on Form 10-Q filed on May 14, 2013 and August 19 2013, and the company’s other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company has no obligation, and expressly disclaims any obligation to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, visit http://www.kalobios.com.
# # #
Contact:
Herb C. Cross
Chief Financial Officer
KaloBios Pharmaceuticals, Inc.
(650) 243-3114
ir@kalobios.com
Media Contact:
Joan E. Kureczka
Kureczka/Martin Associates
Tel: (415) 821-2413
Mobile: (415) 690-0210
Joan@Kureczka-Martin.com