Off The Hook YS Inc. to Announce Third Quarter 2025 Financial and Operating Results on Monday, December 15, 2025

Rhea-AI Summary

Haystack Oncology (Quest Diagnostics NYSE: DGX) announced a research collaboration with Rutgers Cancer Institute and RWJBarnabas Health to evaluate Haystack MRD, a circulating tumor DNA (ctDNA) test, in a prospective phase II trial titled MRD-PORT (NCT06979661) to guide postoperative radiation and systemic therapy in stage II/III non-small cell lung cancer.

Key context: an April 2025 NEJM study found Haystack MRD identified clinical complete response at a median of 1.4 months vs >6 months by imaging, and the test received FDA Breakthrough Device Designation in August 2025.

Positive

• FDA Breakthrough Device Designation in August 2025
• NEJM April 2025: ctDNA detected response at 1.4 months median
• Launched phase II MRD-PORT trial NCT06979661 for stage II/III NSCLC

Negative

• None.

Key Figures

Trial phase Phase II MRD-PORT trial in stage II/III NSCLC

Cancer stage Stage II/III Non-small cell lung cancer postoperative setting

Median detection time 1.4 months Time for Haystack MRD to identify clinical complete response

Imaging detection time Over 6 months Time for imaging tests to identify clinical complete response

Oncologist agreement 96% Survey respondents saying MRD testing may identify recurrence earlier

Breakthrough designation date August 2025 FDA Breakthrough Device Designation for stage II colorectal cancer use

Journal publication date April 2025 NEJM study using Haystack MRD as liquid biopsy surrogate

Prior collaboration year 2023 Earlier Rutgers study in early-stage triple-negative breast cancer

Market Reality Check

$3.10 Last Close

Volume Volume 63,216 is below the 20-day average of 156,093 (relative volume 0.4x). low

Technical Shares at $3.1427 are below the $3.35 200-day moving average and 19.42% under the 52-week high.

Peers on Argus

No peer stocks or sector momentum data provided; recent -4.48% move appears stock-specific based on available context.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 02	Conference presentation	Positive	+1.4%	NobleCon21 emerging growth conference presentation by CEO Brian John.
Dec 01	Tax incentive update	Positive	-0.9%	Reminder of 100% bonus depreciation for qualifying boat and yacht purchases.
Nov 25	Office expansion	Positive	+7.6%	Confirmation of new Jupiter, Florida office for luxury brokerage division.
Nov 14	IPO offering	Neutral	-8.4%	Closing of IPO raising $15M gross proceeds at $4.00 per share.

Pattern Detected

Early trading history shows mixed reactions: expansion news and conferences saw positive moves, while the IPO and a tax-related positive update were followed by declines.

Recent Company History

Over recent months, Off The Hook YS Inc. completed its IPO on November 14, 2025, selling 3,750,000 shares at $4.00 for $15,000,000 in gross proceeds, followed by a -8.38% next-day move. A new Jupiter, Florida office for its Autograph Yacht Group division on November 25, 2025 preceded a 7.57% gain. Subsequent promotional and conference announcements around tax depreciation benefits and the NobleCon21 presentation produced modest, mixed price reactions, framing today’s earnings-date notice within an early, still-forming trading pattern.

Market Pulse Summary

This announcement sets a clear timetable for third-quarter 2025 results, giving investors a defined point to reassess Off The Hook YS Inc.’s progress following its recent IPO that raised $15,000,000. Recent news has covered expansion plans and promotional efforts, alongside notable insider purchases reported on Form 4 filings. Heading into the report, key factors to monitor include revenue trends since the IPO, operational updates related to the new Florida office, and any commentary on growth initiatives.

Key Terms

circulating tumor dna medical

"a highly sensitive circulating tumor DNA (ctDNA) minimal residual disease"

Fragments of DNA shed by cancer cells into the bloodstream that act like tiny fingerprints of a tumor; they can be detected with a blood test rather than a biopsy. Investors care because circulating tumor DNA (ctDNA) enables faster, lower-cost ways to detect disease, track treatment response, identify emerging resistance and enroll patients in trials—factors that can materially affect the commercial prospects of diagnostics and therapeutics.

ctdna medical

"The study will evaluate ctDNA in patients with stage II/III NSCLC"

Circulating tumor DNA (ctDNA) is tiny fragments of genetic material shed by cancer cells into the bloodstream, like breadcrumbs that can reveal a tumor’s presence and genetic makeup without needing a biopsy. For investors, ctDNA matters because tests and technologies that detect and analyze these fragments can speed diagnosis, track treatment response, and signal relapse, creating commercial opportunities in diagnostics, personalized therapies, and monitoring services.

minimal residual disease medical

"a highly sensitive circulating tumor DNA (ctDNA) minimal residual disease (MRD) test"

Minimal residual disease (MRD) is the tiny number of cancer cells that remain in the body after treatment, often too few to show up on standard scans but detectable with very sensitive tests. For investors, MRD is important because it predicts the risk of relapse and can determine whether a therapy is seen as effective, influences regulatory and reimbursement decisions, and affects the size and timing of a drug’s market opportunity—like spotting the last weeds that can make a garden regrow if not removed.

non-small cell lung cancer medical

"patients with stage II/III non-small cell lung cancer (NSCLC)"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

adjuvant therapy medical

"who may benefit from adjuvant therapy in accordance with therapeutic product labeling"

Adjuvant therapy is an extra medical treatment given after the main treatment—often surgery—to reduce the chance that a disease will come back, such as additional drugs, radiation, or immune-based treatments. For investors it matters because successful adjuvant treatments can expand the market for a drug, influence regulatory approval and reimbursement, and change revenue forecasts much like a protective follow-up step that prevents problems from reappearing.

immunotherapy medical

"systemic therapy, including chemotherapy, immunotherapy, or targeted therapy"

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

targeted therapy medical

"systemic therapy, including chemotherapy, immunotherapy, or targeted therapy"

A targeted therapy is a medical treatment designed to attack a specific feature of diseased cells—such as a protein or genetic change—while sparing healthy tissue. For investors, it matters because these precise treatments can be more effective and have clearer paths to approval and market demand than broad drugs; think of them as a guided tool rather than a blunt instrument, which can mean higher returns if safety and effectiveness are proven.

breakthrough device designation regulatory

"the FDA granted Breakthrough Device Designation to Haystack MRD"

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

AI-generated analysis. Not financial advice.

SECAUCUS, N.J. and NEW BRUNSWICK, N.J., Sept. 22, 2025 /PRNewswire/ -- Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, today announced a research collaboration with the Rutgers Cancer Institute to evaluate the use of Haystack MRD^®, a highly sensitive circulating tumor DNA (ctDNA) minimal residual disease (MRD) test, to help optimize postoperative therapy decisions in patients with stage II/III non-small cell lung cancer (NSCLC). Rutgers Cancer Institute together with RWJBarnabas Health is the state's only National Cancer Institute-designated Comprehensive Cancer Center. 

"Trial of ctDNA Guidance to Determine Post Operative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial (NCT06979661)" is a prospective phase II study that will use the Haystack MRD test to assess whether the presence of residual tumor DNA after surgery can help guide the use of radiation and systemic therapies. 

"Circulating tumor DNA is a pivotal marker to figure out how best to individualize patient care for lung cancer," said Salma Jabbour, MD, Vice Chair of Clinical Research and Faculty Development, Department of Radiation Oncology and Associate Director Faculty Affairs and Development, Rutgers Cancer Institute. "Studying new ways to detect this marker are important for helping improve patient outcomes." 

Personalizing postoperative therapy in NSCLC 

The study will evaluate ctDNA in patients with stage II/III NSCLC in the adjuvant setting. Patients who test positive for ctDNA after surgery—indicating potential residual disease—will be considered for adjuvant radiation and systemic therapy, including chemotherapy, immunotherapy, or targeted therapy, based on tumor biology and clinical context. 

"The ability to identify residual disease following curative-intent treatment opens the door to more precise, personalized interventions, moving us closer to truly individualized cancer care," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "While existing data supports the prognostic value of ctDNA in lung cancer, this innovative study will now address the question of how ctDNA-based testing can guide and optimize adjuvant treatment decisions." 

The study is the second by Rutgers Cancer Institute involving Haystack MRD. In 2023, the two parties announced a study to evaluate the test for use in patients being treated for early-stage triple-negative breast cancer. 

Why ctDNA MRD matters 

A growing body of research underscores the potential role of ctDNA MRD tests to identify residual or recurring cancer in patients with solid tumors. In April 2025, a study¹ published in The New England Journal of Medicine (NEJM) found that ctDNA testing, using Haystack MRD, was a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months compared to over 6 months using imaging tests. Nearly all oncologists (96%) in a recent survey² by Harris Poll for Quest Diagnostics said MRD testing has the potential to identify cancer recurrence earlier than other current methods. In August 2025, the FDA granted Breakthrough Device Designation to Haystack MRD for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. 

About Lung Cancer 

Lung cancer is the leading cause of cancer-related deaths in the U.S³. Despite advances in surgery and systemic therapies, recurrence rates remain high, especially for patients with stage II and III NSCLC.⁴ Studies show that patients who test positive for ctDNA after surgery have dramatically worse progression-free survival and overall survival compared to ctDNA-negative patients.^5,6,7 

About Haystack Oncology 

Haystack Oncology represents the culmination of over 20 years of collaboration to advance technical and clinical development in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine. The company, a wholly owned subsidiary of Quest Diagnostics, developed Haystack MRD^®, a tumor-informed, next-generation MRD test that detects ultralow levels of ctDNA to uncover residual or recurrent disease with exceptional sensitivity. Haystack Oncology works with biopharmaceutical companies to accelerate and inform clinical development programs and advance important therapeutics to global markets, from early phase clinical development to companion diagnostics. Haystack MRD was developed and validated in a CLIA-certified laboratory and is available for commercial use as a lab-developed test (LDT) by Quest Diagnostics. Haystack MRD is also available for clinical trials as an investigational device by Haystack Oncology in laboratories located in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland. www.haystackmrd.com 

About Quest Diagnostics 

Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of deidentified clinical lab results, diagnostic insights provided by Quest reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and over 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com. 

 About Rutgers Cancer Institute 

As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute, together with RWJBarnabas Health, provides patients access to the most advanced cancer treatment options including clinical trials close to home at our facilities throughout the state. Our groundbreaking cancer research is the engine that drives access to the most advanced cancer treatments, where our discoveries become your care. 

References

1. Cercek A, Foote MB, Rousseau B, et al. Nonoperative management of mismatch repair-deficient tumors. N Engl J Med. Published online 2025. doi:10.1056/nejmoa2404512. 
2. https://newsroom.questdiagnostics.com/2025-05-13-Oncologists-Report-Seeing-More-Advanced-Cancers-and-Say-Current-Tests-Are-Not-Catching-Cancer-Recurrence-Early-Enough,-New-Quest-Diagnostics-Report-Finds. 
3. American Cancer Society. (2025). Cancer Facts & Figures 2025. Atlanta, GA. 
4. National Cancer Institute. SEER Cancer Stat Facts: Lung and Bronchus Cancer. (2025). 
5. Tie J, Wang Y, Tomasetti C, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016;8(346):346ra92. doi:10.1126/scitranslmed.aaf6219. 
6. Wang Y, Li L, Cohen JD, et al. Prognostic Potential of Circulating Tumor DNA Measurement in Postoperative Surveillance of Nonmetastatic Colorectal Cancer. JAMA Oncol. 2019;5(8):1118–1123. doi:10.1001/jamaoncol.2019.0512. 
7. Tie J, Cohen JD, Wang Y, et al. Serial circulating tumour DNA analysis during multimodality treatment of locally advanced rectal cancer: a prospective biomarker study. Gut. 2019;68(4):663-671. doi:10.1136/gutjnl-2017-315852. 

View original content to download multimedia:https://www.prnewswire.com/news-releases/haystack-oncology-and-rutgers-cancer-institute-collaborate-in-a-clinical-study-to-examine-haystack-mrd-as-a-guide-for-post-surgical-treatment-for-lung-cancer-302561905.html

SOURCE Quest Diagnostics

FAQ

What is the MRD-PORT trial (NCT06979661) announced Sept 22, 2025?

A prospective phase II study using Haystack MRD to guide postoperative radiation and systemic therapy in stage II/III NSCLC patients.

How does the April 2025 NEJM study affect DGX's Haystack MRD credibility?

The NEJM study reported Haystack MRD identified clinical complete response at a median of 1.4 months versus over 6 months by imaging, supporting its diagnostic value.

What did the FDA decision in August 2025 mean for Haystack MRD and DGX?

Haystack MRD received Breakthrough Device Designation in August 2025 for identifying MRD-positive stage II colorectal cancer patients post-surgery.

How might Haystack MRD influence postoperative therapy decisions in stage II/III NSCLC?

Patients testing ctDNA-positive after surgery may be considered for adjuvant radiation and systemic therapies tailored to tumor biology and clinical context.

When was the collaboration with Rutgers and RWJBarnabas announced?

The collaboration was announced on September 22, 2025 to evaluate Haystack MRD in the MRD-PORT trial.

Will the MRD-PORT trial change DGX clinical use timelines for Haystack MRD?

The study aims to assess ctDNA-guided postoperative decisions; any change to clinical use depends on trial results and subsequent regulatory or guideline actions.