Financial Performance - The company reported a net loss of $11.3 million for the three months ended March 31, 2021, compared to a net loss of $9.8 million for the same period in 2020, reflecting an increase in losses of $1.5 million[111]. - Other (expense) income, net was an expense of $1.4 million for the three months ended March 31, 2021, compared to income of $47,000 for the same period in 2020, a change of $1.4 million[130]. - The net loss for the three months ended March 31, 2021, was $11.3 million, compared to a net loss of $9.8 million for the same period in 2020[139][140]. Expenses - Research and development expenses decreased to $4.1 million for the three months ended March 31, 2021, from $6.4 million in the same period of 2020, a reduction of $2.3 million[127]. - General and administrative expenses increased to $5.8 million for the three months ended March 31, 2021, compared to $3.5 million for the same period in 2020, an increase of $2.3 million[129]. - The company expects to incur significant research and development expenses over the next several years as clinical programs progress and new studies are initiated[120]. - The company plans to continue incurring significant research and development expenses in anticipation of a potential commercial launch for TRUDHESA[145][146]. Cash Flow - As of March 31, 2021, the company had an accumulated deficit of $149.6 million and a cash balance of $4.5 million[111]. - For the three months ended March 31, 2021, cash used in operating activities was $9.9 million, compared to $10.6 million for the same period in 2020, reflecting a decrease of approximately 6.8%[138][140]. - Cash provided by financing activities for the three months ended March 31, 2021, was $7.3 million, primarily from the issuance of convertible notes of $7.5 million[142]. - Cash used in investing activities for the three months ended March 31, 2021, was $27,000, a decrease from $418,000 in the same period in 2020[141]. Financing Activities - The company completed an initial public offering (IPO) in April 2021, issuing 5,333,334 shares at a public offering price of $15.00 per share, resulting in net proceeds of approximately $71.4 million[112]. - The company issued convertible promissory notes totaling $7.5 million, which automatically converted into 559,585 shares of common stock upon completion of the IPO[137][136]. - The term loan under the Avenue Agreement has an initial interest rate of 11% per year and is secured by substantially all of the company's assets[133][135]. - The term loan will amortize in equal payments from the end of the interest-only period to the expiration of the 36-month term on November 1, 2023[135]. - The company expects to finance its cash needs primarily through a combination of equity or debt financings until it can generate substantial product revenue[146][147]. Business Strategy - The company plans to build a targeted sales team of approximately 60 representatives for TRUDHESA and other product candidates, leveraging a central organization for market access and support[109]. - The company has retained all development and commercial rights to its product candidates, allowing for independent commercialization if approved[109]. - The company is proactively monitoring the impact of COVID-19 on its business and has implemented strategies to minimize disruptions to the commercialization of TRUDHESA and clinical trials[115]. Off-Balance Sheet Arrangements - The company has not engaged in any off-balance sheet arrangements since its inception[148].