UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO
SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE
ACT OF 1934
Date of Report
(Date of earliest event reported): November 2, 2015
THRESHOLD PHARMACEUTICALS, INC. |
(Exact name of registrant as specified in its charter) |
Delaware |
|
001-32979 |
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94-3409596 |
(State or other jurisdiction |
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(Commission |
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(IRS Employer |
of incorporation) |
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File Number) |
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Identification No.) |
170 Harbor Way, Suite 300 |
South San Francisco, California 94080 |
(Address of principal executive offices, including zip code) |
(650) 474-8200
(Registrant’s telephone number, including area code) |
Check the appropriate box below if
the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition
On November 2, 2015,
Threshold Pharmaceuticals, Inc. issued a press release regarding its financial results for the third quarter ended September 30,
2015. A copy of the press release is furnished as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
The press release contains statements intended as “forward-looking statements” which are subject to the cautionary
statements about forward-looking statements set forth therein.
The information furnished
pursuant to this Item 2.02 (including Exhibit 99.1 hereto) shall not be deemed “filed” for the purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that Section
or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, or the Securities Act. The information contained herein
and in the accompanying exhibit shall not be deemed to be incorporated by reference into any filing under the Securities Act or
the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits
Exhibits
Exhibit Number |
|
Description |
99.1 |
|
Press Release of Threshold Pharmaceuticals, Inc. dated November 2, 2015 regarding its financial results for the third quarter ended September 30, 2015. |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Threshold Pharmaceuticals, Inc. |
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|
|
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|
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By: |
/s/ Joel A. Fernandes |
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|
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Name: Joel A. Fernandes |
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Title: Vice President, Finance and Controller |
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Date: November 2, 2015
EXHIBIT INDEX
Exhibit Number |
|
Description |
99.1 |
|
Press Release of Threshold Pharmaceuticals, Inc. dated November 2, 2015 regarding its financial results for the third quarter ended September 30, 2015. |
Exhibit 99.1
|
NEWS RELEASE |
Threshold Pharmaceuticals Reports Third
Quarter 2015 Financial and Operational Results
SOUTH SAN FRANCISCO, CA – November 2, 2015 –
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today reported financial results for the third quarter 2015. Revenue for the
third quarter ended September 30, 2015 was $3.7 million. The operating loss for the third quarter ended September 30, 2015 was
$6.8 million. The net loss for the third quarter ended September 30, 2015 was $6.4 million, which included the operating loss of
$6.8 million and non-cash income of $0.3 million related to the changes in fair value of the Company's outstanding warrants and
was classified as other income (expense). As of September 30, 2015, Threshold had $56.4 million in cash, cash equivalents and marketable
securities, with no debt outstanding.
“This is an exciting time for Threshold as we anticipate
announcing top-line results from the two pivotal Phase 3 clinical trials of evofosfamide in patients with advanced soft tissue
sarcoma (TH-CR-406) and in patients with advanced pancreatic cancer (MAESTRO) around the end of this year,” said Barry Selick,
Ph.D., Chief Executive Officer at Threshold. “In the third quarter, we also made significant progress with tarloxotinib,
our exclusively-licensed hypoxia-activated EGFR tyrosine kinase inhibitor, with the initiation of two proof-of-concept Phase 2
clinical trials. We expect to have preliminary data from those trials in the first half of 2016."
Third Quarter 2015 Financial and Operational Results
Revenue of $3.7 million was recognized for both the third quarter
of 2015 and 2014. Revenue is related to the amortization of the aggregate of $110 million in upfront and milestone payments earned
in 2013 and 2012 from Threshold’s collaboration with Merck KGaA, Darmstadt, Germany, for evofosfamide (previously known as
TH-302). The revenue from the upfront and milestone payments earned
under the agreement is being amortized over the relevant performance period, rather than being immediately recognized when the
upfront and milestone payments are earned or received.
The net loss for the third quarter of 2015 was $6.4 million
compared to a net loss of $7.7 million for the third quarter of 2014. Included in the net loss for the third quarter of 2015 was
an operating loss of $6.8 million and non-cash income of $0.3 million compared to an operating loss of $7.6 million and non-cash
expense of $0.3 million included in the net loss for the third quarter of 2014. The non-cash income or expense is related to the
change in fair value of the Company's outstanding warrants and was classified as other income (expense).
Research and development expenses were $8.1 million for the
third quarter of 2015 compared to $8.9 million for the third quarter of 2014. The decrease in research and development expenses
was due primarily to a $1.1 million net decrease in clinical development expenses, net of reimbursement from Merck KGaA, Darmstadt,
Germany related to their 70% share of total development expenses for evofosfamide. The decrease in clinical development expenses
was due to a decrease in clinical development expenses for evofosfamide, partially offset by an increase in clinical development
expenses for tarloxotinib.
General and administrative expenses were $2.4 million for both
the third quarter of 2015 and 2014.
Non-cash stock-based compensation expense included in total
operating expenses was $1.5 million for the third quarter of 2015 versus $1.2 million for the third quarter of 2014. The increase
in stock-based compensation expense was due to the amortization of a greater number of options with higher fair values.
|
NEWS RELEASE |
As of September 30, 2015 and June 30, 2015, Threshold had $56.4
million and $67.0 million in cash, cash equivalents and marketable securities, respectively. The net decrease of $10.6 million
in cash, cash equivalents and marketable securities during the third quarter of 2015 was primarily due to the Company’s operating
cash requirements for the third quarter of 2015.
Corporate Highlights
Announced the appointment of Mark
Hopkins, J.D., Ph.D., as Vice President of Intellectual Property and Assistant General Counsel. In this newly created position,
Dr. Hopkins oversees worldwide intellectual property strategy and activities related to further advancement of Threshold's intellectual
property portfolio for its investigational anti-cancer therapeutics, evofosfamide and tarloxotinib, and hypoxia-activated prodrug
technology. Dr. Hopkins is also responsible for oversight of corporate legal matters at Threshold.
Threshold- and Merck KGaA, Darmstadt,
Germany-Sponsored Trials of Evofosfamide: Clinical Development Highlights and Outlook
Announce top-line data from the
two pivotal Phase 3 clinical trials. The companies are focused on efficient execution of the two Phase 3 clinical trials of
evofosfamide: one in patients with advanced soft tissue sarcoma (TH-CR-406) and the other in patients with advanced pancreatic
cancer (“MAESTRO”). The current expectations are that top-line data will be announced around the end of 2015 for both
trials and that the companies will prepare for potential submission of marketing applications, assuming the data from the trials
are supportive.
Continue enrollment in the Phase
2 non-squamous non-small cell lung cancer clinical trial. Threshold is conducting a 440-patient, randomized, double-blind,
placebo-controlled trial of evofosfamide in combination with pemetrexed in patients with second-line advanced non-squamous non-small
cell lung cancer. This international Phase 2 clinical trial is designed to support registration and will compare the combination
of evofosfamide plus pemetrexed versus pemetrexed plus placebo as second-line therapy in this patient population. Overall survival
is the primary endpoint. Enrollment in the trial is ongoing.
Commence enrollment in final cohort
of the Phase 1/2 multiple myeloma clinical trial. Threshold plans to initiate dosing with the combination of evofosfamide,
dexamethasone, and Pomalyst® (pomalidomide, an immunomodulatory drug) in up to 38 patients with relapsed/refractory multiple
myeloma in the final cohort of its ongoing Phase 1/2 trial. A total of 62 patients have been enrolled in the trial in which the
safety and efficacy of evofosfamide plus dexamethasone with or without Velcade® (bortezomib, a proteasome inhibitor) was assessed.
Threshold-Sponsored Trials of Tarloxotinib Bromide*: Clinical
Development Highlights and Outlook
Initiated patient dosing in Phase
2 non-small cell lung cancer clinical trial. In August, Threshold announced that the Company, in collaboration with the Academic
Thoracic Oncology Medical Investigators Consortium (ATOMIC), initiated the first Phase 2 clinical trial of tarloxotinib for the
treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer who have been previously treated
with an EGFR tyrosine kinase inhibitor and are progressing on treatment, but have not acquired the T790M resistance mutation. The
trial is expected to enroll up to 37 patients; preliminary data are expected to be available in the first half of 2016.
|
NEWS RELEASE |
Initiated patient dosing in Phase
2 squamous cell carcinomas clinical trial. In August, Threshold announced initiation of dosing in a Phase 2 clinical trial
of tarloxotinib for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.
The trial is expected to enroll up to 69 patients; preliminary data are expected to be available in the first half of 2016.
About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational
hypoxia-activated prodrug that is thought to be activated under severe hypoxic tumor conditions, a feature of many solid tumors.
Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of
patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.
Evofosfamide is currently in two Phase 3 trials, both of which
are fully recruited: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable
or metastatic soft tissue sarcomas (STS) (the TH-CR-406 trial), 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. The FDA and the European Commission have granted
evofosfamide Orphan Drug designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation
for evofosfamide for both 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 Tarloxotinib Bromide
Tarloxotinib bromide, or "tarloxotinib”, is a prodrug
designed to selectively release a covalent (irreversible) EGFR tyrosine kinase inhibitor under severe hypoxia, a feature of many
solid tumors. Accordingly, tarloxotinib has the potential to effectively shut down aberrant EGFR signaling in a tumor-selective
manner, thus potentially avoiding or reducing the systemic side effects associated with currently available EGFR tyrosine kinase
inhibitors. Tarloxotinib is currently being evaluated in two Phase 2 proof-of-concept trials: one for the treatment of patients
with mutant EGFR-positive, T790M-negative advanced non-small cell lung cancer progressing on an EGFR tyrosine kinase inhibitor,
and the other for patients with recurrent or metastatic squamous cell carcinomas of the head and neck or skin. Threshold licensed
exclusive worldwide rights to tarloxotinib from the University of Auckland, New Zealand, in September 2014.
|
NEWS RELEASE |
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 all statements
regarding anticipated development activities and clinical development outlook related to company- and Merck KGaA, Darmstadt, Germany-sponsored
clinical trials for evofosfamide, including the expected efficient execution of and the expected timing of and availability of
the top-line results from the ongoing evofosfamide Phase 3 clinical trials; and the potential submission of marketing applications
for evofosfamide assuming the data from the Phase 3 clinical trials are supportive; the availability of preliminary data from
the two Phase 2 proof-of-concept clinical trials of tarloxotinib and the timing thereof and the therapeutic potential of evofosfamide
tarloxotinib. 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 evofosfamide clinical trials, including the ability of Threshold and Merck
KGaA, Darmstadt, Germany, to complete the ongoing Phase 3 clinical trials of evofosfamide in the expected timeframe or at all;
the risk that Threshold cannot predict with certainty when data from clinical trials will be available; 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 and the risk of potential
disagreements with Merck KGaA, Darmstadt, Germany, regarding the commencement of additional clinical trials or milestone payments;
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 later trials may not confirm
the results of earlier trials; 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; issues arising in the regulatory process and the results of such clinical trials (including
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; the ability of Threshold to enroll or complete planned tarloxotinib clinical trials; and
Threshold's need for and the availability of resources to develop evofosfamide and tarloxotinib 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 November 2, 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.
* Tarloxotinib bromide is the proposed International Nonproprietary
Name (pINN)
Contact
Laura Hansen, Ph.D.
Senior Director, Corporate Communications
Phone: 650-474-8206
E-mail: lhansen@thresholdpharm.com
|
NEWS RELEASE |
THRESHOLD PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
| |
| | |
| | |
| | |
| |
Revenue | |
$ | 3,680 | | |
$ | 3,680 | | |
$ | 11,041 | | |
$ | 11,041 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 8,081 | | |
| 8,906 | | |
| 28,902 | | |
| 27,223 | |
General and administrative | |
| 2,372 | | |
| 2,407 | | |
| 7,468 | | |
| 7,518 | |
Total Operating Expenses | |
| 10,453 | | |
| 11,313 | | |
| 36,370 | | |
| 34,741 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (6,773 | ) | |
| (7,633 | ) | |
| (25,329 | ) | |
| (23,700 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest income (expense), net | |
| 27 | | |
| 27 | | |
| 99 | | |
| 97 | |
Other income (expense) (1) | |
| 315 | | |
| (341 | ) | |
| (661 | ) | |
| 7,781 | |
Loss before provision for taxes | |
$ | (6,431 | ) | |
$ | (7,947 | ) | |
$ | (25,891 | ) | |
$ | (15,822 | ) |
| |
| | | |
| | | |
| | | |
| | |
Provision (benefit) for income taxes | |
| - | | |
| (202 | ) | |
| - | | |
| (202 | ) |
Net Loss | |
$ | (6,431 | ) | |
$ | (7,745 | ) | |
$ | (25,891 | ) | |
$ | (15,620 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (0.09 | ) | |
$ | (0.13 | ) | |
$ | (0.37 | ) | |
$ | (0.26 | ) |
Diluted | |
$ | (0.09 | ) | |
$ | (0.15 | ) | |
$ | (0.37 | ) | |
$ | (0.37 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average shares used in per common | |
| | | |
| | | |
| | | |
| | |
share calculation: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 71,382 | | |
| 59,845 | | |
| 69,833 | | |
| 59,500 | |
Diluted | |
| 71,382 | | |
| 61,494 | | |
| 69,833 | | |
| 63,419 | |
| (1) | Noncash income (expense) related to change in the fair
value of the Company's outstanding and exercised warrants, classified as other income (expense). |
|
NEWS RELEASE |
THRESHOLD PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| |
September 30, | | |
December 31, | |
| |
2015 | | |
2014 | |
| |
(unaudited) | | |
(1) | |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Cash, cash
equivalents and marketable
securities | |
$ | 56,414 | | |
$ | 58,600 | |
Collaboration Receivable | |
| 4,032 | | |
| 7,248 | |
Prepaid expenses and other current assets | |
| 1,785 | | |
| 832 | |
Property and equipment, net | |
| 404 | | |
| 557 | |
Other assets | |
| 1,329 | | |
| 1,159 | |
Total assets | |
$ | 63,964 | | |
$ | 68,396 | |
| |
| | | |
| | |
Liabilities and stockholders' equity | |
| | | |
| | |
| |
| | | |
| | |
Total current liabilities (2) | |
$ | 24,258 | | |
$ | 25,974 | |
Deferred Revenue | |
| 51,153 | | |
| 62,194 | |
Long-term liabilities (3) | |
| 19,448 | | |
| 4,204 | |
Stockholders' equity (deficit) | |
| (30,895 | ) | |
| (23,976 | ) |
Total liabilities and stockholders' equity (deficit) | |
$ | 63,964 | | |
$ | 68,396 | |
| (1) | Derived from audited financial statements |
| (2) | Amount includes current portion of deferred revenue of
$14.7 million for both September 30, 2015 and December 31, 2014, respectively. |
| (3) | Includes as of September 30, 2015 and December 31, 2014,
$19.3 million and $4.0 million of warrant liability, respectively. |
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