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https://seekingalpha.com/news/3650074-softbank-takes-stake-in-pacific-biosciences-bloomberg?mail_subject=pacb-softbank-takes-stake-in-pacific-biosciences-bloomberg&utm_campaign=rta-stock-news&utm_content=link-3&utm_medium=email&utm_source=seeking_alpha
Jan. 08, 2021 4:38 PM ETSoftBank Group Corp. (SFTBY)By: Vandana Singh, SA News Editor
SoftBank (OTCPK:SFTBY) has reportedly amassed a stake of roughly 6% in Pacific Biosciences of California (NASDAQ:PACB), Bloomberg reports.
The interest, currently worth over $350M, underscores the fast-expanding portfolio of public equity investments by the Japanese conglomerate's asset management business SB Northstar.
In November, the company announced a public offering of $87M priced at $14.25/share.
Last year, the company was blocked by U.S. antitrust enforcers from merging with Illumina in a $1.1B deal.
PACB shares rose as much as 12% on the news before trading was halted.
A Thread (🧵)
— Charles Campbell Roberts (@CCRobertsARK) January 5, 2021
Let's discuss long-read #sequencing, optical mapping, and the implications of a recent study (linked below).
Please view my disclosures at the end. I've intentionally made this thread more technical as I think it's necessary.https://t.co/C0qMRaA986
Great thread on PacBio’s longreads by Ark Invest’s genomics analyst, Simon Barnett:
Long-read #NGS obeys Wright's Law.
— Charles Campbell Roberts (@CCRobertsARK) November 18, 2020
For every cumulative doubling in sequence data generated across its install base, @PacBio has been able to lower (consumables) costs by roughly 30%, as shown below.
What could this imply about the future of long-read #sequencing? pic.twitter.com/kl4ENUCWsP
MjMilo,
I respect a lot of your input on the board. I’ve been holding BABYF for a long time, I just don’t post as much as you and others do. You seem to confuse objective criticism with bashing. The fact is the company stated that they would reveal the manufacturing partner BEFORE covid became a huge issue, and it didn’t happen and still hasn’t happened. That’s an objective fact and not bashing. The timeline for revealing the stores / national retailer has now been delayed by as much as 90-days, per the company’s own update today, that is an objective fact, and not bashing. You seem to expect shareholders to just shut up and have blind faith.
Nothing new with this update. The market wants to know who the National retail chain is and the names of the stores that will be carrying the product. This update basically says there will be a 90-day delay in providing that information. We still have yet to know who’s manufacturing the formula. I’m long BABYF and I’ve been in since .42 cents. I like the long term prospects, but if they don’t have actual news, they shouldn’t put out fluff
The whole page is gone; it’s not a matter of not having posted recently. I’m not worried either. It could be part of the new marketing firm’s plan to redesign it all.
Does anyone have an idea as to why ELSE’s Instagram page is currently inactivated? It’s been like that for about a week now.
Great question, and to add to that, I'd like to see it become tradeable on Robinhood.
Ark Invest is largely focused on tech related companies (molecular diagnostics, genome, etc.), with Tesla being their largest holding. However, if you're able to get Cathie Wood to at least take a look at Else, she may be convinced to give it a shot. The good thing is that it's one of the few ETF's that are actively traded (they pick and choose stocks daily), as opposed to mirroring an index. Good luck and keep us updated.
To be mentioned alongside Beyond Meat is nice for publicity:
https://www.prnewswire.com/news-releases/global-pandemic-has-consumers-increasing-plant-based-nutrition-to-strengthen-immune-systems-301112758.html
NEW YORK, Aug. 17, 2020 /PRNewswire/ -- How we eat, and what we buy for our meal planning is changing during the COVID-19 pandemic, as new surveys show that more people are gravitating towards plant-based sources of protein in response to this health crisis. Part of this can be attributed to meat shortages that took place in some markets, but more positively a shift to plant-based nutrition aligns with the advice of doctors who link diet to our ability to fend off poor COVID-19 outcomes. The market is responding in kind, as companies such as specialized plant-based protein companies Else Nutrition (TSXV: BABY) (OTCQX: BABYF) and Beyond Meat Inc. (NASDAQ: BYND) are both up triple-digits, and larger companies introducing plant-based protein options such as Tyson Foods, Inc. (NYSE: TSN), Kellogg (NYSE: K), and Bunge Ltd. (NYSE: BG) are up double-digits.
Investment in alternative protein companies is growing at a torrid pace, surpassing 2019's record $824 million, with $930 million invested in Q1 2020 alone. Among Else Nutrition's (TSXV: BABY) (OTCQX: BABYF) (FSE: 0YL) achievements during the pandemic have come from the introduction of its plant-based nutrition products for toddlers, which officially launched online on August 11. The safe, clean label, plant-based, dairy-free and soy-free nutrition products have so far received both USDA Organic Certification and multiple other key certifications.
"We are excited to be continuing on our pathway to commercialization," said Ms. Hamutal Yitzhak, CEO and Co-Founder of Else Nutrition. "Obtaining these certifications is a major step as we prepare for our U.S. launch."
Pediatric child health studies state that well-planned, well-balanced vegetarian and vegan diets can provide for the needs of children and adolescents—conditional on ensuring the appropriate caloric and protein intake and sources of essential fatty acids, iron, calcium, and vitamins B12 and D.
Else Nutrition's (BABY.V) (BABYF.QX) (FSE: 0YL) plant-based toddler complete nutrition drink meets the gold standard equivalent of human milk nutritional composition values, based on WHO international standards, among many others. Else Plant-Nutrition meets the strictest regulatory requirements and the highest nutrition standards, providing a full essential amino acid profile and a clean source of protein.
Endorsed by a board of leading U.S. and international pediatricians and nutritionists, this complete nutrition offers healthy and clean fat, protein, and key nutrients such as calcium, vitamin D, B12, and zinc, among others. The product uses a blend of quality whole plant non-GMO ingredients, including almond paste, buckwheat, and tapioca, with overall low sugar content.
In many ways, the pandemic has actually helped us in how we eat. With many restaurants restricted on how many patrons they can serve, we're seeing family meals make a comeback, which studies have shown helps children by improving self-esteem, and lowers the risk of depression, as well as lower rates of childhood obesity.
But you don't have to go vegan to improve your health. Dietitians are recommending an increase in vegetable intake, and a reduction in meat intake to find a balance, including the highly-recommended Flexitarian Diet.
In order to achieve this decrease in meat consumption, we've seen the rise in popularity of plant-based protein alternatives, such as the offerings from Beyond Meat (NASDAQ: BYND). The company recently released its Q2 earnings report, beating investors' expectations on revenue and matched on earnings per share. The key to the company's success has been a rapid expansion in grocery sales.
Many of North America's largest and most prominent food producers have begun adding their products to the sector, including food processors, meat producers, and grain traders.
Long-standing food processing giant Kellogg (NYSE: K) entered the fray earlier this year with its "Incogmeato" product line. The plant-based burgers, bratwurst, and sausage join Kellogg's MorningStar Farms offerings, which have been selling veggie alternatives made with black beans and mushrooms for more than 4 decades. Unlike Else and Beyond Meat, which are not soy-based, all Incogmeato products are made with soy (non-GMO).
Last year, long before the pandemic, the largest meat producer in the US, Tyson Foods (NYSE: TSN), unveiled its own alternative protein products. Through the newly dubbed "Raised & Rooted" brand, Tyson set out to create great-tasting plant-based and blended food products, including plant-based nuggets, as well as blended burgers that combine actual beef and plants. Raised & Rooted nuggets are made from a blend of pea protein isolate and other plant ingredients and contain 5g of fiber and omega-3s.
Back in September of 2019, one of the world's biggest grain traders, Bunge (NYSE: BG), disclosed their own 1.6% stake in Beyond Meat. Today, Beyond Meat has grown its market cap to over 40% larger than Bunge.
That wasn't the end of the story for Bunge's entry into plant-based meat alternatives. In March of this year, through its subsidiary, Bunge Loders Croklaan, the company launched a new portfolio of products designed to replicate the taste, texture, and cooking experience of meat. These products leverage Bunge's supply of high-stability sunflower, canola, coconut, and palm fruit oils. The oils bring to the table flavor and aroma release, specialty fat fractions, and shortenings for juiciness and flakes for marbling, while lecithin helps enhance surface browning to improve visual appeal.
To complement the family's choices for mealtime, parents now have the ability to serve to their toddlers an organic, clean-label and clean process nutrition product, from Else Nutrition (BABY.V) (BABYF.QX) (FSE: 0YL). Soon the US market will be seeing a lot more of Else's products, after the company completed and signed broker agreements with three reputable natural food brokers, with combined networks that span Southern California, Northern California, Arizona, Nevada, the Northwest States, and the North East (including New York City).
"These key broker agreements will significantly accelerate our push to get our product on the shelves of U.S. Natural Food chains," said Ms. Hamutal Yitzhak, CEO and Co-Founder of Else. "This marks a major step towards bringing our clean, plant-based nutrition for toddlers to market, and making it accessible to parents and children at their local retail outlets."
To get more information on Else Nutrition (TSXV: BABY) (OTCQX: BABYF) (FSE: 0YL), please click here.
https://finance.yahoo.com/news/else-nutrition-announces-north-american-110000634.html
Baby Nutrition Paradigm shift: After 120 years, Else introduces a completely novel protein source for baby nutrition (over one year old) with a breakthrough, clean and sustainable production process.Globally patented, and founded by infant nutrition ... Else Nutrition Holdings
Baby Nutrition Paradigm shift: After 120 years, Else introduces a completely novel protein source for baby nutrition (over one year old) with a breakthrough, clean and sustainable production process.
Globally patented, and founded by infant nutrition industry veterans, Else Nutrition is the first dairy and soy- free, clean label, plant-based complete nutrition for babies (1 year and over).
A Revolution in the way babies are fed, Else Nutrition offers parents a great- tasting, dairy-free, soy-free and GMO-free alternative.
Else Plant-Based Complete Nutrition is now available for purchase at elsenutrition.com, U.S. shipping nationwide and to Canada.
VANCOUVER, BC / ACCESSWIRE / August 11, 2020 / ELSE NUTRITION HOLDINGS INC. (TSX-V:BABY) (OTCQX:BABYF) (FSE:0YL) ("Else" or the "Company"), today announces the online product launch of its Else Plant-Based Complete Toddler Nutrition, the first fully certified USDA Organic, Clean Label, Plant-Based, Soy-Free nutritional drink for toddlers. Made with ingredients, vitamins and minerals that help support growth and development after a baby's first year. Else Plant-Based Complete Nutrition is the only globally-patented, real alternative for babies beyond the first year - including those with milk intolerances/sensitivities, those looking to avoid dairy and soy, and for all families looking for a clean, plant-based option for their children
Dairy-free, soy-free, corn syrup-free, gluten-free and non-GMO, Else Nutrition is a unique globally patented combination of whole-plant organic ingredients - almonds buckwheat and tapioca. This combination meets the gold standard equivalent of human milk nutritional composition values, based on WHO international standards, among others. Else Plant- Nutrition meets the strictest regulatory requirements and the highest nutrition standards, providing a full essential amino acid profile and a clean source of protein. It is manufactured in an infant grade U.S. manufacturing site and endorsed by a board of leading U.S. and international pediatricians and nutritionists.
"We are thrilled that today marks a huge leap forward in plant-based alternatives in the baby and toddler category," said Hamutal Yitzhak, CEO and Co-Founder of Else Nutrition. "For more than 120 years, cow's milk and soy have dominated. After seven years of R&D, we are finally able to offer something else to parents and bring a real, clean label alternative to families across North America, so that they will never have to compromise on the health and nutrition of their toddler again."
Else Plant-Based Complete Nutrition for Toddlers is minimally processed. Else intends for all its future products to meet this standard. With more than seven years of research and development, Else's breakthrough process creates nutrition products from whole plants without altering their chemistry or using highly-processed extracts, or harsh chemicals. Through this disruptive process, Else is able to maximize the nutritional value and minimize environmental impact.
Additionally, Else Nutrition's innovation pipeline includes a breakthrough, plant-based, clean label infant formula for babies 0-12 months. It is anticipated to launch in approximately two years, currently on its pathway for final FDA approval.
Beyond the brand's Advisory Board of Pediatricians and nutritionists, Else has already captured the attention of many influential mothers, such as Hilaria Baldwin. As a mother of four with the fifth on the way, Hilaria came across Else as she searched for nutrition products for her toddler Romeo. After using the product, Hilaria decided to partner with Else to support its product launch.
https://finance.yahoo.com/news/else-nutrition-retains-lytham-partners-110000347.html
VANCOUVER, BC / ACCESSWIRE / August 6, 2020 / ELSE NUTRITION HOLDINGS INC. (TSXV:BABY)(OTCQX:BABYF)(FSE:0YL) ("Else" or the "Company"), a developer of plant-based alternatives to dairy-based baby nutrition, is pleased to provide the following ... Else Nutrition Holdings
VANCOUVER, BC / ACCESSWIRE / August 6, 2020 / ELSE NUTRITION HOLDINGS INC. (TSXV:BABY)(OTCQX:BABYF)(FSE:0YL) ("Else" or the "Company"), a developer of plant-based alternatives to dairy-based baby nutrition, is pleased to provide the following corporate update.
"Our team has been working relentlessly, during an unprecedently difficult time, to bring our product to market. As we get set to launch, we are beyond thrilled to have crossed major hurdles over the past months and weeks - including full scale manufacturing with a U.S. based partner and mobilization of our U.S. supply chain which has culminated in our ability to ship samples of our plant-based formula for toddlers to eager parents across North America," said Ms. Hamutal Yitzhak, CEO and Co-Founder of Else.
North America Launch
The Company's proprietary, plant based, clean label formula for toddlers will launch in August 2020. A full-scale marketing campaign for the launch has commenced with samples and pre-order sales over the past few weeks; the product will be shipped to consumers in the U.S. and Canada from two U.S. based warehouses of a third-party logistics partner. The Company's Amazon.com store will launch in the coming weeks.
U.S. Manufacturing
The first full-scale commercial manufacturing run of the toddler nutrition powder product was successfully completed by the Company's U.S. manufacturing partner and packed at a co-packer plant in Nevada.
The terms of the U.S. manufacturing agreement have been negotiated and a formal agreement will be executed upon the receipt of final yield and cost optimization parameters. The next commercial manufacturing run is booked and secured.
FDA Regulatory Pathway
The Company in conjunction with its FDA consulting partner continues to progress on the regulatory pathway for multiple products including an infant formula and new products currently in development for the adult nutrition market.
Health and Happiness International Holdings Limited
The Company's negotiations with its strategic partner, H&H Global, for distribution rights of the toddler and infant formula in France are advancing well. The parties are studying the target market needs, channels, and regulations, in addition to preparing a launch plan and negotiating the distribution terms. Additionally, discussions regarding distribution in additional markets have also commenced.
Cash and Runway
The company is well capitalized, with approximately CAD$7.0 million in cash, and no short or long-term debt, to fully support its manufacturing and go-to-market plans for the next 12 months.
About Else Nutrition Holdings Inc.
Else Nutrition GH Ltd. is an Israel-based food and nutrition company focused on developing innovative, clean and plant-based food and nutrition products for infants, toddlers, children, and adults. Its revolutionary, plant-based, non-soy, formula is a clean-ingredient alternative to dairy-based formula. Else Nutrition (formerly INDI) won the "2017 Best Health and Diet Solutions" award at the Global Food Innovation Summit in Milan. The holding company, Else Nutrition Holdings Inc, is a publicly traded company, listed as TSX Venture Exchange under the trading symbol BABY and is quoted on the US OTC Markets QX board under the trading symbol BABYF and on the Frankfurt Exchange under the symbol 0YL. Else's Executives includes leaders hailing from leading infant nutrition companies. Many of Else advisory board members had past executive roles in companies such as Mead Johnson, Abbott Nutrition, Plum Organics and leading infant nutrition Societies, and some of them currently serve in different roles in leading medical centers and academic institutes such as Boston Children's Hospital, Pediatrics at Harvard Medical School, USA, Tel Aviv University, Schneider Children's Medical Center of Israel, Rambam Medical Center and Technion, Israel and University Hospital Brussels, Belgium
Best time to get in early and wait. It’s coming
YYYH R/M and name change from MSHF. 100M A/S 5M Float
?MSHF R/M ticker change tomorrow. 5M float ?
Failed test for their drug. VBIV is a good buyout candidate
Thanks Sobek. I think this company has a good future in this niche
BABYF - Else Nutrition
This is an Israeli based company that is coming to market in Q2 2020 with the world’s first plant-based toddler and infant formula. Currently, baby formula is either dairy or soy based. Something like 40% of kids that are allergic to dairy are also allergic to soy. It seems these days that vegan / plant based is the new Atkins. This company may have carved out a nice niche for itself.
My last call was VBIV at .87, it’s now around $1.30. BABYF will have a crazy run as this quarter comes to an end.
BABYF - Else Nutrition
This is an Israeli based company that is coming to market in Q2 2020 with the world’s first plant-based toddler and infant formula. Currently, baby formula is either dairy or soy based. Something like 40% of kids that are allergic to dairy are also allergic to soy. It seems these days that vegan / plant based is the new Atkins. This company may have carved out a nice niche for itself.
Wow, that sounds good. Reading up on it now
Awesome, I’ll check it out, thanks.
Haha. I definitely took some time off, now I’m back at it. I’m doing DD on another one in the health care sector (ACST).
Very nice, congrats
I’ve been well, thanks. I stumbled upon VBIV and I knew you’d see its potential, so I thought I’d share. Hope all is well.
VBIV (NASDAQ .86)
VBI Vaccines is a Massachusetts-based biotech company that has a hepatitis B vaccine that’s already approved, and selling in fifteen countries right now. It’s got a very large safety database (something we’ll discuss in a bit more detail shortly) and it’s designed to overcome the limitations of the currently available SOC vaccines. At a glance, then, it seems to not only have the potential to meet the unmet need (and in turn, the $700 million market opportunity) but also to represent a more attractive risk-reward profile than a Dyanavax/Heplisav exposure.
The asset in question is called Sci-B-Vac.
The list of countries in which Sci-B-Vac is already approved includes Hong Kong, Israel, Philippines, Vietnam and a large portion of West and Central Africa. To date, it has demonstrated safety and efficacy in over 300,000 patients, and VBI has a database of safety figures in hand that spans 5,000 doses.
The vaccine is created using hamster cells, which enables Sci-B-Vac to mimic the virus to which it’s designed to induce an immune response far more closely than so-called second generation vaccines, which use yeast cells to ‘package’ antigens. For reference, Heplisav-B uses yeast cells, but is able to reduce the dosing regimen when compared to the SOCs in the sector because it uses what’s called immunostimulatory sequences (ISS) as an adjuvant, instead of the alum adjuvant that things like Engerix (an example of one of the most widely used SOCs) employ.
The employing of hamster cells as packaging for the antigens, as well as Sci-B-Vac’s mimicking of all three surface antigens of the hepatitis B virus (the S antigen and the pre-S1 and pre-S2 surface antigens), results in an increase in immunogenicity without the necessity for an alternate adjuvant.
This is a key point, as it allows for a maintaining of the safety profile of the alum type vaccines, but an increased elicited response.
To put this another way, with Heplisav-B, Dynavax has taken second generation vaccines and added an adjuvant to allow for reduced dosage. In contrast, with Sci-B-Vac, VBI has completely reengineered the vaccine to allow for higher immunogenicity, which reduces the amount of the vaccine needed. In doing this, it’s reduced the necessary dosage, and overcome the dosing issue that we outlined above as serving to underpin the large unmet need in the space.
That’s not all.
VBI’s vaccine has also demonstrated an equally effective immunogenicity across all patient types – young, old, healthy, and (very importantly) immunosuppressed patients such as diabetes sufferers. There’s a real problem right now with current vaccine options not inducing immunogenicity in diabetes sufferers (and Heplisav-B is included in this group), and Sci-B-Vac seems to solve this problem.
So what’s the development pathway like?
The company is pushing right now to add the US and Europe to its list of approved regions. These are the two big-ticket markets, and approval in both could amount to more than $1 billion in revenue potential, above and beyond Dynavax’s $700 million Heplisav-B US potential. The European pathway is slightly ahead of that of the US, with the company having announced back in February that the CHMP (a department of the EMA) has expressed its support of VBI’s proposed plan to proceed to the Phase III clinical studies of Sci-B-Vac, and that the product information, as well as data from ongoing studies, supports the Phase III clinical studies and VBI’s planned filing of a market authorization application (MAA) for the vaccine. A pivotal study should kick off during the third quarter of this year, and this presents us with a potential 2018 approval in Europe.
According to most recent communication from management, the US approval program is running parallel to that of the European program, which suggests we should see a pivotal initiated in the US this year also, again serving up the potential for approval in 2018.
There’s also a considerable amount of institutional interest in the company. Arch Ventures, headed up by Robert Nelson, and Perceptive Advisors, the top performing sub $1 billion hedge fund of 2015, headed up by biotech guru Joseph Edelman, both hold large stakes in VBI.
Through Opko Health Inc. (NASDAQ:OPK), billionaire biotech entrepreneur Dr. Phillip Frost also holds a large, and growing, stake in the company.
The takeaway here is that VBI is likely around eighteen months behind Dynavax in terms of getting a hepatitis B vaccine on the market in the US and Europe, but given the information available right now, it looks as though VBI’s Sci-B-Vac has a far higher chance of getting a regulatory green light. Sci-B-Vac also looks superior to Heplisav-B, especially in the immunosuppressed patient population, giving the drug a higher peak sales potential than that of its Dynavax made counterpart.
VBIV (NASDAQ .86)
VBI Vaccines is a Massachusetts-based biotech company that has a hepatitis B vaccine that’s already approved, and selling in fifteen countries right now. It’s got a very large safety database (something we’ll discuss in a bit more detail shortly) and it’s designed to overcome the limitations of the currently available SOC vaccines. At a glance, then, it seems to not only have the potential to meet the unmet need (and in turn, the $700 million market opportunity) but also to represent a more attractive risk-reward profile than a Dyanavax/Heplisav exposure.
The asset in question is called Sci-B-Vac.
The list of countries in which Sci-B-Vac is already approved includes Hong Kong, Israel, Philippines, Vietnam and a large portion of West and Central Africa. To date, it has demonstrated safety and efficacy in over 300,000 patients, and VBI has a database of safety figures in hand that spans 5,000 doses.
The vaccine is created using hamster cells, which enables Sci-B-Vac to mimic the virus to which it’s designed to induce an immune response far more closely than so-called second generation vaccines, which use yeast cells to ‘package’ antigens. For reference, Heplisav-B uses yeast cells, but is able to reduce the dosing regimen when compared to the SOCs in the sector because it uses what’s called immunostimulatory sequences (ISS) as an adjuvant, instead of the alum adjuvant that things like Engerix (an example of one of the most widely used SOCs) employ.
The employing of hamster cells as packaging for the antigens, as well as Sci-B-Vac’s mimicking of all three surface antigens of the hepatitis B virus (the S antigen and the pre-S1 and pre-S2 surface antigens), results in an increase in immunogenicity without the necessity for an alternate adjuvant.
This is a key point, as it allows for a maintaining of the safety profile of the alum type vaccines, but an increased elicited response.
To put this another way, with Heplisav-B, Dynavax has taken second generation vaccines and added an adjuvant to allow for reduced dosage. In contrast, with Sci-B-Vac, VBI has completely reengineered the vaccine to allow for higher immunogenicity, which reduces the amount of the vaccine needed. In doing this, it’s reduced the necessary dosage, and overcome the dosing issue that we outlined above as serving to underpin the large unmet need in the space.
That’s not all.
VBI’s vaccine has also demonstrated an equally effective immunogenicity across all patient types – young, old, healthy, and (very importantly) immunosuppressed patients such as diabetes sufferers. There’s a real problem right now with current vaccine options not inducing immunogenicity in diabetes sufferers (and Heplisav-B is included in this group), and Sci-B-Vac seems to solve this problem.
So what’s the development pathway like?
The company is pushing right now to add the US and Europe to its list of approved regions. These are the two big-ticket markets, and approval in both could amount to more than $1 billion in revenue potential, above and beyond Dynavax’s $700 million Heplisav-B US potential. The European pathway is slightly ahead of that of the US, with the company having announced back in February that the CHMP (a department of the EMA) has expressed its support of VBI’s proposed plan to proceed to the Phase III clinical studies of Sci-B-Vac, and that the product information, as well as data from ongoing studies, supports the Phase III clinical studies and VBI’s planned filing of a market authorization application (MAA) for the vaccine. A pivotal study should kick off during the third quarter of this year, and this presents us with a potential 2018 approval in Europe.
According to most recent communication from management, the US approval program is running parallel to that of the European program, which suggests we should see a pivotal initiated in the US this year also, again serving up the potential for approval in 2018.
There’s also a considerable amount of institutional interest in the company. Arch Ventures, headed up by Robert Nelson, and Perceptive Advisors, the top performing sub $1 billion hedge fund of 2015, headed up by biotech guru Joseph Edelman, both hold large stakes in VBI.
Through Opko Health Inc. (NASDAQ:OPK), billionaire biotech entrepreneur Dr. Phillip Frost also holds a large, and growing, stake in the company.
The takeaway here is that VBI is likely around eighteen months behind Dynavax in terms of getting a hepatitis B vaccine on the market in the US and Europe, but given the information available right now, it looks as though VBI’s Sci-B-Vac has a far higher chance of getting a regulatory green light. Sci-B-Vac also looks superior to Heplisav-B, especially in the immunosuppressed patient population, giving the drug a higher peak sales potential than that of its Dynavax made counterpart.
VBIV (NASDAQ .86)
VBI Vaccines is a Massachusetts-based biotech company that has a hepatitis B vaccine that’s already approved, and selling in fifteen countries right now. It’s got a very large safety database (something we’ll discuss in a bit more detail shortly) and it’s designed to overcome the limitations of the currently available SOC vaccines. At a glance, then, it seems to not only have the potential to meet the unmet need (and in turn, the $700 million market opportunity) but also to represent a more attractive risk-reward profile than a Dyanavax/Heplisav exposure.
The asset in question is called Sci-B-Vac.
The list of countries in which Sci-B-Vac is already approved includes Hong Kong, Israel, Philippines, Vietnam and a large portion of West and Central Africa. To date, it has demonstrated safety and efficacy in over 300,000 patients, and VBI has a database of safety figures in hand that spans 5,000 doses.
The vaccine is created using hamster cells, which enables Sci-B-Vac to mimic the virus to which it’s designed to induce an immune response far more closely than so-called second generation vaccines, which use yeast cells to ‘package’ antigens. For reference, Heplisav-B uses yeast cells, but is able to reduce the dosing regimen when compared to the SOCs in the sector because it uses what’s called immunostimulatory sequences (ISS) as an adjuvant, instead of the alum adjuvant that things like Engerix (an example of one of the most widely used SOCs) employ.
The employing of hamster cells as packaging for the antigens, as well as Sci-B-Vac’s mimicking of all three surface antigens of the hepatitis B virus (the S antigen and the pre-S1 and pre-S2 surface antigens), results in an increase in immunogenicity without the necessity for an alternate adjuvant.
This is a key point, as it allows for a maintaining of the safety profile of the alum type vaccines, but an increased elicited response.
To put this another way, with Heplisav-B, Dynavax has taken second generation vaccines and added an adjuvant to allow for reduced dosage. In contrast, with Sci-B-Vac, VBI has completely reengineered the vaccine to allow for higher immunogenicity, which reduces the amount of the vaccine needed. In doing this, it’s reduced the necessary dosage, and overcome the dosing issue that we outlined above as serving to underpin the large unmet need in the space.
That’s not all.
VBI’s vaccine has also demonstrated an equally effective immunogenicity across all patient types – young, old, healthy, and (very importantly) immunosuppressed patients such as diabetes sufferers. There’s a real problem right now with current vaccine options not inducing immunogenicity in diabetes sufferers (and Heplisav-B is included in this group), and Sci-B-Vac seems to solve this problem.
So what’s the development pathway like?
The company is pushing right now to add the US and Europe to its list of approved regions. These are the two big-ticket markets, and approval in both could amount to more than $1 billion in revenue potential, above and beyond Dynavax’s $700 million Heplisav-B US potential. The European pathway is slightly ahead of that of the US, with the company having announced back in February that the CHMP (a department of the EMA) has expressed its support of VBI’s proposed plan to proceed to the Phase III clinical studies of Sci-B-Vac, and that the product information, as well as data from ongoing studies, supports the Phase III clinical studies and VBI’s planned filing of a market authorization application (MAA) for the vaccine. A pivotal study should kick off during the third quarter of this year, and this presents us with a potential 2018 approval in Europe.
According to most recent communication from management, the US approval program is running parallel to that of the European program, which suggests we should see a pivotal initiated in the US this year also, again serving up the potential for approval in 2018.
There’s also a considerable amount of institutional interest in the company. Arch Ventures, headed up by Robert Nelson, and Perceptive Advisors, the top performing sub $1 billion hedge fund of 2015, headed up by biotech guru Joseph Edelman, both hold large stakes in VBI.
Through Opko Health Inc. (NASDAQ:OPK), billionaire biotech entrepreneur Dr. Phillip Frost also holds a large, and growing, stake in the company.
The takeaway here is that VBI is likely around eighteen months behind Dynavax in terms of getting a hepatitis B vaccine on the market in the US and Europe, but given the information available right now, it looks as though VBI’s Sci-B-Vac has a far higher chance of getting a regulatory green light. Sci-B-Vac also looks superior to Heplisav-B, especially in the immunosuppressed patient population, giving the drug a higher peak sales potential than that of its Dynavax made counterpart.
VBIV (NASDAQ .86)
VBI Vaccines is a Massachusetts-based biotech company that has a hepatitis B vaccine that’s already approved, and selling in fifteen countries right now. It’s got a very large safety database (something we’ll discuss in a bit more detail shortly) and it’s designed to overcome the limitations of the currently available SOC vaccines. At a glance, then, it seems to not only have the potential to meet the unmet need (and in turn, the $700 million market opportunity) but also to represent a more attractive risk-reward profile than a Dyanavax/Heplisav exposure.
The asset in question is called Sci-B-Vac.
The list of countries in which Sci-B-Vac is already approved includes Hong Kong, Israel, Philippines, Vietnam and a large portion of West and Central Africa. To date, it has demonstrated safety and efficacy in over 300,000 patients, and VBI has a database of safety figures in hand that spans 5,000 doses.
The vaccine is created using hamster cells, which enables Sci-B-Vac to mimic the virus to which it’s designed to induce an immune response far more closely than so-called second generation vaccines, which use yeast cells to ‘package’ antigens. For reference, Heplisav-B uses yeast cells, but is able to reduce the dosing regimen when compared to the SOCs in the sector because it uses what’s called immunostimulatory sequences (ISS) as an adjuvant, instead of the alum adjuvant that things like Engerix (an example of one of the most widely used SOCs) employ.
The employing of hamster cells as packaging for the antigens, as well as Sci-B-Vac’s mimicking of all three surface antigens of the hepatitis B virus (the S antigen and the pre-S1 and pre-S2 surface antigens), results in an increase in immunogenicity without the necessity for an alternate adjuvant.
This is a key point, as it allows for a maintaining of the safety profile of the alum type vaccines, but an increased elicited response.
To put this another way, with Heplisav-B, Dynavax has taken second generation vaccines and added an adjuvant to allow for reduced dosage. In contrast, with Sci-B-Vac, VBI has completely reengineered the vaccine to allow for higher immunogenicity, which reduces the amount of the vaccine needed. In doing this, it’s reduced the necessary dosage, and overcome the dosing issue that we outlined above as serving to underpin the large unmet need in the space.
That’s not all.
VBI’s vaccine has also demonstrated an equally effective immunogenicity across all patient types – young, old, healthy, and (very importantly) immunosuppressed patients such as diabetes sufferers. There’s a real problem right now with current vaccine options not inducing immunogenicity in diabetes sufferers (and Heplisav-B is included in this group), and Sci-B-Vac seems to solve this problem.
So what’s the development pathway like?
The company is pushing right now to add the US and Europe to its list of approved regions. These are the two big-ticket markets, and approval in both could amount to more than $1 billion in revenue potential, above and beyond Dynavax’s $700 million Heplisav-B US potential. The European pathway is slightly ahead of that of the US, with the company having announced back in February that the CHMP (a department of the EMA) has expressed its support of VBI’s proposed plan to proceed to the Phase III clinical studies of Sci-B-Vac, and that the product information, as well as data from ongoing studies, supports the Phase III clinical studies and VBI’s planned filing of a market authorization application (MAA) for the vaccine. A pivotal study should kick off during the third quarter of this year, and this presents us with a potential 2018 approval in Europe.
According to most recent communication from management, the US approval program is running parallel to that of the European program, which suggests we should see a pivotal initiated in the US this year also, again serving up the potential for approval in 2018.
There’s also a considerable amount of institutional interest in the company. Arch Ventures, headed up by Robert Nelson, and Perceptive Advisors, the top performing sub $1 billion hedge fund of 2015, headed up by biotech guru Joseph Edelman, both hold large stakes in VBI.
Through Opko Health Inc. (NASDAQ:OPK), billionaire biotech entrepreneur Dr. Phillip Frost also holds a large, and growing, stake in the company.
The takeaway here is that VBI is likely around eighteen months behind Dynavax in terms of getting a hepatitis B vaccine on the market in the US and Europe, but given the information available right now, it looks as though VBI’s Sci-B-Vac has a far higher chance of getting a regulatory green light. Sci-B-Vac also looks superior to Heplisav-B, especially in the immunosuppressed patient population, giving the drug a higher peak sales potential than that of its Dynavax made counterpart.
Thanks Sobek (no PM). Check out ACRL and let me know what you think. Good SS with promising tech
Nice, i'll read up the DD on it.
Awesome, thanks.