John Vandermosten

John Vandermosten of Zacks asked for a medium-term target for APHEXDA's market penetration, the expected overall survival improvement for GBM to attract pharma interest and FDA approval, and how GLIX1 JV investments will be reflected on BioLineRx's financial statements.

Answer

CEO Phil Serlin stated that BioLineRx cannot provide APHEXDA market penetration guidance as Ayrmid now owns the commercial rights. Chief Development Officer Ella Sorani indicated that a median overall survival improvement of approximately 2.5 months for newly diagnosed GBM (similar to temozolomide) would be significant, with a lower bar for recurrent GBM. Mr. Serlin clarified that since BioLineRx controls the JV, all GLIX1 expenses, including the $80,000 for transition services, will be consolidated and primarily reflected as R&D expenses.

John Vandermosten from Zacks asked about a medium-term market penetration target for Effexta, a reasonable overall survival improvement target for glioblastoma (GBM) to attract pharma interest and FDA approval, and how investments in the GLIX1 JV would be reflected on BioLineRx's financial statements.

Answer

CEO Phil Serlin stated that BioLineRx is not providing guidance on Effexta's market penetration as it is no longer their product. Chief Development Officer Ella Sorani suggested a median overall survival improvement of approximately 2.5 months for newly diagnosed GBM, with a lower bar for recurrent GBM. Mr. Serlin clarified that BioLineRx consolidates the JV, so all JV expenses, including the $80,000 for transition services, would be reflected in BioLineRx's R&D expenses.

John Vandermosten of Zacks Small Cap Research asked about the most attractive sources for new pipeline candidates and whether BioLineRx has a stronger negotiating position for in-licensing deals in the current funding environment.

Answer

CEO Philip Serlin explained that while they look at all sources, smaller private and public companies are the most promising, as they often have interesting assets but lack capital or development expertise. He stated that BioLineRx is in a stronger negotiating position now compared to the past because the company's validated development track record, proven by the FDA approval of motixafortide, resonates well with potential partners, making their development capabilities a key advantage.

John Vandermosten of Zacks Small Cap Research questioned the financial details of the licensing deals and the company's asset acquisition strategy. He asked if the current royalty rate for Effexxa would continue, sought visibility on the types of milestones from both the Aramid and Gloria Bio agreements, and probed the thought process for new asset selection, specifically regarding validated versus novel mechanisms and targeting small versus deep markets.

Answer

CEO Philip Serlin explained that the Effexxa royalty is tiered, starting at 18% and increasing with sales, and is supplemented by up to $87 million in potential commercial-based milestones. He clarified the Gloria Bio agreement includes development and regulatory milestones in addition to commercial ones. Regarding the asset search, Mr. Serlin stated the company is opportunistic but is prioritizing programs with a relatively short and lean clinical development path to a value-creating event, rather than focusing on massive indications that would require large, costly trials.

Asked about the future royalty rate for Effexxa, visibility on milestones from partners Aramid and Gloria Bio, and the strategy for the ongoing new asset search, specifically regarding mechanism novelty and market type.

Answer

The company explained that Effexxa royalties are tiered, starting at 18% and increasing with sales, supplemented by potential commercial milestones. Milestones from partners (Aramid, Gloria) are a mix of commercial, regulatory, and geographic triggers. For the new asset search, the focus is on opportunistic programs with short, lean clinical pathways to a value-creating event.

John Vandermosten of Zacks Small Cap Research inquired about Dyadic's expected cash burn rate for the remainder of the year and the next twelve months, as well as the commercialization timeline for key proteins like transferrin and DNase-one.

Answer

CFO Ping Rawson explained that while Dyadic does not provide specific cash burn guidance, operating expenses are expected to remain at or below last year's levels, with the final burn rate dependent on product sales in Q3 and Q4. President & COO Joe Hazelton added that DNase-one is the most commercially ready product, with revenue expected first, while transferrin is projected for late 2025 or early 2026 pending completion of the commercial manufacturing process.

John Vandermosten of Zacks inquired about the financial arrangement with Fermbox Bio, the progress and order status of the Proliant albumin collaboration, and the comparative margins of the non-dairy product pipeline.

Answer

CEO Mark Emalfarb and COO Joe Hazelton explained that the Fermbox deal involves an immediate profit-sharing split. Regarding the Proliant collaboration, they stated that sampling for recombinant human serum albumin is expected in Q2 2025, with orders to be taken in Q3, and no advanced orders have been placed yet. For non-dairy products, Hazelton identified lactoferrin as having the highest potential margin, but noted that alpha-lactalbumin likely has the largest overall market potential in terms of volume and value.

The analyst asked about the regulatory requirements for research-grade recombinant proteins, the number of certificates of analysis obtained, the manufacturing process for high-dollar research products, and the market dynamics between recombinant and animal-derived products for transferrin and alpha-lactalbumin.

Answer

The company responded that beyond a certificate of analysis, manufacturing must occur in an ISO-certified facility, but no formal regulatory agency review is needed. They currently hold three certificates of analysis (DNASE-1, bovine transferrin, bovine alpha-lactalbumin), plus two for albumin under the Proliant deal. Manufacturing difficulty varies by product; Dyadic's advantage lies in higher yields and lower costs, providing margin flexibility. The preference for recombinant versus animal-derived products depends on the market; recombinant is competitive in research due to purity and consistency, while animal-derived often dominates the food space on cost, a challenge Dyadic aims to overcome.

John Vandermosten from Zacks inquired about the regulatory hurdles for research-grade proteins, the number of certificates of analysis obtained, the manufacturing process for high-value products, and the market dynamics between recombinant and animal-derived proteins like transferrin and alpha-lactalbumin.

Answer

COO Joe Hazelton clarified that beyond a certificate of analysis, an ISO-certified facility is required for manufacturing research-grade proteins. He and CEO Mark Emalfarb confirmed Dyadic has certificates for DNASE-1, bovine transferrin, bovine alpha-lactalbumin, and both human and bovine albumin via its Proliant partnership. Hazelton and Emalfarb explained that while some products are small-batch, Dyadic's high-yield platform provides a cost and margin advantage. Hazelton noted that market preference for recombinant versus animal-derived products depends on the application, with research and pharma increasingly favoring recombinant for its consistency and cleaner profile.

Asked about the new alpha-lactalbumin deal, including market size, customers, and revenue pathway. Also inquired about the evolution of the C1 expression system over the last five years and the margin attractiveness of the C1-produced albumin for the Proliant partnership.

Answer

The alpha-lactalbumin market is approximately $700 million, with a smaller but growing recombinant segment. The deal with the dairy company includes milestones and royalty payments. The C1 platform has evolved significantly, becoming more stable and validated by a successful Phase I human trial, making it a faster, lower-cost platform for vaccine antigens. Regarding the Proliant deal, the C1-produced human albumin is a new product line for Proliant, which currently focuses on bovine proteins, so it's a market expansion for them. While the product is expected to be cost-effective, specific margins for Proliant were not discussed.

John Vandermosten from Zacks Small Cap Research asked about the company's deployment activities in the UK and Australia and the anticipated regulatory pathway for the handheld 'Snapshot M' device following the primary DeepView system's approval.

Answer

Dr. Michael DiMaio, Chairman of the Board, explained that the UK and Australian markets are currently being used to gather usage data to leverage for the U.S. launch, rather than for significant sales. For the handheld device, he stated it is being designed with components identical to the cart-based system, which should allow for a more streamlined 510(k) regulatory pathway using the cart as a predicate device.

Inquired about the development timeline for the Snapshot M device, post-approval commercialization strategy beyond BARDA, and the company's primary focus for the second half of 2025 after the FDA submission.

Answer

The company is working hard on the Snapshot M but cannot confirm an accelerated timeline. Post-approval, the primary focus remains the BARDA partnership, but the commercial team is preparing for broader market entry. The second half of the year will be focused on advancing the DeepView system under the BARDA contract and continuing Snapshot M development.

John Vandermosten requested more context on the 'Dice score' metric from the recent data release and its importance to the FDA. He also asked about the planned pace of further device deployments in Australia and the U.K. in 2025.

Answer

Executive Chairman Dr. Michael DiMaio deferred to the Data Science Chief, who explained the Dice score is a standard metric measuring segmentation overlap that provides a balanced view of precision and recall, as requested by the FDA. Dr. DiMaio then stated that the company does not plan to deploy more units in the U.K. or Australia, but will instead focus on a 'deeper dive' to gather clinical feedback from the existing sites.

John Vandermosten asked if the recent MTEC award for the portable DeepView device contributed to the strong Q3 revenue results. He also inquired about the major development milestones for this 'snapshot' device and sought confirmation of the full-year 2024 revenue guidance.

Answer

CFO and General Counsel Vincent Capone clarified that the higher Q3 revenue was primarily driven by increased activity and higher reimbursement rates under the main BARDA PBS contract, not the MTEC award. Dr. Michael DiMaio, Chairman of the Board, added that upcoming milestones for the MTEC device include getting design feedback from the Brooke Army Medical Center. Mr. Capone concluded by reiterating the full-year 2024 revenue guidance of approximately $28 million, calling it a 'reasonable and conservative' target.

John Vandermosten of Zacks Small Cap Research asked for specifics on how Merck's ownership would enhance O2Ver's market potential and sought clarification on the commercialization partners for Orchestra BioMed's pipeline therapies.

Answer

CEO Todd Davis stated that Merck's global capabilities are expected to significantly accelerate the worldwide commercial rollout of O2Ver. SVP of Investments, Paul Hadden, clarified that Medtronic is the commercial partner for the AVIM therapy program, while Terumo is the partner for the Virtu SAB balloon.

John Vandermosten asked if the ZELSUVMI launch timing depends on the Channel Therapeutics deal closing, questioned the impact of Filspari's shift to standard marketing approval in Europe, and sought clarity on the revenue cadence for the remainder of 2025.

Answer

CEO Todd Davis stated the ZELSUVMI launch is 'fairly independent' of the merger timing, as the team and manufacturing are already in place. Lauren Hay, VP of Strategic Planning, commented that Filspari's full EU approval reinforces momentum but doesn't dramatically alter its trajectory. CFO Octavio Espinoza projected a balanced cadence for Captisol sales and a gradual uptrend for the royalty line through the year, consistent with tiered royalty structures.

John Vandermosten inquired if the D-Fi opportunity assumes similar pricing to VYJUVEK, asked about the financial impact of the CASI termination, and questioned the flow rate of the deal opportunity pipeline.

Answer

SVP Paul Hadden stated that using VYJUVEK as a pricing and penetration analog for D-Fi is a fair assumption. CFO Tavo Espinoza explained the CASI termination is not expected to have a material impact in 2025, as their direct license with Acrotech remains. Paul Hadden also confirmed an uptick in the deal pipeline, reiterating that the team has never been busier.

John Vandermosten asked if Ligand analyzes broader M&A trends in areas like neuro, cancer, and dermatology to guide its investment strategy. He also inquired about Captisol's life cycle management and its competitive environment.

Answer

CEO Todd Davis stated that Ligand's strategy is product-focused on high unmet clinical need, which provides the best defense against payer pressure, rather than following therapeutic area trends. For Captisol, he described its dominant market position as stemming from its high efficacy, broad applicability, and ease of use, which has led to its use in 16 approved products, making it a prolific drug delivery platform.

John Vandermosten from Zacks Small Cap Research asked for details on the initial contact methods for provider outreach and the subsequent communication flowchart based on physician responses.

Answer

Chief Commercial Officer Jaime Xinos explained that the specific outreach channels are still being finalized and will be tailored to the preferences of targeted physicians. She mentioned that potential methods include social media, email, in-person representatives, and virtual reps, with the ultimate goal of meeting providers where they are most receptive.

John Vandermosten questioned the outcomes of recent pricing discussions with payers, the role of pharmacoeconomics, the potential use of digital-first commercialization partners, and the expected timeline between FDA approval and the first commercial sales.

Answer

Jaime Xinos (executive) explained that initial payer feedback is directional and indicates formulary placement will depend on price, but cytisinicline's differentiation from generics is clear. She stated that instead of funding new pharmacoeconomic studies, Achieve will leverage existing literature and focus on demonstrating how cytisinicline's adherence profile improves outcomes. She confirmed the company is heavily leveraging agency partners like Omnicom and Credera for its digital launch strategy. Regarding launch timing, she noted that as a smaller company, Achieve will require some time post-approval to get the drug into the channel before sales commence.

John Vandermosten asked for the company's perspective on recent JAMA articles regarding smoking during pregnancy and the ineffectiveness of vaping for smoking cessation. He also inquired about the manufacturing ramp-up at Sopharma and whether the company had decided on a brand name for cytisinicline.

Answer

Chief Commercial Officer Jaime Xinos viewed the pregnancy topic as a long-term market expansion opportunity and noted the vaping data reinforces the need for a true cessation therapy. CEO Richard A. Stewart confirmed that resources are being prioritized to ensure product availability at launch. Chief Medical Officer Dr. Cindy Jacobs revealed that they have conditional FDA approval for a brand name but are not disclosing it publicly yet, though work on brand identity is underway.

John Vandermosten of Zacks Small-Cap Research asked about the strategic contributions of the recent hire, Dr. Mark Rubinstein, and inquired about the estimated cost and cash flow for the planned Phase III vaping trial.

Answer

CEO Rick Stewart and CCO Jaime Xinos highlighted Dr. Rubinstein's value in honing messaging and medical strategy due to his direct experience as a practitioner in the nicotine dependence field. Regarding the trial cost, Rick Stewart indicated it would likely be similar to previous Phase III trials, with more specific guidance to be provided after the protocol is finalized with the FDA.

John Vandermosten from Zacks Small Cap Research asked if the new Polarify formulation would expand the overall market and if it is intended to completely replace the existing version.

Answer

CEO Brian Markison confirmed the new formulation is expected to "completely replace" the current one. He believes it will enable a "return to growth" by leveling the reimbursement playing field and winning back customers who have experienced poor performance with a competing F-18 agent. He also noted the new formulation will have a wider delivery radius.

John Vandermosten asked about the conditions under which launching a generic or radio-equivalent competitor makes sense and which leading tau therapeutic candidates would benefit from Lantheus's imaging agents.

Answer

President Paul Blanchfield explained that launching a radio-equivalent like PNT2003 is justified by a positive financial return, a sizable market, and the strategic benefit of creating a theranostic pair with OCTEVY. CEO Brian Markison stated that any tau therapeutic would benefit from their sensitive imaging agents (MK-6240, PI-2620) for better patient selection, noting MK-6240 is already used in numerous sponsored and academic trials.

John Vandermosten asked if the assets acquired from Radiopharm Theranostics are fully under Lantheus's control and if other assets at that company are attractive.

Answer

CEO Brian Markison confirmed that Lantheus has 100% control of the acquired assets. He added that Radiopharm Theranostics as a whole looks interesting due to its development portfolio, and Lantheus's investment allows them to stay close and support the management team, leaving the door open for future partnerships.

John Vandermosten of Zacks Small Cap Research inquired about the status of a manufacturing proposal with BARDA, which checkpoint inhibitor would be used with Gideptin, and how changing public health guidance on COVID-19 has impacted the company's vaccine strategy.

Answer

Chairman & CEO David Dodd stated that their manufacturing proposal was selected by BARDA but is in a 'holding basket' pending funding availability, and confirmed the Gideptin trial will use pembrolizumab. Mr. Dodd and Chief Medical Officer Dr. Kelly McKee explained that recent guidance aligns perfectly with their strategy of focusing their multi-antigen COVID vaccine on immunocompromised populations, reinforcing their current clinical focus.

John Vandermosten of Zacks Small-Cap Research inquired about the visibility on Elfabrio sales milestones, the potential for a less frequent dosing schedule for Elfabrio in the U.S., how PRX-115 compares to competitors like Novartis' ILARIS, and the status of recently expiring warrants.

Answer

Executive Dror Bashan stated that partner Chiesi's commercial patient recruitment for Elfabrio is strong and improving quarterly, but specific sales numbers are confidential. He confirmed an application for less frequent dosing is under review by the EMA and U.S. plans will be updated when available. Regarding PRX-115, Bashan declined to compare it to specific competitors before Phase II data is available. Executive Eyal Rubin clarified that most of the 2020 warrants expired unexercised, with 908,000 exercised and approximately 12.5 million expiring.

John Vandermosten of Zacks Investment Research asked about the composition of Chiesi revenues for gross margin analysis, new takeaways from the Elfabrio BRIGHT study, the expected duration of the upcoming PRX-115 Phase II trial, and the status and economics of the Elfabrio trial in Japan.

Answer

Executive Eyal Rubin confirmed Chiesi revenues are entirely from product sales but cautioned that a simple gross margin calculation would be misleading due to varying product margins. Executive Dror Bashan added that the BRIGHT study extension data is not new and Chiesi is discussing it with regulators. He stated the PRX-115 Phase II trial is planned for a 12-month duration, starting in H2 2025 with results expected in early 2027. Regarding Japan, the trial is ongoing, and it is considered a unique market.

John Vandermosten inquired about the market uptake and payer negotiations for Elfabrio, the potential for sales guidance related to partner Chiesi, the frequency of update meetings with Chiesi, and the likelihood of near-term sales milestones. He also asked about the specific conference targeted for the release of PRX-115 Phase I data.

Answer

Executive Dror Bashan explained that as a private company, Chiesi's specific payer negotiations are not public, but confirmed they are performing well with market penetration in the U.S. and Europe. He stated it is too early for sales guidance due to the lumpy nature of inventory-building orders but reiterated that Protalix is pleased with Chiesi's efforts and maintains a very good, multi-disciplinary relationship with them. Executive Eyal Rubin added that the full PRX-115 data is expected around early November and that the company plans to attend the ACR conference.

John Vandermosten asked a series of questions regarding PRX-115, including the trend of PK levels, the rationale for the observation period, details on the reported anaphylactic reaction, and plans for global sites in Phase II. He also inquired about the future R&D spending breakdown, the increase in contract liability on the cash flow statement, and the status of the Chiesi-led study in Japan.

Answer

Executives Dror Bashan and Eyal Rubin responded. Bashan deferred sharing full PRX-115 PK data until all cohorts are complete but confirmed the anaphylactic reaction was an isolated, resolved incident. He also noted Phase II sites would likely expand to the U.S. and other continents, and that PRX-115 would be the primary R&D focus. Rubin clarified that the increase in contract liability was due to cash received from partner Chiesi for product that has not yet been recognized as revenue, indicating strong ongoing commercial activity. Regarding the Japan study, Rubin stated it is ongoing but could not provide a timeline for a BLA submission as it is Chiesi's proprietary data.

John Vandermosten asked about the expected clinical development pathway for ProGen's subcutaneous version of PG-102 and how Rani's timeline for the oral RT-114 would align with it for regulatory submission.

Answer

Executive Talat Imran confirmed that partner ProGen has completed its Phase 1, is in a Phase 2a, and plans to file a U.S. IND for its subcutaneous drug. He explained that this parallel development is advantageous for Rani, as it allows them to leverage ProGen's data on dosing and titration to make RT-114's clinical studies faster and more efficient, with a potential for regulatory advantages down the line.

Asked about pipeline focus post-Celltrion deal, progress on manufacturing automation, and the company's perspective on the biosimilar market environment.

Answer

If a deal is signed, focus will shift to obesity and the RT-105 program. Manufacturing automation is progressing well, with a pilot line planned for Phase III trials. The company views itself as creating novel 'bio-better' products, not competing directly on price as a biosimilar, thus differentiating its strategy from the broader biosimilar market trends.

Inquired about what data beyond safety and PK might be shared from the BT-600 trial, the nature of evolving BioJet partnership discussions, negotiation strategy with multiple parties, and the next steps for improving the capital structure.

Answer

The company expects to share data confirming sustained drug delivery to colon tissue with low plasma concentration over multiple doses. BioJet partnership discussions have intensified as the company drives a process to select a partner for clinical development. The negotiation strategy focuses on maximizing value while retaining optionality. Future capital structure improvements are expected to follow upcoming clinical data catalysts, which could improve market capitalization.

Asked about remaining checklist items for the BT-600 trial besides FDA clearance, the timeline for advancing BioJet research collaborations into clinical-stage partnerships with milestones, and whether a new fourth collaborator could advance more quickly.

Answer

The executive confirmed that all controllable aspects for the BT-600 trial (supply, sites, CROs) are being prepared to start immediately after the expected FDA clearance in November. For BioJet, the current focus is on generating data within research collaborations to enable future partnership discussions. A new collaborator would benefit from existing data and progress faster than earlier ones.

John Vandermosten of Zacks inquired about Intelligent Bio Solutions' expansion plans for its IFP product, specifically the timeline for initial sales in Australia and New Zealand, the strategy for subsequent regions like the U.S. and Asia, and the revenue potential of a U.K. police force project. He also asked about the timing of grant funding for the new manufacturing facility, the market opportunity for the next biosensor test for cortisol, and the publication schedule for the saliva-blood correlation study.

Answer

Chairman and CEO Harry Simeonidis stated that Australian sales are expected in Q1 2023, with the U.S. market being a two-year goal. He noted the cortisol test market is under analysis and results from the saliva-blood study are expected in late Q1 or early Q2 2023. Philip Hand, Executive Chairman of IFP, described the U.K. police project as a large, active market with significant interest. CFO Spiro Sakiris explained that grant funding is milestone-based and reimburses expenses already incurred, with the next reimbursement expected shortly.

John Vandermosten inquired about the key characteristics GBS is seeking in APAC distribution partners, the status of engagement with the FDA and EMA on clinical protocols, and the construction timeline for the new manufacturing facility.

Answer

President and CEO Harry Simeonidis explained that ideal distribution partners must have an existing large footprint for rapid market access and strong relationships with healthcare and regulatory bodies. Regarding clinical protocols, he confirmed ongoing discussions and a pending presubmission with the FDA, expected by the end of the calendar year. For the manufacturing facility, a site is expected to be secured by the end of the current quarter, with the full build-out timeline dependent on sourcing high-tech equipment.

John Vandermosten from Zacks inquired about the revenue timeline for the new Indegene partnership, Indegene's experience with similar products, their geographical focus, and potential shipping delays to Canada similar to those experienced with Italy.

Answer

President and CEO Sunil Bhonsle explained that the partnership with Indegene began in late June, with the first campaign launching in early August, and expects to see growth in the following quarters. Executive Director of Commercial Operations Joe Schrei added that they anticipate significant improvement by Q4. Bhonsle also noted that while Indegene is a global company, this is their first product in the addiction space. Regarding supply, he clarified that European shipping delays were due to specific EU regulatory modifications at a US facility and will not impact US or Canadian supply. Executive Chairman Marc Rubin tempered expectations, stating that while a 50% Q4 enrollment increase is a goal, it is not official guidance, though meaningful increases are expected.

John Vandermosten of Zacks Investment Research asked about the trends in online prescribing for Probuphine, the latest count of trained healthcare providers, any pandemic-related impacts on the distribution chain, progress on the European launch with Molteni, and the funding implications for the nalmefene program following new FDA guidance.

Answer

President and CEO Sunil Bhonsle explained that while an online prescription processing hub is operational, new patient starts have been limited by restricted facility access during the pandemic. He also noted minor communication delays in the supply chain but no major product shipment issues. On Europe, the launch with Molteni is still targeted for H2 2020, with manufacturing preparations in the final stages. EVP and Chief Scientific Officer Dr. Kate DeVarney added that a fully virtual REMS training program is awaiting FDA approval to address a backlog of interested providers, with a notable increase in interest from nurse practitioners and physician assistants. She also clarified that the revised nalmefene development plan will be funded by reallocating existing NIDA grant funds.

John Vandermosten inquired about the partnerships involving the RXI-762 compound, whether the molecule is identical across collaborations, the next development steps such as animal model work, and the status of grant funds from BioAxone.

Answer

CEO Geert Cauwenbergh and Chief Development Officer Gerrit Dispersyn clarified that RXI-762 is being developed with multiple partners, including CCIT and Iovance, for different applications to avoid overlap and maximize its potential. They confirmed it is the same molecule across partnerships, but tested within each collaborator's proprietary protocols. Gerrit Dispersyn explained that due to the nature of TIL therapy, animal models are not the likely next step, potentially accelerating the timeline to clinical trials. Principal Accounting Officer Caitlin Kontulis added that the BioAxone grant is active through Q3 2018, with second-year funding contingent on meeting specific NIH aims.

John Vandermosten of Zacks Small Cap Research inquired about the potential market impact of a competitor's RNAi compound approval and the process for out-licensing RXi's dermatology and ophthalmology assets.

Answer

President and CEO Dr. Geert Cauwenbergh stated that a competitor's RNAi approval would validate the entire field, signaling that RNAi therapies have 'arrived' and would benefit all companies in the space. Regarding the asset out-licensing, he confirmed RXi has engaged an experienced intermediary, a former investment banker, to professionally manage the high volume of interest.

John Vandermosten from Zacks inquired about the company's anticipated quarterly cash burn, the potential for a different evaluation approach by Health Canada for Levosimendan, and whether trial protocols allowed for interventions to manage hypotension.

Answer

CFO Michael Jebson detailed the expected cash burn, projecting $5-5.5 million in G&A for the year and $2.5 million in remaining R&D costs for the LEVO-CTS study closeout, with sufficient capital through H1 2018. CEO John Kelley explained that Health Canada often benchmarks against European approvals and might view the drug differently than the FDA. Kelley also clarified that the trial protocol permitted standard-of-care interventions for blood pressure, such as vasopressors, and that dose titration was common in the Levosimendan arm to manage it.

John Vandermosten from Zacks Investment Research asked for an update on the number of active LEVO-CTS trial sites, whether enrollment remains concentrated at top sites, and what the incentive structure for a future sales force might look like.

Answer

CEO John Kelley reported that the number of active LEVO-CTS trial sites has been consolidated from 79 to approximately 60. He confirmed that enrollment remains concentrated in top-performing sites like the Cleveland Clinic, which has enrolled over 50 patients. Regarding sales force incentives, Kelley stated that the company has not yet determined a structure.