-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, R4JnKr8s1TL+Srcd2E4jKJAWNaNMyJO4aEJ+oELK3KDTEICPgUWc038N2vc9/n3C RHbriQJ1T0ZAGzFcM80I8g== 0001021408-02-009111.txt : 20020702 0001021408-02-009111.hdr.sgml : 20020702 20020702163522 ACCESSION NUMBER: 0001021408-02-009111 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20020701 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: FILED AS OF DATE: 20020702 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CORTEX PHARMACEUTICALS INC/DE/ CENTRAL INDEX KEY: 0000849636 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330303583 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-16467 FILM NUMBER: 02695215 BUSINESS ADDRESS: STREET 1: 15241 BARRANCA PKWY CITY: IRVINE STATE: CA ZIP: 92718 BUSINESS PHONE: 7147273157 MAIL ADDRESS: STREET 1: 15241 BARRANCA PARKWAY CITY: IRVINE STATE: CA ZIP: 92718 8-K 1 d8k.txt FORM 8-K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) July 1, 2002 CORTEX PHARMACEUTICALS, INC. - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) Delaware 0-17951 33-0303583 - ------------------------------- -------------------------- ------------------------------------- (State or other jurisdiction of (Commission File Number) (I.R.S Employer Identification No.) incorporation)
15241 Barranca Parkway Irvine, California 92618 - ---------------------------------------------------- -------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (949) 727-3157 - -------------------------------------------------------------------------------- N/A - -------------------------------------------------------------------------------- (Former name or former address, if changed since last report.) Item 5. Other Events. Attached to this report as Exhibit 99.1 is the press release issued by Cortex Pharmaceuticals, Inc. dated July 1, 2002 relating to Shire Pharmaceuticals Group plc's election not to exercise its option to develop certain of Cortex's technology and compounds for the treatment of Attention Deficit Hyperactivity Disorder, which press release is incorporated herein by reference. Item 7. Financial Statements and Exhibits. (c) Exhibits.
Exhibit Description Exhibit ------- Number ------ Press Release dated July 1, 2002 99.1 Transcript of conference call held July 1, 2002 at 1:30 p.m., Pacific Daylight Time. 99.2
Item 9. Regulation FD Disclosure. The information provided in connection with Item 9 of this report is being furnished pursuant to Regulation FD of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). In accordance with General Instruction B.2 of Form 8-K, the information provided in connection with Item 9 of this report shall not be deemed to be "filed" for purposes of the Exchange Act, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. The furnishing of the information set forth in connection with Item 9 of this report is not intended to, and does not, constitute a determination or admission as to the materiality or completeness of such information. Cortex Pharmaceuticals, Inc. held a conference call on Monday, July 1, 2002, at 1:30 p.m., Pacific Daylight Time to discuss issues and answer questions regarding Shire Pharmaceuticals Group plc's election not to exercise its option to develop certain of Cortex's technology and compounds for the treatment of Attention Deficit Hyperactivity Disorder. A copy of the transcript from this conference call is attached to this report as Exhibit 99.2 and is incorporated herein by reference. An audio replay of the conference call will be available through July 12, 2002 by calling (800) 642-1687 or (706) 645-9291. 2 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. CORTEX PHARMACEUTICALS, INC. Date: July 2, 2002 By: /s/ Maria S. Messinger ---------------------------------------- Maria S. Messinger Vice President, Chief Financial Officer and Corporate Secretary 3 EXHIBIT INDEX
Exhibit Sequential Number Description Page No. - ------------------------------------------------------------------------------------ 99.1 Press Release dated July 1, 2002 5 99.2 Transcript of conference call held July 1, 2002 at 1:30 p.m., 8 Pacific Daylight Time.
4 EX-99.1 3 dex991.txt PRESS RELEASE DATED JULY 1, 2002 Exhibit 99.1 Press Release [GRAPHIC REMOVED HERE] FOR IMMEDIATE RELEASE Contacts: Vincent F. Simmon, Ph.D. Jenny Moede or Andrew Fowler President and CEO Investor and Media Relations Cortex Pharmaceuticals, Inc. Waggener Edstrom Bioscience (949) 727-3157 (503) 443-7000 CORTEX SEEKS NEW PARTNER TO PURSUE ADHD TREATMENT OPPORTUNITY Shire Elects Not to Exercise Its Option for ADHD -- Conference Call Scheduled for 1:30 PM PDT -- IRVINE, Calif., July 1, 2002 -- Cortex Pharmaceuticals, Inc. (AMEX: COR), today announced that Shire Pharmaceuticals Group plc has decided not to exercise its option to develop Cortex's AMPAKINE(R) technology and compounds for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The decision frees Cortex to pursue new partners that have expressed interest in applying Cortex's technology platform toward ADHD. Shire undertook a Phase II clinical trial using the AMPAKINE CX516 in 72 adult patients with ADHD. The trial was terminated prior to expiration of the option period and prior to the recruitment of additional patients into the trial. Based on the results of this study, Shire has decided not to continue development of CX516 or any other AMPAKINE. Under terms of the previously negotiated option agreement, all rights to CX516 and the AMPAKINE technology will be returned to Cortex. Cortex plans to execute its right to get the data from the clinical trial. "Unfortunately, Shire has decided not to pursue our AMPAKINE technology for the ADHD indication," said Vincent F. Simmon, Ph.D., President and CEO of Cortex. "However, this does not invalidate the use of AMPAKINE compounds or technology for this indication." "Several major pharmaceutical companies have approached Cortex with a strong interest in our AMPAKINE technology as a nonscheduled (not regulated by the Drug Enforcement Agency) 5 alternative to amphetamines for the treatment of ADHD," Simmon continued. "Now that Shire has made its decision, Cortex will vigorously pursue another partner for this opportunity." Cortex's Partner Les Laboratoires Servier Selects CX516 for MCI and AD Under the terms of a separate agreement, Les Laboratoires Servier has now selected CX516 as its Phase II lead AMPAKINE compound to treat Mild Cognitive Impairment ("MCI"), Alzheimer's Disease ("AD") and other neurodegenerative diseases in its territory, primarily Europe and Asia. Shire had previously held the first right of refusal to keep CX516. Cortex and Servier are currently enrolling patients in the first Cross-National Collaborative MCI Study at 31 sites across the United States and in five countries in Europe. This large, double-blind, placebo-controlled Phase II clinical trial will compare the effectiveness and safety of CX516 over 28 days in patients meeting strict criteria for MCI. Enrollment in the Cross-National MCI Study is expected to be completed by the end of March 2003, and the data analysis should be completed a few months later. The advantage to Cortex and Servier of Shire's decision is that if CX516 appears safe and effective, it can go into Phase III studies for MCI. James H. Coleman, Senior Vice President of Business Development at Cortex, added that several large pharmaceutical companies are also interested in the AMPAKINE compounds for AD and MCI in the Americas, which Servier is developing in Europe and Asia. "The Americas represents more than 60 percent of the total market value and most large pharmaceutical companies prefer to have a later-stage clinical candidate, such as CX516," said Coleman. Conference Call Cortex will host a conference call on Monday, July 1, at 1:30 p.m. PDT, to discuss today's announcement. Following the conference call, the company will open the phone lines to answer questions from investors and members of the media. Those who wish to participate may do so using the following dial-in information: In the United States, call (877) 543-9367, passcode: 4766855. Internationally, call (706) 679-4549, passcode: 4766855. An audio replay of the conference call will be available two hours after the completion of the conference call until Friday, July 12, 2002. To access the replay in the U.S., call (800) 642-1687 and provide the following passcode: 4766855. To access the replay internationally, call (706) 645-9291, passcode: 4766855. About Cortex Pharmaceuticals, Inc. Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer's disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain's neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease, including MCI and Alzheimer's disease.(http://www.cortexpharm.com/) 6 Forward-Looking Statement: Note -- This press release contains forward-looking statements concerning the Company's research and development activities, clinical trials and business development plans. Actual results may differ materially, depending on a number of risk factors, including the risks that the Company may be unable to secure a corporate partner for the ADHD indication; that the Company may be unable to obtain additional capital needed to continue its operations; that the agreements with Organon and Servier will not result in any commercial products or that any additional milestone payments will be earned by the Company; that the Company may be unable to arrive at additional corporate partnerships with other pharmaceutical companies on acceptable terms and therefore be required to independently fund clinical development of AMPAKINE compounds through the sale of additional equity securities or otherwise; that the Company's proposed products may at any time be found to be unsafe or ineffective for any or all of their proposed indications; that competitors may challenge or design around the Company's patents or develop competing technologies; and that clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company's Securities and Exchange Commission filings, the Company's proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not yet been shown to have efficacy in the treatment of any disease. # # # 7 EX-99.2 4 dex992.txt TRANSCRIPT OF CONFERENCE CALL HELD JULY 1, 2002 EXHIBIT 99.2 CORTEX PHARMACEUTICALS, INC. Moderator: Vincent F. Simmon July 1, 2002 1:30 pm PDT Operator: Welcome to the Cortex Pharmaceuticals Conference Call. I will now turn the call over to Maria Messinger, CFO of Cortex Pharmaceuticals. Ms. Messinger, you may begin. Maria Messinger: Thank you for joining us this afternoon. My name is Maria Messinger, Chief Financial Officer of Cortex Pharmaceuticals, and with me today is Dr. Vincent F. Simmon, President and CEO of Cortex Pharmaceuticals. Today, Cortex announced that Shire Pharmaceuticals Group will not exercise its option to develop our AMPAKINE(R) technology and compounds for the treatment of Attention Deficit Hyperactivity Disorder. Shire previously held an option to acquire the worldwide rights to use Cortex's AMPAKINE(R) technology in the development and marketing of ADHD drugs. As a result of Shire's decision, all licensing rights will be returned to Cortex immediately. Cortex has the right to obtain all the data and intends to do so. After we have reviewed the data, we will have a better idea of whether the AMPAKINE technology may work in this indication. In a moment, I will be handing things over to Dr. Simmon, who will provide a brief summary, after which we will open the lines for questions. Before I turn things over to Dr. Simmon, I would like to remind you, that during the course of this call Cortex may make projections and other forward- looking statements, regarding future events or financial performance of the Company. Please note that such statements are just predictions, and actual events or results may differ from the statements made. Please see documents that Cortex files from time to time with the SEC for information about risks that affect the Company. And with that, I'd like to turn the call over to Vince. Vincent F. Simmon: Thank you for joining us today. Before I start, I should inform you that under the terms of our contract with Shire, public disclosure of information must be mutually agreed upon, in advance; therefore, I am limited in what I can tell you. First, it appears that Shire ran a well-designed clinical trial in ADHD and made a decision to terminate it before reaching full enrollment, in order to make a decision by the June 30 deadline. We've had a productive relationship with Shire, and we're sorry to lose them as a partner for ADHD. Shire made a decision to focus resources on other clinical programs. Overall, the pharmaceutical sector has had a challenging year, and several companies have made tough decisions regarding their product pipelines. Shire has provided Cortex with some preliminary information about the results of the trial. Cortex's statistical consultant, Dr. Andy Leon, who is Associate Professor of Biostatistics at Cornell, has looked at the preliminary information provided to Cortex by Shire. He has determined that the information was inadequate for him to evaluate efficacy or safety. That, presumably, is because it is in a very summary form, and preliminary. The trial was double-blind, randomized and placebo-controlled. Approximately half of the 72 patients received placebo, and half received drug. Patients were given a fixed dose of drug, based on the amount of drug we had given to patients with schizophrenia. Some of you may be aware of a recent publication by Dr. Marc Caron at Duke, indicating that CX516 had an effect on hyperactivity in genetically-engineered mice. Dose required was 70 to 100 mg per kg. This is substantially higher than the dose that we have used to improve memory in animal studies and in humans. It is possible that the dose required to treat ADHD is much higher than anticipated. It is possible that CX516 does not work in this disorder, at any safe dose. It is also possible that other molecules, other AMPAKINE molecules that are much more active in Dr. Caron's test, might be better than CX516 for ADHD. There are many possibilities, and we will need to review the data to make a scientific assessment. For a variety of reasons, not all of the 72 patients completed the trial. I am not currently at liberty to say a lot more than that. As stated in our press release, we do not believe that the results Shire obtained invalidate the use of AMPAKINE compounds for treating ADHD. We will need to look at the data more closely to make a determination if this indication is worth pursuing with a new partner. You may recall, we began our interest in ADHD based on clinical results in patients with schizophrenia who were treated with CX516, and seemed to have improvements in attention; however the main thrust of AMPAKINE technology has been in memory improvement. And we believe that the market value in Alzheimer's disease and Mild Cognitive Impairment is substantially larger. While we are disappointed at this outcome, our partner Servier is pleased to have clear rights to CX516. They are investing a lot in clinical trials with this compound. The Cross-National MCI trial is currently about 20% enrolled in the U.S. We expect enrollment to continue to ramp up in the U.S., but summer holidays in Europe during July and August will probably keep things slow over there, until the Fall. As we mentioned in the press release, we now have CX516 available for licensing for Mild Cognitive Impairment, Alzheimer's disease, and other indications. Several large pharmaceutical companies are interested in these indications, but had expressed concern that CX516 was not clearly available to them. Now it is. I have previously stated that Cortex is looking to raise additional capital. This morning, I spoke with our lead group regarding the potential financing. They stated that they were not totally surprised about the Shire outcome, and were continuing to review the transaction documents and to finish their due diligence. With that, I will now open this telephone conference for questions. Do we have any questions? Operator: If you would like to ask a question at this time, please press star, then the number 1, on your telephone keypad. We'll pause for just a moment, to compile the Q&A roster. Your first question comes from (Stephen Leby) of GMT Capital. (Stephen Leby): Just give us a little more color on your financing situation. What's the approximate amount that you're looking to raise here; what's your cash position now on the balance sheet, give or take; and what's your anticipated forward-looking burn? Vincent F. Simmon: Okay. Cash in the balance sheet, as of end of March, was about $2.5 million. In our filings, we indicated that should last us into the November time frame. If we have to stretch that, we can add roughly about three months. (Stephen Leby): Okay. Vincent F. Simmon: In terms of the amount we're looking to raise, it's in the range of say $3 to $4 million. And, if we were to raise $3 million, it would put us through the end of next fiscal year, which starts 365 days from today. (Stephen Leby): Okay. All right, so you're seeking to raise 3 to 5, is that the number again? Vincent F. Simmon: Yes, sir. (Stephen Leby): And how does that strategy tie in with your hopes to partner the drug in the United States for the... Vincent F. Simmon: It's independent -- those are independent, ongoing events. (Stephen Leby): Okay, so you're running them on two separate tracks. Vince Simmon: Yes, sir. (Stephen Leby): Thank you. Operator: Your next question comes from William Charleston. William Charleston: Dr. Simmon, nice to talk to you. CX516, I saw some speculation that the half-life was so short. Do you actually see that coming to market in its form, and how do you intend to address the short half-life? Vincent F. Simmon: A good question. We have been studying the issue for a number of years, and a number of pharmaceutical companies have expressed concern regarding the short half-life of CX516. Recent studies conducted at the University of California, Irvine suggest that pulsatile, or on for a brief period of time, off for a longer period of time, administration of this drug may actually be more beneficial than having, what's called in the pharmaceutical industry, constant coverage, or having drug at a specified level in the blood, during a whole 24-hour period. So, that's one point. The second point is, we know from studies that have been done at UC Irvine, done at Cortex, and also published by Eli Lilly, that these compounds are capable of up-regulating neurotrophic factors. These compounds are around for substantially longer, that is the proteins, the neurotrophins are around for substantially longer than the active drug, and may account for some prolonged effects we've seen of the drug. That is to say, benefit of the drug in improving memory seems to last even after the last drug administration, when the drug has been administered over a period of multiple days or weeks. So, it's entirely possible that this drug, despite its short half-life, is a very viable candidate. William Charleston: Yes, sir. I - that reminds me of a press release you all had a while back, where you said you were going to give rats prolonged dosages, and see the long-term effects. Has that ever been published? Vincent F. Simmon: We are currently analyzing the brains from those rats. They were treated for approximately seven or eight months. We've sacrificed the animals and we are currently doing the analysis on that. I have indicated at a couple of scientific presentations that preliminary analysis suggested there was an up-regulation of brain derived neurotrophic factor, messenger RNA, suggesting that, indeed, this -- at the doses given, was effective in up-regulating the protein. We did not look specifically at the protein, we looked at the precursor to that, the messenger RNA. William Charleston: Yes, then, and one last question, after Lilly's experience, have you seen any problems with toxicity, any negative effects? Vincent F. Simmon: In all clinical trials, there are toxic or adverse events that occur. We have not seen any clear brain-related issues relating to toxicity. It's our understanding that the toxicity observed by Lilly was in animals, not in humans, but -- they're not communicating regularly with us on this issue. William Charleston: Okay, thank you then. Vincent F. Simmon: Sure thing. Operator: Your next question comes from Roy Sanders. Roy Sanders: Dr. Simmon, how long do you anticipate it will take to study the results and come out with some further description of exactly what took place. Vincent F. Simmon: Yeah, that's a little hard to answer, but our preliminary guesstimate (sic) is around a month, after we've gotten the data. In part, that will depend on the format, how easy it is to maneuver around it. We didn't design the system that allows you to access the data, we're not familiar with it, yet. We haven't seen it. So, once we get into it, our preliminary guess in that area is about a month. Roy Sanders: Okay, and one other question, about the Lilly patent dispute. Is there any further word about that? Vincent F. Simmon: It always seems it's next week, doesn't it? I did receive communication from my lawyer in San Francisco, where he gave the final approval with a couple of comments to our lawyer in London, at J.A. Kemp, to file additional information with the patent office in Europe. As part of that, they inquired if this action, whatever the action is, has been docketed yet, or, is there a planned date for it to occur. And looking quickly through the e-mail, there was -- the response came back that no, it hasn't been docketed, and they plan to have this new information to the patent examiner on his or her desk, tomorrow, July 2. Roy Sanders: Okay, thank you. Vincent F. Simmon: Sure. Operator: Your next question comes from (John Hales). (John Hales): Hi, Vince. Are there any other restrictions on the sale of -- or, any restrictions as a result of our agreements with any companies, that would preclude us from marketing or having relationships to sell and market CX516, or other AMPAKINE drugs, with our other partners? Vincent F. Simmon: Good question, John. Under our agreement with Servier, we'd like to have whatever drug they develop there. If we were to use it outside of their territory, it's our understanding amongst each other, that we would limit that to the same indications that Servier was using the drug for. So, we wouldn't have a drug to develop a compound -- let's take CX516, we wouldn't develop CX516 for anything other than the indications that Servier is developing it for in Europe. That's, of course, subject to subsequent agreements of any kind between us. But, that's the limitation. (John Hales): Okay, but there's no other blanket like we had with Shire, as far as first right of refusal on... Vincent F. Simmon: No, no. The drug has a home, and the people at Servier are very happy. (John Hales): Okay, thank you. Operator: At this time, sir, there are no further questions. Vincent F. Simmon: Okay, if there are no further questions, I would like to thank each and all of you. It's been a difficult day for our shareholders at Cortex, but I think we've weathered the storm pretty well. I thank you for your allegiance, and for participating in today's conference call. And with that, I'll say good-bye. Operator: This concludes today's conference call, you may now disconnect. END -----END PRIVACY-ENHANCED MESSAGE-----