World's First Therapeutic Vaccine for Brain Cancer (NWBO) Posted Tue Jul 10, 08:26 am ET Monday, NWBO was up 249%. With a lead headline like the following, it's a wonder it was not up a lot more. When you start digging into the SEC filings, you start to see why. Most of the companies stock is owned by Toucan Venture Capital and there is no way to know for sure how many shares and warrants are out there. If I invest in a company I want to know what the dilution is, guessing is not an option.
I will probably not put real money into NWBO, however I may buy some for the Simulator. Reading the SEC filings was like reading a "how not to run a biotech company". I do hope their platform works. "BUYERS BEWARE"
Happy hunting to all,
Shoe
World's First Therapeutic Vaccine for Brain Cancer Commercially Available to Patients in Switzerland Monday July 9, 2:00 am ET Swiss 'Authorization for Use' Approved for DCVax(R)-Brain ~ Patient survival is more than doubled in both newly diagnosed and recurrent brain cancers ~ BOTHELL, Wash., July 9 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBO; AIM: NWBS and NWBT), is pleased to announce that it has received Authorization for Use from the Swiss Institute of Public Health (Bundesamt fur Gesundheit; "BAG") to make DCVax®-Brain commercially available for treatment of brain cancer patients in Switzerland. As such, DCVax®-Brain is the first commercially available therapeutic vaccine for such cancers. The Company intends to begin making the product available to patients in Q3 2007. Dr. Alton Boynton, President and CEO of Northwest Biotherapeutics, said: "We are delighted to be the first company to reach the market with a personalized therapeutic vaccine for brain cancers, which carry a very bleak prognosis for patients today. We look forward to providing DCVax®-Brain at leading medical centers and hospitals in Switzerland. Switzerland is an attractive place to begin commercialization, due to its highly respected regulatory oversight, and its growing experience with cellular therapies. Switzerland is also increasingly noted for medical tourism, and is easily accessible for many medical tourists. We look forward to being able to bring DCVax®-Brain to patients in additional countries, and to applying our DCVax® technology to many other cancers, including the five for which we already have FDA clearance to begin clinical trials." "Finally, we are especially pleased to achieve such a major milestone substantially ahead of schedule and so soon after our flotation on the AIM market of the London Stock Exchange." Brain cancers can strike all ages, and are the leading cause of cancer deaths in children under the age of 20. Brain cancers are among the most rapidly lethal cancers: with the limited treatments available today, even newly diagnosed patients have a median survival of only 14.6 months. In clinical trials, both newly diagnosed and recurrent brain cancer patients treated with DCVax®-Brain had more than double the survival time of patients who did not receive DCVax®-Brain (to over 33 months and continuing -- median not yet reached -- for newly diagnosed patients). In addition, unlike chemotherapy, DCVax®-Brain does not cause any debilitating side effects. Under the Swiss Authorization for Use, the Company is permitted to manufacture DCVax®-Brain in the US and make it available for the treatment of patients with brain cancer at select centers in Switzerland. The Authorization was granted in response to the Company's application in mid-February, 2007. It was based upon the Company's clinical data to date, and upon an extensive inspection by Swissmedic (the Swiss Agency for Therapeutic Products) on behalf of the BAG. NWBT's DCVax® is a platform technology which is anticipated to be applicable to most cancers. DCVax® works by mobilizing the full spectrum of immune response, both innate and adaptive, rather than just single immune agents such as antibodies alone or T cells alone. As such, DCVax® mobilizes the patient's immune system to function in its normal, natural way. This leads to both improved efficacy and lack of problematic toxicities. Unlike conventional cancer drugs, DCVax® does not cause any debilitating side effects. DCVax® products are personalized treatments, made by combining a patient's own master immune cells (dendritic cells) with cancer biomarkers derived from or displayed by the patient's own tumor. Precursors of the master immune cells are continuously circulating in a patient's blood and are obtained through a blood draw. The master immune cells are then matured and activated through a series of proprietary steps, then "educated" by exposure to the patient's tumor biomarkers, and injected back into the patient through a simple intradermal injection in the arm or thigh, consisting of just a few drops. Unlike many personalized therapies under development, DCVax® products will be cost-effective. The key to their cost-effectiveness is a proprietary batch manufacturing process pioneered by NWBT, through over 10 years of development, under which a single manufacturing run is used to produce at least 3 years of personalized treatments for a particular patient. The treatments are stored frozen in single-dose vials, ready for use on an off-the-shelf basis for that patient. Such storage is highly reliable and low cost. By doing only one manufacturing run, and thereafter having the product available off-the-shelf, NWBT is able to keep the costs of its personalized vaccines at a level that can enable product pricing in a range comparable to other cancer drugs. In parallel with making DCVax®-Brain commercially available to patients at selected medical centers in Switzerland, NWBT is also conducting a Phase II pivotal trial in 141 patients in the US. The trial began enrolling patients in December 2006, and is anticipated to conclude around the end of 2008. The Company plans to seek product approval in both the US and EU in early 2009, based upon the results of the Phase II pivotal trial. DCVax®-Brain has been granted orphan drug status in both the US and the EU. Such status will afford DCVax®-Brain 7 years of market exclusivity in the US and 10 years in the EU, if DCVax®-Brain is the first product of its type to reach product approval. Clinical trial data to date in brain cancer patients have shown that DCVax®-Brain delays disease recurrence by nearly 3-fold, from 6.9 months to 18.1 months for newly diagnosed patients. DCVax®-Brain also extends these patients' survival from 14.6 months to more than 33 months (and continuing -- median not yet reached). The DCVax® Technology platform is anticipated to be applicable to most cancers. NWBT is already at the Phase III, pivotal trial stage in prostate cancer, and has also received FDA clearance for clinical trials in five other cancers (including lung cancer, the leading cause of cancer deaths worldwide). Clinical trial data to date in hormone independent prostate cancer patients have shown striking results similar to the results in brain cancer About Northwest Biotherapeutics, Inc. Northwest Biotherapeutics, Inc. is a US-based biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis. The Company has two broad platform technologies: (1.) dendritic cell-based therapeutic vaccines and (2.) antibody drugs. The Company's lead product candidates are: 1. DCVax®-Brain, a personalized dendritic cell vaccine for treatment of Glioblastoma multiforme, which has reached the market commercially in Switzerland and, in parallel, has been under way since December, 2006, in a Phase II pivotal clinical in the US which is expected to finish around the end of 2008; and 2. DCVax®-Prostate, a personalized dendritic cell vaccine for treatment of hormone independent non-metastatic prostate cancer, which has been cleared by the FDA to enter a Phase III pivotal clinical trial in the US.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
FORM 10-Q
þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2007 OR
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission file number 0-26825
Northwest Biotherapeutics, Inc.
Incorporated under the laws of the State of Delaware I.R.S. Employer Identification No. 94-3306718
18701 — 120th Avenue NE, Suite 101 Bothell, Washington 98011 (425) 608-3000 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act
Large accelerated filer o Accelerated filer o Non-accelerated filer þ
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes o No þ As of April 30, 2007, the total shares of common stock outstanding is 65,241,287.
Toucan Capital and Toucan Partners beneficially own the vast majority of our stock and, as a result, the trading price for our shares may be depressed and these stockholders can take actions that may be adverse to your interests. As of April 30, 2007, Toucan Capital beneficially owned an aggregate of approximately 360.7 million shares of our common stock issuable pursuant to conversion of Series A Preferred Stock, Series A-1 Preferred Stock and warrants, representing beneficial ownership of approximately 85% of our outstanding common stock, on an as-converted to common stock basis. In additional, Toucan Partners, an affiliate of Toucan Capital, holds convertible notes in aggregate principal amount of $4.1 million (which had accrued interest of $216,000 as of April 30, 2007). These notes are not currently convertible for a determinable number of shares. Additionally, Toucan Partners holds a series of warrants that are exercisable at the same price as the convertible notes are convertible, which as noted above has not yet been fixed. Once the conversion price has been fixed, the warrants will be exercisable for the same number of shares into which the promissory notes are convertible (including accrued interest a the time of the conversion or repayment of the promissory notes). The Series A Preferred Stock and Series A-1 Preferred Stock is convertible into common stock (at the rate of 1-for-1 in the case of Series A Preferred Stock and at the rate of 1-for-40 in the case of Series A-1 Preferred Stock). This significant concentration of ownership may adversely affect the trading price for our common stock because investors often perceive disadvantages in owning stock in companies with controlling stockholders. Toucan Capital and Toucan Partners have the ability to exert substantial influence over all matters requiring approval by our stockholders, including the election and removal of directors and any proposed merger, consolidation or sale of all or substantially all of our assets. In addition, they can dictate the management of our business and affairs. This concentration of ownership could have the effect of delaying, deferring or preventing a change in control, or impeding a merger or consolidation, takeover or other business combination that could be favorable to you. In addition, Toucan Capital and Toucan Partners each has a right of first refusal to participate in our future issuances of debt or equity securities. Also, under the terms of our recapitalization agreement, we are required to consult with Toucan Capital on how we conduct many aspects of our business. As a result, Toucan Capital has significant influence in regard to how we conduct our business, and with its stock ownership, could influence any matters requiring stockholder approval. This influence may cause us to conduct our business differently from the way we have in the past. The concentration of ownership may also delay, deter or prevent acts that would result in a change in control, which, in turn, could reduce the market price of our common stock. The finalization of the terms of the 2007 Convertible Notes and 2007 Warrants will result in further dilution of the value of our common stock. A noted above, the number of shares into which the 2007 Convertible Notes can be converted and the number and price of the 2007 Warrants have not yet been determined. Upon completion of the negotiations with Toucan Partners, the finalized terms for these notes and warrants are likely to include additional significant dilution to the value of our existing outstanding common stock. There may not be an active, liquid trading market for our common stock.
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