Bert Hazlett

Robert Hazlett of BTIG asked for anecdotal evidence regarding the sales force's traction with Talicia and whether the market for diagnosing H. pylori was improving. He also requested a revenue breakdown between Movantik and Talicia for the quarter.

Answer

SVP of Sales and Marketing Rob Jackson confirmed that field traction for Talicia is improving, with better execution and more consistent growth, and noted that diagnostic conditions have improved since the peak of the pandemic. CFO Micha Ben-Chorin provided the revenue breakdown, stating that Movantik contributed a little over $19 million and Talicia contributed almost $2.25 million in the quarter.

Robert Hazlett asked if the upcoming opaganib Phase 2/3 results could lead to an Emergency Use Authorization (EUA), questioned its manufacturing status, inquired about the I-SPY trial data timeline, the reason for increased R&D spending, and future investment in the prostate cancer program.

Answer

COO Gilead Raday stated that the opaganib data will determine the regulatory path, including a potential EUA, and that scaled-up manufacturing is being prepared. CEO Dror Ben-Asher noted it's too early for an I-SPY timeline but expects rapid enrollment. CFO Micha Ben-Chorin attributed higher R&D spend to COVID-19 and NTM programs. COO Gilead Raday confirmed continued development of opaganib in oncology pending full data.

Bert Hazlett of BTIG asked about the expected trajectory of R&D expenses with the initiation of three new clinical studies, how the observed durability of LYR-210 affects retreatment rate assumptions, and whether to expect additional data publications in the near future.

Answer

CFO Jason Cavalier projected a slight uptick in R&D spending due to clinical trial expenses, offset by the completion of the tech transfer, noting cash is sufficient through 2022. President and CEO Maria Palasis and SVP Corinne Noyes explained that the durable response seen in about half of patients aligns with their internal modeling of 1.5 uses per year. They also confirmed that abstracts have been submitted for the COSM conference in April, where new data may be presented.

Bert Hazlett of BTIG inquired about the study design for LYR-220, including size and endpoints, the anticipated pace of R&D spending, and the strategic implications of recent M&A activity in the ENT sector for Lyra.

Answer

President & CEO Maria Palasis detailed that the LYR-220 study will enroll approximately 60 patients to evaluate safety, pharmacokinetics, and symptoms, with three arms. CFO Don Elsey explained that R&D spend will see clinical operations costs increase late in the year before leveling off. Regarding M&A, Maria Palasis and SVP Corinne Noyes stated that Medtronic's acquisition of Intersect ENT validates the large market opportunity, will help develop the ENT market to Lyra's benefit, and noted Lyra's products are differentiated and do not overlap.

Bert Hazlett from BTIG asked about potential adjustments to the upcoming pivotal study for LYR-210, whether the rapid PK study enrollment indicates faster pivotal trial enrollment, details on the planned Phase 2 study for LYR-220, and any near-term plans for the broader XTreo platform.

Answer

President & CEO Maria Palasis stated that the LYR-210 pivotal trial design will be similar to the successful Phase 2, with a primary endpoint based on cardinal symptoms at 24 weeks and an expected size of 300-350 patients. She noted it was too early to project enrollment timing. For LYR-220, the Phase 2 study will enroll approximately 40 patients using the 7,500 microgram dose and test two different matrix designs. She also confirmed the company is currently focused on LYR-210 and LYR-220 before pursuing other XTreo platform opportunities.