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MESO (update)
Q3/18 expecting 180-day follow-on data to Ph3 study that successfully met its primary endpoint
The expectation is to have the first industrial mfred allogenic mesenchymal lineage cell-based product in the U.S.
Although there is competition, it's very likely that there will be a niche for this GVHD treatment.
Cash runway now extends into Q4/19 and would likely get MESO thru a PDUFA decision.
TGCDF is a multi-asset West Africa miner
Sabadal is their operating mine in the Birimian Gold Camp in Senegal
Wahgnion is under construction in Burkina Faso.
David Mimran owns 21.7% of TGCDF and recently bought another 155K shares at C3.58.
The best bull case here revolves around whether a major will consolidate West African resources
Teranga will likely continue to trade with price of Gold. But, it will be interesting to see if beaten up gold miners will experience a January Effect.
ZIOP has been developing a novel CAR-T platform and an IL-2 platform (gene therapy for solid tumors )
6/18 FDA placed a clinical hold on Ph1 CAR-T trial for relapsed/refractory leukemia/lymphoma.
At ASCO, ZIOP presented survival data from a Ph1 combo (IL-2 + Veledimex) study. Overall survival was 12.7 months for this injection therapy.
There is much skepticism regarding intratumoral injection therapies.
Cash runway does not extend thru H1/19.
I won't touch this during tax loss season.
WWR has pivoted the emphasis of their operations to graphite battery parts and the development of their recentrly acquired graphite deposit in AL
A pilot plant is expected to be completed in H2/19
Full-scale manufacturing is expected to ready in 2020.
Manufacturing operations are expected to be cash flow positive in 2021
Their graphite deposit is expected to become a working mine in 2026. It is the only battery-grade graphite deposit in the lower 48.
Mercedes is building a battery manufacturing plant in Alabama. WWR hopes to be a supplier to this plant.
WWR recently raised 2.9mn in a direct offering giving them operating cash runway thru Q3/19. They still need 7mn to complete the manufacturing plant.
Turkey nationalized 2 of their Uranium deposits. WWR is negotiating for compensation.
ASND.TO is a Zn, Ag and Pb miner
At pps ~0.55, EV = 1x 2018 EBITDA
Also, it has upside exploration value at its property in Portugal
VTNR is a used oil refiner that has reached the back end of its turnaround.
In 2016, it cleaned up its balance sheet
In 2017, it focused on regaining profitability.
Guidance for H2/18 doubles revs and EBITDA
Future growth depends on increasing the portion of used oil that it collects itself rather than collects from third party aggregators.
PCTI focuses on solving complex RF problems by designing specialized antennae and test/scanning equipment
2018 was a difficult year because of the delayed 5G spend of two large customers.
5G development hype gets lots of press; but, 2018 was a year of rolling out fixed 5G in 3 American pilot cities. Optimistically, mobile 5G will start to be deployed in mid to late 2019.
CSCO brands PCTI antennae products and VZ & Huawei brand PCTI test and scanning equipment.
IOT product revs are even more important to PCTI than 5G rollout
PCTI has cash of ~$36.5mn and yields ~5%. Covering the yield has been the focus of 2018.
LUNMF is directed by an ambitious mining magnate willing to consolidate industrial metal mines
LUNMF recently failed to acquire NSU
Lukas Lundin has earmarked $3B from a strong balance sheet for acquisitions.
It's producing mines are:
* Cu in the Candeleria of Chile ( 80% owned)
* Ni-Cu in the Upper Peninsula of MI
* Cu-Zn in Portugal
* ZN-Pb-Cu in Sweden
Two-thirds of Rev comes from Copper
RDHL focuses on GI diseases
RDHL reported disappointing Ph3 Crohns Dissease trial results 7/31/18. This trial took the novel approach of treating CD as an
infection rather than a complex inflammation.
The CD treatment space is increasingly competitive. Although safe,
RDHL's approach should include a diagnostic to prove the concept. In any case, it should run another Ph3 trial.
RDHL's H Pylori treatment has a higher probability of success. Trial results for this program will be available Q4/18
Cash runway only extends into H1/19
ZNGA gets a license to make 2games for Starwarzfagz and take over the Star Wars Commander franchise.
EA presently has a Star Wars themed blockbuster
ZNGA has 23mn daily active users. Average booking per daily user is $0.11.
In last Q, ZNGA gave positive guidance that did not include Star Wars Commander revenue.
RIGL (update)
FDA approved Fostamatib for Chronic Immune Thrombocytopenic Purpuri 4/18.
Fostamatib could eventually become a $1B drug if it is approved in all of its indications. That is the bull case. The bear case revolves around the competition that may evolve in its other indications.
Fostamatib is now in Ph2 for warm Autoimmune Hemolytic Anemia (AIHA). This open label study should complete 6/19. There are other competing in this indications, not the least of which is a compound in Ph2 being developed by INCY
Fostamatib is also being studied in IgA Nephropathy where it competes with a promising compound being developed by OMER as well as compounds by RETA and RTRX.
Cash runway extends to Q4/19
TSRO has lost 3/4 of its value in the last 12 months.
This decline in equity value is mostly due to lower than expected sales of Zaluja along with poorly controlled operating expenses.
First full year sales of Zaluja = ~230mn
Patent expiration for Zaluja is 2030.
Pipeline is focused on combo trials with Zaluja including Ovarian and Triple Negative Breast Cancer.
Triple Negative Breast Cancer is an unmet need and this program should be monitored closely
Zaluja is likely to face even more competition from more advanced therapies.
TSRO is not a viable standalone company, A take-out between $55 - 70 is likely. I will be watching this closely if it makes it to tax loss selling season.
NITE is a clinical stage gene therapy company focusing on currently untreatable retinal diseases.
Commercialization of lead product is 2 - 3 years away.
Lead program is in Ph3. One year follow-up data is expected in 2020.
The second program is Retinitis Pigmentosa. Ph1/2 data will be read out at the 9/18 R&D day. Then, one year follow up data will be due H2/19.
Cash runway extends into 2020. But, there is some possibility of gaining capital thru foreign partnership(s).
TNXP (update)
Tonmya failed Ph3 for military PTSD.
Subsequently, data mining found that there was a treatment effect for patients who were diagnosed within the last 9 years. The new
narrative is that this analysis confirms that PTSD patients must be
diagnosed as early as possible.
AMR is a Scoop/Stack basins-based explorer & mid-stream company that lost 1/3 of MC due to a 10-Q delay.
Is this equity loss due to CFO incompetence or market reaction to the company's assets?
AMR may be a tax loss selling candidate; but, a decision will require more DD.
ICCC is a animal health biotech with potential for equity to double in value by 2020.
ICCC could gain FDA approval for its revolutionary Mastitis treatment by H1/20.
MAST OUT will not require milk discard as antibiotic treatments do. Milk discard cost an average of $82 per treated cow or about $200mn per year.
ICCC presently generates $11mn p.a. from its treatment for scours in newborn calves. The market for this product expected to grow
ENSV ( update )
ENSV reported a disappointing net loss in the most recent Q & sold off > 30%, despite 24% YoY rev growth
Frac water heating fleet is nearly fully booked for the upcoming cold season. Best year since 2014 is within reach unless winter is significantly warmer than usual.
60% of Revs come from DJ Basin in CO. November ballot may contain a measure to extend the distance from homes to drilling pads. This would be a setback.
I won't play seasonality until after Nov. elections.
ADMA markets & develops plasma derived products to treat Primary Immune Deficiency Disease (PIDD) and certain other infectious diseases
10/25/18 PDUFA
After a previous CRL due to mfrng issues at a third party facility, ADMA acquired the mfr and its products then addressed the issues internally
Plasma derived proteins are not subject to patents, instead quant methods to reliably test for appropriate levels of neutralizing antibodies are patentable
CEO & CFO bought a combined 57,000 shares at $4.78
Cash runway is into H2/19.
FTK is chemical company with 2 divisions.
75% of revs come from their well completion chemistry division. 25% comes from flavor division.
Recently received the largest order in the history of the company from the middle east for complex nanofluids.
Most recent Q saw 30% revenue growth YoY.
FTK's competitive orientation is to treat each well as individually as their knowledge base allows thru Prescriptive Chemical Management (PCM)
APA has been their partner in developing many of their prescriptions.
One focus of PCM approach is remediation of wells that were formerly completed using a more generic approach.
NEM may have the healthiest balance sheet in gold mining.
NEM is nearly a 10% holding in GDX
Ave AISC is ~990 and projected to improve over the next few years
Yield = 1.7%
If Gold market turns this may be a good choice. I doubt it will turn, but I may be a contra-indicator
HIVE is a busted IPO from 2014 that is about to make its first annual profit as its first adaptor 802.11ax standard comes to market.
HIVE competes against CSCO, HPE, ARRS & UBNT
Most recently, revs have fallen due to declines from sales in a legacy primary education business.
If the new 802.11ax standard products succeed, this equity is a relative value.
TRTC seems to be a scammy cannabis operation deriving most of its revs from dispensaries.
CEO's wife is/was an officer under another name
TRTC paid an insider 365K for security services
TRTC has its own branded division, but does not sell these products in its own dispensaries
Grow production is a perpetual forward looking event.
MGTA (update)
Technology is based on a molecule in-licensed from NVS that expands stem cell count from cord blood 300 - 400 fold
Ph2 results may be reported at ASH 12/18
Cash runway is now expected to last well into 2021.
PERI is an Israeli online advertising company with a history of overpaying for acquisition, yet still remaining profitable.
The bullish comparative value argument revolves around the company trading at less than 1x Revs while unprofitable market analogs such as SRAX trade at multiples of Rev and BV
PERI will reverse split at market close 8/24/18.
CNTTF is a profitable Canadian cannabis producer that will soon uplist to the TSE.
CNTTF gets lost among more heavily publicized Canadian producers.
Uplisting will occur Autumn/19
60% of Revs are derived from value added extracts
CNTTF is partnered with Grey Wolf Animal Products to produce products for pet health care market.
SRRK is a 5/18 IPO focusing on localized protein growth factors.
Other biotech firms focusing on protein growth factors do so in a systemic way that does not control side effects well.
The lead program is a selective inhibitor of Myostatin activation aimed at reversing/preventing spinal muscle atrophy.
Cash runway extends into 2020 but dilution is likely in 2019.
CERC recently shifted model to include marketed pediatric healthcare treatments and supplements
11/17 Acquired Zylera Pharma. Shkreli touted their new business model as reminiscent of his own acquisition strategies.
It's lead clinical asset is the Ph2 CERC-301, an adjunctive treatment for Major Depressive Disorder.
Balance sheet is heavily laden with intangibles and they only have a cash runway thru 2018.
CNST is a 6/18 Oncology IPO that focuses on epigenetic regulators
Lead program is a Ph2 combo trial in Metastatic Castrate-Resistant Prostate Cancer. Proof of Concept results should be available mid/19.
Proof of concept results will also be available mid/19 for their Ph2 combo trial in Myelofibrosis
Cash runway is into H2/2020.
IOVA focuses on TIL therapy in Metastatic Melanoma and has a relatively long cash runway.
IOVA is presently enrolling a Ph2 trial in Metastatic Melanoma
If the bloom continues to fade on CART-T therapies, the equity market may pay more attention to TIL
At present the burn rate, IOVA's cash runway extends into 2022.
KVAEF is a Norwegian energy services firm with a backlog of 1.3B and a MC of 453mn
Aside from oil and gas market challenges, KVAEF equity has been discounted for a work order change on a windfarm with RWE. 86mn is the maximum loss in this arbitration and KVAEF has already set aside 31mn
If you believe the market has more than discounted the impact of this case on KVAEF, the stock might be worth a stink bid for some shares.
CGM.T is Columbia-based gold miner that has used it's tribal connections to modernize meso-american artisanal mines.
EMES and CVIA are frac sand producers that have dipped precipitously on news that well completions are being delayed by takeaway constraints.
Oil demand may not support more completions during the remainder of 2018.
When E&Ps start focusing on their 2019 production goals, cheap brown local sand demand may not not pick up as fast as northern white.
E&P companies are increasingly asking for conductance tests from potential suppliers.
Under these circumstances, CVIA & EMES may recover most rapidly.
HL acquired KLDX Nevada assets 7/18
Unlike many mid-large cap North American miners, HL reserves are in relatively good shape.
In addition, Lucky Friday has a remaining 30-yr mine life with an automation initiative in its early stages.
ALKS focus is shifting from its marketed to products to its questionable pipeline:
ALKS5461 received refusal to file letter from FDA. PDUFA is 1/31/19. Efficacy is very dubious, but the drug is safe and FDA has a history of being soft on depression medications that don't really work.
ALKS4230 is an IL-2 agonist that was included in a collaboration with NKTR/BMY. Ph1 dose escalation data will be out H2/18. If skepticism about toxicity proves unwarranted, this collaboration has promise.
ALKS3831 will report Ph3 results in a weight gain trial. If approved, this drug will have limited commercial viability
BIIB098 will have an NDA filing Q4/18. There is skepticism surrounding the competitiveness of this drug.
PEYUF is a low-cost hydrocarbon producer with the unique ability to conserve NG production for many years until NG becomes more valuable.
Most recently, PEYUF has been meeting their obligations with hedges and NGL production.
Part of the reason they can do this is that debt has been structured prudently.
APVO is a $100mn MC biotech with a fast growing FDA-approved Hemophilia treatment
IXINITY grew 50% QoQ last Q.
The global Hemophilia market has a TAM of ~10B. It's not inconceivable that IXINITY is worth $100mn alone.
APVO also has a Ph2 asset in T-cell Lymphoma and a Ph1 asset in Prostate Disease.
IXINITY is growing so fast that it's difficult to determine the cash runway. There is an outside chance that this product may cover the burn rate by sometime next year.
AXSM has a deep pipeline of 5 CNS treatments
Equity has been weak after a 1/18 Ph3 Failure in Complex Regional Pain Syndrome
Its leading drug is presently in two Ph3 trials, one in Treatment Resistant Depression and another in Agitation associated with Alzheimers.
Interim results for both should be available Q4/18
Cash runway will only get them into Q1/19
AXSM may be a tax loss selling candidate.
CKPT is a subsidiary of FBIO with a pipeline of me-too oncology assets
Lead program is CK-101. It's presently in a Ph1/2 trial. It would compete with AZN's Tagrisso based on a better safety profile.
CK-301 Ph1 results in lung cancer will be read out by EOY/18
Cash runway is into Q2/2019.
STML has a PDUFA date 2/21/19 in a rare, but unmet oncology need.
FDA approval is high probability.
Traders must balance STML's need for capital with the promise of their pipeline.
STML has three promising cancer drugs.
Cash runway extends into mid/19
PGNX may be a decent analog for STML's equity arc.