•Company expects to initiate pivotal Phase III clinical trial by year-end 2017; will take approximately 9-12 months to complete
Soleno Therapeutics, Inc. (Soleno) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase III clinical development program at the end of 2017.
Market Opportunity for PWS is Substantial.
While the lack of approved treatments for PWS alone make it difficult to assess the market, sales of Pfizer’s (NYSE: PFE) Genotrop in (somatropin) can provide some insight despite being indicate for PWS, in addition to, growth failure due to growth hormone deficiency(GHD),Turner syndrome,idiopathic short stature,and small for gestational age.This product achieved its highest revenue in 2008,with worldwide sales of approximately $900 million.While somatropin has been proven to improve growth and body composition, it does not affect the key disease component of hyperphagia and use is associated with substantial risk. Soleno is developing DCCR for the treatment of PWS,to help address the unmet need of this patient population. To assess the potential of DCCR for PWS, we performed a scenario analysis, which indicates that annual sales could be in the range of $1.1 billion given a moderate price point and 50% market penetrance.
I've learned a lot about how biotechs and shorts/MMs work on them over the past year or so. The price has nothing to do with reality but what I do notice is for similar co's like INFI, MRNS, VSTM, and their ilk, they like to bring them down under a buck. But as long as company survives one can really make a lot on them, as they will go to $2, 3, 4+ really fast. INFI is in that situation now, who knows how long they will take it, we've been through this movie once before, the last time they took it to $0.84, so will they take a $1.31/sh cash and $1.46 BV with enough case to last through 2019 to a FAKE price they determine and will that be somewhere less than $0.84, the 52 week low? Keep in mind Adeline has many shares way under water and current INFI board members have shares at an exercise price or bought at prices way higher so they should have an incentive to move thisto a price such that they can make a profit.
Sub Buck Not Cool . . . Long, but not lost.
"Infinity Shares Soar...", that is going to be coming soon and whatever shorts remain will cover and MMs will help rocket it to $2+
Thursday, Dec. 17 PITTSFIELD -- Adeline Q. Perkins was inspired by her math and science courses at Taconic High School. And she honed her business acumen working at GE Plastics during and after …
cash on hand $1.1 per share. The value of this share should be at least $1.1 period!
I'm kind of ticked :^), I set my limit order too high at $1.04, it dropped to .99, closed $1, good jobs MMs and shorts, but short will start getting squeezed next week, after hours $1.10 again, today was a day I knew one could get it cheap, come on the book value $1.46, cash per share $1.31 sheesh, time to suffocate the shorts :^)
now that the MMs and shorts have had their fun, time to cheer/root for going over $1 :^), and for Adeline and mgmt team to start releasing some news, vs many other not even as good companies in terms of cash, financial health, book value, etc. INFI is way better, tired of these MMs and shorts posting penny pinching fractional shares for sale, buy longs he have the cash and are accumulating are loving this now.
There is a guy by name Dan either pessimistic or intentionally wanted to bring it down. Placed few neg comments and disappears. I am not sure if his comments contributed to the decline. But nothing has changed from data perspective to change the outlook Dan wanted to see responses. But most patients who went into dose escalation were pancreatic or ovarian ca who don't respond to immunotherapy. Which is company mistake in selecting the phase one center to include such patients There was an individual with colon ca on the single agent who stayed on therapy more than 8 months (I have not seen an update on that ) which is hard to explain by chance Dan needs to know that if they had one response the company would have been snatched for a billion dollar Even ipilimumab that generated 1 b annually would not have shown a response on this poplulation One can go to Incyte IDO inh and see the response rate in single agent was 5 out of 57 had stable disease for 6 months Infinity reported 6 out of 15 stable disease for 6 months. The drug is worth 5 billion from Incyte cap
People are giving up easily on this promising drug before any data emerge
Dan, in a previous post, you stated there are problems with opdivo/ ipi549 combo. Would you expound !
Early lease termination now. Bad news.
Buy back at .90
on 2nd thought read up on the executive mgmt at the website, on paper they should have the skill to get the company sold, the execs in place at least on paper and if true seem to competent enough to sell the company for $3.50+sh:
Lawrence Bloch, M.D., J.D. is president of Infinity. He joined the company as chief financial officer and chief business officer in 2012 and has played a key role in developing and executing the company’s corporate and financial strategies. Prior to joining Infinity in 2012, Dr. Bloch served as chief executive officer of NeurAxon, Inc., a company focused on developing next-generation pain therapeutics, from 2007 to 2011. Previously, he served as chief business officer and chief financial officer of NitroMed, Inc., raising $150 million in equity and $20 million in venture debt to support the commercial launch of BiDil®. From 1999 to 2004, he served as chief financial officer and vice president of business development of Applied Molecular Evolution, Inc., leading the company’s $101 million initial public offering and $420 million merger with Eli Lilly and Company.
Dr. Bloch began his career as an emergency medicine resident physician at Massachusetts General Hospital and Brigham & Women’s Hospital. He holds a J.D. from Harvard Law School, an M.D. from Harvard Medical School and an MBA from Harvard Business School. > less Claudio Dansky Ullmann, M.D.
Senior Vice President, Clinical Development
Claudio Dansky Ullmann, M.D., serves as senior vice president, clinical development at Infinity and has nearly 30 years of experience in drug development. Dr. Dansky Ullmann joined Infinity as vice president, clinical development in 2015 and has since led Infinity’s clinical development team. Prior to joining Infinity, he served as a senior medical director, global clinical lead, at Takeda Pharmaceutical Company Limited from 2012 to 2015. From 2005 to 2012, Dr. Ullmann worked at the Cancer Therapy Evaluation Program of the National Cancer Institute as a senior investigator where he participated in numerous early-phase and late-phase clinical trials, including studies evaluating treatments for lung and head and neck cancers, melanoma and other solid tumors. During his career, Dr. Dansky Ullmann also held research roles at the National Institute of Health and at Biomira Inc., and he held postdoctoral fellowship positions in tumor immunology and drug resistance at the National Cancer Institute. Dr. Dansky Ullmann is a native of Argentina and earned his M.D. at the School of Medicine, Universidad de Buenos Aires. He completed his medical oncology training at Guemes Private Hospital, Buenos Aires. > less Jeffery Kutok, M.D., Ph.D.
Chief Scientific Officer
Jeffery Kutok, M.D., Ph.D. serves as Infinity’s chief scientific officer. Prior to joining Infinity in 2010, Dr. Kutok was an associate professor of pathology at Harvard Medical School and Brigham and Women’s Hospital. His laboratory focused on translational medicine research and biomarker identification in cancer, and he is an author on over 190 journal articles, reviews and book chapters. Dr. Kutok is board certified in Anatomic Pathology and Hematology and had clinical duties in Hematopathology and Molecular Diagnostics at Brigham and Women’s Hospital. Dr. Kutok received his B.S. in biology and his M.D., Ph.D. in medicine and molecular pathology from the State University of New York at Stony Brook. His Ph.D. was earned working in the laboratory of Dr. Barry Coller, M.D. in the field of platelet pathobiology. He was also a post-doctoral fellow at Harvard University in the laboratory of Dr. Gary Gilliland, M.D., Ph.D. > less Adelene Perkins
Chair and Chief Executive Officer
Adelene Perkins serves as Infinity’s chief executive officer and Infinity’s chair, a position she has held since 2012. She was named chief executive officer and elected to the Board of Directors in 2009. Before serving as CEO, Ms. Perkins served as Infinity’s President, a position she held since 2008. Ms. Perkins joined Infinity in June 2002 as executive vice president and chief business officer.
Ms. Perkins joined Infinity from TransForm Pharmaceuticals where she served as vice president of business and corporate development and an early member of the management team that built the company prior to its acquisition by J&J. Prior to TransForm, from 1992-1999, she was at Genetics Institute, now a unit of Pfizer, where she was vice president of emerging businesses and the co-founder and general manager of the DiscoverEase™ business unit. She also formed and served as chief executive officer of MetaMorphix, a joint venture between Genetics Institute and Johns Hopkins University. She joined Genetics Institute in corporate and business development where she led corporate and product strategy initiatives. From 1985-1992, Ms. Perkins worked at Bain & Company, an international strategy consulting firm, where she provided strategic and operational advice to clients in the healthcare industry.
Ms. Perkins received her M.B.A. from Harvard Business School and her B.S. in chemical engineering from Villanova University. In addition to chairing the Infinity (NASDAQ: INFI) Board, she is on the Boards of Bruker Corporation (NASDAQ: BRKR), Massachusetts General Hospital, BIO (Biotechnology Industry Organization), the Massachusetts Biotechnology Council, and is the vice chairman of the Board of Project Hope. She is a past member of the Boards of Padlock Therapeutics, prior to its acquisition by Bristol-Myers Squibb, and the Massachusetts Life Science Center.
ok disclosure I have 33,000 shares at dollar cost average $1.0601, needless to say I watch this stock like hawk and want shorts squeezed and suffocated and MMs to bring price higher :^), one stock I have where they changed leadership and the thing taking off after is INAP, my 20,000 shares dollar cost average is $0.99/share and its going to get in the 5s soon, so your right the many who said that, if Adeline doesn't get this thing sold for at least $3.50/share by end of year dump her and #$%$ leadership, they just entitled figureheads with a piece of paper degree from top institution and alum of GE management, get somewhere in there who can get the company turned around and sold, people are running out of patience with the entitled woman, she has family if she not up to the task take her payout and hand over the reins to someone else who will get it done and spend more time with your family at entitled beach house in cape cod and all haha:^)
? Strange smell. A few months ago they were hosted by JP Chase for a "meeting"-nothing else known. a. Lease termination-pay 5 mil to get out of it ???? b. Amended deal with Takeda to "not pay royalties on worldwide sales" a+b+?=buyout or management just fkkng with us
go to cctl
Regardless of the price action recently and now I know where this is going long term. Ok shorts/MMs can you bring it down to 85cents again? Probably not, if I knew that I'd set my limit order to accumulate a ton at that price. Take it under $1, also unlikely, so I got a buy order at $1.04 for 4,000 more shares. I've been close to INFI and it sure it a better company than ones taking off today such as MRNS (Marinus) yet that 14 employee co. with a way lesser book value ($0.88cents/sh) is trading in the $3s today with no recent news, less institutional ownership and its 52 week low was $0.82/share. INFI is comparable to VSTM already in the $3s now (52 week low $1.05/sh). Wait until INFI starts to get positive attention from institutions and traders, that's when it will rise to the $3s+, time to accumulate is now while price is low, low, low bargain.
darn, should have bought today not last friday, the trough or price MMs willing to sell, lower today, $0.96 and not ripoff $1.04 MM shorts game price :^)