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Post by Deleted on Feb 9, 2016 8:52:14 GMT -5
I vote for Algomedix too "developing novel therapeutics for the treatment of chronic pain and inflammation".
Algomedix has discovered and is developing a novel non-opiod drug that solves these problems. The estimated market for this potential first-in-class drug in the primary indication is estimated > $1 billion.
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Post by Deleted on Feb 9, 2016 8:56:01 GMT -5
Lakers - if it were this group being spun off, why the secrecy by investors? If it is one or more of the specific G-protein related antibodies - why the secrecy? Do they have IP? This group you've cited has IP around the GPRC's. Why would there not be shared IP with Mannkind for a new TS drug? What is Receptor's "proprietary compound" then? Would it not be a specific drug? How could you miss The detail of RLS (Omeros) compound on this page? RLS can do a reverse merger in the future with Mnkd although Matt said "Our reverse merger with Receptor is not under consideration at this time." Read more: mnkd.proboards.com/thread/5151/mannkind-sheds-inhaled-formulation-partne#ixzz3zekl6tbMThere are many companies that perform reverse mergers, also known as reverse takeovers, as opposed to other, more traditional forms of raising capital. A reverse merger is when a private company becomes a public company by purchasing control of the public company. The shareholders of the private company usually receive large amounts of ownership in the public company and control of its board of directors (B of D). Once this is complete, the private and public companies merge into one publicly traded company. Advantages of Reverse Mergers The following are the many advantages to performing reverse mergers. The ability for a private company to become public for a lower cost and in less time than with an initial public offering (IPO). When a company plans to go public through an IPO, the process can take a year or more to complete. This can cost the company money and time. With a reverse merger, a private company can go public in as little as 30 days. Public companies have higher valuations compared with private companies. Some of the reasons for this include: greater liquidity, increased transparency and publicity, and they have a faster growth rates compared to private companies. Reverse mergers are less likely to be canceled or put on hold because of the adverse effects of current market conditions. This means that if the equity markets are performing poorly or there is unfavorable publicity surrounding the IPO, underwriters can pull the offering off the table. The public company can offer a tax shelter to the private company. In many cases, the public company has taken a series of losses. A percentage of the losses can be carried forward and applied to future income. By merging the private and public company, it is possible to protect a percentage of the merged company's profits from future taxes. www.investopedia.com/articles/stocks/08/reverse-merger.aspMatt also said SNY was not buying in just yet and look where that went. |
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Post by lakers on Feb 9, 2016 12:25:22 GMT -5
I vote for Algomedix too "developing novel therapeutics for the treatment of chronic pain and inflammation". Algomedix has discovered and is developing a novel non-opiod drug that solves these problems. The estimated market for this potential first-in-class drug in the primary indication is estimated > $1 billion. Algomedix doesn't have CNS disorder compound (MS, Alzheimer's,...). As said before I called Algomedix, a man picked up the phone acknowledged that it was Algomedix not RLS. He said no one there named Andrea Leone-Bay when I asked to be transferred to Andrea. Algomedix wasn't funded by Vulcan Capital either. Check capital.vulcan.com, click Investments, Life Sciences. Omeros has pain, Inflammation (RA), CNS disorder Receptor compounds, funded by Vulcan Capital. Omeros likely spun off RLS startup w/ Vulcan and other funding to get RnD cost off the expense. Paul Allen's Mom died with Alzheimer's. So it hit home with him. He invested a lot in this field. Interestingly, Algomedix CEO used to work for Omeros. One can guess Algomedix may use the Receptor approach for pain, Inflammation too. |
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Post by Deleted on Feb 9, 2016 12:28:47 GMT -5
I vote for Algomedix too "developing novel therapeutics for the treatment of chronic pain and inflammation". Algomedix has discovered and is developing a novel non-opiod drug that solves these problems. The estimated market for this potential first-in-class drug in the primary indication is estimated > $1 billion. Algomedix doesn't have CNS disorder compound (MS, Alzheimer's,...). As said before I called Algomedix, a man picked up the phone acknowledged that it was Algomedix not RLS. He said no one there named Andrea Leone-Bay when I asked to be transferred to Andrea. Algomedix wasn't funded by Vulcan Capital either. Omeros has pain, Inflammation (RA), CNS disorder Receptor compounds, funded by Vulcan Capital. Omeros likely spun off RLS startup w/ Vulcan and other funding to get RnD cost off the expense. Paul Allen's Mom died with Alzheimer's. So it hit home with him. Her linked in states she is NY. I was wondering why change the job to seattle but not the area |
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Post by kc on Feb 9, 2016 13:19:51 GMT -5
She will work from NY and direct the research work from there.
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Post by sluggobear on Feb 9, 2016 13:39:33 GMT -5
"Matt did say we'll know who Receptor Life Sciences is "soon"... the problem is that Matt's definition of "soon" is always much longer than mine!"
I didn't hear Matt say "soon". I heard him say "ultimately"...which might be 2-3 years from now if clinical trials for TS versions of their "proprietary compounds" move forward.
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Post by sluggobear on Feb 9, 2016 14:51:29 GMT -5
Lakers - Matt did say, " A reverse merger is not under consideration at this time". I don't think this is the reason for secrecy. I certainly see the rabbit trail here; you could be right and Receptor might be Omeros. That would bring my wild (excited for a few seconds too) speculation crashing down to earth. I was hoping RLS was on to something completely out of the box that could turn the tide much more quickly for MNKD than another long shot, 10 year clinical program. I looked at the medical uses for THC and CBD as a possibility b/c: RLS is in Washington state, the secrecy, the FAQ's describe proprietary compounds (not specific patented pharmaceuticals) for conditions specifically proposed for THC and CBD, and there is a perceived need for controlled, regulated dosing of medical marijuana, not to mention recreational use. "Technosphere technology is to be used as a vehicle to deliver regulated doses of a proprietary compound to treat a variety of medical conditions, including chronic pain, spasticity and inflammatory diseases such as rheumatoid arthritis. investors.mannkindcorp.com/faq.cfm?faqid=2#sthash.gY8mLj9G.dpufIn Wikipedia: "In April 2014 the American Academy of Neurology published a systematic review of the efficacy and safety of medical marijuana and marijuana-derived products in certain neurological disorders.[21] The review identified 34 studies meeting inclusion criteria, of which 8 were rated as Class I quality.[21] The study found evidence supporting the effectiveness of cannabis extracts and THC in treating certain symptoms of multiple sclerosis, but found insufficient evidence to determine the effectiveness of cannabis products in treating several other neurological diseases.[21]" The first entry for AAN-reviewed medical use of marijuana in Wikipedia is for spasticity in MS symptoms. The second is pain: Multiple sclerosis symptoms Spasticity. Based on the results of 3 high quality trials and 5 of lower quality, oral cannabis extract was rated as effective, and THC as probably effective, for improving patient's subjective experience of spasticity. Oral cannabis extract and THC both were rated as possibly effective for improving objective measures of spasticity.[21] Centrally mediated pain and painful spasms. Based on the results of 4 high quality trials and 4 low quality trials, oral cannabis extract was rated as effective, and THC as probably effective in treating central pain and painful spasms.[21] I did see Omeros' assay for selecting GPCR compounds is proprietary (CRA - "cell redistribution assay") so maybe they consider the compounds selected in the assay to be proprietary. Why would they not claim patent-protection for their compounds though? Is that the reason for the secrecy? They list many possible conditions (every human condition?) that might be treated by their GPCR's including MS. I'm probably wrong but if RLS was developing THC / CBD - it would not be FDA-regulated and they could corner the market on inhaled controlled doses in an industry that is growing at over 30% per year and is in the billions of $$. Matt also mentioned that "the real money would be in the royalties on sales". Why would he mention that if he thought it would be 10 years before drug sales were realized. I'm reaching I know... |
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Post by mnholdem on Feb 9, 2016 14:56:23 GMT -5
"Matt did say we'll know who Receptor Life Sciences is "soon"... the problem is that Matt's definition of "soon" is always much longer than mine!" I didn't hear Matt say "soon". I heard him say "ultimately"...which might be 2-3 years from now if clinical trials for TS versions of their "proprietary compounds" move forward. You remind me that I should probably state whenever I am paraphrasing. Matt's actual comment on Feb 3 was, "They’re working closely with us to develop these proprietary compounds of theirs, and we feel pretty excited about it for reasons which ultimately become known, but there’s not much more beyond – I think we’ve kind of pushed the limits of what we’re allowed to say at this point, but I hope that will change in the near term."
So... I'll revise my statement to state that Matt's definition of "near term" may be longer than mine. 
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Post by dreamboatcruise on Feb 9, 2016 18:50:46 GMT -5
"Matt did say we'll know who Receptor Life Sciences is "soon"... the problem is that Matt's definition of "soon" is always much longer than mine!" I didn't hear Matt say "soon". I heard him say "ultimately"...which might be 2-3 years from now if clinical trials for TS versions of their "proprietary compounds" move forward. You remind me that I should probably state whenever I am paraphrasing. Matt's actual comment on Feb 3 was, "They’re working closely with us to develop these proprietary compounds of theirs, and we feel pretty excited about it for reasons which ultimately become known, but there’s not much more beyond – I think we’ve kind of pushed the limits of what we’re allowed to say at this point, but I hope that will change in the near term."
So... I'll revise my statement to state that Matt's definition of "near term" may be longer than mine.
And more importantly than distinction between "soon" and "near term" is the distinction between him saying "we will know" vs saying he "hoped" that they'd be able to say more. That doesn't imply any certainty or even necessarily a high probability. There are plenty of things regarding this company that I "hope" for that I know are very likely not going to happen. |
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Post by mnholdem on Feb 11, 2016 19:08:31 GMT -5
This Seattle company is worth considering, IMO. Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Our lead clinical candidate, ALD403, inhibits a well validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is currently undergoing Phase 2b clinical testing for the treatment of chronic migraines. We have initiated a pivotal trial for the treatment of frequent episodic migraine and plan to initiate additional advanced clinical trials for ALD403 in frequent episodic and chronic migraines in 2016. Our second program, ALD1613, which targets adrenocorticotropic hormone (ACTH) is undergoing Investigational New Drug (IND)-enabling preclinical studies with the initiation of clinical studies in Congenital Adrenal Hyperplasia or Cushing’s disease planned for 2016. Finally, clazakizumab, previously known as ALD518, is designed to block the pro-inflammatory cytokine IL-6 and has completed a Phase 2b clinical trial. Source: www.alderbio.com/overview/Alders current work on migraine pain may explain the sudden disappearance of pain drugs from the MannKind 2.0 drug pipeline candidates list. CEO Pfeffer stated that they are re-evaluating their pain API, but it may have been tabled so as to not conflict with their new partner's API for chronic pain. I believe that migraines are classified as acute pain, but Alders describes their trials for ALD403 for both episodic (acute) and chronic migraines. Hmmm...? |
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Post by Deleted on Feb 11, 2016 19:33:20 GMT -5
This Seattle company is worth considering, IMO. Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Our lead clinical candidate, ALD403, inhibits a well validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is currently undergoing Phase 2b clinical testing for the treatment of chronic migraines. We have initiated a pivotal trial for the treatment of frequent episodic migraine and plan to initiate additional advanced clinical trials for ALD403 in frequent episodic and chronic migraines in 2016. Our second program, ALD1613, which targets adrenocorticotropic hormone (ACTH) is undergoing Investigational New Drug (IND)-enabling preclinical studies with the initiation of clinical studies in Congenital Adrenal Hyperplasia or Cushing’s disease planned for 2016. Finally, clazakizumab, previously known as ALD518, is designed to block the pro-inflammatory cytokine IL-6 and has completed a Phase 2b clinical trial. Source: www.alderbio.com/overview/Alders current work on migraine pain may explain the sudden disappearance of pain drugs from the MannKind 2.0 drug pipeline candidates list. CEO Pfeffer stated that they are re-evaluating their pain API, but it may have been tabled so as to not conflict with their new partner's API for chronic pain. I believe that migraines are classified as acute pain, but Alders describes their trials for ALD403 for both episodic (acute) and chronic migraines. Hmmm...? I like this even better with 2016 all plastered over and Matt saying he might get some milestone this year |
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Post by mnholdem on Feb 11, 2016 19:45:02 GMT -5
Alder's current Phase 2b trial - clinicaltrials.gov/ct2/show/NCT02559895?term=ALD&recr=Open&rank=1 - uses IV administration, but their site (above) states that they are planning more advance-stage trials. Perhaps administered via Technosphere? It is, after all, the next best route to IV, and would definitely be more convenient. |
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Post by sluggobear on Feb 11, 2016 19:51:36 GMT -5
This Seattle company is worth considering, IMO. Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Our lead clinical candidate, ALD403, inhibits a well validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is currently undergoing Phase 2b clinical testing for the treatment of chronic migraines. We have initiated a pivotal trial for the treatment of frequent episodic migraine and plan to initiate additional advanced clinical trials for ALD403 in frequent episodic and chronic migraines in 2016. Our second program, ALD1613, which targets adrenocorticotropic hormone (ACTH) is undergoing Investigational New Drug (IND)-enabling preclinical studies with the initiation of clinical studies in Congenital Adrenal Hyperplasia or Cushing’s disease planned for 2016. Finally, clazakizumab, previously known as ALD518, is designed to block the pro-inflammatory cytokine IL-6 and has completed a Phase 2b clinical trial. Source: www.alderbio.com/overview/Alders current work on migraine pain may explain the sudden disappearance of pain drugs from the MannKind 2.0 drug pipeline candidates list. CEO Pfeffer stated that they are re-evaluating their pain API, but it may have been tabled so as to not conflict with their new partner's API for chronic pain. I believe that migraines are classified as acute pain, but Alders describes their trials for ALD403 for both episodic (acute) and chronic migraines. Hmmm...? From their website, all programs involve monoclonal antibodies (mAb's): "Our pipeline includes three internally discovered humanized monoclonal antibodies (including one preclinical monoclonal antibody), as well as preclinical programs targeting additional indications that are in the discovery phase." I am not positive but if they are typical molecular weight IgG antibodies then the MW average is around 150 kDa. From the Technosphere page: "Technosphere formulations have been prepared with a diverse assortment of drugs that have a broad range of physicochemical characteristics. For example, drugs ranging in molecular weight from 500 to 140,000 Da have been successfully adsorbed onto Technosphere particles. Anionic and cationic drugs, hydrophobic and hydrophilic drugs, proteins, peptides, and small molecules have all been formulated successfully. Systemic drug delivery using many of these formulations has been demonstrated in a rat model of pulmonary drug delivery. Clinical drug delivery has been demonstrated with insulin/Technosphere, PTH/Technosphere, sCT/Technosphere, and GLP-1/Technosphere. I believe most (or all) of the very expensive mAb drugs (biologics) can only be injected so the idea of being able to deliver by inhalation always seemed promising. I think Humira must be injected once a month...But mAb's may be beyond the size limit for TS. Has anyone ever heard that proposed? |
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Post by sluggobear on Feb 11, 2016 20:12:29 GMT -5
This Seattle company is worth considering, IMO. Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Our lead clinical candidate, ALD403, inhibits a well validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is currently undergoing Phase 2b clinical testing for the treatment of chronic migraines. We have initiated a pivotal trial for the treatment of frequent episodic migraine and plan to initiate additional advanced clinical trials for ALD403 in frequent episodic and chronic migraines in 2016. Our second program, ALD1613, which targets adrenocorticotropic hormone (ACTH) is undergoing Investigational New Drug (IND)-enabling preclinical studies with the initiation of clinical studies in Congenital Adrenal Hyperplasia or Cushing’s disease planned for 2016. Finally, clazakizumab, previously known as ALD518, is designed to block the pro-inflammatory cytokine IL-6 and has completed a Phase 2b clinical trial. Source: www.alderbio.com/overview/Alders current work on migraine pain may explain the sudden disappearance of pain drugs from the MannKind 2.0 drug pipeline candidates list. CEO Pfeffer stated that they are re-evaluating their pain API, but it may have been tabled so as to not conflict with their new partner's API for chronic pain. I believe that migraines are classified as acute pain, but Alders describes their trials for ALD403 for both episodic (acute) and chronic migraines. Hmmm...? From their website, all programs involve monoclonal antibodies (mAb's): "Our pipeline includes three internally discovered humanized monoclonal antibodies (including one preclinical monoclonal antibody), as well as preclinical programs targeting additional indications that are in the discovery phase." I am not positive but if they are typical molecular weight IgG antibodies then the MW average is around 150 kDa. From the Technosphere page: "Technosphere formulations have been prepared with a diverse assortment of drugs that have a broad range of physicochemical characteristics. For example, drugs ranging in molecular weight from 500 to 140,000 Da have been successfully adsorbed onto Technosphere particles. Anionic and cationic drugs, hydrophobic and hydrophilic drugs, proteins, peptides, and small molecules have all been formulated successfully. Systemic drug delivery using many of these formulations has been demonstrated in a rat model of pulmonary drug delivery. Clinical drug delivery has been demonstrated with insulin/Technosphere, PTH/Technosphere, sCT/Technosphere, and GLP-1/Technosphere. I believe most (or all) of the very expensive mAb drugs (biologics) can only be injected so the idea of being able to deliver by inhalation always seemed promising. I think Humira must be injected once a month...But mAb's may be beyond the size limit for TS. Has anyone ever heard that proposed? Lakers found the link to Omeros which is a pretty reasonable candidate based on what they describe as their approach to screening for G-protein coupled receptor small molecule drug "agents". These small molecule agents are typically peptides / proteins which can be loaded on TS (and are difficult to make oral formulations. See last sentence!) FYI - agonists bind receptors to turn on G-protein cascade, antagonists bind receptors to block the G-protein cascade. If anyone cares... www.omeros.com/pipeline/gpcr.htm"Omeros uses its proprietary high-throughput cellular redistribution assay (CRA) to identify small-molecule agonists and antagonists for orphan GPCRs, unlocking them to drug development. Omeros believes that it is the first to possess the capability to conduct high-throughput drug discovery for orphan GPCRs, and that currently there is no other existing high-throughput technology able to "unlock" orphan GPCRs. Unlocking these receptors could lead to the development of drugs that act at these new targets. There is a broad range of indications linked to orphan GPCRs including cardiovascular disease, asthma, diabetes, pain, obesity, Alzheimer's disease, Parkinson's disease, multiple sclerosis, schizophrenia, learning and cognitive disorders, autism, osteoporosis, osteoarthritis and several forms of cancer." Is there any disease that was left out of this list? The FAQ's for Receptor mentioned chronic pain, spasticity, and inflammation from rheumatoid arthritis. Funny the only one not on this list is RA...but it's in their table of targets. "Omeros has begun screening orphan GPCRs against its small-molecule chemical libraries using its proprietary, high-throughput CRA. In addition to Class A orphan GPCRs, we have also begun screening orphan and non-orphan Class B receptors. Class B GPCRs have large extracellular domains and their natural ligands are generally large peptides, making the development of orally active, small-molecule drugs against these receptors, such as glucagon and parathyroid hormone, a persistent challenge."
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Post by lakers on Feb 12, 2016 18:12:08 GMT -5
Gregory A Demopulos, MD Owns 9.7% Stake in Omeros Co. (OMER)
Posted by mitch on Feb 12th, 2016 // No Comments Omeros logoGregory A Demopulos, MD revealed that they own a 9.7% stake in Omeros Co. (NASDAQ:OMER) in a Form 13G/A disclosure that was filed with the Securities and Exchange Commission on Thursday, February 11th. The investor owns 3,919,691 shares of the stock valued at about $41,274,346. The disclosure is available through EDGAR at this link. Several other large investors also recently bought and sold shares of the company. DekaBank Deutsche Girozentrale boosted its stake in Omeros by 1.6% in the fourth quarter. DekaBank Deutsche Girozentrale now owns 19,300 shares of the biopharmaceutical company’s stock worth $300,000 after buying an additional 300 shares during the period. Baird Financial Group Inc. boosted its stake in Omeros by 0.8% in the fourth quarter. Baird Financial Group Inc. now owns 49,768 shares of the biopharmaceutical company’s stock worth $783,000 after buying an additional 380 shares during the period. Mutual of America Capital Management LLC boosted its stake in Omeros by 0.6% in the fourth quarter. Mutual of America Capital Management LLC now owns 116,171 shares of the biopharmaceutical company’s stock worth $1,827,000 after buying an additional 694 shares during the period. California State Teachers Retirement System boosted its stake in Omeros by 1.8% in the fourth quarter. California State Teachers Retirement System now owns 70,144 shares of the biopharmaceutical company’s stock worth $1,103,000 after buying an additional 1,249 shares during the period. Finally, Wells Fargo & Company MN boosted its stake in Omeros by 15.0% in the fourth quarter. Wells Fargo & Company MN now owns 19,770 shares of the biopharmaceutical company’s stock worth $311,000 after buying an additional 2,575 shares during the period. Omeros Co. (NASDAQ:OMER) traded up 0.19% on Thursday, hitting $10.53. 247,810 shares of the stock traded hands. The company’s 50 day moving average price is $11.83 and its 200-day moving average price is $13.62. The stock’s market cap is $399.81 million. Omeros Co. has a 52-week low of $8.90 and a 52-week high of $30.23. Omeros (NASDAQ:OMER) last issued its quarterly earnings results on Monday, November 9th. The biopharmaceutical company reported ($0.46) earnings per share for the quarter, topping the Thomson Reuters’ consensus estimate of ($0.47) by $0.01. During the same quarter in the prior year, the business earned ($0.54) EPS. The business had revenue of $3.30 million for the quarter, compared to analysts’ expectations of $7.97 million. The company’s revenue was up 1423.4% compared to the same quarter last year. On average, analysts forecast that Omeros Co. will post ($1.95) earnings per share for the current fiscal year. OMER has been the topic of a number of research reports. Zacks Investment Research raised shares of Omeros from a “sell” rating to a “hold” rating in a report on Friday, January 1st. Needham & Company LLC reaffirmed a “buy” rating and issued a $30.00 price target (down previously from $32.00) on shares of Omeros in a report on Tuesday, November 10th. Wedbush reaffirmed an “outperform” rating and issued a $65.00 price target on shares of Omeros in a report on Monday, January 4th. Finally, FBR & Co. reaffirmed an “outperform” rating on shares of Omeros in a report on Friday, October 30th. One equities research analyst has rated the stock with a hold rating, seven have given a buy rating and one has assigned a strong buy rating to the company’s stock. The company presently has a consensus rating of “Buy” and a consensus target price of $41.43. In other news, VP Marcia S. Kelbon sold 15,900 shares of Omeros stock in a transaction on Tuesday, December 22nd. The shares were sold at an average price of $15.00, for a total transaction of $238,500.00. Following the transaction, the vice president now owns 138,426 shares in the company, valued at approximately $2,076,390. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available at this hyperlink. Omeros Corporation is a biopharmaceutical company. The Company is engaged in discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Its marketed drug product Omidria is approved in the United States for use during cataract surgery or intraocular lens (NASDAQ:OMER), which is replacement surgery, to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. www.thevistavoice.org/2016/02/12/gregory-a-demopulos-md-owns-9-7-stake-in-omeros-co-omer/813996/
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