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Q BioMed Partners with SRI to Develop Pediatric Developmental Nonverbal Disorder Therapy

Part of Q BioMed's autistic spectrum disorder drug development program (Image: Autism Speaks)

About one out of every 59 children has been identified with autism spectrum disorder according to estimates from the CDC’s Autism and Developmental Disabilities Monitoring Network. Autism affects children across all racial, ethnic and socioeconomic groups, though it has been reported to be about four times more common among boys than girls. Epilepsy has an unusually high prevalence among those with autism, affecting up to one-third of this population, as compared to only 1% to 2% of the general population.

About 18,000 children in the US—and a similar number in Europe—have pediatric developmental nonverbal disorder, the majority of whom are diagnosed as young children and fall within the autism and epilepsy spectrum disorders. Though certain approved medications exist that are prescribed to those with autism, such as Abilify, Vyvance and Risperdal, these are merely psychotherapeutics that affect mood and temperament, doing nothing for the underlying disorder.

Q BioMed

New York City-based Q BioMed QBIO seeks to license undervalued biomedical assets in order to accelerate development toward the achievement of clinical and commercial milestones. The company has five assets in its pipeline, diversified across four different areas of significant medical need. Q BioMed announced today a strategic partnership with SRI International to provide formulation development, preclinical development and early clinical manufacturing in support of Q BioMed’s autistic spectrum disorder drug development program for non-verbal or minimally verbal autistic children.

Source: Q BioMed

SRI International is an independent, nonprofit research center that serves government and industry to help commercialize products. For more than 70 years, SRI has led the discovery and design of ground-breaking products, technologies and industries, including Apple’s AAPL Siri virtual assistant, online banking, medical ultrasound and cancer treatments. SRI has broad expertise in solving formulation, drug delivery, and characterization challenges of small molecule drugs and biologics.

Q BioMed’s QBM-001 compound targets toddlers with pediatric developmental nonverbal disorder, where an underlying commonality may lead to developmental delay, an autism diagnosis and eventual nonverbal or very minimally verbal capability for the rest of their lives. According to the company, the economic cost for toddlers that become non- or minimally verbal averages $10 Million per person over a life span, and, collectively, an estimated $200 billion is spent annually on individuals who have become nonverbal in the US.

We are pleased to have found both experience with autism models and expertise in formulation of products like QBM-001 in SRI International. This important step will be the catalyst for several milestones for QBM-001 over the next few months as we prepare clinical product for the trials we anticipate starting in 2019.

– Denis Corin, CEO, Q BioMed.


Q BioMed’s most advanced segment is in metastatic cancer bone pain relief. In August 2018, the company filed with the FDA for the approval of a new manufacturing facility that, if cleared, would be permitted to manufacture generic strontium chloride Sr89 injection in accordance with current good manufacturing practice (cGMP) standards. Strontium chloride Sr89 is an FDA-approved non-opioid injectable radiopharmaceutical indicated to relieve cancer bone pain in patients with painful skeletal metastases. Q BioMed’s strontium chloride is the only generic form of Metastron approved by the FDA, and in November 2018, the company moved to strengthen its bone pain franchise by acquiring the branded Metastron from GE Healthcare GE. The agreement gives Q BioMed ownership of the brand, trademarks and market authorizations in 22 countries.

This is a major deal for Q BioMed. Strategically, it affirms our belief in this drug as an effective and underutilized non-opioid therapy for the treatment of debilitating pain associated with skeletal cancer metastases. Importantly, as we enter this market, we will now have access to all information related to Metastron in 22 countries in which the drug is already approved for sale. This gives us a tremendous springboard to accelerate our revenue potential and establishes a formidable barrier to entry as we grow this market. With regards to the market, it is important to note that our focus is not on the short-term horizon, but rather on the long-term strategic initiative as we look 2 and 5 years down the road at expanding the therapeutic scope for the drug.

– Denis Corin, CEO, Q BioMed.

Source: Q BioMed

Investment issues to consider

Q BioMed trades on the OTCQB Venture Market at $1.74, giving it a market capitalization of about $25 million. The stock is down about 64% over the past year, but the current levels may represent attractive value on the risk-reward spectrum given the company’s momentum and potential near-term revenue from strontium chloride. Adequate capital will be the primary concern, as the company had just $787,000 in cash as the end of its fiscal Q3 on August 31, 2018. Q BioMed is taking steps to shore up the balance sheet, however, with a September 2018 agreement with an accredited investor for $4 million in convertible debt.

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