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A peer-reviewed, multi-clinic study published in the Journal of Assisted Reproduction and Genetics suggests an epigenetic sperm-quality profile can add missing information for infertile couples and clinicians, especially when they are considering IUI (Intrauterine Insemination), IVF (In Vitro Insemination), and/or ICSI (Intracytoplasmic Sperm Injection).

Path Fertility’s review of this capstone research, including the data gathered from preceding studies, confirms clinical data show that “up to 25% of men with a ‘normal’ Semen Analysis result have sperm that are incapable of producing a healthy pregnancy without intervention via advanced fertility techniques.”

SALT LAKE CITY, UT / ACCESS Newswire / March 10, 2026 / A newly published, peer-reviewed study adds real-world evidence that some couples are stuck in “fertility limbo” even after a Semen Analysis comes back “normal.”

Recently published in the Journal of Assisted Reproduction and Genetics (JARG), the multi-clinic report found that while traditional Semen Analysis tests measure sperm count, movement, and shape, they do not directly measure whether sperm function well enough for certain fertility treatments to work.

According to Andy Olson, CEO and Co-Founder of Path Fertility^TM, while it’s obvious that traditional Semen Analysis testing is a crucial first step for understanding sperm viability, for many infertile couples, Semen Analysis alone is not enough.

“This new study reinforces what so many couples experience firsthand: ‘normal’ Semen Analysis test results don’t always come with answers,” Olson said. “In fact, our review of the clinical data shows that up to 25% of men with a ‘normal’ Semen Analysis result have sperm that are incapable of producing a healthy pregnancy without intervention via advanced fertility techniques.

“When couples are stuck in such fertility limbo, they deserve better information sooner. Peer-reviewed, real-world evidence like that shown in this JARG report (and data gathered from prior studies), can help patients and clinicians have a more informed conversation about what to try next and what expectations are realistic.”

^{PHOTO CAPTION: Andy Olson, CEO and Co-Founder of Path Fertility. March 2026.}

What the JARG Study Found

The JARG study analyzed outcomes from 537 couples treated at 10 U.S. fertility clinics and reported a clear pattern: when men had an Abnormal result on an epigenetic sperm test, no pregnancies were recorded from Intrauterine Insemination (IUI) in the outcomes captured in this real-world dataset. {NOTE: Epigenetics is a DNA-level method for scientists to study how cells turn genes on and off, including within sperm cells.}

By contrast, outcomes for in-vitro fertilization (IVF) using Intracytoplasmic Sperm Injection (ICSI) did not show a meaningful difference based on the epigenetic result.

A Quick Translation of the Treatments Mentioned in the Study

To understand why these findings matter, it can help to understand the difference between common fertility treatments. For example,

• IUI (intrauterine insemination) is a procedure in which sperm is placed into the uterus around the time of ovulation. It is often tried early by couples attempting to overcome fertility challenges because it is less invasive and less costly than IVF;

• IVF (in vitro fertilization) is a process where eggs are retrieved and fertilized in a lab; and

• ICSI (intracytoplasmic sperm injection) is a common IVF technique where a highly trained IVF lab embryologist injects a single sperm into an egg to help fertilization occur.

What Semen Analysis Can Show and What it Cannot

Within the medical community, a Semen Analysis test is considered the “Standard of Care” in the field of infertility when it comes to identifying how many sperm are present in a semen sample, how they look, and how they move.

But a Semen Analysis test does not answer the question most infertile couples care about the most: Can these sperm do the job needed to create a pregnancy, especially with a treatment like IUI?

In reality, some sperm can look “normal” with a Semen Analysis test, but still struggle with the key functions required for conception: finding the egg, binding to the egg, penetrating the egg, and fertilizing the egg.

What the Newer Test Looks at, in Plain English

The new JARG study focuses on a still new sperm test based on epigenetics that measures chemical markers that help control how genes behave and how well sperm are likely to function.

SpermQT^™, the new sperm-DNA test offered by Path Fertility, is designed to complement Semen Analysis testing by providing this additional epigenetics information about sperm quality and function.

^{PHOTO CAPTION: The at-home version of SpermQT, a newsperm-DNA test offered by Path Fertility. March 2026}

Why this New JARG Study Matters Now

What makes this JARG paper important is that it reports real-world outcomes across 10 clinics, based on anonymous patient data.

Specifically, the JARG study showed that for IUI outcomes, “Abnormal” epigenetic sperm results resulted in zero recorded IUI pregnancies among the couples in the JARG dataset. Conversely, in IVF cases that used ICSI, outcomes did not differ significantly based on the epigenetics result.

For mainstream readers, the takeaway is straightforward: a “normal” Semen Analysis test result is not always the end of the male-fertility conversation.

^{VIDEO CAPTION: SpermQT introductory video posted on YouTube (https://www.youtube.com/watch?v=EHvFUEBctTs). SpermQT is a new sperm-DNA test offered by Path Fertility.}

In fact, additional sperm-focused information may help couples and clinicians set better expectations earlier, especially when deciding whether to keep trying IUI or to move more quickly to more advanced fertility techniques like IVF and/or ICSI.

How Prior Scientific Studies Led to this “Capstone” Result with JARG

This JARG report builds on two peer-reviewed research studies published in 2023, starting with a July 2023 study in Frontiers in Genetics. This data validated the broader scientific approach behind the testing available with SpermQT.

It also found that sperm epigenetic variability was linked with pregnancy and live birth outcomes for IUI, while IVF outcomes did not show a similar separation.

Additionally, a November 2023 study in F&S Science reported that adding epigenetic sperm information could improve how well an analysis of sperm predicted IUI outcomes. This same study reported that IVF outcomes, largely using ICSI, did not show the same differences across epigenetic sperm quality groups.

Together, the 2023 findings laid the scientific groundwork for a greater understanding of sperm viability for infertile couples, while the new JARG paper extended that work into a larger, multi-clinic, real-world setting.

A Perspective from the Clinic

“Many couples hear that the Semen Analysis results are ‘normal’ and assume the male side has been cleared,” said Kaylen Silverberg, MD, Medical Director and fertility specialist with Texas Fertility Center. “However, the type of peer-reviewed research in this JARG study supports a more comprehensive evaluation of male fertility, just as we do with our female patients. SpermQT test results enable couples to make decisions with clearer expectations, especially when considering whether to pursue repeated IUI cycles or proceed to IVF with ICSI.”

A Comment from Path’s Scientific Leadership

“Clinicians and couples alike should think of the data provided by SpermQT results as another piece of the puzzle,” said Kristin Brogaard, Ph.D., Co-Founder and Chief Science Officer of Path Fertility, and a co-author of the JARG study. “Clearly, traditional Semen Analysis testing is still the ‘Standard of Care’ in fertility circles. However, this new test provides a deeper level of detail about sperm function that standard testing does not measure directly, and this additional information can be invaluable to couples struggling with infertility.”

^{PHOTO CAPTION: Kristin Brogaard, Ph.D., Chief Science Officer and Co-Founder pf Path Fertility. March 2026.}

Responsible Interpretation

This new study in JARG reports real-world associations across clinics and treatments, but it does not tell any individual couple what they should do. Patients should discuss testing and treatment options with a qualified clinician who can consider the full medical picture of both partners.

^{PHOTO CAPTION: SpermQT Test Results Overview Page from Path Fertility. March 2026}

About Path Fertility and SpermQT

Path Fertility is focused on raising the “Standard of Care” in male fertility by providing deeper insight into sperm quality and function. As such, SpermQT is a sperm quality test based on epigenetic DNA-markers and is designed to complement Semen Analysis by adding new information related to sperm function.

NOTE: Published Studies Referenced in this Release

• Journal of Assisted Reproduction and Genetics (JARG), 2026: “Epigenetic sperm quality testing for predicting fertility treatment success: a real-world and multi-site analysis.”

• F&S Science, 2023: “Epigenetic determinants of reproductive potential augment the predictive ability of the semen analysis.”

• Frontiers in Genetics, 2023: “Tissue-specific DNA methylation variability and its potential clinical value.”

Path Fertility and SpermQT are trademarks of Inherent Biosciences, Inc. All other trademarks are property of their respective owners.

# # #

Media Contact: David Politis, me@davidpolitis.com, +1-801-556-8184

SOURCE: Path Fertility

View the original press release on ACCESS Newswire

Dr. Raza Bokhari, Executive Chairman & CEO will participate in panel discussions and highlight Company’s AI-enabled Drug Development Strategy

PHILADELPHIA, PA / ACCESS Newswire / March 10, 2026 / Medicus Pharma Ltd. (NASDAQ:MDCX) (“Medicus” or the “Company”), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce its participation in the Longwood Miami CEO forum being held March 11-13, 2026, at the Ritz-Carlton Key Biscayne.

Dr. Raza Bokhari, Executive Chairman & CEO of Medicus, will serve on a panel titled “Accelerating the Path to Patient Care” and will highlight company’s AI enabled Drug development strategy designed to make clinical trials not only cost efficient but also time efficient.

Other panelists include Lindsay Edwards, CTO & President of Platform, Relation Therapeutics; Julie Gerberding, CEO, Foundation for the NIH and Former Director, CDC; and Gilmore O’Neill, CEO, Editas Medicine. The panel will be moderated by Jon Cohen, Head of Life Sciences Go-To-Market at ServiceNow.

Event details:

Event: Longwood Healthcare Leaders Miami CEO

Date: March 12-13, 2026

Venue: The Ritz-Carlton Key Biscayne.

Information and registration: https://www.longwoodhealthcareleaders.com/miamiceo

Longwood Miami CEO is an invitation-only event, that brings together Industry leaders, innovators, thought leaders and opinion makers, who will speak on curated fireside chats, roundtables, and discussion panels.

Notable Participants in the conference include Brent Saunders (CEO, Bausch + Lomb), Chris Boshoff (CSO & President, R&D, Pfizer), Rob Califf (former Commissioner, FDA), Sidney Taurel (Chair Emeritus, Lilly), Bill Mezzanotte (Head, R&D, CSL), David Redfern (President, Corporate Development, GSK), Pablo Cagnoni (Head, R&D, Incyte), Julie Gerberding (former Director, CDC), Bill Hait (Chief Scientific Advisor, AACR; former CMO, J&J), Jeremy Levin (Chair & CEO, Ovid Therapeutics), David Meek (former CEO, Ipsen; CEO, Genetix), Frank Nestle (CEO, Deerfield Discovery), Benj Garrett (Managing Director, Stifel), among others.

For further information contact:

Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.com

About Medicus Pharma Ltd.

Medicus Pharma Ltd. (Nasdaq:MDCX) is a precision-guided biotech/life sciences company focused on accelerating the clinical development programs of novel and potentially disruptive therapeutics assets. The Company is actively engaged in multiple countries across three continents.

SkinJect Inc., a wholly owned subsidiary of Medicus Pharma Ltd., is a development-stage life sciences company focused on commercializing a novel, non-invasive treatment for basal cell skin cancer using a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumor cells.

In August 2025, the Company announced its entry into a non-binding memorandum of understanding (MoU) with Helix Nanotechnologies, Inc. (HelixNano), a Boston-based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.

In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next-generation gonadotrophin-releasing hormone (GnRH) antagonist, as a first-in-market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.

Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.

In October 2025, the Company announced a strategic collaboration with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.

Under the collaboration, Medicus and the GSA will jointly pursue the Expanded Access IND Program with the FDA to allow patients with multiple, recurrent, or inoperable basal cell carcinomas (BCCs) to access SkinJect under physician-supervised treatment protocols. The initiative aims to establish a framework for expanded access while collecting valuable real-world safety and tolerability data to inform future regulatory filings. It will also more tightly integrate patient community-led insights and data into the design, monitoring, and long-term development of SkinJect in this rare disease population.

In November 2025, the Company received full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The approvals were issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Wales Research Ethics Committee (WREC). The MHRA approval followed a comprehensive scientific review of the Investigational Medicinal Product Dossier (IMPD) and protocol. The WREC issued a favorable ethical opinion, and the HRA granted study-wide governance approval, confirming compliance with UK Good Clinical Practice and National Health Service capacity and capability standards.

In December 2025, the Company announced that it has successfully completed enrolment of 90 patients in the United States for Phase 2 clinical study (SKNJCT-003) evaluating D-MNA to non-invasively treat BCC of the skin. The Company expects to secure an end-of-Phase 2 meeting with the FDA in the first half of 2026.

In December 2025, Medicus announced a non-binding letter of intent with Reliant AI Inc., a decision-intelligence company specializing in generative AI for the life sciences industry, to collaborate on the development of an AI-driven clinical data analytics platform. Subject to execution of definitive agreements, the platform is expected to support capital-efficient clinical development through data-driven dynamic clinical-site selection, patient stratification and enrollment forecasting. The initial phase of the collaboration is expected to support an upcoming Teverelix clinical study planned for 2026, with potential expansion into later-stage development programs in collaboration with a strategic partner.

In February 2026, the Company announced that it has received “study may proceed” clearance from the U.S. Food and Drug Administration (FDA) to initiate its Phase 2b dose-optimization study of Teverelix^®, an investigational next generation long-acting GnRH antagonist, in men with advanced prostate cancer (APC).

Cautionary Notice on Forward-Looking Statements

Certain information in this news release constitutes “forward-looking information” under applicable securities laws. “Forward-looking information” is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the Company’s leadership and prospects, the collaboration with GSA including the potential benefits thereof for GSA, those suffering with Gorlin Syndrome and Medicus (including as it relates to the development of SkinJect^™), ability to be approved for the Expanded Access IND Program to enable those suffering with Gorlin Syndrome to access SkinJect^™ under physician-supervised treatment protocols, the development of Teverelix and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr, high CV risk prostate cancer, women’s health indications like endometriosis, and the potential market opportunities related thereto, the MOU, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano’s proprietary mRNA vaccine platform with Medicus’s proprietary microneedle array (MNA) delivery platform, the Company’s aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof, including with respect to the Company’s submission for approval in the FDA Commissioner’s National Priority Voucher program, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the Company’s expectations regarding reported efficacy findings and whether there will be material changes to its reported SKNJCT-003 topline results and to secure an EOP2 meeting with the FDA in the first half of 2026, entry into definitive documents with Reliant and the expected terms thereof, engaging in proposed Medicus-sponsored studies currently contemplated in the Reliant non-binding letter of intent and the expected benefits thereof, the expansion of SKNJCT-003 into the United Kingdom and the potential benefits therefrom, the advancement of the SKNJCT-004 study and the potential results of and benefits of such study. Forward-looking statements are often but not always, identified by the use of such terms as “may”, “on track”, “aim”, “might”, “will”, “will likely result”, “could,” “designed,” “would”, “should”, “estimate”, “plan”, “project”, “forecast”, “intend”, “expect”, “anticipate”, “believe”, “seek”, “continue”, “target”, “potential” or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company’s annual report on form 10-K for the year ended December 31, 2024 (the “Annual Report”), and in the Company’s other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company’s common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

SOURCE: Medicus Pharma Ltd

View the original press release on ACCESS Newswire