Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
The following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere in this Quarterly Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Quarterly Report and in the Company’s other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” below.
As used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated, the terms “the Company”, “we”, “us”, “our” and similar terminology refer to HedgePath Pharmaceuticals, Inc.
Critical Accounting Policies
See Note 3 of the Notes to Condensed Financial Statements included in Item 1 of this Quarterly Report for a summary of significant accounting policies and information on recently issued accounting pronouncements.
Results of Operations
For the three months ended September 30, 2018 compared to the three months ended September 30, 2017
Research and Development Expenses. We recognized approximately $0.8 million in research and development expenses during the three months ended September 30, 2018 compared to approximately $0.4 million for the three months ended September 30, 2017. Research and development expenses for both periods primarily include expenses related to our clinical trial for Basal Cell Carcinoma Nevus Syndrome, regulatory activities, legal expenses relating to patents, and stock-based compensation. The increase is due primarily to an increase in expenses related to regulatory consulting associated with the preparation for an NDA filing.
General and Administrative Expenses. We recognized approximately $0.4 million in general and administrative expenses during the three months ended September 30, 2018 compared to $0.2 million for the three months ended September 30, 2017. General and administrative expenses consist primarily of compensation and related costs for corporate administrative staff and Board members, facility expenditures, professional fees, consulting and taxes. The increase is due primarily to an increase in stock compensation expense associated with stock options issued in March and June of 2018.
Interest Income.We recognized interest income of $3,995 during the three months ended September 30, 2018 compared to $2,086 for the three months ended September 30, 2017 for interest earned on cash balances in our money market account.
For the nine months ended September 30, 2018 compared to the nine months ended September 30, 2017
Research and Development Expenses. We recognized approximately $2.0 million in research and development expenses during the nine months ended September 30, 2018 compared to approximately $1.7 million for the nine months ended September 30, 2017. Research and development expenses for both periods primarily include expenses related to our clinical trial for Basal Cell Carcinoma Nevus Syndrome, regulatory activities, legal expenses relating to patents, and stock-based compensation. The increase is due primarily to an increase in expenses related to regulatory consulting associated with the preparation for an NDA filing.
General and Administrative Expenses. We recognized approximately $1.3 million in general and administrative expenses during the nine months ended September 30, 2018 compared to $2.5 million for the nine months ended September 30, 2017. General and administrative expenses consist primarily of compensation and related costs for corporate administrative staff and Board members, facility expenditures, professional fees, consulting and taxes. The decrease is due primarily to a reduction in stock compensation expense of approximately $1.4 million. A change in control in November 2016 resulted in the revaluation of RSUs increasing the expense which carried forward to the nine months ended September 30, 2017.
Interest Income.We recognized interest income of $10,707 during the nine months ended September 30, 2018 compared to $16,726 for the nine months ended September 30, 2017 for interest earned on cash balances in our money market account.
Liquidity and Capital Resources
We had approximately $1.4 million cash on hand at September 30, 2018.
We intend to seek additional financing for our research and development, commercialization and distribution efforts and our working capital needs primarily through:
| • | | proceeds from public and private financings (including financing from our majority shareholder, Mayne Pharma) and, potentially, other strategic transactions; |
| • | | proceeds from the exercise of outstanding warrants previously issued in private financings to investors (including, potentially, warrants held by our majority shareholder, Mayne Pharma); |
12