On May 5, 2026 MimiVax Inc. and Roswell Park Comprehensive Cancer Center reported the launch of a phase 2 clinical trial (NCT06202066) evaluating SurVaxM in combination with temozolomide in patients with progressing neuroendocrine tumors, also known as NETs. The study is being conducted at Roswell Park in Buffalo, New York, under the direction of principal investigator Dr. Jasmeet Kaur.

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The phase 2 study compares the safety and effect of temozolomide combined with SurVaxM to temozolomide alone in patients with metastatic NETs that are progressing.

SurVaxM is a peptide vaccine that has been shown to produce an immune system response against cancer cells that express the protein survivin and may block the growth of new tumor cells. The new clinical trial builds directly on phase 1 findings from NCT03879694, in which SurVaxM was well tolerated in NET patients and demonstrated measurable clinical benefit with elevated antibody responses.

"This phase 2 trial is the result of years of careful, collaborative science between MimiVax, Roswell Park Comprehensive Cancer Center, and the neuroendocrine tumor community," said Michael Ciesielski, PhD, CEO and Co-founder of MimiVax. "NET patients deserve more options, and we are excited to see if SurVaxM can become a new treatment for them."

Neuroendocrine tumors are a rare type of cancer that arise from hormone-producing cells throughout the body, most commonly in the gastrointestinal tract and lungs. Their incidence has increased significantly over the past two decades, with an estimated 28,000 people diagnosed in the U.S. each year. While many NETs grow slowly, metastatic NET disease carries a poor prognosis, and treatment options are limited once patients progress on first-line therapy. Immunotherapy has shown limited efficacy in NETs to date, making the identification of new immunologic targets and approaches important to patient care.

The phase 2 trial builds on Roswell Park’s previous NET research, which demonstrated that survivin, the protein targeted by SurVaxM, is expressed in approximately 52 percent of NET specimens, and that its expression correlates with more aggressive tumor biology and shorter survival. Importantly, the phase 1 study demonstrated that SurVaxM was safe and generated measurable immune responses in NET patients.

"Patients need more options to treat NETs, and the phase 1 data gave us confidence this is a safe, immunologically active approach to try in a larger patient population," said gastrointestinal oncologist Jasmeet Kaur, MD, FACP, study principal investigator and Assistant Professor at Roswell Park. "We are excited to see if the next trial confirms a meaningful clinical benefit that advances patient care."

The initiation of this phase 2 trial comes as MimiVax begins data analysis from its phase 2b SURVIVE trial of SurVaxM in newly diagnosed glioblastoma. SurVaxM is also being evaluated in pediatric brain tumors and multiple myeloma.

"The phase 2 NET study underscores the breadth of cancers in which survivin is a relevant therapeutic target," noted Robert Fenstermaker, MD, Roswell Park Chair Emeritus in Neurosurgery and a co-founder of MimiVax. "Once discarded as too difficult a target, our research into survivin is yielding results that are giving hope to patients with some of the toughest cancer diagnoses."

For more information about this study or other Roswell Park clinical trials, please call 1-800-ROSWELL (1-800-767-9355) or send an e-mail to [email protected] interested in participating in this study may contact Roswell Park Comprehensive Cancer Center at 1-800-ROSWELL (1-800-767-9355) or [email protected]. Additional information is available at clinicaltrials.gov (NCT06202066).

(Press release, MimiVax, MAY 5, 2026, View Source;utm_medium=rss&utm_campaign=mimivax-and-roswell-park-open-phase-2-trial-of-survaxm-for-patients-with-metastatic-neuroendocrine-tumors [SID1234665123])

On May 5, 2026 Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

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"The first quarter of 2026 was marked by encouraging regulatory progress," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "We were pleased to receive the minutes from our end-of-Phase 2 meeting with the FDA and align on the major elements of our proposed pivotal Phase 3 trial to evaluate VCN-01 with gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy in patients with metastatic PDAC. The FDA feedback was consistent with the positive scientific advice previously received from the EMA, with both agencies agreeing to repeated dosing ‘macrocycles’ of VCN-01 and SoC chemotherapy. Additional data analyses presented in a poster at the AACR (Free AACR Whitepaper) Annual Meeting in April 2026 concluded that the additional data may reflect a potential immune-mediated mechanism of action for VCN-01 in metastatic PDAC. We believe that repeated macrocycle dosing of VCN-01 and chemotherapy may enhance this immune action, providing increased and more durable tumor responses and longer survival. As we finalize the pivotal Phase 3 study protocol, we plan to generate feasibility data for the intended Phase 3 macrocycle dosing regimen, by conducting a small study in metastatic PDAC patients administering more frequent VCN-01 doses for a longer period. This dosing feasibility study is expected to commence at a single site in Spain in the second half of this year. In parallel with our PDAC program, discussions are ongoing with clinicians and key opinion leaders to design a Phase 2/3 clinical trial protocol for the VCN-01 plus topotecan combination in retinoblastoma patients. We believe that intravitreal coadministration of VCN-01 with topotecan may provide a new treatment option for children with refractory retinoblastoma and vitreous seeds, which remains an unmet medical need in patients with this rare disease. In the first quarter of 2026, we made VCN-01 available to investigators for compassionate use in treating patients with retinoblastoma. We expect that outcomes from these compassionate use patients will provide valuable information on the feasibility and tolerability of this combination for use in a potential Phase 2/3 clinical trial. If a protocol is ultimately submitted to, and agreed by, the FDA, we expect the first patient to be enrolled in December 2026, with rolling Biologic Licensing Application (BLA) submissions expected to be made in 2029 (if successful), targeting potential approval of the BLA prior to September 30, 2029."

Recent Highlights and Anticipated Milestones

VCN-01

Metastatic PDAC:

As recently announced, Theriva received minutes from Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic PDAC. The FDA provided general agreement with Theriva’s proposed design for a Phase 3 clinical trial, which closely tracks the design of the successful VIRAGE Phase 2 trial. As announced in 2025, the VIRAGE trial met its primary endpoints, with metastatic PDAC patients receiving VCN-01 with SoC chemotherapy having improved overall survival (OS), progression-free survival (PFS) and duration of response (DoR) compared to SoC chemotherapy alone. Greater improvements in OS and PFS were observed in patients who received two doses of VCN-01, leading Theriva to plan the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial’s timelines and outcomes.
Tumor response, biomarker, and subgroup analyses from the VIRAGE Phase 2b clinical trial were recently presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 annual meeting. The poster concluded that the additional data may reflect an immune-mediated mechanism of action for VCN-01, with later and more durable responses and improved overall survival and progression-free survival in patients treated with VCN-01 plus SoC chemotherapy, compared to SoC chemotherapy alone. Improved overall survival was observed in VCN-01-treated patients across multiple subgroups, including patients with liver metastases.
Retinoblastoma:

Made VCN-01 available to investigators for compassionate use in treating patients with retinoblastoma. Two patients have been treated with intravitreal VCN-01 in combination with intravitreal topotecan and are being followed by the treating physicians.
Continued discussions with clinicians and key opinion leaders to design a Phase 2/3 clinical trial protocol for the VCN-01 plus topotecan combination in retinoblastoma patients.
First Quarter Ended March 31, 2026 Financial Results

General and administrative expenses

General and administrative expenses increased to $2.1 million for the three months ended March 31, 2026, from $1.4 million for the three months ended March 31, 2025. This increase of 43% is primarily comprised of an increase in legal fees, investor relations costs, registration fees, and salary costs. The charge related to stock-based compensation expense was $111,000 for the three months ended March 31, 2026, compared to $54,000 for the three months ended March 31, 2025.

Research and Development Expenses

Research and development expenses decreased to $355,000 for the three months ended March 31, 2026, from approximately $3.0 million for the three months ended March 31, 2025. This decrease of 88% is primarily the result of lower clinical trial expenses related to the completion of our VIRAGE Phase 2b clinical trial of VCN-01 in PDAC, the recognition of the Spanish research and development rebate, lower indirect costs related to compensation and lower clinical trial expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, offset by higher patent expenses related to SYN-020. We anticipate research and development expense to decrease in the near future until we commence additional clinical trials as we focus on regulatory interactions regarding a proposed pivotal clinical trial of VCN-01 in retinoblastoma, continue with VCN-01 manufacturing scale-up activities, commence a proposed Phase 2a study in metastatic PDAC patients evaluating VCN-01 dosing frequency and continue limited preclinical studies supporting VCN-01 and VCN-12, the first candidate from our VCN-X discovery program. The charge related to stock-based compensation expense was $24,000 for the three months ended March 31, 2026, compared to $46,000 for the three months ended March 31, 2025.

Other Income/Expense

Other income was $83,000 for the three months ended March 31, 2026 compared to other income of $93,000 for the three months ended March 31, 2025. Other income for the three months ended March 31, 2026 is comprised of interest income of $82,000 and an exchange gain of $1,000. Other income for the three months ended March 31, 2025 is comprised of interest income of $96,000 and an exchange loss of $3,000.

Cash and cash equivalents

Cash and cash equivalents totaled $14.4 million as of March 31, 2026, an increase of $1.4 million from December 31, 2025. During the year ended December 31, 2025 and the quarter ended March 31, 2026, the primary use of cash was for working capital requirements and operating activities, which resulted in a net loss of $23.7 million and $2.0 million for the year ended December 31, 2025 and the quarter ended March 31, 2026, respectively.

(Press release, Theriva Biologics, MAY 5, 2026, View Source [SID1234665143])

On May 5, 2026 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers, reported the presentation of Phase 2 clinical data highlighting the potential abscopal effects of the Company’s novel oncolytic peptide, VP-315 (ruxotemitide), in the treatment of basal cell carcinoma (BCC) at the 2026 Society for Investigative Dermatology (SID) Annual Meeting, taking place from May 13-16, 2026, in Chicago, Illinois. Patients with BCC frequently present with multiple tumors, and approximately one-third will develop additional primary tumors over their lifetime, highlighting the need for therapies that address diseases such as BCC with multifocal potential.

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"The peripheral anticancer activity we are observing well beyond the injection site suggests that VP-315 could be exerting an abscopal effect for the treatment of basal cell carcinoma," said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica Pharmaceuticals. "Such activity may indicate a broader immune activation within the tumor microenvironment of non-target lesions. If this is demonstrated in further pivotal testing, it could suggest that VP-315 has a unique potential to not only effectively treat primary BCC lesions but could also address the unmet need in patients with more than one lesion. It could also benefit patients with difficult to detect, residual disease that can sometimes be left behind after surgical excision of the tumor," Dr. Rieger continued.

The poster, titled "VP-315 Demonstrates a Potential Abscopal Effect in Untreated Non-Target Basal Cell Carcinoma (BCC) Lesions" will be presented by Noah Rosenberg MD, Verrica’s Chief Medical Officer. Dr. Rosenberg commented "We are excited about the potential of VP-315 to provide a primary and/or neoadjuvant treatment option for patients with BCC, whether it be their first lesion or multiple lesions after a long history of BCC. While the best outcome for patients is to completely eliminate the tumor, which we have observed in many patients in our Phase 2 study, overall tumor size was reduced on average by 86%, which is clinically meaningful. This highlights the potential for VP-315 to improve the patient experience by reducing the size and potential complexity of future procedures, even where surgical excision is ultimately required," Dr. Rosenberg concluded.

Presentation Details:

Poster Number: LB1190
Category: Non-Melanoma Cancers and UV Biology/Injury
Poster Session Dates and Time:
Friday, May 15, 2026 (4:30 pm – 6:00 pm)
Location: (Salons B, C, D – Lower Level, Hilton Chicago)

Key Findings:

Background

VP-315 (ruxotemitide) is a potential first-in-class oncolytic chemotherapeutic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death and thereby unleashing a broad spectrum of tumor antigens for T-cell responses, which may offer a non-surgical option for patients suffering from skin cancer. Verrica holds an exclusive worldwide license to develop and commercialize VP-315 for certain dermatologic oncology indications, including non-metastatic melanoma and non-metastatic merkel cell carcinoma, and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. VP-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials.

Type of Study:
Open-Label Phase II trial

Methods

Subjects received <8 mg (in 0.5mL) intratumoral VP-315 injections in up to 2 treated lesions (TLs). Up to 3 non-treated lesions (NTLs) per subject were monitored over 12 weeks. Changes in NTL size were assessed histologically after excision on digital images in relation to tumor bed size, histologic subtype and NTL location relative to TLs.

Results:

14 untreated NTLs in 9 subjects demonstrated an overall 67% reduction in lesion size following treatment of TLs. Reductions ranged from 50-100% (superficial) and 25-100% (nodular). Complete histologic clearance was observed in 21% of NTLs (3 /14). Reductions in tumor size were observed in all NTL locations including proximal, distal and contralateral to TLs. No skip lesions were observed. Non-serious local skin reactions were reported in 1 NTL.

Conclusions

The therapeutic effects of VP-315 extended beyond treated lesions. Reductions in untreated NTLs suggest a potential abscopal effect consistent with broader immune activation within the tumor microenvironment of remote NTLs.

About Basal Cell Carcinoma

Basal cell carcinoma is the most common form of cancer in the U.S., and incidence is rising worldwide. There are approximately 3.6 million diagnoses of basal cell carcinomas in the U.S. each year, with a high unmet need for new treatment options. Basal cell carcinoma is generally treated with invasive surgery to remove the tumor, which can cause pain, infection, bleeding and scarring.

(Press release, Verrica Pharmaceuticals, MAY 5, 2026, View Source [SID1234665158])

On May 5, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of targeted oncology therapies, reported that it has entered into a securities purchase agreement with certain institutional investors, and an additional securities purchase agreement with certain members of management, to issue and sell up to an aggregate of approximately $35 million upfront and $105 million in milestone-based securities in a registered direct offering of common stock and a concurrent private placement of common stock, pre-funded warrants, and milestone-based warrants.

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The oversubscribed financing was led by Nantahala Capital Management, with participation from Balyasny Asset Management, Caligan Partners, Janus Henderson Investors, SilverArc Capital Management, Stonepine Capital Management, Stempoint Capital LP, Empery Asset Management LP, and other dedicated healthcare funds along with members of the executive management team.

Ladenburg Thalmann & Co. Inc. acted as exclusive placement agent for the financing.

"We are highly encouraged by the strong demand for this financing and the support from a distinguished group of leading healthcare-focused investors who recognize both the urgent need for new treatment options for patients with Waldenström macroglobulinemia (WM) and the promise of iopofosine I 131," said James Caruso, president and chief executive officer of Cellectar Biosciences. "This oversubscribed financing provides important validation of our strategy to pursue accelerated approval in the US and conditional marketing approval in Europe for iopofosine, while supporting our plans to initiate a global confirmatory study in the fourth quarter of 2026. Importantly, this funding also underscores the strength of our proprietary Phospholipid Drug Conjugate (PDC) delivery platform and enables continued advancement of CLR 125, our differentiated Auger-emitting program for triple-negative breast cancer. Together, these efforts position us to deliver meaningful impact for patients with significant unmet medical needs while driving long-term value for our stakeholders."

In connection with the transaction, Andrew Gu of Nantahala Capital Management, LLC will join Cellectar’s Board of Directors upon closing.

Andrew Gu of Nantahala stated, "Waldenström macroglobulinemia is a rare hematologic malignancy, and Cellectar has built a meaningful body of clinical evidence for iopofosine I 131 across multiple Phase 2 studies in this patient population. I look forward to working with Jim and the team as a member of the Board."

Andrew Gu is an analyst at Nantahala, focused on investments in the biotechnology sector. Prior to joining Nantahala in 2021, Mr. Gu graduated from the University of Pennsylvania’s Roy and Diana Vagelos Life Sciences and Management (LSM) Program in 2021 with a B.S. in Economics (Finance concentration) from the Wharton School and a B.A. in Neuroscience from the College of Arts and Sciences. He was also a recipient of the Robert L. Benz and Marie Uberti-Benz Family Prize in Life Sciences and Management.

The registered direct offering involves the issuance and sale of 1,618,053 shares of common stock, $0.00001 par value per share (the "Common Stock") and the private placement involves the issuance and sale of (i) 2,116,887 shares of Common Stock, (ii) Pre-Funded Warrants to purchase 9,471,086 shares of Common Stock (the "Pre-Funded Warrants", and the shares issuable upon exercise of the Pre-Funded Warrants, the "Warrant Shares") and (iii) 13,206,026 each of milestone based Tranche A, Tranche B and Tranche C Warrants. The milestone warrants will be exercisable upon approval by the company’s stockholders, and are callable by the company upon the achievement of certain events and have the following terms:

Tranche A Warrant shall have a one-year term from the date of stockholder approval and have an exercise price of $2.65. The company may call the Tranche A Warrant after the initiation of the Randomized Confirmatory Pivotal Clinical Trial (defined as enrollment of the first patient in the study) for iopofosine I 131 and the price of the common stock exceeds 130% of the exercise price for 20 consecutive trading days.
Tranche B Warrant shall have a two-year term from the date of stockholder approval and have an exercise price of $2.65. The company may call the Tranche B Warrant for cash after the acceptance for review of the New Drug Application ("NDA") for iopofosine I 131 with the U.S. Food and Drug Administration (FDA) and the price of the common stock exceeds 130% of the exercise price for 20 consecutive trading days.
Tranche C Warrant shall have five-year term from the date of stockholder approval and have an exercise price of $2.65. The company may call the Tranche C Warrant for cash after the approval of the New Drug Application ("NDA") for iopofosine I 131 with the FDA and the price of the common stock exceeds 130% of the exercise price for 20 consecutive trading days.
Certain members of the executive management team of the Company have agreed to participate in the financing at a purchase price of $2.88 per share of Common Stock and accompanying milestone-based Tranche A, Tranche B and Tranche C Warrants with an exercise price of $2.88 per share. All other terms of the Warrants are identical to those being purchased by the Investors.

The shares Common Stock in the registered direct offering are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-279731) previously filed and declared effective by the Securities and Exchange Commission. The offering of such shares of Common Stock will be made only by means of a prospectus supplement that forms a part of the registration statement. The offer and sale of the foregoing securities in the private placement are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, such securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

(Press release, Cellectar Biosciences, MAY 5, 2026, View Source [SID1234665108])

On May 5, 2026 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported financial results for its first quarter ended March 31, 2026, and reaffirmed its financial guidance for the full-year 2026.

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"We are seeing strong performance across a number of key areas, including the Cancer Care Continuum as we begin to realize a return on our focused strategy. We have implemented a dedicated hereditary cancer sales force and other key programs designed to support the expected continued growth in germline testing. And with decisive steps taken to address our Prenatal Health business, we expect improved performance in the remainder of 2026," said Sam Raha, President and CEO, Myriad Genetics. "Our limited launch of Precise MRD for breast cancer patients has received positive early feedback and we remain on track with our other planned launches in 2026, as part of our milestone-rich year. We are confident these tests will be important drivers of our growth in 2027 and beyond."

Financial and Operational Highlights
•Test volumes of 385,000 in the first quarter of 2026 were stable year-over-year.
•The following table summarizes year-over-year testing volume changes in the company’s core product categories:
Three Months Ended March 31,
(in thousands) 2026 2025 % Change
Product volumes:
Cancer Care Continuum 96 85 13 %
Prenatal Health 153 173 (12) %
Mental Health 136 127 7 %
Total 385 385 — %

•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three Months Ended March 31,
(in millions)
2026 2025 % Change
Product revenues:
Cancer Care Continuum $ 120.2 $ 115.6 4 %
Prenatal Health 41.9 49.3 (15) %
Mental Health 38.3 31.0 24 %
Total $ 200.4 $ 195.9 2 %

Product Categories:
Cancer Care Continuum – MyRisk, BRACAnalysis CDx, MyChoice CDx, Prolaris, Precise Tumor, Precise MRD
Prenatal Health – Foresight, Prequel, FirstGene, SneakPeek
Mental Health – GeneSight

•Operating expenses in the first quarter of 2026 were $168.3 million, increasing $5.1 million year-over-year. Adjusted operating expenses in the first quarter of 2026 increased $7.9 million year-over-year to $148.5 million, partially reflecting the company’s progress in its multi-year investment program in key strategic areas.
•Operating loss in the first quarter of 2026 was $30.7 million.

Cash Flow and Liquidity
First quarter 2026 cash flow used in operations was $15.7 million; adjusted operating cash outflow in the first quarter of 2026 was $13.4 million. Capital expenditures and capitalization of internal use software costs totaled $6.5 million in the first quarter 2026 resulting in adjusted free cash flow of $(19.9) million in the first quarter of 2026.

As of the end of the first quarter of 2026, the company had cash and cash equivalents of $124.4 million.

Business Performance and Highlights
Cancer Care Continuum
The Cancer Care Continuum business delivered revenue of $120.2 million in the first quarter of 2026.
•First quarter 2026 hereditary cancer testing revenue increased 5% year-over-year driven by a 14% year-over-year increase in volume.
•First quarter 2026 Prolaris testing revenue grew 3% year-over-year. The company continues to make progress on its first AI-enabled prostate cancer test, in partnership with PATHOMIQ, and expects to launch the test in the second quarter of 2026.
•In April 2026, the company shared new data at a number of annual clinical society meetings, including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the Society of Gynecologic Oncology (SGO) underscoring Myriad Genetics’ commitment to the Cancer Care Continuum and highlighting its progress in precision oncology. For example, data from one poster presentation showed that Precise MRD testing after adjuvant therapy for ovarian cancer is significantly prognostic of recurrence and that elevated risk was observed even at ctDNA levels detectable only by an ultrasensitive assay. The company believes this data reinforces the scientific strength behind the company’s precision oncology programs and focus on advancing clinically meaningful innovations for patients and providers.
•In April 2026, Myriad Genetics received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the use of the MyChoice CDx test for prostate cancer patients as a companion diagnostic for Lynparza(olaparib). With this approval, clinicians in Japan can now order the MyChoice CDx test to determine homologous recombination deficiency (HRD) status for patients with ovarian cancer, and BRCA1/2 status for breast and prostate cancers.

Prenatal Health
The Prenatal Health business delivered revenue of $41.9 million in the first quarter of 2026.
•Prenatal testing revenue in the first quarter of 2026 declined 15% year-over-year, as volume decreased 12% year-over-year reflecting a difficult year-over-year comparison as the company continues to engage with customers and address the disruption caused by the Q2 ’25 implementation of the company’s new order management system.
•In April 2026, a national payor updated its medical policy to cover expanded carrier screen tests, like the Company’s Foresight Universal Plus test.
•The multi-site CONNECTOR study, using the company’s FirstGene Multiple Prenatal Screen, continues to see progress in enrollment and the Company expects this study, if successful, to support future commercial launch activities and expand capabilities in prenatal testing.

Mental Health
GeneSight test revenue was $38.3 million in the first quarter of 2026.
•First quarter 2026 revenue grew 24% year-over-year reflecting 7% GeneSight volume growth, and overall improved reimbursement trends.

Financial Guidance
Myriad Genetics does not provide forward-looking guidance in accordance with accounting principles generally accepted in the United States (GAAP) for the measures on which it provides forward-looking non-GAAP guidance as the company is unable to provide a quantitative reconciliation of forward-looking non-GAAP measures to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, are dependent on various factors, are out of the company’s control, or cannot be reasonably predicted. Such adjustments include, but are not limited to, strategic realignment, costs related to amortization of intangibles from acquisitions, impairment and related charges, depreciation, equity compensation, tax benefits, and other adjustments. For example, stock-based compensation may fluctuate based on the timing of employee stock transactions and unpredictable fluctuations in the company’s stock price. Any associated estimate of these items and their impact on GAAP performance could vary materially.

Below is a table summarizing Myriad Genetics’ full-year 2026 financial guidance*:

(in millions, except percentages)
2026 Guidance
FY 2026 Comments
Revenue $860 – $880
Reiterate the full year 2026 revenue range, reflecting current business trends.

Expect 2H’26 revenue to be greater than 1H’26
Adjusted Gross Margin %**
68% – 69% Gross margins expected to fluctuate quarter to quarter given product mix and pricing trends.
Adjusted EBITDA***
$37 – $49

*
Assumes currency rates as of May 5, 2026.
**
Adjusted Gross Margin is defined as Gross Margin plus non-cash cost of sales, such as amortization of intangible assets and share-based compensation expense, and non-recurring one-time expenses.
***
Adjusted EBITDA is defined as Net income (loss) plus income tax expense (benefit), total other income (expense), non-cash operating expenses, such as amortization of intangible assets, depreciation, impairment of goodwill and long-lived assets, and share-based compensation expense, and one-time expenses such as expenses from strategic realignment..

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release.

Conference Call and Webcast
A conference call will be held today, Tuesday, May 5, 2026, at 4:30 p.m. ET to discuss Myriad Genetics’ financial results and business developments for the first quarter of 2026. A live webcast of the conference call can be accessed on Myriad Genetics’ Investor Relations website at investor.myriad.com. To participate in the live conference call via telephone, please register at View Source Upon registering, a dial-in number and unique PIN will be provided to join the conference call. Following the conference call, an archived webcast of the call will be available at investor.myriad.com.

(Press release, Myriad Genetics, MAY 5, 2026, View Source [SID1234665124])