Dividend equivalents may be credited in respect of shares covered by a restricted stock unit award, as determined by the Board of Directors. At the discretion of the Board of Directors, such dividend equivalents may be converted into additional shares covered by the restricted stock unit award.If a restricted stock unit award recipient’s service relationship with the Company terminates, any unvested portion of the restricted stock unit award is forfeited upon the recipient’s termination of service. Dr. Brenneman has over 30 years of research experience as a Section Chief within the intramural program at NICHD and as a Senior Research Fellow at Johnson & Johnson. He has more than 170 scientific publications and 15 patents focused on both evaluating neurotoxic and neuroprotective substances with various Central Nervous System preparations. At Johnson & Johnson, he was a team leader of the drug discovery group that advanced three compounds through discovery and preclinical testing.
During the past ten years, none of our directors and executive officers has been involved in any of the events described in Item 401 of Regulation S-K. The Company does not currently manufacture any API and relies solely upon third party manufacturers to produce research quantities of its compounds, KLS-13019; KLS-13022; and KLS-13023, in the 5 gram to 100 gram scale for its preclinical research. From June 1, 2015, cannabidiol has what are the effects of vaping cbd oil been included under Schedule 4 Prescription Only Medicine of the Poisons Standard (/publication/poisonsstandard-susmp) when preparations for therapeutic use contain 2% or less of other cannabinoids found in cannabis. More than any other group, people with diabetes have a particularly high risk of developing foot ulcers. This is because the long-term complications of diabetes often include neuropathy and circulatory problems.
On September 26, 2019, the Company issued 1,500,000 shares of common stock for the conversion of $123,627 convertible notes payable and $26,373 of related accrued interest. Outside the United States, particularly in member states of the European Union, the pricing of prescription drugs is subject to governmental control. In these countries, pricing negotiations or the successful completion of health technology assessment procedures with governmental authorities can take considerable time after receipt of marketing approval for a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Certain countries allow companies to fix their own prices for medicines, but monitor and control company profits.
More than 25 million Americans live with daily chronic pain and lack effective and safe non-opioid options for pain management. Research offered by the PSPP will be a key step in transitioning HEAL preclinical programs into clinical programs, directly aligned with the HEAL Initiative goal of accelerating the discovery and pre-clinical development of non-addictive pain treatments (NINDS – Preclinical Screening Platform for Pain – ninds.nih.gov). We are currently raising capital and we anticipate raising funds sufficient to commence Phase 1 clinical trials for KLS for patients with chemotherapy induced peripheral neuropathy. General and administrative expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation, for personnel serving in our executive, finance, accounting, legal and human resource functions. Our general and administrative expenses also include facility and related costs not included in research and development expenses, professional fees for legal services, including patent-related expenses, consulting, tax and accounting services, insurance and general corporate expenses. We expect that our general and administrative expenses will increase with the continued development and potential commercialization of our product candidates.
During the second half of 2020, the anti-dilution clause was triggered, and the exercise price was reset to $0.15 resulting in the number of warrants to be increased to 1,002,677. On June 8, 2020, the Company entered into a securities purchase agreement, dated as of June 2, 2020 (the “Purchase Agreement”), with an accredited investor pursuant to which the investor purchased a 12% unsecured convertible promissory note (the “12% Note”) from the Company. The 12% Note has a principal amount of $165,000 less a $9,000 original issue discount (“OID”) for a purchase price of $156,000, of which $52,000 was paid on June 8, 2020 less $3,100 in transaction fees (the “First Tranche”). All principal amounts and the interest thereon are convertible into shares of the Company’s common stock at the option of the Investor, after six months from the date of the 12% Note. The 12% Note is convertible at the option of the holder at any time into shares of the Company’s common stock at an effective conversion price of the lesser of 68% multiplied by the lowest Trading Price (representing a discount rate of 32%) during the previous fifteen trading day period ending on the latest complete trading day prior to the date of the 12% Note or the Variable Conversion Price. In connection with the Purchase Agreement and the 12% Note, the Company issued a common stock purchase warrant to purchase 36,666 shares of the Company’s common stock at $0.75 per share (the “Warrant”) which may be exercised by cashless exercise, exercisable for a period of three years.
The Second Plan Amendment remains subject to shareholder approval, which the Company shall undertake to obtain as soon as reasonably practicable, but in no event later than one year from the amendment date. In the event that the Company does not obtain the requisite shareholder approval of the Second Plan Amendment within one year, the Second Plan Amendment shall not be effective. The loans represent working capital advances from shareholders, bear interest at 0.5%, and grant a security interest in the Company’s assets as collateral.
We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do. There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, or HHS, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Even if we are able to commercialize KLS or KLS-13023, the products may not receive coverage and adequate reimbursement from third-party payors, which could harm our business.
A number of targeted cancer-fighting drugs also have come onto the market through this pathway. Since February 2020, the Company’s lead compound, KLS has been in the preclinical screening program for pain at the National Institutes of Health – National Institute of Neurological Disorders and Stroke (NIH-NINDS). With NIH-HEAL support, NINDS has developed the PSPP program to facilitate the identification of potential non-addictive treatments for acute and chronic pain conditions. In 2019, nearly 50,000 people in the United Statesdied from opioid-involved overdoses(CDC/NCHS, National Vital Statistics System, Mortality 2019). The misuse of and addiction to opioids—includingprescription pain relievers,heroin, and synthetic opioids such asfentanyl– is a serious national crisis that affects public health as well as social and economic welfare.
Compliance with these requirements may make it more difficult for investors in our common stock to resell their shares to third parties or to otherwise dispose of such shares. Our common stock is deemed to be “penny stock” as that term is defined in Rule 3a51-1 of the Securities Exchange Act of 1934, as amended (“the Exchange Act”). Penny stocks are stocks with a price of less than five dollars per share; that are not traded on a “recognized” national exchange; whose prices are not quoted on an automated quotation system sponsored by a registered national securities association; or whose issuer has net tangible assets less than $2,000,000 ; or $5,000,000 ; or with average revenues of less than $6,000,000 for the last three years. In addition, the stock market in general, and pharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
In accordance with this obligation, on September 22, 2020, we filed the registration statement of which this prospectus is a part, registering the resale by Cross of up to 8,108,108 shares that may be issued and sold to Cross under the Equity Line. Like the drug molecule EpidiolexÒ, which was recently approved by the FDA for marketing and sale for use in treating Dravet’s Syndrome and Lennox-Gasteau Syndrome , KLS would need to follow the guidance set forth by the CSA, complete a successful human clinical trial, and apply for rescheduling, as was the case with EpidiolexÒ, now a Schedule 5 drug, before it can be sold and marketed to the public. Upon completion of all requisite preclinical studies, we expect to open an Investigational New Drug Application, or IND, to pursue a clinical development program with either the U.S. Food and Drug Administration (“FDA”) in the U.S. or the Therapeutic Goods Administration (“TGA”), the regulatory body for therapeutic goods in Australia. It perplexes us that even though the FDA is responsible for protecting public health, the agency has failed to respond adequately to the IOM’s findings seven years after the study’s publication date. Additionally, this release failed to make note of the FDA’s Investigational New Drug Compassionate Access Program, which allowed patients with certain medical conditions to apply with the FDA to receive federal marijuana.
•Calcineurin inhibitor is identified as the most lucrative segment of the market on account of high usage rate of these drugs in combination therapy for the treatment of pruritus in patients suffering from chronic pruritus and growing market penetration rates. Moreover, the introduction of new products such as Pimecrolimus cream and Tacrolimus ointment is expected to further drive this market.•Anti-histamines owing to its growing use as a first line treatment and presence of drugs in pipeline with expected commercialization is also expected to grow at a healthy rate during the forecast period. Free radical mediated stress and oxidative stress are also known to contribute to additional pathological conditions including epilepsy, neuropathic pain, traumatic head injury, stroke, CTE, and neurodegenerative diseases such as Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, and ALS. The majority of these toxins are produced in the intestine by the bacterial flora, and are absorbed into the portal venous flow.
The current approach to treating diabetic foot ulcers requires offloading the wound by using appropriate therapeutic footwear,daily saline or similar dressings to provide a moist wound environment,debridement when necessary, antibiotic therapy if osteomyelitis or cellulitis is present,optimal control of blood glucose, and evaluation and correction of peripheral arterial insufficiency. Wound coverage by cultured human cellsor heterogeneic dressings/grafts, application of recombinant growth factors,and cbd oil vape how to use hyperbaric oxygen treatments also may be beneficial at times, but only if arterial insufficiency is not present. Among people with diabetes, most severe foot infections that ultimately require some part of the toe, foot or lower leg to be amputated start as a foot ulcer. SeeDiabetic Ulcers Treatment & Management, V.L. Rowe, MD, R. Khardori MD, PhD, FACP, Medscape, March 12, 2018. In addition, they are also difficult to imitate due to their complex molecular structure and origin.
In connection with the execution of this agreement, the Company issued 25,000 shares of the Company’s common stock at $0.53 a share to the research organization. In August 2019, the Company issued 150,000 shares of common stock at the price of $0.10 per share to a product development consultant for services rendered. The embedded conversion feature of this Note was deemed to require bifurcation and liability classification, at fair value. Pursuant to the Securities Purchase Agreement, the Company also sold warrants to the investors to purchase up to an aggregate of 100,000 shares of common stock. The Company records, when necessary, deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred shares. We have audited the accompanying consolidated balance sheets of Neuropathix, Inc. (the “Company”) as of December 31, 2020 and 2019, the related consolidated statements of operations, stockholders’ equity , and cash flows, for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”).
Cross is an “underwriter” within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), in connection with the resale of our common stock under the Equity Line, and any broker-dealers or agents that are involved in such resales may be deemed to be “underwriters” within the meaning of the Securities Act in connection therewith. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. For more information, please see the section of this prospectus titled “Plan of Distribution” beginning on page 51. That’s why the leading professional medical organizations do not support legalization of marijuana outside the FDA approval process. While around 15,000 Americans die every year from overdoses on prescription opiates, there has never been a medically documented fatal overdose on marijuana. Meanwhile, research has shown that cannabis can allow patients to reduce or eliminate their need for opiates.
If an ownership change is triggered, it will limit our ability to use some of our net operating loss carryforwards. In addition, since we will need to raise substantial additional funding to finance our operations, we may undergo further ownership changes in the future, which could further limit how many drops cbd oil for cats our ability to use net operating loss carryforwards. As a result, if we generate taxable income, our ability to use some of our net operating loss carryforwards to offset U.S. federal taxable income may be subject to limitations, which could result in increased future tax liability to us.