Financial Performance - The company reported net losses of $23.6 million and $44.6 million for the three and nine months ended September 30, 2020, respectively, with an accumulated deficit of $99.9 million[130]. - The net loss for the three months ended September 30, 2020, was $23.6 million, compared to a net loss of $7.3 million for the same period in 2019, representing an increase of $16.3 million[150]. - The company recognized no revenue for the nine months ended September 30, 2020, compared to $0.2 million for the same period in 2019 due to the termination of the CPRIT grant[156]. - Net cash used in operating activities was $39.7 million for the nine months ended September 30, 2020, compared to $11.3 million for the same period in 2019, reflecting a significant increase in operating losses[169][170]. - The increase in cash used in operating activities of $28.4 million for the nine months ended September 30, 2020, was primarily due to higher research and development expenses related to the development of Viralym-M and ALVR106[171]. - General and administrative expenses for the three months ended September 30, 2020, were $6.7 million, up $3.9 million from $2.8 million in the same period of 2019[153]. - General and administrative expenses for the nine months ended September 30, 2020, were $13.0 million, up $5.2 million from $7.8 million in the same period of 2019[159]. Cash and Investments - As of September 30, 2020, the company had cash, cash equivalents, and short-term investments of $378.5 million, which it believes will fund operations into 2023[133]. - The company had $378.5 million in cash, cash equivalents, and short-term investments as of September 30, 2020[161]. - As of September 30, 2020, the company held cash, cash equivalents, and short-term investments of $378.5 million, a significant increase from $126.1 million as of December 31, 2019[183]. - Net cash used in investing activities was $171.4 million for the nine months ended September 30, 2020, compared to $99.5 million for the same period in 2019, driven by the purchase of investments totaling $242.4 million[172]. - Net cash provided by financing activities was $292.3 million for the nine months ended September 30, 2020, due to proceeds from the IPO, compared to $120.9 million in the same period of 2019 from the issuance of Series B Preferred Stock[173]. - The company had no debt outstanding as of September 30, 2020, eliminating exposure to interest rate risk related to debt[184]. Research and Development - The company has generated five innovative, allogeneic, off-the-shelf VST therapy candidates targeting 12 different viruses, with the lead product candidate, Viralym-M, having treated over 275 patients[126][127]. - The company plans to initiate three Phase 3 pivotal and three Phase 2 proof-of-concept trials for Viralym-M in 2020 and 2021, representing potential commercial opportunities[127]. - The company anticipates filing an IND application for its second cell therapy, ALVR106, in the second half of 2020, targeting severe respiratory diseases[127]. - Research and development expenses for the three months ended September 30, 2020, were $17.2 million, an increase of $11.5 million from $5.7 million in the same period of 2019[150]. - Research and development expenses for the nine months ended September 30, 2020, totaled $32.9 million, an increase of $23.3 million from $9.6 million in the same period of 2019[157]. - The company expects to incur significant expenses and operating losses as it advances its product candidates through clinical development and seeks regulatory approval[164]. Operational Challenges - The company is assessing the impact of the COVID-19 pandemic on its operations, which has caused delays in clinical trials[133][135]. - The company expects to incur significant and increasing expenses and operating losses as it initiates additional clinical trials and expands its product development efforts[131]. Corporate Actions - The company completed an IPO on August 3, 2020, issuing 18,687,500 shares at $17.00 per share, resulting in net proceeds of $292.0 million[128]. - The company has not generated any revenue from product sales to date and relies on equity financings for funding[128][137]. - The company has a relationship with ElevateBio, leveraging its expertise for rapid manufacturing of VST therapies[136]. - The company anticipates that general and administrative expenses will increase in the future as it expands its headcount to support ongoing research activities[147].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| ...