Zacks Small Cap Research Press Releases

BLRX: First Quarter 2026 Results

Thu, 28 May 2026 15:17:00 -0400

NASDAQ: BLRX

BioLineRx Ltd. (NASDAQ: BLRX) reported first quarter 2026 financial and operational results in a May 27^th press release. For the quarter, it produced license revenues of $477,000 and a net loss of $2.6 million. The joint venture (JV) with Hemispherian, Tetragon Biosciences, has started a Phase I/IIa study evaluating GLIX1 in glioblastoma (GBM) and other cancers. The first patient has been dosed. The Phase I trial seeks to establish the safety, recommended dose, and proof-of-concept for the drug. Additionally, BioLineRx will present two abstracts at the upcoming ASCO conference that highlight preclinical data for GLIX1. Enrollment for Columbia’s CheMo4METPANC Phase 2b study continues, and management anticipates that an interim readout will occur later in 2026.

1Q:26 Operational and Financial Results

BioLineRx reported first quarter sales of $477,000, producing a net loss of $2.6 million or $0.00 per share. The results were announced in a press release on May 27^th, 2026, followed by a conference call with management and the filing of Form 6-K providing additional information.

Below we summarize financial results for the three-month period ended March 31^st, 2026, compared to the same prior year period:

Total and license revenues were $477,000 from the sale of Aphexda compared to $255,000. Ayrmid’s Aphexda product sales for 1Q:26 were $2.7 million vs $0.9 million;
Cost of revenues was $95,000 compared with $34,000. The amounts represent license fee and royalty pass-throughs to Biokine as a proportion of royalty on motixafortide revenues;
Research and development (R&D) expenses totaled $2.5 million, rising 56% from $1.6 million. The increase is attributable to spending on the new GLIX1 development program;
General and administrative (G&A) expenses were $858,000, down 13% from $989,000, primarily due to lower legal and other miscellaneous expenses;
Non-operating income was $458,000 vs. $7.6 million, predominantly reflecting changes in fair-value adjustments of warrant liabilities on the balance sheet;
Net financial expense amounted to $42,000, reflecting interest expense exceeding interest income;

Net loss was $2.6 million or $0.00 compared to net income of $5.1 million, or $0.00. Cash, equivalents, and short-term bank deposits as of March 31^st, 2026, totaled $17.3 million, down from the year-end 2025 balance of $20.9 million. Cash burn for 1Q:26 was $2.3 million, and net cash used in financing was $1.2 million. Financing cash outflows were related to loan repayments and lease liability repayments. At the end of the first quarter, loans were carried at $7.8 million on the balance sheet. The term loan is expected to be fully repaid by the end of 2027. Management reiterated its forecast of holding sufficient cash to support operations until 1H:27.

GLIX1 Phase I/IIa Clinical Trial in the Treatment of Glioblastoma

BioLineRx announced the start of its Phase I/IIa clinical trial evaluating GLIX1 for the treatment of glioblastoma in a March 26^thpress release. As of late May, the trial has dosed the first patient at NYU Langone Health and added two additional sites at Northwestern University and Moffitt Cancer Center.

The Phase I/IIa GLIX1 trial is an open-label, multicenter trial. Its first part is a dose escalation study where an anticipated 30 glioblastoma patients will receive GLIX1 daily as monotherapy. It will seek a maximum tolerated and recommended dose for the next stage of the trial. The Phase I portion will also identify pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy. Trial updates are anticipated in 2H:26 and full results in 2027. Management is optimistic on enrollment, anticipating efficient enrollment and limited competition for patients from other investigational modalities. It also has a favorable view on the space, as few other treatments are showing success.

The Phase IIa portion will include additional indications beyond GBM, including newly diagnosed GBM and other select cancers. The study will evaluate GLIX1 as monotherapy and in combination with standard of care. It will also evaluate GLIX1 in combination with Poly (ADP-ribose) Polymerase (PARP) inhibitors. The Phase IIa expansion will identify preliminary efficacy, PD assessments, and dose optimization data.

GLIX1 ASCO Presentation

BioLineRx and partner Hemispherian AS will feature two presentations at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting, which is being held May 29^th to June 2^nd, 2026, in Chicago, Illinois. Details of BioLineRx’s participation in the event are included in a May 2026 press release. Below we provide the titles and summaries of the two abstracts.

GLIX1: A first-in-class oral molecule targeting the DNA damage response by restoring TET2^[1] activity
- The abstract describes GLIX1 and its role in restoring activity of the TET2 enzyme. TET2 is usually suppressed in cancer, and its inhibition in tumors contributes to abnormal DNA hypermethylation. By reactivating TET2, GLIX1 increases DNA demethylation and triggers excessive base excision repair, leading to the accumulation of single-strand DNA breaks that ultimately convert into lethal double-strand breaks in cancer cells;
- The mechanism works in many tumor types and is particularly relevant in glioblastoma, where TET2 activity is significantly impaired;
- Preclinical studies have shown that GLIX1 increases TET2 activity and 5hmC production. The drug has demonstrated strong antitumor activity in multiple glioblastoma xenograft models with desirable brain penetration levels;
- The abstract presents a favorable safety profile in animals with a 2000 mg/kg dose tested in rats and a 1000 mg/kg dose tested in dogs. Investigators assessed that the animals tolerated the doses well.
Synergistic antitumor activity of GLIX1, a small molecule TET2 activator, in combination with PARP inhibition across multiple cancers
- The abstract reviews synergies resulting from the combination of GLIX1 with PARP inhibitors (PARPi). PARP detects and repairs single-stranded DNA breaks; when inhibited, the repair process is blocked, leading to cell death;
- GLIX1 may increase tumor-selective DNA damage by restoring TET2 activity, which generates single-stranded DNA breaks through base excision repair. Combined with PARPi, GLIX1 is able to prevent cancer cell DNA from repairing itself, resulting in apoptosis;
- In preclinical models, GLIX1 / PARPi combinations have demonstrated strong and consistent cytotoxic effects, including in tumor types less responsive to PARPi. The results were repeatable with multiple PARPi;
- The findings discussed in this abstract provide a compelling mechanistic rationale for using GLIX1 and PARPi in combination.

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^[1]^{TET2 (Ten-Eleven Translocation 2) is a key epigenetic enzyme that initiates active DNA demethylation by converting 5-methylcytosine (5mC) in DNA into oxidized derivatives, ultimately leading to the restoration of unmethylated cytosine. This process alters gene expression by "turning on" or activating previously silenced genes.}

AINMF: Company Encouraged by Rising Interest in Leveraging AI to Improve & Derisk Clinical Trial Activity

Thu, 28 May 2026 11:11:00 -0400

By M. Marin

OTCQB: AINMF

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AINMF believes platform is well-positioned, as use of AI in clinical development is expected to rise

NetraMark (OTCQB: AINMF), an AI company developing AI and Machine Learning (ML) solutions to help optimize pharmaceutical clinical research trial activities, AINMF believes its NetraAI platform is well-positioned to support the next-gen of clinical development as the use of AI in clinical development activities is expected to rise. As sponsors of new drugs encounter rising pressure to improve trial designs, identify responder populations and improve their insights from complex clinical datasets, according to AINMF, it supports increasing use of its AI technology.

The company believes the NetraAI platform is well-positioned to support the next generation of clinical development as the use of AI in clinical development activities is expected to rise. As it advances its business strategy and continues to position the NetraAI platform – beginning initially with oncology and central nervous system (CNS) indications – the company notes that sponsors of new drugs encounter rising pressure to improve trial designs, identify responder populations, and improve their insights from complex clinical datasets, which AINMF believes supports increasing use of its AI technology. Over time, NetraMark expects to expand its focus to a range of other medical indications.

Moving Worldwide Clinical Trials collaboration forward

Moreover, AINMF is encouraged by the continued growth of its commercial pipeline. One example is that work advances to integrate NetraAI into affiliate Worldwide Clinical Trials’ offerings. In April 2025, NetraMark formed a global agreement with leading CRO Worldwide Clinical Trials, which expects to make NetraMark's NetraAI a dedicated solution within its offerings. Worldwide Clinical Trials is a full-service global CRO with a footprint that reaches more than 60 countries. Worldwide has about 30 years of clinical experience. Its focus on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease aligns with NetraMark’s focus on CNS and the oncology space. The two companies believe that leveraging NetraMark's NetraAI platform to identify key patient subpopulations can help Worldwide deliver insights to improve its clients’ clinical activities and enhance trial efficiency. Initially, NetraMark's AI technology will be used for Phase 2 neuroscience and oncology clinical trials and for some Phase 3 clinical studies selectively. In the future, the partners expect to use the NetraMark technology across all therapeutic areas and trial phases.

Oncology & central nervous system (CNS) initial focus; Over time, expansion to a range of medical indications expected

In the oncology space, NetraMark announced a strategic research collaboration with Fondazione per la Medicina Personalizzata (FMP) in FY 2Q26 to analyze FMP’s ROME Phase II oncology trial dataset (NCT04591431) using NetraMark’s proprietary NetraAI platform, with the objective of identifying clinically actionable insights that may inform future precision-oncology strategies and clinical trial design.

The collaboration is expected to support the company’s aim to demonstrate the value of its technology in complex, high-impact clinical research settings. In addition to leveraging NetraAI’s capabilities to uncover clinically actionable insights for FMP’s ROME program, the collaboration is also expected to enable NetraMark to advance and refine its platform and strengthen its ability to support future clinical trial design, biomarker development, and strategies for a potentially growing client base.

In addition, at the 2026 AD/PD (Alzheimer's and Parkinson's Diseases) conference in March 2026, NetraMark also introduced AI-discovered treatment-responsive subgroups from the A4 Alzheimer’s Trial. The company views this as further proof-of-concept supporting the potential of NetraAI to identify meaningful patient subpopulations in neurodegenerative disease. The company believes patient heterogeneity among people who suffer from these conditions has created challenges for clinical trial design and interpretation in the past that its platform can potentially address.

Consistent with advancing its opportunities in the CNS space, AINMF signed a new contract with a leading global biopharmaceutical company developing innovative treatments for psychiatric and neurological disorders to analyze data from the client’s Phase 2 clinical trial for depression. The aim is to leverage NetraMark’s platform to analyze the Phase 2 dataset to identify patient subpopulations most likely to benefit from treatment and provide insights that may inform the client’s future study design. The Company believes this engagement further supports NetraMark’s commercial focus on applying NetraAI to neuroscience and psychiatry datasets, where complex patient variability can make traditional clinical trial analyses difficult.

Growing commercial pipeline, revenue backlog

Reflecting rising interest from pharma, biotech, and clinical research players that want to leverage advanced AI-driven approaches to clinical trial design, stratification, enrichment, and interpretation, NetraMark is encouraged by its growing commercial pipeline and revenue backlog. Year-to-date in FY 2026, NetraMark has signed customer agreements representing aggregate contract value of roughly C$3.09 million, of which about C$129k has been recognized as revenue in FY 2026. AINMF believes this illustrates its ongoing commercial progress with its platform. The company has indicated that it has an additional seven proposals being reviewed. Agreements noted above follow multiple earlier partnerships NetraMark formed to grow its pipeline and/or advance R&D.

In addition, NetraMark appointed Dr. Panteli Theocharous as Fractional Chief Medical Officer to strengthen its clinical leadership team and support the global adoption of its NetraAI technology. Dr. Theocharous has extensive experience in clinical development, medical strategy, and biopharmaceutical partnerships, according to AINMF. The company believes this addition to its team will help it advance commercial and clinical engagement with drug sponsors and partners.

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MTVA: No Evidence for Changes in Cardiovascular Parameters in Phase 1 Trial of DA-1726

Thu, 28 May 2026 10:54:00 -0400

By David Bautz, PhD

NASDAQ: MTVA

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Business Update

Treatment with DA-1726 Shows No Evidence of Cardiovascular Changes

On May 26, 2026, MetaVia, Inc. (NASDAQ: MTVA) announced the presentation of new Phase 1 data for DA-1726, the company’s oxyntomodulin analog agonist that targets glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR). The data were presented in a late-breaking poster session at the European Association for the Study of the Liver Congress 2026 (EASL 2026). The Phase 1 study included both single ascending dose cohorts and multiple ascending dose cohorts at different dose levels, as shown below. The presentation at EASL included data from the 48 mg cohorts.

Thus far, DA-1726 has had a favorable tolerability profile, as shown in the following table. Gastrointestinal adverse events (AEs) have been mostly mild-to-moderate in severity as well as being transient. There have been no serious AEs reported or any treatment-related discontinuations.

Perhaps most importantly of all, there have been no clinically meaningful changes in heart rate or QTcF, which is the corrected QT interval (the time it takes for the heart’s lower chambers to electrically reset between beats) adjusted for heart rate using the Fridericia correction formula. A rising QTcF suggests there may be altered cardiac ion channel activity (a potential arrhythmia risk), which can occur with some pharmaceuticals. Normal absolute QTcF numbers are generally <450 msec for men and <470 msec for women. As the QTcF rises >500 msec, it can be cause for concern. In addition, drugs that target glucagon receptors can theoretically increase heart rate more so than pure GLP-1 agonists. The data for DA-1726 show that the QTcF values remain near ~410-420 msec, and show no increase toward 500 msec. In fact, if anything, the QTcF numbers decrease slightly for those treated with DA-1726. In addition, the recorded heart rates remained roughly stable (65-75 bpm). Thus, we see no effect, thus far, of DA-1726 on cardiovascular parameters.

In regards to body weight (BW), DA-1726 48 mg showed an average decrease of -6.1% at Day 26 and -9.1% at Day 54, with no plateau seen. Waist circumference (WC) also showed a substantial reduction of -5.8 cm at Day 26 and -9.8 cm at Day 54.

Lastly, FibroScan was utilized to monitor liver fat (CAP), fibrosis/inflammation (Liver Stiffness), and a marker of active fibrotic MASH (FAST Score). Treatment with DA-1726 resulted in a decrease in CAP score, which signifies a reduction in liver fat. This is in contrast to placebo-treated patients that saw an increase in CAP score. The same trend was true for Liver stiffness, which showed a decrease for DA-1726 treated participants compared to an increase for those treated with placebo. Lastly, the FAST score showed a directional improvement from Day 26 to Day 54 for those treated with DA-1726. While the sample size is small, these data point to DA-1726 showing preliminary signs of improving liver fat accumulation and liver health biomarkers after only eight weeks of treatment.

Overall, we view the data collected so far for DA-1726 as very encouraging in regards to weight loss and its potential in liver health while showing no obvious cardiac safety concerns.

Phase 1 Part 3 Trial of DA-1726 Continues

In April 2026, MetaVia announced the first patient was dosed in the company’s Phase 1 Part 3 study of DA-1726. The trial is planning to enroll 40 obese but otherwise healthy individuals across two parts, with 20 subjects per part randomized 4:1 (16 active; 4 placebo). Part 3A will evaluate a one-step titration regimen with 16 mg DA-1726 for four weeks followed by 48 mg DA-1726 for 12 weeks. Part 3B will evaluate a two-step titration regimen, with 16 mg DA-1726 for four weeks, 32 mg DA-1726 for four weeks, and 64 mg DA-1726 for eight weeks. The primary endpoints include monitoring adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs leading to discontinuation. Secondary and exploratory endpoints including pharmacokinetic (PK) profiling and evaluation of metabolic, glycemic, lipid, and body composition measures, including weight, waist circumference, and body mass index (BMI). We anticipate topline results in the fourth quarter of 2026.

Conclusion

We are glad to see that there are no obvious cardiac safety signals thus far for DA-1726 and we are hopeful this will help to quell any investor hesitation that may exist due to the compounds targeting of glucagon receptor. The company will continue to collect safety and tolerability data on the drug, however at this point we are confident that DA-1726 is unlikely to have any cardiovascular issues. We look forward to the topline results for Phase 1 Part 3, which we continue to anticipate in the fourth quarter of 2026. With no changes to our model, our valuation remains at $30 per share.

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RVPH: First Quarter 2026 Results

Wed, 27 May 2026 10:55:00 -0400

By John Vandermosten, CFA

OTCQB: RVPH

READ THE FULL RVPH RESEARCH REPORT

Reviva Pharmaceutical Holdings, Inc. (OTCQB: RVPH) reported first quarter 2026 results following the announcement of the implementation of a new strategy intended to extend the patent life of brilaroxazine. Despite the prospect of materially extended intellectual property (IP) life, news of the company’s delisting from the NASDAQ caused a violent reaction in its share price. Reviva has sufficient capital to begin its RECOVER 2 Phase III trial in fall 2026. It is waiting for a response from the FDA regarding its formulation change before it will begin. Patient enrollment is anticipated in 3Q:26 and trial completion approximately one year later. Reviva requires an additional $35 million two to three quarters down the road to maintain this timeline and to fund the second half of the trial.

Operational and Financial Results

On May 13^th, 2026, Reviva reported 1Q:26 financial and operational results and filed its Form 10-Q with the SEC. Reviva generated no revenues in 1Q:26 and posted an operational loss of $3.2 million, halving the prior year’s loss due to the completion of the RECOVER open label extension (OLE) study last year. For the quarter ending March 31^st, 2026, and versus the same prior quarterly period:

Research & development expense totaled $1.4 million, down 65% from $4.1 million, with the change attributable to lower salaries and wages, external research and development costs, and a shift towards lower-cost post-data readout activities and trial wind-down efforts;
General & administrative expenses totaled $1.8 million, declining 24% from $2.4 million on account of lower stock-based compensation and legal expenses, lower consultant and professional expenses, and lower employee related expenses, partially offset by higher legal expenses;
Other income of $79,000 compared to $111,000 with the difference almost entirely attributable to less interest and other expense;
Provision for taxes was $3,000 compared to $5,000 related to payment of state and foreign taxes;
Net loss was $3.2 million vs $6.4 million, or $0.46 and $2.64 per share, respectively.^[1]

As of March 31^st, 2026, Reviva held $22.2 million in cash on its balance sheet. 1Q:26 cash burn was $3.8 million while cash flows from financing were $11.6 million. Financing transactions from a public offering and an ATM facility were slightly offset by repayment of short-term debt. The company estimates that the balance is sufficient to start the RECOVER 2 trial and to support operations into 1Q:27.

Letter to Shareholders

On behalf of Reviva Pharmaceuticals Holdings, Chief Executive Officer, Dr. Laxminarayan Bhat, composed a letter to shareholders acknowledging the difficult path over the last year. The missive justified the capital raises over the last 10 months, citing the priorities of strengthening the balance sheet, supporting operations to achieve the next milestone, and developing brilaroxazine to address schizophrenia and potentially other neuropsychiatric indications. The letter illuminates the pathway ahead for the RECOVER 2 trial and introduces new intellectual property related to brilaroxazine’s formulation that may extend its patent life.

The most recent capital raise generated $10 million in gross proceeds, bringing cash on the balance sheet to $23 million following the transaction. The amount provides sufficient funds to support the initiation of the RECOVER 2 trial in 2Q:26, enroll first trial patients in 3Q:26, and support further trial and operational costs until 1Q:27.

The news that can most significantly impact brilaroxazine’s valuation is the new composition of matter patent that Reviva has filed. If granted by the United States Patent and Trademark Office (USPTO) and if the FDA agrees to the proposed development strategy, it will reset brilaroxazine’s patent clock. The patent was filed earlier this year, which would provide protection for brilaroxazine that will expire in 2046. Not only would this provide brilaroxazine with additional patent protection for the schizophrenia indication, but it would also have implications for other indications in bipolar disorder, major depressive disorder, and Reviva’s other pipeline targets that would use the same formulation.

While the exact modification has not been disclosed, management indicates that the new formulation will use Generally Recognized as Safe (GRAS) substances that are expected to enhance the properties of the Active Pharmaceutical Ingredient (API). Salt and polymorph changes are the most common modifications and are allowed by the FDA, but must be approved. These changes can change and improve solubility, bioavailability, and stability, among other features. Salt changes require new supporting Chemistry, Manufacturing and Controls (CMC) and pharmacokinetic (PK) data prior to approval. If a drug has already received marketing approval, a Prior Approval Supplement (PAS) or New Drug Application (NDA) is required, which requires substantially more time, effort, and cost to execute. Polymorph changes require a CMC update and potentially bridging studies if bioavailability is affected. The FDA allows changes to a drug’s formulation but requires supportive data that is part of the development and registration process. If there is a change in the formulation between trials, the agency requires data showing that the new formulation is bioequivalent or that the change does not negatively impact the product's profile.

If the changes to the formulation are allowed by the FDA, then Reviva could see a dramatic extension of intellectual property (IP) protection. The formulation of brilaroxazine used in the RECOVER trial was supported by a composition of matter patent that expires in November 2030. The new filed patent could extend this to 2046. Before all of this can be integrated in our model, the new patent must be reviewed and granted, and the FDA must allow the change.

We expect to see a busy next few months at Reviva that will be occupied by trial preparation activities, interactions with the FDA to permit the new formulation of brilaroxazine, and first enrollment in RECOVER 2. The trial is expected to run for about a year, and the program will require additional capital midway through. The trial should wrap up and provide a topline readout before year end 2027. This sets up Reviva for an NDA submission in early 2028 for FDA review.

Dr. Bhat discussed many of the details provided in the shareholder letter in a video series. He provides more information on the anticipated formulation change and its patent implications, among other topics, in the associated clips. Links to the excerpts are provided below.

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^[1]^{We adjust prior year earnings per share using a 1:20 reverse stock split effective March 9th, 2026.}

SNES: Hantavirus Ship Shines Light on Problem SNES Tackles – Initiating Coverage

Wed, 27 May 2026 09:43:00 -0400

By M. Marin

NASDAQ: SNES

READ THE FULL SNES RESEARCH REPORT

Rodent infestations are pervasive, but problem is often undisclosed

SenesTech, Inc. (NASDAQ: SNES) is a leader in solutions for managing and reducing rodent populations. Rodent infestations are a pervasive but often undisclosed problem. The recent outbreak of hantavirus aboard the MV Hondius cruise ship shines a light on the magnitude and scope of issues that can result if rodent populations are not managed to contain the spread of disease and minimize the human and economic impact of food contamination, in our view.

Global public health crisis shines a light on need to control rodent populations

According to the Centers for Disease Control (CDC), “Hantaviruses are a family of viruses which can cause serious illnesses and death…They are spread mainly by rodents.”

AcfiPress Noticias Canarias, CC BY 4.0, via Wikimedia Commons

SNESdevelops birth control solutions to contain animal pest populations through fertility control

SenesTech has a growing portfolio of solutions to help control rodent populations through birth control. According to the National Institutes of Health (NIH), “Rodent infestation is a substantial global issue …. It is necessary to take measures to control rodent damage in order to protect human health and wealth… “

The use of chemical agents -- the most widely used rodent control measure -- is often sub-optimal and raises concerns about environmental safety and sustainable control, as well as ethical concerns, as the application of chemical agents can cause excessive suffering to rodents and often inadvertently to other non-targeted animal populations.

Many regulators are restricting the use of chemical rodenticides. Moreover, used alone, rodenticides and other chemical tools generally are not sustainable as rodents develop resistance to these methods. The industry is increasingly adopting Integrated Pest Management (IPM) programs that include fertility management, such as SNES offers.

Broadening product portfolio expected to expand SNES addressable market

SNES’s growth strategy includes broadening its product portfolio. The company has a growing portfolio of effective and sustainable products for both professionals and consumers to help manage rodent populations by restricting fertility through nonlethal birth control methods. In turn, this is expected to expand its addressable market. In early 2024, SenesTech launched Evolve^TM Soft Bait, which the company developed to offer customers a product with similar efficacy to ContraPest® in a format that is easier to deploy. Unlike the liquid ContraPest product, Evolve is a solid that has longer shelf life, is easier to distribute and deploy, and is cost-effective. Evolve is roughly the size and shape of a miniature sausage and is the first soft bait developed to control pest populations through fertility control. Its active ingredient is cottonseed oil, which decreases sperm production and ovarian follicle growth in rodents. SNES has also initiated pilot deployments with multiple U.S. cities.

E-commerce Growth: Amazon Direct Management

With a broadening product portfolio that is expected to appeal to the consumer, as well as the professional market segments, the company is focusing more efforts on the direct-to-consumer (DTC) and e-commerce channels. As a result, the company has refocused its efforts on online sales, including the SenesTech e-commerce portal and Amazon, as well as through big box retailers.

The target market is sizable. Industry estimates place the global rodenticides market at north of $5.5 billion and growing at an estimated CAGR of nearly 6%, putting it on track to reach nearly $8.7 billion by 2031.

With a new CEO in place, the company has launched multiple growth initiatives, including expanding its product line, redesigning the product packaging, emphasizing the DTC and online channels, including managing its Amazon store itself, and refreshing its proprietary e-commerce distribution, as well as increasing its focus on certain strategic large-scale opportunities and adding international markets opportunistically. Moreover, demand for control solutions from agricultural companies is generally expected to rise as rodent infestations cause damage to crops, and SNES is optimistic about its prospects in this sector.

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HURA: Refining TBS-2025 Development Plan

Tue, 26 May 2026 15:22:00 -0400

By John Vandermosten, CFA

NASDAQ: HURA

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Operational and Financial Results

On May 15^th, 2026, TuHURA Biosciences, Inc. (NASDAQ: HURA) reported 1Q:26 financial and operational results and filed its Form 10-Q with the SEC. There have been several highlights recently, most notably the $50 million loan facility, which TuHURA believes is sufficient to provide a cash runway until 2028. There were also two new appointments to the executive suite. Dr. Craig Tendler will take on the responsibilities of Chief Medical Officer at TuHURA, and Amanda Garofalo will serve as Senior Vice President of Clinical Operations. TuHURA announced the receipt of an Orphan Drug Designation for IFx-2.0 in specific cutaneous melanoma settings and expects to receive another orphan designation for Merkel cell carcinoma (MCC) by mid-year. Management provided an update to its anticipated milestones for the IFx-2.0, TBS-2025, and ADC assets.

TuHURA generated no revenues in 1Q:26 and expended $7.5 million on operational activities related to advancing IFx-2.0, TBS-2025, and other programs, producing a net loss of $7.5 million or $0.13 per share. For the quarter ending March 31^st, 2026, and versus the same prior period:

Research & development expense totaled $5.2 million, increasing 14% from $4.6 million on higher non-cash stock compensation expenses and public company costs, along with greater personnel and facilities related costs. By program, spending was initiated on the TBS-2025 program, which was absent in the prior year period, while disbursements for the IFx-2.0 program and preclinical work declined;
General & administrative expense totaled $2.3 million, falling 6% from $2.4 million. The change was predominantly due to the absence of acquisition-related costs in 1Q:26;^[1]
Net interest expense was $7,000 compared to net interest income of $100,000, with the change due to interest on notes issued to former Kineta employees;
Net loss was $7.5 million or $0.13 per share.

As of March 31^st, 2026, TuHURA held $6.3 million in cash on its balance sheet. Cash burn for 1Q:26 was $4.5 million. Net cash generated from financing sources was $7.1 million, which consisted of proceeds from common stock issuance offset by cash dividend, Kineta promissory note, and finance lease payments, along with transaction costs for the capital raise. In November 2025, 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. In April 2026, TuHURA entered into a Loan Agreement with Parkview Holdings, which provides access to a $50 million revolving credit facility.

$50 Million Credit Facility

On April 22^nd, TuHURA announced that it had entered into a loan agreement with Parkview Holdings One, providing a $50 million revolving credit facility. Parkview is an affiliate of TuHURA’s largest stockholder, K&V Investment One LLC. The agreement provides for a maximum of $50 million in borrowing at an annual rate of 12%. TuHURA may draw $1.7 million per month or agreed budgeted monthly expenses from the facility. Access to the funds is expected to provide sufficient capital to support operations into 1Q:28 without contributions from other sources. If TuHURA defaults, an additional 6% will be added to the interest rate. If TuHURA generates profits, under certain conditions, it must allocate 75% of the net profits to repay the loan.

Under the loan agreement, TuHURA must pay a one-time loan commitment fee of $5 million, or 10% of the total commitment. It also must pay an annual cash facility fee of 1.5% of the total commitment, which is equal to $750,000 annually. The arrangement also amends the terms of 4,364,873 warrants held by K&V, extending the warrant life until April 2031. Parkview may appoint a director to the company’s board. Parkview is also granted a low to mid-single digit royalty on sales of up to $450 million in sales that will continue until the last patent protecting IFx-2.0 expires. Additional details of the arrangement are included in the April 22^nd, 2026 Form 8-K filing and related exhibits.

Anti-VISTA (TBS-2025) Program

TuHURA closed its acquisition with Kineta 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) Acute Myeloid Leukemia (AML). TuHURA has been speaking with the FDA about the trial design and has received helpful feedback regarding the safety component of the trial. Previous work conducted in solid tumors will help streamline the dose finding efforts in the trial and refine the combination work that is expected with a menin inhibitor. Management is planning for another FDA meeting in July to fine tune the study design, followed by anticipated IND clearance in August and trial start in September.

Research has demonstrated that mutated NPM1 and DNMT3A result in high expression of VISTA on the surface of leukemic blasts.^[2] 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.

In February, TuHURA filed an 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. In response to the filing, the FDA provided valuable feedback and recommendations on how to transition from the trial design that appears in the existing IND in solid tumors to a design that would support an abbreviated Phase Ib trial in AML. The patient population for this study is expected to include individuals who have no approved or effective therapies available for treatment. Based on this feedback, TuHURA is planning a Phase Ib dose escalation study that will identify a recommended Phase II dose (RP2D) in blood related cancers including AML.

The development plan for TBS-2025 will seek patients with molecularly defined subsets of AML such as NPM1 mutated AML. This population lacks effective therapies and the majority of them are expected to be NPM1 mutated enrollees who failed to respond or who relapsed after treatment with a menin inhibitor. If the study generates favorable complete remission (CR), or complete remission with partial hematologic recovery (CRh) results, this may be sufficient to expand into an accelerated approval trial in this defined subset. Once the RP2D has been identified, TuHURA expects to proceed to a study evaluating NPM1 mutated r/r AML in combination with a menin inhibitor.

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 eliminate 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.

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^[1]^{Our review uses originally reported data for comparisons.}

^{[2] NPM1 and DNA methyltransferase 3A (DNMT3A) are two of the most common mutations in AML and typically co-mutated in myelodysplasia (MDS).}

UJOGF is Worth a Look for US Investors

Tue, 26 May 2026 11:03:00 -0400

By Brad Sorensen, CFA

OTCQB: UJOGF | LSE: USO

READ THE FULL UJOGF RESEARCH REPORT

Union Jack Oil (OTCQB: UJOGF, LSE: USO) has continued to position itself as a differentiated small-cap energy company focused on onshore oil and gas production, development, and exploration across both the United Kingdom and the United States. The company’s strategy has increasingly centered on balancing cash-generating UK production assets with higher-growth drilling opportunities in the U.S., creating a geographically diversified portfolio that management believes can deliver both operational stability and upside exploration potential.

A key strength for Union Jack Oil has been its flagship Wressle field in the UK, which remains an important cash-flow engine for the business. The company has continued to invest in upgrades and infrastructure improvements at Wressle while also restarting and enhancing production activities at the Keddington oilfield. These producing assets provide an operational foundation that helps support the company’s broader drilling and expansion plans. Management has repeatedly emphasized that Wressle remains a high-value asset with substantial reserves potential, reinforcing the long-term significance of the field within Union Jack’s portfolio.

Over the last year, Union Jack has also increased its focus on Oklahoma, where the company has been pursuing a multi-well drilling strategy alongside local operating partners. The successful Moccasin discovery represented an important milestone, with the well entering production and demonstrating the company’s ability to generate new production growth outside the UK. The company subsequently advanced additional projects, including the Sark, Crossroads, and Wolverine wells, which have the potential to be meaningful catalysts capable of expanding reserves, production volumes, and future cash flow generation.

The financial results associated with the company’s recent annual report highlighted both the challenges and resilience of the business. Union Jack remained debt-free and maintained a relatively robust balance sheet despite lower oil prices and currency headwinds during portions of 2025. The company reported that weaker oil prices and the decline of the US dollar versus Sterling pressured profitability during the year, yet management continued to stress the strength of the company’s asset base and liquidity position. Importantly, Union Jack maintained positive gross profit generation and continued funding operational development while avoiding debt accumulation, a notable distinction among smaller exploration and production companies.

Another encouraging development was the company’s successful institutional fundraising during 2025, which brought in approximately £2 million of gross proceeds to support the Oklahoma drilling campaign. Beyond strengthening liquidity, the financing also introduced additional institutional participation to the shareholder register, something we interpret as validation of the company’s operational strategy and asset portfolio.

Union Jack’s broader investment case continues to revolve around the combination of low financial leverage, existing production revenue, and multiple near-term operational catalysts. With exposure to improving UK production assets, expanding U.S. drilling activity, and leverage to oil prices, the company appears positioned to benefit if energy markets remain supportive. In addition, management’s emphasis on disciplined capital allocation and targeted project selection has helped Union Jack maintain operational flexibility during a volatile commodity environment.

Looking ahead, Union Jack appears positioned at an interesting inflection point. The company already has established producing assets and operational experience, which we believe should be attractive to investors. Combined with elevated oil prices and disciplined financial management, we believe investors should take a look at UJOGF.

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CRDF: First Quarter 2026 Results

Fri, 22 May 2026 14:15:00 -0400

By John Vandermosten, CFA

NASDAQ:CRDF

READ THE FULL CRDF REPORT HERE

1Q:26 Financial Results

Cardiff Oncology, Inc. (NASDAQ:CRDF) reported first quarter 2026 financial and operational results in a press release and Form 10-Q filing with the SEC on May 14^th, 2026. For the three-month period ending March 31^st, 2026 Cardiff reported revenues of $41,000 and operational expense of $12.9 million. Loss per share was $0.18. Operational expenses fell 11% as lower Research and Development (R&D) expenses were partially offset by higher General and Administrative (G&A) expenses. For the quarter ending March 31^st, 2026 and versus the same prior quarterly period:

Revenues of $41,000 compared to $109,000 and represent Cardiff’s sales-based and usage-based royalties on assets unrelated to onvansertib;
Research and development expenses totaled $6.8 million, down 35% from $10.5 million attributable to a reduction in clinical trial expenses and a decrease in preclinical activities for the CRDF-004 clinical trial;
Selling, General & Administrative expenses were $6.1 million, up 53% from $4.0 million. Increases relate to employee severance agreements and an increase in stock-based compensation attributable to the modification of stock options. These increases were offset by a decline in Outside Services and Professional Fees and Facilities and Other costs;
Net interest income of $0.5 million was down compared with prior period amounts due to reduced interest income on lower cash levels and other expense of $1,000 compared to other income of $7,000;
Net loss was $12.4 million vs. a net loss of $13.4 million or $0.18 and $0.20 per share, respectively.

As of March 31^st, 2026, cash, equivalents and short-term investments totaled $46.1 million. This amount compares to the $58.3 million balance in cash held at the end of 2025. Cash burn for 1Q:26 was $12.3 million versus $12.8 million for 1Q:25. Cardiff’s cash is expected to support operating activities until 1Q:27. The company will need to raise additional capital to fund the CRDF-005 Phase III registrational study.

Nerviano Dispute

Earlier this year, Nerviano Medical Sciences sent written notice to Cardiff alleging that it was in a material breach of the onvansertib license agreement between the two. Brief details of the interaction were included in the 2025 Form 10-K. Nerviano attributed the breach to the failure of Cardiff to name a Nerviano employee as joint inventor for US patents 12,144,813 and 12,263,173. Cardiff maintains that there is no breach and that the agreement does not require Cardiff to name Nerviano employees on patents that have been developed exclusively by Cardiff. It seeks injunctive relief requiring Nerviano to continue performing under the agreement and for the court to declare that it did not breach the agreement. Details of the event are in a Form 8-K filed on May 19^th, 2026.

The patent licensed by Nerviano has an expiry of May 2030 and it is likely that a full five years of patent term extension (PTE) will be allowed. With the PTE, the effective end of protection is 2035. We believe that the wording in the original license arrangement will be key to the outcome. While we do not provide legal opinions and lack complete visibility into the patents' development, we can point investors to the language in the agreement dated March 13^th, 2017 with Cardiff’s predecessor Trovagene. The language states that Trovagene/Cardiff has entire rights to intellectual property it solely develops:

10.2 Ownership of Inventions. Subject to the terms hereof, including the licenses and other rights granted hereunder, all Inventions shall be owned as follows:

Nerviano shall own the entire right, title and interest in and to all Inventions (including all patents and other intellectual property rights thereto) made solely by its employees or others acting on behalf of Nerviano (or solely by such persons and Third Parties performing work for Nerviano) in the performance of the Development Plan or other activities undertaken under this Agreement (“After-Developed Nerviano Inventions”). All After-Developed Nerviano Inventions will be included in the license and right granted under Article 3 above;

Trovagene shall own the entire right, title and interest in and to all Inventions (including all patents and other intellectual property rights thereto) made solely by its employees or others acting on behalf of Trovagene (or solely by such persons and Third Parties performing work for Trovagene) in the performance of the Development Plan or other activities undertaken under this Agreement;

(c) The Parties shall jointly own all Joint Inventions (as defined below). Nerviano’s rights in and to each Joint Invention (including all patent rights and other intellectual property rights to it) will be included in the license and rights granted under Article 2 above, and, subject to such license and rights, each Party may make, use, sell, keep, license or assign its interest in Joint Inventions and otherwise undertake all activities a sole owner might undertake with respect to such Joint Inventions, without the consent of and without accounting to the other Party. “Joint Inventions” means Inventions for which it is determined, in accordance with United States patent law, that both: (i) one or more employees, consultants or agents of Nerviano or any other persons obligated to assign such Invention to Nerviano; and (ii) one or more employees, consultants or agents of Trovagene or any other persons obligated to assign such Invention to Trovagene, are joint inventors.

Starting a New Chapter

On January 27^th, 2026, the Cardiff board of directors announced that it had appointed a new chief executive officer in an interim role and would seek a new executive team to lead the company. Dr. Mani Mohindru took the reins of the company and was later confirmed as permanent President and CEO as disclosed in an April 9^thpress release. Two other executive appointments were concurrently announced in that same release including Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, as Chief Operating Officer.

AACR Poster

Cardiff presented a poster at the 2026 American Association for Cancer Research (AACR) Annual Meeting held in San Diego, California from April 17 to 22. The title of the poster is PLK1 inhibitor onvansertib potentiates the antitumor efficacy of trastuzumab deruxtecan (T-DXd) and reverses its resistance in therapy-resistant HER2-low breast cancer models. It summarized preclinical work that examined the combination of trastuzumab deruxtecan (T-DXd) (Enhertu) with onvansertib and its effect on patient-derived xenograft models. Tumor volumes were measured using monotherapy of T-DXd and onvansertib and the combination of the two compared with a control. The xenograft models consistently showed that the combination therapy limited and even reversed tumor growth.

The poster concluded that onvansertib enhances T-DXd efficacy and overcomes its resistance across triple negative breast cancer (TNBC) and hormone receptor positive (HR+) breast cancer models. The combination induces synergistic DNA damage and apoptosis. The authors claim that PLK1 inhibition offers a strategy to deepen and prolong T-DXd response in advanced HER2-low breast cancer resistant to first-line therapies.

Next Steps for Onvansertib

Following meetings with the FDA, Cardiff has essentially finalized its design of the anticipated Phase III registrational trial for onvansertib in 1H:26. The trial will be designated CRDF-005 and will evaluate 30 mg of onvansertib with FOLFIRI and bevacizumab (bev) vs. the standard of care of FOLFOX/bev and FOLFIRI/bev. In its latest investor presentation, management provided a preliminary trial design that seeks to enroll first line mCRC patients that are KRAS and NRAS positive presenting unresectable tumors. Dual primary endpoints are anticipated to be ORR and PFS with secondary endpoints of DoR and OS. We expect more detail after funding arrangements are clear.

Source: Cardiff May 2026 Corporate Presentation

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EDSA: Preparing for Mid-2026 Start to Phase 2 Vitiligo Trial

Fri, 22 May 2026 12:15:00 -0400

By David Bautz, PhD

NASDAQ:EDSA

READ THE FULL EDSA RESEARCH REPORT

Business Update

Vitiligo Trial to Initiate in Mid-2026

Edesa Biotech, Inc. (NASDAQ:EDSA) is planning for a Phase 2 study of EB06, its anti-CXCL10 monoclonal antibody, for the treatment of moderate-to-severe non-segmental vitiligo patients. Vitiligo is a disease that causes areas of the skin to lose color, with non-segmental vitiligo being characterized by patches appearing on both sides of the body. It is caused when pigment-producing cells (melanocytes) die or stop producing melanin as a result of an autoimmune disease, genetics, or a triggering event (e.g., stress, sunburn, skin trauma).

Past research showed that the chemokine CXCL10 was elevated in both vitiligo patient skin and serum (El-Domyati et al., 2022). In a mouse model of vitiligo, which includes CXCL10 expression in the skin, neutralization of CXCL10 in mice with established, widespread depigmentation induced reversal of disease as shown by repigmentation (Rashighi et al., 2014). In addition, serum CXCL10 levels are significantly increased in vitiligo patients compared to controls, suggesting that CXCL10 may play a role in the pathogenesis of vitiligo in humans (Gharib et al., 2021). The following slide gives an overview of the mechanism of action of EB06 and data supporting its use in the treatment of vitiligo.

A 2022 publication reported that the estimated prevalence of vitiligo patients in the U.S. is between 1.9 million and 2.8 million (Gandhi et al., 2022). This corresponds to a vitiligo market that is projected to reach approximately $1.2 billion by 2030 (EvaluatePharma). Currently, the only FDA approved therapy is topical ruxolitinib (Opzelura^®), which generated $678 million in revenue in 2025, with approximately $390 million of that coming from sales for vitiligo (EvaluatePharma). Opzelura carries a black-box warning due to the potential for serious infections, major adverse cardiovascular events, and thrombosis (Opzelura prescribing information). Thus, there is clearly an unmet need to additional safe and effective treatment options for vitiligo patients.

Edesa is currently readying an IND submission for EB06 and has already received approval from Health Canada to conduct a Phase 2 trial. In addition, the company has initiated manufacturing activities to supply drug product for the Phase 2 trial. Edesa has also begun outreach to potential investigators. The study as currently planned will enroll approximately 160 patients with severe nonsegmental vitiligo, will evaluate three different doses of EB06 (2.5 mg/kg, 5 mg/kg, 10 mg/kg) administered IV every two weeks for up to 24 weeks followed by a 12-week follow up period, and will have a primary efficacy outcome of the percentage of patients that achieve ≥50% decrease from baseline in facial Vitiligo Area Scoring Index (F-VASI50), a composite measurement of the overall area of facial vitiligo patches and degree of depigmentation within patches. The final trial protocol will be contingent on feedback from the FDA and we anticipate enrollment initiating in mid-2026, dependent upon completion of manufacturing and regulatory activities.

Updated Phase 3 ARDS Results Continue to Show Mortality Benefit

In February 2026, Edesa announced additional Phase 3 results from its paridiprubart (EB05) study in acute respiratory distress syndrome (ARDS) that extend beyond the initial 104-patient cohort that was previously disclosed in October 2025. The updated dataset includes the full 278-patient safety population, which is comprised of both invasive mechanical ventilation (IMV) patients and those who were not on IMV at baseline.

An examination of the full 278-patient population revealed:

28-day adjusted mortality was 24% on paridiprubart plus standard-of-care (SOC) compared to 33% on placebo + SOC, which represents a 27% relative reduction in risk of death (P<0.001).

Patients receiving paridiprubart also demonstrated a higher rate of clinical improvement at Day 28 based on WHO severity scoring.

The company also conducted exploratory analyses across clinically relevant subgroups, which suggested patients receiving paridiprubart + SOC consistently had reduced adjusted mortality compared to those receiving placebo + SOC:

Acute Kidney Injury, n=48: 35% relative reduction (35% vs. 53%; P<0.05)
Sepsis, n=41: 36% relative reduction (40% vs. 63%; P<0.05)
Pneumonia, n=108: 30% relative reduction (35% vs. 49%; P<0.05)

Importantly, the safety profile remained consistent compared to prior exposures, with similar rates of adverse events and infections in paridiprubart compared to placebo arms. Over 400 patients have now received paridiprubart.

Given the strength of this data, management has indicated plans to engage with regulatory agencies in both the U.S. and Canada to determine the most appropriate regulatory pathway. Discussions are likely to be focused on whether the robust mortality and clinical improvement signals in the full 278-patient dataset support a registrational submission, the potential for accelerated approval pathway given the high unmet need and the severity of ARDS, and the role of exploratory subgroup data in shaping labeling or accelerated pathways. We anticipate further updates from the company on the regulatory front as the year progresses.

As a reminder, paridiprubart is also being evaluated in an ongoing 200-patient study under funding from BARDA. That study is part of a broader ARDS platform evaluating multiple host-directed therapies and is likely to further inform regulatory decision-making and confirmatory evidence.

Edesa recently presented the data from the Phase 3 study in an oral presentation at the American Thoracic Society (ATS) 2026 International Conference. In addition, the company will be presenting new data on paridiprubart in acute kidney injury (AKI) at the European Renal Association (ERA) Congress on June 5, 2026 that will feature exploratory data and analysis from the Phase 3 trial regarding ARDS patients who also experienced AKI.

Financial Update

On May 14, 2026, Edesa announced financial results for the second quarter of fiscal year 2026 that ended March 31, 2026. There were no revenues reported for the second quarter of fiscal year 2026. R&D expenses in the second quarter of fiscal year 2026 were $2.8 million, compared to $0.5 million for the second quarter of fiscal year 2025. The increase was primarily due to higher manufacturing costs and other preparations for the planned Phase 2 clinical study of EB06 in vitiligo patients. G&A expenses totaled $1.5 million for the second quarter of fiscal year 2026 compared to $1.2 million for the second quarter of fiscal year 2025. The increase was primarily due to an increase in salaries and professional fees.

As of March 31, 2026, Edesa had approximately $10.0 million in cash and cash equivalents. As of May 13, 2026, Edesa had approximately 8.9 million shares outstanding and, when factoring in stock options, warrants and the Series B-1 convertible preferred shares, a fully diluted share count of approximately 15.7 million.

Conclusion

Edesa’s stock has had an incredible run since our last update, rising from approximately $2 to currently over $10 as more investors have begun to appreciate the potential for the company’s lead assets, EB05 and EB06. However, we believe there is additional upside to be had as Edesa gets set to initiate the Phase 2 trial in vitiligo for EB06 in mid-2026 and as discussions with regulatory agencies occur to determine the most appropriate path forward for EB05. With no changes to our model, our valuation remains at $19 per share.

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AZTR: More Background on Cosmetic Opportunity

Fri, 22 May 2026 11:15:00 -0400

By John Vandermosten, CFA

NYSE:AZTR

READ THE FULL AZTR RESEARCH REPORT

Azitra, Inc. (NYSE:AZTR) reported first quarter 2026 financial and operational results on May 13^th and provided a business update. For 2026 to date, Azitra has raised over $10 million in capital that will support the launch of a new indication in cosmetics and cosmeceuticals along with its other clinical programs. It has also presented a poster at the Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), added a new site for the ATR-04 trial and secured a new patent for ATR-12.

Operational and Financial Results

Azitra’s first quarter 2026 results were presented in a press release and Form 10-Q filing with the SEC on May 13^th. For the quarter ending March 31^st, 2026 and versus the prior year’s comparable period, no revenues were reported. Net loss for the three-month period totaled $3.9 million or $0.25 per share.[1] Operating expenses increased year over year due to an increase in General and Administrative expenses related to patent write-off costs. Below, we detail 1Q:26 financial results compared to the same prior year period:

Research and Development expenses increased by 25% to $1.6 million from $1.3 million stemming from greater chemistry, manufacturing and controls (CMC) expense partially offset by declines in preclinical and clinical research and personnel and consultant related expense. By program, ATR-01 costs increased by $484,000 over the prior year, and a $54,000 increase in ATR-04 expenses offset by declines in spending for the ATR-12 program;
General & Administrative expenses totaled $2.4 million, up 28% from $1.9 million primarily related to the write-off of approximately $624,000 in certain deferred patent costs, an increase in approximately $47,000 in legal fees, an increase of approximately $63,000 in the use of business consultants. These amounts were offset by lower payroll and benefits, accounting and auditing financing costs and insurance costs;
Net interest income was $11,000 compared to $36,000 due to lower average cash balances during the quarter;
Other expense was $5,000 compared with $4,000;
Net loss was $3.9 million or $0.25 per share vs. $3.1 million or $1.55 per share;[2]

As of March 31^st, 2026, cash and equivalents totaled $10.1 million. This compares with the $2.1 million at the end of 2024. There is no debt. Cash burn for 1Q:26 was $2.5 million, lower than the $3.1 million consumed in 1Q:25. Cash from financing was $10.5 million representing proceeds from a private placement. Preferred stock is carried on the balance sheet as Additional Paid-In Capital and does not yet appear in the share count or as debt. There are 85.2 million shares that will eventually convert into equity shares that will later be added to shares outstanding.

ASGCT Poster Featuring ATR-01

Azitra presented its poster entitled An Engineered Human Filaggrin Secreting Staphylococcus epidermidis Strain for the Topical Treatment of Ichthyosis Vulgaris at the 2026 Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT 2026). Roger Léger, Ph.D., Azitra’s Vice President of Chemistry, Formulation and Development delivered the address.

The poster highlighted Azitra's engineered live biotherapeutic ATR-01. The candidate is designed to treat ichthyosis vulgaris (IV) by delivering recombinant human filaggrin directly into the skin using a modified Staphylococcus epidermidis strain. IV is a common genetic skin disorder caused by filaggrin deficiency, leading to impaired skin barrier function and increased trans-epidermal water loss.

The data presented at ASGCT 2026 highlighted ATR-01's mechanism of action and translational potential, including its ability to elicit robust secretion of a recombinant human filaggrin domain. The bacteria achieve peak production 6 to 8 hours following application. In an ex vivo pig skin model, ATR-01 significantly reduced transepidermal water loss across all dose levels (p < 0.001), with levels returning near baseline within 20 hours. In parallel, studies in reconstructed human epidermis showed restoration of key structural features such as increased filaggrin levels and co-localization with keratin proteins, supporting functional integration into the skin barrier.

ATR-01 Cosmeceutical Derivatives

At the March 2026 BIO conference, COO Travis Whitfill introduced a new opportunity in cosmeceutical indications. Azitra’s new product, now designated ATR-COSF, is produced by inserting a gene fragment that encodes filaggrin into S. epidermidis to be later used in skin applications. The filaggrin is a byproduct of ATR-01 and may free amino acids and natural moisturizing factors that could improve the appearance of fine lines and wrinkles. One of the advantages of a cosmeceutical application is that the regulatory pathway is shorter and less costly. Additionally, there is substantial demand from cosmetics companies, especially in Asia, for new products that show benefits. This is an early-stage initiative, but merits further review as it evolves.

Azitra expects to report results from synthesized filaggrin ingredients and its repeat application study on cosmetic surgery skin in mid-2026. This is anticipated to be followed by a Human Cosmetic Application study slated for 3Q:26.

Filaggrin Background for Skin Smoothing Treatment

Filaggrin’s role in reducing the appearance of lines and wrinkles is mostly indirect. It helps keep the stratum corneum hydrated, compact and mechanically resilient, so skin looks smoother and less creased. As filaggrin is broken down, it generates a natural moisturizing factor, which helps retain water and maintain the skin barrier. Loss of filaggrin is associated with dry, scaly, more visibly lined skin.[3]^,[4]

The protein accumulates keratin filaments in the outer epidermis, helping corneocytes flatten and pack tightly, which supports barrier strength and the physical smoothness of skin. Its degradation products become natural moisturizing factors, which help hold water in the stratum corneum and support an optimal skin pH. When filaggrin is reduced, water loss rises and the skin tends to look drier and more lined, especially in chronically dry or aging skin.[5]

Filaggrin is not a collagen or elastin replacement, so it does not directly rebuild the dermis or erase established wrinkles. Rather, it can improve the appearance of fine lines by improving hydration, barrier integrity and surface texture, which makes them less noticeable. Filaggrin-supportive approaches emphasize smoothing and moisture retention as opposed to true wrinkle reversal.[6]

Private Placement Financing

Azitra entered into a securities purchase agreement on March 18^th, 2026 where the company sold 10,485 shares of Series A convertible, non-redeemable preferred stock, along with warrants to purchase common stock. When authorized shares are increased in accordance with NYSE American rules, the preferred stock may convert into 85,223,126 shares of common stock. The financing raised $10.5 million and has the potential to contribute another $20.9 million if the attached warrants are exercised. Two series of warrants were issued: Series B and Series C. 85,223,126 were issued for each series with an exercise price of $0.123. Series B warrants have an 18-month life while the Series C warrants will expire 30 days after data is reported from the cosmetic filaggrin study. Details of the arrangement were provided in a Form 8-K filing. The Series C warrants have an anti-dilution provision that reduces the exercise price if the stock closes below $0.123 on the series C termination date.

Participating investors include institutional healthcare focused funds, Stonepine Capital and Nantahala Capital along with other institutional funds and individual healthcare professionals. Azitra’s CEO and other company insiders also participated.

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[1] We update per share amounts in this report to reflect the 1:6.66 reverse stock split that took place on August 21^st, 2025.

[2] We use financial statement data as originally reported and apply a 1:6.66 reverse stock split ratio for periods prior to August 21^st, 2025. Prior year numbers in our reporting may not match Azitra’s current period comparisons.

[3] Murphy, G.F. Aging Skin: A Dermatitis To Which All Flesh Is Heir? Journal of Cutaneous Pathology. January 2026.

[4] Medline Plus. FLG Gene, Filaggrin. Accessed May 2026.

[5] Kim, Y., Lim, K.M. Skin barrier dysfunction and filaggrin. Archives of Pharmaceutical Research. January 2021.

[6] Harding, C.R. et al. Filaggrin – Revisited. International Journal of Cosmetic Science. March 2013.