Joanne Lee

On behalf of Jason McCarthy, Joanne Lee asked about the specific steps Bionano is taking to increase Saphyr system utilization among its existing routine users.

Answer

CEO Robert Holmlin detailed a three-part strategy to boost utilization. First, driving adoption and proficiency with the AI-powered VIA software to increase lab capacity. Second, supporting menu expansion by helping labs adopt OGM for new applications, such as multiple myeloma, based on recent publications. Third, ensuring overall customer proficiency with the unique OGM workflow through dedicated support from the company's largest internal organization.

Joanne Lee of Maxim Group inquired about Acurx's plans to leverage recent publications on ibezapolstat's selective activity and microbiome-preserving effects, asking if these findings would influence the Phase III trial design or lead to new microbiome-related endpoints.

Answer

President and CEO David Luci confirmed that microbiome preservation is already a secondary endpoint for the Phase III trial. He highlighted this as a key differentiator explaining lower C. diff recurrence rates and mentioned the company is internally exploring alternative regulatory pathways based on these strong mechanistic data.

Joanne Lee, on behalf of Jason McCarthy at Maxim Group, asked for a review of the key design elements and objective measures for the upcoming ORALTO Phase III non-inferiority study for MAT2203.

Answer

Executive Jerome Jabbour first clarified that the partnership is not yet finalized. Dr. Theresa Matkovits then detailed the ORALTO trial design: a two-arm, non-inferiority study in patients with invasive aspergillosis who have limited treatment options. The trial will compare MAT2203 (following a brief IV amphotericin B step-down) to IV liposomal amphotericin B, with a primary endpoint of all-cause mortality at 6 weeks. Key secondary endpoints include safety, global response at 12 weeks, and pharmacoeconomic impact.

Joanne Lee, on behalf of Jason McCarthy at Maxim Group, asked for a review of the key design elements and objective measures for the upcoming ORALTO Phase III non-inferiority study for MAT2203.

Answer

Executive Jerome Jabbour first clarified that the company has a non-binding term sheet, not a definitive agreement. Dr. Theresa Matkovits then detailed the ORALTO trial design: a two-arm, non-inferiority study in patients with invasive aspergillosis who have limited treatment options. The trial will compare MAT2203 (following a 2-day IV amphotericin lead-in) against IV liposomal amphotericin, with a primary endpoint of all-cause mortality at 6 weeks. Key secondary endpoints include safety, global response at 12 weeks, and pharmacoeconomic impact.

Joanne Lee of Maxim Group, on behalf of Jason McCarthy, requested a review of the key design elements and objective measures for the upcoming ORALTO Phase III non-inferiority study for MAT2203.

Answer

CEO Jerome Jabbour first clarified that a definitive partnership agreement is a goal but not yet a secured milestone. Dr. Theresa Matkovits then detailed the ORALTO trial design, explaining it is a two-arm, non-inferiority study comparing MAT2203 to IV liposomal amphotericin B in patients with invasive aspergillosis who have limited treatment options. The primary endpoint is all-cause mortality at 6 weeks, with key secondary endpoints including safety, global response at 12 weeks, and pharmacoeconomic impact.

Joanne Lee, on behalf of Jason McCarthy at Maxim Group, asked for a review of the key design elements and objective measures for the upcoming ORALTO Phase III non-inferiority study for MAT2203.

Answer

Executive Jerome Jabbour first clarified that the partnership is not yet definitive before turning the question to Dr. Theresa Matkovits. Dr. Matkovits detailed the ORALTO trial as a two-arm, non-inferiority study in patients with invasive aspergillosis. The primary endpoint is all-cause mortality at 6 weeks. Key secondary endpoints include safety (testing for superiority vs. IV amphotericin), global response at 12 weeks, and the pharmacoeconomic impact of transitioning patients to an oral, outpatient therapy.

On behalf of Jason McCarthy, Joanne Lee from Maxim Group inquired about the key design elements and objective measures for the upcoming ORALTO Phase III non-inferiority study for MAT2203.

Answer

Executive Jerome Jabbour clarified that a definitive partnership agreement is not yet secured but significant progress has been made. Dr. Theresa Matkovits then detailed the ORALTO trial design: a two-arm, non-inferiority study in invasive aspergillosis patients with limited treatment options. The trial will compare MAT2203 to IV liposomal amphotericin B, with a primary endpoint of all-cause mortality at 6 weeks. Key secondary endpoints include safety, global response, and pharmacoeconomic impact at 12 weeks.

Joanne Lee, on behalf of Jason McCarthy, inquired about the CMC alignment with the FDA, asking if any new actions were required. She also requested details on the revised ALSFRS entry criteria for the upcoming Phase IIIb study and the mechanistic rationale for why these changes might better identify NurOwn's therapeutic effect.

Answer

Executive Chaim Lebovits confirmed that alignment with the FDA was reached to enable trial initiation. Executive Ibrahim Dagher elaborated on the new trial criteria, explaining that patients must have scores of 2, 3, or 4 on all 12 items of the ALSFRS score, with a total score of 45 or less. He stated these changes, combined with other criteria like slow vital capacity above 65%, are designed to enroll patients earlier in their disease progression, a population where NurOwn is expected to show the most benefit.