paul.nowak wrote: Matt, thanks for the comments. I made an error on the version of Plone. It's 2.5 Plone running on Zope 2.9x.
In regards to the additional products, we have a skin installed and we have a product that we had custom developed for us that connects to a PostgreSQL database. We've looked at slow PostgreSQL queries causing problems and have not been able to find an issue. We've also tested for the case where the PostgreSQL server is down and have not been able to create an issue. We therefor...
MONTREAL, QUEBEC -- (MARKET WIRE) -- 05/09/07 -- Ambrilia Biopharma Inc. (TSX: AMB), a biopharmaceutical company developing novel small molecules and peptides to treat infectious diseases and cancer, announced today the first quarter 2007 financial results and provided an update on its development program.
FIRST QUARTER 2007 HIGHLIGHTS AND BEYOND
- Ambrilia is pleased to share a productive relationship with Merck regarding PPL-100. As the Company continues to follow-up with Merck in their advancement of the compound towards development in HIV/AIDS patients, it will inform its stakeholders on a timely basis of any material information pertaining to the partnership, in accordance with the terms of the agreement with Merck.
- Ambrilia initiated a pivotal Phase III clinical trial in Europe with its improved prolonged- release formulation of Octreotide in acromegaly patients. Furthermore, the Company announced that its U. S. licensing partner, Mallinckrodt, a division of Tyco Healthcare, filed an Investigational New Drug (IND) application with the U. S. Food and Drug Administration (FDA) to conduct a Phase III clinical trial with Octreotide.
- Ambrilia announced the positive findings of a Phase I/II study conducted at the Memorial Sloan Kettering Cancer Center, New York City, which showed that its therapeutic peptide drug PCK3145 had clinical activity in metastatic prostate cancer patients. PCK3145 was found to be safe and well tolerated, and was shown to increase PSA (Prostate Specific Antigen) doubling time and down-regulate MMP-9 (a matrix metalloproteinase enzyme involved in facilitating tumor metastasis). Disease stabilization as assessed by time to radiographic progression was also observed in several patients.
- On April 18th, Stephen G. Sudovar, Chairman of the Board of Directors, was elected as Executive Chairman and interim CEO as Hans J. Mader stepped down as President and CEO and as a member of the Board. On the same date, the Company announced a $5.4 million private placement by certain investors, almost all of them being current shareholders of Ambrilia.
"Ambrilia has made significant progress in advancing its programs. For PCK3145, the encouraging conclusions of a Phase I/II study showing clinical activity in advanced prostate cancer patients now justify further development of the drug. We also have taken another step in the right direction with the start of clinical trials in Europe with Octreotide," said Stephen G. Sudovar, Executive Chairman and interim CEO of Ambrilia. "At this stage, Ambrilia's R&D knowhow in HIV and its expertise in delivery system technology have been validated by strong partnerships with leading companies. Leveraging these core competencies will drive our business strategy going forward. Accordingly, Ambrilia's HIV Integrase Inhibitor Program will be at the forefront of our R&D projects, as we will be moving Octreotide and Goserelin closer to the market," he concluded.
$5.4 MILLION PRIVATE PLACEMENT
On April 18, Ambrilia announced it had agreed to issue 2,231,405 of its common shares to certain investors, almost all of them being current shareholders of Ambrilia, at a price of $2.42 per share for an aggregate consideration of $5.4 million. This $5.4 million transaction is subject to usual conditions, including the approval of the TSX and applicable regulatory authorities and is scheduled to close no later than May 18, 2007. The issue price of $2.42 per share represents the volume weighted average price of Ambrilia's common shares on the TSX for the five days ending on April 11, 2007.
HIV/AIDS
HIV INTEGRASE INHIBITOR PROGRAM
The Company is now accelerating its HIV Integrase Inhibitor Program: this new class of drug to treat HIV/AIDS emerges as a significant market opportunity. Clinical data published to date from pharmaceutical companies who have integrase inhibitors show promise in terms of safety and efficacy. Ambrilia's R&D team is currently working on a portfolio of novel structures which are believed to potentially have a different mechanism of action. The Company has currently identified a number of lead compounds and aims to have a drug candidate within the next 12 months.
ONCOLOGY
IMPROVED FORMULATION OF OCTREOTIDE
In February, Ambrilia initiated a pivotal Phase III clinical trial in Europe with its improved prolonged-release formulation of Octreotide in acromegaly patients. Furthermore, Ambrilia announced that its U.S. licensing partner, Mallinckrodt, a division of Tyco Healthcare, filed an IND with the U.S. FDA to conduct a pivotal Phase III clinical trial with Octreotide. Mallinckrodt has the sales and marketing expertise to reach specialists who will prescribe Octreotide in the U.S. along with a track record of successful product launches. This will be key in the product adoption by physicians and patients.
Ambrilia's formulation of Octreotide, a therapeutic alternative to Novartis' Sandostatin® LAR developed with a patented technology, was found to have a longer bioavailability than the original product and should therefore present an advantage to the patients in terms of convenience. Ambrilia expects to complete the Phase III clinical efficacy study towards the end of 2007, and the safety studies around mid 2008. Filing for approval by its licensing partners is expected during the course of 2008, starting with Europe and followed by North America.
THERAPEUTIC PEPTIDE PCK3145
In April, Ambrilia announced the positive findings of a Phase I/II study conducted at the Memorial Sloan Kettering Cancer Center, New York City, which showed that its therapeutic peptide drug PCK3145 had clinical activity in metastatic prostate cancer patients. PCK3145 was found to be safe and well tolerated, and was shown to increase PSA doubling time and down-regulate MMP-9. Disease stabilization as assessed by time to radiographic progression was also observed in several patients. This study of 28 metastatic hormone refractory patients was led by co-investigators Drs. Susan Slovin and Howard Scher.
These data are encouraging and warrant further development of the drug in late-stage prostate cancer patients, who have very limited treatment options. Ambrilia is currently evaluating various partnering and product development strategies to move forward with PCK3145.
NEW FORMULATION OF GOSERELIN
Ambrilia's therapeutic alternative to Astra Zeneca's Zoladex®, a new prolonged-release formulation of Goserelin developed with a patented technology, is now in the final stages of optimization. The Company expects to begin a Phase I/II study in hormone-sensitive prostate cancer patients in 2007.
TUMOR AND TUMOR VASCULATURE TARGETING (TVT) TECHNOLOGY
As previously indicated, Ambrilia is advancing its tumor and Tumor Vasculature Targeting (TVT) Technology, a drug delivery platform that selectively delivers drugs to the vasculature of tumors and surrounding tumor cells. Proof-of-concept was established with doxorubicin, a targeted liposomal formulation which showed convincing results in animal solid tumor models. The Company is currently setting up a preclinical program for anticancer agents to be integrated into the TVT delivery system.
BIOMARKER ASSAY PSP94
Ambrilia is pursuing its discussions with diagnostic companies for the partnering of PSP94, its novel diagnostic/prognostic marker for prostate cancer.
FINANCIAL RESULTS
Quarter ended March 31, 2007 compared with the Quarter ended March 31, 2006
The Company incurred a net loss of $6,112,379 or $0.21 per common share for the first quarter of 2007, compared with a net loss of $2,962,830 or $0.19 per common share for the same quarter last year. The acquisition of Ambrilia France on March 1, 2006, represented the merger of two companies of similar size and the results for the current quarter, which fully include those of Ambrilia France, thus reflect this growth.
Revenues for the first quarter of 2007 were $208,007, compared with $130,321 in the corresponding quarter last year. The higher revenues resulted primarily from an increase in interest income, due to higher average cash balances and an increase in interest rates in the current quarter compared to the first quarter of 2006.
Research and development expenses amounted to $2,616,751 in the first quarter of 2007, compared with $1,393,782 in the same quarter last year. The increase of $1,222,969 resulted primarily from the increased R&D expenditures on Octreotide and Goserelin added as a result of the acquisition of Ambrilia France and higher compensation costs, partially offset by reduced spending on PPL-100 following its licensing to an affiliate of Merck & Co., Inc. in October 2006. Research and development tax credits increased to $273,954 in the current quarter from $124,988 in the corresponding quarter last year.
General and administrative expenses amounted to $2,408,049 in the first quarter of 2007, an increase of $1,275,551 over the total of $1,132,498 for the same quarter last year. Increased compensation costs and professional fees, together with expenses at our regional office in Paris for a full three months, compared to only one month in the first quarter last year, were the principal reason for the increased expenses. Non-cash compensation during the current quarter amounted to $0.4 million, while an additional $0.3 million of expenses were of a non-recurring nature.
Amortization expense increased to $2,170,923 in the current quarter from $871,722 in the same quarter last year. The increase resulted almost entirely from the added amortization on intellectual property arising from the acquisition of Ambrilia France on March 1, 2006.
Interest on long-term debt was $259,366 in the first quarter of 2007, compared to $266,616 in the same quarter last year. The decrease was mainly due to the reduced interest expense on the Biolevier loan as a result of the $2 million loan repayment in December 2006, partially offset by interest capitalized to November 2006 and a higher interest rate in the current quarter compared to the first quarter of 2006.
As a consequence of the intellectual property arising on the acquisition of Ambrilia France, a future income tax liability totaling $10,540,785 has been recorded to date. This future income tax liability is being drawn down over a term of up to the 7-year period during which the intellectual property is being amortized. This resulted in a future income tax recovery on the consolidated statement of operations of $1,091,305 for the first quarter of 2007, compared to a recovery of $324,585 in the first quarter of 2006. The recovery in the current quarter was partially offset by a foreign exchange loss on the future income tax liability of $106,989, whereas in the corresponding quarter last year the recovery was supplemented by a foreign exchange gain on the future income tax liability of $358,047.
LIQUIDITY AND CAPITAL RESOURCES
Cash and cash equivalents and short-term investments totaled $15,393,535 at March 31, 2007, compared with $22,359,604 at December 31, 2006. The decrease of $6,966,069 resulted from the utilization of $5,897,476 to finance operating activities for the first quarter of 2007, including an increase of $1,521,323 in non-cash working capital. In addition, an amount of $313,334 was used in the period for additional property, plant and equipment and intellectual property. Also, an amount of $766,391 was utilized to repay an Ambrilia France 12% loan payable on March 1, 2007.
Management believes that it will have sufficient funds available, including the net proceeds to be received from the $5.4 million private placement of common shares announced on April 18, 2007, to support its ongoing activities for at least the next 15 months.
AMBRILIA BIOPHARMA INC.
CONSOLIDATED BALANCE SHEETS
(unaudited)
As at
December
March 31, 31,
2007 2006
$ $
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ASSETS
Current assets
Cash and cash equivalents 11,955,530 3,155,854
Short-term investments 3,438,005 19,203,750
Accounts receivable 482,962 847,688
Investment tax credits recoverable 961,621 1,902,212
Prepaid expenses 141,123 116,154
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16,979,241 25,225,658
Long-term receivables 1,226,747 1,095,130
Property, plant and equipment 1,909,996 1,782,558
Intellectual property 53,581,795 53,379,022
Deferred financing costs - 979,534
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73,697,779 82,461,902
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued liabilities 3,067,904 5,762,426
Deferred license revenues 3,402,446 3,377,976
Loan payable - 768,841
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6,470,350 9,909,243
Minority interest 1 1
Biolevier loan facility 8,118,959 8,927,466
Future income tax liability 6,064,044 6,295,095
Convertible debentures 2,345,262 2,408,559
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22,998,616 27,540,364
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Shareholders' equity
Share capital 115,978,300 114,401,167
Warrants 6,143,141 6,143,141
Contributed surplus 8,233,084 7,920,211
Equity component of convertible debentures 1,920,914 1,920,914
Deficit (81,576,276) (75,463,895)
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50,699,163 54,921,538
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73,697,779 82,461,902
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AMBRILIA BIOPHARMA INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS, DEFICIT AND COMPREHENSIVE INCOME
(unaudited)
Three months ended
March 31,
2007 2006
$ $
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REVENUES
License revenue 7,364 2,226
Interest and other income 200,643 128,095
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208,007 130,321
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EXPENSES
Research and development 2,616,751 1,393,782
Research and development tax credits (273,954) (124,988)
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Net research and development 2,342,797 1,268,794
General and administrative 2,408,049 1,132,498
Amortization of property, plant and
equipment 123,960 63,103
Amortization of intellectual property 2,046,963 772,928
Amortization of deferred financing fees - 35,691
Accretion on long-term debt 107,730 60,250
Interest on long-term debt 259,366 266,616
Financial charges 29,100 13,971
Foreign exchange (gains) losses (13,263) 161,932
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7,304,702 3,775,783
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Loss before income taxes (7,096,695) (3,645,462)
Future income tax recovery 1,091,305 324,585
Foreign exchange (loss) gain on future
income tax liability (106,989) 358,047
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984,316 682,632
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Net loss & comprehensive loss (6,112,379) (2,962,830)
Deficit, beginning of period (75,463,897) (73,124,430)
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Deficit, end of period (81,576,276) (76,087,260)
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Basic and diluted loss per share (0.21) (0.19)
Weighted average number of common shares
outstanding 29,207,370 15,662,695
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AMBRILIA BIOPHARMA INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three months ended
March 31,
2007 2006
$ $
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OPERATING ACTIVITIES
Net loss (6,112,379) (2,962,830)
Items not affecting cash
Amortization of property, plant and
equipment 123,960 63,103
Amortization of intellectual property 2,046,963 772,928
Amortization of deferred financing fees - 35,691
Accretion on long-term debt 107,730 60,250
Loan interest capitalized - 205,366
Future income tax recovery and related
foreign exchange gain (984,316) (682,632)
Exchange loss (gain) (2,444) 32,299
Services paid by issuance of stock options 319,533 71,381
Executive compensation 124,800 -
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(4,376,153) (2,404,444)
Net change in non-cash balances relating
to operations (1,521,323) (1,597,296)
------------------------------------------------------------------
Cash flows related to operating activities (5,897,476) (4,001,740)
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INVESTING ACTIVITIES
Acquisition of intellectual property (101,316) (7,879)
Acquisition of property, plant and
equipment (212,018) (186,267)
Cash and cash equivalents obtained on
acquisition of business - 174,625
Business acquisition costs - (1,979,031)
Purchase of short-term investments (989,280) -
Maturities of short-term investments 16,755,025 3,955,475
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Cash flows related to investing activities 15,452,411 1,956,923
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FINANCING ACTIVITIES
Issue of common shares 11,132 18,095,904
Share issuance costs - (1,213,429)
Repayment of loan (766,391) -
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Cash flows related to financing activities (755,259) 16,882,475
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Net increase in cash and cash equivalents 8,799,676 14,837,658
Cash and cash equivalents, beginning of
period 3,155,854 417,953
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Cash and cash equivalents, end of period 11,955,530 15,255,611
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CONFERENCE CALL INFORMATION
Ambrilia will be hosting a conference call and webcast on Thursday, May 10th at 9:00 AM ET, to discuss its first quarter 2007 financial results and give an update on its development program. Interested parties may access the conference call by way of telephone or webcast. The number to access the conference call is 1(800) 762-8908 (toll free). The webcast will be available at www.ambrilia.com, Investors section, Conference calls and webcasts. A replay of the call will be available at www.ambrilia.com, Investors section, Conference calls and webcasts, and the numbers to access the replay are (416) 640-1917 (local) and 1(877) 289-8525 (toll free) with access code 21231629.
Ambrilia's forward-looking statements
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the Company's filings. We refer you to the Risk Factors section of the Company's Management's Discussion & Analysis of Financial Condition and Results of Operations which contain a more exhaustive analysis of the risks and uncertainties that are generally connected to the business of the Company. Such statements are also based on various assumptions, including the successful and timely completion of clinical studies on Ambrilia's products demonstrating efficacy and safety for human use, their successful commercialization within the forecasted timelines and the attainment of the forecasted milestone payments and other revenues. While Ambrilia anticipates that subsequent events and developments may cause Ambrilia's views to change, Ambrilia specifically disclaims any obligation to update these forward looking statements.
ABOUT AMBRILIA BIOPHARMA
Ambrilia Biopharma Inc. (TSX: AMB) is a biopharmaceutical company developing novel small molecules and peptides to treat infectious diseases and cancer. Ambrilia's product portfolio includes promising anti-HIV treatments (PPL-100 and an HIV Integrase Inhibitor Program), two new formulations of existing drugs developed with a patented technology (Octreotide and Goserelin), an anti-cancer therapeutic peptide (PCK3145), a tumor and tumor-vasculature targeting (TVT) technology platform, as well as other anti-virals and immunomodulators. Exclusive worldwide rights to PPL-100 and its related compounds have been granted to Merck & Co., Inc. in return for a $US 17 million upfront payment, potential milestones that could reach $US 212 million, and royalties. Ambrilia's head office, research and development and manufacturing facilities are located in Montreal with a regional office in France. For more information, please visit the Company's web site: www.ambrilia.com