Merck & Co., Inc. (NYSE: MRK) Investors should look to Galectin Therapeutics (NASDAQ: GALT) as a Hedge

Mark & Co.'s KEYTRUDA® Achilles Heel Exposed by Recent Research

Emerging Growth Companies
Merck & Co., Inc. (NYSE: MRK) Investors should look to Galectin Therapeutics (NASDAQ: GALT) as a Hedge

Miami, FL–(EmergingGrowth.com Newswire – April 18, 2019) – EmergingGrowth.com, a leading independent small cap media portal with an extensive history of providing unparalleled content for the Emerging Growth markets and companies, reports on a hedge against Merck & Co. (NYSE: MRK) with Galectin Therapeutics (NASDAQ: GALT).

  • Cancer and Liver Disease therapiesDemonstrate Efficacy
  • KEYTRUDA®improved by GR-MD-02 but major weakness in monotherapy exposed
  • Valuation gap versus other developers in the same arena 
  • Research by outside scientists continue to show the critical role of Galectin 3 
  • Company valuations with engaged management team eclipse $5.0 billion for Cancer and NASH

Merck Inc. (NYSE: MRK) is the biggest name in Immuno-Oncology (I-O) and has developed one of the most successful cancer franchises the world has ever seen.  It’s almost unfathomable to think that anything could stop them, let alone some doctors from Italy.  Like Merck, Galectin Therapeutics Inc. (NASDAQ: GALT) has deep rooted origins in cancer with their first phase 3 ready candidate in 2006, but then switched strategies in 2010 to liver disease, specifically advanced NASH. Almost 10 years after GALT started their NASH studies, investors are at the same crossroads they faced in 2006. They have a phase 3 ready drug, and not enough development money in the bank to pursue it.  Is this Deja vu all over again or is there really a plan this time? The most truthful answer is that nobody knows, and unfortunately that may include GALT’s management and BOD. Big pharmaceuticals like Merck (MRK) do know, and they control the narrative for the moment with their large cash hordes, but newly released data, covered in this article could alter the dynamic as KEYTRUDA®’s Achilles heel is uncovered.  It’s no secret that GALT has for a better part of a year, telegraphed their willingness to partner or sell through their consultant, Back Bay. The recent rights offering is an attempt to raise money, and give the shareholders the chance to minimize dilution. Chairman Uihlein is trying to do the right thing for present investors. But having money is not a strategy.  Reality is that GALT has not received an acceptable offer from big pharma yet. Uihlein’s strategy may be to go it alone, or to get big pharma to move forward with an offer. With all this posturing from the drug companies and management, it’s easy for an investor to lose sight of how revolutionary this technology really is and its true value.  It is also difficult to see the long term game plan. 

The Cancer Franchise (GR-MD-02 makes KEYTRUDA® ~ twice as Good)

Last month the company announced a presentation by Providence Cancer Institute that highlights how GR-MD-02 could be used as a successful combination therapy.  This presentation was given on March 25, 2019 at the Keystone Symposia on Molecular and Cellular Biology.  Dr. Sturgill was quoted as saying “Galectin-3 Inhibition with GR-MD-02 Synergizes with T Cell-Targeting Immunotherapy, Leading to Reduced Immune Suppression and Improved Overall Survival.”  In layman’s terms GR-MD-02 appears to work with any T-Cell targeting therapy, which could make this a must have for every immuno-oncology company that includes the biggies like Merck (MRK), Bristol Myers Squibb (NYSE: BMY), Gilead (NASDAQ: GILD) and Roche Holdings (RHHBY).  She added that they got same results when used in combination with an anti-OX40 monoclonal antibody manufactured by Innovent Biologics, Inc. (HKEX:01801).  Innovent was given FDA approval to proceed in early December 2018 with its phase 1 clinical trial in China.  The data in the poster presentation was overwhelmingly favorable concerning GR-MD-02 combination therapy versus monotherapy. But again there wasn’t any embellishment or even follow up news from GALT regarding these trials.  Investors continue to wonder why the company is so silent with such good data. 

Assuming the addition of GR-MD-02 to most immunotherapy drugs improves overall survival, the FDA’s gold standard for approval, and it reduces side effects of the other drugs, why wouldn’t most companies want to use the combination rather than monotherapy? Additionally, the combination could extend their patent life.

There was a pleasant surprise at the end of the presentation. They chose to expand their studies to include Genentech’s (bought by RHHBY) drug Anti-OX40.   Anti-OX40 (MOXR0916) is currently in a Phase I study for Locally Advanced or Metastatic Solid Tumors. They are also planning a Phase 1b study with Tecentriq®, the newest Immuno-Oncology drug, in combination with AVASTIN®, and Anti-OX40.  The Providence Center presented a plethora of preclinical data they are clearly excited about.  The full presentation can be seen here. The highlights are that the GR-MD-02 combination therapy improved survival in mice as much as 55% and reduced spontaneous lung metastasis. There was also a noticeable increase in CD8+ Cell proliferation and trafficking which drove up CD8+ T-Cell recruitment and maturation.  While the waterfall plot for GR-MD-02 in combination with KEYTRUDA® has a small number of patients, it is huge in terms of response rates.  What researchers have been able to glean out of the studies is that an optimal treatment dose exists for GR-MD-02.  There is a balance whereby the T-cells activated against the tumor need to be numerous enough to overcome the growing colony of tumor cells, but not numerous enough to set off the reaction controlled by the Myeloid Derived Suppressor Cells (MDSC’s), which recruit suppressor cells into the tumor microenvironment.  When GR-MD-02 blocks the galectin-3 shroud that protects the tumor from T-Cells entering and makes it too easy for them to get into the tumor, it literally wakes up the MDSC’s which send signals to recruit the T-Reg cells.  The reality is that too much galectin-3 inhibition dampens the treatments efficacy.  This is a very real effect seen not only in cancer but also in GALT’s NASH Cirrhosis trial. Investors should realize that part of the treatment of NASH is the recruitment of specialized T-cells to the site of chronic inflammation in the liver.  This is essentially an immune response just like cancer. 

Focus on the 2ndcohort (Red Lines) of 4 mg/kg of GR-MD-02 which appears to be close to the optimal dose in both disease indications (NASH & Cancer).  In this second cohort there was a 100% Overall Response Rate (ORR) of refractory patients in a period of 5 months versus KEYTRUDA®’s 33% historical ORR after 2 years.  

Providence Cancer Institute and the Company decided to pursue a phase 2b trial in Melanoma and/or Head and Neck Squamous Cell Cancer (HNSCC). The projected trial results could dramatically alter the way cancer is treated.  There were 6 patients dosed for HNSCC. The results using the GR-MD-02 combination achieved a 67% stable disease rate in 5 months compared to a 19.1% ORR with KEYTRUDA® alone over a period of 2 years.  In melanoma KEYTRUDA® alone has a 7% complete response (CR) rate over a 2 year period versus a 25% CR (2 of 8 patients in the 1st& 2ndcohort). The GR-MD-02 combination with KEYTRUDA® was seen over a period of just 5 months.  Hypothetically, if the patients continued the treatment a little longer many of these ORR’s might have turned to Complete Responses (CR).  There was actually partial validation of this theory when Providence announced additional datafrom their melanoma trial.  They said “a significant decrease in the frequency of suppressive MDSCs following treatment in the responding patients was observed compared to non-responders” (on day 85 post-treatment). They also said that Moncytic Myeloid-Derived Suppressor Cells (Mo-MDSC) may be good biomarkers to determine if the patient is responsive to the therapy.    

It’s of paramount importance that investors understand the fundamental concept that GR-MD-02 makes KEYTRUDA® much betterin at least 2 indications with the possibility of many more in the future.  There are many types of cancer and KEYTRUDA® has been approved for 12 indications using a common biomarkerrather than the location in the body where the tumor originated. KEYTRUDA® was the first drug approved in this manner.  The FDA considered the drug’s novel mechanism of action (MOA) in the approval process.  GR-MD-02 falls into the same category as a novel first in class drug that is a tissue-agnostic drug.  Once the drug is approved it just needs to conduct a study in the new indication using its MOA as the basis of approval.  This will allow for a rapid expansion of indications.  It’s conceivable that GR-MD-02 could move even faster through approval than KEYTRUDA® did primarily due to its lack of toxicity and ability to reduce the side effects of the combination.  Additionally, if the results continue to come in skewed toward CR’s, then fewer patients will need to be dosed over a shorter period of time.  

Outside research continues to validate the critical importance of the role of Galectin 3 in cancer. A research group from Rome and Stockholm published a clinical research study entitled “Predictive Biomarkers for Checkpoint Inhibitor-Based Immunotherapy: The Galectin-3 Signature in NSCLCs.”  These results show that “galectin-3 has a strong regulatory effect on cancer-related inflammation and could present a key target in the management of lung, and potentially other galectin-3–driven carcinomas, in combination with immune checkpoint blockade.” 

The authors evaluated 34 consecutive patients with non-small cell lung cancers who were treated with the checkpoint inhibitor, KEYTRUDA®, and then looked at their initial biopsies and stained them for galectin-3. They observed that most of the patients (about 90%) with high galectin-3 tumor expression showed an early and dramatic progression of disease after three cycles of therapy. However, those with negative or low expression of galectin-3, showed an early and durable response to KEYTRUDA®, indicating galectin-3 as a predictive marker of tumor responsiveness. The researchers call this the “galectin-3 signature.” 

The results have significant implications for Galectin Therapeutics!They now have results with multiple types of cancer and different types of immunotherapy, all of which has been done by outside research groups, not the Company. This validates GALT’s ability to get huge acceptance in the solid tumor market. Hopefully, the Company will recognize this multi-billion dollar opportunity, get their act together and start acting like they realize that the cancer franchise could be bigger than the liver fibrosis franchise.

Major KEYTRUDA® Weakness Exposed in Recent Study

A summary graph of the patients’ responses divided into two groups – those with high versus low galectin-3 levels is inserted below.  It’s very important to note that these patients ALL tested PD-L1 positive.  Low galectin-3 expression patients all showed favorable outcomes as shown by their results (green lines). All were below baseline showing a reduction in tumor size.  Those non-small cell lung carcinoma (NSCLC) patients with high galectin-3 expression had very poor responses.  In fact 21 out of 34 patients(68%) had poor responses and the graph below shows their  time of the study was truncated to about only 3-4 months.  Visually it’s easy to see the correlation that high galectin-3 expression leads to poor outcomes so it only makes sense that through combination therapy adding a galectin-3 inhibitor will lead to much better outcomes.  Additional corroborating data from the phase 1 melanoma study done by the Providence Cancer Institute might be forthcoming later this year if they tested for galectin-3 expression.  This NSCLC study was very powerful at demonstrating that high galectin-3 expression is associated with failed PD-L1 positive therapy.  KEYTRUDA® with a 68% failure rate simply doesn’t work well on this patient population.  In the abstract Carlo Capalbo said “these markers need to be urgently identifiedfor a better selection of patients that can be candidates for immunotherapy.” This data could force the hand of MRK if clinicians like Dr Capalbo believe that cancer patients need to be PD-L1 positive AND Galectin-3 negative to get treatment withKEYTRUDA®. Over half of MRK’s market share of KEYTRUDA® could be jeopardized until a galectin-3 inhibitor is approved for combination therapy.This study published on March 31, 2019 unearthed a major downside risk of continuing with KEYTRUDA® monotherapy without proper galectin-3 testing.  

Source

The Liver Disease Franchise (Only Late Stage Drug Capable of Meeting Phase 3 Endpoints)

It should be recognized that the detection of Esophageal Varices (EV) doesn’t involve risky medical procedures such as a liver biopsy. Additionally, the detection of EV is a standard procedure for all patients with severe liver disease.  This procedure can be done in most doctor’s offices. In the Galectin Therapeutics’ CX trial, there was a low patient dropout rate of 6% which suggests the drug was well tolerated and patients adhered to the regimen. Therefore, the probability of approval and subsequent acceptance by doctors and patients is extremely high.

GALT has obtained FDA direction for advancing GR-MD-02 into a pivotal trial. The Phase 2b trial results showed that GR-MD-02 has potential as a treatment for the prevention of esophageal varices. This is significant because there is no treatment for EV, or the prevention of EV, which are enlarged veins in the esophagus that result from obstructed blood flow through the liver portal vein (i.e., high hepatic venous pressure gradient or HVPG). 

The strategy for the Phase III trial and approval is ingenious. Using two Primary Endpoints; Progression to esophageal varices OR, change in hepatic venous pressure gradient (HVPG), dramatically increases the probability of success!  Furthermore, both of the endpoints already achieved statistical relevance in the phase 2 study. The original strategy for the development program and the NASH CX trial was quite risky. Even though the preclinical and Phase I results indicated that GR-MD-02 should be effective in patients with late stage liver disease (compensated NASH cirrhosis), it is inherently more difficult to treat a late stage disease. This is the reason that most other companies and development programs are directed at early stage NASH.  Additionally, going after the late stage disease with no approved treatment and where liver transplant is the only option, the FDA usually is more willing to help with the trial design and drug approval process. 

Author Graphic

Significantly, while GALT’s NASH-CX trial showed statistically meaningful results, others that addressed this late stage disease have failed!GILD and Conatus were the only other companies in development for late stage disease. With their failure only GALT remains. See below

Company Presentation

Platform Technology

Galectin-3 has been shown to have a role in multiple diseases. The Company has very positive patient results for Psoriasis and Atopic Dermatitis. However, GALT has decided not to follow up on these opportunities. They do have patent protection for these and other disease indications. Hopefully, they will initiate research in these areas after the Phase III trial starts.  It is critical that they accelerate the cancer development work also.

Valuation Gap

Just recently, GALT announced its plans for a phase 3 trial design in late stage NASH, but the market reaction was muted instead of celebratory.  The current market capitalization of GALT doesn’t even reflect a fraction of its true valuation in the context of a big pharmaceutical buyout. The reason this valuation gap even exists can be traced exclusively back to management.  Over the past year they have done little to help investors understand the opportunity.  When the ex-CEO, Traber, left and Dick Uihlein took over as Chairman of the Board, investors thought that the business aspects would finally be a focus. But from the market’s point of view nothing has changed and the stock languishes.  It seems to the investors that their strategic consultant, Back Bay has had little oversight and no results.  The company didn’t perform any preclinical or clinical development on any other indications even though they have patents (assigned and pending) on many applications for other organ fibrosis.  While the technology has consistently improved significantly, albeit slowly, a cohesive message from management continues to elude investors.  

Articles from writers not associated with the Company have made a bigger impact on the stock price than the positive but scarce news from the Company. However, these positive price improvements never lasted because the shorts/sellers know that there will be no follow up from GALT. A lack of comprehensible and consistent information from the Company has allowed the outside world to define the message and potential of the Company. With no regular updates from the Company the technology believers battle with the shorts and sellers.  From the investors’ point of view, the presentations made by the Company are poorly constructed and given. 

When determining valuation it comes down to the fact that there is no published active or credible plan to move drug development forward.  The Phase III liver trial is one defined aspect. In these circumstances the valuation of a drug development company defaults to the amount of money poured into its intellectual property.  That valuation will only change when the market perceives the company is going to actively move forward with trials or if the market believes the company will license or sell its technology.  

Valuations After a Credible Development Plan and Initiation of the Phase III Liver Trial 

The announcement of a rights offering was the inflection point that the company was transitioning from an R&D valuation scenario to an active drug development scenario.  The impassioned shareholder letter from Mr. Uihlein showed frustration that big pharma was not willing to engage with a realistic proposal.  The rights offering was a shot across the bow to big pharma, showing Mr. Uihlein’s willingness to pursue a “go it alone strategy.” A typical strategy that big pharmaceuticals employ is to starve the company of finances,  let them do a dilutive offering and then pick them up at a bargain basement price.  The rights offering is a clear signal that those negotiation tactics will not be tolerated by GALT.  

Cancer Valuations
There are many ways to measure the size of the cancer market. One can look at each type of cancer, each type of treatment, new cases, and international vs. domestic. Because GR-MD-02 is added to other immunotherapy, one can get a good estimate of the market for GALT’s therapy by looking at the therapies which are approved.  The Providence Cancer Institute presentationindicated that the addition of GR-MD-02 to KEYTRUDA® increases overall survival and decreases the side effects vs. KEYTRUDA® alone. Based on the data, combination therapy should have a high probability of approval.  Merck’s Keytruda tops $2.0 billionin sales each quarter and spans 11 indications of cancer.  It follows that GR-MD-02 which actually enhances the effectiveness of KEYTRUDA®, could achieve a valuation based on the success of KEYTRUDA®.   Goldman Sachs, Jamie Rubinsaid “KEYTRUDA® could be a $16 billion asset by 20205.”

It is obvious that MRK is very aggressive in expanding the present use of KEYTRUDA® and going for new approvals. But look only at the present numbers from Merck, $8.6 billion annually growing at 66%. The law of larger numbers indicate this growth may not be sustainable and even less likely now that a galectin-3 test might be warranted prior to treatment.  Assuming it will take 1 to 2 years to get approval for GR-MD-02, the KEYTRUDA® sales should be about $20 billion. Using only 20% of KEYTRUDA® for the price of GR-MD-02, the sales could be $4 billion. The acceptance rate should be high and faster than normal due to the additional benefit of reduced side effects from KEYTRUDA®.

Conservative investors should cut this number by 50%, $2 billion is a big number. Consider that is just for KEYTRUDA® whereas we know that GR-MD-02 can be used by most other cancer immunotherapy. To date Optiva® and KEYTRUDA® have been studied and aOX40 is planned.

NASH Valuations
There are many different calculations that estimate the size of the NASH market.  Most of which are in the $35 billion range, however, there is no delineation between the early and late stage NASH patients.  There is a compelling argument that the early stage NASH patients do not represent a viable market. Most do not have any or serious symptoms. Also, early stage responds to change in diet and lifestyle. Investors need to face the brutal reality of early stage NASH, which boils down to whether the treatments are reimbursable.  The probability is that most insurance companies would be hesitant to pay for therapy for a disease with few or no symptoms.  In early NASH, patients may take up to 10 years for the disease to progress and it is impossible to predict which patients will progress to the serious stage. 

When GR-MD-02 announced clinical trial data last year they put all these early stage companies on life support, but investors do not seem to be paying attention as evidenced by GALT’s paltry $216 million market capitalization.  Madrigal (MDGL $2.1 B), Intercept (ICPT $3.6 B), Galmed (GLMD $.18 B), Viking (VKTX $.76 B), and Genfit (GNFTF $1.0 B) are early stage NASH companies enjoying a collective market capitalization of $7.5 billion while the only company studying late stage serious disease languishes.  GALT’s GR-MD-02 is the only viable candidate for a reimbursable therapy presently. Its current valuation should be close to the average market capitalizations of the early stage companies.  Based on the recent completion of the phase 3 trial design, there is an 85.3% likelihood of approval  and that the company may be worth over $6.0 billion.     

Here is the summary of what is reasonable for GR-MD-02.

As stated above, Galectin Therapeutics decided to go after late stage disease. One issue with this strategy is that the patient population is smaller. The total addressable population for Galectin Therapeutics therapy at this point seems to be about 230,000 patients and growing. However, since there is no approved therapy and liver transplant is very limited and very expensive, Galectin Therapeutics should be able to capture most of the patient population quickly.

Pricing is unknown at this point.  A few facts are worth considering. According to the United Network for Organ Sharing (UNOS), the average cost of a liver transplant falls around $500,000. If the price is related to the cost of liver transplant, any price significantly less than this could be considered. If you use $100,000 per year, and if only 100,000 patients are treated the total is $10 billion. If this is off by an order of magnitude, it is still $1 billion. Also, consider that this is not a one time treatment. Patients will be treated as long as they do not develop EV or until the disease is resolved. GR-MD-02 might also be used for patients which have EV, also late stage, since the CX trial showed efficacy in these patients and barely missed the end point.

Potential Paths Forward

About 4 weeks ago GALT announced a rights offering and accompanied this with an impassioned open letter to shareholdersby Chairman Richard Uihlein.  A Rights Offering is essentially a structure to raise money that allows individual investors to participate in order to minimize their dilution.  It’s perceived as a very fair way to mitigate the effects of dilution while doing a financing.  Whether the present investors will put more of their money into the offering is questionable.  However, Mr. Uihlein stated in his letter to the shareholders; “My intention is to personally subscribe $20 million dollars in this offering.  This would be a significant portion of the total we hope to raise in this round.” Mr. Uihlein owns 5.7% of the company and beneficially owns 10.8% if you include purchase warrants. This equates to 5,203,202 shares that are eligible for the rights offering.  Obviously Mr. Uihlein will oversubscribe to acquire rights that are not used by other shareholders. Also, he bought more shares earlier this year and last week, which increased his potential participation.

Mr. Uihlein is director of only one public company, GALT. His is very concerned about his reputation and legacy. He is very ethical and would not like any negative publicity or the perception that he took advantage of investorsThat is why they will do a rights offering instead of a traditional financing. There are many reasons Mr. Uihlein will participate up to $20 million, but it seems clear that Mr. Uihlein is not going to let the Company fail, and he has the resources to insure success. 

Risks

The uncertainty over the amount of money raised and whether it will get enough in the rights offering to do a Phase III and run the Company for 3 years seems to weigh on investors’ minds.   According to the company S-3/Athe trial will cost over $100 million over the next three years.  Mr Uihlein agreed to pledge $20 million in the rights offering and the company still has access to an additional $20 million which includes the cash and credit line.  Will they get enough in the rights offering? Probably not. But they do not need all of the money at the start of the trial and the worst case scenario seems to be $40 million. Most trials ramp up slowly depending on recruiting. If they get subscriptions for $50 to $60 million that should be enough for the first two years at least.

Investors should question whether  it’s conceivable that GALT can do the phase 3 trial. But is it reasonable that they will finish it and proceed to develop a sales force and market it or will big pharma take it over?  The case was made above that the Company and technology are a prime target for big pharma and ideal for MRK. Both the cancer and liver therapies are multi-billion dollar markets. I speculate that the start of the Phase III fibrosis trial would be a catalyst for a potential suitor to take a very active interest in partnering/acquiring the technology. One obstacle is how to separate the cancer therapy from the liver therapy, since the drug is the same for both. Which leads me to believe that the top contenders are Merck (MRK), Gilead (GILD) and Bristol Myers (BMY) because they have interest in both, the resources to make an offer, and a pipeline that needs new products. However, MRK rises to the top of the list because there is a very real risk that clinicians will see this very powerful galectin-3 dataand start requiring patient testing which could erode over 50% of the KEYTRUDA® sales.  Owning GR-MD-02 is the only way to insulate from this risk.  This is not to say that someone like Allergan (AGN) would not show up with an offer but it’s a case of who has the most to lose. 

The point is with the potential markets for both the cancer and liver treatments being so large, I doubt the Company will be independent next year. 

Investment Summary

FBR and HC Wainwright Analyst targets are $11 to $12

There appear to be major internal changes percolating behind closed doors at GALT.  Chairman Uihlein’s open letter to shareholders is equivalent to the shot across the bow that things are going to change and perhaps in a dramatic fashion very soon.  Many investors were surprised that Mr. Uihlein would step up to the plate with a rights offering to fund the company so as to avoid dilution.  Investors selling on fears of dilution were taken advantage of at least 3 times by the shorts. However, Uihlein delivered a non-dilutive financing each time.  Now Uihlein is promising to increase his stake in a major way through a rights offering with at least a $20 million investment.  The tone of the shareholder letter indicated he was frustrated by the lack of enthusiasm for the company and its technology, and has clearly served notice for a go it alone strategy.  

Some leadership has finally emerged.  This could be the classic game of playing hard to get with the major drug companies in order to draw them into a dialogue with the Company, or it could be a primary strategy.  With a readout in NASH set for Q4 2022, and defined endpoints, there is little mystery in what the future holds for the NASH franchise.  The open question is what is the strategy for the cancer franchise? Therein lies a huge opportunity.As uncovered in this article, Merck may have a very real multibillion dollar problem if the idea of galectin-3 testing takes root.  MRK investors should consider owning GALT as a hedge to clinicians requiring galectin-3 tests prior to administering KEYTRUDA®.  GALT clearly has enough significant positive results to move forward with a pivotal trial. Building a cancer franchise will take less time and money. They can accelerate the development by managing their own trials as well as working with partners like the Providence cancer center. GR-MD-02 has little competition because by design, it is additive to primary cancer therapies. After the rights offering GALT will have the resources to develop both simultaneously. It will be an exciting year!

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