On May 5, 2022 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported its first quarter 2022 financial results for the period ended March 31, 2022 (Press release, Merrimack, MAY 5, 2022, View Source [SID1234613712]).

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"During the first quarter of 2022 we continued to see reductions in our operating expenses and were able to close the sale of an additional preclinical asset" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We continue to be focused on maintaining cash balances that will allow us to be in a position to receive milestone payments from Ipsen and Elevation if the programs that we have licensed to them continue to progress."

First Quarter 2022 Financial Results

Merrimack reported a net loss of $132 thousand for the first quarter ended March 31, 2022, or $0.01 per basic and diluted share on a fully diluted basis, compared to a net loss of $696 thousand, or $0.05 per basic and diluted share on a fully diluted basis, for the same period in 2021.

Merrimack reported a gain on the sale of assets for the first quarter ended March 31, 2022, of $445 thousand, attributable to the sale of certain of our preclinical programs, compared to $50 thousand for the same period in 2021.

General and administrative expenses for the first quarter ended March 31, 2022, were $577 thousand, compared to $746 thousand for the same period in 2021.

As of March 31, 2022, Merrimack had cash and cash equivalents and investments of $14.3 million, compared to $14.2 million as of December 31, 2021.

As of March 31, 2022, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On April 27, 2022, Ipsen released to the public an update on its sales performance for the first quarter of 2022. At the same time, Ipsen publicly indicated that a data readout from its ongoing Phase 3 trial of ONIVYDE as a treatment of second line small cell lung cancer would be provided in the second half of 2022. In addition, Ipsen reported that it is continuing to study ONIVYDE in Phase III clinical trials in first line pancreatic ductal adenocarcinoma, with a data readout expected in 2023.

Elevation Oncology

– On April 27, 2022 Elevation Oncology announced that initial data from its Phase 2 CRESTONE Study of Seribantumab has been selected for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 7, 2022.

On May 5, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the first quarter ended March 31, 2022 (Press release, Oncolytics Biotech, MAY 5, 2022, View Source [SID1234613729]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Recent updates from multiple clinical trials have showcased pelareorep’s wide-ranging therapeutic potential as well as the advantages of our corporate strategy," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Our latest data in HR+/HER2- breast cancer show pelareorep driving changes in the tumor microenvironment that are known to be associated with improved patient outcomes and a decreased risk of recurrence. These results increase our understanding of pelareorep’s mechanism of action and build upon our prior phase 2 data that showed pelareorep delivering a clinically meaningful and statistically significant survival benefit to HR+/HER2- breast cancer patients. They also further de-risk our lead program’s upcoming randomized phase 2 data readout, which is expected to confirm and expand upon these prior findings and move us forward into a registrational study."

Dr. Coffey continued, "Recent clinical and preclinical data also showed pelareorep safely combined with a range of drug classes and demonstrated its potential to enable the success of CAR T cell therapies against solid tumors. We believe our strategy has positioned us for sustained success, as its execution allowed us to generate proof-of-concept data in multiple indications while maintaining a strong balance sheet and a clear focus on our lead breast cancer program."

First Quarter and Subsequent Highlights

Breast Cancer Program

AWARE-1 data demonstrate pelareorep’s ability to improve the prognosis of HR+/HER2- breast cancer patients and decrease their risk of recurrence

New clinical biomarker analyses from AWARE-1’s first two cohorts presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Meeting evaluated changes in the tumor microenvironment (TME) following treatment with pelareorep and letrozole with (cohort 2) or without (cohort 1) the checkpoint inhibitor atezolizumab (link to PR). Gene expression analyses showed 100% of evaluable patients with a Risk of Recurrence Score (ROR-S) classified as "low" 21-days post-treatment vs. 55% with a "low" ROR-S prior to treatment. In both cohorts, the treatment regimen caused tumors to convert from the more aggressive luminal B classification to luminal A classification, which is associated with improved clinical outcomes. Collectively across both cohorts, the percentage of evaluable patients with a luminal A classification increased from 55% before treatment to 85% 21 days after treatment. Statistically significant increases in markers of tumor cell death and T cell activation were also observed with treatment. Altogether, these results reaffirm pelareorep’s ability to improve the prognosis of breast cancer patients and decrease their risk of recurrence by remodeling the TME and stimulating anti-tumor immunity.

Partner Adlai Nortye advanced Chinese bridging trial of pelareorep-paclitaxel combination to final dosing cohort

The ongoing bridging trial is evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Initiation of the trial’s final cohort followed the completion of the dose escalation evaluation periods of the first two cohorts, which indicated that the studied combination was well tolerated with no new safety signals observed. The dosing regimen for the trial’s second cohort is equivalent to that administered in IND-213, while the regimen for the third cohort is equivalent to the regimen being administered in BRACELET-1, an ongoing phase 2 trial in HR+/HER2- breast cancer that is evaluating pelareorep plus paclitaxel with and without a checkpoint inhibitor. Completion of the bridging trial is expected to accelerate pelareorep’s development in China, the world’s second largest oncology market.

Gastrointestinal Cancers Program

Successfully completed safety run-ins for the phase 1/2 GOBLET trial

The GOBLET trial is evaluating the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with advanced or metastatic pancreatic, colorectal, and anal cancers. The three-patient safety run-ins for the trial’s pancreatic cancer and third-line metastatic colorectal cancer (mCRC) cohorts have each been successfully completed following an independent review by the study’s Data Safety Monitoring Board (DSMB), which noted no safety concerns. Following the DSMB reviews and authorization from the Paul Ehrlich Institute (PEI; Germany’s medical regulatory body), all of the trial’s four cohorts are now cleared for full enrollment.

In addition to providing data on the safety and efficacy of pelareorep-atezolizumab combinations, the GOBLET trial is designed to evaluate CEACAM6 and T cell clonality as predictive biomarkers of treatment response. Use of a predictive biomarker in future studies may increase their likelihood of success by ensuring selection of the most appropriate patients.

Additional Immunotherapeutic Opportunity

Preclinical data demonstrating the synergistic anti-cancer activity of pelareorep combined with chimeric antigen receptor (CAR) T cell therapy in solid tumors published in Science Translational Medicine

Though CAR T cells have generated long-term cures in patients with hematological malignancies1, they have thus far had limited success against solid tumors due primarily to challenges posed by short-lived perseverance, immunosuppressive TMEs, and antigen escape. A peer-reviewed preclinical study published recently in Science Translational Medicine showed the persistence and anti-cancer activity of CAR T cells improved dramatically when these cells were loaded with pelareorep (link to PR, link to publication). Compared to either treatment alone, treatment with pelareorep-loaded CAR T cells led to statistically significant survival benefits in murine models of skin and brain cancer. In addition, boosting mice treated with pelareorep-loaded CAR T cells with a subsequent intravenous dose of pelareorep led to a further enhancement in efficacy and tumor cures in >80% of mice treated in each model. Mechanistic analyses indicated that the enhanced efficacy of this combination was due to pelareorep’s ability to increase CAR T cell perseverance, reverse immunosuppressive TMEs, and reduce antigen escape. The reduction in antigen escape was linked to the creation of dual-specific CAR T cells that target both the tumor directly and pelareorep proteins within the tumor. Given that solid tumors represent the vast majority of cancer cases, these results demonstrate pelareorep’s potential to significantly expand the commercial opportunity offered by CAR T cell therapies.

Financial Highlights

As of March 31, 2022, the Company reported $39.5 million in cash and cash equivalents.
Operating expense for the first quarter of 2022 was $2.6 million, compared to $3.1 million for the first quarter of 2021.
R&D expense for the first quarter of 2022 was $3.7 million, compared to $2.8 million for the first quarter of 2021.
The net loss for the first quarter of 2022 was $6.8 million, compared to a net loss of $6.4 million in the first quarter of 2021. The basic and diluted loss per share was $0.12 in the first quarter of 2022, compared to a basic and diluted loss per share of $0.13 in the first quarter of 2021.
Net cash used in operating activities for the first quarter of 2022 was $6.3 million, compared to $5.6 million for the first quarter of 2021.
Anticipated Milestones and Catalysts

Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q2 2022
GOBLET pancreatic cohort update: Q3 2022
Top-line data from phase 2 BRACELET-1 metastatic breast cancer study: Q4 2022
Oncolytics expects to provide updates on the timing of the following milestones:

Interim safety update from BRACELET-1 metastatic breast cancer study
Webcast and Conference Call

Management will host a conference call for analysts and institutional investors at 5:00 p.m. ET today, May 5, 2022. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 6952-6976. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 526-976#.

On May 5, 2022 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that it will report financial results for the first quarter ended March 31st, 2022, on Thursday, May 12th, 2022, after the close of the US market (Press release, Cellectis, MAY 5, 2022, View Source [SID1234613755]).

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The announcement will be followed by a conference call and live audio webcast on Friday, May 13th, 2022, at 8:00 AM EDT / 2:00 PM CET. The call will include the Company’s first quarter results and an update on business activities. Details for the call are as follows:

On May 5, 2022 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, reported financial results for the first quarter 2022 and provided program updates (Press release, Aeglea BioTherapeutics, MAY 5, 2022, View Source [SID1234613606]).

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"We have started off 2022 with significant progress in both our clinical programs. With AGLE-177, we were pleased to see total homocysteine lowering in all patients in our first, low dose cohort and we look forward to sharing clinical data later this year. This program is another example of innovation with human enzyme therapies and has the potential to address a significant unmet need," said Anthony Quinn, M.B., Ch.B., Ph. D., president and chief executive officer of Aeglea. "I’m also proud of the work we have done with our pegzilarginase program enabling our recent BLA submission to the FDA with what we believe are very compelling data to support approval for the treatment of Arginase 1 Deficiency. Some of these data were presented recently at the SIMD Annual Meeting, providing additional insight into the potential positive impact of pegzilarginase treatment. We look forward to working with the FDA throughout the review of our BLA as they assess the potential effectiveness of pegzilarginase in addressing the unmet need that impacts the lives of Arginase 1 Deficiency patients and their families."

Program Updates

Pegzilarginase in Arginase 1 Deficiency

Submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D).
Requested Priority Review at the time of submission.
Presented new data from the PEACE Phase 3 clinical trial at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting, including patient-level outcomes, results from additional secondary endpoints and previously announced topline results. Highlights of the data presented include:
76.7% reduction in mean plasma arginine in pegzilarginase treated patients compared to placebo (p<0.0001); normal plasma arginine levels achieved in 90.5% of pegzilarginase treated patients compared to no patients receiving placebo.
Eleven patients (65%) treated with pegzilarginase reached or exceeded response criteria for ≥1 mobility assessment compared to four patients (44%) receiving placebo.
Eight patients (47%) treated with pegzilarginase met or exceeded prespecified clinical response criteria for ≥2 mobility assessments compared to no patients receiving placebo.
In a post hoc analysis correcting for a missed assessment that was improperly scored as 0 rather than "not assessed," the least squares mean Gross Motor Function Measure Part D score of patients treated with pegzilarginase improved from baseline by 2.25 units compared to placebo (p=0.0896).
Pegzilarginase treated patients showed statistically significant biochemical improvements in measures of ornithine and guanidino compounds compared to placebo.
On track to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2022.
AGLE-177 in Homocystinuria

Working to initiate U.S. sites to support enrollment in the ongoing Phase 1/2 clinical trial and a potential pivotal Phase 3 trial after opening an Investigational New Drug (IND) application with the FDA.
Expect to announce Phase 1/2 clinical data in the second half of 2022.
First Quarter 2022 Financial Results

As of March 31, 2022, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $68.6 million. The Company expects its cash, cash equivalents and investments will enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2023.

Aeglea recognized development fee revenues of $1.4 million in the first quarter of 2022, as a result of its license and supply agreement with Immedica for the commercial rights to pegzilarginase in certain territories outside the U.S. The revenues recorded in the first quarter of 2022 are related to the PEACE Phase 3 trial and BLA package. Aeglea recognized no revenue for the first quarter of 2021.

Research and development expenses totaled $17.0 million for the first quarter of 2022 and $11.9 million for the first quarter of 2021. The increase was primarily associated with expenses related to the BLA submission, management and dosing of ongoing patients in the PEACE Phase 3 trial, and increased enrollment in our Phase 1/2 trial of AGLE-177 for the treatment of patients with Homocystinuria.

General and administrative expenses totaled $8.8 million for the first quarter of 2022 and $6.4 million for the first quarter of 2021. This increase was primarily due to ramping-up the Company’s commercial capabilities and infrastructure as well as personnel expenses.

Net loss totaled $24.4 million and $18.2 million for the first quarter of 2022 and 2021, respectively, with non-cash stock compensation expense of $2.1 million and $1.8 million for the first quarter of 2022 and 2021, respectively.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is a novel recombinant human enzyme engineered to degrade the amino acid arginine and has been shown to rapidly and sustainably lower levels of the amino acid arginine in plasma. Aeglea is developing pegzilarginase for the treatment of people with Arginase 1 Deficiency (ARG1-D), a rare debilitating and progressive disease characterized by the accumulation of arginine. ARG1-D presents in early childhood and patients experience spasticity, seizures, developmental delay, intellectual disability and early mortality.

The PEACE Phase 3 clinical trial met its primary endpoint with a 76.7% reduction in mean plasma arginine compared to placebo. Additionally, 90.5% of pegzilarginase treated patients achieved normal plasma arginine levels. The arginine lowering was accompanied by a positive trend in Gross Motor Function Measure Part E, a measure of patient mobility. Aeglea’s Phase 1/2 and Phase 2 Open-Label Extension (OLE) data for pegzilarginase in patients with ARG1-D demonstrated clinical improvements and sustained lowering of plasma arginine. Pegzilarginase has received multiple regulatory designations, including Rare Pediatric Disease, Breakthrough Therapy, Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration as well as Orphan Drug Designation from the European Medicines Agency.

About AGLE-177 in Homocystinuria

AGLE-177 is a novel recombinant human enzyme, which is engineered to degrade the amino acid homocysteine and its dimer, homocystine. AGLE-177 is currently being studied in a Phase 1/2 clinical trial for the treatment of patients with Classical Homocystinuria, a rare inherited disorder of methionine metabolism that results in elevated levels of total homocysteine. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities (including severe osteoporosis), developmental delay, intellectual disability, lens dislocation and severe near sightedness. Preclinical data demonstrated that AGLE-177 improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. AGLE-177 has received both U.S. and EU Orphan Drug Designation as well as U.S. Rare Pediatric Disease Designation.

On May 5, 2022 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its first quarter 2022 (Press release, Myriad Genetics, MAY 5, 2022, View Source [SID1234613635]). The company also reiterated long-term and 2022 financial guidance and provided an update on business performance, recent product launches and strategic growth initiatives.

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"We continue to execute on our transformation and growth plan with strong commercial demand for new offerings like our recently launched suite of Precise Oncology Solutions. In Mental Health, the GeneSight Psychotropic test reached one of its highest quarterly volume levels ever while our Women’s Health products generated double digit year-over-year revenue growth in the first quarter of 2022. Fast Company also named Myriad Genetics among its 2022 list of the world’s most innovative companies. Throughout the COVID-19 pandemic, we continued to invest in innovation to meet the needs of patients and healthcare providers, digital engagement to drive increased demand, tech-enabled commercial tools to improve customer experience, and our Lab of the Future to improve productivity. We are pleased to see the results of these efforts across multiple lines of business, and I want to thank my teammates and our provider partners for their continued efforts to serve our patients during the pandemic in what continues to be a very difficult operating environment," said Paul J. Diaz, president and CEO, Myriad Genetics.

Financial and Operational Highlights:

Diagnostic test volumes of 241,000 in the first quarter of 2022 increased 10% year-over-year and 2% sequentially from the fourth quarter of 2021, excluding divested businesses. Sequential volumes were impacted during the first six weeks of 2022 by access constraints and staffing challenges due to COVID-19 and its variants, particularly in the hereditary cancer testing business.
Hereditary cancer test volumes for the quarter decreased 12% year-over-year and 10% sequentially. Excluding the impact of COVID-19 and its variants in the first six weeks of the quarter, the company estimates hereditary cancer test volumes for the quarter would have decreased 3% year-over-year and 1% sequentially in-line with typically weaker first quarter seasonal trends.
Prenatal test volumes in Women’s Health for the quarter decreased 1% year-over-year and increased 3% sequentially.
Tumor profiling test volumes in Oncology for the quarter increased 12% year-over-year and 17% sequentially.
Pharmacogenomics test volumes in Mental Health for the quarter increased 49% year-over-year and 7% sequentially.
Overall, average selling price (ASP)1 in the first quarter of 2022 increased 1% year-over-year and sequentially, excluding divested businesses. Positive ASP trends are primarily due to benefits realized from operational efficiencies and improved revenue cycle management.
Total revenue in the first quarter of 2022 was $164.9 million, an increase of 11% year-over-year and 2% sequentially, excluding the divested business revenue from Myriad RBM, Autoimmune and myPath Melanoma.
Sequential 2% revenue improvement came in spite of an estimated $7-9 million negative revenue impact due to access restraints and staffing challenges from new COVID-19 variants and typical weaker first quarter seasonality trends.
The following table summarizes year-over-year quarterly revenue changes in the company’s core businesses by product category:

GAAP gross margin in the first quarter of 2022 was 70.9%; adjusted gross margin in the quarter was 71.1%, which decreased 40 basis points year-over-year.
GAAP total operating expenses in the first quarter of 2022 were $142.5 million, decreasing $27.0 million year-over-year; adjusted operating expenses in the quarter decreased $7.0 million year-over-year to $120.0 million.
GAAP operating loss in the first quarter of 2022 was $25.6 million, improving $21.1 million year-over-year; adjusted operating loss was $2.8 million, improving $0.5 million year-over year.
Diluted GAAP EPS in the first quarter of 2022 were $(0.26), improving $0.26 year-over-year; adjusted EPS were $(0.03), improving $0.03 year-over-year.
Ended the first quarter of 2022 with $339.2 million in cash, cash equivalents and investments and no debt outstanding.
Business Performance and Highlights:

Oncology
The Myriad Genetics Oncology business provides hereditary cancer testing, including MyRiskTM hereditary cancer test with RiskScore, for patients who have cancer. It also provides tumor profiling products such as the EndoPredict breast cancer prognostic test, the Precise Tumor molecular tumor profiling test, the Prolaris prostate cancer test, and the myChoiceCDx companion diagnostic test for predicting response to PARP inhibitors. The Oncology business delivered revenue of $69.8 million in the first quarter of 2022, a decrease of 8% year-over-year and an increase of 4% sequentially from the fourth quarter of 2021.

In March of 2022, Myriad Genetics launched Precise Tumor for molecular tumor profiling – part of a suite of Precise Oncology Solutions that combines the company’s MyRisk germline hereditary cancer testing technology and its myChoiceCDx companion diagnostic test with a Myriad Genetics tumor profiling test powered by Illumina, Inc.’s TruSightTM Oncology 500 (TSO500) assay and processed by Intermountain Precision Genomics.
In April of 2022, Myriad Genetics announced an expansion of its partnership with Intermountain Precision Genomics to add a new liquid biopsy therapy selection test to its suite of Precise Oncology Solutions. The Myriad Genetics liquid biopsy test will use Illumina’s TSO500 ctDNA assay and be processed by Intermountain Precision Genomics.
In March of 2022, Myriad Genetics received U.S. Food and Drug Administration (FDA) approval for BRACAnalysis CDx as a companion diagnostic test for use with Lynparza in early-stage breast cancer treatment. BRACAnalysis CDx is now the only germline test approved by the FDA as a companion diagnostic for treatment of HER2 negative high-risk early-stage breast cancer.
Prolaris is a prostate cancer prognostic test designed to assess prostate cancer aggressiveness. It is the only test that measures how fast prostate cancer tumors are growing. In the first quarter of 2022, Prolaris saw continued volume growth with a record-breaking number of tests ordered in a month during March of 2022, beating its previous monthly volume record by 8%.
Women’s Health
The Myriad Genetics Women’s Health business serves women of all ancestries by assessing their risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. Women’s Health delivered revenue of $65.5 million in the first quarter of 2022, an increase of 19% year-over-year and 2% sequentially from the fourth quarter of 2021.

Hereditary Cancer
Myriad Genetics continues to address the health inequities and accessibility challenges that exist within the hereditary cancer testing market. Myriad Genetics’ MyRisk hereditary cancer test with RiskScore for all ancestries offers the first and only personalized 5-year and lifetime breast cancer risk assessment for all women, including those of non-European ancestry. RiskScore is available at no additional cost to women who take the MyRisk test.
In March of 2022, Myriad Genetics expanded its MyRisk hereditary cancer test to include thirteen additional actionable gene markers and four new indications: including indications for renal, lung, endocrine and gastric cancers.
Prenatal
Myriad Genetics saw continued growth in the first quarter of 2022 from its Prequel noninvasive prenatal screening (NIPS) test, including proprietary AMPLIFY technology, which significantly enhances the test’s performance and works to reduce test failure rates so that patients may avoid unnecessary invasive procedures. Prequel continues to provide future parents with critical genetic insights for family planning.
Mental Health
The Myriad Genetics Mental Health business consists of the GeneSight psychotropic test that covers 64 medications commonly prescribed for depression, anxiety, attention deficit hyperactivity disorder, and other psychiatric conditions. GeneSight helps physicians understand how genetic alterations impact patient response to antidepressants and other drugs. In the pharmacogenomics category, GeneSight delivered revenue of $29.3 million in the first quarter of 2022, an increase of 66% year-over-year and flat sequentially from the fourth quarter of 2021.

For the first quarter of 2022, the Mental Health business reported one of its highest GeneSight volumes ever, overcoming industry-wide challenges presented in the first six weeks of 2022 by new COVID-19 variants, which the company believes demonstrates the effectiveness of the company’s new commercial capabilities, marketing strategies, and customer-centric sales initiatives implemented during the past year.
Myriad Genetics recently launched GeneSight Psychotropic 4.1 in March of 2022 – an update to the GeneSight test featuring improved clinical considerations, drug categorization, additional medications, and revised phenotype language for certain genes.
Key Accomplishments in the Quarter
In the first quarter of 2022, Myriad Genetics unveiled a number of new technological capabilities with the launch of several new digital enhancement tools and partnerships.

In February of 2022:
The company launched its Unified Provider Ordering Portal in February of 2022 to create a new digital engagement experience for oncologists and their patients – offering a streamlined, tech enabled portal that simplifies ordering and reporting processes. The portal will be rolled out in the Women’s Health business unit in the third quarter of 2022 and for all other Myriad Genetics products by the second quarter of 2023.
Myriad Genetics partnered with Genome Medical, Inc. to launch a virtual care solution that guides patients through the end-to-end hereditary cancer testing process from ordering a MyRisk test to receiving and reviewing results with a Genome Medical expert. This service is designed to expand awareness and access to genetic insights while providing professional guidance and support to those in need.
The new MyGeneHistoryTM 3.0 platform also launched in February of 2022. This new technology provides a customizable assessment service that was created to meet the needs of clinicians with a modern user experience that easily integrates with Myriad Genetics’ Unified Provider Ordering Portal and Genome Medical, Inc.’s systems.
In March of 2022, the company put in place new solutions to address patient and provider expectations on price transparency and affordability for its prenatal and hereditary cancer tests. Myriad Genetics has a wide breadth of coverage for prenatal and hereditary cancer testing and has taken steps to equip providers and patients with more accurate pricing information at the point of service and enhanced affordability programs to enable them to make the best decisions for the health and well-being of every patient.
As part of Myriad Genetics’ $50+ million technology investment to drive volume and improve productivity, the company is in the process of implementing new sequencing capabilities, powered by advanced robotics and data analytics, in its Lab of the Future. Construction of the company’s new advanced molecular diagnostics lab in Salt Lake City began in April 2022, and construction of the company’s new research and innovation center in South San Francisco is expected to begin in August of 2022.
"We are confident that these new technological capabilities, together with the product enhancements and new products rolled-out this quarter, significantly improve the company’s competitive position, and will accelerate growth in the second half of 2022 and 2023," said Paul J. Diaz.

Myriad Genetics’ fiscal year 2022 non-GAAP guidance begins with the comparable GAAP financial measure and excludes the impact of stock-based compensation expense ($36.5 million), non-cash amortization associated with acquisitions ($41.0 million) and special items such as costs related to transformation initiatives ($8.5 million). In addition to fiscal 2022 non-GAAP guidance, Myriad Genetics reiterates its long-term financial guidance of 9-12% estimated organic revenue growth through 2024. 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. The company will provide further details on its business outlook during the conference call today and discuss first quarter 2022 financial results. Myriad Genetics plans on hosting its 2022 Investor Day in New York City on August 11, 2022.

Conference Call and Webcast
A conference call will be held today, Thursday, May 5, 2022, at 4:30 p.m. EDT to discuss Myriad Genetics’ financial results and business developments for the first quarter 2022. The dial-in number for domestic callers is 1-800-954-0620. International callers may dial 1-212-231-2920. All callers will be asked to reference reservation number 22018216. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call and slide presentation will be available through a live webcast at www.myriad.com.