Ocuphire Pharma(US:OCUP)2022-11-04 21:01PART I – FINANCIAL INFORMATION Financial Statements The company reported a net loss of $4.5 million for Q3 2022 and $16.1 million for the nine months ended September 30, 2022, with cash and cash equivalents decreasing to $13.9 million by September 30, 2022, primarily due to operating activities Condensed Balance Sheets Balance Sheet Highlights (in thousands) | Balance Sheet Highlights (in thousands) | Sep 30, 2022 (unaudited) | Dec 31, 2021 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $13,855 | $24,534 | | Total current assets | $14,561 | $26,067 | | Total assets | $14,568 | $26,077 | | Liabilities & Equity | | | | Total current liabilities | $2,691 | $3,855 | | Total liabilities | $2,691 | $3,855 | | Total stockholders' equity | $11,877 | $22,222 | | Total liabilities and stockholders' equity | $14,568 | $26,077 | Condensed Consolidated Statements of Comprehensive Loss Income Statement Highlights (in thousands, except per share) | Income Statement Highlights (in thousands, except per share) | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | 2022 | 2021 | 2022 | 2021 | | Collaborations revenue | $0 | $489 | $0 | $589 | | General and administrative | $1,703 | $1,595 | $5,215 | $6,707 | | Research and development | $2,835 | $3,126 | $10,769 | $10,437 | | Loss from operations | $(4,538) | $(4,232) | $(15,984) | $(16,555) | | Net loss | $(4,531) | $(4,230) | $(16,053) | $(50,380) | | Net loss per share (basic and diluted) | $(0.22) | $(0.25) | $(0.82) | $(3.64) | - The significant net loss in the nine months ended Sep 30, 2021, was primarily driven by a $33.8 million non-cash expense related to the fair value change of warrant liabilities, which did not recur in 202212168 Condensed Consolidated Statements of Cash Flows Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,477) | $(13,724) | | Net cash used in investing activities | $0 | $0 | | Net cash provided by financing activities | $3,798 | $19,575 | | Net (decrease) increase in cash | $(10,679) | $5,851 | | Cash and cash equivalents at end of period | $13,855 | $22,250 | - Net cash from financing activities in 2022 primarily came from the at-the-market (ATM) program ($4.4 million gross proceeds)16196197 In contrast, 2021 financing activities were significantly higher due to proceeds from a Registered Direct Offering ($15.0 million) and the ATM program ($5.8 million) Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's focus on its two clinical-stage ophthalmic product candidates, Nyxol® and APX3330, reporting a net loss of $16.1 million for the first nine months of 2022, and noting a going concern uncertainty despite sufficient funds into Q4 2023 Overview and Recent Developments - Nyxol® (phentolamine mesylate): The lead product candidate, a once-daily eye drop, with an anticipated NDA submission to the FDA in Q4 2022 for the Reversal of Mydriasis (RM) indication125 - APX3330: The second product candidate, an oral tablet for diabetic retinopathy (DR) and diabetic macular edema (DME), with top-line results from the ZETA-1 Phase 2b trial expected in early 2023126127131 - Presbyopia Program: The company submitted a Phase 3 protocol (VEGA-2) to the FDA for Nyxol for presbyopia, with trial initiation anticipated in Q4 2022132 - Regulatory Update: The FDA granted a small business waiver for the $3.1 million PDUFA fee for the Nyxol NDA submission136 Results of Operations Operating Results Comparison (in thousands) | Operating Results Comparison (in thousands) | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | 2022 vs 2021 | 2022 vs 2021 | | Collaborations Revenue | $(489) | $(589) | | General & Administrative Expenses | $108 | $(1,492) | | Research & Development Expenses | $(291) | $332 | | Net Loss | $(301) | $34,327 | - G&A expenses for the nine months ended Sep 30, 2022 decreased by $1.5 million compared to the prior year, primarily due to a one-time $1.6 million non-cash settlement with investors in 2021166 - R&D expenses for Q3 2022 decreased by $0.3 million compared to Q3 2021, mainly due to the completion of certain clinical trials and the timing of manufacturing activities for Nyxol and APX3330160 - The significant decrease in net loss for the nine-month period is primarily due to a $33.8 million non-cash fair value change in warrant liabilities recorded in 2021, which did not recur in 2022164168 Liquidity and Capital Resources - As of September 30, 2022, the company had cash and cash equivalents of $13.9 million173 - Management believes current cash will be sufficient to fund operations into the fourth quarter of 2023, but the company's financial statements include a going concern warning, indicating substantial doubt about its ability to continue without raising additional capital173201 - Through September 30, 2022, the company has raised $17.9 million in gross proceeds from its At-The-Market (ATM) program established in March 2021175 Quantitative and Qualitative Disclosures About Market Risk This section is not applicable as the company is a smaller reporting company - Not applicable for smaller reporting companies223 Controls and Procedures Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2022, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of September 30, 2022, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective226 - No changes in internal control over financial reporting occurred during the quarter ended September 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls227 PART II – OTHER INFORMATION Legal Proceedings The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any legal proceedings that management believes are likely to have a material adverse effect on the business229 Risk Factors There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2021 - Risk factors have not changed materially from those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2021230 Unregistered Sales of Equity Securities and Use of Proceeds None reported for the period - None231 Defaults Upon Senior Securities None reported for the period - None232 Mine Safety Disclosures This section is not applicable to the company - Not applicable to our Company234 Other Information None reported for the period - None235 Exhibits This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, a lease amendment, and certifications by the Principal Executive Officer and Principal Financial Officer - A Fourth Lease Amendment, dated October 17, 2022, was filed as an exhibit236 - Certifications pursuant to Section 302 and 906 of the Sarbanes-Oxley Act of 2002 were filed236