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She runs the Bigger Capital Fund GP, LLC along with Michael Bigger.
Yesterday Patricia Winter just filed a "Statement of acquisition of beneficial ownership", which is also known as a 13G. In the filing, it appears as though Patricia Winter claims to own 180,000 shares. This represents 2.3% of TrovaGene.
http://www.conferencecalltranscripts.org/13G/summary2/?id=7387192
InsiderForms Reported:
12:50 PM 2/5/2020
ARCH VENTURE CORP,has filed Form 13F for Q4 2019.Opened NEW positions in $IOTS
Adesto Technologies Corporation Common Stock (IOTS) Institutional Holdings
https://www.nasdaq.com/market-activity/stocks/iots/institutional-holdings
May want to re-listen to this podcast if you have not heard it yet all the better.
Episode Info
The latest episode of The Cannabis Investing Podcast features Dan Ahrens, manager of the newly launched AdvisorShares Pure Cannabis ETF (YOLO). With the global cannabis industry still in its infancy, Ahrens makes the case for a much more hands-on approach in managing a diversified ETF portfolio of cannabis stocks. The result is a portfolio with some real surprises - both in terms of its top holdings as well as what doesn't make the cut.
https://www.stitcher.com/podcast/seeking-alpha/the-cannabis-investing-podcast/e/63063236
Best Marijuana ETF to Buy in 2020
AdvisorShares Pure Cannabis ETF (YOLO)
AdvisorShares Pure Cannabis is the first actively managed marijuana ETF. The fund invests roughly 80% of its total assets in companies that earn more than 50% of their income from cannabis, hemp, and derivative products.
Unlike the other ETFs, the AdvisorShares Pure Cannabis doesn’t track any underlying index. Instead, it focuses on mid- and small-cap companies. The companies are mostly in the pharmaceutical, biotech, and life-science sectors.
This marijuana ETF invests in both domestic and international companies. Some of its overseas holdings include; CannTrust, OrganiGram Holdings Inc., and HEXO Corp.
With assets under management of over $40 million, it is one of the largest cannabis ETFs. The expense ratio of 0.74% is in line with the industry average. AdvisorShares Pure Cannabis is a unique ETF is that offers simultaneous exposure to cannabis and other consumer stocks.
The 5 Best Marijuana ETFs for Conservative Portfolios
Speculate on America's growing pot adoption with these marijuana ETFs
AdvisorShares Pure Cannabis ETF (YOLO)
30 Marijuana Stocks to Buy as the Future Turns Green
Source: Shutterstock
Expense Ratio: 0.74%
The AdvisorShares Pure Cannabis ETF (NYSEARCA:YOLO) cannabis ETF is an actively managed investment fund, not a marijuana index ETF. The fund targets firms across multiple cannabis-related industries, including agriculture, biotechnology, pharmaceutical, real estate, retail, finance and other medical applications.
As the second-largest cannabis fund, YOLO has around $40 million in assets under management and an 0.74% expense ratio.
The fund owns distinct companies from the former ETFs and offers dedicated cannabis exposure as well as consumer product companies. YOLO’s top holdings include Village Farms International (NASDAQ:VFF), Innovative Industrial Properties (NYSE:IIPR), Trulieve Cannabis (OTCMKTS:TCNNF), GW Pharmaceuticals and OrganicGram Holdings (NASDAQ:OGI).
https://investorplace.com/the-5-best-marijuana-etfs-for-conservative-portfolios/
AdvisorShares CEO says 2020 'could be a good year' for cannabis
Despite waning investor optimism in the cannabis space, AdvisorShares CEO Noah Hamman says 2020 could be a big year for the sector, amid a greater legislative push to legalize recreational marijuana.
“It was a tough year last year,” Hamman tells Yahoo Finance’s “The First Trade.” “But I think this will be a much better year for them. You could probably still see some challenges with many of the Canadian cannabis companies -- not all of them -- they'll definitely be a few winners there. But we're really focused on the U.S. cannabis space for sure in 2020.”
Hamman points to New York Gov. Cuomo’s push to legalize cannabis in the state. Cuomo is highlighting the issue as one of his priorities for 2020. His proposal includes the formation of an Office of Cannabis Management to regulate use and the creation of a cannabis and help research center. Cuomo also notes he hopes to work with Connecticut, New Jersey and Pennsylvania to coordinate a system for legalizing adult cannabis use.
If Cuomo’s efforts are successful, New York would be the 12th state to legalize recreational pot. Projections from BDS Analytics show New York could grow to a $1.6 billion cannabis market by 2024. The governor says legalizing marijuana could bring in $300 million annually in tax revenue.
In 2019, the cannabis sector dropped 32%, according to Stifel. Analysts at Stifel say the industry’s rapid growth, in addition to now slowing opportunity to develop, is creating challenges for the sector.
And the optimism the cannabis sector saw last year following recreational legalization in Canada is diminishing. Firms are now downgrading prominent names in the space, like Aurora (ACB). Piper Sandler’s Michael Lavery dropped Aurora from a “hold” to a “sell” rating amid weaker sales. Lavery also lowered his price target on the stock from $3 to $1, roughly 60% below Aurora’s market value.
Stifel also cut its yearly revenue expectations for big players in the space, turning bearish on Canopy Growth (CGC), Aurora, Tilray (TLRY) and Cronos (CRON).
But Hamman points to two companies investors should keep an eye on.
“The biggest one that probably comes to mind in our cannabis ETF is True Leaf (TRLFF),” Hamman notes. “They've done an outstanding job moving into different states. [They’re] based out of Florida, continuing to gain market share in the U.S.”
Hamman also points to Green Thumb Industries (GTBIF), saying investors could see “good long-term growth, especially as the U.S. market expands.’
One of 7 Semiconductor Stocks To Buy On Coronavirus Weakness
Arya said Marvell should be able to sustain double-digit revenue growth for at least the next couple of years as 5G-related sales ramp from between $40 million and $50 million in the second half of 2019 to between $300 million and $400 million in 2020 and between $500 million and $600 million in 2021.
Bank of America has a Buy rating and $32 price target for MRVL stock.
Tsfg LLC Acquires 8,731 Shares of AbbVie Inc (NYSE:ABBV)
https://newsfilter.io/a/f08c11d33fde694734f5df79ee01e6f0
Today was perfect for adding more $MRVY.....
$MYOV
Jan 15, 2020 at 10:30 AM EST
38th Annual J.P. Morgan Healthcare Conference
Supporting Materials
Presentation
Events | Myovant Sciences Ltd.
Click here for webcast
https://investors.myovant.com/news-and-events/events
$ABBV - Why AbbVie Could Be a Great Buy in 2020
https://www.fool.com/investing/2020/01/13/why-abbvie-could-be-a-great-buy-in-2020.aspx
Abeona Therapeutics (NASDAQ:ABEO)‘s stock had its “buy” rating restated by research analysts at HC Wainwright in a note issued to investors on Monday, December 30th, MarketBeat.com reports. They presently have a $11.00 price objective on the biopharmaceutical company’s stock, down from their prior price objective of $15.00. HC Wainwright’s price objective would suggest a potential upside of 366.10% from the company’s current price.
Other research analysts have also recently issued research reports about the company. ValuEngine raised Abeona Therapeutics from a “hold” rating to a “buy” rating in a research note on Tuesday, December 3rd. Cantor Fitzgerald started coverage on shares of Abeona Therapeutics in a research note on Tuesday, December 10th. They set a “hold” rating and a $4.00 price objective on the stock. Zacks Investment Research lowered shares of Abeona Therapeutics from a “buy” rating to a “hold” rating in a research report on Tuesday, October 15th. Finally, Mizuho reaffirmed a “hold” rating and issued a $4.00 price target on shares of Abeona Therapeutics in a research note on Tuesday, December 10th. Five equities research analysts have rated the stock with a hold rating and three have issued a buy rating to the stock. Abeona Therapeutics presently has a consensus rating of “Hold” and an average target price of $7.50.
Shares of NASDAQ ABEO opened at $2.36 on Monday. Abeona Therapeutics has a 12-month low of $1.46 and a 12-month high of $8.41. The company has a current ratio of 2.45, a quick ratio of 2.45 and a debt-to-equity ratio of 0.07. The company has a market cap of $129.15 million, a price-to-earnings ratio of -1.98 and a beta of 2.13. The stock’s 50 day simple moving average is $3.26 and its 200 day simple moving average is $2.93.
Abeona Therapeutics (NASDAQ:ABEO) last released its quarterly earnings results on Tuesday, November 12th. The biopharmaceutical company reported ($0.35) earnings per share for the quarter, beating the Zacks’ consensus estimate of ($0.44) by $0.09. As a group, equities analysts forecast that Abeona Therapeutics will post -1.52 earnings per share for the current fiscal year.
In other Abeona Therapeutics news, Director Stefano Buono bought 200,000 shares of the company’s stock in a transaction dated Tuesday, December 24th. The shares were bought at an average price of $2.50 per share, for a total transaction of $500,000.00. Following the acquisition, the director now directly owns 270,000 shares of the company’s stock, valued at $675,000. The acquisition was disclosed in a filing with the Securities & Exchange Commission, which is available at the SEC website. Insiders own 33.60% of the company’s stock.
Several large investors have recently made changes to their positions in the stock. Tower Research Capital LLC TRC raised its position in Abeona Therapeutics by 434.6% during the second quarter. Tower Research Capital LLC TRC now owns 8,719 shares of the biopharmaceutical company’s stock valued at $42,000 after acquiring an additional 7,088 shares in the last quarter. Ellington Management Group LLC acquired a new position in shares of Abeona Therapeutics during the second quarter worth approximately $50,000. Trexquant Investment LP bought a new stake in shares of Abeona Therapeutics in the second quarter valued at approximately $53,000. D. E. Shaw & Co. Inc. acquired a new stake in shares of Abeona Therapeutics in the second quarter worth $59,000. Finally, Marshall Wace LLP increased its position in Abeona Therapeutics by 45.9% during the second quarter. Marshall Wace LLP now owns 13,254 shares of the biopharmaceutical company’s stock worth $63,000 after acquiring an additional 4,168 shares during the period. Institutional investors and hedge funds own 55.85% of the company’s stock.
About Abeona Therapeutics
Abeona Therapeutics Inc, a clinical-stage biopharmaceutical company, focuses on developing and delivering gene therapy products for severe and life-threatening rare diseases. The company's lead programs are EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB); ABO-102, which are AAV based gene therapies for Sanfilippo syndrome type A; and ABO-101, an adeno-associated virus (AAV) based gene therapies for Sanfilippo syndrome type B.
https://rivertonroll.com/news/2020/01/14/abeona-therapeutics-nasdaqabeo-price-target-increased-to-15-00-by-analysts-at-hc-wainwright-updated-updated.html
State Street Corp grew its holdings in Myovant Sciences Ltd (NYSE:MYOV) by 70.6% in the third quarter, according to its most recent disclosure with the Securities and Exchange Commission (SEC). The institutional investor owned 57,500 shares of the company’s stock after buying an additional 23,800 shares during the quarter. State Street Corp owned 0.06% of Myovant Sciences worth $299,000 as of its most recent SEC filing.
Several other institutional investors have also bought and sold shares of the company. Victory Capital Management Inc. boosted its stake in shares of Myovant Sciences by 169.8% in the second quarter. Victory Capital Management Inc. now owns 2,272,013 shares of the company’s stock worth $20,562,000 after acquiring an additional 1,429,770 shares during the last quarter. Price T Rowe Associates Inc. MD boosted its stake in shares of Myovant Sciences by 33.8% in the second quarter. Price T Rowe Associates Inc. MD now owns 1,086,893 shares of the company’s stock worth $9,836,000 after acquiring an additional 274,745 shares during the last quarter. Point72 Asset Management L.P. acquired a new stake in shares of Myovant Sciences in the second quarter worth approximately $7,733,000. Rock Springs Capital Management LP boosted its stake in shares of Myovant Sciences by 29.5% in the second quarter. Rock Springs Capital Management LP now owns 450,000 shares of the company’s stock worth $4,073,000 after acquiring an additional 102,500 shares during the last quarter. Finally, First Manhattan Co. boosted its stake in shares of Myovant Sciences by 2,146.6% in the second quarter. First Manhattan Co. now owns 400,000 shares of the company’s stock worth $3,620,000 after acquiring an additional 382,195 shares during the last quarter. Institutional investors and hedge funds own 39.23% of the company’s stock.
NYSE MYOV opened at $14.06 on Tuesday. Myovant Sciences Ltd has a fifty-two week low of $4.14 and a fifty-two week high of $26.02. The company has a debt-to-equity ratio of 5.88, a current ratio of 2.79 and a quick ratio of 2.79. The stock’s fifty day moving average is $15.87 and its two-hundred day moving average is $9.23.
Myovant Sciences (NYSE:MYOV) last posted its earnings results on Tuesday, November 12th. The company reported ($0.79) EPS for the quarter, missing the Zacks’ consensus estimate of ($0.72) by ($0.07). On average, research analysts anticipate that Myovant Sciences Ltd will post -3.29 earnings per share for the current year.
A number of analysts have recently issued reports on the company. Zacks Investment Research lowered Myovant Sciences from a “buy” rating to a “hold” rating in a research note on Wednesday, October 9th. Cowen reissued a “buy” rating on shares of Myovant Sciences in a research note on Tuesday, November 12th. ValuEngine lowered Myovant Sciences from a “buy” rating to a “hold” rating in a research note on Tuesday, December 3rd. JMP Securities reissued a “buy” rating and set a $34.00 price objective on shares of Myovant Sciences in a research note on Tuesday, November 19th. Finally, Goldman Sachs Group reissued a “buy” rating and set a $20.00 price objective (up previously from $18.00) on shares of Myovant Sciences in a research note on Tuesday, November 19th. Two investment analysts have rated the stock with a hold rating and eight have assigned a buy rating to the company’s stock. The company has an average rating of “Buy” and an average price target of $23.46.
In other Myovant Sciences news, insider Frank Karbe sold 19,701 shares of Myovant Sciences stock in a transaction on Monday, December 30th. The stock was sold at an average price of $15.55, for a total value of $306,350.55. Following the sale, the insider now owns 43,324 shares in the company, valued at $673,688.20. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available through the SEC website. Also, major shareholder Sciences Ltd. Roivant bought 179,193 shares of Myovant Sciences stock in a transaction on Monday, December 2nd. The stock was acquired at an average price of $18.44 per share, for a total transaction of $3,304,318.92. Following the transaction, the insider now directly owns 44,623,079 shares of the company’s stock, valued at $822,849,576.76. The disclosure for this purchase can be found here. In the last 90 days, insiders acquired 4,046,099 shares of company stock worth $61,228,506 and sold 41,304 shares worth $644,009. 3.68% of the stock is owned by insiders.
About Myovant Sciences
Myovant Sciences Ltd., a clinical-stage biopharmaceutical company, focuses on developing and commercializing therapies for women's health and endocrine diseases. The company's lead product is relugolix, an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone receptor antagonist for the treatment of heavy menstrual bleeding related with uterine fibroids, endometriosis-associated pain, and advanced prostate cancer.
https://rivertonroll.com/news/2020/01/14/myovant-sciences-ltd-nysemyov-shares-acquired-by-state-street-corp-updated.html
Abeona Therapeutics (ABEO) Begins Phase 3 Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa
Abeona Therapeutics Inc. (NASDAQ: ABEO) today announced that it has received Institutional Review Board (IRB) approval from Stanford University to commence the VIITAL™ study, the Company’s pivotal Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The majority of patients targeted for enrollment have completed the pre-screening process at Stanford, and the Company expects the first patient in the VIITAL™ study to be treated in the first quarter of 2020.
“We expect 2020 to be a transformational year at Abeona, and we are proud to start it with the initiation of our pivotal Phase 3 study evaluating EB-101 in RDEB,” said João Siffert, M.D., Chief Executive Officer. “We look forward to the first patient receiving EB-101 this quarter, setting in motion the final stages of this important program. We have devoted significant effort to establish and validate our independent, fully-functional GMP facility that will produce EB-101 for the VIITAL™ study and has capacity to support commercial launch. EB-101 has the potential to be the first approved therapy for RDEB and the only durable treatment to address large chronic wounds, which are the most painful and debilitating.”
The VIITAL™ Phase 3 study is a multi-center, randomized clinical trial assessing EB-101 in up to 15 RDEB patients, with approximately 30 large, chronic wound sites treated in total. The primary study endpoint is the proportion of wounds with greater than 50% healing at three months, comparing treated with untreated wound sites on the same patient. Secondary endpoints include the patient’s global impression of change from baseline in pain as well as other patient reported outcomes assessing pain during dressing changes, pain impact and physical function. Investigators at Stanford University Medical Center are currently enrolling eligible patients into the VIITAL™ study, with additional study sites expected to be added in the coming months. Additional information about the trial is available at abeonatherapeutics.com/clinical-trials/rdeb.
Abeona will produce EB-101 for the pivotal VIITAL™ study at the Elisa Linton Center for Rare Disease Therapies, its fully-functional gene and cell therapy manufacturing facility, centrally-located in Cleveland, OH. The center is a 26,000 ft2 facility housing large-scale cGMP capacity and state-of-the-art laboratories to support CMC development for process and analytics, all of which is validated and governed by comprehensive quality systems and overseen by experienced staff. The facility is also capable of clinical production of the Company’s AAV gene therapies.
About EB-101
EB-101 is an autologous, gene-corrected cell therapy in late-stage clinical development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. Treatment with EB-101 involves gene transfer to deliver COL7A1 genes into a patient’s own skin cells (keratinocytes) and transplanting them back to the patient to enable normal Type VII collagen expression and facilitate wound healing. Data from a Phase I/IIa clinical trial conducted by Stanford University evaluating EB-101 showed that the gene-corrected cell therapy provided durable wound healing for RDEB patients lasting several 2+ to 5+ years, including for the largest, most challenging wounds that affect the majority of the RDEB population. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Breakthrough Therapy, and Rare Pediatric designations for EB-101 and Orphan Drug designation in both the U.S. and EU.
About Recessive Dystrophic Epidermolysis Bullosa
Recessive dystrophic epidermolysis bullosa (RDEB) is a rare connective tissue disorder characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning Type VII collagen which is necessary to anchor the dermal and epidermal layers of the skin. There is currently no approved treatment for RDEB.
https://www.streetinsider.com/Corporate+News/Abeona+Therapeutics+%28ABEO%29+Begins+Phase+3+Clinical+Trial+Evaluating+EB-101+Gene+Therapy+for+Recessive+Dystrophic+Epidermolysis+Bullosa/16327388.html
Abeona Therapeutics: Speculative Buy After Financing
Summary
Shares have lost half their value since our first look at this gene therapy story in 2016.
A crisis of confidence in management and lack of timely execution in the clinic brought the valuation down to lows recently seen in Q4.
A highly dilutive offering occurred at a low price point, but there is a silver lining given participation of Great Point Partners and shakeup of the board of directors.
Lead program EB-101 in RDEB was given the green light to proceed into phase 3, and a look at prior data plus the low bar set suggests a high probability of success.
Data for MPS III programs is also promising, and there is long-term value in the AIM platform. Abeona Therapeutics is a Speculative Buy.
Shares of Abeona Therapeutics (ABEO) have lost half of their value since we uncovered this intriguing gene therapy story back in 2016, highlighting promising early data for ABO-102 in Sanfilippo B syndrome and also for EB-101 in RDEB (recessive dystrophic epidermolysis bullosa). My last update was in early 2018, as shortly after we turned negative on this name, it became apparent that management was failing to execute in the clinic in a timely manner.
Recently, the name popped up on my radar after the company finally got a long-awaited green light from the FDA for its phase 3 VIITAL trial evaluating EB-101 in RDEB (clinical hold removed submission of transport stability data). The primary endpoint is going to be the proportion of wounds showing at least 50% healing at month 3 compared to untreated wounds on the same patient, a very low and achieveable bar to my eyes (long-time readers know I am a fan of assets with a clear path to market).
On the other hand, shares took a dive after a highly dilutive $90 million offering was announced, consisting of a mix of common shares at $2.50 per share and pre-funded warrants at $2.4999 per warrant. While this kind of dilution was absolutely atrocious at first glance, I did find it interesting that well-known institutional investor Great Point Partners acquired $31 million of the offering along with the right to nominate and replace two directors (including new chairman of the board).
Perhaps this was the change the company finally needed to turn the page on its troubled past and start moving forward at a more efficient pace. Thus, I decided to revisit.
Figure 1: ABEO daily advanced chart
(Source: Finviz)
When looking at charts, clarity often comes from taking a look at distinct time frames in order to determine important technical levels to get a feel for what's going on. In the above chart (daily advanced), we can see a sickening decline during Q2 and Q3, with the stock bottoming at $2 level in September. September's spike was due primarily to the company's announcement of "exploring strategic alternatives," which in hindsight appears quite sketchy considering it instead chose to access funding via dilutive offering a few months later. In December, the stock began to run up after a series of positive news developments, but gapped down after the secondary was announced. The recent bounce in share price is encouraging, but the burden of proof is on management to actually deliver on key initiatives going forward.
Q3 Update
For the third quarter, the company reported cash and equivalents of $47.9 million (does not include proceeds from $90 million secondary offering). Net cash used in operating activities was $18.3 million, while research & development expenses fell to $10.9 million from $13.2 million in the same period in 2018. General and administrative expenses fell slightly to $4.7 million.
Figure 2: Pipeline
(Source: Corporate presentation)
Regarding program updates, we are reminded for lead asset EB-101 that the phase 3 VIITAL clinical trial protocol with updated PRO assessments was submitted to the FDA (along with retrovirus comparability protocol and the requested transport stability data related to September's clinical hold letter). Clinical results continued to be impressive, with phase 1/2 data showing that three years after treatment with EB-101, most RDEB patients experienced sustained wound healing (80% or 16 of 20 wounds achieving ≥50% healing, and 70% achieving ≥75%). As you can imagine, this data contrasted sharply with prospectively selected control wounds, with 1 of 6 having over 50% healing). 50% or greater wound healing was associated with no pain and no itch, compared with presence of pain in 53% (20/38) and itch in 61% (23/38) of wound sites at baseline. Safety profile was solid as well, with no serious treatment-related adverse events observed during the 3-year observation period.
Figure 3: Impressive data from early-stage study bodes well for odds of success in pivotal study, low hurdle to overcome
(Source: Corporate presentation)
On the conference call, management stated again touched on the above data for EB-101 and then moved onto ABO-102 (AAV-SGSH) in MPSIIIA. The goal here with a one-time infusion is to correct the underlying deficiency of the SGSH enzyme to prevent the toxic accumulation of heparin sulfate (which often lead to such symptoms as loss of speech & vision, cognitive decline, seizures, behavioral abnormalities, etc.). Consider that 70% of MPS III kids do not reach age 18. We are reminded that interim data of 3 young children treated at the highest dose cohort suggested that preservation of neurocognitive development can be achieved when these patients are treated at an early enough stage. More patients are being screened for the study, and we can expect an update when they are treated. An update will also be provided on regulatory pathway after meeting with FDA and EMA agencies (expect the news in Q1).
Figure 4: Change in Mullen Developmental Age post treatment as compared to natural history
(Source: Corporate presentation)
As for ABT-002 for MPSIIIB, a 2-year, open-label study continues to make progress with 6 patients treated across 2 dose cohorts (showed it's well tolerated with up to 23 months of follow-up for first patient enrolled). Early data is showing improvement in biomarkers and reduction of liver volume of similar magnitude to the MPSIIIA program.
As for preclinical assets that haven't received much attention yet, data presented at European Society of Gene and Cell Therapy highlighted the company's library of novel AIM AAV capsids, including presentations showing increased evasion to neutralizing antibodies, improved AAV capsids for intramuscular delivery, delivery to the retina via intravitreal administration and improved PNS tropism for treating Pompe disease via IV administration.
An Eventful December
On December 9th, Abeona Therapeutics announced that it received the go-ahead from the FDA to move forward with the pivotal phase 3 VIITAL study evaluating EB-101 in RDEB patients. The company is guiding for initiation of the study in Q1 2020.
On December 20th, the company's ABO-102 program for MPS IIIA was granted the coveted PRIME designation by the EMA (equivalent to Breakthrough Therapy designation in US). With more support for the program in the form of interaction and early dialogue, prospects of getting this one across the finish line continue to appear brighter.
As for the disastrous pricing of the secondary offering (over 26.9 million shares at a price point of $2.50 per share plus pre-funded warrants to purchase over 9 million shares of common stock, doesn't include underwriter option), the bright side is the $90 million received plus participation from Great Point Partners along with a shakeup of the board of directors as mentioned above.
Final Thoughts
To conclude, with the highly dilutive financing out of the way and gene therapy stocks currently receiving a well-deserved boost in the past quarter due to impressive buyout premiums (think Audentes Therapeutics (BOLD)) and license deals (Sarepta Therapeutics' (SRPT) ex-US DMD deal just recently), I wouldn't be surprised to see the share price recover in 2020 as clinical progress is made across multiple lead assets. To be fair, there are a number of companies going after the DEB space, including Krystal Biotech (KRYS), which has risen by 475% since my initial recommendation and for good reason given advantages in cost and convenience of administration for products based on its STAR-D platform. Likewise, other approaches to treat MPSIII are being employed, including Orchard Therapeutics' (ORTX) ex-vivo gene therapy candidates OTL-201 and OTL-202, as well as Sarepta Therapeutics' and Lysogene's LYS-SAF302.
With a caveat for competition in lead indications targeted and noting significant long-term potential for Abeona's next-generation AAV AIM platform, Abeona Therapeutics is a Speculative Buy. Readers who are interested in the story and have done their due diligence should take advantage of any near-term dips to initiate a pilot position or add to one's stake.
Risks include further setbacks in the clinic or postponed timelines, additional clinical hold or otherwise negative FDA action, disappointing clinical data and competition for certain indications (backed by companies with much more by way of resources). Another financing is not expected until 2H 2020 or later. When the RDEB program reaches commercialization stage, this will be quite the hurdle as well given complicated manufacturing and logistics (the company claims to currently have capacity to treat 120 patients, with plans to expand and support up to 500 patients annually one year after launch).
As for downside cushion and elements of derisking, to my eyes, data for lead programs looks quite promising in indications that are very well-characterized, and the bar is set low, as these patients have no approved therapeutic options.
For our purposes in ROTY, I will continue monitoring progress of the company's clinical assets to determine if it's worthy of entry for us at some point in 2020. I still consider it to be on the speculative side given previous lack of value creation and execution on the part of management, but I'm optimistic that the recent financing (and especially board shakeup) might be the start of a turnaround.
Author's Note: I greatly appreciate you taking the time to read my work and hope you found it useful. Consider clicking "Follow" next to my name to receive future updates and look forward to your thoughts in the Comments section below.
Disclosure: I am/we are long KRYS. 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: Disclaimer: Commentary presented is NOT individualized investment advice. Opinions offered here are NOT personalized recommendations. Readers are expected to do their own due diligence or consult an investment professional if needed prior to making trades. Strategies discussed should not be mistaken for recommendations, and past performance may not be indicative of future results. Although I do my best to present factual research, I do not in any way guarantee the accuracy of the information I post. I reserve the right to make investment decisions on behalf of myself and affiliates regarding any security without notification except where it is required by law. Keep in mind that any opinion or position disclosed on this platform is subject to change at any moment as the thesis evolves. Investing in common stock can result in partial or total loss of capital. In other words, readers are expected to form their own trading plan, do their own research and take responsibility for their own actions. If they are not able or willing to do so, better to buy index funds or find a thoroughly vetted fee-only financial advisor to handle your account.
https://seekingalpha.com/article/4314055-abeona-therapeutics-speculative-buy-after-financing
This is a sell the news event. Take some profit. GLA
After an overall market correction garb some shares.
New activist and cell gene Therapies will be hot plays going foreword.
NEW YORK and CLEVELAND, Dec. 09, 2019 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (ABEO), a fully-integrated leader in gene and cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has removed its clinical hold and provided clearance to proceed with the VIITAL™ study, the Company’s pivotal Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The FDA removed the clinical hold following the Company’s submission of additional data points on transport stability of EB-101 to clinical sites. Abeona expects to initiate the VIITAL™ study in first quarter of 2020.
“The Abeona team has worked diligently to provide a prompt and thorough response to the FDA, enabling us to proceed with our pivotal Phase 3 trial for EB-101,” said João Siffert, M.D., Chief Executive Officer of Abeona. “Recently published long-term follow up data from our Phase 1/2 trial leaves us increasingly confident that EB-101 can provide durable healing for large, chronic wounds that afflict many RDEB patients. We are now focused on initiating the VIITAL™ study in the first quarter of 2020. The success in building and qualifying a state-of-the-art GMP manufacturing facility also represents a critical step toward bringing this novel product to patients in dire need of effective treatment.”
With two to five years of follow-up, data from a Phase 1/2 clinical trial conducted by Stanford University evaluating EB-101 showed that the gene-corrected cell therapy provided durable wound healing for RDEB patients, including for the largest, most challenging wounds that constitute the majority of wounds in this population.
About The VIITAL™ Study
The VIITAL™ Phase 3 study will be a multi-center, randomized clinical trial assessing EB-101 in 10 to 15 RDEB patients, with approximately 30 chronic wound sites treated in total. The primary study endpoint will be the proportion of wounds with greater than 50% healing at three months, comparing treated with untreated wound sites on the same patient. Secondary endpoints include the patient’s global impression of change in pain from baseline as well as other patient reported outcomes assessing pain during dressing changes, pain impact and physical function.
About EB-101
EB-101 is an autologous, gene-corrected cell therapy in late-stage clinical development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. Treatment with EB-101 involves using gene transfer to deliver COL7A1 genes into a patient’s own skin cells (keratinocytes) and transplanting them back to the patient to enable normal Type VII collagen expression and facilitate wound healing. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Breakthrough Therapy, and Rare Pediatric designations for EB-101 and Orphan Drug designation in both the U.S.and EU.
Kala Pharmaceuticals: Rating Buy Ahead Of STRIDE 3 Data This Quarter
Jan. 8, 2020 4:19 AM ET|18 comments | About: Kala Pharmaceuticals, Inc. (KALA)
Bhavneesh Sharma
Vasuda Healthcare Analytics
Top biotech ideas from MD (trained at Harvard and Cornell) and MBA
(5,596 followers)
Summary
Kala Pharmaceuticals is based in the Boston area, Massachusetts, and is focused on developing topical treatments for eye diseases using its proprietary MPP (Mucus Penetrating Particles) technology.
I am bullish on STRIDE 3 Phase 3 data in dry eye disease, which is expected this quarter.
The company's stock is undervalued based on just NPV of Inveltys, its approved product.
If STRIDE 3 trial succeeds, it would open an additional large target market in dry eye disease. An estimate of its pipeline value is provided.
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Kala Pharmaceuticals (KALA) is based in the Boston area, Massachusetts, and is focused on developing topical treatments for eye diseases using its proprietary MPP (Mucus Penetrating Particles) technology. Topically administered eye medications are usually trapped by the mucus in the tear film that covers the cornea, thus limiting the drug's access to the eye tissues. The MPP technology allows the drug to penetrate the mucus in the tear film effectively, thus creating a potential for lower dose or less frequent dosing. The technology has origins in MIT Labs.
The first product candidate from the MPP technology, Inveltys (1% solution of a topical corticosteroid, loteprednol etabonate, LE) was approved by the FDA to treat pain and inflammation after eye surgery in 2018. Sales are growing 30% quarterly per the recent Q3 earnings call. Peak sales estimate for the drug is approx. $300M.
Kala's stock suffered a setback in January 2018 when KPI-121, a 0.25% QID solution of LE showed mixed results in the two Phase 3 trials required for FDA approval in treating dry eye disease. Dry eye disease is a common clinical indication and could be primarily due to dysfunction of tear glands or secondary to diseases like Sjogren's syndrome or contact lens wear, etc. The disease is thought to affect approx. 16 million people in the U.S. Current treatment includes treating the underlying cause, symptomatic treatment with artificial tears, etc. While 90% of cases are mild and don't need chronic treatment, rest 10% of patients need chronic treatments, like Allergan's (NYSE:AGN) Restasis (topical cyclosporine) or Novartis' (NYSE:NVS) Xiidra (topical inhibitor of ICAM-1 and LFA-1). In addition, many patients with mild or moderate symptoms experience occasional flare-ups of the symptoms when Restasis or Xiidra may be useful. The target market for dry eye disease is estimated to grow at approx 5% per year to $7 billion by 2025. Restasis had $1.5 billion in peak sales while peak sales estimates for Xiidra are also >$1 billion. Novartis acquired Xiidra from Takeda (NYSE:TAK) for approx. $5 billion (including an upfront payment and milestone payments), thus showing the NPV of a successful medication in treating this common condition. More than 20 treatments are under development currently for dry eye disease.
The key primary endpoint, an improvement in eye discomfort, was not achieved in the second Phase 3 trial called STRIDE 2 in Kala's dry eye disease program. The management attributed the result to a higher-than-expected placebo response in the STRIDE 2 trial. The management submitted an NDA for this indication to FDA but was issued a CRL and FDA requested another Phase 3 trial.
The management started another trial, STRIDE 3, making some changes to the inclusion/exclusion criteria to reduce the placebo response probability. Most notably, it monitored the initially screened patients who were given a placebo vehicle during the initial two week run-in period. Patients who reported an improvement in ocular discomfort (STRIDE 3 primary endpoint) were excluded from the next part of the study, the randomization part into the drug and placebo arms for two weeks (since they are showing a placebo response). This intervention and a couple of other protocol changes have improved the probability of success in STRIDE 3 trial. In the recent Q3 earnings call, the management mentioned that when it performed a retrospective analysis of the failed STRIDE 2 trial using the revisions in the protocol for STRIDE 3 trial, STRIDE 2 trial would have achieved statistical significance in ocular discomfort by a wide margin (p= 0.002).
Some other signals support a near-term bullish view for the company's stock and its drug development efforts. Major institutional investors like RA Capital ($17M stake) and Orbimed ($13M stake) have invested in the company before IPO and continue to hold the stock despite its beaten-down condition after CRL in dry eye disease and mixed STRIDE results. Last week, the management was granted stock options equivalent to approx 1 million of common stock (including 365K stock options for the CEO, which will vest if the stock price is >$3.84). The stock was up this week on high volume, suggesting investor interest in the stock. The management is quite experienced. CEO Mark Iwicki was CEO at Civitas (acquired by Acorda Therapeutics (NASDAQ:ACOR)) and ex-CEO at Sunovion Pharmaceuticals (acquired by a Japanese Pharma). He also was Business Unit Head for several therapeutic areas like CVS, Diabetes, etc., at Novartis. Other members of the management team have impressive bios as well, including CMO Brazzell who was Global Head and SVP of R&D at Novartis eye division, and CSO Chen who worked in vaccine delivery and development at AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK).
The company is expected to have $72M in cash reserves in 2019 end at the current operating burn rate. Long-term debt was $71M at Q3 end. From the target market point of view, I used 10% of patients of total U.S. patient population as input (who are expected to have chronic symptoms or frequent flares needing KPI-121 or 1.6M). The input price was $5K/year, equivalent to Restasis and Xiidra. Using these inputs, the estimated target U.S. revenue opportunity is $8 billion/year. Even if KPI-121 captures just 10% of the market, peak sales could reach $800M/year in the U.S. 6 years after the launch in 2020. Using peak sales multiple of 4 for enterprise value (average for pharma companies), probability adjustment by 65% (average for drugs in phase 3) and discounting by 15% rate, I estimate risk-adjusted NPV for KPI-121 as $900M. The company's current market cap is just $167M. In addition, I did not include Inveltys which is estimated to have a peak of $300M in sales. Using these assumptions, if STRIDE 3 trial succeeds, the company's stock could have a >5x upside potential in a few years. Even if STRIDE 3 trial fails and Inveltys is the company's sole marketed product, the company's fair value based on just Inveltys (assuming $300M peak sales in 2025) is estimated as $750M, which is much higher than the current market cap. The company's stock thus appears a bargain at its current level. The STRIDE 3 data is expected in Q1 and April options are implying +/- 60% move in the stock price (range $7.75 to $2/share).
A bear case for the investment would include high debt (resulting in a negative liquidation value by net-net formula), the possibility of placebo response in STRIDE 3 trial despite protocol modifications, no buying by prominent institutions or direct common stock purchases by the management and insiders when the stock was beaten down in 2019, possibility of side effects like cataracts, glaucoma, etc. on long-term use of KPI 121 (side effects associated with steroids), though the drug is mostly intended for use for short duration only for rapid relief in flares or in severe cases where the benefits outweigh the risks, increasing competitive landscape in dry eye disease where drugs with novel mechanisms of action (Aldeyra Therapeutics (NASDAQ:ALDX)) could limit KPI-121 market share, delay in STRIDE 3 data release from year-end 2019 to Q1 2020 (explained by the management as slow enrollment, though it could be due to the stricter inclusion/exclusion protocol explained above), etc.
In conclusion, I am rating the stock a Buy (after assessing the Bull and Bear cases) and plan to start a long position over the next 72 hours. The first price target is $7.50/share.
(KALA product pipeline)
Risks in the investment include the bear case mentioned above, high placebo response resulting in STRIDE 3 trial failure which could crash the stock to $2/share, the possibility of a capital raise before the STRIDE 3 data (appears less likely though given the current cash position). Investing in biotechnology companies and playing binary catalysts like data releases may not be suitable for all investors and it is possible to lose the entire capital invested. A small allocation and diversification across at least 25-30 investments are suggested.
https://seekingalpha.com/article/4315703-kala-pharmaceuticals-rating-buy-ahead-of-stride-3-data-this-quarter
Canaccord Genuity began coverage on shares of Bill.com (NYSE:BILL) in a report released on Monday 01-06 2020, The Fly reports. The brokerage set a “hold” rating on the stock.
BILL has been the topic of several other reports. William Blair began coverage on Bill.com in a research note on Monday. They issued an “outperform” rating on the stock. Jefferies Financial Group began coverage on Bill.com in a research note on Monday. They issued a “hold” rating and a $40.00 price target on the stock. KeyCorp started coverage on Bill.com in a research note on Monday. They issued an “overweight” rating and a $45.00 price target on the stock. Goldman Sachs Group started coverage on Bill.com in a research note on Monday. They issued a “neutral” rating and a $32.00 target price on the stock. Finally, Needham & Company LLC initiated coverage on Bill.com in a research note on Monday. They issued a “buy” rating and a $43.00 target price on the stock. Three investment analysts have rated the stock with a hold rating and four have assigned a buy rating to the company. Bill.com currently has an average rating of “Buy” and an average target price of $41.60.
https://www.americanbankingnews.com/2020/01/06/canaccord-genuity-begins-coverage-on-bill-com-nysebill.html
Bill.com Holdings, Inc. provides cloud-based software that digitizes and automates back-office financial operations for small and midsize businesses worldwide. It offers artificial-intelligence (AI)-enabled financial software platform. The company provides software-as-a-service, cloud-based payments products, which allow users to automate accounts payable and accounts receivable transactions, as well as enable users to connect with their suppliers and/or customers to do business, manage cash flows, and enhance office efficiency. It also offers onboarding implementation support, as well as ongoing support and training services. The company serves customers operating in the accounting and accounting software companies, and financial institutions. Bill.com Holdings, Inc. was founded in 2006 and is headquartered in Palo Alto, California.
https://www.marketbeat.com/stocks/NYSE/BILL/
$BILLFirst Mover Advantage
Bill enjoys a first-mover advantage in the SMB back-office financial automation category and it shows in its recent percentage, Goldman Sachs analyst Christopher Merwin wrote in a note. The company showed a 67% year-over-year revenue growth of 67% in 2019 while revenue rose by 57% year-over-year in the first quarter of 2020.
The company faces little direct competition as those who offer similar services target B2B payments among mid-market and enterprise companies, the analyst wrote. In fact, rivals are unlikely to look to compete against Bill directly as the SMB category is full of high churn and lower adoption.
Even if this thesis doesn't play, Bill established a "natural barrier to entry" given its extensive relationship with thousands of partner firms across accounting, financial institutions, and accounting software vendors, the analyst wrote.
BofA: Premium Valuation
Bill should be able to continue growing its core revenue (subscription and transaction revenue) at 30% or more through growing awareness and adoption of the company's cloud offering and electronic payment services, Bank of America analyst Brad Sills wrote. By 2021 total revenue is estimated to be $193.2 million and the stock should be valued at a multiple of 19 times.
The stock warrants a premium valuation versus the overall SaaS software group at 8.6 times 2020 revenue, the analyst wrote. The valuation is justified as the SaaS group as a whole is modeled to grow revenue at a slower rate in the mid-20s in the near-term.
Needham: Large Unaddressed Market
Bill's stock is a direct play not only on the growing electronic B2B payment space but as the sole company able to satisfy the needs of the underserved SMB market, Needham analyst Scott Berg wrote. Meanwhile, at most 25% of the estimated 6 million SMBs make use of electronic payment technologies today and this rate should grow to 100% over time.
Other larger companies are known to develop their own customized solutions as opposed to Bill who offers a platform-agnostic solution that integrates with leading accounting software packages, the analyst wrote.
KeyBanc: Risks To Follow
Bill boasts compelling unit economics and is led by "visionary" founder Rene Lacerte who recognized a compelling opportunity more than 10 years ago, KeyBanc Capital Markets analyst Josh Beck wrote. Nevertheless, there are five potential risks investors should keep in mind.
These include potential changes in the competitive environment, potential need for large balance of reserves to fund losses related to fraud, potential interruptions or delays from partners who process ACH, checks, cross-border, and virtual card payments, and potential deterioration in existing partnerships.
Ratings And Price Targets
Goldman Sachs initiated coverage at Neutral, $32 price target.
BofA initiated coverage at Buy, $48 price target.
Needham initiated at Buy, $43 price target.
KeyBanc initiated at Overweight, $45 price target.
Latest Ratings for BILL
Date Firm Action From To
Jan 2020 Initiates Coverage On Outperform
Jan 2020 Initiates Coverage On Hold
Jan 2020 Initiates Coverage On Buy
Date Research Firm Action Current PT
1/06/20 William Blair Initiates Coverage On Outperform
1/06/20 Canaccord Genuity Initiates Coverage On Hold 40.00
1/06/20 Bank of America Initiates Coverage On Buy 48.00
1/06/20 KeyBanc Initiates Coverage On Overweight 45.00
1/06/20 Needham Initiates Coverage On Buy 43.00
1/06/20 Jefferies Initiates Coverage On Hold 40.00
1/06/20 Goldman Sachs Initiates Coverage On Neutral 32.00
https://thefly.com/landingPageNews.php?id=2993384&headline=HIIQ-Health-Insurance-Innovations-price-target-raised-to--from--at-Lake-Street
Health Insurance Innovations price target raised to $50 from $40 at Lake Street
Lake Street analyst Mark Argento raised his price target for Health Insurance Innovations to $50 from $40 and reiterates a Buy rating on the shares. While the company's Q3 sales were lower than estimates, driven by a slower than anticipated ramp of the new BPO centers focused on Medicare offerings, its profitability was strong, Argento tells investors in a research note. He reiterates a Buy rating on the shares
What's Ahead For Abeona Therapeutics
https://seekingalpha.com/article/4315072-ahead-for-abeona-therapeutics
Seeking Alpha is proud to welcome Michael Meltzer as a new contributor.
Jan 1, 2020 10:57 AM
$KALA $3.69. MC $128M Cash $97.6M runway through 18 months.
Stock High 2019-9+ 2018- 18 2017 25+
Last secondary offering Summer 2019@8.25
Platform:Amplify Delivery Technology (ADT) increases penetration through tissues thereby improving the medicines concentration at site of needed treatment.
Gem of Pipeline:Eysuvis - .25% KPI 121 for Dry Eye Disease(DED)symptom flare ups. The drug is an improved delivery system for Loteprednol through ADT.
Current blockbuster B&L’s .5% Lotemax gel is currently used off label for DED flares as currently approved treatments XIIDRA and Restasis offer lackluster results leaving patients with breakthrough discomfort multiple times per year. At that time Lotemax is used as a ”rescue med” for a 2 week pulse dose to reboot the immune system and lower the inflammatory response causing DED. I and many other doc’s also piggyback Lotemax on top of initiation of treatment to bring faster relief also for 2 weeks. I would use Eysuvis in this role as well.
Lotemax started as a suspension 4x a day and was called a “soft” steroid. It was effective as a general anti-inflammatory for the eye with a far superior safety record then all other steroids. Through use found it was not effective for very difficult to treat uveitis’s and was formulated to a gel with same concentration to improve permeability. B&L also has a .2% Loteprednol called Alrex which is very weak and rarely used for anything more then allergic red eyes.
My concern with KALA is that they went with too weak a concentration and should have gone with .3% MINIMUM and thought might not be strong enough to get the very difficult to treat and pretty miserable dry eye population to admit they were feeling better. First phase 3,Stride1 hit both primary endpoint conjunctival hyperemia(redness of eye) improvement as well as secondary improvement of symptoms in all patients, as well as in difficult to treat one’s. The second Stride2 hit the primary and failed in the symptom relieve though showed significant aid.
The FDA then demanded a third trial to prove effectivity. KALA made the necessary changes to the patient population to have created apassing “p” in Stride 2 for the Stride 3. It will read out Q1 ‘20. If they reach significance in either full population or in the difficult to treat population they will be able to file an NDA. I believe the changes made will achieve success. Eysuvia has blockbuster potential. Lotemax is a key franchise drug for Bausch&Lomb. If approved, B&L will be forced to purchase Eysuvia to defend their franchise. If KALA issues the same $35 copay assistance as Lotemax, every doctor will switch to the approved label as opposed to continuing off label with a Lotemax Gel.
The largest point of deriskment is KALA already has recently launched an approved drug Inveltys, a 1% Loteprednol suspension with the ADT additive. It is approved for post ocular surgeries. It offers the befit of 2x a day dosing as opposed to 3-4x/day with added safety of Loteprednol as opposed to stronger steroids like Durezol or Prednisilone which have many more side issues.
Inveltys Metrics:
WAC price $245 with copay assistance cards available.
57 sales reps. Expect upping to 75 if get Eysuvis approval.
There were 40,000 Rx’s In Q3- a 30% quarterly sequential improvement.
97,000 Total Rx’s so far.
10.1% market share
2700 individual prescribers to date.
Peak sales estimate-$300 M
Cons: could fail Stride 3, though Inveltys mitigates this by establishing a floor value.
Pro’s: Effective changes to trial population increase likelihood of solid data. Hitting endpoints would bring approval and create a massive competitor to B&L’s Lotemax franchise, that B&L would have to buy Eysuvis as it could well be a blockbuster drug.
Myovant Presses Forward After Latest Positive Trial; Multiple Catalysts Loom
Dec. 21, 2019 11:18 AM ET|12 comments | About: Myovant Sciences Ltd. (MYOV)
Terry Chrisomalis
Biotech Analysis Central
Actionable ideas on small-large cap biotech stocks through deep analysis.
(7,817 followers)
Summary
Myovant achieved positive results from its phase 3 HERO study in which the study met on the primary endpoint and all key secondary endpoints for those with advanced prostate cancer.
There were 96.7% of men with advanced prostate cancer patients who had sustained testosterone suppression to castrate levels through 48 weeks.
Based on the positive data from the phase 3 HERO study, the company intends to file an NDA to the FDA for relugolix by Q2 of 2020.
Additional catalysts are approaching in the 1st half of 2020, which, if positive, could cause the stock to trade higher.
This idea was discussed in more depth with members of my private investing community, Biotech Analysis Central. Get started today »
Myovant Sciences (MYOV) is a biotech that should be on everyone's radar. That's because it has been able to achieve positive results in several indications, with the most recent positive results coming out of the HERO study using relugolix to treat men with advanced prostate cancer. This late-stage study had met on the primary endpoint, which will allow the company to file an NDA to the FDA for eventual approval for this indication by Q2 of 2020. In addition, there are several other catalysts that are anticipated in the 1st half of 2020. These involve several trial readouts and potential regulatory filings. With all these catalysts, I view Myovant Sciences as a strong buy.
Relugolix Achieves Positive Data For Advanced Prostate Cancer
Myovant had used its drug relugolix in its late-stage study to treat patients with advanced prostate cancer. Prostate cancer occurs in a man's prostate, which produces the seminal fluid that nourishes and transports sperm. It is estimated that there are about 3 million U.S. cases per year for this type of cancer. It is imperative that additional treatment options exist for these patients. That's because it is the second-leading cause of cancer death for men in the United States. It is estimated that global prostate cancer market could reach $12 billion by 2025.
The positive results, in which the primary endpoint was met, came from the phase 3 HERO study. Specifically, the study was looking at men who had androgen-sensitive advanced prostate cancer. What is so important to know about these patients? First thing to know is that androgen-sensitive means that the prostate cancer in question relies on high levels of androgens to grow. Therefore, decreasing androgen levels should in turn keep the cancer from spreading. Which brings me to the second item that must be known about these patients. They were required to take at a minimum 1 year of continuous androgen deprivation therapy (ADT). Patients were dosed in either one of two dosing groups. One group of patients were randomized to take a single loading dose of 360 mg of relugolix followed by 120 mg of relugolix once daily. The other group of patients took leuprolide acetate (3-month injection). The primary endpoint of this phase 3 HERO study looked to see the percentage of men that were able to obtain sustained testosterone suppression to castrate levels of < 50 ng/dL through 48 weeks. As I highlighted in the introduction above, about 96.7% of men had sustained testosterone suppression to castrate levels through 48 weeks. Not only that, but those treated with relugolix achieved all 6 secondary endpoints with p-values <0.0001.
These positive results just achieved mark an important turning point for the biotech. Especially, since as I described above this is a multi-billion dollar market opportunity. But there is a catalyst to capitalize on that could also cause another boost for the stock with respect to this program. Myovant expects that it will file its NDA submission for relugolix for the treatment of patients with advanced prostate cancer in Q2 of 2020. Additional catalysts would be other regulatory submissions expected in the future for Europe and Japan. However, I don't expect regulatory applications to be filed in these territories right away. I think the biotech will be more focused on getting the NDA in to the FDA first before worrying about other territories.
Additional Catalysts May Provide Significant Upside
Besides the potential regulatory filing of relugolix for the treatment of men with advanced prostate cancer, there are many other catalysts expected in the early part of 2020. The first of which is 12-month safety data from the LIBERTY open-label extension study using the relugolix combination therapy for the treatment of women with uterine fibroids and heavy menstrual bleeding. This data is expected in the company's first quarter calendar year of 2020. This will be bioequivalence data. This type of data, along with the positive results from LIBERTY-1 and LIBERTY-2, are expected to be used as part of the NDA filing to the FDA for relugolix combination therapy expected by April of 2020. However, the marketing authorization application (MAA) for the combination therapy in treating this very same patient population is expected earlier by Q1 of 2020. On top of that, there are trial readouts from two other late-stage studies expected in the 1st half of 2020. This will be data from two phase 3 studies known as SPIRIT-2 and SPIRIT-1, respectively. Both of these studies are exploring a relugolix combination therapy to treat women with endometriosis pain. Many of these catalysts are approaching in the coming months and might provide significant upside for the stock.
Financials
According to the 10-Q SEC filing, Myovant Sciences had $157.6 million as of September 30, 2019. That is a decent amount of cash, but there is extremely good news even on the financing front. Myovant has a term loan facility it is expecting to get from Sumitomo Dainippon Pharma. This is a deal between Myovant's parent company (Roivant Sciences) with Sumitomo. Myovant will obtain $350 million in capital to fund all the products in the pipeline based on this deal. It is good news that it has already secured such a large amount of cash. This means investors won't have to worry about any cash raises in the near-term.
Risks
With many catalysts approaching for Myovant, it's important to highlight that there are several risks. The first of which is that there is no guarantee that all the upcoming trial readouts expected in the 1st half of 2020 will be successful. Any clinical study that doesn't meet expectations may cause the stock to dip in the short term. Not only that, but even if NDAs are filed for relugolix in a few of the indications note above, like uterine fibroids and advanced prostate cancer, there is no guarantee that relugolix will be approved for one or both indications. Still, Myovant has a solid pipeline and has another product known as MVT-602 to help women undergoing assisted reproduction, including in vitro fertilization (IVF). This is another product in the pipeline that may yield value for shareholders.
Conclusion
The positive results obtained in the phase 3 HERO study will allow Myovant to file its NDA by Q2 of 2020. This will allow the biotech to treat men with advanced prostate cancer who are androgen-sensitive. Prostate cancer is a multibillion dollar market opportunity and I believe that the biotech can capture a large chunk of this space. The other indications in the pipeline targeting endometriosis and uterine fibroids are also multibillion dollar markets. This will allow the company to be diversified into several key areas for growth. With so many catalysts on the way, I believe that Myovant is set up for potential success in the coming months. That's why I believe it is a strong buy.
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33.50% discount price of $399 per year.
https://seekingalpha.com/article/4313662-myovant-presses-forward-after-latest-positive-trial-multiple-catalysts-loom
https://www.marketbeat.com/stocks/NYSE/MYOV/price-target/
[img]Date Brokerage Action Rating Price Target Impact on Share Price Details
9/13/2018 JPMorgan Chase & Co. Initiated Coverage Overweight ? Overweight $39.00 High
2/13/2019 Barclays Upgrade Equal Weight ? Overweight $22.00 ? $25.00 High
4/11/2019 Evercore ISI Initiated Coverage Outperform High
5/30/2019 Citigroup Initiated Coverage Buy $25.00 High
8/19/2019 Svb Leerink Initiated Coverage Outperform $26.00 High
8/19/2019 Leerink Swann Initiated Coverage Outperform $26.00 High
11/12/2019 Cowen Reiterated Rating Buy High
11/19/2019 JMP Securities Reiterated Rating Buy $34.00 Low
11/19/2019 Goldman Sachs Group Reiterated Rating Positive Buy $18.00 $20.00 Medium
(Data available from 1/2/2018 forward)[/img]
On December 30, 2019, H.C. Wainwright analyst Raghuram Selvaraju lowered his price target for Abeona Therapeutics to $11 from $15 to account for the company’s recent sale of common stock and pre-funded warrants, telling investors that he believes the funds raised should extend the company’s operational runway into mid-2021. The analyst, who believes the company’s pivotal EB-101 program for recessive dystrophic epidermolysis bullosa is “likely to be rapid,” keeps a Buy rating on Abeona shares.
The company’s recent sale of common stock that Raghuram is referring to is that on December 24, 2019, Abeona Therapeutics announced the closing of its underwritten public offering, with a gross offering size of approximately $103.5 million, which includes the full exercise of the underwriters’ option to purchase 5,400,000 additional shares of common stock, at a public offering price of $2.50 per share. In addition, as part of the offering, Abeona sold to Great Point Partners (“GPP”), an existing investor, pre-funded warrants to purchase up to an aggregate of 9,017,055 shares of common stock at a purchase price of $2.4999 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant.
The Company has granted to affiliates of GPP the right to nominate two Board members to Abeona’s Board of Directors, including a new Executive Chairman, due to GPP’s considerable investment in the transaction. As a result, Steven H. Rouhandeh will step down as Executive Chairman and will retain a seat on the Board, while Mark J. Alvino and Richard Van Duyne will exit the Board. These changes will be effective upon the Board’s qualification and election of GPP’s nominees. Such replacement members will be independent of GPP.
“Today’s event strengthens our financial position, providing cash runway into 2021 and resources that will allow us to fund continued clinical development of pipeline products, including the initiation and enrollment of the EB-101 pivotal Phase 3 VIITALTM study, and achieve critical near-term milestones,” said João Siffert, M.D., Chief Executive Officer of Abeona. “On behalf of the Board and all Abeona employees, I am grateful to our outgoing members for their service and dedication to the company, and particularly to Steven, who has served as Chairman of our Board of Directors for a number of years. Finally, I would like to thank our shareholders and new investors for their ongoing support and confidence in our pipeline and the Abeona team.”
“We are excited to lead this recapitalization of Abeona,” said David Kroin, Managing Director of Great Point Partners. “The Company is one of the world leaders in gene therapy technology, developing products using retrovirus, adeno-associated viruses and next generation capsids with potentially improved tropism profiles for a variety of devastating diseases. This funding greatly enhances Abeona’s financial position, and we believe it can now reach its full potential, as other gene therapy companies in which Great Point Partners has invested have been able to do. We intend to recruit the highest caliber people to guide the Company at the Board level in order to unlock the potential of a fully functioning manufacturing facility in Cleveland, Ohio, a late stage pivotal program in Recessive Dystrophic Epidermolysis Bullosa that has BreakThrough and RMAT Designations from the FDA, a pipeline of exciting neurology programs, and a wonderful team of professionals.”
Concurrently, the Company announced that its review of strategic options announced on September 3, 2019 has been completed. The Board of Directors concluded that it is in the best interest of the Company and its shareholders to develop its pipeline products independently, and with the additional funding and planned leadership nominations announced today. While the Board determined that this pathway was the best course of action to advance the Company’s mission and maximize stakeholder value, it was not due to a lack of interested partners, and Abeona continues to entertain strategic alternatives consistent with standard industry practices.
On December 20, 2019, Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to the Company’s ABO-102 program studying its adeno-associated virus 9 (AAV9) gene therapy for Sanfilippo syndrome type A (MPS IIIA). The PRIME designation is based on nonclinical data and clinical data from the Transpher A Study, a global Phase 1/2 clinical trial evaluating a single-dose of ABO-102 for the treatment of children with MPS IIIA.
“EMA’s PRIME designation for the ABO-102 program recognizes the urgent need for a treatment option for children suffering from MPS IIIA, and underscores the potential of ABO-102 to modify the course of this devastating lysosomal storage disease,” said João Siffert, M.D., Chief Executive Officer.
The Transpher A Study is enrolling patients at sites in the U.S., Spain, and Australia.
The PRIME initiative provides access to enhanced support for the development of medicines targeting an unmet medical need. The designation affords sponsors with enhanced interaction and early dialogue regarding promising medicines, as well as the possibility of accelerated assessment of medicines applications. PRIME is intended to optimize development plans and speed up evaluation so these medicines can help patients to benefit as early as possible from therapies that may significantly improve their quality of life.
ABO-102 is a novel gene therapy in Phase 1/2 development for Sanfilippo syndrome type A (MPS IIIA), a rare lysosomal storage disease with no approved treatment that primarily affects the central nervous system (CNS). ABO-102 is dosed in a one-time intravenous infusion using an AAV9 vector to deliver a functional copy of the SGSH gene to cells of the CNS and peripheral organs. The therapy is designed to address the underlying SGSH enzyme deficiency responsible for abnormal accumulation of glycosaminoglycans in the brain and throughout the body that results in progressive cell damage and neurodevelopmental and physical decline. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations for the ABO-102 clinical program. In the EU, the Company holds PRIME and Orphan medicinal product designations.
Market potential for Relugolix
Basically, the market potential for Relugolix is ??very difficult to estimate. Because the global oncology market is huge, Relugolix addresses a very special part of this market. On the other hand, unlike the previous standard therapeutic agent, it can be taken orally and does not have to be injected by a doctor like this. It is also important to know that many bodybuilders use leuprolide acetate illegally as a doping agent. Relugolix could also replace the standard preparation here, even if you as an investor should not primarily rely on it.
All in all, however, I would trust Relugolix to replace leuprolide acetate as a standard preparation and thus become a blockbuster. As a reminder: In the biotech and pharmaceutical industry, blockbusters are drugs with an annual turnover of at least one billion US dollars. In my opinion, a drug that generates at least $ 1 billion in annual sales has a market value of between $ 5 billion and $ 10 billion, depending on how long and how long patent protection remains.
If the management of Myovant Sciences keeps its word and can actually submit the application for approval for Relugolix in the second quarter of 2020, this would be very positive. However, the discussion of the expert panel of the FDA and ultimately the corresponding market approval are still missing. If everything goes smoothly, this could also be available by the end of 2020. In this case, the market value of Myovant Sciences would have to be estimated at at least five billion US dollars.
$IOTS Based on 3 analysts offering 12 month price targets for Adesto Technologies in the last 3 months. The average price target is $12.00 with a high forecast of $13.00 and a low forecast of $11.00. The average price target represents a 41.18% increase from the last price of
$8.50.
https://www.tipranks.com/stocks/iots/price-target
Based on 3 analysts offering 12 month price targets for Myovant Sciences in the last 3 months. The average price target is $34.00 with a high forecast of $34.00 and a low forecast of $34.00. The average price target represents a 119.07% increase from the last price of $15.52.
https://www.tipranks.com/stocks/myov/price-target
MeiraGTx (NASDAQ:MGTX) Given Buy Rating at Piper Jaffray Companies
Piper Jaffray Companies restated their buy rating on shares of MeiraGTx (NASDAQ:MGTX) in a research note issued to investors on Monday, Stock Target Advisor reports. Piper Jaffray Companies currently has a $40.00 price target on the stock.
A number of other equities analysts also recently commented on the stock. Zacks Investment Research raised shares of MeiraGTx from a hold rating to a buy rating and set a $17.00 price objective for the company in a report on Wednesday, November 13th. Chardan Capital reissued a buy rating and set a $45.00 target price on shares of MeiraGTx in a report on Monday. Finally, ValuEngine downgraded shares of MeiraGTx from a hold rating to a sell rating in a research report on Tuesday, December 3rd. One investment analyst has rated the stock with a sell rating and four have assigned a buy rating to the company’s stock. MeiraGTx has a consensus rating of Buy and a consensus target price of $33.00.
Shares of MGTX opened at $21.43 on Monday. The firm has a market cap of $791.78 million, a price-to-earnings ratio of -4.88 and a beta of 2.22. The stock has a 50 day moving average of $17.85 and a 200-day moving average of $20.48. The company has a current ratio of 6.90, a quick ratio of 6.90 and a debt-to-equity ratio of 0.11. MeiraGTx has a 52 week low of $8.53 and a 52 week high of $30.23.
MeiraGTx (NASDAQ:MGTX) last issued its quarterly earnings results on Thursday, November 7th. The company reported ($0.30) earnings per share for the quarter, beating the Zacks’ consensus estimate of ($0.52) by $0.22. The firm had revenue of $3.58 million during the quarter. On average, sell-side analysts predict that MeiraGTx will post -2.22 earnings per share for the current fiscal year.
In related news, Director Nicole Seligman bought 5,000 shares of the firm’s stock in a transaction on Tuesday, November 19th. The stock was bought at an average cost of $16.31 per share, for a total transaction of $81,550.00. Following the completion of the purchase, the director now directly owns 5,000 shares in the company, valued at approximately $81,550. The purchase was disclosed in a filing with the Securities & Exchange Commission, which is available through this hyperlink. Company insiders own 17.40% of the company’s stock.
Several institutional investors have recently made changes to their positions in the company. Orbimed Advisors LLC raised its position in shares of MeiraGTx by 29.5% during the 3rd quarter. Orbimed Advisors LLC now owns 3,349,060 shares of the company’s stock worth $53,418,000 after purchasing an additional 762,109 shares during the period. BlackRock Inc. grew its stake in MeiraGTx by 39.6% during the 2nd quarter. BlackRock Inc. now owns 789,792 shares of the company’s stock worth $21,230,000 after buying an additional 224,052 shares during the last quarter. State Street Corp increased its position in MeiraGTx by 19.3% in the third quarter. State Street Corp now owns 318,242 shares of the company’s stock worth $5,076,000 after buying an additional 51,522 shares during the period. Millennium Management LLC increased its position in MeiraGTx by 519.2% in the third quarter. Millennium Management LLC now owns 204,966 shares of the company’s stock worth $3,269,000 after buying an additional 171,866 shares during the period. Finally, JPMorgan Chase & Co. lifted its stake in MeiraGTx by 2,008.5% in the second quarter. JPMorgan Chase & Co. now owns 171,168 shares of the company’s stock valued at $4,338,000 after buying an additional 163,050 shares during the last quarter. Institutional investors and hedge funds own 42.18% of the company’s stock.
About MeiraGTx
MeiraGTx Holdings plc, a clinical-stage gene therapy company, focusing on developing treatments for patients living with serious diseases. The company develops various therapies for ocular diseases, including rare inherited blindness, as well as Xerostomia following radiation treatment for head and neck cancers; neurodegenerative diseases, such as amyothrophic lateral sclerosis; and Parkinson's diseases.
https://newsfilter.io/articles/meiragtx-nasdaqmgtx-given-buy-rating-at-piper-jaffray-companies-73eb5a44157d4419e1c8d7380a1f3fc9
Myovant Sciences Announces Closing of $400 Million Loan Facility, Repayment of Debt, Board of Director Transitions, and Executive Promotions
https://seekingalpha.com/pr/17736869-myovant-sciences-announces-closing-of-400-million-loan-facility-repayment-of-debt-board-of
Loop Capital Reaffirms “Buy” Rating for Adesto Technologies (NASDAQ:IOTS)
Loop Capital restated their buy rating on shares of Adesto Technologies (NASDAQ:IOTS) in a research report sent to investors on Monday morning, AnalystRatings.com reports. They currently have a $13.00 target price on the technology company’s stock.
Several other equities research analysts also recently weighed in on IOTS. TheStreet raised shares of Adesto Technologies from a d rating to a c- rating in a research note on Wednesday, November 6th. Needham & Company LLC reaffirmed a buy rating and set a $12.00 price target on shares of Adesto Technologies in a research note on Wednesday, November 6th. Cowen upped their price target on shares of Adesto Technologies from $9.00 to $11.00 and gave the company an outperform rating in a report on Wednesday, November 6th. Zacks Investment Research lowered shares of Adesto Technologies from a buy rating to a hold rating in a research report on Thursday, November 14th. Finally, Craig Hallum initiated coverage on shares of Adesto Technologies in a research note on Thursday, September 19th. They issued a buy rating and a $13.00 price objective for the company. Four investment analysts have rated the stock with a hold rating and four have given a buy rating to the company’s stock. The company presently has a consensus rating of Buy and a consensus price target of $11.50.
NASDAQ IOTS opened at $7.81 on Monday. The business’s 50 day moving average price is $7.32 and its 200-day moving average price is $8.52. Adesto Technologies has a fifty-two week low of $4.10 and a fifty-two week high of $11.97. The company has a market cap of $229.98 million, a P/E ratio of -27.89 and a beta of 1.09. The company has a debt-to-equity ratio of 0.94, a quick ratio of 1.56 and a current ratio of 1.90.
Adesto Technologies (NASDAQ:IOTS) last issued its quarterly earnings results on Tuesday, November 5th. The technology company reported ($0.02) earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of ($0.03) by $0.01. The company had revenue of $32.03 million during the quarter, compared to the consensus estimate of $32.99 million. Adesto Technologies had a negative return on equity of 13.61% and a negative net margin of 21.81%. As a group, equities analysts predict that Adesto Technologies will post -0.19 EPS for the current year.
In other Adesto Technologies news, CEO Narbeh Derhacobian bought 7,500 shares of the firm’s stock in a transaction dated Thursday, November 21st. The stock was acquired at an average cost of $6.85 per share, for a total transaction of $51,375.00. Following the completion of the transaction, the chief executive officer now owns 494,083 shares in the company, valued at $3,384,468.55. The acquisition was disclosed in a document filed with the SEC, which is available through this link. Also, VP Thomas D. Spade sold 5,057 shares of the business’s stock in a transaction on Wednesday, November 27th. The shares were sold at an average price of $6.98, for a total transaction of $35,297.86. Following the sale, the vice president now directly owns 65,252 shares of the company’s stock, valued at $455,458.96. The disclosure for this sale can be found here. Insiders sold a total of 24,810 shares of company stock worth $178,375 in the last ninety days. 12.36% of the stock is currently owned by corporate insiders.
Institutional investors and hedge funds have recently made changes to their positions in the stock. Tower Research Capital LLC TRC bought a new stake in Adesto Technologies during the 3rd quarter valued at about $36,000. First Interstate Bank bought a new position in Adesto Technologies in the 3rd quarter worth about $77,000. Metropolitan Life Insurance Co NY bought a new position in Adesto Technologies in the 3rd quarter worth about $78,000. Susquehanna International Group LLP purchased a new position in shares of Adesto Technologies during the second quarter worth approximately $95,000. Finally, Virtu Financial LLC purchased a new position in shares of Adesto Technologies during the third quarter worth approximately $165,000. Institutional investors own 75.90% of the company’s stock.
Adesto Technologies Company Profile
Adesto Technologies Corporation, together with its subsidiaries, provides application-specific semiconductors and embedded systems that offer the building blocks of Internet of Things (IoT) edge devices operating on networks worldwide. The company's portfolio of semiconductor and embedded technologies are optimized for connected IoT devices and systems used in industrial, consumer, communications, and medical applications.
Featured Story: Stock Symbol
https://newsfilter.io/articles/loop-capital-reaffirms-buy-rating-for-adesto-technologies-nasdaqiots-a5ad31d1584b80c5c1adb48b27e755f9
Could this grocery disrupter take on Amazon?
Dec. 27, 2019 - 4:40 - Grocery Outlet head of marketing Layla Kasha discusses how Grocery Outlet is disrupting the industry.
https://video.foxbusiness.com/v/6118485083001/#sp=show-clips