Virios Therapeutics Inc Aktie

Welcome to the 2026 Annual Stockholders Meeting for Dogwood Therapeutics, Inc. Our host for today's call is Greg Duncan, CEO and Chairman of the Board. [Operator Instructions] I'll now turn the call over to our host, Mr. Duncan, you may begin, sir.

Good morning. I am Greg Duncan, and I have been appointed Chairman of today's meeting. I would like to express a sincere thank you on behalf of the entire Dogwood Therapeutics Board and our executive management team for your attendance at this year's meeting.

I now call the meeting to order. Angela Walsh, Chief Financial Officer and Treasurer of Dogwood will serve as the Secretary for today's meeting. I would also like to introduce Emily White of Equiniti Trust Company, who has been appointed as the Inspector of Elections for today's meeting. Ms. White has previously taken her oath as Inspector of Elections.

To start, I would like to introduce the current directors of the company. In addition to myself, the directors are Dr. Abel De La Rosa, Abel has served as an Independent Director since December 2020. David a.k.a. Rick Keefer. Rick has served as an Independent Director since 2018; John C. Thomas Jr., John has served as an Independent Director since December 2020. Dr. Melvin Toh, Melvin has served as a Director since October 2024. Dr. Richard Whitley, Rich has served as an Independent Director since December 2020.

And last but not least, Alan Yu. Alan has served as a Director since October 2024. Also in attendance today are representatives of FORVIS Mazars LLP, the company's independent registered public accounting firm.

Now let me turn the proceedings over to Angela Walsh, who will provide instructions for today's meeting.

Thank you, Greg. We will proceed with the formal business of the meeting in the order set forth in the notice of our Annual Meeting of Stockholders and the proxy statement. We will first present the 5 proposals submitted for approval by our Board. We will take questions related to the proposals. We will then open the polls for voting.

Please note, if you have already submitted your vote by proxy and do not wish to change your vote, you do not need to vote now and your shares will be voted as previously instructed. You should also have a copy of the rules of conduct for the meeting. These are posted on the registration page and viewing page once you enter the meeting. In order to conduct an orderly meeting, we ask that you follow these rules. Stockholders who are attending this meeting may submit questions through the Ask a Question box located at the bottom of your screen.

Stockholder questions are welcome, but we do not intend to address any questions that are not relevant for the meeting, such as questions specific to an individual shareholder or questions not related to the previously submitted proposals for this meeting. Please submit your questions now to make sure they are received in a timely fashion for our review and response.

At this time, I'll turn the meeting back over to Greg.

Thank you very much, Angela. The following documents will be incorporated in the company's records as part of the minutes of today's meeting. First, a copy of the notice of Annual Meeting of Stockholders stating the date, time, place and purposes of this meeting.

Second, a copy of the proxy statement for today's meeting; and third, the affidavit of Broadridge showing that each stockholder of record on the record date was mailed and deposited with the United States Post Office, packages containing the notice of annual meeting, the proxy statement, form of proxy card and the annual report on Form 10-K.

Will the Secretary please report at this time with respect to the existence of a quorum?

The Board of Directors set April 21, 2026, as the record date for stockholders entitled to notice of and to vote at this meeting. A certified list of the stockholders of the company as of the close of business on the record date has been provided to the company by the company's transfer agent, Broadridge. That list is available for inspection during this meeting and shows that on the record date, there were 33,401,553 shares of common stock of the company issued and outstanding.

On each proposal brought before this meeting, stockholders are entitled to 1 vote for each share of common stock registered in their name. I have been advised that more than 1/3 of the outstanding shares entitled to vote are present. Therefore, I declare that a quorum is present, and this meeting may now proceed.

Let me turn it over to Greg to review the proposals for the meeting.

We will now proceed with the formal business of today's meeting. After all the proposals have been described, we will answer any questions submitted online that are related to these proposals. Please submit any questions as soon as possible for our review. There are 5 proposals to be considered by the stockholders at today's meeting.

The first proposal requiring the vote of stockholders is the election of 7 director nominees to serve until the 2027 Annual Meeting of Stockholders and until their successors are duly elected as well as qualified. The 7 nominees receiving the highest number of votes of shares present virtually or by proxy at this meeting will be elected as directors. The candidates who are nominated for election are Dr. Abel De La Rosa, Greg Duncan, David Keefer, John C. Thomas, Jr., Dr. Melvin Toh, Dr. Richard Whitley and Alan Yu. Each of these nominees currently serves as a director of the company. No other persons have been properly nominated under the procedures required by the bylaws, and I declare the nominations now closed. The Board of Directors recommends that stockholders vote for each of the director nominees.

The second proposal is the ratification of the selection of FORVIS Mazars LLP to serve as our company's independent registered public accounting firm for the fiscal year ending December 31, 2026. The Board of Directors recommends that stockholders vote for ratification of the appointment of FORVIS Mazars LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2026.

The third proposal is to approve the amendment to the company's certificate of incorporation to increase the number of shares of common stock and preferred stock authorized for issuance from 43 million and 2 million, respectively, to 195 million and 5 million, respectively. The Board of Directors recommends that stockholders vote for the approval of the amendment to the company's certificate of incorporation.

The fourth proposal is the advisory vote on the frequency of future advisory votes on named executive officer compensation. As required by the Exchange Act, we are asking our stockholders to vote on an advisory or nonbinding basis on how frequently we should hold future nonbinding advisory stockholder votes on the compensation of our named executive officers, otherwise known as a say-on-pay vote. This is the first say-on-pay vote as 2026 is the first year in which we are required to hold a say-on-pay vote pursuant to the rules of the SEC. We currently do not have an established frequency for such votes.

Stockholders may vote to indicate they would prefer that we hold the say-on-pay vote at future annual meetings every year, every 2 years or every 3 years, or they may abstain from the vote. The vote is commonly known as a say-on-frequency vote. The Board of Directors recommends that stockholders vote for 1 year for the advisory vote on the frequency of future advisory votes on named executive officer compensation.

The fifth proposal is the actual advisory vote on the compensation of our named executive officers or say-on-pay vote itself. As required by the Exchange Act, we are asking our shareholders to approve on an advisory or nonbinding basis, the compensation of our named executive officers as disclosed in this proxy statement. This proposal, commonly referred to as a say-on-pay vote, provides our stockholders the opportunity to express their view on our named executive officers' compensation as a whole.

This vote is not intended to address any specific items of compensation or any specific named executive officer, but rather the overall compensation of all of our named executive officers and the philosophy, policies and practices described in this proxy statement. This is the company's first say-on-pay vote. The Board of Directors recommends that stockholders vote for the advisory vote on the compensation of our named executive officers for 2025.

Before proceeding to the voting, we will check to see if there are any questions submitted about the proposals before we open the polls. Angela, are there any questions?

Greg, there are no questions related to the proposals submitted for the meeting.

Thank you, Angela. The time is now 10:10 a.m. Eastern Time, and the polls are now open for voting. In order to vote during the meeting, you may click on the Vote My Shares button on your viewing page and follow the prompts. If you have voted your shares prior to the start of the annual meeting, your vote has been received by the company's inspector of elections, and there is no need to vote those shares again during this meeting unless you wish to revoke or change your vote. We will now pause 1 minute for stockholders to finish their voting.

[Voting]

The time is now 10:11 Eastern Time, and the polls are now closed for voting. Will the Secretary please report the preliminary results of today's voting?

Greg, based on the preliminary report of the Inspector of Elections, I hereby declare that each of Dr. Abel De La Rosa, Greg Duncan, David Keefer, John C. Thomas, Jr., Dr. Melvin Toh, Dr. Richard Whitley and Alan Yu has received the affirmative vote of more than a plurality of the shares present at the meeting and entitled to vote on the election of directors, and each of them has been elected to serve as a director of the company to serve until the 2027 Annual Meeting.

I hereby declare that the appointment of FORVIS Mazars LLP to serve as the company's independent registered public accounting firm for the fiscal year ending December 31, 2026, has been ratified by the affirmative vote of at least a majority of the shares present and entitled to vote on this proposal. I hereby declare that the amendment to the company's certificate of incorporation to increase the number of shares of common stock and preferred stock has been ratified by the affirmative vote of at least a majority of the shares present and entitled to vote on this proposal.

I also hereby declare that the advisory vote on the frequency of future advisory votes on named executive officer compensation or the say-on-frequency vote has been approved to be 1 year based on the affirmative vote of at least a majority of the shares present and entitled to vote on this proposal.

Lastly, I hereby declare that the advisory vote on the compensation of our named executive officers for 2025 or the say-on-pay vote has been approved by the affirmative vote of at least a majority of the shares present and entitled to vote on this proposal. I will turn the meeting back over to Greg for final comments.

Thank you very much, Angela. I hereby request that the final report of the Inspector of Elections be filed within the minutes of today's meeting. Our final voting results will be filed with the SEC on a current report on Form 8-K within 4 business days after the end of today's meeting. This concludes today's meeting. As there are no other matters to be considered, the Annual Meeting of Stockholders of Dogwood Therapeutics, Inc. is now adjourned.

I want to thank you again for your attendance at today's meeting and for your interest in Dogwood Therapeutics as we work to develop novel new medicines to treat cancer and chemotherapy-related pain and neuropathy.

The meeting has now concluded. Thank you for joining, and have a pleasant day.

Good morning, and welcome to today's Dogwood Therapeutics, Inc. Investor Call. [Operator Instructions] And please be advised that today's call is being recorded at the company's request.

At this time, I'd like to turn the call over to Greg Duncan, Chief Executive Officer for Dogwood Therapeutics. Please proceed, Mr. Duncan.

Thank you. Good morning all, and thank you for joining today's exciting investor call for Dogwood Therapeutics. I'm pleased to be joined by our Chief Medical Officer, Dr. Mike Gendreau. And together, we have the distinct pleasure of sharing how we at Dogwood Therapeutics are expanding our commitment to improve the lives of cancer patients who are suffering from the debilitating effects of chemotherapy-induced peripheral neuropathy, a condition for which there are no FDA-approved treatments.

This expanded commitment is enabled by a very exciting global license to both develop and commercialize SP16, a first-in-class LRP1 agonist as a complement to our lead development compound, Halneuron. SP16 is administered intravenously and has demonstrated in preclinical research an exciting dual mechanism of action, which we think has great utility for patients with chemo-induced neuropathy.

Specifically, SP16 has both anti-inflammatory and analgesic effects, and that's complemented by increased protein signaling that's associated with cell survival, cell growth and cell proliferation. So simply put, SP16 could be used adjunctively with Halneuron as a treatment for chemo-induced peripheral neuropathy, and we also believe SP16 has potential to be used concurrently with chemotherapy to prevent or repair damage that's often associated with the off-target effects of chemotherapy.

And I'm pleased to tell you this exciting new license is enabled by a highly efficient licensing deal. This is an all-stock transaction. The consideration is all Dogwood Therapeutic stock. SP16 is moving forward into Phase Ib clinical research and the forthcoming Phase Ib trial is fully funded by the National Cancer Institute. So there's no need for Dogwood to utilize cash in the short term to get SP16 to its next important clinical milestone.

So we're very excited about the deal. And Mike and I will spend the next few minutes highlighting the details of that transaction as well as the exciting science that underpins SP16.

Before we do that, though, we'd like to provide you with an update on the great progress we have on our ongoing Halneuron Phase IIb chemotherapy-induced pain study. After we give you that great update, we'll talk about the SP16 deal, the science. And then finally, we'll open up the discussion to questions about the SP16 deal or our Halneuron research program.

So let me start with an update on Halneuron. For those of you who are not familiar with the program, Halneuron is a Nav1.7 inhibitor, sodium channel inhibitor that's presently the focus of an ongoing Phase IIb study. Halneuron effectively inhibits peripheral nerve transmission of pain signaling and has delivered clinical benefits to patients with both cancer and for those who have cancer and progress to chemotherapy with the resulting neuropathy that's associated with chemotherapy all too often.

We believe Halneuron has potential to treat broader cancer-related pain. We have completed a Phase II study. And with success in the Phase IIb CINP study, we think we can expand the Halneuron research program to include cancer-related pain, and we're also considering over time, post-acute surgical pain study where we think Halneuron could have great benefit for patients.

To summarize the benefits of Halneuron's for those of you who are new to our story, as I mentioned, Halneuron has reduced pain in both cancer-related pain studies and CINP studies, 2 Phase II studies completed to date. The response for patients who respond to Halneuron therapy is on average for about 2 months.

There is no evidence of addiction, euphoria or tolerance buildup with continued administration of Halneuron. We have demonstrated a very acceptable safety profile in testing, including over 700 patients to date. We have composition of matter intellectual property protection that's complemented by both manufacturing know-how and trade secrets. And as I mentioned earlier, there are no drugs approved to treat CINP, highlighting the very large commercial opportunity that exists for a drug that gets to market, and we hope Halneuron will be the first to get to market to treat these patients who are in desperate need of novel new therapies.

I'd like to provide you with an exciting update on the ongoing Phase IIb study. I'm very pleased to tell you that under Mike's leadership, working with Ralph Grosswald, our Senior Vice President of Operations, we've already enrolled 82 patients into the current trial. By way of background in the trial, these are patients who will be administered either tetrodotoxin or Halneuron, as we call it, or placebo, so it's a 2-arm study.

Patients will be dosed with Halneuron over a course of 2 weeks, 4 injections week 1, 4 injections week 2 and we'll assess patients' pain scores over week 1, week 2, week 3 and week 4, and that average pain score at week 4 will be where we conduct the primary endpoint analysis. These are patients who have moderate to severe chemo-induced neuropathy.

We will effectively assess patients not just on their pain reduction, but also from a global health perspective. We'll assess their fatigue, their anxiety, depression and a whole battery of neuropathic pain symptom inventories. As we've communicated previously, and we're well on track based on the 82 patients we've currently enrolled, we're targeting enrollment of 200 patients subject to any modification of the Phase IIb study by an interim analysis, which remains on target for quarter 4 of this year.

We hope to assess the data in this interim analysis by December of this year. 82 patients in the study, over 50 patients have completed. And to date, only 2 patients have dropped out of the study, highlighting again the acceptable safety profile of Halneuron.

We have very high conviction in this program and are very, very excited with the progress of the recruitment and the community's interest in this novel important trial. Now let's turn our attention to the key features of the SP16 IV transaction. This is a royalty-free global license to both develop and commercialize Serpin Pharma's IV formulation of SP16 as a treatment for neuropathy and potentially to repair or prevent nerve damage that's associated with off-target effects of chemotherapy.

SP16 provides alpha-1 antitrypsin-like activity, specifically by LRP1 agonism. Specifically, as I mentioned before, SP16 has demonstrated anti-inflammatory effects by a reduction of IL-6, IL-8, IL-1B and TNF alpha. These are cytokines as part of your immune response when overexpressed can actually cause damage. And that reduction in that type of inflammation is complemented by an increase in protein signaling, specifically for pAKT and pERK that regulate fundamental processes such as cell growth, proliferation and survival.

SP16 is a clinical stage asset poised to enter Phase Ib treatment of for patients with chemo-induced peripheral neuropathy. We're very excited about this candidate, both on its own merit and as a potential synergistic complement to Halneuron to reduce pain. And as I mentioned before, the Phase Ib trial is both endorsed and fully funded by the National Cancer Institute.

The NCI grant proceeds are already sitting with Serpin Pharma. The studies to be run in collaboration with the University of Virginia to determine the best doses for Phase IIa. And I'm pleased to tell you that based on communication between NCI and Serpin, the Phase IIa study is also potentially eligible for NCI funding.

We're currently planning to file an IND for this exciting new program in quarter 4 of this year and expect to commence dosing in patients in the first half of next year. A little bit more about the deal and the construct of the deal. We're very excited because Serpin has really terrific research expertise in this particular area.

They've identified the active portion of alpha-1-antitrypsin and converted that into SP16. Serpin consideration for the deal is via DWTX stock. There will be 382,000 common shares and 179 preferred shares, A-2 shares, which will provide Serpin with ownership of DWTX stock at about 7%, 7.31%, specifically on a fully diluted basis. That calculation presumes a shareholder vote to convert preferred shares to common shares, which we anticipate sometime in quarter 4 of this year.

The benefits to Serpin are that the DWTX or Dogwood Therapeutics management team has experience in late-stage development, specifically expertise in both pain and neuropathy conditions. As evidence of that expertise, both Mike and I have either developed and/or commercialized Celebrex, Lyrica and Savella, 3 drugs that have actually gone through the development process and made it to market.

A license includes a mutual support agreement between Serpin Pharma and CK Life Sciences to convert their respective preferred shares to common shares at this forthcoming special meeting. Serpin will own 7.31% of our shares on a fully diluted basis and CKLS ownership will be 83% on a fully diluted basis post that conversion, subject to shareholder vote.

That's important for us because it gives us a very large, stable shareholder, a shareholder that's committed to Halneuron and has been so for the past 15 years.

Why are we excited about this? For those of you who know somebody who's had cancer, you know that cancer patients who progress to chemotherapy, and that represents about 50% of newly diagnosed cancer patients often suffer from chemotherapy-induced neuropathy. In fact, roughly 7 out of 10 patients, while they're going through chemo, experience neuropathy, in some cases, so bad that patients peel off of their chemotherapy, the very treatment they're reliant on to save their lives.

The group we're focused on is that 30% of patients who are full 6 months after their last dose of chemotherapy are still suffering from neuropathy. That's a population that needs new therapies, and now we have a second shot on goal. Halneuron specifically inhibits pain signaling and has proven to have great potential to treat neuropathic pain.

SP16, the LRP1 agonist could also reduce pain by its analgesic and anti-inflammatory processes, but also has potential to reach numbness, tingling, muscle weakness and loss of coordination, very troublesome symptoms of neuropathy as a complement to their pain symptoms and something that could be very complementary to our Halneuron focus on pain. So we're very excited about the second shot on goal, the complementarity and the synergy of these 2 potential assets used either alone or in combination moving forward.

So that's an overview of the deal and the construct. I'd like to turn it over to Dr. Gendreau to talk through the science that underpins SP16 and to talk about the Phase Ib trial that we plan to execute moving into 2026. Mike?

All right. Thanks, Greg. My goal here is to cover some of the biology underpinning the activity of SP16, how it's complementary to our Halneuron program and why we're very happy to add this to our stable development technology. As shown on the slide and as Greg summarized a little bit previously, alpha-1-antitrypsin is a member of what are called the Serpin family. And these are serine protein protease inhibitors, and they have a role in biology to offset the activity that happens with inflammation, with pathogens, with insults to cells such as chemotherapy.

We get an inflammatory response that's evolutionarily that's protective of the organism, but you get local cell damage, you get inflammation. And what has evolved with this Serpin family is to offset or to restore the balance to turn down that inflammation to turn down the cell damage and get back the homeostasis.

So the alpha-1-antitrypsin is a member of that Serpin family, and it's important in regulating, as I said, inflammation. It has activity specifically on one of the enzymes that's important is neutrophil elastase. This is one of the proteases that causes damage. And what this activity of alpha-1-antitrypsin does is, again, it restores the hemostasis.

What Serpin and the company discovered was that the active part of alpha-1-antitrypsin could be reduced to a 17 amino acid peptide called SP16, which is the subject of this license that has that same activity in terms of restoring homeostasis. So we now have a 17 amino acid peptide that can give us that activity that was previously required a large protein molecule.

So LRP1 is -- stands for low-density lipoprotein receptor protein. This is the molecule that's actually activated by SP16 or by alpha-1-antitrypsin that causes the molecular biology changes that leads to the reduction in inflammation and cell recovery cell survival. All of these biological effects are related to this activity of LRP1.

So that is the subject of the license, and we'd like to move on to the next slide here and talk a little bit about what LRP1 is specifically doing. It is, as I said, it's LDL receptor-related protein. It is a signaling protein that's fundamental to cell biology, almost all cells have it.

And it's related to turning down inflammation, increasing cell survival, reversing apoptosis. And as shown in this slide, it really is something we want to have when we have damage to the cells such as chemotherapy, we want to be able to reverse these effects. So that's what we have in terms of mechanism.

On the next slide shows some of the activities we've seen with LRP1 activation. This is some preclinical work in mice that shows the ability of SP16 dosing to reduce both mechanical and temperature hypersensitivity that you get with nerve damage. In this case, this is a paclitaxel model where the chemotherapy agent, this is commonly used in breast cancer, for example, is given to the test animal. It causes nerve damage.

And if we give SP16 in conjunction with the chemotherapy, we protect against that nerve damage as shown by reduction in the pain signaling that you see in the animal that we get with the chemotherapy alone and also a reduction in the mechanical hypersensitivity where they are very sensitive to touch.

So giving SP16 in conjunction with chemotherapy seems to be protective against the neuropathic pain that results from the chemotherapy commonly.

Next slide. Now this is another pain model. This is a nerve ligation model where, again, the mice undergo a surgical procedure where you ligate the nerve and you cause directly damage the nerve. And what happens over time, if you do that and don't treat the animal in conjunction, again, they get very sensitive to pain, to touch. So that's mechanical hypersensitivity again.

In this case, giving SP16 in conjunction with that surgical procedure is protective against the development of that mechanical hypersensitivity, again, showing that anti-inflammatory cell recovery ability that we're seeing with SP16 administration.

Next slide. And another study that's been done by the Serpin Company in conjunction with the University of California, San Diego, they used a model to show that you can reverse nerve damage or be at least protective against nerve damage by having these neurotrophic effects given SP16, you see nerve recovery and you see neuro sprouting, which is a sign that the nerves are regenerating, you're signaling to the cell to go into a recovery mode where you protect the nerve and/or cause it to recover from whatever damage was done in this case with chemotherapy.

Now these are another important consideration as you start thinking about using this in conjunction with chemotherapy is that we need to make sure that the dosing of SP16 doesn't somehow interfere with chemotherapy itself. So this is a series of studies that were done to show and to convince the National Cancer Institute that SP16 would not interfere with the chemotherapy these patients need to receive when they're going in for their cancer chemotherapy.

So on the left panel, we show that SP16 is being used for -- with 2 common anticancer drugs, a platinum class drug or a taxane class drug. These are commonly used in breast and colon cancer. And what this study shows is that the effect of the cancer chemotherapy on the cancer cells is not diminished by the use of SP16 in conjunction.

So you get very similar curves in terms of ability to kill the cancer cells with or without SP16 in conjunction. On the right panel is a different model. This is a pancreatic cancer model, again, done in a mouse test case. And here, we're using a different class of cancer drug. This is a topoisomerase inhibitor. And again, the addition of SP16 in conjunction with that cancer chemotherapy does not seem to diminish its cancer effect at all.

So again, safe to use in conjunction with cancer chemotherapy, which was an important consideration when you consider we'd like to use this in conjunction with active chemotherapy for its protective effects. And finally, the study that's been funded by the National Cancer Institute that will be getting going in the first half of next year is a dose escalation study where patients with metastatic cancer will be eligible for the study who are receiving taxanes or platinum drugs that are known to cause neuropathy.

In this case, there'll be cohorts of 8 patients, 6 of which will get a Serpin -- SP16 dose and 2 will get placebo in each of those cohorts.

And every 8 patients will -- assuming the safety is -- looks good, we'll go to the next higher dose, and there's 4 potential dose escalation steps in the study design. Patients will get their baseline chemotherapy, they'll get SP16 or placebo in conjunction with that therapy. And the study endpoints will be looking for safety, tolerability, prevention of neuropathy development and whether the patients stay on their chemotherapy regimen.

One of the problems we get with neuropathy in a lot of these patients is they can't keep taking the chemotherapy because of the development of neuropathy. So if we can protect against that, they're more likely to be able to complete their entire cancer chemotherapy regimen, which, of course, is very important for survival.

So this is the plan that NCI is funding, and we said that will be getting -- going in conjunction with the University of Virginia in the first half of next year.

Thank you, Mike. So we're pretty excited about this. As you can probably tell, Serpin has a terrific scientific discovery that we hope to now apply in the clinic in this Phase Ib study. Just to summarize from a deal rationale perspective, our conviction in Halneuron, late-stage asset, best suited for treating the pain that's associated with chemotherapy is now complemented by SP16, an LRP1 agonist, which we think can be used for both treatment of chemo, attenuation of chemo-induced peripheral neuropathy symptoms but could have protective effects as well.

What we also like about this is these are common call points. So the doctors that treat cancer and pain are relevant to both Halneuron as well as SP16. Co-promotion at targeting infusion sites and pain clinics and both independently and together allows us deeper penetration into the global CINP marketplace, which at present is estimated to be about USD 1.5 billion with the potential to expand into cancer-related pain markets.

The increased shots on goal, we really believe is doubling down on our commitment to these cancer patients that go on to be treated with chemotherapy. There's value both as independent programs and in combination and positive readouts in either arm create unique revenue pathways while combination studies are designed in the future, presuming success in both of the programs.

So we're very excited about the complementarity of these 2 programs. I'm also pleased to tell you that by expanding the pipeline now to include SP16, we have a rich progression of milestones over the next 12 to 18 months, specifically for Halneuron, and we expect to file new synthetic IP sometime this quarter.

That new synthetic IP will allow us to reset our intellectual property protection clock a full 20 years, which will support Phase III and commercialization moving forward. We expect to communicate recruitment of the 100 patients we are targeting for the interim analysis with the interim analysis planned in the end of fourth quarter of this year, with final data for a 200-patient study, presuming no change to the sample size sometime in the middle of 2026, less than a year away.

SP16, our novel new treatment development candidate for a broader milieu of peripheral neuropathy symptoms will be underpinned by activities quarter 4 of this year to file the IND to support the Phase Ib study, which is funded by the National Cancer Institute, and we'll begin enrolling patients sometime in the first half of next year.

So we're very excited about the complementarity and now this broad rich milestone -- clinical milestone portfolio. I would like now to open it up to any questions that people on the call have. We'd be more than happy to answer specific questions about SP16, Halneuron, the complementarity, anything that you see fit to ask the management team, Mike and I are here to answer your questions.

So Ali, I'll open it up back to you to open up to questions.

[Operator Instructions] We have a question from Sean Lee with H.C. Wainwright.

Congrats on this new transaction. I just have a couple of questions on SP16 deal and the clinical plan. So to start off, for the transaction itself, you mentioned that it's all stock with no royalties. So I was wondering whether there are any notable developmental or regulatory milestones that we associated with this deal?

Thank you, Sean, for joining us this morning. So it is an all-stock transaction with no royalty obligations, and there are no future development milestones associated with the deal. So this is an all-stock transaction, providing value to Serpin in the form of Dogwood stock and that is the full consideration for the asset.

Obviously, we hope to progress the asset through continued progress in the clinic, but that does not come with any future anticipated payments back to Serpin.

Great. My second question is on the upcoming Phase Ib study. How is SP16 dosed in these patients? And what's the expected primary efficacy endpoint that you're looking for?

So the dosing is IV. So it's intravenous infusion that's going to be done contemporarily with the chemotherapy itself. So it will be done the same day. In terms of -- I'm sorry, what was the second question? Primary effect. This is really going to be a tolerability and safety study. It's first -- it's really first in man in being used for chemotherapy and also the IV form is going to be first in man.

So the primary from the National Cancer Institute, what they're funding is primarily looking at tolerability and safety. We will be looking for neuropathic endpoints, but that really is a secondary endpoint.

We are working with [indiscernible] and the Serpin team and Dr. Dillon at UVA to finalize the design of the study. So the frequency of administration, what week in the chemotherapy dosing regimen is still TBD. But we have the opportunity, as Mike mentioned, to put in several exploratory endpoints to give us a sense of what would be in the Phase IIa study from a proof-of-concept perspective.

Got it. My last question is on the -- whether SP16 has gone any other previous in human studies before since Serpin is a private company, so the information is not readily available.

Yes, it has. Serpin -- the company has 2 other open INDs that they've done other indications besides cancer chemotherapy. I don't know that they've disclosed the results of those, but there have been several other studies conducted to date.

Thank you, Sean, for attending and for your questions and happy to chat outside of today's call as you see fit.

[Operator Instructions] Okay. As we have no further questions on the lines at this time, I would like to hand the call back over to Mr. Duncan for any closing remarks.

Sure. Thank you. And once again, I want to thank you for those dialing in to today's call. We are very pleased to expand our commitment to cancer patients suffering from peripheral neuropathy. We're really excited about the SP16 license as a complementary asset to Halneuron.

The asset has already demonstrated in preclinical research, good anti-inflammatory activity to reduce harmful inflammation, complemented by increased protein signaling, which is essential to cell growth and survival. So a really interesting dual mechanism of action.

We think it's a very efficient transaction. It's an all-stop deal, royalty-free and the Phase Ib study, which will include safety as a primary, but all these exploratory assessments that we hope to add into the protocol is fully endorsed and funded by the NCI. Those funds are in hand with Serpin. So we're -- this program will start in first half of next year.

So our conviction in Halneuron is now complemented by our interest in the exciting new asset, SP16. We appreciate the time and energy. And as always, we'll provide updates as we progress through both clinical IP and other milestones, and I went through that list of milestones. So it should be a very active quarter 4 for us.

And now with SP16, we're very excited to say the first half of next year, we'll put our second asset into the clinic. Thank you, and have a very nice day.

Thank you, ladies and gentlemen. This does conclude today's call. You may disconnect your lines at this time, and we thank you for your participation.