PharmaTher Holding (CSE: PHRM, OTC: PHRRF) is a company focused on ketamine benefits for mental health, neurological and pain disorders, anesthesia, and procedural sedation. Last month, the company submitted an FDA package for a new drug application for its Ketarx on-body pump system. Since late December 2022, the company gained more valuation from investors as the stock bounced back from its 52-week low. 

Ketamine Overview & Sector Growth

Since ketamine is a surgical anesthetic, it aids in calming the mind and lessens some of the discomforts from specific procedures. Ketamine has several advantages, one of which is a reduction in the requirement for narcotic medications. This is a massive benefit because long-term narcotic use increases the risk of tolerance and problems. Ketamine might be an excellent substitute for conventional therapies if you experience persistent pain. When used correctly, ketamine doesn't significantly alter your heart rate or blood pressure. This makes it highly safe to use during surgery because many other medicines that have a sedative effect can lower your blood pressure, which can cause problems.

MarketWatch estimates that the global market for ketamine treatment was worth USD 132.43 million in 2021 and is projected to grow at a CAGR of 75.52% over the course of the forecast period to reach USD 3871.44 million by 2027. Furthermore, PharmaTher can potentially attain 700M persons with mental health disorders such as depression, suicidal ideation, etc.

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Company Overview

PharmaTher Holding (CSE: PHRM, OTC: PHRRF) is dedicated to the study, creation, and distribution of specialized ketamine pharmaceuticals for anesthesia, procedural sedation, neurological and pain diseases, and mental health conditions.

The company aims to commercialize Ketarx, issued from Ketamine. It can be used either by injection, a pump, or a patch. The company already has 5-FDA approvals and 20 granted patents, PCTs, and provisional patents. 

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On February 7, 2023, in a press statement, PharmaTech stated that it had submitted its Type B meeting package to the FDA in order to discuss the last-minute requirements for the KETARXTM On-Body Pump System (subcutaneous racemic ketamine) and the submission of an NDA through the 505(b)(2) process. In accordance with the FDA-approved label for ketamine, PharmaTher seeks FDA clearance for the KETARXTM On-Body Pump System for the upkeep of anesthesia and as a complement to other anesthetic drugs. In addition, to expand the label for particular areas of application or types of operations where the subcutaneous route of administration would be practical, the use of the KETARXTM On-Body Pump System for sedation during brief diagnostic and surgical procedures is also being investigated. This method encourages and might even enhance the administration of ketamine in clinical and hospital settings.

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“We are in a position to meet with the FDA to obtain guidance on the final requirements for our KETARX™ On-Body Pump System to support a new drug application under the 505(b)(2) pathway. In the short term, we will seek FDA approval for our KETARX™ On-Body Pump System in general anesthesia and sedation for surgical procedures. If successful, this strategy would create a strong foundation in efficiently expanding to mental health, neurological, and pain disorders.”

Fabio Chianelli, CEO of PharmaTher

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What comes next? 

Before being commercialized, there is still some way to go for the company, and several milestones have to be achieved. Amongst them, here are some of the milestones PharmaTher expects to accomplish during 2023: 

-H1-2023: the company already submitted an FDA IND of a Ketarx pump for anesthesia and pain for 505(b)(2) approval. Now the company expects to receive the results of a Phase 2 study of ketamine for Rett Syndrome and initiate a Phase 2 study for Ketarx patch for depression and pain. 

-H2-2023: PharmaTher expects to obtain FDA approval for its Ketarx IV injection and initiate a Phase 3 study for the Rett syndrome and Parkinson’s disease. 

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Share Structure / Financials 

The company is well-funded and can last some time with no financing. On November 30, 2022, the company possessed $7.1M in cash for no debt. Out of all the expenses, Pharmatech used $555k in research, representing 66% of its costs. The more extensive loss results from a loss on investments, representing $1.5M from 6.6M shares of Revive Therapeutics. 

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PharmaTher doesn’t have a high share structure for a research company. So far, only 88.1M shares have been issued and are outstanding. 5.7M options (avg. price: $0.16) and 16.8M warrants (avg. price: $0.80) are available. PharmaTher can exercise options but not the warrants because the stock price is too low. Another piece of information is insiders hold around 19% of the company. 

The stock price trades around $0.17 (March 13, 2023). Its 52-week low is worth $0.055, while the PHRM topped $0.265, representing its 52-week high. 

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Bottom Line

PharmaTher Holding (CSE: PHRM, OTC: PHRRF) makes significant discoveries. With a focus on ketamine benefits, the company penetrates a rapidly growing market. Several landmarks are set to happen between phase results and FDA approvals bringing the company always closer to commercialization. PharmaTer is well-funded and doesn’t have to do any financing for now. The stock price picked up some steam since late December 2022, and the company should gain in valuation over time. 

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