Welcome!

News Feed Item

Threshold Pharmaceuticals Reports Second Quarter 2014 Financial and Operational Results

SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 08/01/14 -- Threshold Pharmaceuticals, Inc. (NASDAQ: THLD), today reported financial results for the second quarter 2014. Revenue for the second quarter ended June 30, 2014 was $3.7 million. The operating loss for the second quarter ended June 30, 2014 was $7.5 million. The net loss for the second quarter ended June 30, 2014 was $0.8 million, which included the operating loss of $7.5 million and non-cash income of $6.7 million related to the changes in fair value of the Company's outstanding warrants and was classified as other income (expense). As of June 30, 2014, Threshold had $75.2 million in cash, cash equivalents and marketable securities, with no debt outstanding.

"With progress made in the second quarter, TH-302 is now the subject of investigation in three large randomized trials, including two pivotal trials in patients with advanced soft tissue sarcoma and advanced pancreatic cancer and a trial designed to support registration in patients with advanced non-squamous non-small cell lung cancer," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "In our pivotal trial of TH-302 in patients with soft tissue sarcoma, we expect that the pre-planned interim safety and efficacy analyses will be conducted by the trial's independent data monitoring committee (IDMC) in September of this year. The IDMC's analyses will be accompanied by their recommendation on next steps, which we plan to announce shortly thereafter. Beyond our major therapeutic areas of focus, we continue to investigate TH-302 in other types of tumors and continue to be encouraged by early data, particularly in glioblastoma and multiple myeloma, as presented in the second quarter at ASCO."

Second Quarter 2014 Financial and Operational Results

For the second quarter ended June 30, 2014, we recognized $3.7 million in revenue from the amortization of the aggregate of $110 million in upfront payment and milestone payments that were earned in 2013 and 2012 from our global license and co-development agreement for TH-302 with Merck KGaA, Darmstadt, Germany. For the second quarter ended June 30, 2013, we recognized $3.2 million in revenue from the amortization of the aggregate of $97.5 million in upfront and milestone payments that were earned in 2012 and in the first quarter of 2013 from our collaboration with Merck, KGaA, Darmstadt, Germany. The revenue from the upfront payment and milestone payments earned under the agreement is being amortized over the relevant performance period, rather than being immediately recognized when the upfront payment and milestone are earned or received.

The net loss for the second quarter of 2014 was $0.8 million compared to a net loss of $12.8 million for the second quarter of 2013. Included in the net loss for the second quarter of 2014 was an operating loss of $7.5 million and non-cash income of $6.7 million compared to an operating loss of $7.0 million and non-cash expense of $5.8 million in the net loss for the second quarter of 2013. The non-cash income and expense is related to the change in fair value of the Company's outstanding and exercised warrants and was classified as other income (expense).

Research and development expenses were $8.7 million for the second quarter of 2014 compared to $8.0 million for the second quarter of 2013. The increase in research and development expenses was due primarily to a $1.0 million increase in clinical development expenses and consulting expenses, and an increase of $0.7 million in employee related expenses, partially offset by a $1.0 million increase in the reimbursement from Merck KGaA, Darmstadt, Germany related to their 70% share of total development expenses for TH-302.

General and administrative expenses were $2.5 million for the second quarter of 2014 versus $2.2 million for the second quarter of 2013. The increase in general and administrative expenses was due primarily to an increase in consulting and employee related expenses to support the Company's ongoing collaboration with Merck KGaA, Darmstadt, Germany.

Non-cash stock-based compensation expense included in total operating expenses was $1.5 million for the second quarter of 2014 versus $1.3 million for the second quarter of 2013. The increase in stock-based compensation expense was due to the amortization of a greater number of options with higher fair values.

As of June 30, 2014, Threshold had $75.2 million in cash, cash equivalents and marketable securities, a decrease of $11.2 million during the second quarter of 2014. The net decrease in cash, cash equivalents and marketable securities during the second quarter of 2014 is primarily due to the Company's operating cash requirements for the second quarter of 2014, partially offset by the receipt of a $5.2 million reimbursement payment related to Merck KGaA's 70% share of total development expenses for TH-302 for the first quarter of 2014.

Second Quarter 2014 Key Achievements

TH-302 Clinical Development

In June, Threshold initiated dosing in a 440-patient, randomized, double-blind, placebo-controlled Phase 2 trial of TH-302 in combination with pemetrexed in advanced non-squamous non-small cell lung cancer. The international Phase 2 trial is designed to compare the combination of TH-302 and pemetrexed versus the combination of pemetrexed and placebo as second-line therapy in this patient population. A TH-302 dose of 400 mg/m2 will be utilized in combination with full-dose pemetrexed. Overall survival is the primary endpoint; secondary endpoints include safety and assessment of anti-tumor activity as determined by progression-free survival and objective response rate.

Also in June, Threshold initiated dosing in the final stage of an ongoing Phase 1/2 trial of TH-302, in combination with the proteasome inhibitor bortezomib (Velcade®) and low-dose dexamethasone ("TBorD") in patients with relapsed/refractory multiple myeloma, a cancer of the bone marrow.

TH-302 Data Presentations

In April, two posters were presented at the American Association for Cancer Research (AACR) Annual Meeting 2014, April 5-9, San Diego, California, titled "Combination hypoxia-specific chemotherapy and immunotherapy of prostate cancer" and "Targeting vascular endothelial growth factor A and tumor hypoxia combined with radiation eradicates sarcomas through destruction of tumor vasculature and thwarting of the hypoxic response."

In May, two posters were presented at the American Association for Cancer Research's (AACR's) Special Conference on Pancreatic Cancer: Innovations in Research and Treatment, May 18-21, New Orleans, Louisiana, titled "Combination treatment with hypoxia-activated prodrug TH-302 and radiation reduce pancreatic tumor initiating cells and tumor growth in patient-derived xenografts" and "Pharmacodynamic changes from the TH-302, gemcitabine, and nab-paclitaxel triplet combination in a xenograft model of pancreatic cancer."

Also in May, two posters were presented in poster highlight sessions at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 - June 3, Chicago, Illinois, titled "Phase 1/2 study of investigational hypoxia-targeted drug, TH-302, and bevacizumab in recurrent glioblastoma (GBM) following bevacizumab failure" and "Preliminary safety and efficacy of TH-302, an investigational hypoxia-targeted drug, and dexamethasone in patients with relapsed/refractory multiple myeloma (RR MM)." A presentation summarizing the posters is available under Webcasts in the Investors section of www.thresholdpharm.com or can be accessed using the following link: http://psav.adobeconnect.com/thresholdpharmaceuticals/.

About TH-302

TH-302 is an investigational hypoxia-activated prodrug that 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.

TH-302 is currently under evaluation in two Phase 3 trials: one in combination with doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma, and the other in combination with gemcitabine versus gemcitabine and placebo in patients with advanced pancreatic cancer (MAESTRO). Both Phase 3 trials are being conducted under Special Protocol Agreements with the U.S. Food and Drug Administration (FDA). The FDA and the European Commission have granted TH-302 Orphan Drug Designations for the treatment of soft tissue sarcoma and pancreatic cancer. TH-302 is also being investigated in earlier-stage clinical trials of other solid tumors and hematological malignancies, in combination with chemotherapy and antiangiogenic therapy, and for certain cancers, is being investigated as a monotherapy.

Threshold has a global license and co-development agreement for TH-302 with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize in the U.S.

About Threshold Pharmaceuticals

Threshold Pharmaceuticals, Inc. 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 statements regarding the potential therapeutic uses and benefits of TH-302, statements regarding the pre-planned interim safety and efficacy analyses of the pivotal Phase 3 clinical trial in soft tissue sarcoma and the timing thereof, and statements regarding the TH-302 clinical development program, including potential development and registrational opportunities. 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 ability of Threshold and Merck KGaA, Darmstadt, Germany, to enroll or complete TH-302 clinical trials; the time and expense required to conduct such clinical trials and analyze data; our inability to either control or predict with certainty when the pre-planned interim safety and efficacy analyses of the pivotal Phase 3 clinical trial in soft tissue sarcoma will occur; issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results); the risks that preclinical studies in animal models of disease may not accurately predict the result of human clinical trials of TH-302 and that later trials may not confirm the results of earlier trials; that risk that clinical data from clinical trials sponsored by Threshold and Merck KGaA, Darmstadt, Germany, may be insufficient to support any regulatory approvals to market TH-302; Threshold's and Merck KGaA's (Darmstadt, Germany) dependence on single source suppliers, including the risk that these single source suppliers may be unable to meet clinical supply demands for TH-302 which could significantly delay the development of TH-302; risks related to 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 TH-302; and Threshold's need for and the availability of resources to develop TH-302 and to support Threshold's operations. Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which has been filed with the Securities and Exchange Commission on August 1, 2014 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.

                      THRESHOLD PHARMACEUTICALS, INC.
              CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                  (in thousands, except per share amounts)
                                (Unaudited)


                                  Three Months Ended     Six Months Ended
                                       June 30,              June 30,
                                 --------------------  --------------------
                                    2014       2013       2014       2013
                                 ---------  ---------  ---------  ---------


Revenue                          $   3,680  $   3,180  $   7,361  $   6,102

Operating expenses
  Research and development           8,664      7,983     18,317     14,451
  General and administrative         2,477      2,166      5,111      4,681
                                 ---------  ---------  ---------  ---------
    Total Operating Expenses        11,141     10,149     23,428     19,132
                                 ---------  ---------  ---------  ---------

  Loss from operations              (7,461)    (6,969)   (16,067)   (13,030)

Interest income (expense), net          30         34         70         70
  Other income (expense) (1)         6,665     (5,822)     8,122     (8,938)
                                 ---------  ---------  ---------  ---------
    Income (loss) before
     provision for taxes              (766)   (12,757)    (7,875)   (21,898)
  Provision for income taxes             -         31          -        104
                                 ---------  ---------  ---------  ---------
    Net Income (loss)            $    (766) $ (12,788) $  (7,875) $ (22,002)
                                 =========  =========  =========  =========

Net income (loss) per common
 share
  Basic                          $   (0.01) $   (0.22) $   (0.13) $   (0.39)
                                 =========  =========  =========  =========
  Diluted                        $   (0.12) $   (0.22) $   (0.25) $   (0.39)
                                 =========  =========  =========  =========

Weighted-average shares used in
 per common
share calculation:
  Basic                             59,347     57,037     59,325     56,763
                                 =========  =========  =========  =========
  Diluted                           62,998     57,037     63,433     56,763
                                 =========  =========  =========  =========

(1)  Noncash income (expense) related to change in the fair value of the
     Company's outstanding and exercised warrants, classified as other
     income (expense).




                      THRESHOLD PHARMACEUTICALS, INC.
                   CONDENSED CONSOLIDATED BALANCE SHEETS
                               (in thousands)


                                                   June 30,    December 31,
                                                     2014          2013
                                                 ------------  ------------
                                                  (unaudited)       (1)
Assets


  Cash, cash equivalents and marketable
   securities                                    $     75,215  $     82,033
  Collaboration Receivable                              4,263        18,094
  Prepaid expenses and other current assets             2,845         2,246
  Property and equipment, net                             690           686
  Other assets                                          1,159         1,059
                                                 ------------  ------------
    Total assets                                 $     84,172  $    104,118
                                                 ============  ============

Liabilities and stockholders' equity

  Total current liabilities (2)                  $     27,297  $     27,016
  Deferred Revenue                                     69,555        76,916
  Long-term liabilities (3)                            15,573        23,661
  Stockholders' equity (deficit)                      (28,253)      (23,475)
                                                 ------------  ------------
  Total liabilities and stockholders' equity
   (deficit)                                     $     84,172  $    104,118
                                                 ============  ============


(1)  Derived from audited financial statements
(2)  Amount includes current portion of deferred revenue of $14.7 million as
     of June 30, 2014 and December 31, 2013, respectively.
(3)  Includes as of June 30, 2014 and December 31, 2013, $15.3 million and
     $23.4 million of warrant liability, respectively.

Contact
Laura Hansen, Ph.D.
Senior Director, Corporate Communications
Phone: 650-474-8206
E-mail: [email protected]

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
"Cloud Academy is an enterprise training platform for the cloud, specifically public clouds. We offer guided learning experiences on AWS, Azure, Google Cloud and all the surrounding methodologies and technologies that you need to know and your teams need to know in order to leverage the full benefits of the cloud," explained Alex Brower, VP of Marketing at Cloud Academy, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clar...
In his session at 21st Cloud Expo, Carl J. Levine, Senior Technical Evangelist for NS1, will objectively discuss how DNS is used to solve Digital Transformation challenges in large SaaS applications, CDNs, AdTech platforms, and other demanding use cases. Carl J. Levine is the Senior Technical Evangelist for NS1. A veteran of the Internet Infrastructure space, he has over a decade of experience with startups, networking protocols and Internet infrastructure, combined with the unique ability to it...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
"NetApp is known as a data management leader but we do a lot more than just data management on-prem with the data centers of our customers. We're also big in the hybrid cloud," explained Wes Talbert, Principal Architect at NetApp, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"We're focused on how to get some of the attributes that you would expect from an Amazon, Azure, Google, and doing that on-prem. We believe today that you can actually get those types of things done with certain architectures available in the market today," explained Steve Conner, VP of Sales at Cloudistics, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
It is of utmost importance for the future success of WebRTC to ensure that interoperability is operational between web browsers and any WebRTC-compliant client. To be guaranteed as operational and effective, interoperability must be tested extensively by establishing WebRTC data and media connections between different web browsers running on different devices and operating systems. In his session at WebRTC Summit at @ThingsExpo, Dr. Alex Gouaillard, CEO and Founder of CoSMo Software, presented ...
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...
"There's plenty of bandwidth out there but it's never in the right place. So what Cedexis does is uses data to work out the best pathways to get data from the origin to the person who wants to get it," explained Simon Jones, Evangelist and Head of Marketing at Cedexis, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
WebRTC is great technology to build your own communication tools. It will be even more exciting experience it with advanced devices, such as a 360 Camera, 360 microphone, and a depth sensor camera. In his session at @ThingsExpo, Masashi Ganeko, a manager at INFOCOM Corporation, introduced two experimental projects from his team and what they learned from them. "Shotoku Tamago" uses the robot audition software HARK to track speakers in 360 video of a remote party. "Virtual Teleport" uses a multip...
"We work around really protecting the confidentiality of information, and by doing so we've developed implementations of encryption through a patented process that is known as superencipherment," explained Richard Blech, CEO of Secure Channels Inc., in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
High-velocity engineering teams are applying not only continuous delivery processes, but also lessons in experimentation from established leaders like Amazon, Netflix, and Facebook. These companies have made experimentation a foundation for their release processes, allowing them to try out major feature releases and redesigns within smaller groups before making them broadly available. In his session at 21st Cloud Expo, Brian Lucas, Senior Staff Engineer at Optimizely, discussed how by using ne...
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, provided a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to oper...
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...