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): March 3, 2015
THRESHOLD PHARMACEUTICALS, INC. |
(Exact name of registrant as specified in its charter) |
Delaware |
|
001-32979 |
|
94-3409596 |
(State or other jurisdiction |
|
(Commission |
|
(IRS Employer |
of incorporation) |
|
File Number) |
|
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 March 3, 2015,
Threshold Pharmaceuticals, Inc. issued a press release regarding its financial results for the fourth quarter and year ended December
31, 2014. 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 March 3, 2015 regarding its financial results for the fourth quarter and year ended December 31, 2014. |
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. |
|
|
|
|
By: |
/s/ Joel A. Fernandes |
|
|
Name: Joel
A. Fernandes |
|
|
Title: Vice President, Finance and Controller |
Date: March 3, 2015
EXHIBIT INDEX
Exhibit
Number |
|
Description |
99.1 |
|
Press Release of Threshold Pharmaceuticals, Inc. dated March 3, 2015 regarding its financial results for the fourth quarter and year ended December 31, 2014. |
Exhibit 99.1
|
NEWS RELEASE |
Threshold Pharmaceuticals Reports Fourth
Quarter and Year End 2014 Financial and Operational Results
SOUTH SAN FRANCISCO, CA – March
3, 2015 – Threshold Pharmaceuticals, Inc. (Nasdaq: THLD), today reported financial results for the fourth quarter and
year ended December 31, 2014. Revenue for the fourth quarter and year ended December 31, 2014 was $3.7 million and $14.7 million,
respectively. Net loss for the fourth quarter ended December 31, 2014 was $6.0 million, which included the operating loss of $7.6
million and non-cash income of $1.6 million related to changes in the fair value of the Company’s outstanding and exercised
warrants that was classified as other income (expense). Net loss for the year ended December 31, 2014 was $21.6 million, which
included the operating loss of $31.3 million and non-cash income of $9.3 million related to changes in the fair value of the Company’s
outstanding and exercised warrants. As of December 31, 2014, Threshold had $58.6 million in cash, cash equivalents and marketable
securities, with no debt outstanding. In February 2015, the Company completed an underwritten offering of Threshold common stock
and warrants. Net proceeds from the offering are expected to be approximately $28.2 million.
“We expect 2015 to be a key
year for Threshold,” said Barry Selick, Ph.D., Chief Executive Officer of Threshold. “Based on current
projections, we expect that the number of protocol-specified events for the pivotal Phase 3 trials of evofosfamide in
patients with advanced soft tissue sarcoma as well as in patients with advanced pancreatic cancer (MAESTRO) may be reached in
the second half of 2015 with the results of the primary efficacy analysis for both trials to be available shortly thereafter.
Our top priorities are to continue to efficiently execute the clinical studies to allow for timely data analyses and to
prepare for the potential submission of marketing applications, assuming the data from the trials are supportive.
In parallel, we continue to maintain focus on the Phase 2 trial of evofosfamide designed to support registration for
the treatment of patients with advanced non-squamous non-small cell lung cancer as well as on multiple other earlier-stage
trials in various types of solid tumors and hematological malignancies. Our recently completed financing has strengthened our
cash position and should provide adequate funding to initiate our planned proof-of-concept Phase 2 trial of TH-4000, our
hypoxia-activated epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), in patients with EGFR-positive,
T790M-negative non-small cell lung cancer in the first half of 2015.”
Fourth Quarter and Year End 2014 Financial
and Operational Results
Revenue for the fourth quarter and year
ended December 31, 2014 was $3.7 million and $14.7 million, respectively, compared to $3.2 million and $12.5 million for the same
periods in 2013, respectively. Revenue for the years ended December 31, 2014 and December 31, 2013, related to the amortization
of the aggregate of $110 million in upfront and milestone payments earned in 2013 and 2012 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 fourth quarter of
2014 was $6.0 million compared to a net loss of $7.6 million for the fourth quarter of 2013. Included in the net loss for the fourth
quarter of 2014 was an operating loss of $7.6 million and non-cash income of $1.6 million compared to an operating loss of $7.8
million and non-cash income of $0.2 million in the fourth quarter of 2013. The net loss for 2014 was $21.6 million compared to
a net loss of $28.4 million in 2013. Included in the net loss for 2014 was an operating loss of $31.3 million and non-cash income
of $9.3 million compared to an operating loss of $26.0 million and non-cash expense of $2.3 million in 2013. The non-cash income
or expense is related to changes in the fair value of the Company’s outstanding and exercised warrants that was classified
as other income (expense).
Research and development expenses were
$8.6 million for the fourth quarter ended December 31, 2014, compared to $8.5 million for the same period in 2013. The increase
in research and development expenses, net of reimbursement for Merck KGaA, Darmstadt, Germany’s 70% share of total development
expenses for evofosfamide (previously known as TH-302), was due primarily to a $0.6 million increase in employee related expenses,
including a $0.2 million increase in non-cash stock-based compensation expense, partially offset by a $0.5 million decrease in
consulting expenses and clinical development expenses. Research and development expenses were $35.8 million for 2014, compared
to $29.3 million in 2013. The increase in research and development expenses, net of reimbursement for Merck KGaA, Darmstadt, Germany’s
70% share of total development expenses for evofosfamide, was due primarily to a $3.7 million increase in clinical development
expenses, a $0.2 million increase in consulting expenses and an increase of $2.6 million in employee related expenses, including
a $0.6 million increase in non-cash stock-based compensation expense.
|
NEWS RELEASE |
General and administrative expenses were
$2.6 million for the fourth quarter of 2014 versus $2.5 million for the fourth quarter of 2013. The increase in general and administrative
expenses was due primarily to an increase in consulting expenses. General
and administrative expenses were $10.1 million for 2014 versus $9.2 million for 2013. The increase in general and administrative
expenses was due primarily to a $0.8 million increase in consulting expenses and a $0.1 million in employee-related expenses.
Non-cash stock-based compensation expense
included in total operating expenses was $1.6 million for the fourth quarter of 2014 versus $1.4 million for the fourth quarter
of 2013. Non-cash stock-based compensation expense included in total operating expenses was $5.5 million for 2014 versus $4.9 million
for 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 December 31, 2014 and 2013, Threshold
had $58.6 million and $82.0 million in cash, cash equivalents and marketable securities, respectively. The net decrease of $23.4
million in cash, cash equivalents and marketable securities during 2014 is primarily due to the Company's operating cash requirements
for 2014, partially offset by the $12.5 million in a milestone payment received from Threshold's collaboration with Merck KGaA,
Darmstadt, Germany and $5.5 million in cash proceeds from the exercise of warrants and the exercise of stock options and purchase
rights related to our stock-based equity incentive plans.
Clinical Development Outlook for Company-
and Merck KGaA, Darmstadt, Germany-Sponsored Trials of Evofosfamide
The development plan for evofosfamide is
designed to investigate its safety and efficacy across a broad range of solid tumors and hematologic malignancies. Evofosfamide
is being developed in therapeutic areas supported by preclinical and clinical data and where there is high unmet need for new anti-cancer
agents. To date, evofosfamide has been evaluated in more than 1,500 patients with cancer. Threshold anticipates the following development
activities related to Company- and Merck KGaA, Darmstadt, Germany-sponsored clinical trials for evofosfamide in 2015:
| · | Continue to efficiently execute the
two Phase 3 clinical trials of evofosfamide to allow for timely data analyses and to prepare for the potential submission of
marketing applications, assuming the data from the trials are supportive; |
| · | Continue to enroll the Phase 2
clinical trial of evofosfamide designed to support registration for the treatment of patients with non-squamous non-small
cell lung cancer; |
| · | Complete enrollment in the Phase 2
clinical trial of evofosfamide in combination with bortezomib (Velcade®) and low-dose dexamethasone in patients with
relapsed or refractory multiple myeloma; and |
| · | Continue to enroll patients in the Company’s
Phase 2 biomarker trial in patients with advanced melanoma. |
About Evofosfamide (previously known
as TH-302)
Evofosfamide, 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. 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.
|
NEWS RELEASE |
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 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 a Phase 2 proof-of-concept study in a subset of molecularly-defined
non-small cell lung cancer patients whom Threshold believes may be responsive to TH-4000 in the first half of 2015.
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 anticipated
development activities and clinical development outlook related to company- and Merck KGaA, Darmstadt, Germany-sponsored
clinical trials for evofosfamide, including anticipated enrollment events related to, and the planned conduct of primary
efficacy analyses of, ongoing evofosfamide clinical trials, and the timing thereof; the expected efficient execution of and
the anticipated timing of protocol specified events and the availability of the results of the primary efficacy analyses
from the evofosfamide Phase 3 STS clinical trial and the MAESTRO trial; the potential submission of marketing applications
for evofosfamide; the planned initiation of a Phase 2 proof-of-concept study of TH-4000 and the timing thereof; potential
development opportunities for evofosfamide, including the potential of Threshold’s ongoing evofosfamide Phase 2
clinical trial to support registration for the treatment of patients with non-squamous non-small cell lung cancer; the
potential therapeutic uses and benefits of evofosfamide to treat patients with STS, advanced pancreatic cancer, non-squamous
non-small cell lung cancer and other cancers; and the therapeutic potential 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 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 because the
timing of the availability of top-line 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 top-line data from either Phase 3 clinical trial 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, 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, including the risk that
these single source suppliers may be unable to meet clinical supply demands for evofosfamide and/or TH-4000 which could
significantly delay the development of evofosfamide and/or TH-4000; the risks that Threshold’s evaluation of TH-4000 is
at an early stage and it is possible that TH-4000 may not be found to be safe or effective in the planned Phase 2
proof-of-concept study of TH-4000 or in any other studies of TH-4000 that Threshold may conduct, and that Threshold may
otherwise fail to realize the anticipated benefits of its licensing of this product candidate; 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 Quarterly
Report on Form 10-Q, which has been filed with the Securities and Exchange Commission on November 4, 2013 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.
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 | | |
Year Ended | |
| |
December 31, | | |
December 31, | |
| |
2014 | | |
2013 | | |
2014 | | |
2013 | |
| |
| | |
| | |
| | |
| |
| |
| | |
| | |
| | |
| |
Revenue | |
$ | 3,681 | | |
$ | 3,212 | | |
$ | 14,722 | | |
$ | 12,495 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 8,609 | | |
| 8,533 | | |
| 35,832 | | |
| 29,334 | |
General and administrative | |
| 2,623 | | |
| 2,453 | | |
| 10,141 | | |
| 9,185 | |
Total Operating Expenses | |
| 11,232 | | |
| 10,986 | | |
| 45,973 | | |
| 38,519 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (7,551 | ) | |
| (7,774 | ) | |
| (31,251 | ) | |
| (26,024 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest income (expense), net | |
| 24 | | |
| 32 | | |
| 121 | | |
| 136 | |
Other income (expense) (1) | |
| 1,563 | | |
| 234 | | |
| 9,344 | | |
| (2,325 | ) |
Income (loss) before provision for taxes | |
| (5,964 | ) | |
| (7,508 | ) | |
| (21,786 | ) | |
| (28,213 | ) |
| |
| | | |
| | | |
| | | |
| | |
Provision for income taxes | |
| - | | |
| 81 | | |
| (202 | ) | |
| 202 | |
Net income (loss) | |
$ | (5,964 | ) | |
$ | (7,589 | ) | |
$ | (21,584 | ) | |
$ | (28,415 | ) |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Net income (loss) per common share | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | (0.09 | ) | |
$ | (0.13 | ) | |
$ | (0.36 | ) | |
$ | (0.49 | ) |
Diluted | |
$ | (0.12 | ) | |
$ | (0.13 | ) | |
$ | (0.49 | ) | |
$ | (0.49 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average shares used in per common | |
| | | |
| | | |
| | | |
| | |
share calculation: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 62,814 | | |
| 59,226 | | |
| 60,335 | | |
| 57,832 | |
Diluted | |
| 63,544 | | |
| 59,226 | | |
| 63,386 | | |
| 57,832 | |
| |
| | | |
| | | |
| | | |
| | |
(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) |
| |
| | |
| |
| |
| | |
| |
| |
December 31, | | |
December 31, | |
| |
2014 | | |
2013 | |
| |
(unaudited) | | |
(1) | |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Cash, cash equivalents and | |
| | | |
| | |
marketable securities | |
$ | 58,600 | | |
$ | 82,033 | |
Collaboration Receivable | |
| 7,248 | | |
| 18,094 | |
Prepaid expenses and other current assets | |
| 832 | | |
| 2,246 | |
Property and equipment, net | |
| 557 | | |
| 686 | |
Other assets | |
| 1,159 | | |
| 1,059 | |
Total assets | |
$ | 68,396 | | |
$ | 104,118 | |
| |
| | | |
| | |
Liabilities and stockholders' equity | |
| | | |
| | |
| |
| | | |
| | |
Total current liabilities (2) | |
$ | 25,974 | | |
$ | 27,016 | |
Deferred Revenue | |
| 62,194 | | |
| 76,916 | |
Long-term liabilities (3) | |
| 4,204 | | |
| 23,661 | |
Stockholders' equity (deficit) | |
| (23,976 | ) | |
| (23,475 | ) |
Total liabilities and stockholders' equity (deficit) | |
$ | 68,396 | | |
$ | 104,118 | |
(1) |
Derived from audited financial statements |
(2) |
Amount includes current portion of deferred revenue of $14.7 million and $14.7 million as of December 31, 2014 and 2013, respectively. |
(3) |
Includes as of December 31, 2014 and 2013, $4.0 million and $23.4 million of warrant liability, respectively. |
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