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Current FDA clinical trials:
https://clinicaltrials.gov/ct2/results?term=Eftilagimod+Alpha++LAG-3Ig+or+IMP321&Search=Search
A drug that activates the protein LAG-3 (Lymphocyte Activation Gene-3) used to increase immune response to tumors and treat end-stage breast cancer.
Eftilagimod alpha (LAG-3Ig or IMP321)
https://thehealthhorizon.com/showcases/innovations/846297b8-898f-43bd-99c9-4c843a4f8cbf
Duvelisib Provides CLL Patients With a Later Line of Therapy
https://www.onclive.com/web-exclusives/duvelisib-provides-cll-patients-with-a-later-line-of-therapy
Thanks deri21 for posting the article. Gaining interest is nice and may add to some recognition but management needs to really push now to get into the CBD marijuana industry. If they can license their technology this will finally bring in bankable monies and a likely buyout, but they need to move fast.
I`m adding to my position as I can but it's hard to get large lots. GLTY
Hey bigarena
Good move, I added more to my position today too. Seems the shorts do not know this management team to well and they expect them to fail on sales of Copikta.
Sales will pick up as the drug is better understood and at some point I expect a larger pharma to acquire them as cancer is gaining big interest within the industry.
I like this offering as it`s a reasonable size at good pricing. This will give the company monies needed for further trials to test those 600 compounds they licensed and help start bringing any product to market when ready. The science is solid and Management understands this....
I really can not see losing buying this under $5, it's really an investment as bio`s will still outperform in this market that have good trials.
Small bio`s have been beaten up of late as larger biotech/healthcare are getting the lion share of new purchases in hopes of buyouts, JMO.
Only current concern is gov. shutdown and how much this is going to affect the FDA`s backlog and how fast they can get back up to speed.
Will not effect $TGTX for now.....
Institutional investors purchased a net $6.1 million shares of VSTM during the quarter ended September 2018, and now own 60.32% of the total float, a percentage that is typical for companies in the Biotechnology industry.
https://money.cnn.com/quote/shareholders/shareholders.html?symb=VSTM&subView=institutional
We`ll be well rewarded just need Mike to play by the FDA`s rule book. $TGTX has a solid pipeline and today I added on the drop.
Looking at the latest institutional additions that showed this morning on my TD acct., I did more research and liked what i`m seeing and reading.
Institutional investors purchased a net $6.9 million shares of TGTX during the quarter ended September 2018. This may signal that the smart money is gaining interest in this company as the 58.42% of shares outstanding that institutional investors hold is actually below the Biotechnology industry average.
What are Wall Street analysts saying about TG Therapeutics stock?
Here are some recent quotes from research analysts about TG Therapeutics stock:
1. HC Wainwright analysts commented, "Our $20 price target is based on the net present value of our revenue forecast through 2026, applying a 45% probability of success (POS) for ublituximab in CLL, a 45% POS for umbralisib in 25% POS for both ublituximab and umbralisib in NHL. We use a 4x price/sales multiple for these products, an early stage pipeline value of $2.84/share, and fully diluted net cash of $0.75/share to arrive at our price target. Our P/S multiple of 4x is in-line with TG’s peers that range between 2-5x." (1/22/2019)
2. According to Zacks Investment Research, "TG Therapeutics, Inc. is a biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. The Company is focused on the development of a monoclonal antibody for the treatment of various B-cell proliferative disorders including lymphoma, leukemia, and auto-immune diseases. TG Therapeutics, Inc., formerly known as Manhattan Pharmaceuticals, Inc., is based in New York. " (11/16/2018)
3. Raymond James analysts commented, "We are maintaining our Strong Buy rating for TG Therapeutics. Today, at the American Academy of Neurology (AAN) 70th Annual Meeting, the company provided an update on the ongoing Phase II study of TG-1101 (ublituximab) in patients with relapsing forms of multiple sclerosis (RMS)." (4/25/2018)
TG Therapeutics’ shares jump as umbralisib wins FDA’s breakthrough status
by natalie grover — on January 22, 2019 09:38 AM EST
https://endpts.com/tg-therapeutics-shares-jump-as-umbralisib-wins-fdas-breakthrough-status/?utm_medium=email&utm_campaign=647%20Mon%20011918%20Katrine%20Bosley%20abruptly%20severs%20ties%20with%20CRISPR%20pioneer%20FDA%20halts%20messenger%20RNA%20clinical%20program&utm_content=647%20Mon%20011918%20Katrine%20Bosley%20abruptly%20severs%20ties%20with%20CRISPR%20pioneer%20FDA%20halts%20messenger%20RNA%20clinical%20program+CID_cfd8631b854740aae9ccefd116795c3a&utm_source=ENDPOINTS%20emails&utm_term=TG%20Therapeutics%20shares%20jump%20as%20umbralisib%20wins%20FDAs%20breakthrough%20status
Could be a good set up after managements poor timing on guidance last year. Stocks been beaten down but pipeline is still strong.
TG Therapeutics Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Umbralisib for the Treatment of Marginal Zone Lymphoma
GlobeNewswire
NEW YORK, Jan. 22, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for umbralisib (TGR-1202) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 regimen. There are currently no fully approved agents for MZL.
The Breakthrough Therapy Designation was based on interim data from the MZL cohort evaluating umbralisib monotherapy in the ongoing UNITY-NHL Phase 2b registration-directed clinical trial.
Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer stated, “We look forward to working closely with the FDA to bring umbralisib, our novel PI3K-delta inhibitor to patients as quickly as possible. MZL patients who fail initial chemo-immunotherapy are left with limited treatment options. We believe umbralisib can play an important role in fulfilling this unmet medical need. The MZL single agent umbralisib cohort of the UNITY-NHL study is fully enrolled and we look forward to reporting top-line results from this cohort by mid-year and presenting the data at a major medical meeting in 2019.”
About Breakthrough Therapy Designation
The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.
About Marginal Zone Lymphoma
Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) B-cell non-Hodgkin lymphomas (NHLs) that begin forming in the marginal zone of lymphoid tissue. With an annual incidence of approximately 7,500 newly diagnosed patients, MZL is the third most common B-cell NHL accounting for approximately eight percent of all NHL cases.i MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL).
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta. Umbralisib uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody, TG-1501, as well as its covalently-bound Bruton Tyrosine Kinase (BTK) inhibitor, TG-1701, into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. TG Therapeutics is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: our ability to successfully and cost effectively complete preclinical and clinical trials; the risk that the interim clinical trial results from the UNITY-NHL MZL cohort that supported this Breakthrough Therapy Designation (BTD) will not be reproduced in the final data, or if positive, will not be sufficient to support a filing for approval, the risk that the interim data from the UNITY-NHL MZL cohort will not be reproduced in future studies or in other cohorts of the UNITY-NHL study; the risk that umbralisib will not receive accelerated approval based on data from the UNITY-NHL MZL cohort, the risk that the differentiated tolerability profile for umbralisib observed thus far in clinical trial will not be reproduced in the UNITY-NHL study, the UNITY-CLL study or any other on-going studies; the risk that the combination of ublituximab (TG-1101) and umbralisib (TGR-1202), referred to as U2 and being studied in the UNITY-CLL clinical trial, will not prove to be a safe and efficacious combination, or approved for any indication. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Jenna Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com
i Denlinger NM, Epperla N, William BM. Management of relapsed/refractory marginal zone lymphoma: focus on ibrutinib. Cancer Manag Res. 2018 Mar 27;10:615-624. doi: 10.2147/CMAR.S133291. eCollection 2018
https://resource.globenewswire.com/media/0e613f5f-8c22-4c63-a73b-c08cc0fbec64/small/logo-tg-revised-colors-jpg.jpg
Source: TG Therapeutics, Inc. 2019 GlobeNewswire, Inc.
They may be small buys by Management but they are buying along with shareholders=very positive.
Insider Actions for Pressure BioSciences Inc.
https://www.marketwatch.com/investing/stock/pbio/insideractions
Like 2015 all over again and big gains to be made:
China Offers a Path to Eliminate U.S. Trade Imbalance, Sources Say
https://www.bloomberg.com/news/articles/2019-01-18/china-is-said-to-offer-path-to-eliminate-u-s-trade-imbalance?srnd=premium
Yes it was and now the stock is getting harder to accumulate at the lower end yet I keep adding.
I believe their Ultra Shear technology is very promising in separating CBD oil for consumables and could be an industry standard that really moves the stock in the short to long term. Looking for first target of $5.00-$8.00 this year.
Management sounded as though this was their main concentration current presenting this to MJ industry.
Looking forward to the next live investor updates..............
One really needs to listen to this to see just how positive Management really is:
http://pressurebiosciences.com/audio/Pressure%20BioSciences_121918.mp3
TG Therapeutics (TGTX) Presents At 36th Annual J.P. Morgan Healthcare Conference - Slideshow
Jan. 12, 2018 2:16 PM ET|21 comments
The following slide deck was published by TG Therapeutics, Inc. in conjunction with this event.
https://seekingalpha.com/article/4137302-tg-therapeutics-tgtx-presents-36th-annual-j-p-morgan-healthcare-conference-slideshow
Another upgrade with higher price target:
Corbus Pharma up 11% premarket
Jan. 11, 2019 8:33 AM ET|About: Corbus Pharmaceuticals... (CRBP)
Corbus Pharmaceuticals (NASDAQ:CRBP) is up 11% premarket on light volume. Cantor Fitzgerald raised its fair value target to a Street-high $38 (from $36) while maintaining its Overweight rating.
Uber-bull H.C. Wainwright's price target is a more pedestrian $24. Other sell-side targets range from $22 - $27.
https://seekingalpha.com/news/3422371-corbus-pharma-11-percent-premarket
I would not say that, i`ve written on many sights about the company and its future: Below is not my work though but it represents well....
Corbus And Inventiva In Systemic Sclerosis: Looking Good
Jan. 7, 2019 10:40 AM ET
https://seekingalpha.com/article/4231807-corbus-inventiva-systemic-sclerosis-looking-good
Looks like the buy ratings in Dec. were good calls so let's hope the economy hangs in there and this continued market selloff does not create a recession.....
Verastem Oncology Outlines Strategic Priorities for 2019 and Highlights Recent Progress
Thu January 3, 2019 4:05 PM|Business Wire
“Since the launch of COPIKTRA, we’ve been encouraged by the positive feedback we are hearing from physicians and other healthcare providers about this important new oral monotherapy within the treatment landscape,” said Joseph Lobacki, Executive Vice President and Chief Commercial Officer of Verastem Oncology. “Following the approval, COPIKTRA was quickly added to the National Comprehensive Cancer Network® (NCCN) guidelines, which has led to its inclusion on formularies and extensive reimbursement coverage, including on the top national health plans, reaching approximately 75% of U.S. Pharmacy lives and providing critical access to treatment for appropriate patients. In 2019, the commercial team will be diligently working to engage with physicians and other health care professionals to focus on ensuring COPIKTRA reaches the patients who need it.”
https://seekingalpha.com/pr/17370103-verastem-oncology-outlines-strategic-priorities-2019-highlights-recent-progress
I can only imagine those that sold and jumped on the legal bandwagon for pennies on the dollar, "if they get anything since we've heard nothing from management on any proceedings," will be shocked this time next year with the ongoing trials progress and stocks price back to double digits.
A good New Year ahead for all.........
HC Wainwright Bullish On Corbus Therapeutics' Cystic Fibrosis Opportunity
Priya Nigam , Benzinga Staff Writer December 26, 2018 11:50am
Corbus Pharmaceuticals Holdings Inc CRBP 5.71% has Phase 3 trials ongoing for its lead compound lenabasum in systemic sclerosis and dermatomyositis, and Phase 2 trials for cystic fibrosis and systemic lupus erythematosus.
With cannabinoid receptor type 2 being a critical component of resolution following inflammation, there could be “significant readthrough from one indication to the next,” according to H.C. Wainwright.
The Analyst
Analyst Andrew Fein initiated coverage of Corbus Pharmaceuticals with a Buy rating and $24 price target.
The Thesis
Although success in systemic sclerosis or dermatomyositis alone may be insufficient to lend upside to Corbus Pharmaceuticals’ shares, there is potential in lenabasum’s ability to address inflammation in cystic fibrosis, Fein said in the Wednesday initiation note.
Cystic fibrosis patients experience chronic inflammation that results in a decline in lung function, and the disease is strongly associated with more frequent pulmonary exacerbations and morbidity.
While Vertex Pharmaceuticals Incorporated
VRTX 4.05%'s triple therapies may make modulator therapy available for nearly 90 percent of those with a CF mutation, modulators of the cystic fibrosis transmembrane conductance regulator are unlikely to fully reverse the structural damage in CF patients, the analyst said.
A need exists for anti-inflammatory therapy in the cystic fibrosis space, Fein said, adding that addressing the resolution phase could offer a new approach. Lenabasum provides "the most advanced agent to target resolution," he said.
https://www.benzinga.com/analyst-ratings/analyst-color/18/12/12899545/hc-wainwright-bullish-on-corbus-therapeutics-cystic-fib
Hedge Funds Are Buying TG Therapeutics Inc (TGTX)
Published on December 18, 2018 at 2:08 am by REYMERLYN MARTIN in Hedge Funds,News
“Value has performed relatively poorly since the 2017 shift, but we believe challenges to the S&P 500’s dominance are mounting and resulting active opportunities away from the index are growing. At some point, this fault line will break, likely on the back of rising rates, and all investors will be reminded that the best time to diversify away from the winners is when it is most painful. The bargain of capturing long-term value may be short-term pain, but enough is eventually enough and it comes time to harvest the benefits.,” said Clearbridge Investments in its market commentary. We aren’t sure whether long-term interest rates will top 5% and value stocks outperform growth, but we follow hedge fund investor letters to understand where the markets and stocks might be going. That’s why we believe it would be worthwhile to take a look at the hedge fund sentiment on TG Therapeutics Inc (NASDAQ:TGTX) in order to identify whether reputable and successful top money managers continue to believe in its potential.
TG Therapeutics Inc (NASDAQ:TGTX) was in 19 hedge funds’ portfolios at the end of the third quarter of 2018. TGTX has seen an increase in support from the world’s most elite money managers of late. There were 18 hedge funds in our database with TGTX positions at the end of the previous quarter. Our calculations also showed that TGTX isn’t among the 30 most popular stocks among hedge funds.
Hedge funds’ reputation as shrewd investors has been tarnished in the last decade as their hedged returns couldn’t keep up with the unhedged returns of the market indices. Our research has shown that hedge funds’ large-cap stock picks indeed failed to beat the market between 1999 and 2016. However, we were able to identify in advance a select group of hedge fund holdings that outperformed the market by 18 percentage points since May 2014 through December 3, 2018 (see the details here). We were also able to identify in advance a select group of hedge fund holdings that’ll significantly underperform the market. We have been tracking and sharing the list of these stocks since February 2017 and they lost 24% through December 3, 2018. That’s why we believe hedge fund sentiment is an extremely useful indicator that investors should pay attention to.
We’re going to check out the fresh hedge fund action regarding TG Therapeutics Inc (NASDAQ:TGTX).
How have hedgies been trading TG Therapeutics Inc (NASDAQ:TGTX)?
Heading into the fourth quarter of 2018, a total of 19 of the hedge funds tracked by Insider Monkey were bullish on this stock, a change of 6% from the second quarter of 2018. Below, you can check out the change in hedge fund sentiment towards TGTX over the last 13 quarters. With the smart money’s positions undergoing their usual ebb and flow, there exists an “upper tier” of key hedge fund managers who were upping their stakes considerably (or already accumulated large positions).
More specifically, RA Capital Management was the largest shareholder of TG Therapeutics Inc (NASDAQ:TGTX), with a stake worth $45.9 million reported as of the end of September. Trailing RA Capital Management was venBio Select Advisor, which amassed a stake valued at $23.5 million. Bridger Management, Great Point Partners, and Highland Capital Management were also very fond of the stock, giving the stock large weights in their portfolios.
Consequently, some big names were leading the bulls’ herd. Great Point Partners, managed by Jeffrey Jay and David Kroin, created the most outsized position in TG Therapeutics Inc (NASDAQ:TGTX). Great Point Partners had $10.9 million invested in the company at the end of the quarter. Ari Zweiman’s 683 Capital Partners also made a $2.8 million investment in the stock during the quarter. The only other fund with a new position in the stock is Jim Simons’s Renaissance Technologies.
Let’s go over hedge fund activity in other stocks – not necessarily in the same industry as TG Therapeutics Inc (NASDAQ:TGTX) but similarly valued. These stocks are Merus N.V. (NASDAQ:MRUS), New Gold Inc. (NYSEAMEX:NGD), Dermira Inc (NASDAQ:DERM), and Blackrock MuniYield New York Quality Fund, Inc. (NYSE:MYN). All of these stocks’ market caps are closest to TGTX’s market cap.
Ticker No of HFs with positions Total Value of HF Positions (x1000) Change in HF Position
MRUS 6 104782 1
NGD 14 47687 0
DERM 17 88394 0
MYN 2 2216 -1
Average 9.75 60770 0
As you can see these stocks had an average of 9.75 hedge funds with bullish positions and the average amount invested in these stocks was $61 million. That figure was $113 million in TGTX’s case. Dermira Inc (NASDAQ:DERM) is the most popular stock in this table. On the other hand Blackrock MuniYield New York Quality Fund, Inc. (NYSE:MYN) is the least popular one with only 2 bullish hedge fund positions. Compared to these stocks TG Therapeutics Inc (NASDAQ:TGTX) is more popular among hedge funds. Considering that hedge funds are fond of this stock in relation to its market cap peers, it may be a good idea to analyze it in detail and potentially include it in your portfolio.
https://www.insidermonkey.com/blog/hedge-funds-are-buying-tg-therapeutics-inc-tgtx-684728/
Crossover Study Offers Additional Line of Therapy for Patients with Relapsed CLL/SLL
Single agent Copiktra (duvelisib) induced robust, durable responses in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who experienced disease progression after treatment with Arzerra (ofatumumab).
BY KRISTIE L. KAHL
PUBLISHED DECEMBER 18, 2018
Single agent Copiktra (duvelisib) induced robust, durable responses in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who experienced disease progression after treatment with Arzerra (ofatumumab) alone, according to data from the DUO crossover extension study.
In the phase 3 study, patients treated with Copiktra demonstrated a significant improvement in progression-free survival – or the time to disease progression or worsening – compared with those treated with Arzerra (median, 13.3 months vs. 9.9 months). In addition, the agent showed a manageable safety profile.
“This (trial) led to the (Food and Drug Administration) approval of the drug back in September,” study author Matthew S. Davids, M.D., MMSc, noted in an interview with CURE.
In this open-label, optional, crossover extension study – presented at the 2018 American Society of Hematology (ASH) Annual Meeting – Davids reported on data for the 90 patients who crossed over following disease progression on Arzerra and went on to receive 25 mg of Copiktra twice daily until disease progression, intolerance, death, or study withdrawal.
Median age was 68 years, and the majority of patients were male (63 percent) and white (90 percent). Patients received a median of three therapies prior to Copiktra, with 60 percent who were given three or more prior anticancer therapies.
The median progression-free survival after patients crossed over to Copiktra was 15 months, compared with nine months before patients crossed over. Of note, this was significant among those with a 17p deletion (17 months vs. eight months, respectively).
Similarly, overall response rates were higher in patients after treatment crossover compared with before (77 percent vs. 29 percent), and again in the 17p deletion subset (80 percent vs. 15 percent).
Forty-seven patients experienced no response prior to crossover. The overall response rate in this group was 73 percent after treatment with Copiktra.
Patients treated with Copiktra achieved rapid lymphocytosis (median, 1.1 months) with a median time to first response of 2.6 months.
The most common severe hematologic side effects with Copiktra included neutropenia (23 percent) and thrombocytopenia (4 percent). The most common severe non-hematologic side effects were diarrhea (21 percent), pneumonia (12 percent), colitis (11 percent), lipase increased (7 percent), acute renal failure (6 percent), and bronchitis, rash and sepsis (4 percent, each).
About 70 percent of patients had dose modifications due to side effects, most commonly from diarrhea (27 percent), pneumonia (10 percent), colitis (8 percent), neutropenia and lipase increased (7 percent each). Events of colitis (10 percent), diarrhea (9 percent), pneumonia (2 percent) and rash (2 percent) led to treatment discontinuation.
“(Copiktra) is an effective treatment option for patients with relapsed CLL after two or more lines of therapy,” said Davids, who is the associate director of the Center for Chronic Lymphocytic Leukemia at Dana Farber Cancer Institute in Boston. “Patients may receive other lines of therapy like (Arzerra) and then go on to get (Copiktra) and still do very well. So, I think even though we have many therapeutic options in CLL, it is always important to have new options, and I think this is a good one for our CLL patients.”
https://www.curetoday.com/articles/crossover-study-offers-additional-line-of-therapy-for-patients-with-relapsed-cllsll
Major Cancer Research Center Reports Pressure BioSciences' PCT Platform Could Play Major Role in Improving Cancer Diagnosis and Treatment
Tue December 18, 2018 9:32 AM|Accesswire|About: PBIO
Publication Cites Significant Benefits from Using the PCT Platform in the Analysis of Cancer Tissue Biopsies
SOUTH EASTON, MA / ACCESSWIRE / December 18, 2018 / Pressure BioSciences, Inc. (PBIO) ("PBI" or the "Company") is a leader in the development and sale of broadly enabling, pressure-based instruments, consumables, and platform technology solutions to the worldwide life sciences and other industries. The Company today announced that a team of scientists from the Centre for the Proteome of Human Cancer ("ProCan”) has published a recommended, streamlined, proteomic sample preparation protocol built around PBI's Barocycler instrument system, designed to help optimize the identification and use of novel cancer biomarkers for the improved diagnosis and treatment of cancers. ProCan scientists have named the new protocol Accelerated Barocycler Lysis and Extraction ("ABLE"). While the Company's PCT-based Barocycler system is widely acclaimed for yielding greater diversity and quantities of proteins from biological samples, the ProCan team was motivated initially by its impact in reducing the time, cost, and variable outcomes in tissue sample preparation, often a crucial, laborious, expensive, and under-appreciated but essential part of protein research.
The ABLE method is based on PBI's proprietary pressure cycling technology ("PCT") platform for the rapid breakup of tissue samples and release of the molecules within for analysis. Scientifically described as rapid solubilization and controlled proteolytic digestion, the ABLE protocol offers a standardized, high-throughput, efficient, and reproducible sample preparation method that, when coupled with the SCIEX company's SWATH-MS mass spectrometric analysis method, has the potential to accelerate and strengthen protein analysis, improving cancer characterization in order to provide clinically relevant information on diagnosis and treatment guidance options in a timely manner.
Dr. Natasha Lucas, Senior Scientist at ProCan and lead author of the scientific paper that first described ABLE, said: "The ABLE method optimises the conventional Barocycler protocol, allowing for rapid lysis and digestion of tissue samples and cell lines. For ProCan, this is a great advancement as we are processing 70,000 tumor samples with known clinical outcomes, in an attempt to provide a treatment decision for individual patients and to potentially discover new drug targets. Having a fast turn-around-time for clinical samples is of utmost importance, and this streamlined protocol allows us to go from tumor biopsy to MS (i.e. mass spectrometry) data file in about five hours."
Professor Phil Robinson, Co-Director of ProCan, commented: "The ability to reproducibly collect proteome-scale data on the smallest size tumor samples, a needle biopsy or thin section, has long been a goal for clinical proteomics. Performing tissue digestion with pressure cycling on PBI's Barocycler system is a major advance that now contributes to realising this potential. The new ABLE protocol on the Barocycler truly enables this step in the pipeline, by bringing down cost and time, thus increasing the throughput to 96 samples per day. This fast and robust sample processing combined with SWATH-based mass spectrometry is revolutionizing our ability to collate significantly more cancer data towards clinical translation."
Dr. Bradford Young, Senior VP and Chief Commercial Officer for PBI, said: "We are pleased that ProCan has developed an advanced sample processing system, featuring the use of our Barocycler instrument system. The ABLE method will enable scientists worldwide to benefit from the advantages of our PCT platform technology for cancer profiling and drug development, as reported by ProCan scientists and their colleagues. We believe the ABLE method has the potential to help transform the way cancer is diagnosed and treated for improved patient outcomes."
Mr. Richard T. Schumacher, President and CEO of PBI, commented: "We believe ProCan's novel ABLE method has the potential to profoundly improve cancer research and discovery, and possibly even cancer diagnostics in the clinical lab. ProCan scientists and colleagues have compellingly presented ABLE as a new standard for adoption as the proteomic sample preparation method of choice in Cancer Moonshot and other life science research facilities worldwide. Our business strategy is focused on immediately taking full advantage of this important technology and commercialization opportunity."
Investor Call: Wednesday, December 19, 2018
The Company will host an Investor Update Conference Call at 4:30 PM EST on Wednesday, December 19, 2018. To attend this live teleconference via telephone, dial-in: (877) 407-8033 (North America), (201) 689-8033 (International). Verbal Passcode: PBIO Investor Update Call. Replay Number (877) 481-4010 (North America), (919) 882-2331 (International). Replay ID Number: 41595. Teleconference Replay Available for 30 days.
About ProCan
The Australian Cancer Research Center Foundation International Centre for the Proteome of Cancer ("ProCan") is located in newly-renovated laboratory facilities at the Children's Medical Research Center ("CMRI") near Sydney, Australia. The goal of ProCan is to transform the way cancer is diagnosed and treated. Using specialized equipment, ProCan will analyze over 70,000 cancer samples from all over the world over the next 5-7 years. This will enable a better understanding of cancer, as well as provide a means of personalized precision diagnosis and treatment, giving clinicians the information they need to decide on the best option for each individual patient. CMRI is an official collaborator of the US National Cancer Institute's Cancer Moonshot initiative, with a key objective to accelerate what would normally take ten years of cancer research to completion in five years.
About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. is a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or "PCT") hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). Our primary focus is in the development of high pressure-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, food science, soil & plant biology, forensics, and counter-bioterror applications. Additionally, PBIO is actively expanding the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired PreEMT technology from BaroFold, Inc. to allow entry into the biologics manufacturing and contract research services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology ("UST") platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies.
Forward Looking Statements
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," estimates," "predicts," "projects," "potential" or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. In evaluating these statements, you should specifically consider various factors. Actual events or results may differ materially. These and other factors may cause our actual results to differ materially from any forward-looking statement. These risks, uncertainties, and other factors include, but are not limited to, the risks and uncertainties discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2017, and other reports filed by the Company from time to time with the SEC. The Company undertakes no obligation to update any of the information included in this release, except as otherwise required by law.
For more information about PBI and this press release, please click on the following website link:
http://www.pressurebiosciences.com
Please visit us on Facebook, LinkedIn, and Twitter.
InvestorContacts:
Richard T. Schumacher, President and CEO (508) 230-1828 (T)
Jeffrey N. Peterson, Chairman of the Board(650) 812-8121 (T)
SOURCE: Pressure BioSciences, Inc.
Copyright 2018 ACCESSWIRE. All Rights Reserved.
Analyst Actions: RBC Starts Corbus Pharmaceuticals at Outperform, Speculative Risk, With $23 Price Target
12/07/2018 08:44 AM EST
08:44 AM EST, 12/07/2018 (MT Newswires) -- RBC initiated coverage of Corbus Pharmaceuticals Holdings (CRBP), assigning it an outperform, speculative risk rating and a $23 price target.
Corbus' stock closed Thursday at $6.66 -- a "valuation [that] substantially underappreciates" the potential of its lead drug, lenabasum, RBC said in a note to clients. The stock is up almost 5% in premarket trading.
The brokerage touted lenabasum's potential, based on data and feedback showing a 55% probability of "ultimate success" in the drug's treatment of systemic sclerosis and a 60% success probability in its treatment of dermatomyositis. Those two diseases are "currently treated with poorly-tolerated, repurposed immunosuppressive agents, and ... the bar is low for any novel option."
Lenabasum, "a uniquely differentiated treatment option for immune disease," could "drive [more than] $1.2 [billion] in out-year revenue" for Corbus, according to RBC's analysis.
Price: 6.99, Change: +0.33, Percent Change: +4.95
Register here to listen to webcast:
Dec 2, 2018
8:00 PM PST
TG Therapeutics December 2018 Investor & Analyst Event
Listen to webcast
View Additional Information
The event will take place at the Marriott Gaslamp in San Diego California. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics December 2018 Investor & Analyst Event.
https://www.investornetwork.com/event/presentation/41495
Excellent post on Yahoo message board by a friend......
Update on PI3K inhibitors for CLL: Idelalisib, copanlisib, duvelisib, and umbralisib video link:
http://www.oncologytube.com/video/update-on-pi3k-inhibitors-for-cll-idelalisib-copanlisib-duvelisib-and-umbralisib/10005544
Presentations at ASH December 1st-4th may be a catalyst for the stock finally? Also Dec. 3rd is the deadline on participation in all the BS lawsuits, here's hoping these firms crash and burn due to their frivolous actions.
Presentations at the ASH 2018 meeting include the following:
Oral Presentation Details:
Title: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter’s Transformation
Publication Number: 297
Oral Session: 642. CLL: Therapy, excluding Transplantation: Cellular Therapy and Immunomodulation in CLL
Session Date and Time: Sunday, December 2, 2018; 7:30 AM - 9:00 AM PT
Presentation Time: 8:00 AM PT
Location: Marriott Marquis San Diego Marina, Pacific Ballroom 20
Presenter: Anthony R. Mato, MD, Memorial Sloan-Kettering Cancer Center, New York, NY
Poster Presentation Details:
Title: Combination of Umbralisib, Ublituximab, and Bendamustine Is Safe and Highly Active in Patients with Advanced Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Abstract Number: 4197
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
Date and Time: Monday, December 3, 2018; 6:00 PM - 8:00 PM PT
Location: San Diego Convention Center, Hall GH
Presenter: Matthew A. Lunning, DO, University of Nebraska Medical Center, Omaha, NE
The above referenced abstracts are available online and can be accessed on the ASH meeting website at www.hematology.org. Following each presentation, the data presented will be available on the Publications page of the Company’s website at
http://tgtxinc.com/publications.cfm.
Off topic:
Interesting, thanks.......
Pressure BioSciences $PBIO
This is still a relevant article. Looking forward to earnings update.....
Stock Disrupting The Entire Gig Economy (NASDAQ-PIXY)
By stocktalktoday - October 29, 201820388
ShiftPixy, Inc (NASDAQ-PIXY)
ShiftPixy should release Earnings within 2 weeks, could push PIXY above $4.20
Put PIXY on your watchlist Immediately
Over the years most of us have looked at companies like Uber and Lyft and sighed. They’re multi-billion-dollar “unicorns” transforming the way we work, the way we drive, the whole economic landscape . . . but if you’re not a fancy venture capitalist, you never even got a chance.
We call it the gig economy now. It stretches to 35% of the workforce and generates $8 billion a year in household income for people willing to trade time for compensation. Together they create $700 billion a year in wealth.
And that’s an order of magnitude bigger than Uber. Which gave a couple of veterans of the staffing industry a firecracker of an idea that became ShiftPixy Inc. (PIXY).
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Uber isn’t a taxi company. They’re a technology company that built an app that matches labor capacity (drivers on demand) to customers (people who need a ride). The wheels are incidental . . . it could’ve been any industry they chose to disrupt.
And the staffing gurus had a thought: why stop at the car? If an app can convert leisure time into work time with the tap of a screen, why not finish the job and disrupt restaurants, stores, any other business that relies on paying warm bodies by the hour?
Their colleagues didn’t get it. It sounded like a lot of effort to make a lot of minimum wage work more efficient. You needed to be an expert to even see all the angles. But the guys who built PIXY were experts.
ShiftPixy, Inc (NASDAQ-PIXY)
Today PIXY is on an Uber-like path to exponential growth. They invested the hard work it took to build their app. They tapped a lifetime of connections to seed the customer base. This was back in 2015.
In the first fiscal year they booked zero revenue. Year two, $8 million. Year three, $20 million. Nice ramp, easily doubling every 12 months. Classic startup.
Last quarter PIXY booked $9.4 million revenue, effectively doing the work of the whole of 2016 in three short months. And with raw billings climbing at an exponential rate, that growth curve looks likely to continue into the foreseeable future. Wall Street is looking for $50 million in revenue next year, which is huge when you’re still dealing with an $87 million market cap startup.
They’ve come a long way in three short years. The secret is in that disruptive business model. PIXY approaches a restaurant or retailer and “buys out” the entire human resources side . . . everything from hiring to payroll. They pay all the people and handle all the paperwork.
Then that work force works for PIXY. They’re on call in case someone drops a shift or quits. If someone has free time and wants extra cash in a pay period, they can volunteer for on-demand shifts. Location by location, store by store, the labor pool expands. They’ve got close to 8,000 people on the books now, spread across the country: Texas, California, Chicago, Arizona.
And here’s the twist. Those people aren’t captive to one store any more. If a pizzeria gets busy, PIXY can call cooks and order takers in from other franchises. If you show up on the app as willing and able, everything flows smoothly.
The bosses love it. Their people are happy and scheduling stress drops to zero. PIXY’s app gives them the freedom to “select and swipe” entire shifts as easily as ordering an Uber ride.
The app is smart, powered by IBM’s legendary Watson. It forecasts pinch points, assigns incremental benefits coverage and automatically conserves overtime. Compliance is built in. Workman’s comp . . . Obamacare . . . the hired auto coverage food delivery drivers have to carry. It’s all there.
Turnover is sky high at this end of the economy now. People are constantly drifting from job to job or simply not bothering to show up. Every hire that jumps costs time, money and effort. Once PIXY is in the loop, all of that becomes PIXY’s problem.
Needless to say, it’s a thrill for small business, where close to 6 million managers need to juggle ever-shifting regulations just like a Fortune 500 company but don’t have the scale or the resources to hire a specialist.
As an example, look at just the 14 businesses and 337 employees PIXY took on last quarter. (Yes, that’s about one contract win a WEEK.) That’s 24 workers on average to manage and 14 separate and redundant HR cycles.
PIXY is a technology company. They’re about efficiency and automation. And with their scale, they’re already running payroll. They already buy insurance coverage. Suddenly the whole process of running those 14 companies gets streamlined.
Of course it’s a volume business. Last quarter the company’s partners handed over $60 million for labor and PIXY distributed $50 million back to the actual workers. It’s going to take a lot more scale to squeeze a profit out of those numbers.
But PIXY has time to wait, cash to burn and plenty of ambition. It’s a lean enough operation throwing off enough cash that the burn rate is relatively low . . . and they’ve got $8 million to fill the gaps that emerge in the meantime.
As for the ambition, this was buried in the latest quarterly filing:
Workers are now engaging with the application at the point of onboarding with ShiftPixy. We anticipate that employees will be able to use the app to secure additional shifts within our Ecosystem. When released to the general public, anticipated to be in the calendar year 2018, provided adequate funding is available to complete our development activities, the ShiftPixy mobile application will enable not only ShiftPixy shift employees but also ultimately shifters outside the ShiftPixy Ecosystem, many of them Millennials who connect to the outside world solely through mobile devices, to access available shift jobs at all of ShiftPixy’s participating clients. In addition to the benefits of working not as independent contractors but as employees, enjoying the protections of workers’ compensation coverage and employment laws, as well as the calculation and remittance of applicable employment taxes, among other benefits, shifters are also enabled to participate in ShiftPixy’s benefit plan offerings, including minimum essential health insurance coverage plans and a 401(k) plan.
What does that mean? If all goes as scheduled, PIXY is going to open up the app to anyone willing to show up at a store, restaurant or office . . . sometime in the next three months. If you remember the initial Uber boom where everyone with a driver’s license and a need for cash volunteered the wheels, that’s where this company is headed.
PIXY can go from the employer of record for a few hundred businesses to theoretically becoming the boss of EVERY bartender, waiter, order taker, busboy, janitor, receptionist, cook, checkout clerk, sales assistant, barista, delivery driver. Job after job, company after company, anyone who wants to work a shift only needs to turn on the app.
That sounds a lot like PIXY Nation to me. Go back to those payroll numbers in the “gig economy” we talked about earlier. Even if there’s only $8 billion in overall wages to capture here, that’s still a 3,200% growth opportunity.
Grab 3% of that huge job market, PIXY doubles its billings. And that’s not even counting the true disruptive force: people who migrate from conventional jobs to pick up an extra shift here and there. Uber converted 750,000 amateurs into professional drivers. Tap into the invisible world of moonlighters, students, housewives, retirees and the sky becomes the only limit.
A typical staffing company might grow to the point where they track 600,000 worker files. That’s a global giant. PIXY has built its system to be able to handle 10 MILLION. That’s four Walmarts. Not just four of the stores. Four retail networks, each the size of the giant.
But let’s start small and realistic, like the PIXY founders did. They’re still deeply invested in the company’s success, with 86% of the stock split two ways. They’re having a lot of fun changing the way America works in the 21st Century.
ShiftPixy, Inc (NASDAQ-PIXY)
Granted, they opted for a disruptive IPO path, which may be why you haven’t heard of them. They took a “crowd funding” approach to the market last year via the new Reg A channel . . . a little like how Google or Spotify went public, bypassing Wall Street bankers entirely.
It fits their future-forward business model, but it’s kept PIXY off the traditional analyst radar. That means no real estimates, no “consensus,” nothing but a few mavericks and management’s own guidance to steer expectations.
We don’t mind. This is more of a long-haul dream (backed by a real 3-digit revenue ramp) than a quarter-to-quarter horse race. As the gig economy rises and conventional jobs recede, PIXY is front and center.
Remember, management is here for the long game too with that 86% stake. And they’ve got huge plans . . . you can collect hints if you study the press releases. Their HR records are blockchain-native, which is an asset another staffing company would probably pay money to duplicate or license.
Home delivery keeps popping up around the edges . . . collect enough drivers and you’ve got a GrubHub killer or, depending on the way management pivots, Amazon’s best friend. Stores and restaurants are all desperate to compete on convenience but don’t have the institutional knowledge to keep the vans on the road.
Think back to how FTD took over the florist industry by consolidating the delivery side. Same thing. But it’s not just bouquets. It’s EVERYTHING. The app scales.
What’s that worth to Wall Street? Conventional staffing companies trade as high as 7-10 times revenue. Even on that scale, little PIXY is grossly underrated here at what looks like 0.3X 2018 revenue.
That doesn’t even factor in relative growth or dynamism . . . the founders here want to “disrupt” their old industry first and foremost, so there’s usually a premium for that kind of audacity.
But don’t take my word for it. Check the comps HERE and make up your own mind. People who know PIXY tend to be either true believers or on the short side. With a vision this grandiose and numbers ramping at this speed, it’s hard to stay on the sidelines either way.
https://stocktalktoday.com/cant-trade-uber-meet-the-3-stock-disrupting-the-entire-gig-economy-nasdaq-pixy-v3/
TG Therapeutics Announces Phase I Study of Novel BTK inhibitor, TG-1701, in Patients with Relapsed or Refractory B-cell Malignancies is Open for Enrollment
Tue November 13, 2018 7:30 AM|GlobeNewswire|About: TGTX
First dose cohort fully enrolled
First patient enrolled with relapsed/refractory Mantle Cell Lymphoma achieved Partial Response (PR) to lowest dose being tested
NEW YORK, Nov. 13, 2018 (GLOBE NEWSWIRE) -- TG Therapeutics (TGTX), Inc. (NASDAQ: TGTX) today announced the first Company sponsored Phase I study of its novel, orally available and covalently-bound Bruton Tyrosine Kinase (BTK) inhibitor, TG-1701, is open for enrollment for patients with relapsed or refractory B-cell malignancies. The first cohort evaluating TG-1701 at a dose of 100 mg once-daily has been fully enrolled, and the first patient enrolled, a patient with relapsed/refractory Mantle Cell Lymphoma (MCL), achieved a partial response (PR) at the first efficacy assessment. The remaining two patients are too early to evaluate.
This Phase I open label trial is designed to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of TG-1701 in patients with non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). The trial is first evaluating TG-1701 as a single agent, with subsequent cohorts designed to evaluate the triple combination of TG-1701 with ublituximab, the Company's novel glycoengineered anti-CD20 monoclonal antibody and umbralisib, the Company's novel PI3K delta inhibitor, the combination referred to as “U2”. The primary objective of the study is to determine the Maximum Tolerated Dose (MTD) of TG-1701, with secondary objectives including evaluation of efficacy. The study is being led by Constantine Tam, M.D., Director of Hematology, St. Vincent’s Hospital and Consultant Hematologist, Peter MacCallum Cancer Center, in Australia.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are extremely pleased to announce the commencement of our first TG sponsored trial of TG-1701, our proprietary BTK inhibitor which was licensed from Jiangsu Hengrui earlier this year. The pre-clinical data presented at the European Hematology Association (EHA) annual congress this past summer on TG-1701 showed a highly selective kinase profile giving us confidence in its clinical potential.” Mr. Weiss continued, “We are excited to see the study is off to a strong start with the first cohort rapidly enrolled and the first patient achieving a PR at our lowest evaluated dose. Seeing early activity should accelerate our ability to identify a dose appropriate for use in combination with U2 and for expansion cohorts. We look forward to seeing more data from TG-1701 in 2019 and start
I think that the army ant of lawsuits will have nothing to work with, since the company is still blinded to the efficacy results. Timing results are not related to the management in this case. The patient population is the cause of the delay.
Mike said as much: and investors that have know should realize the law firms 98% of the time fail.
Here's to some great new news from the conference. (-:)
TG Therapeutics CEO: Market reaction to Unity-CLL drug was 'misplaced,' survival will be better gauge in test:
https://www.proactiveinvestors.com/companies/news/205781/tg-therapeutics-ceo-market-reaction-to-unity-cll-drug-was-misplaced-survival-will-be-better-gauge-in-test-205781.html
TG Therapeutics stock sinks after Phase 3 test of leukemia treatment falters, but still has 5 key tests in the pipeline
https://www.proactiveinvestors.com/companies/news/205670/tg-therapeutics-stock-sinks-after-phase-3-test-of-leukemia-treatment-falters-but-still-has-5-key-tests-in-the-pipeline-205670.html
A good look at the company with follow up remarks.
Long Ideas | Healthcare
Now Corbus Joins The NASH Fray
Oct. 8, 2018 10:35 PM ET|6 comments | About: Corbus Pharmaceuticals Holdings, Inc. (CRBP), Includes: GLMD, MDGL
Christiana Friedman
Long only, event-driven, biotech, healthcare
(607 followers)
Summary
Corbus Pharmaceuticals' licensing deal with Jenrin opens the door to the NASH market.
NASH is 4x the size of Corbus's currently addressable market with lenabasum.
CRB-4001, the flagship of 600 endocannabinoid compounds Corbus has licensed, has the same MOA Rimonobant without the psychoactive effects.
The main value proposition for the stock is still lenabasum, with Phase III results on systemic sclerosis due in March 2020.
Corbus Pharmaceuticals (CRBP) made some waves last month after news of a deal with Jenrin Discovery gave it access to 600 compounds targeting the endocannabinoid system. The number 600 is good for headlines, especially for a company that since its inception has only had a single pipeline candidate, renamed twice along the way from resunab, to anabasum, now known as lenabasum. The 600 compounds are, of course, a big deal, but the more important news in terms of near-term shareholder value is CRB-4001. CRB-4001 transforms Corbus from being seen primarily as a cannabis stock to now becoming a NASH stock.
NASH, or non-alcoholic steatohepatitis is an enormous market, projected to be worth about $20 billion annually by 2025. That’s about 4x the size of Corbus’s combined addressable markets before the acquisition of CRB-4001. For reference on how NASH-focused stocks can move when they reach the later clinical development stages, see Madrigal (MDGL) and Galmed (GLMD), for example (whose company names are practically mirror images of each other).
ChartCRBP data by YCharts
While Corbus jumped as high as 64% on the news, on a longer term chart the move actually wasn’t all that impressive considering everything that has happened in 2018, the latest being CRB-4001. Shares were as high as $10 at the beginning of 2018. Since then, the following has happened:
Now we are almost a full year closer to lenabasum’s Phase III data readout for systemic sclerosis scheduled for about 17 months from now according to the trial filing.
Open label extension data for the ongoing Phase II trial was published in Q2 in which 77% of patients achieved a clinically meaningful reduction in skin thickness, the trial’s primary endpoint.
Orphan designation was granted in the European Union and the US for dermatomyositis.
A second Phase 3 study is about to commence in dermatomyositis as well.
A $25M grant was given to Corbus by the Cystic Fibrosis Foundation to help fund its ongoing CF trial.
A Phase 2 study began in systemic lupus erythematosus.
Granted, two equity financings were made since shares topped, and those have negatively affected shares obviously. However, those were back in March and October 2017. Even so, the share price still looks quite low considering the advances made over the last two years, plus the Jenrin licensing deal.
CRB-4001
But onto newer pastures. What’s the big deal with CRB-4001? NASH. The drug is an inverse agonist of the CB1 receptor, the same receptor associated with the psychoactive effect from cannabis. Except, the psychological effects of CB1 come from those receptors in the brain. There are additional CB1 receptors in different organs, including the liver. Since CRB-4001 doesn’t cross the blood-brain barrier in significant amounts, it is not expected to cause any psychological effects, in other words no high.
Preclinical studies have shown the stimulation of fat clearance in mouse models of NASH, and more potent stimulation of pancreatic islet cells, the ones responsible for insulin production, meaning it also has potential as a diabetic treatment. Rimonobant, also a CB1 inverse agonist, was banned for psychiatric side effects because it crossed the blood-brain barrier and stimulated the CB1 receptors in the brain. Corbus believes that CRB-4001 is more potent than Rimonobant, with much fewer side effects because it only minimally crosses the barrier.
Also critical is that CRB-4001 wouldn’t really be competing with any other NASH drug on the market because its mechanism of action is much different than Madrigal’s or Galmed’s NASH drugs, which target entirely different systems.
True, there isn’t much reason to get too excited about CRB-4001 just yet, because it’s only preclinical. A Phase II trial though is planned for late next year with the endpoint of liver fat clearance, and this is when we should know if the drug can be taken more seriously as anything more than purely speculative.
Back to Lenabasum
Meanwhile, while all this early stage work will be going on with CRB-4001, we will be getting closer to the completion of Phase III for lenabasum on systemic sclerosis, the most obvious and near-term value proposition for the stock. By the time the Phase II on CRB-4001 begins, we will only be a few months away from a Phase 3 data readout.
Systemic sclerosis is about 3x more prevalent than cystic fibrosis for which lenabasum is also being tested. CF gets much more attention, though systemic sclerosis is a much deadlier disease, with a survival rate of only 55% at 10 years post diagnosis. Cystic fibrosis patients live to an average of 37 years by comparison. Lenabasum, if approved, would be the first drug ever targeting systemic sclerosis.
What about the danger of further near-term dilution? Unlikely. The company has $65 million in cash and the Jenrin transaction is not expected to affect cash flow through the end of 2019. At last year’s cash burn rate, there is enough cash now to last up and through the upcoming Phase III readout for lenabasum in early 2020. If there will be another financing, always possible, it would most likely occur right around the Phase 3 readout.
At this point I believe the biggest risk for Corbus is beta conditions in the stock market which make speculative stocks like Corbus vulnerable from unrelated margin calls and the like. There is no need to go all in now, nor get too excited about CRB-4001 specifically just yet. Equity markets are getting more volatile lately and if Corbus couldn’t reach new highs on the Jenrin deal, then immediate upside may be limited at this point, until we get nearer to the Phase III results.
Come 2020 I believe Corbus will be a completely different stock. The safety profile of lenabasum is nearly pristine with no serious adverse events, and only 19% of subjects experiencing any adverse events at all. Systemic sclerosis is a highly lethal disease with no treatment besides standard immunosuppression. The Phase II trial data are already long term when combined with the open-label extension, with the longest data stretching out 2 years since the start. If the Phase III efficacy data can get anywhere close to the open label extension data, lenabasum for systemic sclerosis will be a shoe-in just for the risk/reward profile. Then investors can start focusing more on CRB-4001, which, for now at least, is just a bonus to the main value proposition.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Editor's Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
https://seekingalpha.com/article/4210575-now-corbus-joins-nash-fray
Another small gap down to start the week. All stocks getting in on this correction.
Looking forward to this upcoming though:
TG Therapeutics, Inc. Highlights Schedule of Events at the Upcoming 34th Congress of ECTRIMS
Final ublituximab phase 2 Multiple Sclerosis data to be featured in an oral presentation, Thursday, October 11, 2018, 16:51-17:03 CEST
ECTRIMS data review conference call to be held Thursday, October 11, 2018, 19:30 CEST/1:30pm ET
NEW YORK, Oct. 08, 2018 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today recapped the schedule of events featuring ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS) at the upcoming 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), to be held October 10 – 12, 2018, at City Cube in Berlin, Germany.
Final results from the Phase 2 trial of ublituximab in RMS patients will be presented via an oral presentation during the annual congress of ECTRIMS. Following the oral presentation, the Company will host a data review conference call during which Dr. Edward Fox, PhD, Director of the MS Clinic of Central Texas, Central Texas Neurology Consultants, PA, Clinical Associate Professor at the University of Texas Dell Medical School and the Principal Investigator for the Phase 2 trial, will review the data presented and will be available for questions. Additional details are provided below.
Oral Presentation Details:
Title: Final Results of a Placebo Controlled, Phase 2 Multicenter Study of Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple Sclerosis (RMS)
Presentation Date & Time:Thursday, October 11th, 2018; 16:51-17:03 CEST
Session Title: Free Communications 4 - Treatment
Location: City Cube, Berlin, Germany
Presenter: Edward Fox, MD, PhD, Director, MS Clinic of Central Texas, Central Texas Neurology Consultants, PA and Clinical Associate Professor at the University of Texas Dell Medical School
Following the presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.
Conference Call Details:
Title: TG Therapeutics ECTRIMS Data Review Call
Date & Time:Thursday, October 11th, 2018; 19:30 CEST/1:30pm ET
Dial in: 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.)
Webcast:http://ir.tgtherapeutics.com/events
Presenter:Edward Fox, MD, PhD, Director, MS Clinic of Central Texas, Central Texas Neurology Consultants, PA and Clinical Associate Professor at the University of Texas Dell Medical School
An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.
These data support the ongoing international Phase 3 program evaluating ublituximab for the treatment of relapsing form of Multiple Sclerosis (RMS). The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University.
Off $TGTX topic:
Since we are the only 2 messaging for now. i'll throw you a fun one. Going to post the full article as I do not know if the link is sticky for non members.
At least we have beer and football to keep our minds off the market for a few days of the week, Enjoy
A little break from the bio`s as i`m overweight in them mostly. Here`s a startup outside the norm. I managed to pick up a few shares as a long term option due to the shrinking workforce. This is an older article but not a lot out there on it.
https://seekingalpha.com/article/4164363-shiftpixy-shows-impressive-growth-stock-remains-undervalued
$PIXY ShiftPixy INC.
Shows Impressive Growth, Stock Remains Undervalued
Apr. 20, 2018 1:08 PM ET|17 comments | About: ShiftPixy ($PIXY)
Steven Highfill
Long/short equity, momentum, mergers, Blockchain Technology
(34 followers)
Summary
Gross billings increased 58% and continued to accelerate quarter-over-quarter by more than 20%.
Revenue increased 45% and continues to grow sequentially.
Expanding client base and steady increase in the number of on-site gig/shift workers.
Company launches an innovative Driver Management Solution enabling fast-food clients to use their team members to self-deliver under its brand instead of having to rely on expensive third-party services such as GrubHub.
A key differentiator is a unique on-demand Uber-like mobile app connecting gig/shift workers to gig/shift openings in real time.
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On April 13, 2018, ShiftPixy (PIXY), providers of an on-demand human capital management platform connecting employers to part-time shift or "gig” workers, reported fiscal 2018 second quarter results. Gross billings grew 58.1% to $48.6 million, compared to $30.8 million for the 2017 second quarter. Gross billings increased 20.9% sequentially from $40.2 million in the prior quarter. Revenues increased 45.8% to $7.9 million, compared to $5.4 million for the second quarter of 2017. Worksite employees rose by 3,405 to 6,798 compared to 3,393 as of February 28, 2017. The number of employees at the end of the quarter also represents a sequential increase of 1,116 over the number of employees at the end of first fiscal quarter 2018. Gross profit was $0.9 million vs. $1.1 million in the prior year period, and net loss per share was 9 cents during the quarter, vs. a net loss of 4 cents the previous year period. The company beat estimates by a penny per share. This report solidifies a continuing trend of impressive growth for the young Nasdaq-traded company.
During the follow-up conference call, the CFO provided an update for the current fiscal third quarter. During the first half of the quarter, the company added 16 new clients and approximately 1,300 new on-site workers since the end of the fiscal second quarter ending February 28, 2018. He said these wins could add $93 million in new gross billings. The CFO also confirmed the company's goal to reach a breakeven point on cash flow by the end of 2018. The CFO continued: “The sequential month-over-month growth of revenue for March 2018 grew at a rate more than 20% over February 2018.” You can listen to the recorded Fiscal Second Quarter 2018 Webcast.
If the company continues to sustain this growth rate, annual gross billings growth could exceed 240% by the end of 2018. These real-time metrics support a trend of continued growth, which should drive stock price appreciation as more investors become aware of the PIXY opportunity.
PIXY a Growth Play
An investment in PIXY stock is a growth play, not an earnings play. The company has identified and filled a niche in the staffing marketplace for employers who depend on part-time gig/shift workers. The company targets employers in the restaurant, hospitality, retail, and lodging verticals. The company remains an early-stage rapid growth company that continues to make significant investments in its proprietary mobile app, HCM technology, sales and marketing, pre-paid workers compensation costs, and client support capabilities.
As a young company, PIXY decided to fuel its growth by commencing a public Regulation A+ IPO last June. As a result, the company incurred the necessary professional expenses related to being a publicly traded company. I expect profits and margins to remain under pressure for the next few quarters, but the company has potential to turn cash flow positive by the end of the year.
PIXY's continued growth will be supported by market expansion. The company recently announced the opening of new markets in New York, Austin Texas, and Orlando, Florida. These markets have a large number of employers with a substantial need for on-demand gig/shift workers. Gross billings and revenue should continue to expand as these new markets start contributing to overall performance. Operating margins should improve as capital investments subside.
Valuation and Price Target
PIXY’s growth rate and potential for significant margin increases in the future are driven by its unique structure and technology. The stock shouldn’t be valued as a traditional staffing company, Professional Employer Organization (PEO) or Administrative Service Organizations (ASO). It should be valued as a leading hybrid tech/staffing/HCM company. Most staffing companies are valued at 0.7 times enterprise value to sales with some valued as high as 1.8 times enterprise value to sales. Most PEOs/ASOs are valued at a higher multiple due to higher margins. Technology companies trade at even higher multiples. I believe PIXY’s true stock valuation should be based on a multiple of approximately 1.5 times enterprise value to sales given its growth rate and potential. PIXY stock price could appreciate to $9.30 per share by the end of 2018. I project the company's market cap will reach $300 million using my estimate of $200 million in gross billings by the end of 2018 and 1.5 times the enterprise value to sales on a fully diluted share count of 32.2 million shares.
Based on my projections and the company's current growth rate, PIXY stock appears irresistibly undervalued at current levels.
Market Reaction to Report
The company announced its fiscal second quarter earnings before the market opened on April 13, 2018. The stock opened at $3.45. It hit an intraday high of $3.60 and an intraday low of $3.04 before closing at $3.18. The stock has continued to trade in a range from $3.00 to 3.59 as of the writing of this article.
Despite the strong report, investors and traders seem to be expecting more growth. Based on fiscal first quarter guidance provided in the January 22, 2018, earnings announcement, management expected gross billings for the fiscal second quarter 2018 to be in the range of $60 million to $65 million. The company fell short of this expectation. Missing the projected gross billings number may have caused short-term momentum traders to sell positions and exit the trade. The drop in volume since the report supports this assumption.
I believe the company is a young public company and management is still learning how to guide the investing public. The company recently hired a new CFO with an extensive audit and accounting policy background that will help management guide investors more accurately in future quarters.
I also believe investors may have missed the more important story, which is the unique business model and sustained growth offered by the PIXY opportunity. I think a negative cloud has hung over the stock due to a few biased articles and events that made some investors nervous. Short-term traders and short sellers appear to have taken control of the stock once IPO investors started taking profits.
Historical Price Action
On June 30, 2017, PIXY's IPO stock priced at $6 per share. The stock began trading on the Nasdaq exchange and opened at $6.30. The stock steadily gained value throughout the day and closed at $7.70. Early investors saw the value of the PIXY business model and its potential. By July 10, 2017, the stock worked its way up to its all-time of $11.64, a 94% 10-day gain over its IPO price. These impressive gains may have attracted traders who were looking for a quick trade. Many day traders did little due diligence on the company or the offering. As the price was driven up, profit-taking set in. The stock began to drop although bulls put up an intense fight to hold the price above $10. Once that level broke, the stock price started its descent on the back of negative articles and events that created headwinds for the stock. The stock has since traded in a range from its all-time low at $2 per share to around $4.50 over the past six months.
Past Headwinds
PIXY stock suffered several setbacks since becoming publicly traded last June. First, the IPO did so well it attracted too many short-term traders who drove up the price too quickly. This led to profit-taking once the buying slowed downed. With such a low float, the stock turned down sharply. The daily moves were volatile with $2 to $3 price swings in a single trading session. Once the selling started, some panic selling and short selling piled on. Margin calls and losses caused some angry short-term traders to research the stock offering they invested in more carefully. Opinions spawned several negative stories about PIXY's two major shareholders/co-founders, creating headwinds for the stock.
Involvement in Past Legal Proceedings
The stories focused on historical administrative and legal proceedings disclosed voluntarily by the company in its offering documents to meet the conditions of certifying ShiftPixy’s Common Stock for a Nasdaq listing. See pages 32-33 of the offering circular under the section titled "Involvement in Certain Legal Proceedings" in the Offering Circular.
None of the events disclosed occurred during the five years preceding the ShiftPixy IPO. The disclosures show that PIXY CEO, Scott Absher, along with other individuals and entities, received a cease and desist order from the State of Alabama. The order asserts that he was the president of a company that issued unregistered securities to certain Alabama residents. The allegations stem from a previous venture completely unrelated to ShiftPixy. Mr. Absher disputed the assertions in the order, and the matter resolved without his response. The second disclosure related to Co-Founder Stephen Homes. The company disclosed Mr. Holmes' prior conviction for acts associated with making false statements concerning two quarterly IRS Form 941 Employer Federal Quarterly tax returns, one in 1996 and the second 1997, for a company in which he was, at the time, an officer.
The Absher cease and desist order and Holmes' convictions from more than 20 years ago were adequately disclosed in the company's offering documents. Although the disclosures provide easy ammunition to short-biased parties, neither of these background issues should have a material impact on the operations and prospects of the company. Mr. Holmes is not an employee, executive, manager, or board member of the company. He is a significant shareholder who helped to create this unique business model based on his extensive experience in the industry. His mistakes of the past should not hinder the company's operations. In addition to being a major shareholder, Mr. Holmes is an independent contractor with the company. He devotes his efforts to building a sales network and providing consulting services in relation to worker's compensation programs as well as Affordable Care Act health insurance programs. He is not involved in any part of the accounting, tax paying, or IRS return filing areas of company’s operations.
Based on my research, these matters were sufficiently closed years before the IPO and are no longer active legal proceedings. Furthermore, there are currently no pending or threatened lawsuits against the company.
Postponement of Reports
Another setback was the postponement of the release date for the company’s fiscal fourth quarter 2017 and year-end 2017 reports. Postponement announcements are never received well by investors and traders. However, it appears to be an internal growth or administrative problem suffered by a young public company. The company lost their CFO, Stephen DeSantis, in October 2017 to another Southern California technology company, CloudVirga. It took the company a few months to add a new CFO. This critical vacancy may have contributed to the delay in releasing results.
Overhang on Stock
The stock may be suffering from the perceived overhang of insiders (primarily the two founders) holding 87% of the total issued and outstanding stock, outstanding options to purchase Preferred Stock, and the 2,355,725 warrants held by non-affiliated investors at exercise prices from $2 to $4 per share. The exercise period for all warrants expires on March 1, 2019. As of April 30, 2017, none of these warrants have been exercised.
The founders possess significant influence and control over the company. In addition, upon the exercise of the options to purchase preferred stock, the holders of the preferred stock would be entitled to elect a majority of the board according to the terms of the preferred stock. Their ownership and control also may have the effect of delaying or preventing a future change in control, impeding a merger, consolidation, takeover or other business combination or discourage a potential acquirer from making a tender offer. However, I believe having a large percentage of equity held by the primary founders/insiders is a good thing.
Similar to Google (GOOG) (NASDAQ:GOOGL) or Facebook (FB), founders that are confident in their business model and future prospects prefer to control as much equity as possible. As the largest shareholders, founders have the most to gain or lose from the failure of the company to execute its plans. They also are negatively impacted more than others if the company has to experience a dilution event. The outstanding options to purchase preferred stock held by the two founders is nothing more than a poison pill. The preferred stock holds no exclusive rights to dividends and can't be converted into common stock. The preferred stock only provides super-majority voting protection in circumstances when the acquisition of a controlling interest by a shareholder other than the original holders occurs. See the Description of Securities on pages 38-39 in the Offering Circular.
I completely understand the potential dilution concerns shared by investors and traders. This potential dilution may be holding the stock down in the exercise price trading range. However, as long as the stock trades at or under the exercise prices per share, these options will expire. I expect PIXY’s stock price to appreciate as concerns about potential dilution dissipate.
I believe traders are unfairly connecting the stock price to warrant exercise prices. The true valuation of the company should be tied to the company's sustained performance and growth pattern. If the company continues its current growth trend, this overhang will not last much longer in my opinion.
Potential Need to Raise Capital
The company may need to raise additional capital to continue its expansion and product development. However, I see plenty of potential for accelerated growth without the need to raise capital as capital expenditures continue to decline and revenue continues to increase in coming quarters. It is possible the company may not need to tap the secondary market. Nonetheless, upon removal of the warrant overhang, I think the market will absorb any additional shares quickly.
Low Float Microcap Risk
While all investments involve risk, microcap stocks are among the riskiest. Many microcap companies are new or have a limited track record. Many microcap stocks trade in the "over-the-counter" (OTC) market, rather than on a national securities exchange such as the New York Stock Exchange or Nasdaq. PIXY is a Nasdaq traded company. Nasdaq requires the company to meet certain financial, public float, bid price and liquidity standards on an ongoing basis in order to continue the listing of PIXY common stock. If PIXY fails to meet these continued listing requirements, the stock may be subject to delisting. If the stock is delisted and the company is not able to list PIXY stock on another national securities exchange, I expect the securities would be quoted on an over-the-counter market. If this were to occur, PIXY shareholders could face significant material adverse consequences, including limited availability of market quotations for PIXY stock and reduced liquidity for the trading of the securities. In addition, the company could experience a decreased ability to issue additional securities and obtain additional financing in the future.
Another risk that pertains to microcap stocks involves the low volumes of trades. Because many microcap stocks trade in low volumes, any size of trade may have a large percentage impact on the price of the stock. With a small float of only 2 million shares, any bias can move the stock significantly. A low float micro-cap stock like PIXY is not for everyone. It can be extremely volatile and will test the patience of any investor watching the daily trading activity.
PIXY is an emerging growth microcap company subject to microcap risks. However, I believe PIXY stock provides a favorable risk/reward ratio at current price levels.
Investment Case
The trend toward a gig economy has begun. A study by Intuit predicted that by 2020, 40 percent of American workers would be less than full-time independent contractors. See the report published October 14, 2010.
The company has developed solutions for employers and workers in an environment in which shift or part-time/temporary positions, commonly called “gigs,” are performed. In what is now being called the Gig Economy, businesses contract with independent workers for less than full-time engagements primarily in the form of shift work.
There's a large potential market for Pixy's services. Current statistics show that more than 13 million employees are working in PIXY’s target markets - the restaurant and hospitality industries. Statistics from the U.S. Department of Labor. Bureau of Labor Statistics. September 2016. Table B-1: Accommodation and Food Services Industry Sub-Sector.
I believe there are approximately three million restaurant and hospitality entities with under 500 employees in the US, along with the estimated market potential at $3 billion in service fee revenue, or $30 billion in gross billings including wages. ShiftPixy is positioning to capture a meaningful share of this large market opportunity.
PIXY Solutions
The company is structured as a staffing company, with additional capabilities and services typically offered by Professional Employer Organizations (PEOs) or Administrative Service Organizations (ASOs). Such services include outsourced payroll, benefits, and HR functions. Usually, staffing companies focus strictly on staffing and don't cross into payroll management. ASOs and payroll service providers seldom cross over into recruitment, placement, or staffing. PEOs usually act as "co-employers" to on-site workers, while staffing companies are the employer of record of its on-site workers. Drawing on more than 25 years of experience in workers compensation and employer regulatory compliance, PIXY's proprietary operating and processing system is structured to offer employers all three critical service offerings.
The Pixy approach to the staffing business is to offer employment law and regulatory compliance solutions with comprehensive human resources outsourcing capabilities. This service is delivered through active client engagement supported by a robust technology platform. PIXY acts as the employer providing workers to a client, while the client continues to focus on its business. Clients give direction to PIXY on-site employees as necessary for the client to operate its business. PIXY's single-service solution includes key HR management and employee benefits functions, including HR administration, employee benefits, and employer liability management.
How It Works
The company currently focuses its sales, marketing, and business development efforts on the restaurant and hospitality industries. The company targets underserved small and medium businesses (SMBs) with 100-500 employees in these verticals. These companies are prime candidates for PIXY offerings due to increasing regulation and a heavy dependency on gig/shift workers.
A large percentage of PIXY business comes through low-cost introductions or referrals from the company’s extensive network of insurance providers, agents, and vendors. The worker’s compensation component of PIXY services has been a significant driver for these introductions. Potential clients are drawn to PIXY by a desire to outsource worker’s compensation coverage for their shift workers.
Once a referral is received, PIXY's sales staff offers a unique solution to have the prospective client transfer their shift workers over to be employed by PIXY, which then acts as a staffing agency for the customer. By pooling the employees of many smaller companies, PIXY can administrate the human resource management function using economies of scale and group buying power similar to a POE co-employment relationship. In return for providing insurance, payroll processing, benefits, and compliance services these enterprises pay PIXY a fee based on their payroll. The cost is much less than the costs of handling these functions in-house or having to contract with different companies for staffing, PEO, or ASO services.
Innovative Fast Food Driver Management Solution
The company recently announced its new driver management solution for fast food and fast casual dining operators. The service will now allow Pixy clients to use their team members to self deliver under its brand instead of having to rely on expensive third-party services such as GrubHub (GRUB) or UberEats (UBER). Pixy has taken the compliance, management, and insurance issues related to the support of a delivery service and created a unique turn key, self-delivery opportunity for fast food operators. Many restaurants cannot make deliveries due to the inability to get insurance. PIXY’s new insurance offering provides micro-metering which lets restaurants economically send their employees. The restaurant is only charged for insurance when a delivery is in progress, making costs very low. I agree with the company’s belief that there will be significant interest in this product as restaurants seek to expand sales and improve customer service. PIXY can a charge a premium for its driver management solution, which should improve gross margins and increase PIXY’s profitability.
Gig Economy Client Opportunity
PIXY solutions also remove the litigation risk of worker misclassification in the gig economy. Gig economy companies such as Uber regularly classify the people working for them as "independent contractors" rather than as "employees" for gigs. Under state and federal employment laws, workers classified as employees are much more expensive for these companies. However, increasing litigation against Uber and others has raised awareness about this issue. PIXY provides a solution by absorbing workers for these types of gig economy companies, eliminating any risk of litigation, fines and other worker misclassification problems for gig economy companies.
PIXY Technology
Management has developed a proprietary technology stack based on processing employer and gig/shift worker payroll and HR related data through HRPyramid software, provided by PrismHR. PrismHR is the largest payroll, benefits and HR software platform for Professional Employer Organizations (PEOs) and Administrative Service Organizations (ASOs). It powers more than 80,000 organizations, delivering payroll, benefits, and HR to greater than 2 million worksite employees and processes over $55 billion in payroll each year.
PIXY Mobile App
Another critical differentiator that should continue to drive rapid growth is PIXY’s newly launched mobile app. The app is an on-demand uber-like app utilizing IBM’s Watson Artificial Intelligence to onboard new employees. The app is only offered by invitation to an employer client's shift workers who convert to PIXY employees. Soon the company expects it will be able to facilitate scheduling between restaurants and shift workers by matching qualified workers to shifts while giving workers access to their schedules and earnings in real time. It also will create a social job-seeking network for matching job openings with workers or for workers to geo-locate available shifts in real time. The service also can be used to make permanent hires, in which PIXY can earn placement fees. Since all the workers in the network already are employees of PIXY, a restaurant can fill a shift or even hire someone without any additional paperwork or onboarding.
PIXY plans to offer this app to all potential part-time gig/shift workers in target markets, not just those transferred to PIXY by clients. Opening its mobile app to all shift workers should supercharge PIXY’s growth.
PIXY Blockchain Ledger
PIXY has implemented a private, centralized blockchain ledger to ensure unmatched security and privacy of client and employee data and employment-related transactions. PIXY’s use of a blockchain ledger (most likely built upon IBM’s blockchain hyper-ledger technology IBM Blockchain Hyperledger) protects human capital transactions containing some of the most sensitive personal information.
Conclusion
Fortified by the competitive advantages the company is building, I believe PIXY is positioning itself to deliver attractive returns to shareholders. I believe PIXY stock is undervalued at current prices and should be accumulated by investors seeking attractive returns over the next 3-8 months. I base this theory on the belief the company will be able to command a premium share price in the market considering its unique structure, technology, service offerings, focused positioning, and proven growth rate.
Disclosure: I am/we are long PIXY.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: I may increase my position in the next 72 hours.
I have no relationship with the company or any company that has a relationship with ShiftPixy.