Zacks Small Cap Research Press Releases

IZOZF Makes Good Progress Toward Revenue Generation

Fri, 10 Apr 2026 11:11:00 -0400

OTC: IZOZF

Izotropic (OTC: IZOZF) is an emerging medical device company aiming to transform breast imaging with its innovative IzoView Breast CT system. At its core, Izotropic’s mission is straightforward but ambitious: to make breast cancer detection faster, clearer, and more comfortable for patients—particularly for the large number of women whose dense breast tissue makes traditional mammograms less effective. The company holds exclusive global rights to its technology from the University of California, Davis, where the underlying breast CT platform was developed over many years of academic research. With that foundation, Izotropic is now working to bring this technology to market through a dedicated imaging system that could redefine how clinicians see and diagnose breast cancer.

Izotropic represents a rare opportunity in an area that combines cutting-edge imaging innovation with a substantial unmet clinical need. The global market for breast imaging is growing steadily, and nearly half of women fall into the “dense breast” category, a demographic that standard mammography often struggles to serve. IzoView directly targets this challenge by producing true three-dimensional CT images of the breast without the painful compression required by traditional scans. This technology offers clearer visualization of tissue structure and lesions, which can potentially improve both detection rates and diagnostic confidence.

As the company moves closer to commercialization and revenue recognition, being strategic with finances is important. The recent earnings report shows that management is taking that responsibility seriously—increasing cash balances, minimizing expenses, and narrowing the loss per share to a breakeven point. This solid balance sheet and financial management allow flexibility in pursuing business opportunities such as those described below.

As mentioned, company management recognizes that breast cancer and issues with standard breast imaging access and quality exist across the world and has recently announced an agreement to establish an entity known as Izotropic Africa with an entity referred to as “a business group (BG)”. According to the company, the new entity intends to license, market, distribute, and evaluate manufacturing and/or assembly of IzoView Breast CT and certain follow-on products in all of Africa and the Gulf Cooperation Council: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates.

This area has an urgent need for advanced breast cancer screening, with estimates suggesting over 200,000 cases of breast cancer annually and mortality rates exceeding 50% due to delayed diagnoses and the limited access to advanced care many of the citizens have. Additionally, the company reports that the addressable market for advanced imaging devices is expected to exceed $500 million by 2030.

The details of the agreement are that BG will hold a 60% interest and Izotropic will hold a 40% interest—subject to the final structure being agreed to by both parties by April 30, 2026. Other terms of the agreement indicated BG has committed to developing and executing an annual business plan focused on the sales, marketing, and distribution of IzoView and any follow-on products in Africa and the Gulf Cooperation Council. BG has also committed to securing a major hospital site in Morocco in Q1, 2026 for installation of an IzoView Breast CT Imaging System to serve as a research data collection and clinical study and approval location forming the foundation for regulatory engagement and market entry within the region, initiating approval processes with government health ministries in the designated territories, and assessing the feasibility of establishing manufacturing and/or assembly capabilities in Morocco to serve Africa and the Gulf area.

Lastly, the parties have agreed upon an estimated first-year start-up budget, pursuant to which Izotropic’s 40% share is estimated at USD $120K. Izotropic has agreed to advance 25% (USD $30K) for the first three-month period against its portion of those estimated costs. All financial contributions and operational commitments of Izotropic beyond the initial capital advance remain subject to execution of the formal agreement and securing of financing.

This entity in Africa is already showing progress in the region, with the company announcing that Izotropic Africa has entered into partnership discussions with the Mohammed VI Foundation for Science & Health (FM6SS). According to the company, the FM6SS operates as a public utility institution under the patronage of King Mohammed VI, supporting healthcare reform, research advancement, innovation, and institutional partnerships within Morocco. Management notes that as part of these discussions, an IzoView device valued at $500K would be placed at a leading hospital in Morocco at no cost as a clinical research site to support local clinical evaluation and regulatory approvals. The discussions also include the evaluation of opportunities for localized manufacturing and assembly initiatives in Morocco, with the kingdom’s geographic position at the intersection of Europe, Africa, and the Middle East providing access to regional markets with established logistics channels. This is another step in growing the scope of the IzoView technology and toward opening up vast new markets for the game-changing device.

For investors, Izotropic represents a higher-risk, high-potential opportunity that has a management that is clearly aggressively expanding its market opportunity. In our view, the company’s valuation remains modest relative to the scale of the problem it is addressing and the potential impact of its technology. We believe this agreement is another sign that IZOZF is poised to move higher as its superior technology begins to be distributed throughout the world—and investors with a higher risk tolerance should consider investing before the train leaves the station.

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HURA: 2025 Financial Results

Thu, 09 Apr 2026 11:32:00 -0400

By John Vandermosten, CFA

NASDAQ: HURA

READ THE FULL HURA RESEARCH REPORT

Operational and Financial Results

On April 1^st, 2026, TuHURA Biosciences, Inc. (NASDAQ: HURA) reported 2025 financial and operational results and filed its Form 10-K with the SEC. The company is conducting Phase III and Phase Ib/IIa trials in Merkel cell carcinoma (MCC) and is expected to soon start a Phase Ib/II trial for TBS-2025 in acute myeloid leukemia (AML). The IFx-2.0 Phase III is expected to read out in 2027. The TBS-2025 anti-VISTA asset is now the subject of FDA meetings centering on the development plan, and clinical trials could begin in 2H:26. Other program work includes the identification of a lead antibody drug conjugate (ADC) in AML, along with initiation of proof-of-concept studies. Outside of operational efforts, TuHURA added new team members and is presenting at scientific and investor conferences. Below, we summarize the company’s 2025 financial results.

TuHURA generated no revenues in 2025 and expended $31.8 million on operational activities related to advancing IFx-2.0, TBS-2025, and other programs, producing a net loss of $30.1 million or $0.63 per share. For the year ending December 31^st, 2025, and versus the same prior year period:

Research & development expense totaled $20.5 million, increasing 54% from $13.3 million on higher facilities, salary and personnel related costs, greater clinical spending on IFx-2.0 and TBS-2025, and increased allocations to the preclinical IFx-3.0, myeloid derived suppressor cell (MDSC), and REM-001 programs;
General & administrative expense totaled $11.2 million, which includes acquisition related costs of $3.7 million. The total was up markedly from $4.3 million, due to increases in non-cash stock compensation, merger transaction costs, and expenses related to being a public company;
Other items included $2.2 million that consisted of grant income related to Kintara’s REM-001 asset and reimbursements from Health and Human Services, and amounts related to share settlement to former Kineta employees, and employee retention tax credit. The most significant item was $1.6 million in income related to the fair value of Kineta merger holdback shares, partially offset by a $185,000 loss on Kineta employee separation payments;
Net interest expense was $489,000;
Net loss was $30.1 million or $0.63 per share. Removing the nonoperating items from the “Other” line item produces a net loss of $32.3 million or $0.67 per share.

As of December 31^st, 2025, TuHURA held $3.6 million in cash on its balance sheet. Cash burn for 2025 was $27.7 million while net cash generated from financing sources was $19.9 million, which consisted of proceeds from a bridge note, warrants, and common stock issuance, partially offset by capital raising costs and transaction and liability payments related to Kintara. In October, TuHURA entered into a $3.0 million loan agreement, of which $1.5 million of the loan was advanced upon execution. In November, TuHURA entered into an at-the-market (ATM) facility with HC Wainwright as its sales agent, along with the filing of a Form S-3 registration statement, making available $50 million in capacity for the ATM. Following the end of the reporting period, the second and third tranches of December’s $15.6 million raise were completed. This added gross proceeds of $7 million.

Anti-VISTA (TBS-2025) Program

TuHURA closed the Kineta acquisition in June 2025, bringing the latter’s anti-VISTA asset into the fold. Now designated TBS-2025, the candidate is a VISTA-blocking immunotherapy developed to reverse immunosuppression in the tumor microenvironment (TME). It is a fully-human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope at physiologic and acidic pH levels. The product is being developed as an intravenous infusion. Under TuHURA’s aegis, TBS-2025 is expected to be the subject of a Phase Ib/II trial in patients with relapsed/refractory (r/r) mutated nucleophosmin 1 (mutNPM1) AML.

Based on research that has demonstrated that mutated NPM1 and DNMT3A result in high expression of VISTA on the surface of leukemic blasts.^[1] The presence of VISTA on these cells is believed to be the primary mechanism by which leukemic cells escape immune recognition and attack, resulting in a low treatment response rate and a short duration of response in AML.

This February, TuHURA filed an Investigational New Drug (IND) Application with the FDA for TBS-2025. It submitted the document to the Division of Hematologic Malignancies for the treatment of mutNPM1 r/r AML in combination with a menin inhibitor. If cleared, the Phase Ia portion plans to enroll 14 patients and the Phase II, 26 subjects. TuHURA’s next steps with the TBS-2025 program are to determine a starting dose in an abbreviated Phase Ib trial. The subsequent Phase II trial will investigate TBS-2025 in combination with a menin inhibitor for patients with mutNPM1 r/r AML who were previously untreated with a menin inhibitor. These studies are slated to begin in 2H:26.

In the press release announcing the IND, Dr. Bianco pointed out that leukemogenic mutations common in AML may drive the expression of VISTA on the surface of leukemic cells, which in turn shut down the immune response. The anti-VISTA antibody’s mechanism raises the shield so the immune system can kill these cells. He continued, noting that complete response rates using menin inhibitors as monotherapy are below 25% and of short duration. Adding TBS-2025 to the treatment paradigm may markedly increase both the magnitude of response and its duration. Success in this endeavor would provide TuHURA the data it needs to seek an accelerated approval route with the FDA.

In March 2026, TuHURA announced that Dr. Craig Tendler would lead the anti-VISTA program in AML. Dr. Tendler’s first public association with TuHURA was the company’s announcement that he would join TuHURA’s board of directors in March 2025. Last month, it was announced that he would take on the responsibilities consistent with those of Chief Medical Officer (CMO) and lead the TBS-2025 program. He will continue his role on the board. A press release provided a biography for the thirty-year industry veteran, noting his tenure at Johnson & Johnson. Joining Dr. Tendler is Amanda Garofalo, who was announced as SVP of Clinical Operations on April 7^th, 2026. She will assist with the development of TBS-2025 and TuHURA’s other clinical programs.

Menin Inhibitor Background

Menin inhibitors are a targeted therapy for NPM1-mutated r/r AML that work by disrupting the menin-dependent transcriptional program that leukemic cells use to maintain HOX/MEIS1 expression, which helps drive survival and differentiation block.^[2] In practice, these small molecules can induce differentiation and remissions in this disease, and they are now part of the treatment landscape for this molecular subtype, with activity seen most often in heavily pretreated patients. NPM1-mutated AML is biologically dependent on menin-mediated signaling, so blocking menin can turn off an oncogenic program rather than just broadly killing dividing cells. That makes menin inhibition especially relevant in r/r mutNPM1 AML, where options are limited and targeted therapy is needed.^[3]^,[4]

TBS-2025 may pair well with a menin inhibitor because the combination targets two different resistance layers in AML. Anti-VISTA antibodies may reverse immune suppression in the tumor microenvironment, while menin inhibitors suppress the leukemic oncogenic transcription program in mutNPM1 AML. In murine mutNPM1 AML, loss of VSIR (the gene encoding VISTA) was associated with an immune response and improved survival. This suggests VISTA blockade could help the immune system clear leukemic cells that remain after menin inhibition.^[5]

Financing and Corporate Update

TuHURA announced a registered direct offering on December 9^th that raised $15.6 million through the issuance of 9,462,423 shares of common stock and warrants. The purchase price for the equity shares was set at $1.65 and the exercise price for the warrants was $1.95. Warrants can be exercised six months after issue. The closing of the transaction was scheduled to occur in three tranches, with all completed by the end of February 2026.

Phase III IFx-2.0 Trial in MCC

TuHURA launched its pivotal Phase III study for its IFx-2.0 candidate in Merkel cell carcinoma (MCC) in June 2025. In the latest earnings report, TuHURA provided its latest set of milestones for the program. They include obtaining Orphan Drug Designation for IFx-2.0 in MCC in 1H:26, reporting preliminary data from the Phase Ib/IIa study of IFx-2.0 in 2H:26, and a topline readout of the Phase III study in 2H:27.

IFx-2.0 will prepare for a new drug application using the FDA’s accelerated approval program under a special protocol assessment (SPA). The trial was designed with the input of the FDA’s Oncology Center of Excellence (OCE). Accelerated approval allows the sponsor to use surrogate endpoints that predict clinical benefit. In most cases, an accelerated approval will require post-market confirmatory trials to verify the clinical benefit. However, in this case, the FDA has indicated that secondary endpoints that demonstrate clinical benefit may be used. If successfully achieved, the trial may satisfy the requirements for full approval.

Upcoming Milestones

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^[1]^{NPM1 and DNA methyltransferase 3A (DNMT3A) are two of the most common mutations in AML and typically co-mutated in myelodysplasia (MDS).}

^{[2] Differentiation block refers to a state where leukemia cells are held in an immature, rapidly dividing stage and are unable to mature into functional white blood cells.}

^{[3] Isidori, A., Marconi, G. The role of menin inhibitors in acute myeloid leukemia. Current Opinion in Oncology. November 2025.}

^{[4] Fiskus, W., et al. Effective Menin inhibitor-based combinations against AML with MLL rearrangement or NPM1 mutation (NPM1c). Blood Cancer Journal. January 2022.}

^{[5]TuHURA Biosciences Pipeline. Accessed April 2026.}

COSM Announces Liver Health Product with Large Upside Potential

Thu, 09 Apr 2026 11:11:00 -0400

By Brad Sorensen, CFA

NASDAQ: COSM

READ THE FULL COSM RESEARCH REPORT

The latest announcement from Cosmos Health Inc. (NASDAQ: COSM) regarding the planned U.S. launch of Liv18 represents a strategically coherent step in the company’s broader effort to reposition itself around higher-margin, science-backed nutraceutical products.

Highlighting this investment thesis is the market opportunity Liv18 is targeting. Liver disease—specifically metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as NAFLD—has quietly become one of the most prevalent chronic conditions in developed markets. More than 30% of U.S. adults are estimated to be affected, driven largely by obesity, diabetes, and metabolic syndrome trends. This creates a large and underpenetrated preventive-care market, particularly because pharmaceutical interventions remain limited or are focused on more advanced disease states. Against this backdrop, the U.S. liver health supplement market is already estimated at approximately $4.6 billion, with expected mid-single-digit annual growth through the next decade.

We view Liv18’s positioning as designed to bridge the gap between wellness supplements and clinically validated interventions. The product is built around BergacynFF, a patented botanical blend derived from bergamot and wild artichoke, standardized for specific bioactive compounds including flavonoids and sesquiterpenes. These compounds are associated with anti-inflammatory, antioxidant, and lipid-modulating effects—key pathways implicated in liver fat accumulation and metabolic dysfunction. The emphasis on a “synergistic blend” is important from an investment perspective, as it provides both intellectual property protection and a marketing narrative that differentiates the product from commoditized single-ingredient supplements.

What elevates Liv18 above many nutraceutical peers is the level of clinical validation. The underlying ingredient has been tested in two randomized, double-blind, placebo-controlled trials—the gold standard in clinical research, and still relatively uncommon in the supplement industry. In a 16-week study involving patients with NAFLD and type 2 diabetes, participants demonstrated statistically significant reductions in key liver enzymes (ALT and AST) along with regression in liver fat severity. A second 12-week study in non-diabetic individuals with liver steatosis showed a roughly 9% reduction in liver fat versus placebo, with even stronger results (approximately 15%) in older populations. Notably, the trials also indicated ancillary benefits such as weight loss and improvements in inflammatory markers, suggesting a broader metabolic impact rather than a narrowly targeted liver effect.

From our point of view, this clinical backing is central. The supplement industry is often criticized for weak evidence and limited regulatory oversight, which compresses pricing power and increases competition. By contrast, Cosmos Health is attempting to position Liv18 closer to a “medical-grade” nutraceutical—supported by published human trials at the commercial dose level. If successfully communicated to consumers and healthcare practitioners, this could enable premium pricing, physician channel penetration, and stronger brand loyalty.

Commercially, the go-to-market strategy reflects a hybrid distribution model spanning e-commerce, retail, and practitioner channels. This is important because practitioner endorsement can materially influence supplement adoption in categories tied to chronic conditions, while e-commerce provides scalability and margin efficiency. Additionally, U.S.-based manufacturing in GMP-certified, FDA-registered facilities reduces regulatory risk and supports quality positioning—an increasingly important factor in consumer health products.

Ultimately, the Liv18 launch reflects a broader strategic pivot toward evidence-based nutraceuticals targeting large chronic health markets. For investors, the key question is not whether the science is compelling—it appears to be—but whether Cosmos Health can operationalize that science into sustained revenue growth and improved financial performance.

The success of LIV8 ultimately depends on the market penetration achieved by Cosmos and how the company can grow market acceptance and use of the product. The company has proven it can roll out products successfully and we are confident that the COSM price target will be raised in the not-too-distant future as market penetration of LIV18 begins to be realized.

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AMS: Benefits of O&O Strategy Obscured by Lease Expirations, Equipment Upgrades

Wed, 08 Apr 2026 15:20:00 -0400

By M. Marin

NYSE: AMS

READ THE FULL AMS RESEARCH REPORT

As O&O footprint expands, expect it can help smooth out lumpiness of quarterly results over time

American Shared Hospital Services (NYSE: AMS), which provides and operates advanced radiation therapy treatment systems to treat cancer patients, reported 4Q25/2025 results last week. Results were mixed, in our view. In our view, results highlighted the benefits of AMS’s transition from a company that primarily leases expensive cancer treatment medical equipment to one that also owns and operates (O&O) the equipment itself, but also mirrored the pressure on revenue when leasing contracts expire, and/or equipment is temporarily out of service for upgrades.

AMS ended 2025 with eight domestic medical equipment leasing agreements and six direct patient care service centers. The O&O centers operate in the U.S. and Latin America. The company intends to pursue growth opportunities for both its equipment leasing segment and direct patient care services unit. The direct patient segment has recorded strong growth, up 23.7% for the full year. Direct patient services segment revenue benefited from the company’s 2024 acquisition of treatment centers in Rhode Island and the July 2024 opening of its radiation therapy facility in Puebla, Mexico. We believe the strong contribution of the Direct patient services sector reflects the benefits of the company’s recent growth initiatives and, over time, can help smooth out lumpiness of quarterly results.

AMS views 2025 as a transitional year of investing to set the stage for growth in 2026 & beyond

The upgrade of the O&O Gamma Knife center in Lima, Peru to the Esprit platform interrupted operations in that facility for a period. Nevertheless, the upgrade brings newer generation technology to the center and is expected to expand the company’s treatment capabilities there to support future growth.

With the other O&O facilities operating throughout the full year, LINAC treatment sessions nearly doubled in 2025 (up 92% year-over-year) to 28,147, compared with 14,662 in 2024. With LINAC treatment volumes strong, 2025 LINAC revenue was $11.5 million, which represents a 35.4% year-over-year advance. LINAC revenue comprised 40.9% of total revenue and contributed to revenue remaining relatively stable at $28.1 million, compared with $28.3 million in 2024, despite the expiration of leases and upgrade of an O&O center.

The company also secured a seven-year lease extension with Orlando Health for its PBRT system. AMS’ legacy business is the provision of costly advanced radiation cancer treatment equipment under a leasing model. Reflecting its roughly 40 years of operation, the company has developed a partnership model with medical centers and also has relationships with multiple original equipment manufacturers (OEMs) in this sector to support this business model. The partnership between AMS and Orlando Health has been in place for more than two decades. AMS believes this underscores the value of its Leasing model services and long-term relationships with medical centers. We view this lease extension as a positive that is expected to contribute to aggregate revenue and supports the company’s view that its focus on customer care and service can facilitate AMS’s ability to renew and enter into new lease agreements.

Planned construction of two new treatment centers in Rhode Island is a key growth initiative…

One of the company’s key growth initiatives is the planned construction of a PBRT center in Johnston, Rhode Island. We view this project and another planned Rhode Island center positively, particularly given the general lack of patient access to PBRT care. AMS recently obtained Certificate of Need (CON) approvals for a fourth treatment center in Bristol, Rhode Island, and a proton beam radiation treatment (PBRT) center in Johnston, Rhode Island. AMS acquired property in Bristol, Rhode Island, in 1Q25 where it expects to construct the linear accelerator facility.

With the RI centers located near Rhode Island hospital campuses, the company also expects to benefit from synergies as it works on developing new sites in Rhode Island. AMS’s new business lines and revenue streams are aimed at diversifying revenue and markets of operation, fueling growth, and expanding its product portfolio.

… that is expected to strengthen AMS’s footprint within a key market

The expansion strategy is also aimed at strengthening AMS’s footprint within selective key markets. Given its strong relationships within the state of Rhode Island, the company believes it will benefit from synergies among its various facilities there. For example, the company expects to leverage its network to facilitate staffing of medical professionals at its O&O sites once construction is completed.

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CVKD: Results Show 12-LOX Inhibition Targets Inflammation from Obesity and Type 2 Diabetes

Wed, 08 Apr 2026 12:19:00 -0400

By David Bautz, PhD

NASDAQ: CVKD

READ THE FULL CVKD RESEARCH REPORT

Business Update

Published Results Show Potential for 12-LOX Inhibition in Obesity and Type 2 Diabetes

On March 12, 2026, Cadrenal Therapeutics, Inc. (NASDAQ: CVKD) announced the publication of preclinical research findings that show the potential for its first-in-class 12-lipoxygenase (12-LOX) inhibitor, CAD-1005, as a treatment for the inflammatory effects of obesity and type 2 diabetes (T2D).

The progression of obesity and T2D has previously been linked to signaling by the products of 12-LOX enzymes (Kulkarni et al., 2021). The LOX enzymes are responsible for the oxygenation of polyunsaturated fatty acids to form eicosanoids, with 12-LOX producing the pro-inflammatory metabolite 12-hydroxyeicosatetraenoid acid (12-HETE). The main 12-LOX enzyme that produces 12-HETE is encoded by the ALOX12 gene, however human 12-LOX is structurally distinct from its mouse orthologue so inhibitors of human 12-LOX can’t be tested in mice. Thus, the current study utilized a human gene replacement mouse model in which the mouse 12-LOX gene (Alox15) was replaced by the human ALOX12 gene prior to placing male mice on a high-fat diet and then treating with CAD-1005 (VLX-1005) (Kaylan et al., 2026). This work builds upon previously published research showing that VLX-1005 delayed the onset of autoimmune diabetes and reduced islet inflammation in nonobese diabetic mice in which human ALOX12 replaced mouse Alox15 (Nargis et al., 2024).

The results of the study showed that treatment with VLX-1005 improved glucose homeostasis, reduced β-cell dedifferentiation, and alleviated macrophage-mediated inflammation in both pancreatic islets and adipose tissue. The decreased β-cell dedifferentiation was shown by a decrease in ALDH1A3 expression, which is a marker of β-cell failure and reduced glucose-stimulated insulin secretion (Kim-Muller et al., 2016). The decrease in ALDH1A3 following VLX-1005 treatment suggests that the drug improves β-cell health and may contribute to increased capacity to meet insulin secretory needs. Treatment with VLX-1005 also reduced macrophage infiltration and cytokine expression in adipose tissue, which are both implicated in obesity-associated inflammatory responses (Russo et al., 2018).

While Cadrenal continues to be fully focused on advancing CAD-1005 as a treatment for heparin-induced thrombocytopenia (HIT), these results support the potential for 12-LOX inhibition as a therapeutic agent in managing obesity and altered glucose metabolism by targeting peripheral inflammation associated with visceral adiposity.

Planning for Phase 3 Trial in HIT

Cadrenal recently conducted an ‘End-of-Phase 2’ meeting with the U.S. Food and Drug Administration (FDA) to clarify the potential registration pathway for CAD-1005 in HIT. The company is currently in the process of incorporating the feedback into its proposed Phase 3 protocol. While we don’t know the specifics yet, we believe the company intends to use thrombotic event reduction as the primary endpoint in Phase 3, build on the safety profile observed to date, and leverage CAD-1005’s Orphan Drug Designation (ODD) and Fast Track status.

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.

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 March 31, 2025, Cadrenal announced financial results for 20245. As expected, the company did not record any revenues in 2025. R&D expenses in 2025 were $4.1 million compared to $4.2 million in 2024. The decrease was primarily due to reduced consulting expenses partially offset by increased expenses associated with the asset purchase agreements in September and December 2025. G&A expenses were $9.4 million in 2025 compared to $6.8 million in 2024. The increase was primarily due to increased expenses related to being a public company, increased stock-based compensation, and increased consulting and professional fees.

As of December 31, 2025, Cadrenal had approximately $4.0 million in cash and cash equivalents. Subsequent to the end of the year, the company sold 168,690 shares of common stock through its at-the-market (ATM) facility for net proceeds of approximately $1.3 million. Cadrenal is currently evaluating various financing and strategic alternatives to support its planned clinical development activities. As of March 27, 2026, the company had approximately 2.5 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 4.0 million.

Conclusion

We look forward to additional details regarding the planned Phase 3 trial of CAD-1005 in HIT after the company is able to incorporate the FDA’s feedback into the trial plan. In addition, we will be interested to learn how the company is planning to finance the Phase 3 program for CAD-1005. The new results showing positive effects of 12-LOX inhibition in preclinical obesity models is very interesting as it shows the potential for pipeline expansion with CAD-1005. As we await word on next steps for the CAD-1005 program we have made no changes to our model and our valuation remains at $25.00 per share.

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Initiating Coverage of Rapid-Growing PRE

Wed, 08 Apr 2026 11:15:00 -0400

By Brad Sorensen, CFA

NASDAQ: PRE

READ THE FULL PRE RESEARCH REPORT

Zacks SCR is initiating coverage of Prenetics Global Limited (NASDAQ: PRE). Prenetics is a health care company focused on the premium supplement market that has undergone a dramatic transformation over the past several years, evolving from a pandemic-era diagnostics company into a consumer-focused health and wellness platform. Early results indicate that pivot—anchored by its IM8 brand, which was co-founded by David Beckham—is already delivering hypergrowth, with $120 million in annualized recurring revenue achieved within 12 months of launch, and a clear path to profitability.

Prenetics was founded in 2014 as a genomics and diagnostic testing company, building its early reputation through genetic testing products such as CircleDNA and clinical diagnostics services. The company experienced rapid growth during the COVID-19 pandemic, when testing demand drove substantial revenue to the tune of more than $700m revenue in 3 years. However, like many pandemic beneficiaries, Prenetics faced a sharp reset as COVID-related revenues declined. This triggered a multi-year strategic overhaul beginning around 2023–2024, during which the company divested non-core and clinical assets, including ACT Genomics, and shifted toward a consumer health model.

By 2024, Prenetics had entered what management described as a “rebuilding phase,” generating approximately $30.6 million in revenue with its legacy business units. The balance sheet remained solid, with roughly $85 million in cash and no debt, giving the company flexibility to reinvest in growth.

The inflection point that we believe will be the difference maker came in 2025, driven entirely by the launch and rapid scaling of IM8, a premium nutrition and longevity brand co-founded with David Beckham. IM8 demonstrated exceptional early traction, reaching approximately $120 million in annualized recurring revenue within just 12 months—an unusually fast ramp for a consumer health product. This translated into full-year 2025 company revenue of $92.4 million, representing approximately 480% year-over-year growth.

Importantly, this growth was accompanied by a broader simplification of the business. Prenetics exited lower-margin or non-core operations, strengthened its liquidity position to roughly $170 million, and remained debt-free. While the company is still operating at an EBITDA loss, those losses are narrowing even as marketing spend accelerates to support IM8’s global expansion.

Finally, the company has added a couple of impressive athletes to its endorser list-World #1 female tennis player Aryna Sabalenka, global basketball superstar Giannis Antetokounmpo, and F1 phenom driver Ollie Bearman, which we believe further backs up the claims of IM8 and enhances the worldwide marketing effort.

What makes the ambassador model particularly noteworthy from an investment perspective is the structure of these partnerships. Aryna Sabalenka, Giannis Antetokounmpo, and Ollie Bearman chose to take equity in Prenetics rather than a traditional cash endorsement, becoming shareholders in Prenetics. This mirrors the David Beckham co-founder arrangement and represents, to our knowledge, one of the first instances in the supplement industry where multiple world-class athletes across different sports have independently opted into equity-based partnerships with a single brand. We view this as a meaningful signal of product conviction—these athletes and their advisory teams conducted due diligence on IM8 and chose long-term upside over guaranteed cash. This equity-aligned model also reduces the cash burden of ambassador deals on the P&L, which is strategically advantageous as the company scales toward profitability.

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COCP: Fast Track Designation for CDI-988 for Norovirus Infection Treatment and Prevention

Tue, 07 Apr 2026 15:27:00 -0400

By David Bautz, PhD

NASDAQ: COCP

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Business Update

Fast Track Designation for CDI-988

On April 2, 2026, Cocrystal Pharma, Inc. (NASDAQ: COCP) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CDI-988, the company’s pan-viral protease inhibitor targeting 3CL viral proteases and being developed as a treatment for norovirus and coronavirus infections. Fast Track designation is designed to facilitate and accelerate the development of novel therapeutics for serious conditions that address unmet medical needs. It allows companies to have early and frequent communication with the FDA during the entire development process as well as a rolling review of a New Drug Application (NDA). In addition, it may qualify a product for Priority Review when the NDA is submitted.

In March 2026, the company announced that the first subject was dosed in the Phase 1b trial of CDI-988 to evaluate the drug as both a preventive and treatment for norovirus infection. It is a randomized, double blind, placebo controlled study that will enroll up to 40 healthy subjects ages 18-49. All participants in the study will be infected with the norovirus GII.2 (Snow Mountain Virus) strain (NCT07198139).

The initial cohort of subjects is to assess the infectivity rate of the challenge inoculum, GII.2 (Snow Mountain Virus). Subsequent cohorts will be orally administered CDI-988 or placebo. The primary endpoint of the trial is the efficacy of CDI-988 versus placebo in reducing the incidence of clinical symptoms. Secondary endpoints being evaluated include reduction in viral shedding and disease severity, along with safety and pharmacokinetic profile. The challenge study is designed to serve as a surrogate for clinical efficacy data.

CDI-988 was previously tested in a Phase 1a study that enrolled 46 (N=36 drug; N=10 placebo) individuals into the single ascending dose (SAD) cohort and 48 (N=36 drug; N=12 placebo) individuals into the multiple ascending dose (MAD) cohort. The SAD results showed that all doses (100 mg to 1200 mg) were well tolerated, there were no reports of serious adverse events, no clinically relevant ECG changes, no clinically significant pathology results, and no discontinuations from the study or use of the study drug. Similar results were seen in the MAD cohort, as all doses (200 mg to 1200 mg) were well tolerated, there were no reports of serious adverse events, no clinically relevant ECG changes, and no clinically significant pathology results. There was one discontinuation from the study and study drug due to Grade 2 diarrhea for an individual in the 1200 mg BID Fed group. This discontinuation was deemed probably related to study drug. CDI-988 shows a strong food effect (5-fold higher plasma exposure when administered after a high-fat meal), thus that may have contributed to the Grade 2 diarrhea for that individual.

The topline safety data are summarized in the table below. Headache was the most frequently reported treatment emergent adverse event (TEAE) and overall the placebo groups had a higher frequency of TEAEs than the CDI-988 groups.

There are no approved therapies for norovirus infection, which is the most common cause of acute gastroenteritis. According to the Centers for Disease Control (CDC), there are an estimated 685 million cases and 200,000 deaths caused by norovirus infection each year worldwide. In the U.S., norovirus infection causes over 2 million outpatient clinical visits annually and approximately 100,000 hospitalizations. Norovirus prevention and/or therapy is particularly relevant for the military, where a pathogen of that nature can result in significant operational risks. There are multiple military installations, for instance, on navy vessels, where norovirus could spread rapidly and possibly hinder combat readiness. Due to this, work on CDI-988 may qualify for various military-sponsored grants or other funding mechanisms, however we are unaware of any specifics at this point.

CDI-988 was developed using Cocrystal’s proprietary drug discovery platform technology. It binds to a highly conserved region in the active site of noroviruses and coronaviruses 3CL viral proteases and exhibits pan-viral activity against pandemic norovirus and coronavirus strains.

Financial Update

On March 31, 2026, Cocrystal announced financial results for the year ending December 31, 2025. As expected, the company did not report any revenues in 2025. R&D expenses for 2025 were $5.1 million compared to $12.5 million in 2024. The decrease was primarily due to the winddown of the Phase 2a influenza study and reduction in employee-related expenses. G&A expense in 2025 were $4.0 million compared to $5.3 million in 2024. The decrease was primarily due to a reduction in compensation, insurance, and corporate expenses.

Cocrystal exited 2025 with approximately $7.7 million in cash and cash equivalents. As of March 24, 2026, the company had approximately 13.8 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of 21.6 million.

Conclusion

Fast Track designation for CDI-988 is an important milestone for Cocrystal as it allows the company to have more frequent interactions with the FDA as the compound advances through clinical trials. We look forward to updates regarding the Phase 1b study of CDI-988 as the year progresses, along with updates regarding the company’s influenza program, for which another Phase 2a trial is currently being planned. With no changes to our model, our valuation remains at $8 per share.

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MRDN: Believe Noncash Charge Masks Positive Trends

Tue, 07 Apr 2026 13:15:00 -0400

By M. Marin

NASDAQ: MRDN

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With initiatives, positive 2025 trends & upcoming FIFA games, MRDN optimistic about outlook

Meridian Holdings Inc. (NASDAQ: MRDN) reported 4Q25 / 2025 results last week and provided 1Q26 preliminary revenue guidance. The company recently implemented rebranding to align the public company name, Meridian, which management has indicated has significant brand awareness among gaming operators. Meridian continues to advance its B2B and B2C expansion strategy and is optimistic about the outlook, adding new gaming licenses, expanding its geographic footprint, and growing its gaming content library, among other growth initiatives. The company is also optimistic about the benefits of its AI-driven technology and cites this as a key factor contributing to lowering its acquisition costs and extending customer lifetime value.

Year-over-year revenue increases of 8% and 21%, respectively, in 4Q25 and full year 2025 to $49.6 million and $182.9 million would seem to support Meridian’s optimism. MRDN’s 4Q25 gross profit improved 6% to $28.5 million. Reflecting higher selling and marketing expenses designed to drive customer growth, 4Q25 adjusted EBITDA came in at $4.6 million compared to $6.5 million in 4Q24. Full year 2025 gross profit improved 17% year-over-year to $103.5 million.

However, primarily reflecting a $91.8 million non-cash goodwill and intangible asset impairment charge, the company recorded a 4Q25 net loss of $88.4 million, or $7.09 per share, compared with a net loss of $2.1 million, or $0.20 per share, in 4Q24. Largely reflecting the non-recurring charge, which was the result of a decline in the company’s share price, 4Q25 results mask the positive revenue and operating trends, we believe. Specifically, Meridianbet new customer registrations grew 72% year‑over‑year to 1.2 million, and active users and depositors advanced 35% and 40% respectively.

Meridianbet Group segment an engine for growth

Initiatives include debt reduction & stronger balance sheet, leadership change, technology upgrade

MRDN has strengthened its balance sheet, reducing net debt by 59% with total debt down 51% and cash up, and enacted a leadership transition expected to support the execution of its growth strategy. The company has upgraded its technology platform to a next-gen system that leverages AI to ‘learn’ player behavior and preferences in order to deliver targeted game recommendations in the iGaming segment, as well as personalized bet suggestions. The company’s AI technology enables MRDN to learn about players and their preferences, and thereby is expected to boost customer retention. Meridian leverages an omni-channel approach to markets, with its scalable technology systems enabling the company to operate in multiple countries and currencies.

With these initiatives, the tailwind of positive 2025 trends including growth in new customer registrations, active users, and depositors noted above, and the 2026 expected benefits of the FIFA games, the company is optimistic about its outlook. For 1Q26, MRDN expects revenue of about $50 million, representing about 17% annual growth, and adjusted EBITDA of about $6.1, equating to roughly 9% annual growth.

Meridian remains focused on growth, organically and using strategic M&A that prioritizes acquisitions in high-barrier markets with limited licensing to complement organic growth. For example, MRDN’s Expanse subsidiary recently acquired Fairbet Ltd., a licensed retail gaming operator in Malta. Malta’s retail gaming sector operates under one of Europe’s most stringent regulatory frameworks, according to the company. Only three licenses have been granted, and with the Fairbet acquisition, Meridianbet now holds two of the three. The other license is held by Izibet, the National Lottery operator.

The Fairbet acquisition is consistent with a core MRDN objective to diversify its revenue base across geographic markets, by operating segment, and by channel. MRDN views the diversification of its operations across both B2B and B2C channels and geographic markets as a competitive advantage that protects the company from contractions in any single market or channel. As it continues to expand its global footprint, MRDN intends to prioritize expansion into new regulated markets, including in Latin America and Europe, enhance AI-driven gaming innovation, and boost operational efficiencies.

Meridianbet Group segment 2025 revenue up 17% y/y

Meridianbet Group segment revenue grew 17% year-over-year in 2025 to $124.6 million, representing 68% of total revenue. The segment gross margin was roughly 70%. In the Meridianbet Group segment. Expanse Studios develops proprietary gaming content for 1,344 operators across North America, Europe, Latin America, Africa, and Asia. Its operator network grew 630% year-over-year in 2025, contributing to 4Q25 year-over-year revenue growth of 435%.

Among recent network expansion measures, Expanse Studios recently secured a Romanian gaming license, signed a distribution deal with MerkurXtip and one with Admiral Bet, completed multiple U.S. integrations, secured Brazilian iGaming certification, and a U.S. and EU distribution deal with Bragg Gaming, among other measures. Expanse has also filed for system regulatory certification in Ontario, Canada. Expanse recently launched Bonus Bet, a proprietary promotional feature addressing operator retention challenges and promotional spend efficiency. Bonus Bet is designed to improve operator ROI on retention spend and lower player friction points. According to the company, early deployments show improvements in engagement patterns compared to standard bonus mechanics. The company believes the Bonus Bet feature strengthens Expanse’s market position and creates a competitive advantage. MRDN’s other segments also recorded solid 2025 revenue growth.

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ONCY: Initiating Coverage of Oncolytics Biotech; A Focused Path to Unlocking the Potential of Pelareorep

Tue, 07 Apr 2026 09:36:00 -0400

By David Bautz, PhD

NASDAQ: ONCY

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We are initiating coverage of Oncolytics Biotech (NASDAQ: ONCY) with a valuation of $6.00. Oncolytics is a clinical-stage immuno-oncology company advancing pelareorep, a systemically delivered oncolytic virus that selectively replicates in cancer cells and enhances anti-tumor immune responses. Pelareorep has been evaluated across multiple tumor types and combination regimens and has demonstrated the ability to induce tumor-directed immune activation, including increased T-cell infiltration and upregulation of immune checkpoint pathways, supporting its positioning as a potential immune priming agent in combination with checkpoint inhibitors.

Following a strategic reset under new management in June 2025, the company has narrowed its focus to GI indications, specifically second-line metastatic colorectal cancer (mCRC) and second-line or later unresectable squamous cell anal carcinoma (SCAC). This transition reflects a deliberate shift toward indications with both strong biological rationale and clearly defined regulatory pathways, as well as a capital-efficient development strategy centered on combination therapy with established immuno-oncology agents. In particular, both mCRC and SCAC represent tumor types where checkpoint inhibitors alone have demonstrated limited efficacy, creating an opportunity for therapies capable of enhancing tumor immunogenicity and restoring sensitivity to immunotherapy.

A key element of this strategy is Oncolytics’ engagement with the FDA to pursue a single-arm pivotal study in SCAC, a rare disease setting with high unmet need and no clearly established standard of care in later lines of therapy. This approach is expected to be informed by the regulatory precedent potentially established by Replimune Group, whose oncolytic immunotherapy RP1 is currently under FDA review (PDUFA date: April 10, 2026) based on data from a single-arm study in anti–PD-1–refractory melanoma. A favorable outcome for RP1 would represent a significant validation not only of the oncolytic virus class, but also of a capital-efficient regulatory pathway based on response-driven endpoints in high unmet need populations.

Oncolytics is scheduled to meet with the FDA in mid-April, positioning the company to potentially incorporate regulatory feedback informed by the outcome of the RP1 review into its own development strategy. We view this sequence of events as a critical near-term inflection point, with the potential to meaningfully impact both the design and timeline of Oncolytics’ SCAC program, as well as broader investor perception of the oncolytic virus space.

Regulatory precedent may unlock an approval pathway in SCAC. A potential approval of RP1 based on single-arm data could establish a clear framework for ONCY to pursue a similar strategy in a rare, high unmet need indication, significantly reducing development timelines and capital requirement.
Pelareorep is a differentiated immunotherapy backbone with multi-modal activity. The therapy combines selective viral replication, immunogenic cell death, and systemic immune activation, positioning it as a potential sensitizer to checkpoint inhibitors in immunologically “cold” tumors such as MSS colorectal cancer and SCAC.
Focused development strategy improves probability of success. The company has transitioned from a diffuse pipeline to a targeted approach centered on two indications with strong mechanistic rationale and defined regulatory pathways, enabling more efficient allocation of capital and resources.
Attractive risk/reward driven by near-term catalysts. The April 2026 FDA meeting, the outcome of the RP1 PDUFA decision, and continued clinical updates from ongoing studies represent key drivers of potential revaluation in the near to intermediate term.

Valuation

We value Oncolytics using probability-adjusted peak sales estimates for each of the three core indications of SCAC, mCRC, and mPDAC, discounted to present value using a 15% rate, and applying a 3.0x multiple to risk-adjusted revenues, which is consistent with comparable clinical-stage oncology assets. For each indication, we model for peak sales to be seven years following approval.

For SCAC, we model a 2028 BLA filing and a 2029 launch enabled by a potential single-arm registration pathway, with peak U.S. sales of approximately $250 million and peak E.U. sales of approximately $150 million. We estimate a 60% probability of approval for this indication. This leads to an NPV in SCAC of $169 million.

For mCRC, we model for a 2030 BLA filing and a 2031 launch with peak U.S. sales of approximately $1.1 billion and peak E.U. sales of approximately $700 million. We estimate a 50% probability of approval for this indication. This leads to an NPV in mCRC of $477 million.

For mPDAC, we model for a 2030 BLA filing and a 2031 launch with peak U.S. sales of approximately $1.2 billion in the U.S. and peak E.U. sales of approximately $800 million. We estimate a 30% probability of approval for this indication. This leads to an NPV in mPDAC of $371 million.

Combining the contributions from each product results in a total NPV of just over $1 billion. Adding in the current cash position ($5 million) and the potential cash from warrant exercises ($42 million) and dividing by the fully diluted share count, plus an additional 20 million shares for dilution, leads to a valuation of $6.00 per share.

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SNGX: Interim Analysis for Phase 3 CTCL Study in 2Q26

Mon, 06 Apr 2026 15:45:00 -0400

By David Bautz, PhD

NASDAQ: SNGX

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Business Update

Interim Analysis for Phase 3 FLASH2 Trial in 2Q26

Soligenix, Inc. (NASDAQ: SNGX) is currently conducting the Phase 3 FLASH2 Trial of HyBryte™ (SGX301 or synthetic hypericin) in the treatment of cutaneous T cell lymphoma (CTCL). As of the latest update, the company has enrolled 66 of the planned 80 patients. The FLASH2 trial is very similar in design to the successful Phase 3 FLASH trial, as shown in the following figure, which provides a comparison between the two studies. One key difference between the trials is that in the FLASH trial patients were treated for three cycles of six-weeks each, with a two-week break in between cycles and the primary efficacy endpoint was measured after the first treatment cycle, while in the FLASH2 trial patients will be treated for 18 consecutive weeks before the primary efficacy endpoint is assessed. In addition, the overall blinded aggregate response rate remains consistent with what the company reported in November 2025 (48% for all patients that have completed the treatment phase of the study, discussed further below), which is higher than the overall response rate used to design the study (25%), thus our confidence is high that the study will have a positive readout. We anticipate an interim analysis from the study being conducted in the second quarter of 2026 and topline results being reported in the second half of 2026.

Soligenix powered the FLASH2 trial using an anticipated overall blinded study response rate of 25%, which included a very conservative 40% response rate in the HyBryte arm and a 10% response rate in the placebo arm through 18 weeks. Assuming an even number of patients were enrolled into each cohort, the 25% is calculated by combining the two response rates ((40%+10%)/2). Thus, in order for the blinded response rate to be 48%, we believe the treated cohort would need to be far exceeding the powering assumptions so long as the placebo response rate is not unusually high.

If the two cohorts in the blinded response rate analysis were equal, and the placebo response rate was 10% (the same that was used in the powering assumptions for the trial), that would mean the active response rate would be 86% ((86%+10%)/2=48%)! Thus far, Dr. Ellen Kim has seen a response rate of 75% after 18 weeks of treatment in the open-label, investigator-initiated study currently being conducted at the University of Pennsylvania, so 86% would even far exceed that. While the numbers may not be exact, the point of this exercise is to show that for the blinded response rate to be 48%, assuming there have been a relatively equal number of patients that have finished treatment from each cohort and unless the placebo response is drastically higher than previously seen, the active arm is likely exhibiting a very robust response rate. Of course, we will not know the details until the data are unblinded, however that update gives us a lot of confidence that the trial is at the very least trending in the right direction.

The market opportunity for HyBryte in CTCL, if approved, is substantial based on the fact that current treatment options are not highly effective and many of them are associated with significant side effects. For example, narrow-band ultraviolet B therapy (nbUVB) and psoralen + ultraviolet A light therapy (PUVA) are used on early-stage CTCL patients even though they are not approved for that indication. CTCL is a chronic disease necessitating long-term therapy, however long-term use of nbUVB and PUVA increases the risk for skin cancers, including melanoma. Thus, we believe a targeted and well tolerated therapy for CTCL such as HyBryte is likely to be utilized by many CTCL physicians and should help Soligenix achieve a sizeable share of the estimated $250 million worldwide CTCL market.

Results of Study Comparing HyBryte vs Valchlor^® Published in Oncology and Therapy

On April 2, 2026, Soligenix announced the publication of results from a comparability study evaluating HyBryte versus Valchlor^® for the treatment of CTCL were published in Oncology and Therapy (Poligone et al., 2026). The study was designed to obtain preliminary safety and efficacy data in a comparative assessment of HyBryte and Valchlor over 12 weeks of treatment by measuring 3-5 prospectively identified index lesions for each patient. Following 12 weeks of treatment, 60% of the HyBryte patients met the defined level of “Treatment Success” (≥50% improvement in their cumulative mCAILS score compared to baseline) compared to only 20% of the Valchlor patients. The results were not statistically significant due to the small sample size (n=10). The average cumulative improvement in mCAILS at 12 weeks was 52.5% in the HyBryte group and 34.7% in the Valchlor group. HyBryte was well tolerated in all patient while one of the five Valchlor-treated patients had to withdraw due to a clinically significant allergic contact dermatitis from Valchlor. In total, 60% of the Valchlor-treated patients had at least one adverse event “related” to therapy, including rashes, application site sensitivity, allergic contact dermatitis, and dermatitis. No such instances were reported in the HyBryte group.

Orphan Drug and Promising Innovative Medicine Designations for SGX945

Recently, Soligenix has announced that SGX945 (dusquetide) has received the following designations from European and UK regulatory agencies:

On March 26, 2026, Soligenix announced that the European Commission, acting on the the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug designation to dusquetide (SGX945) for the treatment of Behcet’s Disease. Orphan drug designation by the EMA provides a 10-year period of marketing exclusivity in the EU following approval. In addition, there are incentives for companies seeking protocol assistance from the EMA during development along with direct access to the centralized authorization procedure.

On March 10, 2026, Soligenix announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK granted Promising Innovative Medicine (PIM) designation to SGX945 for the treatment of Behcet’s Disease. This is the first step and a prerequisite towards inclusion in the UK Early Access to Medicines Scheme (EAMS), which offers severely ill patients with life-threatening conditions and seriously debilitating conditions the ability to try ground-breaking new medicines much earlier than they would normally be able to. To meet PIM designation, a product must meet three criteria, including treating a life-threatening or seriously debilitating disease with a high unmet medical need, the product needs to offer a major advantage over therapies that are currently used in the UK, and the potential adverse effects of the product are likely to be outweighed by the potential benefits.

Financial Update

On March 31, 2026, Soligenix announced financial results for the year ending December 31, 2025. The company did not report any revenues in 2025 compared to revenues of $0.1 million for 2024. The decrease was primarily due to the conclusion of the zero-margin grant for the HyBryte investigator-initiated study. R&D expenses were $7.5 million in 2025, compared to $5.2 million for 2024. The increase was primarily due to cost associated with the Phase 2a study in Behcet’s Disease and the ongoing second confirmatory trial Phase 3 CTCL study. G&A expenses in 2025 were $4.4 million compared to $4.2 million in 2024. The increase was primarily due to increases in various franchise taxes and stock related expenses partially offset by a decrease in professional fees.

Soligenix exited 2025 with approximately $7.9 million in cash and cash equivalents. We estimate the company has sufficient capital to fund operations into the fourth quarter of 2026. As of March 24, 2026, Soligenix had approximately 10.3 million shares outstanding and, when factoring in stock options, warrants, and the potential convertible debt, a fully diluted share count of approximately 18.0 million.

Conclusion

In addition to the readouts from the Phase 3 FLASH2 trial expected this year, we also anticipate additional scientific publications around HyBryte this year along with updates for the company’s Behcet’s disease program for SGX945 (dusquetide) and the psoriasis program for SGX302. Soligenix is planning to reformulate SGX945 to enable home-based treatment before interacting with regulators regarding a follow-on Phase 2b trial later in 2026. The company will also be planning follow-up studies for the psoriasis program following the release of encouraging topline results from the Phase 2a trial of SGX302 in mild-to-moderate psoriasis. Lastly, the company is continuing to engage in partnering discussions for ex-U.S. markets for HyBryte in CTCL in order to pursue marketing authorizations worldwide. We continue to have high confidence in the chances for a successful Phase 3 readout later this year, however given the continued weakness in the stock we have factored in for additional dilution for future financings, which has decreased our valuation to $20 per share.

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