"There are many biotechs in the neurodegenerative space that are looking at aging, which is good news for the industry as there is a rise of age-related diseases across the globe. However, we feel we are unique in researching the plasma proteome."

Elizabeth Jeffords

CHIEF COMMERCIAL & STRATEGY OFFICER, ALKAHEST

December 17, 2018

Could you update us on the recent developments at Alkahest?

Alkahest has gone through an extensive strategic planning effort over the past few months with the aim of cementing our long-term direction. This has included a significant upscale of our clinical staff with 15 new appointments in the past six months. We have made significant progress in our two ongoing Phase II trials in wet age-related macular degeneration and they will be closing out by Q1/Q2 2019. We also have ongoing Phase II trials for our proprietary plasma factions in mild to moderate Alzheimer’s patients and patients with Parkinson’s Disease with Cognitive Impairment or Dementia, and we are close to starting a trial in severe Alzheimer’s. Overall, we currently have five ongoing phase II trials and are expecting to have significant data for all of them towards 2020.

Could you tell us more about your unique technology platform that clarifies changes in the plasma proteome in healthy aging and in age-related diseases?

Alkahest’s breakthrough research has interrogated the plasma proteome to understand which plasma proteins are most impactful to the aging process. To do this, we investigated plasma samples from a range of ages to understand if the protein signatures were in fact different. About 10% to 20% of proteins on either end of the spectrum either increase or decrease with age, with the majority of proteins preserving their function over time.  The proteins which change with age, which we call chronokines, can be either beneficial or detrimental.  We then target these chronokines for potential therapeutic effect.

Alkahest’s partnership with Grifols has focused on the development of your proprietary plasma products (GRF 6019-6021). What have been the advantages of forming this partnership?

The partnership with Grifols involved a US$37.5 million equity investment, an up-front fee of US$12.5 million and additional funding for research and development of plasma-based products. Aside from financing, Grifols provides significant expertise to our team, having carried out substantial work distributing and ensuring safety of plasma-based products.

How does your technology differentiate from what is currently being researched and developed in the market?

There are many biotechs in the neurodegenerative space that are looking at aging, which is good news for the industry as there is a rise of age-related diseases across the globe. However, we feel we are unique in researching the plasma proteome. Our first approach is to supplement beneficial proteins that tend to decrease as we get older by utilizing our propriety plasma factions. Our second approach is to utilize protein-specific interventions that inhibit the detrimental proteins that tend to increase as we age. There is a treasure trove of proteins involved in the body’s normal process of aging, whether it be healthy aging or aging with disease, and looking at these proteins gives us the opportunity to find multi-factorial answers.

What will be Alkahest’s key objectives in 2019 as well as the company’s long-term vision?

We will be focusing on a full clinical ramp up of our phase II trials in 2019. We have strong pre-clinical evidence, and we now need to test how the animal models translate to efficacy in humans. We are also looking at our therapeutic candidates’ mechanisms of action to better understand the clinical impact of our science.

Ultimately, Alkahest aims to bring commercial products to patients. To do so, we need to ensure our systems and infrastructure are in place and that our products are meaningful, all while ensuring we retain the right culture within the company.

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