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    James Molloy • Alliance Global Partners

    James Molloy's questions to Abeona Therapeutics Inc (ABEO) leadership

    James Molloy's questions to Abeona Therapeutics Inc (ABEO) leadership • Q2 2025

    Question

    James Molloy of Alliance Global Partners asked for perspective on Abeona's launch trajectory compared to its competitor and inquired about the company's plans for European Union filing, partnerships, and launch.

    Answer

    CEO Vishwas Seshadri expressed confidence in the launch, driven by strong initial patient demand (~50 identified), and reiterated the 2025 goal of treating 10-14 patients. Regarding international expansion, he confirmed that Abeona has begun exploring EU and Japanese markets, with a key consideration being whether to supply from the Cleveland facility or build new manufacturing abroad. An update is expected by year-end.

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    James Molloy's questions to Abeona Therapeutics Inc (ABEO) leadership • Q3 2024

    Question

    James Molloy of Alliance Global Partners followed up on manufacturing capacity, asking how the stated '10 patient runs per month' translates to annual supply for the target patient population. He also inquired about the company's pricing power given the expected imbalance between high demand and limited initial supply.

    Answer

    CCO Madhav Vasanthavada confirmed the 10 runs/month capacity equates to about 120 patients per year, with the new facility expansion estimated to take 18-24 months post-design. CEO Vishwas Seshadri addressed pricing, stating they are exploring a price comparable to one-time gene therapies, referencing a previously mentioned floor of $1.5 million per treatment but aiming to capture the full value without limiting access. He noted that in-house manufacturing provides cost control and autonomy.

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    James Molloy's questions to Abeona Therapeutics Inc (ABEO) leadership • Q2 2024

    Question

    James Molloy of Alliance Global Partners inquired about the state of the Priority Review Voucher (PRV) market and whether Abeona had observed any price softening. He also asked if the competitive launch of VYJUVEK had altered the company's plans for a self-launch and requested an update on the early-stage pipeline.

    Answer

    CFO Joe Vazzano stated he has not seen significant softening in the PRV market, with prices remaining around $100 million. Chief Commercial Officer Madhav Vasanthavada affirmed the company's commitment to a self-launch, viewing VYJUVEK's success as a positive indicator for the gene therapy class. CEO Vishwas Seshadri noted that while preclinical work on ophthalmology assets continues, the primary organizational focus remains squarely on the pz-cel launch.

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    James Molloy's questions to Verastem Inc (VSTM) leadership

    James Molloy's questions to Verastem Inc (VSTM) leadership • Q2 2025

    Question

    Matt, on behalf of James Molloy, asked about the current number of sales reps and any plans for expansion, as well as the expected regulatory pathway and timeline for AvmapKefaxin Jakobak in Japan and the EU.

    Answer

    Chief Commercial & Strategy Officer Michael Crowther stated the company launched with a focused team of 16 individuals and has no current plans to expand. President and CEO Dan Paterson explained that for Japan, they are wrapping up a bridging study and will seek conditional approval. For the EU, they have received orphan drug designation and will seek scientific guidance on whether the RAMP-201 data is sufficient for approval or if the confirmatory study will be required.

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    James Molloy's questions to Aquestive Therapeutics Inc (AQST) leadership

    James Molloy's questions to Aquestive Therapeutics Inc (AQST) leadership • Q4 2024

    Question

    James Molloy asked for clarification on the go-forward SG&A spending level and questioned the risk involved in marketing Libervant given the ongoing legal challenges.

    Answer

    CFO Ernie Toth explained that Q4 2024 SG&A was inflated by a one-time severance charge and that 2025 SG&A would increase, particularly in the second half, for Anaphylm pre-commercial activities. CEO Daniel Barber reiterated that the marketing risk for Libervant is 'completely the court system,' which is an uncontrollable factor, but the company remains committed to advocating for patient access.

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    James Molloy's questions to Aquestive Therapeutics Inc (AQST) leadership • Q3 2024

    Question

    James Molloy of Alliance Global Partners inquired about the timeline and deciding factors for a partner versus self-launch decision for Anaphylm. He also asked for a walkthrough of the AQST-108 development timeline leading to its expected 2028 launch, seeking clarification on the transition from Phase IIa to Phase IIb.

    Answer

    CEO Daniel Barber explained that the company does not view the partner vs. self-launch decision as a binary choice but as a continuum, and will pursue whatever path best enhances growth. For AQST-108, he confirmed the plan to start the Phase IIa study in Q2 of next year and mentioned the potential for an adaptive study design to streamline the collection of Phase IIb-type data, keeping the program on track for a 2028 launch.

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