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BDSI has benefited from the growing awareness of the Sackler Opioid Crisis
Q1/18 YoY growth = 19%
Belbuca is their highest growth product. It is a Schedule III opioid that doctors now find more acceptable to prescribe than Schedule II opioids
BDSI is still burning cash; but, the runway could extend thru 2020.
NXE is a Uranium exploration and development company with projects across the Athabasca
NXE owns The Arrow, a deposit comparable to CCJ's Cigar Lake.
Cash = $143mn EOQ2/18
It is still at least 2 years away from production.
At $50/lb U308, NXE would have a share price approaching $10.
RAD may be a tax loss candidate into EOY/18
Albertsons merger failed and the management did not work on a contingency plan during the merger process
As a result, guidance has been lowered into 2019.
New management is a liklihood and would likely provide a short-term catalyst.
There is likely one more chance to bring this company to profitability before debt obligations make it a zero.
KMPH (update)
KMPH will file an NDA for their 30-min onset/13-hr duration ADHD prodrug during Q1/19
Mgmnt maintains that they will garner (a) partnership(s) by EOY/18.
The problem for me here is that they have $96.3mn in convertible notes with Deerfield
NLY is the most diversified mortgage REIT in the market.
NLY yield = 11.5%, but the margin of dividend safety is razor thin.
equity trades around BV
NLY acquired MTGE 5/18
NLY-G (preferred) yields 6.8%
SBBP recently reported positive topline results in their Ph3 trial in Endogenous Cushings Syndrome.
SBBP tends to rely on debt markets more than many other small cap biotechs. They have debt greater than $87mn
Cash runway is only into mid/19
This is the kind of company that issues a surprise secondary. I won't consider doing serious DD until they raise cash.
TCDA is a recent nephrology IPO with a Ph3 asset.
reported positive Ph3 Metabolic Acidosis results 6/18.
NDA will be filed H2/19
presently enrolling an anticipatory post-marketing study that will not read out until 2022.
Cash runway extends into H2/2020, about the time when FDA approval would be anticipated.
UTHR must defend its PAH franchise against both new competitors and generics.
Their strategy involves conducting additional studies to create data that supports label expansion.
The latest Orenitram data suggests a 26% reduction in morbidity/mortality.
Of the three potential new PAH competitors ( ARNA, LQDA & MNKD ), ARNA is the only one with the capital and foresight to create a body of data that may challenge UTHR and the generics.
MESA is a regional airline issuing an IPO to pay down some of its substantial debt
partnered with AAL & UAL with contracts that must be renewed in the coming years.
MESA was the fastest growing regional airline over the last 5 years. My guess is that it won't be over the next 5 years.
MESA had the best on-time performance of any airline over the first 4 months of 2018. This may help them renew some of their agreements.
APTO (update)
APTO-253 dosing will resume before EOY18, now that the clinical hold has been lifted
CG806 will not begin human testing until 2019
Cash runway is only thru H2/19. Until there is real capital in the bank, ATM financing will eat equity holders alive.
PTOTF Every time globalist insect filth brings about a mass shooting, this stock soars
IH Markit reports TAM for schools alone = 2.7Bn
PTOTF offers only threat detection system that can specifically identify threats w/o violating personal privacy
PATSCAN technology will launch commercially EO18.
ARNA has a substantial pipeline and cash runway that extends thru 2021.
Pipeline by target Update:
UC: planning Ph3
CD: planning both Ph2 and Ph3
Primary Biliary Cholangitis: Ph2 ongoing
Oral PAH: Initiating three Ph3s
Pain in CD/CB2 receptor: Ph2 Data due 9/18
10/4/18 R&D Day
LQDA is a recent IPO with a 5% ownership stake by Gates Foundation.
Lead candidate will have Ph3 results during H1/19
Technological edge would be their PRINT platform for producing uniform drug particles.
LIQ861 is an inhalant PAH treatment aimed at reducing off target effects. TAM = ~$1.2Bn MNKD's Tre-T is a competing product.
LIQ865 for post-operative pain will enter Ph2 trial Q4/18
PTGX is a clinical stage biotech with a pipeline of Colitis & Crohns treatments
PTGX recently discontinued its lead asset's Ph2b trial, later blaming it on their CRO's human error.
TBPH competing molecule is now in the lead in the intestinally restricted Ulcerative Colitis (UC) race to approval.
The problem with the PTGX GI platform is slow onset. Its strength is minimal immunosuppression. A problem with TBPH's UC treatment is systemic immunosuppression ( but with relatively quicker onset ).
ACRX (update)
11/18 Dsuvia PDUFA
AdCom TBA
ACRX will resubmit Zalviso IF Dsuvia is approved
With recent financing, cash runway extends into H2/19
Dsuvia may benefit from opioid shortages: https://www.cnn.com/2018/03/19/health/hospital-opioid-shortage-partner/index.html?no-st=1533724065
STRI was a NAsDAQ-listed solar technology company that now trades at nearly half cash value.
STRI returned to profitability Q2/18
There are 4 potential catalysts that could drive the stock price:
1) Sale of Malaysian facility would increase cash, but not BV
2) Monetization of plastic encapsulant IP
3) Transition to toll collector for its Chinese facilities
4) Focusing on new plastic food packaging venture in Spain.
AQST is a recent IPO with a substantial pipeline and two marketed products.
Perhaps the FDA's decision on its NDA for a buccal diazepam epileptic treatment will be a tradeable event; but, the company seems to be trading at an expensive valuation.
AQST grrew revs by 31% in 2017. The operating loss was only ~$100K
Unfortunately, the company has $58mn in debt and lease payments coming due over the next 1 - 3 years.
With IPO proceeds, AQST has about $75mn in cash.
A follow-on offering would reduce debt, interest expense & possibly improve the valuation of the company.
In a bull market, I would consider buying after a well-timed follow-on offering.
TTOO ( update )
Cash runway now extends thru 2019
Revenue beat expectations in the most recent Q by 33%. I believe this was an honest beat.
It's interesting to see the cash flow positive landmark become a little more clear each Q
PETX is a marketing-stage pet pharma company.
Cash runway hinges on the Galliprant medication milestones.
If the Galliprant sales milestone is met, cash runway will be extended thru 2019. If this milestone is not met, PETX will rely heavily on ATM financing.
This is a slow-growth, unprofitable company
GRBK is a home builder focusing on FL, GA, CO & TX
6/18 secondary financing
Stock has been weak post secondary. Insiders have been buying this weakness.
GRBK has recently expanded into mortgage lending.
Optimism for the remainder of 2018 is based on a 56% increase in dollar backlog in the prior Q
HP many knowledgeable market participants regard this company as the best drilling services company in the markets.
HP never cut their dividend during the most recent oil crisis.
HP missed on the bottom line during the most recent Q
HP is highly dependent on their business environment. In the current environment, Revenues are keeping pace with expectations, but margins are suffering due to off-take constraints in the Permian and an excess of Drilled uncompleted wells ( DUCS ).
One way to monitor the next bull phase for drillers in North America is to track DUCS.
IPGP is an innovator in high power lasers.
Earnings growth has been very strong for years. In the most recent Q, Rev growth was 12% YoY and Earnings growth was 16% YoY.
Despite continued strength, stock sold off ~25 after this report.
Here are the explanations:
* Currency issues
* Fears of increased competition.
* Decline in orders from China
* Order book is changing to orders for indeterminate fulfillment
from orders to be fulfilled within a specific time frame
Quite possibly this stock is around full value when everything is factored in.
PGNX received FDA approval for AZEDRA to treat two adrenal cancers w/o any competing agents.
Most drugs that target rare indications with no competitors get valued at 3-5x peak revs. Peak revs for Azedra should be greater than $150mn.
At a MC = ~590mn, the market values the rest of PGNX as worthless.
PGNX has a cash runway that at worst extends deep into 2020.
The next milestone is this Q, Q3/18. Topline Ph3 data for one of PGNX cancer imaging agents will be read out. Approval for this agent should come in 2019.
EBIO ( update )
Now SESN plus dilution.
ENSV is a high probability seasonality play typically initiating during Oct-Nov
70% of Revs occur during the winter months when earnings are boosted by their frac water heating services.
The bullish case is destroyed at $45 per barrel oil
FCSC focuses on gene therapies aimed at rare skin diseases.
Fully diluted MC = ~35mn
The market opty for its lead program in Recessive Dystrophic Epidermolysis Bullossa (RDEB) should exceed $183mn.
FCX-007 is entering Ph2 trials. Q1/19 is the target for Ph2 interim read-out. Testing should complete during Q3/19.
This program faces competition from both KRYS and ABEO. FCSC's edge is that its treatment is systemic. The ABEO treatment uses gene therapy to engineer skin grafts. The KRYS program uses off the shelf genes and requires multiple injections.
In addition, FCX-013 is nearing the clinic in Localized Scleroderma.
Cash runway extends until Q4/19.
SLNO lead program addresses the unmet rare medical need known as Prader Willi Syndrome (PWS)
A Ph3 trial for DCCR was initiated 5/18 and likely complete H1/19.
Cash runway extends only thru the read-out of topline data for this study.
ALBO has a promising Ph3 asset for a rare medical need.
A425 targets the underlying etiology of severe pruritis in Progressive Familial Intrahepatic Cholestasis (PVIC).
This Ph3 trial will read out H2/19
CBAY has an ungoing Ph3 trial for an anti-pruritogenic drug. Eventually A425 may compete in the adult pruritis market.
ALBO has initiated a Ph2 study in NASH.
Cash runway extends at least until 2022.
EBS is a biotech specializing in Medical Countermeasures (MCM)
Globally governments are stockpiling MCMs
Biothrax accounts for 51.1% of EBS annual revs.
Corporate initiatives to diversify Biothrax revs include:
* Emergency use authorization for post exposure vaccine Nuthrax by
EOY/18
* Ph1 trial results for Zika vaccine during Q1/19
* Assimilation of the small pox assets acquired from SNY in 2017
Presently, EBS is excessively dependent on the Biothrax franchise. Watch the Nuthrax, Zika & Small Pox initiatives for trading opties.
SVRA is the product of a reverse merger with the former MAST
SVRA specializes in difficult-to-treat lung diseases
SVRA is presently enrolling 3 studies.
Its lead program is Ph3 Molgradex in Pulmonary Alveolar Proteinosis (PAP). Enrollment is expected to complete Q3/18.
With the 7/18 secondary offering, cash runway extends into 2020.
Dead money until 2019.
QURE is a gene therapy player with an MC of $1.2B
QURE will file an IND for its Huntington's Disease target Q4/18
QURE has a broad partnership with BMY covering up to 10 cardiovascular disease targets
BMY owns 8% of QURE and is on the hook for up to $2.3B in potential milestones.
Cash runway thru Q1/20
COOL markets SkinTE, a patient specific single application product made from a small piece of the patient's own skin.
SkinTE is not simply two-dimensional cell sheets, instead it is 3-dimensional tissue regenerator that can be applied within 24-48 hrs of the initial skin harvest
There is controversy over whether this product should be marketed w/o randomized controlled clinical trials via the HCT/P regulatory pathway. The essence of the problem is that SkinTE's patent language indicates that it would not qualify for this pathway.
CPAH is a SaaS integrated communications over IP solutions provider.
Think of its business as a customizable SKYPE plus support and maintenance.
CPAH has recently signed some high-profile agreements including Bosch as a customer and NTT as a marketing partner.
Insider buying has been consistent.
Despite the seeming promise of this stock, the company is not yet cash flow positive, nor has it been consistently profitable.
IDRA The failed rare disease program and the resultant failed merger with BCRX leaves the future to ride its immuno-oncology program.
IDRA is now focused on Toll-like Receptors (TLRs) technology.
Tilsotolimod (TMOD) has been granted both Fast Track and Orphan Drug status.
A Ph2 combo TMOD - Yervoy trial in Metastatic Melanoma had promising results; and, a Ph1 combo study with Keytruda is in the planning stage.
The next major milestone is the results of the Ph3 combo study in Metastatic Melanoma due mid/19.
Cash runway is into Q3/19.
VCON was recently downlisted to OTCQB. Stock then lost half its value.
Float has gone from 9.3mn to 17.6mn in the last 5Qs
NoNameStocks base valuation method is that a stock is worth the greater of:
1) 1x Sales
2) 10x Earnings
3) 1x BV
VCON is trading at 1x Sales.
Revs grew 21% YoY in the most recent Q
A few months ago, CETX bought 46% of company for .35
Add to tax loss watch list
SCPH received CRL 6/18 for its subcutaneous diuretic treatment
FDA will require human factors studies, device modification and possibly another clinical trial.
When/if approved, this treatment has good commercial potential because it would allow at home treatment w/o IV administration of diuretic.
SCPH is now trading below net cash of $99.5mn
Monitor net cash position & whether another clinical trial will be necessary into tax loss season.
DRRX has to vitally important binaries remaining in 2018:
1) 7/28/18 PDUFA for long-acting Risperidone for schizophrenia.
2) 8/7/18 PDUFA for extended-release Oxycodone
Unfortunately, there was a 14 to 3 No-vote against exnteded release Oxycodone at the 6/26/18 ADCOM.
PTIE may be a better risk reward gamble going into the 8/7/18 PDUFA.
Hoax Train by Graham Hart
KMPH seeks to leverage its technology platform to improve FDA-approved drugs into new and improved prodrug molecules.
Presently, it is focused on its Vyvanse prodrug molecule. Ph3 data was impressive.
NDA submission for KP415 is expected Q1/19
Cash runway may not last until the NDA submission. They have an ATM outstanding; but they are using it sparingly.
KMPH has converts and warrants outstanding that will dilute the current float.