Talon Therapeutics, Inc. Reports Fourth Quarter and Year End 2012 Financial
SOUTH SAN FRANCISCO, Calif., April 1, 2013 (GLOBE NEWSWIRE) -- Talon
Therapeutics, Inc., (OTCQB:TLON), today reported financial results for the
fourth quarter and year ended December 31, 2012.
2012 Corporate Highlights
*FDA accelerated approval of Marqibo® for the treatment of Philadelphia
chromosome negative adult acute lymphoblastic leukemia (ALL) patients in
second or greater relapse or whose disease has progressed following two or
more prior lines of anti-leukemia therapy.
*Enrollment and dosing of the first patient in the Phase 3 confirmatory
study of Marqibo®, named HALLMARQ, in adult patients with newly diagnosed
Philadelphia chromosome negative ALL.
*Publication of the Marqibo® RALLY Study in the Journal of Clinical
Three Months Ended December 31, 2012 Unaudited Financial Results
For the three months ended December 31, 2012, the Company reported net income
of $7.1 million and deemed dividends on preferred stock of $3.2 million, which
when combined, resulted in net income applicable to common stockholders of
$3.9 million, or $0.18 and $.02 per basic and diluted share, respectively. The
change in fair value of Talon's preferred stockholders' right to purchase
additional shares of Series A-3 preferred stock contributed $13.1 million, or
$0.59 per share, of total net income applicable to common stockholders for the
three months ended December 31, 2012. The change in fair value of Talon's
preferred stockholders' right to purchase additional shares of preferred stock
is primarily driven by fluctuations in price of Talon's common stock. This
compares with a net loss of $1.7 million and deemed dividends on preferred
stock of $1.0 million for the three months ended December 31, 2011, which when
combined, resulted in a net loss applicable to common stockholders of $2.7
million, or $0.12 per share, for such 2011 period.
Total operating expenses for the three months ended December 31, 2012 were
$5.3 million, compared with $3.7 million for the three months ended December
31, 2011. Research and development expenses were $2.7 million for the three
months ended December 31, 2012, compared with $2.3 million for the three
months ended December 31, 2011. General and administrative expenses were $2.7
million for the three months ended December 31, 2012, compared with $1.4
million for the three months ended December 31, 2011.
Cash used in operations was $5.5 million for the three months ended December
31, 2012. As of December 31, 2012, the Company had cash and cash equivalents
of $3.0 million. Following the end of the 2012 fiscal year, on January 11,
2013, the Company sold additional shares of its Series A-3 Preferred Stock,
resulting in gross proceeds of $6.0 million.
Year Ended December 31, 2012 Financial Results
For the year ended December 31, 2012, the Company reported a net loss of $43.7
million and deemed dividends on preferred stock of $21.1 million, which when
combined, resulted in a net loss applicable to common stockholders of $64.8
million, or $2.95 per share. The deemed dividends on preferred stock
attributed $0.96 per share to the total net loss applicable to common
stockholders for the year ended December 31, 2012. The change in fair value of
Talon's preferred stockholders' right to purchase additional shares of Series
A-3 preferred stock contributed $18.1 million, or $0.82 per share, of the
total net loss applicable to common stockholders for the twelve months ended
December 31, 2012. This compares with a net loss of $18.8 million and deemed
dividends on preferred stock of $3.9 million, which when combined, resulted in
a net loss applicable to common stockholders of $22.8 million, or $1.06 per
share for the year ended December 31, 2011.
Total operating expenses for the year ended December 31, 2012, were $20.8
million, compared with $18.5 million for the year ended December 31, 2011.
Research and development expenses were $12.9 million for the twelve months
ended December 31, 2012, compared with $13.4 million for the year ended
December 31, 2011. General and administrative expenses were $7.9 million for
the year ended December 31, 2012, compared with $5.1 million for the year
ended December 31, 2011.
Cash used in operations was $20.2 million for the year ended December 31,
About Marqibo® (vincristine sulfate liposome injection)
Marqibo is a novel, targeted Optisome™ encapsulated formulation product
candidate of the FDA-approved anticancer drug vincristine. Talon is primarily
developing Marqibo for the treatment of Ph- adult ALL. Vincristine, a
microtubule inhibitor, is FDA-approved for ALL and is widely used as a single
agent and in combination regimens for treatment for hematologic malignancies
such as lymphomas and leukemias. Talon's encapsulation formulation is designed
to provide prolonged circulation of the drug in the blood and accumulation at
the tumor site. These characteristics are intended to increase the dose of
vincristine delivered in a safe and effective manner.
Talon has received orphan drug and fast track designations for Marqibo for the
treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has
also received orphan drug designation in adult ALL from the European Medicines
Please see important safety information below and the full prescribing
information for Marqibo at www.marqibo.com.
Indication and usage
Marqibo is a liposomal vinca alkaloid indicated for the treatment of adult
patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic
leukemia (ALL) in second or greater relapse or whose disease has progresses
following two or more anti-leukemia therapies. This indication is based on
overall response rate. Clinical benefit such as improvement in overall
survival has not been verified.
Important safety information
*Marqibo is contraindicated in patients with demyelinating conditions
including Charcot-Marie-Tooth syndrome
*Marqibo is contraindicated in patients with hypersensitivity to
vincristine sulfate or any of the other components of Marqibo (vinCRIStine
sulfate LIPOSOME injection
*Marqibo is contraindicated for intrathecal administration
See full prescribing information for complete boxed warning.
*For Intravenous Use Only -- Fatal if Given by Other Routes
*Death has occurred with intrathecal use
*Marqibo (vinCRIStine sulfate LIPOSOME injection) has different dosage
recommendations than vinCRIStine sulfate injection. Verify drug name and
dose prior to preparation and administration to avoid overdosage.
Warnings and Precautions
For Intravenous Use Only
For Intravenous use only. Fatal if given by other routes.
Extravasation Tissue Injury
Only administer through a secure and free-flowing venous access line. If
extravasation is suspected, discontinue infusion immediately and consider
local treatment measures.
Sensory and motor neuropathies are common and are cumulative. Monitor patients
for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia,
hyporeflexia, areflexia, neuralgia, jaw pain, decreased vibratory sense,
cranial neuropathy, ileus, burning sensation, arthralgia, myalgia, muscle
spasm, or weakness, both before and during treatment. Orthostatic hypotension
may occur. The risk of neurologic toxicity is greater if Marqibo is
administered to patients with preexisting neuromuscular disorders or when
other drugs with risk of neurologic toxicity are being given. In the studies
of relapsed and/or refractory adult ALL patients, Grade >= 3 neuropathy events
occurred in 32.5% of patients. Worsening neuropathy requires dose delay,
reduction, or discontinuation of Marqibo.
Monitor complete blood counts prior to each dose of Marqibo. If Grade 3 or 4
neutropenia, thrombocytopenia, or anemia develops, consider Marqibo dose
modification or reduction as well as supportive care measures.
Tumor Lysis Syndrome
Tumor lysis syndrome (TLS) may occur in patients with ALL receiving Marqibo.
Anticipate, monitor for, and manage.
Constipation and Bowel Obstruction
Ileus, bowel obstruction, and colonic pseudo-obstruction have occurred.
Marqibo can cause constipation. Institute a prophylactic bowel regimen to
mitigate potential constipation, bowel obstruction, and/or paralytic ileus,
considering adequate dietary fiber intake, hydration, and routine use of stool
softeners, such as docusate. Additional treatments, such as senna, bisacodyl,
milk of magnesia, magnesium citrate, and lactulose may be considered.
Marqibo can cause severe fatigue. Marqibo dose delay, reduction, or
discontinuation may be necessary.
Fatal liver toxicity and elevated levels of aspartate aminotransferase have
occurred. Elevated levels of aspartate aminotransferase of Grade >=3 occurred
in 6-11% of patients in clinical trials. Monitor hepatic function tests.
Reduce or interrupt Marqibo for hepatic toxicity.
Marqibo can cause fetal harm when administered to a pregnant woman.
Vincristine sulfate liposome injection was teratogenic or caused embryo-fetal
death in animals. Women of childbearing potential should avoid becoming
pregnant while being treated with Marqibo. There are no adequate and
well-controlled studies of Marqibo in pregnant women and there were no reports
of pregnancy in any of the clinical studies in the Marqibo clinical
development program. If this drug is used during pregnancy, or if the patient
becomes pregnant while taking this drug, the patient should be apprised of the
potential hazard to a fetus [see Use in Specific Populations].
The most common adverse reactions (>30%) were constipation (57%), nausea
(52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile
neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and
The most commonly reported SAEs included febrile neutropenia (20.5%), pyrexia
(13.3%), hypotension (7.2%), respiratory distress (6.0%), and cardiac arrest
Twenty-eight percent of patients experienced adverse reactions leading to
treatment discontinuation. The most common adverse reactions that caused
treatment discontinuation were peripheral neuropathy (10%), leukemia-related
(7%), and tumor lysis syndrome (2%).
Deaths occurred in 23% of patients in study 1. The non-leukemia related causes
of deaths were brain infarct (1), intracerebral hemorrhage (2), liver failure
(1), multi-system organ failure (2), pneumonia and septic shock (3),
respiratory failure (4), pulmonary hemorrhage (1), and sudden cardiac death
No formal drug interaction studies have been conducted with Marqibo. Marqibo
is expected to interact with drugs known to interact with non-liposomal
Simultaneous oral or intravenous administration of phenytoin and
antineoplastic chemotherapy combinations that included non-liposomal
vincristine sulfate has been reported to reduce blood levels of phenytoin and
to increase seizure activity.
Vincristine sulfate, the active agent in Marqibo, is a substrate for
cytochrome P450 3A isozymes (CYP3A); therefore, the concomitant use of strong
CYP3A inhibitors should be avoided (e.g., ketoconazole, itraconazole,
voriconazole, posaconazole, clarithromycin, atazanavir, indinavir, nefazodone,
nelfinavir, ritonavir, saquinavir, telithromycin). Similarly, the concomitant
use of strong CYP3A inducers should be avoided (e.g., dexamethasone,
phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St.
Vincristine sulfate, the active agent in Marqibo, is also a substrate for
P-glycoprotein (P-gp). The effect of concomitant use of potent P-gp inhibitors
or inducers has not been investigated; it is likely that these agents will
alter the pharmacokinetics or pharmacodynamics of Marqibo. Therefore the
concomitant use of potent P-gp inhibitors or inducers should be avoided.
Use in Specific Populations
Pregnancy Category D [see Warnings and Precautions]
Based on its mechanism of action and findings from animal studies, Marqibo can
cause fetal harm when administered to pregnant women.
If this drug is used during pregnancy, or if the patient becomes pregnant
while taking this drug, the patient should be apprised of the potential hazard
to a fetus. In an embryofetal developmental study, pregnant rats were
administered vincristine sulfate liposome injection intravenously during the
period of organogenesis at vincristine sulfate doses of 0.022 to 0.09
mg/kg/day. Drug-related adverse effects included fetal malformations (skeletal
and visceral), decreases in fetal weights, increased numbers of early
resorptions and post-implantation losses, and decreased maternal body weights
Malformations were observed at doses >= 0.044 mg/kg/day in animals at systemic
exposures approximately 20-40% of those reported in patients at the
It is not known whether this drug is excreted in human milk. Because many
drugs are excreted in human milk and because of the potential for serious
adverse reactions in nursing infants, a decision should be made whether to
discontinue nursing or discontinue the drug taking into account the importance
of the drug to the mother.
The safety and effectiveness of Marqibo in pediatric patients have not been
Safety and effectiveness in elderly individuals have not been established. In
general, dose selection for an elderly patient should be cautious, reflecting
the greater frequency of decreased hepatic, renal, or cardiac function, and of
concomitant disease or other drug therapy.
The influence of renal impairment on the safety, efficacy, and
pharmacokinetics of Marqibo has not been evaluated.
Non-liposomal vincristine sulfate is excreted primarily by the liver. The
influence of severe hepatic impairment on the safety and efficacy of Marqibo
has not been evaluated. The pharmacokinetics of Marqibo was evaluated in
patients with moderate hepatic dysfunction (Child-Pugh B) secondary to
melanoma liver metastases. The dose-adjusted maximum plasma concentration
(C[max]) and area under the concentration-time curve (AUC) of Marqibo in
patients with moderate hepatic impairment was comparable to the C[max] and AUC
of patients with ALL who had otherwise normal hepatic function.
About Talon Therapeutics
Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing
upon medical opportunities, efficiently and expertly leading product
candidates through clinical development, and transferring value to patients,
patient care providers, shareholders, corporate partners, and employees. In
addition to Marqibo® (vincCRIStine sulfate LIPOSOME injection) which received
accelerated approval from the US FDA in August 2012, Talon has additional
pipeline opportunities some of which like Marqibo, have the potential to
improve delivery and enhance the therapeutic benefits of well characterized,
proven chemotherapies and enable high potency dosing without increased
Additional information on Talon Therapeutics can be found at www.talontx.com.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These statements are
often, but not always, made through the use of words or phrases such as
"anticipates," "expects," "plans," "believes," "intends," and similar words or
phrases. Such statements involve risks and uncertainties that could cause
Talon's actual results to differ materially from the anticipated results and
expectations expressed in these forward-looking statements. These statements
are based on current expectations, forecasts and assumptions that are subject
to risks and uncertainties, which could cause actual outcomes and results to
differ materially from these statements. Such risks and uncertainties include:
Talon's ability to commercialize Marqibo alone or with any strategic partner;
the likelihood of completing a strategic transaction; Talon's lack of
experience commercializing pharmaceutical products; that Talon will be able to
secure the additional capital necessary to fund operational activities for
Marqibo, including its ongoing research and development programs to
completion; Talon's reliance on third-party clinical research organizations to
develop its product candidates, and its lack of experience in developing
pharmaceutical products. Additional risks are described in the company's
Annual Report on Form 10-K for the year ended December 31, 2012. Talon assumes
no obligation to update these statements, except as required by law.
TALON THERAPEUTICS, INC.
Cash and cash equivalents $ 2,973,028 $ 1,028,518
Inventory 283,321 —
Prepaid expenses and other current assets 237,918 635,297
Total current assets 3,494,267 1,663,815
Property and equipment, net 42,714 72,431
Restricted cash 34,004 —
Debt issuance costs, net 517,525 751,401
Total assets $ 4,088,510 $ 2,487,647
LIABILITIES AND STOCKHOLDERS' DEFICIT
Accounts payable and accrued liabilities $ 3,549,276 $ 4,556,951
Investors' rights to purchase shares of Series A-3 14,276,000 —
Other short term liabilities 2,474 2,110
Total current liabilities 17,827,750 4,559,061
Notes payable, net of discount 24,833,183 24,033,257
Investors' right to purchase future shares of — 1,772,100
Series A-1 and A-2 preferred stock
Warrant liabilities, non-current 563,070 501,664
Other long term liabilities — 2,474
Total long term liabilities 25,396,253 26,309,495
Total liabilities 43,224,003 30,868,556
Redeemable convertible preferred stock; $0.001 par
10 million shares authorized, 0.7 million and 0.4
million shares issued and outstanding at December
31, 2012 andDecember 31, 2011, respectively; 47,913,500 30,643,219
aggregate liquidation value of $77.9 million and
$46.4 million at December 31, 2012 and December
31, 2011, respectively
Common stock; $0.001 par value:
600 million shares authorized, 22.0 million and
21.8 million shares issued and outstanding at 22,001 21,779
December 31, 2012 and December 31, 2011,
Additional paid-in capital 136,562,864 120,887,432
Accumulated deficit (223,633,858) (179,933,339)
Total stockholders' deficit (87,048,993) (59,024,128)
Total liabilities, redeemable convertible $ 4,088,510 $ 2,487,647
preferred stock and stockholders' deficit
TALON THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
Three Months Ended YearsEnded
December 31, December31,
2012 2011 2012 2011
General and $ 2,660,675 $ 1,398,422 $ 7,900,846 $ 5,121,678
Research and 2,651,519 2,325,690 12,898,688 13,387,168
Total operating 5,312,194 3,724,112 20,799,534 18,508,846
Loss from operations (5,312,194) (3,724,112) (20,799,534) (18,508,846)
Interest income 597 158 3,324 8,124
Interest expense (928,931) (900,112) (3,751,799) (3,560,444)
Other expense, net — (2,768) — (78,768)
Change in fair value 268,111 454,187 (73,151) (41,146)
of warrant liabilities
Change in fair value
of investors' right to
purchase future shares .— 2,522,900 (1,006,900) 3,358,900
of Series A-1 and A-2
Change in fair value
of investors' right to
purchase future shares 13,064,200 — (18,072,459) —
of Series A-3
Total other 12,403,977 2,074,365 (22,900,985) (313,334)
Net income/(loss) $ 7,091,783 $ (1,649,747) $ (43,700,519) $ (18,822,180)
preferred stock in (1,692,065) (1,028,307) (5,847,123) (3,947,713)
preferred stock in (1,488,750) — (15,236,723) —
applicable to common $ 3,910,968 $ (2,678,054) $ (64,784,365) $ (22,769,893)
Net income/(loss) per $ 0.18 $ (0.12) $ (2.95) $ (1.06)
shares used in
computing net 22,001,891 21,778,812 21,925,200 21,557,062
Net income/(loss) per $ 0.02 $ (0.12) $ (2.95) $ (1.06)
shares used in
computing net 172,472,705 21,778,812 21,925,200 21,557,062
Talon Therapeutics, Inc.
Investor Relations Team
Talon Therapeutics, Inc. Logo
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