On August 6, 2024 recigen, Inc. (Nasdaq: PGEN) reported it has commenced a $30.0 million underwritten public offering of its common stock. In addition, Precigen intends to grant the underwriters a 30-day option to purchase up to an additional $4.5 million of common stock (Press release, Precigen, AUG 6, 2024, View Source [SID1234645431]). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the size or terms of the offering. All of the shares in the proposed offering are to be sold by Precigen.

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Stifel is acting as the sole book-running manager for the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (SEC) and became effective on January 17, 2024. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and base prospectus relating to this offering may be obtained, when available, from Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at +1(415) 364-2720 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

On August 6, 2024 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, reported financial results for the second quarter ended June 30, 2024, and highlighted recent Company progress (Press release, Omega Therapeutics, AUG 6, 2024, View Source [SID1234645430]).

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"We are excited by the meaningful progress achieved to date with our MYCHELANGELO I trial, having generated clinical proof-of-platform data that validates the potential of epigenomic controllers as a new class of programmable mRNA therapeutics. As we approach identification of the recommended dose for expansion for OTX-2002, we look forward to sharing updated dose escalation data and initiating expansion cohorts in monotherapy and combination settings in the fourth quarter of this year," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We are equally energized by the advances we have made with the OMEGA platform, including new preclinical data presented at this year’s ASGCT (Free ASGCT Whitepaper) Annual Meeting showing durable and robust upregulation of gene expression with epigenomic controllers across a broad range of targets. We believe these achievements underscore the potential of our platform to create tremendous value through its ability to prospectively engineer epigenomic controllers with diverse and meaningful therapeutic applications across nearly any human disease."

Recent Highlights and Key Anticipated Milestones

Development Pipeline and Platform

•
Progressed dose escalation portion of Phase 1/2 MYCHELANGELO I clinical trial evaluating OTX-2002 in patients with hepatocellular carcinoma (HCC): Made steady progress towards identifying the recommended dose for expansion (RDE) of OTX-2002, with patient enrollment ongoing in Cohort 6 at the 0.2 mg/kg dose level across sites in the U.S. and Asia. The Company expects to report updated clinical data and is planning for expansion into monotherapy and combination settings in the fourth quarter of 2024.

•
Presented new preclinical data demonstrating durable upregulation of gene expression at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting: Data demonstrated durable and robust upregulation of gene expression across a diverse set of gene types and regulatory mechanisms, including turning on inactive genes, augmenting expression of genes with existing but low baseline expression levels, and increasing expression of poised genes that are typically only responsive to certain external stimuli. Additional data showed reversible downregulation and multiplexed upregulation of gene expression. These findings further demonstrate the OMEGA platform’s potential to engineer an entirely novel therapeutic modality to directly target key drivers of disease across therapeutic areas.
•
Continued to advance and enhance the OMEGA platform: The Company is evaluating multiple epigenomic controller programs in preclinical studies, including OTX-2101 for non-small cell lung cancer (NSCLC), an HNF4A program in liver regeneration, and development of an epigenomic controller for the management of obesity in collaboration with Novo Nordisk. Core work on platform biology, epigenomic controller design, and characterization of LNP delivery to the lung and other high-value tissues continues to progress.

Corporate

•
Strengthened leadership team with appointment of Kaan Certel, Ph.D., as Chief Business Officer and election of Richard N. Kender to Board of Directors:
Dr. Certel is a seasoned biopharmaceutical leader and is responsible for Omega’s global business development activities, including strategic partnerships. Mr. Kender brings extensive expertise across corporate finance, business development and corporate licensing, among other roles he held during his career in the pharmaceutical industry, including 35 years spent at Merck & Co., Inc.

Second Quarter 2024 Financial Results

As of June 30, 2024, the Company had cash and cash equivalents totaling $45.9 million, which is expected to fund operations into Q1 2025.

Research and development (R&D) expenses for the second quarter of 2024 were $12.9 million, compared to $25.0 million for the second quarter of 2023. The $12.1 million decrease in R&D expenses was primarily driven by a decrease in external research costs, contract manufacturing costs, and personnel-related expenses.

General and administrative (G&A) expenses for the second quarter of 2024 were $5.8 million, compared to $6.6 million for the second quarter of 2023. The $0.8 million decrease in G&A expenses was primarily driven by a decrease in personnel-related expenses and consulting and professional fees.

Net loss for the second quarter of 2024 was $16.3 million, compared to $29.7 million for the second quarter of 2023. The decrease in net loss was driven predominantly by the decrease in R&D expenses.

On August 6, 2024 Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Olema Oncology, AUG 6, 2024, View Source [SID1234645429]).

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"The clinical data we presented at the ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in May demonstrated that the palazestrant-ribociclib combination was well tolerated with no new safety signals or enhancement of toxicity. The preliminary efficacy data is highly encouraging and we look forward to updating with more mature efficacy," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "The OPERA-01 Phase 3 clinical trial for palazestrant as a monotherapy in second/third-line metastatic breast cancer is ongoing, and later this year we are looking forward to presenting new data on our KAT6 inhibitor, OP-3136, and filing an Investigational New Drug (IND) application with the FDA."

Second Quarter 2024 Highlights

•
Presented interim Phase 1b/2 clinical results of palazestrant (OP-1250) in combination with ribociclib at the ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress 2024 in Berlin, Germany. Results showed palazestrant in combination with ribociclib was well tolerated with no new safety signals or enhancement of toxicity and no meaningful impact on drug exposure of either therapy. In addition, a preliminary clinical benefit rate (CBR) of 85% was observed across 13 CBR-eligible patients.
•
Presented trial-in-progress poster on OPERA-01, a pivotal Phase 3 monotherapy clinical trial in the second- and third-line setting of ER+/HER2- advanced or metastatic breast cancer, at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.
•
Successfully completed IND-enabling studies for OP-3136 in support of a potential IND filing in late 2024

Upcoming Milestones

•
Initiate Phase 1b/2 clinical study of palazestrant in combination with mTOR inhibitor, everolimus, in the third quarter of 2024.
•
Present pre-clinical data supporting the Investigational New Drug (IND) application for OP-3136, an orally-bioavailable KAT6 inhibitor, anticipated in the fourth quarter of 2024.
•
File an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for OP-3136 in late 2024 and advance clinical development.
•
Present updated Phase 2 clinical study results for palazestrant in combination with CDK4/6 inhibitor, ribociclib, anticipated at a future medical meeting.

Second Quarter 2024 Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2024, were $239.1 million.

Net loss for the quarter ended June 30, 2024, was $30.4 million, as compared to $20.1 million for the quarter ended June 30, 2023. The increase in net loss for the second quarter was primarily related to increased spending on clinical development and research activities as a result of late-stage clinical trials for palazestrant and the advancement of our KAT6 inhibitor program, as well as general and administrative activities. The increase was partially offset by higher interest income earned from marketable securities.

GAAP research and development (R&D) expenses were $29.1 million for the quarter ended June 30, 2024, as compared to $18.0 million for the quarter ended June 30, 2023. The increase in R&D expenses was primarily related to increased spending on clinical development activities as we continue to advance palazestrant into late-stage clinical trials, research-related activities associated with the advancement of our KAT6 inhibitor program, and personnel related costs, including non-cash stock-based compensation expense of $1.3 million.

Non-GAAP R&D expenses were $24.9 million for the quarter ended June 30, 2024, which excluded $4.2 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $15.0 million for the quarter ended June 30, 2023, excluding $3.0 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $4.4 million for the quarter ended June 30, 2024, as compared to $3.6 million for the quarter ended June 30, 2023. The increase in G&A expenses was primarily due to increased spending on corporate-related costs, and an increase in non-cash stock-based compensation expense of $0.3 million.

Non-GAAP G&A expenses were $2.9 million for the quarter ended June 30, 2024, excluding $1.5 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $2.4 million for the quarter ended June 30, 2023, excluding $1.2 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

About Palazestrant (OP-1250)

Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information on OPERA-01, please visit www.opera01study.com.

On August 6, 2024 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the second quarter 2024 and provided an update on recent business progress (Press release, Nuvectis Pharma, AUG 6, 2024, View Source [SID1234645428]).

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "During the second quarter we continued to advance our clinical trials for NXP800 and NXP900. For NXP800, the Phase 1b clinical trial in platinum resistant, ARID1a-mutated ovarian cancer is continuing to enroll patients at approximately 15 clinical sites in the United States and United Kingdom and we remain on track to provide an update from this study during this fall. In addition, the Investigator-sponsored clinical trial in cholangiocarcinoma is also recruiting patients, and we plan to provide an update from this trial by the end of 2024. For NXP900, the dose escalation clinical trial is ongoing, and so far, three cohorts have been completed with no reports of dose limiting toxicities. We are continuing to plan the next steps in the development of NXP900, with particular interest in combination strategies with EGFR and ALK inhibitors in patients with advanced non-small cell lung cancer resistant to EGFR and ALK targeting drugs. Lastly, we continue to effectively manage our financial resources, which we believe can take us through the key milestones for both development programs".

Second Quarter 2024 Financial Results

Cash, and cash equivalents were $18.1 million as of June 30, 2024 compared to $19.5 million as of March 31, 2024. The decrease of $1.4 million in the cash balance during the second quarter of 2024 is a result of the operating expenses for the quarter, partially offset by the utilization of the at-the market facility.

The Company’s net loss was $4.4 million for the three months ended June 30, 2024, compared to $5.8 million for the three months ended June 30, 2023, a decrease in net loss of $1.4 million, rounded. Net loss for the second quarter of 2024 fiscal year included $1.3 million in non-cash stock-based compensation.

Research and development expenses, including non-cash stock-based compensation, were $2.9 million for the three months ended June 30, 2024, compared to $4.3 million for the three months ended June 30, 2023, a decrease of $1.4 million, rounded.

General and administrative expenses, including non-cash stock-based compensation, were $1.7 million for the three months ended June 30, 2024, compared to $1.5 million for the three months ended March 31, 2023, an increase of $0.2 million.

Interest income was $0.2 million for the three months ended June 30, 2024, compared to $0.1 million for the three months ended June 30, 2023, an increase of $0.1 million.

On August 6, 2024 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its second quarter ended June 30, 2024 and raised its previously issued financial guidance on business performance for the full-year 2024 (Press release, Myriad Genetics, AUG 6, 2024, View Source [SID1234645427]).

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"We are very proud to have delivered another quarter of strong double digit year-over-year revenue growth in the second quarter of 2024. Our year-to-date 2024 revenue growth of 13% year-over-year, following our 11% year-over-year revenue growth in calendar year 2023, and our 15% year-over-year revenue growth in the second quarter 2024, demonstrate the sustainability of our organic growth and gives us the confidence to raise our long-term revenue growth target to 12%," said Paul J. Diaz, President and CEO of Myriad Genetics. "In the second quarter, we saw strong performance across our portfolio, highlighted by increasing evidence of market share gains in prenatal testing. We anticipate these trends to continue as we move through the year and into 2025. In addition, second quarter average revenue per test improved across our product portfolio, benefiting from expanded coverage and our ongoing efforts in revenue cycle management. We remain optimistic about the evolution of our product portfolio as we continue to publish additional clinical validation studies and launch new products.

At the same time, we continue to improve access and ease of use for our customers, as we accelerate electronic medical record (EMR) integrations for new customers and make meaningful progress in our Labs of the Future initiative. Myriad Genetics is growing profitably and delivering improved financial results, including a 17% year-over-year increase in gross profit of $147.1 million, cash flow from operations of $2.6 million, and $16.4 million of adjusted operating cash flow. All while continuing to invest in the innovation required to achieve our mission and vision to reach more patients with life-saving precision medicine."
Financial and Operational Highlights
•Test volumes of 389,000 in the second quarter of 2024 increased 9% year-over-year.
•The following table summarizes year-over-year testing volume changes in the company’s core product categories:
Three months ended Six months ended
(in thousands)
June 30, 2024 June 30, 2023
% Change
June 30, 2024 June 30, 2023
% Change
Product volumes:
Hereditary cancer
73 71 3 % 144 136 6 %
Tumor profiling
14 16 (13) % 28 32 (13) %
Prenatal 173 154 12 % 345 312 11 %
Pharmacogenomics
129 117 10 % 253 227 11 %
Total 389 358 9 % 770 707 9 %

•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three months ended Six months ended
(in millions)
June 30, 2024 June 30, 2023
% Change
June 30, 2024 June 30, 2023
% Change
Product revenues:
Hereditary cancer
$ 91.5 $ 76.7 19 % $ 179.6 $ 152.4 18 %
Tumor profiling
32.6 36.0 (9) % 63.5 73.3 (13) %
Prenatal 44.4 35.6 25 % 88.7 71.8 24 %
Pharmacogenomics
43.0 35.2 22 % 81.9 67.2 22 %
Total $ 211.5 $ 183.5 15 % $ 413.7 $ 364.7 13 %

•Gross margin of 69.6% in the second quarter of 2024 increased 110 basis points year-over-year, reflecting operating leverage and improved average revenue per test. Adjusted gross margin in the second quarter of 2024 was 70.1%, an increase of 110 basis points year-over-year as the company’s revenue cycle, Labs of the Future and supply chain initiatives begin to take hold.
•Second quarter of 2024 operating expenses were $183.6 million. Adjusted operating expenses were $140.8 million, increasing 6% over the year ago period. This increase was driven by investments in technology, product development and R&D. Adjusted operating expenses accounted for 67% of total revenue in the second quarter of 2024, down from 73% of total revenue in the second quarter of 2023.
2

•Operating loss in the second quarter of 2024 was $36.5 million, improving $77.2 million year-over-year; adjusted operating income in the second quarter of 2024 was $7.4 million, improving $14.2 million year-over-year.

Business Performance and Highlights

Oncology
The Oncology business delivered revenue of $82.2 million in the second quarter of 2024.
•Second quarter 2024 hereditary cancer testing revenue in Oncology grew 11% year-over-year, reflecting ongoing initiatives to improve average revenue per test through payer coverage expansion and revenue cycle process improvements that are reducing the company’s no pay rate.
•Second quarter 2024 tumor profiling revenue of $32.6 million grew 5% compared to first quarter 2024 but decreased 10% year-over-year, reflecting the ongoing challenging biopharma environment, slow ramp of biopharma contracts executed in 2023, and challenges in the international business.
•In July 2024, Myriad Genetics received a patent relating to detecting circulating tumor DNA in patient fluid samples, which is complementary to a patent granted earlier in the year for the company’s methods of preparing cell-free DNA. Both of these patents support advancing commercialization of the company’s high sensitivity tumor informed Molecular Residual Disease (MRD) assay.
•In July 2024, Myriad Genetics entered into an agreement with Personalis, Inc. (Nasdaq: PSNL) to cross-license patent estates covering tumor-informed approaches to detect MRD. The agreement helps solidify each company’s freedom to operate in the MRD market and broadens patient access to the benefits of MRD testing.
•Announced a collaboration with GSK (NYSE: GSK) aimed at improving access to homologous recombination deficiency (HRD) diagnostic testing for high-grade serous ovarian cancer (HGSOC) patients, leveraging Myriad Genetics’ MyChoice HRD Plus and MyChoice CDx Plus tests in nine countries outside the United States.
•Myriad Genetics and QIAGEN (NYSE: QGEN) agreed to develop a globally distributable kit-based test for analyzing HRD status to support research into personalized medicine in multiple solid tumor types, including ovarian cancer.
3

•In August 2024, Myriad Genetics announced that it further advanced its international reorganization efforts, including the closing of the sale of its EndoPredict business to Eurobio Scientific. The reorganization of its international operations better aligns company resources to its domestic opportunities while continuing to serve key biopharma partners and patients globally and builds on Myriad Genetics’ efforts this year to accelerate profitable business growth across its portfolio.

Women’s Health
The Women’s Health business delivered revenue of $86.3 million in the second quarter of 2024.
•Second quarter 2024 hereditary cancer testing revenue in Women’s Health grew 31% year-over-year as more practitioners see the benefit of incorporating MyRisk with RiskScore as part of a comprehensive breast cancer risk assessment program.
•Prenatal testing revenue in the second quarter of 2024 grew 25% year-over-year, reflecting market share gains, expanded coverage by payers, and ongoing initiatives to improve average revenue per test.
•Myriad Genetics launched the Universal Plus Panel for Foresight Carrier Screen, which includes 39 new conditions and screens up to 272 genes associated with serious inherited conditions.
•Ten abstracts, including four on FirstGene, have been accepted to be showcased at the National Society of Genetic Counselors’ 43rd annual meeting, which begins on September 17, 2024, in New Orleans, LA.

Pharmacogenomics
In the pharmacogenomics category, GeneSight test revenue was $43.0 million in the second quarter of 2024.
•Second quarter 2024 GeneSight testing revenue grew 22% year-over-year, reflecting ongoing initiatives to improve average revenue per test.
•Currently, biomarker legislation for state-regulated plans has passed in 15 states. In many of these states, commercial and managed Medicaid payers have modified their coverage policies to include GeneSight and Prolaris. Additionally, there are a number of states that have legislation in process. Myriad Genetics continues to see an increasing number of payors incorporating, or planning to incorporate, GeneSight into their coverage. Notably, this includes Blue Shield of California, a major commercial and managed Medicaid plan, effective July 1, 2024.

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’ fiscal year 2024 financial guidance*:
(in millions, except per share amounts) PRIOR
FY 2024 CURRENT
FY 2024 Expected Year-Over-Year Change
Revenue $820 – $840 $835 – $845 11% – 12%
Gross margin % 69.5% – 70.5% 70.0% – 70.5%
100 – 150 bps
Adjusted OPEX $572 – $582
$575 – $585
6% – 8%
Adjusted EBITDA** $20 – $30
$25 – $35
$36 – $46
Adjusted EPS*** $0.00 – $0.05
$0.08 – $0.12
$0.35 – $0.39
*
Assumes currency rates as of August 6, 2024.
** 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 2024 adjusted EPS is based on a 91 million share count.

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, August 6, 2024, at 4:30 p.m. EDT to discuss Myriad Genetics’ financial results and business developments for the second quarter 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/BI620080625d0e42be9b313c17391abf61. 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.