New Leadership Focused on Increasing Commercial
Potential of Proven Durasert™ Sustained Release Platform
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development
of sustained release drug products and technologies, today reported
financial results for its fiscal first quarter ended September 30,
2016. In addition, the Company’s new leadership team updated
corporate objectives and anticipated product development milestone
timeline.
“Since joining the Company in mid-September, I
have been working with our team to assess the impressive clinical
and commercial potential of our pipeline that is largely based on
pSivida’s proven Durasert™ sustained drug release technology, the
only intraocular sustained release technology with approval of
three different products,” said Nancy Lurker, President &
CEO. “We’ve made significant progress on a number of fronts
and I’m even more excited about the potential for pSivida to make a
true difference in patients’ lives while we build returns to our
shareholders. Our assessment reaffirmed the clear strength
and quality of clinical data from studies of our Durasert
three-year treatment for posterior segment uveitis (formerly known
as Medidur) and we remain focused on preparing our submission for
approval of this product candidate in both the European Union and
United States during 2017. We’ve also begun a thorough examination
of how to most efficiently and effectively launch the Durasert
three-year uveitis product in the United States while we actively
explore partnership possibilities to address patients with a
similar diagnosis in Europe.”
“Our review also resulted in our management team
deploying more focus on lower risk and nearer term market
opportunities as well as a renewed emphasis on potential
collaborations for our Durasert technology and implementation of
improvements to our product candidate evaluations. Since joining,
we have continued to advance our uveitis clinical program and have
reprioritized our development programs. These now include a next
generation Durasert bio-erodible shorter duration treatment for
posterior segment uveitis, increased emphasis on Durasert for
severe osteoarthritis (OA) of the knee in conjunction with HSS, and
continued work on our Durasert tyrosine kinase inhibitor (TKI)
program for Wet AMD. We also continue to pursue our Tethadur™
platform for large molecules,” Ms. Lurker added.
Fiscal First Quarter 2017
Results
Revenue for the first fiscal quarter ended
September 30, 2016 totaled $277,000 compared to $466,000 for the
prior year quarter. The year-over-year decrease was primarily
attributable to $157,000 of non-royalty sublicense consideration
earned from Alimera in the prior-year period. Operating expenses
for the three months ended September 30, 2016 totaled $7.5 million
compared to $5.4 million a year earlier. The increase was primarily
attributable to approximately $1.1 million of severance costs,
professional fees and stock-based compensation expense related to
the September CEO transition, $436,000 of costs for the previously
announced U.K. restructuring and approximately $300,000 of CRO and
regulatory contractor costs for our Durasert three-year uveitis
product candidate. Net loss for the quarter ended September 30,
2016 was $7.2 million, or $0.21 per share, compared to net loss of
$4.9 million, or $0.17 per share, for the prior year quarter.
At September 30, 2016, cash, cash equivalents
and marketable securities totaled $22.5 million.
Product Candidate Program Update &
Anticipated Milestones
Durasert three-year treatment for
posterior segment uveitis: The Company met its
enrollment target in the second uveitis Phase 3 trial of 150
patients in September. Readout of this second trial, which is
required by the U.S. Food & Drug Administration for the
Company’s NDA filing, is currently expected by the end of the first
half of 2017. The first Phase 3 study met its primary
efficacy endpoint with a p value of <0.001 and safety data that
are consistent with the known effect of ocular corticosteroid
use. With regard to the planned E.U. submission for marketing
authorization, management’s goal remains to submit during the first
quarter of 2017. The Company was recently notified that
protocol approval for a pediatric study would be required by the
European regulatory authority prior to the acceptance of the
application for market authorization. The protocol for the
pediatric study has been submitted and the timing of its approval
could move the acceptance of the market application into the second
quarter of 2017.
Next Generation Durasert bio-erodible
shorter duration treatment for posterior segment
uveitis: The Company has initiated and prioritized a
development program for a next generation Durasert bio-erodible for
uveitis. The Company is initiating formulation testing now
and expects to begin pre-clinical safety and PK studies of this
product candidate in the first half of 2017. Management believes
this product candidate will provide enhanced benefits to patients
and physicians by offering a shorter delivery time period of
corticosteroid and providing more flexibility to physicians with
multiple Durasert dosing intervals.
Durasert implant for severe
osteoarthritis (OA) of the knee: On August 1, 2016,
the Hospital for Special Surgery in New York, NY and pSivida
announced the opening of an IND in support of an
investigator-sponsored clinical study of a Durasert implant to
treat severe OA of the knee. Management believes severe OA of
the knee is a large and growing condition with continued high unmet
medical needs. The implant is designed to provide long-term pain
relief for this condition, which, if effective, could potentially
result in the delay of knee replacement surgery. The study is
an open-label, single dose, safety and tolerability study of the
screw implant to deliver dexamethasone, a corticosteroid previously
proven to provide pain relief in knee OA. Six patients will
each receive the implant in one knee. While a safety and
tolerability study, change from baseline in weekly mean of pain
intensity scored at rest, during activity and at night will be
assessed through 24 weeks. To date two patients have
received the implant and HSS expects to have all six patients
implanted over the next few months.
Durasert bio-erodible TKI for Wet
AMD: Management believes that pSivida’s TKI program could
represent a valuable advancement to the treatment of Wet AMD.
As part of the new leadership’s program assessment, it has been
determined that further evaluation of additional TKIs is needed to
optimize candidate selection, and management is actively pursuing a
lead candidate for the clinic.
Tethadur for large
molecules: The Tethadur program applies proprietary
technology to achieve the sustained release of large molecules such
as biologics. Recently, management narrowed its focus to
silica-based technology from the earlier silicon-based technology
in an effort to advance the program in a cost-effective way.
Pre-clinical activities on this program are continuing.
"During the past few weeks I have had the
pleasure of getting to know the people that developed pSivida's
terrific technology. With the recent additions of Dr. Dario
Paggiarino and Deb Jorn, we have a talented and committed team with
a singular focus to successfully bring pSivida's products to
patients and deliver greater shareholder returns," concluded Ms.
Lurker.
Conference Call
pSivida Corp. will host a live webcast and
conference call today, November 7, 2016, at 4:30pm ET. The
conference call may be accessed by dialing (877) 312-7507 from the
U.S. and Canada, or (631) 813-4828 from international locations.
The conference ID is 9987331. The conference can also be accessed
on the pSivida Corp. website at www.psivida.com. A replay of the
call will be available approximately two hours following the end of
the call and can be accessed by dialing (855) 859-2056 within the
U.S. and Canada or (404) 537-3406 from international locations,
Conference ID number 9987331.
About pSivida Corp. pSivida
Corp. (www.psivida.com), headquartered in Watertown, MA, is a
leader in the development of sustained release drug technologies
for eye diseases. pSivida has developed three of only four
FDA-approved sustained-release treatments for back-of-the-eye
diseases. The most recent, ILUVIEN®, a micro-insert for diabetic
macular edema, licensed to Alimera Sciences, is currently sold in
the US and three EU countries. Retisert®, an implant for posterior
uveitis, is licensed to and sold by Bausch &
Lomb. pSivida's lead product candidate, Durasert micro-insert
for posterior segment uveitis being independently developed, is
currently in pivotal Phase 3 clinical trials. pSivida's
pre-clinical development program is focused on using its core
platform technologies Durasert™ and Tethadur™ to deliver drugs and
biologics to treat wet and dry age-related macular degeneration,
glaucoma, osteoarthritis and other diseases. To learn more about
pSivida, please visit www.psivida.com and connect on Twitter,
LinkedIn, Facebook and Google+.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made
in this release are forward-looking, and are inherently subject to
risks, uncertainties and potentially inaccurate assumptions. All
statements that address activities, events or developments that we
intend, expect or believe may occur in the future are
forward-looking statements. Some of the factors that could cause
actual results to differ materially from the anticipated results or
other expectations expressed, anticipated or implied in our
forward-looking statements include uncertainties with respect to:
our ability to obtain needed capital; our ability to achieve
profitable operations; potential declines in Retisert royalties;
fluctuations in our operating results; further impairment of our
intangible assets; our ability to obtain marketing approvals for
and successfully commercialize Durasert three-year uveitis for
posterior segment uveitis; performance by CROs, vendors and
investigators; timing of filing marketing approval applications for
Durasert three-year uveitis; acceptability of data to be filed in
support of Durasert three-year uveitis marketing applications;
maintenance of European orphan designation for Durasert three-year
uveitis; potential off-label sales of ILUVIEN for posterior segment
uveitis; successful commercialization of, and receipt of revenues
from, ILUVIEN for DME; Alimera's ability to continue as a going
concern; the effect of pricing and reimbursement decisions on sales
of ILUVIEN for DME; consequences of fluocinolone acetonide side
effects; outcome of dispute with Alimera on commercialization
expenses; any exercise by Pfizer of its option with respect to the
latanoprost product; our ability to develop Tethadur to
successfully deliver large biologic molecules and develop products
using it; efficacy and future development of severe OA implant by
us; our ability to successfully develop product candidates,
initiate and complete clinical trials and receive regulatory
approvals; our ability to market and sell products; the success of
current and future license agreements; termination or breach of
current license agreements; effects of competition and other
developments affecting sales of products; market acceptance of
products; effects of guidelines, recommendations and studies;
protection of intellectual property and avoiding intellectual
property infringement; retention of key personnel; product
liability; industry consolidation; compliance with environmental
laws; manufacturing risks; risks and costs of international
business operations; effects of potential U.K. exit from the EU;
legislative or regulatory changes; volatility of stock price;
possible dilution; absence of dividends; and other factors
described in our filings with the SEC. You should read and
interpret any forward-looking statements in light of these risks.
Should known or unknown risks materialize, or should underlying
assumptions prove inaccurate, actual results could differ
materially from past results and those anticipated, estimated or
projected in the forward-looking statements. You should bear this
in mind as you consider any forward-looking statements. Our
forward-looking statements speak only as of the dates on which they
are made. We do not undertake any obligation to publicly update or
revise our forward-looking statements even if experience or future
changes makes it clear that any projected results expressed or
implied in such statements will not be realized.
|
PSIVIDA CORP.
AND SUBSIDIARIES |
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
(Unaudited) |
|
(In thousands
except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
|
|
|
September
30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
Collaborative research
and development |
|
$ |
34 |
|
|
$ |
180 |
|
|
|
Royalty income |
|
|
243 |
|
|
|
286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
277 |
|
|
|
466 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and
development |
|
|
4,178 |
|
|
|
3,482 |
|
|
|
General and
administrative |
|
|
3,285 |
|
|
|
1,968 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
7,463 |
|
|
|
5,450 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(7,186 |
) |
|
|
(4,984 |
) |
|
Interest
and other income |
|
|
24 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before
income taxes |
|
|
(7,162 |
) |
|
|
(4,974 |
) |
|
Income tax
benefit |
|
|
- |
|
|
|
41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(7,162 |
) |
|
$ |
(4,933 |
) |
|
|
|
|
|
|
|
|
|
Net loss
per common share: |
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.21 |
) |
|
$ |
(0.17 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding: |
|
|
|
|
|
|
Basic and diluted |
|
|
34,175 |
|
|
|
29,416 |
|
|
|
|
|
|
|
|
|
|
PSIVIDA CORP.
AND SUBSIDIARIES |
|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
(Unaudited) |
|
(In
thousands) |
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
June
30, |
|
|
|
|
2016 |
|
2016 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
22,546 |
|
|
$ |
28,992 |
|
|
|
Other current assets |
|
|
957 |
|
|
|
971 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current assets |
|
23,503 |
|
|
|
29,963 |
|
|
Intangible
assets, net |
|
910 |
|
|
|
1,102 |
|
|
Other
assets |
|
520 |
|
|
|
554 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
$ |
24,933 |
|
|
$ |
31,619 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
4,703 |
|
|
$ |
4,946 |
|
|
|
Deferred revenue |
|
|
139 |
|
|
|
147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current liabilities |
|
4,842 |
|
|
|
5,093 |
|
|
Deferred
revenue |
|
5,585 |
|
|
|
5,585 |
|
|
Deferred
rent |
|
58 |
|
|
|
60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
10,485 |
|
|
|
10,738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
Capital |
|
|
312,985 |
|
|
|
312,242 |
|
|
|
Accumulated deficit |
|
|
(299,375 |
) |
|
|
(292,213 |
) |
|
|
Accumulated other comprehensive
income |
|
|
838 |
|
|
|
852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
stockholders' equity |
|
14,448 |
|
|
|
20,881 |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
24,933 |
|
|
$ |
31,619 |
|
|
|
|
|
|
|
|
Contact:
EVC Group
Michael Polyviou/Doug Sherk – Investors
mpolyviou@evcgroup.com; dsherk@evcgroup.com
212.850.6020; 646-445-4800
Thomas Gibson – Media
tom@tomgibsoncommunications.com
201-476-0322
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