On February 24, 2025 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its fourth quarter and full-year ended December 31, 2024 and reaffirmed its previously issued financial guidance on business performance for the full-year 2025 (Press release, Myriad Genetics, FEB 24, 2025, View Source [SID1234650477]).

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"There is a lot for Myriad Genetics to be proud of in 2024. We generated 11% revenue growth over 2023, making this our second consecutive year of double-digit growth, and $40 million in adjusted EBITDA. This achievement is the result of the company’s multi-year investment strategy along with our team’s hard work and focus on the needs of our patients and the healthcare providers who serve them," said Paul J. Diaz, President and CEO, of Myriad Genetics.

"We believe 2025 will be another year of opportunity for our stakeholders as Myriad Genetics continues to grow and has the financial flexibility to continue to invest in research and development and technology innovations to achieve our Mission and Vision to advance health and well-being for all by helping people take control of their health. Today’s announcement of our collaboration with PATHOMIQ and their AI-technology platform is an exciting example of how Myriad will continue to deliver innovative insights to patients and clinicians in their fight against cancer. As we look to 2025 and beyond, we are excited about the potential contribution from recent product launches, including Prequel with 8-week Gestational Age, Foresight Universal Plus, and the continuing traction with our Precise Tumor comprehensive genomic panel. In addition, we are excited for the future launches of FirstGene, Precise Liquid, and Precise MRD, which is already available for research use by our pharmaceutical partners.

Lastly, I would emphasize that it has been an honor to serve as Myriad’s President and CEO and help to further its mission. I believe the Company is well positioned for the future and will continue to grow under Sam Raha and the entire executive team’s leadership."

Financial and Operational Highlights
•Test volumes of 374,000 in the fourth quarter of 2024 increased 4% year-over-year and 7% for the twelve months ended December 31, 2024.
•The following table summarizes year-over-year testing volume changes in the company’s core product categories:
Three months ended December 31, Twelve Months Ended December 31,
(in thousands)
2024 2023
% Change
2024 2023
% Change
Product volumes:
Hereditary cancer
75 74 1 % 294 281 5 %
Tumor profiling
12 14 (14) % 53 59 (10) %
Prenatal 160 156 3 % 666 625 7 %
Pharmacogenomics
127 116 9 % 507 459 10 %
Total 374 360 4 % 1,520 1,424 7 %

•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three months ended December 31, Twelve Months Ended December 31,
(in millions)
2024 2023
% Change
2024 2023
% Change
Product revenues:
Hereditary cancer
$ 94.3 $ 88.9 6 % $ 364.5 $ 327.8 11 %
Tumor profiling
30.8 32.1 (4) % 125.8 135.6 (7) %
Prenatal 44.9 40.0 12 % 177.1 151.3 17 %
Pharmacogenomics
40.6 35.6 14 % 170.2 138.5 23 %
Total $ 210.6 $ 196.6 7 % $ 837.6 $ 753.2 11 %

•GAAP operating expenses in the fourth quarter of 2024 were $189.9 million, increasing $23.5 million year-over-year. Adjusted operating expenses in the fourth quarter of 2024 increased $16.0 million year-over-year to $146.0 million, reflecting increased spending on clinical studies to support the development and launches of FirstGene and Precise MRD and other research and development expense during the fourth quarter 2024.
•GAAP operating loss in the fourth quarter of 2024 was $39.0 million, an increase of $7.6 million year-over-year; adjusted operating income in the fourth quarter of 2024 was $5.6 million.
•Fourth quarter 2024 GAAP cash flow from operations was $6.6 million; adjusted cash flow from operations in the fourth quarter of 2024 was $15.4 million, an increase of $1.9 million year-over-year. Capital expenditures and capitalization of internal use software costs were $5.9 million in the fourth quarter 2024.
•During fourth quarter of 2024, Myriad determined that the contingent payment from the Ravgen settlement is no longer probable and reversed the prior accrued amount of 21.3 million.

Business Performance and Highlights
Oncology
The Oncology business delivered revenue of $82.8 million in the fourth quarter of 2024.
•Fourth quarter 2024 hereditary cancer testing revenue in Oncology grew 8% year-over-year.
•In February 2025, Myriad exclusively licensed PATHOMIQ’s AI technology platform for prostate cancer in the United States. This agreement marks a strategic expansion of Myriad’s clinical oncology portfolio and complements the company’s Prolaris Prostate Cancer Prognostic Test. Myriad plans to leverage PATHOMIQ’s prognostic and predictive biomarker capabilities across different phases of the patient journey in prostate cancer and potentially for other cancer indications. Myriad intends to commercially launch its first AI-driven prostate cancer test later in 2025, which would enable Myriad to offer both AI and molecular testing options for prostate cancer, eventually spanning all phases of the prostate cancer patient journey – including at the time of biopsy and post-radical prostatectomy (post-RP).
•Updated Prostate Cancer Guidelines from the National Comprehensive Cancer Network (NCCN) underscore the critical role of Myriad’s portfolio of offerings across the patient’s prostate cancer journey. Myriad’s full suite of prostate cancer products is uniquely aligned with the updated NCCN Guidelines, offering integrated genetic and tumor genomic insights that identify germline risk, provide valuable insights into tumor biology, simplify therapy selection, and help identify clinical trial eligibility for patients.
•In January 2025, The University of Texas MD Anderson Cancer Center and Myriad Genetics announced a five-year strategic alliance to accelerate the clinical evaluation and development of Myriad’s molecular residual disease (MRD) assay. This strategic alliance aims to create a portfolio of studies to evaluate the clinical validity and utility of Myriad’s Precise MRD in breast, gastrointestinal, genitourinary, and gynecological cancers.
•In February 2025, the United States Patent and Trademark Office issued two new patents that further advance Myriad’s ability to bring Precise MRD, its tumor-informed, high-definition, MRD assay to market. This action builds on the three patents issued in 2024 that are related to foundational platform MRD technology and cell-free DNA preparation methods. The Precise MRD test is currently being evaluated in several studies and is processed in the company’s new state-of-the-art laboratory facility in Salt Lake City.

Women’s Health
The Women’s Health business delivered revenue of $87.2 million in the fourth quarter of 2024.
•Prenatal testing revenue in the fourth quarter of 2024 grew 12% year-over-year.
•In the fourth quarter of 2024, Myriad signed a strategic partnership with jscreen, a national organization that delivers education and access to genetic testing with a focus on high-risk populations. The collaboration combines Myriad’s high-quality hereditary cancer and reproductive genetics products, MyRisk with RiskScore and Foresight Carrier Screen, with jscreen’s trusted education and genetic care navigation program.
•In January 2025, Myriad unveiled groundbreaking research at the annual Society for Maternal-Fetal Medicine Conference (SMFM). The company’s "Fetal fraction amplification enables accurate prenatal cell-free DNA (cfDNA) screening at eight weeks gestation" study was awarded SMFM’s "Dru Carlson Memorial Award for Best Research in Ultrasound and Genetics."

Pharmacogenomics
In the pharmacogenomics business, GeneSight test revenue was $40.6 million in the fourth quarter of 2024.
•In the fourth quarter 2024, UnitedHealthcare (UNH) updated its medical policy for commercial and individual exchange benefit plans as well as certain managed Medicaid plans to discontinue coverage of multi-gene panel pharmacogenetic testing, including the company’s GeneSight test, effective in the first half of 2025. Myriad Genetics generated approximately $45 million of GeneSight current period revenue from UNH’s commercial and select managed Medicaid populations in 2024, consisting of approximately $40.0 million for UNH commercial and approximately $5.0 million for impacted UNH managed Medicaid plans.
•While Myriad Genetics continues to pursue a resolution with UNH that allows for its commercial and managed Medicaid enrollees to continue to have access to the GeneSight test, there is no guarantee that these efforts will be successful and Myriad has streamlined operations and cost structure accordingly.

Cash Flow and Liquidity
As of the end of the fourth quarter of 2024, the company had cash and cash equivalents of $102 million and the ability to access an incremental $56 million of availability under its asset-based credit facility (ABL Facility). The company had combined liquidity from its unrestricted cash and cash equivalents and available borrowing under the ABL Facility of $158 million.

Financial Guidance
Myriad Genetics does not provide forward-looking guidance on a GAAP basis 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, real estate optimization and transformation initiatives, certain litigation charges and loss contingencies, costs related to acquisitions/divestitures and the related amortization, impairment and related charges, 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 its impact on GAAP performance could vary materially.

Below is a table summarizing Myriad Genetics’ full-year 2025 financial guidance*:
(in millions, except per share amounts) FY 2025 Guidance FY 2025 Comments
Revenue $840 – $860 2025 revenue range reflects annual growth of between 9% – 11% over 2024, excluding impact from the change in UNH PGx medical policy and divested businesses.

Q1’25 revenue is expected to be between $196 and $204 million.
Gross margin % 69.5% – 70.5% Gross margins expected to fluctuate in any quarter given product mix and pricing trends.
Adjusted OPEX $575 – $595
Adjusted EBITDA** $25 – $35
Adjusted EPS*** $0.07 – $0.11 Q1’25 adjusted EPS is expected to be between $(0.04) and $(0.08).
* Assumes currency rates as of February 24, 2025.
** 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 long-lived assets, and share-based compensation expense, and one-time expenses such as expenses from real estate optimization initiatives, transformation initiatives, legal settlements, and divestitures and acquisitions.
*** Full-year 2025 adjusted EPS is based on a 93 million share count.

Conference Call and Webcast
A conference call will be held today, Monday, February 24, 2025, at 4:30 p.m. EST to discuss Myriad Genetics’ financial results and business developments for the fourth quarter and full-year 2024. 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 https://register.vevent.com/register/BId9d5a2edc11e4b3fbbce726836037dc9. 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.

On February 24, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, will present at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 3:10 p.m. ET in Boston, MA (Press release, Nuvation Bio, FEB 24, 2025, View Source [SID1234650493]).

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A live webcast of the presentation will be available on the Nuvation Bio website at View Source An archived recording will be available for 90 days following the event.

On February 24, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, reported that Northwestern University/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product (Press release, Calidi Biotherapeutics, FEB 24, 2025, View Source [SID1234653215]).

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Calidi Biotherapeutics has completed the shipment of the first batch of CLD-101, which comprises allogeneic neural stem cells loaded with the oncolytic adenovirus CRAd-S-pk7. This batch will support a new clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer.

This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, represents a major step forward in cancer therapy. Building on the promising results from a prior Phase 1 trial involving 12 patients treated with a single dose of CLD-101 published in the prestigious journal The Lancet Oncology, the upcoming Phase 1B/2 trial introduces multiple doses of CLD-101 regime in newly diagnosed patients, aiming to enhance therapeutic efficacy and improve patient outcomes.

"I am extremely excited about the commencement of recruitment for the multiple dose CLD-101 trial in newly diagnosed HGG patients. This increases the probability of success due to the improved treatment regimen initiated as early as possible in this devastating disease," said Dr. Lesniak, chairman of the Department of Neurological Surgery at Northwestern University’s Feinberg School of Medicine. The trial has been granted funding by the NIH/NCI SPORE to support this pioneering study.

Both Dr. Lesniak and Dr. Stupp bring a wealth of experience in treating brain tumors. Dr. Stupp is globally recognized for developing the FDA-approved Stupp Protocol, a treatment that transformed Glioblastoma care.

"We are proud to have assembled a world-class team of surgeons and neuro-oncologists to lead this trial," said Allan Camaisa, Chief Executive Officer and Chairman at Calidi Biotherapeutics. "Should the results of this trial demonstrate treatment outcomes consistent with the previous study, now in a larger patient group and with multiple doses of CLD-101, the implications could be transformative for the treatment of brain tumors. Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer."

On February 24, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the full year ended December 31, 2024, and provided a business update (Press release, Azitra, FEB 24, 2025, View Source [SID1234650461]).

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FY 2024 and Recent Business Highlights

Initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients; Initial safety data from first set of Netherton syndrome patients expected in the first half of 2025 with topline data from the Phase 1b trial by year-end 2025
Received clearance from the U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for adults with moderate to severe EGFRi-associated dermal toxicity
FDA granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash
Announced closing of $10.0 million and $5.0 million public offerings
Strengthened intellectual property (IP) portfolio with newly granted and allowed patents
"This is a very exciting time in the growth and evolution of Azitra as we seek to drive shareholder value through development of first-in-class drugs to treat dermatological diseases," said Francisco Salva, CEO of Azitra. "Azitra is currently advancing a therapeutic pipeline with multiple programs developed from our proprietary platform of engineered proteins delivered using topical live biotherapeutic products. Our initial focus is the development of genetically engineered strains of Staphylococcus epidermidis (S. epidermidis) to enable the delivery of critical missing natural proteins and disease-modifying proteins through the stratum corneum of the skin. This advantage could allow Azitra to address several dermatological conditions that are significantly underserved by current standards of care."

Salva continued, "Our lead product, ATR-12, is an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. In August 2024, we initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients to assess multiple safety, tolerability, and efficacy endpoints. Initial safety data from this trial is expected in the first half of 2025 with topline results by year-end 2025."

Salva continued, "In addition to ATR-12, Azitra has made significant progress with our next most advanced product, ATR-04. ATR-04 is a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFR inhibitor ("EGFRi") associated rash, which impacts approximately 150,000 patients in the United States annually, representing a market opportunity in excess of $1 billion. Our next milestone in the development of ATR-04 is the first patient dosed in a multicenter, randomized, controlled Phase 1/2 clinical trial in patients undergoing EGFR inhibitors with dermal toxicity, which we expect to occur in the first half of 2025."

Salva concluded, "We look forward to capitalizing on multiple value-building milestones during 2025, including clinical data from our ATR-12 program. These events are expected to provide key inflection points for the company and investors throughout the year as we continue to position Azitra as a leading and innovative company developing transformative drugs for underserved patients with life-altering dermatological diseases."

Pipeline and Upcoming Milestones
ATR-12 – Advancing Phase 1b Clinical Trial in Netherton Syndrome with Multiple Milestones Expected

In August 2024, initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients. Trial is designed to assess multiple safety, tolerability, and efficacy endpoints, providing a springboard for several potential value creating events during the year
Initial safety data from first set of Netherton syndrome patients in the first half of 2025
Topline data from the Phase 1b trial by year-end 2025
Azitra presented compelling preclinical data for ATR-12 in Netherton syndrome at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 Annual Meeting. Among the findings presented at the conference, ATR-12 significantly reduced protease activity in skin samples compared to a Netherton syndrome model skin (p<0.01). Additionally, ATR-12 produced higher amounts of LEKTI subunit compared to topical application of LEKTI protein alone after 24 hours and resulted in deeper skin penetration of LEKTI.

ATR-04 – Addressing an Unmet Need in a Multi-billion Dollar Market Opportunity

In August, Azitra received clearance from the U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for moderate to severe EGFRi-associated dermal toxicity
In September, the FDA granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash
Also in 2024, Azitra presented preclinical data at the Society of Investigative Dermatology (SID) and the European Academy of Dermatology and Venereology (EADV) annual meetings showing ATR-04 inhibits IL-36g and S. aureus, both of which are key drivers of the disease
Plan to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial in patients undergoing EGFR inhibitors with dermal toxicity in first half of 2025
Financial Results for the Year Ended December 31, 2024
Service Revenue – Related Party: The Company generated $0.8 thousand of service revenue during the year ended December 31, 2024, compared to $0.7 million for fiscal year 2023.
Research and Development (R&D) expenses: R&D expenses for the year ended December 31, 2024, were $4.7 million compared to $3.6 million for fiscal year 2023.
General and Administrative (G&A) expenses: G&A expenses for the year ended December 31, 2024, were $6.3 million compared to $4.5 million for fiscal year 2023.
Net Loss was $9.0 million for the year ended December 31, 2024, compared to $11.3 million for fiscal year 2023.
Cash and cash equivalents: As of December 31, 2024, the Company had cash and cash equivalents of $4.6 million, which does not include gross proceeds of approximately $2.2 million from follow-on offerings in January and February, 2025.

On February 24, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the publication of circulating tumor DNA (ctDNA) results for its lead immunotherapy candidate, Versamune HPV, in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, PDS Biotechnology, FEB 24, 2025, View Source [SID1234650478]).

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The trial demonstrated that Versamune HPV was associated with greater and earlier clearance of HPV16-positive cancer cells from the bloodstream in patients with locally advanced cervical cancer. Notably, the elimination of HPV16-positive ctDNA correlated with extended patient survival without cancer recurrence, reinforcing its potential to improve long-term outcomes. The data underscore the potential of Versamune HPV in HPV16-positive cancers as the Company prepares to initiate a Phase 3 clinical trial for Versamune HPV in HPV16-positive head and neck squamous cell carcinoma (HNSCC) in the first quarter of this year.

"These findings highlight the transformative potential of Versamune HPV in broadly treating various HPV16-associated cancers. Combining Versamune HPV with chemoradiation (CRT) was linked to rapid HPV16 ctDNA decline," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe that such results showing a strong correlation between a biomarker such as ctDNA and survival may allow us to initiate discussions with the U.S. Food and Drug Administration regarding the potential for an accelerated regulatory pathway such as Breakthrough Therapy designation in cervical cancer. We also think this finding that links the reduction of ctDNA level with improved survival may apply to other HPV16-positive cancers like HNSCC. This endpoint is currently included within our VERSATILE-003 Phase 3 clinical trial."

A total of 66 patients with locally advanced cervical cancer were enrolled, with 49 receiving CRT and 17 receiving a combination of CRT and Versamune HPV. Patient blood was collected at baseline, weeks 1, 3, and 5 of CRT, and 3 to 4 months after CRT to measure HPV ctDNA. MRI was performed at baseline and before brachytherapy to determine tumor shrinkage.

Median follow-up was 23 months. At 3-4 months follow-up, 5/5 (100%) HPV16-positive patients receiving CRT + Versamune HPV had no detectable HPV16-positive ctDNA, whereas 3/6 (50%) of patients receiving only CRT had no detectable ctDNA.

HPV ctDNA clearance at 3-4 months correlated with better 2-year recurrence free survival (RFS) (92.9% vs. 30%, log-rank; P = 0.0067). The strongest predictor of RFS was HPV ctDNA clearance at 3-4 months follow-up, achieving a concordance index score of 0.83.

The 36-month overall survival (OS) and progression free survival rates were earlier reported to be 100% for the 8 patients in the trial who received 5 doses of Versamune HPV + CRT and an 84.4% 36-month OS rate for 17 patients who received at least 2 doses of Versamune HPV + CRT.