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CLBS acquired global rights to a late-stage stem cell therapy from SHPG.
Their CMO guided this asset thru Ph1 & 2 studies at Baxter
CLBS will only owe milestones based on success
6/18 FDA granted the therapy RMAT status. This will allow CLBS to submit the therapy for approval w/o late stage trials
It's unclear how much additional work will be required to make this submission. a meeting with the FDA is in the works to clarify the next step.
The best possible outcome is a conditional approval followed by a confirmatory Ph3.
Cash runway will take CLBS into H1/20.
SPHS has a Prostate Cancer drug that had positive Ph2B results after a single dose.
Despite this, the stock sank 40% because one out of 35 patients died. The death is being investigated. The investigation will last at least until August/18.
29% of the patients who topsalyn had not detectable cancer after a single dose. 17% had complete responses.
450 patients have been administered Topsalyn over the course of its clinical history. One patient died. The one that died had a second dose.
Cash runway is into Q2/19, but they will likely raise cash in 2018.
INFI recently showed progress by presenting encouraging data at ASCO 2018
The bull case for INFI revolves around the possiblity of an effective combo therapy with Opdivo (nisolumab)
The ASCO data showed that IPI-549 in combination with Opdivo showed 40% durable disease control in Adrenocortical Cancer
In addition, VSTM will owe INFI a $22mn payment if duvelismib gains PDUFA approval in 10/18.
With this payment, INFI would have a cash runway into Q4/19. Without it, they will only make it thru Q1/19.
NTEC has two promising assets including a Ph3 Parkinsons drug and a Ph1 CBD preparation for Fibromyalgia
NTEC also has a partnership with NVS to enhance delivery of an undisclosed compound.
The next major milestone will be the Ph3 readout in mid/19 for the treatment of severe Parkinson's symptoms.
4/30/18 Cash runway into 2020.
ADVM ( and AAV Gene Therapy)
ADVM is conducting a Ph1 dose escalaton study using AAV to deliver Alpha-1 Antitrypsin gene for early onset emphysema.
If their serotype-payload cassette-immunogenic purity platform work in this application, they may have a blockbuster platform on their hands.
On 3/31/18 their cash runway thru 2019
On Gene Therapy:
Gene therapies target monogenic diseases (those diseases with a single damaged or missing gene)
12/19/17, ONCE received the first FDA approval for a gene therapy. Luxterna is treats a congenital condition of the eye. Luxterna costs $850K to treat both eyes. Luxterna delivers a gene rather than modifying or editing one.
Luxterna ues adeno-associated virus (AAV ) as a vector to deliver this gene. AAV has low immunogenicity and is customizable with regard to its payload.
For companies researching AAV, the secret sauces are the specific serotype, the expression cassette and the purity of the vector preparation. Serotype determines tissue affinity.
LMCNF is a 2-yr old miner that has rolled up special situation cast-off mines to become a mid-tier producer.
Leagold should produce ~450,000 toz gold in 2018 with an AISC of 930/oz
Proven and probable reservices = 5.4mn toz
MC as of 6/18 ~$557mn with 284mn shares outstanding. The market values LMCNF at $103.08 / toz
Comparable gold miners are valued at least 4.9x LMCNF
One explanation is Gold stock ETFS have not yet recognized this company as a mid-tier producer. When and if they do, there will be institutional equity appreciation.
MESO (update)
Ph3 results for children with steroid refractory aGVHD were positive.
Considering there is no approved treatments for this condition chances are good that MESO's treatment will receive an accelerated pathway.
3/31/18 cash = $59.5mn, but they have a non-dilutive credit facility
I expect this to be a profitable run-up into FDA approval.
FTSI consistently good earnings along with the proceeds from their IPO have reduced debt from $1.19B to ~$600mn in less than a year.
As a result, a significant decline in interest expense is flowing to their bottom line and the equity has become a putative value.
Next ER is 8/7/18
AST uses human pluripotent stem cells to treat cervical spinal cord injuries and telomerase presenting cancer cells
BTX owns 40% of AST
The reis is high, the capital is low and the updates are few
Their spinal cord injury (SCI) treatment is in Ph1/2 dose escalation study
The oncology program was initiated by the same team that discovered Imelestat. The lead treatment in this program is in Ph2 POC study in AML
Cash runway is only into Q4/18.
HSGX may receive FDA approval for its Knee Cartilage replacement product in 2019; but, it's not a buy until funding issues are resolved.
The present standard of care for knee cartilage trauma is a surgical procedure known as Microfracture. The Ph2 Neocart study demonstrated statistical significance at years 1 and 2.
HSGX has already entered into a commercialization agreement in Japan. This partner is initiating a Ph3 there in H2/18.
Cash runway is into Q4/18, EOY at best
If HSGX does not secure at least one more regional partnership, dilution is highly likely after Ph3 results (if positive)
VCEL is also developing a similar products. Opinions vary about how big of a threat the VCEL product is to NeoCart commercialization efforts.
BIOAF is focused on blood-brain-barrier (BBB) penetrating technology that can be attached to existing therapeutics.
The MedImmune division of AZN has independently validated their platform
The problem is that the company only has a cash runway into early 2019, leaving them short of the ability to initiate a Ph1 study for their lead program.
Presently, BIOAF is preparing for a Pre-IND meeting for its lead program, HER 2+ Brain Metastases therapy.
The easiest solution to financing the company into the clinic would be a NASDAQ IPO. To qualify, the company was reverse split and raise capital to meet NAZ requirements.
KDMN 's recent secondary offering extends cash runway into Q3/19
KDMN has 3 initiatives that are working well for it:
1) Positive Ph2 data in idiopathic pulmonary fibrosis in patients previously treated with pirfenidone and/or nintedinib bodes well for ROCK inhibitor platform in other fibrotic diseases.
2) Lead candidate is likely to establish a niche in treating cGVHD over ibrutinib.
3) 13% ownership in recent gene therapy IPO, MGTX
DOMO is a unicorn software company set to IPO 6/18
Like DBX, DOMO 's offering will represent a downround in the company's financing trajectory
The previous financing valued DOMO at $2B. At $22/share the company would be valued at ~$512mn
Q1/19 growth decelerated to 32% y/y from 46% FY18.
If DOMO is given a multiple of 7x forward revenues (nearly half the valuation of DBX), price could reach $48 per share.
CCEL is a private umbilical cord blood and tissue bank
It derives revenue from processing and storage fees. The annual storage fee is $150/yr. These recurring fees account for 50-60% of revenue.
CCEL started to consolidate this industry by recently acquiring on the highest quality cord banks in the USA
Presently, only 2.6% of U.S. births participate in cord storage. CCEL captures about 4.5% of these participants.
Trading in this issue is quite thin. The best way to invest in this stock may be to set a limit order at an objective value such as 15x EV/EBIT
FIT is showing signs of life as a result of its latest wearables product sales.
Still, it is difficult to imagine a set a circumstances that would bring FIT to profitability on wearable sales alone.
If there is a future for FIT, it will involve making their wearable customers the product. Margins for this business model have great potential.
Presently, FIT does not break out numbers for it's health informatics efforts. The Health Informatics and Wearables businesses may be too intertwined to allow for this kind of clarity.
FOSL, GRMN & AAPL are all competitors. Timothy Cook, however, claims that he will resist making AAPL customers the product.
AVRO is a public company science experiment involving gene-modified stem cells.
Their lead program is a Ph2 studyin Fabry
No milestone dates are available
They acquired their Fabry technology from University Health Network
At the present burn rate, they have about 6Qs worth of cash.
ZFGN has been transformed into a viable biotech speculation by mirroring the efficacy of their first generation MetAP inhibitor while engineering out venous thrombo-embolism risk.
Preliminary Ph2 data in overweight patients wtih Type 2 diabetes melitus have been encouraging
ZFGN has filed an IND to enable studies for PWS. Presently, there are no approved treatments for PWS.
Cash runway extends into H1/19
Wait and see how the next round of financing goes.
CLDX (update)
Data has not excited the market; but, there may still be hope.
Cash balance exceeds MC
Pipeline has 3 Ph2 agents and one Ph1 agents. At this point, the company should direct its resources at the most viable and commercial targets.
There are still two sources of hope:
1) One of the combo studies with Opdivo has yielded some promise. Patients with a very advanced stage of ovarian cancer seem to be responding to the combo.
2) CDX 301 in combination with radiotherapy has yielded partial responses in five out of nine NSCLC patients.
MGTA is a biotech ipo with Ph2 data due in H2/18 and a substantial cash runway.
Technology involves bone marrow transplant using gene modified stem cells.
MGTA intends to use this technology to target the following conditions:
* Blood cancers
* Myelodisplastic syndromes
* Sickle Cell Disease
* beta-Thalessemia
* M.S.
* Scleraderma
The Ph2 data will be a clinical POC study for blood disorders.
After the IPO, MGTA will have a cash runway of greater than 5 years at the present burn rate.
EYPT (update)
MC is ~ 54mn, reflecting the markets lack enthusiasm over the company's prospects.
Cash runway will take them into Spring/19
The trick to profiting from a run-up into 11/5/18 PDUFA is maximizing your entry.
OVID will read out Ph2 results in Anglemans Syndrome with a recycled gabinergic compound
Cash runway extends into H1/19
I can see no edge in trading this stock
XERS is a biotech focusing on injectable products scheduled to IPO 6/18
Lead asset is a glucagon rescue pen
An NDA for the glucagon rescue pen is expected to be submitted Q3/18
The global TAM for this product is expected to reach $41B by 2022. There will be much competition.
XERS has 2 product platforms aimed at eliminating the need for reconstitution or refrigeration:
1) Xerisol for peptides and small molecules
2) Xeriject for biologics and large molecules (to reduce injection
volume)
The run-up into the FDA approval could be a very good trading opty.
ADXS (update)
ADXS has restructured in order to reduce its burn rate.
After the cutbacks, the burn rate will be reduced from $80mn pa to $50mn pa.
Cash runway is now thru Q1/19.
Strategically, these cutbacks will result in the following 3 changes.
1. A partner will be sought for the company's former lead program in Cervical Cancer. Ph2 was promising; so, there is reason to be optimistic.
2. The NEO program that is partnered with AMGN will become the lead program.
3. The HOT program will become the second priority. ADXS-503 will go into a Ph1 study targeting NSCLC.
APTO (update)
You have to be good at not chasing to remain a trader. This means living with the feeling of missing out, often.
This stock moves on gurus' ( who I respect) assessment of promise, despite being early stage and relatively under-capitalized.
One thing I learned from Clover Bio is that some of the APTO optimism revolves around the fact that blood cancer drugs have historically better odds of success.
APTO raised $20mn from a stock purchase agreement with Aspire Capital on 5/31/18. This is about 10% of the capital they would need to become viable commercially viable.
PRTO has a clear pathway to market for its lead asset.
FDA confirmed that its Ph3 study due to read out 3/19 plus prior trials would be sufficient for a BLA submission.
Cash runway extends late into 2019.
There is a risk of dilution before the Ph3 read-out. PRTO could tap its ATM with Cowen.
Also, the results of the Ph3 are far from certain.
The best opty that this equity could present would be a sell-off into tax loss selling season; but, that seems unlikely give the stock's performance so far in 2018.
CHRA provides environmental/regulatory compliance and technical services to Nuclear and Coal-powered energy plants.
It will ipo 6/18
The company will used proceeds to pay down debt.
CHRA is dependent on coal-friendly government. It has benefited greatly from the Trump administration.
Post-ipo, private equity will own 51.4% of the company. I will wach this chart closely before LOE
ONVO is one of those shit-cap companies that is easy to lose track of due to a perception of futility.
Its treatment for alpha-1-antitrypsin deficiency was granted FDA orphan status. ONVO targets fiscal 2020 for filing an NDA for this treatment
Success with this program would legitimize its focus on the $4B market for therapeutic alternative to organ transplants.
ONVO is seeking a 2nd IND-track program in orphan liver disease.
Cash = $44mn while burning ~$6mn / Q, giving them a runway deep into fiscal 2020
JNCE is an immuno-oncology firm with a Ph2 therapy that has not performed up to market expectations.
Its T-effector technology involves: 1) creating an antigenic response 2) attaching to natural killer (NK) cells and directing them to kill regulator cells that block T-cells from getting to the tumor.
This MOA shows efficacy in cancer sub-types with high NK populations and seems to reverse anti-PD1 inhibitor failures.
CELG has an option on the entire pipeline. This technology may complement CELG's new immuno-oncology focus.
Although JNCE has a cash runway of ~2 years, it is doubtful that their runway would make it all the way to commercialization of their lead compound
AMRS engineers yeast to produce useful compounds that are considerably more expensive to extract from natural sources.
Partners contract AMRS to engineer yeast to make these compounds then pay 2x:
1) when the compound is produced
2) when the final product are sold
AMRS has advanced the process to the point where it programs robots to engineer the yeast. It is these robots that proved the competitive edge over other industrial biotechnology companies.
Products presently marketed are Vitamin E, Base oil lubricant, fragrances, Hemisqalene/squalene moisturizer & liquid rubber.
Pipeline products are vanillin, Reb M sweetener & vitamin A.
Revs grew 116% in 2017
The biggest negatives are debt and cash levels. AMRS as ~$165mn in debt and only $33.9mn in cash with a $23.7mn loan due in the current Q.
Worst case scenario is significant dilution. Shares outstanding could go from 50mn to more than 110mn shares outstanding in order to pay off debts and redeem warrants. At the present growth rates, equity may still be a good investment.
ORGS has 2 divisions: 1) CDMO is a NASDAQ listed contract mfr/developer of cell based therapies 2) R & D program focused on converting liver cells into insulin producing cells
CDMO is growing at a rate corresponding to the Cell Therapies growth rates. CDMO grew 58% in 2017.
CDMO competes with WXXWY & LZAGY
CRSP is a significant client of CDMO, along with Servier & Zelluna.
ORGS intends to file an IND for Autologous Insulin Cell Production technology this year.
Potential catalysts include:
* Sell-side coverage. ORGS uplisted from OTC and presently has minimal institutional support
* Positive news associated with a major client. CRSP can be very news driven
* Entering into a agreement with a new mfrng/development client
VKTX has risen on sympathy to the perceived value increase of another NASH play.
VKTX has a Ph2 NASH study that will read out in H-2/18.
The bull case is that VKTX Ph1 data could be interpreted as stronger than the Ph1 data of MDGL
The bear case is that VKTX has undergone > than 100% dilution in the last year at lower pps plus an outstanding ATM agreement with Lincol Park Capital.
Pay attention to relative MC of VKTX,MDGL & ICPT. I believe ICPT is a better stock to stalk short.
RHHBY : The world's biggest Pharma & the world's biggest diagnostic company has been dropping for most of 2018, despite increasing full year guidance.
Yield is ~4%
Pessimism revolves around the upcoming wave of patent expiries for its big 3 products: Rituxin, Avistin & Herceptin.
Plans for growth revolve around 3 new products:
1. Tencentriq has been a disappointment so far; but, it is being studied alone and in combination in 8 Ph3 studies
2. Ocrevus is the only drug approved for PPMS. It is licensed from BIIB
3. Hemlibra has been approved for a subset of Hemophilia A and label expansion is being sought
Ex-div date is once per year. In 2018, Ex-div was 3/15
I would only trade this with a strong bottoming pattern.
True Story
When I was 20, I was a disc jockey at the campus radio station of a Bible School.
We were taught that rock music was the music of satan.
One Sunday morning, I played
Chicago : 25 or 6 to 4
Mr. Bond : Power Level
Vic Chestnutt : Fun Party
Tyrant Fashister: The Normalfag Song
The best thing about getting older is to see how broadly generations that weren't relentlessly propagandized by a handful of media outlets think:
Slurs like neo-nazi don't work very well for the younger-than-boomer crowd.
These guys are wonderful:
ABEO is a rare disease gene platform company that addresses lyposomal storage disorders
Lyposmomal storage disorders are caused by deficiencies of enzymmes needed for stepwise breakdown of glycoaminoglycans (GAGs)
GAG build-up are assoicated with several rare diseases. Consequently, ABEO has a substantial pipeline.
5/18, ABEO reported Ph2 results against San Filippo Syndrome that showed stellar efficacy over 18 months.
The lead program is in Ph3 against Epidermolysis.
Cash runway is into H-1 2020.
MOR upside potential is substantial due to well-negotiated deal economics plus key assets for which full rights have been retained.
Near-term, annual royalties from its psoriasis compound partnered with JNJ could reach $65-125mn
MOR will have up to 14 mid- and late-stage study read-outs later in 2018.
After a very well received US IPO, MOR has ~$500mn in cash.