On August 3, 2021 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2021 (Press release, Cerus, AUG 3, 2021, View Source [SID1234585610]).

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Recent developments and highlights include:

Second quarter 2021 total revenue of $37.8 million, reflecting a 41% increase over the prior year period. Total revenue was composed of (in thousands, except %):

As of this release, the Company is increasing its 2021 annual product revenue guidance range to $118 million to $122 million (from the prior guidance of $110 million to $114 million), representing an approximately 28% to 33% increase over full year 2020 reported product revenue.
Submitted PMA supplement to U.S. FDA for 7-day storage of INTERCEPT platelets.
Announced collaboration with LifeSouth Community Blood Centers to manufacture INTERCEPT Fibrinogen Complex, expanding the initial launch footprint into the Florida market.
First hospital customer contracts signed in initial launch states for INTERCEPT Fibrinogen Complex.
Announced the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-On Payment (NTAP) for INTERCEPT Fibrinogen Complex.
Submitted fourth and final module (Manufacturing) of CE Mark application for INTERCEPT red blood cells.
Cash, cash equivalents, and short-term investments of $123 million at June 30, 2021.
"The second quarter of 2021 was exceptional for Cerus on numerous fronts. Our record quarterly product revenue of $31.5 million exceeded our expectations and was led by U.S. platelet adoption," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "This strong momentum gives us confidence in delivering significant top-line growth over the balance of the year, and we are raising our full year product revenue guidance accordingly."

"In addition to our strong commercial execution, I am also very proud of several other accomplishments we made as an organization during the second quarter. As planned, we made two important regulatory submissions, with our PMA supplement to the FDA for 7-day storage of INTERCEPT platelets, as well as the fourth and final module of our CE Mark submission for INTERCEPT red blood cells. In addition, for our therapeutics business, we have signed initial customer contracts with hospitals who plan to begin using INTERCEPT Fibrinogen Complex in the second half of 2021, expanded our initial reach into the state of Florida through our collaboration with LifeSouth and received the NTAP from CMS," Greenman continued.

Revenue

Product revenue during the second quarter of 2021 was $31.5 million, compared to $21.5 million during the same period in 2020. Product revenue growth during the quarter benefited from increased demand for INTERCEPT platelet products in the U.S., with broad-based demand from blood centers across the country.

Second quarter government contract revenue was $6.3 million, compared to $5.3 million during the same period in 2020. Second quarter government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Cells as well as sponsored efforts related to the development of next generation pathogen reduction technology to treat whole blood.

Product Gross Profit & Margin

Product gross profit increased $4.4 million over the same period in 2020, however, product gross margins on product revenue during the second quarter of 2021 were 51.3% compared to 54.9% for the second quarter of 2020. The decrease in product gross margin was expected and was tied to increased sales to our U.S. customers, who typically use the Company’s single dose platelet kits, which provide a lower product gross margin percentage compared to our double dose kits that are used more broadly outside of the U.S. Additionally, increased freight costs also contributed to the decrease when compared to the prior year period.

Operating Expenses

Total operating expenses for the second quarter of 2021 were $36.8 million compared to $31.7 million for the same period of the prior year. In general, operating expenses were higher, in part due to the resumption of certain activities that had been suspended due to the effects of the COVID-19 pandemic.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2021 totaled $19.8 million, compared to $16.1 million for the second quarter of 2020. The year-over-year increase in SG&A expenses was tied to incremental expenses associated with the launch of the Company’s INTERCEPT Fibrinogen Complex product, incentive compensation costs, as well as increases in certain vendor fees.

R&D expenses for the second quarter of 2021 were $17.1 million, compared to $15.6 million for the second quarter of 2020. Higher R&D expenses were driven in part by costs associated with the INTERCEPT red blood cell programs in the U.S. and Europe, including the submissions of the third and fourth modules of the Company’s CE Mark application during the quarter. For the most part, U.S. red blood cell efforts are reimbursed and recorded as Government Contract Revenue on the Company’s statement of operations. Additionally, R&D expense during the 2021 period also included elevated costs associated with the development of a next generation, LED-based illuminator.

Net Loss

Net loss for the second quarter of 2021 was $15.4 million, or $0.09 per basic and diluted share, compared to a net loss of $14.9 million, or $0.09 per basic and diluted share, for the second quarter of 2020.

Balance Sheet

At June 30, 2021, the Company had cash, cash equivalents and short-term investments of $122.8 million, compared to $133.6 million at December 31, 2020.

During the quarter, the Company continued its investments in inventory in response to the expected growth of its business. At the same time, the Company continued to manage its accounts receivable, maintaining healthy days sales outstanding and managed cash use from operations down to $8.7 million. The Company continues to have access to additional funds under its loan agreement and, separately, revolving line of credit. During Q2, the Company exercised its option to extend the interest-only duration of its term loans through 2023, in accordance with its loan agreement. At June 30, 2021, the Company had approximately $54.7 million in outstanding term loans and $9.3 million of borrowings under its revolving loan credit agreement, compared to $39.6 and $8.5 million, respectively, at December 31, 2020.

Increasing 2021 Product Revenue Guidance

Based on the strong first half revenue and expectations for the second half of 2021, the Company now expects 2021 product revenue to be in the range of $118 million to $122 million, as compared to the prior range of $110 million to $114 million. The revised guidance range represents approximately 28% to 33% growth compared to 2020 reported product revenue.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 6554004. The replay will be available approximately three hours after the call through August 17, 2021.

On August 3, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the first patient has been treated with FT819, an off-the-shelf chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies (Press release, Fate Therapeutics, AUG 3, 2021, View Source [SID1234585625]). FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, a renewable cell source that enables mass production of high quality, allogeneic CAR T cells with greater product consistency, off-the-shelf availability, and broader patient accessibility. FT819 is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy.

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"Remarkable clinical outcomes have been achieved through treatment with patient-derived CAR T-cell therapy, however, next-generation approaches are necessary to reach more patients who are in need of these highly-effective therapies," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Treatment of the first-ever patient with FT819 ushers in a new era for off-the-shelf CAR T-cell therapy, with the potential to overcome the real-world limitations of existing patient- and donor-derived therapeutic approaches and unlock the full potential of CAR T-cell therapy. We would like to thank our collaborators at Memorial Sloan Kettering Cancer Center, whose partnership over the past five years has profoundly contributed to this landmark achievement."

FT819 was designed to specifically address several limitations associated with the current generation of patient- and donor-derived CAR T-cell therapies. Under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering and Head, Gene Expression and Gene Transfer Laboratory, the Company incorporated several first-of-kind features into FT819 including:

Use of a clonal master engineered iPSC line as the starting cell source, which enables CAR T cells to be mass produced and delivered off-the-shelf for broad patient access;
Incorporation of a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion as described in the journal Nature Medicine (View Source);
Insertion of the CAR transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR expression and enhanced T-cell potency as described in the journal Nature (View Source); and
Complete bi-allelic disruption of T-cell receptor (TCR) expression for the prevention of graft-versus-host disease (GvHD), a potentially life-threatening complication associated with allogeneic T-cell therapy.
The multi-center Phase 1 clinical trial of FT819 is designed to determine the recommended Phase 2 dose and schedule of FT819 and assess its safety and clinical activity in adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-cell lymphomas (BCL). Three treatment regimens will be independently evaluated for each type of malignancy in dose escalation: Regimen A as a single dose of FT819; Regimen B as a single dose of FT819 with IL-2 cytokine support; and Regimen C as three fractionated doses of FT819. For each indication and regimen, dose-expansion cohorts may be enrolled to further evaluate the clinical activity of FT819. The first patient with relapsed / refractory ALL was enrolled in Regimen A and received a dose of 90 million cells.

At the 24th American Society of Gene & Cell Therapy Annual Meeting held in May 2021, the Company presented preclinical data demonstrating that FT819 exhibits uniform 1XX CAR expression with complete elimination of endogenous TCR expression. The product candidate was shown to contain a stem- and central-memory T-cell phenotype, and had high-level expression of the activation marker CD25 and the trafficking marker CXCR4 and very low-level expression of the checkpoint proteins PD1, TIM3, CTLA4 and LAG3. Additionally, data from functional assessments showed that FT819 had potent antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of healthy donor-derived CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia.

Pursuant to a license agreement with MSK, Fate Therapeutics has an exclusive license for all human therapeutic use to U.S. Patent No. 10,370,452, which covers compositions and uses of effector T cells expressing a CAR, where such T cells are derived from a pluripotent stem cell including an iPSC. In addition to the patent rights licensed from MSK, the Company owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

Fate Therapeutics has licensed intellectual property from MSK on which Dr. Sadelain is an inventor. As a result of the licensing arrangement, MSK has financial interests related to Fate Therapeutics.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT819
FT819 is an investigational, universal, off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line, which is engineered with the following features designed to improve the safety and efficacy of CAR19 T-cell therapy: a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion; integration of the CAR19 transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR19 expression and enhanced T-cell potency; and complete bi-allelic disruption of TCR expression for the prevention of graft-versus-host disease (GvHD). FT819 demonstrated antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of primary CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia (Valamehr et al. 2020). FT819 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell malignancies, including B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia (NCT04629729).

On August 3, 2021 Omeros Corporation (NASDAQ: OMER), reported that the company will issue its second quarter financial results for the period ended June 30, 2021, on Monday, August 9, 2021, after the market closes (Press release, Omeros, AUG 3, 2021, View Source [SID1234585642]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

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Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 4195376. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 4195376.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at View Source

On August 3, 2021 Unum Group (NYSE: UNM) reported net income of $182.9 million ($0.89 per diluted common share) for the second quarter of 2021, compared to net income of $265.5 million ($1.30 per diluted common share) for the second quarter of 2020 (Press release, Unum Therapeutics, AUG 3, 2021, View Source [SID1234585659]).

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Unum Group Reports Second Quarter 2021 Results
Included in net income for the second quarter of 2021 are the after-tax cost related to the early retirement of debt of $53.2 million ($0.26 per diluted common share), an after-tax impairment loss on the right-of-use (ROU) asset related to one of our operating leases for office space that we are no longer using to support our general operations of $11.0 million ($0.05 per diluted common share), the net tax expense related to a U.K. tax rate increase of $24.2 million ($0.12 per diluted common share), the after-tax amortization of the cost of reinsurance of $15.5 million ($0.08 per diluted common share), and a net after-tax realized investment gain on the Company’s investment portfolio of $0.6 million ($0.01 per diluted common share). Included in net income for the second quarter of 2020 are an after-tax impairment loss on the ROU asset of $10.0 million ($0.05 per diluted common share), as well as well as a net after-tax realized investment gain on the Company’s investment portfolio of $25.4 million ($0.12 per diluted common share). Excluding the items above, after-tax adjusted operating income was $286.2 million ($1.39 per diluted common share) in the second quarter of 2021, compared to $250.1 million ($1.23 per diluted common share) in the second quarter of 2020.

"We are very pleased with our strong second quarter results, highlighted by positive investment returns and aided by improved COVID dynamics relative to the first quarter. Our core business segments exhibited solid underlying fundamental trends, with improving sales and overall stable benefits experience," said Richard P. McKenney, president and chief executive officer. "These favorable results drive an improvement in our outlook for the full year, which we expect to continue to be influenced by the pandemic."

RESULTS BY SEGMENT

We measure and analyze our segment performance on the basis of "adjusted operating income" or "adjusted operating loss", which differ from income before income tax as presented in our consolidated statements of income due to the exclusion of net realized investment gains and losses, amortization of cost of reinsurance, and certain other items. These performance measures are in accordance with GAAP guidance for segment reporting, but they should not be viewed as a substitute for income before income tax or net income.

Unum US Segment

Unum US reported adjusted operating income of $179.3 million in the second quarter of 2021, a decrease of 22.7 percent from $231.9 million in the second quarter of 2020. Premium income for the segment was $1,522.1 million in the second quarter of 2021, which was generally consistent with the $1,522.7 million in the second quarter of 2020. Net investment income for the segment increased 3.8 percent to $183.6 million in the second quarter of 2021, compared to $176.9 million in the second quarter of 2020.

Within the Unum US operating segment, the group disability line of business reported a 21.2 percent decrease in adjusted operating income to $59.9 million in the second quarter of 2021, compared to $76.0 million in the second quarter of 2020. Premium income for the group disability line of business increased 1.1 percent to $672.2 million in the second quarter of 2021, compared to $664.6 million in the second quarter of 2020, due to higher sales in the group short-term disability product line. Net investment income decreased 2.6 percent to $94.0 million in the second quarter of 2021, compared to $96.5 million in the second quarter of 2020, due to a decline in the yield on invested assets and a lower level of invested assets, partially offset by higher miscellaneous investment income. The benefit ratio for the second quarter of 2021 was 74.7 percent, compared to 72.8 percent in the second quarter of 2020, due to higher claims incidence in the group short-term disability product line. Group long-term disability sales were $42.0 million in the second quarter of 2021, a decrease of 23.9 percent from $55.2 million in the second quarter of 2020. Group short-term disability sales were $31.2 million in the second quarter of 2021, an increase of 5.4 percent from $29.6 million in the second quarter of 2020. Persistency in the group long-term disability product line was 90.1 percent for the first half of 2021, compared to 89.4 percent for the first half of 2020. Persistency in the group short-term disability product line was 87.2 percent for the first half of 2021, compared to 86.9 percent for the first half of 2020.

The group life and accidental death and dismemberment line of business reported adjusted operating income of $5.2 million in the second quarter of 2021, a decrease of 73.2 percent from $19.4 million in the second quarter of 2020. Premium income for this line of business was $456.6 million in the second quarter of 2021, which was generally consistent with the $456.3 million in the second quarter of 2020. Net investment income increased 15.5 percent to $26.9 million in the second quarter of 2021, compared to $23.3 million in the second quarter of 2020, due to higher miscellaneous investment income, partially offset by a decline in the yield on invested assets. The benefit ratio in the second quarter of 2021 was 85.2 percent, compared to 81.8 percent in the second quarter of 2020, due primarily to higher average claim size in the group life product line. Sales of group life and accidental death and dismemberment products increased 12.7 percent in the second quarter of 2021 to $63.8 million, compared to $56.6 million in the second quarter of 2020. Persistency in the group life product line was 90.1 percent for the first half of 2021, compared to 88.6 percent for the first half of 2020. Persistency in the accidental death and dismemberment product line was 89.6 percent for the first half of 2021, compared to 87.8 percent for the first half of 2020.

The supplemental and voluntary line of business reported a decrease of 16.3 percent in adjusted operating income to $114.2 million in the second quarter of 2021, compared to $136.5 million in the second quarter of 2020. Premium income for the supplemental and voluntary line of business decreased 2.1 percent to $393.3 million in the second quarter of 2021, compared to $401.8 million in the second quarter of 2020, due to a decline in the voluntary benefits product line as a result of lower sales, partially offset by growth in the dental and vision product line. Net investment income increased 9.8 percent to $62.7 million in the second quarter of 2021, compared to $57.1 million in the second quarter of 2020, due to higher miscellaneous investment income, partially offset by a decline in the yield on invested assets. The benefit ratio for the individual disability product line was 48.4 percent for the second quarter of 2021, compared to 52.8 percent for the second quarter of 2020, due primarily to lower claims incidence. The benefit ratio for the voluntary benefits product line was 44.2 percent in the second quarter of 2021, compared to 43.1 percent for the second quarter of 2020, due to higher claims incidence in the group critical illness product line. The benefit ratio for the dental and vision product line was 77.1 percent for the second quarter of 2021, compared to 36.0 percent for the second quarter of 2020, due to higher utilization compared to lower utilization experienced in the same period of 2020 resulting from the impacts of COVID-19. Relative to the second quarter of 2020, sales in the individual disability product line increased 4.9 percent in the second quarter of 2021 to $14.9 million. Sales in the voluntary benefits product line declined 7.0 percent in the second quarter of 2021 to $43.7 million. Sales in the dental and vision product line totaled $13.0 million for the second quarter of 2021, an increase of 2.4 percent compared to the second quarter of 2020. Persistency in the individual disability product line was 89.0 percent for the first half of 2021, compared to 90.1 percent for the first half of 2020. Persistency in the voluntary benefits product line was 74.5 percent for the first half of 2021, compared to 73.0 percent for the first half of 2020. Persistency in the dental and vision product line was 86.6 percent for the first half of 2021, compared to 81.7 percent for the first half of 2020.

Unum International

The Unum International segment reported adjusted operating income of $24.8 million in the second quarter of 2021, an increase of 64.2 percent from $15.1 million in the second quarter of 2020. Premium income increased 16.8 percent to $183.5 million in the second quarter of 2021, compared to $157.1 million in the second quarter of 2020. Net investment income increased 35.7 percent to $35.7 million in the second quarter of 2021, compared to $26.3 million in the second quarter of 2020. Sales increased 10.0 percent to $33.1 million in the second quarter of 2021, compared to $30.1 million in the second quarter of 2020.

The Unum UK line of business reported adjusted operating income, in local currency, of £16.8 million in the second quarter of 2021, an increase of 66.3 percent from £10.1 million in the second quarter of 2020. Premium income was £115.1 million in the second quarter of 2021, an increase of 3.0 percent from £111.7 million in the second quarter of 2020, due to growth in the in-force block resulting from the impact of rate increases in the group long-term disability product line and higher overall persistency. Net investment income was £24.3 million in the second quarter of 2021, an increase of 22.1 percent from £19.9 million in the second quarter of 2020, due to higher investment income from inflation index-linked bonds, partially offset by a lower yield on fixed-rate bonds. The benefit ratio in the second quarter of 2021 was 82.5 percent, which was consistent with the second quarter of 2020, with improved experience in the group long-term disability product line and lower claims incidence in the group life product line, offset by higher inflation-linked experience in benefits. Sales decreased 3.2 percent to £21.2 million in the second quarter of 2021, compared to £21.9 million in the second quarter of 2020. Persistency in the group long-term disability product line was 89.4 percent for the first half of 2021, compared to 87.7 percent for the first half of 2020. Persistency in the group life product line was 84.3 percent for the first half of 2021, compared to 83.0 percent for the first half of 2020. Persistency in the supplemental product line was 89.2 percent for the first half of 2021, compared to 90.5 percent for the first half of 2020.

Colonial Life Segment

Colonial Life reported a 5.4 percent increase in adjusted operating income to $95.8 million in the second quarter of 2021, compared to $90.9 million in the second quarter of 2020. Premium income decreased 4.3 percent to $419.7 million in the second quarter of 2021, compared to $438.6 million in the second quarter of 2020, due to lower prior period sales. Net investment income increased 13.0 percent to $41.6 million in the second quarter of 2021, compared to the $36.8 million in the second quarter of 2020, due to higher miscellaneous investment income and a higher level of invested assets, partially offset by a decline in the yield on invested assets. The benefit ratio was 51.7 percent in the second quarter of 2021, compared to 50.7 percent in the second quarter of 2020, with unfavorable experience in the accident, sickness, and disability product line, partially offset by improved experience in the life product line.

Sales increased 53.7 percent to $111.1 million in the second quarter of 2021, compared to $72.3 million in the second quarter of 2020. Persistency in Colonial Life was 78.3 percent for the first half of 2021, compared to 77.5 percent for the first half of 2020.

Closed Block Segment

The Closed Block segment reported adjusted operating income of $111.2 million in the second quarter of 2021, an increase from the $36.7 million in the second quarter of 2020. Premium income for this segment declined 0.5 percent in the second quarter of 2021, compared to the second quarter of 2020, due to policy terminations mostly offset by rate increases on certain in-force business in the long-term care line of business. Net investment income decreased 9.7 percent to $294.7 million in the second quarter of 2021, compared to $326.3 million in the second quarter of 2020, due to a decrease in the level of invested assets supporting the individual disability line of business resulting from the reinsurance transaction that occurred in the first quarter of 2021 and fourth quarter of 2020, as well as a decline in the yield on invested assets. These decreases were partially offset by higher miscellaneous investment income, primarily related to increases in the net asset values on our private equity partnerships.

The interest adjusted loss ratio for the long-term care line of business was 74.6 percent in the second quarter of 2021, compared to an interest adjusted loss ratio of 67.0 percent in the second quarter of 2020, driven primarily by lower claimant mortality. The interest adjusted loss ratio for long-term care for the rolling twelve months ended June 30, 2021, excluding the update of assumptions during the fourth quarter of 2020, was 70.0 percent which is below our long-term expected range. The interest adjusted loss ratio for the individual disability line of business was 69.6 percent in the second quarter of 2021, compared to 89.5 percent in the second quarter of 2020, driven primarily by lower submitted claims.

Corporate Segment

The Corporate segment reported an adjusted operating loss of $48.5 million in the second quarter of 2021, which excludes the before-tax cost related to the early retirement of debt of $67.3 million and the before-tax impairment loss on the ROU asset of $13.9 million, compared to an adjusted operating loss of $58.1 million in the second quarter of 2020, which excludes the before-tax impairment loss on the ROU asset of $12.7 million.

OTHER INFORMATION

Shares Outstanding

The Company’s weighted average number of shares outstanding, assuming dilution, was 205.3 million for the second quarter of 2021, compared to 203.7 million for the second quarter of 2020. Shares outstanding totaled 204.3 million at June 30, 2021. The Company did not repurchase shares during the first half of 2021.

Capital Management

At June 30, 2021, the weighted average risk-based capital ratio for the Company’s traditional U.S. insurance companies was approximately 375 percent, and cash and marketable securities in the holding companies equaled $1,717.0 million.

Book Value

Book value per common share as of June 30, 2021 was $53.57, compared to $51.90 at June 30, 2020.

Outlook

The Company expects a decline of approximately 1 percent to 3 percent in after-tax adjusted operating income per share for full-year 2021 relative to full-year 2020, compared to its previous expectation of a 5 percent to 6 percent decline. The improved outlook reflects strong second quarter performance, and the Company’s revised expectations

On August 3, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the Company will be evaluating mirdametinib, an investigational MEK inhibitor, in a platform study sponsored by Memorial Sloan Kettering Cancer Center (MSK) and supported by SpringWorks exploring the compound both as a monotherapy and as a combination therapy in advanced solid tumors harboring MAPK-activating mutations (Press release, SpringWorks Therapeutics, AUG 3, 2021, View Source [SID1234591664]). The trial, which is expected to begin recruiting patients during the third quarter of 2021, will initially explore mirdametinib in two patient cohorts: the first in combination with fulvestrant, a selective estrogen receptor degrader (SERD) in patients with estrogen receptor positive (ER+) metastatic breast cancer (mBC) with MAPK alterations (particularly inactivating mutations in NF1), and as a monotherapy in advanced solid tumors harboring oncogenic MEK1 or MEK2 mutations.

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"Emerging evidence points to alterations in the MAPK pathway playing a key role in mediating resistance to hormone therapy in ER+ mBC, which represents a significant unmet medical need," explained Ezra Rosen, M.D., Ph.D., Medical Oncologist, Assistant Member of MSK’s Early Drug Development Service, and the study’s principal investigator. "Based on emerging preclinical data, combinations of MAPK pathway inhibitors with ER-targeted therapy could potentially address this resistance mechanism and we look forward to studying mirdametinib to evaluate whether this MEK inhibitor can provide a clinical benefit. Separately, given the preclinical evidence that activating mutations in MEK1 and MEK2 can also act as oncogenic drivers in cancer, we’re looking to explore a potential role for mirdametinib monotherapy in solid tumors harboring these driver mutations."

Approximately 70% of breast cancers are ER+. Hormonal therapies targeting ER, such as SERDs, can be effective in treating ER+ mBC, but over 90% of patients eventually develop resistance to ER-targeted therapy. Loss of NF1 function has been shown to be responsible for enhanced ER transcriptional activity and reduced sensitivity to fulvestrant in preclinical models, with up to 6% of ER+ mBC patients harboring a detectable NF1 mutation.1 Combinations of MAPK pathway inhibitors and ER-targeted therapy could potentially address this resistance, as demonstrated by a combination of a MEK inhibitor and fulvestrant showing anti-tumor activity in fulvestrant-refractory NF1-deficient ER+ mBC preclinical models.1,2

In addition, MEK1 and MEK2 mutations are present in up to 2% of solid tumors and have been validated as oncogenic drivers. Recent publications demonstrate the activity of MEK inhibitors, including mirdametinib, in preclinical models driven by a subset of these MEK mutations.3,4

"This biomarker-driven platform study will enable us to evaluate mirdametinib’s ability to address subsets of patients with solid tumors that harbor specific MAPK pathway mutations," said Mike Burgess, M.B.Ch.B., Ph.D., Head of Research and Development at SpringWorks. "We are committed to exploring the full potential of mirdametinib on behalf of patients with devastating cancers and look forward to collaborating with Dr. Rosen and his colleagues at MSK on this important trial."

About the MSK-Sponsored Phase 1b/2a Trial

The open-label Phase 1b/2a parallel design, platform study will evaluate the safety and tolerability, efficacy, and pharmacokinetics of mirdametinib in two study arms: (1) in combination with fulvestrant in postmenopausal patients with ER+ mBC harboring NF1 loss of function or other alterations of the MAPK pathway and (2) as a monotherapy in adult patients with advanced solid cancers driven by the alterations of the MAPK pathway, including MEK1 or MEK2 mutations.

The primary objectives of the trial will be to evaluate the safety and tolerability and anti-tumor efficacy of mirdametinib in combination with fulvestrant and as a single agent. The efficacy endpoints will include best objective response by RECIST 1.1, disease control rate, duration of response, progression-free survival, and pharmacokinetic endpoints. Biomarker analyses will also be conducted to evaluate the changes from baseline in the biomarkers of tumor biology and anti-tumor activity and characterize potential mechanisms of resistance.

About Mirdametinib

Mirdametinib is an oral, potent, allosteric, brain-penetrant small molecule designed to inhibit MEK1 and MEK2, which are proteins that occupy pivotal positions in the MAPK pathway and that play a central role in multiple oncology and rare disease indications. To date, over 250 subjects have been exposed to treatment with mirdametinib across clinical trials, with preliminary evidence of clinical activity against tumors driven by over-activated MAPK signaling.5

Mirdametinib is being evaluated as a monotherapy in a Phase 2b trial for pediatric and adult patients with NF1-associated plexiform neurofibromas (NF1-PN), and in a Phase 1/2 trial for patients with pediatric low-grade gliomas. In addition, mirdametinib is being evaluated in a Phase 1b/2 trial in combination with BeiGene’s RAF dimer inhibitor, lifirafenib, in patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations, and other MAPK pathway aberrations.