Rein Therapeutics Inc.

For the third quarter of 2019, R&D expense was $4.5 million versus $4.3 million in the third quarter of 2018, and G&A expense was $3.4 million versus $3.2 million a year ago. Net loss was $7.7 million, or $0.28 per share, compared with a net loss of $7.4 million, or $0.50 per share, in the same period of 2018. Cash, cash equivalents and investments were $24.6 million as of September 30, 2019, up from $20.7 million at December 31, 2018. Management said that cash is expected to fund operations into the fourth quarter of 2020. Forward guidance: final data from the palbociclib combination study and dose optimization data for the myelopreservation program are both expected in the second quarter of 2020; enrollment in the two added lung cancer cohorts is planned to begin in the second quarter of 2020, and Phase 2 enrollment is targeted for mid-2020 contingent on resources.

Manuel Aivado framed this as a strategic reset completed over the prior year, with the company now focused on two clinical programs for ALRN-6924. He emphasized that 6924 is differentiated as a dual MDM2/MDMX inhibitor with a better thrombocytopenia profile, and said the new myelopreservation strategy is supported by nonclinical data and biomarker-based patient selection. His tone was confident and forward-looking, repeatedly stressing that several milestones are due in the first half of 2020.

Rick Wanstall reported third-quarter R&D expense of $4.5 million, up from $4.3 million a year ago, mainly due to higher 6924 clinical development costs tied to the palbociclib expansion cohort and preparation for the myelopreservation trial. G&A expense was $3.4 million versus $3.2 million last year, and net loss was $7.7 million, or $0.28 per share. He also noted $24.6 million in cash, cash equivalents and investments at quarter-end, and said that balance should fund operations into the fourth quarter of 2020.

Analysts focused on the myelopreservation strategy, asking about the FDA/regulatory path, the relevance of G1 Therapeutics’ data, and how Aileron’s program could show survival benefit. Management said it sees two possible benefits: better delivery of full-dose chemotherapy and a possible immune-system effect of p53 activation, and said G1’s public regulatory progress is a precedent Aileron intends to follow. Questions also covered partnership plans in the palbociclib program, additional combination studies, biomarker endpoints, and the rationale for biomarker-selected patients; management said it is not disclosing further partnership steps, is focused only on the two current programs, and will collect pharmacodynamic biomarker data alongside patient selection biomarkers.