Neues marihuana-aktien IPO: Zynerba -Konkurrenz für GWPH?

http://zynerba.com/

 

Zynerba IPO

Das seit 10 Jahren am Markt etablierte Pharmaunternehmen Zynerba ist spezialisiert auf die Entwicklung und den Vertrieb von syntethischen sog. "Next-Generation" Cannabinoid-Therapeutika  die in erster Linie über die Haut in Form von Gels oder Cremes aufgenommen werden. Das Unternehmen reiht sich ein in die Peergroup GW Pharmaceuticals, Cara Therapeutics, INsys Therapeutics u.a. Ob sich das Unternehmen gegenüber ihrer Konkurrenz am Markt behaupten kann wird sich zeigen. Auf alle Fälle stellt die Neuemission eine Chance für diejenigendar, die die Anfänge der Highflyer wie GW oder Insys verpasst haben. 

Zynerba Pharmaceuticals reichte nun bei der SEC das für das IPO erforderliche S-1 Formular ein und steht somit kurz vor ihrem Börsengang. Die Bookbulidingspanne beträgt voraussichtlich 13-15 $ für 3 Mio. Aktien, der Greenshoe (Mehrzuteilungsoption) beträgt zudem 1,45 Mio. Aktien. Wird das obere Ende der Bookbulidingspanne erreicht spült dies 51,075 Mio. USD in die Kasse von Zynerba.

Zynerba wird zukünftig an der Nasdaq unter dem Symbol ZYNE handelbar sein.

Read more: Zynerba Updates IPO Terms - 24/7 Wall St. http://247wallst.com/healthcare-business/2015/08/03/zynerba-updates-ipo-terms/#ixzz3hpKUEB4X

http://www.nasdaq.com/markets/ipos/company/zynerba-pharmaceuticals-inc-946800-78846

Company Description


We are a ten-year-old specialty pharmaceutical company focused on developing and commercializing proprietary next-generation synthetic cannabinoid therapeutics formulated for transdermal delivery. Our management team is highly experienced and has a successful history of development, regulatory  approval and commercialization of patch and gel transdermal delivery  products. We are evaluating two patent-protected product candidates, ZYN002 and ZYN001, in five indications. We intend to study ZYN002 in patients with refractory epilepsy, Fragile X syndrome, or FXS, and osteoarthritis, or OA. We intend to study ZYN001 in patients with fibromyalgia and peripheral neuropathic pain. We expect to initiate Phase 1 clinical trials for ZYN002 in the second half of 2015 and ZYN001 by mid-2016. Cannabinoids are a class of compounds derived from Cannabis plants. The two primary cannabinoids contained in Cannabis are cannabidiol, or CBD, and †9-tetrahydrocannabinol, or THC. Clinical and preclinical data suggest that CBD has positive effects on treating refractory epilepsy, FXS and arthritis and THC has positive effects on treating pain. Interest in cannabinoid therapeutics has increased significantly over the past several years as preclinical and clinical data has emerged highlighting the potential efficacy and safety benefits of cannabinoid therapeutics. The cannabinoid therapeutics market is expected to grow significantly due to the potential benefits these products may provide over existing therapies. In addition to ZYN002 and ZYN001 potentially offering first-line therapies to patients suffering from FXS, OA, fibromyalgia and peripheral neuropathic pain, we believe ZYN002 may provide a  omplementary treatment for patients suffering from epilepsy who are refractory to their current treatment regimens. We believe that we offer an attractive alternative to existing cannabinoid therapies by synthetically manufacturing and transdermally delivering our product candidates. Most cannabinoid therapies have drawbacks and limitations due to their botanical (plant-derived) nature, as well as the fact that they are administered orally. Botanical cannabinoids create significant challenges for drug manufacturers because of the natural resources and security measures required to grow Cannabis, as well as the strict batch controls required by regulatory agencies in pharmaceutical manufacturing. In addition, we believe all currently approved and development-stage cannabinoid therapeutics, except ZYN002 and ZYN001, are designed to be administered orally which can lead to limitations in safety and efficacy including low bioavailability, inconsistent plasma levels, degradation by stomach acids, and significant first-pass liver metabolism. First-pass liver metabolism refers to the process by which the liver breaks down therapeutics ingested directly or indirectly through the gastrointestinal system, such as through oral or oral mucosal delivery methods, allowing only a small amount of drug to be absorbed into the circulatory system. In contrast, transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and degradation by stomach acids, and potentially enabling lower dosage levels of active pharmaceutical ingredients and rapid and reliable absorption with high bioavailability, fewer negative psychoactive effects and fewer drug-drug interactions. We have assembled a highly experienced management team, each of whom has over 25 years of pharmaceutical industry experience, including our chief executive officer and president, who have a track record of success for obtaining regulatory approval of and commercializing products using transdermal delivery. Armando Anido, our chairman and chief executive officer, previously served as the chief executive officer of two publicly traded companies, Auxilium Pharmaceuticals Inc., or Auxilium, and NuPathe, Inc., or NuPathe. Terri B. Sebree, our president, previously co-founded NuPathe and served as senior vice president, development at Auxilium, and has successfully developed ten products from Investigational New Drug Application to regulatory approval. Ms. Sebree most recently oversaw the development and regulatory approval of Testim® gel and Zecuity® patch. Richard A. Baron, our chief financial officer, has extensive experience as chief financial officer of public and private pharmaceutical companies, most recently having served as chief financial officer of Globus Medical, Inc. and, prior to that, at Avid Radiopharmaceuticals, Inc. ---
We were incorporated in Delaware in January 2007 under the name AllTranz, Inc., and in June 2007 we merged with AllTranz LLC, a Kentucky limited liability company that was founded in 2004 by Audra Stinchcomb, a pharmacologist and transdermal expert, with AllTranz, Inc. surviving. In May 2014, we were reorganized and recapitalized pursuant to an agreement and plan of merger whereby BCM Partners IV, Corp., a non-operating entity owned by BCM X1 Holdings, LLC and Audra Stinchcomb, two of our principal stockholders at that time, was merged with and into Alltranz, Inc., with Alltranz, Inc. surviving. In August 2014, AllTranz, Inc. changed its name to Zynerba Pharmaceuticals, Inc.  Our primary executive offices are located at 80 W. Lancaster Avenue, Suite 300, Devon, PA 19333 and our telephone number is (484) 581-7505. Our website addressis www.zynerba.com.


Read more: http://www.nasdaq.com/markets/ipos/company/zynerba-pharmaceuticals-inc-946800-78846#ixzz3hpQ6HtXR

Useof Proceeds

We estimate that we will receive net proceeds of approximately $36.3 million (or approximately $42.1 million if the underwriters' option to purchase additional shares is exercised in full) from the sale of the shares of common stock offered by us in this offering, based on an assumed initial public offering price of $14.00 per share (the mid-point of the price range set forth on the cover page of this prospectus), and after deducting the estimated  nderwriting discounts and commissions and estimated offering expenses payable by us. A $1.00 increase  decrease) in the assumed initial public offering price of $14.00 per share would increase (decrease) the net proceeds to us from this offering by approximately $2.8 million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, a 100,000 share increase (decrease) in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase (decrease) the net proceeds to us by approximately $1.3 million, based on an assumed initial public offering price of $14.00 per share (the mid-point of the price range set forth on the cover page of this prospectus), and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. The principal purposes of this offering are to obtain additional capital to support our operations, to establish a public market for our common stock and to facilitate our future access to the public equity markets. We intend to use the net proceeds from this offering for the following purposes: . approximately $16.4 million in the aggregate to fund the development efforts of ZYN002 for its target indications through Phase 2, of which we expect: . approximately $9.9 million will fund the general development efforts, including preclinical studies and Phase 1 clinical trials; and . approximately $6.5 million in the aggregate will fund three Phase 2a clinical trials, one for each target indication of refractory epilepsy, FXS and OA; . approximately $14.2 million in the aggregate to fund the development efforts of ZYN001 for its target indications through Phase 2, of which we expect: . approximately $9.7 million will fund the general development efforts, including preclinical studies and Phase 1 clinical trials; and . approximately $4.5 million in the aggregate will fund two Phase 2a clinical trials, one for each target indication of fibromyalgia and peripheral neuropathic pain. The remaining $5.7 million of the net proceeds from this offering will be used to fund working capital, research and development and general corporate purposes. We may also use a portion of the remaining net proceeds to in-license, acquire, or invest in complementary
businesses, intellectual property, products or assets. However, we have no current commitments or obligations to do so. We expect that the net proceeds  from this offering and our existing cash and cash equivalents will be
sufficient to fund our operations and capital requirements for the next 24 months. We believe that these available funds will be sufficient to complete (i) Phase 1 clinical trials for ZYN002 and three Phase 2a clinical trials for this product candidate, one for each target indication of refractory epilepsy, FXS and OA and (ii) Phase 1 clinical trials for ZYN001 and two Phase 2a clinical trials for this product candidate, one for each target indication of
fibromyalgia and peripheral neuropathic pain. The progress of ZYN002 and ZYN001 for each target indication is uncertain due to numerous factors, including, without limitation, the rate of progress of clinical trials, the results of preclinical studies and clinical trials for such indication, the costs and timing of seeking and obtaining FDA, DEA and other regulatory approvals for clinical trials and FDA guidance regarding clinical trials for such indication. In addition, it is difficult to predict our required spending for our product  candidates prior to obtaining FDA approval. Moreover, changing circumstances may cause us to expend cash significantly faster than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control. Our expected use of the net proceeds from this offering represents our current intentions based upon our present plans and business condition. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering, or the amounts that we will actually spend on the uses set forth above. The amounts and timing of our actual use of the net proceeds will vary depending on numerous factors, including our ability to gain access to additional financing, the relative success and cost of our research, preclinical and clinical development programs and whether we are able to enter into future licensing arrangements. As a result, our management will
have broad discretion in the application of the net proceeds, and investors will be relying on our judgment regarding the application of the net proceeds of this offering. Pending their use, we plan to invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.


Read more: http://www.nasdaq.com/markets/ipos/company/zynerba-pharmaceuticals-inc-946800-78846#ixzz3hpR0EmKM