James Molloy

James Malloy, Managing Director and Biotechnology and Specialty Pharmaceuticals Equity Research Analyst at Alliance Global Partners, inquired about the status of the 35 expanded CALMA trial sites, specifically if they are fully operational and past the 80-patient mark, and sought anecdotes regarding enrollment progress. He also asked for details on what to expect from the upcoming December presentation for the potential $1 million MINT program award.

Answer

Ram Mukunda, CEO of IGC Pharma, confirmed that the company is significantly further along than 50% enrollment and that new U.S. sites are coming online, with a 2-3 month setup time. He noted increased patient sign-ups, attributing it to successful social media and geotargeting advertising, citing an acceleration from 4 to 14 patients per month. Regarding the MINT program, Mukunda explained that IGC Pharma is a semifinalist (top 10 out of 300 contestants) in the ADDI contest, presenting their AI idea for accelerating Alzheimer's research on December 5th to a panel of judges.

James Malloy inquired about the current status of the 35 CALMA trial sites, enrollment progress beyond 80 patients, and any anecdotal insights into enrollment challenges or successes. He also asked for details on what to anticipate regarding the potential $1 million award for the MINT program in December.

Answer

Ram Mukunda, CEO of IGC Pharma, confirmed that enrollment is significantly further along than 50%, with expanded U.S. sites coming online after the typical 2-3 month regulatory and training period. He noted a considerable acceleration in patient recruitment, increasing from four patients a month to 14 last month, largely due to successful online advertising and geotargeting. Regarding the MINT program, Mr. Mukunda explained that IGC Pharma is a semifinalist (top 10 out of ~300 contestants) in the Alzheimer's Drug Discovery Initiative (ADDI) contest, presenting their AI-driven approach to accelerate Alzheimer's research on December 5th, highlighting the team's recognition, including two previous awards from the National Institute on Aging.

Asked for updates on the CALMER trial timeline, details on the planned plaque/tangle trial (size, cost, time), potential for ARIA side effects, positioning against traditional cannabis, and the reason for the recent decrease in G&A expenses.

Answer

The CEO expects the CALMER trial to finish this fiscal year (by March 2026). The new disease-modifying trial will be a smaller, cost-effective pilot study of about 50 patients. ARIA side effects are not expected as IGC-81 is not a monoclonal antibody. The drug is positioned as a medically controlled, safer, and more precise alternative to traditional cannabis. The drop in G&A reflects a strategic refocus on key clinical and AI development priorities.

James Molloy of Alliance Global Partners asked for the timeline for the CALMA trial's top-line data, details on the planned Plaque and Tangle trial, the risk of ARIA side effects, positioning against traditional cannabis, and the reason for the recent drop in G&A expenses.

Answer

CEO Ram Mukunda projected the CALMA trial would conclude by the end of the fiscal year (March 2026). He described the upcoming disease-modifying trial as a smaller, cost-effective pilot study of about 50 patients. Mukunda clarified that ARIA is not expected as IGC-81 is not a monoclonal antibody. He differentiated the drug from cannabis based on its precise formulation, replicability, and safety for elderly patients. Lastly, he attributed the lower G&A to a strategic refocus on completing the CALMA trial, launching the next Phase II trial, and developing the MINT AD AI platform.

James Molloy from Alliance Global Partners questioned the status of heparin and citrate shortages, the risk to receiving further financing due to the stock price condition, and the reason for expected higher OpEx in the second half of the year.

Answer

CEO Vincent Angotti described the heparin and citrate supply issues as ongoing and episodic, creating unpredictability for healthcare providers. Regarding financing, CFO Raffi Asadorian explained that investors can waive the stock price condition and were primarily focused on the patient enrollment milestone, which is nearing. Asadorian also confirmed that operating expenses are projected to increase in the second half of 2025 due to the costs associated with accelerating clinical trial enrollment.

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.

James Molloy from Alliance Global Partners inquired about the identity of the priority review voucher (PRV) buyer, sought clarification on whether the 2026 profitability target is based on EPS or cash flow, and asked if the stronger balance sheet has attracted acquisition interest.

Answer

CFO Joe Vazzano confirmed the PRV buyer is undisclosed and clarified that the 2026 profitability projection refers to positive EPS. CEO Dr. Vish Seshadri stated it was premature to comment on any potential inbound acquisition interest.

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.

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.

James Molloy of Alliance Global Partners inquired about the future trend of operating expenses and the expected timeline for securing a partnership or funding for the Phase 3 trials of ibezapolstat.

Answer

Co-Founder & CFO Robert Shawah confirmed that the trend of reduced operating expenses and cash preservation will continue, noting the current cash burn is approximately $400,000 per month. Regarding partnerships, which he defined broadly to include government agencies, Mr. Shawah stated an announcement could occur in the second half of the year but acknowledged that the government funding process could extend into 2026 due to federal budget cycles.

James Molloy of Alliance Global Partners questioned the future trajectory of operating expenses, the expected start date for the ibezapolstat Phase III trial, and sought updates on potential non-dilutive funding sources like the PASTEUR Act.

Answer

President and CEO David Luci explained that both G&A and R&D costs will continue to decrease until Phase III funding is secured, for which there is no set timeline. He noted a new $12M equity line provides operational flexibility. CFO Robert Shawah added that while there's no specific PASTEUR Act update, they are actively pursuing multiple funding avenues, including BARDA and CARB-X.

James Molloy of Alliance Global Partners inquired about the current partnership environment amid market turmoil, the potential timing for securing a partnership to start Phase III trials, and the projected timeline from trial initiation to top-line data.

Answer

President and CEO David Luci acknowledged the challenging market but expressed confidence that a funding event would occur in 2025, enabling the start of Phase III trials. He noted that discussions with government-related bodies seem more advanced than those with private sector firms. Luci clarified there might be a lag of a few months between securing funds and patient enrollment due to manufacturing timelines. He projected a two-year period from first patient enrollment to top-line data and explained the company opted against an interim analysis to avoid increasing the required patient count.

James Molloy from Alliance Global Partners asked about the potential timelines for CardiAmp if the company receives a positive response from Japanese and U.S. regulators in Q4, and questioned whether the partnership environment is currently on hold pending this regulatory clarity.

Answer

CEO Peter Altman stated that a positive response from the PMDA or FDA would initiate an approval process that could take up to a year, involving audits and other steps. He clarified that while CardiAmp distribution partnerships are awaiting regulatory clarity, discussions for the Helix, Morph, and CardiAllo platforms are very active and not on hold. He emphasized that for CardiAmp in Japan, partners would likely be medical device distributors, and discussions are ongoing.

An analyst on for James Molloy asked about the current and planned size of the sales force for the AvmapKefaxin Jakobak launch and the regulatory timeline for the drug in Japan and the European Union.

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 it. President and CEO Dan Paterson explained that for Japan, they are wrapping up a bridging study to seek conditional approval, while for the EU, they are seeking scientific guidance on the approval pathway after receiving orphan drug designation.

James Molloy from Alliance Global Partners sought confirmation on the timing of a potential Xpro partnership, suggesting it would be post-FDA meeting, and asked about expert feedback on the EMAC endpoint.

Answer

CEO David Moss confirmed it was fair to assume a partnership would be considered after the end-of-Phase 2 meeting. VP of Neuroscience, CJ Barnum, added that while there were no in-depth discussions with partners on EMAC, early interest from neuropsychology consultants at AAIC was 'extremely supportive,' and there was no pushback from potential partners, which he viewed as a positive sign.

James Molloy asked about the CORDStrom BLA filing timeline in relation to the Pediatric Review Voucher (PRV) program's expiration and inquired about the likelihood of the PRV program being renewed.

Answer

CFO David Moss explained that the company is working diligently to meet the September approval deadline for the PRV. He expressed his belief that the program is likely to be extended by the U.S. government because it incentivizes rare disease drug development at no cost to taxpayers. He noted that while they are planning for the contingency that it is not renewed, they expect to have more clarity by the end of the year.

James Molloy from Alliance Global Partners asked if the HRD screening process could slow trial enrollment, sought clarification on whether positive HRD data could support an FDA filing, inquired about the timeline for the next data release from the Avastin trial, and asked about the current partnership environment.

Answer

Chief Medical Officer Dr. Douglas Faller stated that HRD screening is standard of care and they have partnered with Foundation Medicine to expedite results, so it should not cause delays. He confirmed an HRD-positive result would be acceptable for filing with both the FDA and EMA. Regarding the Avastin trial, he noted they have established safety and seen early signs of benefit. President and CEO Dr. Stacy Lindborg commented on partnerships, stating that while discussions are active and interest is being shown, she could not provide further details as these processes take time.

James Molloy of Alliance Global Partners asked about Imunon's expectations for its end-of-Phase II FDA meeting, the anticipated design and timeline for the Phase III trial, and the current partnership environment for both its PlaCCin platform and its lead asset, IMNN-001.

Answer

CEO Stacy Lindborg outlined that the primary goal of the upcoming FDA meeting is to review OVATION 2 data and gain alignment on the Phase III trial design, with overall survival as the expected primary endpoint. She noted the company is on track to enroll the first patient in Q1 2025. Regarding partnerships, she explained it is premature to comment on the environment for the PlaCCin platform pending data, but the company is actively engaging potential partners and remains open to discussions around the core TheraPlas technology as well.

Questioned the company's strategic focus between its immunotherapy and PlaCCine DNA platform, and inquired about the partnership environment for both programs.

Answer

The company's primary strategic focus remains on its IL-12 immunotherapy (IMNN-001). The PlaCCine platform is considered an offshoot, with the COVID study serving as a proof-of-concept for the technology to attract a partner for the entire platform. It is premature to comment on specific partnerships, but they see great potential for the platform technology. The response did not directly address the partnership environment for the immunotherapy program.

James Molloy questioned if there was a strategic shift back to immunotherapy from the PlaCCine DNA platform and asked about the partnership environment for both the PlaCCine platform and the core IMNN-001 immunotherapy program.

Answer

CEO Stacy Lindborg clarified that Imunon has always been highly focused on its core IL-12 immunotherapy program, viewing the PlaCCine platform as a valuable offshoot. She emphasized the IMNN-101 COVID study was always intended as a proof-of-concept for the platform technology to attract a partner, rather than a strategic shift into infectious diseases. She stated it was premature to comment on specific partnership discussions but reiterated the platform's significant potential for a future partner.

James Molloy of Alliance Global Partners asked about the start date, size, and duration for the Gideptin trial, the rationale for its endpoints, and the expected timing for interim or final readouts for both the Gideptin and GEO-MVA programs.

Answer

Chairman & CEO David Dodd confirmed a targeted 2H 2026 start for the Gideptin trial. Chief Medical Officer Dr. Kelly McKee estimated a trial size of 36-40 patients and explained that the pathologic endpoint allows for quicker readouts than a survival endpoint, though event-free survival is a secondary measure. Dr. McKee noted that while Gideptin has a planned interim look, providing a precise readout timeline for the GEO-MVA trial is difficult due to enrollment variables.

Inquired about the next steps for various vaccine trials post-data, the competitive landscape for mpox vaccines, the current partnering environment, and revenue modeling for the BARDA contract.

Answer

Next steps for trials involve reviewing data to decide on further company-sponsored studies, with Project NextGen being an expansion of the healthy volunteer trial. MVA is seen as the preferred mpox vaccine platform, and GeoVax's AGE1 technology aims to solve manufacturing supply issues. The partnering environment is improving, with interest in Gedeptin and mpox. Modeling $3M/quarter in BARDA revenue is reasonable.

James Molloy inquired about the enrollment status of the VERSATILE-003 trial, asking if the first patient had been enrolled and what anecdotal feedback from physicians was. He also asked if the quarter's operating expenses represent a stable run rate for the future.

Answer

Executive Frank Bedu-Addo stated that the company has not yet made enrollment progress public and will provide updates once recruitment rates are better understood. CFO Lars Boesgaard addressed the expense question by explaining that while PDSB does not provide financial guidance, trial spending can be higher in the initial quarters but is expected to be relatively stable going forward.

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.

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.

James Molloy of Alliance Global Partners asked for expectations on potential near-term catalysts from the company's various investigator-sponsored trials (ISTs) and inquired about the current partnership environment, including what potential partners might be waiting for.

Answer

Thomas Equels (executive) explained that while the timing of IST data is controlled by the investigators, the results consistently de-risk future, larger trials by indicating Ampligen's broad potential. He stated it is an opportune time for partnerships, highlighting their engagement with a business development group and existing research collaborations with AstraZeneca and Merck. Mr. Equels also noted that recently issued U.S. patents for Ampligen's synergistic combination with checkpoint inhibitors strengthen their position in discussions with potential commercial partners.

Inquired about the company's M&A strategy, seeking clarification on the timing for trial data readouts, and asking for an update on discussions with the FDA regarding special designations like rare pediatric or priority review.

Answer

The M&A focus remains on later-stage rare and orphan disease assets, with any potential deal likely funded by a new capital raise. The early 2025 data readout is for the blinded study, which includes both adults and children. Discussions with the FDA regarding special designations are planned for sometime in 2024.

James Molloy of Alliance Global Partners inquired about the data timeline and potential registration path for the Phase IIb VIRAGE trial in PDAC. He also sought updates on the timelines for the retinoblastoma program and the next-generation VCN-11 candidate, the status of various investigator-sponsored studies, and the reason for the significant drop in Q3 G&A expenses.

Answer

Executive Steven Shallcross explained that while VIRAGE's primary endpoint data is expected in mid-to-late 2025, strong response rate data, available sooner, could facilitate regulatory discussions for accelerated approval. He noted an FDA meeting for the retinoblastoma program is set for December. Dr. Manel Cascalló added that a new candidate from their R&D platform is expected to be selected in H1 2024. Dr. Vince Wacher provided an update on the delayed University of Leeds study. Shallcross identified PDAC and head and neck cancer as the most promising programs and clarified the low G&A was a one-time accounting anomaly.

James Molloy inquired about the expected timelines for interim and top-line data from several investigator-sponsored trials (ISTs) for VCN-01, including studies in brain tumors, ovarian/pancreatic cancer with CAR-T, and head and neck cancer with Imfinzi. He also asked for clarification on the VIRAGE trial's enrollment completion, potential interim looks, and top-line data release schedule. Additionally, he sought updates on the VCN-11 IND timeline and the potential for partnerships for the SYN-004 and SYN-020 programs.

Answer

Steven Shallcross, an executive, provided updates on the ISTs, noting that head and neck cancer survival data will be presented at ESMO in October 2023, while timelines for the UPenn and Leeds studies remain flexible. He confirmed the VIRAGE trial's enrollment is on track for completion by Q1 2024, with overall survival data expected in 2025, but mentioned a potential earlier look at secondary endpoints could inform regulatory discussions. Regarding partnerships for SYN-004/020, he confirmed they are a realistic possibility with ongoing discussions. Manel Cascalló, another executive, added that for VCN-11, the team is focused on manufacturing and does not have a formal IND/IMPD deadline for the year, while also actively working on new candidates.

James Molloy from Alliance Global Partners inquired about the data release timelines for several investigator-sponsored trials (ISTs), including the UPenn CAR-T study, the Leeds brain tumor trial, and the head and neck cancer trial. He also sought clarification on the VIRAGE trial's data milestones, the development status of VCN-11, and the potential for partnering the SYN-004 and SYN-020 assets.

Answer

CEO and CFO Steven Shallcross provided updates, noting that survival data for the head and neck cancer trial will be presented at the ESMO Conference in October 2023. He clarified that while VIRAGE enrollment is on track for Q1 2024 completion, primary overall survival data is expected in 2025, though earlier secondary endpoint data might prompt regulatory discussions before public release. He also confirmed partnering discussions for SYN-004/020 are active. Dr. Manel Cascalló, General Director, added that VCN-11 is focused on manufacturing, with no formal IND application deadline set for the year.

James Molloy inquired about the timeline for the VIRAGE trial, seeking clarity on interim and top-line data readouts. He also asked for updates on the investigator-sponsored trials (ISTs) at Leeds and UPenn, including communication frequency, and questioned the partnership environment for the SYN-004 program.

Answer

Executive Steven Shallcross stated that VIRAGE trial enrollment is expected to complete by early 2024, with a potential interim data review by late 2023 to assess response and explore acceleration options; full data is anticipated in 2025 due to the overall survival endpoint. Regarding the ISTs, he noted the Leeds trial has dosed its first patient and the UPenn trial may have a communication update in Q3 2023. On the SYN-004 partnership, Shallcross confirmed inbound interest but stated he could not provide a definitive timeline.

James Molloy of Alliance Global Partners inquired about the revenue and commercialization timeline for the FastPack PRO COVID-19 test, the IND filing schedules for the ALAN and AS1411 drug candidates, the historical safety data for AS1411, the expected G&A expense run rate, and the company's cash runway.

Answer

CEO Michael Poirier stated that while FastPack PRO revenue will be recognized this quarter, the company's primary focus is on therapeutics. He outlined IND filing goals for AS1411 in October and for ALAN in Q2 2021, highlighting AS1411's strong existing safety profile. CFO Christopher Lotz clarified that the current $16 million in cash provides a two-year runway with an approximate quarterly cash burn of $2 million, and advised that G&A savings from one-time costs may be offset by new public company expenses.