Sometimes having an apparently approvable project is not enough to save a company from oblivion. Phasebio looks destined for the biopharma graveyard after its development partner, SFJ Pharmaceuticals, demanded rights to the group’s lead asset, the Brilinta reversal agent bentracimab. The writing has been on the wall for Phasebio for some time, with timelines for an accelerated approval filing slipping earlier this year and the company running dangerously low on cash. As such, it is no wonder that SFJ wants to safeguard the $99m it has so far ploughed into bentracimab. The private equity-backed group, which specialises in such co-development deals, should have the wherewithal to get the agent past the FDA. This assumes the regulator is on board with Phasebio’s plan to include phase 3 data from just 25-30 patients with uncontrolled bleeds in its filing – the small proportion of these patients, versus those undergoing surgery, had always looked like a potential sticking point. Phasebio itself faces the prospect of a protracted legal battle with SFJ, according to Stifel analysts, but it hardly has the funds for this: the biotech had under $8m in the bank at last count.
| The final phase of Phasebio? A timeline | |
|---|---|
| Jan 2020 | Phasebio & SFJ sign financing & co-development deal on bentracimab; SFJ to provide up to $120m and "assume central role" in OUS development |
| Mar 2020 | Ph3 Reverse-It trial begins |
| May 2021 | Phasebio raises $64m in secondary |
| Aug 2021 | First 143 patients enrolled in Reverse-It (138 surgical, 5 uncontrolled bleeds); Phasebio targeting BLA submission in mid-2022 |
| Nov 2021 | Interim results from Reverse-It presented at AHA (142 surgical, 8 uncontrolled bleeds); met co-primary endpoints but questions over approval chances in bleeding pts |
| Mar 2022 | In 10-K filing, Phasebio raises doubts about ability to continue as a going concern; company begins looking for partners for clinical/commercial development of bentracimab |
| "Early 2022" | SFJ & Phasebio start discussions on transfer of bentracimab to SFJ "on mutually acceptable terms" |
| May 2022 | Following pre-BLA meeting with FDA, Phasebio says filing now due Q4 2022, with plans to include more bleeding pts; cash balance $18.7m |
| Aug 2022 | Phasebio's cash balance is $7.8m, enough to last around a quarter |
| Sep 2022 | Phasebio discloses in SEC filing that SFJ has demanded bentracimab be transferred |
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