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The Federal Register NuScale link:
https://www.federalregister.gov/documents/2023/08/04/2023-16679/nuscale-power-llc
Medium/Long Term Investment
Thank you Thermo for your (usual!) well-articulated and written response.
One thought I had was that with an FDA approved Lytenava, OTLK sales can argue that in case of any incident with off-label bevacizumab, the risk of liability and lawsuit against the ophthalmologist could increase.
"A great return from here doesn't require very much market share." Indeed. And the possibility of a buyout post approval can't be ignored.
Thanks again Thermo! (And really, no need to apologize. I appreciate your conduct, even when interacting with small retailers like me. And I did see the flurry of posts on NWBO addressed to you. )
Kind regards and best of luck with your investments!
Hi Thermo,
Thank you. Looking forward to your response!
I did post my inquiry on the OTLK board. (I do check the NWBO board but I don't post on it any more; Too many bashers. )
22 days until FDA decision.
Best of luck with your investments!
LWA Submittal, an SMR First
https://www.powermag.com/two-big-nuclear-regulatory-milestones-for-idaho-nuscale-smr-project/
CFPP LLC—the entity UAMPS established to develop, build, and operate the first-of-a-kind SMR project at an INL site in Idaho Falls, Idaho—on Monday confirmed the project is still targeting an end-of-year 2029 commercial operation date. The company’s submittal of an LWA as the project’s first part of its COLA marks an “imperative” milestone, noted Mason Baker, CFPP LLC president. When approved, the LWA could “pave the way for the initiation of early-scope construction which is expected to start mid-2025,” CFPP said
“Commencing with construction activities allows for progress to continue on the CFPP site prior to the full authorization granted in the COL,” Baker explained on Monday. “It also marks a significant milestone as a major CFPP submittal to the NRC, and more broadly, the first application to the NRC for construction of a full-scale, commercial SMR.”
CFPP began work on its COLA in August 2021 with backing from engineering firm Fluor and NuScale. For now, it plans to submit the second part of the CFPP COLA in January 2024. If the NRC approves the COLA, construction of the project could begin in 2026, with the first VOYGR-6 module scheduled to be in service by December 2029. All modules are slated to be in service by November 2030.
CFPP, however, continues to grapple with the tough task of signing up project participants—subscribers who could eventually offtake portions of the project’s power. As of March 2023, 26 project participants lodged financial commitments to continue the CFPP in February, clearing the project’s second “off-ramp,” which was triggered by a Class 3 project cost estimate put forth by CFPP contractors Fluor and NuScale in December 2022. The entity confirmed to POWER no changes have occurred since March.
However, CFPP and NuScale continue to implement a subscription plan that includes several collaborative efforts to boost subscription levels to 370 MW—or about 80% of the project’s capacity—over the next six months, or at least by the time the full COLA is submitted to the NRC.
CFPP in March noted that while the current subscription represents just 26% of the CFPP’s gross 426-MWe, it marked an “overwhelming approval,” which was especially notable because NuScale and Fluor’s Class 3 project cost estimate failed to reach its levelized cost of electricity (LCOE) price target of $58/MWh (in 2020 dollars).
Under Fluor’s Class 3 estimations, the total CFPP project cost—which factors in updated owner’s costs, interest rate assumptions, the cost of acquisition and construction, and operating and maintenance costs—now hover at $9.24 billion. CFPP expects, however, that a 2020 cost-sharing agreement with the DOE will furnish the project with another $1.4 billion. Along with $9 million of prior cost-sharing payments from NuScale, that could reduce total costs to $7.972 billion. Further cost reductions could meanwhile come from the August 2022–enacted Inflation Reduction Act (IRA), it suggested. A preliminary CFPP analysis indicates that the project could reap about $2.8 billion in benefits, which could reduce net project costs to $5.1 billion.
In December 2022, meanwhile, as required by its Development Cost Reimbursement Agreement (DCRA) with CFPP, NuScale unveiled the results of an economic competitiveness test (ECT) to determine project LCOE. Factoring in findings from the Class 3 estimates, the DOE cost-sharing payments, estimated IRA benefits, and the owner’s cost estimate, NuScale projected LCOE had soared to $89/MWh (in July 2022 dollars).
29-1=28. 28 days to FDA decision!
Reminds me of that ideal gas law, PV=nRT. Well, if the pressure increases as it gets closer to the PDUFA date, like compressed like air, the PPS could behave like T :) (One can dream a little).
Anyways, whatever the decision, we will know before the end of the month. The likelihood of a complete response letter (CRL) is very low at this late in the game and getting lower every day. The likelihood of approval is very high, but never 100%.
Best of luck with your investments!
USNRC Accepts SMR SDA Application!
That's some real news!
Updated design will support a wider range of customers seeking clean energy through small modular nuclear reactors
PORTLAND, Ore. – NuScale Power Corporation (NYSE: SMR) today announced the U.S. Nuclear Regulatory Commission (NRC) accepted its Standard Design Approval (SDA) Application for formal review. After beginning the technical review of NuScale’s application in March 2023, the NRC has docketed the application for NuScale’s VOYGR™-6 plant design featuring an uprated 77 MWe small modular nuclear reactor (SMR), which will support capacity requirements for a wider range of customers. The NRC provided a 24-month review schedule for approval, which will align with the timing needs of NuScale’s U.S. customers.
Russel and Kevin in the same panel. Will they "talk"?
One can only guess. What incentive do OTLK C-suite have again :) ? Remember this post?
* https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167601827
OK, enough fun guesses!
Best of luck with your investments!
Reliability Threats & SMR Benefits
“NuScale Power’s VOYGR™ small modular reactor power plant features a wide variety of attributes well suited to provide reliable, carbon-free energy, even during extreme weather events,” John Hopkins, NuScale’s president and CEO, said via email.
https://www.publicpower.org/periodical/article/rising-reliability-threats-underscore-benefits-small-modular-reactors
As the threats to the resilience and reliability of the electric power grid caused by extreme weather events rise, the advantages of small modular reactors are becoming more apparent.
Those threats were underscored last month when a prolonged heat wave and deadly storms knocked out power for hundreds of millions of people in an area of the South stretching from Texas to Mississippi.
Those outages, unfortunately, are part of a wider trend. The average annual number of weather-related power outages increased by roughly 78 percent during 2011-2021, compared with 2000-2010, according to a 2022 report from Climate Central. Between 2000 and 2021, the report found, about 83 percent of reported major outages in the United States were attributed to weather-related events.
Power outages are not just an inconvenience, they are also costly, particularly for commercial and industrial customers. In a 2017 report, Lawrence Berkeley National Laboratory estimated that power interruptions cost $59 billion per year, an increase of more than 68 percent since its initial 2004 study. The study also showed that 13 percent of customers in the commercial and industrial classes accounted for more than 97 percent of the costs incurred by the outages.
Recognizing the need to protect critical federal facilities from even momentary interruptions of electric power, the Department of Energy in 2018 recommended federal facilities explore the development of small modular reactors.
“NuScale Power’s VOYGR™ small modular reactor power plant features a wide variety of attributes well suited to provide reliable, carbon-free energy, even during extreme weather events,” John Hopkins, NuScale’s president and CEO, said via email.
Those attributes include fuel security, flexibility, operational security, and independent operation. Small modular reactors, for example, can store up to two years’ worth of fuel on-site, allowing them to generate power when extreme events disrupt supplies of gas or coal to thermal generators. And, unlike large, traditional nuclear plants that must run at nearly full capacity around the clock, some small modular reactors, such as NuScale Power’s, have the flexibility to vary their output over days, hours and even minutes, allowing them to respond quickly to grid conditions.
In addition, at a time when regulators and grid operators are looking for ways to bolster resiliency, NuScale’s SMR design offers several advantages for reliable grid operation. NuScale’s SMR design has black start capability, meaning it can generate power from a cold start without an external grid connection.
NuScale’s VOYGR SMR plant design includes two backup generators that have the ability to start one SMR. Once a single module is running, it can supply the electrical power to start up the rest of the plant.
NuScale’s SMR design is unique in that it is the only design certified by the U.S. Nuclear Regulatory Commission (NRC) that does not require class 1E power, a safety standard for electrical equipment and systems that are essential to emergency reactor shutdown, containment isolation, reactor core cooling, and containment and reactor heat removal.
NuScale’s design also includes a unique passive safety system that does not require operator or computer actions to implement safety procedures in the event there is a total loss of power to the plant.
A VOYGR plant may include up to 12 power modules. Each incorporates a reactor pressure vessel, which includes the nuclear core, steam generator, and pressurizer, and a containment vessel that surrounds the reactor vessel.
During normal operation, each containment vessel is fully immersed in a water-filled, underground stainless steel-lined concrete pool. The pool is housed in a Seismic Category I building, a Nuclear Regulatory Commission standard for structures that can withstand maximum potential earthquake stresses, making it capable of withstanding a Fukushima type earthquake, as well as hurricanes and tornados.
The pool is large enough to provide 30 days of core and containment cooling without adding water. After 30 days, the core decay heat generation is so small that the natural convection heat transfer to air at the outside surface of the containment, coupled with thermal radiation heat transfer, is sufficient to remove the core decay heat for an unlimited period.
Even in the face of more malicious threats, a VOYGR plant is armed with safety features that could make it a key asset in a time of emergency. A NuScale nuclear plant is also resistant to an electromagnetic pulse event that could cripple more conventional generation assets on the electrical grid.
With its passive shut-down capability, ability to operate in steam bypass mode, its electrical isolation of safety equipment, and its multi-layered shielding and redundant fiber optic cabling, NuScale’s VOYGR SMR power plant design is still able to perform and even shut down safely even when the electric grid is crippled.
The combination of those attributes also gives a NuScale Power Module™, the company’s trademark SMR design, the ability to operate in island mode during an outage or an emergency, that is, a single SMR could supply all the electricity needs of the plant while continuing to provide power to a mission critical facility without external grid connection via a micro-grid connection.
“NuScale SMR design can support microgrid or remote installations for customers anywhere grid stability is less than desirable or nonexistent,” Hopkins said.
The ability to operate in isolation from the grid, also gives NuScale’s VOYGR™ power plants first responder status. When the transmission system goes down and a conventional nuclear plant loses its external power, it is designed to automatically shut down. A VOYGR plant, however, would remain online, ready to provide electricity to the grid when the transmission system comes back online.
In a scenario in which a catastrophe resulted in the loss of the electric grid and of transportation infrastructure, NuScale said its 12-module plant design would be able to provide 154 megawatts of electricity for 12 years to a microgrid of a mission-critical facility without the need for new fuel.
And even when refueling becomes necessary, NuScale’s scalable plant design permits staggered refueling of a single module while the other 11 modules continue providing 92 percent of the facility’s electrical output.
“In short, NuScale’s SMR design has fewer and simpler systems, resulting in enhancements to safety and resilience compared to traditional large nuclear plants,” Hopkins said.
“As energy demands rise, it makes sense that utilities, regulators and policymakers are looking closely at the unique features NuScale SMRs can provide to increase and safeguard the reliability of the electric grid,” Hopkins said.
Trenary at OIS Innovation Showcase at 8:35 AM PT, Seattle on July 27th
https://ois.net/ois-retina-agenda-2023/
Best of luck with your investments!
Bought another slice at $1.67
Best of luck with your investments!
MOUs, Poland, Korea
Korean, Polish construction firms team up for nuclear projects
17 July 2023
KGHM noted that one of the "important projects that will bring the company closer to achieving energy independence" is the deployment of SMR technology. In February 2022, KGHM signed a definitive agreement with NuScale Power of the USA to initiate work towards deploying a first NuScale VOYGR SMR power plant in Poland as early as 2029. It said NuScale's reactor design is based on the well-known concept of pressurised light water reactors, while its modular, integrated design allows for the simplification and shortening of the investment and construction process.
Last week,Poland's Ministry of Climate and Environment issued a decision-in-principle to KGHM on the construction of a power plant based on NuScale Power's SMR technology. The decision-in-principle is a general opinion on selected conditions enabling the construction of a NuScale VOYGR modular nuclear power plant with a capacity of 462 MWe consisting of six modules, each with a capacity of 77 MWe. The decision represents official state approval for the planned investment in accordance with the assumptions and concept presented by the company.
Hi rdneum,
A bit further down the PR, CVM evokes the possibility to have a conditional approval followed by confirmatory studies after approval for Britain & Europe. For the FDA, it's clearly a requirement prior to approval. Canada may be different and could be approved without additional data.
A confirmatory clinical trial will be required by the FDA based on the agreed upon selection criteria for patients that will be treated with Multikine as assessed by methods including PET-CT/MRI screening. We will collaborate closely with the FDA to design a clinical protocol that will allow us to generate, as expeditiously as possible, the confirmatory data they require for approval of Multikine. This includes confirming the pre-surgical tumor responses that arise within just weeks of Multikine treatment in the agreed upon population.
Our meeting with Health Canada earlier this year was also positive, and we are preparing our application for the NOCC approval as they suggested, which we hope to file later this year/early next year.
Our planned meetings with the MHRA in Britain and the EMA in Europe will help us understand if a conditional approval can be given in those countries with a promise to do confirmatory studies after approval or if it is possible to get a conditional approval with the enrollment of just a small number of patients. Our goal is to obtain approval of Multikine worldwide and then make it available to patients as fast as possible
Ouch!
weaker than expected global demand for capital equipment; clinical trial start delays; and slower than expected ramps from certain clients
Second quarter revenue expected in the range of $56.5 - $57.5 million
Full year 2023 revenue now expected in the range of $233 - $243 million
Trial Results Reminder
The NORSE TWO Phase 3 pivotal trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. NORSE TWO was a superiority trial comparing the safety and efficacy of ONS-5010 ophthalmic bevacizumab dosed monthly against ranibizumab (LUCENTIS®) dosed according to the PIER regimen in the Lucentis labeling. Participants in the trial were treated for 12 months, with the primary endpoint at Month 11 being the difference in proportion of patients who gained at least 15 letters (3 lines) in best corrected visual acuity (BCVA). The key secondary endpoint was the mean change in BCVA from baseline to Month 11. NORSE TWO data showed a strong safety profile, results consistent with previously reported safety data for ONS-5010, and similar to safety levels reported in prior research for bevacizumab used off-label in ophthalmology.
The NORSE TWO pivotal data met both primary and secondary endpoints with statistically significant and clinically relevant results:
41.7% (p = 0.0052) ONS-5010 subjects gained ≥ 15 letters of vision
56.5% (p = 0.0016) ONS-5010 subjects gained ≥ 10 letters of vision
68.5% (p = 0.0116) ONS-5010 subjects gained ≥ 5 letters of vision
ONS-5010 subjects gained 11.2 letters (p = 0.0043) in BCVA
Results from NORSE TWO also demonstrated that ONS-5010 ophthalmic bevacizumab has a strong safety profile. In findings that are consistent with historical bevacizumab data reported in prior research, in all three ONS-5010 registration trials there was only one ocular inflammatory adverse event, which was treated topically and resolved without sequelae. The safety findings continue to support minimal ocular inflammation and safety signals consistent with what was previously reported in the 2011 CATT trial (National Eye Institute) and other large bevacizumab-controlled ophthalmic studies.
July, August! 55 calendar days.
the next couple months should be interesting for the PPS. And of course, with (hopefully) a positive PDUFA outcome would make it even more interesting. I place approval's chances as high as any biotech I've been following. Always the possibility for a negative outcome, but for Outlook, that perspective seems quite remote.
Best of luck with your investments!
New Bullish SA Article
https://seekingalpha.com/article/4615166-cryoport-cyrx-strong-player-cold-chain-logistics-solid-growth-prospects
I remain bullish on CYRX due to its dominant position in cold-chain logistics, comprehensive range of services, significant growth potential, and capable management team. As the field of cell and gene therapy experiences more regulatory filings and approvals, CYRX is well-positioned to benefit from the overall industry growth. Additionally, CYRX can leverage its existing cryogenic offerings by pursuing strategic mergers and acquisitions in the cold-chain solutions space. I view the stock as a buy and have an end-of-year price target of $25 on the stock.
Hi Thermo,
I'm trying to reconcile two elements that seem contradictory on the surface. I was wondering if you would enlighten me. I did send IR a question about the legal enforcement around compound pharmacies continuing post approval but I did not get any reply.
The two elements:
1. It seems that legally, compound pharmacies would not be able to continue providing doctors with repackaged beva:
https://ir.outlooktherapeutics.com/static-files/b4e4a969-af03-4f17-9680-882c1c84239d
Feb 2022 presentation:
Slide 11 : " Once a drug or biologic is FDA approved and commercially available compounding is no longer authorized.2,3,4,5" (more on that slide)
Slide 31: " Initial U.S. target segment worth potentially billions in yearly revenue are served by compounding pharmacies which by law should give way to Outlook Therapeutics’ ONS 5010, if FDA approved"
2. However, the 12/29/2022 filing competitive landscape includes compound pharmacies
https://www.annualreports.com/HostedData/AnnualReports/PDF/NASDAQ_OTLK_2022.pdf
Competitive Landscape
Off-label use of bevacizumab (Avastin) is estimated to be approximately 50% of the overall market in the United States. The current FDA approved market leaders for the treatment of wet AMD are VEGF inhibitors, including EYLEA, BEOVU, LUCENTIS, SUSVIMO and VABYSMO.
Thank you Thermo for sharing your thoughts, always appreciated!
I do not have your experience in these matters and where a company's vulnerability lies definitely helps get the full story.
Best of luck with your investments!
Compounding Pharmacies Article: Additional Context for the OTLK Story
https://www.nbcnews.com/health/health-news/ozempic-wegovy-weight-loss-compounded-crackdowns-rcna82405
[...]
“Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” the agency said. “Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs.”
Compounding is sometimes allowed in pharmacies during drug shortages, according to the FDA. However, those drugs have not met certain standards under the U.S. Federal Food Drug and Cosmetic Act, said the agency.
[...]
The FDA said it has received “adverse event reports” after patients received compounded versions of semaglutide. It then warned that “patients should not use a compounded drug if an approved drug is available to treat a patients” and that “patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.”
Furthermore, “Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards,” said the notice.
Officials in states like Louisiana, Mississippi, North Carolina, and West Virginia have threatened to take action against pharmacies that make compounded, unauthorized versions of Ozempic and Wegovy, according to reports.
“The Board is charged with protecting the public,” said the West Virginia Board of Pharmacy, a body that oversees pharmacies in the state, said in an April 21 statement. “Therefore, compounding semaglutide drug products in a way that fails to conform with governing law may lead to enforcement action.”
This represents approximately 3.5 million injections of off-label, repackaged bevacizumab each year in the United States alone.
June. July, August! 89 days.
In less than three months, we'll know if the FDA approved ONS-5010 / LYTENAVA™ (bevacizumab-vikg). It looks straightforward, especially given the more creative, interesting, far-fetched BLAs, NDAs the FDA deals with on a regular basis. Then again, it's not approved yet.
Best of luck with your investments!
Hi Thermo,
Thanks for sharing your thoughts and I do appreciate them :) !
If I may, I am not seeing H.C.W. shorting OTLK. The reason for this is their Buy Recommendation date May 16h, 2023:
As of May 11, 2023, the average one-year price target for Outlook Therapeutics is 6.74. The forecasts range from a low of 4.04 to a high of $10.50. The average price target represents an increase of 461.60% from its latest reported closing price of 1.20.
M.S. Howells & Co. acted as placement agent with respect to certain accredited investors in the offering. BTIG, LLC acted as exclusive financial advisor to Outlook Therapeutics in connection with the offering. BTIG, LLC is not acting as an underwriter or a placement agent in connection with the offering and, accordingly, BTIG, LLC is neither purchasing securities nor offering securities to the public in connection with the offering.
Starting to take off already? 24% in less than 2 days...
Could be a spasm, could be a start. I was expecting things to heat up in July and August, maybe it will start earlier. With the potential run-way from an MC at $400M (as of now) to 'a-hell-of-a-lot-higher', it could start now too, and continue/soften by August. Always fun to watch.
Best of luck with your investments!
Today's Market Cap $344M
(typo in earlier post).
Best of luck in your investments!
101 days to PDUFA, Aug. 29. 2023
It would not be surprising if, leading to the PDUFA, July and August were hot :)
Best of luck with your investments!
Off-Label Avastin Injection, First Target
According to GlobalData, the use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year.
This represents approximately 3.5 million injections of off-label, repackaged bevacizumab each year in the United States alone.
Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.
Bought another slice at $1.20
May, June, July, August... It's going to be upon us before long.
Best of luck with your investments!
Nucor/NuScale MOU
https://www.nuscalepower.com/en/news/press-releases/2023/nuscale-and-nucor-sign-mou-to-explore-using-smrs-to-power-electric-arc-furnace-steel-mills
Continuing to fill the sales pipeline.
Best of luck with your investments!
Pricing Space from latest Presentation:
The $500-$1000 space is wide open.
See VMLG17's post
"Vabysmo reduced dosing even further, to once every four months. Its annual list price of $6,570 during that maintenance phase, or $2,190 a shot, is competitive with Lucentis biosimilars, which cost around $1,000 a shot. Eylea biosimilars are expected to enter sometime this year or next."
Pre-launch activities, PDUFA August 29, 2023, just three short months away.
These initiatives are focused on positioning Outlook Therapeutics as an upcoming leader in the anti-VEGF space by meeting FDA requirements for an ophthalmic approval. The ONS-5010 Biologics License Application (BLA) was submitted and accepted for filing by the FDA as a 351(a) stand-alone BLA. We believe ONS-5010, if approved, has the potential to be the standard of care in the retinal anti-VEGF space and look forward to potentially bringing to market the first FDA-approved ophthalmic formulation of bevacizumab,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics.
Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023;
PDUFA goal date of August 29, 2023;
Continued evaluation of ONS-5010 in a pre-filled syringe in the NORSE SEVEN clinical trial; and
Estimated decision date from the EMA’s CHMP on the Company’s submitted MAA in the EU for ONS-5010 expected in early 2024.
Commercial Planning Underway to Support Potential Approval of the First Ophthalmic Formulation of Bevacizumab for Use in Retinal Indications
According to GlobalData, the use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year. This represents approximately 3.5 million injections of off-label, repackaged bevacizumab each year in the United States alone. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.
Because patients, physicians and payors rely heavily on bevacizumab as an important option for treating wet AMD, ONS-5010 has been developed to address the potential potency and safety issues that have been reported to be associated with using off-label, repackaged bevacizumab from compounding pharmacies, including:
As reported in a study published in JAMA, 81% of all tested syringes of repackaged bevacizumab received from compounding pharmacies contained suboptimal protein concentrations, which could result in lower clinical efficacy.
Non-standard materials used to transfer and hold repackaged bevacizumab can potentially add particulates to non-ophthalmic-designed bevacizumab, which in turn may fail to meet the standards FDA requires for ophthalmic compounds.
In August 2022, Outlook Therapeutics submitted a PHSA 351(a) BLA for ONS-5010 as a standalone biologic to potentially become the only approved ophthalmic formulation of bevacizumab. ONS-5010, if approved, cannot qualify as a biosimilar because the PHSA requires a biosimilar to have the same “conditions of use” (e.g., indications) as a reference product. AVASTIN, the currently marketed non-ophthalmic formulation of bevacizumab, is not approved by FDA for the treatment of wet AMD or other retinal diseases.
Particulate Matter & Ophthalmic Standards
I don't remember seeing this slide before. Another strong point for OTLK's approval.
1. High standards
2. Monoclonal Antibody Shearing/Fragmentation During the Repackaging Process (Slide 11)
3. "Extended storage of the drug in the syringe can potentially increase the chance of particle formation, especially in silicone-based systems. Unwanted particles in the solution can cause irritation in the eye and potentially react with the active drug to lower efficacy.¹" (slide 12)
4. "Storage of a protein solution in a plastic syringe can extract leachable material from the syringe barrel and rubber plunger tip. Compounds can induce protein aggregation and potentiate adverse effects in patients such as immunogenicity. Therefore, properly developed therapeutic proteins are not stored in plastic containers." (Slide 13)
Their April presentation has additional info.
https://ir.outlooktherapeutics.com/static-files/e2080eef-8a6b-438b-8447-bf12984db904
Best of luck in your investments!
10 Commercial Therapies at the end of Q1 2023
As of the end of the first quarter, Cryoport supported 10 commercial therapies and a total of 652 clinical trials globally, with 82 of these in Phase 3. We expect up to an additional 18 anticipated application filings, 10 new therapy approvals and an additional 11 label or geographic expansion approvals in 2023.
First Quarter 2023 Results
Record revenue of $63 million, representing 20% growth year-over-year
Growth across all lines of business: Biopharma/Pharma revenue up 19%; Animal Health revenue up 30%; Reproductive Medicine revenue up 13% year-over-year
Commercial Cell and Gene Therapy revenue up 28% year-over-year, now supporting 82 Phase 3 clinical trials
Strong balance sheet with $523 million in cash and short-term investments
NASHVILLE, Tenn., May 4, 2023 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or the "Company"), a leading global provider of innovative temperature-controlled supply chain solutions for the life sciences, today announced financial results for the three months ended March 31, 2023.
Jerrell Shelton, CEO of Cryoport, commented, "We are pleased to report that we delivered record revenue of $62.8 million for the first quarter, representing top-line growth of 20% or 23% in constant currency compared to the first quarter of last year. This quarterly performance was driven by solid demand for our comprehensive set of products and services as we achieved double digit growth in each of our markets, Biopharma/Pharma, Reproductive Medicine, and Animal Health.
"We saw solid growth in Biopharma/Pharma with revenue increasing 19% year-over year. The Regenerative Medicine industry was one of the fastest growing therapeutic segments in 2022, with new innovative cell and gene therapies entering the market. This trend has continued in 2023 driving year-over-year growth in revenue from commercial therapies by 28% for the first quarter. Patient demand continues to outpace commercial cell therapy supply; however, biopharma companies and contract development and manufacturing organizations (CDMOs) are continuing to build out manufacturing capacity to meet patient demand and the expected future demand for cell and gene therapies. This bodes well for Cryoport as we believe that we are well positioned to support this expected growth with our advanced temperature-controlled supply chain solutions.
"Growth in Animal Health revenue for the quarter increased over 30% year-over-year. This was due to increases in our growing global population and its demand for animal protein as well as the expanding ownership of companion animals in developing and emerging regions. Companion animals are fueling the need for therapeutic innovation in this area to improve animals' lives. We are seeing increasing activity from top global animal health pharmaceutical companies to meet this demand.
"Reproductive Medicine revenue was $2.8 million for the first quarter of 2023 with revenue increasing 13% year-over-year. Growth was primarily driven by our continued progress in contracting with key reproductive clinic networks, as evidenced by our recent announcements regarding our support of Boston IVF and Inception Fertility.
"Looking ahead, given the current geopolitical instability and imbalance in the world economy, we remain committed to continuing our momentum throughout the remainder of 2023. We expect to benefit from growth in all our markets and especially the dynamic cell and gene therapy industry where Cryoport supports a total of 652 clinical trials globally with 82 of these in phase 3.
"As a leader in the development of advanced temperature-controlled supply chain solutions for the life sciences industry, we have recently launched the Cryoportal® v2 Logistics Management System. The Cryoportal® v2 is the first and, to our knowledge, the only ISPE GAMP® 5.0 validated system of its type to serve the life sciences and provides many new features and enhancements.
"Of course, we have not stopped there. Other key product and services initiatives planned for launch this year include our next generation, advanced Cryoport Elite™ shipper line, which is now starting to roll out with our ELITE™ Ultra-cold -80°C line of shippers supporting gene therapies. Cryoport ELITE™ shippers will provide additional de-risking, longer temperature hold-times, more advanced communications features, and new security controls. Near the end of the year, our SkyTrax™ Condition Monitoring System, a generational leap to an advanced condition monitoring system that will support temperature ranges from controlled room temperatures to cryogenic temperatures, will also be released as well.
"As we move forward, we expect the robust cell and gene therapy industry to continue its march forward and we will continue to provide new, innovative services and products that will drive our organic growth. Good examples of this are the build-out of our Global Supply Chain Center Network, the introduction of our IntegriCell™ platform to supply autologous and allogeneic cell therapies a standardized apheresis collection and end-to-end cryopreservation service for leukapheresis derived therapies, as well as our Fusion® and Vario® Cryogenic Freezer Systems.
"Our strategy and our team are committed to ensuring Cryoport is always delivering the highest quality, most reliable solutions to support life-saving cell and gene therapies, and we are constantly evaluating opportunities to ensure this – because we know 'a patient is waiting.'
"In my opinion, Cryoport is in a great position in the industry today and has never been stronger than it is today. We are looking forward to fulfilling our vision of becoming the essential supply chain company serving the life sciences," concluded Mr. Shelton.
Total revenues by market for the three months ended March 31, 2023, as compared to the same period in 2022 was as follows:
Hi VMLG17,
What I'm reading from it is the price pressure to remain competitive.
1. "Meanwhile, insurers — primarily Medicare in the U.S. — have been looking to reduce the costs of paying for physician services."
2. "Vabysmo [...] $2,190 a shot, is competitive with Lucentis biosimilars, which cost around $1,000 a shot."
From memory, OTLK is targeting a price structure under $1,000, and above the current compound pharmacies. In other words, in a sweet spot which will make it attractive to payers and quite competitive against the established players.
And since it's positioned to replace the need to use unapproved repackaged IV bevacizumab, which is fairly widely used today, it's not going to be a big step to move there.
All in all, the price pressure makes sense and OTLK can carve a nice place in this market.
My 2 cents.
Best of luck with your investments!
ISO 9001:2015 certification further demonstrates our commitment to a strong quality program that can satisfy global standards for quality. Achieving this critical milestone recognizes the maturity of our QMS, with processes that are scalable and repeatable. We look forward to utilizing the QMS to meet customer and regulatory requirements globally,” said Karin Feldman, Interim Chief Operating Officer/Chief Nuclear Officer.
PORTLAND, Ore. – Today, NuScale Power Corporation (NYSE: SMR), the industry-leading provider of proprietary and innovative advanced nuclear small modular reactor (SMR) technology, announced that Orion Register Inc., a leading International Organization for Standardization (ISO) and industry-specific certification body, issued NuScale the highly regarded ISO 9001:2015 certification. Orion Register issued the certification after completing an evaluation of NuScale’s quality management system (QMS). The rigorous review process confirmed that NuScale has a strong quality system, which ensures consistent, high-quality work, with strong focus on customer feedback and improvement.
NuScale first received U.S. Nuclear Regulatory Commission approval of its quality assurance program under Title 10, Code of Federal Regulations, Appendix B / Nuclear Quality Assurance-1 (NQA-1) in 2011, and since 2019, NuScale has held an N Certificate of Authorization issued by the American Society of Mechanical Engineers (ASME). Both NQA-1 and the ASME N Certificate are considered hallmarks for nuclear quality programs.
Doosan Enerbility & Export-Import Bank of Korea Agreement
Apr. 25, 2023 5:45 PM ET
During the President of the Republic of Korea’s visit to the United States, NuScale and its partners revealed a business development milestone, highlighting Global Supply Chain Development Opportunities
PORTLAND, Ore.--(BUSINESS WIRE)-- NuScale Power Corporation (SMR) announced today it has signed an memorandum of understanding (MOU) with Doosan Enerbility Co., Ltd. (Doosan) and Export-Import Bank of Korea (KEXIM) to strengthen collaboration among the three parties and support NuScale’s small modular reactor (SMR) deployment. This announcement leverages and bolsters an existing relationship between NuScale and Doosan, and it highlights the domestic and global manufacturing opportunities to build SMRs around the world.
The agreement outlines areas of cooperation, such as marketing, technical support, and further development of a global supply chain, and Doosan and NuScale commit to strengthening their cooperation to deploy NuScale VOYGR™ plants globally. Specifically, Doosan committed to helping establish a US-based supply chain for NuScale Power Module™ production through capacity expansion and manufacturing technology advancement.
“Today’s news underscores how our SMRs fill a unique global need: providing flexible, reliable and carbon-free energy while driving economic activity in manufacturing and supply chain development. With our Korean partners and their technical expertise, we are well-positioned to meet this ambitious goal,” said John Hopkins, President and Chief Executive Officer of NuScale Power. “The momentum towards creating a domestic and global supply chain to deploy our SMR technology is accelerating.”
This announcement builds upon a longstanding collaboration between NuScale and Doosan. At the end of 2022, NuScale placed the first upper reactor pressure vessel long lead material production order with Doosan.
In March 2023, KEXIM and NuScale signed an MOU in which they agreed to financial cooperation in support of deploying NuScale VOYGR plants. KEXIM is the official export credit agency of Korea providing comprehensive export credit and guarantee programs to support Korean enterprises conducting overseas business. The organization continues to explore potential opportunities to provide credit facilities to NuScale and facilitate overseas business of Doosan in collaboration with NuScale. With KEXIM’s assistance, Doosan and NuScale will be able to deploy NuScale VOYGR plants worldwide and utilize a Korean supply chain when deploying NuScale plants in the Asian market.
Boston IVF Agreement: Reproductive Material Shipments Across the U.S.
Apr. 25, 2023 8:30 AM ET
NASHVILLE, Tenn., April 25, 2023 /PRNewswire/ -- Cryoport, Inc. (CYRX) (NASDAQ: CYRX) ("Cryoport" or the "Company"), a leading global provider of innovative temperature-controlled supply chain solutions for the life sciences, reproductive medicine and animal health industries, today announced that it has signed a new three-year agreement with Boston IVF, a pioneer in reproductive healthcare and innovative research and one of the world's most experienced fertility treatment providers.
Utilizing Cryoport's end-to-end supply chain solutions, Boston IVF will now have the ability to integrate its regional and satellite labs across Massachusetts, New Hampshire, Maine, Rhode Island, New York and Indiana, along with its partner sites in Delaware, Ohio, Idaho, Utah and North Carolina. Cryoport's platform will improve the overall efficiency of Boston IVF's reproductive material shipments and ensure significant risk mitigation for patients and families entrusting Boston IVF with their care.
"Boston IVF is a widely recognized leader for reproductive medicine, having supported more than 150,000 babies born since 1986 while achieving some of the highest IVF success rates in the country," said Jerrell Shelton, CEO of Cryoport. "As we seek to provide more patients with peace of mind that their reproductive materials are being handled safely and securely, we're proud to partner with a team that is equally committed to delivering the best outcomes and experiences for their patients."
"Inside our clinics, our physicians are among the best in treating infertility and have affiliations with the Beth Israel Deaconess Medical Center and Harvard Medical School," said David Stern, CEO of Boston IVF. "We're always looking for ways to ensure exceptional patient care from start to finish in each fertility journey, and this includes the vital logistical component outside of the clinic. Cryoport's cutting-edge technology and nonstop monitoring simplify the entire supply chain process by ensuring that patients' reproductive materials are safe every step of the way."
That's big Flipper!
Poly-iclc goes off patent July 1, 2023.
May 20th, UCLA Brain Tumor Conference
Immunotherapy for Brain Tumor Patients
9 AM
What is immunotherapy? Come learn about immunotherapy and how the body’s natural T-cells have the potential to destroy cancer cells.
Robert Prins PhD
UCLA Department of Neurosurgery & Department of Molecular and Medical Pharmacology
http://events.provideriq.com/
Best of luck to Patients, Longs, and NWBO!
Hoffman, paint me impressed with the contributions you make to this board.
Thank you for your research and sharing your findings!!!
Best of luck to Patients, NWBO, and Longs!