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Top Covid Stocks In Play After Pfizer Vaccine Approval: TOMDF ENZC TSOI

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With the FDA approval of the Pfizer-BioNTech vaccination many biotech stocks moved higher.  Leading the microcaps was Todos Medical (OTCMKTS: TOMDF).  Shares of leading vaccines makers Pfizer (NYSE: PFE), BioNTech (NASDAQ: BNTX), and Moderna (NASDAQ: MRNA) moved higher on the news due to anticipation of future approvals. The White House immediately took advantage of this approval to pitch the vaccine after hours in a press conference with President Biden claiming that COVID-19 was now a pandemic of the unvaccinated.  President biden said

“Those who have been waiting for full approval should go get your shot now.” – Pres Biden

All this attention on vaccines trickled down to some promising therapeutics drug developers. One of the most interesting plays of the day was COVID-19 diagnostics and pharmaceutical maker Todos Medical (OTMKTS: TOMDF) which surged on record volume of 74 million shares and ended the day up a whopping 103%. Before the market opened the company announced that their lab in Georgia had a fully validated neutralizing antibody test called cPass which can help in quantifying a person’s current level of immunity to the Delta Variant. Their cPass test has an EUA and their lab is the only fully automated lab which can do up to 1500 tests daily.  However, what really moved the stock was an interview on FOX Business with Stuart Varney.

Volume before the interview was a brisk 10 million but shortly after the interview volume started surging.  Investors appeared to connect the dots that the recent debate over the policy to administer the booster shots was coming under heavy fire and testing may be the saving grace.  The Biden administration is trying to walk a fine line between encouraging new people to get a shot and protecting those who were vaccinated from the delta variant.  They also unleashed a new program to make booster shots widely available to those who reach the 8 month mark.  In the interview the CEO of Todos Medical let out a bombshell that studies in Israel where the Delta Variant already surged found out the immunity from the virus wanes after 6 months and that there is potentially this 2 month window where people may be lacking protection. The debate on boosters was further complicated by a WHO announcement recommending a delay on boosters to prioritize under-vaccinated countries.  

What is clear is that testing is making its way into the narrative and since TOMDF appears to be the largest lab with neutralizing antibody tests they would be the direct recipient.  Speculation seems to be brewing that since cPass is the only EUA approved test capable of medically determining if a booster is appropriate the Biden Administration may have to compromise.  This means that booster shots may only be allowed with a cPass test that confirms the need.  This could be a game changer for the diagnostics company.  

Provista Diagnostics is the name of the testing company, and it is a subsidiary of Todos Medical.  In their latest press release, Provista indicated that they have the capability to do up to 20,000 PCR tests daily which equates to $2 million in sales daily or $60 million monthly.  With respect to the cPass Neutralizing Antibody test it appears that they can do up to $3.6 million in sales monthly.  Investors need to keep in mind these estimates assume maximum utilization.  The company closed the day with a market cap of approximately $25 million which represents about 10% of its fair value using comparable drugs.       

Todos has a diagnostics business that is slated to do $50 million in revenues this year and the stock barely trades at a multiple of projected sales including the massive bump today.  Todos also has joint venture agreement with NLC Pharma for Tollovir which is a phase 2/3 oral antiviral which by many estimates would be valued in the range of $250 – $400 million.  Last year Roche Holdings (OTCMKTS: RHHBY) licensed the ex-US rights of Atea Pharmaceuticals (NASDAQ: AVIR) for an oral antiviral for $350 million. The value gap on the pharmaceutical side is enormous.  

If investors are curious about the reason for the massive valuation gap that currently exists, it can be traced back to a restructuring done in January 2021.  The company consolidated legacy convertible notes into one primary holder who has been trickling out his investment over the past 6 months.  These stock sales have been weighing heavily on the shares, but the price action today indicates that he has finished his conversion.  The stock is back up to the price point where their strategic South Korean investor Yozma Global Genomic Fund put in a sizable investment in January and April 2021.  Both investments were at $.06 and represented a premium to the market price at the time.    

While TOMDF is more of a pure play in COVID-19 Enzolytics (OTCMKTS: ENZC) is more of a focused play in HIV with exposure to COVID-19 as a potential label expansion in the future should they get their HIV drug approved.  Most of the excitement surround ENZC is coming from an initiation of their HIV trials.  One of the things that makes their drug ITV-1 stand out from the pack is the drugs safety profile. ITV-1 is really a form of immunotherapy that strengthens the immune system.  Most of the HIV drugs are part of the Highly Active Antiretroviral Therapy (HAART) which does its best to use chemotherapy in multiple ways to disrupt the proliferation of the HIV virus.  The point to make is all the drug has to do is keep the viral load at bay and the safety profile will be what drives the approval process forward.       

There are some major catalysts that have impacted ENZC.  The letter of intent with Creative Biolabs to license anti-HTLV-1 was a major step forward in advancing the clinical trials by completing the commercial manufacturing of the drug.  ENZC was able to leverage the financial balance sheet of Creative Biolabs in order to get the production manufacturing ready for sale. In addition, the LOI provided for Artificial Intelligence to screen for conserved sites on the virus and potentially use them in the development of a compound. They have identified these conserved targets for HIV, COVID-19, HTLV-1, Influenza-A, Influenza-B, H1N1 influenza, Herpes Zoster, and many more.   

The value proposition of ENZC can be found in its platform technology which has the capability to produce monoclonal antibodies that can target the conserved regions of various viruses.  According to their last press release they have a partner willing to fund the initial round of production.  Clinical trials in HIV are due to start shortly in the European Union.  The key

The market cap is $357 million and there are 2.8 billion outstanding shares out of 3.0 billion authorized.  The potential dilution at this point is minimal which means the stock could run if a small amount buying hits the tape.    

Therapeutic Solutions International (OTCMKTS: TSOI) has been on a tear after the FDA gave it the go ahead to start its pivotal Phase 3 trial for COVID-associated lung failure using its JadiCell universal donor stem cell treatment.  Since that kickoff announcement it has been a news bonanza that keeps building on the story.  They are also planning on filing an EUA which is a very bold initiative given the past failures of other COVID-19 companies like CytoDyn Inc. (OTCMKTS: CYDY) which appears to have a drug that works but was denied due to their lack of data.  The treatment is called Jadi Cell and they had excellent clinical trial data supporting their EUA application.  In a randomized controlled clinical trial the JadiCell treatment showed 100% effectiveness in saving COVID-19 ICU patients under age 85. This was the rationale for the application.

The story continued to build with the all encompassing Mechanism of Action (MOA).  At the heart of the MOA are the CD73 expressing T-Cells.  They were able to show that a small dose of IL-2 had a noticeable effect in expanding the class of this type of cell. Many stem cell therapies have been struggling for years to overcome the body’s natural suppressor function and the stem cell desire to differentiate quickly.  Donor stem cells simply don’t last long in the body due to suppression so by expanding the colony of stem cells it allowed for a durable response in these studies.  

The company has a market cap of $270 million with 3.5 billion authorized shares.  There are 2.2 billion shares issued and outstanding.  The company made a statement in a blog post that dilution was something that they were going to try to avoid by going after government funding.  Sticking to this mindset could allow the stock to continue its run higher unimpeded.  

Investment Summary

The rising tide in COVID is managing to lift many COVID stocks.  These focus stocks have tremendous potential to outperform the rest of the market.  At the core of their story is a platform technology.  When looking at biotech investments it is essential that the underlying science that underpins the company is sound.  Having this fundamental element in place derisks the stock in the long run.  These biotech runners are set to scale new heights so make a place in your portfolio for them.   Investors should pay special attention to TOMDF because that stock was depressed due to structural reasons and NOW it’s poised for an epic run with a short term target price of $.34 which represents a $250 million market cap now that the overhang of the seller is gone. 

Disclosure: we hold no position in TOMDF ENZC TSOI either long or short and we have not been compensated for this article.

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4 Comments

4 Comments

  1. George Luniv

    August 24, 2021 at 11:24 am

    For those stuck of scientific validity of what you read. It is daunting at times to make a decision whether to by or not. Myself, I learned the science, to help me in making the correct decision. I recommend making time in our schedules to financially benefit you in the long run, with a deep peace of mind knowing the results and the superiority of a product will catch up to the narrative. Just like in the discovery that the current x-19 vaccines’ effect only lasted 6 months, not 8 months and this 2 month gap actually corresponds to the number of vaccinated people becoming I’ll again. I myself was wondering if the vaccine could be causing the mutated Delta strain within the vaccinated people, as opposed to the unvaccinated becoming infected. Now with the knowledge and scientific proof from being able to MEASURE the amount of antibodies inside us, and comparing it against the data of vaccinated people at varying times from the date of their vaccination on a monthly basis, a biological truth was discovered that invalidated a previously know fact which has led to an increase in DELTA infections, straining hospital and medical resources. This discovery is not momentary, but will remain a FACT OF NATURE, perpetually, allowing mankind to get a grip on deadly viruses around the world.. thanks for reading this far. . It will improve your life in more ways than one. Hosea 4:6 !

  2. FranNeo

    August 25, 2021 at 5:05 pm

    The Covid shots will turn us into Gods enemies like unto those that hate Him. The fear of the Lord is the beginning of wisdom.! Is the
    Very first lesson we need to learn as custodians of the vessels of God.

  3. Jim Johnson

    August 26, 2021 at 10:20 am

    Let people get the vaccine if they want it but don’t force it on anyone. Same with masks if you want to wear one go ahead but respect those that don’t want to wear one. Live and let live, if you don’t want to be around ppl not wearing masks avoid sporting events and keep your distance when you see someone not wearing one. But don’t force anyone to wear a mask and there is little evidence that masks stop the spread of covid among children anyway. Anything that fauci says is highly suspect and probably false.

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    September 18, 2021 at 11:21 pm

    If getting herpes cure was that easy then why do people still suffer from herpes? I was diagnosed of herpes back in 2014 and i was also told it has no cure,I have been leaving with it since then, but i kept praying and doing everything possible to get cured, so i never stop doing research about finding a cure,I came across testimonies about people getting cured through herbal medication and i have always believe in herbs and its medical properties, after doing so many research about it i found DRASHAOSEMUDIAMEN and I discovered he was a professional in herbal medication and he has also helped many people,I contacted him through his mail: DRASHAOSEMUDIAMEN@GMAIL. COM, and +2349135214547 we talked on phone and i confirmed he was genuine,I did all what he told me to do, i received the medicine,use it as he prescribed,and glory be to God almighty i am completely cured, i went back to my doctor to confirm it. do not be deceived THERE IS A CURE FOR HERPES. He is also good at saving you from any kind of diseases like Herpes. HIV/aids.Gonorrhea.Cardiac problem.cold sore.Hpv cure.Cancer.Watering sperm.Womb fertilization.Penis erection.Witch craft attack.S T D diseases.Internal heat Rashes.Fibroid.Low sperm count.Dairy.long sickness.I promise I will always testify for your good work.you can contact the doctor on email drashaosemudiamen@gmail. com or whatsapp +2349135214547.
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Brainstorm Cell Therapeutics’ (NASDAQ: BCLI) Post-Setback Resurgence: Unpacking FDA Impact & Market Expectations

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Brainstorm Cell Therapeutics (NASDAQ: BCLI) continues to gain momentum with a surge of over 125% since its low on October 31st, 2023. Following an unfavourable FDA decision on its ALS treatment, the stock hit an all-time low of $0.13 per share. Nethertheless, the stock experienced a significant rebound today, November 30th, 2023, rising by 26%, without accompanying press releases or SEC filings.

This resurgence prompts us to evaluate the possibilities for yet another company struggling to meet NASDAQ’s minimum bid requirements. A closer examination of recent months reveals intriguing developments that might pique the interest of potential investors. Our findings suggest BCLI holds promising near term prospects that could significantly alter its course.

Background:

BCLI specializes in developing therapies that utilize a patient’s own stem cells to combat severe neurodegenerative ailments like Amyotrophic Lateral Sclerosis (ALS) and progressive Multiple Sclerosis (MS). ALS affects nerve cells in the brain and spinal cord, while MS affects the central nervous system, causing problems with vision, balance, and muscle control.

The company holds exclusive global rights for the clinical advancement and commercialization of the NurOwn® technology platform, enabling the production of autologous MSC-NTF cells. These cells have received significant recognition and were awarded Orphan Drug designation by both the FDA and the European Medicines Agency (EMA).

Autologous MSC-NTF cells:

The way Autologous MSC-NTF cells work is very interesting. They’re a specific cell type obtained from an individual’s mesenchymal stem cells (MSCs). These cells are then genetically altered to produce neurotrophic factors (NTFs), which are designed to support and stimulate the growth and survival of nerve cells within the nervous system.

BrainStorm has conducted a Phase 3 clinical trial (NCT03280056) investigating the safety and effectiveness of multiple doses of autologous MSC-NTF cells for ALS. This trial received support from the California Institute for Regenerative Medicine, the ALS Association, and I AM ALS. Additionally, the company completed a Phase 2 open-label multicenter trial (NCT03799718) for progressive MS using these cells, backed by a grant from the National MS Society (NMSS).

Back to Square One:

Unfortunately for BCLI, 17 FDA advisory panel members voted that the data presented for their Phase 3 clinical trial for ALS did not demonstrate substantial evidence of the effectiveness of NurOwn for the treatment of mild-to-moderate ALS. There was simply only one member who voted in favour and another member that abstained from voting entirely.

Predictably, this resulted in a substantial downturn in the company’s share price, causing BCLI to plummet 87% below NASDAQ’s minimum bid compliance threshold of $1.00.

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Is it Over?:

To those not well-versed in this matter, it might appear as if BCLI is forced to throw in the towel and start everything from scratch, but the reality is actually quite different.

When a drug fails in clinical trials, the pharmaceutical company or researchers typically reassess the data to understand why the drug failed.

They might conduct further analysis to determine if there were unforeseen side effects, issues with the study design, or if the drug simply didn’t show the desired effectiveness. They’ll work to make adjustments, refine the drug’s formulation, or in some cases, explore other alternatives by re-designing new clinical trials to evaluate the drug’s safety & efficacy for a different condition.

If none of those efforts yield a positive outcome, it’s typical to halt further development of that specific drug.

Regardless of the FDA’s decision, Co-CEO Lindborg mentioned, “We firmly believe that the data for NurOwn presented today provide a compelling case for approval, with clinical evidence in those with less advanced disease supported by strong and consistent biomarker data that are predictive of clinical response,”

Unfortunately for Lindborg, the decision does not rest with her. A panelist from the FDA, Lisa Lee, expressed, “Providing false hope can be ethically problematic and false hope is provided when the probability of a positive outcome is overestimated. And I think that seems to be the case here.”

After the devastating press release on September 27th, 2023, most of the retail crowd was on board with the FDA, mentioning it was time for BCLI to pack up, and go home – especially after seeing these comments from the FDA.

What Happened:

Amid FDA skepticism and investor uncertainties, BCLI took decisive action, securing a chance for a new phase 3 trial to showcase the effectiveness and safety of their NurOwn® technology for ALS treatment.

On October 24th, 2023, BCLI issued a press release affirming their conviction in the compelling data and expressing their intent to further substantiate it to the FDA.

More specifically, this was a “Strategic realignment” designed to:

  • Support the company plans to conduct a double-blind, placebo-controlled Phase 3b U.S. clinical trial for NurOwn in ALS with an open-label extension and
  • Continue to publish data from NurOwn’s Phase 3 clinical trial on biomarkers, long-term safety, survival, and the Expanded Access Program, providing transparency around NurOwn data and progressing ALS drug development.

Big Release:

Then on November 20th, 2023, BCLI issued another press release, stating that the FDA granted them an in person meeting to discuss the regulatory path forward for NurOwn® in ALS.

Within’ the last month or so, it appears the market is HIGHLY anticipating the outcome of this meeting, given it is now scheduled to take place on December 6, 2023.  

This meeting allows BCLI to have a Special Protocol Assessment (SPA) with the FDA to agree on the overall protocol design for a confirmatory Phase 3 trial in ALS.

If you aren’t familiar with a SPA, it’s an agreement between a pharmaceutical company and the FDA regarding the design, endpoints, and size of a clinical trial intended to support a New Drug Application (NDA) or Biologics License Application (BLA). This agreement aims to confirm that the trial design, data analysis, and endpoints are acceptable to the FDA for the regulatory approval process.

A favorable result from this meeting could greatly benefit BCLI, paving the way for the actual launch of NurOwn®. This outcome stands in stark contrast to the prior belief, post the September 27th, 2023 news, which led many to assume otherwise.

If the trend remains positive, BCLI could see a significant surge in valuation, given the substantially reduced risk associated with a drug nearing commercial availability.

Conclusion:

Boosting the optimism for December 6th is the heightened enthusiasm among retail investors surrounding the company. Some speculate that the surge might mirror what SNGX experienced today, on November 20th, 2023. With technical day traders and swing traders in the mix, many perceive this as the final opportunity to join the trend before it gains further momentum. It’s crucial to remain vigilant as December 6 approaches rapidly, potentially ushering BCLI into an entirely altered and positive scenario.

We will update you on BCLI when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

Picture by ckstockphoto from Pixabay.com

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Apollomics (NASDAQ: APLM) Market Momentum: Pipeline Potential, Market Trends, and Retail Insights

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Apollomics, Inc. (NASDAQ: APLM) has seen a significant surge in its shares, rising by ~20% at time of writing, accumulating a staggering 58% gain since November 21st, 2023. Surprisingly, there haven’t been any noticeable press releases or filings to explain this sudden valuation shift, so it’s prompted a closer examination on our end. Fortunately enough, we found the force driving the substantial gain, but first let’s look into APLM’s background to build a better picture of the opportunity at hand.

Background:

APLM’s emergence as a public company is relatively recent, stemming from its merger with Maxpro Capital Acquisition Corp. (Nasdaq: JMAC) on March 30th, 2023. This merger also involved a $23.65 million private investment in public equity (PIPE) financing, a typical move when companies go public, aiming to secure capital. With this recent funding, APLM anticipates financial support through mid-2024, empowering the company to push forward with its ambitious lineup of 9 drug candidates.

APLM stands as an innovative player in the field of clinical-stage biopharmaceuticals, specializing in crafting cancer therapies that work hand-in-hand with the immune system and target precise molecular pathways to combat cancer. With a focus on oncology, the company boasts a lineup of nine potential drug candidates, six of which are actively progressing through clinical development stages.

Among its flagship projects are vebreltinib (APL-101), a potent c-MET inhibitor that targets multiple forms of non-small cell lung cancer (NSCLC), and uproleselan (APL-106), an E-Selectin antagonist designed to potentially enhance standard chemotherapy in treating acute myeloid leukemia.

Latest Release:

APLM recently announced significant news concerning its Chinese partner, Avistone Biotechnology, on November 11th, 2023. Avistone received conditional approval from China’s National Medical Products Administration (NMPA) to market vebreltinib. This medication is intended for treating a particular type of lung cancer known as MET exon 14 skipping non-small cell lung cancer (NSCLC).

Dr. Guo-Liang Yu, Apollomics’ leader, praised Avistone for this achievement, saying it’s a big step toward finding better treatments for tough cancers. Vebreltinib is a powerful medicine that targets how cancer cells grow. It could be a breakthrough for people with this specific lung cancer and other cancers caused by similar changes in cells.

Apollomics is talking with the U.S. Food and Drug Administration (FDA) about using vebreltinib to treat this kind of lung cancer in the U.S. They’re using data from their global study and Avistone’s study in China to do this.

It’s no secret, Lung cancer is a big problem, especially for people with non-small cell lung cancer (NSCLC), which is responsible for most lung cancer cases. This specific mutation has a significant unmet need, and APLM’s vebreltinib could be hope for those battling the devastating disease.

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Market Opportunity:

To keep things simple, we’ll continue focusing on APLM’s Vebreltinib (APL-101), which is just 1 of 9 drugs in their pipeline.

This specific drug, cultivated through a collaboration with Beijing Pearl Biotechnology (now merged with Avistone Biotechnology), appears to display considerable potential. Its appeal lies in its demonstrated safety, effectiveness, and its potential to address a specific market segment where there’s a significant demand for treatments due to unmet medical needs.

Vebreltinib (APL-101):

APL-101 is being evaluated for its potential use in combating specific types of Non-Small Cell Lung Cancer (NSCLC), and a particularly aggressive form of brain cancer, secondary glioblastoma multiforme (sGBM).

APL-101 is a Type 1b class highly selective c-MET inhibitor. More simply put, it’s a drug that effectively targets and blocks the c-MET protein.

c-MET inhibitors have a wide potential range of markets due to the involvement of the c-MET pathway in various cancers and other diseases. The c-MET receptor, also known as the hepatocyte growth factor receptor (HGFR), plays a crucial role in cell growth, survival, and migration. Dysregulation of the c-MET pathway is associated with tumor growth, metastasis, and resistance to certain therapies in multiple cancer types.

Outside of NSCLC and sGBM, Apollomics has already seen promising effects inhibiting tumors related to certain types of cancers like gastric, hepatic, and pancreatic. But to keep things simple, we’ll stick to Apollomics core focus in NSCLC and sGBM.

The Market:

According to statistics published by the World Health Organization (WHO) from February 2022, 2.2 million patients were diagnosed with lung cancer in 2020, and non-small cell lung cancer accounted for nearly 85% of all lung cancer patients.

The global non-small cell lung carcinoma (NSCLC) market is expected to garner a market value of US$ 8.25 Billion in 2023 and is expected to accumulate a market value of US$ 21.40 Billion by registering a CAGR of 10% in the forecast period 2023 to 2033.

Delving deeper into particular types of NSCLC, the market potential for Exon-14 skip mutated NSCLC, c-MET amplifications in NSCLC (denovo), and c-MET amplifications in NSCLC (resistance driven) collectively represents a 3 billion-dollar opportunity.

In contrast, the market size for the population affected by epidermal growth factor receptor (EGFR) mutated NSCLC stands at a larger 7 billion-dollar opportunity.

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SPARTA Trial: 

SPARTA is part of a larger study combining Phase 1 and Phase 2 trials, conducted in 13 countries, 90+ sites and 370+ patients worldwide. It aims to understand how safe and effective vebreltinib is in treating various cancers. More specifically, it’s looking at non-small cell lung cancer (NSCLC) with a specific genetic mutation called c-MET exon 14 skipping, as well as other cancers with c-MET amplification or fusions.

The trial involves different groups of patients: those new to treatments targeting the c-MET protein and those who have previously received such treatments for NSCLC with the mutation. Additionally, it includes patients with various solid tumors showing c-MET amplifications or fusions, including glioblastoma multiforme, a severe type of brain cancer.

The main goal of SPARTA is to measure how well vebreltinib works by assessing the overall response rate (ORR) and how long the response lasts (duration of response) using specific evaluation criteria for each type of tumor. Secondary goals involve looking at any side effects and additional measures like time to progression, progression-free survival, and overall survival.

Overall the clinical findings show that vebreltinib could be a promising new treatment for cancers caused by MET alterations, especially in Non-Small Cell Lung Cancer (NSCLC) with MetEx14 skipping mutation. In a phase 2 trial, there was 75% overall response rate in patients with advanced NSCLC.

If you’d like more formal clinical trial information for vebreltinib, it’s is available on clinicaltrials.gov under the Phase 1/2 SPARTA trial (NCT03175224).

Big Picture:

This is just 1 of 9 drugs in APLM’s pipeline, and APL-101 is just 1 of 2 key assets. With our initial examination of the company, we were taken aback by the comparatively low valuation despite the promising pipeline. Like many, there has been a considerable decline in share value since their public listing.

Now that China’s National Medical Products Administration (NMPA) has given conditional approval, the company intends to get Vebreltinib (APL-101) approved in the U.S. and has met with the FDA in July. With an existing approval by the NMPA, receiving the NDA Approval from the FDA should realistically be a much quicker process.

On top of this, more interesting developments have occurred from online sources, indicating substantial short activity, further hinting at the possibility of APLM being the next big short squeeze candidate.

What Happened & Retail Insights:

APLM seems to be gaining attention across various social media platforms, notibly Twitter and Reddit.

Numerous investors are discussing on different platforms that APLM might become a potential candidate for a short squeeze. Users have pointed out that the cost to borrow shares has risen significantly. This increased short activity seems to have also led to a shortage of available shares to borrow.

Increased buying activity is likely to intensify the pressure on short sellers, compelling them to buy back shares to cover their positions. Given today’s substantial surge in trading volume, short sellers may find themselves in a tight spot, potentially regretting their initial choice to wager against APLM.

We came across additional analysis (due diligence) about APLM on Reddit, providing concise insights. This is but one piece of content that’s drawing increased interest in the stock among retail investors.

APLM – Apollomics Inc- DD THREAD – BIO STOCK –
byu/StockProfilers inpennystocks

In recent times, Reddit has become a hub for discussions regarding stocks and potential market movements. It gained particular prominence in 2020 as a platform for detailed research and discussions about stocks, witnessed notably during the retail trading frenzy involving stocks like GME (GameStop) and AMC (AMC Entertainment Holdings).

Analyst Ratings:

Two analysts have set notably optimistic price targets for APLM, suggesting it might reach $21.00, representing a potential 1650% increase from its current value. Additional sources offer different projections, with estimates of $11.00 (an 816% increase), $14.00 (a 1066% gain), and $17.00 (a 1326% rise). It’s crucial to understand that analyst ratings are not certainties but rather projections based on their research. We commonly advise examining past coverage to assess the accuracy of analysts’ ratings and forecasts.

Conclusion:

In summary, APLM experienced a substantial surge, seemingly fueled by retail investors countering short sellers. However, beyond the retail-driven buzz speculating a potential short squeeze akin to TPST, a deeper narrative unfolds, signalling a compelling long-term proposition.

APLM’s pipeline exhibits fairly de-risked assets and promising data across multiple indications, not to mention large amount of partnership opportunities.

Analyst forecasts reflect a highly optimistic outlook, echoing positive retail sentiment. The ongoing SPARTA trial also unveils compelling data, suggesting a more profound story from a long term perspective.

Is APLM set for a short squeeze akin to TPST? Time will tell…. Nonetheless, within this realm, APLM seems fundamentally undervalued, making it a stock to keep a close eye on as more developments arise.

We will update you on APLM when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Processa Pharmaceuticals (NASDAQ: PCSA): Revolutionizing Cancer Treatment through Next-Generation Chemotherapies

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Processa Pharmaceuticals’ (NASDAQ: PCSA) shares skyrocketed by over 260% from their October lows of $0.18 per share. Shares peaked at $0.65 on November 14th and more recently has consolidated around $0.43. The reason for this surge was not immediately clear given the lack of material  events. However upon digging deeper, we’ve uncovered a very interesting aspect driving the sudden rise. Let’s take a closer look at their pipeline and company history to understand what potential developments might be on the horizon and whether the current levels are justifiable.

Background:

PCSA is a clinical stage Pharmaceutical company that’s working to create better versions of chemotherapy that’s safer and more effective. More specifically called, “Next Generation Chemotherapy” or NGCs for short – they’re essentially just modified versions of existing FDA-approved oncology drugs.

The objective is of course to improve clinical outcomes and have less adverse events (AEs). They do this through altering the metabolism and distribution of the drug while maintaining the main mechanism that kills the actual cancer cells.

It’s all based off over 30 years of drug development expertise. Although efficacy and safety can vary drastically depending on the type of chemotherapy, it’s widely known that undergoing chemo is undeniably challenging for patients due to the potential negative impact on their well-being.

PCSA has a few clinical drugs that are based on Capecitabine, Gemcitabine, and Irinotecan.

Respective problems that occur with these drug treatments: 

  • Low treatment response with high side effect profile.
  • High drug resistance and/or acquired resistance; administered as IV
  • Significant side-effect profile limits dosing and drug use.

PCSA is actively working to achieve:

  • Actively minimizing Adverse Events (AEs), consequently broadening the patient base.
  • Developing an oral therapy that accelerates the action of cancer-killing molecules while enhancing their quantity to mitigate drug resistance.
  • Ensuring that cancer-killing molecules selectively enter cancer cells rather than normal cells, enhancing effectiveness and reducing toxicity.

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What Happened:

We took a closer look at PCSA’s SEC filings and found something interesting: in October, there were a lot of Form 4 submissions. This seems to be the main reason for the sudden increase in PCSA’s valuation. Between October 10th and October 12th, insiders bought over 590,000 shares, and it wasn’t just one person—several insiders made these purchases. More often than not, this suggests a high expectation for something big happening soon.

Management Team:

Another important aspect to consider is the leadership team. It’s a fundamental step in conducting your due diligence since past achievements and expertise often pave the way for future success. Let’s swiftly overview just two key individuals in the company. For more information on others, click here.

George Ng | CEO:

Mr. Ng is a highly experienced figure in the life sciences industry with an extensive career involving founding and leading various companies. Notably, at Scilex Pharmaceuticals, Inc. (now, Scilex Holding Co (NASDAQ:SCLX)), where he played a key role in the company’s journey from development and clinical trials to NDA submission, FDA approval, a substantial $140 million financing round, the successful commercial launch of their first FDA-approved drug product, and the ultimate sale of the company. His career history includes a range of senior management positions across globally recognized biotechnology and pharmaceutical companies like Sorrento Therapeutics, Inc. (NASDAQ: SRNE), BioDelivery Sciences International, Inc. (NASDAQ: BDSI), Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI), and Alpharma, Inc. (NYSE:ALO), which is now part of Pfizer Inc. In these roles, Mr. Ng played pivotal roles in strategy, development, fundraising, and the commercialization of multiple pharmaceutical drug products.

David Young | President, Research & Development:

Dr. Young possesses extensive expertise in pharmaceutical research and development, spanning over three decades. As the Chief Scientific Officer of Questcor Pharmaceuticals from 2009 to 2014, he collaborated with the FDA to modernize Acthar Gel’s label and secure FDA approval for Infantile Spasms. His impactful involvement contributed significantly to Questcor’s transformation from near bankruptcy in 2007 to an esteemed orphan drug specialty company, reaching a valuation of around $5.6 billion by 2014. He was also the Founder and CEO of GloboMax LLC, a CRO specializing in FDA drug development that was purchased by ICON plc in 2003. Preceding his tenure at GloboMax, Dr. Young held a tenured Associate Professor position at the University of Maryland School of Pharmacy, leading a team of 30 individuals dedicated to evaluating the biological properties of drugs and drug delivery systems in both animals and humans.

Young’s experience extends even further: he served on FDA Advisory Committees, played a key role in an FDA-funded Clinical Pharmacology contract, oversaw the evaluation of oral products in a UMAB-FDA contract leading to FDA Guidance improvements, educated FDA reviewers for five years, participated in NIH grant review committees, and co-led a National Cancer Institute contract evaluating new oncology drugs.

Overall, Young’s met more than 100 times with the FDA on more than 50 drug products and played a vital role in over 30 NDA/supplemental NDA approvals. Additionally, he has over 150 published works, including presentations to the FDA, and numerous talks at scientific and investment gatherings.

It’s certainly significant that someone with such vast experience as Dr. Young is associated with PCSA, valued at ~10M at time of writing. Considering this executive’s extensive background in navigating FDA approvals, we hold a strong positive outlook on its potential trajectory. Dr. Young’s substantial insider purchases also strongly hint at positive developments ahead.

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Phase 1B Trial Update:

The last Phase 1B trial update is written in a fairly scientific format, so we’ve taken the liberty of simplifying the release to better your understanding.

The Phase 1B trial of NGC-Cap in patients with gastrointestinal cancer aims to create a personalized treatment method that could be safer and more effective.

NGC-Cap is a treatment that mixes PCS6422, which stops an enzyme called DPD, with small amounts of a common chemotherapy drug, capecitabine. This chemotherapy drug turns into 5-FU in the body. DPD helps change 5-FU into another substance called FBAL, which usually causes strong side effects, making it tough to give higher doses of the chemotherapy treatment.

Processa discovered that regularly checking DPD levels, (shown by the substance FBAL), could help understand how each patient reacts to different NGC-Cap doses. This information might help doctors create specific treatment plans for each patient, aiming to reduce side effects and make the treatment work better while keeping the patient safe and comfortable.

Capecitabine is among the most widely used chemotherapy drugs and is dosed based on a standard dosage regimen for all patients. That said, many patients cannot tolerate that dose and must either have their dose reduced or have their treatment interrupted, which means ultimately means it’s less effective overall.

The discoveries made in this interim data is very promising and could mean that PCSA is now capable of personalized treatment plans, helping patients potentially handle the treatment much better without AEs.

Key Catalysts and Considerations:

There’s supposedly more updates soon for PCSA’s two main drugs, PCS6422/NGC-Cap and PCS3117/NGC-Gem.

For PCS6422/NGC-Cap, they’re finishing up the Phase 1B study and planning the Phase 2 trial based on feedback from the FDA.

With PCS3117/NGC-Gem, they’re working closely with the FDA to plan the drug’s development and how it will be tested.

There’s also been a recent change in leadership, bringing in a new CEO, George Ng in August 2023. This new leader has experience in turning companies around, developing business, and as mentioned, knows a lot about cancer treatment. The company is also considering licensing non-core assets to bring in money without dilution.

Overall PCSA’s new chemotherapy drugs look promising for treating a diverse range of cancers, meaning a potential billion-dollar US market opportunity alone. They have experienced leaders who know how to get medicines approved and make successful deals.

As of June 2023, they have about $8.7 million in cash, meaning a runway into the second half of 2024. They’re also thinking looking into potential partnership opportunities to further to develop their pipeline to avoid dilution.

Some of these events would be considered significant catalysts, potentially propelling the company to new heights. With a relatively low float, price fluctuations could be volatile in nature—leading to substantial gains or complete loss of investment. However at these levels, PCSA certainly seems like an interesting opportunity for potential upside, be sure to keep them on your radar.

We will update you on PCSA when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

Picture by 127071 from Pixabay

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