News & Events

SOUTH SAN FRANCISCO, Calif., Aug. 19, 2013 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) a biopharmaceutical company with a portfolio of patient-targeted, first-in-class, monoclonal antibodies (mAbs) to treat serious medical conditions with a primary clinical focus on severe respiratory diseases and cancer, announced today its corporate highlights and financial results for the second quarter ended June 30, 2013.

"During the second quarter, we announced several important milestones in the development of our clinical pipeline," said David Pritchard, KaloBios President and Chief Executive Officer. "We announced the early completion of enrollment in our Phase 2 study of KB003 in severe asthma. As noted, we now expect to announce top line results of that study early in the first quarter of 2014, and to present detailed results later in 2014 at a major scientific meeting.

"For KB001-A," Mr. Pritchard continued, "we announced that the U.S. Food and Drug Administration has granted our partner Sanofi Pasteur Fast Track designation for use of KB001-A in protection against bacterial pneumonia caused by Pseudomonas aeruginosa (Pa) in mechanically ventilated patients. However, we also noted that enrollment has been slower than planned in our ongoing Phase 2 study of KB001-A in patients with cystic fibrosis (CF) who are chronically infected with Pa. As a result, we now expect to complete enrollment of this study in mid-2014 and announce top-line data in the fourth quarter of that year.

"For our third product candidate, KB004, the subject of an ongoing Phase 1 dose escalation and safety study in hematologic malignancies (blood-based cancers), we announced testing of the sixth dose level (190 mg). KaloBios now plans to initiate the Phase 2 expansion phase of the study in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) when confirmatory safety and pharmacokinetic data is obtained from the Phase 1 study. We anticipate initiating this expansion Phase 2 study in the fourth quarter of 2013."

Mr. Pritchard also noted that KaloBios announced the appointment of Don Joseph as Chief Legal Officer of the company and, after the close of the quarter, the retirement plans in the late fourth quarter for Jeffrey Cooper as Chief Financial Officer. In addition, KaloBios was added to the Russell 2000 Index, a subset of the Russell 3000 Index which measures the performance of the small-cap segment of the U.S. equity universe.

Mr. Pritchard also noted that after the close of the quarter, KaloBios received Orphan Drug Status from the European Commission regarding its applications for KB001-A for the treatment of Pa lung infection in CF. The U.S. Food and Drug Administration has completed their review of a similar request and has asked for additional information. KaloBios is planning to provide the requested data following completion of the ongoing Phase 2 CF study.

Financial Results

The net loss for the second quarter of 2013 was $11.8 million, or $0.49 per basic and diluted share. This compared to a net loss of $2.1 million, or $1.01 per basic and diluted share, for the same period in 2012. Net loss for the six months ended June 30, 2013 was $20.4 million ($1.02 per share), compared to net loss of $3.2 million ($1.57 per share) for the six months ended June 30, 2012. Increased spending for our clinical trial programs and general and administrative expenses associated with being a public company resulted in the increased loss during the second quarter and first half of 2013 compared to the same periods in 2012. As of June 30, 2013, cash, cash equivalents and investments, excluding restricted cash, totaled $63.7 million.

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 planned 150-patient 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 Pa infection. KaloBios has retained rights for the CF indication and has initiated a 180-patient Phase 2 study in CF subjects with chronic Pa lung infection in the United States. 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: the statements under the heading "Anticipated Upcoming Milestones for 2013-2014"; and 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 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.

Contact:

Jeffrey H. Cooper
Chief Financial Officer
KaloBios Pharmaceuticals, Inc.
(650) 243-3146
[email protected]

Media Contact:

Ellen M. Martin
Kureczka/Martin Associates
Tel: (510) 832-2044
[email protected]

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