Zacks Small Cap Research Press Releases

CVKD: Designing Phase 3 Trial for CAD-1005 in HIT

Fri, 08 May 2026 12:15:00 -0400

NASDAQ: CVKD

Business Update

Planning for Phase 3 Registration Trial of CAD-1005 in HIT

On April 30, 2026, Cadrenal Therapeutics, Inc. (NASDAQ: CVKD) announced an ‘End-of-Phase 2’ meeting with the U.S. Food and Drug Administration (FDA) in which the agency provided critical guidance on the company’s upcoming Phase 3 pivotal trial for CAD-1005 for the treatment of heparin-induced thrombocytopenia (HIT).

The planned Phase 3 trial, which will be the first randomized, double blind, placebo-controlled registration trial for HIT, will enroll approximately 120 patients from up to 50 clinical centers worldwide. Patients will be randomized to CAD-1005 or placebo while receiving standard-of-care anticoagulant therapy and treated for up to 14 days during hospitalization. The centrally adjudicated primary endpoint will be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT. The trial will also have at least one planned interim analysis.

Background on HIT

HIT is a severe, immune-mediated prothrombotic disorder triggered by exposure to heparin, an anticoagulant used widely in clinical practice (e.g., surgery, dialysis). It is estimated to occur in approximately 1 in 1500 hospital admissions (Dhakal et al., 2018). Data shows that certain variables can increase the risk of developing HIT, including cardiac surgery (Pishko et al., 2017) and exposure to unfractionated heparin vs. low molecular weight heparin (Warkentin et al., 1995), while a shorter exposure to heparin appears to decrease the risk of developing HIT (Smythe et al., 2007).

Diagnosis of HIT uses the “4Ts Score”, which is a pre-test scoring system that assesses the probability of HIT (Lo et al., 2006). It is calculated as a sum of points from four components: Thrombocytopenia, Timing of platelet count fall, Thrombosis or other sequelae, and oTher causes of thrombocytopenia. Laboratory diagnosis of HIT is divided into two steps: an immunoassay and a functional assay. The immunoassay examines for the presence of anti-platelet factor 4 (PF4)/heparin antibodies. If anti-PF4/heparin antibodies are identified, a functional assay is performed to determine if those antibodies are pathogenic. The 14C-serotonin release assay (SRA) is the “gold standard” functional assay and has both high sensitivity (~0.95) and specificity (~0.95) (Warkentin et al., 2015).

Management for patients suspected of suffering from HIT includes 1) the avoidance of heparin, indefinitely if possible, and 2) use of non-heparin anticoagulation. The duration of non-heparin anticoagulation will be dictated by the presence of absence of thrombosis. Preferred agents for non-heparin anticoagulation therapy include argatroban and bivalirudin, which can be administered IV, or danaparoid, which can be administered subcutaneously.

For patients who develop HIT, there are a number of potential negative outcomes, including thrombosis, bleeding, amputation, increased risk of hospital stay, and even death. Despite decades of research, no approved therapy directly targets the core immune and platelet activation mechanisms in HIT. Current anticoagulants decrease the risk of coagulation but do not modulate immune-mediated platelet activation, which leaves patients at persistent risk of thrombosis.

CAD-1005 for HIT

CAD-1005 is a highly selective inhibitor of human 12-LOX and is designed to reduce or prevent platelet activation and the downstream pro-thrombotic cascade in HIT. By inhibiting 12-LOX activity, CAD-1005 reduces the production of proinflammatory and procoagulant 12-LOX metabolites that feed into platelet activation loops. The drug also addresses the immune-driven aspect of HIT pathogenesis, which is the pathway that links immune complexes and platelet hyperactivity, a mechanism wholly distinct from direct anticoagulation. Lastly, preclinical and Phase 1 clinical trial results indicate there is no increased bleeding signal, which distinguishes CAD-1005 from traditional anticoagulants that reduce the risk of clotting at the cost of an increased risk of bleeding.

12-LOX Biology

12-LOX (encoded by the ALOX12 gene) catalyzes the oxidation of arachidonic acid to proinflammatory lipid mediators such as 12-hydroxyeicosatetraenoic acid (12-HETE) (Dobrian et al., 2011). 12-LOX is expressed in platelets (Contursi et al., 2022), unlike cycolooxygenase-1 (COX-1), which drives thromboxane A2 (TXA2) production and classical platelet aggregation, 12-LOX does not primarily initiate aggregation but instead acts as a potentiator and amplifier of platelet activation. The main bioactive product of 12-LOX, 12-HETE, is a lipid molecule that easily transits cell membranes and can induce its effects both intracellularly, where it promotes oxidative stress, and extracellularly, where it impacts a variety of signaling pathways to modulate inflammatory activity. Importantly, 12-HETE does not cause strong platelet activation alone; it just lowers the activation threshold, thus making platelets hyper-responsive (Tamang et al., 2024).

In HIT, platelets are activated via FcγRIIa binding of anti-PF4/heparin antibody complexes (Yeung et al., 2024). 12-LOX acts downstream of FcγRIIa signaling: FcγRIIa activation leads to phospholipase A2 activation that leads to arachidonic acid release. The arachidonic acid is then converted to 12-HETE, and it is the 12-HETE that feeds back to sustain and amplify the activation signal. By inhibiting 12-LOX, pathologic amplification is selectively inhibited by reducing 12-HETE generation. This targets the disease itself and as opposed to current HIT therapies does not result in a residual thrombotic risk. The high selectivity of CAD-1005 helps to preserve baseline platelet function and allows it to be used with standard anticoagulants while being short-lived and controllable in an in-patient setting.

Phase 1 Results

Veralox previously completed a Phase 1a study in healthy volunteers that consisted of a single ascending dose (SAD) and multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CAD-1005. In that study, CAD-1005 was found to be well tolerated with no reports of serious adverse events (SAEs), dose-limiting toxicities (DLTs) or discontinuations. The data showed a dose linear increase in key PK metrics with no upper limits on tolerability to the maximum dose tested.

Veralox also completed a Phase 1b drug-drug interaction (DDI) study of CAD-1005 in combination with argatroban, an anticoagulant drug approved for the treatment of HIT. The results showed that co-administration of CAD-1005 with argatroban was well tolerated with no SAEs. Analysis of the PK and PD data showed no evidence for DDI.

Market Opportunity

Currently approved HIT treatments focus on non-heparin anticoagulation, which mitigate clot propagation but do not directly modulate immune platelet activation, which is the core driver of HIT pathology. Thus, there is a high residual risk of thrombosis that persists in HIT patients despite anticoagulant therapy. In addition, there are no approved agents that target the immune-mediated platelet activation pathway, thus positioning CAD-1005 as a first-in-class drug. There are approximately 240,000 suspected cases and approximately 48,000 confirmed cases of HIT in the U.S. each year, thus offering a large patient population that could potentially benefit from a safe and effective HIT therapy.

Financial Update

On May 7, 2026, Cadrenal announced financial results for the first quarter of 2026. As expected, the company did not record any revenues for the three months ending March 31, 2026. R&D expenses in the first quarter of 2026 were $0.8 million compared to $1.7 million in the first quarter of 2025. The decrease was primarily due to lower expenses associated with chemistry, manufacturing, and controls (CMC), lower personnel expenses, and decreased stock-based compensation. G&A expenses were $1.7 million in the first quarter of 2026 compared to $2.3 million in the first quarter of 2025. The decrease was primarily due to lower expenses related to being a public company, along with decreased personnel, stock-based, and consulting expenses.

As of March 31, 2026, Cadrenal had approximately $2.3 million in cash and cash equivalents. Subsequent to the end of the quarter, the company completed a $2.5 million financing to support near-term development activities. We estimate the company has sufficient capital to fund operations into the fourth quarter of 2026. However, it will need to raise additional capital to conduct the planned Phase 3 CAD-1005 trial. The company currently has approximately 2.9 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 4.3 million.

Conclusion

We are glad to see the FDA provided the company with clear guidance as it prepares for the Phase 3 trial of CAD-1005 in HIT. Cadrenal is continuing to evaluate various financing and strategic alternatives to advance the trial, and we anticipate an update once there is a clear plan in place. With no changes to our model, our valuation remains at $25 per share.

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REVB Poised for Big Year

Fri, 08 May 2026 12:04:00 -0400

By Brad Sorensen, CFA

NASDAQ: REVB

READ THE FULL REVB RESEARCH REPORT

Revelation Biosciences (NASDAQ: REVB) is a potentially high-upside clinical-stage biotechnology company focused on immune modulation and inflammatory disease management. The company’s core centers around its Gemini platform, which is designed to rebalance immune function and inflammatory responses in serious medical conditions such as chronic kidney disease (CKD) and acute kidney injury (AKI). In 2026, the company has increasingly emphasized that its technology may have broad applicability across multiple inflammatory and immune-compromised disease states, potentially expanding the addressable market well beyond its current clinical targets.

In the 1Q2026 earnings release, the company reported a good cash balance, aided by a warrant inducement in January, of $14.1 million. The company believes that amount should carry the company through the first quarter of 2027—a great sign for a clinical stage company.

Company management highlighted several important milestones early in 2026 that could shape investor sentiment for the remainder of the year. Perhaps most notably, the company recently announced that it reached agreement with the FDA on an approval pathway for Gemini in acute kidney injury, including a single adaptive Phase 2/3 study design and a clinically relevant composite endpoint. For a small-cap biotechnology company, clarity from the FDA on a potential registration pathway can materially reduce perceived regulatory uncertainty and may accelerate development timelines.

Another significant catalyst has been the continued positive data emerging from the PRIME clinical study. Revelation reported that Gemini demonstrated the ability to normalize inflammatory responses at the cellular level in stage 3 and stage 4 CKD patients while also restoring aspects of immune competence. The company has provided this as evidence that Gemini may address both inflammation and immunoparalysis simultaneously, an approach that could differentiate the therapy from more narrowly targeted anti-inflammatory drugs. Additional data presentations during 2026 could continue to strengthen the mechanistic and clinical narrative around the platform.

Revelation also announced the initiation of GMP manufacturing for Gemini and placebo supplies intended to support later-stage clinical development. This move suggests management is increasingly focused on scaling operations in anticipation of larger studies and potentially accelerated development activity.

Another potentially favorable development for 2026 is the formation of an Acute Kidney Injury Advisory Board. Building relationships with nephrology experts and clinical opinion leaders will help strengthen trial design, physician awareness, and eventual market positioning if Gemini continues to produce favorable data. AKI remains an area of substantial unmet medical need with limited therapeutic options, creating the possibility for significant commercial opportunity if Revelation can successfully advance its clinical program, as we believe they can.

Like many development-stage biotech companies, Revelation carries risk related to financing needs, clinical execution, and regulatory outcomes. However, investors should consider that the company’s relatively small valuation compared with the potential commercial opportunity in kidney disease and inflammatory disorders creates asymmetric upside potential if Gemini continues to demonstrate strong clinical results. With improving operational efficiency, a clearer FDA pathway, additional expected data releases, and several anticipated catalysts during 2026, REVB should remain a closely watched speculative biotechnology story over the coming year.

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UJOGF Makes Major Announcement

Fri, 08 May 2026 11:07:00 -0400

By Brad Sorensen, CFA

OTCQB: UJOGF | LSE: USO

READ THE FULL UJOGF RESEARCH REPORT

Union Jack Oil (OTCQB: UJOGF, LSE: USO) has increasingly positioned itself as a differentiated small-cap onshore oil and gas producer with exposure to both the United Kingdom and the United States, a strategy that gives the company geographic diversification while maintaining a disciplined capital structure. The company has built a reputation for maintaining relatively low corporate overhead, preserving cash resources, and selectively participating in projects that can provide meaningful production and reserve upside without excessive balance-sheet risk. In an environment where many junior energy companies have struggled with debt burdens and repeated equity dilution, Union Jack has emphasized funding projects from existing cash resources while steadily expanding its portfolio of producing and development assets.

A very recent example of execution for the company is the spudding of the Crossroads well in Oklahoma, a project that could become an important catalyst for future growth. Union Jack announced that the Crossroads well was spudded on May 5, 2026, with drilling expected to take approximately ten days. The company currently holds a substantial 43% working interest in the project, and importantly, management stated that its share of drilling costs was funded from existing cash resources.

The Crossroads project is strategically important because it expands Union Jack’s exposure to the highly productive and infrastructure-rich Oklahoma hydrocarbon region. Oklahoma remains one of the most established onshore oil jurisdictions in the United States, with extensive pipeline networks, experienced service providers, and relatively efficient permitting and development processes. For a company of Union Jack’s size, a successful well can have an outsized impact on both revenues and valuation. Even a modest commercial discovery could materially increase production volumes, reserves, and operating cash flow while validating the company’s broader strategy of expanding its U.S. footprint.

The economics of a successful Crossroads well could be particularly attractive given Union Jack’s sizable ownership stake. Because the company already funded its participation from cash on hand, the project avoids the near-term burden of additional financing costs or shareholder dilution. If the well encounters commercially productive hydrocarbons, Union Jack would be positioned to benefit from long-lived production revenue while potentially opening additional drilling opportunities in the surrounding acreage. In many onshore U.S. plays, one successful well can substantially de-risk neighboring prospects, creating the potential for follow-on development that extends beyond the initial discovery.

The timing of the Crossroads drilling program may also prove highly advantageous given the recent recovery in oil prices. Crude prices have strengthened in recent weeks amid ongoing geopolitical tensions, supply concerns, and expectations for tighter global inventories. Higher oil prices can have a dramatic effect on small-cap producers because incremental revenue often flows disproportionately to cash flow and profitability once fixed operating costs are covered. For Union Jack, stronger commodity prices improve the potential economics not only of Crossroads, but also of its broader portfolio of producing and development assets.

This rising oil price environment could create a powerful operational and financial tailwind for the company. Higher realized prices increase project returns, shorten payout periods on new wells, and improve reserve valuations. They can also enhance investor sentiment toward smaller independent producers that offer leverage to commodity upside. Union Jack’s combination of existing production, low debt exposure, and active development projects means that it may be particularly well positioned to benefit if elevated oil prices persist through 2026 and beyond.

Another encouraging aspect of Union Jack’s current position is the company’s financial discipline. The announcement that drilling costs for Crossroads were funded from existing cash reserves reinforces management’s focus on maintaining balance-sheet flexibility. This conservative approach may allow the company to participate in additional opportunities while limiting dilution risk for shareholders.

Looking ahead, Union Jack appears positioned at an interesting inflection point. The company already has established producing assets and operational experience, but the Crossroads well introduces a potentially transformative growth opportunity at a time when oil market fundamentals have become more supportive. If the well delivers encouraging results, the project could significantly strengthen the company’s production profile, cash flow generation, and reserve base while reinforcing the value of its expanding U.S. portfolio. Combined with elevated oil prices and disciplined financial management, we believe investors should take a look at UJOGF.

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LNTH: Lantheus Reports 1Q:26 Financial and Operational Results

Fri, 08 May 2026 09:35:00 -0400

By John Vandermosten, CFA

NASDAQ: LNTH

Lantheus Holdings, Inc. (NASDAQ: LNTH) reported first quarter 2026 financial results on May 7^th. Revenue was $377 million, up 1% from 1Q:25 but down 7% sequentially. Adjusted fully diluted earnings per share were $1.46, falling 5%. Full year 2026 guidance remains the same as issued in late February: revenues between $1.4 and $1.45 billion and adjusted earnings per share of $5.00 to $5.25. First quarter growth in Definity and Strategic Partnerships was partially offset by declines in Pylarify revenue. However, the addition of revenue from NeuraCeq compensated for the loss of SPECT revenues, which were divested on January 1^st. At quarter-end, cash and equivalents were $499 million compared to $359 million at the end of 2025. Operating cash flow and proceeds from the sale of the SPECT business were only partially offset by cash used in financing, generating a net contribution of $139 million during the first quarter.

At the beginning of the year, prior Chairperson of the Board and former CEO, Mary Anne Heino, returned as the interim chief executive following the retirement of Brian Markison. Her return ushers in a new strategic focus to prioritize investment in the development and commercialization of innovative PET radiodiagnostics, alongside a decision to pursue value‑maximizing alternatives for radiotherapeutic assets to support long‑term growth. The company notched several successes since the beginning of the year, with approval of Pylarify TruVu and tentative approval for PNT2003 in March. The target action date for Octevy was extended by three months to June 29^th, 2026, in order for the FDA to review manufacturing-related information.

See below for links to key materials related to first quarter 2026 results:

1Q:26 Financial and Operational Results

Lantheus’ earnings release on May 7^th, 2026, was followed by a conference call which included interim CEO Mary Anne Heino, CFO Bob Marshall, and Chief Commercial Officer Amanda Morgan. The team highlighted its strategy of maintaining market leadership in PSMA PET, building momentum for NeuraCeq, advancing Lantheus’ late-stage clinical portfolio, and maintaining disciplined capital allocation. A financial comparison for 2025 follows.

For the quarter ending March 31^st, 2026, relative to the prior year:

Net sales were $377 million, up 1.2% from $373 million. The increase was driven by the addition of $35.4 million in NeuraCeq revenue and a 6.8% increase in Definity sales. Pylarify revenues declined 6.5% to $241 million as price declines of ~12% were only partially offset by 5.8% volume growth. The sale of the SPECT business on January 1^st was also a detractor, as TechneLite, NeuroLite, Xenon Xe-133 gas, and CardioLite were all divested to SHINE. The remaining line item, Strategic Partnerships and Other, rose 52% in the quarter to $16.3 million due to the addition of CDMO services from the Evergreen acquisition;
Cost of goods sold rose 8% to $146 million, and gross margin declined to 59.4% from 62.7% due to lower prices for Pylarify.^[1] Pylarify’s margin impact was offset by the removal of lower margin SPECT revenues and their replacement with higher margin NeuraCeq revenues. Other offsets to the margin decline include the contribution from MK-6240 sales for investigational use and an increase in Definity sales volume;
Sales and marketing expenses were $52.7 million, up 24% from $42.5 million, driven by higher costs related to NeuraCeq sales, and marketing expenditures related to launch preparations, primarily for Pylarify TruVu;
General and administrative expenses were $57.5 million vs. $56.8 million, increasing 1%. The change was attributable to the acquisitions of Life Molecular and Evergreen. Higher professional fees and employee-related costs, such as stock-based compensation, also contributed. These increases were offset by lower litigation costs and a legal settlement received in 1Q:26;
Research and development expenses were $39.4 million, up 8% from $36.3 million. The increase was related to additional costs related to the Life Molecular and Evergreen acquisitions. An increase in project costs related to LNTH-2403 also contributed. Increases were offset by the absence of a $5.4 million payment that was made to Lantheus Biosciences for LNTH-2401 that occurred in the prior year;
Interest expense was $4.9 million, up from $4.8 million in the prior year, and relates to the 2.625% convertible notes;
Other items generated a gain of $80.0 million vs. a loss of $734,000 due to the gain on the sale of the SPECT business, an increase in equity value for investments in Perspective and Radiopharm Theranostics, and other miscellaneous income;
Income tax expense of $38.0 million represents a 24.3% tax rate, with state income taxes, nondeductible stock compensation, and non-deductible acquisition-related costs contributing to the difference between the reported rate and the U.S. statutory rate of 21%. This was partially offset by tax credits;
GAAP net income was $118 million or $1.80 per diluted share. Adjusted net income as presented by Lantheus was $95.8 million or $1.46 per diluted share. The majority of the difference is explained in part by the removal of stock and incentive plan compensation, gain on sale of the SPECT business, investment gain from equity holdings, acquisition, integration, and divestiture-related items, and the income tax effect of these non-GAAP adjustments.

On March 31^st, 2026, Lantheus held $499 million in cash and equivalents compared to $359 million at the end of 2025. Free cash flow for 1Q:26 was $122 million vs. $99 million in 1Q:25. Lantheus recognized an additional $29 million in investing cash flows from the sale of SPECT and the sale of other assets.

Pylarify TruVu

Lantheus announced that it was developing a new formulation of Pylarify last year and disclosed that it had been submitted to the FDA for review in August 2025. It was submitted using the 505(b)(2) regulatory pathway and later approved on March 6^th, 2026. The new formulation, called TruVu, contains a new radiolytic stabilizer that enhances product stability at higher radioactive concentrations. The change is expected to increase batch size by 50% and supports higher radioactive concentrations, which improve efficiency and distribution. Manufacturing TruVu requires PET Manufacturing Facilities (PMFs) with high-energy cyclotrons. According to Lantheus, approximately 70% of their PMF network has these cyclotrons in place. As the company prepares to roll out TruVu, it will execute a technology transfer across its partner PMFs. Following a conversion of a PMF to TruVu, legacy Pylarify will no longer be manufactured. In addition to ensuring that the PMFs are ready for manufacturing, Lantheus will also ensure that customers are prepared for the change and that coding and insurance coverage are in place prior to sale. TruVu should be a strong contributor to 2027 growth, and it will benefit from a reset of transitional pass-through (TPT) status. TPT is a reimbursement medium used for outpatient payments that provides a three-year period of additional reimbursement for certain new medical technologies.

NeuraCeq

NeuraCeq was a strong positive contributor in the first quarter of 2026. It was part of the acquisition of Life Molecular Imaging and first contributed revenues to Lantheus’ income statement in 3Q:25. Sequential growth has been strong, with 14% growth in the first quarter. Revenue growth for the beta amyloid imaging agent was driven by increased utilization within existing accounts and from the ongoing adoption of Alzheimer’s disease-modifying therapies. Since Lantheus acquired LMI, it has expanded the manufacturing footprint and leveraged Lantheus’ existing relationships.

Other Key Assets

Octevy was acquired as part of the Evergreen merger and is also known as LNTH-2501. It is a registrational stage PET diagnostic imaging agent targeting neuroendocrine tumors. Evergreen had submitted the application to the FDA for review and a Prescription Drug User Fee Act (PDUFA) date was assigned for March. The FDA extended this date to June 29^th, 2026 to allow it additional time to review manufacturing-related information. Management indicated that the delay was unrelated to product safety or efficacy and expects Octevy to be commercially launched in early 2027.

PNT2003 received tentative FDA approval on March 2^nd, 2026. It is a Lu-177 dotatate radioequivalent of Lutathera. It is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lantheus anticipates launching the product with consideration of the Hatch-Waxman 30-month stay,^[2] disposition of legal proceedings, and execution of a successful manufacturing and commercial strategy.

Corporate Milestones

Completion of SPECT business unit transfer to SHINE – January 1^st, 2026
Reformulated Pylarify approval – March 6^th, 2026
Target Action Date for LNTH-2501 (Octevy) in SSTR+ NETs – June 29^th, 2026
Launch six additional PET Manufacturing Facility (PMF) sites in support of NeuraCeq - 2026
Target action date for MK-6240 – August 13^th, 2026
MK-6240 market launch – 2H:26
FDA approval and launch of PNT2003 after Hatch-Waxman resolution – 2026
Launch of reformulated Pylarify (TruVu) – 4Q:26
Commercial launch of LNTH-2501 (Octevy) - 2027

Summary

Lantheus delivered a modest 1.2% year‑over‑year revenue increase in the first quarter, driven primarily by the addition of NeuraCeq, continued Definity growth, and a sharp rise in Strategic Partnership and Other revenues. These gains were partially offset by Pylarify price declines and the impact of the SPECT business divestiture, which together muted top‑line momentum.

Despite the slight revenue lift, adjusted earnings declined, reflecting lower Pylarify pricing and reduced operating leverage, though this was partially cushioned by a lower share count and strong cash generation. Free cash flow benefited from the SPECT divestiture, which bolstered the company’s cash position.

Regulatory progress was a major highlight of the quarter. The FDA approved Pylarify TruVu, a next‑generation PSMA PET formulation designed to enable larger batch sizes at high‑energy cyclotron sites, with a phased launch expected to begin in late 2026. The company also received tentative approval for PNT2003, a radioequivalent therapy for gastroenteropancreatic neuroendocrine tumors. Meanwhile, the review of Octevy was extended as the FDA requested additional time to evaluate manufacturing‑related information.

Management reiterated that these regulatory milestones are expected to set the stage for accelerated growth in 2027, following what is likely to be a transition and rebuilding year in 2026 as TruVu conversion ramps and pipeline launches begin to contribute.

Looking ahead, Lantheus is increasingly concentrating its strategy around PET radiodiagnostics, having divested its SPECT business and signaling that it may monetize certain radiotherapeutic assets to sharpen its focus. The company is also investing heavily in neurology imaging, including Alzheimer’s-related diagnostics, which management views as a significant long‑term growth engine given rising demand for disease‑modifying therapies and earlier detection.

Lantheus advances through 2026 with a strengthened balance sheet, a deep and advancing pipeline, and multiple regulatory catalysts that support a multi‑year growth trajectory anchored in next‑generation imaging technologies.

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^[1]^{We calculate gross margin as 1-COGS/(revenues from Pylarify, Definity, TechneLite, NeuraCeq and Other Precision Diagnostics) as reported in company filings. We exclude revenues from Strategic Partnerships and Other from the calculation.}

^{[2] The Hatch-Waxman 30-month stay expires in June 2026; however, other barriers may exist.}

CXW 1Q26 First Look: Strong Momentum & Benefits of Growth Initiatives

Thu, 07 May 2026 09:22:00 -0400

By M. Marin

NYSE: CXW

CoreCivic (NYSE: CXW) reported 1Q26 results yesterday after the close that CXW believes illustrate the strong momentum in the company’s business and the benefits of its growth initiatives. Reflecting the reactivation of four previously idled facilities since 1Q25 (adding more than 7,700 beds) and the acquisition of the Farmville Detention Center on July 1, 2025, total revenue of $614.7 million increased 25.8% y/y. Revenue from ICE increased 96.2% to $261.3 million, and revenue from state customers increased 3.6%.

1Q26 net income was $37.9 million, and EPS was $0.38, compared with $25.1 million and $0.23, respectively, in 1Q25. EPS benefited from employee retention credits and a 10.1% decrease in average shares outstanding as the company repurchases shares. Adjusted EPS was $0.40 compared to $0.23.

Occupancy levels increased to 79.6% compared with 77.0%. CXW expects further increases in 2H 2026 as demand from federal, state, and local governments increases.

Results in 1Q26 were partially offset by a transition in inmate populations at the 2,552-bed Trousdale Turner Correctional Center that temporarily lowered populations and raised expenses there. As the population at this facility ramps, occupancy and margins are expected to increase.

Normalized Funds From Operations (FFO) for 1Q26 was $0.64 per share, compared with $0.45 in 1Q25. Adjusted EBITDA was $110.1 million in 1Q26, up from ~$81.0 in 1Q25.

CXW acquired Clinical Solutions Pharmacy (CSP), one of the largest domestic providers of mail

order pharmacy services to correctional facilities, for $148.0 million plus a potential earnout. CSP serves 600+ correctional facilities across 28 states, including CXW’s. The acquisition helps diversify CXW’s revenue and cash flows into an adjacent business that management believes has significant runway to grow.

The CSP transaction was funded with cash on hand and borrowings, and CXW obtained a $100 million incremental term loan subsequent to quarter-end at 0.25% above its initial term loan / revolving facility. It matures on April 9, 2027, and CXW has indicated that it would be open to opportunistic asset sales to refinance it.

CXW repurchased 2.3 million shares at an aggregate $44.7 million. Since the share repurchase program began in May 2022 through March 31, 2026, CXW has repurchased 28.1 million shares at an aggregate $444.2 million, or $15.82 per share, with $255.8 million remaining under the plan as of March 31, 2026.

Reactivation at the 1,033-bed Midwest Regional Reception Center in Leavenworth, Kansas, started on March 12, 2026. CXW expects this facility to reach stabilized occupancy in 3Q26 and contribute ~$0.05 to $0.06 in incremental EPS over the remainder of 2026.

Reflecting strong 1Q26 results and the acquisition of CSP, CXW raised 2026 guidance.

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COSM Introduces New Product for Sexual Health

Wed, 06 May 2026 16:11:00 -0400

By Brad Sorensen, CFA

NASDAQ: COSM

READ THE FULL COSM RESEARCH REPORT

Cosmos Health Inc. (NASDAQ: COSM) has increasingly positioned itself as a differentiated healthcare and nutraceutical company that combines pharmaceutical distribution, manufacturing infrastructure, telehealth initiatives, and science-driven supplement development into a vertically integrated operating model. Unlike many small-cap supplement companies that rely heavily on marketing narratives without clinical substantiation, Cosmos Health has been building a portfolio centered on patented ingredients, published human studies, exact clinical dosing, and internally aligned manufacturing and distribution capabilities.

A major component of Cosmos Health’s current growth strategy is the rollout of its “18 Series,” a platform of science-based nutraceutical products designed around clinically studied ingredients and proprietary formulations. Management has stated that the long-term objective is to develop a portfolio of 18 products targeting large health and wellness categories. Current products include Liv18 for liver health, Cur18 for joint health and inflammation support, Noor18 for anti-aging and collagen support, and now Fort18, which expands the company into the large and rapidly growing men’s wellness market.

The recent addition of Fort18 to the portfolio represents one of the more commercially intriguing products in Cosmos Health’s emerging nutraceutical portfolio because it targets a category with substantial recurring consumer demand, strong margins, and growing acceptance of clinically supported natural alternatives. The product is designed as a men’s sexual stamina and endurance supplement utilizing a proprietary blend of botanical extracts and nutrients that collectively target hormonal, vascular, neurological, and stress-response pathways associated with male performance and vitality. According to the company, the formulation includes L-arginine along with extracts of fenugreek, mucuna, ashwagandha, and artichoke leaf, standardized to specific saponin and flavonoid concentrations.

Mechanistically, the formulation is designed to address multiple physiological systems simultaneously rather than relying on a single stimulant effect. L-arginine supports nitric oxide production and blood flow, potentially improving vascular function. Fenugreek has been associated in published research with support for testosterone balance, stamina, and energy. Ashwagandha functions as an adaptogenic botanical that may reduce stress and support nervous system regulation, which is important because stress and cortisol dysregulation are often linked to diminished sexual performance and endurance. Mucuna contains naturally occurring L-DOPA precursors that interact with dopamine-related pathways associated with motivation and male wellness, while artichoke extract may further support endothelial and vascular health. Collectively, the formulation attempts to create a broader systems-based approach to male vitality rather than a narrow pharmaceutical-style intervention.

It’s important to note that Fort18 is not simply a generic supplement assembled from commodity ingredients. The blend utilizes an exclusive and patent-protected standardization fingerprint held by the ingredient supplier, helping create differentiation in a crowded supplement market. In the nutraceutical industry, intellectual property protection and standardized ingredient consistency can be extremely valuable because they support premium pricing, help defend against commoditization, and provide a more credible scientific narrative for consumers and healthcare practitioners.

In our view, the strongest aspect of the Fort18 investment case may be the presence of published human clinical research supporting the active formulation. According to the company, the active ingredient was evaluated in a randomized, double-blind, placebo-controlled study involving 60 healthy men between the ages of 18 and 60 experiencing reduced sexual stamina. Over an eight-week period, the published data demonstrated a 5.1-fold improvement in endurance versus placebo, with measurable effects observed as early as week four. The study also reportedly observed no significant adverse changes in vital signs or laboratory safety markers. In the supplement industry, where many products rely on anecdotal marketing claims or animal studies, the existence of placebo-controlled human clinical data can significantly strengthen consumer credibility and improve the product’s positioning in premium channels.

The commercial opportunity for Fort18 is also potentially substantial. Cosmos Health cited projections indicating that the U.S. sexual health supplement market could grow to approximately $1.93 billion by 2030, with men representing more than half of the overall consumer base. Demographic and behavioral trends appear favorable for continued expansion, including aging populations, increasing consumer willingness to use wellness supplements, growing acceptance of preventative health products, and rising interest in natural alternatives supported by clinical data. Importantly, this category often benefits from recurring purchasing behavior, which can create highly attractive customer lifetime economics if a company successfully builds brand loyalty.

Fort18 fits well into Cosmos Health’s broader strategic transition toward higher-margin proprietary products. Historically, portions of the company’s pharmaceutical distribution business operated with relatively modest margins, which is common in wholesale pharmaceutical distribution. However, management has recently emphasized the margin potential of its new nutraceutical products. For example, the company projected gross margins approaching 75% for Liv18 in the U.S. market through direct-to-consumer commercialization strategies. If Fort18 achieves similar economics, the product could become a meaningful contributor to both revenue growth and margin expansion over time.

An important aspect of the business strategy is that Cosmos Health is positioning the entire 18 Series around evidence-based differentiation. Management has repeatedly emphasized that each product within the platform is intended to meet three criteria: proprietary ingredients, published clinical research, and dosing consistent with clinical studies. This creates a coherent branding strategy that may resonate with increasingly sophisticated health consumers who are becoming more skeptical of unsupported supplement claims. If Cosmos can continue building recognition around the “18 Series” as a clinically substantiated wellness platform, the company could potentially develop meaningful brand equity across multiple large health categories simultaneously, resulting in increasing revenues and profitability and a boost in shares of COSM.

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TLGRF: Talga Group Reports Q3 2026 Cash Flow and Business Updates

Tue, 05 May 2026 09:23:00 -0400

By Thomas Kerr, CFA

OTCQX: TLGRF | ASX: TLG

READ THE FULL TLGRF RESEARCH REPORT

Talga Qualification Anode Plant Update

Talga Group (OTCQX: TLGRF, ASX: TLG) has recently achieved record customer validation and sales volumes through its test EVA plant (see below for more details on this plant). Talnode® anode products are now being supplied to 21 active qualification and technical validation programs with battery manufacturers in specific fast charge/high-power applications. These include AI Datacenter / BESS (Battery Energy Storage Systems), defense, robotics, drones, performance BEV’s, and hybrids.

The performance benefits of highly engineered fast-charge, high-power natural graphite is garnering wide market recognition as the current high petroleum costs are threatening many synthetic graphite producers. As opposed to Talga’s natural graphite processes, synthetic graphite production is significantly more energy-demanding and expensive.

Many customers also continue to highlight concerns around supply security due to geopolitical tensions and policy factors, and Talga is actively working with them and their governments to enable supply chain diversification.

Multi-year qualification activities with several Japanese customers of both Talnode® and Talphite® products progressed during the quarter, which is setting the stage for commercial and strategic discussions scheduled to take place this May and June in Japan. This is supported by Talga’s recently granted Japanese patents and the impact of China’s export restrictions on dual-use graphite, affecting dozens of Japanese companies.

Financing Update

Talga is actively pursuing non-dilutive funding through various government programs to accelerate its path to commercial production, while other European Commission programs are still being finalized. This approach builds on the company's already substantial funding situation, which includes a €150 million (A$260 million) European Investment Bank debt facility and a €70 million (A$120 million) EU Innovation Fund grant.

The Vittangi Anode Project's Strategic development status, combined with its strong alignment with Europe's supply-chain sovereignty, sustainability, and defense priorities, positions Talga to secure additional non-dilutive support. This is also reinforced by the company's proven track record in attracting state funding.

Front-End Engineering Design (FEED) Study

Talga’s FEED studies and activities in Sweden for the first 5,000 tpa commercial anode line continue to advance. This progress follows the awarding of The Industrial Leap 1 grant of SEK 82.6 million (~A$13.35 million), which provides funding support on the pathway to a Final Investment Decision (FID). Phase 1 of pre-construction works at the Luleå site to support the development of the 5,000 tpa plant is complete. The facility will produce premium graphite anodes for fast-charge, high-power lithium-ion battery applications and is set to deliver hundreds of direct and indirect jobs in northern Sweden while contributing to a more secure and self-reliant European battery industry.

The company’s technical team is working closely with its primary engineering partner Worley to deliver process, mechanical, and piping work packages, while Sweco and ABB are providing civil/structural and electrical engineering design. The FEED Study is on track to finish mid-year, with six of the nine work packages directly related to engineering, technical, and financial aspects of the project.

Looking ahead, Talga's key priorities include securing additional non-dilutive funding under EU and member state programs, converting new active EVA customer programs into multi-year offtake agreements, and completing the FEED study to support a Final Investment Decision targeting commercial output in 2027-28.

The company also aims to roll out additional high-performance Talnode® variants with a focus on ultra-fast charge and ultra-long life products to drive premium pricing, expand its offtake base, and strengthen its market-leading IP portfolio. In addition, the company plans to continue to advance previously announced U.S. and Japanese opportunities for the Talnode® process and product technologies to deepen strategic partnerships and broaden its revenue profile.

3^rd Quarter Capital Raise

During the quarter, the oversubscribed Share Purchase Plan closed successfully, raising A$7.3m through the issuance of 17.7 million new shares at A$0.41 per share. Eligible SPP participants also received one free unlisted attaching option for every two New Shares allocated with an exercise price of A$0.58 per option with an expiration date of February 11, 2028.

Holders of the Attaching Options may receive one fully paid ordinary share and one free unlisted piggyback option for every Attaching Option exercised. The Piggyback Options have an exercise price of A$0.65 and an expiration date of 2 years from the expiration of the Attaching Option.

U.S. Market Opportunity

In the 3^rd quarter, Talga advanced its strategic entry into the U.S. market by hiring United Catalyst Corporation (UCC) as its Program Facilitator and U.S. contracting representative. This move followed engagement with U.S.-based battery manufacturers at the International Battery Seminar (Orlando, FL, 3/24/26), as well as subsequent meetings with federal agencies in Washington, D.C., and Tokyo.

UCC is supporting Talga’s plans to expand graphite and anode production into the U.S. “Battery Belt,” leveraging the company’s existing Swedish production plant design and its FEOC-free supply platform to address growing demand for critical minerals in the United States.

The U.S. "Battery Belt" refers to a corridor of states across the South and Midwest that has emerged as the hub of American battery and electric vehicle manufacturing. Prominent states include South Carolina, Tennessee, Kentucky, Georgia, Michigan, Ohio, North Carolina, and Alabama.

The partnership is actively pursuing federal and state funding opportunities tied to offtake agreements, stockpiling, and domestic production. Talga is engaging with multiple U.S. agencies, including the DOE, DOD, Defense Logistics Agency, ARPA-E, Department of Commerce, and Economic Development Administration. Also, the company has begun site selection work with the South Carolina Department of Commerce and is in discussions with a growing number of U.S.-based battery cell manufacturers, particularly those focused on defense applications where its FEOC-free materials are highly valued.

Industry Developments

Global anode market conditions during the 3^rd quarter were shaped by geopolitical tensions, robust demand growth from the energy storage sector, and accelerating efforts by Western economies to reduce dependence on Chinese anode supply chains. A late-2025 agreement to delay China's planned export restrictions to the U.S. until November 2026 offered a degree of near-term market stability. Furthermore, existing trade barriers and the continued application of "Foreign Entity of Concern" (FEOC) rules kept pressure on Western manufacturers to prioritize non-Chinese feedstock.

In March, the U.S. International Trade Commission rejected higher anti-dumping and countervailing duties on Chinese active anode material, keeping tariffs around 35% instead of up to 220% and preserving the cost advantage of imports over domestic supply, though a potential appeal remains uncertain. Meanwhile, rising Japan/China tensions led Beijing to impose export controls on key dual-use minerals, including graphite, underscoring supply chain risks for Japan’s battery industry.

Against this broader geopolitical backdrop, the anode market sustained strong volume growth through the 3^rd quarter, driven by moderating EV demand across different jurisdictions alongside accelerating demand from battery energy storage systems (BESS) and AI-driven data center infrastructure. All of these dynamics continue to reshape global anode supply chains and reinforce the strategic importance of securing diversified, non-Chinese sources of feedstock for Western and allied manufacturers.

3^rd Quarter 2026 Financial Update

Talga ended the period with a cash balance of A$28.2 million, including an unrealized loss of A$839,000 due to foreign exchange fluctuations. Restricted funds were A$10.4 million related to grant funding.

Revenues in the quarter were A$57,000 related to sales of anode products from the current EVA 50 tpa plant. Operating cash flow was a use of cash of (A$4.2) million, and capital expenditures were (A$2.0) million. Due to the capital raise during the quarter, the cash position was mostly unchanged.

The company has 510.9 million quoted ordinary shares, 41.3 million unlisted options, and 500,000 performance rights on issue. The current market capitalization is approximately US$95.0 million.

Second Half (December 2025) Financial Report

On March 12, 2026, the company released its full 2^nd half financial report for the period ending December 31, 2025. The results were largely in line with expectations as the company continues to make progress on the development of its graphite mine and advanced anode refinery. Talga generated minimal revenues totaling approximately A$518,000 from small amounts of anode sales, interest, and grant income. Cash used in operations was (A$7.4) million, and capital expenditures were A$4.2 million in the 2^nd half.

Talga ended the quarter with A$28.4 million in cash, which includes A$13.35 million in restricted funds from the Industry Leap grant (see below). Net working capital was positive and totaled A$13.3 million.

The company also had conditional financing facilities totaling A$125 million from the EU Innovation Fund and Environmental Bonds. The company has 510 million shares outstanding, 14.8 million unlisted options, and the market capitalization is approximately US$98.0 million currently.

Commercial, Product, and Project Developments

Commenced the Front-End Engineering Design (FEED) study for a 5,000 tpa anode plant to start commercial production as part of a modular scale-up.

Delivered strong commercial traction with EVA anode customer receipts doubling from the prior corresponding period, including the largest anode shipment to date under existing offtake agreements.

Record demand from battery manufacturers for qualification material since production commenced in 2022.

Launched Talnode®-R, a proprietary graphite anode produced from recycled lithium-ion battery waste.

Secured a Supply Agreement with Aurubis to provide black mass graphite for Talnode®-R manufacturing.

Executed a Strategic Cooperation Agreement with leading US auto-industry recycling firm, United Catalyst Corporation, to explore the establishment of Talnode® production in North America.

Achieved major regulatory milestones for the Nunasvaara South mining concession with land-use approvals and Detailed Plan progression.

Received Exploitation Concession approvals for the Nunasvaara North, Niska South, and Niska North graphite deposits of the Vittangi Graphite Project in northern Sweden.

Strengthened Talga’s intellectual property portfolio with three new graphite anode product patents secured in the US and one in Japan.

Expanded the product portfolio with performance-enhancing additives based on Talga’s high-purity graphite, opening new commercial opportunities across a wider range of battery technologies.

Advanced participation in multiple EU-funded R&D projects to enhance supply chain resilience and commercial pathways for Talga’s high-performance graphite and silicon-carbon anodes.

Mutually agreed to terminate the Aero Joint Venture with global lithium giant SQM after the Swedish Inspectorate for Strategic Products did not satisfy the conditions precedent in a reasonable time.

Aero Project in Sweden

On January 15, 2026, the company announced that recent rock chip sampling programs, field mapping, and evaluation have confirmed evidence of high-grade gallium and other critical elements at the 100% owned Aero Project in northern Sweden. The Aero Project covers 270 km², located 20 km southeast of Gällivare, a major mining hub in Sweden's Norrbotten region. Previous exploration activity at Aero has identified lithium oxide over a 50 km total strike with surface sample grades of up to 1.9% Li2O.

Gallium is a soft, silvery metal and a chemical element with unique properties, where it can melt in your hand at a temperature of 86°F (30°C). It is considered a strategic or critical metal due to its important uses in semiconductors, LEDs/lasers, and defense and space applications.

Talga recently completed field mapping and geochemical rock outcrop sampling and re-evaluated the project through the application of the Exploration Information System (EIS) digital tool. The company plans on refining and updating this model as exploration activities progress and new data is made available. The surface rock exposures have returned high-grade and anomalous concentrations of gallium, other rare earth elements (REEs), including yttrium, and other critical minerals and elements, which statistically exceed bulk crustal abundances. These results are considered significant for a first pass exploration such as this.

This collection of critical minerals and elements is gaining importance in global supply chains as governments such as the US, UK, Japan, Europe, South Korea, Australia, and Canada collaborate to build strategic reserves. Gallium and cesium are used in semiconductors, which drive advanced telecommunications among other applications. Niobium, scandium, tantalum, and yttrium are commonly used in alloys for lightweight applications that are crucial in the aerospace, defense, and automotive industries. Yttrium is also used in lasers.

We believe the potential of Aero will be greater than previously recognized due to recent exploration results. Although still in the exploration phase, the company is pursuing US and EU funding opportunities, including applications under DOE critical minerals programs and EU CRMA strategic project calls, to accelerate development of the project. In addition, Talga is engaging with major strategic partners for joint ventures targeting global companies in mining, technology, and defense sectors. This approach will allow Talga to unlock Aero's value while prioritizing the company’s core graphite battery anode business.

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FATN: FatPipe Releases Preliminary Results for FYQ4 Ending March 31

Fri, 01 May 2026 12:32:00 -0400

By Lisa Thompson

NASDAQ: FATN

READ THE FULL FATN RESEARCH REPORT

Today, FatPipe Inc. (NASDAQ: FATN) said its preliminary revenues for FYQ4, ending March 31, 2026, would be in the range of $6.6 million to $7.0 million, and its adjusted EBITDA would fall between $3.0 million and $3.2 million. As a result, we are raising Q4 numbers to the midpoint of both. The company will report this quarter on May 18^th after the close.

This brings FYQ4 EPS up to $0.16 per share compared to our previous estimate of $0.06. Our FY2026 estimates are now revenues of $18.8 million, up 15.3%, and EPS of $0.23 compared to $0.15 the year before (up 51.9%). Adjusted EBITDA for the year is estimated at $5.5 million versus $5.0 million in FY2025. We will revisit our FY2027 numbers after the company reports.

Given the increase in valuation of its peers and the increase in our 2026 calendar year revenue estimate, we are raising our current valuation from $5.00 to $6.00 per share.

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CEO Chat with Jared Kelly, CEO of Oncolytics Biotech

Fri, 01 May 2026 10:48:00 -0400

NASDAQ: ONCY

David Bautz: Welcome to the next episode of our CEO Chat series. My name is David Bautz, and I'm a senior biotechnology analyst here at Zacks Small Cap Research. Joining me today is Mr. Jared Kelly. He's the CEO of Oncolytics Biotech (NASDAQ: ONCY). Oncolytics is a biopharmaceutical company developing pelareorep, which is an Oncolytic virus that helps to create a more immunologically favorable tumor microenvironment, thus making tumors more susceptible to various treatment combinations. We recently initiated coverage of Oncolytics with a $6 valuation. Hey Jared, thanks for joining me today.

Jared Kelly: Hey David, thanks for having me, and it's really a pleasure to be here to speak with you.

DB: Alright, so for those investors who might be new to the story, why don't we just start with a brief overview of pelareorep and maybe how it helps to differentiate you in the immuno-oncology space?

JK: Pelareorep is a double-stranded oncolytic virus, and as far as we know, it's the only one being developed that is a double-stranded RNA reovirus that's naturally occurring and that can be intravenously delivered. That allows us to hit primary and metastatic tumors. We are not neutralized by the blood, which is a key advantage, allowing us to go throughout the blood and search for tumors. Pela selectively replicates within RAS mutations and other mutations that are found only in tumor cells. If pela were to infect a normal healthy cell, if there is no mutation, then pela will not be able to replicate. It's really perfectly designed by nature’s way of getting into tumor cells only, causing a sort of what we call havoc in the tumor microenvironment and really lighting up the tumor for the body's immune system to fight the tumor, which in turn allows other drugs, such as checkpoint inhibitors and RAS inhibitors, to work better in really immunologically cold tumors.

DB: Alright, so the company's recently shifted its focus to GI tumors. Can you tell us a little bit about what drove that reprioritization, and then where are you seeing the most compelling signals today?

JK: Absolutely. So, the company's been around for a long time, almost 30 years, with a long history of doing government-funded trials, investigator-sponsored trials, and just a lot of single-arm type exploratory trials. And with that comes 1300 patients’ worth of data, 30 trials, and over 15 different tumor types. Luckily for us, pela shows a signal in all of these tumors and replicates in every one of these tumors, from lung cancer to glioblastoma to breast cancer to all these GI tumors. I joined the company just about 10 months ago, and took about four months to go through all the data with my team, and I brought some new members in. But what we found was that, you know, strong signals across the board, but looking back throughout the history, you can go back as far as 15 years ago and find just fantastic lung cancer data or breast cancer data, but what is it versus the current standard of care? How can we help and get a registration-enabled study going very quickly? Where are we going to add to the treatment landscape? It became abundantly clear pretty quickly that it was colorectal cancer, anal cancer, and pancreatic cancer. So those just happened to be all of these GI tumors that are immunologically cold.

And with our drug delivery system, we create this havoc in the tumor microenvironment, causing all this upregulation of immunoactivity, which then allows us to combine with other treatments and use an immunotherapy in tumors where we never have before. So, the most compelling data that we have right now is by far our colorectal cancer data, where we're showing 27 months versus 11 months on an overall basis when you combine pela with the current standard of care. This is the standard care that's been in colorectal cancer for almost a decade, and we're adding onto it and just making it three times better. Even our duration of response is 19 months, versus four to six months, which is what you'd expect. So, a really strong signal that I think sets us up to move quickly in a very large tumor. And then, we have these other signals in anal cancer and pancreatic cancer. Pancreatic cancer, obviously a little crowded now, so maybe not our lead program, but still a very good opportunity for us. And then anal cancer, this rare tumor type, for which we hope to be able to add anything past the first line. We're excited to move all three of these forward, using our clinical trial and regulatory expertise to manage that process.

DB: So, one of the things that I was most struck by in researching the company was the data that suggests that pelareorep kind of enhances checkpoint inhibitor therapy and chemo, but without adding significant toxicity. What have you learned about what's driving that synergy there?

JK: Pela is a combination therapy. That's how cancer treatment is in the real world these days. While we have strong single-agent activity established from decades ago, it was never really meant to be on its own, so when you add this into any tumor, pela can go to primary and metastatic tumors, so you're not just limited to injecting the virus like you are at other oncolytic virus companies. You're in the blood, causing havoc in all these different tumors. What that does to the tumor microenvironment is it rearranges it. And what it does to the upregulation of the immunoresponse is allow other drugs to get in there, like checkpoint inhibitors or other immunostimulatory drugs, even chemotherapy. So, if we're remodeling the tumor microenvironment, we're making chemotherapy even more effective, and that's been evidenced in multiple trials where we've combined it with chemo alone. For example, in pancreatic cancer, we have a chemo-only trial, a controlled study chemo versus chemo plus pela, and you see the experimental arm with pela show 4X the two-year survival.

DB: Yeah, that's good. So, the company recently had a pretty important meeting with the FDA regarding plans for pela in anal cancer. What can you tell us about the outcome of that meeting?

JK: You know, we've spoken to the FDA, believe it or not, four times since I've been here. The process can be frustrating because each one of these type C meetings takes about four months from start to finish. You start with a briefing packet, you wait for a meeting date, and you go through the meeting, and so you want to rush and do things as quickly as you can. Our strategy all along was to take these studies where we combine with checkpoint inhibitors - this is anal cancer, and this is pancreatic cancer - and go and get registration-enabled trials, and so that's what we've done now. In eight months or so, we've accomplished two registration-enabled trials: one in pancreatic cancer first line, one now in anal cancer second line, and later. Now these are partnerable studies. This is a checkpoint inhibitor. We’re in discussions with potential partners to do the study together with checkpoint inhibitor partners, but both of them are based on checkpoint inhibitor combinations, so we'll need that buy-in from pharma types.

But what we learned from the FDA is really quite simple. They want a controlled study. We were seeking a single arm based on some other movement, I'll say, in the regulatory space, and that became quite clear even before our meeting that it wasn't going to be permitted based on a combination approach. However, it only adds about 20 patients to the full trial, and it only adds probably six months and maybe $2-$3 million to what our trial design was initially with a single arm, so the outcome was fantastic for us. The best thing that we found here is that in a single trial, we can have an accelerated approval shot on goal based on a response and duration endpoint. And then we can also have a full approval based on a survival or time to event endpoint, it's called, within the same trial. So, we don't have to start over or run two trials side by side, and that's very good in this rare tumor because enrollment could be slow. We're very excited by the potential for the anal cancer and the pancreatic cancer studies based on our regulatory work. Now we’ve checked the box for a very clear regulatory path, and I'm thankful to the FDA for making that possible for us in both of these indications.

DB: Yeah, so you mentioned partnerships. It's going to be important for the company going forward. So, what are you looking for in an ideal partner right now?

JK: I'm looking for a partner to believe in the opportunity to use immunotherapies in tumors that have never been able to be used for immunotherapy. This is checkpoint inhibitors and this is GI cancer. That's why we're doing what we're doing. You have a checkpoint inhibitor in anal cancer that works reasonably well in the first line, but nothing sort of later line. Checkpoint inhibitors don't work hardly at all in pancreatic cancer, and they don't work in most of the colorectal cancer diseases, only in MSI-high patients, and that's a very small portion of the population of cancer patients. What we want to do first and foremost is partner out these studies where we have regulatory clarity. That's one thing we're working on very closely with potential partners. That's something that we'll focus on.

Meanwhile, our flagship study is our colorectal cancer study, where I said we have the best data. We don't have to raise an inordinate amount of money to move that forward. We're going to get controlled data by the end of this year in a $3-$5 billion indication, which is second line, RAS mutant microsatellite stable. You're talking about half of the colorectal cancer market in a second-line setting where the standard of care hasn't changed in a long time, and partners are really paying attention to that study as well, and the outcome, and I'm sure that if we hit our marks where we expect to hit, partners will come to us to get more information on how that colorectal cancer study has played out. But it's very important to us as a small biotech.

Obviously, we're not going to go at this alone and market a drug. I think a lot won't say that, but I'm a realist, and I'm a transactional CEO, and in my mind, there is a chain of drug development, and biotech is the innovative and development arm until they can prove to pharma that it's worth investing. Then, pharma is really built to take drugs to the market and sell them. You need thousands of people out there speaking to PIs and going to doctors and getting prescribers and ready to support your drug as it enters into the market. It's just something that, as a 30-person biotech, is very, very difficult to do. What we're good at is running clinical trials to show strong signals and navigating the regulatory environment to set these up for partners to be able to come in. So, we're looking for a partner who's going to believe in what we're doing and really take it from here in a serious way.

DB: Alright, sounds good. We'll finish kind of big picture: if everything goes right over the next few years, where do you see pelareorep fitting into the treatment landscape, and then what does success look like for Oncolytics?

JK: Yeah, I see pelareorep fitting into the frontline of many different tumor types. Obviously, we're focused right now on GI tumors because I think that's our best shot on goal versus the current standard of care. But there are other indications: lung cancer, breast cancer, et cetera, that this drug will work, at least, that's what we strongly believe based on previous clinical evidence. I could see pelareorep being a backbone immunotherapy across all tumor types. As I said, it's tumor-agnostic. We can replicate within any tumor type and cause tumor microenvironment and havoc, and immunoresponses. What success looks like for Oncolytics is partnering out or moving this drug candidate on to someone who can really invest a lot of dollars into the development of the product candidate and put it where it needs to be.

DB: Sounds good. Jared, thanks again for joining me today.

JK: Absolutely. Thanks for having me.

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DISCLOSURE: Zacks Investment Awareness (ZIA) is a Zacks SCR product. The Zacks SCR analyst conducting this Chat hereby certifies that the views expressed accurately reflect the personal views of the analyst about the subject securities and issuer. Zacks SCR certifies that no part of any analyst’s compensation was, is, or will be, directly or indirectly, related to the recommendations or views expressed in this Chat. Zacks SCR believes the information used for the creation of this Chat has been obtained from sources considered to be reliable, but we can neither guarantee nor represent the completeness or accuracy of the information herewith. Such information and the opinions expressed are subject to change without notice. This text is not a verbatim transcript. This transcript has been edited and does not reflect the video-recording exactly. You may find the video recording in its entirety here. Full Disclaimer HERE.

ASBP: A Platform Approach to Drug Delivery with an Unconventional Path to Commercialization

Thu, 30 Apr 2026 09:27:00 -0400

By David Bautz, PhD

NASDAQ: ASBP

Aspire Biopharma Holdings, Inc. (NASDAQ: ASBP) is attempting something relatively uncommon in the biotech space: building a pharmaceutical platform while simultaneously testing commercialization through a consumer-facing product.

The company’s strategy is centered on a patent-pending sublingual drug delivery system designed to improve how quickly and efficiently certain medications are absorbed. By reformulating already approved drugs, Aspire is attempting to reduce development risk while targeting meaningful improvements in performance, particularly in situations where speed of action is critical.

At the same time, the company has launched “Buzz Bomb,” a single serving 50-mg caffeine product sprinkled under the tongue, targeting the large and growing wellness, energy, and sports performance market. This commercial supplement opportunity does not require FDA approval and provides Aspire with an early opportunity to generate revenue while it pursues development of a variety of existing approved drug formulations that could utilize its sublingual technology to improve efficacy or reduce side effects.

Aspire represents a differentiated approach within the broader biotech landscape by combining platform innovation with early-stage commercialization. If successful, Aspire’s approach could offer a unique path to value creation that combines lower-risk drug reformulation with a scalable delivery platform.

A Platform-Driven Approach to Drug Delivery

Aspire Biopharma is not a single-asset company, but rather is developing a drug delivery platform that can be utilized to enhance multiple classes of already approved pharmaceuticals. Its core technology is designed to enable rapid sublingual absorption that delivers drugs directly into the bloodstream through oral tissues rather than through the digestive system, thus bypassing first-pass metabolism in the liver.

This distinction is important. Traditional oral medications must pass through the gastrointestinal tract and liver before entering systemic circulation, which can delay onset and reduce the amount of active drug available. Aspire’s approach is designed to bypass this process, potentially improving both speed of onset and bioavailability.

Aspire’s delivery system is engineered to support multiple formats, including powders, tablets, and oral suspensions, which suggests that the platform could be applied broadly across a range of therapeutic areas and compounds. In addition, it offers a number of advantages for drug delivery, including:

Fast Acting: Medications enter the bloodstream much more rapidly compared to oral tablets and capsules

Convenience and Ease of Use: Dissolves easily under the tongue; perfect for those who cannot swallow pills

Dose Management: Drugs avoid first-pass metabolism in the liver, thus potentially increasing the amount of active compound in the bloodstream

Bypasses Digestive Tract: Could potentially reduce or eliminate adverse reaction in the gastrointestinal tract

Reduces Pills and Tablets: Decreases burden on patient and caregivers

Rather than developing entirely new drugs, Aspire is focused on reformulating existing approved generic drugs that address large markets. This strategy allows the company to potentially leverage known safety profiles while concentrating on improving how drugs are delivered and how quickly they act.

Sublingual Aspirin as a Proof of Concept

Aspire’s most advanced pharmaceutical program is a high-dose sublingual aspirin formulation, which the company is positioning for use in acute settings such as suspected heart attack or stroke.

In a completed clinical study, Aspire reported that its sublingual aspirin achieved significantly faster absorption and therapeutic effect compared to standard chewable aspirin tablets. The following graph shows that meaningful drug impact levels were reached within two minutes following dosing, five times faster than a chewable aspirin tablet.

This speed advantage could be particularly important in emergency situations, where faster platelet inhibition may help reduce damage during a cardiac event. However, it could also offer an advantage for other pain management indications as well (headache, post-surgery, general pain relief, etc.).

The company’s go-to-market strategy will likely involve a product launch initially in the prescription market with a licensing or partnership agreement. This could also open the door for additional licensing opportunities with partners experienced in end-to-end marketing and distribution. The market opportunity for sublingual aspirin is significant, with the combined opioid and non-opioid markets currently estimated at approximately $80 billion, which is expected to grow to $100 billion over the next five years.

Aspire expects to conduct the final clinical trial for high-dose aspirin in mid-2026, followed by a potential regulatory submission later in the year. Notably, the company has received feedback from the FDA supporting a potential regulatory pathway under the 505(b)(2) framework, which is commonly used for reformulated versions of existing drugs. If successful, sublingual aspirin could serve as an initial validation of the platform’s ability to deliver clinically meaningful improvements.

A Broad Pipeline of Reformulated Drugs

Beyond aspirin, Aspire is already positioning its platform across multiple therapeutic categories. The company has outlined additional programs involving reformulated versions of widely used drugs, including:

Alprazolam (generic Xanax^®) – market value of ~$3.6 billion (Market Research Future)
Clopidogrel (generic Plavix^®) – market value of ~$9.5 billion (Verified Market Reports)
Ondansetron (generic Zofran^®) – market value of ~$1.7 billion (Data Insights Market)
Meclizine (generic Dramamine Less Drowsy^®) – market value of ~$1.8 billion (Data Intelo)

The company is currently undergoing formulation work on alprazolam and expects to commence its first clinical trial in 3Q 2026. The other therapeutic targets in the pipeline are in the planning stage, but they highlight the potential scalability of the platform. If Aspire can demonstrate consistent improvements in absorption and onset across different compounds, it could open the door to a broader portfolio of reformulated products targeting large, established markets.

This platform-driven model introduces a different type of upside profile compared to traditional biotech companies. Rather than relying on the success of a single novel drug, Aspire is attempting to build a system that can be applied across multiple existing therapies.

Early Commercialization and Real-World Validation with Buzz Bomb

In parallel with its pharmaceutical development efforts, Aspire has entered the consumer market with Buzz Bomb, a single-serving caffeine supplement designed for quick energy and convenience. The product delivers 50mg of caffeine in a compact powder format that is used without water, offering a convenient alternative to traditional energy drinks, soda, coffee, or pre-workout supplements.

Aspire is positioning Buzz Bomb around several potential advantages, including faster impact, precise servings, zero sugar, and convenience, which could appeal to athletes and consumers seeking more control over their caffeine intake. The company has already taken steps to scale production and distribution, including a broader product relaunch and expanded marketing efforts.

The pre-workout supplement market is currently estimated at approximately $20 billion and is expected to reach approximately $28 billion by 2030 (Grand View Research). This growth is being driven by a number of factors, including rising fitness culture, expanding demographics, and digital fitness and influencer-led marketing. The market is highly competitive with a wide range of options for energy boosting and hydration products. However, most products are based on a “mix + water” combination that takes upwards of 20-30 minutes to provide benefits. Consumers are most interested in products that show immediate results and are easy to use, two areas where Buzz Bomb could differentiate itself, drive market penetration, and demonstrate the commercial opportunity for Aspire’s delivery approach in a real-world setting.

Intellectual Property and Financial Position

Aspire’s goal is to build a foundation of intellectual property protection around its sublingual delivery platform. The current strategy is centered on a series of recently filed and pending applications covering its formulation technology, delivery methods, and potential use across eleven drugs and supplements. These filings include both specific product formulations, such as the sublingual aspirin program, as well as broader claims designed to protect the underlying delivery platform across different therapeutic areas.

The company has also taken a layered approach to its intellectual property, combining patent filing with trade secrets, proprietary processes, and ongoing development work. In addition, Aspire has filed an “omnibus” patent application intended to extend protection across multiple classes of compounds, reflecting a platform-oriented strategy rather than a single-product focus.

The following table provides an overview of the company’s patent filings as of February 2026.

To strengthen its balance sheet, Aspire recently completed a $21 million private placement through the sale of 26,250 shares of Series A Convertible Preferred Stock at a purchase price of $800 per Preferred Share. The proceeds from the financing will be used to support working capital, to fund a portion of the cash component of the proposed DCS acquisition, and other general corporate purposes.

Aspire also recently secured a commitment letter from a leading financial institution for up to $22.5 million to finance the remainder of the DCS purchase.

Diversification into Automotive Supply

In a development that may come as a surprise to investors, Aspire recently announced plans to acquire DCS, a designer and manufacturer of automotive driver control systems, for $30 million. While the transition is outside the company’s core strategy, management has indicated that the target business is cash flow positive, with the potential to provide a more stable source of revenue. When viewed from that angle, the acquisition appears to be positioned as a way to support Aspire’s long-term pharmaceutical plans by helping to fund operations and reduce reliance on external capital.

DCS is a tier-one supplier specializing in vehicle electrification, safety, and human-machine interface (HMI) systems. Based on the announced LOI from the company, for the fiscal year ended December 31, 2025 (unaudited), DCS generated revenue of more than $200 million, net income of more than $17 million, and adjusted EBITDA of more than $22 million.

This type of diversification is not typical for early-stage biotech companies, which are generally more focused on drug development. While the transaction could provide meaningful near-term financial support, it does add complexity to the company’s strategic focus and capital allocation. For now, Aspire has indicated that it intends to continue pursuing its biopharma strategy alongside this potential acquisition, making for an important development for investors to monitor as the story evolves.

What Investors Should Look For

Looking ahead, there are several key developments that investors should watch out for that could play a role in shaping Aspire’s trajectory:

Additional clinical data from its sublingual aspirin program, with another trial planned for mid-2026
Progress along the 505(b)(2) pathway, with a potential regulatory filing anticipated in the second half of 2026
Expansion of the pipeline into additional reformulated drugs, including treatments for anxiety, blood clot prevention, nausea, and motion sickness, in markets that total upwards of $100 billion
Commercial traction for Buzz Bomb, including evidence of repeat demand and broader distribution
Partnership or licensing agreements, particularly on the pharmaceutical side
Completion of the DCS Purchase

Conclusion

Aspire Biopharma is not following the traditional biotech model. By focusing on drug delivery rather than drug discovery, and pairing that effort with early commercial initiatives, the company is attempting to build both a platform and a business simultaneously.

The early clinical data around its sublingual aspirin program provides an initial indication that the approach may have merit, particularly in applications where speed of action is critical. At the same time, the company is working to expand its technology across a broader pipeline of reformulated drugs, while using products like Buzz Bomb to begin establishing commercial traction.

The recent move to acquire DCS adds another layer to the story and introduces both potential financial support along with strategic complexity. If successful, this approach could provide Aspire with a more flexible operating model than a traditional early-stage biotech company, though it also places greater importance on execution across multiple fronts.

Ultimately, Aspire represents a different kind of early-stage opportunity that combines elements of platform innovation, regulatory strategy, and commercial execution. As the company advances its pipeline and begins to test its commercial strategy, the key question will be whether its delivery technology can demonstrate advantages that are not only scientifically valid but meaningful in real-world use.

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