For BioNTech, the COVID-19 vaccine was simply the opening act

BioNTech’s founding story dates back to the late 1990s, when CEO and co-founder Uğur Şahin, his wife and co-founder Özlem Türeci, and the rest of the seven-person founding team began their research.

Focused specifically on an area dubbed “New Technologies,” mRNA stood out as one area with tremendous potential to deliver the team’s ultimate goal: Developing treatments personalized to an individual and their specific ailments, rather than the traditional approach of finding a solution that happens to work generally at the population level.

Şahin, along with Mayfield venture partner Ursheet Parikh, joined us at TechCrunch Disrupt 2021 to discuss the COVID-19 vaccine, his long journey as a founder, what it takes to build a biotech platform company, and what’s coming next from BioNTech and the technologies it’s developing to help prevent other outbreaks and treat today’s deadliest diseases.

“At that time, mRNA was not potent enough,” Şahin recalled. “It was just a weak molecule. But the idea was great, so we invested many years in an academic setting to improve that. And in 2006, we realized ‘Wow, this is now working. Okay, it’s time to initiate a company’.”

Gingko Bioworks, valued at $15B, begins trading today: Here’s how their business works

Gingko Bioworks, a synthetic biology company now valued at around $15 billion, begins trading on the New York Stock Exchange today.

Gingko’s market debut is one of the largest in biotech history. It’s expected to raise about $1.6 billion for the company. It’s also one of the biggest SPAC deals done to date — Gingko is going public through a merger with Soaring Eagle Acquisition Corp., which was announced in May. 

Shares opened at $11.15 each this morning under the ticker DNA — biotech dieharders will recognize it as the former ticker used by Genentech. 

The exterior of the NYSE is decked out in Gingko decor. The imagery is clearly sporting Jurassic Park themes, as MIT Tech Review’s Antonio Regalado pointed out. It’s probably intentional: Jason Kelly, the CEO of Ginkgo Bioworks, has been re-reading Jurassic Park this week, he tells TechCrunch. 

The decor also sports a company motto: “Grow everything.”

Ginkgo was founded in 2009, and now bills itself as a synthetic biology platform. That’s essentially premised on the idea that one day, we’ll use cells to “grow everything,” and Gingko’s plan is to be that platform used to do that growing. 

Kelly, who often uses language borrowed from computing to describe his company, likens DNA to code. Gingko, he says, aims to “program cells like you can program computers.” Ultimately, those cells can be used to make stuff: like fragrances, flavors, materials, drugs or food products. 

The biggest lingering question over Gingko, ever since the SPAC deal was announced, has centered on its massively high valuation. When Moderna, now a household name thanks to its Covid-19 vaccines, went public in 2018, the company was valued at $7.5 billion. Gingko’s valuation is double that number. 

“I think that surprises people to be honest,” Kelly says. 

How is Gingko going to make money? 

Ginkgo’s massive valuation seems even starker when you look at its existing revenues. SEC documents show that the company pulled in $77 million in revenue in 2020, which increased to about $88 million in the first 6 months of 2021 (per an August investor call) The company has also reported losses: including $126.6 million in December 2020 and $119.3 million in 2019. 

Gingko is aiming to increase revenue a significant amount in 2021. SEC documents initially noted that the company aimed to draw about $150 million in revenue in 2021, but the August earning call updated that total for the year to over $175 million. 

Gingko aims to make money in two ways: first it contracts with manufacturers during the research and development phase (i.e. while the company works out how to manufacture a cell that spits out a certain fragrance, bio-based nylon, or a meatless burger). That process happens in Gingko’s “foundry” a massive factory for bioengineering projects. 

This source of money is already starting to flow. Gingko reported $59 million in foundry revenue for 2020, and anticipates $100 million in 2021, per the August investor call

This revenue, though, isn’t covering the full costs of Gingko’s operations according to the information shared by the company in SEC documents. It is covering an increasing share, though, and as Gingko scales up its platform, costs will come down. Based on fees alone, Kelly projects Gingko will break even by 2024 or 2025. 

The second type of revenue comes from royalties, milestone payments, or in some cases equity stakes in the companies that go on to sell products, like fragrances or meatless burgers, made using Gingko’s facilities or know-how. It’s this source of income that will make up the vast majority of the company’s future worth according to its expectations. 

Once the product is made and marketed by another company, it requires little to no more work on Gingko’s part – all the company does is collect cash. 

The company is often hesitant to incorporate these earnings into projections, because they rely on other companies bringing products to market. That means it’s hard to know for sure when these downstream payments will emerge. “In our models, we are very sensitive that, at the end of the day, they’re not our products. I cannot predict when Roche might bring a drug to market and give me my milestones,” says Kelly. 

Kelly says there’s evidence this model will start to work in the near-term. 

Gingko earned a “bolus” milestone payment of 1.5 million shares of The Cronos Group, a cannabis company, for developing a commercially viable, lab grown rare cannabinoid called CBG for commercial use (there are seven more in strains development, says Kelly). These milestone payments (in cash or shares) are earned when a company achieves some predetermined goal using Gingko’s platform. 

Gingko has also worked with Aldevron to manufacture an enzyme critical to the production of mRNA vaccines, and plans to collect royalty payments from that relationship — though no foundry fees were collected from this project. 

Finally, Gingko has negotiated an equity stake in Motif Foodworks, a spinout company based on its technology. That company has so far raised about $226 million, and will aim to launch a lab-grown beef product developed at Gingko’s foundry, paying Gingko the aforementioned foundry fees already for this contribution.

“The biggest value driver” of Gingko, according to Kelly

This rich source of cash will depend a lot on the outside contractor’s ability to manufacture and sell products made using Gingko’s platform. This opens the company up to some risk that’s beyond its control. Maybe, for instance, it turns people don’t want bio-manufactured meat as much as many anticipated – that means some types of downstream payments may not materialize. 

Kelly says he’s not particularly worried about this. Even if one particular program fails, he’s planning on having so many programs running that one or two are bound to succeed. 

“I’m just sorta like: some will work, some won’t work. Some will take a year, some will take three years. It doesn’t really matter, as long as everybody is working with us,” he says. “Apple doesn’t stress about what apps are going to be the next big app in the app store,” he continues.  

One key metric to watch for Gingko going forward will be how many new cell programs they’re managing to close. So far, Gingko has added thirty programs this year, says Kelly. Last year, there were 50 programs. 

Remember: some of the projects are Gingko spinouts, like Motif Foodworks, not customers that come to the platform on their own. And historically, the number of companies Gingko has partnered with has been a point of criticism. Per SEC documents, the majority of revenue came from two large partners in 2020 – though Kelly told Business Insider that this was a pandemic-related downturn. 

The more programs Gingko has, the more it becomes insulated from the success or failure of any one product. Plus it’s a sign that people are at least using the “app store” for biology. 

“The biggest value driver of Gingko is how quickly we add programs,” Kelly says. 

New Zealand startup HeartLab raises $2.45M to bring heart scanning software to the US

New Zealand-based medtech startup HeartLab has raised $2.45 million in seed funding that it says will help the company expand its AI-powered heart scanning and reporting platform to cardiologists in the United States by early next year.

HeartLab provides an end-to-end solution for echocardiograms, the ultrasound tests that doctors use to examine a patient’s heart structure and function. Not only does the software help sort and analyze ultrasound images to help doctors diagnose cardiovascular disease, but it also streamlines the workflow by generating patient reports for doctors that can then be added to a patient’s health record.

Will Hewitt, 21, started HeartLab when he was 18 years old studying applied mathematics and statistics at the University of Auckland and working as a researcher at the Auckland Bioengineering Institute. The idea for the startup came to him as he listened to cardiologist, and now co-founder, Patrick Gladding explain how time-consuming and potentially inaccurate it is for doctors to have to review multiple scans manually everyday.

“You’ve got a really repetitive manual task done by a highly trained professional,” Hewitt told TechCrunch. “To start with, we just decided to train the AI to do one really small part of the doctor’s job, which was to look at these scans and generate a couple of different measurements that normally the doctor would have to do themselves,” said Hewitt.

In order to replicate the tedious process that doctors were doing, HeartLab built its own in-house labeling tool with sonographers that includes step-by-step guides and prompts to collect data on a range of different measurements. Hewitt said this initiative was one of the most valuable efforts of engineering the company has invested in to date because it has lead to cross validation, which is used to test the ability of the machine learning model to predict new data, as well as flag problems like selection bias and overfitting.

Once HeartLab was able to successfully replicate the scanning process, the company worked to expand its services in a way that would relieve doctors of further admin minutiae so they could spend more time actually treating their patients. Usually, doctors use a software tool that analyzes the images, another that visualizes patterns and another that actually writes up the report, says Hewitt. HeartLab’s platform, called Pulse, can now condense those processes into one software.

Cardiologists and sonographers at four different sites in New Zealand are trialing HeartLab’s tech now, which is also awaiting regulatory approval from the U.S.’s Food and Drug Administration. HeartLab anticipates FDA approval of Pulse by the first quarter of 2022, which is when the startup can begin selling the SaaS product.

“To begin with we want to talk to small and medium clinics over in the U.S.,” said Hewitt. “We’ve actually found that our products are most popular at those clinics because it replaces more software than at a larger clinic. At a larger clinic some of these bits of software they’ve already had to purchase, versus a smaller clinic, it’s stuff that they couldn’t access anyway. So when we get to the states, we want to start shipping mostly to those sorts of users while we work out how to best pitch our value proposition to the larger clinics.”

Hewitt says the funds from this round will also help the startup hire 10 more staff members to join the existing 13-member team based in Auckland. Having more tech talent on board will help HeartLab advance its product offering. At the moment, Pulse is at the point where it sees so many scans and takes so many measurements that it can get through the process quicker than a doctor could on their own and actually pick out patterns that a doctor wouldn’t see, according to Hewitt. The next step, which a good chunk of the seed funding is going toward, is how to be diagnostic about disease rather than just being able to indicate it.

“How do we actually provide something that normally doctors would have to order another scan for?” said Hewitt. “One of the key ideas with AI is you can create mappings from low-resolution images like ultrasounds. How can we try to learn a pattern from an ultrasound that’s similar to what you might see from an MRI, for example?”

If HeartLab can figure out how to glean advanced information from an echocardiogram instead of an MRI, it would be able to save hospitals, clinics and patients a lot of money. Each cardiac MRI can cost about $1,000 to $5,000, which is about five times the price of an echocardiogram.

“I’d say the biggest challenge for us is, how can we transform from a company that at the moment can deliver products to a few local clinics successfully to actually building a product that scales and delivers a really good experience to lots of users and different hospitals?” said Hewitt.

Advancements in early diagnostics and imaging tech like HeartLabs’ is causing an increased demand for such tools. As a result, the global AI-enabled medical imaging solutions market is expected to reach $4.7 billion by 2027. By extending its reach to the U.S., where heart disease is the leading cause of death, HeartLab is poised to take a big piece of that pie.

In total, HeartLab has publicly raised about $3.2 million in funding, which includes a pre-seed last October of about $800,000 led by Icehouse Ventures with support from Founders Fund, the San Francisco-based VC firm that led the round announced on Thursday. Icehouse Ventures also contributed to the oversubscribed seed round, along with another New Zealand firm Outset Ventures and private investor and CEO of design platform Figma, Dylan Field.

“The use of AI in medicine is reducing pressures on health systems and ultimately saving lives,” said Founders Fund partner Scott Nolan, who has led investment rounds for three other New Zealand startups, in a statement. “The HeartLab team has built a really compelling AI-powered platform that doctors love to use.”

African genomics startup 54gene raises $25M to expand precision medicine capabilities

Less than 3% of genetic material used in global pharmaceutical research is from Africa. The staggering gap is quite surprising because Africans and people of African descent are reported to be more genetically diverse than any other population.

Since launching in 2019, African genomics startup 54gene has been at the forefront of bridging this divide in the global genomics market. Today, the company has secured $25 million in Series B funding to bolster its efforts.

This round comes a year after the company, founded by Dr Abasi Ene-Obong, raised $15 million in Series A and two years after closing a $4.5 million seed round.

In total, 54gene has raised more than $45 million since its inception.

With the world’s analyzed genomes coming mostly from anywhere that isn’t Africa, the continent remains a valuable source of new genetic information for health and drug discovery research.

This is where 54gene’s work is relevant. The company conducts and leverages this research to ensure Africans are recipients of upcoming drug and medical discoveries.

Last year when we covered the company last year, CEO Ene-Obong disclosed that for 54gene to conduct this research, it recruits voluntary participants who donate genetic samples via swab or blood tests.

It still very much works this way. However, instead of depending on third-party health centres like hospitals and sending the samples abroad for analysis, 54gene launched its own genetics sequencing and microarray lab in Lagos last September. The company did this in partnership with U.S.-based biotech company Illumina.

Speaking with TechCrunch, Ene-Obong says in addition to the genotyping capabilities offered, the lab also provides whole-genome sequencing (WGS) and whole-exome sequencing (WES).

Not to bore you with the jargon but here’s why this is important. Genotyping tends to show only 0.02% of an individual’s DNA; however, WGS can show almost 100% of the same person’s DNA.

For WES, although it represents only 1.5% of the human genome, it shows approximately 85% of known disease-related variants.

With these three in place, the company can advance genomics research and expand its ability to help scientists and researchers in Africa.

Unlike fintech and other fast-moving sectors like e-commerce, innovation in healthtech takes some time to take shape finally. 54gene is one of the few startups in the sector and even in Africa to have moved from seed stage to Series B in under two years.

It’s this sort of frightening speed that makes one wonder what the company is doing right. So I ask the CEO whether the company is indeed seeing significant progress in advancing African genomics; he answers in the affirmative.

“Though the arc of conducting early research through drug approval can be long in biotech, we have taken the approach to building the backbone that is needed for short-term successes to long-term gains that provide better healthcare delivery and treatment outcomes from diseases,” he added.

In addition to setting its first lab, the CEO says the company increasing its biobanking capacity by 5x and is counts that as a major success.

During its last raise, 54gene had a biobank capacity for 60,000 samples. If Ene-Obong comments are anything to go by, the two-year-old company currently has a biobank with over 300,000 samples, close to its longer-term aim to manage up to 500,000.

Another one is the recruitment and training of talent to generate and process data needed to produce insights for the company’s drug discovery efforts.

Nigeria has a dearth of experienced clinicians and with the remaining few leaving in droves, it is not hard to see why it is a win for the company. Knowing this, 54gene plans to use part of the new funding to recruit and train more professionals

Other use of funding will expand its capabilities in sequencing, target identification and validation, and precision medicine clinical trials. Also of great importance is its expansion across the African continent.

To aid this expansion, 54gene will have to carry out partnerships. A recent one occurred between the company and the Tanzania Human Genetics Organization and Ene-Obong says 54gene is in varying stages of conversations with more partners. However, he was tight-lipped on who they might be.

“We are excited about our Africa-first approach which will see us expand to countries within East and West Africa in the coming year,” he added.

54gene made some hires to this end: Michelle Ephraim, Colm O’Dushlaine, Peter Fekkes, Teresia Bost, Jude Uzonwanne — all of who have decades of experience working with companies like Leica Biosystems, Regeneron Genetic Center, Novartis, Celgene, and the Bill and Melinda Gates Foundation

Pan-African venture capital firm Cathay AfricInvest Innovation Fund led this round. Lead investor from the company’s Series A funding, Adjuvant Capital invested once again with participation from other VCs including KdT Ventures, Plexo Capital, Endeavor Capital, and Ingressive Capital.

AgBiome lands $166M for safer crop protection technology

AgBiome, developing products from microbial communities, brought in a $116 million Series D round as the company prepares to pad its pipeline with new products.

The company, based in Research Triangle Park, N.C., was co-founded in 2012 by a group including co-CEOs Scott Uknes and Eric Ward, who have known each other for over 30 years. They created the Genesis discovery platform to capture diverse microbes for agricultural applications, like crop protection, and screen the strains for the best assays that would work for insect, disease and nematode control.

“The microbial world is immense,” said Uknes, who explained that there is estimated to be a trillion microbes, but only 1% have been discovered. The microbes already discovered are used by humans for things like pharmaceuticals, food and agriculture. AgBiome built its database in Genesis to house over 100,000 microbes and every genome in every microbe was sequenced into hundreds of strains.

The company randomly selects strains and looks for the best family of strains with a certain activity, like preventing fungus on strawberries, and creates the product.

AgBiome co-CEOs Scott Uknes and Eric Ward. Image Credits: AgBiome

Its first fungicide product, Howler, was launched last year and works on more than 300 crop-disease combinations. The company saw 10x sales growth in 2020, Uknes told TechCrunch. As part of farmers’ integrated pest program, they often spray fungicide applications 12 times per year in order to yield fruits and vegetables.

Due to its safer formula, Howler can be used as the last spray in the program, and its differentiator is a shorter re-entry period — farmers can spray in the morning and be able to go back out in the field in the afternoon. It also has a shorter pre-harvest time of four hours after application. Other fungicides on the market today require seven days before re-entry and pre-harvest, Uknes explained.

AgBiome aims to add a second fungicide product, Theia, in early 2022, while a third, Esendo was submitted for Environmental Protection Agency registration. Uknes expects to have 11 products, also expanding into insecticides and herbicides, by 2025.

The oversubscribed Series D round was co-led by Blue Horizon and Novalis LifeSciences and included multiple new and existing investors. The latest investment gives AgBiome over $200 million in total funding to date. The company’s last funding round was a $65 million Series C raised in 2018.

While competitors in synthetic biology often sell their companies to someone who can manufacture their products, Uknes said AgBiome decided to manufacture and commercialize the products itself, something he is proud of his team for being able to do.

“We want to feed the world responsibly, and these products have the ability to substitute for synthetic chemicals and provide growers a way to protect their crops, especially as consumers want natural, sustainable tools,” he added.

The company has grown to over 100 employees and will use the new funding to accelerate production of its two new products, building out its manufacturing capacity in North America and expanding its footprint internationally. Uknes anticipates growing its employee headcount to 300 in the next five years.

AgBiome anticipates rolling up some smaller companies that have a product in production to expand its pipeline in addition to its organic growth. As a result, Uknes said he was particular about the kind of investment partners that would work best toward that goal.

Przemek Obloj, managing partner at Blue Horizon, was introduced to the company by existing investors. His firm has an impact fund focused on the future of food and began investing in alternative proteins in 2016 before expanding that to delivery systems in agriculture technology, he said.

Obloj said AgBiome is operating in a $60 billion market where the problems include products that put toxic chemicals into the ground that end up in water systems. While the solution would be to not do that, not doing that would mean produce doesn’t grow as well, he added.

The change in technology in agriculture is enabling Uknes and Ward to do something that wasn’t possible 10 years ago because there was not enough compute or storage power to discover and sequence microbes.

“We don’t want to pollute the Earth, but we have to find a way to feed 9 billion people by 2050,” Obloj said. “With AgBiome, there is an alternative way to protect crops than by polluting the Earth or having health risks.”

How Colossal sold investors on a quest to resurrect a woolly mammoth

There are a growing number of companies interested in CRISPR’s potential to upend medicine. It’s probably safe to say there’s only one company interested in using the gene-editing system to create a living, breathing woolly mammoth. Or, at least, something pretty close to it. 

That’s the primary mission of a new company called Colossal. Co-founded by maverick geneticist George Church, and entrepreneur Ben Lamm, the former CEO of Hypergiant, the company aims to bring one of those creatures back to life using CRISPR to edit the genomes of existing Asian elephants. In that sense the creature would be very similar to a woolly mammoth, but would be more like an elephant-mammoth hybrid. 

It’s a project that Church’s lab has been invested in for years. But now, Church and Lamm have managed to sell investors on the idea that bringing back a mammoth is more than a science-fiction project. 

Today Colossal announced its launch and a $15 million seed round led by Thomas Tull, former CEO of Legendary Entertainment (the company responsible for the likes of Dune, Jurassic World, the Dark Knight). The round includes investments from Breyer Capital, Draper Associates, Animal Capital, At One Ventures, Jazz Ventures, Jeff Wilke, Bold Capital, Global Space Ventures, Climate Capital, Winklevoss Capital, Liquid2 Ventures, Capital Factory, Tony Robbins and First Light Capital.

“These two are a powerhouse team who have the ability to completely shift our understanding of modern genetics while developing innovative technologies that not only help bring back lost species, but advance the entire industry,” Robbins tells TechCrunch. “I am proud to be an investor in their journey.”

Lamm comes to Colossal as the founder of Hypergiant, a Texas-based A.I company. He has also built and sold three other companies: Conversable (acquired by LivePerson), Chaotic Moon Studios (acquired by Accenture) and Team Chaos (acquired by Zynga). 

And big, provocative, projects are part of what Church is already famous for. 

Church created the first direct genomic sequencing method in the 1980s, and went on to help initiate the Human genome project. Now, he leads synthetic biological efforts at the Wyss Institute, where he has focused on synthesizing entire genes and genomes. 

 While CRISPR gene editing has only just entered human trials, and typically aims to edit a single disease-causing gene, Church’s projects often think far bigger – often along the lines of speeding along evolution. In 2015, Church and colleagues edited 62 genes in pig embryos (a record at the time), in an effort to create organs for human transplants. 

The company spun out of that endeavor, eGenesis, is behind on Church’s initial timeline (he predicted pig organs would be viable transplants by 2019), but the company is performing preclinical experiments on monkeys.

Resurrecting a woolly mammoth has long been in Church’s crosshairs. In 2017, his lab at Harvard University reported that they had managed to add 45 genes to the genome of an Asian elephant in an attempt to recreate the mammoth. Through a sponsored research agreement, this company will fully support the mammoth work at Church’s lab.

The company’s pitch for bringing back the Mammoth, per the press release, is to combat the effects of climate change through ecosystem restoration. Lamm expands on that point: 

“Our goal is not to just bring back the Mammoth, that’s a feat in itself,” he says. “It’s for the successful re-wilding of mammoths. If you take that toolkit, you have all the tools are your disposal to prevent extinction or to bring back critically endangered species.”

About 1 million plant and animal species are threatened with extinction. Colossal’s mammoth project, should it succeed, would suggest they have developed the capacity to both repopulate recently dead creatures, and even perform what Lamm calls “genetic rescue” to stop them from disappearing in the first place. 

Genetic rescue is the process of increasing genetic diversity in an endangered population – this could be achieved through gene-editing, or in some cases, cloning new individuals to create a wider gene pool (provided the clone and the existing animals have different enough genes). There is already some evidence that this is possible. In February 2021, a black footed ferret named Elizabeth Ann became the first cloned endangered species native to North America. She was cloned from the DNA housed in frozen tissue samples collected in 1988. 

Mammoth in the middle of mountains. This is a 3d render illustration

Bringing back extinct species might help combat a consequence of climate change, but it doesn’t solve the root problem. As long as the human- based drivers of climate change remain in-tact, there’s not much hope for a newly reborn creature that was killed by climate change the first time; in fact, fluctuating climates were one reason megafauna died off in the first place.

And, there could be serious ecosystem ramifications from re-wilding long-dead species, like spreading novel disease, displacing existing species, and altering the actual landscape (elephants are ecosystem engineers, after all). 

If tackling biodiversity is part of Colossal’s core pitch, why go directly for the mammoth when there are species that might be saved right now? Lamm notes that the company may also try to edit the genomes of Asian elephants to make them more resilient, however, the mammoth project remains the company’s “north star.”

The argument, from Lamm’s perspective, is that the mammoth project is a moonshot. Even if the company shoots for the moon and lands among the stars, they will have to develop proprietary technology for de-extinction that might then be licensed or sold to potential buyers. 

“It’s very similar to the Apollo program – which was a literal moonshot. A bunch of technologies were created along the way. Things like GPS, the fundamentals of the internet, and semiconductors. All those were highly monetizable,” he says.  

In short, the mammoth project is more like an incubator for developing a host of intellectual property. That might include projects like artificial wombs or other applications of CRISPR, Lamm notes. These products will still face massive scientific hurdles – existing artificial womb projects aren’t even near entering human trials – but those hurdles might be slightly more achievable than living, breathing beings. 

Not that Colossal doesn’t have plenty of interim plans while that research is being done. The company is also out to create an especially memorable brand along the way.  Lamm says you could think of the brand as “Harvard meets MTV” says Lamm. 

Though there’s no company that Lamm says is a direct comparison to Colossal, he mentioned several large space brands and agencies like Blue Origin, SpaceX, and notably NASA in our conversation — “I think that NASA is the best brand the United States ever made,” he notes. 

“If you look at SpaceX and Blue Origin and Virgin, my 91 year-old grandmother knew these guys went to space. ULA and other people have been launching rockets and putting satellites up there for decades – nobody cared. These companies did a great job of bringing the public in,” he says. 

It’s all a bit reminiscent of Elon Musk’s plan for sending humans to Mars, although Starship (the vehicle that’s supposed to get us there) hasn’t moved beyond prototype test flights. 

The big ideas, says Lamm, draw in the public. The intellectual property developed along the way can pacify investors in the meantime. The perspective is inescapably sci-fi, but perhaps it’s supposed to be that way. 

And that’s not to say that the company isn’t absolutely dead-set on bringing a mammoth to life. This capital, says Lamm, should be sufficient to help develop a viable mammoth embryo. They’re aiming to have the first set of calves born in the next four to six years. 

Teatis, low-sugar superfood powders developer for diabetics, closes seed round

A serial entrepreneur Hiroshi Takatoh recognized the need for convenient and nutritious food for critically ill consumers after losing his late wife to cancer.

Takatoh founded Teatis, a plant-based sugar blocking superfood powder for diabetic consumers, in 2017 in stealth mode and went fully operational in April 2021 by teaming up with a group of doctors and registered nutritionists.

Teatis announced today it has raised $700,000 seed funding to advance its growth in the US market.  The seed money brings Teatis’ total funding to over $1million.

The seed round was led by Genesia Ventures, Ryo Ishizuka, former CEO and co-founder of Japanese e-commerce company Mercari and Takuya Noguchi, CEO and founder of Japan’s skincare brand BULK HOMME. Seven other angel investors also participated in the seed funding.

Teatis will use the seed money for production and marketing in the US, where 122 million diabetics and pre-diabetics continue to work for prevention and treatment against diabetes, CEO and co-founder of Teatis Hiroshi Takatoh told TechCrunch. The company is now focusing on the US market where its production is located while its next funding, a Series A, is set for next year, Takatoh added.

“Most of our consumers, about 88%, are diabetics, and our recipe is built to help diabetics manage their blood sugar. A staggering number of Americans suffer from diabetes, and there is significant demand for diabetic-friendly foods that are nutritious, convenient and functional,” Takatoh said.

Teatis develops a supplement for all consumers interested in low-sugar foods, as well as pre-diabetics, Takatoh said. Teatis’ plant-based powders does not contain chemicals or sweeteners but include a special Japanese ingredient such as brown seaweed extract (Arame) that is proven to suppress the absorption of sugar from the intestinal tract and reduce blood sugar levels. The low-sugar powder can be made into teas, lattes or added to smoothies.

The US meal placement market size for diabetes is estimated at $5 billion while the US consumer packaged foods market for diabetes is approximately $300 billion, Takatoh said.

“We combine food science and technology to solve problems for diabetics through food products and telehealth,” Takatoh said.

With its plan on building out a comprehensive one-stop shop for diabetic health, Teatis will launch a Registered Dietitian platform, Teatis RD on Demand, this month, to offer a full-service such as food products, telehealth, and recipes, for those battling diabetes.

Teatis RD on Demand will provide private, 1-on-1 sessions with registered dietitians. It will start at $29 per 30 minutes, which is a reduced cost, versus traditional offline appointments that cost $150 per 30 minutes, and Teledoc, which costs $90 per 30 minutes, according to Takatoh.

“Many existing players in space are old companies that don’t have digital competency and data-driven production methods. Mr. Takatoh is a proven serial entrepreneur with the qualities and boldness to take over the market…I’m excited to see how Teatis’ great ideas and products will help many people who are suffering from diabetes and other chronic diseases in the future,” Genesia Ventures Manager Shunsuke Sagara said.

Emulate Inc closes $82M Series E to fund expansion of “organ-on-a-chip” products

Emulate Inc., a biotech company focused on developing “organ-on-a-chip” technology, closed an $82 million Series E round on Tuesday. This latest round is intended to formulate a massive investment in a “roadmap” for developing model organ systems created to fit drugmakers’ needs and bring the idea of an organ-on-a-chip into use in the lab. 

An organ-on-a-chip is pretty much exactly what it sounds like: it’s a recreation of a human organ (or system of human organs) scaled down into a tiny piece of hardware about the size of a AA battery. That hardware, the so-called “chip,” contains chambers where human cells (like brain cells, the kidney, lung, brain intestine, etc), can be grown. Then the chip can be manipulated to simulate breathing, blood flow through an organ or other mechanical forces that might happen in a human body. 

Ultimately, the chip is supposed to mimic the conditions within a human body, and allow drugmakers to better predict what might happen when a new candidate is introduced. It’s a new model for experiments that could prove critical in the pre-clinical study process. Right now that area of research is dominated by traditional cell- or animal-based models – though Emulate, and other similar companies are hoping to change that paradigm. 

Emulate was founded in 2013 and has, so far, raised about $255 million in funding. This most recent Series E round, led by Northpond Ventures and Perceptive Advisors, is part of Emulate’s plan to invest more heavily in R&D, and create specific organ-on-a-chip applications that they’ve honed in on through conversations with drug companies. So far, Emulate counts 21 major drug companies, including Roche, Genentech, Johnson & Johnson and Gilead Sciences as customers. 

“We researched what pharma is spending their R&D dollars on – particular types of molecules, biologics and so-forth – then we created a roadmap, a series of applications aligned to where big pharma is spending their money” Jim Corbett, the CEO of Emulate tells TechCrunch. 

In January, Emulate announced several new products and services that are part of this roadmap. They include the Emulate brain chip, designed to aid with research into central nervous system disorders (like Alzheimer’s), an immune cell recruitment application that will investigate how the immune system interacts across the lungs, liver, and intestine (using lung-chips, liver-chips, and intestine chips), and a microbiome model integrated into the liver chip. 

Corbett says the company will look to roll out 14 applications over the next two years, seven of which will roll out next year. 

Organs on chips have been around for about a decade. The NIH has launched them into space to study the effects of spaceflight, and has been developing tissue chip testing and validation programs since 2010.

A 2020 review paper in Bioengineering notes the organ-on-a-chip industry was recently valued around $21 million, but could grow to about $220 million by 2025. 

A lot of that growth will depend on the potential for an organ-on-a-chip to disrupt the preclinical side of the drug testing process. And that itself depends a lot on how the FDA views data collected on that platform. 

The specific organ-on-a-chip technology itself doesn’t need to be FDA approved (it’s not a  therapeutic or device), but drug companies will almost certainly seek assurance that the agency is receptive to experiments using organs-on-chips. 

From Corbett’s perspective, he says the FDA has proved “very receptive” to data collected on these platforms. 

There is evidence the company has worked closely with the FDA in the past. In 2020, for instance, Emulate entered into a Cooperative Research and Development Agreement (CRADA), with the FDA. A CRADA agreement allows a non-federal collaborator to provide funding and equipment for a research project conducted at an FDA laboratory. The FDA provides no funding, but does allow for the collaborator to license intellectual property developed during such projects. 

Through this program, Emulate’s lung chips were used in COVID-19 research. The brain chip, liver, and intestine chips were also used for individual research projects. 

FDA collaboration aside there’s also been regulatory movement that could favor companies pursuing organ chips. For instance, the FDA Modernization Act of 2021, introduced in Congress in April, which would allow the FDA to use “alternative testing methods to animal testing” to evaluate safety and efficacy of drugs. The bill specifically includes organs on chips in its definition of a non-clinical test or study.

“If the Modernization Act goes through, it’s clearly spelled out,” says Corbett. 

Still, the field of organ-on-a-chip research is relatively new. Whether or not it will eventually help more drug candidates materialize is still theory. Though, with a new round of funding and a changing regulatory environment, we could have solid answers sooner rather than later. 

 

Avalo uses machine learning to accelerate the adaptation of crops to climate change

Climate change is affecting farming all over the world, and solutions are seldom simple. But if you could plant crops that resisted the heat, cold, or drought instead of moving a thousand miles away, wouldn’t you? Avalo helps plants like these become a reality using AI-powered genome analysis that can reduce the time and money it takes to breed hardier plants for this hot century.

Founded by two friends who thought they’d take a shot at a startup before committing to a life of academia, Avalo has a very direct value proposition, but it takes a bit of science to understand it.

Big seed and agriculture companies put a lot of work into creating better versions of major crops. By making corn or rice ever so slightly more resistant to heat, insects, drought or flooding, they can make huge improvements to yields and profits for farmers, or alternatively make a plant viable to grow somewhere it couldn’t before.

“There are big decreases to yields in equatorial areas — and it’s not that corn kernels are getting smaller,” said co-founder and CEO Brendan Collins. “Farmers move upland because salt water intrusion is disrupting fields, but they run into early spring frosts that kill their seedlings. Or they need rust resistant wheat to survive fungal outbreaks in humid, wet summers. We need to create new varieties if we want to adapt to this new environmental reality.”

To make those improvements in a systematic way, researchers emphasize existing traits in the plant; this isn’t about splicing in a new gene but bringing out qualities that are already there. This used to be done by the simple method of growing several plants, comparing them, and planting the seeds of the one that best exemplifies the trait — like Mendel in Genetics 101.

Nowadays, however, we have sequenced the genome of these plants and can be a little more direct. By finding out which genes are active in the plants with a desired trait, better expression of those genes can be targeted for future generations. The problem is that doing this still takes a long time — as in a decade.

The difficult part of the modern process stems (so to speak) from the issue that traits, like survival in the face of a drought, aren’t just single genes. They may be any number of genes interacting in a complex way. Just as there’s no single gene for becoming and Olympic gymnast, there isn’t one for becoming drought-resistant rice. So when the companies do what are called genome-wide association studies, they end up with hundreds of candidates for genes that contribute to the trait, and then must laboriously test various combinations of these in living plants, which even at industrial rates and scales takes years to do.

Numbered, genetically differentiated rice plants being raised for testing purposes.

“The ability to just find genes and then do something with them is actually pretty limited as these traits become more complicated,” said Mariano Alvarez, co-founder and CSO of Avalo. “Trying to increase the efficiency of an enzyme is easy, you just go in with CRISPR and edit it — but increasing yield in corn, there are thousands, maybe millions of genes contributing to that. If you’re a big strategic [e.g. Monsanto] trying to make drought tolerant rice, you’re looking at 15 years, 200 million dollars… it’s a long play.”

This is where Avalo steps in. The company has built a model for simulating the effects of changes to a plant’s genome, which they claim can reduce that 15-year lead time to 2 or 3, and the cost by a similar ratio.

“The idea was to create a much more realistic model for the genome that’s more evolutionarily aware,” said Collins. That is, a system that models the genome and genes on it that includes more context from biology and evolution. With a better model, you get far fewer false positives on genes associated with a trait, because it rules out far more as noise, unrelated genes, minor contributors, and so on.

He gave the example of a cold-tolerant rice strain that one company was working on. A genome-wide association study found 566 “genes of interest,” and to investigate each costs somewhere in the neighborhood of $40K due to the time, staff, and materials required. That means investigating this one trait might run up a $20M tab over several years, which naturally limits both the parties who can even attempt such an operation, and the crops that they will invest the time and money in. If you expect a return on investment, you can’t spend that kind of cash improving a niche crop for an outlier market.

“We’re here to democratize that process,” said Collins. In that same body of data relating to cold-tolerant rice, “We found 32 genes of interest, and based on our simulations and retrospective studies, we know that all of those are truly causal. And we were able to grow 10 knockouts to validate them, 3 in a 3-month period.”

In each graph, dots represent confidence levels in genes that must be tested. The Avalo model clears up the data and selects only the most promising ones.

To unpack the jargon a little there, from the start Avalo’s system ruled out more than 90 percent of the genes that would have had to be individually investigated. They had high confidence that these 32 genes were not just related, but causal — having a real effect on the trait. And this was borne out with brief “knockout” studies, where a particular gene is blocked and the effect of that studied. Avalo calls its method “gene discovery via informationless perturbations,” or GDIP.

Part of it is the inherent facility of machine learning algorithms when it comes to pulling signal out of noise, but Collins noted that they needed to come at the problem with a fresh approach, letting the model learn the structures and relationships on its own. And it was also important to them that the model be explainable — that is, that its results don’t just appear out of a black box but have some kind of justification.

This latter issue is a tough one, but they achieved it by systematically swapping out genes of interest in repeated simulations with what amount to dummy versions, which don’t disrupt the trait but do help the model learn what each gene is contributing.

Avalo co-founders Mariano Alvarez (left) and Brendan Collins by a greenhouse.

“Using our tech, we can come up with a minimal predictive breeding set for traits of interest. You can design the perfect genotype in silico [i.e. in simulation] and then do intensive breeding and watch for that genotype,” said Collins. And the cost is low enough that it can be done by smaller outfits or with less popular crops, or for traits that are outside possibilities — since climate change is so unpredictable, who can say whether heat- or cold-tolerant wheat would be better 20 years from now?

“By reducing the capital cost of undertaking this exercise, we sort of unlock this space where it’s economically viable to work on a climate-tolerant trait,” said Alvarez.

Avalo is partnering with several universities to accelerate the creation of other resilient and sustainable plants that might never have seen the light of day otherwise. These research groups have tons of data but not a lot of resources, making them excellent candidates to demonstrate the company’s capabilities.

The university partnerships will also establish that the system works for “fairly undomesticated” plants that need some work before they can be used at scale. For instance it might be better to super-size a wild grain that’s naturally resistant to drought instead of trying to add drought resistance to a naturally large grain species, but no one was willing to spend $20M to find out.

On the commercial side, they plan to offer the data handling service first, one of many startups offering big cost and time savings to slower, more established companies in spaces like agriculture and pharmaceuticals. With luck Avalo will be able to help bring a few of these plants into agriculture and become a seed provider as well.

The company just emerged from the IndieBio accelerator a few weeks ago and has already secured $3M in seed funding to continue their work at greater scale. The round was co-led by Better Ventures and Giant Ventures, with At One Ventures, Climate Capital, David Rowan and of course IndieBio parent SOSV participating.

“Brendan convinced me that starting a startup would be way more fun and interesting than applying for faculty jobs,” said Alvarez. “And he was totally right.”

FDA fully approves Pfizer-BioNTech’s COVID-19 vaccine

The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer-BioNTech’s COVID-19 vaccine, making it the first vaccine to achieve that status. The mRNA-based vaccine has been available since late last year through an Emergency Use Authorization (EUA), and will continue to be offered under that designation for those aged 12 to 15 until that separate approval process goes through, but the U.S. drug regulator now recognizes the Pfizer vaccine as fully approved and certified for adults 16 and up.

Part of receiving the approval means that Pfizer and BioNTech can now officially market their vaccine in the U.S., and the FDA revealed it’ll be offered under the trade dress ‘Comirnarty,’ which doesn’t strike me as particularly catchy but at least it’s less of a mouthful than ‘the Pfizer-BioNTech COVID-19 vaccine.’ FDA approval also means that the vaccine has met all of the administration’s standards for safety and efficacy, including preclinical and clinical trial data, as well as information about tits manufacture, and data gathered from its use during the EUA period.

There’s hope that this new full authorization will encourage fence-sitters who have offered up ‘I’ll wait until it’s fully approved’ as an excuse for not yet having gotten the vaccine despite its availability. At the very least, it’s going to be a lot harder for those hesitating to justify their unreasonable and irresponsible stance in the face of the ongoing pandemic.

Comirnarty got flagged for ‘Priority Review’ by the FDA, which essentially means that the administration devoted its full attention to the process in order to expedite it. No word yet on a timeline for Moderna’s approval, but it’s also in the priority review queue.

We’ll be talking to BioNTech CEO and co-founder Uğur Şahin at TC Disrupt 2021 this year, so be sure to check out that virtual event coming up September 21-23.

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