Marla Marin

Marla Marin inquired about the Aethlon Medical oncology trial, specifically clarifying the treatment regimen for Cohort 2, which involves two Hemopurifier treatments within the same follow-up period as Cohort 1. She also asked about the potential impact of integrating the Hemopurifier with the SLAMB system, focusing on how it could simplify administration for hospital staff and make the treatment less invasive for patients, thereby expanding access to different medical centers. Finally, she questioned CEO Jim Frakes on the company's continued cost-conscious approach, particularly regarding R&D spend and preclinical research like Long COVID.

Answer

Dr. Steven LaRosa, Chief Medical Officer, confirmed that Cohort 2 participants receive two Hemopurifier treatments, allowing for observation of EV and T-cell kinetics between treatments and long-lasting effects. He explained that the SLAMB system would enable the use of smaller, less invasive catheters (like PICC lines) and a simplified pump, removing the need for large dialysis catheters, dialysis machines, and nephrologists. This would allow treatments to be administered in oncology or infusion units, making it less daunting for patients and more integrated into their care. CEO and CFO Jim Frakes affirmed the company's commitment to cost containment, stating that preclinical work, including Long COVID research, is conducted in-house with minimal external lab use and a focus on obtaining samples at low cost, all while prioritizing the oncology trial.

Marla Marin with Zacks Investment Research inquired about the Aethlon Medical Australian oncology trial, specifically clarifying the treatment frequency and follow-up duration for Cohort 2 participants receiving two Hemopurifier treatments. She also asked about the strategic implications and patient benefits of integrating the Hemopurifier with the simplified SLAMB system, and how Aethlon Medical maintains cost-effectiveness in its R&D, including preclinical Long COVID research.

Answer

Steven LaRosa, CMO of Aethlon Medical, confirmed that Cohort 2 involves two treatments with the same follow-up period, allowing for kinetic analysis of EV and T-cell changes. He detailed how the SLAMB system, with its smaller catheter and simplified pump, could enable Hemopurifier treatments in oncology or infusion centers, making the process less invasive for patients and easier for hospital staff. Jim Frakes, CEO and CFO, along with Dr. LaRosa, affirmed their commitment to cost-effective R&D by leveraging in-house scientific staff and seeking low-cost samples, while prioritizing the oncology trial.

Marla Marin of Zacks Investment Research inquired about the Australian trial's primary safety endpoint, whether the high efficacy seen in preclinical data (98.5% EV removal) is a realistic expectation for the clinical study, and the strategic versus financial rationale for discontinuing the planned trial in India.

Answer

Chief Medical Officer Dr. Steven LaRosa confirmed the trial is on track to meet its primary safety endpoint after the first cohort passed review by the independent Data Safety Monitoring Board. He also clarified that while preclinical data is encouraging, clinical results in actual patients are the true measure of efficacy. Dr. LaRosa and CEO James Frakes explained the decision to cancel the India trial was primarily strategic, driven by unforeseen regulatory slowness in India that could have significantly delayed the overall program and subsequent PMA application, making the focus on Australia the fastest path forward.

Marla Marin of Zacks Investment Research inquired about Aethlon Medical's primary strategic focus, asking if oncology remains the top priority despite new initiatives in long COVID. She also questioned the cost-efficiency of the long COVID collaboration, the expected timeline for data from the Australian oncology trial, and whether nonrecurring executive severance costs have concluded.

Answer

CEO & CFO James Frakes confirmed that the company's focus remains "almost entirely on oncology," positioning the long COVID research as a cost-effective, early-stage opportunity. He stated that preliminary data from the first Australian cohort is expected in about three months. Frakes also clarified that the final executive severance payouts are scheduled to conclude by September 2025, and he does not anticipate further similar costs.

Marla Marin asked for more details on the first three patients in the Australian oncology study, questioning why two did not proceed to treatment and how this affects the 9-to-18 patient enrollment target. She also inquired if the new, amended protocol would be used for the India trial and asked about the Australian R&D tax rebate.

Answer

Chief Medical Officer Dr. Steven LaRosa clarified that the 9-to-18 patient target refers specifically to Hemopurifier-treated patients, so two new patients will be needed for the cohort. He confirmed the amended protocol will also be submitted for the India trial to improve efficiency. CEO and CFO James Frakes added that the new protocol eliminates a two-month run-in period and confirmed that Australian trial expenses are eligible for a 43% cash rebate, which is filed for annually after the March fiscal year-end.

Marla Marin inquired about the progress of Aethlon's Australian oncology trial, asking if the first two patients represent different tumor types, the company's confidence in securing ethics approval for a third site, and the mechanics of the 43% tax benefit in Australia.

Answer

Executive Steven Larosa confirmed the first two patients have two different tumor types representative of those treated with anti-PD-1 therapies. He also expressed high confidence in the third site's approval, noting it's contingent on a minor radiation assessment update. CEO James Frakes explained the Australian financial incentive is a 43% cash payment on all project-related expenses incurred in the country, which is submitted for annually.

Marla Marin of Zacks asked about the potential for small tuck-in acquisitions, similar to the Farmville acquisition, and questioned CoreCivic's liquidity to support its various strategic initiatives (new demands, reactivations, share buybacks, growth) in light of potential delayed government payments.

Answer

CEO Patrick Swindle stated that while a business development team actively looks for opportunities, nothing is imminent, and any acquisition would need to be compelling given the current stock valuation. CFO David Garfinkle affirmed strong liquidity, with over $300 million available on the Revolving Credit Facility and nearly $100 million in cash at year-end, emphasizing that CoreCivic is not liquidity-constrained and recently expanded its credit facility to $700 million. Patrick Swindle added that CoreCivic maintains a conservative leverage approach and made preemptive investments in idle facilities.

Marla Marin asked about potential small tuck-in acquisitions similar to Farmville and addressed concerns about CoreCivic's liquidity to support various initiatives (capacity, reactivations, buybacks, growth) amidst potential delayed government payments.

Answer

Patrick Swindle, CEO, stated that the business development team actively evaluates opportunities, but nothing is imminent, and acquisitions would need to be compelling given the current stock valuation. David Garfinkle, CFO, assured that CoreCivic is not liquidity constrained, citing over $300 million available on the revolving credit facility plus $100 million cash, and the recent $300 million expansion of the facility. Patrick Swindle added that the company maintains a conservative leverage approach and has preloaded capital for activations.

Marla Marin of Zacks Investment Research questioned how much room CoreCivic has to negotiate higher per diem rates before losing its cost advantage and asked which other idle facilities are strategically located and attractive to government partners like ICE.

Answer

CEO Damon Hininger explained that CoreCivic remains highly cost-competitive compared to city/county rates, federal alternatives, and potential international options. CFO David Garfinkle added that their existing, built-out capacity provides a significant price advantage. Hininger identified idle facilities in Tennessee (near Memphis), Oklahoma (large, centrally located), and Colorado (serving the western U.S.) as the most attractive next options for ICE.

Marla Marin asked about the low-cost initiatives CoreCivic could undertake in advance of a contract award to shorten the start-up time for an idle facility. She also inquired if the South Texas facility would require significant retrofitting to operate under a more standard contract model.

Answer

President Patrick Swindle explained that CoreCivic has already formed an internal activation team and is performing pre-activation work, creating project plans, and preparing leadership and training teams to shorten the typical 4-6 month timeline, potentially by 2-3 months in high-priority locations. CEO Damon Hininger stated that any retrofitting for the South Texas facility would be "very modest" as it was only recently deactivated.

Marla Marin inquired about the typical timeline from a Request for Information (RFI) to a Request for Proposal (RFP) for detention capacity and asked if staffing for new contract awards would require new hiring or if personnel were already in the pipeline.

Answer

CEO Damon T. Hininger explained that while there is no standard timeline, ICE can move very quickly, citing the 120-day activation of the South Texas facility as an example of their ability to expedite the process when needed. CFO David Garfinkle added that a typical RFI-to-RFP process might take six months but could be accelerated. Regarding staffing, Hininger stated that CoreCivic has a 'playbook' and populated pipelines ready to scale up hiring, with associated costs being part of the start-up expenses for new contracts. Garfinkle clarified they have not hired in advance for idle facilities but could absorb 1,500-2,000 additional people in currently operational facilities.

Marla Marin from Zacks Investment Research inquired about LogicMark's customer mix as it expands into broader safety demographics and asked about the potential impact of government funding cutbacks on its long-term partnership with the VA.

Answer

CEO & Director Chia-Lin Simmons explained that the business is still heavily skewed towards the government sector and medical alerts but is expanding into adjacent areas like senior and independent living. Regarding the VA, Simmons stated that while administrative changes are possible, the company has not seen a slowdown in demand for its products for aging veterans and doesn't anticipate one, as the fundamental need persists.

Marla Marin inquired about the market traction for the new Freedom Alert Mini, the strategy for direct-to-consumer sales via Amazon, the potential for licensing the company's growing IP portfolio, and any early customer feedback on the Aster product.

Answer

CEO Chia-Lin Simmons attributed the Freedom Alert Mini's success to its differentiated features and active marketing to partners like the Veterans Administration. She noted that while direct-to-consumer efforts on Amazon are promising, it is still early. Simmons confirmed a strategic focus on building a licensable IP portfolio, particularly in applied AI, and mentioned that the company is still gathering feedback to refine the new Aster product.

Marla Marin inquired about the company's strategy for its Direct-to-Consumer (DTC) channel and the growth prospects for its new Aster safety app, which targets a broader demographic beyond elder care.

Answer

CEO Chia-Lin Simmons detailed the DTC strategy, emphasizing sales through the company website, app stores, and particularly Amazon, where they are optimizing logistics and product listings. Simmons explained that while the traditional elder care market remains strong, the Aster app opens a significant new Total Addressable Market (TAM) by addressing widespread personal safety concerns and enabling B2B2C partnerships.

Marla Marin of Bluegrass Capital Partners inquired about the market reception for the new Aster software, plans for third-party device integration, and the specifics of the Q4 goodwill impairment charge.

Answer

Executive Chia-Lin Simmons addressed the product questions, stating that the Aster app, especially when paired with its Bluetooth button, is receiving positive initial feedback for its unique, user-friendly design that enhances personal safety. Simmons also confirmed that LogicMark is in discussions to integrate third-party services and devices to expand its Caring Platform as a Service (CPaaS) ecosystem, citing potential integrations for medicine reminders and biometric monitoring. CFO Mark Archer explained that the goodwill impairment charge was a non-cash charge related to the original LogicMark acquisition, which predates the current management team, and was necessitated by the company's current market capitalization.

Marla Marin of Blue Deep Capital inquired about the potential impact of regulatory changes to reimbursement on the company's revenue and asked about the ability to manage fixed cost absorption with the addition of a new center in Rhode Island.

Answer

Executive Raymond Stachowiak clarified that the company has minimal exposure to Medicaid, mitigating risks from reimbursement changes, as revenue is primarily driven by private insurers and Medicare. He also explained that the expanding Direct Patient Services segment offers greater control over operations, which will help manage the fixed-cost business model as new centers are added.

Marla Marin inquired about the potential synergies and economies of scale from American Shared Hospital Services' expanding footprint in Rhode Island, specifically asking about the benefits of the Brown University agreement and the proximity of new facilities to existing ones.

Answer

Executive Chairman Raymond Stachowiak confirmed that there will be synergies from their new relationship with Brown University Health. He highlighted that AMS has strong partnerships with the three largest healthcare systems in the small state of Rhode Island: Brown University Health for professional services, and both Care New England and Prospect Charter Care as 20% equity owners in their three radiation therapy centers, which will advance cancer care in the state.