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A new study by researchers at University of California, San Diego School of Medicine reveals a protein’s critical – and previously unknown – role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer. The finding offers a novel target for better treating AML, and possibly other cancers, by cutting off the ability of tumors to access nearby cellular players that feed its growth.
SOUTH SAN FRANCISCO, Calif., July 29, 2015 /PRNewswire/ — KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO), a monoclonal antibody company focused on developing innovative therapies to benefit patients with diseases of unmet medical need, with a focus on oncology, announced today that it received a formal determination letter from The NASDAQ Stock Market LLC (“NASDAQ”) notifying the company that it is now compliant with the minimum bid price requirement for continued listing on the NASDAQ Global Market and is no longer subject to delisting. The NASDAQ staff has determined that for the 10 consecutive business days from July 14, 2015, to July 27, 2015, the closing bid price of the company’s common stock has been at $1.00 per share or greater.
As previously disclosed, the company had received a letter from NASDAQ earlier this year, indicating that KaloBios did not comply with the $1.00 minimum closing bid price requirement for its common stock for continued listing on the NASDAQ Capital Market. NASDAQ granted the company a compliance period of 180 calendar days, or until August 19, 2015, to regain compliance with the listing rule. Because the company has regained compliance, the matter is now closed.
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 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) from the patient’s own immune system, 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 intends to evaluate in oncology indications where GM-CSF may play a key role such as chronic myelomonocytic leukemia (CMML). KaloBios is working with investigators to commence clinical evaluation of KB003 in this patient population in 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.
This 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 any of its present or future products; 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 May 11, 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.
Chief Financial Officer
KaloBios Pharmaceuticals, Inc.
Joan E. Kureczka
Tel: (415) 821-2413
Mobile: (415) 690-0210
SOURCE KaloBios Pharmaceuticals, Inc.
Pfenex To Report Second Quarter 2015 Results and Provide Business Update on Thursday, August 13, 2015
SAN DIEGO, July 29, 2015 /PRNewswire/ — Pfenex Inc. (NYSE MKT: PFNX) announced today that its second quarter 2015 financial results will be released on Thursday, August 13, 2015, before the open of market. At 8:30 am Eastern Time, Pfenex management will host a conference call to discuss the financial results and provide a business update. A press release outlining the financial results and business update will be publicly distributed prior to the call.
Please call 1-866-376-8058 (US) or 1-412-542-4131 (international) and reference Pfenex to access the call. A replay of the conference call will be available approximately one hour after the call until August 21, 2015. To access the teleconference replay please call 1-877-344-7529 (US) or 1-412-317-0088 (international) and enter the passcode 10070389. The conference call will also be available as a webcast. To access the webcast link please log on to www.pfenex.com.
Pfenex has used, and intends to continue to use, its Investor Relations website (http://pfenex.investorroom.com), as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, visit (http://pfenex.investorroom.com).
About Pfenex Inc.
Pfenex Inc. is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. The company’s lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex has leveraged its Pfēnex Expression Technology® platform to build a pipeline of product candidates and preclinical products under development including other biosimilars, as well as vaccines, generics and next generation biologics.
SOURCE Pfenex Inc.