It’s been quite a year for biotech and healthcare innovation.
While mRNA vaccines and the current health disaster get most of the attention, there’s a silent revolution going on behind the scenes. A revolution that’s so generationally massive that we could finally be on the verge of curing one of the most debilitating conditions known to mankind- Alzheimer’s.
Both patients and physicians have long been clamoring for effective treatments. The current ones are simply not working. This progressive neurodegenerative disease still has no cure, and it’s devastating for all involved.
Investors are always looking for stocks that show potential in solving this problem. Because of the desperate need for cutting-edge treatments, when there’s any semblance of progress, the stock can skyrocket in a matter of days, hours, minutes, and even seconds.
Look at Biogen, for example. This is a large-cap pharma stock with a 42.56B market cap as of September 29, 2021.(3) On the surface, you’d think this isn’t the type of stock that has a massive one-day spike the same way that small-cap biotech stocks can have.
Well, when word gets out that you may have the first Alzheimer’s treatment to win FDA approval in nearly 20 years,(2) you can throw those assumptions out the window.
After Biogen’s Alzheimer’s dr-ug Aduhelm won accelerated FDA approval, the stock surged as much as 63.83% on June 7, 2021, from a low of $286.00 to a high of $468.55.(1)
In one day.
Eli Lilly, another big-time pharma company with potential Alzheimer’s treatments, jumped by more than 10% that same week after the FDA approval for Aduhelm was announced.(4)
Other pharma companies with a focus on Alzheimer’s treatments have seen their stocks show eye-popping moves too.
- Cassava Sciences- Was trading at only $6.70 on Dec 29, 2020. As of Sep 29, 2021, it was trading at $62.14- an 827.46% move in a matter of months. (5)
- INmune Bio- Traded as low as $7.28 on Oct 30, 2020, trading at $19.22 as of Sep 29, 2021- a 164.01% move.(6)
- Annovis Bio- Was only trading at roughly $4.14 on Nov 02, 2020. As of Sep 29, 2021, it was sitting at $31.34- a stunning 657% move.(7)
Maxim analyst Jason McCarthy said the approval of Biogen’s dr-ug, the flurry of activity in the space, and growing interest merits a “recalibration” of promising AD players’ valuations.(8)
Alpha Cognition Inc. (TSXV:ACOG.V) (US:ACOGF) is a late-stage biopharmaceutical company focused on neurodegenerative diseases. But this isn’t just some biotech company with experimental treatments that hopefully work. It has a large addressable market, a potentially accelerated path to FDA approval, a differentiated product suite, and efficient management.
Overall, this could be one of the most cutting-edge companies transforming medicine that we’ve ever seen.
Read on and learn why. Your mind will be blown just as much as ours was.
Reason #1: A Large Established Market With Underserved Patients and Frustrated Physicians
Let’s cut to the chase. Alzheimer’s is horrendous, heartbreaking, and excruciating. It is characterized by the loss of cholinergic neurons in the brain. Decreased acetylcholine levels and loss of receptors negatively impact learning, memory, and function.
Basically, suppose you’ve ever had a family member suffer from it. In that case, you know exactly what I’m talking about and how soul-crushing it is to have a parent or grandparent, or aunt or uncle, not even know you.
The fact that there’s still no satisfactory cure for this progressive neurodegenerative condition is despicable. Especially when you consider how many people it affects.
According to the Alzheimer’s Association, this disease impacts an estimated 6 million people in the U.S. alone, with 1 person diagnosed every 65 seconds.(9)
Treatments are only getting more expensive too. The estimated healthcare cost for Alzheimer’s and other dementias is roughly $355 Billion per year. It is expected to increase to more than $1.1 Trillion annually by 2050.(9)
Furthermore, 8 out of 10 patients start on an ACHEI as standard first-line therapy, and only 4.5 out of 10 remain on therapy at 12 months due to the side-effects.(10)
Do the math. 30% discontinue treatment by month 4, and 45% discontinue treatment by the end of 1 year.(10)
Luckily, Alpha Cognition Inc. (TSXV:ACOG.V) (US:ACOGF) and its ALPHA-1062 dr-ug candidate could have an answer to all of these problems. This potential best-in-class treatment is designed to optimize efficacious dose, minimize treatment-limiting side-effects and improve long-term outcomes.
Reason #2: A Dr-ug With An Accelerated Path to FDA Approval That Can Keep Patients Out of Long-Term Care Without Side Effects
Let’s talk a bit more about Alpha Cognition’s ALPHA-1062. This is a patented potential new chemical entity for the treatment of mild-to-moderate Alzheimer’s Dementia.
It could be a potential best-in-class treatment designed to optimize efficacious dose, minimize treatment-limiting side-effects and improve long-term outcomes.
It is a pro-dr-ug of Galantamine with potential decreased side effects and increased bioavailability. The formation of the benzoyl ester eliminates AChE inhibition. The gluconate salt increases solubility.
Galantamine, the metabolite, is then free to circulate with greater bioavailability. ALPHA-1062 is subject to 1st pass effect, cleaving the benzoyl ester, resulting in the release of Galantamine (active moiety).
It is then absorbed in the small intestine as an inactive compound with minimal or no side effects.
Compare this to the traditional ACHEI treatments with their activity in the GI Nervous System overstimulating local neurons resulting in side effects.
Exploratory studies have also demonstrated an improved gastrointestinal side effect profile.
Not to mention, long-term usage of Galantamine is associated with delayed placement in long-term care. 80% of galantamine-treated patients were living independently versus 30% of untreated patients at 36 months.(10) With each year of treatment with Galantamine, the risk of nursing home admission was reduced by a stunning 31%.(10)
- In an April 2021 Neurology publication, 39,196 Alzheimer/Mixed Dementia patients (Swedish Dementia Registry) were evaluated between 2007-2017 with a 5yrs follow-up.
- Galantamine was associated with a lower risk of death (P-value <0.001) compared to untreated patients. It was also superior to donepezil and rivastigmine-treated patients.
- Galantamine had the most potent effect on cognitive decline and was the only AChEI demonstrating a statistically significant reduction in the risk of developing severe dementia (P-value 0.05) compared to donepezil (P-value 0.13) and rivastigmine (P-value 0.24).
- Donepezil, having the highest number of patients studied, could not show more significant benefit than Galantamine.
Reason #3: De-Risked With Patents Extending To 2040
Here’s what could honestly give Alpha Cognition Inc. (TSXV:ACOG.V) (US:ACOGF) an edge towards accelerated FDA approval. ALPHA-1062 is a De-risked 505(b)(2) new dr-ug application (NDA) with a high probability of success.(10)
For this NDA, a single bioequivalence study is required. Already, ALPHA-1062’s pilot studies more than support the requirements.
With patents extending to 2040, a pivotal trial initiation by Q3 2021, a safety and tolerability trial expected to be initiated by H1 2022, and NDA Submission by Q3 2022, watch out.(10)
Reason #4: Diverse Product Suite Addressing Areas of High Unmet Medical Needs
Alpha’s early-stage pipeline provides additional opportunities for value creation. Outside of treatment of mild-to-moderate Alzheimer’s Dementia, ALPHA-1062 + Memantine could be very promising in the treatment of moderate-to-severe Alzheimer’s dementia as well.
Memantine has been indicated for moderate-to-severe Alzheimer’s dementia and is often used in combination with an ACHEI. Roughly 7.7 million Rx have been written for memantine-containing products. There is also a 505(b)2 regulatory path for approval of a combination product like this. Look at NAMZARIC, for instance.(10)
ALPHA-1062’s intranasal delivery could also show potential in treating mild Traumatic Brain Injury. A preclinical study is ongoing, with Phase 1a and 1b intranasal studies complete. The indicators already look vastly promising.
There’s also a promising candidate to treat ALS called ALPHA-0602. Already granted Orphan Dr-ug status by the U.S. FDA in 2020,(10) this just gives the company yet another avenue to treat an unmet medical need without a cure.
It’s in the midst of ongoing preclinical development to identify optimal constructs with top-line results expected by Q1 2022.(10)
Reason #5: A Tightly Held Stock That’s Shown Explosive Moves And Upside Potential
If you want a company showing high-growth possibility, you want that company to be tightly held with a stock showing breakout potential. If analysts give the stock a robust upside target, that’s icing on the cake.
The stock has only been trading since Mar 31, 2021, and has seen some jaw-dropping breakouts. For instance, on Jun 24, 2021, the stock traded as low as $0.750 a share. It then promptly broke out by as much as 232% to reach its highest level to date of $2.49 on Sep 14, 2021.(11) So while the stock has since pulled back, it could touch these levels again if everything goes according to plan and as the movement to find an Alzheimer’s cure gains steam. Already, the stock has moved 12% in a matter of days, between Sep 27-29, 2021.(11)
According to Yahoo! Finance, the stock is also tightly held, with a float of just about 31.84M and 31.99% of shares held by insiders.(12) On any inkling of good news, and believe me, the potential catalysts are mounting for the company, this stock could explosively pop in a short amount of time. Its 232% rally between Jun 24, 2021, and Sep 14, 2021, reflects this.(11)
Is it any wonder why then, according to data from Finbox that the ACOG.V stock’s latest twelve months upside (analyst target) could be an astounding 159.3%?(12)
The bottom line is this…
When you catch an innovative pharma stock meeting an unmet medical need at the right time, the moves can be life-changing.
We’ve seen it in the recent past with biotech stocks like Moderna. But specifically, when it comes to companies focusing on Alzheimer’s, some of the breakouts have been stunning.
When we unearthed Alpha Cognition Inc. (TSXV:ACOG.V) (US:ACOGF), the possibilities excited us to no end. It’s tightly held, the stock has moved explosively, and it’s well on track to have potential full FDA approval for a transformative Alzheimer’s treatment within the next 2 years.
After seeing what Biogen did in one day after receiving FDA approval for an Alzheimer’s dr-ug, can you imagine the potential?
Analysts are certainly hip to it based on that potential 159.3% twelve months upside (analyst target), according to Finbox.(12)