Biotech Co. Initiates Feasibility Study

Earlier this month, biotech company Awakn Life Sciences Corp. (AWKN:NEO; AWKNF:OTCQB) announced a study of a novel oral thin-film ketamine formulation designed to make its therapy possible without syringes.  This morning the company released it has initiated a feasibility study of MDMA leveraging Catalent’s proprietary Zydis ODT fast dissolve technology. 

According to the company, "Zydis ODT is a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, allowing for dosing with no water required. When formulated appropriately, the technology affords the potential for better pre-gastric absorption, a more efficient delivery, rapid onset of effects, an enhanced patient experience, and compliance."

Feasibility Study

This study will work on establishing Catalent’s Zydis ODT technology for the delivery of MDMA. If proven feasible, Awakn will then develop a production formula. The company believes if successful, this will aid in the delivery of MDMA and minimize the dose required and variability in absorption, which will increase the overall speed of onset. 

Shaun McNulty, Awakn’s CSO, said, “ The Zydis platform offers the potential to minimize both the MDMA dose and the duration of therapy sessions. This study has the potential to demonstrate that Zydis ODT technology can provide an ideal MDMA formulation option both for patients and for health care providers.”

CEO Anthony Tennyson further commented, saying, "If successful we will most likely lead to an exclusive global license agreement for MDMA on Zydis."

For reference, Awakn competitor Lusaris Therapeutics entered into a strategic collaboration with Zydis in November. Lusaris was awarded an exclusive worldwide license to Zydis for its 5-MeO-DMT program. With this program, Lusaris closed US$60 million in series A financing. 

Tennyson sees this as a promising sign for Awakn, if the feasibility goes well.

You can read more about Awakn's other upcoming catalysts here.

Why MDMA?

While the use of psychedelics has been controversial in the past, Research and Markets predicted that the global psychedelic drugs market would reach US$10.75 billion by 2027. This is not simply for recreation but because psychedelics have been shown to aid in mental disorders.

One of these disorders is AUD, which Awakn focuses heavily on, and studies have shown MDMA can have positive effects when treating this illness. 

In 2022, Netflix released a docu-series on the waves psychedelics have been making in the bio-pharma world titled "How to Change Your Mind." 

The third episode of the series features Dr. Ben Sessa, a co-founder of Awakn, and focuses heavily on the history of MDMA, its effects, and how it could be used to treat both PTSD and addiction as the drug turns off the fear center of the brain, allowing for a patient and therapist to dig into deepest wounds without pain or fear.

Experts Concur

Øyvind Schanke of TD Veen told Streetwise Reports in a January article, "We believe in combining the [MDMA] compound with therapy at Awakn, and that is our belief that it needs to happen . . .  I know this is needed."

In a July report, H.C. Wainwright & Co. Analyst Patrick Trucchio focused on the company’s concurrent trials involving the equally ‘circumspect’ pharmaceutical MDMA. “We estimate (that MDMA-assisted therapy) could have blockbuster drug potential based on the significant unmet medical need and evidence generated to date pointing to the potential of MDMA-assisted therapy in a variety of mood disorders."

The company is covered by a number of analysts, including Andrew Partheniou of Stifel, Patrick Trucchio of H.C. Wainwright & Co, Jason McCarthy of Maxim Group, and technical analyst Clive Maund of clivemaund.com. Click the bottom of the data box above to read more of what they are saying about Awakn.

Ownership and Share Structure

Awakn’s management owns 18.82% of the company’s 32,476,187 common shares. Awakn also has 9,049,240 warrants, 2,971,746 stock options, and 35,172 DSUs outstanding for a fully diluted of 44,532,345.

OrbiMed Advisors LLC files as an insider, with a 7.40% equity stake (2,403,550 regular shares) and 989,583 warrants exercisable at prices of CA$1.80 or higher.

According to Reuters, 18.27% of shares are held by institutions and strategic investors, 8.35% by investment managers, and 9.93% by individual investors. Other institutional investors of note include Iter Investments, Palo Santo, Negev Capital, Neo Kuma, TD Veen, JLS, and Ambria. 

Awakn has a market cap of CA$19.48 million, with 28.8 million shares outstanding. It trades in the 52-week range between CA$0.2500 and CA$2.0400.

Disclosures:

1) Katherine DeGilio wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports. They members of their household own securities of the following companies mentioned in the article: None. They or members of their household are paid by the following companies mentioned in this article: None.

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