Squarex Pharmaceutical Corp.

General Information

Squarex Pharmaceutical Corp. is a Phase 2 biotech developing a therapy to prevent cold sores.

We are a late-clinical-stage pharmaceutical company developing a drug that is intended to improve immune function to reduce severity and incidence of infectious disease with an initial focus on oral herpes.

Our drug SQX770 has completed a Phase 1 and a Phase 2 placebo-controlled clinical trial and showed a statistically significant1 effect in non-primary endpoints in both trials of delaying time to next herpes labialis (on or near the lips) or oral herpes (cold sore) outbreak (from day 1 to day 121 in the Phase 1 and from days 42 to 121 in the Phase 2) and reducing the number of outbreaks of cold sores (herpes labialis) in the period from 42 to 121 days after a single dose in persons with frequent outbreaks (in the Phase 2). (These were not the planned primary endpoints in either clinical trial and the results failed to meet the planned primary endpoints in each trial.) In a third exploratory clinical trial testing the mechanism of action of the drug without a defined primary endpoint, SQX770 was shown to alter the immune response against the herpes simplex virus of patients with frequent outbreaks to more closely match the immune response at the cellular level of persons who are infected with HSV-1 but have few or no oral herpes outbreaks. For instance, eight weeks after one dose of SQX770, expression of interferon gamma, a key anti-viral cytokine, by immune cells exposed to herpes simplex virus type 1 (HSV-1) in vitro was significantly increased. The same clinical trial showed that persons infected with HSV-1 with 0 to 2 outbreaks in the prior 12 months had significantly higher interferon gamma expression in the same test than persons with 6 or more outbreaks in the prior 12 months. The drug has been well tolerated in clinical trials with no serious adverse events. None of the data obtained in clinical trials to date would be accepted by the FDA as indicative of efficacy. The FDA will base any approval on the results of Phase 3 clinical trials, which have not been initiated.

The SQX770 drug is topically applied on a patient’s arm, not the face or lip or a lesion. In the Phase 3 trials and commercially, we plan to dose patients once every three months.

The use of SQX770 was co-invented by the Company’s founder and CEO, Hugh McTavish, who initially tested it on himself to prevent his own frequent cold sores. It almost eliminated his cold sores. This self-testing of the product candidate did not provide any data that the FDA or other regulators would accept as indicative of safety or efficacy.

**Note: We are a pre-revenue company. Figures for revenue (none from commercialization of a product) and net loss are for the year ended Dec. 31, 2021.

 We believe that we possess a number of competitive strengths that position us to become a leading pharmaceutical company focused on oral and genital herpes, including:



Patent protection with patent exclusivity in the U.S. under method of treatment patents until at least 2036 with a composition of matter patent expiring in 2028.


Our SQX770 drug has shown a statistically significant effect of preventing oral herpes outbreaks in two of two clinical trials where outbreaks were counted, although the measurement showing significant efficacy (a significant difference between the treatment group and a placebo group) was not the measurement pre-specified as the primary endpoint in either case. SQX770 significantly altered the anti-herpes immune response of immune cells isolated from patients in a third clinical trial, where the alteration eight weeks after one dose of the drug made the immune characteristics of the patients with frequent outbreaks more similar to those of persons infected with HSV-1 but having few or no outbreaks.


We have completed an End-of-Phase-2 Meeting with the U.S. Food and Drug Administration (“FDA”).


Oral herpes is a common condition, with about 15% of the U.S. and world populations having at least one outbreak each year.


SQX770 would be the first drug approved for the indication of preventing oral herpes outbreaks.


SQX770 is relatively inexpensive to manufacture.

Our goal is to be the leader in preventing and treating both oral and genital herpes outbreaks and, potentially, develop drugs for other infectious diseases. Key elements of our strategy include:



To obtain FDA approval of SQX770 for preventing herpes labialis outbreaks. We believe this to be a potentially enormous market.


To obtain FDA approval for preventing genital herpes outbreaks. Clinical trials for that indication may be conducted in parallel with the trials for oral herpes. We believe that the genital herpes market potential is probably about the same size as the oral herpes market potential.

(Note: Squarex Pharmaceutical Corp. filed its S-1 on Jan. 17, 2023.) 

Employees: 1
Founded: 2012
Contact Information
Address 1000 Westgate Drive Suite 1010 Saint Paul, MN 55114
Phone Number 651-207-8270
Web Address https://www.healthcaretriangle.com/
View Prospectus: Squarex Pharmaceutical Corp.
Financial Information
Market Cap
Revenues $0 mil (last 12 months)
Net Income $-0.36 mil (last 12 months)
IPO Profile
Symbol SQRX
Exchange NASDAQ
Shares (millions): 0.0
Price range $0.00 - $0.00
Est. $ Volume $15.0 mil
Manager / Joint Managers EF Hutton
Expected To Trade:
Status: TBA
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