Ayala Pharmaceuticals, Inc.

Second-quarter 2020 revenue was not stated on the call. R&D expense was $3.9 million, down from $5.9 million a year ago, and G&A was $2.6 million versus $3.1 million in the prior-year quarter. Net loss was $6.3 million, or $0.10 per share, compared with a net loss of $9.4 million, or $1.59 per share, in Q2 2019. Cash and cash equivalents were $28.2 million at April 30, 2020. Management said 12-month spend should be around $23 million to $25 million, and current cash should last at least until August of next year, excluding any inflows. For guidance, the company expects first patient dosing in ADXS-504 prostate cancer in the fourth quarter, more ADXS-503 Part B data by year-end, and Part C data toward the end of this year and into next year.

Ken Berlin framed Advaxis as a focused Listeria-based immuno-oncology company, emphasizing that the broad platform has been narrowed to programs with the best chance of success. He highlighted encouraging early signals from ADXS-503, especially the combination arm, and said the data suggest the drug may restore or enhance sensitivity to checkpoint blockade. His tone was optimistic but cautious, repeatedly noting the need for more patients and more data before drawing firm conclusions.

Molly Henderson emphasized capital discipline and the shift away from non-strategic programs. She said Advaxis raised $10 million in a January public offering, added an ATM in May for flexible financing, and ended the quarter with $28.2 million in cash and cash equivalents. She also cited the lower Q2 R&D and G&A spend, the reduced burn from winding down HPV and personalized neoantigen work, and said the company remains in a runway of at least August next year.

Analysts focused on how long ADXS-503 Part B and Part C could take, what would constitute enough evidence to advance, and whether the third Part B patient might resemble the first two responders. Management said timing depends on enrollment and COVID-related site disruptions, but expected more Part B data by year-end and Part C data late this year into next year. On the go/no-go bar, management said two additional responses in the next 15 patients would support moving on, while noting the response-rate target is 25% and that current results are already above typical rescue-therapy rates in KEYTRUDA failures. Ken also said PSA would require about $20 million to $25 million for the next randomized study and would likely need non-dilutive partner funding, but that 503 is now the priority.