Ampio Pharmaceuticals, Inc.

Ampio reported a net loss of $6.2 million in Q4 2021 versus a net loss of $4.6 million in Q4 2020, and a net loss of $17.1 million for full-year 2021 versus $15.9 million in 2020. R&D expense was $4.7 million in Q4 2021 versus $2.1 million a year ago, and $11.9 million for 2021 versus $9.2 million in 2020; G&A was $4.5 million in Q4 2021 versus $1.8 million, and $8.7 million for 2021 versus $6.7 million. Cash and cash equivalents were $33.9 million at Dec. 31, 2021, up from $17.3 million at Dec. 31, 2020, aided by $20.7 million from a registered direct offering and $10 million from at-the-market sales, partially offset by $14.1 million of operating cash used. Management said cash should fund current operations into the second half of 2023. Forward-looking timing guidance was unchanged: FDA clarity on AP-013 by the end of the first half of 2022, BLA submission by the end of the second quarter of next year, and an approval cycle that could take up to a year.

Mike Martino emphasized that the company is focused on three fronts: preparing the BLA, engaging potential partners, and refining the commercial strategy for osteoarthritis and possible expansion into other joints and formulations. He said the team has made good progress and maintained or increased momentum, and described himself as “optimistic, cautiously so,” with the next major value inflection point being FDA feedback. On COVID, he said the landscape has changed materially, which makes the program decisions more dependent on the totality of data from the ongoing and prior studies.

Dan Stokely walked through the year-over-year increases in spending and losses, tying higher R&D mainly to the COVID-19 Phase 1 and 2 studies and higher G&A to non-cash share-based compensation and professional fees. He noted that some Q4 costs were skewed by restricted stock units and other fourth-quarter professional fees, and said Q1 cash burn should be slightly lower now that AP-018 enrollment is complete and the non-cash expense acceleration rolls off. He also highlighted that the balance sheet strengthened to $33.9 million in cash, supported by the December registered direct offering and ATM sales.

Analysts pressed on the timing for FDA approval, and Martino said the realistic path is FDA clarity by the end of the first half of 2022, with BLA submission by the end of Q2 next year and approval potentially taking up to a year after that. Questions also focused on partnership structure and future indications; management said all partnership “sizes, shapes and flavors” remain on the table, but specifics will come once heads of agreement are in hand. On COVID, management said the evolving treatment landscape and slower enrollment make it hard to predict the final role of Ampion until AP-019 and AP-018 are fully analyzed.