Gossamer Bio, Inc. Q4 FY2020 earnings call

Gossamer Bio discussed four clinical product candidates. Seralutinib (GB002) for PAH is enrolling in the Phase II TORREY study with top line results expected in H1 2022. GB004 for IBD is in the Phase II SHIFT-UC study with top line 12-week results expected in H1 2022. GB1275, an oral CD11b modulator, is in a Phase I/II trial for solid tumors with data expected in 2021. GB001, an oral DP2 antagonist for asthma, has a viable clinical path but needs a partner for further trials. The team highlighted progress in clinical programs and a robust preclinical pipeline.

As of year-end 2020, Gossamer Bio had $512 million of cash and cash equivalents. For the quarter ended December 31, 2020, R&D expenses were $38.9 million compared to $42.6 million in the same period of 2019. Full year 2020 R&D expenses were $160.9 million vs. $143.4 million in 2019. Fourth quarter 2020 in-process R&D expenses were $5.3 million vs. $1.6 million in 2019, with full year 2020 in-process R&D expenses at $23.4 million vs. $3.6 million in 2019. G&A expenses in Q4 2020 were $15.9 million vs. $11.6 million in 2019, and full year 2020 G&A expenses were $49.7 million vs. $39.1 million in 2019. Net loss for Q4 2020 was $64.6 million vs. $54.7 million in 2019, and full year 2020 net loss was $243.4 million vs. $180.3 million in 2019.

Top line results for seralutinib's Phase II TORREY study and GB004's Phase II SHIFT-UC study are expected in the first half of 2022. Cash and cash equivalents plus capital available via debt facility is expected to provide sufficient resources into the second half of 2023. The company is focused on executing its current pipeline programs.

Uncertainties related to the COVID-19 pandemic impacting trial enrollments and data collection. Regulatory uncertainties regarding new endpoints like disease clearance in IBD. Dependence on partnerships for advancing certain programs such as GB001.

Q: Following the GB004 event, color on disease clearance secondary endpoint for Phase II.

A: Disease clearance is a new concept, extrapolation suggests ~20% or more could be meaningful, regulators haven't placed it in approval context yet but will consider in totality of data.

Q: Efforts to hit timelines for SHIFT-UC trial despite COVID.

A: Took steps like geographic site distribution, user-friendly protocol, and leveraged team experience with IBD.

Q: Pipeline outlook 12-18 months.

A: Expect top line data from seralutinib and GB004 Phase II trials, outline first next clinical program later in spring, and focus on executing current pipeline without immediate business development.

Q: Interactions with regulators for GB001 and strategy for GB1275.

A: Interactions with regulators for GB001 have been constructive with a Phase III path forward but need a partner; GB1275's longer-term strategy is to explore other tumor types if positive Phase I data is seen.

Q: COVID impact on data collection and GB004 baseline characteristics.

A: No impact on data collection/quality, GB004's SHIFT-UC trial enrolls post 5 ASA inadequate response, moderate disease population, with regulatory guidelines applying similarly to classic populations.

Q: Expectations for 002 and 1275 readouts.

A: Hoping for imatinib-like results for seralutinib to move to Phase III; GB1275 expects robust results like PR in expansion phase to inform next steps, with updates planned at ASCO and SITC.