Financial Performance - For the three months ended June 30, 2021, total operating expenses were $10.5 million, an increase of $6.5 million compared to $4.0 million for the same period in 2020[106]. - The net loss for the three months ended June 30, 2021, was $10.4 million, compared to a net loss of $4.0 million for the same period in 2020[106]. - The net loss for the six months ended June 30, 2021, was $17.2 million, compared to a net loss of $7.1 million in 2020, reflecting a $10.1 million increase[111]. - Cash used in operating activities was $15.8 million for the six months ended June 30, 2021, compared to $6.7 million in 2020, indicating a significant increase in cash outflow[117]. Expenses - Research and development expenses for the three months ended June 30, 2021, were $7.9 million, up from $3.6 million in 2020, primarily due to increased costs associated with the Phase 1 clinical trial of EDG-5506[107]. - General and administrative expenses rose to $2.6 million for the three months ended June 30, 2021, compared to $0.3 million in 2020, largely due to costs related to operating as a public company[108]. - Research and development expenses increased to $13.2 million for the six months ended June 30, 2021, up from $6.6 million in 2020, representing a $6.6 million increase[112]. - General and administrative expenses rose to $4.1 million in the first half of 2021, compared to $0.6 million in the same period of 2020, marking a $3.5 million increase[113]. Cash and Funding - As of June 30, 2021, the accumulated deficit was $51.3 million, with total gross proceeds from private placements and the IPO amounting to $346.8 million[90]. - The company believes its existing cash and cash equivalents of $299.2 million will fund operations for at least the next 24 months[90]. - The company had cash, cash equivalents, and marketable securities totaling $299.2 million as of June 30, 2021, following gross proceeds of $186.1 million from its IPO[116]. - Net cash provided by financing activities was $186.1 million for the six months ended June 30, 2021, primarily from the IPO, compared to $0.1 million in 2020[121]. - The company expects to require substantial additional capital to fund ongoing operations and product development, particularly as it seeks regulatory approvals and commercializes products[124]. Interest Income - Interest income increased to $107,000 for the three months ended June 30, 2021, compared to $3,000 in 2020, due to higher cash and marketable securities balances[109]. - The increase in interest income to $149,000 in the first half of 2021 from $66,000 in 2020 was due to higher cash and marketable securities balances[114]. Company Classification - The company is classified as an "emerging growth company" and will adopt new accounting standards on the relevant dates for private companies[140]. - The company will remain an emerging growth company until it exceeds $1.07 billion in annual revenue or meets other specified criteria[142]. - The company is also a "smaller reporting company" with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million[143]. Risk Factors - The company had no outstanding debt as of June 30, 2021, thus no exposure to interest rate risk related to debt[145]. - The company is subject to foreign currency exchange risk due to service agreements in currencies other than the U.S. Dollar, primarily the British Pound and Euro[146]. - A hypothetical 10% change in foreign exchange rates would not have materially impacted the company's financial condition or results of operations[146]. - There was no material foreign currency risk for the three and six months ended June 30, 2021[147].
Edgewise Therapeutics(EWTX) - 2021 Q2 - Quarterly Report