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More news this month. Should be good !MO!
Institutions have been buying big time!
I have invested in many small biotechs over many years as have many others on this board. I see two common issues.
One. Many of these small companies have problems with the FDA while Big Pharma sail through rapidly with very ineffective products with huge safety concerns!
Two. Many of them have problems raising finances.
In regard to the first issue, Anavex has certainly been delayed relative to the rapid approval of Big Pharma's marginally effective antibody drugs with very scary safety profiles!
In regard to the second issue, finances, Anavex has done very well.
We still need to see the peer reviewed article! (Which will be savagely attacked by the usual players!)
We still need to see some positive response from EMA or FDA!
It looks like a classic HOLD situation with potentially large gains, OR significant losses.
Time will tell!
Surely we can all agree that we will get news seventually.
Steady progress on DMD is great. But the elephant in the room are the partnerships for the Exosome platforms.
Here is what the company has said...
"Exosome-Based Therapeutics and Vaccines (Preclinical): We are focused on developing a precision-engineered exosome platform technology that has the ability to deliver defined sets of effector molecules which exert their effects through defined mechanisms of action. We recently published preclinical data on our StealthXTM platform showing the rapid development of a recombinant protein-based.... At this time, we are developing vaccines and therapeutics for infectious diseases, monogenic diseases and other potential indications. Our platform builds on advances in fundamental RNA and protein science, targeting technology and manufacturing, providing us the opportunity to potentially build a broad pipeline of new therapeutic candidates. Our current strategy is FOCUSED on SECURING PARTNERS who will provide capital and additional resources..."
I forgot to add that they will also earn a Priority Review Voucher (PRV) which have sold recently for $110 million.
The recent $10 million milestone is only the start. There is another $90 million coming upon approval. And another $600 million in future milestones. And the ROW rights outside US and Japan should be significant. And very few shares out. Future exosome partnerships could be huge...with buy-out potential anytime IMO.
Interesting article about the "new drug"...
"A paper outlining the efficacy of a new drug for Alzheimer’s disease has been published. The hotly awaited findings confirm that the compound, donanemab, can delay the rate of decline in individuals with early-stage Alzheimer’s by 22.3%. Over the study’s 18-month timeline, that equates to a 4-month delay in disease progression. Those four months come at a cost, however, as over 6% of patients receiving donanemab infusions showed symptoms related to brain swelling and bleeding that included headache, confusion and even seizures. The publication of the trial’s full results in the Journal of the American Medical Association follows a press release from manufacturer Eli Lilly in May.
The results are “fantastic news” for the overall progression of the field, said Professor Tara Spires-Jones, group leader at the UK Dementia Research Institute at the University of Edinburgh and president of the British Neuroscience Association in an interview with Technology Networks. Spires-Jones pointed to the recent approval of another compound, Leqembi, which was given the go-ahead by the U.S. Food and Drug Administration (FDA) earlier this month to suggest that the field is moving in the right direction. “It shows that we can do something that will help people even if it is a moderate slowing,” .
The overall clinical significance of dodanemab’s performance will remain under debate in a field that has desperately sought treatments of any efficacy after two decades of failure. The compound seems tipped for approval, given that its performance roughly matches Leqembi’s.
Donanemab is an anti-amyloid monoclonal antibody, a type of treatment that aims to reduce the amount of a protein called amyloid-beta drastically in the brain. One of the first and most defining clinical signs of the disease is amyloid-beta buildup. The protein is deposited in lumps and plaques across the Alzheimer’s-affected brain. The protein’s significance to the current direction of Alzheimer’s research cannot be overstated. The amyloid hypothesis, a theory that puts the protein at the heart of the disease’s effects, has driven much of the thinking around drug design in the area for multiple decades.
Tau-informed trial design
Donanemab was assessed in a Phase 3 trial called TRAILBLAZER-ALZ 2. This trial’s setup was slightly different from comparable efforts, changes that acknowledge the growing influence of another protein, tau, on the Alzheimer’s field. Increases in tau are also seen in the Alzheimer’s brain. Although this rise happens sequentially after amyloid-beta, research has recognized that tau levels are a greater indicator of disease progression in Alzheimer’s. Reflecting this, TRAILBLAZER-ALZ 2 stratified its cohort into different groups, depending on the level of tau detected in their brains using positron emission tomography imaging.
The study enrolled 1,736 participants, all of whom had early symptoms of dementia. The cohort was divided in two and, every four weeks, patients were intravenously infused with either donanemab or a placebo. This continued for 18 months.
The treatment’s effect was measured using several different dementia rating scales. In total, 24 different outcomes were measured to assess how well donanemab addressed dementia-related decline.
These included the integrated Alzheimer disease rating scale (iADRS) and the sum of boxes of the clinical dementia rating scale (CDR-SB) score. In iARDS ratings, lower scores indicate greater impairment. After 18 months, scores in patients given donanemab fell by 2.92 points less than those given a placebo, a statistically significant difference. Scores in the CDR-SB, which uses a different scale where higher values indicate greater impairment, were 0.7 points lower in the drug-treated cohort, a finding that was also statistically significant. Eli Lilly was keen to promote more impressive differences noted among those who had been segmented into lower-tau groups. As more tau indicates a more advanced disease progression, this suggests that people with early-stage disease stand to benefit most from donanemab. Individuals in high tau groups saw no benefit from the drug as measured by the iARDS rating system and most other secondary measures.
The Eli Lilly researchers behind the paper were keen to put these figures in terms of slowing of disease progression. The iARDS scores suggested a 22.3% slowing of disease while the CDR-SB showed a 28.9% slowing of disease. These figures are “hopeful”, said Spires-Jones, who acknowledged that a 30% slowing of disease progression would only be the first step towards treatments that could stop or reverse Alzheimer’s.
Safety data raises red flags and black boxes
There are some reasons not to take this promising result as an indication we are on the way to an Alzheimer’s-free future.
Some critics suggest that the reliance on “slowing of disease” in data around monoclonal antibodies is meant to mask unconvincing raw data – it is unclear whether a 2.92-point difference in iARDS rating at the 18-month mark will produce a clinically meaningful difference. The iARDS scale itself is an Eli Lilly creation and the only assessment of clinically significant differences on the scale was authored by Eli Lilly researchers.
The most significant hurdle facing donanemab, by far, is its safety data. Monoclonal anti-amyloid antibodies have been noted to cause changes in the brain that can be picked up on imaging machines. These are collectively called amyloid-related imaging abnormalities (ARIA). There are two types of ARIA, ARIA-E and ARIA-H. ARIA-E reflects swelling in the brain, while ARIA-H is indicative of microbleeds.
These kinds of effects already happen in the brains of people with Alzheimer’s disease, but are more common in people treated with donanemab. In this group, 36.8% of those dosed showed at least one type of ARIA, compared to 14.9% of the placebo group. Many of these cases will not produce any symptoms and will have only emerged after careful analysis of brain images. But in 52 cases, ARIA-E swelling was severe enough to produce symptoms that the authors listed as including confusion, headache and seizures. The rate of brain bleeds was far higher in the donanemab group as well. In 1.6% of the cohort, the side effects were so dramatic that patients were hospitalized. Three patients died as a result of ARIA effects brought on by the drug.
These side effects, although present, are thought to be less severe in Eisai’s Leqembi, which may ultimately reduce the adoption of donanemab. The fact that the drug is most useful to those with less severe disease, who would stand to lose the most from a severe reaction to the drug, does not tip the scales in Eli Lilly’s favor.
Reference: Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. Published online July 17, 2023. doi:10.1001/jama.2023.13239
SORRENTO PIPELINE (including majority owned SCILEX pipeline)
Sorrento’s R&D is focused on driving innovation in COVID-19, cancer treatment, full pain control and autoimmune diseases
COVID-19 Programs
Key Programs (Indication) Phase
COVISTIX™ (diagnostic) FDA EUA
COVIMARK™ (diagnostic) FDA EUA
VIREX (diagnostic) PH III
FUJOVEE™ (Abivertinib) Ph III
OQORY™ (COVI-MSC) Ph III
OVYDSO (Olgotrelvir) Ph II (pivotal)
Omicron mRNA Vaccine Preclinical
Immunotherapy
Key Programs (Indication) Phase
FUJOVEE™ (Abivertinib) Ph III
FUJOVEE™ (Abivertinib) Ph II
FUJOVEE™ (Abivertinib) Preclinical
PD-L1 (Socazolimab)* Ph III
PD-L1 (STI-3031)** Ph III
CD47 (Solid Tumors) Ph I
CD38 DAR-T (Multiple Myeloma) Ph I
CD38 ADC (Amyloidosis, Multiple Myeloma, T-ALL, and esophageal) Ph I
TROP2 ADC* (Solid Tumors) Ph I
Seprehvec™ oncolytic virus (Solid Tumors; CNS Tumors) PH I
BCMA ADC (Liquid Tumors) Preclinical
Bevacizumab-ADNAB™ (Endometrial Cancer) Ph I
Bevacizumab-ADNAB™ (Ovarian Cancer) Ph I
Rituximab-ADNAB™ (B-cell Lymphomas) Ph I
Sofusa® anti-PD-1 (Cutaneous T-Cell Lymphoma (CTCL), Melanoma) Ph I
Pain
Key Programs (Indication) Phase
ZTlido® 1.8% (Postherpetic Neuralgia - PHN) FDA Approval
Gloperba® 1.8% Treatment of Gout (Oral) FDA Approval
SEMDEXA (SP-102) Ph III
SP-103 (Lidocaine Topical System 5.4%) Ph II
SP-104 (Delayed Burst Low Dose Naltrexone) Preclinical
RTX (resiniferatoxin) Epidural injection Ph II
RTX (resiniferatoxin) Intra-articular route Ph II
Lymphatic Delivery
Key Programs (Indication) Phase II
Sofusa® anti-TNF (Autoimmune RA) Ph I
Sofusa® anti-PD-1 (Cutaneous T-Cell Lymphoma (CTCL), Melanoma) Ph I
Sofusa® anti-CTLA-4 (Melanoma) Ph I
I don't know the exact timeline. SEMDEXA, SOCAZOLIMAB, OVYDSO and ABIVERTINIB all have very large partnering potential IMO! So I am very hopeful!
Jess...I am not sure. At one time they owned 25%. It is really just the big potential programs , that at present are wholly owned , that interest me. SEMDEXA, SOCAZOLIMAB, OVYDSO and ABIVERTINIB all have very large partnering potential IMO!
5 CATALYSTS ... any time now!
1. OVYDSO (Mpro)
2. SOCAZOLIMAB
3. ABIVERTINIB
4. SEMDEXA
5. PSS SETTLEMENT
OVYDSO, SOCAZOLIMAB and ABIVERTINIB news could come from China at any time. ROW partnerships for each should be worth multi-billions (upfront, milestones and royalties). SEMDEXA is also a multi-billion asset. PSS may want to settle out of court...or battle on and pay more in a court imposed settlement! All the best to all faithful longs!
Nice. That is the TROP2 ADC listed in the Sorrento portfolio.
SORRENTO COVID,IMMUNOTHERAPY, PAIN AND LYMPHATIC DELIVERY PROGRAMS
COVID-19 PROGRAMS
Key Programs (Indication) Phase
COVISTIX™ (diagnostic) FDA EUA
COVIMARK™ (diagnostic) FDA EUA
VIREX (diagnostic) PH III
FUJOVEE™ (Abivertinib) Ph III
OQORY™ (COVI-MSC) Ph III
OVYDSO (Olgotrelvir) Ph II
Omicron mRNA Vaccine Preclinical
IMMUNOTHERAPY PROGRAMS
Key Programs (Indication) Phase
FUJOVEE™ (Abivertinib) Ph III
FUJOVEE™ (Abivertinib) Ph II
FUJOVEE™ (Abivertinib) Preclinical
PD-L1 (Socazolimab)* Ph III
PD-L1 (STI-3031)** Ph III
CD47 (Solid Tumors) Ph I
CD38 DAR-T (Multiple Myeloma) Ph I
CD38 ADC (Amyloidosis, Multiple Myeloma, T-ALL, and esophageal) Ph I
TROP2 ADC* (Solid Tumors) Ph I
Seprehvec™ oncolytic virus (Solid Tumors; CNS Tumors) PH I
BCMA ADC (Liquid Tumors) Preclinical
Bevacizumab-ADNAB™ (Endometrial Cancer) Ph I
Bevacizumab-ADNAB™ (Ovarian Cancer) Ph I
Rituximab-ADNAB™ (B-cell Lymphomas) Ph I
Sofusa® anti-PD-1 (Cutaneous T-Cell Lymphoma (CTCL), Melanoma
PAIN PROGRAMS
Key Programs (Indication) Phase
ZTlido® 1.8% (Postherpetic Neuralgia - PHN) FDA Approval
Gloperba® 1.8% Treatment of Gout (Oral) FDA Approval
SEMDEXA (SP-102) Ph III
SP-103 (Lidocaine Topical System 5.4%) Ph II
SP-104 (Delayed Burst Low Dose Naltrexone) Preclinical
RTX (resiniferatoxin) Epidural injection Ph II
RTX (resiniferatoxin) Intra-articular route Ph II
LYMPHATIC DELIVERY PROGRAM
Key Programs (Indication) Phase
Sofusa® anti-TNF (Autoimmune RA) Ph I
Sofusa® anti-PD-1 (Cutaneous T-Cell Lymphoma (CTCL), Melanoma) Ph I
Sofusa® anti-CTLA-4 (Melanoma) Ph I
Big Pharma need to refill their pipelines!
Astellas buys Iveric Bio for about $5.9 billion for opthalmology treatments.
Takeda bought Nimbus Therapeutics psoriasis unit for $6 billion in December.
Sorrento has at least 5 phase 3 drugs to spin off for multi-billions.
Abivertinib, 2 PD-L1's, Semdexa and Ovydso.
JUST ONE SALE OR PARTNERSHIP IS NEEDED!
I've been away on a 3 week cruise so I don't pretend to know much about what has gone on recently. So please correct me if my assumptions are wildly incorrect!
ASSUMPTIONS
Sorrento has about 600 million shares out.
Insiders hold about 1%
Institutions hold about 30%
Sorrento holds about 40-50% of Scilex
CATALYSTS(drugs other companies may want to partner or acquire)
1. SEMDEXA ph.3 complete USA
2. OVYDSO ph.3 CHINA
3. ABIVERTINIB ph.3 NDA CHINA
4. SOCAZOLIMAB ph.3 NDA CHINA
5. PSS settlement anytime pretrial (Following DOMINION/FOX settlement model)
6. Lymphatic drug delivery technology
Any of these partnerships or settlements could happen at any time!
Jess...several sources say Sorrento still holds 52% of Scilex.
Jess they have a big stake...many millions of shares... but I must admit I have not been following day by day. I am confident all is turning out very well. And in a few days I am going on an18 day cruise...and will not follow the market. So far I am in the money as I averaged down.
Lots of news coming in the next weeks IMO!
I wonder how the new FDA quidelines might affect Sorrento's cancer portfolio?
FDA spells out how cancer drug developers can use one trial for both accelerated and full approvals
Zachary Brennan, Senior Editor Endpoints
"The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.
While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.
OCE officials discussed this concept of a single trial in the NEJM last October, explaining: “AA could be granted on the basis of a planned interim analysis of overall response rate, and traditional approval granted on the basis of clinical benefit (usually improvement in overall survival) at the trial’s conclusion.”
But the design of that trial must be precise as FDA says in today’s draft guidance that it must be “powered for the longer-term clinical endpoint with follow-up in the same trial to verify clinical benefit,” and should ensure that the accelerated nod doesn’t inadvertently introduce bias.
So what are the benefits of such an approach? FDA points to “a more thorough safety assessment and earlier definitive evidence of the benefit–risk balance,” as well as reducing the risk of halting the drug’s development too early, or one with a limited overall response rate that may end up as an OS improvement. Moreover, the randomized trial could be conducted in patients in an earlier treatment setting, the draft adds, so the drug would reach more patients in whom efficacy might be greater.
As far as logistics, the draft notes, “The trial sample size should be chosen so that it has adequate power to detect a clinically meaningful and statistically significant improvement in both the endpoints for accelerated approval (e.g., response rate) and verification of clinical benefit (e.g., PFS or OS).”
Because the treatment landscape for cancer is constantly in flux, FDA explains that sponsors should discuss any updates with the agency, which could lead to deferred accelerated submissions until the results for a traditional approval are available. That may be a sticking point for industry, which if they run one trial and a confirmatory follow-up, can make money on the AA while the follow-up trial is ongoing.
FDA also makes clear, as with the passage of the omnibus at the end of last year stipulated, that the agency may “require, as appropriate, that studies intended to verify clinical benefit be underway prior to approval, or within a specified time period after the date of approval, of the applicable product.”
Such confirmatory trials must be carried out with “due diligence,” the agency notes, as the OCE officials previously explained in the NEJM how the median time for oncology accelerated approvals to either confirm benefit or fail was longer if the confirmatory trial was initiated after the approval. The guidance also does not discuss the expedited ways in which FDA can pull AAs if they fail those confirmatory trials, which was also included in the omnibus."
NEXT 1-5 MONTHS = 5 CATALYSTS
1. SEMDEXA
2. SOCAZOLIMAB
3. ABIVERTINIB
4. OVYDSO
5. PSS SETTLEMENT
Each catalyst has blockbuster potential. And each could come next month or 5 months from now!
Interesting times!
THE ACTION ON OVYDSO IN CHINA HAS BEEN VERY RAPID!
JAN 9. Following a successful Australian safety study in healthy volunteers Sorrento announced the very positive results from a phase 1b trial of OVYDSO in Covid patients in China. They stated that they had applied to Chinese authorities for a phase 3 pivotal trial in 1200 patients.
FEB. 2. Sorrento announced that the first patient had been dosed in a 1200 patient phase 3 trial to be conducted in 40 centers in China.
THIS IS VERY RAPID ACTION!
This trial should enroll very rapidly and results could be available as early as May IMO!
What is Next?
" “We are excited to see the similarities of PK in the China study and the Australian study. The significant antiviral effectiveness and tolerability of OVYDSO in COVID patients suggests this compound will significantly benefit patients and will require no boosting with Ritonavir. We expect to initiate the Phase 3 trial very soon in China(done!), and meanwhile we are engaging with regulatory agencies on a global Phase 2/3 trial design in order to initiate OVYDSO Phase 2/3 trials in Mexico and the U.S. as soon as possible,” stated Henry Ji, Ph.D., Chairman and CEO of Sorrento."
China first, followed by Mexico and the US, will open up an enormous Global market for a safer and far cheaper oral anti-viral to combat Covid.
WHAT ARE SCILEX AND SORRENTO NEAR TERM SHARE PRICE MOVERS?
I'm glad to have some SCILEX shares because SEMDEXA, ZTlido, Gloperba (gout), EYYXYB (migraine) and SP-103 (lower back pain) all look like winners to me. And the sales force is already in place! And world-wide partnerships are coming!
But my main interest is in SORRENTO! They hold a majority interest in SCILEX so will benefit from SCILEX's success! But they also have ABIVERTINIB and SOCAZOLIMAB which look to be approved in the big Chinese market this year. They also have a potential multi-blockbuster in the oral anti-viral OVYDSO which China moved from a phase 1b trial directly into a pivotal phase 3 trial! This trial is obviously fast-tracked as the first phase 3 patient was dosed Feb.7! And might China also be interested in Sorrento's second generation mRNA vaccine? These also are all partnerable! And I must admit I would not be surprised to hear some good news about the SOFUSA, RTX, VIREX and DAR-T programs! And I like Sorrento's chances in the upcoming PSS trial!
There is a lot of news coming in 2023. Much of it in the next few months IMO.I don't know of another small biotech with so many potential blockbusters!
Here is more information on the trial in China. First patient was dosed Feb.2 2023 and the trial will be completed in a few months! Ignore the completion dates...1200 patients in 40 hospitals will recruit rapidly!
https://www.clinicaltrials.gov/ct2/show/NCT05716425
OVYDSO (oral anti-viral) phase 3 trial began dosing in China Feb.2 2003! Summary...
"40 trial centers with an avg. 30 patients per center. Trial is double blinded, 50/50 Mpro v. placebo, 600 patients get Mpro and 600 get a placebo. Dosing 2x day for 5 days + 24 days follow up (+29Days from day 1). Trial could be completed rapidly ..." Pfizer drug(with liver and drug/drug interaction problems) with very high cost(subsidized by Western governments) earned $20+ Billion last year!
Others have discussed the various financial possibilities. I always think about the portfolios of SCILEX and SORRENTO. Don't you think some BP's might want to partner or BO both SCILEX and SORRENTO? In fact isn't a bidding war likely? Might Izzy know this and want in on the gains?
SCILEX has ZTlido (lidocaine patch), SEMDEXA (sciatica injection), GLOPERBA (gout) , ELYXYB (liquid for migraine) and SP-103 ( lower back pain).They indicate a Global Opportunity of over $40 Billion.
SORRENTO has 3 blockbusters in phase three...ABIVERTINIB (NSCLC and Prostate cancer)SOCAZOLIMAB (anti-PDL-1)and OVYDSO (oral anti-viral).These have another Global Opportunity of well over another $40 Billion.
There will be news about approvals, marketing initiation and partnerships or BO for both portfolios in the coming 3-6 months IMO. Everyone must make their own decision...but I am a buyer.
Others have discussed the various financial possibilities. I always think about the portfolios of SCILEX and SORRENTO.
SCILEX has ZTlido (lidocaine patch), SEMDEXA (sciatica injection), GLOPERBA (gout) , ELYXYB (liquid for migraine) and SP-103 ( lower back pain).They indicate a Global Opportunity of over $40 Billion.
SORRENTO has 3 blockbusters in phase three...ABIVERTINIB (NSCLC and Prostate cancer)SOCAZOLIMAB (anti-PDL-1)and OVYDSO (oral anti-viral).These have another Global Opportunity of well over another $40 Billion.
There will be news about approvals, marketing initiation and partnerships for both portfolios in the coming 3-6 months IMO. Everyone must make their own decision...but I am a buyer.
Both Sorrento and Scilex have very strong portfolios with great promise IMO! One or two partnerships would change everything. Will they happen ?
New Scilex product.
I like SCILEX but I love SORRENTO!
The SCILEX share dividend issues will be resolved! I'm glad to have some SCILEX shares because SEMDEXA, ZTlido, Gloperba (gout) and SP-103 (lower back pain) all look like winners to me. And world-wide partnerships are coming!
But my main interest is in SORRENTO! They hold a majority interest in SCILEX so will benefit from SCILEX's success! But they also have ABIVERTINIB and SOCAZOLIMAB which look to be approved in the big Chinese market this year. They also have a potential multi-blockbuster in the oral anti-viral OVYDSO which China moved from a phase 1b trial directly into a pivotal phase 3 trial! And might China also be interested in Sorrento's second generation mRNA vaccine? These are all partnerable! And I must admit I would not be surprised to hear some good news about the SOFUSA, RTX, VIREX and DAR-T programs!
There is a lot of news coming in 2023. I don't know of another small biotech with so many potential blockbusters!
COVIDROPS could not treat variants! But ABIVERTINIB, SOCAZOLIMAB and OVYDSO in China look good!
And SEMDEXA in US. All in 2023. All are highly partnerable world-wide for big upfront, milestone and royalty payments.
OVYDSO does more and faster than COVIDROPS and has huge market potential.
In fact all 4 have very large (multibillion!) potential. HAPPY 2023!
SCILEX and SORRENTO look good!
SCILEX already has a US wide sales force in place...so new products will advance rapidly. And World-wide partnerships can be added to target $40+ billion in sales targets. Here is how SCILEX outlines their portfolio.
"Scilex Holding Company (Nasdaq: SCLX, “Scilex”), majority-owned by Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain
The company’s lead product ZTlido® (lidocaine topical system) 1.8%, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with Post-Herpetic Neuralgia (PHN), which is a form of post-shingles nerve pain. Scilex in-licensed the exclusive right to commercialize Gloperba® (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex is planning to commercialize Gloperba® in 2023 and is well-positioned to market and distribute the product.
Scilex’s three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status. If approved by the FDA, the company expects SP-102 to be the first FDA-approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica, with the potential to replace 12 million off-label epidural steroid injections administered each year in the US. SP-103 (lidocaine topical system) 5.4%, a triple strength formulation of ZTlido®, for the treatment of low back pain, with FDA Fast Track status. SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia."
SORRENTO owns 54% of SCILEX (and SORRENTO shareholders as dividend holders hold a huge chunk!) as well as Phase 3 cancer drugs ABIVERTINIB, SOCAZOLIMAB and STI-3031 and the exciting oral antiviral OVYDSO entering Phase 3 in China and Phase 2/3 in Mexico and the US.
Clearly SORRENTO is a Worldwide Partnership or Buy-out candidate!
Hi Jess...Yes I think someone said 54% ownership by Sorrento.
Paul Snowman points out that the strange Seeking Alpha article ignores SEMDEXA news!
The latest Seeking Alpha Alpha article mentions that Scilex "has a pipeline" but goes on to ignore the impact of advances in that pipeline!
It ignores the advance of SEMDEXA.
It ignores the advance of GLOPERBA.
It ignores the advance of SP-103.
It ignores the advance of SP-104.
There is news coming on all four programs this year. Scilex says the Global opportunity of these programs exceeds $40 Billion! The advance of these programs and world-wide partnering opportunities are what will drive the share price of Scilex. SEMDEXA has completed phase 3 and has Fast Track. SP-103 is Phase 3 ready and has Fast Track. And GLOPERBA has Marketing approval and will hit the market any day now! IT IS ADVANCES IN THE PIPELINE THAT WILL DRIVE THE SHARE PRICE!
On Jan.16 Sorrento advertised for two scientists for it's 50% owned Cytimm Therapeutics. What are they up to? The latest information I could find was a presentation made by their Co-founder and CSO Haining Huang in March 2022...as follows.
CTM101, Next Generation IL-2Rß? Selective IL-2
Derivative for Cancer Therapy
• Site-specific PEGylation of IL2 without affecting its function
• Complete abolished alpha activity led to better CD8 activation with minimum toxicity
• CHO cell manufacturing gave good yield with high stability and low aggregation
Haining Huang, Chief Scientific Officer, Cytimm Therapeutics, Inc.
Dr. Huang was formerly employed as a Scientist at Sorrento. If they are hiring two scientists something must going right! Another arrow in the Sorrento quiver!
Winston Churchill's quotation, made in a radio broadcast in October 1939:
"I cannot forecast to you the action of Russia. It is a riddle, wrapped in a mystery, inside an enigma; but perhaps there is a key. That key is Russian national interest."
That was certainly true of Russia in 1939...and it is true today! And it is certainly true of China!
That is why Sorrento could have a very interesting year in China.
If it is in China's national interest there could certainly be approval of ABIVERTINIB and SOCAZOLIMAB in several cancer indications.
But right now China has a very great national interest to control Covid19! The Chinese have refused to pay high prices for Pfizer anti-virals but have moved Sorrento's antiviral OVYDSO from a 1b trial directly into a phase 3 trial! Might they also be interested in some Sorrrento tests? Or how about Sorrento's second generation mRNA vaccine? Their own vaccines have been relatively ineffective. Could Sorrento provide a more effective and safer alternative...AND advance it first in China just as they are doing with OVYDSO? China likes things developed in China! It is in their national interest!
Year of the Cat in Vietnam...and in my house! Year of Rabbit in China!
Vietnamese Year of Cat begins Jan.22...every year is Year of Cat in my home...it is ruled by my black cat Tommy!
In China it is Year of the Rabbit. Or for Sorrento investors Year of the Wealthy Rabbit!
Sorrento could receive Chinese approvals for ABIVERTINIB, SOCAZOLIMAB and OVYDSO in 2023!
And SCILEX could receive US approval and marketing for SEMDEXA(sciatica), GLOPERBA(gout) and SP-103(lower back pain)...3 very large indications.
And all 6 of these products could lead to world-wide partnerships! 2023 Year of Fat Rabbit for Sorrento investors?
I am a value investor. SORRENTO has a very large portfolio. I estimate that the top 3 products could produce a combined revenue in excess of $35 billion. All 3 are in phase 3 and could receive approval this year.
ABIVERTINIB
2 PD-L1's
OVYDSO oral antiviral
SCILEX has a smaller portfolio. However I estimate the top 3 products could produce a combined revenue in excess of another $35 billion.
GLOPERBA gout market approved
SEMDEXA sciatica phase 3 completed. Fast track.
SP-103 lower back pain phase 2 completed, Fast track.
Both SORRENTO and SCILEX intend to partner for World-wide markets. I expect large upfront, milestone and royalty payments. A lot of news to come in 2023!
On the other hand , it might not be chance. Many treated with 2-73 would be getting better, thinking more clearly, and thereby avoiding falls! Placebo patients were steadily getting worse, more fragile. It makes sense.
Falls can be serious. Interesting that those on placebo had a higher rate of falls than those on drug. And dosing at bed time makes sense as does extended release to level out the dose curve. The patent granted in November 2022 is really interesting. This recent Patent issued by the USPTO "for composition of matter of Anavex 2-73 Blarcamesine A2-73 crystalline polymorph compositions of matter and methods of use thereof" discusses EXTENDED RELEASE (1 to 7 days or more) and a TRANSDERMAL PATCH (1 day to 1 month or more).
I don't have them yet. But I won't be selling until we get SEMDEXA, GLOPERBA, SP-103 and Global partnership news. So I'm not anxious.