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Labcorp Acquires Diagnostic Clinical Laboratory Services From AtlantiCare

On May 9, 2022 Labcorp (NYSE: LH), a leading global life sciences company, and AtlantiCare, the largest health care organization in southern New Jersey, reported that they have closed a transaction to expand their long-term strategic relationship (Press release, LabCorp, MAY 9, 2022, View Source [SID1234613936]). Labcorp will acquire select assets from AtlantiCare’s clinical outreach business, which serves the AtlantiCare Physician Group and Affiliated Physicians and their patients across southern New Jersey. The transaction is the latest in a series of new and expanded collaborations between Labcorp and health systems across the country, demonstrating the value that Labcorp brings to improve laboratory services and help enhance patient care.

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"Labcorp is keenly focused on delivering value to our health system partners, physicians, and the broader community," said Bill Haas, senior vice president of Labcorp’s Northeast Division. "Our multi-year, comprehensive relationship with AtlantiCare is a prime example of that focus. Through this enhanced outreach relationship, Labcorp is furthering its commitment to AtlantiCare’s patients and providers to improve health and improve lives in the region, including through increased diagnostic testing access."

AtlantiCare’s patients will be able to access Labcorp’s expansive test menu and services through the company’s extensive network of patient service centers including Labcorp at Walgreens. Many of AtlantiCare’s physician office phlebotomy sites and outpatient collection services will now be operated by Labcorp.

"As a health system, we are committed to evolving the care and services we provide," said Lori Herndon, MBA, BSN, RN, president and CEO of AtlantiCare. "Our past collaboration with Labcorp has helped us provide comprehensive testing services to meet the growing needs of our community. Most recently, this has included Labcorp’s ability to provide critical testing, collections, lab equipment and supplies throughout the pandemic. This collaboration will enhance the breadth and quality of laboratory services patients and healthcare providers have come to expect from both of our organizations."

Myovant Sciences and Accord Healthcare, Ltd. Enter into Exclusive License Agreement to Commercialize ORGOVYX® for Advanced Hormone-Sensitive Prostate Cancer in Europe

On May 9, 2022 Myovant Sciences (NYSE: MYOV) and Accord Healthcare, Ltd. (Accord) reported that they have entered into an exclusive license agreement for Accord to commercialize relugolix for the treatment of advanced hormone-sensitive prostate cancer under the trade name ORGOVYX (relugolix, 120 mg) in the European Economic Area, United Kingdom, Switzerland and Turkey, with the right of first negotiation if Myovant decides to enter into licensing arrangements in countries in the Middle East, Africa and India (Press release, Myovant Sciences, MAY 9, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-and-accord-healthcare-ltd-enter-exclusive [SID1234613935]).

Under the terms of the agreement, Myovant will receive an upfront payment of $50 million and is eligible to receive commercial launch, sales-based and other milestones totaling up to $90.5 million. In addition, Myovant is eligible to receive tiered royalties from the high-teens to mid-twenties on net sales. Myovant will continue to lead the global development of relugolix and provide initial product supply to Accord. Accord will be responsible for certain local clinical development, all commercialization for its territories, and has the option to manufacture relugolix in the future.

"We’re delighted to join forces with Accord to make available the first and only oral androgen deprivation therapy for men with advanced hormone-sensitive prostate cancer in Europe," said David Marek, Chief Executive Officer of Myovant. "Accord has a longstanding commitment to oncology with proven commercial capabilities that they will leverage to accelerate the launch to reach more patients with this meaningful therapy."

"We are proud to launch ORGOVYX in Europe, as an addition to our specialty brand offerings," said Binish Chudgar, Managing Director of Accord. "Accord currently supplies around 1 in 3 injectable oncology medicines in Europe and this agreement underpins our commitment to patients with cancer and our continued investment in novel therapies. With over 1.9 million men living with prostate cancer in Europe, our partnership with Myovant will provide men living with hormone-sensitive advanced prostate cancer a new oral treatment option."

On April 29, 2022, the European Commission approved the marketing authorization application for ORGOVYX (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The decision applies to all 27 European Union member states plus Iceland, Norway, and Liechtenstein. The marketing authorization application for ORGOVYX is pending review by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). Accord expects to launch ORGOVYX in Europe in the second half of calendar year 2022.

Goldman Sachs & Co. LLC has acted as the exclusive financial advisor to Myovant and Sidley Austin LLP represented Myovant in the transaction.

About Prostate Cancer
In 2020, the total number of men in Europe with prostate cancer was approximately 1.9 million according to the World Health Organization’s Agency for Cancer Research WHO IntlAgencyCancerResearch PC.

Prostate cancer is considered advanced when it has spread beyond the prostate, is localized to the prostate and unlikely to be cured by surgery or radiation or has comeback after initial treatment and cannot be treated with salvage surgery. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. LHRH agonists are associated with an initial surge in testosterone levels that may exacerbate clinical symptoms in some patients and delayed testosterone recovery after the drug is discontinued due to their depot injection formulation.

About ORGOVYX (relugolix)
ORGOVYX (relugolix, 120 mg) is indicated in Europe for the treatment of adult patients with advanced hormone-sensitive prostate cancer. As a gonadotropin-releasing hormone (GnRH) receptor antagonist ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

Supernus Announces First Quarter 2022 Financial Results

On May 9, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported preliminary financial results for the first quarter of 2022, and associated Company developments (Press release, Supernus, MAY 9, 2022, View Source;2022.htm [SID1234613934]).

Qelbree Launch Update

Total IQVIA prescriptions were 47,324 in the first quarter of 2022, an increase of 38% compared to total prescriptions of 34,328 in the fourth quarter of 2021. In March 2022, the most recent month available, total prescriptions reached 18,380.
Qelbree continues to expand its base of prescribers, with approximately 6,900 prescribers in the first quarter of 2022, up from 5,600 prescribers from the fourth quarter of 2021.
Continued progress in securing and improving managed care coverage.
At the end of April 2022, the U.S. Food and Drug Administration (FDA) approved Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults. Supernus is expecting to launch Qelbree for adult patients by the end of May 2022. According to recent IQVIA Xponent 52-week data, prescriptions for the adult market represented approximately 68% of the total ADHD market.
Product Pipeline Update

SPN-830 (apomorphine infusion device) – Continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease (PD)

The Company will continue to work closely with the FDA as it reviews the New Drug Application (NDA) resubmission for SPN-830 for the continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease. The Company is preparing for the commercial launch of SPN-830 in the first quarter of 2023, assuming timely approval by the FDA. The FDA has established a PDUFA target action date in early October 2022.
SPN-820 – Novel first-in-class activator of mTORC1

The Company continues to enroll patients in a Phase II multi-center, randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale.
SPN-817 – A novel product candidate for the treatment of epilepsy

An open-label Phase II clinical study of SPN-817 in patients with treatment-resistant seizures is expected to start in the second half of 2022.
Financial Highlights

Net Product Sales

For the first quarter 2022, net product sales were $147.5 million, a 15% increase over $128.4 million for the same period in 2021. The increase was primarily due to net product sales of GOCOVRI from the Adamas acquisition in November 2021 (Adamas Acquisition) and growth in net product sales of Qelbree that was launched in the second quarter of 2021.

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(1) Includes net product sales of MYOBLOC, XADAGO and Osmolex ER.

Operating earnings (GAAP and non-GAAP)

First quarter 2022 operating earnings (GAAP) was $2.0 million, as compared to $13.2 million for the same period in 2021. The decrease is primarily due to amortization of acquired intangible assets from the Adamas Acquisition. First quarter 2022 adjusted operating earnings (non-GAAP) was $28.0 million, an increase of 11% compared to $25.2 million in the first quarter of 2021.

Reconciliation of GAAP to Non-GAAP Adjustments

An itemized reconciliation between operating earnings on a GAAP basis and operating earnings on a non-GAAP basis is as follows:

Non-GAAP operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation. Included in the amortization of intangible assets for the first quarter of 2022 is amortization of acquired intangible assets from the Adamas Acquisition in November 2021.

Net earnings (GAAP)

First quarter 2022 net earnings and diluted earnings per share (GAAP) were $25.6 million and $0.43, respectively, as compared to $5.7 million, or $0.11 per diluted share, in the same period in 2021.

Cash, cash equivalents and marketable securities

At March 31, 2022, the Company’s cash, cash equivalents, current and long-term marketable securities are approximately $437.5 million, compared to $458.8 million as of December 31, 2021. This decrease is primarily due to milestone payments associated with the 2020 USWM acquisition and transition expense payments related to the Adamas acquisition, partially offsetting cash generated from operations.

Full Year 2022 Financial Guidance (GAAP)

For full year 2022, the Company reiterates its prior financial guidance as set forth below:

(1) Includes net product sales and royalty revenue.
(2) Includes amortization of intangible assets and contingent consideration expense (gain).

Full Year 2022 Financial Guidance – GAAP to Non-GAAP Adjustments

An itemized reconciliation between projected operating earnings on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows:

Non-GAAP Financial Information

This press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP operating earnings adjust for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables in this press release. We believe the use of non-GAAP operating earnings is useful supplemental information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. There are limitations associated with the use of non-GAAP financial measures. Including such measures may not be entirely comparable to similarly titled measures used by other companies, may not reflect all items of income and expense, as applicable, that affect our operations, potential differences among calculation methodologies, may differ from the non-GAAP information used by other companies, including peer companies, and therefore comparability may be limited. We mitigate these limitations by reconciling the non-GAAP financial measure to the most comparable GAAP financial measure. Investors are encouraged to review the reconciliation. The Company’s 2022 financial guidance is also being provided on both a reported and a non-GAAP basis.

Conference Call Details

Supernus will host a conference call and webcast today, May 9, 2022, at 4:30 p.m. Eastern Time to discuss these results.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference Call Name: Supernus Pharmaceuticals First Quarter 2022 Financial Results Conference Call
Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".

Olema Oncology Reports First Quarter 2022 Financial Results and Provides Corporate Update

On May 9, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported first quarter financial results for the period ended March 31, 2022 and provided a business update (Press release, Olema Oncology, MAY 9, 2022, View Source [SID1234613933]).

"Following the successful completion of the Phase 1a dose escalation portion of our trial for OP-1250 late last year, we are pleased with the continued robust enrollment we are achieving across our development program. Both our Phase 1/2 monotherapy expansion study and the Phase 1b combination trial with palbociclib are advancing, and we expect to initiate additional combination trials later this year. In parallel, we plan to evaluate OP-1250’s potential in the treatment of patients with ER+/HER2+ breast cancer and CNS metastases, an important and underserved patient population with limited treatment options," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our knowledge and clinical experience with OP-1250 is rapidly expanding. We are fortunate to be supported by both a strong team and balance sheet as we approach potential near-term value drivers for our business. We look forward to presenting updated clinical data later this year."

Recent Corporate Highlights

Achieved target enrollment of 30 patients in Phase 1b monotherapy dose expansion at 60 mg and 120 mg dose levels (N=15 per cohort).

Enrolled initial dose cohorts in the dose escalation portion of the Phase 1b combination study with palbociclib and dose escalation of OP-1250 continues.

Presented two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 8-13, 2022. Data presented showed that 10 mg/kg OP-1250, a complete estrogen receptor (ER) antagonist (CERAN), alone or in combination with palbociclib, substantially inhibits primary tumor growth in an endocrine-resistant breast cancer model with ERα Y537S mutation. A second poster showed that OP-1250 is able to effectively reverse estradiol-induced transcriptional changes associated with the activated estrogen receptor in two ER+ cell lines, MCF7 and CAMA-1.
Anticipated Milestones

Select the Recommended Phase 2 Dose (RP2D) for OP-1250 in the second quarter of 2022, followed by initiation of the Phase 2 portion of the trial. Phase 2 will include enrollment across three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15) and patients with CNS metastasis (N=15).

Initiate additional Phase 1b combination studies with CDK4/6 and PI3Kα inhibitors in 2022.

Initiate Phase 1b study of OP-1250 in patients with ER+/HER2+ breast cancer and CNS metastases in the second half of 2022.

Present updated monotherapy and initial combination data for OP-1250.
Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2022, were $267.9 million. Olema anticipates that this balance will be sufficient to fund operations into 2024.

Net loss for the quarter ended March 31, 2022, was $23.0 million, compared to $15.3 million for the same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, and an increase in general and administrative (G&A) costs.

GAAP research and development (R&D) expenses were $16.0 million for the quarter ended March 31, 2022, compared to $10.7 million for the same period of the prior year. The increase in R&D expenses was primarily related to the advancement of the development program for OP-1250, increase in nonclinical development activities, and higher personnel-related expenses, including non-cash stock-based compensation expenses. Non-GAAP R&D expenses were $12.9 million for the quarter ended March 31, 2022, excluding $3.1 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $9.0 million for the quarter ended March 31, 2021, excluding $1.7 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 news release.

GAAP G&A expenses were $7.2 million for the quarter ended March 31, 2022, as compared to $4.8 million for the same period of the prior year. The increase in G&A expenses was primarily related to higher personnel-related expenses, including non-cash stock-based compensation expenses, and other corporate costs. Non-GAAP G&A expenses were $5.3 million for the quarter ended March 31, 2022, excluding $1.9 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.3 million for the quarter ended March 31, 2021, excluding $1.5 million non-cash stock-based compensation expense.

Sutro Biopharma Reports First Quarter 2022 Financial Results, Business Highlights, and Anticipated Milestones

On May 9, 2022 Sutro Biopharma, Inc. ("Sutro" or the "Company") (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application ofprecise protein engineering and rational design to create next-generation cancer therapeutics, reported its financial results for the quarter ended March 31, 2022, its recent business highlights, and a preview of anticipatedselect milestones (Press release, Sutro Biopharma, MAY 9, 2022, View Source [SID1234613932]).

"Sutro remains steadfastly dedicated to advancing next generation cancer therapeutics by leveraging the advantages of our proprietary platform," said Bill Newell, Sutro’s Chief Executive Officer. "We are pleased with the progress of our lead program, STRO-002, a FolRα-targeting antibody-drug conjugate. Our top priority is charting the course for a potential registrational trial for patients with advanced ovarian cancer. We are also expanding our clinical studies into endometrial cancer and have plans for non-gynecological indications, including NSCLC, to explore the possibility of treatment with STRO-002 for people who suffer from these debilitating cancers and have limited available treatment options."

Recent Business Highlights and Anticipated Select Milestones
STRO-002, FolRα-Targeting Antibody-Drug Conjugate (ADC): STRO-002 is being studied in the clinic, in both the United States and Europe, for patients with ovarian and endometrial cancers.

The Phase 1 dose-expansion cohort for patients with advanced ovarian cancer has completed enrollment and is ongoing. Sutro expects to report additional data on efficacy, safety, and durability from the dose-expansion cohort in the second half of 2022.
Regulatory discussions on a potential registrational study for patients with advanced ovarian cancer are planned for mid-year 2022.
The STRO-002 study in combination with bevacizumab for patients with advanced ovarian cancer is ongoing and the first patient was dosed in March 2022. A dose-expansion study of STRO-002 for patients with endometrial cancer continues to enroll patients.
Nonclinical data presented at the AACR (Free AACR Whitepaper) Annual Meeting 2022 in April demonstrated STRO-002’s ability to induce immunogenic cell death. Additionally, studies showed robust STRO-002 activity in endometrial and non-small cell lung cancer (NSCLC) patient-derived xenograft models with diverse levels of folate receptor alpha (FolRα) expression.
Sutro expects to initiate clinical trials for STRO-002 in NSCLC and other non-gynecologic solid tumors in the second half of 2022.
STRO-001, CD74-Targeting ADC: The Phase 1 study for patients with B‑cell malignancies, including patients withnon-Hodgkin’s lymphoma and multiple myeloma, continues in dose escalation.

Dose escalation is ongoing to achieve a recommended phase 2 dose (RP2D), with the last reported doses of 5.0 mg/kg in the multiple myeloma (MM) cohort and 5.0 mg/kg in the non-Hodgkin’s lymphoma (NHL) cohort.

Additional Pipeline Programs: Research and preclinical development are underway for several internal candidates.

Discovery and preclinical work on multiple programs are underway to determine Sutro’s next product candidates to advance to the clinic.
Sutro presented preclinical data for a novel immunostimulatory antibody-drug conjugate (iADC) at the 12th Annual World ADC Conference in March 2022. The iADC modality provides for dual mechanisms to attack the tumor, through cytotoxic killing as well as potentially building a protective immune response.
Corporate Updates: Sutro expands the strength of its leadership team with several appointments and promotions.

Venkatesh Srinivasan joined Sutro in April 2022 as Senior Vice President, Process and Analytical Development and part of the senior management team. Dr. Srinivasan brings more than 25 years of experience in bioprocess development, biologics manufacturing and tech transfer in the biopharmaceutical industry. He was most recently Vice President, Global Manufacturing Sciences & Technology at Bayer.
Kristin Bedard, Vice President of Discovery, who joined Sutro in February 2020, recently became part of the senior management team. Recent promotions within the senior management team include Brunilda Shtylla to Senior Vice President of Business Development and Annie Chang to Vice President of Investor Relations.
Collaboration Updates: Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has received from collaborators an aggregate of approximately $456 million in payments, including equity investments, through March 31, 2022.

Sutro is manufacturing initial drug supply for the potential clinical development of the first molecule in the Merck cytokine derivative collaboration; clinical trial materials for Bristol Myers Squibb’s (BMS) CC-99712, a BCMA‑targeting ADC, for treatment of multiple myeloma, in Phase 1 studies; and clinical trial materials for M1231, a MUC1-EGFR-targeting bispecific ADC, for Merck KGaA, Darmstadt, Germany, known as EMD Serono in the U.S. and Canada (EMD Serono), in Phase 1 studies.
Sutro supplies cell-free extract to Vaxcyte for the manufacture of clinical trial materials for VAX-24, which is designed to prevent invasive pneumococcal disease. Vaxcyte announced in April 2022 that the first participants were dosed in the Phase 2 portion of the clinical study of VAX-24.
Sutro plans to support BioNova Pharmaceuticals (BioNova) in clinical trial initiations for STRO-001 in the Greater China market and provide clinical drug supply as needed.
In April 2022, Sutro and Tasly Biopharmaceuticals (Tasly) amended Tasly’s exclusive license to develop and commercialize STRO-002 in Greater China. Pursuant to the amended agreement, the upfront payment due from Tasly was changed to $25.0 million and $15.0 million will become payable to Sutro based on certain regulatory milestones. The amended agreement provides for additional potential payments to Sutro totaling up to $350.0 million related to development, regulatory and commercialization milestones. Sutro plans to support Tasly for initiation of clinical development activities in Greater China and provide clinical drug supply as needed.
First Quarter 2022 Financial Highlights
Cash, Cash Equivalents and Marketable Securities

As of March 31, 2022, Sutro had cash, cash equivalents and marketable securities of $192.1 million, as compared to $229.5 million as of December 31, 2021, with projected cash runway into the second half of 2023, based on current business plans and assumptions. The above balances do not include the value associated with Sutro’s holdings of Vaxcyte common stock.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock

As of March 31, 2022, Sutro held approximately 1.6 million shares of Vaxcyte common stock, with a fair value of $37.7 million. The non-operating, unrealized gain of $0.6 million in the first quarter of 2022 was due to the increase since December 31, 2021 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’sstatements of operations.

Revenue

Revenue was $5.9 million for the quarter ended March 31, 2022, as compared to $14.7 million for the same period in 2021, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any additional collaboration partners, will fluctuate as a result of the amountand timing of revenue recognition of upfront, milestones, and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the quarter ended March 31, 2022 were $45.0 million, as compared to $33.7 million for the same period in 2021. The first quarter of 2022 includes non-cash expenses for stock-based compensation of $7.0 million and depreciation and amortization of $1.3 million, as compared to $4.0 million and $1.3 million, respectively, in the comparable 2021 period. Total operating expenses for the quarter ended March 31, 2022 were comprised of research and development expenses of $30.0 million and general and administrative expenses of $15.0 million, which are expected to increase in 2022 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.