Bio-Path (BPTH) Q3 2024 earnings summary

Executive summary

• Expanded clinical pipeline beyond oncology by initiating BP1001-A for obesity and metabolic diseases, leveraging DNAbilize® technology.

• Advanced multiple oncology programs, including BP1001-A, prexigebersen (in Phase 2 for AML), BP1002 (rapid enrollment in refractory AML), and BP1003 (preclinical solid tumors), with positive interim and preclinical data published.

• Reported net loss of $2.1 million for Q3 2024 and $7.1 million for the nine months ended September 30, 2024, both improved from prior year periods.

• Operations funded primarily through equity offerings and private placements, with $6.5 million raised in 2024 and a $4.0 million private placement closed in October 2024.

• Substantial doubt exists about ability to continue as a going concern due to insufficient cash and a pending Nasdaq delisting appeal.

Financial highlights

• Q3 2024 net loss was $2.1 million ($0.70/share), improved from $3.2 million ($6.36/share) in Q3 2023; nine-month net loss was $7.1 million, down from $12.7 million year-over-year.

• R&D expenses decreased to $1.3 million from $2.3 million year-over-year, mainly due to lower manufacturing and clinical trial costs.

• G&A expenses increased to $1.3 million from $1.0 million, driven by higher legal fees and personnel costs.

• Cash balance was $0.6 million as of September 30, 2024, down from $1.1 million at year-end 2023.

• Net cash used in operations was $7.7 million for the first nine months of 2024, with $7.2 million provided by financing activities.

Outlook and guidance

• Anticipates early 2025 data readout from BP1001-A solid tumor trial and expects preclinical results for BP1001-A in obesity and metabolic diseases in the near term.

• Plans to complete IND application for BP1003 following new oligonucleotide detection method and pursue FDA expedited programs.

• Enrollment in key clinical trial cohorts for prexigebersen expected to be completed in 2026, with interim analysis and FDA review ongoing.