Healthcare
See the 25-slide pitch deck a Baltimore biotech used to raise $56 million to develop a blood test that detects recurring cancer
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- A Baltimore biotech startup has raised $56 million to develop a cancer blood test.
- Haystack Oncology’s test looks for lingering traces of cancer in patients after they’re treated.
- The company hopes that finding these cancer fragments can help doctors treat recurrences early.
Haystack Oncology has raised $56 million in a Series A round to continue development of its cancer blood test in 2023, the startup said Wednesday.
The Baltimore biotech says it has a blood test that can find tiny, lingering traces of cancer in patients who’ve already had cancer and received treatment. Haystack says its test can detect minimal residual disease, or when patients have only a tiny number of cancer cells left in their body. Those cancerous cells shed small pieces of their DNA into the bloodstream, and Haystack’s test is designed to detect those molecules. That can help doctors provide earlier treatments for patients and, the company hopes, prevent cancer recurrence.
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The chances of cancer coming back vary widely by the type of tumor. One of Haystack’s first studies was in colon cancer, where 30% to 40% of patients typically have a recurrence. Other cancers like glioblastoma and ovarian cancer have far higher recurrence rates, where the vast majority of patients’ cancer comes back.
Haystack’s founders include Bert Vogelstein, an influential genomics researcher at Johns Hopkins who has spent more than two decades researching better ways to detect cancer earlier. Haystack CEO Dan Edelstein said the company was helping realize that grand vision.
“If you detect cancer early enough, you can provide a patient with interventions that can lead to a cure for that patient and change the number of patients being diagnosed with late-stage disease,” Edelstein told Insider.
Haystack’s blood test, called a liquid biopsy, can find signs of cancer that aren’t detectable by imaging like CT scans. The test is also personalized to each individual, by first sequencing a key part of a patient’s genome and tailoring the test for that person’s cancer.
Haystack CEO Dan Edelstein said the Series A round would fund the firm’s plans to launch the test as a CLIA validated assay in 2023 — meaning a doctor could order it for patients but it wouldn’t have gone through the Food and Drug Administration’s full approval process. Edelstein declined to disclose Haystack’s valuation or the amount of money it had raised before this Series A.
Catalio Capital Management, a life-sciences venture-capital firm, helped create Haystack and led the Series A financing. Last December, Haystack was named to Insider’s list of 34 healthcare and biotech startups set to take off in 2022.
Here’s the 25-slide pitch deck Haystack used to raise a $56 million Series A from Catalio, Bruker, Exact Ventures and other investors.
Haystack Oncology is one of the newest entrants in the growing space of cancer blood tests, also known as liquid biopsies.
Haystack Oncology
Haystack was founded in April 2021 and is based in Baltimore and Hamburg, Germany. Its test seeks to detect tiny numbers of cancer cells left in the body after treatment.
Haystack Oncology
Haystack’s founding trio previously cofounded Thrive Earlier Detection, a blood-cancer-testing startup that Exact Sciences bought in 2021 for $2.15 billion.
Haystack CEO Edelstein and CTO Frank Holtrup were previously executives at Sysmex Inostics, a blood-testing subsidiary of the Japanese healthcare giant Sysmex.
Haystack Oncology
While Thrive and other companies are developing blood tests to screen seemingly healthy people for a range of cancers, Haystack is focused on super-sensitive tests for cancer patients after they’ve been treated.
Haystack Oncology
Haystack’s test could alert doctors to intervene in patients whose cancer comes back. Starting treatments earlier, when only a tiny amount of cancer is present, could boost the chances of success.
Haystack estimates the US market for minimal residual disease tests is $13 billion to $15 billion.
Haystack also sees potential to eventually develop its test to see whether certain drugs are working for patients with late-stage cancer. That could allow doctors to stop treatments that are ineffective, earlier.
Haystack Oncology
Haystack’s initial focus will be on following cancer patients who receive a therapy meant to be curative. Its test can see whether that’s truly the case, by seeing whether tiny amounts of cancer remain after treatment.
Haystack Oncology
Haystack’s scientific founders have been researching noninvasive cancer tests for over two decades.
Haystack Oncology
A recent study found that using a version of Haystack’s test allowed some cancer patients to receive about half as much chemo while having similar survival rates.
Haystack Oncology
Source: New England Journal of Medicine
The biotech’s name comes from the needle in a haystack. “We’re talking five in a million, one in a million molecules is tumor DNA,” Edelstein said.
Haystack Oncology
Haystack touts the test’s sensitivity as a key advantage, lowering the risk of false-negative test results, meaning it’s designed to not miss cancer cases.
Haystack Oncology
Haystack plans to begin commercializing their test in 2023, initially focusing on rolling it out as a CLIA validated assay. Discussions with regulators and insurance companies are ongoing, Edelstein said.
Haystack Oncology
Haystack makes personalized tests for each cancer patient by analyzing a part of each person’s genome called the exome. The test then looks for signature of that person’s specific cancer.
Haystack Oncology
Isaac Ro, the former CFO of Thrive, joined Haystack’s board as chairman in May. He told Insider he was excited by Vogelstein’s work in effectively “redesigning” Thrive’s test to be useful for people who already have cancer.
Haystack Oncology
In addition to its recent study in colon cancer, Haystack plans to study how its test works in other forms of cancer including including lung cancer, head and neck cancer, and melanoma.
Haystack Oncology
Haystack says its test is more specific than competing tests sold by Natera and Inivata. Haystack’s can detect cancerous DNA that makes up as little as 0.0005% of a blood sample.
Haystack Oncology
“It provides a level of information that’s been lacking in the clinic, in terms of a real-time assessment of whether or not interventions were successful,” Edelstein said.
Haystack Oncology
Over the past few years, researchers have found that circulating tumor DNA (ctDNA) does predict recurring cancer cases. Additional studies have found that analyzing ctDNA can improve patient outcomes.
Haystack Oncology
Several clinical studies are also underway testing Haystack’s technology in pancreatic, rectal, colon, and ovarian cancer. Results are expected over the next two years.
Haystack Oncology
The first study results found patients with colon cancer who used the test received about half as much chemotherapy as the control group, without worse survival outcomes.
Haystack Oncology
Haystack’s test takes three to 4 1/2 weeks to run. It takes two weeks to sequence the sample, a few days to build a personalized test for that individual’s cancer, and a few more days to run that test.
Haystack Oncology
Haystack has 55 full-time employees based in Baltimore and an R&D site in Hamburg, Germany, Edelstein said.
Haystack Oncology
Edelstein declined to say how much Haystack planned to hire up over the next year but said, “we are going to grow in 2023, that’s without a doubt.”
Haystack Oncology