KaloBios Highlights Priority Milestones in Letter to Stakeholders
BRISBANE, Calif., Dec. 05, 2016 (GLOBE NEWSWIRE) -- KaloBios Pharmaceuticals, Inc. (OTC:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, announced that Cameron Durrant, MD, chairman and CEO, has issued a Letter to Stakeholders highlighting the company’s priorities and milestones. The full text of the letter, which has also been posted to the company’s website, follows below.
We have come a long way in a short time at KaloBios. But much work remains. As we focus on developing our pipeline, the high-quality talent that drove us to overcome numerous hurdles this year continues to work hard to help create shareholder value.
Our strategy is to focus on advancing medicines for patients with neglected and rare diseases, with an ancillary interest in pediatric conditions, through what we believe are innovative and responsible business models. We see this as a foundation for a differentiated company. The KaloBios investor presentation available on our website also outlines our model and story in detail.
Overall, we believe our model combines near-term return options with long-term value creation. The two prongs of this approach are (1) value options from the potential sale of priority review vouchers and what we believe to be cost-effective development pathways afforded by certain FDA regulatory incentives, and (2) commercial return opportunities from specialty products with societal interest.
Our near-term priorities are:
- Benznidazole – expect to have an FDA meeting to confirm the regulatory pathway for benznidazole in the treatment of Chagas disease.
- Lenzilumab – continue enrolling patients in the company’s ongoing Phase 1 study of lenzilumab for chronic myelomonocytic leukemia (CMML), with the expectation to use the data to help inform a possible study in juvenile myelomonocytic leukemia (JMML), a rare pediatric condition.
- Partnering – explore partnering our other proprietary monoclonal antibodies (mAbs), such as ifabotuzumab (formerly known as KB004).
- Corporate – build our financial strength and, ultimately, to seek re-listing on a national stock exchange.
Our lead program is benznidazole, which we are developing in the U.S. for the treatment of Chagas disease, an FDA-designated neglected tropical disease. Chagas is a potentially life-threatening chronic disease caused by a protozoan parasite, Trypanosoma cruzi, carried and transmitted by triatomine insects (often called “kissing bugs”). It is endemic in Latin America, and increasingly reported in other developed world countries. About 300,000 people in the U.S. are estimated to be infected with Chagas, according to health authorities.
Benznidazole is not approved by FDA in the U.S. despite being the current preferred treatment for Chagas disease in other parts of the world. Legislation is in place to incentivize companies to bring treatments to the U.S. market for certain neglected tropical diseases, including Chagas. If approved, benznidazole could be eligible to receive a priority review voucher from FDA – which could have stand-alone value as a marketable asset.
Work on the benznidazole program has accelerated since we acquired the rights in June 2016. We anticipate the next milestone to be an FDA meeting to confirm the regulatory pathway.
A monoclonal antibody, lenzilumab is an antagonist of circulating granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine involved in driving certain blood cancers and other conditions. CMML and JMML are two hematologic malignancies for which we see potential for lenzilumab based on pre-clinical data. Both CMML and JMML are rare diseases with high unmet medical need. Also, as a rare pediatric disease, JMML has the potential for a priority review voucher if lenzilumab is first approved for that indication.
In July 2016, we dosed the first patient on lenzilumab in an open-label, multicenter Phase 1 clinical trial. An important additional goal is to use the data to help inform a possible Phase 1 JMML study.
Ifabotuzumab is an anti-EphA3 mAb that has the potential to offer a novel approach to treating both solid tumors and hematologic malignancies. EphA3 is aberrantly expressed on the surface of tumor cells and stroma cells in certain cancers. We are exploring partnering/development of ifabotuzumab for the treatment of certain solid and hematologic cancers.
We are working diligently to improve and strengthen the financial platform of KaloBios. We regained compliance with Securities and Exchange Commission (SEC) periodic reporting requirements on September 23, 2016. In addition, we are actively seeking to raise the new capital needed to support our intended business objectives and ultimately intend to seek to re-list on a national securities exchange, thereby further improving our capital flexibility.
In summary, each new step we take helps position KaloBios to succeed ahead.
Cameron Durrant, MD
Chairman and Chief Executive Officer
December 5, 2016
About KaloBios Pharmaceuticals, Inc.
KaloBios Pharmaceuticals, Inc. (OTC:KBIO) is an emerging biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases through innovative and responsible business models. Lead compounds in the KaloBios portfolio are benznidazole for the potential treatment of Chagas disease in the U.S., and the proprietary monoclonal antibodies, lenzilumab and ifabotuzumab (formerly KB004), for the potential treatment of various solid and hematologic cancers such as CMML and potentially JMML. For more information, visit www.kalobios.com.
This release contains forward-looking statements that are intended to be subject to protection afforded by the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. 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 events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements related to expectations regarding the Company’s product candidates; the Company’s opportunity to benefit from the application of our Responsible Pricing Model; and expectations for the Company’s future financial position. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, our lack of profitability and the need for additional capital to operate our business as a going concern; the uncertainties inherent in the development and launch of any new pharmaceutical product; our ability to successfully and timely complete clinical trials for our drug candidates in clinical development; our ability to obtain the necessary U.S. and international regulatory approvals for our drug candidates and to qualify for or benefit from various regulatory incentives; the scope and validity of intellectual property and other competitive protection for our drug candidates; our ability to identify, in-license and acquire additional product candidates or to form partnerships for the sale, licensing, collaborative development or marketing of our existing product candidates; our ability to maintain or engage third-party manufacturers to manufacture, supply, store and distribute supplies of our drug candidates for our clinical trials; and the success of any product; and the various risks and uncertainties described in the "Risk Factors" and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.
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Released December 5, 2016