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HLS Therapeutics granted medical device license for One WBC System by Health Canada

22 Oct HLS Therapeutics granted medical device license for One WBC System by Health Canada

HLS Therapeutics Inc (OTCPINK: HLTRF), a specialty pharmaceutical Company developing solutions for the treatment of central nervous system and cardiovascular disorders, announced the grant of a medical device license for the Athela One WBS system. Indicated to serve as a point-of-care device, it is capable of generating white blood cells count and neutrophilis percentage in the capillary or venous whole blood, in a span of minutes from a single drop of blood from the tip of a finger. This can help simplifying the mandatory safety blood monitoring process for Treatment Resistant Schizophrenia patients that are prescribed Clozaril® (clozapine).

The Company will lower the barrier for using Clozaril® and will be introduced to the Clozaril Support and Assistance Network (CSAN®), in addition to being made available to Canadian Institutions and HCPs under the name CSAN® Pronto™ as per a company statement.

Greg Gubitz, CEO of HLS stated

“CSAN Pronto requires only a finger prick and a single drop of blood and generates a diagnostic result in just minutes right in the doctor’s office. This compares to the traditional blood monitoring process which requires patients to undergo venous blood sampling at a laboratory with results available a day or two later. CSAN Pronto fits in very well with our Clozaril franchise and we think the device may help reduce two important barriers to clozapine use, which are a patient’s non-adherence to blood work and the burden of the blood work regimen on the patient1.”

Clorazil is usually prescribed to adults over the age of 18 years for the management of symptoms associated with treatment-resistant schizophrenia and is the only treatment approved by the Canadian Psychiatric Association for patients intolerant of, or non-responsive to conventional antipsychotic medications. The device obtained a clearance from the FDA in November 2018.

Athelas WBC system uses imaging technology and artificial intelligence to quantitatively determine white blood cell and Neutrophil percentages from a finder-prick test, the results of which are populated within minutes and uploaded to a patient’s CSAN profile for easy access by the healthcare team.

In March 2019, the Company in-licensed the exclusive Canadian rights for the device from Athelas Inc, which will be responsible for supplying the devices, test strips and performing the blood monitoring services, in exchange for performance-based fees and commercial milestones contingent on commercial success.

HLS Therapeutics Inc (OTCPINK: HLTRF)

Market Cap: $288.75M; Current Share Price: 11.44 USDChart
Data by YCharts

Schizophrenia is defined as a mental disorder in which there are disturbances in thought (Delusions), perceptions (hallucinations), behavior (disjointed speech) and social interactions. It is one of the leading causes of disability worldwide. In U.S alone mental and Behavioral disorders account for 13.6 percent of total DALY’s (Disability-adjusted life Years) according to the statistics released by National Institute of Mental Health. The disease affects 1% of the population, or approximately 370,000 Canadians, out of which 25-30% of patients with schizophrenia (approximately 111,000) meet the criteria for Treatment resistant Schizophrenia.

Schizophrenia is characterized by symptoms such as failure to distinguish between perception and reality, hallucinations which are visual (Seeing people), Auditory (Hearing voices), or related to taste, touch and the sense of smell. Some patients suffer from delusions related to being persecuted or being victimized, while other may experience sexual and religious delusions. In addition their speech does not follow any logic or exhibits incoherent thoughts, leading to social withdrawal, reticence, lack of self-care, emotionally distant behavior and lack of motivation.

The treatment for schizophrenia is life-long, even when the symptoms have reduced. Anti-Psychotic drugs, that can control dopamine and glutamate, are the most preferred course of medication. These are usually combined with psychosocial therapy (family therapy, individual counseling, rehabilitation and employment support) and other drugs such as antidepressants and anti-anxiety medication. However the medications used for treatment of these symptoms have some significant side-effects such weight gain or loss, changes in vision, severe headaches, light-headedness or breathlessness, Erratic Mood Swings, insomnia , loss of appetite, spasms, stiffness, twitches and tics, issues with sexual health.

Research shows that a whopping 86.19% of people experience at least one of the above mentioned side affects prompting them to stop taking medication. Only 42.5% of the patients reported total adherence to the medication. These side effects prevent people from taking their medication diligently, thereby leading to worsening of symptoms overtime.

Agitation is a common condition observed in those suffering from psychiatric disorders such as schizophrenia and bipolar disorder. In the absence of effective therapeutic options, physical restraint and seclusion are the only options available to control aggression that stems out of agitation.

The Company is focused on the acquisition, development and commercialization of late-stage established branded pharmaceutical products for the treatment of disorders related to central nervous system and cardiovascular health. The Company is helmed by a seasoned management team with extensive experience in the industry. HLS has operational locations in Toronto, Montreal and Philadelphia.

The Company’s has tie-ups with best-in-class manufacturing partners and its products conform to the highest standards of quality, in compliance with FDA and Health Canada’s regulations.

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HLS’s pipeline consists of candidate for the treatment of Acne (Absorica), CV risk reduction (Vascepa, Trinomeia) and Perseris (Schizophrenia). The Company claims to have successfully executed $8 billion (CAN) of transactions in the pharmaceutical space along with building a portfolio of legacy therapies for treatment of CNS Disorders.

As per its Q2, 2019 financial results, the Company has filed a New Drug Submission (NDS) for Vascepa® with Health Canada under the priority review status. The Company has also acquired the license for the Canadian rights to PERSERIS™, an injectable risperidone product for the treatment of schizophrenia.

Risk Assessment

  • HLS has a strong cash flow and balance sheet, with sufficient resources to fund its pipeline as well fulfill its regulatory and marketing obligations. The Company completed a bought-deal financing for C$50M and also has a $ 100M debt expansion facility available. The Company closed Q2, 2019 with $9.0 million from cash from operations and a revenue of $13.6 million compared to $16.3 million in Q2 2018.
  • The Company is following a value creating strategy with 2 cash flowing asses, in addition to filing New Drug Submission for two more products. Furthermore the Company’s portfolio has two pre-registration assets in the pipeline.
  • HLS is upbeat about the prospects of Vascepa, indicated for reducing the risk of ischemic cardiovascular events in statin-treated patients with elevated triglycerides, which has demonstrated positive results in clinical trials and has the potential to be a game changer in the treatment of cardiovascular anomalies.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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