Goldman Sachs Asset Management (GSAM) has raised $650 million for its inaugural life sciences private equity fund, West Street Life Sciences I, reflecting the firm’s bullish outlook on the high-growth potential in the sector.
The fund exceeded its original fundraising target and ranks as one of the largest-ever first-time private life sciences growth funds. GSAM secured commitments from a diverse group of institutional, strategic, and high net worth investors, including meaningful capital from Goldman’s own employees.
“We are in a golden-era of innovation in the life sciences, where technological breakthroughs are creating new approaches to diagnosing and treating disease,” said Amit Sinha, head of GSAM’s Life Sciences Investing Group. “We believe the current environment provides an attractive opportunity for investing in the next generation of leading life sciences companies.”
GSAM’s entrance into life sciences PE highlights the wave of investor interest into the sector, as rapid scientific and technological advancements transform healthcare. The strategy will focus on high-growth investment opportunities in early to mid-stage therapeutic companies developing innovative drugs and treatments, as well as life sciences tools and diagnostics companies.
Specifically, the fund will target several key themes that GSAM believes will drive significant growth, including precision medicine, genetic medicine, cell therapy, immunotherapy, synthetic biology, and artificial intelligence. By leveraging GSAM’s global platform and Advisory Board of seasoned life sciences experts, the fund aims to identify the most promising companies in these emerging areas.
The Life Sciences Investing Group at the helm of managing the fund was established in 2021 and is led by Amit Sinha. The team brings decades of combined experience investing in life sciences and will tap into GSAM’s broader resources and expertise to source deals and create value.
According to Marc Nachmann, global head of Asset & Wealth Management at Goldman Sachs, “Life sciences represents one of the most exciting areas in the private investing landscape, with advances in technology transforming healthcare at an unprecedented pace. We have a long history of partnering with companies in this space and look forward to bringing the full resources of Goldman Sachs to world-class management teams who are driving progress in the industry.”
The new fund has already made 5 investments totaling approximately $90 million into high-potential life sciences startups. The deals include companies using precision medicine, immunotherapy, and artificial intelligence to develop new therapies in oncology, neurology, rare diseases, and other areas.
One portfolio company, MOMA Therapeutics, is pioneering novel therapeutics targeting mitochondrial diseases, which lack effective treatments. Another investment, Nested Therapeutics, is developing a new modality of antibody therapeutics focused on hard-to-drug intracellular protein targets.
Overall, the launch of West Street Life Sciences I demonstrates Goldman Sachs’ confidence in the booming life sciences sector and its commitment to funding innovation. With its deep expertise, global resources, and strategic focus on cutting-edge healthcare technologies, GSAM is positioning itself to capitalize on the most promising opportunities. The new fund is a bellwether for the growing intersection of finance, biotech, and next-gen medicine.
Standard BioTools and SomaLogic have announced plans to unite through an all-stock merger aimed at creating a diversified life sciences tools platform with over $1 billion in equity value. The deal brings together technologies, expertise and customer bases across genomics, proteomics and other omics fields.
Standard BioTools provides genomic analysis tools catering to academic and clinical research settings. SomaLogic specializes in proteomics technology that profiles proteins for biopharmaceutical drug discovery. Their complementary offerings provide scale, synergies, and cross-selling opportunities.
Under the merger agreement, SomaLogic shareholders will receive 1.11 shares of Standard BioTools stock for each SomaLogic share they own. This values SomaLogic at over $370 million based on recent Standard BioTools share prices.
The combined company expects to generate $80 million in cost synergies by 2026 through optimization of its integrated operations. It will also hold over $500 million in cash to fund growth initiatives and new product development.
Standard BioTools CEO Michael Egholm touted SomaLogic’s proteomics capabilities as an ideal fit to accelerate his company’s strategy in the over $100 billion life science tools industry. The deal diversifies Standard BioTools’ portfolio beyond genomics while leveraging its global commercial infrastructure.
SomaLogic provides proteomic analysis that reveals functional expressions of genes, filling a key gap left by genomics. Its SOMAscan platform uses aptamer-based technology to measure thousands of proteins in biological samples.
The technology has become an industry leader in enabling biopharma researchers to identify and validate new drug targets. SomaLogic has relationships with nine of the ten largest pharma companies along with partnerships like its recently launched proteogenomics offering with Illumina.
Standard BioTools plans to tap into these biopharma relationships to cross-sell its genomic analysis tools. Meanwhile, SomaLogic can leverage Standard BioTools’ strong presence selling to academic labs. The combined customer base spans nearly all major end markets.
SomaLogic interim CEO Adam Taich called the merger an opportunity to better serve translational and clinical research customers while creating shareholder value. The healthy $500 million cash position provides ample capital to fund the commercial ramp.
Standard BioTools increased its 2023 revenue outlook to $100-105 million following the merger news. SomaLogic maintained its full-year guidance of $80-84 million. Together, the combined entity expects to generate over $180 million this year.
The boards of both companies have unanimously approved the transaction. Major shareholders holding around 16% of Standard BioTools stock and 1% of SomaLogic have also committed support through voting agreements.
The deal is expected to close in the first quarter of 2024 after securing shareholder and antitrust regulatory approvals. The combined company will operate under the Standard BioTools name and stock ticker, with dual headquarters in South San Francisco and Boulder, Colorado.
Standard BioTools has undergone major changes after a period of underperformance, divesting its sequencing business earlier this year. The merger with SomaLogic continues its strategic shift toward life science research tools.
Together, the companies aim to accelerate development of new diagnostics and precision medicines through their multi-omics technology. Providing genomics, proteomics and other readouts on disease samples provides deeper insights to researchers.
With scale, synergies, ample resources, and multi-pronged revenue opportunities, the combined Standard BioTools and SomaLogic expects to occupy a strengthened position in the competitive life science tools space. Their integration marks the continued consolidation in the industry amid rising demand for omics-based research capabilities.
Image Credit: Interscatter Data Sharing Contact Lens, UW News (Flickr)
The Challenges Surrounding AI/ML are Taken Head on by the FDA
Should artificial intelligence or machine learning (AI/ML) be allowed to alter FDA approved software in medical devices? If so, where should the guardrails be set? The discussions and debates surrounding AI/ML are heated; some believe the technology may destroy humanity, while others look forward to the speed of advancement it will allow. The FDA is getting out ahead on this debate. This week the agency drafted a list of “guiding principles” intended to begin developing best practices for machine learning within medical devices.
Background
The FDA views its role as protecting patients while at the same time avoiding standing in the way of progress. In the case of ML, not preventing the modification of medical treatments or procedures that would improve outcomes. AI/ML has the potential to more quickly evaluate data sets, improve diagnosis, adjust how used, and overall alter processes based on what is learned.
On April 3, the FDA drafted AI-Enabled Medical Device Life Cycle Plan Guidance, with a comment period ending July 3, 2023. The U.S. regulator’s proposal attempts to find science-based requirements for medical devices powered by artificial intelligence and machine learning. The overall goal is to not slow the implementation of improved new devices that may quickly be modified, updated, and rapidly deliver an improved response to new data.
Greg Aurand, Senior Healthcare Services & Medical Devices Analyst at Noble Capital Markets, summed up the purpose for the FDA’s actions in this way: “The FDA needs to move cautiously, but they don’t wish to slow down healthcare improvements on an ongoing basis.” Aurand gave examples where machine learning has the potential to make better assessments, better decipher data sets such as antibiotic resistance, and improve results while perhaps taming medical expenses. He said, “new draft guidelines from the FDA should make it easier for approval of modifications to occur so previously unrecognized improvements may occur within the guidelines, and the process is less static.”
How is Artificial Intelligence Likely to Revise Medical Devices?
As is written into the FDA guidance, “Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care.”
The FDA accepts that a great benefit of AI/ML in software is its ability to learn from real-world use and experience, then the ability to improve its own performance.
How is the FDA Expected to Regulate AI/ML Devices?
Traditionally, the FDA reviews medical devices and improvements through a premarket pathway for approval. The FDA may also review and clear modifications to medical devices, including software as a medical device, depending on the significance or risk posed to patients by that modification. The industry is going through a paradigm shift which the FDA is helping to enable.
The FDA’s current paradigm of medical device regulation was not designed for adaptive artificial intelligence. Under the FDA’s current approach to software modifications it anticipates that many of these artificial intelligence and machine learning-driven software changes to a device need a premarket review. The new regulation is expected to create broader parameters of pre-approval to allow adjustments with set allowable boundaries.
A new framework envisioned by the FDA includes a “predetermined change control plan” in premarket submissions. This plan would include the types of anticipated modifications, referred to as “Software as a Medical Device Pre-Specifications”. The associated methodology used to implement those changes in a measured and controlled approach that manages risk the FDA calls the “Algorithm Change Protocol.”
Take Away
Artificial intelligence will transform many industries, and while some want to hit the pause button on progress, the FDA is trying to define how much control can be left to machine learning. The Guidance released in April with a three-month comment period is expected to allow medical equipment and software designers to progress into the unknown, with all stakeholders having as their goal better outcomes for patients.
If you wish to send requested comments to the FDA, the agency requests it be received by July 3, 2023 to ensure the agency considers your comment on the draft guidance before it begins work on the final version of the guidance.
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Issuing New Shares. Last Friday, Avivagen announced the closing of a first tranche of a non-brokered private placement of shares. The total amount of common shares issued in the first tranche was 2.15 million for approximately $430,000, or $0.20 per share. The total amount of the placement financing is up to $1 million. We expect the Company to issue the full amount in the private placement.
Use of Financing. The use of the funds will be for funding research and development expenses, sales and marketing costs, product registration, interest expense, working capital, and general corporate purposes. We anticipate the use of the funding will be for product expansion as the Company is continuing to work towards a No Objection Letter in the U.S., targeting an expansion in the European Union, and is seeing increased interest in South America.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Exercise is well-known to help people lose weight and avoid gaining it. However, identifying the cellular mechanisms that underlie this process has proven difficult because so many cells and tissues are involved.
In a new study in mice that expands researchers’ understanding of how exercise and diet affect the body, MIT and Harvard Medical School researchers have mapped out many of the cells, genes, and cellular pathways that are modified by exercise or high-fat diet. The findings could offer potential targets for drugs that could help to enhance or mimic the benefits of exercise, the researchers say.
“It is extremely important to understand the molecular mechanisms that are drivers of the beneficial effects of exercise and the detrimental effects of a high-fat diet, so that we can understand how we can intervene, and develop drugs that mimic the impact of exercise across multiple tissues,” says Manolis Kellis, a professor of computer science in MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL) and a member of the Broad Institute of MIT and Harvard.
The researchers studied mice with high-fat or normal diets, who were either sedentary or given the opportunity to exercise whenever they wanted. Using single-cell RNA sequencing, the researchers cataloged the responses of 53 types of cells found in skeletal muscle and two types of fatty tissue.
“One of the general points that we found in our study, which is overwhelmingly clear, is how high-fat diets push all of these cells and systems in one way, and exercise seems to be pushing them nearly all in the opposite way,” Kellis says. “It says that exercise can really have a major effect throughout the body.”
Kellis and Laurie Goodyear, a professor of medicine at Harvard Medical School and senior investigator at the Joslin Diabetes Center, are the senior authors of the study, which appears today in the journal Cell Metabolism. Jiekun Yang, a research scientist in MIT CSAIL; Maria Vamvini, an instructor of medicine at the Joslin Diabetes Center; and Pasquale Nigro, an instructor of medicine at the Joslin Diabetes Center, are the lead authors of the paper.
The Risks of Obesity
Obesity is a growing health problem around the world. In the United States, more than 40 percent of the population is considered obese, and nearly 75 percent is overweight. Being overweight is a risk factor for many diseases, including heart disease, cancer, Alzheimer’s disease, and even infectious diseases such as Covid-19.
“Obesity, along with aging, is a global factor that contributes to every aspect of human health,” Kellis says.
Several years ago, his lab performed a study on the FTO gene region, which has been strongly linked to obesity risk. In that 2015 study, the research team found that genes in this region control a pathway that prompts immature fat cells called progenitor adipocytes to either become fat-burning cells or fat-storing cells.
That finding, which demonstrated a clear genetic component to obesity, motivated Kellis to begin looking at how exercise, a well-known behavioral intervention that can prevent obesity, might act on progenitor adipocytes at the cellular level.
To explore that question, Kellis and his colleagues decided to perform single-cell RNA sequencing of three types of tissue — skeletal muscle, visceral white adipose tissue (found packed around internal organs, where it stores fat), and subcutaneous white adipose tissue (which is found under the skin and primarily burns fat).
These tissues came from mice from four different experimental groups. For three weeks, two groups of mice were fed either a normal diet or a high-fat diet. For the next three weeks, each of those two groups were further divided into a sedentary group and an exercise group, which had continuous access to a treadmill.
By analyzing tissues from those mice, the researchers were able to comprehensively catalog the genes that were activated or suppressed by exercise in 53 different cell types.
The researchers found that in all three tissue types, mesenchymal stem cells (MSCs) appeared to control many of the diet and exercise-induced effects that they observed. MSCs are stem cells that can differentiate into other cell types, including fat cells and fibroblasts. In adipose tissue, the researchers found that a high-fat diet modulated MSCs’ capacity to differentiate into fat-storing cells, while exercise reversed this effect.
In addition to promoting fat storage, the researchers found that a high-fat diet also stimulated MSCs to secrete factors that remodel the extracellular matrix (ECM) — a network of proteins and other molecules that surround and support cells and tissues in the body. This ECM remodeling helps provide structure for enlarged fat-storing cells and also creates a more inflammatory environment.
“As the adipocytes become overloaded with lipids, there’s an extreme amount of stress, and that causes low-grade inflammation, which is systemic and preserved for a long time,” Kellis says. “That is one of the factors that is contributing to many of the adverse effects of obesity.”
Circadian Effects
The researchers also found that high-fat diets and exercise had opposing effects on cellular pathways that control circadian rhythms — the 24-hour cycles that govern many functions, from sleep to body temperature, hormone release, and digestion. The study revealed that exercise boosts the expression of genes that regulate these rhythms, while a high-fat diet suppresses them.
“There have been a lot of studies showing that when you eat during the day is extremely important in how you absorb the calories,” Kellis says. “The circadian rhythm connection is a very important one, and shows how obesity and exercise are in fact directly impacting that circadian rhythm in peripheral organs, which could act systemically on distal clocks and regulate stem cell functions and immunity.”
The researchers then compared their results to a database of human genes that have been linked with metabolic traits. They found that two of the circadian rhythm genes they identified in this study, known as DBP and CDKN1A, have genetic variants that have been associated with a higher risk of obesity in humans.
“These results help us see the translational values of these targets, and how we could potentially target specific biological processes in specific cell types,” Yang says.
The researchers are now analyzing samples of small intestine, liver, and brain tissue from the mice in this study, to explore the effects of exercise and high-fat diets on those tissues. They are also conducting work with human volunteers to sample blood and biopsies and study similarities and differences between human and mouse physiology. They hope that their findings will help guide drug developers in designing drugs that might mimic some of the beneficial effects of exercise.
“The message for everyone should be, eat a healthy diet and exercise if possible,” Kellis says. “For those for whom this is not possible, due to low access to healthy foods, or due to disabilities or other factors that prevent exercise, or simply lack of time to have a healthy diet or a healthy lifestyle, what this study says is that we now have a better handle on the pathways, the specific genes, and the specific molecular and cellular processes that we should be manipulating therapeutically.”
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Results for Q3. Total revenue for the quarter was $48,606 (all figures are in Canadian $), down from $505,886 the previous year and below our estimate of $100,000. The decrease was due to lower sales in the OxC-Beta product. Net loss was at $1.9 million versus a loss of $1.5 million in the prior year and our loss estimate of $1.54 million. The increased net loss was due to higher salaries expense and a decrease in government grants.
Sales Update for OxC-Beta. Avivagen sold a total of 350 kilograms of OxC-Beta during the third quarter, down from 925 kg in Q2 and 2,550 kg in Q1. Thailand ordered 250 kg during the quarter while Taiwan ordered 100 kg. The average price per kilogram in the quarter was $103.10 versus $102.27 in the second quarter.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
ARPA-H: High-Risk, High-Reward Health Research is the Mandate of New, Billion-Dollar US Agency
A new multibillion-dollar federal agency was created with a goal of supporting “the next generation of moonshots for health” in science, logistics, diversity and equality. And the agency now has it’s first leader, as President Joe Biden announced Renee Wegrzyn as director of the Advanced Research Projects Agency for Health, or ARPA-H, on Sept. 12, 2022.
Since the announcement of the intention to establish ARPA-H two years ago, this new agency has sparked interest and questions within both academia and industry.
This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Tong Sun, Assistant Dean of Translational Health Sciences, University of Washington.
I have been a director of innovation-driven health institutes for decades and have worked with many of the government agencies that fund science. I and many of my colleagues hope ARPA-H will become an agency that can quickly turn scientific discoveries into real-world advances to detect, prevent and treat diseases like cancer, diabetes and Alzheimer’s. But questions still remain surrounding how it will work and what makes it different from other government-funded agencies such as the National Institutes of Health and the National Science Foundation.
What is ARPA-H?
ARPA-H is the newest entity established within the National Institutes of Health. ARPA-H was explicitly set up as an independent agency within NIH, in theory allowing it to benefit from the NIH’s vast scientific and administrative expertise and resources while still being nimble and forward-thinking.
ARPA-H was inspired by and modeled after the Defense Advanced Research Projects Agency, or DARPA, to rapidly develop cutting-edge technologies. DARPA is small compared to other federal research and development agencies, but has long been hugely successful. It played a critical role in spawning many technologies ranging from the internet to GPS, and even funded Moderna to develop mRNA vaccine technology in 2013.
ARPA-H is not the only DARPA spinoff. In 2006, the federal government created the Intelligence Advanced Research Projects Activity to tackle difficult challenges in the intelligence community, and in 2009, the Advanced Research Projects Agency for Energy was launched. Though its budget is small compared to the Department of Energy, ARPA-E has been incredibly effective in funding ambitious research into fighting climate change. By funding ambitious mid- and long-term projects, IARPA, ARPA-E and now ARPA-H are meant to operate in between slow, government-funded basic research and short-term, profit-driven private sector venture capital.
ARPA-H is modeled after the Defense Advanced Research Projects Agency, which played a key role in developing many modern technologies, including personal computers. Tim Colegrove (Wikimedia Commons)
How Will the Agency Function?
Biden wants ARPA-H to replicate the success of DARPA, but in the health care realm, by providing “leadership for high-risk, high-reward biomedical and health research to speed application and implementation of health breakthroughs equitably.”
Established federal agencies like the NIH and the National Science Foundation prefer to fund more basic research and less risky projects compared to the high-risk, high-reward, applied science approach of DARPA. If ARPA-H wants to achieve the success of its predecessor, it will need to operate differently from NIH and NSF.
DARPA employs about 100 program managers who are “borrowed” from academia or industry for three to five years. These managers travel across the nation to meet with scientists and experts in different fields in order to generate ideas and start projects. These managers make funding decisions and work closely with their funded teams to overcome problems, but will cut funding if teams cannot deliver promised milestones on time. Many DARPA projects don’t produce spectacular successes, yet they pushed the boundaries of science and technology.
Many years ago, I had the privilege of working with a DARPA program manager alongside numerous experts in various scientific and medical fields. After several months of meetings, the program manager came up with the idea to develop “fracture putty” – a puttylike material that could be applied to the shattered bones of a wounded soldier in the battlefield. The material would support weight, prevent infection, expedite healing and bone regeneration and eventually dissolve away. The program launched in 2008, and our team of chemists, nanomaterials experts, bioengineers, mathematical modelers and surgeons was one of the funded teams in this program.
President Joe Biden appointed Renee Wegrzyn, a former DARPA project manager and biotech industry expert, to lead ARPA-H. Image: Renee Wegrzyn (@rwegrzyn)
Who is the New Director?
Wegrzyn holds a Ph.D. in molecular biology and bioengineering from Georgia Tech. She is currently a vice president of business development at Ginkgo Bioworks, a U.S. biotech company. Wegrzyn spent four and half years as a program manager in DARPA’s Biological Technologies Office, where she managed projects that focused on using genetic engineering and gene editing for biosecurity and public health. She also worked for another DARPA-inspired agency, Intelligence Advanced Research Projects Activity.
At this moment, we don’t know yet the exact plan and progress in hiring APPA-H program managers and where APAR-H’s headquarters will be located. Several cities have expressed interest.
What Should People Look for as ARPA-H Gets Started?
DARPA is driven by talented, ambitious and risk-taking program managers. They are the ones who generate ideas and turn lofty goals into executable projects. It will be interesting to see how many and what kind of program managers ARPA-H hires in its early days, as these decisions will give an indication of which areas within health care the agency will be prioritizing.
I’ll also be watching to see how well ARPA-H and its program managers work within the NIH, which has an unbelievable depth of resources and expertise in all health care related fields that ARPA-H can tap into. But the NIH has very different funding mechanisms and culture from DARPA.
The final question is money. Biden wants US$6.5 billion in funding for ARPA-H, and he’s only gotten $1 billion from Congress so far. This is its first, biggest challenge. Finding political unity for funding may have to be this new agency’s first big breakthrough if it is to reach its goals.
