Valion Bio, Inc. Common Stock Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 14, 2025

Key Takeaways

  • Positive Sentiment: Tivic expanded into the biopharmaceutical sector by licensing Sotera’s TLR5 agonist portfolio, including Phase III candidate entolimod targeting acute radiation syndrome with multi‐hundred million dollar stockpile potential.
  • Positive Sentiment: Entolimod received FDA Fast Track and Orphan Drug designations for ARS and the company plans a Type B meeting to confirm BLA requirements for an accelerated approval path.
  • Positive Sentiment: The company initiated GMP manufacturing validation with Scorpius and is transferring two INDs to enable bioequivalence and stability testing as steps toward regulatory filings.
  • Negative Sentiment: Tivic announced its intention to exit the ClearUp consumer device business by year‐end due to underperforming sales and is refocusing resources on prescription therapeutics.
  • Neutral Sentiment: Second quarter revenue fell to $86K and net loss widened to $1.9M, with cash down to $1.2M, though the company raised $900K post‐quarter to fund key development milestones.
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Earnings Conference Call
Valion Bio, Inc. Common Stock Q2 2025
00:00 / 00:00

There are 3 speakers on the call.

Speaker 1

Welcome to Tivic Health Systems' second quarter 2025 financial results and operational update conference call. This call has been pre-recorded. This call is being webcast, and the replay will be available on the IR section of the company's website for three months. Before we begin, let me remind you that during today's call, management will make various forward-looking statements. Investors are cautioned that these forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated in our forward-looking statements.

Speaker 1

Please read the safe harbor statement contained in the press release that Tivic Health issued today, as well as the risk factors contained in Tivic Health's filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2024, and the Form 10-Q to be filed with the SEC today, as well as other company SEC filings. On today's call, we have Tivic Health's Chief Executive Officer Jennifer Ernst and Chief Financial Officer Lisa Wolf. Now, let me turn the call over to Jennifer Ernst.

Operator

Thank you, and welcome to those of you who are joining us today. Before we cover the financial portion of the earnings call, I want to lay the groundwork for those who may have just begun to follow Tivic. Over the course of the last six months, we have reshaped the company by expanding Tivic into the biopharmaceutical sector. We've also been advancing ongoing work with our next generation of vagus nerve stimulation devices. This combination of assets makes Tivic unique in having the ability to treat disease by addressing both the body's biochemical and bioelectronic systems that regulate immune responses. We believe we now have quite a robust set of opportunities in the pipeline and ones that are able to generate a significant return on investment.

Operator

In this context, our expansion into drug development with our exclusive licensing of Statera Biopharma's portfolio, a portfolio of TLR5 agonist assets, provides Tivic a late-stage, highly de-risked phase three drug candidate and multiple additional indications. Specifically, Entolimod, the first commercial opportunity of the TLR5 portfolio, was developed as a military countermeasure to lethal levels of ionizing radiation. Most governments maintain a national stockpile of emergency use quantities of treatments for ARS to be accessed in the instance of a nuclear event. Now, in addition to that, in addition to the strategic national stockpile, U.S. defense agencies maintain ARS treatments to protect active duty personnel. This includes, for example, the nearly quarter million military and civilians deployed overseas. Because of the volume and because of these stockpile opportunities, a single contract for ARS has the potential to total several hundred million dollars.

Operator

During the second quarter and in recent weeks, we have made additional progress in validating the U.S. government's interest in Entolimod for ARS. Most recently, we met with key decision makers at the Military Health System Research Symposium, MHSRS, as it's known in the industry, and these meetings reinforced our belief that both avenues present opportunities for us to generate significant sales of Entolimod and a great value for our shareholders. Which takes us to the regulatory front. We previously met with senior officials at the FDA in the form of an educational meeting. In parallel at that point, and as we've continued, we've also discussed the potential for an emergency use authorization for Entolimod for ARS, which may enable earlier approval of this potentially life-saving drug. The FDA has already granted Entolimod a fast-track designation for ARS and an orphan drug designation for pediatric ARS.

Operator

We are now in the process of planning a type B meeting this year to confirm the final clinical manufacturing and validation requirements for our planned BLA. We will be further discussing these accelerated paths with the FDA as we move towards the filing process. In addition, we are in the process of transferring two existing INDs to Tivic from Statera Biopharma. Completion of this transfer will enable us a full formal engagement with the FDA under the two fronts of the INDs. In May, we began work with Scorpius Biomanufacturing on the GMP manufacturing validation of Entolimod for acute radiation syndrome. This is the next step in our process towards preparing a Biologics License Application. Once the first lot of GMP materials has been manufactured at Scorpius, we will begin bioequivalence and biostability testing, and the latter of those two can take approximately a year.

Operator

As a whole, the second quarter began an aggressive push on the ARS indication for Entolimod. As I mentioned, though, this exclusive licensing agreement is helping us build a pipeline. Entolimod and its derivative Entolasta, for both of which we have a worldwide exclusive license, also have the potential to treat radiation and chemotherapy side effects that are caused by cancer treatments, specifically, neutropenia and GI tract damage. According to various market research firms, neutropenia drugs represent anywhere from a $19 billion to $24 billion market over the next few years. The lion's share of that market is being addressed by colony-stimulating factors such as the GCSF drugs. Because Entolimod works upstream in the immune system, it engages not only the GCSF pathway, but a much wider range of mechanisms, potentially yielding a wider range of benefits.

Operator

Neutropenia itself is a condition characterized by an abnormally low number of neutrophils or white blood cells that reduces the body's ability to combat infections. Entolimod has been shown to prevent cell death or apoptosis, such as that seen during radiation treatment, and thereby promoting cell preservation. Now, at this time, we are in the early stages of investigating potential research sites for a future clinical trial program for Entolimod for neutropenia. We have a great deal of flexibility on the timing of any trials. While we may or may not commence trials this year, we are working to secure the right advisors and research partners. We believe this is now becoming an important part of our strategic pipeline.

Operator

Our belief is that Entolimod could be a very significant opportunity in the oncology market, as it is potentially the only therapy that can both prevent and treat radiation-related damage to both human hematopoietic and gastrointestinal cells, and to do so with a single dose. The licenses we acquired align very well with our internal developments in vagus nerve stimulation. Together, they create a robust pipeline focused on various forms of immune dysregulation. I'll note that we've been investing in bioelectronics because we believe this is one of the most compelling new areas of immune system regulation. Our novel non-invasive approach utilizes electrical signals to target immune responses that are implicated in cardiac, neurologic, and autoimmune conditions. In late June, we announced that we have completed all of the study visits in an optimization study for a patent-pending non-invasive cervical vagus nerve stimulation device.

Operator

Because of the greater understanding gained from this trial, including initial findings that reinforce for us the importance of personalization to drive the therapeutic efficacy, we're more confident than ever that our NCVNS device has the potential to deliver clinical outcomes similar to or better than those of the surgically implanted vagus nerve devices. The Feinstein Institute, which is a leader in the study of vagus nerve stimulation, is working with us now to prepare a report on the optimization trial findings. I definitely look forward from seeing the previews to reporting those trial results later this year. As I've just described, Tivic now has a very compelling and unique clinical pipeline. Our therapeutics marshal the immune system to treat underserved medical conditions through biologic and bioelectronic therapies.

Operator

With this robust and compelling pipeline as backdrop, we have determined that it is in the best interest of shareholders to exit the consumer health tech business by year end, whether through a strategic transaction, spin-off, or a full divestiture. While ClearUP demonstrated the company's ability to successfully advance a treatment through the FDA and launch a regulated product, ClearUP's sales simply have not met our expectations. We believe it is now in the best interest of shareholders in order to build value to focus Tivic's resources solely on our prescription-based therapeutic pipeline. This refocusing is evident in our financial results as we down-prioritize marketing and sales of ClearUP. At this point, I'd like to ask Lisa Wolf to review the financial results for the quarter.

Speaker 2

Thank you, Jennifer. For ease of listening, all of the financial metrics I will be reporting compare the second quarter ended June 30, 2025 to the prior year quarter ended June 30, 2024, and the six months ended June 30, 2025 to the six months ended June 30, 2024, unless otherwise stated. Financial results for the second quarter and the first half of the year reflect our transition as a company with our focus towards the biopharmaceutical market and away from the consumer device market. Revenue net of returns totaled $86,000 for the quarter compared to $140,000 in the year ago quarter. Revenue net of returns totaled $156,000 for the first half of 2025 compared to $474,000 for the first half of 2024. The decline was due to decreased unit sales of ClearUP, which were a result of reductions in our overall marketing expenditures.

Speaker 2

We have intentionally reduced our advertising expenses in order to focus our capital resources into the advancement of our TLR5 program. Cost of sales decreased to $32,000 from $110,000 in the year ago quarter and to $52,000 from $277,000 for the six-month period. The decreases were primarily due to the decreases in unit sales and the restructuring of our supply chain with new partners that was completed in August 2024. Gross margins have increased to 63% for the second quarter compared to 21% a year ago and increased to 67% from 42% for the first half of 2025 compared to 2024. The increases were due to reductions of our product support and fulfillment costs. Operating expenses were $2,000,000 for the second quarter of 2025 compared with $1.3 million for the same period in 2024.

Speaker 2

Operating expenses for the first half of 2025 were $3.5 million compared to $3 million for the first half of 2024. The increases were primarily due to increased research and development investments in our biologics program offset by reductions in sales and marketing costs for ClearUP. Net loss was $1.9 million for the second quarter of 2025 compared with $1.3 million for the second quarter of 2024. Net loss for the first half of 2025 was $3.4 million compared with $2.7 million for the first half of 2024. At June 30, 2025, cash and cash equivalents totaled $1.2 million compared with $2 million at December 31, 2024. Subsequent to the quarter's end, we raised gross proceeds of $0.9 million through utilization of our equity line of credit and the sale of Series B preferred stock pursuant to our preferred purchase agreement. The company has no debt on its balance sheet.

Speaker 2

We believe these funds, along with the $7 million in remaining planned tranches of our preferred purchase agreement, will allow us to make meaningful progress toward GMP manufacturing validation for Entolimod, which is a key value inflection point for the company and will provide a strong signal of our potential to achieve commercialization. With that, I'll turn the call back over to Jennifer.

Operator

Thank you, Lisa. Let me finish my prepared remarks by highlighting a few other areas of important progress that we achieved during the quarter. We made important adjustments to our staff to align the team more closely with our newly defined focus. One of those changes included having Lisa join us now as our CFO from her previous role as Interim CFO. Lisa, let me congratulate you on that move. We also made important investments in talent to advance the Entolimod program. To support our clinical work and create a government relations capacity, we hired key team members from Statera Biopharma that include a Head of Regulatory and Quality, Clinical Operations, and a new Business Development Lead. We're very pleased to have this infusion of talent, and I'm looking forward to working with these new team members and to their contributions in advancing our clinical and commercial opportunities.

Operator

Blake Gurfein stepped down as our Chief Scientific Officer, but stays on as a consultant to support advancing our non-invasive vagus nerve stimulation device program as we continue to refine the focus of that program. Looking ahead, our next milestones include completing the transfer of existing INDs from Statera Biopharma to Tivic Health Systems, completing the cell line verification, completing our first batch of GMP materials, validating bioequivalence, which we can commence working on upon receipt of those materials, reporting out the study results of our non-invasive vagus nerve stimulation device trial, and meeting with the FDA for the previously mentioned Type B meeting on Entolimod. We will, of course, be providing updates to our shareholders as each of those milestones are completed.

Operator

I look forward to reporting to you as we move the company increasingly into these new clinical areas and delivering what we expect will be life-changing treatments for patients in need and strong value creation for shareholders. With that, I'd like to say thank you for the time you've taken today and have a very good rest of the day.

Speaker 1

Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.

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