# Squarex, LLC

Preventing oral herpes with a topical application to the arm

## Elevator pitch
We are developing a drug that prevents cold sores or oral herpes outbreaks in people with frequent outbreaks. The drug has completed Phase 2 clinical trials and has worked great. It significantly reduces the number and severity of cold sores, with 1 topical dose to the arm (not the face or lip) every 3 months. It acts by boosting immune function.

- Canonical URL: https://wefunder.com/squarexllc
- Entity ID: wefunder:company:73723
- Last updated: 2026-06-27T05:04:03Z
- Generated at: 2026-06-27T21:16:22Z

## Quick facts
- Successfully completed Phase 2 clinical trials with clear path to commercialization
- A single topical dose to the arm prevents outbreaks for over 4 months
- Clinical trials conducted at Harvard and Stanford
- Raised $5.75M in initial seed round
- Global Oral Herpes Market projected $1.29B by 2028
- Cofounded by former Executive Director of the American Board of Dermatology

## Active fundraises
- wefunder:fundraise:39656: 4(a)(6) successful (USD)
- wefunder:fundraise:39657: 4(a)(6) successful (USD)

## Story
>50% of persons suffer from HSV-1 infection15% of adults have 1 or more cold sore outbreaks annually2.1% of adults have 6+ outbreaks annuallyIn today’s oral herpes market, over 15% of the world population suffers from annual cold sore outbreaks with no means of prevention. Available treatments must be administered within hours of the first sign of a tingle, well before an open sore or redness develops, which is not feasible in many or most cases, and even then they only act to shorten the length of outbreaks once they occur, and only shorten the length by about 20% at most.SolutionSQUAREX: Prevention of Oral HerpesSquarex, developers of SQX770, a first-in-class immunomodulator that prevents Oral Herpes outbreaks for over 4 months with just a single topical application to the arm, offers relief to those suffering from cold sores.ProductSQUAREX Technology SQX770 is a topical immuno-sensitizer that prevents HSV-1 outbreaks though it’s active ingredient, Squaric Acid Dibutyl Ester (SADBE), which has been proven effective in preventing cold sores in two randomized double-blind placebo controlled clinical trials.SQX770 is easy to administer during or between outbreaks, requiring only a single dose to the arm to PREVENT outbreaks for 4 months or even longer. This means that annual prevention is sustained through just 4 quarterly applications.PatentsSquarex owns issued U.S. and foreign patents that provide market exclusivity for topical SQX770 in the US, as well as Japan, Canada, and Europe until at least 2036.  Additional patent applications not yet issued are pending in Europe, China, Canada, Japan, India, & Australia.The following patents are issued in the U.S.U.S. Patent No. 10,245,314U.S. Patent No. 10,940,197U.S. Patent No. 9,205,065U.S. Patent No. 10,744,084TractionSQX770 - Effective in All 3 Clinical Trials PHASE 144 persons, all reported 6+ outbreaks in prior year, treated on day 1 with Squaric Acid Dibutyl Ester (SADBE) or placebo.TRIPLED time to next cold sore outbreak versus placebo.No serious adverse events (mild reversible redness at sensitization site)PHASE 2 Mechanism of ActionPart 1. 36 persons, all anti-HSV1+ withGood immune control (0-2 outbreaks per year)Bad immune control (6+ outbreaks per year).Blood tests of immune function on day 1Result: Those with fewer outbreaks, better immune control had:Higher T-cell, type 1 immune responseLower antibody, type 2 immune responsePart 2. Effect of SQX770Patients with 6+ outbreaks per year were dosed once with SADBE on day 1. Immune tests repeated 8 weeks later.Result: SQX770 Improves the Immune Systems Response to HSV-1 Eight Weeks After Just ONE DoseIncreased immune cell proliferation to HSV-1 virusImproved immune gene expression against HSV-1 virus Restored immune levels even beyond that seen in persons with infrequent or zero outbreaksShifted immune response from type 2, antibody, response, to more effective type 1, T cell, response.PHASE 2139 patients with 4+ outbreaks per year, treated with Squaric Acid Dibutyl Ester (SADBE) replicated earlier Phase 1 outcome:Reduced frequency of cold sore outbreaksReduced severity of cold sore outbreaksMaximal effectiveness after initial immune training period, similar to a vaccineSafe & effective up to 4 monthsMarketA $1.29B Market by 2028 According to the report published by Data Bridge Market Research, in 2021 the global market for treating oral herpes is valued at $274M USD, and it is estimated that by the end of 2028 it will reach a valuation of $1.29B USD. The increase in market valuation will be driven by the increment of the number of new cases over time.SQUAREX plans to progress forward to FDA Approval through two simultaneous 12-month Phase 3 trials, with 1,800 patients, in the process of bringing SQX770 to market as the ONLY drug we believe to prevent HSV-1 outbreaks. Sales Revenue & Market PlansSales Revenue ForecastThe table below represents valuation scenarios based on multiples of enterprise value to revenues. We believe these estimates represent fairly both the growth potential and inherent risks in the Squarex business model. These projections are forward-looking and cannot be guaranteed.Disclaimer: These projections cannot be guaranteedCompany expects to complete a US FDA Phase 3 clinical Trial and to begin commercializing its product by 2025. Based on standard industry practices, it is important for investors to focus on year 2025 revenues and beyond. For example, should we meet our revenue expectations in 2026, transacting at a conservative revenue multiple of only 2.25X would represent a 400% gain to existing shareholders. These projections cannot be guaranteed.Market PlansSQX770 planned market entry opportunities leverage sales force partnerships to access physicians & D2C, including television & online marketing – comparable to other pharmaceuticals. Additionally, Squarex may partner with major pharmaceutical entities for market penetration and growth. Potential Exit Opportunities These potential exit opportunities are included to illustrate possible scenarios; none of these possibilities can be guaranteed.M & ABig Pharma continually seeks out new products through the use of Brokers, consultants, and industry insiders. Squarex would be an attractive acquisition or licensing opportunity for large pharmaceutical companies, both pre-and post-approval and revenue of the Squarex lead drug.PartneringSquarex may partner with an established pharmaceutical company, particularly one with a sales and marketing team that fits the Squarex product market, to market the Squarex product more efficiently. Initial Public Offering (IPO)Public markets are open and looking for new promising companies, providing greater liquidity and valuation. Squarex will consider an IPO within the next two to three years, which would give the current investors liquidity. CompetitionThe ONLY Way to Prevent Oral HerpesAvailable remedies for Oral Herpes from Abreva & Valtrex are for “treatment only,” must be taken within hours of feeling the first signs of a tingle, well before an open sore or redness develops, and only act to shorten the length of outbreaks once they occur. This includes drugs currently in clinical trials, other than SQX770. Because no other drug currently available, or in clinical trials, prevents cold sores, SQX770 is positioned to disrupt & dominate the HSV medication market. VisionLong Term Solution for Millions of People Suffering from Oral HerpesWith your investment, SQUAREX will make a sustainable impact on the millions of people suffering from Oral Herpes through our further development and market launch of SQX770. And we won’t stop there, as our technology has the further potential to similarly address Genital Herpes and other viruses.Timeline & Use of Funds (raising $1.07M on Wefunder)$5M Capital Raise, 18 MONTHS: Phase 2 Bridging StudyDrug manufacture and stability testing.Further animal safety testing.$20-40M Capital Raise, 13 - 36 MONTHS: Phase 3 Clinical TrialsNew Drug ApplicationINVESTING IN PREVENTION OF ORAL HERPESEARLY STAGE STARTUP OPPORTUNITY. When you invest in Squarex you are buying stock in an Early Stage startup — like investing in Gilead Sciences when it was just the founders, and where the company now garners annual revenues of approximately $24B. Such successful companies are often measured in tens or hundreds of billions of dollars— you are buying into Squarex at an early stage valuation. There are always risks in investing (see below) so investing in strong teams, with strong products, and successful backgrounds such as Squarex embodies helps limit risk while seeking high returns.OPEN TO ALL INVESTORS. Prior to the JOBS ACT, investing in early-stage startups was not an option for non-accredited investors, and now everyone has the opportunity to participate in the startup economy. With approximately $6 million invested in its lead drug SQX770 and in enterprise development, and as creator of the only drug shown to prevent cold sore outbreaks, and the only drug that reduces both the frequency and severity of cold sore outbreaks.FOUNDERSHugh McTavishFounder & CEO, Ph.D. biochemist and patent attorney, and inventor of the company's drug. Hugh has additionally founded a company with a targeted cancer drug as well as a nonprofit. “I invented this treatment to cure my own frequent cold sores. At the time I was having almost constant cold sores, and I had had frequent colds sores my whole life. After trying this on myself, I have fewer than 1 cold sore episode per year now. We want to help other people with this painful, annoying, and embarrassing condition.”Thomas D. HornThomas D. Horn, M.D., is the co-founder of the company, co-inventor of the company’s technology, and an advisor to Squarex. He is a dermatologist, is on the dermatopathology Faculty at Harvard Medical School, and is former Executive Director of the American Board of Dermatology.Management TeamKathleen Littrell Kathleen Littrell, M.S., is Squarex’s Vice President for Business Development and Clinical Development. She is a scientist and manages the Company's clinical trials. She has over 10 years of working experience in all aspects of clinical trials. Arkadiusz DudekArkadiusz Dudek, M.D., Chief Medical Officer and Board Member of Squarex, is a practicing physician at Regions Hospital, Saint Paul, MN, and a professor at the University of Minnesota Medical School. He has previously been on the faculty at the University of Illinois Chicago medical school. He has extensive experience in clinical trial design & is also on the Board of IGF Oncology and other small pharmaceutical companies.Gary Hildebrand Gary Hildebrand, J.D., Board Member, is a licensed attorney, army veteran, and past president of two industrial technology companies, and consultant to several companies.Joe Cunningham Joe Cunningham, CFO, has a multi-faceted background and an institutional toolbox to help realize Squarex’s ambitions. As an economist and former investment banker, he has raised over $5 billion. He has run public and private companies globally, led complex negotiations, handled complicated deal structures, managed investors relations, structured and executed numerous deals, run legal and compliance, developed and implemented strategy; and, as a CFO, he has run the day-to-day functions of diverse and often global finance departments. Joe’s experience in pharmaceuticals includes Healthcare Management Asia, Systems for Health Management (a clinical trail data management company), AXM Pharma and Gamma Pharmaceuticals. Previously, as an investment banker he worked for BNP Paribas in Singapore and ANZ Investment Bank in Singapore and London and as an economist for Polyconomics in New York. Joe Graduated from Northeastern University (Boston) with a BS in Economics and has an MBA from the Thunderbird School of Global Management.

## FAQ
1. **Is the future equity common or preferred, and are you all planning on remaining an LLC for tax purposes prior to any IPO?**
   - The future equity is preferred. It would be an LLC currently and we plan on remaining an LLC until we go public, for tax purposes as you say. When we go public we would become a C corporation and your equity would be preferred stock, and I would like to take the company public.
2. **Hello, how many people participated in the clinical trials to date?**
   - 43 in Phase 1, 29 of whom got real drug and the rest placebo. 32 in a mechanism of action clinical trial got real drug. 143 in Phase 2, of whom 2/3 got real drug. In total about 150 people have been dosed with SQX770.
3. **Could you explain your valuation?**
   - Hi Nelson, it's Joe Cunningham, Squarex's CFO please note the following DCF calculations. Please know we look at the valuation from a number of different perspectives. We use various methods including a discounted cash flow and comparative marginal analysis. Ultimately it's a function of demographics. 15% of the adult population has 1 or more cold sore outbreaks each year, and 2.1% has 6 or more per year. Approximately 3-4%, therefore, have 4 or more outbreaks per year. The condition is about...
4. **Hello. Is the finished product envisioned to be applied by a physician or would it be in-home use by the patient themselves?**
   - It will be applied by the patient at home. It would be sold like an ordinary prescription drug, picked up at the pharmacy, and applied at home. That is more convenient for patients and better for our business than if it were sold and applied at physicians' offices.
5. **When will this product be available for public use?**
   - That depends on fundraising. If we are successful in this raise and raising the investment money we need to complete the Phase 3 trials, it could be available in as soon as 2 years.

## Team
- Hugh McTavish (Founder and CEO)
- Thomas D. Horn ( Co-Founder)
- Kathleen Littrell (Vice President for Business Development)
- Arkadiusz Dudek (Chief Medical Officer & Board Member)
- Gary Hildebrand (Board Member)
- Joseph Cunningham (CFO)

## Recent posts
- Squarex Wefunder Campaign is Closing1 Last Chance to Invest by Feb. 28! Team had success before with another pharma company. (2022-02-24T20:14:24Z)
- Squarex Wefunder Campaign Closing on February 28 (2022-02-15T02:06:24Z)
- Investment Bank Update (2022-01-06T20:11:45Z)
- Squarex Pharma has signed a term sheet to go public and receive $12 to 75 million investment. (2021-11-22T22:38:24Z)
- Webinar: Squarex Pharma--the only drug that prevents cold sores. Tuesday 9/28 at 7 pm Central. Forward and invite your friends! (2021-09-25T20:08:04Z)
- Money Nation-Squarex-CEO & Founder Hugh McTavish-Ed Gardner-Podcast Interview (2021-09-22T22:25:30Z)
- Wefunder has filed the Form C for Squarex! We can now officially accept investments! (2021-09-14T15:29:41Z)
- Squarex Passes the $70k Mark. Discussing Strategic Partnerships. (2021-08-09T21:05:16Z)
- Together, WE can Prevent Herpes Outbreaks! (2021-06-28T22:18:42Z)

## Q&A
- Q: Could you explain your valuation?
  - A: Hi Nelson, it's Joe Cunningham, Squarex's CFO please note the following DCF calculations. Please know we look at the valuation from a number of different perspectives. We use various methods including a discounted cash flow and comparative marginal analysis. Ultimately it's a function of demographics. 15% of the adult population has 1 or more cold sore outbreaks each year, and 2.1% has 6 or more per year. Approximately 3-4%, therefore, have 4 or more outbreaks per year. The condition is about equally common in children as in adults. The DFC calculation is as follows: Discount Rate 30% Terminal Growth Rate -2.0% PV Terminal Value $13,500,000 PV Free Cash Flow $141,918,127 Less Debt $ - PV - Equity $119,552,406 Thanks for your question. JC
- Q: How often will we receive updates on the company? As an investor I like to keep up-to-date on where the company stands and next steps being taken to get to market.
  - A: I will email you all an update next week after Thanksgiving. I see this was from July 28. I think I sent an email since then, but anyway I will send one next week.
- Q: Hello, how many people participated in the clinical trials to date?
  - A: 43 in Phase 1, 29 of whom got real drug and the rest placebo. 32 in a mechanism of action clinical trial got real drug. 143 in Phase 2, of whom 2/3 got real drug. In total about 150 people have been dosed with SQX770.
- Q: Is the future equity common or preferred, and are you all planning on remaining an LLC for tax purposes prior to any IPO?
  - A: The future equity is preferred. It would be an LLC currently and we plan on remaining an LLC until we go public, for tax purposes as you say. When we go public we would become a C corporation and your equity would be preferred stock, and I would like to take the company public.
- Q: Dear Hugh, I have two questions to your interesting journey: 1) in a press release earlier this year you stated “ Squarex seeks a global strategic partner with which it can collaborate to exploit its SQX770 drug and take it through final clinical development to market authorisation.”, how is this going? 2) do you have any other products in your pipeline/other future uses for the same drug?
  - A: We have interest from a large Indian pharma company for a license for the India market. But we are less interested in finding a global partner in the near term. We plan to go public and raise enough money to complete the clinical trials ourselves, and then we will evaluate whether to sell the drug ourselves or sell the company or license or partner with a large pharma company to sell the drug.
- Q: I purchased $1,000 last night, Thank you. On StartEngine I bought MedVector which does telemedecine for clinical trials recruiting. Have you used them or similar for recruiting? Also, can investors' Friends/family gain access to participate in trials? It would be a great perk and my best beautiful friend would be delighted and empowered by taking part. Thank you!
  - A: Thank you for your investment, Robert. We have not used MedVector but have explored using telemedicine in our next clinical trial, which we probably will do. That will help recruiting we think. Anyone meeting criteria can participate in our clinical trials. When we start our next trial we will email all who have invested to invite them to enroll or tell their friends to enroll if they wish.
- Q: Hi Hugh, can you confirm please. I'm reading through the phase two trial notes, 23% of the one dose group experienced one or more outbreaks during days 43-121, correct? So based on that we can hypothesis that this product has an efficacy rate greater than 75% for completely stopping outbreaks for 4 months? Do you also think that the 23% will see an improved immune response if they continue to use the product? Thank you
  - A: Those numbers are right. But not everyone would have had an outbreak in those 4 months, so I think a better way to look at is that in that time frame the people on real drug had 2.6-fold fewer outbreaks than those on placebo. So the drug cuts number of outbreaks more than in half (by 62%). Also, the outbreaks people had were significantly less severe (less likely to be an open sore or fluid-filled blister) than the outbreaks of those on placebo. So it significantly reduced the severity of the (fewer) outbreaks people had as well as reducing their number. And yes, I think if you continue to take the drug you will continue to have fewer outbreaks. Actually, over time I would expect you might ultimately not need to continue to take it. But we have no data on that. Personally, I have been taking it for years and have not had an outbreak in maybe 3 years or so. Before I took this drug I was getting probably 6 episodes per year.
- Q: So, you're massively valuing your company based on the size of the market for your unproven product (3 tiny trials with a total of 150 people who actually received your drug)? I'll admit that I'm not educated in your field. But I've watched Shark Tank for a decade now and they always chastise the entrepreneurs who do that. Can you explain why this is a proper valuation?
  - A: First, it really doesn't matter that we are valuing the company at $99 million. You will get a 15% discount relative to the next IPO or venture capital round, plus the 15% early bird discount, so actually a 30% discount at this point, whatever the market or the venture capital firm values us at. Second, we are not comparable to the garage businesses on Shark Tank selling a pet collar or something. The pharmaceutical business is a very big business with very big valuations and it takes a lot of money to get to drug approval. We have raised $6 million and spent that very efficiently to get through Phase 2 clinical trials. That is unheard of. We are two-thirds of the way to drug approval. But the phase 3s will cost $20-40 million, and we will raise that through an IPO and/or VC round. Pharmaceutical companies through Phase 2 clinical trials that are publicly traded have valuations north of $200 million usually. In fact, there are plenty of pharma companies that are publicly traded and do not even have a drug into clinical trials and the drugs they have planned have much smaller market than ours and have valuations of over $200 million. We are one of a handful of companies on Wefunder that have a real shot at being a large publicly traded company. And we plan to be.
  - A: My answer above is now correct. Investors are getting the lower share price (better deal for investors) of (a) 30% below the next priced round for early bird investors (15% after the early bird is over) or (b) $89.1 million maximum valuation ($99.1 million after the early bird is over). When I wrote the answer below the early bird discount really only applied to the valuation cap but not to a price determined by the next priced round. But we have now updated this, so it is a better deal for investors. The deal applies of course also to those who have already invested.
- Q: In one of your answers, you say there are no approved products for HSV prevention. That is patently untrue. Valacyclovir is approved by the FDA for suppressive therapy (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf). You should clarify your comment to be in line with the truth.
  - A: There are no approved products for oral herpes prevention, which is the indication we are seeking approval for. I think that is what I said. Valacyclovir is approved for prevention of genital herpes, not oral herpes.
- Q: How will the project and the company continue while Huge McTavish runs for governor? or during your time in government?
  - A: I would not worry too much about it. It is unlikely I will win. If I win, I will stay on as CEO while I am Governor while we hire someone else to be Chief Operating Officer. After 6 months or so I would expect to hand the CEO job to that person and stay on as Chairman of the Board.
- Q: There's not been any news online since early last year with the end of phase two trials. Can you post an update.
  - A: We have posted news about the wefunder raise and now about the fact that we have a signed term sheet with a VC firm to invest $12 to $75 million into Squarex and take it public. We have not conducted any clinical trials since the Phase 2, so there is no news on that front. We need to get money in the door first and resume clinical trials.
- Q: What kind of side effects are there? As far as the efficacy and side effects, what would make it or break it in Phase 3?
  - A: The main side effect is a mild rash and redness that appears on the arm at the drug application site. This occurs in about a third of patients. The rash entails mild itching and pain that people score in most cases at 1 on a 1 to 5 scale and resolves in most cases within 2 or 3 days. The redness can last up to 2 months in some cases, but it is hidden under your arm so no one sees it.
- Q: Hi Hugh. Thanks for the detailed answers to my previous questions. Just wanted to clarify in the manufacturer you've identified, while FDA qualified, has any products currently on market and / or has the manufacturing site been inspected previously. Thanks
  - A: I am not sure about other products on the market, but I think so. They are FDA inspected.
- Q: If your exit plan is a buyout, do you have a price in mind? How about a likely interested party? Do you see your productand IP being of interest to any companies in particular?
  - A: The exit plan is probably an IPO or going public by reverse merger within the next year. Our stated valuation of $99 million would be at the low end of the price we would have in mind. That is, as a public company we think we would have a market capitalization of over $99 million. We would be open to buyouts from bigger pharma companies, but we do not have a specific target in mind. We are in discussions now with Abbot India about licensing the rights for the India market. Any large pharma company might be interested in this drug, but I think we are more likely to get an offer and a better offer if we have a credible plan to take the drug to market ourselves. As a public company we would have the capital to credibly take the drug to market ourselves.
- Q: Hello. I watched the webinar and have a few specific questions: 1. Regarding the delivery device itself, have you identified a manufacturer to design it? If so, what is the status? Does the manufacturer have any products currently on the market? 2. Have you had (or have scheduled) your end of phase 2 meeting w the FDA? 3. Have you attempted any PK/PD modeling to validate the dosing regimen prior to P3 trials beginning? Thank you.
  - A: (1) We do have a manufacturer who has manufactured our delivery device and will in the future and whom we plan to use for the commercial product. They are an FDA-qualified manufacturer. (2) We have completed our End of Phase 2 meeting with the FDA and it was successful. We have a clear plan and agreement on what we need to do in our remaining clinical trials to get approval. We need to do two Phase 3s in parallel, following patients for 12 months and including pediatrics. We do not need to follow for more than 12 months in any way, and do not need to do any further carcinogenicity testing or any other unexpected or onerous testing. (3) We have not done any PK/PD testing (it stands for pharmacokinetics and pharmacodynamics, for others who are reading this). We will do PK testing in animals and in our Phase 3s on a subset of patients. That is standard and should not be a problem. PK is measuring drug levels in blood. I do not really expect any drug to be detectable in blood because we are dosing a small amount and I believe it reacts with proteins in the skin and very little ever reaches the blood.