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.80 9m vol
PTX is on fire.
VANCOUVER, Washington, Aug. 17, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that management will hold an investment community conference call on Friday, August 19, 2016, at 1:30 p.m. PT / 4:30 p.m. ET to provide an update on clinical trial and regulatory developments.
Conference Call and Webcast Instructions
CytoDyn’s management team will host a conference call and live audio webcast on August 19, 2016 at 1:30 p.m. PT / 4:30 p.m. ET.
Interested participants and investors may access this conference call by dialing 877-407-2986 (U.S./Canada) or 201-378-4916 (international).
A live audio webcast may also be accessed via CytoDyn’s corporate web site at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 60 days. Web participants are encouraged to go to the web site 15 minutes prior to the start of the call to register, download and install any necessary software. The webcast can also be accessed via the following link: http://cytodyn.equisolvewebcast.com/inv-call-8-19-16.
A replay of the conference call will be available until October 19, 2016. To access the replay, interested parties may dial 877-660-6853 (U.S./Canada) or 201-612-7415 (international); Conference ID: 13643977.
Contact:
CONTACTS:
Investors:
LHA
Jody Cain
Office: 310-691-7100
E-mail: jcain@lhai.com
Media:
RooneyPartners
Marion Janic
Office: 212-223-4017
Email: mjanic@rooneyco.com
OGEN has been moving up this week?
PTX chart.
$PTX pic.twitter.com/wi9WTf8pvC
— Phil Martin (@fm23) August 19, 2016
PTX moving fast. A lot of buyout rumors have been going around.
Unbelievable the Olympics let a dude compete in the women's 800m. HE/She. He won the heat.
How do you like the warrants? ONTXW.
MMs took out stops. Usually means something big is coming. IMO
How nice MM pulled a bear raid after I paid 4.07. ONTX. It will go back up.
I can't post on that board. Not premium.
ONTX. SCHEDULE 13D/A 08/11/16
Name of Reporting Person
Michael B. Hoffman
Aggregate Amount Beneficially Owned by Each Reporting Person
1,410,345 20.9%
Several recent form 4's.
BRIEF-Tyndall Capital reports 13.5 percent passive stake in Onconova
BY Reuters
— 6:26 AM ET 08/18/2016
Aug 18 (Reuters) - Onconova Therapeutics Inc ( ONTX
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* Tyndall Capital Partners LP reports 13.5 percent passive stake in Onconova Therapeutics Inc ( ONTX
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), as of July 29, 2016 - SEC filing Source text for Eikon: Further company coverage:
Item 4. Ownership
(a) Amount Beneficially Owned: 911,456**
(b) Percent of Class: 13.5%**
ONTX. Answered my own question. So this puts the OS at about 7m.
Completion of $17.4 Million Oversubscribed Financing
On July 29, 2016, Onconova closed its oversubscribed rights offering. Although the number of units able to be sold was capped at a maximum of 4,256,186 units (or approximately $17.4 million in gross proceeds), there was a total demand for approximately 4.9 million units in the rights offering.
Overall, 4,256,186 units consisting of a total of 3,599,786 shares of common stock, pre-funded warrants to purchase an additional 656,400 shares of common stock, and 3,192,022 tradable warrants were issued in this offering.
Including the net proceeds from the rights offering of approximately $15.8 million, Onconova had cash and cash equivalents of approximately $27.6 million at July 31, 2016.
Ash I went long on ONTX. Chart.
$ONTX back in play....big buyers here..... huge accumulation on charts.... Could explode higher. pic.twitter.com/x5H7NjrC0x
— Antonio Costa (@ACInvestorBlog) August 18, 2016
Chart
$ONTX back in play....big buyers here..... huge accumulation on charts.... Could explode higher. pic.twitter.com/x5H7NjrC0x
— Antonio Costa (@ACInvestorBlog) August 18, 2016
RPTP and PTX buyout rumors.
https://twitter.com/SFULL34/status/766026525686759425
RPTP. Shire buyout rumors. Up AH.
ARTH.
Regis999 Wednesday, 08/17/16 08:44:03 AM
Re: None
Post #
3852
of 3882 Go
Interesting comment on ARTH ARCH from seeking alpha:
"Several observations: ARTH cannot fully publish data and then get an article in a peer-reviewed publication. Strategic partners look at peer-reviewed publications as being the litmus test of credibility.
The ARTH advisory group is not going to risk their scientific credibility by hyping the results of this initial trial so I place great emphasis on what they have to say.
Anyone who doesn't think a 41% reduction in bleeding is significant is a moron. ANYTIME you can reduce bleeding time, you do so. Period. Ask any surgeon.
Finally, any company in this space that shows even modest results is eventually purchased. I have no doubt that ARTH will find a strategic partner or get purchased and at multiples significantly higher than the stock price today."
Elevator Summary of ARCH http://www.archtherapeutics.blogspot.com/
PTX. Orbimed holdings.
Orbimed holdings? What is PRN?
PERNIX THERAPEUTICS HLDGS IN COM 71426V108 481 1,073,000 SH DFND 1 485,000 0 588,000
PERNIX THERAPEUTICS HLDGS IN DBCV 4.250% 4/0 71426VAK4 2,549 12,000,000 PRN DFND 1 6,500,000 0 5,500,000
https://www.sec.gov/Archives/edgar/data/1055951/000117266116003893/xslForm13F_X01/infotable.xml
Orbimed holdings? What is PRN?
PERNIX THERAPEUTICS HLDGS IN COM 71426V108 481 1,073,000 SH DFND 1 485,000 0 588,000
PERNIX THERAPEUTICS HLDGS IN DBCV 4.250% 4/0 71426VAK4 2,549 12,000,000 PRN DFND 1 6,500,000 0 5,500,000
https://www.sec.gov/Archives/edgar/data/1055951/000117266116003893/xslForm13F_X01/infotable.xml
FYI Baker bros sold out of LIFE.
MGT chart.
$MGT is breaking out of a flag formation on hourly. pic.twitter.com/l6xFA1mNBa
— Antonio Costa (@ACInvestorBlog) August 15, 2016
RespireRx Pharmaceuticals Inc. Files June 30, 2016 Quarterly Report on Form 10-Q
Marketwired August 15, 2016
GLEN ROCK, NJ--(Marketwired - Aug 15, 2016) - RespireRx Pharmaceuticals Inc. ( OTCQB : RSPI ) ("RespireRx" or the "Company"), a leader in the development of medicines for respiratory disorders, including sleep apneas and drug-induced respiratory depression, has filed its June 30, 2016 Quarterly Report on Form 10-Q and is hereby providing an update on the Company's ongoing clinical trials, financing activities and its plans for the remainder of 2016.
Comments by Chief Executive Officer
James S. Manuso, Ph.D., President, Chief Executive Officer and Vice Chairman of RespireRx, commented, "We are pleased to report to RespireRx shareholders the clinical development accomplishments that occured during the second quarter of 2016. These important milestones further establish the foundation for RespireRx's growth going forward. Phase 2 clincal trials for CX1739 for opioid-induced respiratory depression and dronabinol for Obstructive Sleep Apnea are on schedule to conclude and report results in the coming months."
Dr. Manuso continued, "To fund our clinical trial activities, we successfully raised additional equity capital during the three months ended June 30, 2016. We are continuing our efforts to fully fund our drug development activities, including our clinical trial programs, and to strengthen our balance sheet."
Dr. Manuso concluded, "We encourage those interested in learning more about the current clinical landscape for treating respiratory diseases to follow continuing developments at RespireRx."
Developments during the Three Months Ended June 30, 2016
Key developments during the three months ended June 30, 2016 included the following:
The Company conducted a Phase 2A human subject clinical trial at the Duke University School of Medicine to evaluate the Company's lead oral compound, CX1739, for the prevention of respiratory depression caused by remifentanil, a potent opioid, while maintaining its desired analgesic effects. The double-blind, placebo-controlled dose-ascending Phase 2A clinical trial completed dosing in June 2016 and was formally completed on July 11, 2016. The Company expects to complete a preliminary top-line analysis of the respiratory data by the end of September 2016 and to issue a final report on the results of the clinical trial by the end of December 2016.
A Phase 2B clinical trial evaluating dronabinol in 120 patients with Obstructive Sleep Apnea is being led by University of Illinois researchers. The University of Illinois has indicated that recruitment for this clinical trial was completed during the second quarter of 2016. Final research results are expected to be published in the fourth quarter of 2016.
The Company raised aggregate gross proceeds of approximately $115,000 from the sale of units comprised of common stock and warrants and approximately $762,000 from warrant exchange transactions effected in conjunction with the Note Exchange Agreements and Unit Exchange Agreements.
The Note Exchange Agreements resulted in the elimination from the Company's balance sheet of convertible notes with a principal amount of $303,500, plus accrued interest of $40,993.
All outstanding shares of Series G 1.5% Convertible Preferred Shares (including accrued but unpaid dividends) were automatically and mandatorily redeemed via conversion into shares of common stock on April 17, 2016.
The Company presented at and otherwise participated in a number of investor conferences.
Research and Development Overview
RespireRx is a leader in the development of medicines for respiratory disorders, holding exclusive licenses and owning patents and patent applications for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders. The Company also controls rights and associated patents covering claims for novel uses of known drugs.
RespireRx has a pipeline of medicines in Phase 2 clinical trials focused on a variety of different breathing disorders. Clinical development advancements in the area of respiratory disorders, particularly drug-induced respiratory depression and sleep apnea, have created multiple opportunities for the ultimate commercialization of the Company's medicines.
RespireRx's pharmaceutical candidates in development, which are derived from two platforms, are as follows:
One platform of medicines being developed by RespireRx is a class of proprietary compounds known as ampakines, which act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors. Several ampakines, in both oral and injectable form, are being developed by the Company for the treatment of a variety of breathing disorders. In clinical studies, select ampakines have shown preliminary efficacy in central sleep apnea and in the control of respiratory depression produced by opioids, without altering the opioid analgesic effects. In animal models of orphan disorders, such as Pompe Disease, spinal cord damage and perinatal respiratory distress, it has been demonstrated that certain ampakines improve breathing function. The Company's compounds belong to a new class that does not display the undesirable side effects previously reported for other ampakines.
The other platform is the class of compounds known as cannabinoids, including, in particular, dronabinol. Under a license agreement with the University of Illinois, the Company has rights to patents claiming the use of cannabinoids for the treatment of sleep-related breathing disorders. In a double-blind, placebo-controlled, dose-ascending Phase 2A clinical study conducted by the Company, dronabinol produced a statistically significant reduction in the Apnea-Hypopnea Index, the primary therapeutic end-point, and was observed to be safe and well-tolerated in a group of patients with Obstructive Sleep Apnea.
Information with respect to current clincal trials involving RespireRx's pharmaceutical candidates is as follows:
The Company filed an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") in September 2015 to conduct a double-blind, placebo-controlled, dose-ascending Phase 2A clinical trial in approximately 18 subjects to determine the ability of orally administered CX1739, the Company's proprietary lead ampakine, to prevent the respiratory depression produced by remifentanil, a potent opioid, without altering remifentanil's analgesic properties. The clinical protocol was designed to evaluate the safety and efficacy of three escalating doses of CX1739 versus placebo when administered prior to remifentanil, with respiration, analgesia and a number of other clinical measures being taken after administration of both drugs. The commencement of this clinical trial was subject to resolution of two deficiencies raised by the FDA in its clinical hold letter issued in November 2015. These issues were satisfactorily resolved in early 2016, and the FDA removed the clinical hold on the Company's IND for CX1739 on February 25, 2016, thus allowing for the initiation of the clinical trial. During March 2016, upon receiving unconditional approval from the Institutional Review Board of the Duke Clinical Research Unit, this Phase 2A clinical trial at Duke University School of Medicine was initiated, with the dosing portion of the clinical trial completed in June 2016 and the clinical trial formally completed on July 11, 2016. The Company is currently working with the Duke University clinical research team to analyze the data collected. The Company expects to complete a preliminary top-line analysis of the respiratory data by the end of September 2016 and to issue a final report on the results of the clinical trial by the end of December 2016.
The University of Illinois and three other research centers are currently investigating dronabinol in a potentially pivotal, six week, double-blind, placebo-controlled Phase 2B clinical trial in 120 patients with OSA. The University of Illinois has indicated that recruitment for this clinical trial was completed during the second quarter of 2016. Final research results are expected to be published in the fourth quarter of 2016. This clinical trial is fully funded by the National Heart, Lung and Blood Institute of the National Institutes of Health. The Company is not managing or funding this clinical trial.
Financial Overview and Selected Financial Information
The Company incurred a net loss of $2,731,249 and $1,249,632 for the three months ended June 30, 2016 and 2015, respectively, and $5,412,200 and $1,977,584 for the six months ended June 30, 2016 and 2015, respectively. The Company incurred negative operating cash flows of $867,898 and $322,695 for the six months ended June 30, 2016 and 2015, respectively. The Company expects to continue to incur net losses and negative operating cash flows for the next few years.
As a result of adjustments related to the Series G 1.5% Convertible Preferred Stock, for the three months ended June 30, 2016 and 2015, the Company incurred a net loss attributable to common stockholders of $2,731,433 and $1,251,206, respectively, reflecting a net loss per common share of $0.00 for both 2016 and 2015. For the six months ended June 30, 2016 and 2015, the Company incurred a net loss attributable to common stockholders of $5,413,365 and $1,982,356, respectively, reflecting a net loss per common share of $0.01 for both 2016 and 2015.
At June 30, 2016, the Company had 656,159,420 shares of common stock outstanding, as compared to 489,846,883 shares of common stock outstanding at December 31, 2015. The exercise of all outstanding stock options and warrants, and the conversion of all outstanding convertible debt, would have resulted in the issuance of an additional 573,126,198 shares of common stock.
At June 30, 2016, the Company had a working capital deficit of $3,743,908, as compared to a working capital deficit of $2,922,279 at December 31, 2015, reflecting an increase in the working capital deficit of $821,629 for the six months ended June 30, 2016. At June 30, 2016, the Company had cash aggregating $347,256, as compared to $53,199 at December 31, 2015,
At June 30, 2016, the Company had $276,000 principal amount of 10% convertible notes payable outstanding (plus accrued interest of $46,757), which mature and become due and payable in full on September 15, 2016. The Company is continuing efforts to extend and/or satisfy these notes payable through the issuance of the Company's securities prior to the maturity date, although there can be no assurances that the Company will be successful in this regard.
The Company is continuing efforts to raise additional capital in order to pay its liabilities, fund its business activities and underwrite its research and development programs. The Company regularly evaluates various means to satisfy the Company's liquidity needs, including the development of agreements with collaborative partners and, when necessary, the exchange or restructuring of the Company's outstanding securities. As a result of the Company's current financial situation, the Company has limited access to external sources of debt and equity financing. Accordingly, there can be no assurances that the Company will be able to secure additional financing in the amounts necessary to fund its operating and debt service requirements. If the Company is unable to access sufficient cash resources on a timely basis, the Company may be forced to reduce operations indefinitely or to discontinue operations entirely and liquidate.
Additional information with respect to the Company's financial condition, results of operations, cash flows, capital structure and other matters involving the business, operations and research and development activities of the Company is included in the Company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016, as filed with the U. S. Securities and Exchange Commission.
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the development of medicines for respiratory disorders, with a focus on sleep apneas and drug-induced respiratory depression. The Company holds exclusive licenses and owns patents and patent applications for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.
RespireRx has a pipeline of compounds in Phase 2 clinical development focused on pharmaceutical treatments for a variety of different breathing disorders. Clinical development in the area of respiratory disorders, particularly drug-induced respiratory depression and sleep apnea, has created opportunities for the development and commercialization of the Company's compounds.
In addition to its cannabinoid platform, RespireRx is developing pharmaceutical candidates in derived from a platform of ampakines, a class of proprietary compounds which act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors.
Several ampakines, in both oral and injectable forms, are being developed by RespireRx for the treatment of a variety of breathing disorders. In clinical studies, select ampakines have shown preliminary efficacy in central sleep apnea and in the control of opioid-induced respiratory depression, without altering the analgesic effects. In animal models of orphan disorders, such as Pompe Disease, spinal cord damage and perinatal respiratory distress, it has been demonstrated that certain ampakines improve breathing function. The Company's compounds belong to a new class that does not display the undesirable side effects previously reported for other ampakines.
Additional information about the Company and the matters discussed herein can be obtained on the Company's web-site at www.RespireRx.com or in the Company's filings with the U.S. Securities and Exchange Commission at www.sec.gov.
Cautionary Note Regarding Forward-Looking Statements
Arch Therapeutics Reports AC5 Topical Hemostatic Device Meets Primary and Secondary Endpoints in First Clinical Study
Marketwired August 15, 2016
FRAMINGHAM, MA--(Marketwired - Aug 15, 2016) - Arch Therapeutics, Inc. ( OTCQB : ARTH ) ("Arch" or the "Company"), developer of devices for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, successfully met the objectives of its recently completed single-center, randomized, single-blind prospective clinical study (NCT 02704104) of the AC5 Topical Hemostatic Device in skin lesion patients with bleeding wounds. This was the first study assessing the safety and performance of AC5 in humans.
The objectives of the study were to evaluate the safety and performance of AC5 in patients scheduled to undergo excision of skin lesions on their trunk or upper limbs. The primary endpoint was safety throughout the surgical procedure and until the end of a 30-day follow-up period post procedure. Safety of the clinical investigation device was determined by monitoring for treatment related adverse events. The primary objective was met, as the safety outcomes of both the AC5 treatment group and the control group were similar. No serious adverse events were reported.
A secondary endpoint was performance as assessed by time to hemostasis. The median time to hemostasis of wounds in the AC5 treatment group was 41% faster than for those in the control group. This result was statistically significant (p < 0.001, Wilcoxon signed rank test).
An additional secondary endpoint of healing of treated wounds was assessed as measured by the ASEPSIS wound score at Days 7 and 30. There was no evidence, at either follow-up day, of an adverse effect of AC5 treatment on the wound ASEPSIS score. The ASEPSIS score did not appear to be compromised, as the majority of patients had an ASEPSIS score of 0 in both wounds at Days 7 and 30. All AC5-treated wounds healed satisfactorily as per wound healing scoring criteria.
Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, "As we had anticipated, these top-line data support that AC5 was safe and performed as expected in the patients enrolled in this study throughout the completion of the patient assessments post-treatment and as supported in the subsequent statistical analysis. These successful results mark a significant milestone in the development of AC5 and we are grateful to all of those involved in the process. We look forward to further advancing our self-assembling peptide technology platform for this and other applications, including through conducting additional studies."
The clinical study enrolled 46 patients, including 10 who were taking antiplatelet monotherapy. Each patient had bleeding wounds created as a result of the excision of at least two skin lesions under local anesthetic in the same setting. On a randomized basis, one lesion received AC5 and the other(s) received a control treatment consisting of standard therapy plus a sham. Each subject was followed-up for safety assessment both on Day 7 and again on Day 30, which marked the end of the subject's participation in the clinical study.
Jack Kelly, MD, Principal Investigator of the study, and a plastic, reconstructive and aesthetic surgeon and Professor of Surgery at Galway University Hospital, Galway, Ireland, said, "These study results indicate significant potential for AC5 in the treatment of bleeding skin wounds. The safety and efficacy outcomes for AC5 in this study were impressive and reassuring. While possessing a safety profile at least as good as that of the control group, AC5 was associated with a clinically significant improvement in time to hemostasis. We are encouraged by how patients responded to the unique formulation of AC5 and how easy it was for a clinician to use."
Arch's clinical advisory committee has deemed the study results to be clinically significant and have recommended submitting a manuscript to a peer-reviewed medical journal for publication. The committee said, "In completing its first human study assessing the safety and performance of AC5, Arch has obtained impressive safety and efficacy data. We are incredibly enthusiastic about AC5 and its potential scope for other applications."
The advisors include Arthur Rosenthal, PhD, Professor of Practice, Emeritus, Department of Biomedical Engineering, Boston University, and a former member of Arch's Board of Directors; Steven Schwaitzberg, MD, Professor and Chairman of the Department of Surgery at the University of Buffalo's Jacobs School of Medicine and Biomedical Sciences and past President of the Society of American Gastrointestinal Endoscopic Surgeons; Paresh Shah, MD, Vice Chair of Surgery, Director of General Surgery and Professor of Surgery at New York University Langone Medical Center, New York University Langone School of Medicine; and William Denman, MD, anesthesiologist at Massachusetts General Hospital, past Chief Medical Officer of GE Healthcare and past Chief Medical Officer of Covidien.
The Company expects to submit further study details and data, including subgroup analysis, to a peer-reviewed journal for publication. The Company also plans to include data from this trial in a CE mark application for AC5, which is currently anticipated to be filed at the earliest by the end of this year. Arch is currently planning its next clinical-regulatory steps for both the EU and the US.
The study, conducted at University College Hospital, Galway, Ireland, was carried out in collaboration with CÚRAM, Science Foundation Ireland Centre for Research in Medical Devices and the Clinical Research Facility based at National University of Ireland in Galway.
"These results demonstrate significant improvement in efficacy without compromising patient safety. We believe that AC5 represents a unique technology that will provide both rapid and sustained hemostasis and important differentiable clinical benefits," concluded Norchi.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate, known as the AC5 Surgical Hemostatic Deviceâ„¢, is being designed to achieve hemostasis in surgical procedures.
About HRB Clinical Research Facility, Galway, Ireland
The HRB Clinical Research Facility, Galway (CRFG) is a joint venture between Galway University Hospitals (GUH), Saolta, and National University of Ireland, Galway (NUIG) and has been in operation since March 2008. The HRB-CRFG provides the infrastructure, physical space, facilities, expertise and culture needed to optimally support clinical research. It focuses on studies aimed at understanding a range of diseases and speedily translating the knowledge obtained through this research work into advances in patient care.
About CÚRAM
CÚRAM is the Science Foundation Ireland Centre for Research in Medical Devices, based at NUI Galway. Supported by Science Foundation Ireland (SFI) and industry partners, CÚRAM enhances Ireland's standing as a major hub for the global medical devices industry. Its goal is to radically improve quality of life for patients with chronic illness by developing the next generation of smart, implantable medical devices. CÚRAM's innovative approach incorporates biomaterials, drug delivery, cell based technologies, glycosciences and device design to enhance, develop and validate both traditional and new combinational medical devices, from molecular design stage to implant manufacturing. CÚRAM's devices are being developed with strong clinical collaborations to enable rapid translation of research findings to clinical application. Key to the approach is the establishment of unique networks of national and international collaborations, integrating world class clinical, academic and industrial partners
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27(a) of the Securities Act of 1933, as amended, and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this press release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, references to novel technologies and methods, our business and product development plans and projections, or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company, our ability to retain important members of our management team and attract other qualified personnel, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, our ability to obtain required regulatory approvals, our ability to develop and commercialize products based on our technology platform, and market conditions. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in the reports and other documents we file with the SEC, available at www.sec.gov.
On Behalf of the Board,
Terrence W. Norchi, MD
Arch Therapeutics, Inc.
ARTH. Arch Therapeutics Reports AC5 Topical Hemostatic Device Meets Primary and Secondary Endpoints in First Clinical Study
Marketwired August 15, 2016
FRAMINGHAM, MA--(Marketwired - Aug 15, 2016) - Arch Therapeutics, Inc. ( OTCQB : ARTH ) ("Arch" or the "Company"), developer of devices for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, successfully met the objectives of its recently completed single-center, randomized, single-blind prospective clinical study (NCT 02704104) of the AC5 Topical Hemostatic Device in skin lesion patients with bleeding wounds. This was the first study assessing the safety and performance of AC5 in humans.
The objectives of the study were to evaluate the safety and performance of AC5 in patients scheduled to undergo excision of skin lesions on their trunk or upper limbs. The primary endpoint was safety throughout the surgical procedure and until the end of a 30-day follow-up period post procedure. Safety of the clinical investigation device was determined by monitoring for treatment related adverse events. The primary objective was met, as the safety outcomes of both the AC5 treatment group and the control group were similar. No serious adverse events were reported.
A secondary endpoint was performance as assessed by time to hemostasis. The median time to hemostasis of wounds in the AC5 treatment group was 41% faster than for those in the control group. This result was statistically significant (p < 0.001, Wilcoxon signed rank test).
An additional secondary endpoint of healing of treated wounds was assessed as measured by the ASEPSIS wound score at Days 7 and 30. There was no evidence, at either follow-up day, of an adverse effect of AC5 treatment on the wound ASEPSIS score. The ASEPSIS score did not appear to be compromised, as the majority of patients had an ASEPSIS score of 0 in both wounds at Days 7 and 30. All AC5-treated wounds healed satisfactorily as per wound healing scoring criteria.
Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, "As we had anticipated, these top-line data support that AC5 was safe and performed as expected in the patients enrolled in this study throughout the completion of the patient assessments post-treatment and as supported in the subsequent statistical analysis. These successful results mark a significant milestone in the development of AC5 and we are grateful to all of those involved in the process. We look forward to further advancing our self-assembling peptide technology platform for this and other applications, including through conducting additional studies."
The clinical study enrolled 46 patients, including 10 who were taking antiplatelet monotherapy. Each patient had bleeding wounds created as a result of the excision of at least two skin lesions under local anesthetic in the same setting. On a randomized basis, one lesion received AC5 and the other(s) received a control treatment consisting of standard therapy plus a sham. Each subject was followed-up for safety assessment both on Day 7 and again on Day 30, which marked the end of the subject's participation in the clinical study.
Jack Kelly, MD, Principal Investigator of the study, and a plastic, reconstructive and aesthetic surgeon and Professor of Surgery at Galway University Hospital, Galway, Ireland, said, "These study results indicate significant potential for AC5 in the treatment of bleeding skin wounds. The safety and efficacy outcomes for AC5 in this study were impressive and reassuring. While possessing a safety profile at least as good as that of the control group, AC5 was associated with a clinically significant improvement in time to hemostasis. We are encouraged by how patients responded to the unique formulation of AC5 and how easy it was for a clinician to use."
Arch's clinical advisory committee has deemed the study results to be clinically significant and have recommended submitting a manuscript to a peer-reviewed medical journal for publication. The committee said, "In completing its first human study assessing the safety and performance of AC5, Arch has obtained impressive safety and efficacy data. We are incredibly enthusiastic about AC5 and its potential scope for other applications."
The advisors include Arthur Rosenthal, PhD, Professor of Practice, Emeritus, Department of Biomedical Engineering, Boston University, and a former member of Arch's Board of Directors; Steven Schwaitzberg, MD, Professor and Chairman of the Department of Surgery at the University of Buffalo's Jacobs School of Medicine and Biomedical Sciences and past President of the Society of American Gastrointestinal Endoscopic Surgeons; Paresh Shah, MD, Vice Chair of Surgery, Director of General Surgery and Professor of Surgery at New York University Langone Medical Center, New York University Langone School of Medicine; and William Denman, MD, anesthesiologist at Massachusetts General Hospital, past Chief Medical Officer of GE Healthcare and past Chief Medical Officer of Covidien.
The Company expects to submit further study details and data, including subgroup analysis, to a peer-reviewed journal for publication. The Company also plans to include data from this trial in a CE mark application for AC5, which is currently anticipated to be filed at the earliest by the end of this year. Arch is currently planning its next clinical-regulatory steps for both the EU and the US.
The study, conducted at University College Hospital, Galway, Ireland, was carried out in collaboration with CÚRAM, Science Foundation Ireland Centre for Research in Medical Devices and the Clinical Research Facility based at National University of Ireland in Galway.
"These results demonstrate significant improvement in efficacy without compromising patient safety. We believe that AC5 represents a unique technology that will provide both rapid and sustained hemostasis and important differentiable clinical benefits," concluded Norchi.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate, known as the AC5 Surgical Hemostatic Deviceâ„¢, is being designed to achieve hemostasis in surgical procedures.
About HRB Clinical Research Facility, Galway, Ireland
The HRB Clinical Research Facility, Galway (CRFG) is a joint venture between Galway University Hospitals (GUH), Saolta, and National University of Ireland, Galway (NUIG) and has been in operation since March 2008. The HRB-CRFG provides the infrastructure, physical space, facilities, expertise and culture needed to optimally support clinical research. It focuses on studies aimed at understanding a range of diseases and speedily translating the knowledge obtained through this research work into advances in patient care.
About CÚRAM
CÚRAM is the Science Foundation Ireland Centre for Research in Medical Devices, based at NUI Galway. Supported by Science Foundation Ireland (SFI) and industry partners, CÚRAM enhances Ireland's standing as a major hub for the global medical devices industry. Its goal is to radically improve quality of life for patients with chronic illness by developing the next generation of smart, implantable medical devices. CÚRAM's innovative approach incorporates biomaterials, drug delivery, cell based technologies, glycosciences and device design to enhance, develop and validate both traditional and new combinational medical devices, from molecular design stage to implant manufacturing. CÚRAM's devices are being developed with strong clinical collaborations to enable rapid translation of research findings to clinical application. Key to the approach is the establishment of unique networks of national and international collaborations, integrating world class clinical, academic and industrial partners
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27(a) of the Securities Act of 1933, as amended, and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this press release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, references to novel technologies and methods, our business and product development plans and projections, or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company, our ability to retain important members of our management team and attract other qualified personnel, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, our ability to obtain required regulatory approvals, our ability to develop and commercialize products based on our technology platform, and market conditions. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in the reports and other documents we file with the SEC, available at www.sec.gov.
On Behalf of the Board,
Terrence W. Norchi, MD
Arch Therapeutics, Inc.
STDY. Orbimed just filed a 13d showing a 14% stake. Large insider form 4 also. Something going on with this one?
Some probably had to drop due to the stock price.
This makes me feel better about my MGT shares.
http://www.nasdaq.com/symbol/mgt/institutional-holdings
MGT. McAfee is a speaker.
http://isc.360.cn/2016/en/index.html
FYI
I understand that, just that I don't have enough to make it worth to travel and celebrate somewhere.
You all must have a lot of shares. I only have 1000. Can't buy more right now. Had big hopes for my PTX but the 10Q wasn't as well as expected. A buy out is talked about hopefully that happens then I could come over here big. Even if I did get one million I would not go to NYC. Too big for me.
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Form 8-K for AMARIN CORP PLC\UK
12-Aug-2016
Entry into a Material Definitive Agreement, Other Events, Financial Statements
Item 1.01. Entry into a Material Definitive Agreement
On August 11, 2016, Amarin Corporation plc (the "Company," "we," "us" and "our") entered into an Underwriting Agreement (the "Underwriting Agreement") with Citigroup Global Markets Inc. and Jefferies LLC, as representatives of the several underwriters listed therein (the "Underwriters"), relating to the issuance and sale (the "Offering") of up to 21,100,000 American Depositary Shares ("ADSs"), including 3,165,000 ADSs issuable to the Underwriters pursuant to a 30-day option, with each ADS representing one of the Company's ordinary shares, par value ?0.50 per share. The price to the public in this offering is $2.85 per ADS, and the Underwriters have agreed to purchase the ADSs from Amarin pursuant to the Underwriting Agreement at a price of $2.679 per ADS. The net proceeds to us from the Offering are expected to be approximately $56.1 million, after deducting underwriting discounts and commissions and other estimated offering expenses, assuming no exercise of the option by the Underwriters. The Offering is expected to close on or about August 16, 2016, subject to customary closing conditions. The Company currently intends to use the net proceeds from the Offering to advance its REDUCE-IT cardiovascular outcomes trial and for general corporate and working capital purposes.
In the Underwriting Agreement, the Company makes customary representations, warranties and covenants and also agrees to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or to contribute to payments that the Underwriters may be required to make because of such liabilities. The Underwriting Agreement has been filed with this report to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. The foregoing is only a brief description of the material terms of the Underwriting Agreement and does not purport to be a complete description of the rights and obligations of the parties thereunder. The Underwriting Agreement is filed as Exhibit 1.1 to this report, and the description of the terms of the Underwriting Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of K&L Gates LLP relating to the legality of the issuance and sale of the ADSs in the Offering is attached as Exhibit 5.1 hereto.
The Offering was made pursuant to our effective registration statement on Form S-3 (Registration Statement No. 333-97936) previously filed with the U.S. Securities and Exchange Commission (the "SEC") on August 7, 2014 and declared effective on August 22, 2014, and a prospectus supplement thereunder filed on August 10, 2016.
Item 8.01. Other Events
On August 10, 2016, the Company issued a press release announcing that it had commenced the Offering. A copy of this press release is attached as Exhibit 99.1 hereto.
Forward-Looking Statements
This report contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about our issuance of securities, the amount of proceeds from the Offering, the closing of the Offering and our expectations regarding its anticipated use of proceeds from the Offering and the effects thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from any results expressed or implied by such forward-looking statements. For example, there are risks associated with the Underwriters fulfilling their obligations to purchase the securities, our ability to satisfy its conditions to close the Offering and our discretion in using the proceeds from this Offering. These and other risks and uncertainties are described more fully under the headings "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016 and the prospectus supplement related to the Offering. All forward-looking statements are qualified in their entirety by this cautionary statement. We are providing this information as of this date and do not undertake any obligation to update any forward-looking statements contained in this rep