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CDXP SEC Suspension:
http://www.sec.gov/litigation/suspensions/2014/34-72416.pdf
Order:
http://www.sec.gov/litigation/suspensions/2014/34-72416-o.pdf
Admin Proceeding:
http://www.sec.gov/litigation/admin/2014/34-72417.pdf
Cordex Retains WBB Securities to Explore Strategic Options
LA JOLLA, Calif., Feb. 1 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that it has retained WBB Securities LLC to help the company explore strategic alternatives to enhance shareholder value.
Cordex has developed a portfolio of diagnostic and therapeutic drug candidates, two of which are in late stages of clinical development: ATPace™ has an approved SPA to enter a pivotal Phase 2b/3 clinical trial for the treatment of a common heart arrhythmia called paroxysmal supraventricular tachycardia. Cordex believes that ATPace™ is a more reliable and superior product than existing therapies because of its unique ability to recruit the vagus nerve.
As a diagnostic test for syncope, ATPace™ is ready for a Phase 3 clinical trial. Diagnosis of syncope is a major unmet medical need. Cordex believes this product may impact the syncope market much the same way adenosine-based pharmaceutical stress agents expanded the myocardial perfusion imaging market.
Another of Cordex's ATP-based product, ATPotent™, targets male factor infertility. Pre-clinical data have demonstrated the ability of ATPotent™ to improve sperm motility and increase conception rates. ATPotent™ can be developed either as a therapeutic agent (in IUI or IVF procedures) or as a medical device (a sperm wash). Other ATP-based products target the P2 receptors in the lung and the eye for the treatment of COPD and chronic cough and glaucoma, respectively.
A Cordex program at the Phase 2 proof-of-concept clinical trial stage is a nitric oxide-based product for the treatment of heart failure.
"We believe that we can best serve the interests of all our shareholders by exploring every possible alternative to enhance shareholder value," stated Cordex's CEO Shepard Goldberg.
About Cordex Pharma, Inc.
Cordex is focused on hospital-based therapies based upon the emerging new pharmacological mechanisms of adenosine 5'-triphosphate (ATP) and nitric oxide (NO). These two molecules play critical roles in cellular metabolism and signal transduction, the manipulation of which constitute novel therapeutic modalities for the treatment of major cardiovascular disorders. For further information regarding Cordex, please visit the company's website at www.cordexpharma.com.
About WBB Securities LLC.
Headquartered in San Diego, WBB is an independent broker/dealer specializing in biotechnology, specialty pharma, and medical devices investment banking and research. For further information regarding WBB or to contact the firm, please visit www.wbbsec.com.
Steve Brozak
President
WBB Securities LLC
125 Elm Street
Westfield, NJ 07090
Contact: Mark Molowa
(908) 518-7610
Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. The forward-looking statements are based on current expectations, estimates and projections made by management. Cordex intends for the forward-looking statements to be covered by the safe harbor provisions for forward-looking statements. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," or variations of such words are intended to identify such forward-looking statements. All statements in this release regarding the future outlook related to Cordex are forward-looking statements, including, but not limited to, the statements regarding the expected results of the use of ATPace(TM) and enhancing shareholder value. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Such risks include the risk that the data derived from the trials may not be sufficient to support marketing or approval of the products, the market may not be as anticipated and that our technology may not lead to expected results including the development or the successful commercialization of technologies relating to the use of ATP or nitric oxide. Additional uncertainties and risks are described in Cordex's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-KSB. Copies of these filings are available through the SEC website at http://www.sec.gov. All forward-looking statements are based upon information available to Cordex on the date hereof. Cordex undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law.
Updated the iBOX a bit... Still some work left to be done. I'll finish it in the next couple of days.
GLTA.
Cordex looks promising, if they can pay the note that's due...
JMO.
GLTA.
New 8-k form filed...
http://www.sec.gov/Archives/edgar/data/1127842/000135448809002291/0001354488-09-002291-index.htm
GLTA.
Cordex Signs European Development Partnership for ATPotent(TM) Sperm Motility Drug
Press Release
Source: Cordex Pharma, Inc.
On Monday June 22, 2009, 8:15 am EDT Technology Intended to Improve Outcome of Intrauterine Insemination and In Vitro Fertilization Procedures
LA JOLLA, Calif., June 22 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP - News) announced today that it has entered into an agreement with Clinical Trials International, LLC, (CTI), regarding a license to develop and market Cordex's drug candidate, ATPotent(TM).
ATPotent(TM) is a novel ATP-based drug candidate designed for in vitro (outside of the human body) treatment of sperm in conjunction with intrauterine insemination (IUI) and in vitro fertilization (IVF) procedures. ATPotent(TM) is based on Cordex's proprietary technologies related to the use of adenosine 5'-triphosphate (ATP) for improving human and animal sperm motility and fertilization capacity.
According to the agreement, CTI has obtained exclusive rights for the clinical development and marketing of ATPotent(TM) in the European Union (EU) as well as Russia and Ukraine. CTI intends to initiate with Cordex's scientific support a proof-of-concept clinical trial in Italy later this year, the end-point of which is expected to be increased pregnancy rate in IUI procedures prescribed for couples with male infertility due to asthenozoospermia (i.e., low or lack of sperm motility). Cordex will have access to the clinical data to be obtained in this study to support the development of ATPotent(TM) in the rest of the world.
Male factor infertility is implicated in about half of the six million infertile couples in the United States. Lack of, or low sperm motility or movement, is a common cause of human male infertility. It has been reported in the medical literature that the prevalence of asthenozoospermia in infertile men is approximately 82 percent. Currently, there is no FDA-approved drug that enhances sperm motility.
Cordex has sponsored studies at the University of Pennsylvania and the University of Padua, which have shown that in vitro ATP treatment of poorly motile human sperm resulted in improved motility parameters and increased frequency of hyperactivated sperm. The improved motility parameters were also observed in human sperm derived from males with asthenozoospermia and in thawed cryopreserved human sperm.
Results from these published studies support earlier observations from a non-Cordex sponsored European study in which increased success rate of IVF procedures were observed when ATP-treated sperm derived from infertile males with asthenozoospermia were used.
"We are pleased to enter this agreement with CTI as we feel it will accelerate the development of ATPotent(TM) as a novel treatment for the majority of male infertility cases in the United States and other parts of the world," said James S. Kuo, M.D., M.B.A., Cordex's Chairman and CEO. "CTI has the experience, expertise, and track record of obtaining EU regulatory approval for medical products originally developed in the US and marketing them there," he added. "Data obtained by CTI in its clinical trial are expected to support Cordex's efforts to seek marketing approval for ATPotent(TM) from the FDA," said Amir Pelleg, Ph.D., Cordex's President and CSO.
About ATPotent(TM)
ATPotent(TM) is Cordex's novel and proprietary drug candidate for the in vitro treatment of human and animal sperm, in which the active ingredient is adenosine 5'-triphosphate (ATP). ATP is a ubiquitous purine nucleotide found in every cell of the human body where it plays a critical role in cellular metabolism and constitutes the source of energy for all bodily functions. ATP is released from cells under physiologic and pathophysiologic conditions; extracellular ATP acts as a local physiologic regulator by activating cell surface receptors called P2 receptors. Extracellular ATP plays an important role in sperm maturation in the male reproductive tract and is a mandatory co-factor of fertilization in the female reproductive tract. Cordex's sponsored studies have shown that ATP treatment can improve the motility and fertilization capacity of malfunctioning sperm obtained from infertile males due to asthenozoospermia as well as thawed sperm that had been cryopreserved.
About Cordex Pharma, Inc.
Cordex is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging pharmacology of adenosine triphosphate (ATP) and nitric oxide (NO). These two molecules play critical roles in cellular metabolism and signal transduction, the manipulation of which constitute novel therapeutic modalities for the treatment of major cardiovascular disorders. Cordex has a portfolio of investigational medicines, two of which are in late stages of clinical development. ATPace(TM) is expected to enter a Phase 2b/3 clinical trial for the treatment of paroxysmal supraventricular tachycardia. Cordex's CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure. In addition, Cordex has a preclinical program to develop new chemical entities that target a recently discovered pathway in the pathophysiology of chronic obstructive pulmonary diseases. For further information regarding Cordex, please visit the company's website at www.cordexpharma.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. The forward-looking statements are based on current expectations, estimates and projections made by management. Cordex intends for the forward-looking statements to be covered by the safe harbor provisions for forward-looking statements. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," or variations of such words are intended to identify such forward-looking statements. All statements in this release regarding the future outlook related to Cordex are forward-looking statements, including, but not limited to, the statements regarding the timing and expected results of the ATPotent(TM) proof-of-concept clinical trial in Italy, the statements regarding the timing of ATPace(TM)'s expected entry into a pivotal Phase 2b/3 clinical trial for the treatment of paroxysmal supraventricular tachycardia, the timing of CDP-1050's expected commencement of a Phase 2 clinical trial for the treatment of heart failure, the expected results of the use of ATPace(TM) and the estimated PSVT market. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Such risks include the risk that the data derived from the trials may not be sufficient to support marketing of approval of the products, clinical trial for approval of ATPace(TM) and the Phase 2 clinical trial for our CDP-1050 may not be successful, the results of the clinical trial for ATPotent(TM) may not be as expected, that our preclinical program to develop new chemical entities that target a newly discovered pathway in the pathophysiology of chronic obstructive pulmonary disease may not be successful, the market may not be as anticipated and that our technology may not lead to expected results including the development or the successful commercialization of technologies relating to the use of ATP or nitric oxide. Additional uncertainties and risks are described in Cordex's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-KSB. Copies of these filings are available through the SEC website at http://www.sec.gov. All forward-looking statements are based upon information available to Cordex on the date hereof. Cordex undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law.
Cordex Receives Special Protocol Assessment Approval from FDA for ATPace(TM)
Jun 2, 2009 8:15:00 AM
Email Story Discuss on ZenoBank
View Additional ProfilesLA JOLLA, Calif., June 2 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that the U.S. Food and Drug Administration (FDA) has approved the design of pivotal, Phase 2b/3 clinical trials evaluating its lead product ATPace(TM) as an antiarrhytmic drug for the acute treatment of patients with paroxysmal supraventricular tachycardia (PSVT) under the Special Protocol Assessment (SPA) process.
ATPace(TM) is a novel stable liquid formulation of adenosine 5'-triphosphate (ATP). It is being developed as a therapeutic and diagnostic drug for the management of patients with cardiac arrhythmias. ATP has been used in Europe for more than five decades as the drug of choice for the acute termination of PSVT. During this extended period of time, formulations of ATP have manifested an excellent safety and efficacy profile.
Cordex intends to initiate prospective, double-blind, placebo-controlled and randomized clinical trials with its lead product ATPace(TM) in approximately 200 patients aimed at demonstrating clinical safety and efficacy sufficient to support a New Drug Application filing of ATPace(TM) for the treatment of PSVT in emergency room patients.
"We are very pleased with the FDA's decision; we believe that data to be obtained in the proposed trials would constitute sufficient evidence to support the marketing approval of ATPace(TM) for the proposed indication," commented Amir Pelleg, Ph.D., Cordex's President and CSO. "Due to its unique mechanism of action in the heart, which involves a central vagal reflex and adenosine, the product of its rapid degradation, ATPace(TM) has the potential to be an important advance in the treatment of patients with PSVT," he added.
About PSVT
PSVT is an episodic, rapid, regular heart rate originating in the atria. The heart rate in PSVT can range from 150 to 250 beats per minute. There are approximately 570,000 persons with PSVT in the United States alone, with an estimated 89,000 new cases diagnosed each year. Patients with PSVT may report palpitations, pounding in the chest, chest pressure or pain, weakness, shortness of breath, or dizziness. Unless it self-terminates, PSVT patients need to seek medical intervention to terminate the arrhythmia.
About Cordex Pharma, Inc.
Cordex is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging pharmacology of adenosine triphosphate (ATP) and nitric oxide (NO). These two molecules play critical roles in cellular metabolism and signal transduction, the manipulation of which constitute novel therapeutic modalities for the treatment of major cardiovascular disorders. Cordex has a portfolio of investigational medicines, two of which are in late stages of clinical development. ATPace(TM) is expected to enter a Phase 2b/3 clinical trial for the treatment of paroxysmal supraventricular tachycardia. Cordex's CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure. In addition, Cordex has a preclinical program to develop new chemical entities that target a recently discovered pathway in the pathophysiology of chronic obstructive pulmonary diseases. For further information regarding Cordex, please visit the company's website at www.cordexpharma.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. The forward-looking statements are based on current expectations, estimates and projections made by management. Cordex intends for the forward-looking statements to be covered by the safe harbor provisions for forward-looking statements. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," or variations of such words are intended to identify such forward-looking statements. All statements in this release regarding the future outlook related to Cordex are forward-looking statements, including, but not limited to, the statements regarding the timing of ATPace(TM)'s expected entry into a pivotal Phase 2b/3 clinical trial for the treatment of paroxysmal supraventricular tachycardia, the sufficiency of the data obtained and the anticipated results of the trial, the timing of CDP-1050's expected commencement of a Phase 2 clinical trial for the treatment of heart failure, the expected results of the use of ATPace(TM) and the estimated PSVT market. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Such risks include the risk that the data derived from the trial may not be sufficient to support marketing of approval of ATPace(TM), clinical trial for approval of ATPace(TM) and the Phase 2 clinical trial for our CDP-1050 may not be successful, that our preclinical program to develop new chemical entities that target a newly discovered pathway in the pathophysiology of chronic obstructive pulmonary disease may not be successful, the market may not be as anticipated and that our technology may not lead to expected results including the development or the successful commercialization of technologies relating to the use of ATP or nitric oxide. Additional uncertainties and risks are described in Cordex's most recently filed SEC documents, such as its most recent annual report on Form 10-KSB, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-KSB. Copies of these filings are available through the SEC website at http://www.sec.gov. All forward-looking statements are based upon information available to Cordex on the date hereof. Cordex undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law.
SOURCE Cordex Pharma, Inc.
----------------------------------------------
James S. Kuo
M.D.
M.B.A.
Chairman and CEO of Cordex Pharma
Inc.
+1-858-551-5700
Fax
+1-858-551-5704
jkuo@cordexpharma.com
I would start to watch DSKA real closely here- MMS have been creeping up on bid and ask over the last week. Might see some action...
NEWS :)
Form 10QSB for DUSKA THERAPEUTICS, INC.
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15-Aug-2007
Quarterly Report
Item 2. - Management's Discussion and Analysis of Financial Condition And Results of Operations
SAFE HARBOR STATEMENT
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. This document contains forward-looking statements, which reflect the views of our management with respect to future events and financial performance. These forward-looking statements are subject to a number of uncertainties and other factors that could cause actual results to differ materially from such statements. Forward-looking statements are identified by words such as "anticipates," "believes," "estimates," "expects," "intends," "plans," "projects," "targets" and similar expressions. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based on the information available to management at this time and which speak only as of this date. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For a discussion of some of the factors that may cause actual results to differ materially from those suggested by the forward-looking statements, please read carefully the information under "Risk Factors" beginning on page 16.
The identification in this document of factors that may affect future performance and the accuracy of forward-looking statements is meant to be illustrative and by no means exhaustive. All forward-looking statements should be evaluated with the understanding of their inherent uncertainty.
Overview
On August 30, 2004, we completed a merger in which Duska Scientific Co. ("Duska Scientific"), through which we currently carry out all of our business operations, became our wholly-owned subsidiary. At the time of the merger, we had virtually no assets or liabilities (prior to the merger we had engaged in very limited landscaping and irrigation operations). In connection with the merger, we changed our name to "Duska Therapeutics, Inc.", replaced our officers and directors with those of Duska Scientific, ceased our landscaping business and moved our offices to Bala Cynwyd, Pennsylvania. We currently do not plan to conduct any business other than the business that Duska Scientific has conducted since its organization. Duska Scientific is a development stage company that has at this time a portfolio of two current product candidates and two proposed product candidates that are in various early stages of development. We have not generated any revenues to date. We expect to continue to incur significant research, development and administrative expenses before any of our current or proposed product candidates are approved for marketing, if ever, and generate any revenues.
Although we acquired Duska Scientific in the merger, for accounting purposes, the merger was accounted for as a reverse merger since the stockholders of Duska Scientific acquired a majority of the issued and outstanding shares of our common stock, and the directors and executive officers of Duska Scientific became our directors and executive officers. No goodwill was recorded as a result of the merger.
Recent Developments
On April 6, 2007, we authorized issuance of up to 6,000,000 units at a purchase price of $0.50 per unit, each unit consisting of 1 share of common stock and one five-year warrants exercisable at $0.60 per share during the first year and increasing by $0.10 per share each year thereafter. The warrant may be called when the trading price of the common stock equals or exceed $1.50 per share for twenty (20) consecutive trading days. The subscriptions for this private offering to qualified investors have not yet been completed.
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By unanimous written consent in lieu of a special meeting, on May 22, 2007, the Board of Directors filled a Board vacancy by the appointment of James S. Kuo, M.D., M.B.A to the Board to serve the unexpired term of his predecessor and/or until his successor is elected and qualified.
On June 8, 2007, the Company issued 807,217 shares of its restricted common stock at a price of $0.30 per share for total proceeds of $242,165. The Company collected $242,165 in total. The issuance of these shares represents a private placement of units sold to accredited investors. Each unit consists of one share of common stock and two (2) five-year warrants. The A warrants are exercisable at a price of $0.30 per share and the B Warrants are exercisable at a price of $0.60 per share during the first year, increasing by $0.10 per share each year thereafter.
On July 6, 2007, the Board of Directors filled Board vacancies with the nomination and acceptance of Philip Sobol, M.D. and Manuel Graiwer, Esq. These new board members will hold office for the unexpired term of their predecessor(s) and/or until their successor(s) are elected and qualified. At the same meeting, James S. Kuo was elected Chairman of the Board.
On July 27, 2007, the shareholders of the Company agreed to undertake a forward split of the stock purchase warrants issued for cash pursuant to the private placement in 2004 on a basis of 1 for 10. This only related to warrants issued in 2004.
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates based upon historical experience and various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Our actual results may differ materially from these estimates.
We believe our critical accounting policies affect our more significant estimates and judgments used in the preparation of our consolidated financial statements. Our Annual Report on Form 10-KSB for the year ended December 31, 2006 contains a discussion of these critical accounting policies. There have been no significant changes in our critical accounting policies since December 31, 2006. See our Note 1 in our unaudited consolidated financial statements for the three and six month periods ended June 30, 2007, as set forth herein.
New Accounting Pronouncements
In February 2007, the FASB issued Financial Accounting Standards No. 159, "The Fair Value Option for Financial Assets and Financial Liabilities-Including an amendment of FASB Statement No. 115" ("SFAS 159"). SFAS 159 permits companies to measure many financial instruments and certain other items at fair value at specified election dates. SFAS 159 is effective beginning January 1, 2008. The Company is currently assessing the impact of SFAS 159 on its financial statements.
Results of Operations
We recorded net losses of $268,302 and $798,687 for the three and six month periods ended June 30, 2007 as compared to losses of 368,385 and $1,196,137 for the same periods in 2006.
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General and administrative expenses were $260,705 and $507,795 during the three and six month periods ended June 30, 2007, as compared to $378,143 and $947,336 for the same periods in 2006. General and administrative expenses consist principally of officers' salaries, legal and accounting fees, insurance premiums, and facilities costs. The higher cost in 2006 is primarily attributable to recognizing stock-based compensation expense of $368,468 to directors and consultants as required under SFAS No. 123(R), which was only $97,901 in 2007.
Research and development expenses were $7,831 and 97,473 during the three and six month periods ended June 30, 2007, as compared to $(878) and $262,085 for the same periods in 2006. Research and development expenses consist principally of costs directly associated with our activities related to the development of ATPace™ and ATPotent™. The decrease from 2006 to 2007 is attributable to the completion of preclinical development of ATPotent and the suspension of Phase II clinical trials for ATPace™, offset by the development work on a 503(b)(4) application for ATPace™. During the three and six month periods ended June 30, 2007, we recorded $0 and $12,684 of expense associated with the Cato Agreement, which was included in research and development expense, of which $5,073 will be satisfied through the release of Cato Units from escrow.
Interest income was $762 and $1,820 during the three and six month periods ended June 30, 2007, as compared to $8,880 and $13,284 for the same periods in 2006. The variance generally corresponds to fluctuating cash balances. We did not incur any interest expense during the three and six months period ended June 30, 2006; for the three and six month periods ended June 30, 2007, we incurred $528 and $58,842 of interest expense, the majority of which was related to the amortization of debt discount on the convertible notes issued in the third and fourth quarters of 2006. We also incurred $136,397 of expense related to the sweetened terms to the convertible debt holders to induce conversion of that debt to common stock.
Liquidity and Capital Resources
At June 30, 2007, we had cash and cash equivalents of $60,350, compared to $8,236 at December 31, 2006. Negative working capital totaled $426,674 at June 30, 2007, compared to negative working capital of $898,263 at December 31, 2006. To date, we have funded our operations, including our research and development activities, through funds derived from several private placements of an aggregate of approximately $6.1 million of equity securities and convertible debt issues.
We do not currently anticipate that we will derive any revenues from either product sales or from governmental research grants during the next twelve months. Based on our current plan of operations and the closing of a bridge loan, we believe that our current and anticipated cash balances will be sufficient to fund our planned expenditures through approximately the end of November, 2007. However, the estimated cost of completing the development of our current and proposed product candidates and of obtaining all required regulatory approvals to market our current and proposed product candidates is substantially greater than the amount of funds we currently have available. As a result, we believe that we will need to obtain at least $3 million of additional funds to fund our planned operations through to August 2008. We do not have any bank credit lines and have financed all of our prior operations through the sale of securities. We will seek to obtain these additional funds through additional financing sources and strategic alliances with larger pharmaceutical or biomedical companies, but there can be no assurance that we will be able to obtain any additional funding from any potential financing sources or create any such alliances, or that the terms under which we obtain any funding will allow us to fund our operations. If we are unsuccessful or only partly successful in our efforts to secure additional funding, some or all of our research and development activities related to current and proposed product candidates could be delayed and we could be forced to reduce the scope of these activities or otherwise limit or terminate our operations altogether. We may also seek to sell certain of our assets or sell our company.
In their report dated April 13, 2007, and included in our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2006, our independent auditors stated that our financial statements for the year ended
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December 31, 2006 were prepared assuming that we would continue as a going concern. Our ability to continue as a going concern is an issue raised as a result of our recurring negative cash flows from operations and accumulated deficit of approximately $8.4 million that existed as of December 31, 2006. As of June 30, 2007, we had an accumulated deficit of approximately $9.2 million. Our ability to continue as a going concern is subject to our ability to obtain significant additional capital to fund our operations, and there can be no assurance that we will be able to do so. The going concern qualification in the auditor's report could materially limit our ability to raise additional capital.
As of June 30, 2007, we had no long-term debt obligations, no capital lease obligations, no operating lease obligations, no purchase obligations, or other similar long-term liabilities, except for those related to the Cato Agreement. We have the right to terminate the Cato Agreement at any time, subject to a 90 day notice requirement and the payment to Cato of 20% of the estimated remaining unbilled amounts for the work orders covered by the agreement. At June 30, 2007, such obligations would have amounted to approximately $0.
We do not believe that inflation has had a material impact on our business or operations.
Off-Balance Sheet Arrangements
We are not a party to any off-balance sheet arrangements, and we do not engage in trading activities involving non-exchange traded contracts. In addition, we have no financial guarantees, debt or lease agreements or other arrangements that could trigger a requirement for an early payment or that could change the value of our assets.
Risk Factors
In addition to the other information set forth in this Form 10-QSB, you should carefully consider the factors discussed in Part II, Item 6, subsection "Risk Factors" of our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2006 which could materially affect our business, financial condition or future results of operations. The risks described in our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2006 are not the only risks that we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition and future results of operations. Other than as set forth below, there have been no material changes from the risk factors previously disclosed in Item 6, subsection "Risk Factors" to Part II of our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2006.
Risks Related To Our Business
We have never generated any revenues, have a history of losses, expect significant future losses and cannot assure you that we will ever become or remain profitable, and as a result, we may have to cease operations and liquidate our business.
We have not generated any revenues to date and have incurred operating losses since our inception. We do not expect to generate any revenues in the foreseeable future and therefore expect to continue to incur significant operating losses for the foreseeable future. To date, we have dedicated most of our financial resources to research and development and general and administrative expenses. We have funded all of our activities through sales of our securities. For the six month periods ended June 30, 2007 and 2006, we had net losses of approximately $798,687 and $1,196,137, respectively. We expect to incur losses for at least the next several years as we continue to spend substantial amounts on the research and development of our current and proposed product candidates, including pre-clinical research and clinical trials. There can be no assurance that we will ever generate any revenues or that any revenues that may be generated will be sufficient for us to become profitable or thereafter maintain profitability. If we cannot generate any revenues or become and remain profitable, we may have to cease our operations and liquidate our business.
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Our independent auditors have expressed doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing.
In their report dated April 13, 2007, our independent auditors stated that our financial statements for the year ended December 31, 2006 were prepared assuming that we would continue as a going concern. Our ability to continue as a going concern was an issue raised as a result of our recurring negative cash flows from operations and accumulated deficit of approximately $8,425,000 as of December 31, 2006. As of June 30, 2007, we had an accumulated deficit of approximately $9.2 million. Our ability to continue as a going concern is subject to our ability to obtain significant additional capital to fund our operations, of which there is no assurance. The going concern qualification in the auditor's report could materially limit our ability to raise additional capital. If we fail to raise sufficient capital, we may have to liquidate our business.
We continue to need to obtain significant additional capital to fund our operations, and we may be unable to obtain such financing at all or on acceptable terms.
We have used substantial funds to develop our technologies and our products and will require substantial additional funds to conduct further research and development. We do not have any bank credit lines and have financed all of our prior operations through the sale of securities, which have generated approximately an aggregate of $6.1 million of net proceeds since 1996. The estimated cost of completing the development of our current and proposed product candidates and of obtaining all required regulatory approvals to market our current and proposed product candidates is substantially greater than the amount of funds we currently have available. We believe that our cash balances will only be sufficient to fund our planned level of operations through approximately August 2007. We will need substantial additional funding to carry out our planned development work for our current product candidates, ATPace™ and ATPotent™, and to expand the scope of our operations (including employing senior executives and additional support personnel on a full-time basis), to develop our technologies and three proposed product candidates, Vagonixen™, Ocuprene™, and Aspirex™ and to acquire and develop any new relevant technologies and product candidates that may become available to us. Our actual expenditures needed to complete the development of ATPace™ alone could substantially exceed our current expectations due to a variety of factors, many of which are difficult to predict or are outside of our control, including revisions to our current development plan required by the FDA and higher than anticipated clinical research costs. We will also incur substantial costs to develop ATPotent™, and our actual costs will be significantly higher than presently anticipated if CooperSurgical, Inc. does not elect under our agreement to assist with the funding of our Phase II and Phase III trials for ATPotent™ and acquire a marketing license for this product candidate (see "Business-Strategic Alliances-CooperSurgical, Inc."). Our costs to commence even limited drug candidate discovery and pre-clinical work on our proposed product candidates, Vagonixen™ and Ocuprene™, will be significant. Clinical development expenses for each of these proposed product candidates will be very substantial and will require a strategic alliance with a larger pharmaceutical company that has expertise and sufficient resources to fund the clinical development costs. If we are successful in our attempts to obtain a small molecule from a large pharmaceutical company that would be developed as a Vagonixen™ drug candidate, we would have to pay significant upfront fees and additional substantial milestone-dependent fees. We may seek to obtain these additional funds through additional financing sources, including the possible sale of our securities, and strategic alliances with other pharmaceutical or biomedical companies, but there can be no assurance that we will be able to obtain any additional funding from any potential financing sources or create any such alliances, or that the terms under which we obtain any funding will be sufficient to fund our operations. We may also seek to sell certain assets or our company. If we are unsuccessful or only partly successful in our efforts to secure additional funding, some or all of our current and proposed product candidates could be delayed and we could be forced to reduce the scope of our research and development projects or otherwise limit or terminate our operations altogether.
Other than the company having a low float I haven't been following as much because of some other things thats been going on.
I bought some of this a ways back..., bought on
a whim...for more serious investors here, what's
happening..? TIA
Our float has increased to approx 3.4mn shares since May.
Just noticed them on Schwab, thought this would never happen.
Thanks for the heads up.
WoW your kidding...Still waiting at etrade and Choicetrade.
did everybody get their new shares from the split, mine showed up today in scottrade
Yeah! and we've yet to hear one good thing about AT or ET.
Wow, first good thing I've heard about them
in I don't know how long. This is my eigth roundup with them
and the execution has been miserable on every one.
Not much fun to sit and watch nearly every other broker
get the round up shares to their customers before ST.
Glad you're happy.
My first but they told me a month or so ago that they were not gonna allow it to trade with them till shareholders got the shares the company owed them......They did their homework.
How many of these have you done with ST?
If it weren't for ST making them hold up to their end we wouldn't have got them.
This low share count this could move up nicely.
Just got 'em, lol.
Scottrade seriously sucks.
Jim Bishop said he got his shares over 3 mo.s ago.
DSKA 8k filing:
Form 8-K for DUSKA THERAPEUTICS, INC.
--------------------------------------------------------------------------------
12-Jun-2007
Entry into a Material Definitive Agreement, Unregistered Sale of Equity
ITEM 1.01 ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT.
On June 1, 2007, Duska Therapeutics, Inc. (the "Company") entered into a Consulting Agreement with James S. Kuo, M.D., M.B.A. an individual (the "Consultant"). Pursuant to the Consulting Agreement to conduct a private placement offering for the Company with accredited investors, James S. Kuo, M.D., M.B.A. receives a consulting fee for his services of 10,000 options to purchase 10,000 shares of the Company's common stock at an exercise price of $0.50 per share. The Company's common stock is traded on the OTC-BB. The term of this agreement ends on the sooner of July 31, 2007 or the closing of the private placement, unless extended by mutual consent of the parties. The agreement is attached hereto as an exhibit and incorporated by reference (Exhibit 10.30 attached hereto).
ITEM 3.02 UNREGISTERED SALE OF EQUITY SECURITIES.
On June 8, 2007, the Company issued 807,217 shares of its restricted common stock at a price of $0.30 per share for total proceeds of $242,165 to the Company. The proceeds are to be used to cover in part our operational and research and development costs. The issuance of these shares represent a private placement of equity securities in the form of Units (the "Units") sold solely to accredited investors.
Each Unit consists of shares of common stock and two (2) five-year warrants for the purchase of restricted common stock: Warrant A represents a total of 807,217 restricted common shares exercisable at $0.30 per share; and Warrant B represents a total of 807,217 restricted common shares exercisable at $0.60, $0.70, $0.80, $0.90, $1.00, respectfully.
For this transaction, the offer and sale of the common stock was made pursuant to exemptions from the registration requirements of the Act pursuant to Section 4(2) and Rule 506 of Regulation D promulgated thereunder. All of the offers and sales of the common stock were made exclusively to "accredited investors" (as such term is defined in Rule 501(a) of Regulation D) in offers and sales not involving a public offering. The purchasers in the private placements purchased the securities for their own account and not with a view towards or for resale. The private placements were conducted without general solicitation or advertising.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits:
10.30 Consulting Agreement between Duska Therapeutics, Inc. and James S. Kuo, M.D., M.B.A effective June 1, 2007.
i bought DSKT / DSKA back in March 2007. still haven't received anything after the R/S. It's still showing as DSKT# in my scottrade account. Anybody has any idea what the deal is?????
My understanding through another broker (nobletrading) is that for some reason the round up is not being handled by the DTC, so they're not sure when the round up shares will be received. Just an FYI..
I still have not recieved mine from Scottrade either.
After agreeing w/me on the shares I was due
ST told me 5 wk.s ago I would receive them in 3 wk.s
In response to an e-mail I sent yest. staing I knew of
many ST traders who had received their shares, I received
a reply this morning.
Dear Mr. Wehopeyouarethisnaive:
Thank you for your email. Unfortunately, there is still no definite
date
for the payout of these shares. This was an issue with the company
itself and things having to be processed manually instead of through
the
Depository Trust Company. The shares are being paid to Scottrade
slowly,
but not all shares have been paid and it may be a few more weeks before
they are received.
We apologize for any inconvenience this has caused you, but at present
we cannot make the payout until we actually receive the physical
shares.
Please let us know if we can be of further assistance to you.
Thank you for choosing Scottrade.
Sincerely,
Sonya L
www.scottrade.com
www.scottradeElite.com
Switch to Scottrade now for up to $100 in transfer-fee reimbursement.
Visit www.scottrade.com/switch for details.
After a few conversations ST agreed w/the
terms of the roundup. Still another wk.-10 days
to receive them.
FYI On the status of shares:
I played the DSKA round up through 3 brokers. Two did not have information on the status of the round-up lots. One of my brokers told me that the shares were not being handled through the DTC for this round-up (he did not know why), so this might take longer to receive than the NWMO shares. I'm only out $20- I ain't too worried.
I wouldn't mine seeing the PPS go up while we wait :)
yea it's taking forever. still getting the we're waiting on the transfer agent to send em.... we'll see. maybe in 4 months we login and see them happily waiting for us...
Hey red, do you own DSKA? It still shows 5 shares in my Etrade acct, LOL. This has been one long RS!
Did you hear anything on this yet?
will be keeping an eye out. thx
Apprx. 20 more days.
10ksb filed today:
http://biz.yahoo.com/e/070417/dska.ob10ksb.html
yup, none here either. wait some more i guess..
still showing DSKT on Scottrade..:(
duska... nice print
Has anyone been able to find out what is going on with DSKA?
No, that is a waste of time. Scottrade will put them in my account when they get them.
Same deal with the roundup shares of PAVC, when they get here....
But you can always call Scottrade and ask if they have been given a PAY DATE yet.
any idea on how long? have you tried to tell scottrade at all?
Same here, the Gainskeeper knows that the R/S took place, but the roundup shares have not been received. So we wait!
Does this show up on your account yet?
My scottrade has still not updated yet in the gainskeeper it changed the symbol but says I have 5 shares and also will not let me sell.
Just in case someone forgot:
"This reverse stock split will reduce the number of issued and outstanding common shares from 48,751,510 to 2,437,575 common shares and have no effect on the authorized number of shares."
Does anyone really want to sell below 55 cents?
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Who is Cordex Pharma, Inc.?
Cordex Pharma, Inc. (Cordex) is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging new pharmacology of adenosine 5'-triphosphate (ATP) and nitric oxide (NO). These two molecules play critical roles in cellular metabolism and signal transduction, the manipulation of which by several pharmaceuticals constitute novel therapeutic modalities for the treatment of major cardiovascular disorders.
What's in their pipeline?
ATPace:
ATPace (adenosine triphosphate injection) is a proposed product for the acute treatment and diagnosis of certain cardiac arrhythmias (abnormal heart rate). These include the termination of paroxysmal supraventricular tachycardia (PSVT), a rapid regular heart rate originating in the atria. ATPace is also being developed to diagnose bradycardia (slow heart rate), which is one of the main causes of fainting.
Therapeutic Indication:
ATPace, a stable liquid formulation of adenosine 5’-triphosphate (ATP) for intravenous injection, is an investigational drug for the acute termination of PSVT. The bradycardic effect of ATP, in particular its blockade of atrio-ventricular nodal conduction, has been shown in numerous published clinical studies to safely and effectively terminate re-entrant PSVT involving the atrio-ventricular node. Design of a pivotal Phase 3 clinical trial for ATPace in PSVT is in the planning stage.
PSVT, one of the most common cardiac arrhythmias, is a rapid, regular heart rate originating in the atria. It has been estimated that there are 89,000 new cases of PSVT per year and approximately 570,000 persons with PSVT in the United States alone.
Currently, adenosine is the only approved treatment for PSVT in the United States. Cordex believes that the initial dose of ATPace will be significantly more efficacious than the initial labeled dose of adenosine in terminating PSVT. While both ATP and adenosine inhibit atrio-ventricular nodal conduction, ATP is believed to have dual inhibitory action; one mediated by adenosine, the product of its rapid enzymatic degradation, and the other a triggered vagal reflex. Vagal maneuvers aimed at enhancing vagal tone to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia. Injectable formulations of ATP have been approved in Europe for over 50 years as safe and efficacious treatments for PSVT.
Cordex has established its own safety database for ATPace, which was obtained in its Phase 1 and 2 clinical trials, and has obtained more than 1,000 patients records from other clinical trials. On April 16, 2008, Cordex met with the FDA and confirmed that a New Drug Application under section 505(b)(2) would be the appropriate regulatory pathway for filing an ATPace marketing application for the acute treatment of PSVT. Cordex is in the process of modifying the proposed Phase 3 clinical trial in accordance with the FDA’s comments and plans to submit a revised protocol to the FDA for Special Protocol Assessment procedure approval. Cordex intends to initiate a single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with PSVT to demonstrate ATPace’s clinical safety and efficacy. Upon successful completion, Cordex would intend to file a New Drug Application under section 505(b)(2).
CDP-1050:
Heart failure, a condition characterized by the inability of the heart to effectively pump blood as well as by fluid accumulation in the lungs and other tissues, is suffered by an estimated five million Americans and is responsible for 300,000 deaths in the U.S. annually, according to the National Heart, Lung and Blood Institute. It is the single largest Medicare expense, at a cost of $33.2 billion each year. The five-year mortality rate with heart failure can be as high as 50 percent.
Cordex's scientific consultants, Jonathan S. Stamler, M.D., and Joshua M. Hare, M.D., have developed and tested new therapeutic modalities to preserve and improve cardiac function. Cordex has been granted an exclusive, worldwide license from Duke University and Johns Hopkins University to develop and commercialize their portfolio of investigational cardiovascular drugs for the treatment of heart failure.
The most advanced heart failure drug candidate in the portfolio is CDP-1050. The drug is expected to enter a Phase 2 clinical study early in 2009. CDP-1050 is designed to correct nitric oxide and redox imbalance in the failing heart and the cardiovascular system. The drug has a dual mechanism of action; it inhibits the production of tissue-damaging reactive oxygen radicals, and restores nitric oxide to physiologic levels. The principal therapeutic target of the drug is the ryanodine receptor, a key calcium-ion channel in the heart that supplies the calcium necessary for the heart to contract. By improving the redox/nitric oxide balance, CDP-1050 is expected to improve the fucnction of the ryanodine receptor and calcium cycling in the heart. These effects at the sub-celluar level, would be manifested on the organ level in increased efficiency of cardiac contractility.
Vagonixen:
Chronic obstructive pulmonary disease (COPD) is a progressive disease that permanently damages the lungs and is usually caused by smoking. COPD is comprised of both emphysema and chronic bronchitis. COPD is the fourth leading cause of death in the U.S. and is on track to become the third leading cause of death by the year 2020. Currently, about 120,000 Americans die each year from COPD. Approximately 16 million patients in the U.S. alone are afflicted with this disease. COPD costs about $42 billion a year in medical bills and lost productivity. On November 29, 2007,
The New York Times wrote that COPD is “the largest uncontrolled epidemic in the United States today.”
Currently, COPD is treated by physicians with a combination of oral steroids, anticholinergics and asthmatic medications. Bronchodilation is a hallmark of current therapy for COPD. ATP is known to cause bronchoconstriction and cough in normal subjects, and more so in patients with obstructive airway diseases. Abnormally high levels of ATP have been measured in the lungs of COPD patients. Cordex’s proprietary technology is comprised of the selective blockade of specific P2R in the lungs that mediate the bronchoconstrictive cough-inducing actions of ATP. By blocking nerve impulses in the afferent neural traffic, bronchoconstriction, cough and neurogenic inflammation should be inhibited in COPD patients.
Cordex is identifying lead compounds that could be developed for the treatment of COPD and chronic cough.
ATPotent:
Male factor infertility is implicated in about half of the 6 million infertile couples in the U.S. Asthenozoospermia, lack of or low sperm motility, is a common cause of human male infertility. It has been reported in the medical literature that the prevalence of asthenozoospermia in infertile men is approximately 82 percent. Currently, there is no FDA-approved product that enhances sperm motility.
Cordex's proprietary ATPotent is being developed as a sperm processing medium to enhance sperm motility in conjunction with in vitrofertilization (IVF) and intrauterine insemination (IUI) procedures. One component of ATPotent is ATP, a naturally occurring biological molecule that is found in all human cells. Naturally occurring ATP in the female reproductive tract is believed to play a facilitating role in normal egg fertilization. Several in vitro studies conducted on sperm of human and other species suggest that ATP treatment of poorly motile sperm resulted in improved motility parameters and increased frequency of hyperactivated sperm.
Results of a study sponsored by Cordex was recently published in the journal of Reproductive Sciences (Scott E. Edwards, et al., "Effects of Extracellular Adenosine 5'-Triphosphate on Human Sperm Motility," 2007; 14: 655-666). The study, conducted by scientists from the Center for Research on Reproduction and Women's Health of the University of Pennsylvania and the Department of Medical and Surgical Sciences of the University of Padova, Italy, showed that ATP treatment of poorly motile human sperm in vitro (outside of the human body) resulted in improved motility parameters and increased frequency of hyperactivated sperm. Furthermore, improved motility parameters were also observed in human sperm derived from males with asthenozoospermia (a disorder characterized by lack of or low sperm motility), and human sperm from cryopreservation.
The authors suggested that these effects of ATP could explain the increased success rate of IVF procedures observed in an earlier non-Cordex sponsored European study, in which ATP-treated sperm derived from infertile males with asthenozoospermia were used.
Cordex believes that the data in this study and other studies strengthen the rationale for the development of ATPotent, which contains ATP, as a novel, sperm motility enhancement medium in conjunction IVF and IUI procedures. Cordex plans a 510(k) FDA medical device approval route and is planning to meet with the FDA to discuss such a regulatory path.
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