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Due Diligence Report: Commencement of Clinical Trials Sends ARTH Soaring
Arch Therapeutics, Inc. (Arch), incorporated on September 16, 2009, is a life science medical device company. Arch is a biotechnology company, which is focused on developing an approach for the cessation of bleeding (hemostasis) and control of fluid leakage (sealant) during surgery and trauma care. The Company’s technology is based on a self-assembling peptide that creates a physical, mechanical barrier, which could be applied to seal organs or wounds that are leaking blood and other fluids. Arch Biosurgery, Inc. is a subsidiary of the Company.
The Company’s products are in preclinical development. Its development-stage product, AC5 Surgical Hemostatic Device (AC5), is designed to achieve hemostasis in minimally invasive and open surgical procedures. AC5 is designed to be a biocompatible synthetic peptide that consists of naturally occurring amino acids and used for direct application as a liquid. When applied to a wound, AC5 intercalates into the interstices of the connective tissue where it self-assembles into a physical, mechanical structure that provides a barrier to leaking substances, such as blood. It conforms to irregular wound geometry, allows for normal healing, and helps maintain a clear field of vision. AC5 is a clear transparent gel that enables doctors to see through it as they work, performing Crystal Clear Surgery. The Company is focused on conducting its human clinical trial of AC5, a randomized controlled single-blind investigation, which is designed to assess safety and performance of AC5 in bleeding wounds created during the course of a dermatological procedure in approximately 50 patients. The Company is in the development stage, has not generated any revenues.
Arch Therapeutics, Inc. has a current market capitalization of $23.89 M with 109.57 M outstanding shares. Its daily average volume traded is 151,008 shares.
Financial Highlights (Q3 2015):
Gross Profit: Nil
Net Income: -1.16M
Cash and Cash Equivalents: 2.82 M
Total Debt: 1.24 M
Recent News and Analysis:
The company recently announced that it has initiated patient enrollment and treatment in its first clinical trial in Western Europe. The randomized controlled single-blind investigation is designed to assess safety and performance of AC5 during the course of a dermatological procedure performed in up to approximately 45 patients, of whom 10 will be taking an antiplatelet medication (commonly referred to as a “blood thinner”) during the study period. Patients participating in the study will have at least two dermatological lesions removed surgically. One of the wounds created as a result of the excision will receive AC5 while the other will receive a control treatment. The endpoints include product related adverse effects and time to hemostasis. Follow-up assessments of patients are planned for seven and 30 days following the procedure. As previously stated, data are projected to be available within two quarters of the start of the trial.
Dr. Norchi, President and CEO of Arch said, “This clinical trial is a key component of our commercialization plan, representing the first time that AC5 has been used on humans in a surgical setting. Further, it highlights that Arch has completed a number of important achievements that are required before a patient could be treated with AC5. As we are getting closer to bringing AC5 to market, we continue to advance our pre-clinical work and clinical-regulatory planning for additional indications for AC5 and other products, in each case with the ultimate goal of making a difference in patients’ lives.”
Entering the clinical trials sent the stock up 14.5% mid-day Monday as investors hope for positive results from these trials in the quarters to come. With the mindset that entering into a position early will pay off, the stock doubled its daily average of shares traded by mid-day Monday and has tested and held above its 20 day SMA all morning. Investors should watch for whether it closes and above the 20 day SMA to strengthen the trend reversal into the positive, upward direction. As always, perform your due diligence before investing in stocks, especially small caps.
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