SOUTH SAN FRANCISCO, Calif.,
Aug. 14, 2020 /PRNewswire/ -- Titan
Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company")
today reported financial results for the second quarter ended
June 30, 2020 and provided an update
on its business.
Second Quarter 2020 Highlights
- In June 2020, Titan initiated a
fully-virtual Probuphine® (buprenorphine) implant Risk Evaluation
and Mitigation Strategy ("REMS") training and certification program
for qualified health care providers ("HCPs") who treat patients
with Opioid Use Disorder ("OUD").
- In June 2020, the Company entered
into a co-promotion partnership with Indegene, Inc., a leading
healthcare solutions company, to establish multichannel digital
marketing programs throughout the United
States to increase awareness of Probuphine as a long-term
maintenance treatment for OUD, and expand the capabilities for the
engagement of HCPs who can be certified to prescribe Probuphine to
eligible patients.
- Since January 1, 2020, Titan
received proceeds of approximately $7.0
million as a result of the exercise of previously issued
common stock purchase warrants.
COVID-19 Impact and Adjusted Probuphine Commercial
Strategy
Early this year, Titan implemented its staffing plans for
expanded commercial operations with additions to its sales and
medical liaison teams, including support from additional marketing
and medical access staff to enable improved coverage across all 50
states and Puerto Rico.
Unfortunately, the COVID-19 pandemic-related shelter in place and
social distancing restrictions and minimized personal
physician/patient interaction have hindered the full effectiveness
of the commercial team. In order to try and mitigate the impact of
the ongoing public health crisis, Titan has undertaken a number of
key activities during this period, including:
- Training the commercial team in utilizing digital communication
techniques to establish relationships with existing and new HCPs
and their staff;
- Providing Probuphine information in electronic format for ease
of virtual communication for HCPs to use with their patients and to
highlight the potential benefits of Probuphine as a treatment
modality in the increasing telemedicine environment;
- Establishing a social media presence in select geographies to
increase awareness of Probuphine and enhance its share of voice in
the OUD medication assisted treatment space;
- Rapidly developing and obtaining FDA approval to implement a
virtual REMS training program to certify HCPs during this period;
and
- Seeking partnering opportunities to increase the commercial
capabilities in support of Probuphine.
"We continue to adapt to this ever-changing pandemic
environment, and thanks to our dedicated staff, we are making
progress," said Titan's President and CEO, Sunil Bhonsle. "We are pleased with the FDA's
prompt approval of our fully-virtual REMS training program, which
enables us to continue to certify HCPs to prescribe and administer
Probuphine, facilitating access to our six-month maintenance
treatment option for eligible patients with OUD. Our commercial
team continues to focus on digital outreach to establish
relationships with the medical community and to inform HCPs, their
staff and their patients of the potential benefits of Probuphine,
particularly at a time when patient/physician interactions are
limited. Following a substantial decline in the number of patient
enrollments for Probuphine treatment during the first two months of
the quarter, clinics in certain regions began to see an increase in
enrollments in June, which has continued. We believe this is an
early indication that the efforts of our commercial team are
working and we look forward to continued progress in the coming
months."
Probuphine is indicated for the maintenance treatment of OUD in
eligible patients.
Please see Full Indication and Important Safety Information
below, and link below to Full Prescribing Information.
"Our goal is to increase the use of Probuphine for the
maintenance treatment of OUD, and in the current environment, our
recently established co-promotion partnership with Indegene is
timely," said Titan's Executive Chairman, Dr. Marc Rubin. "With the support of our commercial
team, Indegene's capabilities provide Titan with sophisticated
multichannel marketing tools, predictive analytics and social media
campaigns that will be critical to expanding our outreach to the
medical community and patients. The first virtual nationwide
outreach campaign commenced last week, and the Titan-Indegene team
is looking forward to continuing the implementation of a
comprehensive program over the next few months. During the third
quarter we will also implement a three-month program to seek and
assist patients who may be suitable for treatment with Probuphine
and connect them with REMS-certified HCPs. I want to emphasize that
our progress can be sustained only if our stockholders approve the
proposal to increase the authorized shares at our special
stockholder meeting scheduled for August 31,
2020.
"In addition, Sunil has expressed his desire to retire,
hopefully by the end of the year. To prepare for this transition,
and contingent on our ability to raise additional capital, we will
look for a successor with experience in the commercial space, as we
continue our transition to a commercial-stage company."
Second Quarter 2020 Financial Results
For the three months ended June 30,
2020, Titan reported approximately $1.3 million in revenue, which reflects
approximately $0.1 million in product
sales and approximately $1.2 million
related to the Company's National Institute on Drug Abuse ("NIDA")
grant. This compared with revenues of approximately $0.5 million in the same period in 2019, which
was comprised of $0.3 million in
product sales and $0.2 million
related to the NIDA grant. Product revenue during the quarter ended
June 30, 2020 declined substantially
from the comparable period in 2019 due to substantial decreases in
unit sales volumes, increased utilization of our patient assistance
programs and the COVID-19 pandemic and the related shelter in place
restrictions and clinic closures. Also, the second quarter of 2019
unit sales volume included initial purchases by a specialty
pharmacy.
Total operating expenses for the second quarter of 2020 were
approximately $5.7 million,
compared with approximately $5.4
million from the same quarter in 2019, and consisted
primarily of research and development ("R&D") and selling,
general and administrative ("SG&A") expenses and costs of goods
sold, inclusive of distribution expenses. R&D expenses for the
quarter ended June 30, 2020 were
approximately $2.0 million,
compared to approximately $1.9
million in the same three month period in 2019. SG&A
expenses for the 2020 second quarter were approximately
$3.5 million, compared with
approximately $3.2 million in the
same quarter a year ago. Costs of goods sold for the second quarter
of 2020 were approximately $0.2
million, consistent with the 2019 second quarter.
Net other expense, consisting primarily of interest expense, was
approximately $0.3 million in
the second quarter of 2020, consistent with the second quarter of
2019.
Net loss applicable to common stockholders in the second quarter
of 2020 was approximately $4.6
million, or approximately $0.05 per share, compared with a net loss
applicable to common stockholders of approximately $5.2 million, or approximately $0.38 per share, in the same quarter in 2019.
As of June 30, 2020, Titan had
cash and cash equivalents of approximately $5.5 million, which the Company believes are
sufficient to fund planned operations through the third quarter of
2020.
Conference Call Details
Titan management will host a conference call today at
12:00 p.m. ET / 9:00 a.m. PT to review these financial results
and discuss business developments in the period. The conference
call will be hosted by Sunil
Bhonsle, President and CEO; Kate
Beebe DeVarney, Ph.D., Executive Vice President and Chief
Scientific Officer; Brian Crowley,
Vice President of Finance; Joe
Schrei, Executive Director, Commercial Operations;
Mike Fritz, National Sales Director;
and Marc Rubin, M.D., Executive
Chairman.
The live conference call may be accessed by dialing
1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and
providing passcode 8493149. The call will also be broadcast live
and archived on Titan's website at www.titanpharm.com/news/events.
About Probuphine
Probuphine is the only subdermal implant designed to deliver
buprenorphine continuously for six months following insertion.
Probuphine was developed using ProNeura®, the continuous drug
delivery system developed by Titan that consists of a small, solid
implant made from a mixture of ethylene-vinyl acetate and a drug
substance. The resulting construct is a solid matrix that is placed
subdermally, normally in the upper inner arm in an outpatient
office procedure and removed in a similar manner at the end of the
treatment period. The U.S. Food and Drug Administration ("FDA")
approved Probuphine in May 2016, and
it is the first and only buprenorphine implant available for the
maintenance treatment of opioid addiction in eligible patients.
IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED
WARNING
INDICATION
PROBUPHINE is an implant that contains the medicine
buprenorphine. PROBUPHINE is used to treat certain adults who are
addicted to (dependent on) opioid drugs (either prescription or
illegal). PROBUPHINE is indicated for the maintenance treatment of
opioid dependence in patients who have achieved and sustained
prolonged clinical stability on low-to-moderate doses (doses no
more than 8 mg per day) of a buprenorphine-containing product.
PROBUPHINE is part of a complete treatment program that also
includes counseling and behavioral therapy.
It is not known if PROBUPHINE is safe or effective in children
less than 16 years of age.
IMPORTANT SAFETY INFORMATION
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WARNING:
COMPLICATIONS FROM INSERTION AND REMOVAL OF
PROBUPHINE
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See Full
Prescribing Information for complete Boxed Warning
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Serious
complications may happen from insertion and removal of
PROBUPHINE, including:
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Nerve or blood vessel
injury in your arm
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Movement of implant
(migration). PROBUPHINE or pieces of it can move into blood
vessels, possibly to your lung, and could lead to death
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Implant sticks out of
the skin (protrusion)
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Implant comes out by
itself (expulsion)
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Call your healthcare provider right away if:
- PROBUPHINE sticks out of the skin or comes out by itself
- You have bleeding or symptoms of infection at the site after
insertion or removal, including excessive or worsening itching,
pain, irritation, redness, or swelling
- You have numbness or weakness in your arm after the insertion
or removal procedure
- You have weakness or numbness in your arm, or shortness of
breath
If the implant comes out by itself, keep it away from others,
especially children, as it may cause severe difficulty in breathing
and possibly death.
Because of the risk of complications of, migration, protrusion,
expulsion and nerve injury with insertion and removal of
PROBUPHINE, it is only available through a restricted program
called the PROBUPHINE REMS Program. Healthcare providers who
prescribe and/or insert PROBUPHINE must be certified with the
program by enrolling and completing live training.
- PROBUPHINE is not available in retail pharmacies
- PROBUPHINE must be inserted or removed only in the facility of
the certified prescriber
Implants may be difficult to locate if inserted too deeply, if
you manipulate them, or if you gain significant weight after
insertion. Your healthcare provider may do special procedures
or tests, or refer you to a surgical specialist to remove the
implants if they are difficult to locate.
The medicine in PROBUPHINE can cause serious and
life-threatening problems, especially if you take or use certain
other medicines or drugs. Call your healthcare provider right
away or get emergency help if you:
Feel faint or dizzy, have mental changes such as confusion,
slower breathing than you normally have, severe sleepiness, blurred
vision, problems with coordination, slurred speech, cannot think
well or clearly, high body temperature, slowed reflexes, feel
agitated, stiff muscles or have trouble walking.
These can be signs of an overdose or other serious
problems.
Coma or death can happen if you take anxiety medicines or
benzodiazepines, sleeping pills, tranquilizers, or sedatives,
antidepressants, or antihistamines, or drink alcohol during
treatment with PROBUPHINE. Tell your healthcare provider if you are
taking any of these medicines or if you drink alcohol.
Who should not use PROBUPHINE?
Do not use PROBUPHINE if you are allergic to buprenorphine or
any of its ingredients, this includes buprenorphine hydrochloride
and the inactive ingredient ethylene vinyl acetate or EVA.
PROBUPHINE may not be right for you. Before starting
PROBUPHINE tell your doctor about all of your medical conditions,
including:
Trouble breathing or lung problems, an enlarged prostate gland
(men), a head injury or brain problem, problems urinating, a curve
in your spine that affects your breathing, liver problems,
gallbladder or adrenal gland problems, Addison's disease, low
thyroid hormone levels (hypothyroidism), a history of alcoholism, a
history of keloid formation, connective tissue disease (such as
scleroderma), or history of MRSA infections, mental problems such
as hallucinations, an allergy to numbing medicines or medicines
used to clean your skin, are pregnant or plan to become pregnant or
are breastfeeding or plan to breastfeed.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements.
What should I avoid while being treated with
PROBUPHINE?
- Do not drive, operate heavy machinery, or perform any other
dangerous activities until you know how this medication affects
you
- You should not drink alcohol during treatment. You
should not take anxiety medicines or benzodiazepines, sleeping
pills, tranquilizers, or sedatives that are not prescribed to you
during treatment with PROBUPHINE, as this can lead to slowed
breathing, drowsiness, delayed reaction time, loss of consciousness
or even death
What are the possible side effects of PROBUPHINE?
PROBUPHINE can cause serious side effects, including:
- Infection at the insertion or removal
site. Infection may happen at the implant site during
insertion or removal. Do not try to remove PROBUPHINE implants
yourself
- Opioid withdrawal. If PROBUPHINE comes out of your
arm or if you stop treatment, tell your doctor right away as you
can have symptoms of shaking, sweating more than normal, feeling
hot or cold more than normal, runny nose, watery eyes, goose bumps,
diarrhea, vomiting and muscle aches
- Physical dependency
- Liver problems. Call your doctor right away if you
notice signs of liver problems that may include your skin or the
white part of your eyes turning yellow (jaundice)
- Allergic reaction. If you get a rash, hives,
itching, swelling of your face, or wheezing, low blood pressure,
dizziness or decrease in consciousness
- Decrease in blood pressure. You may feel dizzy when you
get up from sitting or lying down
- Sleep Apnea. Call your doctor right away if you or
someone close to you notices: Observed episodes of stopped
breathing or abnormal breathing patterns during sleep
Tell your healthcare provider if you develop any of the
symptoms listed.
Common side effects of PROBUPHINE include: Headache,
nausea, toothache, constipation, depression, vomiting, back pain,
mouth and throat pain.
Common risks with the minor surgical procedure:
Itching, pain, irritation, redness, swelling, bleeding, or bruising
at the insertion or removal site. Scarring around the insertion
site.
Please read Full Prescribing Information,
including BOXED WARNING regarding IMPLANT MIGRATION,
PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION
AND REMOVAL.
Titan encourages you to report negative side effects of
prescription drugs to the FDA. You can
visit www.fda.gov/safety/medwatch/ or call
1-800-FDA-1088.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage
company developing proprietary therapeutics with its
ProNeura® long-term, continuous drug delivery technology.
The Company's lead product is Probuphine® (buprenorphine) implant,
a novel and long-acting formulation of buprenorphine for the
long-term maintenance treatment of opioid dependence. Approved by
the U.S. Food and Drug Administration in May
2016, Probuphine is the first and only commercialized
treatment of opioid dependence to provide continuous,
around-the-clock blood levels of buprenorphine for six months
following a single procedure. The ProNeura technology also has the
potential to be used in developing products for treating other
chronic conditions such as Parkinson's disease and hypothyroidism,
where maintaining consistent, around-the-clock blood levels of
medication may benefit the patient and improve medical outcomes.
For more information about Titan, please visit
www.titanpharm.com.
Forward-Looking Statements
This press release may contain "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. Such statements
include, but are not limited to, any statements relating to our
product development programs and any other statements that are not
historical facts. Such statements involve risks and uncertainties
that could negatively affect our business, operating results,
financial condition and stock price. Factors that could cause
actual results to differ materially from management's current
expectations include those risks and uncertainties relating to the
commercialization of Probuphine; the regulatory approval process;
Titan's ability to access capital; the development, testing,
production and marketing of our drug candidates; patent and
intellectual property matters; and strategic agreements and
relationships. We expressly disclaim any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in our expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as
required by law.
CONTACTS:
Sunil Bhonsle
President & CEO
(650) 244-4990
Stephen Kilmer
Investor Relations
(650) 989-2215
skilmer@titanpharm.com
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TITAN
PHARMACEUTICALS, INC.
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CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
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(in thousands,
except per share amount)
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(unaudited)
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Three Months
Ended
June 30,
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Six Months
Ended
June 30,
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2020
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2019
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2020
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2019
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Revenue:
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License
revenue
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$
6
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$
-
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$
6
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$
313
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Product
revenue
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115
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304
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|
325
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621
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Grant
revenue
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1,204
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198
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2,330
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513
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Total
revenue
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1,325
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502
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2,661
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|
1,447
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Operating
expense:
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Cost of goods
sold
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228
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246
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399
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550
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Research and
development
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2,007
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1,907
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4,284
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3,751
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Selling, general and
administrative
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3,474
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3,231
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6,589
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6,313
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Total operating
expense
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5,709
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5,384
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11,272
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10,614
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Loss from
operations
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(4,384)
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(4,882)
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(8,611)
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(9,167)
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Other expense,
net
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(257)
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(315)
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(1,614)
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(547)
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Net loss and
comprehensive loss
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$
(4,641)
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$
(5,197)
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$
(10,225)
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$
(9,714)
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Basic and diluted net
loss per common share
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$
(0.05)
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$
(0.38)
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$
(0.12)
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$
(0.73)
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Weighted average
shares used in computing
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basic and diluted net
loss per share
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94,930
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13,576
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88,785
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13,397
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CONDENSED BALANCE
SHEETS
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(in
thousands)
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(unaudited)
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June
30,
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December
31,
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2020
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2019
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Assets
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Cash and cash
equivalents
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$
5,498
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$
5,223
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Receivables
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1,061
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993
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Inventory
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969
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998
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Prepaid expenses and
other current assets
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1,162
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1,094
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Total current
assets
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8,690
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8,308
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Property and
equipment, net
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799
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817
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Operating lease
right-of-use asset
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273
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397
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Total
assets
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$
9,762
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$
9,522
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Liabilities and
Stockholders' Equity
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Current
liabilities
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$
4,857
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$
3,600
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Operating lease
liability, non-current
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-
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150
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Long-term debt,
non-current
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3,345
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4,019
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Warrant
liability
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-
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320
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Stockholders'
equity
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1,560
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1,433
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Total liabilities and
stockholders' equity
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$
9,762
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$
9,522
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SOURCE Titan Pharmaceuticals, Inc.