SOURCE: Threshold Pharmaceuticals

Threshold Pharmaceuticals

April 16, 2015 07:00 ET

Threshold Pharmaceuticals to Host Analyst and Investor Day on April 24 in New York City

SOUTH SAN FRANCISCO, CA--(Marketwired - Apr 16, 2015) - Threshold Pharmaceuticals, Inc. (NASDAQ: THLD), today announced that it will host an Analyst and Investor Day on Friday, April 24, 2015, from 11:30 AM to 1:30 PM Eastern Time in New York City. Members of Threshold's senior management team will be joined by other research and clinical leaders in the field of tumor hypoxia, hypoxia-activated prodrugs, and next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy to discuss its clinical development programs for evofosfamide (formerly TH-302) and TH-4000.

Guest speakers scheduled to give presentations at this event include Stephen V. Liu, M.D., Assistant Professor of Medicine, Georgetown University Medical Center; Adam Patterson, Ph.D., Head of Translational Therapeutics, University of Auckland, New Zealand; and Jeff Smaill, Ph.D., Senior Medicinal Chemist, University of Auckland, New Zealand. Drs. Patterson and Smaill are co-inventors of TH-4000, the Company's proprietary hypoxia-activated, irreversible EGFR-TKI. Dr. Liu will serve as Principal Investigator for the Company's planned Phase 2 clinical trial of TH-4000 in patients with mutant EGFR-positive, T790M-negative non-small cell lung cancer and co-investigator for the Company's planned Phase 2 clinical trial of TH-4000 in patients with head and neck squamous cell carcinoma.

The event is open to investors and analysts. Threshold invites the public and the media to listen to the presentations via the live webcast, which will be available under Webcasts in the Investors section of www.thresholdpharm.com or can be accessed using the following link: http://lifesci.rampard.com/20150424/index.jsp. The presentations are scheduled to begin at approximately 12:00 p.m. EDT. A replay of the presentations will be archived on the site for at least 30 days.

Event Details

Date: April 24, 2015
Time: 11:30 AM - 1:30 PM Eastern Time

For those wishing to attend the event, please contact lhansen@thresholdpharm.com and vmolina@lifesciadvisors.com.

About Evofosfamide

Evofosfamide (previously known as TH-302), an investigational hypoxia-activated prodrug, is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood supply as a result of aberrant vasculature. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

Evofosfamide is currently under evaluation in two Phase 3 trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (STS), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Based on current projections, the number of protocol-specified events for both Phase 3 trials may be reached in the second half of 2015, with the results of the primary efficacy analyses for both trials to be available shortly thereafter. The FDA and the European Commission have granted evofosfamide Orphan Drug Designation for the treatment of STS and pancreatic cancer. Evofosfamide is also being investigated in a Phase 2 trial designed to support registration for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies.

Threshold has a global license and co-development agreement for evofosfamide with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize in the U.S.

About TH-4000

In September 2014, Threshold licensed exclusive worldwide rights to a clinical development program based on TH-4000 (formerly referred to as PR610 or Hypoxin™) from the University of Auckland. TH-4000 is a hypoxia-activated epidermal growth factor receptor, or EGFR, tyrosine-kinase inhibitor (TKI). TH-4000 is designed to selectively release a potent, irreversible EGFR-TKI in hypoxic tumors. Preclinical and Phase 1 clinical data suggest that plasma concentrations of TH-4000 that are active in EGFR-dependent tumor xenograft models in mice could be attained in patients with an acceptable therapeutic index. Threshold expects to initiate Phase 2 proof-of-concept studies in patients with EGFR-positive, T790M-negative non-small cell lung cancer (NSCLC) after conventional EGFR-TKI therapy has failed and in patients with head and neck cancer.

About Threshold Pharmaceuticals

Threshold is a biotechnology company focused on the discovery and development of drugs targeting tumor hypoxia, the low oxygen condition found in microenvironments of most solid tumors as well as the bone marrows of some hematologic malignancies. This approach offers broad potential to treat a variety of cancers. By selectively targeting tumor cells, we are building a pipeline of drugs that hold promise to be more effective and less toxic to healthy tissues than conventional anticancer drugs. For additional information, please visit our website (www.thresholdpharm.com).

Forward-Looking Statements

Except for statements of historical fact, the statements in this press release are forward-looking statements, including all statements regarding the potential therapeutic applications for TH-4000 and evofosfamide; the anticipated timing of the protocol-specified events and the availability of the results of the primary efficacy analyses of the evofosfamide Phase 3 STS clinical trial and the MAESTRO trial; and Threshold's plans to initiate Phase 2 proof-of-concept studies of TH-4000. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to: the difficulty and uncertainty of pharmaceutical product development, including the time and expense required to conduct clinical trials and analyze data, and the uncertainty of clinical success and regulatory approval; the risk that because the timing of the availability of primary efficacy data from the ongoing Phase 3 clinical trials of evofosfamide is driven by the number of events in each trial, which neither Threshold nor Merck KGaA, Darmstadt, Germany, controls, Threshold cannot predict with certainty when the primary efficacy data from either Phase 3 clinical trial will be available; the ability of Threshold and Merck KGaA, Darmstadt, Germany, to complete evofosfamide clinical trials; the ability of Threshold to initiate or enroll planned TH-4000 clinical studies, including as a result of Threshold's potential inability to develop a formulation of TH-4000 with adequate quality that meets the need for testing in its clinical trials; Threshold's dependence on its collaborative relationship with Merck KGaA, Darmstadt, Germany, including its dependence on decisions by Merck KGaA, Darmstadt, Germany, regarding the amount and timing of resource expenditures for the development of evofosfamide; the risks that the design of, or data collected from, the ongoing Phase 3 clinical trials of evofosfamide may be inadequate to demonstrate safety and efficacy, or otherwise may be insufficient to support any marketing authorization submissions and/or regulatory approvals, and that despite the potential benefits of the SPA agreements with the FDA, significant uncertainty remains regarding the regulatory approval process for evofosfamide and that evofosfamide may not receive any marketing approvals in a timely manner or at all; issues arising in the regulatory process and the results of such clinical trials (including product safety issues and efficacy results); dependence of Threshold and Merck KGaA, Darmstadt, Germany, on single source suppliers for evofosfamide, including the risk that these single source suppliers may be unable to meet clinical supply demands for evofosfamide which could significantly delay the development of evofosfamide; Threshold's dependence on single source suppliers for TH-4000, including the risk that these single source suppliers may be unable to meet clinical supply demands for TH-4000 which could significantly delay the development of TH-4000; and Threshold's need for and the availability of resources to develop evofosfamide and TH-4000 and to support Threshold's operations. Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission on March 3, 2015 and is available from the SEC's website (www.sec.gov) and on our website (www.thresholdpharm.com) under the heading "Investors". We undertake no duty to update any forward-looking statement made in this news release.

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