ProMIS Neurosciences Issues Letter to Shareholders
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Insights
The recent update from ProMIS Neurosciences on their clinical development path for antibody therapeutics targeting neurodegenerative diseases has significant implications for the biotechnology sector. The company's unique scientific platform, which incorporates artificial intelligence to identify novel epitopes on misfolded proteins, represents a cutting-edge approach in the treatment of Alzheimer's disease and other dementias. The advancement of their lead clinical drug candidate, PMN310, into Phase 1a clinical development and the subsequent clearance to move to the second dose level in the Single Ascending Dose trial is a critical milestone. This progress underscores the potential for PMN310 to offer a more targeted and effective treatment with fewer side effects compared to current therapies.
From an industry perspective, the specificity of PMN310 in targeting only toxic oligomers of amyloid-beta could set a new standard in Alzheimer's treatment, addressing a significant unmet medical need. The biotechnology market closely monitors such advancements as they can disrupt existing treatment paradigms. Moreover, ProMIS's aggressive intellectual property strategy and robust patent portfolio could provide a competitive edge and protect their innovations in the market. As the company pursues strategic partnerships, this could lead to an infusion of resources, expertise and potential accelerated development timelines, further enhancing the company's value proposition.
The financial implications of ProMIS Neurosciences' recent clinical developments are multifaceted. The progression of PMN310 through clinical trials is a significant value driver for the company, with the potential to attract investor interest and strategic partnerships. The company's focus on a rigorous intellectual property strategy indicates a long-term vision to safeguard its technological advancements and maintain a competitive advantage, which is a positive signal for investors.
However, the mention of the need for 'sufficient capital' to continue the Phase 1b Multiple Ascending Dose study is a reminder of the financial risks inherent in biotech. The capital-intensive nature of clinical trials means that ProMIS will likely require additional funding, which could come from equity financing, partnerships, or other sources. While successful clinical outcomes can lead to significant stock appreciation, there is also the risk of dilution or unfavorable partnership terms if the company is in a weak bargaining position. Investors will be closely watching for the mid-2024 data release on the Phase 1a study, as positive results could lead to a revaluation of the company's stock and enhance its ability to secure favorable financing terms.
The clinical development of PMN310 for Alzheimer's disease represents a notable advancement in medical research for neurodegenerative diseases. The focus on toxic oligomers of amyloid-beta is based on a growing consensus in the scientific community that these misfolded proteins play a pivotal role in the pathogenesis of Alzheimer's. ProMIS Neurosciences' approach of using artificial intelligence to identify novel epitopes could lead to highly selective antibodies, potentially translating into a treatment that is both efficacious and with a reduced side effect profile.
In the broader context of Alzheimer's research, many previous therapeutic attempts have failed, making the safety and efficacy data from the ongoing and future trials of PMN310 highly anticipated. The potential for PMN310 to provide the first clinical evidence of benefit in patients would be a landmark achievement. Additionally, the company's research into other diseases such as ALS and MSA indicates a strategic approach to leverage their platform across multiple indications, which could significantly expand the therapeutic impact and commercial potential of their technology.
TORONTO, Ontario and CAMBRIDGE, Massachusetts, Jan. 08, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Issues Letter to ShareholderProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that its Chief Executive Officer, Neil Warma, issued the following letter to the Company’s shareholders.
Dear ProMIS Shareholders,
On behalf of the Board of Directors, I am honored to have recently joined the ProMIS management team as the interim CEO to steer the company through what we believe will be an exciting and informative clinical development path that could demonstrate the potential of ProMIS in the treatment of multiple dementias. Your steadfast support has been instrumental in our progress thus far, and I am excited to share some pivotal developments that will shape the future of our company.
As part of our commitment to becoming a leader in the treatment of dementias, we are intensifying our focus on advancing our drug candidates into and through clinical development. Our ultimate goal is to get these potential new drugs to patients who are in desperate need of safe and effective treatment options.
ProMIS’ scientific platform is truly unique. Designed and developed by our Chief Scientific Officer, Dr. Neil Cashman, MD, it leverages artificial intelligence (AI) to identify novel epitopes on toxic misfolded proteins, which have been shown to be an underlying cause of multiple diseases. Using a complex and proprietary algorithm, Dr. Cashman and the team at ProMIS are able to identify novel epitopes on misfolded proteins and design antibodies (drug candidates) that we believe will bind with high affinity to these targets, resulting in the elimination of these toxic and harmful proteins from the brain to prevent or slow disease progression. It is an elegant, yet complex solution that we believe is clearly differentiated among neurology-focused companies. The deliberate specificity of our antibodies is one unique aspect of our approach and we have been aggressive with our Intellectual Property strategy and have built a robust patent portfolio. Our belief is that if you can specifically target only the harmful or pathogenic proteins (i.e., misfolded proteins), this should result in a beneficial outcome to the patient and with fewer side effects. Our wealth of preclinical data demonstrates this, and we are hopeful the clinical data will continue to support this belief.
I am pleased to share that our lead clinical drug candidate, PMN310, is progressing well through Phase 1a clinical development for the treatment of Alzheimer’s disease (AD). We recently received clearance from the Independent Data and Safety Monitoring Board to advance PMN310 to the second dose level in this Single Ascending Dose (SAD) trial in healthy volunteers. This milestone is a testament to the dedication and hard work of our clinical development team. We believe PMN310 holds immense promise to address the urgent need for effective treatments in AD and remains unique in its ability to specifically target only misfolded forms (i.e., toxic oligomers) of amyloid-beta (Aβ), which are believed to drive disease progression in AD. This specificity is expected to improve efficacy outcomes and prevent any off-target safety issues, which are common with other AD therapies currently marketed or in development.
We remain committed to advancing PMN310 through the rigorous clinical development process. Over the coming months, we will be laser-focused on completing the SAD clinical study with PMN310 and, subsequently, rolling into the Phase 1b Multiple Ascending Dose (MAD) study, subject to the availability of sufficient capital. As the Phase 1b MAD study will be conducted in AD patients, this could provide the first signal demonstrating that PMN310 positively benefits patients with AD. We expect to report data on the Phase 1a study around mid-2024. This is our first drug candidate to advance into the clinic based on our novel and differentiated platform and should lead the way for others to follow. Beyond AD, we have our targets set on the treatment of amyotrophic lateral sclerosis (ALS), multiple system atrophy (MSA), and Parkinson’s disease.
In line with our commitment to collaboration and growth, we are aggressively pursuing partnering discussions to leverage synergies and enhance our capabilities. We believe that strategic partnerships will not only accelerate our progress but also enable us to bring innovative treatments to patients more efficiently and could provide significant validation to the platform.
We truly believe that we have a powerful technology platform from which multiple drug candidates could be developed and we are diligent in identifying ways to untap this potential while not distracting our focus from the lead development program with PMN310 and our tight control on cash management. Specific to our pipeline candidates, earlier this year, we presented data at key scientific conferences including validation of RACK1 as a potentially novel target for the treatment of ALS and frontotemporal lobar degeneration (FTLD-TDP). We remain excited about the early data generated for these debilitating diseases.
In summary, I am honored to be representing you as ProMIS’ interim CEO. Our priorities are clear: to advance PMN310 through clinical development; to increase the Company’s visibility to better highlight the significant value of ProMIS; to advance strategic partnering discussions; and to effectively allocate and manage cash. We remain committed to our goal of generating shareholder value and improving the lives of patients worldwide.
Finally, I want to express my deepest gratitude for your ongoing support as shareholders. Your belief in our mission and commitment to making a meaningful impact on the lives of those affected by neurodegenerative diseases drive us every day. Together, we are building a company that has the potential to treat multiple dementias and revolutionize the field in order to bring hope to millions of individuals and their families.
As we navigate this transformative period, I am confident that ProMIS will emerge stronger, more resilient, and better positioned to make significant contributions to healthcare. We are on an exciting journey, and I look forward to sharing more successes with you in the future.
Thank you for your continued trust and support.
Sincerely,
Neil Warma
Chief Executive Officer
ProMIS Neurosciences, Inc.
About ProMIS Neurosciences Inc.
ProMIS Neurosciences Inc. is a clinical stage biotechnology company focused on generating and developing antibody therapeutics selectively targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA). The Company’s proprietary target discovery engine applies a thermodynamic, computational discovery platform - ProMIS™ and Collective Coordinates - to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and MSA. ProMIS has offices in Toronto, Ontario and Cambridge, Massachusetts.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, “forward-looking information”) within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “excited to”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to the Company's planned timing for completion and anticipated data readout of the Phase 1a clinical trial and the anticipated use of proceeds from the private placement. Statements containing forward-looking information are not historical facts but instead represent management's current expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including, but not limited to, the Company’s ability to fund its operations and continue as a going concern, its accumulated deficit and the expectation for continued losses and future financial results. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the “Risk Factors” section of the Company's most recently filed annual information form available on www.SEDAR.com, in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2022 and the section entitled “Risk Factors” in its Post-Effective Amendment No. 1 to Form S-1, filed March 17, 2023, each as filed with the Securities and Exchange Commission, and subsequent quarterly reports. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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For Investor Relations:
Stern Investor Relations
Anne Marie Field, Managing Director
annemarie.fields@sternir.com
Tel. 212-362-1200
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