Michael Higgins

Speaking on behalf of Michael Higgins from Ladenburg Thalmann, an analyst asked for confirmation that alignment with the EMA for BX004 is planned for 2024 and inquired about any potential gating factors for completing enrollment in the Phase II DFO study for BX211.

Answer

CEO Jonathan Solomon confirmed that the Phase IIb study for BX004 will be a global trial including key sites in Europe, consistent with the 2024 timeline. For BX211, he stated that enrollment is progressing well, having surpassed the 70% mark, and while clinical studies are always challenging, it is meeting expectations with efforts underway to potentially improve recruitment rates.

Michael Higgins from Ladenburg Thalmann asked if the WHO's priority fungal pathogen list could improve prospects for non-dilutive funding or global partnerships, requested an update on site activation and enrollment for the MARIO study, and inquired about any recent FDA feedback ahead of the November 30 PDUFA date.

Answer

Chief Medical Officer Dr. David Angulo clarified that while ibrexafungerp is not named in the WHO report, the company's development program aligns perfectly with the WHO's priorities, which is a strong positive signal. President & CEO Dr. Marco Taglietti added this could help influence funding bodies and legislation. Regarding the MARIO study, Dr. Angulo confirmed that site activation is on track to meet enrollment completion goals by the end of the following year. He also stated that no late-cycle meetings with the FDA were required for the sNDA and all signs remain positive for approval.

Michael Higgins of Ladenburg Thalmann inquired about the response rates in the FURI and CARES trials compared to other novel antifungals, the projected patient numbers for an NDA filing, the proportion of BREXAFEMME prescriptions for recurrent VVC, and the enrollment status of the Synergia trial.

Answer

Chief Medical Officer Dr. David Angulo stated that the FURI and CARES response rates are very positive for a salvage therapy setting and that the Synergia trial enrollment, while previously slow, has seen more activity this year. Chief Commercial Officer Christine Coyne clarified that promotion is strictly on-label for VVC. CEO Dr. Marco Taglietti added that BREXAFEMME's fungicidal nature may help cure infections that might otherwise become recurrent.

Michael Higgins of Ladenburg Thalmann inquired about potential changes to the marketing strategy for BREXAFEMME and whether early prescribers were the targeted 'early adopters'. He also asked about the status of discussions with potential European partners. In a follow-up, Higgins asked for the outlook on the timing and design of the IV liposomal formulation, whether SCYNERGIA data was still expected in H2 2022, and if any mucormycosis patients had been enrolled in the FURI study.

Answer

Chief Commercial Officer Christine Coyne confirmed the targeting of early adopters was successful and the marketing approach remains unchanged, attributing January softness to Omicron-related office closures. CEO Dr. Marco Taglietti added that discussions for ex-U.S. partnerships have intensified post-approval. Chief Medical Officer Dr. David Angulo addressed the clinical questions, stating they are discussing an abbreviated regulatory path for the IV formulation, are still targeting H2 2022 for SCYNERGIA data, and are actively encouraging FURI investigators to enroll mucormycosis patients based on promising preclinical data.

Michael Higgins of Ladenburg Thalmann questioned if the company was analyzing trial data for specific outcomes by age group, inquired about the development status of the spray device, including human factors studies, and asked about the timing of milestone payments.

Answer

CEO Paul Wagner responded that age is a stratification factor in the trial, but no significant differences were observed by age in the prior 2a study. Regarding the device, he explained that it has an existing master file and is used in an FDA-approved product, so issues are not expected. He also confirmed that human factor studies are moving forward. On milestones, Paul Wagner stated that payments are back-end loaded and due after major value inflection points in the program.

Michael Higgins from Ladenburg Thalman asked for clarification on the combined company's financial outlook, including the projected cash burn for 2019 and the timing of the reverse stock split. He also inquired about the clinical pipeline, specifically the start date for the Phase 1b trial, the concurrent development of pseudomonas and staph aureus programs, the nature of FDA discussions, and details on the bacteremia patients treated under the AB-SA01 expanded access program.

Answer

Steve Martin, CFO of AmpliPhi Biosciences, projected that the combined company's $18 million in cash would provide a runway into the third quarter of 2020. He confirmed a reverse stock split is planned, but the ratio is yet to be determined. Dr. Brian Varnum, CDO of C3J Therapeutics, stated the synthetic pseudomonas program is targeting a Phase 1b trial in the second half of 2019, with plans to run it concurrently with the staph program in a future Phase 2 pneumonia study. He clarified that while discussions with the FDA will cover broad indications, each product will also require separate CMC-focused reviews. Regarding the expanded access program, Dr. Varnum noted that a majority of the 15 patients treated had bacteremia, referencing a case series of about 11 patients.