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 10, 2016
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 10, 2016,
Threshold Pharmaceuticals, Inc. issued a press release regarding its financial results for the fourth quarter and year ended December
31, 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 March 10, 2016 regarding its financial results for the fourth quarter and year ended December 31, 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. |
|
|
|
|
By: |
/s/ Joel A. Fernandes |
|
|
Name: Joel A. Fernandes |
|
|
Title: Vice President, Finance and Controller |
Date: March 10, 2016
EXHIBIT INDEX
Exhibit
Number |
|
Description |
99.1 |
|
Press Release of Threshold Pharmaceuticals, Inc. dated March 10, 2016 regarding its financial results for the fourth quarter and year ended December 31, 2015. |
Exhibit 99.1
|
NEWS
RELEASE |
Threshold Pharmaceuticals Provides Corporate
Update and Reports Fourth Quarter and Year-End 2015 Financial Results
-- Rights to Evofosfamide and Relevant
Merck KGaA, Darmstadt, Germany Technology Returned to Threshold; Merck KGaA, Darmstadt, Germany Retains Certain Royalty and Milestone
Payments Dependent Upon Successful Development and Commercialization of Evofosfamide --
-- Additional Analyses of Data from the
MAESTRO Study in Pancreatic Cancer Demonstrate Meaningful Improvement in Median Overall Survival and Other Secondary Efficacy Endpoints
for Japanese Patients --
SOUTH SAN FRANCISCO, Calif., – Mar. 10, 2016 (GLOBE
NEWSWIRE) – Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), a clinical-stage biopharmaceutical company developing novel
therapies for cancer, today reported financial results for the fourth quarter and year ended December 31, 2015 and provided an
update on the Company's corporate and clinical development activities.
“A key focus for Threshold has been to analyze all of
the evofosfamide clinical data to determine whether there might be a path forward in patients with pancreatic cancer as well as
other cancer indications,” said Barry Selick, Ph.D., Chief Executive Officer of Threshold. “We have finalized an agreement
with Merck KGaA, Darmstadt, Germany to license back all rights to evofosfamide and, based upon a detailed ongoing analysis of the
data from the Phase 3 MAESTRO trial, we have seen a meaningful improvement in median overall survival and other secondary efficacy
endpoints in the 116 Japanese patients with pancreatic cancer who were enrolled in that trial.”
Corporate Highlights
On March 10, 2016, the Company terminated the global license
and co-development agreement (License Agreement) with Merck KGaA, Darmstadt, Germany, originally entered into February 2, 2012
for evofosfamide, Threshold’s investigational hypoxia-activated prodrug of a cytotoxic DNA-alkylating agent. Under the terms
of the Termination Agreement, all rights to evofosfamide under the original agreement were returned to Threshold, as well as all
rights to Merck KGaA, Darmstadt, Germany technology developed under the License Agreement. The Termination Agreement provides tiered
royalties on sales and milestone payments to Merck KGaA, Darmstadt, Germany contingent upon the future successful development and
commercialization of evofosfamide.
In January 2016 at the American Society of Clinical Oncology
2016 Gastrointestinal Cancers Symposium (ASCO GI), Merck KGaA, Darmstadt, Germany’s analysis of the results from the Phase
3 MAESTRO trial were presented. While the primary efficacy endpoint of overall survival narrowly missed statistical significance,
secondary efficacy endpoints of progression-free survival and confirmed overall response rates demonstrated significant improvements
for patients treated with gemcitabine plus evofosfamide (the “treatment arm”) compared to gemcitabine plus placebo
(the “control arm”). No new safety findings were identified in the MAESTRO study and the safety profile was consistent
with that previously reported in other studies of evofosfamide plus gemcitabine.
| NEWS RELEASE |
As previously reported, a meaningful improvement in overall
survival was reported for the subgroup of 123 Asian patients enrolled at Japanese and South Korean sites in which the risk of death
was reduced by 42 percent for patients on the treatment arm compared to patients on the control arm with an associated hazard ratio
of 0.58 (95% CI: 0.36 – 0.93).
Of particular note, based upon Merck KGaA, Darmstadt, Germany’s
MAESTRO data, the Company reported that the 116 patients from Japan from the treatment arm had a median overall survival of 13.6
months compared to 9.1 months for those patients in the control arm. The patients from Japan also had significant improvements
in progression free survival, objective response rates, and reductions in the pancreatic cancer biomarker, CA19-9.
The Company is conducting additional analyses of data from the
MAESTRO study in pancreatic cancer and intends to discuss potential registration pathways with health regulatory authorities. While
the Company has ongoing clinical development collaborations investigating evofosfamide in patients with pancreatic neuroendocrine
tumors (pNET), recurrent glioblastoma (GBM) and hepatocellular carcinoma (HCC), it has suspended the development of evofosfamide
in various other tumor types.
“The detailed analysis of the MASTRO data combined with
our previous Phase 2 experience strongly suggests that evofosfamide plus gemcitabine is an active regimen in patients with pancreatic
cancer, most notably in the Japanese patients, and we look forward to being able to share our future plans based on these data,”
added Dr. Selick. “Beyond evofosfamide, we continue to make progress with our two Phase 2 proof-of-concept trials of tarloxotinib,
our hypoxia-activated EGFR tyrosine kinase inhibitor, and plan to share preliminary results of those clinical trials in mid-2016.”
Fourth Quarter and Year End 2015 Financial Results
| · | As of December 31, 2015 and 2014, Threshold had $48.7 million and
$58.6 million in cash, cash equivalents and marketable securities, respectively. The net decrease of $9.9 million in cash, cash
equivalents and marketable securities during 2015 is primarily due to the Company's operating cash requirements for 2015, partially
offset by the $28.1 million in net proceeds from our public offering in February 2015 and $0.7 million in cash proceeds from the
exercise of stock options and purchase rights related to our stock-based equity incentive plans. |
| · | Revenue for the fourth quarter and year ended December 31, 2015 was
$65.9 million and $76.9 million, respectively, compared to $3.7 million and $14.7 million for the same periods in 2014, respectively.
Revenue for the years ended December 31, 2015 and December 31, 2014, related to the amortization of the aggregate of $110 million
in upfront and milestone payments earned in 2013 and 2012 from the Company’s collaboration with Merck KGaA, Darmstadt, Germany.
The revenue from the upfront payment and milestone payments earned under the agreement was previously being amortized over the
relevant performance period, rather than being immediately recognized when the upfront payment and milestone were earned or received.
As a result of Merck KGaA, Darmstadt, Germany’s and our decision to cease further joint development of evofosfamide in December
2015, we immediately recognized $65.9 million of the remaining deferred revenue into revenue during the quarter ending December
31, 2015. Also as a result of the termination of the agreement, we are no longer eligible to receive any further milestone payments
from Merck KGaA, Darmstadt, Germany. |
| NEWS RELEASE |
| · | Research and development expenses were $11.4 million for the fourth
quarter ended December 31, 2015, compared to $8.6 million for the same period in 2014. 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 $1.2 million increase in employee related expenses, including a $0.3 million increase in non-cash stock-based
compensation expense and a $1.6 million increase in clinical development expenses and consulting expenses. Research and development
expenses were $40.3 million for 2015, compared to $35.8 million in 2014. 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 $2.1 million increase in clinical development expenses and an increase of $2.7 million in employee related expenses, including
a $1.0 million increase in non-cash stock-based compensation expense. Partially offsetting these increases was a $0.4 million decrease
in consulting expenses. |
| · | General and administrative expenses were $2.2 million for the fourth quarter of 2015 versus $2.6 million for the fourth quarter
of 2014. The decrease in general and administrative expenses was due primarily to a $0.2 million decrease in consulting expenses
and a $0.2 million decrease in employee related expenses. General and administrative expenses were $9.7 million for 2015 versus
$10.1 million for 2014. The decrease in general and administrative expenses was due primarily to a $0.4 million decrease in consulting
expenses. |
| · | Non-cash stock-based compensation expense included in total operating expenses was $2.0 million for the fourth quarter of 2015
versus $1.6 million for the fourth quarter of 2014. Non-cash stock-based compensation expense included in total operating expenses
was $6.8 million for 2015 versus $5.5 million for 2014. The increase in stock-based compensation expense was due to the amortization
of a greater number of options with higher fair values. |
| · | Net income for the fourth quarter of 2015 was $69.7 million compared
to a net loss of $6.0 million for the fourth quarter of 2014. Included in the net income for the fourth quarter of 2015 was an
operating income of $52.3 million and non-cash income of $17.4 million compared to an operating loss of $7.6 million and non-cash
income of $1.6 million in the fourth quarter of 2014. The net income for 2015 was $43.8 million compared to a net loss of $21.6
million in 2014. Included in the net income for 2015 was an operating income of $26.9 million and non-cash income of $16.8 millio7n
compared to an operating loss of $31.3 million and non-cash income of $9.3 million in 2014. 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). |
| NEWS RELEASE |
About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational
hypoxia-activated prodrug of a bis-alkylating agent that is preferentially 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. On December
6, 2015, the Company announced the outcomes of two Phase 3 studies (MAESTRO and TH-CR-406/SARC021) of evofosfamide stating that
neither study met its primary endpoint. The related news release can be accessed on the Company's website.
About Tarloxotinib Bromide
Tarloxotinib bromide (the proposed International Nonproprietary
Name, previously known as TH-4000), 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.
About Threshold Pharmaceuticals
Threshold is a clinical-stage biopharmaceutical company focused
on the discovery and development of drugs and diagnostic agents 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 the Company’s
website.
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-sponsored clinical trials for evofosfamide and tarloxotinib, including establishing collaborations
for our product candidates, the planned analyses of evofosfamide and tarloxotinib 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 and tarloxotinib clinical trials; the potential submission of marketing applications
for evofosfamide; the timing of the Phase 2 proof-of-concept study of tarloxotinib; potential development opportunities for evofosfamide,
including the potential for Threshold’s evofosfamide Phase 3 clinical trial to support registration for the treatment of
patients with advanced pancreatic cancer, and other cancers; and the therapeutic potential of 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 to establish collaborations for our product
candidates or otherwise raise substantial additional capital; Threshold's dependence on the transfer of development activities
from Merck KGaA, Darmstadt, Germany, including its dependence on decisions by Merck KGaA, Darmstadt, Germany regarding the amount
and timing of resource expenditures for the transfer of evofosfamide development activities and the risk of potential disagreements
with Merck KGaA, Darmstadt, Germany, regarding the time and expense required to transfer clinical trials and analyze data; the
uncertainty of clinical success and regulatory approval; the risk that later analysis may not confirm the results of earlier analysis;
the risks that the design of, or data collected from, the 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 on single source suppliers, including the risk that these single source suppliers may be unable
to meet clinical supply demands for evofosfamide and/or tarloxotinib which could significantly delay the development of evofosfamide
and/or tarloxotinib; Threshold’s ability to enroll or complete tarloxotinib clinical trials, including the ability of Threshold
to complete the ongoing clinical trials in the expected timeframe or at all; the risks that Threshold’s evaluation of tarloxotinib
is at an early stage and it is possible that tarloxotinib may not be found to be safe or effective in the Phase 2 proof-of-concept
study of tarloxotinib or in any other studies of tarloxotinib 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 tarloxotinib 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 10, 2016 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:
Denise Powell
denise@redhousecomms.com
510.703.9491
Source: Threshold Pharmaceuticals, Inc.
| 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, | |
| |
2015 | | |
2014 | | |
2015 | | |
2014 | |
| |
| | |
| | |
| | |
| |
Revenue | |
$ | 65,874 | | |
$ | 3,681 | | |
$ | 76,915 | | |
$ | 14,722 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 11,369 | | |
| 8,609 | | |
| 40,271 | | |
| 35,832 | |
General and administrative | |
| 2,248 | | |
| 2,623 | | |
| 9,716 | | |
| 10,141 | |
Total Operating Expenses | |
| 13,617 | | |
| 11,232 | # | |
| 49,987 | # | |
| 45,973 | |
| |
| | | |
| | | |
| | | |
| | |
Income (loss) from operations | |
| 52,257 | | |
| (7,551 | ) | |
| 26,928 | | |
| (31,251 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest income (expense), net | |
| 26 | | |
| 24 | | |
| 125 | | |
| 121 | |
Other income (expense) (1) | |
| 17,430 | | |
| 1,563 | | |
| 16,769 | | |
| 9,344 | |
Income (loss) before provision for taxes | |
| 69,713 | | |
| (5,964 | ) | |
| 43,822 | | |
| (21,786 | ) |
| |
| | | |
| | | |
| | | |
| | |
Provision for income taxes | |
| - | | |
| - | | |
| - | | |
| (202 | ) |
Net income (loss) | |
$ | 69,713 | | |
$ | (5,964 | ) | |
$ | 43,822 | | |
$ | (21,584 | ) |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Net income (loss) per common share | |
| | | |
| | | |
| | | |
| | |
Basic | |
$ | 0.98 | | |
$ | (0.09 | ) | |
$ | 0.62 | | |
$ | (0.36 | ) |
Diluted | |
$ | 0.86 | | |
$ | (0.12 | ) | |
$ | 0.54 | | |
$ | (0.49 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average shares used in per common | |
| | | |
| | | |
| | | |
| | |
share calculation: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 71,457 | | |
| 62,814 | | |
| 70,242 | | |
| 60,335 | |
Diluted | |
| 73,686 | | |
| 63,544 | | |
| 73,483 | | |
| 63,386 | |
| (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, | |
| |
2015 | | |
2014 | |
| |
(unaudited) | | |
(1) | |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Cash, cash equivalents and | |
| | | |
| | |
marketable securities | |
$ | 48,680 | | |
$ | 58,600 | |
Collaboration Receivable | |
| 1,891 | | |
| 7,248 | |
Prepaid expenses and other current assets | |
| 2,599 | | |
| 832 | |
Property and equipment, net | |
| 333 | | |
| 557 | |
Other assets | |
| 166 | | |
| 1,159 | |
Total assets | |
$ | 53,669 | | |
$ | 68,396 | |
| |
| | | |
| | |
Liabilities and stockholders' equity | |
| | | |
| | |
| |
| | | |
| | |
Total current liabilities (2) | |
$ | 10,828 | | |
$ | 25,974 | |
Deferred Revenue | |
| - | | |
| 62,194 | |
Long-term liabilities (3) | |
| 1,995 | | |
| 4,204 | |
Stockholders' equity (deficit) | |
| 40,846 | | |
| (23,976 | ) |
Total liabilities and stockholders' equity (deficit) | |
$ | 53,669 | | |
$ | 68,396 | |
| (1) | Derived from audited financial statements |
| (2) | Amount includes current portion of deferred revenue of
$0 million and $14.7 million as of December 31, 2015 and 2014, respectively. |
| (3) | Includes as of December 31, 2015 and 2014, $1.9 million
and $4.0 million of warrant liability, respectively. |
Molecular Templates (NASDAQ:MTEM)
Historical Stock Chart
From Feb 2024 to Mar 2024
Molecular Templates (NASDAQ:MTEM)
Historical Stock Chart
From Mar 2023 to Mar 2024