Last month, the American Red Cross declared a Emergency anemia after nationwide supplies fell by greater than 25% in July. A startup's solution: lab-grown blood.

Shortages might be devastating for patients, as doctors must make difficult decisions about who needs blood transfusions most. The American Red Cross collects and distributes about 40% of the U.S. blood supply, in accordance with its website, and the organization is beg more people donate.

But if Doug McConnell has his way, hospitals and clinics won't need to depend on donations endlessly. McConnell is CEO of a four-year-old startup called Safi Biotherapeutics, which is working to provide inexpensive red blood cells at scale.

Scientists have already discovered grow red blood cells from stem cells, nevertheless it is a costly and sophisticated process that typically produces only small amounts at a time. In November 2022, for instance, researchers within the UK successfully transfused As a part of a clinical study, about one to 2 teaspoons of artificial blood are administered to people.

Safi's goal is to construct on these advances and produce large quantities of blood that might at some point be used commercially to take care of patients and forestall blood shortages.

“People have tried, but technology has moved on and we're seeing that path now,” McConnell said in an interview with CNBC. “I think it's moving from science fiction to science, but there's still a lot of work to do. There's no doubt about that.”

Safi has received greater than $16 million from the U.S. Department of Defense thus far, and because of one other ongoing grant, that quantity could exceed $20 million by yr's end. The company also recently announced it has received a further $5 million in seed funding led by J2 Ventures. McConnell said this combined funding will help the corporate begin its work with regulators on the U.S. Food and Drug Administration.

The FDA has not yet approved Safi's technology to be used, and the corporate still has years of rigorous testing to prove its red blood cells are functional and secure. The company must also reveal that its manufacturing process meets the agency's standards.

“We need to show that they are safe, we need to show that they are effective, that they do their job: they deliver oxygen, they circulate in a way that is comparable to a donor's red blood cells,” McConnell said.

Earlier this month, Safi began working with a Manchester, New Hampshire, manufacturer called the Advanced Regenerative Manufacturing Institute (ARMI) to optimize its production process. McConnell said ARMI is a component of an ecosystem that receives government funding to expand biomanufacturing capability within the U.S.

Safi starts its production process with a “precursor cell,” an adaptable cell that may turn into differing kinds. Precursor cells come from stem cells within the bone marrow, and Safi converts them into red blood cells.

McConnell said growing red blood cells is a bit like making a stew since it requires many alternative ingredients. The challenge, nevertheless, is finding the most cost effective and best recipe, determining when to stir or shake the stew, and which ingredients might be replaced with cheaper alternatives.

The company also develops special formulations for certain patient groups, as some chronic blood transfusion patients require blood that is freed from certain antigens.

The cells grow by dividing, or “doubling,” as they’re passed through a bioreactor. McConnell said Safi spends a whole lot of time specializing in what number of doublings it achieves during bioreactor runs because that's a very good indication of how efficiently it's producing cells. The cells are filtered, and Safi receives units, or bags, of blood that look identical to what can be collected from a donor.

Safi believes it’s currently capable of produce a unit of blood for under $2,000. The company's ultimate goal is to cut back costs to under $500 and even $300 per unit, which is comparable to the value of donated blood, McConnell said.

The average amount U.S. hospitals paid for a unit of donated red blood cells was $214 in 2021, in accordance with a report by analytics firm Statista.

McConnell said Safi can currently use a 10-liter bioreactor that produces about one unit of blood per run. In eight or nine years, McConnell said, the corporate hopes to make use of much larger tanks that may produce about 100 units per run. That means only one stem cell donation could help produce a whole lot of luggage of blood.

“That’s more than one person could donate in their lifetime,” McConnell said.

To achieve large-scale production, Safi still has a protracted strategy to go. McConnell said the corporate's launch will likely take one other six or seven years, partially because the corporate is aiming to provide around 100,000 units of blood in its first yr of launch. Safi plans to proceed to expand production until it produces greater than 1,000,000 units per yr, he added.

McConnell said he doesn't need to make doctors or patients worry about access to blood, and he believes Safi might help fill those gaps.

“It's kind of crazy that we're still tolerating this,” he said. “Frankly, one of the solutions … is to build our own supply chain.”

Big pharmaceutical firms are betting billions on a brand new class of cancer treatments that some on Wall Street are calling a “huge opportunity.”

This method is known as targeted radiopharmacology. It essentially delivers radiation directly into tumors by binding a radioactive particle to a goal molecule.

RBC Capital Markets sees a market potential of 25 billion US dollars for this area.

“We believe that TRT development is still in its infancy and that next-generation technologies that enable improved therapeutic efficacy and address a broader range of cancer targets have the potential to drive value creation in this space,” analyst Gregory Renza, MD, wrote in a February note.

In the previous couple of months alone, 4 takeovers have been announced on this area. The last one was by Novartis, The company already has two targeted radiotherapies available on the market. Pluvicto treats a particular style of advanced prostate cancer, while Lutathera targets neuroendocrine tumors.

Pluvicto, which struggled with some supply bottlenecks in 2023 which have since been resolved, is approaching blockbuster status and can generate sales of $980 million in 2023. The two drugs combined are expected to generate sales of $5 billion by 2028, Renza said.

Earlier this month, Novartis announced that it had entered into an agreement to acquire Mariana Oncology for $1 billionThe preclinical-stage company is concentrated on developing radiopharmaceutical programs, also called radioligand therapies, to treat breast, prostate and lung cancer. One candidate, generally known as MC-339, is being investigated for the treatment of small cell lung cancer.

“They are clearly the market leader in this space with an aggressive strategy that includes both successfully commercializing their products, expanding the market opportunity for those products and developing a pipeline behind them,” said Oppenheimer analyst Jeff Jones. “The acquisition of Mariana … gives them even greater discovery opportunities.”

Shares are up about 1% year-to-date. The average analyst rating is “Hold,” with an 8% upside from the typical analyst price goal, in keeping with FactSet.

Novartis' success has caused turmoil amongst its competitors. Piper Sandler analyst Edward Tenthoff calls this “FOMO” – the fear of missing out.

“I think that's what's happening right now, and the big pharma companies are gathering capacity in this new modality,” he said.

Eli Lillywhich has benefited from the joy within the GLP-1 space with its diabetes drug Mounjaro and weight reduction drug Zepbound, accomplished its $1.4 billion acquisition of the radiopharmaceutical company Point Biopharma in December.

Shortly before the transaction closed, Point Biopharma's targeted radiation drug PNT2002 met its primary endpoint in a Phase 3 study in metastatic castration-resistant prostate cancer.

In addition, Eli Lilly announced earlier this week pay Actis Oncology $60 million to make use of its novel miniprotein technology platform to provide radiopharmaceuticals against cancer.

Eli Lilly has a mean analyst rating of “Overweight” and an upside of 8.3% from the typical analyst price goal, in keeping with FactSet. Shares are already up nearly 38% through 2024.

“I think investors are clearly focused on the obesity issue right now, but we think they certainly have opportunities with the acquisition on the supply side, which is one of the challenges facing radiopharmaceutical companies,” said investor Dan Lyons, portfolio manager and research analyst at Janus Henderson Investors.

Bristol-Myers Squibb has also entered the fray, completing its acquisition of RayzeBio for $4.1 billion in February. The company now owns RayzeBio's pipeline, including the targeted radiopharmaceutical therapy RYZ101 for late-stage gastroenteropancreatic neuroendocrine tumors. It can be in a Phase 1 trial for small cell lung cancer.

The deal's announcement in December got here shortly after Bristol-Myers Squibb said it might buy schizophrenia drug developer Karuna Therapeutics for $14 billion. At the time, William Blair analyst Matt Phipps said the deals showed Bristol's urgent have to bring more products to market as a few of its older therapies lose patent protection over the course of this decade.

The pharmaceutical giant's shares have been on a losing streak, losing greater than 18% because the starting of the 12 months. The company has a mean “hold” rating, in keeping with FactSet.

Last in March AstraZeneca announced plans to buy clinical stage biopharmaceutical company Fusion Pharmaceuticals for $2.4 billion. Fusion is currently conducting a phase two clinical trial for a possible latest treatment called FPI-2265 for patients with metastatic castration-resistant prostate cancer.

According to FactSet, AstraZeneca shares have a mean chubby rating and are almost 6 percent above analysts' average price goal.

“All of these companies had more or less built up or are in the process of building out manufacturing sites and will be operational on a commercial scale very soon,” said Jefferies analyst Andrew Tsai. “They have that under control, and I think that's partly what the big pharma companies wanted.”

There are also some smaller listed biopharmaceutical firms, but not many.

In addition, there are several private firms within the space which have attracted private investors, especially recently. Innovative radiopharmaceuticals received $518 million in enterprise capital last 12 months, a whopping 722% increase from the $63 million they received in 2017, in keeping with GlobalData's Pharma Intelligence Center Deals Database.

Both these private and non-private names may very well be ripe for acquisition in some unspecified time in the future, said Janus Henderson's Lyons.

“There are several large pharmaceutical companies that do not yet have radiopharma programs that may be interested in this space,” he said. “In addition, I think some of the players that already have programs will be interested in finding additional targets and pipeline programs to expand their portfolio.”

Everyone, including the massive pharmaceutical firms, is either working on improving existing treatment methods or attempting to expand their activities to combat various cancer tumors.

Novartis, for instance, received FDA approval for Lutathera for pediatric patients in April. Last month, the corporate also announced that it might seek an expanded label for Pluvicto for the early treatment of prostate cancer.

“Novartis has a clear path and strategy to expand the market opportunities for these two products,” Jones said.

Then there are firms developing therapies against these same targets. Some, like Bristol-based RayzeBio, use an alpha emitter reminiscent of actinium as an alternative of the beta emitter lutetium utilized by Pluvicto and Lutathera.

“This Alpha [emitters] have a much stronger impact and are very localized, literally to the length of a cell,” said Tenthoff of Piper Sandler.

It is also being examined whether radiopharmaceuticals can be used in combination with other treatments, such as immunotherapy.

Depending on the outcome of current and future clinical trials, the therapy could ultimately be used to treat all types of cancer, including ovarian, breast or brain cancer, he said.

“Wherever radiotherapy is used, but not necessarily in a targeted approach, it is very useful because we are dealing with radiosensitive tumors,” says Tenthoff.

Companies may also leverage the a long time of research they’ve already conducted on this area to discover latest opportunities, Jones says.

“You can really leverage all of the work we've done in the sphere of cancer research during the last 30 to 40 years to discover goal molecules on cancer cells that aren’t expressed or are expressed way more strongly than on normal cells. And each of those targets offers the opportunity of targeted radiation therapy,” he said.

“I see enormous opportunities for targeted radiotherapy,” he added. “Today we’ve two products, two targets and thus practically your entire universe of cancer research and cancer control.”