Zacks Small Cap Research Press Releases

CEO Chat with Dr. Ragula Bhaskar, Chairman and CEO, and Kanishka Ragula, CFO of FatPipe, Inc.

Tue, 22 Sep 2026 11:40:00 -0400

NASDAQ: FATN

Lisa Thompson: Hi everyone, I'm Lisa Thompson, Senior Technology Analyst with Zacks Small Cap Research, and welcome to another episode of our CEO Chat. Today we have the Chairman and CEO of FatPipe Networks (NASDAQ: FATN), Dr. Ragula Bhaskar, as well as Kanishka Ragula, who is the newly appointed CFO, here to answer our questions and to talk a little bit about what's going on at the company. Dr. Bhaskar, will you please start off? And tell us about the company and what you do.

Dr. Ragula Bhaskar: FatPipe Networks makes mission-critical networking products. We focus on customers who need a connected network all the time. We make high-performance networking products that include a single stack for SD-WAN, cybersecurity, network visibility, and network monitoring. Essentially, an all-in-one package for customers.

LT: Can you talk about your industry and how fast it's growing and who some of your competitors are and how you compare against them?

RB: The SD-WAN industry is growing at the rate of around 25%. Cybersecurity is growing at 11%. Network monitoring is growing around 15 to 11%. That is the typical rate in the industry. In terms of competitors, on the high end, we have the major networking companies. But we have better products, and we have more innovative products. And if you look at all the customer reports or customer surveys, FatPipe is always number one on product and number one in customer service. Even though we are smaller, we are better in terms of product and service, and that's the reason why we land customers when we compete against the big boys.

LT: I really think one thing that gets lost sometimes is how unique your product is in that you created it and it's your platform and it's patented and you've never bought a product to add on to it. Talk about how that's an advantage when you go up against the others.

RB: That's a good question. Very insightful, because when you are a big company, whether you are a Juniper or Cisco, you buy multiple products from multiple startups. The problem with that is integration. Getting it all to work and getting to do it efficiently is always a challenge. And then supporting the customer is an even bigger challenge, because you have all these product specialists who have to come to the table to help the customer. In our case, since it's the same company developing all the features, we have a single-stack solution. The major advantage is the speed of performance of the product, and the ability to bring all the parts together and deliver a solution for the customer. And now that we are adding AI to it in the next several months, we'll be able to take all the data and make more sense out of it for AI to deliver predictive networking results. That's a major advantage.

LT: Interesting. Could you give us an example to just make it simple for people: a customer that came to you, why they came to you, and what's better for them?

RB: Number one again, the product is the best in the market. We have thirteen unique patents; we invented SD-WAN. We have a lot of unique patents. The second part of that is that after SD-WAN, we added cybersecurity, network monitoring, and network visibility. Now, if you have to analyze a network issue, we can look into the network side of things. We can look at the network devices’ performance, up/down status performance, and we can look at cybersecurity issues. Together, we can understand if there's a network issue; together we can understand all the different things that are affecting the network, and we can make a faster root cause analysis. There's a big advantage to having a single product from a single company.

Kanishka Ragula: Bhaskar, if I may add on top of that, just as a customer case study example to make it easier for some of the viewers to understand, we had a mid-sized business in the Midwest with multiple locations that served multiple customers on a regular basis. They had used FatPipe to initially connect two different ISPs to get redundant internet connectivity using FatPipe SD-WAN.

After they made the initial purchase with SD-WAN, because of our platform offering that we have, we were able to expand this platform to add cybersecurity for this customer, so they were now protected on their network connection from any inbound threats to their offices. After we released monitoring as well, this customer has expanded their solutions that they purchased from FatPipe to include monitoring for both their wide area network on the public-facing internet as well as the local area network, which is the devices and computers within this network. A FatPipe customer oftentimes will start with one FatPipe product, which is our SD-WAN offering, and then expand beyond that to include other additional features like our cybersecurity offerings or our network monitoring offerings. That's what you get when you offer a platform that has been built in-house from the ground up as opposed to bolting on multiple smaller acquisitions over the course of multiple years.

LT: Sounds great. Well, let's not forget one of the major factors that's helping your sales growth is that you almost tripled, or did triple, your sales force. Talk about how that's working out.

RB: We have hired people in different geographies and different market segments. For instance, in mid-markets or in government, we are adding more people to that. And as these people become productive, they are bringing in deals. And that is helping us with the growth. And we are adding more people. By the end of the fiscal year, we should have around 36 salespeople.

KR: And our salespeople go beyond just going door to door selling products. FatPipe has a unique channel model, which is similar to some other companies in the industry, but the goal is for our salespeople to amplify our selling capabilities by engaging with partners. Whereas a single salesperson can only call maybe ten customers in any given day, what FatPipe salespeople do is go to the various channel partners we sell through. We go to the individual sales representatives at these partners, train them up on the advantages of FatPipe products, and support them as they go out and sell to their customers.

What that allows us to do is, even though we have a lean sales force of only 36 people, we're able to actually get activation across all our channel partners and have hundreds, if not thousands, of people who know what FatPipe is and can communicate to their end customers what the FatPipe solutions and what the FatPipe offerings are, enabling our lean sales force to have a much more outsized impact on the overall sales effort of SD-WAN and FatPipe's awareness in the market.

LT: I know you have one channel partner that's over 30% of sales. Can you describe a little bit what that relationship's like and what they do and what you do?

RB: They are a major ISP in the country, one of the largest ISPs in the country. And so they sell FatPipe to their corporate customers. If a customer has a need for networking of different types, of different lines, they use FatPipe to deliver the last-mile connectivity. Our products, our support, our services, and their data lines and their sales team.

LT: I wanted to point out that people should know a little bit about your financial situation: that you're an $81 million market cap company, growing, profitable, and when we compare you to all the other people in the industry, you're about a quarter to a third of the valuation of these other companies that do the same thing. I think there's a lot of upside there for investors. They should take a look. Can you tell a little bit about what to expect going forward? What should we be looking for? New contracts or new channel partners? What should investors check?

RB: We are adding more channel partners. We just recently signed Carahsoft, which is a government distributor, and we also signed Harvard Technologies, which also has a big reach. It's a $4-some billion-dollar company. Besides signing up new partners, our focus is to make our current partners productive. For instance, let us say a partner has 100 or 500 employees. We have not reached out to all 500 or 100 employees. The task is twofold. One is to reach out to more employees within the partner channel and to add more strategic partners. Those are the two things we are doing. In terms of what to expect, more of the same. Our growth, as I said in the last several quarters, is to have about 18% growth and 18% EBITDA. We have been doing 20-some percent growth and 25% EBITDA, but in terms of forecasting, we say 18% and 18%.

LT: That's great. Look forward to hearing more news from you folks. Anything else you want to add?

KR: I think one additional feature I do want to talk about is, when FatPipe approaches, call it, how we operate a business. Unlike many smaller companies our size, our goal is that whenever we're growing the business, we want to grow profitably and remain a Rule of 40 company, in that we want to match any revenue growth we have with the equivalent profitability on the bottom line to ensure that we're not burning cash unnecessarily to keep the company growing and keep investors with decent returns, in our view.

The company itself has been cash efficient for nearly thirty years since it was founded. And we keep the same financial discipline that we have been holding the business to for the past two decades. And overall, FatPipe as a company, we look to continue growing, continue being successful in the market, and supporting our channel partners and helping them win sales across various categories and various end markets that they compete in.

LT: That's great. That's a great summary. Also, glad that you added that, because it's kind of a rare thing nowadays to not need more cash. I think we had a good conversation here. If anybody wants more information, I'm sure you can contact the company, go to their website, or, if you want my research reports, you can get them at scr.zacks.com and give us a call. Thank you so much for your time.

RB: Thank you, Lisa.

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BDRX: Enrollment in Phase 3 SERENTA Trial Reaches 92 Patients

Tue, 22 Sep 2026 11:26:00 -0400

By David Bautz, PhD

NASDAQ: BDRX

READ THE FULL BDRX RESEARCH REPORT

Business Update

Enrollment Continues in Phase 3 SERENTA Trial

Biodexa Pharmaceuticals, PLC (NASDAQ: BDRX) is conducting the Phase 3 SERENTA trial of MTX230 (eRAPA) in patients with familial adenomatous polyposis (FAP). It is a double blind, placebo controlled trial that will enroll 168 high-risk patients with germline or phenotypic FAP diagnosis (NCT06950385). Patients are randomized 2:1 drug/placebo to evaluate the safety and efficacy of MT230. The primary outcome of the trial is PFS as determined by a composite clinical progression measure between the following four conditions: Surgery/Meets Criteria for Surgery, Advancement of Spigelman Stage, Diagnosis of high-grade dysplasia or cancer, or death by any cause. The endpoints were agreed to by the U.S. FDA in a Type C meeting. The first patient was enrolled in August 2025, and there will be an interim analysis after 25 PFS events, and the database will be locked after 75 PFS events. The trial is being partly funded by a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). Thus far, a total of 92 patients have been enrolled across 29 active sites in the U.S. and five E.U. countries, with another two sites expected to open in Canada in the fourth quarter of 2026.

MTX230 (eRAPA) is a reformulated version of Rapamune^® (rapamycin) and represents a late-stage, mechanistically validated approach to chemoprevention in a genetically defined cancer predisposition syndrome. The reformulated version of rapamycin offers improved pharmacokinetics and bioavailability and targets dysregulated cellular proliferation downstream of APC loss, which is a foundational driver of disease pathogenesis. MTX230 leverages decades of biological insight into mTOR signaling, intestinal tumorigenesis, and rapamycin pharmacology, but applies this knowledge through a differentiated formulation and dosing strategy designed specifically for chronic use in FAP patients.

FAP is an autosomal dominant cancer predisposition syndrome caused by germline mutations in the adenomatous polyposis coli (APC) tumor suppressor gene (Half et al., 2009). Loss of APC function leads to constitutive activation of the Wnt/β-catenin signaling pathway, resulting in uncontrolled proliferation of intestinal epithelial cells and the formation of hundreds to thousands of adenomatous polyps throughout the gastrointestinal tract. Over time, these polyps accumulate additional genetic alterations, ultimately progressing to colorectal carcinoma. Historically, the lifetime risk of colorectal cancer in untreated FAP patients approaches 100%, often by the fourth decade of life (Kinzler et al., 1996).

Current management of FAP is largely surgical, with most patients undergoing prophylactic colectomy or proctocolectomy in early adulthood to mitigate cancer risk. While effective in reducing colorectal cancer incidence, these procedures are associated with significant long-term morbidity, including altered bowel function, nutritional complications, and reduced quality of life. In addition, surgery does not eliminate the risk of neoplasia in the duodenum, stomach, or residual rectal tissue, necessitating lifelong surveillance and repeated interventions (Peterson et al., 1991). Despite the severity and well-characterized biology of the disease, no pharmacologic therapies are currently approved that meaningfully alter its natural history, underscoring a significant unmet medical need.

MTX240 Update

MTX-240 (formerly OPB-171775) was licensed by Biodexa in February 2026. It is a molecular glue that is being developed for the treatment of gastrointestinal stromal tumors (GIST). Molecular glue therapeutics enable the pharmacologic modulation of protein function through induced protein binding, including stabilizing transient or non-existent protein-protein interactions. MTX240 specifically brings together two intracellular proteins, PDE3A and SLFN12, that are co-expressed in GIST cancer cells. PDE3A regulates intracellular levels of cyclic nucleotides while SLFN12 is implicated in the regulation of cell growth and differentiation. The interaction between PDE3A and SLFN12 leads to activation of SLFN12’s RNase activity, resulting in inhibition of global protein translation and induction of apoptosis.

Preclinical studies showed that MTX240 showed antitumor activity in a series of patient-derived xenograft (PDX) models of GIST, including both tyrosine kinase inhibitor (TKI)-sensitive and TKI-resistant tumors harboring diverse KIT mutations. This is particularly important since first-line treatment of GIST involves TKI’s, however resistance typically develops within 2-3 years of treatment initiation through secondary mutations in the KIT kinase domain. While new TKI’s have been developed to address specific resistance mutations, median progression-free survival (PFS) declines in later-line settings. Thus, there continues to exist a significant unmet medical need for additional GIST treatment options.

Biodexa is planning to initiate development of MTX240 with a Phase 1b/2a dose escalation study in patients with advanced GIST to establish safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) for dose optimization. The company is currently manufacturing GMP drug supplies, which should be available in December 2026. We anticipate an IND filing in the first quarter of 2027 and the dose escalation study to initiate in the second quarter of 2027.

Financial Update

On September 11, 2026, Biodexa announced financial results for the first half of 2026. As expected, the company did not report any revenues in the first half of 2026. R&D expenses in the first half of 2026 were £2.92 million compared to £1.67 million for the first half of 2026. The increase was primarily due to increased activity on the MTX230 Serenta trial and manufacturing costs for MTX240. Administrative costs in the first half of 2026 were £1.74 million compared to £2.38 million in the first half of 2025. The decrease was primarily due to foreign exchange movements, along with a decrease in professional fees.

Total cash burn for the first half of 2026 was £4.61 million, and the company exited the first half of 2026 with approximately £3.23 million in cash and cash equivalents. Subsequent to the end of the quarter, the company raised gross proceeds of approximately £2.3 million through a warrant exercise transaction. We estimate that the company has sufficient capital to fund operations into the first quarter of 2027.

Following a share consolidation in July 2026, we estimate Biodexa has approximately 3.2 million ADS outstanding (each ADS representing 50 of the company’s ordinary shares along with 0.35 million pre-funded warrants, 0.61 million abeyance shares, and 5.1 million warrants for a fully diluted ADS count of approximately 9.2 million.

Conclusion

The SERENTA trial continues to enroll patients at a fast pace, and the expansion of clinical sites into Canada will likely continue to support the current pace of enrollment. We look forward to updates from the company regarding the potential timing of the first interim analysis, which is set to occur following the first 25 events. For MTX240, the company continues to be on pace to file an IND in the first quarter of 2027 and initiate the dose-escalation Phase 1 trial in the second quarter of 2027. We have incorporated the recent warrant exercise and exchange into our model, and our valuation is now $9 per ADS.

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CEO Chat with Dr. Christopher Burns, Chief Executive Officer and Managing Director of Amplia Therapeutics – OTC Markets Life Sciences Virtual Investor Forum

Mon, 21 Sep 2026 11:38:00 -0400

OTCQB: INNMF | ASX: ATX

Greg Young: Hello, and welcome to the Life Science Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we are very pleased you have joined us. The next presentation of the day is from Amplia Therapeutics. Their session will be moderated by Brad Sorensen, Senior Equity Analyst with Zacks Small Cap Research. I'm very pleased to welcome Chris Burns, Chief Executive Officer and Managing Director of Amplia Therapeutics (OTCQB: INNMF, ASX: ATX). Welcome back, Chris. Over to you, Brad.

Brad Sorensen: Thank you very much. Glad to be here. And Chris, welcome. Glad to be talking with you.

Dr. Christopher Burns: Thanks, Brad. Nice to be here as well. Thanks to everyone who's dialing in.

BS: Thanks to everybody for being here. And let's just jump right into it, because I'm really excited. I've had the chance to do a lot of work on Amplia and research them, and I'm really excited about what we have to share with investors today. Let's start with the ACCENT study, because that's where it starts out. And you talk about the 5 complete responses, and how it deals with pancreatic cancer. Explain a little bit about that, and how significant that is, and how exciting that can be.

CB: Thanks, Brad. We have announced data from a study that's been running for the last couple of years. It's combining our drug, narmafotinib, with standard of care chemotherapy, gemcitabine/nab-paclitaxel, in metastatic pancreatic cancer. These are first-line patients. They would normally get chemotherapy. And what we've done is given patients the option to take our drug on top of their standard of care chemotherapy. And what we reported earlier this year, based on the blinded, independent central review, is that from the comparison with historical data, we saw a significantly better response. In particular, 5 complete responses out of 64 patients. To put that into context, the clinical study we compare against, which is called the MPACT study, they had 431 patients in that study. They saw 1 confirmed complete response. We've seen 5 out of 64 patients. And on top of that, we actually had an additional patient who left our study, underwent surgery, and ultimately was a pathological complete response. Essentially, 6 out of 64 patients had a complete response by independent review.

BS: Chris, could you just explain what a complete response is, for somebody who doesn't know that? Thanks.

CB: Absolutely. Thank you, Brad. A complete response is where there's no apparent tumor present across the board. It's not just tumors in the pancreas, but tumors anywhere in the body. We look at patients every two months. There were 5 patients who had a confirmed complete response, which means there were no tumors apparent at one time point, and then at a two-month subsequent to that, there were no apparent tumors. You need to see that for at least two months, and many of our patients had no tumors apparent for many months. It's essentially what you'd call a remission in other cancers. That was a really exciting output of our clinical trial. We also saw a very good response rate, 42% response rate, which includes unconfirmed responses. Again, much better than what's been reported previously for chemotherapy alone. And lastly, we saw a median overall survival of 11.1 months, which again is 2 to 3 months better than what's been reported for chemotherapy alone.

If we look at the direct comparison with the chemotherapy versus chemotherapy plus narmafotinib, we see significantly better responses across all possible measures. It was an open-label study, and it was a single-arm study, but it definitely gives us very strong confidence to move ahead with a registrational-enabling study. Just one final point is that on top of seeing these good responses, patients who are taking our drug and chemotherapy really didn't see any additional toxicity from our drug. Obviously, chemotherapy carries its own toxicities. And when we look across those adverse events that you get with chemotherapy, the patients taking the narmafotinib and chemotherapy didn't show any worse outcome in terms of adverse events. We don't think the drug's adding any burden to the patients. But the data we've got strongly suggests that the drug is improving the outcome.

BS: And I just want to emphasize, there's been a lot of media attention in the United States about a recent drug approval, that you mentioned, for pancreatic cancer. And this is in concert with that drug. It's not in competition with it, it's used with that, and that's improving the responses to that. Now that we've gotten to this point, what are the plans for the future? That's what investors want to know. Over the next 12 to 24 months, how can we get to an approval, so we can get this to patients and, hopefully, get pancreatic cancer solved?

CB: There's a dual pathway, to be honest. First of all, we want to build on that promising data we saw with narmafotinib and the chemotherapy. We've been working with the FDA on a design for a registrational study. We're pretty much agreed that's a three-part study. There's an optimization of the dose of narmafotinib; and then there's choosing that one dose; and then taking that forward in combination with the chemotherapy. To do that dose optimization, we've actually started a run-in of that work now, just optimizing the daily dose of narmafotinib. That work's already started in Australia. And once we've got that data, we'll take that to the FDA in the end of the first quarter next year, in 2027, to discuss that safety and pharmacokinetic data, to finalize the protocol for the registrational 2b/3 study.

Prior to that, we'll be also speaking to the FDA. We've got a meeting scheduled later this year, where we'll be talking to them about some safety and pharmacology data. We've got a couple of FDA interactions. And it's worth noting we have Fast Track designation from the FDA, so we have a really good interaction with the team there. That's the first thing we're working on, the registrational pathway. We've already started a run-in in that program. And then finalizing the protocol with FDA input over the coming months.

Then in parallel, we're actually looking at combining narmafotinib, based on the safety and tolerability that we've seen in patients, with this new class of drugs called RAS inhibitors that are being developed in pancreatic cancer. And we're talking to a number of parties about opportunities there. Nothing that we can formally announce in pancreatic cancer. And we did announce last month a relationship with Eli Lilly. Lilly have a RAS inhibitor that they're developing in non-small cell lung cancer. That's a drug called olomorasib. It's in phase three, two phase three studies now, in non-small cell lung cancer. And we're about to start a study where we combine narmafotinib on top of olomorasib. And based on our preclinical data, and in fact, a lot of scientific evidence, we strongly believe that the FAK inhibitor and the RAS inhibitor, be it olomorasib in non-small cell lung cancer or be it another RAS inhibitor in pancreatic cancer, will enhance the durability of that response. And it does that by blocking resistance pathways that we know develop in the presence of RAS inhibitors.

That's our second arm. First arm, combination with chemotherapy. Second arm, combination with RAS inhibitors. And the first time we're testing a combination clinically with a RAS inhibitor is actually not in pancreatic, but it's in lung cancer. But it's an exciting collaboration to be working with Eli Lilly. And that's a fabulous drug they've got, olomorasib, and we're excited about that combination potential.

BS: And I think it shows what the promise of this is, because Lilly wanting to team up with somebody for this, that's a pretty significant step. I know quite a bit about Lilly, too. I do want to go back, just really quick. You mentioned the dosing, finding the optimal dosing. What was the dosing for the original study? And then, if you increase the dosing, do you speculate that the results could be better? Just tell us a little bit about that.

CB: Absolutely. Short answer is, yes. We do think we can do better. The original study was run using intermittently dosed narmafotinib. Narmafotinib is a drug, it's presented to patients as a capsule. Patients take it orally. And the way we designed the trial was really built on some preclinical data that indicated that patients should take the drug in the days preceding chemotherapy, but then not take the drug in between the chemotherapy. They'd take the drug, they'd get chemotherapy, wait a few days, take our drug, then chemotherapy, wait a few days, like that. Since we started that trial, we then did a lot of further preclinical studies. We saw how well the drug was tolerated by patients. And really, we want to shift from that intermittent dosing regimen of narmafotinib to a daily dosing regimen. We believe that'll lead to better patient outcomes, in terms of durability of response and depth of response, though we already see pretty good data there, as we've discussed.

But it's also more convenient for patients. You just take our drug every day, get your chemotherapy when your oncologist tells you to get your chemotherapy, but you're taking our drug, which we think, based on all the preclinical work we've done since initiating the ACCENT study, will lead to better outcomes. We've seen great outcomes. As I said, the 5 complete responses, a complete response rate of 8%. We think we can improve on that by going to daily dosing.

BS: I think that's great. I look forward to seeing those results, and I certainly hope and believe that would be true. And you mentioned, going back to the Lilly partnership, that the KRAS inhibitors and the KRAS cancers, it's the lung cell cancer that you're working with them. But I'm guessing that that's just a starting point. And you believe that this might lead to other KRAS-type cancer.

CB: Combinations. Absolutely. I'm sure many of the audience will be familiar with KRAS inhibitors. But KRAS is a mutant protein. It's overexpressed in a number of different cancers, but most notably pancreatic cancer, colorectal cancer, and non-small cell lung cancer. There's two drugs approved in non-small cell lung cancer already that target the KRAS protein. That's sotorasib and adagrasib. Those drugs have some efficacy, but they've got a lot of toxicity associated with them. There's this next generation of drugs coming through in non-small cell lung cancer, and the Lilly drug, olomorasib, is one of those. We're combining with that drug in non-small cell lung cancer. But there's other RAS inhibitors that are being developed in pancreatic cancer and in colorectal cancer. We're talking to potential partners about those combinations. What's important, though, is that the mechanism of resistance to RAS inhibitors seems to be common regardless of the cancer. The same kind of resistance processes that we see in non-small cell lung cancer also occur in pancreatic cancer, also occur in colorectal, and indeed other KRAS-driven tumors. We think what we can learn from the collaboration with Lilly about combining narmafotinib with that Lilly KRAS inhibitor, we can translate that knowledge to combining with other RAS inhibitors in other cancers.

BS: That's excellent. And you actually described it to me in a very simple way, and how it works with chemotherapy. I don't know if you want to do that here, just to give them an idea of why it works. It made a lot of sense when I was talking about it, for somebody that's not intimately involved with this process; that helped understand why this really helps.

CB: Sure. We launched straight into the data, and I didn't really explain how the drug works. It targets a protein called Focal Adhesion Kinase. That protein is overexpressed in pancreatic cancer and, in fact, a lot of solid tumors, lung cancer, and so on. That protein's involved in resistance. It's involved in cancer cell survival and migration. But it's also involved in making a scar tissue that sits around solid tumors and protects them from attack by the immune system or attack by other drugs. And so what our drug does is it actually breaks down that fibrosis, that scar tissue, so you're actually allowing more drug to penetrate into the cancer cells. Once the chemotherapy or the KRAS inhibitor's into the cancer cells, our drug, by inhibiting FAK, blocks some resistance pathways that develop over time. It has, what we like to say, a one-two punch on cancer. There's a punch on that microenvironment, that area around the tumor; and there's a punch on the cancer cells itself. And when you combine that with a toxic therapy, like a RAS inhibitor or chemotherapy, you get this double whammy and a better therapeutic outcome. We've shown that in many preclinical models. And now we're starting to see that data clinically.

BS: That helps a lot, because I think a lot of people have had experience with those kind of cancers, and why is it so hard to treat? Well, that's one of the reasons. And this breaks down that in a big way. I also note that you're moving the drug into research for ovarian cancer. Do you want to address that process, and why you decided to do that?

CB: I'll elaborate a little bit on that. Thanks, Brad. Because I think ovarian cancer has a lot of similarities to pancreatic cancer. Many of those cancers are highly fibrotic, so they have this scar tissue. But there's also a very, very clear association with the severity of the disease and the level of this FAK enzyme in ovarian cancer. It's elevated in ovarian cancer, and the levels of that enzyme increase as patients go through their therapy, clearly indicating that FAK is involved in resistance and, ultimately, unfortunately, cancer progression. We have preclinical data. There's a lot of data in the scientific literature showing that by inhibiting the FAK enzyme, you resensitize cells to chemotherapy, be it platinum-based chemotherapy that's widely used in ovarian cancer or, indeed, more traditional cytotoxic therapy. We've also shown that we resensitize ovarian cancer cells to PARP inhibitors, and that's now a major treatment for ovarian cancer.

What we're looking at in this particular study is combining our drug with chemotherapy for patients that are not responding to chemotherapy in first line. Unfortunately, a lot of patients in ovarian cancer will get chemotherapy before surgery. Most of those patients will go on to successful surgery, and then into maintenance with PARP inhibitors. Unfortunately, there's about 20% of patients who don't respond to that initial chemotherapy. And we believe, based on our preclinical data and all the scientific literature, that by adding the FAK inhibitor on top of the chemotherapy, we can improve the likelihood of response and therefore give those patients more chance of getting to surgery.

I should say, this is a small study being run here in Australia. But we're working with one of the best clinical trial not-for-profit groups associated with ovarian cancer. It's the Australia New Zealand Gynaecological Oncology Group. There's a Gynecologic Oncology Group in the US, GOG. We're working with the Australian version, and this is an investigator-sponsored study that they're running. We're supporting that, obviously, with supply of drug and additional financial support. But it's a project they're running. But we're really excited about it. We're not doing it ourselves. We can't do everything. We're only a small team here in Melbourne, Australia. Our team's primary focus is the pancreatic work and the work now that we're doing with Lilly. The ovarian work will be run out of ANZGOG. But we're excited about that opportunity. And we think, based on the science and based on the fact that there's another FAK inhibitor already approved from Verastem in ovarian cancer, that there's a real opportunity here that we want to explore.

BS: I understand that. And these groups like Lilly and the Australian gynecology group wanting to work with you shows, I think, a lot of confidence in what you guys are doing. But you brought it up, and investors are going to wonder, what is the financial picture? This costs a lot of money to bring things to the commercial stage and to do the testing. And people always wonder how much dilution is there going to be, how many shares are going to have to be offered? Are you going to go into debt? Just explain what the situation is and what it looks like over the next couple years as you go through these processes.

CB: Thanks, Brad. At the last quarterly financial update, we had AU$24 million in the bank. That money is being deployed on the first stage of the ACCENT registrational study that I spoke about, that we're running here in Australia. It's also supporting the Lilly collaboration. Both of those are now fully funded. We're finishing off the ACCENT study. We're doing all the regulatory work, engaging with the FDA. All that work's covered by existing funds. We do have discussions with some regional partners to look at some regional partnering opportunities. Those discussions continue. They would obviously bring in some money. But the reality is that running a pivotal study in pancreatic cancer is expensive and will take a number of years. We will be looking to raise money in due course. I can't say much more than that at this point in time, but we definitely have funding that gets us well into 2027 at the moment, and definitely supports the Lilly and the first part of the ACCENT clinical study that I've spoken about today.

BS: And I work with a lot of clinical-stage biotech companies. And being funded through next year, that's a pretty good stage. There's not a lot of companies that do that. Go ahead.

CB: Sorry, Brad. I just wanted to add, we've been running the development out of Australia. We're at the point where we are now, which is mid-stage clinical studies heading into Phase 3 studies, and we've done all that, based on US dollars, about US$50 million. We've run this program in a very lean way. We continue to do that. We've only got a small team of a dozen, literally 12 people, on our team, and we work with a fabulous group of collaborators and contractors. But we do run very lean and mean. And we'll be looking to continue that mindset as we take the drug into the pivotal studies.

BS: That's great to know that you're paying attention to that, and that helps get those studies further along with the same funds that you have. I'm going to finish with this overall broad question. This will let you talk about things that maybe I haven't mentioned that you want to talk about. Just think in the next two, three years, for investors that want to look at Amplia, and I encourage them to do that, what should they be looking for? If everything was executed well, what the next two or three years look like? And what would enhance investor value in the next couple years?

CB: As I said, our primary focus is in pancreatic cancer, and we continue to drive forward in that space. I think the key interactions with the FDA over the next six months are worth noting. And then as we prepare for that registrational study, which would start sometime in 2027, second half of 2027, we believe that study will start then. We'll have early data from the first part of that study that we're doing now. That's something to watch. And we strongly believe that there's an ongoing role of chemotherapy in the treatment of pancreatic cancer. I think all the data would indicate that chemotherapy is an integral part of the treatment landscape. Nevertheless, we're very conscious of what's happening with KRAS inhibitors. And we've started the work now with Lilly, looking at a combination with their KRAS inhibitor. But obviously, we're very interested in combinations with KRAS inhibitors in pancreatic cancer.

You look at companies like Revolution Medicines, like Erasca, and others, they've got very high market caps on the back of their exciting clinical data. We think that there's a real opportunity for Amplia to enhance the efficacy and prolong the duration of response to KRAS inhibitors. And a company like Tango Therapeutics is probably a good comparator because they have a drug that is being tested in combination with KRAS inhibitors in pancreatic cancer. Their drug works, maybe, on 30% of patients with pancreatic cancer. Our drug works regardless of the kind of genetic makeup of the pancreatic cancer. We think we can really ride that wave of enthusiasm and excitement around KRAS inhibitors, by combining with them, making them work better, and building out that data set. That's something that, I think, investors will want to be watching closely over the next 12 months. We're starting the Lilly collaboration. We're talking to other parties about combinations with KRAS inhibitors in pancreatic cancer. And hopefully, we'll have something we can announce in the shorter term about that.

BS: Excellent. I said that was the last question, but I have one more. I know that the FDA has certain programs that fast track some drugs, as they see good results and it's an urgent need. Is that something that you don't know, the FDA just tells you when they decide it? Or do you get a feeling about it? Is that a thing that's in the cards?

CB: We already have Fast Track designation from the FDA, which is great. We've got Orphan Drug designation as well, which gives us extended marketability, exclusive marketability of the drug. We're talking, also, to the European regulator about similar schemes in Europe. As we develop our data set, we'll go back to the FDA and look for additional pathways, Breakthrough designation or accelerated approvals. That's ongoing, obviously, as we generate clinical data. Yes. We're definitely thinking about those opportunities and those ways of moving the program faster to a point where we can actually get registration. That's something we're very active in. We're active in talking to pharma and biotech partners who we can work with to help progress the drug as well. Very much across those opportunities.

BS: I knew that you had those. I wanted to make sure investors knew that, because those can be very valuable to companies. And they don't give them out to everybody. Well, we're about at the end of time. I know that you have in front of you, I'm sure there's a lot of questions that have come in. You have about a minute or two. You can either choose to answer a couple of questions or just summarize what you want. It's your show right now.

CB: Thanks, Brad. I'll just finish up. There's a few questions coming in around the mechanism of the drug and how it will work in combination with KRAS inhibitors. Let me reiterate there that a KRAS inhibitor is a very powerful drug in treating cancers. And what we see is that when you block the KRAS signaling, cells often rewire. And when they rewire to get around that KRAS inhibitor, the signaling involves FAK. By blocking FAK and KRAS, you're getting a double hit on those cells. And that's data that we've got ourselves, we're really digging into that deeply. But it's data that other people have shown preclinically, and indeed, clinically. I think the rationale is very strong there. I can come back to individuals with answers to those questions. But I thank everyone for their interest. And thank you, Brad, for the questions today.

BS: Thank you. And thank everybody for listening. We appreciate it. And like you said, Chris is available for questions, and he'll get back to you, and for individual meetings if you're interested. Thank you very much for joining us.

CB: Thank you, Brad.

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Melisron: Initiation of Israel’s Leading Real Estate Operator

Thu, 17 Sep 2026 13:14:00 -0400

By Tom Kerr, CFA

TASE: MLSR.TA

READ THE FULL MLSR.TA RESEARCH REPORT

Melisron (TASE: MLSR.TA) is Israel's largest mall owner/operator with a NIS 25.8 billion income-producing portfolio spanning malls, offices, and residential development across 909 thousand sqm. Total managed area is 1,067,000 sqm, and total managed asset value is ~NIS 29.6 bn. The company has multiple projects under development which are expected to boost growth in the mid-to-long term. The newer residential segment has over 13,000 units in the pipeline, of which 5,400 are expected to be constructed in the near term. The residential segment pipeline has the potential to produce over NIS 17 billion in revenues and approximately NIS 2.7 billion in operating income. We expect continued growth in NOI and FFO.

The company has a diversified portfolio spanning retail, offices, hi-tech parks, residential development, and single-tenant properties, which provides exposure to multiple segments of Israel’s commercial and residential real estate markets. Melisron is controlled by Liora Ofer through Ofer Investments.

The company’s core portfolio comprises 18 Ofer-branded malls and shopping centers located in high-quality, high-traffic locations nationwide. Key retail assets include Ofer Ramat Aviv, Kiryon, Ofer Grand Mall Haifa, Ofer Grand Mall Be’er Sheva, Ofer Grand Mall Petah Tikva, and Ofer Rehovot. The retail portfolio represents Melisron’s primary operating platform and provides a significant base of recurring rental income.

Melisron also owns six major office and hi-tech properties, including Ofer East and Ofer West in Petah Tikva, Ofer Carmel, Ofer Yokne’am, Ofer Millennium Buildings, and Landmark in Tel Aviv’s Sarona district, a flagship mixed-use development jointly owned with AFI Properties. The office portfolio provides further diversification and exposure to Israel’s technology and business-services sectors.

Residential real estate represents a growing component of the platform through Aviv Melisron, which focuses on residential construction and urban renewal in high-demand Israeli markets. The business has dozens of projects under development encompassing thousands of housing units, with a strategy centered on mixed-use developments that combine residential and commercial components.

Valuation

We use multiple valuation methodologies to arrive at a valuation and price target.

Our DCF calculation projects modest organic, or same-store, growth, but adds the value of future projects over a 6–7-year period. Future project growth is driven primarily by the residential segment as discussed above. Using the current cap rate of 6.7% as the discount rate provided a valuation of NIS 51,500 cents per share.

We also use an after-tax NOI / Cap Rate calculation based on future projections of NOI.

The current 6.8% cap rate may still be reflecting a relatively high Israeli interest-rate and geopolitical risk premium, while the underlying environment is already moving in the opposite direction. We believe a case can be made that cap rates should be lower, perhaps around 6.0%.

A reasonable case can be made for Israeli real-estate cap rates to decline from approximately 6.8% toward 6.0% as interest rates normalize. The Bank of Israel has already reduced its policy rate to 3.25% and forecasts an average rate of approximately 3.0% in 2Q27, while inflation is expected to remain below 2%. Israeli 10-year government yields have also declined to approximately 3.65%. Against this backdrop, a 6.8% capitalization rate implies a spread of more than 300 bps over the risk-free rate, which appears increasingly conservative for high-quality, well-occupied commercial properties. The spread is even larger when you take into consideration the real cap rate to the nominal 10-year rate, which would imply a spread of approximately 480bps.

Melisron's own 2025 disclosures indicate actual NOI yields of approximately 6.6% on malls and 6.0% on offices, suggesting that a 6.0% stabilized cap rate is achievable for its highest-quality assets.

A reduction in the portfolio capitalization rate from 6.8% to 6.0% would increase property values by approximately 13%, before accounting for NOI growth. With Israeli economic growth expected to accelerate and interest rates continuing to normalize, further cap-rate compression represents a material potential source of NAV upside for Melisron and other leading Israeli real-estate companies.

Therefore, a cap rate of 6.0% on estimated 2027 NOI estimates would create a value of NIS 25,240,400 or NIS 52,964 cents per share.

In addition, if we apply the new estimated cap rate of 6.0% to our DCF model, the valuation increases to NIS 62,583 cents per share.

We take a conservative approach and average all 3 rates, which creates a price target of NIS 55,680 cents per share.

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LGVN Posts Disappointing Trial Results

Thu, 17 Sep 2026 11:14:00 -0400

By Brad Sorensen, CFA

NASDAQ: LGVN

READ THE FULL LGVN RESEARCH REPORT

Longeveron’s (NASDAQ: LGVN) September 16 announcement represents an important turning point for the company. The Phase 2b ELPIS II trial of laromestrocel in hypoplastic left heart syndrome, or HLHS, failed to meet its primary efficacy endpoint, a result that understandably caused a sharp reset in investor expectations. The primary endpoint measured the change in right ventricular ejection fraction at 12 months, and the difference between laromestrocel and the control group was essentially nonexistent: negative 0.7 percentage points, with a p-value of 0.8336. That is not a near miss and should not be portrayed as one. On the trial’s prespecified primary efficacy measure, ELPIS II was unsuccessful.

That said, the announcement contained considerably more information than the headline suggests, and we believe it leaves Longeveron with potentially valuable assets and strategic options.

Longeveron is developing laromestrocel, formerly known as Lomecel-B, a proprietary allogeneic mesenchymal stem cell therapy derived from the bone marrow of young healthy adult donors. The underlying idea is that these cells may exert anti-inflammatory, vascular, regenerative and tissue-repair effects rather than simply replacing damaged tissue. Longeveron has been attempting to leverage that biology across several diseases, creating what management has previously described as a “pipeline-in-a-product” strategy. Its current programs include HLHS, Alzheimer’s disease, pediatric dilated cardiomyopathy and Aging-related Frailty.

Until yesterday, HLHS was the company’s most advanced and arguably most important near-term value driver. That makes the ELPIS II failure significant. Investors should assume that the probability of a straightforward near-term regulatory filing for HLHS has declined materially, with the company noting it has a meeting scheduled with the FDA to discuss paths forward.

However, it would also be premature to conclude that the HLHS program has no remaining value.

ELPIS II enrolled only 40 infants, an unavoidable challenge in studying an extremely rare pediatric disease. Although the primary endpoint failed, several exploratory clinical observations moved numerically in favor of laromestrocel. During the first 12 months, there were no deaths among treated patients compared with one death in the control group. During longer-term follow-up of as much as five years, there was one transplant-free survival event among 17 laromestrocel-treated patients compared with two among 21 control patients. Most interestingly, adjudicated Major Adverse Cardiovascular Events (MACE) totaled 12 in the treated group versus 19 in the untreated group, approximately 31% fewer events.

Those findings should be interpreted carefully. The MACE analysis was not statistically significant, hospitalization burden was similar between the groups, and exploratory endpoints cannot retroactively turn a failed primary endpoint into a successful trial. Nevertheless, reducing major cardiovascular complications, transplantation or mortality would arguably matter considerably more to families and physicians than improving an imaging measurement if such an effect could eventually be demonstrated conclusively. That distinction may become central to Longeveron’s discussions with the FDA mentioned above.

The safety findings are also worth emphasizing. No new safety signals emerged, and investigators did not attribute any treatment-emergent adverse events or serious adverse events to laromestrocel. Across Longeveron’s clinical programs, approximately 644 participants have now received the therapy. For a cellular treatment platform intended for use in very vulnerable populations, including infants and elderly patients, an expanding safety database is an important asset.

We believe the broader investment argument is still interesting when attention shifts away from HLHS.

Longeveron has generated some of its strongest clinical evidence in Aging-related Frailty. Earlier this year, Phase 2b results published in Cell Stem Cell showed that intravenous laromestrocel improved physical function compared with placebo. At nine months, the treatment produced a 63.4-meter improvement relative to placebo in the six-minute walk test, with a p-value of 0.0077. This was not merely a numerical trend; it was a statistically significant result on a clinically understandable functional endpoint.

That research subsequently helped Longeveron become one of the finalists in the XPRIZE Healthspan competition, selected from more than 600 applicants. The company received a $1 million Milestone 2 award and remains eligible to compete for a grand prize of as much as $81 million, although reaching that stage requires successful completion and financing of the competition's required clinical trial.

Longeveron has also already completed Phase 1 and Phase 2 work in Alzheimer’s disease and has received both RMAT and Fast Track designations from the FDA for that program. Importantly, the company previously aligned with the FDA regarding the design of a potential Phase 3 trial. Data presented this summer also suggested that laromestrocel may reduce neuroinflammation in key areas of the brain, adding biological support to the clinical program.

The challenge is financial. A Phase 3 Alzheimer’s trial is well beyond what Longeveron can realistically finance independently at its present size. Management has been seeking strategic partners and non-dilutive funding for that program.

This brings us to what may now be the most important portion of yesterday’s announcement: Longeveron has begun a formal review of alternatives designed to maximize shareholder value and intends to engage an investment bank as strategic advisor. The company is simultaneously implementing cash-conservation measures.

Longeveron possesses more than a single failed clinical trial. It owns a cell-therapy platform with human clinical data across several indications, a growing safety database, FDA regulatory designations, intellectual property, manufacturing know-how and published clinical research. The Alzheimer’s program has RMAT and Fast Track status, while the HLHS program has historically carried Orphan Drug, Fast Track and Rare Pediatric Disease designations. Across its development programs, laromestrocel has received five FDA designations.

These assets could potentially be worth more to a larger biotechnology or pharmaceutical company with the capital necessary to conduct late-stage trials than they are inside a small company attempting to finance several programs simultaneously.

In our view, without a partnership, asset monetization or additional financing, Longeveron would face additional capital requirements. That creates dilution risk for existing shareholders and represents arguably the most significant near-term financial risk following the ELPIS II result.

The investment case for LGVN has consequently changed substantially.

Before ELPIS II, the story centered heavily on the possibility that positive Phase 2b HLHS data could support a relatively direct regulatory path toward commercialization. That scenario is no longer the base case. In our view, LGVN is now better viewed as a deeply discounted biotechnology platform with several pieces of clinical and regulatory optionality.

Laromestrocel has demonstrated a broad safety profile in hundreds of patients. Aging-related Frailty has produced statistically significant Phase 2b functional data and external validation through publication and the XPRIZE competition. The Alzheimer’s program has FDA RMAT and Fast Track designations and a potential Phase 3 pathway. HLHS itself may still have some value if the exploratory cardiovascular outcomes generate sufficient regulatory interest to justify another development strategy.

The risks, however, are substantial. The company remains a clinical-stage biotechnology business with minimal commercial revenue. ELPIS II failed its primary endpoint. The exploratory cardiovascular findings were not statistically significant. The company will need more capital unless a strategic transaction or meaningful non-dilutive funding occurs. Additional equity financing could materially dilute current shareholders. There is also no guarantee that the FDA will identify a practical path forward in HLHS or that a pharmaceutical partner will emerge for Aging-related Frailty or Alzheimer’s disease. For that reason, we believe LGVN today is a substantially more speculative investment than it appeared immediately before the ELPIS II readout and have reduced the valuation of LGVN as a result.

This announcement does not necessarily mean that Longeveron’s underlying technology has failed. It means that laromestrocel failed to improve one specific cardiac-function endpoint in one small trial in one exceptionally difficult pediatric disease. Other clinical programs have generated different outcomes, including statistically significant results in Aging-related Frailty.

The next several developments may therefore be unusually important. Investors should watch for the FDA’s reaction to the complete ELPIS II dataset, additional analyses of cardiovascular events and survival, details of Longeveron’s cost reductions, progress in the XPRIZE Healthspan program, advancement or partnering of the Alzheimer’s program, and—perhaps most importantly—the outcome of the newly announced strategic review. The risks of investing in LGVN have increased, but we believe the opportunity for shares to gain value in a meaningful way also exists.

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HITI: High Tide Strong Growth Profile Supports Price Target of US$5.00

Wed, 16 Sep 2026 09:14:00 -0400

By Tom Kerr, CFA

NASDAQ: HITI

READ THE FULL HITI RESEARCH REPORT

3rd Quarter Results (period ending July 31, 2026)

On September 14, 2026, High Tide (NASDAQ: HITI) released fiscal 3^rd quarter results, which set company records at almost all levels. Both business segments appear to be firing on all cylinders.

Revenue reached a record $198.8 million in the 3^rd quarter, increasing 33% year-over-year and 11% sequentially, marking the fifth consecutive quarterly revenue record. Gross profit increased 32% year-over-year to a record $52.7 million, while gross margin remained stable at 27%.

Adjusted EBITDA rose 53% year-over-year and 17% sequentially to a record $16.2 million, with EBITDA margin reaching 8.2%, its highest level in 12 quarters. Operating income also hit a record $8.7 million, up 133% year-over-year and 43% sequentially, while net income reached a record $12.7 million versus $0.8 million a year ago.

The company continued to improve operating efficiency, with G&A expenses declining to 3.9% of revenue from 4.4% a year ago, and salaries, wages, and benefits falling to 11.4% from 12.2%. Revenue and adjusted EBITDA growth also significantly outpaced share-count dilution, growing 2.5x and 3.9x faster than the average basic share count, respectively.

Cash flow from operations before working-capital changes reached a record $11.9 million, up 44% year-over-year and 36% sequentially. Free cash flow was $7.0 million, an increase from $1.5 million sequentially, despite an additional $4.2 million investment in working capital to support growth.

Cash and restricted cash totaled $47.1 million as of July 31, 2026, up from $36.5 million sequentially but below $63.8 million a year earlier. Net working capital was $48.4 million, and the current ratio was 1.5x. The company has $25 million in availability on its new Bank of Montreal credit line.

Segment & Operational Review – Retail

Canna Cabana remains Canada’s largest cannabis retail chain with 232 locations and a 14% market share (excluding British Columbia), up from 13% a year ago. Cabana Club membership surpassed 2.73 million, up 27% year-over-year, while ELITE membership increased 62% to more than 186,000. We believe the average Canna Cabana store generates 1.8x the revenue of its peers.

3^rd quarter same-store sales were roughly flat year-over-year, although sales turned positive in June and July, while same-store transaction volume increased 1.1%. Since launching its discount club model in 2021, Canna Cabana’s same-store sales have risen 171%, compared with a 1% decline for the average operator. Over the 12 months through June 2026, industry sales in its five provinces grew 3%, versus 10% growth for Canna Cabana.

Operational performance also remained strong, with shrink at just 0.2%. Excluding newer stores still ramping, annualized sales reached $1,721 per square foot, highlighting Canna Cabana’s strong store productivity and positioning it among leading international retailers.

Segment & Operational Review – Medical Cannabis

Remexian delivered record performance in the 3^rd quarter, distributing 10.2 tonnes of medical cannabis into Germany, up 62% year-over-year and 35% sequentially. Revenue reached a record $38.2 million, up from $31.6 million in Q2, with a 26% gross margin.

Valuation

We are maintaining our DCF derived price target of US$5.00 per share, which still represents meaningful upside from current price levels. While many cannabis stocks do tend to move together in response to major industry-wide catalysts (such as rescheduling), we believe there can be major divergence in specific companies based on specific fundamentals. High Tide is likely one of those positive outliers due to a potential recovery of Canadian same-store sales growth to normal levels, successful new store openings, continued margin improvement, and a successful expansion into European markets.

We also look at peer multiples to provide a secondary valuation methodology. Although it’s difficult to find exact comparisons due to a variety of business models, country location, and financial data, we believe a set of cannabis related stocks are trading at an EV/EBITDA ratio of approximately 8.5x currently.

With HITI trading at only approximately 5.5x annualized run-rate EBITDA, there appears to be material upside from a peer perspective.

In addition, Canadian-based Organigram Global recently acquired Germany-based Sanity Group, a competitor to Remexian. The Sanity Group acquisition is roughly the same size as High Tide’s purchase of Remexian in terms of revenue (Remexian is more profitable), but Organigram is paying substantially higher multiples than High Tide did (believed to be over 12x). This demonstrates High Tide’s European business is truly an undervalued and unrecognized asset.

Summary and Outlook

Physical Retail

Canna Cabana is the largest cannabis retail chain in Canada with 232 locations. Canna Cabana also owns and operates a location in Berlin, Germany, selling consumption accessories. The company reiterates its long-term goal of surpassing 350 locations across Canada and opening over 20 locations in calendar 2026, mostly through organic growth, while also evaluating tuck-in acquisitions of various sizes.

White Label Initiatives

High Tide continues to expand its white label cannabis product portfolio under its flagship Queen of Bud and Cabana Cannabis brands, increasing SKUs from 41 to 48 compared to Q2. The company is also developing several new offerings to further develop its white label portfolio. Currently, white label cannabis SKUs represent approximately 1.9% of physical retail cannabis sales. Over the long term, the company anticipates significant growth in its white label portfolio.

Cabana Club & ELITE

The Cabana Club and ELITE loyalty programs remain the largest cannabis loyalty programs in the world and continue to expand at a rapid pace across Canada. Cabana Club membership has now surpassed 2.73 million members in Canada, which is up 27% in the past year. Over the long term, the company anticipates exceeding 3 million Cabana Club members in Canada. ELITE, the paid membership tier, now exceeds 186,000 members in Canada after growing by 62% compared to last year, with additional members being onboarded daily.

Europe

High Tide’s German medical cannabis subsidiary, Remexian Pharma GmbH, has continued to gain momentum since the company acquired a majority stake, with market share rising from 6.5% to 10.5% in the first six months post-transaction. While industry data is unavailable, Remexian’s shipments have increased 44% since the three months ended March 31, 2026. Management believes Remexian is well positioned to sustain and potentially expand its German market share, supported by strong Canadian supply relationships and continued growth in Germany’s medical cannabis sector. Record Q3 distribution volumes further demonstrate this momentum and, assuming the regulatory framework remains largely unchanged, could signal the business’s growth potential in coming quarters. The company is also evaluating opportunities in other European markets while remaining strategic about expansion to maximize shareholder value. The company disclosed it has been having conversations with operators in the U.K.

United States

The company's conviction in the long-term opportunity for its U.S. hemp-derived CBD subsidiaries continues to be reinforced by evolving federal policy. As a founding member of the U.S. National Compassionate Care Council, the company and NuLeaf Naturals remain focused on shaping medical cannabis policy and expanding access to cannabinoid therapies. Federal reform accelerated on April 23, 2026, when the DOJ and DEA moved FDA-approved cannabis drugs and state-licensed medical marijuana from Schedule I to Schedule III, marking the most significant shift in U.S. federal cannabis regulation in decades. The DEA subsequently held a June 29–July 15 hearing to consider broader cannabis rescheduling.

Broader rescheduling, if implemented, could significantly impact the U.S. cannabis industry and the listing policies of major North American exchanges. High Tide is assessing whether it could enable exchange-listed companies to enter the U.S. state-legal adult-use market while maintaining their listings. The company has engaged Nasdaq and the TSX Venture Exchange regarding potential policy changes and continues to explore U.S. adult-use opportunities with multiple counterparties.

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PBSV Changes Proving to be Beneficial to Business

Tue, 15 Sep 2026 11:09:00 -0400

By Brad Sorensen, CFA

OTCQB: PBSV

READ THE FULL PBSV RESEARCH REPORT

Pharma-Bio Serv, Inc. (OTCQB: PBSV) is beginning to show the benefits of the operational changes management has been implementing over the past several quarters. The company’s fiscal third-quarter results provide additional evidence that the strategy of concentrating resources on higher-value markets, improving operating efficiency, and controlling overhead is beginning to translate into better financial performance.

Pharma-Bio Serv is a specialized consulting company serving highly regulated industries, particularly pharmaceutical and biotechnology manufacturers. The company provides regulatory compliance, quality assurance, validation, technology transfer, engineering, project management, and process-support services. Its core competency is helping clients comply with requirements imposed by the FDA and international regulatory agencies. PBSV also works with companies in the medical-device, chemical, cosmetics, and food industries.

That specialization is important. Compliance work in pharmaceutical and biotechnology manufacturing is generally not discretionary in the same way as many conventional consulting projects. Manufacturers operating FDA-regulated facilities must continually demonstrate that their processes, equipment, documentation, and quality systems meet increasingly demanding regulatory standards. PBSV brings experienced engineering, life-science and quality-assurance professionals into these environments, allowing customers to supplement their internal teams with specialized expertise.

The company operates primarily in Puerto Rico, the continental United States, and Europe, with a smaller presence in Brazil and other markets. Puerto Rico remains particularly important because of the island's substantial pharmaceutical manufacturing base, while PBSV has increasingly sought opportunities in Europe and other markets where it believes its capabilities can generate attractive margins.

The latest results suggest that this strategy is gaining traction.

For the fiscal third quarter ended July 31, 2026, revenue increased to approximately $2.34 million from $1.96 million a year earlier, representing growth of roughly 19%. Importantly, the growth was geographically diversified. Revenue increased by approximately $200,000 in Puerto Rico, $100,000 in the United States, and $100,000 in Europe compared with the prior-year quarter.

The improvement becomes even more meaningful to us when viewed against the company's recent history. PBSV spent much of fiscal 2025 rationalizing its service portfolio, reducing expenses and concentrating resources on markets and customers where it believed it could generate stronger returns. The current quarter increasingly looks like evidence that those actions are working.

Gross profit increased to approximately $692,000 from $574,000 in the year-earlier quarter. Gross margin also improved modestly, from 29.2% to 29.6%. While the percentage-point increase appears small, the combination of higher revenue and stable-to-improving margins suggests PBSV is not sacrificing profitability simply to generate additional sales.

Perhaps the most encouraging development, however, is occurring further down the income statement.

Selling, general and administrative expenses fell to approximately $764,000 during the quarter, compared with approximately $888,000 a year earlier. For the first nine months of fiscal 2026, SG&A declined to approximately $2.34 million from $2.67 million. Management attributed much of the reduction to lower occupancy costs and other planned administrative savings.

We believe that combination—revenue growth alongside lower overhead—is particularly attractive for a consulting business. Because PBSV has already built much of the administrative infrastructure needed to support its operations, incremental revenue has the potential to produce increasingly meaningful operating leverage if management can continue keeping expenses under control.

PBSV reported a third-quarter net loss of just $14,219, compared with a loss of approximately $204,000 in the comparable quarter last year. Effectively, the company came very close to quarterly break-even while improving earnings by approximately $190,000 year over year.

The nine-month comparison is even more impressive. Revenue increased to approximately $7.33 million from $6.85 million, a gain of roughly 7%. PBSV generated net income of approximately $252,000, or $0.011 per diluted share, compared with a net loss of approximately $100,000, or $0.004 per share, during the same period last year. That represents a roughly $352,000 year-over-year improvement in earnings.

In other words, relatively modest revenue growth has produced a disproportionately large improvement in profitability. That is exactly the type of operating leverage we believed we would see following the restructuring and cost-rationalization program.

CEO Victor Sanchez emphasized this point in discussing the quarter, saying the results demonstrate the strength of PBSV's customer relationships and specialized regulatory and compliance capabilities. Management specifically credited its sharper focus on markets where PBSV believes it has a competitive advantage, together with improved operating efficiency, for the improvement in financial results. Sanchez also expressed confidence that the company can carry the momentum into the fiscal fourth quarter.

There are also signs that the improvement is not confined to one geographic market. For the first nine months of fiscal 2026, Puerto Rico revenue increased by approximately $500,000 and European revenue increased by approximately $100,000, partially offset by about a $100,000 decline in U.S. consulting revenue. The geographic diversification gives PBSV multiple avenues for growth rather than leaving the company dependent entirely on conditions in one market.

Another element of the PBSV investment story that deserves considerably more attention is the balance sheet.

As of July 31, the company held approximately $1.52 million in cash and cash equivalents and another $7.06 million in marketable securities, primarily short-term U.S. Treasury securities. That gives PBSV approximately $8.6 million of combined cash and marketable securities. Total liabilities were only approximately $1.0 million, while working capital stood at roughly $10.2 million.

For a company generating roughly $9 million to $10 million of annual revenue, this is a substantial liquidity position and provides an unusually strong financial cushion. Management stated that its working capital, operations, cash flows, and high-quality receivables should be sufficient to fund expected expenses and contractual obligations for at least the next twelve months and beyond.

The strength of that balance sheet has already allowed management to return capital directly to shareholders. Earlier this year, PBSV paid a special cash dividend of $0.075 per share, distributing approximately $1.72 million to investors. Remarkably, the company retained its strong liquidity position even after making that payment.

This capital-allocation history is an important component of our positive view of the company. PBSV is not a heavily leveraged small company that must continually access the capital markets to finance operations. Instead, it carries a sizable pool of liquid assets relative to the size of the business and has demonstrated a willingness to return excess capital to shareholders through dividends and share repurchases.

To summarize, third-quarter revenue rose nearly 19%, gross profit increased, administrative expenses declined substantially, and the quarterly loss was reduced from more than $200,000 to essentially break-even. On a nine-month basis, PBSV has already moved from a $100,000 loss last year to approximately $252,000 of net income this year. Meanwhile, the company continues to hold approximately $8.6 million in cash and Treasury securities and more than $10 million of working capital.

To us, PBSV appears to be entering a more interesting and compelling phase of its turnaround. The latest quarter does not represent explosive growth, and the company remains small, but the direction of the numbers is increasingly favorable: revenue is growing, margins are holding, overhead is declining, profitability has improved dramatically, and the balance sheet remains exceptionally strong relative to the scale of the business. For a micro-cap investor, that combination can be attractive, and we urge investors to take a good look at PBSV.

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ATNM: Initiating Coverage – Diversified Nuclear Medicine Portfolio

Tue, 15 Sep 2026 09:08:00 -0400

By John Vandermosten, CFA

NYSE: ATNM

READ THE FULL ATNM RESEARCH REPORT

We are initiating coverage of Actinium Pharmaceuticals, Inc. (NYSE: ATNM) and assign a valuation of $4.00 per share. This valuation is based on our estimates for successful development, approval, and commercialization of ATNM-400 in solid tumors, Actimab-A, Iomab-ACT, and Iomab-B in acute myeloid leukemia (AML), solid tumors, and conditioning regimens in the United States and developed world. Actinium is a clinical-stage biopharmaceutical company developing radiopharmaceuticals for both therapeutic and conditioning applications in multiple areas.

Actinium is developing a pipeline of therapeutic and conditioning assets pursuing important indications in oncology and gene therapy. This includes targets in solid tumors for its preclinical ATNM-400 program and cell surface protein targets CD33, CD45, and CD38 in other areas. In alignment with its name, Actinium’s warhead portfolio includes Ac-225; however, it employs other radioisotopes, including Iodine-131 for its conditioning candidates and Lutetium-177 in preclinical work. Combination therapies are another area of interest for Actinium, where it is working with checkpoint, FLT3, and menin inhibitors.

Actinium’s primary focus is on ATNM-400, which is being developed for an undisclosed target expressed in prostate, lung and breast cancer. The radioconjugate’s target is prolific in these tumors and is scarce on non-cancerous cells compared with the prevalence of prostate-specific membrane antigen (PSMA). Actinium’s recent presentations suggest that ATNM-400 should be more effective in micrometastases compared with alternatives. The company has presented posters at leading oncology conferences characterizing the candidate’s activity in several solid tumor settings. It is positioning ATNM-400 to be the next generation of therapy in prostate cancer, leveraging the effective emissions profile of Ac-225. Actinium is also developing other preclinical assets in relapsed/refractory (r/r) AML using its Actimab-A combinations and theranostic applications in solid tumors.

Actinium’s most advanced candidate is Iomab-B, which has been evaluated in a Phase III trial. It is a CD45-directed monoclonal antibody called apamistamab conjugated to Iodine-131. The candidate was evaluated as a targeted conditioning agent in hematopoietic stem cell transplantation (HSCT) for older patients with r/r AML. While the Phase III trial results were positive, the FDA changed its requirements for accepting the biologic license application (BLA) prior to evaluation and did not accept it. The program is on hold pending partner identification. A derivative of Iomab-B called Iomab-ACT, which has the same construct, is designed to deliver nonmyeloablative or lymphodepleting conditioning prior to CAR‑T or gene therapy. These indications are in early-stage clinical trials.

Actimab-A is Actinium’s hematology franchise and is being investigated in multiple AML indications. The company has advanced the Actimab-A candidates in clinical trials and is seeking to collaborate. These programs are supported by a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute, which enables cost-effective clinical development with commercial rights retained by Actinium. Actimab-A is a targeted α‑particle radiotherapeutic composed of a humanized anti-CD33 monoclonal antibody, called lintuzumab, conjugated to Actinium‑225. The most clinically advanced Actimab-A program is pursuing r/r AML with a combination approach including CLAG-M and is preparing for a Phase II/III study. The radiotherapeutic is also being evaluated in combination therapy with venetoclax and a menin inhibitor among other agents. The other important Actimab-A program targets myeloid-derived suppressor cells (MDSCs) in combination with checkpoint inhibitors. Eradicating CD33+ MDSCs may overcome resistance to immunotherapy and help checkpoint inhibitors work better.

Ac-225 is more difficult to source compared with other isotopes, such as industry workhorses like Lutetium-177. Nevertheless, Ac-225 is an attractive alternative that combines high-energy α-particles with an optimal half-life to treat resistant cancers. Furthermore, Actinium is developing a new process to more efficiently manufacture Ac-225, which can reduce its cost by a factor of 10 or more. The related facility should be operational by 2H:26. Ac-225’s α particles emit substantial energy over a short distance, generating lethal double-strand breaks in DNA compared with β-emissions that transmit less energy over a wider field. Ac-225’s decay mechanism releases four α particles, delivering a lethal dose to tumor tissue. Ac-225 can be chelated to a targeting vector such as a monoclonal antibody, allowing it to be precisely delivered. Its half-life of ten days balances ease of distribution with patient radiation exposure.

Based on the candidates' status, management intent and capital resources, our valuation captures ATNM-400 in solid tumors, Iomab-ACT, Actimab-A and Iomab-B in AML and conditioning. We expect both Actimab-A and Iomab-B to be advanced with partners, who will carry the programs through regulatory approval and commercialization. In return, Actinium is expected to receive customary upfront payments, milestones and royalties. To simplify, our approach estimates a royalty rate that will represent all components of value received.

Radiopharmaceuticals are essential tools for diagnostic, therapeutic, and conditioning applications across multiple disease states. In oncology, these agents enable early cancer detection, tumor localization, and precise metastasis staging. Beyond diagnostics and direct cancer therapy, radiopharmaceuticals play a critical role in targeted conditioning regimens, such as myeloablation and lymphodepletion, to safely prepare patients for bone marrow transplants and other cellular therapies.

Key reasons to own Actinium Pharmaceuticals shares:

Diverse radiopharmaceutical pipeline with multiple indications under development
- ATNM-400 for multiple solid tumor targets (prostate, lung & breast)
- Actimab-A to resensitize the immune system by depleting MDSCs in solid tumors
- Iomab-ACT conditioning directed against CD45 for gene therapy and CAR-T
  - Achieves selective lymphodepletion at lower doses
  - Preserves hematopoietic recovery
- Late stage partnering opportunities
  - Actimab-A + CLAG-M in AML
  - Iomab-B in AML directed against CD45 for bone marrow transplant conditioning
    - Offers improved access and outcomes
    - Reduced toxicity compared with standard-of-care
  - Pipeline of in-development clinical assets
    - Combination therapies with PD-1 inhibitors
    - Undisclosed targets and theranostics
  - $36 million cash position supporting operations into 2028
  - No debt, material warrants or preferred issues on the balance sheet

The initiation report introduces radiopharmaceuticals to investors, defining the industry and discussing the different types of radiation and particles involved. We start with a brief history, then describe the conditioning and therapeutic categories, including details regarding the important subcategories of the therapeutic modality. Radiopharmaceuticals require advanced logistics, management, and care compared to other biopharmaceutical offerings. We describe the framework behind their regulation, transportation, and disposal. The report provides an industry review tracing the recent commercial history of the drug class, including new company formation and merger and acquisition activity.

The next section examines Actinium’s primary end markets. Products and pipeline are next, as we review the firm’s assets. Peers and competitors are reviewed, including a summary of their industry focus. We list historical milestones and background on Actinium, followed by a summary of recent financial performance. Key members of senior management are introduced, and risks related to life sciences companies in general and for Actinium specifically are discussed. The report concludes with valuation work and a presentation of our model’s assumptions. The target price relies on a discounted cash flow (DCF) model that estimates contributions from ATNM-400, Iomab-ACT, Actimab-A and Iomab-B in both the U.S. and developed countries. We initiate on Actinium Pharmaceuticals, Inc. with a valuation of $4.00 per share.

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DFNS: T3 Defense Reports 2nd Quarter 2026 Financial Results

Mon, 14 Sep 2026 17:05:00 -0400

By Tom Kerr, CFA

NASDAQ: DFNS

READ THE FULL DFNS RESEARCH REPORT

2nd Quarter 2026 Financial Results

On August 17, 2026, T3 Defense (NASDAQ: DFNS) filed its 10-Q for the period ending 6/30/26. For the quarter, revenues increased to $4.0 million, compared with no revenue in the prior year period. Gross profit was $1.0 million, which was a 25.4% gross margin, which was above our expectations. We believe that most of the company’s subsidiaries are profitable on an individual basis.

Operating expenses increased to $4.4 million, compared with $1.0 million in the year-ago period. The increase was primarily driven by $3.6 million in G&A expenses, with additional spending of $348,000 on R&D and $184,000 on sales and marketing.

Despite generating gross profit, the company reported a net loss of ($81.4) million, compared with net income of $3.0 million in the prior-year quarter. The significant loss was driven primarily by an $81.0 million loss from the change in fair value of stock purchase warrant liabilities, resulting in a net loss attributable to shareholders of ($82.5) million.

As of June 30, 2026, the Company had $21.2 million in current assets, including $4.1 million of cash and cash equivalents. Based on management’s current expectations, approximately $5.0 million will be required to fund operations over the next 12 months.

The company had negative working capital of approximately $131 million as of June 30, 2026, which was primarily driven by approximately $124 million of stock purchase warrant liabilities that do not require cash settlement.

Valuation

We believe T3 Defense can generate double-digit revenue growth over the next 10 years through organic growth and accretive acquisitions. We believe gross margins can reach the mid-to-high 30% range and, over the long term, approach 40%. Typically, Israeli defense companies have higher-than-industry-average gross margins due to a greater emphasis on software, sensors, and simulation technology rather than large-scale platform manufacturing. We believe EBITDA margins will be slightly positive in 2027 and grow significantly thereafter.

Our primary valuation tool utilizes a Discounted Cash Flow process. Under the scenario described above, we arrive at a target valuation of $100.00 per share. Our target price may be conservative as it incorporates a high discount rate of 12.5% due to the unpredictability of earnings, prevailing interest rates, and the timeline for reaching its margin goals on an annual basis. Also, this price target is based on the current portfolio of companies and does not take into account future acquisitions.

We also use forward price/sales multiples to validate our target price. The average 2027 price/sales multiple for small-cap & mid-cap defense companies based on 2027 revenue estimates is approximately 3.5x. That would provide a valuation in the range of $60.00-$70.00 per share for DFNS based on our 2027 revenue estimates.

We believe the company will reach cash flow breakeven at some point in calendar year 2027 and may not require additional funding to execute on its growth plans. However, it’s possible the company could access the capital markets to make important acquisitions.

The current market cap of only $15 million appears to be irrational and more reflective of the ongoing microcap stock malaise as opposed to company fundamentals.

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VNRX: VolitionRx Prepays Outstanding Balance on the $7,500,000 Lind Senior Secured Convertible Promissory Note Dated May 20, 2025. Review of Papers, Posters, and Videos Released in Mid-2026. Sysmex Collaboration is the 3rd Recent Agreement in the Human Space.

Mon, 14 Sep 2026 16:17:00 -0400

By Steven Ralston, CFA

NYSE: VNRX

READ THE FULL VNRX RESEARCH REPORT

EXECUTIVE OVERVIEW

VolitionRx Limited (NYSE: VNRX) continues to advance its multi-pillar epigenetics platform through mid-2026, generating a continued stream of clinical validation across Nu.Q NETs, Nu.Q Cancer, and Capture-Seq. Management has simultaneously decreased operating expenses, which were reduced in the most recent quarter by 32% year-over-year on a 25%-27% reduction in headcount in the R&D and sales & marketing areas. Another commercial partner was added through a collaboration agreement with Sysmex Corporation (TYO: 6869, OTCPK: SSMXY) in June, joining existing relationships with Werfen (antiphospholipid syndrome), Hologic (Nu.Q Discover co-marketing) and Revvity (formerly PerkinElmer), whose automated platform underpins Volition's CE-marked Nu.Q NETs test in Europe. Management indicates that active discussions continue with more than a dozen additional diagnostics and liquid biopsy companies across its three main technology pillars.

Significant Progress with Point-of-Care Breakthroughs, primarily for Sepsis: In July, clinical evaluations of the Nu.Q NETs lateral flow test for whole venous blood samples were shown to be strongly correlated with those processed in an automated central laboratory. Then, in the next month, August, a finger-prick point-of-care test using capillary blood samples was also determined to be highly correlated with the Nu.Q NETs test processed through a centralized laboratory, enabling the rapid receipt of results (minutes instead of hours) that could support quicker therapeutic decision-making.

Sepsis Clinical Trial in France: The French government-sponsored DETECSEPS study is scheduled to launch in the fall of 2026. The study will prospectively triage and risk-stratify patients at risk of deterioration and progression to sepsis. The study will be using Nu.Q NETs as the sole biomarker for real-world early sepsis detection.

A Mayo Clinic collaboration in a clinical study extended Nu.Q NETs into trauma care, a new clinical indication, with the study demonstrating sharply elevated nucleosome levels in trauma patients, particularly those who went on to develop venous thromboembolism.

Capture-Seq technology reached a milestone with its first peer-reviewed paper in July and a September 2026 presentation at ESMO MAP demonstrating that the platform detected 49 of 49 cancers, including early Stage I/II cases, with no false positives in one validation cohort. Nu.Q Cancer generated supportive data with two pre-print papers in lung cancer and a clinical study paper in ovarian cancer.

In August, a peer-reviewed paper provided a retrospective analysis of the SISPCT trial (971 patients, 33 ICUs). The paper concluded that elevated levels of H3.1 nucleosomes at admission are independently associated with mortality and acute kidney injury (AKI) requiring renal replacement therapy (RRT).

Management continues to pursue a reimbursement pathway in France for the Nu.Q Lung Cancer test, with a decision anticipated later in 2026 and the potential entry into clinical use by year-end. The reimbursement dossier is being supported by Hospices Civils de Lyon.

Nu.Q Vet (Feline): During 2026, management expects to publish a feline lymphoma clinical study in a peer-reviewed journal, which should trigger a $5 million milestone payment from Antech/Heska on the nine-month anniversary of the publishing date or on the first commercial sale of the monitoring test for lymphoma in felines. Volition officially submitted the clinical manuscript for peer review in May 2026. The manuscript is currently still undergoing peer review.

On September 14, 2026, VolitionRx prepaid the outstanding balance on the $7,500,000 Lind Senior Secured Convertible Promissory Note dated May 20, 2025. The $2,400,000 Lind Senior Secured Convertible Promissory Note (dated January 7, 2026) remains outstanding in the amount of $2,041,667. This action relieves about 75% of the dilution associated with the Lind Notes.

PRESENTATIONS, PAPERS & POSTERS (mid-2026)

Nu.Q NETs (Sepsis)

Discovery of Method to Identify Progression of the Severity of Sepsis: On June 10, 2026, Volition's research team published a paper titled "Cytokine-induced chromatin accessibility in whole blood neutrophils links to sepsis transcriptional states" by Justin Cayford et al. in Frontiers in Immunology. The study used ATAC-Seq to profile chromatin accessibility in neutrophils stimulated with relevant inflammatory factors (TNF-α, GM-CSF, fMLP, C5a, and IL-1β), both individually and in combination. The combined stimulus induced a chromatin response. When integrated with two published sepsis cohorts (VANISH and SUBSPACE), the neutrophil chromatin accessibility programs related to severity states of patients. Four genes (TLR8, THOC1, PDE4B, and SERPINB1) achieved an AUC (Area Under the Curve) over 0.70, and when combining all four genes, an AUC of 0.79 was achieved for separating non-severe from severe/fatal sepsis. The authors characterized this study as hypothesis-generating rather than diagnostic. The work was funded by VolitionRx and contributes to the company's proprietary platform.

https://volition.com/wp-content/uploads/2026/06/fimmu-17-1796580.pdf

Lateral Flow Test for Point-of-Care Quantification of Nucleosomes: On July 8, 2026, Volition announced the results of a blinded study, which was conducted as part of the SUMMIT program. Whole venous blood samples from 25 hospital patients in Intensive Care or the Emergency Department were tested by a Nu.Q Nets assay through both an automated central laboratory and a simple bedside lateral flow device. The bedside results, which are delivered within minutes, are strongly correlated with those processed through an automated central laboratory, which requires hours to process.

On August 12, 2026, Volition announced that results from a lateral flow finger-prick point-of-care test are also highly correlated with the Nu.Q NETs test processed through a centralized laboratory: the Spearman correlation was 0.85, and the Pearson correlation was 0.88. This is a major advancement toward making the results of Nu.Q NETs test available at the point of care using capillary blood samples within minutes, which would enable quicker clinical decision-making.

https://ir.volition.com/news-events/press-releases/detail/897/volition-demonstrates-utility-of-rapid-point-of-care-finger-prick-test-in-sepsis-patients

Clinical Validation of Nu.Q H3.1 Biomarker in Sepsis: On August 3, 2026, a peer-reviewed paper titled “H3.1 Nucleosomes to Predict Renal Replacement Therapy and Mortality in Sepsis—A Secondary Analysis of the SISPCT Randomized Control Trial,” by Caroline Neumann et al., was published in the journal Critical Care Medicine. The study is based on a retrospective analysis of the SISPCT (Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis), a randomized controlled trial led by Professor Michael Bauer of Jena University Hospital in Germany. The study included 971 patients with sepsis or septic shock who had plasma H3.1 levels measured at admission, and 927 patients with complete RRT-outcome data, all drawn from 33 ICUs in Germany. A total of 443 patients (45.6%) presented with sepsis and 520 patients (53.6%) were in septic shock. Admission H3.1 levels were higher in patients with septic shock than sepsis (median, 921.84 vs. 432.71 ng/mL; p < 0.001). The study concluded that elevated levels of H3.1 nucleosomes at admission are independently associated with mortality and acute kidney injury (AKI) requiring renal replacement therapy (RRT). Specifically, every log-10 increase in baseline H3.1 concentration raised the 28-day risk of needing RRT by 80%.

https://www.ovid.com/jnls/ccmjournal/pdf/10.1097/ccm.0000000000007270~h31-nucleosomes-to-predict-renal-replacement-therapy-and

Nu.Q NETs (Traumatic Injury)

Study on Traumatic Injury: On May 28, 2026, Volition announced the publication of a clinical study in the journal SHOCK titled "Quantification of Circulating Nucleosomes Using Novel Assays Shows Elevated Levels in Patients After Traumatic Injury" by Sergio M. Navarro et al. Conducted in collaboration with the Mayo Clinic, the pilot study analyzed plasma from 639 trauma patients, along with 10 healthy volunteers, using the Nu.Q H3.1 and Nu.Q H3R8 Citrulline assays. Trauma patients exhibited elevated nucleosome levels (H3.1 levels averaged 359.7 nanograms per mL) compared to the healthy controls (H3.1 levels averaged 22.3 ng/mL). Significantly higher H3.1 levels (H3.1 levels averaged 828.4 ng/mL) were observed in patients who subsequently developed VTE (venous thromboembolism). The findings extend the potential application of Volition's biomarkers beyond sepsis into trauma care and possibly into other critical care settings. Volition is supplying the Mayo Clinic with an IDS i10 automated analyzer (the established Nu.Q automated platform) during Q3 2026 to assist Dr. Park in developing a trauma patient model.

https://www.ovid.com/jnls/shockjournal/abstract/10.1097/shk.0000000000002807~circulating-nucleosomes-are-elevated-in-trauma-patients-with

Nu.Q NETs

ISTH 2026 Presentation and Poster: On July 11, 2026, at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress, Volition's Justin Cayford, PhD, delivered a presentation titled "Red blood cell lysis modulates neutrophil extracellular trap release in response to physiological inflammatory stimuli," along with a companion poster from the Cytokine-induced chromatin paper (see above). The presentation examined three different red blood cell processing methods for neutrophil isolation and how each processing technique affected both the timing of NET-associated DNA release and downstream chromatin accessibility. The study demonstrates the importance of sample handling and the use of physiologically relevant models in NET-based assay development.

https://volition.com/wp-content/uploads/2026/07/Cayford_Final_talk_ISTH2026.pdf

Nu.Q Cancer (Lung Cancer) – Nu.Q H3K27Me3 Assay

Lung Cancer Prognostic Preprint Paper: On July 7, 2026, a preprint (i.e., a paper that has not yet been peer-reviewed by a journal) titled "Prognostic value of circulating H3K27Me3-nucleosomes in newly diagnosed lung cancer patients" by Kotronoulas et al. was posted to Research Square. The retrospective study analyzed plasma from 617 treatment-naïve lung cancer patients using targeted NGS for ctDNA alongside Nu.Q immunoassay for circulating H3K27Me3-nucleosomes. Among 514 patients with at least eight months of follow-up, those with H3K27Me3 levels below 56 ng/mL had significantly longer overall survival than those above that threshold (26 vs. 12 months, p<0.0001), a relationship that held even in ctDNA-negative patients (29 vs. 12 months, p<0.0001).

https://www.researchsquare.com/article/rs-9880337/v1

Lung Cancer Treatment-Intent Cohort Preprint Paper: Also related to Nu.Q Cancer, a preprint (a paper yet to be peer-reviewed) titled "Prognostic value of baseline circulating trimethylated H3K27 nucleosomes in treatment-intent cohorts of non-small cell lung cancer" by Piecyk et al. was posted to SSRN. The paper is a retrospective analysis of plasma samples collected in the ONCOPRO study. The study stratified non-small cell lung cancer (NSCLC) patients (n=64) into three treatment-intent cohorts to evaluate the association between baseline circulating H3K27Me3 levels and both overall and progression-free survival across the treatment spectrum. Patients with H3K27Me3 nucleosome levels below the median experienced significantly improved clinical outcomes. The study concluded that there is a potential prognostic value for circulating H3K27Me3 nucleosomes in metastatic NSCLC.

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=7198235

Lung Cancer Clinical Compendium Video: On July 17, 2026, Volition released a video titled "Nu.Q Cancer: Lung Cancer Clinical Compendium," in which Dr. Andrew Retter reviews the accumulated clinical data supporting Nu.Q Lung Cancer.

https://volition.com/nu-q-lung-cancer-new-clinical-data/

Nu.Q Cancer (Ovarian Cancer)

Phase II CHIVA Trial Sub-Study: On July 30, 2026, a clinical study titled "Baseline value and longitudinal kinetics of circulating nucleosomes during neo-adjuvant chemotherapy in newly diagnosed ovarian cancer: Results from a GINECO/GINEGEPS study of the randomized phase II CHIVA trial" by Pauline Corbaux et al. was published in Translational Oncology. Using Nu.Q assays, the study measured H3K27Me3 and H3K36Me3 nucleosomes from 148 patients enrolled in the Phase II CHIVA trial and found that levels were significantly elevated compared to 201 healthy controls. A lower baseline H3K36Me3 was independently associated with a higher likelihood of complete interval cytoreductive surgery, while a lower baseline H3K27Me3 was independently associated with longer progression-free survival. Funded by AstraZeneca, the study represents Volition's first published data supporting Nu.Q nucleosome biomarkers as a complementary prognostic tool in ovarian cancer.

https://volition.com/wp-content/uploads/2026/07/CHIVA.pdf

Nu.Q Capture-Seq

Capture-Seq Methodology Paper: On July 21, 2026, Volition's paper titled "Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy" by Pamart et al. was published in Clinical Epigenetics, a peer-reviewed publication subsequent to the preprint posted to Research Square on March 16, 2026. This paper is Volition’s first peer-reviewed paper related to the Capture-Seq technology.

The paper showcased Volition’s Capture-Seq methodology that physically enriches ultrashort DNA fragments in the blood, including CTCF transcription factor-bound DNA, by removing 99.7% of background DNA, which results in a 180-fold enrichment (17,900%). The study analyzed three independent cohorts (n=49, n=4, and n=14). The patient sample results provide proof-of-concept for the use of plasma CTCF-cfDNA nucleoproteins as biomarkers, supporting Capture-Seq's potential as a novel class of liquid biopsy biomarker for multi-cancer early detection.

https://link.springer.com/article/10.1186/s13148-026-02205-x

Capture-Seq - Early Stage I Solid Cancer Detection abstract: On September 10, 2026, Dr. Andrew Retter presented an abstract titled "Early stage I solid cancer detection by direct ChIP-seq of short CTCF-protected plasma ctDNA," in the main auditorium at the European Society of Medical Oncology Molecular Analysis for Precision Oncology (ESMO MAP) Conference in London. The Capture-Seq method isolates CTCF-protected plasma ctDNA from background cell-free DNA bound to nucleosomes.

The presentation highlighted the use of Capture-Seq technology for the detection of early-stage I solid cancers in two independent cohorts. In one, the methodology detected 49 of 49 cancers (including 23 early-stage I/II cases) with no false positives; there were 21 healthy controls. In the other, 13 of 14 later-stage cancers (93%) were detected; the cohort included 10 healthy controls.

Results from another blinded validation cohort, consisting of 81 subjects (59 colorectal and lung cancer patients and 22 healthy controls), detected 95% of stage I and II cancers.

https://volition.com/presents-early-stage-i-solid-cancer-detection-at-the-esmo-map-conference/

Nu.Q NETs (Summary Slide 2020-2026)

Nu.Q NETs Summary Slide (2020-2026): On July 26, 2026, Volition released a Summary Slide (and accompanying YouTube video) condensing the scientific and clinical evidence for the Nu.Q NETs H3.1 assay over the last 6 ½ years. The findings of many studies demonstrate that the Nu.Q H3.1 assay can help distinguish sepsis from non-infectious systemic inflammation, and the assay is highly correlated with disease severity, providing a tool for prognostic utility. The studies include the 971-patient German multi-center ICU SEPNET study by Neumann et al., the 1,713-patient MARS cohort by Filippini et al., and the 832-participant U.S. multi-center DXOCRO study by Kotronoulas et al. The Summary Slide also includes the French government-sponsored DETECSEPS study, which is scheduled to launch in the fall of 2026 and will prospectively triage and risk-stratify patients.

https://volition.com/wp-content/uploads/2026/07/NETs-summary-slide-July-26-1.pdf

Video Presentation of Summary Slide is titled "Volition Advances Nu.Q NETs Platform Towards Commercialization": https://www.youtube.com/watch?v=jzeBP83EiPw

AGREEMENTS (HUMAN SPACE)

Collaboration Agreement with Sysmex

In mid-June of 2026, Volition announced a collaboration agreement with Sysmex Corporation (TYO: 6869, OTCPK: SSMXY), a multi-billion-dollar market capitalization company listed on the Tokyo Stock Exchange. Sysmex is a global leader in the field of in vitro diagnostics for hemostasis and thrombosis, where neutrophil extracellular traps (NETs) play an important role. This agreement marks Volition's third human licensing deal. The Nu.Q NETs assay has already been transferred onto Sysmex's platform, and Sysmex has commenced the optimization phase in diseases associated with NETosis.

Commercial Relationship with Revvity

Volition has a multi-year existing commercial relationship with Revvity, whose automated IDS i10 platform serves as the gold-standard instrument for Volition's CE Mark Nu.Q NETs assay in Europe; IDS is a wholly-owned subsidiary of Revvity (NYSE: RVTY), which was formerly known as PerkinElmer prior to 2023. Under the current arrangement, Revvity co-markets Volition's CE Mark Nu.Q NETs kits to hospitals across Europe, with the product already reaching dozens of hospital sites.

Volition Entered into a Research License for APS with Werfen S.A.

In September 2025, VolitionRx signed its first human licensing deal. The agreement is a Research License for Antiphospholipid Syndrome (APS) with Werfen S.A., which is headquartered in Barcelona and has eight (8) Technology Centers located in Spain (1), Germany (1), and the United States (6). Under the out-licensing agreement, Werfen has access to the components of Volition's Nu.Q H3.1 NETs assay and is investigating the assay’s clinical utility in managing APS patients. Werfen’s work is being conducted at its Immunoassay Technology Center, which is located in Lliçà d’Amunt (approximately 30 kilometers north of Barcelona). Volition’s Nu.Q NETs assay has already successfully transferred to Werfen’s AcuStar platform. Also, Volition and Werfen have entered into an Exclusive Commercial Option Rights Agreement for APS. APS is an autoimmune disorder that affects approximately four million people worldwide. The full terms of the agreement are confidential.

Volition Entered into a Co-Marketing Agreement for Nu.Q Discover Services

In September 2025, Volition signed a co-marketing agreement with Hologic Diagenode (NASDAQ: HOLX) for marketing Volition’s Nu.Q Discover services to Hologic's large client base and also at conferences & on webinars. The initial term is one (1) year; however, the agreement could expand into an exclusive arrangement.

EXPECTED MILESTONES IN 2026

Pathway for Improved Market Access through Submission of Reimbursement Dossier for Nu.Q Assay: Volition is working towards the submission of a reimbursement dossier in France under the "Innovative Procedures Outside the Nomenclature," which is a framework that allows for the early and temporary support of innovative procedures. The reimbursement application for the Nu.Q Cancer Lung Cancer test is being supported by the Hospices Civils de Lyon (France's second-largest university hospital) and two other French institutions. If the dossier is classified as admissible, the determination of eligibility for reimbursement coverage typically occurs within five months. The achievement of a reimbursement regimen would be a major milestone. If approved within the typical 5-month timeframe, management anticipates that the Nu.Q Lung Cancer test will enter clinical use in France by 4Q 2026 and potentially advance to routine clinical use in 2027.

Initiative to Transition Nu.Q NETs from IVDD to IVDR to Improve Market Access & Clinical Adoption in Europe: Volition’s Nu.Q NETs assay received the CE mark designation in May 2022 with a broad claim for detecting and monitoring diseases with a NETs component under the requirements of the In Vitro Diagnostic Directive (IVDD), a self-certification framework. Volition is now pursuing a transition to the new In Vitro Diagnostic Regulation (IVDR) directive, a rigorous regulatory system that would have profound implications in promoting clinical adoption of the company’s assays in Europe. The critical requirements for the upgrade involve significant medical and technical documentation, which management believes can be achieved through the government-backed DETECSEPS program (an evaluation for the early detection of sepsis) in France. Management believes this program is on track to launch in 3Q 2026.

Licensing Agreements for Human Diagnostic Applications: Volition continues to be in active discussions with at least 12 diagnostics and liquid biopsy companies. The discussions range from due diligence and technology transfer to clinical sample evaluation and contract negotiations, particularly under the Nu.Q NETs, Nu.Q Cancer and Capture-Seq pillars. In addition to the Collaboration Agreement with Sysmex Corporation (TYO: 6869, OTCPK: SSMXY) announced in 2Q 2026, management anticipates additional human licensing agreements to be signed in 2026.

RECENT FINANCIAL REPORT

On August 13, 2026, after the market close, VolitionRx reported financial results for the second quarter ending June 30, 2026. Total revenues decreased 2.0% YOY to $398,657, compared to $406,688 in the second quarter of 2025. There was not any Service revenue (contract lab services) due to the timing of the completion of contracts and the lumpy nature of Nu.Q Discover’s revenue recognition. There are several projects in the pipeline earmarked for completion beyond the end of the second quarter. Product revenue from sales of the Nu.Q Vet cancer screening test and H3.1 kits increased 62.8% to $398,657, driven by higher Nu.Q Vet revenue and the continued recognition of deferred revenue under the Heska agreement.

Operating expenses decreased 32.1% YOY. R&D expenses declined 33.8% YOY and 36.9% sequentially as the number of full-time equivalent (FTE) personnel declined by 25% to 36. Sales and marketing expenses decreased 47.4% YOY (35.6% sequentially) as the number of FTE personnel decreased 27% to 8. G&A expenses decreased 25.0% YOY and 16.1% sequentially to approximately $2.21 million, primarily due to lower personnel expenses from a 31.6% YOY reduction in FTE personnel, though somewhat offset by higher legal and professional fees. The release of bonus provisions for personnel aided in the reduction of personnel expenses in all three line items of operating expenses.

Net cash used in operating activities decreased approximately 17.5% YOY to roughly $1.73 million a month during the second quarter of 2026.

VALUATION

Utilizing a financial model based on DCF methodology, which forecasts out to 2032 and uses a 15% discount rate (based on CAPM), a 2% terminal growth rate, and a terminal P/S multiple of 0.53, the indicated value of VNRX is $2.11 per share.

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