pSivida Corp. Builds Momentum During First Quarter FY18; Continues Operating Milestone Execution
November 07 2017 - 6:00AM
NDA Filing for Durasert Three-year Treatment for
Posterior Segment Uveitis Remains on Track for Late December
2017/Early January 2018
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 2018 first quarter.
Recent Operating Highlights
- Following a pre-NDA meeting with the FDA for Durasert
three-year uveitis, which resulted in no changes to our proposed
clinical data package, we continue to execute plans to file an NDA
in late December 2017/early January 2018.
- Entered into two collaboration agreements with global
pharmaceutical companies to develop sustained release formulations
of glaucoma drugs.
- Improved upon the existing collaboration agreement for ILUVIEN®
to change the terms of the arrangement to a net sales-based royalty
to pSivida, effective as of July 1, 2017.
- Commenced a GLP safety and pharmacokinetic (PK) study of a
shorter-duration Durasert for posterior segment uveitis.
“We continued to build our operating momentum
during the fiscal first quarter,” commented Nancy Lurker, President
& CEO. “We signed two collaboration agreements with
leading pharmaceutical companies that illustrate our ability to
leverage our proven drug release technology to generate
non-dilutive financing. We have a number of milestones
over the next few months, primarily the NDA filing for posterior
segment uveitis, which we continue to expect to file in late
December 2017 or early January 2018. We await the data from
the Phase 1 knee osteoarthritis (OA) trial and continue
pre-clinical work on our shorter-duration Durasert.”
Fiscal First Quarter
Results
Revenue for the first fiscal quarter ended
September 30, 2017 totaled $385,000 compared to $277,000 for the
prior year quarter. Operating expenses for the three months ended
September 30, 2017 totaled $6.4 million compared to $7.5 million a
year earlier. Net loss for the quarter ended September 30, 2017 was
$6.0 million, or $0.15 per share, compared to a net loss of $7.2
million, or $0.21 per share, for the prior year quarter.
During the fiscal 2018 first quarter, the
Company issued 843,784 shares of common stock for gross proceeds of
approximately $1.0 million through utilization of its existing
at-the-market (ATM) equity offering program. At September 30,
2017, the Company’s cash and cash equivalents totaled $11.8
million. Subsequent to the first quarter, the Company has
continued to strengthen its balance sheet by further utilizing the
ATM program, issuing approximately 5.0 million additional shares of
common stock for gross proceeds of approximately $6.2
million.
Anticipated Near-Term
Milestones:
- File the Durasert three-year posterior segment uveitis NDA in
the U.S. in late December 2017/early January 2018.
- Present clinical study data at leading medical conferences,
including the American Academy of Ophthalmology (AAO) annual
meeting.
- Report the initial 24-week data for the Phase 1 trial of knee
osteoarthritis (OA).
- Finalize additional collaboration agreements with
biopharmaceutical companies and other third parties.
- Successful completion of GLP safety and PK studies of a
shorter-duration Durasert for posterior segment uveitis in the
fourth quarter of calendar 2018.
Conference Call
pSivida Corp. will host a live webcast and
conference call today, November 7, 2017 at 8:30am 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 99811898. A live webcast will be available on
the Investor Relations section of the corporate website at
http://www.psivida.com.
A replay of the call will be available beginning
November 7, 2017, at approximately 11:30 a.m. ET and ending on
November 14, 2017, at 11:59 p.m. ET. The replay may be accessed by
dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406
from international locations, Conference ID Number: 99811898. A
replay of the webcast will also be available on the corporate
website during that time
About pSivida Corp.
pSivida Corp. (www.psivida.com), headquartered
in Watertown, MA, is a leader in the development of sustained
release drug products for treating 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 directly in the U.S. 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, is being
independently developed. Two pivotal Phase 3 studies with Durasert
achieved their primary efficacy endpoint of prevention of
recurrence of uveitis at six months of follow-up with statistical
significance, and the Company plans to file an NDA by late December
2017/early January 2018. pSivida's pre-clinical development program
is focused on using its core platform technology Durasert™ to
deliver drugs to treat wet 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 achieve profitable operations and access to needed
capital; fluctuations in our operating results; successful
commercialization of, and receipt of revenues from, ILUVIEN® for
diabetic macular edema (“DME”), which depends on Alimera’s ability
to continue as a going concern; Alimera’s ability to obtain
marketing approvals and the effect of pricing and reimbursement
decisions on sales of ILUVIEN; the number of clinical trials and
data required for the Durasert three-year uveitis marketing
approval application in the U.S.; our ability to file and the
timing of filing and acceptance of the Durasert three-year uveitis
NDA in the U.S.; our ability to use data in a U.S. NDA from
clinical trials outside the U.S.; our ability to successfully
commercialize Durasert three-year uveitis, if approved, in the
U.S.; potential off-label sales of ILUVIEN for uveitis;
consequences of fluocinolone acetonide side effects; the
development of our next-generation Durasert shorter-duration
treatment for posterior segment uveitis; potential declines in
Retisert® royalties; efficacy and our future development of an
implant to treat severe osteoarthritis; 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,
including our agreement with Alimera; termination or breach of
current license agreements, including our agreement with Alimera;
our dependence on contract research organizations, vendors and
investigators; 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 the 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 Securities and Exchange
Commission. 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.
Contact:
EVC Group
Michael Polyviou/Doug Sherk –
Investorsmpolyviou@evcgroup.com; dsherk@evcgroup.com212.850.6020;
646-445-4800
Thomas Gibson –
Mediatom@tomgibsoncommunications.com
201-476-0322
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PSIVIDA CORP. AND SUBSIDIARIES |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(Unaudited) |
|
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
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|
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Three Months
Ended |
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September 30, |
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|
|
|
|
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|
2017 |
|
|
|
2016 |
|
|
|
Revenues: |
|
|
|
|
|
|
|
Collaborative research and development |
|
$ |
140 |
|
|
$ |
34 |
|
|
|
|
Royalty
income |
|
|
245 |
|
|
|
243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
385 |
|
|
|
277 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
|
3,819 |
|
|
|
4,178 |
|
|
|
|
General and
administrative |
|
|
2,572 |
|
|
|
3,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
6,391 |
|
|
|
7,463 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(6,006 |
) |
|
|
(7,186 |
) |
|
|
Interest
and other income |
|
|
23 |
|
|
|
24 |
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(5,983 |
) |
|
$ |
(7,162 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss
per common share: |
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding: |
|
|
|
|
|
|
Basic and
diluted |
|
|
39,430 |
|
|
|
34,175 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
PSIVIDA CORP. AND SUBSIDIARIES |
|
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
|
(Unaudited) |
|
|
(In thousands) |
|
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September 30, |
|
June 30, |
|
|
|
|
|
|
2017 |
|
2016 |
|
|
|
|
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|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
11,833 |
|
|
$ |
16,898 |
|
|
|
|
Other
current assets |
|
714 |
|
|
|
842 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
current assets |
|
12,547 |
|
|
|
17,740 |
|
|
|
Intangible
assets, net |
|
184 |
|
|
|
364 |
|
|
|
Other
assets |
|
|
596 |
|
|
|
573 |
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
13,327 |
|
|
$ |
18,677 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts
payable and accrued expenses |
$ |
4,269 |
|
|
$ |
5,240 |
|
|
|
|
Deferred
revenue |
|
10 |
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
current liabilities |
|
4,279 |
|
|
|
5,290 |
|
|
|
Deferred
rent |
|
|
47 |
|
|
|
51 |
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
4,326 |
|
|
|
5,341 |
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Capital |
|
|
324,967 |
|
|
|
323,323 |
|
|
|
|
Accumulated
deficit |
|
(316,803 |
) |
|
|
(310,820 |
) |
|
|
|
Accumulated
other comprehensive income |
|
837 |
|
|
|
833 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
stockholders' equity |
|
9,001 |
|
|
|
13,336 |
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
13,327 |
|
|
$ |
18,677 |
|
|
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