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MDGL may be overvalued considering the remaining obstacles:
MGL-3196 success in the upcoming Ph3 NASH trial is, of course, not a sure thing
MGL-3196 would meet with fierce competition, if approved. ICPT, GILD & AGN also have Ph3 candidates. There are also ~30 Ph2 candidates in NASH
VKTX + LGND have a NASH drug with a similar MOA that will soon read out Ph2 results. ( There is some concern that the VKTX + LGND candidate causes elevated liver enzymes).
FNKO licenses pop culture content, then makes shit to take advantage of temporal cultural whims
FNKO has over 1000 licenses from over 130 content providers
FNKO controls its own production facilities. As a result, it can make timely shit ( < 70 days )
Earnings 8-11-2-5
Cash = $6.4mn ; Long-term debt = 200.1mn
MC = 364mn
This stock will implode in a recession.
CLRB recently reported promising preliminary Ph2 data for the first patient in its trial in refractory hematologic malignancies.
These results should help CLRB enroll their goal of 80 patients.
Hematologic malignancies are expected to reach a TAM of ~86B by 2025
Cash runway would only be sufficient to get the company into Q4/18. Dilution is imminent.
ESNX (formerly ZBB) uses its battery and control technology to bring distributed energy systems to challenging environments.
ESNX has two divisions:
* Building smaller scale interdependent utility systems and selling
long-term contracts for the power that it produces.
* Building smaller scale utility systems in challenging
environments as a product.
ESNX is probably within 2 - 5 Qs from going cash flow positive.
Cash runway is into 2019. They will likely raise cash or take on debt in 2019. Backlog is $16mn.
ESTA Costa Rica-based silicon gel breast implant IPO during 7/18
ESTA has 3 Products:
* Motiva = implant supposedly differentiated by ergonomic factors
* Puregraft = surgical tool for purifying blood, lipids and lymph
* Divina = 3D tool to aid surgeon create patient-specific design
Most recent QoQ Rev growth = 114.1%
Gross margin is 53.4% and still growing
2017 cash burn was $32mn
Anticipated IPO proceeds = $57.5mn
VOXX is an under-delivering buy on fundamentals, despite the fact that the company is a prime example of merchant-based capitalism.
Mgmt is paid 8.75% of pre-tax profits.
Mgmt has over promised on guidance for nearly 5 years running.
The most bullish case revolves around analyzing the company ex-consumer accessories business.
MC = 133mn @ P/S of 5.55
Conservative sum-of-parts analysis:
Cash = 31mn
Klipsch Brand = 104mn
ASA = 80mn
Automotive ex ASA = 40mn
360 fly = ( 11mn in liabilities )
FENC is a biotech with one valuable product and dwindling cash
Pedmark is a Breakthrough Therapy that protects pediatric cancer patients against Cisplatin-induced hearing loss.
FENC anticipates filing an NDA for Pedmark H2/18.
The best outcome for shareholders would be a buy out. FENC does not have the capital necessary to market the drug.
Some believe that FENC could fetch $12-15/share without further dilution.
TENB is subscription-based cyber security software company that has filed for an IPO.
51% YoY Rev growth
71% of Revs are derived from recurring subscriptions.
Growth profile comparable to the recent Zscaler IPO, which has been notably successful
One negative is that the company spent $.66 of every dollar of revenue in the last Q on marketing.
ACRX may benefit from legislation that allows DOD to use medical products that are unapproved by the FDA.
Rather than cede control of a group of treatments to another agency, FDA has agreed to expedite development and review of treatments upon Secretary of Defense request.
As a result, DSUVIA is in a much stronger position for approval for its 11/3/18 PDUFA.
Watch for an October Adcom.
IOVA is the old LBIO
Tumor Infiltrating Lymphocytes ( TILs ) is the platform upon which its deep pipeline is based.
TILs are isolated from a patient's tumor following resection and expanded in vitro away from the cancer's immune suppressing effects.
IOVA has 10 Ph2 programs and 2 Ph1 programs.
Its lead program received Orphan Drug designation for the treatment of Cervical Cancer
The rise of neoantigens may render this platform relatively useless.
GMS equity may be depressed on a net income shortfall that can be attributed to acquisition costs
Gross profit increased 2.4% YOY while net income declined.
GMS has acquired Canada's largest gypsum dealer along with 5 other acquisitions. It is now one of two nation-wide gypsum dealers in Canada.
Is this a hurricane stock?
ZYNE (update)
There are 19 FDA orphan Drug Designations for Fragile X Syndrome. If this treatment makes it all the way to FDA approval, It better have the advantage of market exclusivity.
In Medical Cannabis states, Fragile X patients would do well to try products that take advantage of the Entourage Effect. Rx Green and Mary's Medicinals produce transdermal patches. I doubt ZYNE's patch would prevail in a double blind trial against these products.
I'm watching ZYNE's capital levels closely. It will probably dilute in 2018.
YY (update)
YY continues to languish while it's HUYA spinout flourishes.
YY MC = ~$6.5B. HUYA MC = ~$6B. At 48% ownership, the market is valuing YY at ~$3.6B ( less than 10x earnings)
Plus YY has ~$2B in cash
The drag on YY equity has to do with its agreement with TCEHY to have the option of acquiring a total of 50.1% ownership of HUYA
If TCEHY takes this option, YY ownership of HUYA would be reduced to 30%; but, their cash position would increase accordingly.
ADXS (news update)
AXAL EMA application is withdrawn prompting a multi-day swoom to 52-WL.
Parnered Ph1/2 study with AZN gets clinical hold lifted. This is an AXAL-PDL1 antibody combo study. Stock spikes premarket and sells off all day.
APTX 6/18 IPO with two Ph2 trials with the same compound, both reading out H1/19
NYX 925 is being studied for the treatment of Painful Diabetic Neuropathy (DN) AND the treatment of Fibromyalgia.
APTX is also partnered with AGN in a program for Major Depressive Disorder.
FDA has been granted fast track status for the DN program. This market has TAM of over $5.5B , but strong competition.
After the IPO proceeds, the company's cash runway extendes thru 2020.
ISR the worldwide market for Cesium-131 radiation therapies is gradually improving and this company has cornered it.
Presently, the great majority of revs come from selling brachytherapy seeds for prostrate cancer patients.
This week, FDA approved their collagen-based Cesium-131 carrier technology for recurrent brain tumors.
In the most recent Q, revs were up 23% YOY.
With this financing, cash runway now extends into 2020.
The next time this stock bases, it will likely be a good investment.
VKTX (update)
MDGL is now valued at 6x VKTX. If the H2 Ph2 NAFELD read out goes well VKTX should undergo another upward re-valuation.
In addition, VK5211 demonstrated promising signs of efficacy in a mid-stage trial in patients who recently suffered a hip fracture.
VKTX is seeking a partnership for VKTX
VKTX raised gross proceeds of $67.5mn in 6/18.
AVEO must raise cash in 2018
The question is whether they will do it before or after their coming TIVO-3 results are read out.
Q3/18 scheduled release of TIVO-3 Renal Cell Carcinoma Progression Free Survival results.
Positive TIVO-3 results are a likely sell-the-news event, if they haven't raised cash at that point.
ACHN has 2 important assets: 1) relatively long cash runway 2) Ph2 Factor D inhibitor for rare diseases.
RARX & ALXN approach rare diseases with a broad spectrum proteolytic. The consequences of this approach is that a lot of non-specific cell lysis winds up in the kidneys causing damage.
ACHN's approach is to inhibit hemolysis. The Ph2 POC studies presently being conducted are intended to determine whether rare diseases can be effectively treated with a more kidney-sparing agent.
Q1/19 The 6-mo Ph2 will compare starting and endpoint kidney biopsies.
3/31/18 Cash runway extends into H1/2020.
QRON is a start-up Traumatic Brain Injury (TBI) therapy developer trading on OTCPK
QRON licensed technology transfers and research services from Ariel University ( oh OH )
QRON also entered a technology license for printable biocompatible materials
Wait for POC
PRTK (update)
PRTK has 3 PDUFA decisions during 10/18
Omadocycline would be the first once daily, multi-indicated oral antibiotic to be approved in 10 years.
Its second antibiotic will be marketed by AGN and has a PDUFA later in October.
Cash runway extends thru Q1/21
AdCom for Omadocycline will be 8/8/18
GELYF is now the #2 domestic car brand in China.
Tariff and trade war talk has stuffed the equity by ~33% this year.
Bullish arguments for Geely's recovery include the following:
* Geely is a leader in EV mfring & development of charging
stations, areas of Chinese govt planning emphasis.
* Sales have been up every month of 2018 YoY
* Its Emgrand GL is the best selling A+ class sedan in China
* Geely's acquisition of Volvo gives it a presence in the export
market
AG has been outperforming the price of silver, is the stock performance warranted?
Consider these factors:
CEO is a silver perma-bull who begins to look like a hypester the longer you pay attention.
Newly elected Mexican head-of-state is Marxist filth who heightens of risk of doing business there.
Why doesn't CEO hold some of his ounces for a real silver bull market, instead of maximizing production at negligible profitability?
The recently acquired San Dimas mine may need capital improvements.
AKBA - KERX will merge in a deal that will give KERX shareholders .3743 AKBA shares for each share they own.
On the day before the merger their combined MC = $1.13B with a combined $453mn in cash and the potential to save $50mn/yr in cost savings.
AKBA Ph3 Anemia drug will address a $4B TAM; however, they will only receive a double-digit tiered royalty from Otsuka ( the owner of the drug).
MLNT was formed when CEMP agreed to pay $265mn + royalties for MDCO's infectious disease business.
7/18 MC = ~$400mn with a cash balance of ~$200mn after 5/18 secondary.
Important milestones during the remainder of 2018:
* Ph3 readout in CABP for Baxdela
* EMA regulatory decsion for Vabomere
* Baxdela regulatory submissions in latin america.
Pipeline is deep, but cash burn is projected into 2020. More dilution in the future is probable.
AQXP failed Ph3 Cystitis Pain Syndrome trial.
With ~$92.7mn in the bank this company is a reverse merger candidate
Otherwise, the next milestone is 7/19 POC study in patients with chronic prostatitis/pelvic pain syndrome.
Best scenario might be cancelling this study and actively pursuing a reverse merger.
GBT Ph2 SCD drug voelotor trial had strong results for its primary endpoint (hemolytic anemia)
Voxelotor has already received Breakthrough Therapy designation from the FDA as well as Priority Medicine designation and Orphan designation from the EMA.
If the FDA grants Accelerated Approval designation, Voxelotor will be on the market in 2019.
FDA has already expressed the importance of new therapeutics for SCD.
CNTE is a coal company that plans to uplist to the NYSE in 9/18
CNTE generates 50% annual FCF and plans to begin paying dividends after its uplist
A pending merger with Alpha Natural Resources will make CNTE the largest Met Coal producer in America.
HCC (Warrior Met Coal) may have foreshadowed the story of CNTE
GEMP Ph2B showed at 47% reduction in TGs with all secondary endpoints achieved.
GEMP is HOPING that these results will translate into a positive POC studies in NASH/NAFLD
Victory in NASH is likely to go to the treatment that produces the most desirable reversal in fibrosis. It's highly unlikely to be GEMP's compound.
Even so, a MC < $120mn is cheap for a company with an effective lipid treatment.
Cash runway is into 2019; but, they will need cash to run the PH3 SHTG study.
JD is the 3rd largest Chinese ecommerce site.
What makes JD unique is that it owns its entire logistics network from supply chain to warehouses to last mile logistics, like Amazon.
Their top two competitors are both owned by BABA. Their business model is more like EBAY.
JD controls customer experience. BABA does not.
JD meets all 6 criteria on the compounder's checklist:
* Founder led
* Durable competitive advantage
* Industry tailwinds
* Long runway for growth
* Profitable
* Safe Balance Sheet
EIGR recently announced an expanded licensing deal MRK
MRK is now partnered with EIGR in both their Lonafamib programs. These programs will initiate Ph3 trials before the end of Q1/19.
EIGR is a leader in Hepatitis D, likely to become a disease of greater concern as Central Asian human filth continues to pour into Western Civilization.
EIGR raised cash on 5/18 expanding its runway into 2020.
Also, it would be wise to track the prospect of EIGR receiving a priority review voucher.
EVER recent IPO that acts as a distribution platform for third party insurance providers
EVER Q1/18 revs grew 28% YOY
If we assume a FY18 growth rate of 15%, it's trading at 2.78x EV/FY18 Revs. DBX is an example of a recent tech ipo that is trading at a much higher multiple, 10x EV/FY18 Revs.
By this measure, the EVER IPO is a comparative value.
EYEN has a pioneering precision ophthalmology dosing technology that could disrupt eye droppers.
Lead program is a treatment for closed angled glaucoma that will enter Ph3 Q1/19
EYEN is expecting data in 2019 for their pharmacologic dilation program.
They have an OTC artificial tears device that may be ready to market in 2019.
Their program with the greatest commercial potential is their treatment to arrest Myopia. It's entering the clinic in 2019 and is expected to be ready for regulatory submission ins 2022.
Cash runway will take them into Q4/19.
FRD had an earnings surprise.
In addition, the stock price is now supported by margin expansion, Trump's proposed tariffs and recent dividend increases.
YOY revs rose 55%
Ex Div is 7/12/18 for .03
AKAO FDA approved their antibiotic for the Urinary Tract Infection indication, but did not approve its use in the bloodstream infections indication.
As a result the stock dropped more than 25%.
Their cash runway will barely get them to the end of 2018.
OTOH, their antibiotic will be priced at 1000 per day for a minimum 10-day course. If their launch puts them on a course to acheive 10%
market share, their revs could equal $450mn. If they trade at 3xRevs, that would be $30/share.
AKAO maintains that it has a go-it-alone strategy, but that might just be a negotiating ploy.
I will keep this on my watch list and watch scripts.
CARA just announced results from a Ph2/3 trial for its IV pain drug.
The hook is that CARA 's pain and itch treatments are non-opioid and non-addictive.
The problem may be that it does not provide sufficient morphine rescue during the first 16 hours after surgery. It's primary benefit it does not induce vomiting like morphine.
The big question is whether the trial was large enough and confirming enough to receive fast-track designation. (Probably Not)
FMS has licensed CR-835 and paid CARA milestone of $70mn on 5/18.
With this milestone, CARA has a cash runway into 2020.
In addition, CARA's lead program is in Ph3 against Pruritis.
VSLR may be the solar installer with greatest opty to succeed in the solar sector
Even if tariffs make panels more expensive, VSLR is likely to benefit when technological innovation brings solar energy collection costs down.
Right now, Pervskite seems to be that new technology. Perovskite can be sprayed onto the side of buildings or printed on sheets and hung on walls.
If VSLR becomes a pioneer in the installation of Perovskite it will build on its status as top installer.
SCYX ( the stock and the fungal superbug)
Presently there are only 9 FDA-approved antifungals .
The most recently approved antifungal is an azole marketed by ALPMY in the U.S. and PFE in Europe. First year revs in USA were $53mn. PFE paid 70mn (+ $427mn in potential milestones) for European rights.
GILD's antifungal of last resort produced revs of $366mn in 2017.
SCY-078 is a semi-synthetic derivative of a compound found in Juniper.
Data from a Ph2B trial in vaginal candidiasis will read out 7/18.
SCY-078 has a clinical hold on its IV formulation for invasive candidiasis.
SCY-078 may provide an opty for licensing to regions outside of the USA for the emerging fungal superbug, C. Auris.
3/31/18 SCYX had $63.7mn in cash and $10mn in debt.
Emergence of the Fungal Superbug
The theory that dinosaurs may have been wiped out by a fungal infection has been gaining credence.
In 2009 C. Auris was first identified in an ear canal in Japan. Since then it has been found in many countries. In 2013, it was first found in the USA.
C. Auris is unique in that it is a fungus that acts like a bacterium. Some now recognize it as the first fungal Superbug.
AXON (update)
AXON transformed itself into a gene therapy company by acquiring a second generation Parkinson treatment
All approved PD therapies treat symptoms. This therapy is intended to reverse/control progression
OXB-102 delivers 3 genes that encode for enzymes required to synthesize dopamine.
AXON will conduct a Ph1 dose escalation study followed by a Ph2 double blind sham study.
The investigation for the first generation of this treatment failed to demonstrate efficacy and did not test for increased dopamine levels. If the AXON's investigations do not test for increased dopamine levels, the results will be very controversial
6/22/18 filed for $75mn ATM financing