Aquestive Therapeutics, Inc is a clinical and commercial-stage pharmaceutical company focusing on the development and commercialization of various therapeutic drugs to meet various unmet needs in the United States and across the globe. 

AQST has focused on the development of orally-soluble film as a delivery platform for several drugs to treat various medical conditions. The core strength of the company’s pipeline is reinventing the way of treatment by administering the pre-existing drug via a novel drug delivery proprietary platform called Pharmafilm Technology. 

AQST believes – the drug efficacy tends to be higher upon administration via the novel drug delivery platform.

Some of the drugs that AQST markets are Sympazan, an oral film formulation of Clobazam for the treatment of Lennox-gastaut syndrome (LGS), Suboxone, a sub-lingual film formulation of buprenorphine and naloxone for the management of opioid dependence, Zuplenz, a soluble film formulation of ondansetron for management of chemotherapy and postoperative nausea and vomiting and Azstarys for treatment of attention-deficit hyperactivity disorder. Exservan (Riluzole) for amyotrophic lateral sclerosis. Libervant is the proprietary, oral soluble film formulation of diazepam for seizures; Libervant has received tentative approval from the USFDA. Other pipelines include AQST-108, AQST-305, AQST-109, and KYNMOBI for the treatment of emergencies other than anaphylaxis, acromegaly, allergic reactions including anaphylaxis, and management of episodic off-periods in Parkinson’s disease, respectively. 

Recent events

December 22nd, 2022 – Aquestive Therapeutics announced completion of FDA End-of-Phase 2 meeting for AQST-109 (epinephrine sublingual film)

November 10th, 2022 – Aquestive Therapeutics to present positive data from pharmacokinetic studies for AQST-109 (epinephrine sublingual film) at the American Academy of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting

November 2nd, 2022 – Aquestive Therapeutics reported third-quarter 2022 financial results and provides a business update.

October 27th, 2022 – Aquestive Therapeutics licensed Sympazan® (clobazam) oral film to Assertio Holdings, Inc.

Addressable market

ALS:

In 2020, the global ALS treatment market was USD 513 million and is forecasted to reach USD 762.3 million by 2027.

Seizures associated with Lennox-Gastaut syndrome (LGS): 

The LGS treatment market is expected to reach USD684.75 between 2021 and 2026 at a CAGR of 4.42%. 

Vomiting:

The global vomiting and nausea treatment market was USD4883.4 million in 2020, which is projected to reach USD7580.9 million by 2027. 

Parkinson’s disease:

In 2021, the global Parkinson’s disease treatment market was USD 4697.3 million and is expected to increase at a rate of 6.3% from 2021 to 2028. 

Attention deficit hyperactivity disorder (ADHD):

The global ADHD treatment market was valued at USD 2018.1 million and is forecasted to increase at the rate of 7.1% between 2020 and 2030. 

The global market size of medical opioids was USD 4.4 billion in 2020 and is expected to reach USD 6.1 million by 2030 at a CAGR of 3.2% between 2021 and 2030. 

Current finances

By Q3 2022, the total revenue was USD 11.5 million, compared to USD 13.3 million in Q3 2021. While the company reported a 15% increase in Sympazan net revenue, the net loss for Q32022 was USD 12.5 million due to a decrease in interest expenditure, and decrease in R&D expenses and cost, etc.

As of September 2022, the net cash and cash equivalents were USD 18.6 million.

The total revenue in 2022 was USD 46-49 million and non-GAAP adjusted EBITDA loss was USD 37-43 million. Not so appreciable revenue, considering the company’s novel treatment approach!  

The revenue generated says all about the market potential of the drugs and clinical viability. Maybe, the old wine in the new bottle approach fails to work.

Insider activity

Competitors:

Like AQST, Eagle Pharmaceuticals has been developing small molecule pipelines for various unmet needs including nerve-agent-induced brain damage. Other portfolio includes Ryanodex (Dantrolene sodium), vasopressin, Pemetrexed injection, Fulvestrant, Belrapzo (bendamustine) injection, and Bendeka (bendamustine) injection.

Heron Therapeutics is developing a variety of oncology care solutions such as Sustol (Ganisedron) injection and Cinvanti (Aprepitant) injectable solutions, in addition to, acute care solutions including Zynrelef (bupivacaine and meloxicam) solution, Aponvie (aprepitant) injectable emulsion and HTX-034 (bupivacaine, meloxicam, and aprepitant) injectable solutions. Except for HTX-034, other portfolio drugs are in the commercial stage. 

Summary

AQST has a plethora of assets in their pipeline for various indications, all of which existing drugs being tried in a new proprietary platform to achieve better drug delivery and improved treatment success. They have been making deals to generate cash to help develop their epinephrine candidate, AQST-109. Aquestive appears to be going all-in on AQST-109’s clinical and commercial success.

Retail loves AQST, some comments from twitter:
“JMP Securities analyst Jason Butler reiterated a Buy rating on Aquestive Therapeutics today and set a price target of $7.00. The company’s shares closed last Friday at $0.89, close to its 52-week low of $0.62”

“invest for 2025 for buccal film epinephrine, 700%-1000% upside pending FDA approval“

The initiation of Phase III AQST-109 (epinephrine sublingual film) is expected by early Q2 2023, and no other near-term catalysts are available for short-term investment.