SOUTH SAN FRANCISCO, Calif.,
Nov. 14, 2019 /PRNewswire/
-- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today reported
financial results for the third quarter ended September 30, 2019 and provided an update on its
business.
Third Quarter 2019 and Recent Business Highlights
- In July 2019, Titan announced a
specialty product distribution agreement for Probuphine®
(buprenorphine) implants with CVS Caremark, a subsidiary of CVS
Health.
- In August 2019, Titan completed a
$2.1 million offering resulting in
net cash proceeds of approximately $1.8
million.
- In September, 2019, the National Institutes of Health's
National Institute on Drug Abuse ("NIDA") approved approximately
$6.1 million in second-year funding
for Titan's non-clinical development of a ProNeura™ based six-month
implantable formulation of Nalmefene, an opioid antagonist,
intended for the prevention of relapse to opioid addiction,
following opioid detoxification.
- In October 2019, Titan announced
that Crossroads of Southern Nevada
rehabilitation facility began offering Probuphine for use in
eligible patients with Opioid Use Disorder ("OUD").
- In October 2019, Titan completed
a $9.1 million offering resulting in
net cash proceeds of approximately $8.1
million.
- In October 2019, Titan presented
two posters on its Probuphine implant at the 10th
American Conference on Pharmacometrics.
"This quarter, we continued to make important progress on the
commercial activities for Probuphine by expanding the specialty
product distribution network and implementing the patient portal to
enhance the capabilities of the product order processing hub," said
Titan's President and CEO, Sunil
Bhonsle. "We have also been engaged in addressing the
company's capital needs and raised gross proceeds of approximately
$11.2 million from two financings,
which enables us to expand our commercial efforts in select market
segments, including potential partnering with other companies if
possible."
Probuphine is indicated for the maintenance treatment of opioid
dependence in eligible patients. Please see full indication
below.
Titan's Executive Chairman, Dr. Marc
Rubin, commented, "While our recent financing has provided
the requisite resources to execute additional components of our
growth plan, we are also continuing to opportunistically improve
our overall cost structure in order to further extend our cash
runway. The recent receipt of a second year of NIDA funding for our
Nalmefene program was a very positive development, as it enables us
to progress the program toward the clinic while continuing to focus
our resources on the achievement of commercial success with
Probuphine. Also, in collaboration with other companies or
institutions, we are exploring opportunities for the use of our
ProNeura platform technology in additional important medical
applications, including chronic pain and malaria prophylaxis, and
just starting a non-clinical feasibility study to evaluate the
long-term delivery of CBD."
Third Quarter 2019 Financial Results
For the three months ended September 30,
2019, Titan reported approximately $0.9 million in total revenues, which reflect
approximately $0.2 million in product
revenues and approximately $0.8
million of grant revenues. This compared with total revenues
of approximately $1.7 million in the
same period in 2018. The decrease was primarily related to one-time
payments in 2018 from license agreements associated with
Probuphine, which were partially offset by 2019 grant revenue.
Total operating expenses for the third quarter of 2019 were
approximately $4.8 million, compared
with approximately $3.6 million in
the same quarter in 2018, 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 third quarter of 2019 were
approximately $1.6 million, compared
with approximately $1.9 million in
the same quarter in 2018. The decrease was primarily due to
approximately $0.6 million of lower
R&D expenses related to Probuphine and approximately
$0.2 million of lower expenses
related to employee compensation; partially offset by approximately
$0.5 million of higher R&D
expenses related to the Nalmefene product development program,
which were partially reimbursed under the NIDA grant.
SG&A expenses for the 2019 third quarter were approximately
$3.0 million, compared with
approximately $1.5 million in the
same quarter a year ago. The increase in SG&A expenses for the
three months ended September 30, 2019
was primarily attributable to increases in employee-related
expenses of approximately $0.5
million, expenses related to consulting, professional and
outside services of approximately $0.8
million and expenses related to facilities and travel of
approximately $0.2 million.
Costs of goods sold, which reflects product costs and other
distribution expenses associated with sales of Probuphine, were
approximately $0.2 million for both
quarters ended September 30, 2019 and
2018.
Net other income was approximately $1.1
million for the three month period ended September 30, 2019, compared with net other
expense of approximately $0.1 million
in the same quarter a year ago. The increase was primarily
attributable to an approximately $1.0
million non-cash gain on changes in the fair value of
warrants issued in connection with the August 2019 offering and an approximately
$0.3 million non-cash gain on debt
extinguishment associated with the modification of the Molteni
convertible loan.
Net loss applicable to common shareholders in the third quarter
of 2019 was approximately $2.8
million, or approximately $0.18 per share, compared with a net loss
applicable to common shareholders of approximately $2.3 million, or approximately $0.64 per share, in the same quarter in 2018.
As of September 30, 2019, Titan
had cash and cash equivalents of approximately $0.9 million. Titan believes that its cash and
cash equivalents as of September 30,
2019, along with the approximately $8.1 million of net cash proceeds from the public
offering completed in October 2019,
will be sufficient to fund its operations into the third quarter of
2020.
Conference Call Details
Titan management will host a conference call today at
4:30 p.m. ET 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; Dane Hallberg,
Executive Vice President and Chief Commercial Officer; Brian Crowley, Vice President of Finance; 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 9174896. 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
WARNING: COMPLICATIONS FROM INSERTION AND
REMOVAL OF PROBUPHINE
See Full Prescribing Information
for complete Boxed Warning
Serious complications may happen from insertion and
removal of PROBUPHINE, including:
- Nerve or blood vessel injury in your arm
- Movement of implant (migration). PROBUPHINE or pieces of it can
move into blood vessels, possibly to your lung, and could lead to
death
- Implant sticks out of the skin (protrusion)
- Implant comes out by itself (expulsion)
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
TITAN
PHARMACEUTICALS, INC.
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(in thousands,
except per share amount)
|
(unaudited)
|
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenue:
|
|
|
|
|
|
|
|
|
License
revenue
|
$
-
|
|
$
1,406
|
|
$
313
|
|
$
5,063
|
|
Product
revenue
|
190
|
|
244
|
|
811
|
|
318
|
|
Grant
revenue
|
757
|
|
-
|
|
1,270
|
|
-
|
|
|
Total
revenue
|
947
|
|
1,650
|
|
2,394
|
|
5,381
|
|
|
|
|
|
|
|
|
|
|
Operating
expense:
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
188
|
|
178
|
|
738
|
|
248
|
|
Research and
development
|
1,619
|
|
1,910
|
|
5,370
|
|
5,623
|
|
Selling, general and
administrative
|
3,023
|
|
1,514
|
|
9,336
|
|
4,508
|
|
|
Total operating
expense
|
4,830
|
|
3,602
|
|
15,444
|
|
10,379
|
Loss from
operations
|
(3,883)
|
|
(1,952)
|
|
(13,050)
|
|
(4,998)
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
1,080
|
|
(93)
|
|
533
|
|
(521)
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
$ (2,803)
|
|
$(2,045)
|
|
$ (12,517)
|
|
$ (5,519)
|
|
|
|
|
|
|
|
|
|
|
Deemed dividend on
trigger of down round provision
|
-
|
|
(285)
|
|
-
|
|
(285)
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
(2,803)
|
|
(2,330)
|
|
(12,517)
|
|
(5,804)
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per
common share
|
$
(0.18)
|
|
$
(0.64)
|
|
$
(0.89)
|
|
$
(1.62)
|
|
|
|
|
|
|
|
|
|
|
Diluted net loss per
common share
|
$
(0.18)
|
|
$
(0.68)
|
|
$
(0.89)
|
|
$
(1.66)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic and diluted net loss per
share
|
15,517
|
|
3,650
|
|
14,112
|
|
3,573
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
$
921
|
|
$
9,295
|
|
Restricted
cash
|
-
|
|
361
|
|
Receivables
|
775
|
|
1,737
|
|
Inventory
|
1,309
|
|
1,262
|
|
Contract
assets
|
-
|
|
99
|
|
Prepaid expenses and
other current assets
|
941
|
|
547
|
|
|
Total current
assets
|
3,946
|
|
13,301
|
|
Property and
equipment, net
|
752
|
|
794
|
|
Operating lease
right-of-use asset
|
456
|
|
-
|
|
Deferred offering
costs
|
150
|
|
-
|
|
|
Total
assets
|
$
5,304
|
|
$14,095
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
|
Current
liabilities
|
$
3,482
|
|
$
3,452
|
|
Operating lease
liability, non-current
|
222
|
|
-
|
|
Long-term debt,
non-current
|
3,872
|
|
3,787
|
|
Warrant
liability
|
388
|
|
-
|
|
Derivative
liability
|
-
|
|
25
|
|
Stockholders' equity
(deficit)
|
(2,660)
|
|
6,831
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
$
5,304
|
|
$14,095
|
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SOURCE Titan Pharmaceuticals, Inc.