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If One Leading Coronavirus Vaccine Works, Thank This Tiny Firm in Rural Austria
Pfizer and BioNTech reliance on Polymun’s product shows the fragility of the vaccine supply chain
At a Polymun laboratory in Klosterneuburg, Austria, the size distribution of lipid nanoparticles is measured. MARYLISE VIGNEAU FOR THE WALL STREET JOURNAL
By Bojan Pancevski
Nov. 6, 2020 7:00 am ET
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VIENNA—A key ingredient in what could be the first U.S.-approved Covid-19 vaccine comes from a family-owned company with 90 employees in the Austrian countryside, underscoring the fragility of the potential treatment’s supply chain.
Polymun Scientific Immunbiologische Forschung GmbH is one of a handful of makers of lipid nanoparticles, microscopic vessels used to deliver genetic material into the body.
For years, this was a niche application, used to deliver new forms of cancer treatment, for instance. Then came the coronavirus pandemic.
Lipid nanoparticles are required in the manufacture of so-called mRNA vaccines, including the one developed by Pfizer Inc. and Germany’s BioNTech SE that is currently being tested in humans and is a front-runner in the global race for a Covid-19 shot.
Lipid nanoparticles produced by Polymun are a key ingredient in vaccines.
PHOTO: MARYLISE VIGNEAU FOR THE WALL STREET JOURNAL
Such vaccines are made of genetic material that needs to be protected by a lipid nanoparticle before it can be injected into patients. This means a product few outside the most advanced fields of medical research had heard about until recently is now in high and urgent demand—similar to other parts of vaccine and virus-testing supply chains, from refrigeration equipment to certain chemicals and medical-grade glass.
In September, Pfizer Chief Executive Albert Bourla and BioNTech counterpart Ugur Sahin used the American company’s executive jet to travel to Polymun’s headquarters in Klosterneuburg, Austria, whose spires and domes overlook the river Danube, and reassure themselves that their partner would meet its production targets, according to representatives of the companies.
The partners expect to submit their jab for authorization in the U.S. and Europe in November and bring it to market before the end of the year, pending successful final-stage clinical trials and authorization. Governments around the world have preordered nearly 500 million doses of the vaccine, meaning delivery would be staggered over many months once the product is approved.
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Among the many constraints on producing vast quantities of the vaccine at high speed is Polymun’s limited ability to scale up production.
One reason is that the technology used by the company is both complex and niche, which makes it hard to find qualified staff to handle it and time consuming to train people with adjacent expertise, said Polymun CEO Dietmar Katinger.
“It’s like retraining metal workers to process wood—the principle might appear similar but the shift takes its time,” Mr. Katinger said. “It is a new technology that very few people have been involved with so far.”
A filtration step at a Polymun laboratory used in the development of the company’s product.
PHOTO: MARYLISE VIGNEAU FOR THE WALL STREET JOURNAL
The company, which hires mainly graduates from the region, is so reliant on its scientists’ highly specialized skills that it suffered a minor disturbance recently when three employees applied for parental leave, Mr. Katinger said.
One way Polymun has tried to increase production is by sharing some of its know-how with Pfizer. Polymun employees are now overseeing an effort by the pharmaceutical giant to manufacture the lipid nanoparticles in house. A Pfizer spokesperson said that the process was being set up in Pfizer’s factories both in Europe and the U.S. to secure the supply chain for the vaccine.
“This is a common practice during tech transfer, and highly valuable,” the spokesperson said.
For shipping, Polymun relies on a specialized carrier—another potential bottleneck in the supply chain—that ferries its products in refrigerated trucks to the Pfizer factory in Puur, Belgium, from which finished doses are distributed globally.
Prof. Luigi Battaglia of the University of Turin in Italy said that there has been extensive academic research into lipid nanoparticles but very few companies produce them commercially because gene-based treatments are an emerging field of pharmacology and aren’t yet in widespread use.
With the pandemic abruptly reordering priorities in the medical field, small companies such as Polymun and BioNTech have been thrown into the spotlight.
Founded in 1992 by Mr. Katinger’s father, Polymun has limited direct competition—the other two key companies in the field are Acuitas Therapeutics in Canada and Avanti Polar Lipids Inc. in the U.S. Because of that, Polymun now works for several companies and institutions developing Covid-19 jabs, including U.S. firm Arcturus Therapeutics Inc., Germany’s CureVac AG and Imperial College London.
Polymun’s head of liposome technology, Andreas Wagner, left, and CEO Dietmar Katinger on the roof terrace of the company building.
PHOTO: MARYLISE VIGNEAU FOR THE WALL STREET JOURNAL
U.S.-based Moderna Inc., which is also developing an mRNA vaccine, is producing its lipid nanoparticles in-house.
“Up until recently, the few companies focusing on LNP production could meet the demand of mRNA delivery companies, but the unanticipated high demand for LNP production in the pandemic is very likely to delay some companies, and put them in the queue,” said Nenad Svrzikapa, a researcher with the University of Oxford specializing in oligonucleotide therapeutics, which include mRNA platforms.
Hermann Katinger, Polymun’s 80-year-old founder, stepped down as CEO in 2009, handing the reins to his son. Both have refused to sell or go public and only very few employees have ever left after joining, Mr. Katinger said.
Andreas Wagner, who has been the company’s chief scientist since 2001, developed what would become one of its key manufacturing processes for his doctoral dissertation, a project that was itself funded by Polymun.
But Mr. Katinger doesn’t see the company’s diminutive stature and tightknit team as weaknesses. On the contrary: The choir singer who wears Birkenstocks at work says Polymun’s scale and cohesive staff make it innovative and unbureaucratic—both valuable traits in a pandemic that is stress testing swaths of the medical and pharmaceutical fields.
“In the pandemic the requirements are ideas and innovation,” he said.
—Jared Hopkins contributed to this article.
Write to Bojan Pancevski at bojan.pancevski@wsj.com
https://www.wsj.com/articles/if-one-leading-coronavirus-vaccine-works-thank-this-tiny-firm-in-rural-austria-11604664001
ITEM 8.01 OTHER EVENTS
On October 30, 2020, the Company signed a term sheet with Alpha Holdings, Inc (Alpha) whereby Alpha, subject to a definitive agreement agreeable to both parties will invest US $ 5,000,000 in the Company. The term sheet outlines the terms of the agreement with a projected closure by December 31, 2020 for an initial investment of $2,500,000 and an additional investment of $2,500,000 on about April 30, 2021. The investment will be in the Company’s common stock to be priced at a low of six cents per share and a high of 10 cents per share subject o a 90 day weighted average pricing before closing. Upon completion of the $5,000,000 investment Alpha may elect a majority of the board of directors of the Company.
https://www.otcmarkets.com/filing/html?id=14478596&guid=kn5eUKuJUT_Wdth
ASMB 5.15 - trading down to cash level...took a first position.
The investment will be in the Company’s common stock to be priced at a low of six cents per share...
I've raised my bid to pick at these lingering .06 shares. What goes unsaid here is that there should be no further need to pay suppliers-et-al in shares thereby completely turning around those same suppliers-et-al from being sellers of stock into potential buyers of stock...n'est ce pas?
Best financial news this little startup-biotech has ever had, by far, and continues trading at alltime lows?
https://bigcharts.marketwatch.com/quickchart/quickchart.asp?symb=nbio&insttype=&freq=2&show=&time=20
Quite the disconnect...
It's a formal 8-K filing...wonder if they'll follow-up with a pr? Either way we can expect a more complete update as the Q2 filing comes due on 11/15...expecting it sooner, anyday now...
NBIO .06 - ITEM 8.01 OTHER EVENTS
On October 30, 2020, the Company signed a term sheet with Alpha Holdings, Inc (Alpha) whereby Alpha, subject to a definitive agreement agreeable to both parties will invest US $ 5,000,000 in the Company. The term sheet outlines the terms of the agreement with a projected closure by December 31, 2020 for an initial investment of $2,500,000 and an additional investment of $2,500,000 on about April 30, 2021. The investment will be in the Company’s common stock to be priced at a low of six cents per share and a high of 10 cents per share subject o a 90 day weighted average pricing before closing. Upon completion of the $5,000,000 investment Alpha may elect a majority of the board of directors of the Company.
https://www.otcmarkets.com/filing/html?id=14478596&guid=kn5eUKuJUT_Wdth
NBIO .06 - ITEM 8.01 OTHER EVENTS
On October 30, 2020, the Company signed a term sheet with Alpha Holdings, Inc (Alpha) whereby Alpha, subject to a definitive agreement agreeable to both parties will invest US $ 5,000,000 in the Company. The term sheet outlines the terms of the agreement with a projected closure by December 31, 2020 for an initial investment of $2,500,000 and an additional investment of $2,500,000 on about April 30, 2021. The investment will be in the Company’s common stock to be priced at a low of six cents per share and a high of 10 cents per share subject o a 90 day weighted average pricing before closing. Upon completion of the $5,000,000 investment Alpha may elect a majority of the board of directors of the Company.
https://www.otcmarkets.com/filing/html?id=14478596&guid=kn5eUKuJUT_Wdth
NBIO .06 - ITEM 8.01 OTHER EVENTS
On October 30, 2020, the Company signed a term sheet with Alpha Holdings, Inc (Alpha) whereby Alpha, subject to a definitive agreement agreeable to both parties will invest US $ 5,000,000 in the Company. The term sheet outlines the terms of the agreement with a projected closure by December 31, 2020 for an initial investment of $2,500,000 and an additional investment of $2,500,000 on about April 30, 2021. The investment will be in the Company’s common stock to be priced at a low of six cents per share and a high of 10 cents per share subject o a 90 day weighted average pricing before closing. Upon completion of the $5,000,000 investment Alpha may elect a majority of the board of directors of the Company.
https://www.otcmarkets.com/filing/html?id=14478596&guid=kn5eUKuJUT_Wdth
BGFV 7.34 - I would imagine a good number of shorts closed out when stock was driven down to low $6s on day after earnings
Wouldn't a downspike be indicative of more shorting? Dumbfounding how since the preliminary earnings announcement on 7/9/20 and subsequent fundamentally deserved pps tear from $2's to $7's, the short interest has remained mostly at the same ludicrous high number:
https://www.nasdaq.com/market-activity/stocks/bgfv/short-interest
...when logic and proportion have fallen sloppy dead...
Bottom line is, without the super low S,G,&A, the stock would be in the $2-$3 area.
a bit cheesy (even if this was all in your sub-conscious), but you gotta get an A+ for your effort...sheesh
REGN setback...
https://endpts.com/in-a-second-big-setback-for-covid-19-antibody-treatment-hopes-regeneron-halts-enrollment-for-more-severe-patients/
https://investor.regeneron.com/news-releases/news-release-details/regn-cov2-independent-data-monitoring-committee-recommends/
A disappointing replication: monoclonal antibodies to #SARSCoV2 don't provide benefit to hospitalized patients w/ moderate-severe illness. The need to treat #COVID19 early or preventativelyhttps://t.co/2Ul2gP1Uj2 like Lilly futility Phase 2 trial decision
— Eric Topol (@EricTopol) October 30, 2020
BGFV 7.39 - they would've still crushed the Q3 earnings number without the $5.6M reduction in SG&A...
Net income for the third quarter of fiscal 2020 was $28.4 million, or $1.31 per diluted share, which compares to net income of $6.4 million, or $0.30 per diluted share, in the third quarter of fiscal 2019.
The expected continued SG&A reduction only serves to make it a much sweeter strong buy...
BGFV 7.50 - added a quad at 6.50 earlier in the day and just sold the Nov./7.50 calls on those at .80.
Looking to write some $10 (or higher) calls on the low 7's I purchased in yesterday's afterhours...
BGFV 7.45 - why not close on the plus side?? We all watch looloo-stock after looloo-stock spike like rocket ships and here we've got one with the most absolute SOLID of numbers...why flip it??
down here below $8, $10, $12....
BGFV 7.60 - how much stronger will consumers buying of sporting goods get vs what we've seen the last two qtrs
I'm showing they filed last year's 10-K on 2/25/20 so maybe we won't know until late/Feb./21, several months down the road? In the meantime, BGFV will hold some spectacular numbers.
I tripled down in afterhours on more than just the spectacular fundys...also in anticipation of some more lucrative option-selling oppurtunities in the days ahead. The premiums have been very good here...
BGFV - was looking for a sector-sympathy-play to trade on the BGFV stellar news? There are none that I can see because BGFV remains so ludicrously cheap...
wade, I was listening...did you re-enter?
BGFV - As a percentage of net sales, selling and administrative expense decreased to 23.4%, versus 28.9% in the prior year
Voila Sheesh
BGFV 7.25 - added a bunch on a stellar report...Steven G. Miller, the Company’s Chairman, President and Chief Executive Officer, said, “I am pleased to report an exceptional third quarter, which represents the strongest sales and earnings performance in our 65-year history. During this unprecedented time, our product offerings are resonating with consumers who are looking for ways to stay healthy and active. Clearly, customers are recognizing our stores as a convenient and safe environment to fulfill their fitness and outdoor recreational needs. Additionally, we continue to benefit from substantial cost reductions that have enabled us to achieve meaningful operating leverage. I am extremely proud of our team’s tremendous dedication and execution during these challenging times.”
Mr. Miller continued, “Our success navigating the COVID-19 environment to date has substantially strengthened our balance sheet and enhanced our financial flexibility. At the end of the third quarter, we had zero borrowings on our revolver and nearly $56 million in cash. As a result, our Board of Directors has authorized an increase in our regular cash dividend to double its prior rate. Looking at the fourth quarter, we have continued to see solid momentum with sales increasing 15.1% for our fiscal October period. We believe our inventory is well positioned for the upcoming winter and holiday seasons. That said, we recognize there is tremendous uncertainty impacting the consumer environment over the coming months and we are prepared to be nimble and make adjustments as necessary.”
BGFV has traded like a yoyo for several months now but today's afterhours drop defies all logic...
ARPO 1.30 - accumulating on two partially funded covid therapeutic trials and a few more pans hot on the fire...
https://finance.yahoo.com/news/aerpio-announces-first-patient-dosed-200100014.html
https://secfilings.nasdaq.com/filingFrameset.asp?FilingID=14327189&RcvdDate=8/12/2020&CoName=AERPIO%20PHARMACEUTICALS,%20INC.&FormType=8-K&View=html
About Razuprotafib (formerly known as AKB-9778)
Razuprotafib binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes and more recently has been shown to contribute to the development of increased IOP and glaucoma. Razuprotafib activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation. Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy. In addition, a subcutaneous formulation of razuprotafib is being explored for its therapeutic potential in treating or preventing ARDS associated with COVID-19.
ARPO 1.30 - accumulating on two partially funded covid therapeutic trials and a few more pans hot on the fire...
https://finance.yahoo.com/news/aerpio-announces-first-patient-dosed-200100014.html
https://secfilings.nasdaq.com/filingFrameset.asp?FilingID=14327189&RcvdDate=8/12/2020&CoName=AERPIO%20PHARMACEUTICALS,%20INC.&FormType=8-K&View=html
About Razuprotafib (formerly known as AKB-9778)
Razuprotafib binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes and more recently has been shown to contribute to the development of increased IOP and glaucoma. Razuprotafib activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation. Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy. In addition, a subcutaneous formulation of razuprotafib is being explored for its therapeutic potential in treating or preventing ARDS associated with COVID-19.
ARPO 1.30 - accumulating on two partially funded covid therapeutic trials and a few more pans hot on the fire...
https://finance.yahoo.com/news/aerpio-announces-first-patient-dosed-200100014.html
https://secfilings.nasdaq.com/filingFrameset.asp?FilingID=14327189&RcvdDate=8/12/2020&CoName=AERPIO%20PHARMACEUTICALS,%20INC.&FormType=8-K&View=html
About Razuprotafib (formerly known as AKB-9778)
Razuprotafib binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes and more recently has been shown to contribute to the development of increased IOP and glaucoma. Razuprotafib activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation. Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy. In addition, a subcutaneous formulation of razuprotafib is being explored for its therapeutic potential in treating or preventing ARDS associated with COVID-19.
APT 14.70 - Filing Date: 5/6/2020...The phase 2 expansion is expected to be operational by late summer 2020....
Filing Date: 8/4/2020...The Company continues to expect the phase 2 expansion of additional N-95 face mask manufacturing lines to be initially operational by the latter part of the third quarter of 2020...
No update so a double-whiff in this book, in my book. Pulled all bids and unless it dips hard I'll be waiting for an update on this DOUBLE-WHIFF.
CPSS 3.85 - adding. Congrats on your flippers this morning. Ok to send you & nelson this weekend's bartab?
CPSS 4.07 - rebuying here on the very good numbers and the recent offer...
...200 Million dollars in the bank...? I can't find this number anywhere? Do you have a link?
TRVN 2.60 - bought this biotech covid-wannabeonthebandwagon here and sold the Nov.20/$2.50 calls at .45. How these option buyers love to gamble Gamble GAMBLE...
CPSS 4.58 - exited the position for flat over the past two days. In the CC, they mentioned that they haven't spoken with the potential buyer and mentioned a deadline of 10/30 for making a final decision (18:00 minute mark of CC).
https://edge.media-server.com/mmc/p/32itxemt
Sounds to me like they'll reject the offer and we might get a chance to rebuy around $4 or less, nearterm...
BGFV 8.20 - after being called out at 7.50 for the rest of my shares, I've begun re-assuming my position today. Agree that a $'teens pps looks very possible here...
My guess is some of the recent "$740,000 Equity Round of Funding":
https://www.otcmarkets.com/stock/NBIO/news/Nascent-Biotech-Inc-Completes-740000-Equity-Round-of-Funding?id=271674
And whollotta of the payment-in-shares-recipients, which are listed in the 10-K:
https://www.otcmarkets.com/filing/html?id=14230107&guid=nm_eU6iylEtdfth
That's how these biotechs continue pursuing their goals when they have no revenue imo.
The longterm prospects of NBIO are the same...a $5M-marketcap-stock in an ocean full of $500M-marketcap-stocks having lesser fundamentals...
CPSS 4.56 - Consumer Portfolio Services, Inc. (Nasdaq: CPSS) (“CPS” or the “Company”) today announced earnings of $3.8 million, or $0.16 per diluted share, for its third quarter ended September 30, 2020. This compares to net income of $1.8 million, or $0.08 per diluted share, in the third quarter of 2019.
Revenues for the third quarter of 2020 were $70.7 million, a decrease of $14.9 million, or 17.4%, compared to $85.5 million for the third quarter of 2019. Total operating expenses for the third quarter of 2020 were $64.8 million compared to $82.7 million for the 2019 period for a decrease of $17.9 million, or 21.7%. Pretax income for the third quarter of 2020 was $5.9 million compared to pretax income of $2.8 million in the third quarter of 2019, an increase of 108.2%.
https://ih.advfn.com/stock-market/NASDAQ/consumer-portfolio-servi-CPSS/stock-news/83488789/cps-announces-third-quarter-2020-earnings
Not exactly the blockbuster I was eagerly anticipating but not too shabby for a mid$4's stock...
CPSS 4.60 - Consumer Portfolio Services, Inc. (Nasdaq: CPSS) (“CPS” or the “Company”) today announced that it will hold a conference call on Tuesday, October 20, 2020 at 1:00 p.m. ET to discuss its third quarter 2020 operating results.
https://ih.advfn.com/stock-market/NASDAQ/consumer-portfolio-servi-CPSS/stock-news/83487108/cps-to-host-conference-call-on-third-quarter-2020
This is way early - a definite positive....
"non-human primate challenge...funded by Operation Warp Speed"
One of the reasons I'm not seeing any fraud is that this entire OWS has been top-secret, on a who-needs-to-know basis, from day one! I can't find much info on this 'non-human primate challenge' except that INO is also participating...any other participants...can Vaxart succeed in this 'challenge'?
Started re-buying, slowly, as more downside is very likely imo...but...Vaxart has a legitimate ongoing Phase-1 for a covid-19-vaccine in a world full of coronakooks and well out in front of many higher-marketcap-peers.
Also I'm not seeing any fraud whatsoever...
In a statement to ABC News, a spokesperson for Vaxart denied the allegations, writing, "The Vaxart non-human primate challenge study was organized and funded by Operation Warp Speed, as stated in the June 26, 2020 company press release. The statements made in that press release are accurate and any allegation to the contrary is baseless."
https://abcnews.go.com/Health/vaccine-company-vaxart-faces-federal-investigation-allegedly-exaggerating/story?id=73657030
O.T. & a little bit APT - I realize there's alot of fuzzymath going around in the corona-kookout and the 6 o'clock newscasters tend to make the fuzzymath even fuzzier...but...as they all-in-unison broadcast recent covid case increases - has anyone questioned the "mask"?
Six months ago like 2 people, total, wore a "mask" outside of a hospital environment...while now "masks" are worn by almost EVERYONE. hmmmmmmmmm
VXRT 5.70 - hit my pre-market bid of 5.35 and I immediately wrote the $5.50-Oct. 23-Call at .50...right at 10% juice for a week. Fundies are complex but 10%-per-week can cure alotta warts.
Cuomo calls that a "chinguard" and I thank him for the idea...much more comfortable, no...
The study, which was not peer-reviewed, found that four treatments tested — remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon — had “little or no effect" on whether or not patients died within about a month or whether hospitalized patients recovered.
https://www.fox2detroit.com/news/remdesivir-among-4-drugs-with-little-or-no-effect-on-covid-19-survival-who-study-says