SOUTH SAN FRANCISCO, Calif.,
Nov. 16, 2020 /PRNewswire/
-- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the
"Company") today reported financial results for the third quarter
ended September 30, 2020 and provided
an update on its business.
Third Quarter 2020 and Recent Highlights
- In September 2020, the Company
completed a registered direct offering, resulting in net cash
proceeds of approximately $2.4
million.
- In October 2020, Titan announced
a strategic restructuring, where it will focus on
ProNeura®-based product development; and discontinue its
U.S. Probuphine implant sales and wind down Probuphine
commercialization activities.
- In October 2020, Kate DeVarney, Ph.D., was promoted from the
position of Executive Vice President and Chief Scientific Officer
to President and Chief Operating Officer. In addition, Sunil Bhonsle stepped down from his executive
role. Dr. Marc Rubin, Titan's
Executive Chairman, together with Dr. DeVarney, will oversee the
Company's product development activities.
- In October 2020, Titan completed
a public offering resulting in net cash proceeds of approximately
$5.7 million.
- In October 2020, the Company
settled all of its debt obligations with Molteni & C. dei F.lli
Alitti Società di Esercizio S.p.A and Horizon Credit LLC II.
- In October 2020, Titan acquired
JT Pharmaceuticals, Inc.'s kappa opioid agonist peptide, JT-09, for
use in combination with Titan's ProNeura® long-term,
continuous drug delivery technology, for the treatment of chronic
pruritus.
"Subsequent to the end of the third quarter, Titan began an
important, focused restructuring to position the Company for future
growth," said Dr. DeVarney. "We believe that our ProNeura platform,
which has the potential to provide continuous drug delivery over
extended periods of up to six to 12 months, offers potential key
value-generating opportunities. These include the platform's
application to the recently-acquired JT-09, for which we plan to
establish proof-of-concept as a treatment of chronic pruritus in
the first half of next year. In addition, we remain committed to
helping individuals impacted by the opioid epidemic through our
ongoing, National Institute on Drug Abuse-funded nalmefene implant
development program, with plans to file an investigational New Drug
Application with the U.S. Food and Drug Administration in the first
half of 2021."
"In addition to refocusing our efforts on the ProNeura platform,
our recent restructuring significantly reduced operating expenses,
while our debt settlements restored our ability to fully capitalize
on our IP," said Dr. Rubin. "These, combined with the recent
completion of two financings, positions Titan to execute on our new
strategy."
Third Quarter 2020 Financial Results
For the three months ended September 30,
2020, Titan reported approximately $1.1 million in revenue, which reflects
approximately $0.1 million in product
sales and approximately $1.0 million
related to the Company's National Institute on Drug Abuse ("NIDA")
grant. This compared with revenues of approximately $0.9 million in the same period in 2019, which
was comprised of $0.2 million in
product sales and $0.8 million
related to the NIDA grant. Product revenue during the three month
period ended September 30, 2020
declined from the comparable periods in 2019 due to a substantial
decrease in unit sales volumes; increased utilization of patient
assistance programs; and the effects of the COVID-19 pandemic and
the related shelter-in-place restrictions and clinic
closures.
Total operating expenses for the third quarter of 2020 were
approximately $5.8 million,
compared with approximately $4.8
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 September 30, 2020 were
approximately $1.6 million,
consistent with the same three month period in 2019. SG&A
expenses for the 2020 third quarter were approximately $3.5 million, compared with approximately
$3.0 million in the same quarter a
year ago. Costs of goods sold for the third quarter of 2020 were
approximately $0.7 million, compared
with approximately $0.2 million the
2019 third quarter.
Net other expense, consisting primarily of interest expense, was
approximately $0.3 million in
the third quarter of 2020, compared with net other income of
approximately $1.1 million in the
third quarter of 2019. The increase in other expense, net for the
three months ended September 30, 2020
was primarily due to an approximately $1.0
million non-cash gain on changes in the fair value of
warrants issued in connection with Titan's August 2019 offering and an approximately
$0.3 million non-cash gain on debt
extinguishment related to the modification of Titan's loan from
Molteni.
Net loss applicable to common stockholders in the third quarter
of 2020 was approximately $4.9
million, or approximately $0.05 per share, compared with a net loss
applicable to common stockholders of approximately $2.8 million, or approximately $0.18 per share, in the same quarter in 2019.
As of September 30, 2020, Titan
had cash and cash equivalents of approximately $4.1 million, which the Company believes, along
with the proceeds of public offering, is sufficient to fund planned
operations into the third quarter of 2021.
Conference Call Details
Titan management will host a conference call today at
12:00 p.m. ET / 9:00 a.m. PT to discuss business developments in
the period. The conference call will be hosted by Marc Rubin, M.D., Executive Chairman, and
Kate DeVarney, Ph.D., President and
Chief Operating Officer.
The live conference call may be accessed by dialing
1-888-317-6003 (U.S.) or 1-412-317-6061 (international) and
providing passcode 9502574. The call will also be broadcast live at
https://www.webcaster4.com/Webcast/Page/1655/38848, and archived on
Titan's website at
www.titanpharm.com/news/events.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a development
stage company developing proprietary therapeutics with its
ProNeura® long-term, continuous drug delivery
technology. The ProNeura technology has the potential to be used in
developing products for treating a number of chronic conditions,
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 our
ability to raise capital, the winding down of U.S. commercial
activities related to Probuphine, the regulatory approval process,
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.
CONTACT:
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,
|
|
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
License
revenue
|
|
|
$
-
|
|
$
-
|
|
$
6
|
|
$
313
|
|
Product
revenue
|
|
|
102
|
|
190
|
|
427
|
|
811
|
|
Grant
revenue
|
|
|
1,018
|
|
757
|
|
3,348
|
|
1,270
|
|
|
Total
revenue
|
|
|
1,120
|
|
947
|
|
3,781
|
|
2,394
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expense:
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
683
|
|
188
|
|
1,081
|
|
738
|
|
Research and
development
|
|
|
1,562
|
|
1,619
|
|
5,846
|
|
5,370
|
|
Selling, general and
administrative
|
|
|
3,549
|
|
3,023
|
|
10,137
|
|
9,336
|
|
|
Total operating
expense
|
|
|
5,794
|
|
4,830
|
|
17,064
|
|
15,444
|
Loss from
operations
|
|
|
(4,674)
|
|
(3,883)
|
|
(13,283)
|
|
(13,050)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
|
(258)
|
|
1,080
|
|
(1,874)
|
|
533
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
|
|
$
(4,932)
|
|
$
(2,803)
|
|
$
(15,157)
|
|
$
(12,517)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
|
$
(0.05)
|
|
$
(0.18)
|
|
$
(0.17)
|
|
$
(0.89)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in computing
|
|
|
|
|
|
|
|
|
|
|
basic and diluted net
loss per share
|
|
|
97,906
|
|
15,517
|
|
91,848
|
|
14,112
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
|
|
December
31,
|
|
|
|
|
|
|
|
2020
|
|
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
$
4,073
|
|
|
|
$
5,223
|
|
Receivables
|
|
|
|
|
423
|
|
|
|
993
|
|
Inventory
|
|
|
|
|
1,073
|
|
|
|
998
|
|
Prepaid expenses and
other current assets
|
|
|
|
|
1,080
|
|
|
|
1,094
|
|
|
Total current
assets
|
|
|
|
|
6,649
|
|
|
|
8,308
|
|
Property and
equipment, net
|
|
|
|
|
1,161
|
|
|
|
817
|
|
Operating lease
right-of-use asset
|
|
|
|
|
208
|
|
|
|
397
|
|
|
Total
assets
|
|
|
|
|
$
8,018
|
|
|
|
$
9,522
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
$
5,877
|
|
|
|
$
3,600
|
|
Operating lease
liability, non-current
|
|
|
|
|
-
|
|
|
|
150
|
|
Long-term debt,
non-current
|
|
|
|
|
3,038
|
|
|
|
4,019
|
|
Warrant
liability
|
|
|
|
|
-
|
|
|
|
320
|
|
Stockholders' equity
(deficit)
|
|
|
|
|
(897)
|
|
|
|
1,433
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
8,018
|
|
|
|
$
9,522
|
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SOURCE Titan Pharmaceuticals, Inc.