KaloBios Reports Second Quarter Financial Results and Provides Clinical Update

SOUTH SAN FRANCISCO, Calif., Aug. 10, 2015 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO), a monoclonal antibody company focused on oncology, today announced its financial results for the second quarter of 2015 and provided an update on its clinical development progress.

Second Quarter 2015 Financial Results

Net loss for the quarter ended June 30, 2015 was $6.0 million or $1.46 per common share, as compared to $9.8 million or $2.38 per common share for the same period in 2014. All per-share amounts have been adjusted to reflect the impact of the one-for-eight reverse stock split effected in July 2015, as previously announced.

Research and development (R&D) expenses were $3.3 million for the quarter ended June 30, 2015, as compared to $6.7 million for the same quarter in 2014. The decrease in R&D expense was primarily due to decreased clinical trial activity compared with the prior period, largely as a result of the completion of the KB001-A Phase 2 study targeting Pseudomonas lung infections in cystic fibrosis patients in the first quarter of 2014. General and administrative (G&A) expenses were $2.3 million for the second quarter of 2015, compared to $2.8 million for the second quarter of 2014. The decrease in G&A expenses was primarily due to reduced employee-related costs as a result of restructuring activities undertaken in the first quarter of 2015.

As of June 30, 2015, KaloBios had cash, cash equivalents and investments totaling $23.2 million.

Development Program Updates

KB004 Immuno-oncology Program

KB004, the company's monoclonal antibody (mAb) targeting EphA3, is currently in clinical development in the phase 2 expansion portion of an open-label Phase 1/2 study in hematologic malignancies. The Phase 2 portion of the study is currently enrolling two cohorts of up to 20 patients each at the 250mg dose level selected as a result of the Phase 1 dose escalation portion of the study. One cohort consists of patients with myelodysplastic syndrome (MDS), and a second cohort consists of patients with myelofibrosis (MF).  Patients in both cohorts must be relapsed-refractory to standard-of-care treatment, and pre-screened to ensure tumor EphA3 expression. As of August 1, 2015, the phase 2 expansion portion of the study has enrolled a total of 8 patients in the MDS cohort and 6 patients in the MF cohort. Based on current enrollment rates, and with several additional clinical sites expected to commence enrollment in the coming months, the company expects enrollment to continue to accelerate. The drug continues to be well tolerated with the most commonly reported side effects being infusion reactions.

KB003 Oncology Program

In July, KaloBios announced that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for KB003, an anti-GM-CSF mAb, testing in patients with chronic myelomonocytic leukemia (CMML), an orphan oncology indication. As a result, KaloBios is initiating an open-label Phase I study designed to evaluate the safety, pharmacokinetics and clinical activity of KB003 in previously treated CMML patients. The study will consist of an accelerated dose-escalation component starting at 200 mg and escalating up to 600 mg, followed by a cohort expansion of up to 13 additional patients to explore clinical activity at the selected dose level. Site initiation activities are underway, and the company anticipates that enrollment will begin later this year.

"We have made excellent progress in 2015 in strengthening our oncology focus at KaloBios," said Herb Cross, KaloBios' Chief Financial Officer and Interim Chief Executive Officer. "We continue to work to expand our portfolio of oncology programs in clinical development, most notably with the addition of a third oncology indication as a result of the July FDA clearance of our IND for KB003 in CMML. We continue to enroll patients in the KB004 Phase 2 program in MDS and MF, as well as evaluating additional potential oncology indications for KB004 including solid tumors where EphA3 is expressed. With several oncology indications either in development or moving into the clinic, and other potential indications under evaluation, we continue to be excited about the potential of our assets."

About KaloBios

KaloBios Pharmaceuticals, Inc. is seeking to improve the lives of patients by developing innovative therapies to treat diseases of high unmet medical need, with a focus on oncology.

Currently, KaloBios is focused on advancing the following immuno-oncology and oncology programs in clinical development:

• KB004 is a non-fucosylated mAb targeting EphA3 with the potential to treat hematologic malignancies and solid tumors. KB004 is designed to kill tumor cells through multiple mechanisms, including antibody-directed cellular cytotoxicity (ADCC), direct apoptosis or disruption of the tumor stem cell environment and the vasculature that feeds it. KaloBios is conducting an ongoing Phase 1/2 study evaluating KB004 in hematologic malignancies. The Phase 1 dose escalation portion of the study is fully enrolled, and KaloBios is currently enrolling in the Phase 2 expansion portion of the study. The Phase 2 portion of the study, which requires screening patient tumors for EphA3 expression, is currently focused on patients with myelofibrosis (MF) or myelodysplastic syndrome (MDS). KaloBios is evaluating other potential oncology indications for KB004, including additional hematologic malignancies as well as solid tumors.     
• KB003 is an anti-GM-CSF mAb that KaloBios is evaluating in oncology indications where GM-CSF may play a key role, such as chronic myelomonocytic leukemia (CMML). The IND for KB003 in CMML, an orphan oncology indication, has been cleared by the FDA, and KaloBios is currently undertaking site initiation activities for a Phase 1 study of KB003 in previously treated CMML patients. KaloBios expects to commence dosing patients in this study during the second half of 2015.

All of the company's antibodies were generated using its proprietary Humaneered® technology, a method that converts non-human antibodies (typically mouse) into recombinant antibodies that have a high binding affinity to their target and are designed for chronic therapeutic use.

For more information on KaloBios Pharmaceuticals, please visit our web site at http://www.kalobios.com.

Forward-Looking StatementsThis release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and statements regarding the company's clinical development of KB004 and KB003. 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 potential timing and outcomes of clinical studies of KB004 and KB003 undertaken now or in the future; the ability of the company to timely source adequate supply of its development products from third party manufacturers on whom the company depends; the potential, if any, for future development of our product candidates; the company's ability to successfully progress, partner or 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 most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2015, the Annual Report on Form 10-K filed on March 16, 2015, 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 CrossChief Financial OfficerKaloBios Pharmaceuticals, Inc.(650) 243-3114[email protected]

Media Contact:

Joan E. KureczkaKureczka/Martin Associates Tel: (415) 821-2413Mobile:  (415) 690-0210[email protected]

 

 

 

 

 

 

 

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SOURCE KaloBios Pharmaceuticals, Inc.