PART I. FINANCIAL INFORMATION Condensed Financial Statements (Unaudited) The company reported an increased net loss of $18.4 million for Q1 2022, with total assets decreasing to $315.0 million due to reduced cash and cash equivalents, resulting in a net cash use of $18.0 million from operations Condensed Balance Sheets (Unaudited) As of March 31, 2022, total assets decreased to $315.0 million, primarily due to reduced cash, while liabilities remained stable and stockholders' equity declined to $291.8 million due to the net loss for the period Condensed Balance Sheet Data (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $115,772 | $172,467 | | Marketable securities, current | $167,221 | $124,696 | | Total current assets | $288,040 | $301,286 | | Total assets | $315,008 | $331,568 | | Liabilities & Equity | | | | Total current liabilities | $11,685 | $12,219 | | Total liabilities | $23,165 | $23,009 | | Accumulated deficit | $(186,159) | $(167,726) | | Total stockholders' equity | $291,843 | $308,559 | Condensed Statements of Operations and Comprehensive Loss (Unaudited) For Q1 2022, the company reported an increased net loss of $18.4 million, or ($0.41) per share, primarily driven by higher operating expenses, including increased Research and Development and General and Administrative costs Condensed Statement of Operations (in thousands, except per share data) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Research and development | $11,836 | $7,500 | | General and administrative | $6,783 | $4,174 | | Total operating expenses | $18,619 | $11,674 | | Loss from operations | $(18,619) | $(11,674) | | Net loss | $(18,433) | $(11,602) | | Net loss per share | $(0.41) | $(0.26) | Condensed Statements of Cash Flows (Unaudited) Net cash used in operating activities increased to $18.0 million for the first quarter of 2022, with significant cash used in investing activities for marketable securities, resulting in a net decrease of $56.7 million in cash and cash equivalents during the quarter Condensed Statement of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(17,998) | $(12,904) | | Net cash used in investing activities | $(38,825) | $(139,897) | | Net cash provided by financing activities | $128 | $162 | | Net decrease in cash and cash equivalents | $(56,695) | $(152,639) | Notes to Unaudited Condensed Financial Statements The notes confirm the company's precision oncology focus, state that current liquidity is sufficient for the next twelve months despite losses, and detail significant operating lease commitments and available shares under the equity incentive plan - The company is a precision oncology firm focused on developing small molecule therapies targeting p53, having devoted its efforts to R&D and raising capital since its 2013 inception25 - As of March 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $294.8 million. Management believes these funds are adequate to support operations for at least the next twelve months27 - The company signed a lease for a new headquarters in Princeton, NJ, extending through 2032. As of March 31, 2022, total future minimum lease payments under all operating leases are $16.7 million5658 - As of March 31, 2022, there were 5,321,975 shares available for issuance under the 2020 Equity Incentive Plan63 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's p53-targeting cancer therapies, anticipates continued significant operating expenses and net losses, and highlights strong liquidity of $294.8 million expected to fund operations through 2023 - The company is a precision oncology firm developing therapies targeting p53 mutations. Its lead product candidate, PC14586, is in a Phase 1/2 clinical trial, with the first patient dosed in Q4 20207980 - The company expects operating expenses to increase significantly as it advances product candidates through clinical development and seeks regulatory approval80 - As of March 31, 2022, the company had $294.8 million in cash, cash equivalents, and marketable securities, which is expected to be sufficient to fund operations at least through 202396100 Results of Operations Operating loss for Q1 2022 increased to $18.6 million, primarily driven by a $4.3 million rise in R&D expenses for the PC14586 clinical trial and a $2.6 million increase in G&A expenses due to expanded headcount and infrastructure Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2022 | Q1 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $11,836 | $7,500 | $4,336 | | General and administrative | $6,783 | $4,174 | $2,609 | | Total operating expenses | $18,619 | $11,674 | $6,945 | - The $4.3 million increase in R&D expenses was primarily due to a $3.7 million increase in development costs for the PC14586 Phase 1/2 clinical trial and a $0.7 million increase in personnel-related costs92 - The $2.6 million increase in G&A expenses was mainly due to a $1.5 million increase in personnel and office costs from higher headcount and a $0.6 million increase in facility costs for the new Princeton office9397 Liquidity and Capital Resources The company's liquidity, primarily from $294.8 million in cash and marketable securities from its 2020 IPO, is expected to fund operations through 2023, with future funding likely required for development and commercialization Financial Position Summary (in thousands) | Category | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $115,772 | $172,467 | | Total financial assets | $294,766 | $314,074 | | Total working capital | $276,355 | $289,067 | - The company's cash runway is expected to last at least through 2023, based on current research and development plans100 - The company has a shelf registration statement on Form S-3 for a potential future offering of up to $150.0 million, though no shares have been sold under it as of the reporting date96 Critical Accounting Policies and Significant Judgments and Estimates The company's critical accounting policies include Research and Development Costs, requiring estimates for accrued expenses, and Stock-Based Compensation, which uses the Black-Scholes model with significant assumptions for fair value determination - A key estimate is for accrued research and development expenses, which involves reviewing contracts and communicating with vendors (CROs, CMOs) to determine costs for services performed but not yet invoiced116 - The fair value of stock options is estimated using the Black-Scholes model, which requires management to make significant assumptions, including using historical volatilities of comparable public companies due to its own limited trading history117118119 Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is from interest rates on its $294.8 million in short-term financial assets, which is not considered material, and it currently has no significant foreign currency exchange rate risk - The company's market risk is primarily from interest rate changes affecting its $294.8 million in cash, cash equivalents, and marketable securities, but this exposure is not considered material122123 - There is no significant current exposure to foreign currency exchange rate risk, though this could become a factor with future international vendor contracts124 Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2022126 - No changes in internal control over financial reporting occurred during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, these controls127 PART II. OTHER INFORMATION Legal Proceedings The company is not currently involved in any legal proceedings that are expected to have a material adverse effect on its business - The company reports no current involvement in litigation or legal proceedings that would likely have a material adverse effect130 Risk Factors No material changes to risk factors were reported, except for new disclosures concerning international operations, including differing regulatory requirements, sociopolitical instability, foreign currency fluctuations, and supply chain disruptions - No material changes to risk factors are reported, except for new disclosures regarding risks associated with international operations131 - Newly highlighted international risks include: differing foreign regulatory requirements, sociopolitical instability, foreign currency fluctuations, and supply chain disruptions due to geopolitical conflicts or trade restrictions134142 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities and no material change in the planned use of approximately $223.2 million in net proceeds from its September 2020 IPO - There were no unregistered sales of equity securities in the period136 - The company received net proceeds of approximately $223.2 million from its IPO in September 2020, and there has been no material change in the planned use of these funds137138 Defaults Upon Senior Securities None - The company reports no defaults upon senior securities140 Mine Safety Disclosures Not applicable - This item is not applicable to the company141 Other Information Not applicable - This item is not applicable to the company142 Exhibits This section lists all exhibits filed with the Form 10-Q, including the company's certificate of incorporation, bylaws, various agreements, and certifications by the principal executive and financial officers
PMV Pharmaceuticals(PMVP) - 2022 Q1 - Quarterly Report