Narrated year to date overview; Nov. 2018
Dr. Elliot Goldstein, ProMIS CEO
Hello,This is Dr. Elliot Goldstein, ProMIS CEO, I am here today to offer a brief year-to- date update and outlook. On the agenda today are:
– an update on progress with our lead Alzheimer’s antibody, PMN310
– followed by update and overview of our rapidly developing portfolio
– I’ll then make a few comments regarding share price performance, and
– finally, conclude with a brief outlook.
First, let’s take a closer look at our lead Alzheimer’s program, PMN310
Testing the right amyloid beta hypothesis
Based on results of prior clinical trials targeting amyloid beta in Alzheimer’s disease (AD) and years of scientific research, there is a growing body of evidence that the optimum profile for successful disease modifying therapy should selectively target the toxic, low molecular weight oligomers of amyloid beta.
Testing the right product
PMN 310 is the right product for this approach; as announced earlier this year, PMN310 has demonstrated in multiple preclinical tests that it selectively binds the low molecular weight oligomers of amyloid beta from Alzheimer’s patients, with no binding to either plaque or monomer forms of amyloid beta. Other antibodies, such as Aducanumab and Ban2401, have shown encouraging clinical trial results, as they do bind to oligomeric forms of amyloid beta, but not selectively, unlike PMN310 as they also target plaque, and are associated with the dose limiting toxicity of brain swelling.
Using the right clinical paradigm
We are moving forward on an innovative trial design for the PMN310 phase 1 program. In addition to evaluating the safety of increasing doses of PMN310, we are looking to include evaluation of biomarkers that may show early evidence of protection against death of neurons in the brain. One example of such a biomarker is nfl (neurofilament light chain); it can be measured in the blood and is increased in settings where neuronal death is occurring, such as Alzheimer’s and other neurodegenerative diseases. We are in the process of finalizing the design of the PMN310 clinical program with outside expert advice. Our goal is to have initial results available by the end of 2020, around the time of aducanumab phase 3 data read out.
The opportunity to use biomarkers to predict clinical response has gained much support and attention from the scientific community and FDA. Regulatory authorities are offering the potential for accelerated approval based on this approach. ProMIS is playing an active role in the biomarker arena, and is a full participant in the NIH consortium on biomarkers in neurodegenerative diseases.
I would now like to turn to a brief overview of progress on the expanding ProMIS portfolio
Using our unique, proprietary discovery platform, we have successfully ramped up work on selectively targeting toxic oligomers of several proteins, considered root causes of neurodegenerative diseases. We recently announced identification of novel targets on Tau protein, implicated in Alzheimer’s disease, chronic traumatic head injury (CTE) and other dementias. We have also identified novel targets and are evaluating potentially selective antibodies for TDP43 in ALS and frontotemporal dementia and finally, novel targets and selective antibodies for alpha-synuclein are also under evaluation for Parkinson’s disease and Lewy Body dementia.
Based on multiple interactions with potential pharmaceutical partners, we believe our proprietary discovery platform and the resulting expanded portfolio offer real partnering opportunities. We know that antibody therapeutics targeting toxic forms of tau, TDP43 and especially alpha-synuclein are high on the list of partnering objectives for many companies in the field; comparables for preclinical deals in this area are shown on the slide. We are actively pursuing discussions to achieve our partnering goals of further value creation and endorsement from large pharma companies.
Now, let’s turn to our next subject, Share price performance and value creation
Several factors can contribute to how the company is perceived in the market.
Company performance to date, is an obvious important factor. We have made great strides since company inception. Importantly since the beginning of this year, we have achieved all key objectives for both our lead program PMN310 in AD, and for portfolio expansion to other opportunities, with a view to partnering, as discussed previously.
The microcap space is inherently volatile and this can contribute to share price inflections. And there is, among some investment groups a degree of skepticism (a sort of weariness, if you like) regarding clinical programs in Alzheimer’s, as the field awaits anticipated results of aducanumab in 2020. This is one reason behind our drive to expand the ProMIS portfolio to encompass multiple opportunities outside of Alzheimer’s.
However, in our opinion a major contributor to the rapid price rise in January & February of this year was related to unsolicited, published speculation at that time that major announcements were soon to be made, promising huge returns. These of course were unsubstantiated comments that were in no way supported by ProMIS. We saw unusually heavy share trading by investors, largely based on this speculation. This has created a negative drag, or overhang on the stock, which has persisted throughout the year, in our opinion. We believe that this overhang has been slowly reduced and anticipate it should no longer be a significant factor after the end of this tax year. For our part, we have strived to present clear, updated information to the markets on a regular basis, and in this respect have stepped up our communication efforts to retail investors.
Finally, we shall consider up-listing to the NASDAQ when market conditions are favorable.
In conclusion, let’s summarize by taking a brief view on the outlook moving forward.
We have 3 core objectives as we move forward:
- First, to finalize the PMN310 phase 1 biomarker trial program. This should allow to test and verify the right target (toxic oligomer), with the right oligomer selective therapeutic (PMN310) with the right innovative trial design using biomarkers.
- Second, to continue to develop the portfolio and validate oligomer selective antibodies targeting ALS, PD, AD and other dementias.
- Third, to continue full on efforts to pursue partnering with large pharma.
I look forward to further dialogue in the future and thank you for your attention.