– VONJO® (pacritinib) net product
revenue of $12.3 million in the
second quarter –
– Management to host conference call today at
4:30 p.m. ET –
SEATTLE, Aug. 8, 2022
/PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today reported
its financial results for the second quarter ended June 30, 2022.
"CTI continues to make substantial headway with the U.S.
commercial launch of VONJO, as we work to become the market leader
in the treatment of cytopenic myelofibrosis. In the second quarter,
we have performed well generating net product revenue of
$12.3 million," said Adam Craig, President and Chief Executive
Officer of CTI BioPharma. "With a differentiated profile, VONJO is
a simple, safe and effective treatment that is a meaningful
alternative to existing therapies. We look forward to extending the
reach of VONJO over the coming months and years."
Recent Accomplishments and Updates
- VONJO listed as recommended treatment in the National
Comprehensive Cancer Network®
(NCCN®) Clinical Practice Guidelines in Oncology
for Myeloproliferative Neoplasms, as a first-line treatment for
high-risk patients with myelofibrosis with platelet counts <50 x
109/L who are not candidates for transplant, and as a
second-line treatment for lower-risk and higher-risk patients with
myelofibrosis with platelet counts ≥50 x 109/L who are
not candidates for transplant.
- Planned data presentations at international medical meetings by
end of year that demonstrate pacritinib's activity as a potent
ACVR1/ALK2 inhibitor as well as data on pacritinib's substantial
anemia benefit in myelofibrosis.
- Data presented at the European Hematology Association (EHA)
2022 Congress demonstrating that full dose pacritinib achieved
higher response rates and a similar, manageable safety profile
compared to lower-dose ruxolitinib in patients with myelofibrosis
who have moderate or severe thrombocytopenia.
- Data presented at the 2022 American Society of Clinical
Oncology (ASCO) Annual Meeting demonstrating the safety profile of
pacritinib 200 mg twice a day is comparable to best available
therapy, including ruxolitinib, and that pacritinib 200 mg twice
daily could be a full-dose therapeutic option for patients with
myelofibrosis, including those who experience severe
thrombocytopenia.
- Filing of patent term extension application for the composition
of matter U.S. Patent No. 8,153,632, with a requested five-year
extension, which, if granted, would extend the expiration date of
that patent from January 2029 to January 2034.
Second Quarter Financial Results
Net product sales of $12.3 million
and $14.6 million for the three and
six months ended June 30, 2022, respectively, were entirely
attributable to VONJO product sales in the United States. There were no product sales
for the comparable periods in 2021. Operating loss was $18.9 million and $19.5
million for the three months ended June 30, 2022 and 2021,
respectively, and $54.0 million and
$36.6 million for the six months
ended June 30, 2022 and 2021, respectively. The decrease in
operating loss between the three-month periods ended June 30, 2022
and 2021 was primarily attributable to net product sales, offset by
an increase in selling, general and administrative activities
related to the commercial launch of VONJO. The increase in
operating loss between the six-month periods ended June 30, 2022
and 2021 resulted primarily from an increase in selling, general
and administrative activities related to the commercial launch of
VONJO, as well as a $10.3 million
milestone expense related to FDA approval of VONJO, which was
included in other operating expenses.
Net loss for the three months ended June 30, 2022 was
$22.7 million, or $0.21 for basic and diluted loss per share,
compared to net loss of $19.7
million, or $0.21 for basic
and diluted loss per share, for the same period in 2021. Net loss
for the six months ended June 30, 2022 was $59.8 million, or $0.57 for basic and diluted loss per share,
compared to net loss of $36.9
million, or $0.44 for basic
and diluted loss per share, for the same period in 2021.
As of June 30, 2022, our cash, cash equivalents and short-term
investments totaled $95.9 million. We
expect our present financial resources, along with expected cash
receipts from net product sales of VONJO and up to $25.0 million in contractual funding commitments
receivable upon achievement of minimum net product sales of VONJO
under the terms of the previously-announced debt and royalty
transactions with DRI Healthcare Trust, will enable us to fund our
operations for at least one year.
Conference Call and Webcast
CTI will host a conference call and webcast to review its second
quarter 2022 financial results and provide an update on business
activities today, August 8, 2022, at 4:30 p.m. ET. To access the
live call by phone please dial (888) 317-6003 (domestic), (855)
669-9657 (Canada) or (412)
317-6061 (international); the conference ID is 0078819. A live
audio webcast of the event may also be accessed through the
"Investors" section of CTI's website at www.ctibiopharma.com. A
replay of the webcast will be available for 30 days following the
event.
About VONJO (pacritinib)
Pacritinib is an oral kinase inhibitor with activity against
wild type Janus Associated Kinase 2 (JAK2), mutant
JAK2V617F form and FMS-like tyrosine kinase 3 (FLT3),
which contribute to signaling of a number of cytokines and growth
factors that are important for hematopoiesis and immune function.
Myelofibrosis is often associated with dysregulated JAK2 signaling.
Pacritinib has higher inhibitory activity for JAK2 over other
family members, JAK3 and TYK2. At clinically relevant
concentrations, pacritinib does not inhibit JAK1. Pacritinib
exhibits inhibitory activity against additional cellular kinases
(such as CSF1R and IRAK1), the clinical relevance of which is
unknown.
VONJO is indicated for the treatment of adults with intermediate
or high-risk primary or secondary (post-polycythemia vera or
post-essential thrombocythemia) myelofibrosis with a platelet count
below 50 × 109/L. This indication is approved under
accelerated approval based on spleen volume reduction. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial(s).
Important VONJO Safety Information
Hemorrhage:
Serious (11%) and fatal (2%) hemorrhages have occurred in
VONJO-treated patients with platelet counts <100 ×
109/L. Serious (13%) and fatal (2%) hemorrhages have
occurred in VONJO-treated patients with platelet counts <50 ×
109/L. Grade ≥3 bleeding events (defined as requiring
transfusion or invasive intervention) occurred in 15% of patients
treated with VONJO compared to 7% of patients treated on the
control arm. Due to hemorrhage, VONJO dose reductions, dose
interruptions, or permanent discontinuations occurred in 3%, 3%,
and 5% of patients, respectively.
Avoid use of VONJO in patients with active bleeding and hold
VONJO seven days prior to any planned surgical or invasive
procedures. Assess platelet counts periodically, as clinically
indicated. Manage hemorrhage using treatment interruption and
medical intervention.
Diarrhea:
VONJO causes diarrhea in approximately 48% of patients compared
to 15% of patients treated on the control arm. The median time to
resolution in VONJO-treated patients was two weeks. The incidence
of reported diarrhea decreased over time, with 41% of patients
reporting diarrhea in the first eight weeks of treatment, 15% in
weeks 8 through 16, and 8% in weeks 16 through 24. Diarrhea
resulted in treatment interruption in 3% of VONJO-treated patients.
None of the VONJO-treated patients reported diarrhea that resulted
in treatment discontinuation. Serious diarrhea adverse reactions
occurred in 2% of patients treated with VONJO compared to no such
adverse reactions in patients in the control arm.
Control pre-existing diarrhea before starting VONJO treatment.
Manage diarrhea with antidiarrheal medications, fluid replacement,
and dose modification. Treat diarrhea with antidiarrheal
medications promptly at the first onset of symptoms. Interrupt or
reduce VONJO dose in patients with significant diarrhea despite
optimal supportive care.
Thrombocytopenia:
VONJO can cause worsening thrombocytopenia. VONJO dosing was
reduced due to worsening thrombocytopenia in 2% of patients with
pre-existing moderate to severe thrombocytopenia (platelet count
<100 × 109/L). VONJO dosing was reduced due to
worsening thrombocytopenia in 2% of patients with pre-existing
severe thrombocytopenia (platelet count <50 ×
109/L).
Monitor platelet count prior to VONJO treatment and as
clinically indicated during treatment. Interrupt VONJO in patients
with clinically significant worsening of thrombocytopenia that
lasts for more than seven days. Restart VONJO at 50% of the last
given dose once the toxicity has resolved. If toxicity recurs hold
VONJO. Restart VONJO at 50% of the last given dose once the
toxicity has resolved.
Prolonged QT interval:
VONJO can cause prolongation of the QTc interval. QTc
prolongation of >500 msec was higher in VONJO-treated
patients than in patients in the control arm (1.4% vs 1%). QTc
increase from baseline by 60 msec or higher was greater in
VONJO-treated patients than in control arm patients (1.9% vs 1%).
Adverse reactions of QTc prolongation were reported for 3.8% of
VONJO-treated patients and 2% of control arm patients. No cases of
torsades de pointes were reported.
Avoid use of VONJO in patients with a baseline QTc of
>480 msec. Avoid use of drugs with significant potential for QTc
prolongation in combination with VONJO. Correct hypokalemia prior
to and during VONJO treatment. Manage QTc prolongation using VONJO
interruption and electrolyte management.
Major Adverse Cardiac Events (MACE):
Another JAK)-inhibitor has increased the risk of MACE, including
cardiovascular death, myocardial infarction, and stroke (compared
to those treated with TNF blockers) in patients with rheumatoid
arthritis, a condition for which VONJO is not indicated.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with VONJO, particularly in
patients who are current or past smokers and patients with other
cardiovascular risk factors. Patients should be informed about the
symptoms of serious cardiovascular events and the steps to take if
they occur.
Thrombosis:
Another JAK-inhibitor has increased the risk of thrombosis,
including deep venous thrombosis, pulmonary embolism, and arterial
thrombosis (compared to those treated with TNF blockers) in
patients with rheumatoid arthritis, a condition for which VONJO is
not indicated.
Patients with symptoms of thrombosis should be promptly
evaluated and treated appropriately.
Secondary Malignancies:
Another JAK-inhibitor has increased the risk of lymphoma and
other malignancies, excluding non-melanoma skin cancer (NMSC)
(compared to those treated with TNF blockers), in patients with
rheumatoid arthritis, a condition for which VONJO is not indicated.
Patients who are current or past smokers are at additional
increased risk.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with VONJO, particularly in
patients with a known malignancy (other than a successfully-treated
NMSC), patients who develop a malignancy, and patients who are
current or past smokers.
Risk of Infection:
Another JAK-inhibitor has increased the risk of serious
infections compared to best available therapy (BAT) in patients
with myeloproliferative neoplasms. Serious bacterial,
mycobacterial, fungal and viral infections may occur in patients
treated with VONJO. Delay starting therapy with VONJO until active
serious infections have resolved. Observe patients receiving VONJO
for signs and symptoms of infection and manage promptly. Use active
surveillance and prophylactic antibiotics according to clinical
guidelines.
Interactions with CYP3A4 Inhibitors or Inducers:
Co-administration of VONJO with strong CYP3A4 inhibitors or
inducers is contraindicated. Avoid concomitant use of VONJO with
moderate CYP3A4 inhibitors or inducers.
Drug interruptions due to an adverse reaction occurred in 27%
patients who received VONJO 200 mg twice daily compared to 10% of
patients treated with BAT. Dosage reductions due to an adverse
reaction occurred in 12% of patients who received VONJO 200 mg
twice daily compared to 7% of patients treated with BAT. Permanent
discontinuation due to an adverse reaction occurred in 15% of
patients receiving VONJO 200 mg twice daily compared to 12% of
patients treated with BAT.
Please
visit http://www.ctibiopharma.com/vonjo_prescribing_information for
full Prescribing Information and the Medication Guide.
About Myelofibrosis
Myelofibrosis is bone marrow cancer that results in formation of
fibrous scar tissue and can lead to thrombocytopenia and anemia,
weakness, fatigue and an enlarged spleen and liver. Within
the United States, there are
approximately 21,000 patients with myelofibrosis, 7,000 of which
have severe thrombocytopenia (defined as blood platelet counts of
less than 50 x109/L). Severe thrombocytopenia is
associated with poor survival and high symptom burden and can occur
as a result of disease progression or from drug toxicity with other
JAK2 inhibitors, such as JAKAFI and INREBIC.
About CTI BioPharma Corp.
We are a commercial biopharmaceutical company focused on the
acquisition, development and commercialization of novel targeted
therapies for blood-related cancers that offer a unique benefit to
patients and their healthcare providers. CTI has one FDA-approved
product, VONJO® (pacritinib), a JAK2 and IRAK1
inhibitor, that spares JAK1. VONJO is approved for the treatment of
adults with intermediate- or high-risk primary or secondary
(post-polycythemia vera or post-essential thrombocythemia)
myelofibrosis with a platelet count below 50 × 109/L.
This indication is approved under FDA accelerated approval based on
spleen volume reduction. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in a confirmatory trial(s). CTI is conducting the Phase 3 PACIFICA
study of VONJO in patients with myelofibrosis and severe
thrombocytopenia as a post-marketing requirement.
VONJO® is a registered trademark of CTI
BioPharma Corp.
Forward-Looking Statements
Statements included in this press release that are not
historical in nature are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, and the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are based on current assumptions that involve risks,
uncertainties and other factors that may cause the actual results,
events or developments to be materially different from those
expressed or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to: our
ability to successfully commercialize VONJO and generate future
revenues with respect to VONJO; our limited experience in
generating revenue from product sales; the accuracy of our
assumptions regarding our planned expenditures and sufficiency of
our cash to fund operations; risks and uncertainties related to the
COVID-19 pandemic as it relates to our operations and ongoing
clinical trials; and those risks more fully discussed in the
section entitled "Risk Factors" in our Annual Report on Form 10-K
for the year ended December 31, 2021
and subsequent quarterly reports on Form 10-Q. These
forward-looking statements speak only as of the date hereof and we
assume no obligation to update these forward-looking statements,
and readers are cautioned not to place undue reliance on such
forward-looking statements. "CTI BioPharma" and the CTI BioPharma
logo are registered trademarks or trademarks of CTI BioPharma Corp.
in various jurisdictions. All other trademarks belong to their
respective owner.
CTI BioPharma Investor Contacts:
Argot Partners
+212-600-1902
cti@argotpartners.com
(tables follow)
CTI BioPharma
Corp.
Condensed Statements of
Operations
(In thousands, except
per share amounts)
(unaudited)
|
|
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Net product
sales
|
$ 12,329
|
|
$
—
|
|
$ 14,624
|
|
$
—
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of
sales
|
917
|
|
—
|
|
1,195
|
|
—
|
Research and
development
|
8,705
|
|
9,293
|
|
16,753
|
|
18,737
|
Selling, general and
administrative
|
21,590
|
|
10,213
|
|
39,636
|
|
17,839
|
Other operating
expenses
|
—
|
|
—
|
|
11,023
|
|
—
|
Total operating costs
and expenses
|
31,212
|
|
19,506
|
|
68,607
|
|
36,576
|
Loss from
operations
|
(18,883)
|
|
(19,506)
|
|
(53,983)
|
|
(36,576)
|
Non-operating
expenses:
|
|
|
|
|
|
|
|
Interest expense,
net
|
(3,761)
|
|
(167)
|
|
(5,824)
|
|
(354)
|
Foreign exchange
loss
|
(10)
|
|
(2)
|
|
(22)
|
|
(11)
|
Total non-operating
expenses
|
(3,771)
|
|
(169)
|
|
(5,846)
|
|
(365)
|
Net loss
|
$ (22,654)
|
|
$ (19,675)
|
|
$ (59,829)
|
|
$ (36,941)
|
Basic and diluted net
loss per common share
|
$
(0.21)
|
|
$
(0.21)
|
|
$
(0.57)
|
|
$
(0.44)
|
Shares used in
calculation of basic and diluted net loss per common
share:
|
108,529
|
|
92,341
|
|
104,205
|
|
84,398
|
|
|
|
Balance Sheet Data
(unaudited):
|
(amounts in
thousands)
|
|
June
30,
|
|
December 31,
|
|
2022
|
|
2021
|
Cash and cash
equivalents
|
$
66,091
|
|
$
65,446
|
Short-term
investments
|
29,779
|
|
—
|
Accounts receivable,
net
|
8,159
|
|
—
|
Working
capital
|
77,583
|
|
1,728
|
Total assets
|
134,534
|
|
72,434
|
Current portion of
long-term debt
|
—
|
|
47,380
|
Total stockholders'
(deficit) equity
|
(5,274)
|
|
3,767
|
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SOURCE CTI BioPharma Corp.