Edward Woo

Edward Wu asked about changes in Genasys' sales cycle, specifically if it has lengthened or contributed to the robust pipeline growth compared to the previous year, and sought clarification on the 50% gross margin goal for the current fiscal year versus a longer-term objective.

Answer

CEO Richard Danforth explained that the sales cycle had lengthened due to frozen federal government grants but is now starting to thaw, as evidenced by current contracts. He confirmed that the 50% gross margin is the target for the full fiscal year.

Edward Woo from Ascendiant Capital Markets asked about changes in Genasys's sales cycle, particularly if it has lengthened, and how this impacts the growing pipeline. He also sought clarification on the 50% gross margin goal, asking if it's a target for the current fiscal year or a longer-term objective, considering the mix of hardware and software revenues.

Answer

CEO Richard Danforth explained that the sales cycle had lengthened due to frozen federal government grants but is now starting to thaw, leading to current contracting phases. He confirmed that the 50% gross margin target is expected for the full fiscal year.

Edward Woo from Ascendiant Capital asked about Genasys's flood product offerings in light of recent major weather events and inquired if there has been a noticeable increase in customer interest for such solutions.

Answer

CEO Richard Danforth confirmed a significant increase in interest, particularly East of the Rockies, driven by recent floods in Texas and North Carolina. He highlighted a partnership with FloodMap, which integrates flood prediction models into the Genasys Protect platform. SVP Brian Alger added that this integration allows for highly precise, targeted emergency alerts, which is a key differentiator that prevents over-alerting large, unaffected populations.

Edward Woo asked if the delays caused by U.S. federal budget issues were similarly extending lead times for the company's international opportunities.

Answer

CEO Richard Danforth responded that while international opportunities inherently have longer cycles, the company is not currently experiencing any additional or increased time to close those deals.

Edward Woo of Ascendiant Capital asked for the hardware backlog figure at the end of the first quarter and inquired whether the high-profile success in the recent fires has led to an increase in potential competition.

Answer

CFO Dennis Klahn confirmed the hardware backlog was $40 million. CEO Richard Danforth responded that the company has not yet observed any increase in competition, suggesting it may be too soon for new entrants to emerge following the recent events.

Edward Woo from Ascendiant Capital asked about Genasys's potential for acquisitions given the expected cash flow from the Puerto Rico contract and the current strength of the balance sheet. He also inquired about the company's readiness to integrate any new opportunistic acquisitions.

Answer

CEO Richard Danforth stated that Genasys has no current plans for acquisitions, emphasizing that any future deals would be opportunistic, contingent on strategic product fit and the right price. He also confirmed that previous integrations are complete, and the company is operating as a single, unified entity, suggesting they are well-positioned if an opportunity arises.

Edward Woo from Ascendiant Capital Markets inquired about the progress in partnering with the top 200 U.S. cancer centers and asked about the company's plans for marketing the Renovacath in international markets.

Answer

Shaun Bagai, CEO & Director, stated that the company is focused on penetrating the top 200 U.S. cancer centers, which handle the majority of relevant cases. He reported that 13 hospitals are already approved to purchase the device, with four actively reordering. He also mentioned a new website will launch soon to help patients find these centers. Regarding international expansion, Bagai explained that the company is currently hyper-focused on the U.S. market due to favorable reimbursement and market needs, with international plans to be explored later, possibly with a partner.

Edward Woo from Ascendiant Capital Markets asked about the recent power deal in Mexico and the potential for Duos to expand its edge data center or power generation business into other North American markets or internationally.

Answer

CEO Charles Ferry clarified that the Mexico deal was a successful short-term deployment executed via the asset management agreement with APR Energy. He noted that Duos is already deploying power assets for large data centers within the United States. While the primary focus is the U.S. market due to high demand, Ferry stated the company would opportunistically consider projects in stable jurisdictions like Mexico, Canada, or Puerto Rico, but intends to avoid the riskier international locations where APR previously operated.

Edward Woo asked about the legislative appetite for new rail safety regulations and whether the uncertainty around trade tariffs has impacted customer demand for the company's edge data center or power solutions.

Answer

Executive Charles Ferry stated that a comprehensive rail safety legislative package is unlikely under the current administration, though some regulations could still pass. He added that potential tariffs have not yet impacted business, as rail materials are mostly U.S.-sourced, their data center partner is taking mitigating measures, and the power assets are already located domestically.

Edward Woo from Ascendiant Capital questioned the competitive landscape for Lifeline, asking if Surgepays is taking market share from others and what the risk of future price competition is.

Answer

President & CEO Brian Cox attributed their competitive edge to their compensation strategy for field agents and the speed and ease of their proprietary enrollment platform. He emphasized that owning their platform allows for rapid development to meet regulatory and agent needs, such as creating an image compression tool in-house. This agility, combined with support from their team in El Salvador, makes their offering highly attractive to enrollment agents compared to competitors.

Edward Woo of Ascendiant Capital inquired about the economic outlook for SurgePays' convenience store partners and whether the company is observing any changes in the economic activities of its underserved customer base.

Answer

President and CEO Brian Cox stated that their target customers are generally insulated from macroeconomic volatility as they typically lack market-linked investments. He explained that tighter economic conditions can be beneficial, increasing their addressable market and making their value-based wireless offerings more attractive to both new customers seeking savings and store owners looking for new revenue streams. Cox concluded that 'stormy' economic times create opportunities for SurgePays' product suite.

Edward Woo of Ascendiant Capital Markets asked for management's perspective on the economic outlook for their core customer base—the working class and underserved communities—and how that economic environment might impact SurgePays' business.

Answer

Executive Kevin Cox explained that SurgePays' target market is consistently value-conscious. He stated that when economic conditions are tight, these customers actively seek out savings, making them more willing to switch service providers. This dynamic also applies to their convenience store partners, who become more open to adding new revenue streams like wireless activations. Cox believes this counter-cyclical demand provides a unique opportunity, suggesting that a tighter economy can serve as a tailwind for the business by making their value proposition more attractive.

Asked about the economic sentiment among their end customers and convenience store partners post-election and how this might impact the business.

Answer

The company's target market is largely insulated from economic cycles, and tougher times can even expand their potential customer base as people become more value-conscious. While it's too early to gauge post-election sentiment, there is political optimism for connectivity programs. The company believes future funding may come as an enhanced Lifeline program, validating their current strategic focus. They are banking on the current $9.25 Lifeline revenue, with any future increase being a bonus.

Edward Woo from Ascendiant Capital asked about the company's current testing capacity and whether a significant investment would be required to ramp up production following a potential Medicare approval.

Answer

Lishan Aklog, Chairman and CEO, confirmed that the company has substantial excess capacity. He stated the lab can handle at least a five-fold increase in volume with minimal new personnel, and that manufacturing for collection kits and vials has been scaled with high-volume partners. Aklog clarified that no significant capital investment is needed for capacity, and the primary ramp-up would be an incremental increase in the sales and marketing team in line with revenue growth.

Edward Woo asked whether recent market volatility has impacted PAVmed's ability to raise capital for its various initiatives.

Answer

Dr. Lishan Aklog, Chairman and CEO, stated it has not. Dennis McGrath, CFO, elaborated that the company maintains access to capital, citing the successful Q1 financing for Veris at a $35 million pre-money valuation as evidence. He expressed confidence in securing future funding for both Veris and the planned biopharma expansion as needed.

Edward Woo asked about the competitive landscape for the Veris Health platform and whether the company has encountered any significant competing products during discussions with other cancer centers.

Answer

Dr. Lishan Aklog, Chairman and CEO, characterized the competitive landscape as attractive. He explained that while generic remote patient monitoring (RPM) tools exist, the Veris platform is uniquely designed for oncology. He emphasized that the proprietary, patent-protected implantable monitor will serve as a key long-term differentiator and a significant barrier to entry for competitors, highlighting Veris's selection by OSU as proof of its superior, dedicated offering.

Edward Woo of Ascendiant Capital questioned the competitive environment for the Veris Health pilot at The Ohio State University, asking if Veris was competing with other platforms or if it was a new initiative for the center.

Answer

Dr. Lishan Aklog, Chairman and CEO, explained that the pilot represented the cancer center's first engagement with a cancer-specific digital health platform. He noted that while the broader institution was evaluating general remote monitoring solutions, Veris was the only product being utilized for this specific cancer care pilot.

Edward Woo from Ascendiant Capital asked about Lucid's current testing capacity and the level of investment required to scale up operations following a potential Medicare approval.

Answer

Chairman & CEO Lishan Aklog confirmed that the company has significant excess capacity. He stated the laboratory can handle at least a five-fold increase in volume with minimal new personnel, and that manufacturing for both collection kits and vials has been outsourced to high-volume partners that can scale without significant capital investment. Dr. Aklog noted the primary ramp-up cost would be the incremental, judicious expansion of the sales and marketing team in parallel with revenue growth.

Edward Woo of Ascendiant Capital inquired about the potential for operating leverage and gross margin expansion if Medicare coverage drives a significant increase in test volume.

Answer

CFO Dennis McGrath explained that with an established Medicare price point near $2,000 and a 90% margin on the next patient test, the company has substantial operating flexibility. He stated this high-margin reimbursement would help reduce cash burn and could change the company's financial dynamics quickly by providing a reliable, high-value revenue stream from the large Medicare-eligible population.

Edward Woo asked about the geographic dispersion of EsoGuard tests and whether the company has stronger traction in certain areas of the country.

Answer

CEO Dr. Lishan Aklog stated that while Lucid has a national presence, it has developed particular strength in California, Texas, and Florida. He also noted that the company strategically considers states with favorable biomarker legislation when allocating commercial resources.

Edward Woo of Ascendiant Capital Markets asked about the company's visibility for large testing events for the remainder of the year and if there is any seasonality associated with them.

Answer

CEO Dr. Lishan Aklog responded that the pipeline for large testing events, particularly with fire departments, is deep and scheduled months in advance. He emphasized that a key strategic goal is to transition these events from the traditional claims process to pre-contracted arrangements with guaranteed payment. While not addressing seasonality directly, he noted these events generate strong local media coverage, which increases visibility.

Edward Woo of Ascendiant Capital asked about the company's focus on enterprise opportunities versus federal ones and whether there have been any significant shifts in customer budgets or sales cycles in either sector.

Answer

President, CEO & Director Tony Scott explained that while government opportunities are a natural fit due to the company's history, the best entry point for the corporate sector is through managed service providers (MSPs) and managed security service providers (MSSPs), which is their current focus. He noted that sales cycles remain long and customers are under pressure to justify cybersecurity spending, with significant interest in protecting Operational Technology (OT) environments, a less crowded market space.

Edward Woo asked about the current sales cycle environment for both federal and enterprise customers, particularly in light of administrative changes and evolving cyber threats.

Answer

The executive described the federal sales cycle as 'fluid' but ultimately positive, with potential short-term delays but long-term focus on cyber. For enterprise customers, concern and spending are increasing due to the rising threat landscape, which bodes well for the industry.

Edward Woo of Ascendiant Capital asked about potential opportunities in U.S. election integrity following the company's success in the Philippines, and whether the end of the election cycle might spur CIOs to finalize 2025 spending plans.

Answer

CEO Anthony Scott responded that while Intrusion has received inquiries regarding U.S. election security, no business has been signed. He believes the long-term opportunity remains. Regarding post-election spending, Scott stated it was too early to determine if CIOs were accelerating their plans but hoped to gain more insight at an upcoming industry event.

Edward Woo of Ascendiant Capital asked about the potential implementation timeline for E15 gasoline in California if the legislation passes and how quickly Aemetis anticipates seeing an increase in demand for its ethanol.

Answer

Todd Waltz, Executive VP & CFO, projected a gradual 18-month implementation cycle but noted the added 600 million gallons of demand in California would quickly rebalance the national market toward a supply shortage, increasing ethanol's value. Andy Foster, EVP - North America, added that recent state-level regulatory reforms should help streamline the construction of needed fuel storage infrastructure to support the transition.

Edward Woo inquired about the potential use of proceeds from the planned India IPO and asked for confirmation that the India business remains self-sufficient.

Answer

CEO Eric McAfee explained that the use of proceeds for an Indian IPO is highly regulated and will be detailed later, but noted that repaying the parent company for prior investments is a possibility. He confirmed the India business is still self-sufficient and has been investing in inventory, with upcoming shipments to OMCs expected to improve its liquidity.

Edward Woo asked about the company's plans for the capital that would be raised from the potential IPO of its India business.

Answer

Eric McAfee, Founder, Chairman, and CEO, explained that the IPO proceeds are planned for expanding to additional biodiesel plant sites to maintain market leadership in India. He also mentioned diversifying into synergistic businesses like renewable natural gas, where Aemetis has expertise and sees significant opportunity, aligning with India's goal of reducing petroleum imports.

Edward Woo of Ascendiant Capital asked about the planned use of proceeds from the India subsidiary IPO, specifically questioning if funds would be allocated for significant expansion into RNG or Sustainable Aviation Fuel.

Answer

Chairman and CEO Eric McAfee stated that the India IPO proceeds will be primarily used to build out the India business itself. He also mentioned plans to establish a significant cash balance on the parent company's consolidated balance sheet and to use a portion of the funds for repayment of parent company debt. He reiterated that debt repayment is a high priority, with efforts underway to refinance into lower-cost financing.

Edward Woo from Ascendiant Capital asked for an assessment of the current travel industry environment in the U.S. and Europe. He also inquired about any observed changes in consumer behavior, such as high-end spenders trading down, and asked about the long-term outlook of travel suppliers.

Answer

Global CEO Holger Bartel noted that both North America and Europe are experiencing softer demand, evidenced by falling flight and hotel prices, which helps Travelzoo secure strong offers. He stated that the company has not seen its affluent member base trading down, as the value of Travelzoo's offers allows them to 'do more with less.' Bartel concluded that due to the uncertain environment, travel suppliers are currently focused on the short term and are not making long-term predictions.

Edward Woo from Ascendiant Capital asked for an assessment of the travel industry in the US and Europe, whether there have been changes in consumer behavior like trading down, and about the longer-term outlook of travel suppliers heading into 2026.

Answer

Global CEO Holger Bartel stated that both North American and European travel markets are seeing softer demand, evidenced by falling flight and hotel prices, which creates opportunities for Travelzoo to secure strong offers. He has not observed their affluent member base trading down, as the membership's value allows them to 'do more with less.' Bartel concluded that due to the uncertain environment, travel suppliers are focused on the short term and are not making long-term predictions for 2026.

Edward Woo asked for an assessment of the current travel industry in the US and Europe, whether consumer behavior was changing (e.g., trading down), and what the sentiment was among travel suppliers for the second half of the year and into 2026.

Answer

Global CEO Holger Bartel noted that both North America and Europe are seeing some softness, with lower flight and hotel prices, which creates opportunities for Travelzoo to secure strong offers. He stated they have not observed their affluent member base trading down. He also mentioned that due to the uncertain environment, travel suppliers are currently focused on the short term rather than making long-term predictions for 2026.

Edward Woo from Ascendiant Capital asked about the current state of the travel industry in the US and Europe, any observed changes in consumer behavior such as trading down, and the longer-term outlook of travel suppliers.

Answer

Global CEO Holger Bartel responded that both North American and European travel markets are experiencing some softness, evidenced by falling flight and hotel prices, which helps Travelzoo secure strong offers. He noted that the company's affluent members are not trading down, but rather using the platform's value to travel more. Bartel concluded that due to the uncertain environment, travel suppliers are currently focused on the short term.

Edward Woo from Ascendiant Capital asked about the current state of the travel industry in the US and Europe, whether consumer behavior was changing, and what the outlook was among travel suppliers for the second half of the year and into 2026.

Answer

Global CEO Holger Bartel responded that both North America and Europe are experiencing softer demand, evidenced by falling flight and hotel prices, which helps Travelzoo secure strong offers. He has not observed their affluent member base trading down. Bartel noted that due to general uncertainty, travel suppliers are thinking short-term and not making long-term predictions for 2026.

Edward Woo from Ascendiant Capital inquired about current travel industry trends in the US and Europe, any observed changes in consumer spending behavior, and the long-term outlook of travel suppliers regarding potential market weakness.

Answer

Global CEO Holger Bartel confirmed that softer demand and lower prices are visible in both North America and Europe, creating opportunities for Travelzoo to secure strong offers. He stated the company has not seen its affluent members trade down, as the deals provide exceptional value. Bartel noted that due to the uncertain environment, travel suppliers are focused on the short-term and are not making long-term predictions.

Edward Woo from Ascendiant Capital asked if the observed decrease in demand for travel into the U.S. is also seen for U.S. residents traveling internationally.

Answer

Holger Bartel, an executive, clarified that they are seeing two different trends. While there is hesitation for inbound travel to the U.S., particularly from Canada, they are not seeing a corresponding decrease in demand from Americans traveling outbound to destinations like Europe.

Edward Woo asked whether the Jack's Flight Club and Travelzoo Club memberships are separate products and if there are any plans to combine them into a single offering.

Answer

Christina Ciocca (executive) clarified that the memberships are currently operated independently because the two brands serve slightly different markets. While the company seeks synergies and engages in some cross-promotion, the plan for now is to keep the membership products separate.

Edward Woo from Ascendant Capital asked about the growth of Jack's Flight Club, inquiring about its current market presence and the long-term strategy for converting Travelzoo members to the service.

Answer

Executive Christina Ciocca explained that Jack's Flight Club operates in the U.K., Canada, the U.S., and parts of Europe, with further expansion and multi-language editions under consideration for 2025. She noted that while converting Travelzoo members was an initial goal, the strategy is being reconsidered in light of Travelzoo's own new paid membership model.

Edward Woo from Ascendiant Capital asked if using Facebook for geo-targeting would increase clinical trial costs and requested an updated timeline for the next interim data release or trial completion.

Answer

CEO Ram Mukunda explained that the social media recruitment strategy is budgeted at approximately $1,000 per new patient, which will only marginally increase the overall trial cost. He also stated that the company will not conduct another interim data analysis to avoid a statistical penalty that would require increasing the trial size. The primary focus is on completing the trial, with a target of finishing within the current fiscal year.

Edward Woo from Ascendiant Capital inquired about the company's plans for international expansion for both its lead drug candidate, NRX-100, and its Hope Therapeutics clinic network.

Answer

Jonathan Javitt, Founder, Chairman, and CEO, confirmed that NRx Pharmaceuticals intends to make NRX-100 available internationally. He noted that European regulators are particularly sensitive to toxic substances in drugs, which could create a significant opportunity for the company's preservative-free formulation. Javitt also mentioned that NRx has already been approached by several international entities regarding potential partnerships.

Edward Woo asked about the company's international strategy for NRX-100 and NRX-101 following potential FDA approvals.

Answer

CEO Jonathan Javitt highlighted a strong focus on Europe, particularly France, where the company has existing relationships and can leverage data from a large, French government-funded study. He mentioned that a European filing would have broad resonance. While the company has had relationships in Asia Pacific, the primary focus for now remains the U.S. and Europe.

Edward Woo of Ascendiant Capital Markets asked about the new Tempe foundry, inquiring about potential near-term capacity constraints and whether the company has considered opening a second facility.

Answer

Dr. Yuping Huang, Interim CEO and Chairman, acknowledged that while capacity constraints are a consideration, the immediate focus is on customer discovery and product validation, which he expects will lead to rapid revenue growth. He noted that with a stronger financial position, the company will now expand its sales and business development teams. Dr. Huang also confirmed that discussions about a second foundry, or 'Fab 2', are already underway with the Board as part of a multi-phase strategy.

Edward Woo of Ascendiant Capital Markets inquired about potential near-term capacity constraints at the new Tempe foundry and whether the company has considered opening a second facility.

Answer

Interim CEO and Chairman Dr. Yuping Huang acknowledged that while constraints are possible, the immediate focus is on customer discovery and validation before an anticipated rapid increase in revenue. He noted that after a period of cost-cutting to fund the foundry, the company is now in a stronger financial position to expand its sales team. Dr. Huang also confirmed that the board has already held discussions regarding a second fab, or 'Fab 2'.

Edward Woo of Ascendiant Capital Markets inquired about Quantum Computing, Inc.'s geographic focus, asking if opportunities were primarily domestic or international. He also questioned the operational ramp-up for the new foundry business, specifically its initial efficiency.

Answer

CEO William McGann explained that while the primary focus for the Dirac-3 machine is currently domestic, the company has secured offshore orders for its photonic chips in Europe and Asia. Regarding the foundry, McGann confirmed a ramp-up period is expected, starting with proof-of-concept chip deliveries in Q2 2025 as they establish their process design kits (PDKs) before scaling to a multi-project wafer platform.

Edward Woo asked if the company is considering increasing its investment in the German market to accelerate growth, given its strong performance.

Answer

CEO Paul Gudonis confirmed that the company is actively investing more in its German operations. He stated they are adding to the local team, increasing social media advertising, and recruiting more O&P clinics to support another year of expected strong growth. He clarified that while they receive inbound interest from other countries, the primary focus remains on the large opportunities in the U.S. and Germany.

Edward Woo from Ascendiant Capital inquired about the potential risks from tariffs on the company's gross margin and its sales into the German market.

Answer

CEO Paul Gudonis stated that a supply chain review indicated minimal risk to gross margins from tariffs, as most components are sourced from the U.S. He noted that while there are currently no tariffs on exports to Germany, the situation is fluid and could potentially impact pricing for their German O&P partners in the future.

Edward Woo of Ascendiant Capital Markets inquired about the potential for increased operating leverage with the new facility and whether higher volumes could lead to gross margin expansion.

Answer

CFO David Henry explained that while the new facility has higher rent, the doubled capacity should drive operating leverage. He noted that gross margins, currently in the mid-70s, may actually decrease as the lower-ASP O&P channel grows. However, he expects this shift to be accretive to the operating margin because the O&P channel requires less incremental operating expense, particularly in advertising and clinical support.

Edward Woo of Ascendiant Capital inquired about the historical seasonality of Myomo's business and what patterns should be expected for 2025.

Answer

CFO David Henry explained that historically, revenue is stronger in the second half of the year. He attributed this to patients meeting their annual insurance deductibles, making decisions easier later in the year. He noted that Q1 is typically the softest quarter, with growth through the rest of the year, though Q4 growth can sometimes flatten due to factors like advertising challenges during election years.

Edward Woo of Ascendiant Capital Markets inquired about Plus Therapeutics' commercialization strategy for its CNSide diagnostic platform, specifically whether the company plans to build a large internal sales force or seek partnerships.

Answer

President and CEO Marc Hedrick explained that the initial plan is to build a niche, focused sales force targeting about 300 neuro-oncologists at major NCI-designated cancer centers, which covers roughly 80% of the market. Hedrick stated that this is within their financial and operational capability and that partnering, while a future possibility for U.S. expansion or ex-U.S. markets, is not the immediate focus.

Edward Woo from Ascendiant Capital Markets inquired about the current landscape for grant funding, whether it has changed, and the potential impact of the incoming government.

Answer

Executive Marc Hedrick responded that while the federal government's impact is uncertain, the company is well-positioned for the next year, particularly due to its strong relationship with Texas-based CPRIT. Hedrick noted their successful execution on an almost $18 million active grant and suggested potential for further funding from CPRIT, while also confirming plans to continue seeking other non-dilutive capital.

Edward Woo of Ascendiant Capital Markets asked about the nature of non-dilutive grant funding, specifically its seasonality and whether its availability has changed recently.

Answer

Executive Marc Hedrick explained that grant funding is often seasonal, citing CPRIT's biannual grant cycles which involve a roughly six-month review process. In contrast, funding from bodies like the NIH or DoD can be more sporadic, often tied to specific Requests for Proposals (RFPs). Hedrick affirmed the company's strong relationship with CPRIT and its continued strategy to leverage these non-dilutive capital sources to minimize shareholder dilution.

Edward Woo asked about the potential to expand the $3 million U.S. Department of Defense grant for the pediatric brain cancer program beyond the initial Phase I trial.

Answer

Chief Medical Officer Dr. Norman LaFrance confirmed that there are opportunities to expand funding beyond Phase I. He stated the company is 'cautiously optimistic' about securing other funding to accelerate the trial and potentially expand to more sites, but was not at liberty to discuss specific details. He noted the team already has funding options in play for post-Phase I development.

Edward Woo of Ascendiant Capital asked whether Atossa Therapeutics plans to pursue its metastatic breast cancer indication globally and if it intends to engage with regulatory bodies in Europe or Australia.

Answer

Dr. Steven Quay, Chairman, CEO, and President, stated that the company is maintaining a 'razor sharp' focus on the U.S. FDA process throughout 2025. He emphasized the strategy is to first establish a clear clinical trial design and parameters with the FDA before approaching other major international markets, which would likely occur early next year.

Edward Woo of Ascendiant Capital asked whether Atossa Therapeutics plans to pursue regulatory approval for its metastatic breast cancer program globally, including discussions with European or Australian authorities.

Answer

Dr. Steven Quay, Chairman, CEO, and President, clarified that the company's focus for 2025 is sharply on the U.S. FDA process to finalize the clinical trial design. He indicated that pursuing approvals in other major international markets would be considered early next year, after the U.S. path is well-defined.

Edward Woo inquired about the current inventory levels of Ampligen, questioning if the supply is sufficient for all of AIM's clinical trials for the year and asking about the process for procuring new supply.

Answer

Executive Thomas Equels assured that Ampligen inventory is budgeted and adequate for all ongoing clinical trials, barring unforeseen issues. He clarified that manufacturing additional Ampligen for future trials requires capital, and the company is actively analyzing the process with its vendors.

Edward Woo from Ascendiant Capital Markets inquired about AIM's current inventory of Ampligen, questioning if the supply is adequate for all clinical trials scheduled for the year and how easily the company could procure new supply.

Answer

Executive Thomas Equels stated that AIM has budgeted sufficient Ampligen for its ongoing clinical activities and does not anticipate a supply issue for current trials, barring unforeseen events. He clarified that manufacturing additional Ampligen for future trials will require capital, but the company is actively managing the process with its vendors.

Edward Woo asked about the current inventory levels of Ampligen, its sufficiency for planned clinical trials, and the feasibility of manufacturing additional supply.

Answer

Executive Thomas Equels confirmed that the current Ampligen supply is budgeted and sufficient for ongoing trials, barring unforeseen events. He noted that future trials will require manufacturing more Ampligen, a capital-intensive process for which the company is actively preparing with its vendors.

Edward Woo of Ascendiant Capital Markets inquired about the specifics of the cost and time reduction for producing Ampligen and asked if further manufacturing improvements were possible.

Answer

Executive Thomas Equels confirmed ongoing efforts to improve manufacturing efficiency, noting that mass production via a large pharma partnership would create significant savings. Science Officer Dr. Christopher McAleer detailed that recent process optimizations reduced polymer production time by approximately 40% and cut batch costs from about $400,000 to $200,000. He outlined a future goal to implement a continuous flow process, which could increase production three- to four-fold and reduce the final cost of Ampligen by an estimated 60-70%.

Edward Woo of Ascendiant Capital Markets inquired about the recent manufacturing run of Ampligen, asking about its relative difficulty, cost compared to previous batches, and the outlook for future production needs.

Answer

Thomas Equels (executive) reported that the recent manufacturing process with their contract partner, Jubilant HollisterStier, went well without any issues. He acknowledged that costs have increased over time, in line with broader trends in medical R&D. Mr. Equels stated that current reserves are adequate for the next two years of planned activity, but a large-scale trial with a commercial partner would necessitate manufacturing more Ampligen. He added that mass production has the potential to be significantly more cost-effective than the current smaller, more expensive clinical lots.

Edward Woo of Ascendiant Capital Markets inquired about Phunware's geographic focus, asking if the company plans to remain concentrated on the U.S. market or pursue international opportunities.

Answer

Executive Stephen Chen responded that while he has an emerging markets background and sees international expansion as a long-term goal (approximately 3 years out), the company's immediate priority is the domestic U.S. market. The current strategy is to first establish a strong U.S. foothold, demonstrate value through pilot programs, and solve customer problems profitably before expanding abroad.

Edward Woo from Ascendiant Capital asked if there have been any recent changes in the sales cycle, questioning whether customers are showing more caution or if the cycle length has remained consistent.

Answer

Executive Mike Snavely responded that the sales cycle has remained stable at approximately 90 days. He elaborated that the company's strategic focus is now on securing 'one-to-many' relationships with property portfolio owners and management companies. This approach aims to accelerate 'rooftop wins' by signing multiple properties in a single sales cycle, thereby increasing the pace of customer acquisition.

Edward Woo of Ascendiant Capital inquired about any changes in the competitive environment and the outlook for the sales cycle throughout the remainder of the year.

Answer

Executive Mike Snavely responded that the competitive landscape is largely unchanged, consisting mainly of smaller app companies. He highlighted Phunware's growing success in engaging with operators of property portfolios, which he believes is a key differentiator and a strategy competitors are not widely pursuing.

Edward Woo of Ascendiant Capital Markets inquired about the implementation timeline for ENDRA's new strategic path and sought clarification on the target date for the FDA de novo submission.

Answer

Executive Alexander Tokman explained that the company's priorities for the next 9-12 months are set, focusing on completing the clinical study and preparing for regulatory submission. He clarified the goal is to complete the current study in 2024, start a pivotal study in early 2025, and submit the FDA application by mid-2025.

Edward Woo of Ascendiant Capital Markets inquired about the implementation timeline for ENDRA's new strategic plan and sought clarification on the target date for the FDA submission in 2025.

Answer

Executive Alexander Tokman explained that the company's clear priority for the next 9-12 months is executing the clinical study to gather data for the FDA submission and commercial promotion. He added that the longer-term strategic vision will be developed over the next 6-9 months. Tokman confirmed the goal is to complete the clinical study in the current year, start a pivotal study early next year, and submit the de novo application to the FDA by mid-2025.

Edward Woo of Ascendiant Capital Markets inquired about ENDRA's potential expansion plans into other parts of Asia, beyond its existing distribution agreement in Vietnam.

Answer

Executive Francois Michelon responded that while ENDRA has a distribution agreement for Vietnam contingent on FDA approval and a past clinical study agreement in China, the company's primary focus is on establishing a strong foothold in Europe and the U.S. first. He emphasized a disciplined strategy of building a foundational base of clinical evidence in these core markets before committing resources to a broader Asian expansion.

Edward Woo asked whether there have been any changes in the company's distribution or advertising costs, particularly on the Amazon platform.

Answer

Executive Justin Hall responded that despite industry-wide cost increases, their advertising costs have remained consistent. He noted that the company closely monitors Google and Meta ad spending to maintain efficiency, but emphasized that the majority of customer acquisition is driven by the physician-dispensed channel and advertising within the Amazon ecosystem.

Edward Woo of Ascendiant Capital Markets asked about NovaBay's marketing strategy for the remainder of the year, focusing on customer acquisition for its direct and Amazon channels and plans for marketing spend.

Answer

Executive Justin Hall responded that the strategy balances marketing efficiency with growth. He stated that while new customer acquisition is expensive, the focus for the rest of the year will be on converting patients from the physician-dispensed channel into long-term OTC customers on either Avenova.com or Amazon, leveraging the initial doctor recommendation to drive online sales.

Edward Woo asked about the manufacturing and supply strategy for Europe and whether the company anticipates needing to move production to Europe for commercialization.

Answer

Executive C. Trenary responded that while current U.S.-based manufacturing partners can supply Europe initially, the company will continuously evaluate its global manufacturing footprint. He noted that their partners also have European facilities, which could be leveraged in the future to optimize costs and logistics as the European launch scales.

Edward Woo of Ascendiant Capital inquired about potential opportunities for Knightscope in emergency preparedness for government or business organizations, citing the recent Maui wildfires as an example.

Answer

Executive William Li responded that while Knightscope's thermal cameras could aid in prevention, the company's current model is better suited for 24/7 deployments rather than event-driven emergencies. Li noted one inquiry from FEMA and discussed the long-term strategy to develop more portable, responsive technology. He also suggested that current products could enhance security at FEMA facilities, freeing up human resources for emergencies.