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): April 30, 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:
| ¨ | Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | 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 April 30, 2015,
Threshold Pharmaceuticals, Inc. issued a press release regarding its financial results for the first quarter ended March 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 April 30, 2015 regarding its financial results for the first quarter ended March 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: April 30, 2015
EXHIBIT INDEX
Exhibit
Number |
|
Description |
99.1 |
|
Press Release of Threshold Pharmaceuticals, Inc. dated April 30, 2015 regarding its financial results for the first quarter ended March 31, 2015. |
Exhibit 99.1
|
NEWS
RELEASE |
Contact
Laura Hansen, Ph.D.
Senior Director, Corporate Communications
Phone: 650-474-8206
E-mail: lhansen@thresholdpharm.com
Threshold Pharmaceuticals Reports First
Quarter 2015 Financial and Operational Results
SOUTH SAN FRANCISCO, CA – April
30, 2015 – Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today reported financial results for the first quarter 2015.
Revenue for the first quarter ended March 31, 2015 was $3.7 million. The operating loss for the first quarter ended March 31, 2015
was $9.6 million. The net loss for the first quarter ended March 31, 2015 was $11.2 million, which included the operating loss
of $9.6 million and non-cash expense of $1.5 million related to the changes in fair value of the Company's outstanding warrants
and was classified as other income (expense). As of March 31, 2015, Threshold had $83.1 million in cash, cash equivalents and marketable
securities, with no debt outstanding.
"Our two pivotal clinical trials with
evofosfamide remain on track," 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 analyses to be available shortly thereafter. We look forward to providing clinical updates
on earlier-stage programs with evofosfamide at upcoming medical meetings. In addition, we are pleased with the level of interest
in our first data presentation on TH-4000, our proprietary hypoxia-activated epidermal growth factor receptor tyrosine kinase inhibitor
(EGFR-TKI), at the recent AACR annual meeting. We are looking forward to initiating two Phase 2 clinical trials of TH-4000 this
year, the first in patients with EGFR-positive, T790M-negative non-small cell lung cancer and the second in patients with head
and neck cancer."
First Quarter 2015 Financial and Operational
Results
Revenue of $3.7 million was recognized
for both the first quarter of 2015 and 2014. Revenue 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.
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 first quarter of 2015
was $11.2 million compared to a net loss of $7.1 million for the first quarter of 2014. Included in the net loss for the first
quarter of 2015 was an operating loss of $9.6 million and non-cash expense of $1.5 million compared to an operating loss of $8.6
million and non-cash income of $1.5 million included in the net loss for the first 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
$10.7 million for the first quarter of 2015 compared to $9.7 million for the first quarter of 2014. The increase in research and
development expenses was due primarily to a $0.5 million increase in clinical development expenses, net of reimbursement from Merck
KGaA, Darmstadt, Germany related to their 70% share of total development expenses for evofosfamide (previously known as TH-302),
and an increase of $0.5 million in consulting and employee related expenses.
General and administrative expenses were
$2.6 million for both the first quarter of 2015 and 2014.
|
NEWS
RELEASE |
Non-cash stock-based compensation expense
included in total operating expenses was $1.4 million for the first quarter of 2015 versus $1.3 million for the first 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.
As of March 31, 2015 and December 31, 2014,
Threshold had $83.1 million and $58.6 million in cash, cash equivalents and marketable securities, respectively. The net increase
of $24.5 million in cash, cash equivalents and marketable securities during the first quarter of 2015 was primarily due to the
$28.1 million in net proceeds from our public offering in February 2015, and a $7.2 million reimbursement payment related to Merck
KGaA, Darmstadt, Germany's 70% share of total development expenses for evofosfamide for the fourth quarter of 2014, partially offset
by the Company’s operating cash requirements for the first quarter of 2015.
First Quarter and Recent Key Achievements
Corporate
In February, Threshold completed
an underwritten offering of 8,300,000 shares of its common stock together with accompanying warrants to purchase an aggregate of
8,300,000 shares of common stock. The net proceeds to Threshold from this offering were $28.1 million, which the Company expects
to use for working capital and general corporate purposes, including research and development expenses, general and administrative
expenses and manufacturing expenses.
Research & Development
In April, Threshold presented data on its
investigational drugs at the annual meeting of the American Association for Cancer Research (AACR) 2015. Data on TH-4000, the Company’s
proprietary, hypoxia-activated irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), were presented
in collaboration with its co-inventors from The University of Auckland (Abstract 5358). The Company believes the data presented
support its two planned Phase 2 proof-of-concept clinical trials of TH-4000 in patients with mutant EGFR-positive non-small cell
lung cancer (NSCLC) after conventional EGFR-TKI therapy has failed as well as in patients with head and neck cancer for which EGFR
over-expression is associated with worse outcomes. In addition, preclinical data evaluating the potential use of evofosfamide in
a variety of tumor types were presented by Threshold and Merck KGaA, Darmstadt, Germany (Abstract Nos. 2424, 2603, 3867, 5271,
and 5333).
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 enrollment in 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. |
|
NEWS
RELEASE |
Clinical Development Outlook for
Company-Sponsored Trials of TH-4000
Threshold is planning to initiate two
Phase 2 proof-of-concept clinical trials of TH-4000 in 2015; one in patients with EGFR-positive, T790M-negative non-small cell
lung cancer after conventional EGFR-TKI therapy has failed, and one in patients with head and neck cancer for which EGFR over-expression
is associated with worse outcomes.
About Evofosfamide
Evofosfamide (previously known as TH-302),
an investigational hypoxia-activated prodrug, is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers.
Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood supply as a result of aberrant vasculature.
Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.
Evofosfamide is currently under evaluation
in two Phase 3 trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable
or metastatic soft tissue sarcoma (STS), and the other in combination with gemcitabine versus gemcitabine and placebo in patients
with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase 3 trials are being conducted
under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide
Orphan Drug Designation for the treatment of STS and pancreatic cancer. Evofosfamide is also being investigated in a Phase 2 trial
designed to support registration for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials
of other solid tumors and hematological malignancies.
Threshold has a global license and co-development
agreement for evofosfamide with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize in the
U.S.
About TH-4000
In September 2014, Threshold licensed
exclusive worldwide rights to a clinical development program based on TH-4000 (formerly referred to as PR610 or Hypoxin™)
from the University of Auckland. TH-4000 is a hypoxia-activated epidermal growth factor receptor, or EGFR, tyrosine-kinase inhibitor
(TKI). TH-4000 is designed to selectively release an irreversible EGFR-TKI in hypoxic tumors. Preclinical and Phase 1 clinical
data suggest that plasma concentrations of TH-4000 that are active in EGFR-dependent tumor xenograft models in mice could be attained
in patients with an acceptable therapeutic index.
Threshold expects to initiate Phase
2 proof-of-concept clinical trials in patients with EGFR-positive, T790M-negative non-small cell lung cancer (NSCLC) after conventional
EGFR-TKI therapy has failed, and in patients with head and neck cancer.
About Threshold Pharmaceuticals
Threshold 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).
|
NEWS
RELEASE |
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 potential for 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; the planned initiation of two Phase 2 proof-of-concept clinical trials of TH-4000 and the timing
thereof; Threshold's belief that the data presented at AACR support Threshold's planned development of TH-4000; 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 primary efficacy data from the ongoing Phase 3 clinical trials of
evofosfamide is driven by the number of events in each trial, which neither Threshold nor Merck KGaA, Darmstadt, Germany, controls,
Threshold cannot predict with certainty when the primary efficacy data from either Phase 3 clinical trial will be available; 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 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 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 trials 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; the risk that preclinical studies and Phase 1 or 2 clinical trials of our
product candidates may not predict the results of subsequent human clinical trials, including the risks that TH-4000 preclinical
and Phase 1 clinical data may not accurately predict whether a safe and effective dose can be attained in the patient populations
for TH-4000 that Threshold is targeting; the ability of Threshold to enroll or complete planned TH-4000 clinical trials, including
as a result of Threshold's potential inability to develop a formulation of TH-4000 with adequate quality that meets the need for
testing in its clinical trials; Threshold's dependence on single source suppliers for TH-4000,
including the risk that these single source suppliers may be unable to meet clinical supply demands for TH-4000 which could significantly
delay the development of TH-4000; and Threshold's need for and the availability of resources to develop evofosfamide and TH-4000
and to support Threshold's operations. Further information regarding these and other risks is included under the heading "Risk
Factors" in Threshold's Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission on March 3, 2015 and
is available from the SEC's website (www.sec.gov) and on our website (www.thresholdpharm.com) under the heading "Investors".
We undertake no duty to update any forward-looking statement made in this news release.
|
NEWS
RELEASE |
THRESHOLD PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
| |
Three Months Ended | |
| |
March 31, | |
| |
2015 | | |
2014 | |
| |
| | |
| |
| |
| | |
| |
Revenue | |
$ | 3,681 | | |
$ | 3,681 | |
| |
| | | |
| | |
Operating expenses | |
| | | |
| | |
Research and development | |
| 10,680 | | |
| 9,653 | |
General and administrative | |
| 2,616 | | |
| 2,634 | |
Total Operating Expenses | |
| 13,296 | | |
| 12,287 | |
| |
| | | |
| | |
Loss from operations | |
| (9,615 | ) | |
| (8,606 | ) |
| |
| | | |
| | |
Interest income (expense), net | |
| 33 | | |
| 40 | |
Other Income (expense), net (1) | |
| (1,572 | ) | |
| 1,457 | |
| |
| | | |
| | |
Net loss | |
| (11,154 | ) | |
| (7,109 | ) |
| |
| | | |
| | |
Net loss per common share: | |
| | | |
| | |
Basic | |
$ | (0.17 | ) | |
$ | (0.12 | ) |
Diluted | |
$ | (0.17 | ) | |
$ | (0.14 | ) |
| |
| | | |
| | |
Weighted-average shares used in per common share calculations: | |
| | | |
| | |
Basic | |
| 66,732 | | |
| 59,303 | |
Diluted | |
| 66,732 | | |
| 61,300 | |
(1) Non-cash income (expense)
related to the change in 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)
|
|
March 31, |
|
|
December 31, |
|
|
|
2015 |
|
|
2014 |
|
|
|
(unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
83,086 |
|
|
$ |
58,600 |
|
Collaboration Receivable |
|
|
1,993 |
|
|
|
7,248 |
|
Prepaid expenses and other current assets |
|
|
1,226 |
|
|
|
832 |
|
Property and equipment, net |
|
|
503 |
|
|
|
557 |
|
Other assets |
|
|
1,201 |
|
|
|
1,159 |
|
Total assets |
|
$ |
88,009 |
|
|
$ |
68,396 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities (2) |
|
$ |
28,975 |
|
|
$ |
25,974 |
|
Deferred Revenue |
|
|
58,513 |
|
|
|
62,194 |
|
Long-term liabilities (3) |
|
|
20,410 |
|
|
|
4,204 |
|
Stockholders' equity (deficit) |
|
|
(19,889 |
) |
|
|
(23,976 |
) |
Total liabilities and stockholders' equity (deficit) |
|
$ |
88,009 |
|
|
$ |
68,396 |
|
| (1) | Derived from audited financial statements |
| (2) | Amount includes current portion of deferred revenue of
$14.7 million for both March 31, 2015 and December 31, 2014, respectively. |
| (3) | Includes as of March 31, 2015 and December 31, 2014,
$20.2 million and $4.0 million of warrant liability, respectively. |
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