Followers | 129 |
Posts | 2150 |
Boards Moderated | 1 |
Alias Born | 12/27/2007 |
![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Tuesday, June 09, 2009 2:10:51 PM
Psivida (PSDV)
MarketCap : 32,8 M$
Cash : 8,02 M$
Price : 1,80$
Shares Out : 18,26 M .... Pfizer is biggest Shareholder (1,9 million shares)
Iluvien™ NDA filing remains on schedule for early calendar 2010
Positive 12 month interim safety and efficacy data from Iluvien PK study
PDSV has two ophthalmic sustained delivery products approved by the FDA for treatment of back of the eye diseases
With our existing partnerships and planned cash burn, we believe we can fund our operations as currently conducted without needing to access the capital markets prior to FDA approval of Iluvien. If approved, we are due to receive a $25 million milestone payment and, once commercialized, a 20% profit share.”
“We are confident in our strategy to capitalize on our core strength of developing drug delivery systems and bringing products to a point where they can be partnered or further developed by the Company,” stated Dr. Paul Ashton, President and CEO of pSivida. “Following the independent Data Safety Monitoring Board’s final review recommending the continuation of the Iluvien Study for the treatment of DME, an NDA filing remains on schedule for early calendar 2010.”
Dr. Ashton noted that the Company’s net cash burn has averaged $1.5 million per quarter during the past six months. “With our existing partnerships and planned cash burn, we believe we can fund our operations as currently conducted without needing to access the capital markets prior to FDA approval of Iluvien. If approved, we are due to receive a $25 million milestone payment and, once commercialized, a 20% profit share.”
An ongoing PK study running concurrently with the pivotal Phase III clinical trials is also designed to provide information on the safety and efficacy of Iluvien in the DME population. Twelve month data from this study was recently presented at the ARVO annual meeting. “We were extremely pleased with the safety and efficacy data from the 12 month PK study readout,” said Dr. Ashton. “There were no adverse events related to IOP (intra ocular pressure) in the low dose patients and even the high dose patients had a lower incidence of IOP compared to the published Retisert DME data. Additionally, the efficacy data continues to be consistent with our expectations.” pSivida’s partner, Alimera Sciences, has worldwide marketing rights to Iluvien.
DME is a potentially blinding disease that affects over one million people in the United States. Currently there are no FDA approved drugs for the treatment of DME.
For the quarter ended March 31, 2009, the Company reported a consolidated net loss of $636,000, or $0.03 per share, compared to a consolidated net loss of $5.5 million, or $0.30 per share, for the quarter ended March 31, 2008. Revenues for the three months ended March 31, 2009 were $3.2 million compared to revenues of $542,000 for the three months ended March 31, 2008. Cash and cash equivalents totaled $8.0 million at March 31, 2009.
Recent EYPT News
- EyePoint Pharmaceuticals to Host R&D Day on June 26, 2024 • GlobeNewswire Inc. • 06/18/2024 11:00:00 AM
- EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 06/17/2024 11:00:00 AM
- EyePoint Pharmaceuticals to Present at Goldman Sachs 45th Annual Global Healthcare Conference • GlobeNewswire Inc. • 06/05/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/28/2024 11:05:42 AM
- EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 05/16/2024 11:00:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 02:12:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/08/2024 08:23:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2024 11:05:11 AM
- EyePoint Pharmaceuticals Reports First Quarter 2024 Financial Results and Highlights Recent Corporate Developments • GlobeNewswire Inc. • 05/08/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 01:25:17 PM
- EyePoint Pharmaceuticals Announces Topline Data from the Phase 2 PAVIA Trial of DURAVYU™ in Non-Proliferative Diabetic Retinopathy • GlobeNewswire Inc. • 05/06/2024 11:00:00 AM
- EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 04/16/2024 11:00:00 AM
- EyePoint Pharmaceuticals Expands Scientific Advisory Board with World-Renowned Retina Specialists • GlobeNewswire Inc. • 04/02/2024 11:00:00 AM
- EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 03/18/2024 11:00:00 AM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/08/2024 06:53:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 12:05:09 PM
- EyePoint Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Developments • GlobeNewswire Inc. • 03/07/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/04/2024 10:40:53 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 03/04/2024 10:37:18 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/04/2024 12:01:44 PM
- EyePoint Pharmaceuticals Announces Appointment of Ramiro Ribeiro, M.D., Ph.D. as Chief Medical Officer • GlobeNewswire Inc. • 03/04/2024 12:00:00 PM
- EyePoint Pharmaceuticals to Report Fourth Quarter and Full-Year 2023 Financial Results on March 7, 2024 • GlobeNewswire Inc. • 02/29/2024 12:00:00 PM
- EyePoint Pharmaceuticals Announces Participation at Upcoming Investor Conferences • GlobeNewswire Inc. • 02/27/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/22/2024 10:08:48 PM
- EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 02/16/2024 12:00:00 PM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM
ATWEC Announces Major Acquisition and Lays Out Strategic Growth Plans • ATWT • Jun 20, 2024 7:09 AM
North Bay Resources Announces Composite Assays of 0.53 and 0.44 Troy Ounces per Ton Gold in Trenches B + C at Fran Gold, British Columbia • NBRI • Jun 18, 2024 9:18 AM
VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM
Fifty 1 Labs, Inc Announces Acquisition of Drago Knives, LLC • CAFI • Jun 18, 2024 8:45 AM
Hydromer Announces Attainment of ISO 13485 Certification • HYDI • Jun 17, 2024 9:22 AM