Prescient ends June quarter with notable progress in cancer programs and a healthy financial position

On August 3, 2021 Prescient Therapeutics Limited (ASX:PTX) reported its June 2021 results, marked by impressive progress in its cancer programs and a robust financial position to support and drive further clinical development (Press release, Prescient Therapeutics, AUG 3, 2021, View Source;utm_medium=rss&utm_campaign=prescient-ends-june-quarter-with-notable-progress-in-cancer-programs-and-a-healthy-financial-position [SID1234585681]). Notably, the Company ended the quarter with a healthy cash balance of AU$16.1 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As the Company continues to advance the development of its targeted cancer therapies, a strong cash position, coupled with prudent financial management, would help Prescient aim for several value-generating milestones.

Prescient-Peter Mac research partnership
Prescient and Peter MacCallum Cancer Centre (Peter Mac) entered into a crucial research partnership to advance PTX’s next-generation CAR-T therapy using the OmniCAR platform. The collaboration builds on an earlier agreement between the two parties, announced in August 2020 and will now include OmniCAR. International CAR-T expert Professor Phil Darcy is leading PTX’s work in the CAR-T space.

RELATED: Prescient Therapeutics inks new deal with Peter Mac to rev up its OmniCAR programs

It is worth mentioning that Prescient would own any resulting intellectual property (IP) from this research partnership. The Company has also secured a grant funding worth AU$100K from the Innovation Connections scheme of the Australian Federal Government for this vital research.

After the June quarter, Prescient hit another major milestone, having confirmed the non-immunogenic profile of key components of the OmniCAR platform. The firm conducted immunogenicity testing to assess the immune response against OmniCAR’s components – SpyTag and SpyCatcher, which demonstrated positive responses.

The results showed both SpyTag and SpyCatcher have incredibly low predicted immunogenicity compared to a panel of humanised therapeutic antibodies already approved for human use.

Source: PTX Update, 5 July 2021

TO KNOW MORE, DO READ: Positive results from immunogenicity testing send Prescient’s shares higher

Consolidation of Cell Therapy Enhancement programs
Prescient has been undertaking Cell Therapy Enhancement (CTE) programs at Carina Biotech as well as Peter Mac. During the quarter, the Company consolidated these two programs, which are now being undertaken at Peter Mac, another testament to the growing relationship between the two parties.

Prescient also expressed its gratitude to Carina Biotech and its partners at the University of Adelaide for their contribution to the collaboration.

Progress of PTX’s targeted therapies – PTX-100 & PTX-200
During the quarter, Prescient’s targeted therapy studies for PTX-100 and PTX-200 continued making excellent progress and enrolled patients without any reported safety issues.

On 23 April 2021, the Company reported that its Phase 1b study of PTX-200 and cytarabine in acute myeloid leukemia (AML) patients had completed the second cohort at a dose level of 35 mg/m2 under a modified study protocol, with no safety or toxicity-related issues observed. The study is now progressing at the higher dose level of 45 mg/m2, and Prescient anticipates providing updates in the upcoming months.

RELATED ARTICLE: Prescient Therapeutics’ (ASX:PTX) AML trial progresses to next dosing level

After the June quarter, the Company announced that the Phase 1b basket trial of PTX-100 in a mix of solid and haematological cancers had completed patient recruitment for the highest dose level of 2,000 mg/m2 without any safety issues reported.

As highlighted on 27 July 2021, PTX-100 was well-tolerated and exhibited an excellent safety profile in Phase 1b basket trial without any related serious adverse events. These findings have encouraged Prescient and Professor H. Miles Prince, principal investigator of the study, to conduct a new expansion study with up to 12 patients with T-cell lymphoma. Prescient looks forward to providing further details about the exciting development in the coming months.

TO KNOW MORE, DO READ: Prescient takes its PTX-100 trial to next level after Phase 1b success

Overall, Prescient has been making great strides in developing multiple cancer programs to treat challenging cancers with unmet medical needs. The Company is thankful to all its shareholders for their support and looks forward to updating them as it works to bring effective, innovative personalised cancer therapies to clinicians and patients who need them.

Aptose Reports Results for the Second Quarter 2021

On August 3, 2021 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, reported financial results for the three months ended June 30, 2021 and provided a corporate update (Press release, Aptose Biosciences, AUG 3, 2021, View Source [SID1234585668]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The net loss for the quarter ended June 30, 2021 was $13.5 million ($0.15 per share) compared with $15.8 million ($0.21 per share) for the quarter ended June 30, 2020. The net loss for the six months ended June 30, 2021 was $29.7 million ($0.33 per share), compared with $27.3 million ($0.36 per share) for the six months ended June 30, 2020. Total cash and cash equivalents and investments as of June 30, 2021 were $103.3 million. Based on current operations, Aptose expects that cash on hand and available capital provide the Company with sufficient resources to fund all planned Company operations including research and development into the first half of 2023.

"The progress we are seeing in our Phase 1 a/b clinical trials with luxeptinib in very challenging patient populations with AML and B-cell malignancies is especially encouraging," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "As we have begun to observe dose-dependent anti-tumor activity, we plan to continue dose escalation for extended duration to treat as many patients as possible on these higher dose levels and tackle these increasingly refractory patient populations."

Key Corporate Highlights

Luxeptinib Phase 1 a/b Clinical Study in AML – Luxeptinib is currently being evaluated in a Phase 1 a/b dose escalation clinical study in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). In concurrence with participation at the EHA (Free EHA Whitepaper)2021 Virtual Congress (EHA) (Free EHA Whitepaper) in June, Aptose reported encouraging anti-leukemic activity in multiple patients, including a durable MRD-negative complete response in a FLT3-ITD AML patient who had relapsed after two allogeneic stem cell transplants, multiple lines of chemotherapy, and prior FLT3 inhibitor therapy. Aptose has completed the 450 and 600 mg dose levels, with some patients remaining on treatment at those levels, and has fully enrolled the 750 mg dose cohort. More information is available at www.clinicaltrials.gov (NCT04477291).

Luxeptinib Phase 1 a/b Clinical Study in B-cell Malignancies – In parallel with the trial in AML patients, luxeptinib is being evaluated in a Phase 1 a/b dose escalation clinical study in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to two or more lines of established therapies, including drugs such as ibrutinib, rituximab and venetoclax or for whom no other treatment options are available. Thus far, luxeptinib has been well-tolerated in patients treated at 150mg, 300mg, 450mg and 600mg BID over multiple cycles. Of the evaluable patients at these dose levels, two-thirds of them experienced various reductions of lesion size or IgM measurements compared to baseline, demonstrating measurable anti-tumor activity. Patients now are being treated at the fifth dose level of 750mg BID, which is fully enrolled. More information is available at www.clinicaltrials.gov (NCT03893682).

APTO-253 Phase 1 a/b Clinical Study in AML and MDS – As a direct inhibitor of MYC transcription, APTO-253 represents a novel approach for targeting MYC, an oncogene estimated to contribute to the majority of all human cancers, including hematologic malignancies. Given this mode of action, Aptose is expanding the target patient population to include those with relapsed or refractory B-cell malignancies characterized by chromosomal translocations involving the MYC locus. These include Burkitt’s lymphoma, double- or triple-hit diffuse large B-cell lymphomas, and other aggressive lymphomas with MYC translocations.

In the ongoing Phase 1a/b study in patients with relapsed or refractory AML and high-risk myelodysplastic syndrome (MDS), APTO-253 has been well-tolerated in five dose cohorts ranging from 20 – 150 mg/m2 over multiple cycles. Thus far, there is no evidence of drug-related adverse events, including no myelosuppression. Aptose currently is treating patients in the sixth dose cohort at 210 mg/m2 and several subsequent dose escalations are anticipated. More information is available at www.clinicaltrials.gov (NCT02267863).
RESULTS OF OPERATIONS

A summary of the results of operations for the three-month and six-month periods ended June 30, 2021 and 2020 is presented below:

The net loss for the three-month period ended June 30, 2021 decreased by $2.3 million to $13.5 million as compared with $15.8 million for the comparable period in 2020. The net loss for the six-month period ended June 30, 2021 increased by $2.4 million to $29.7 million as compared with $27.3 million for the comparable period in 2020. Components of the net loss are presented below:

Research and Development
The research and development expenses for the three-month and six-month periods ended June 30, 2021 and 2020 were as follows:

Research and development expenses increased by $3.0 million to $9.8 million for the three-month period ended June 30, 2021, as compared with $6.9 million for the comparative period in 2020. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for luxeptinib increased by approximately $1.97 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation and higher costs related to the luxeptinib AML trial, for which we received an IND allowance in June 2020.

Program costs for APTO-253 increased by approximately $263 thousand, mostly as a result of higher manufacturing costs.

Personnel-related expenses increased by $668 thousand, mostly related to new positions hired to support our clinical trials and manufacturing activities.

Stock-based compensation increased by approximately $65 thousand in the three months ended June 30, 2021, compared with the three months ended June 30, 2020, mostly related to higher total compensation expense in the current period on options issued in the first half of 2021.
Research and development expenses increased by $5.3 million to $18.1 million for the six-month period ended June 30, 2021, as compared with $12.8 million for the comparative period in 2020. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for luxeptinib increased by approximately $3.0 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation and higher costs related to the luxeptinib AML trial, for which we received an IND allowance in June 2020.

Program costs for APTO-253 increased by approximately $474 thousand, mostly as a result of higher manufacturing costs.

Personnel-related expenses increased by $1.2 million, mostly related to new positions hired to support our clinical trials and manufacturing activities.

Stock-based compensation increased by approximately $643 thousand in the six months ended June 30, 2021, compared with the six months ended June 30, 2020, mostly related to higher total compensation expense in the current period on options issued in the first half of 2021.
General and Administrative
The general and administrative expenses for the three-month and six-month periods ended June 30, 2021 and 2020 were as follows:

General and administrative expenses for the three-month period ended June 30, 2021 were $3.7 million, as compared with $9.0 million for the comparative period in 2020, a decrease of approximately $5.4 million. The decrease was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, increased by approximately $242 thousand in the three months ended June 30, 2020, primarily as a result of higher insurance costs, professional costs and investor relations advisory costs offset by lower personnel related costs and lower office administrative costs.

Stock-based compensation decreased by approximately $5.6 million in the three months ended June 30, 2021 as compared with the three months ended June 30, 2020, mostly as a result of a lower number of options granted in the six month period ended June 30, 2021 as compared with the six month period ended June 30, 2020, that those options granted in the current period had a lower grant date fair value, and that in the comparative period the Company had issued restricted share units (RSUs) that had fully vested by the end of the comparative period. No RSUs were granted in the current period.
General and administrative expenses for the six-month period ended June 30, 2021 were $11.7 million as compared with $14.9 million for the comparative period, a decrease of approximately $3.2 million. The decrease was primarily a result of the following:

General and administrative expenses, other than share-based compensation and depreciation of equipment, increased by approximately $702 thousand in the six months ended June 30, 2021, primarily as a result of higher insurance costs, higher professional costs, higher investor relations advisory costs offset by lower office administrative costs and lower travel expenses.

Stock-based compensation decreased by approximately $3.9 million in the six months ended June 30, 2021, compared with the six months ended June 30, 2020. Stock-based compensation decreased by approximately $5.6 million mostly as a result of a lower number of options granted in the six-month period ended June 30, 2021 as compared with the six month period ended June 30, 2020, that those options granted in the current period had a lower grant date fair value, and that in the comparative period the Company had issued RSUs that had fully vested by the end of the comparative period. This decrease was offset by increased compensation of approximately $1.7 million, mostly related to the modification of option agreements of one officer as part of a separation and release agreement. Vested options of 1,679,169 with exercise prices ranging from $1.03 to $7.44 were allowed to continue to be exercisable for an additional twelve-month period, and also 504,833 options that would have expired unvested, were allowed to continue to vest for a twelve-month period. As there was no service requirement, the Company recorded $945 thousand and $663 thousand additional compensation in the current period related to these modifications for the vested and unvested options, respectively.
Conference Call and Webcast

Aptose will host a conference call to discuss results for the quarter ended June 30, 2021 today, Tuesday, August 3, 2021 at 5:00 PM ET. Participants can access the conference call by dialing 1-844-882-7834 (North American toll-free number) and 1-574-990-9707 (international/toll number) and using conference ID # 7272387. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call for seven days by dialing 1-855-859-2056 (toll free number) and 1-404-537-3406 (international/toll number), using the conference ID # 7272387.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended June 30, 2021 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

Cumberland Pharmaceuticals To Announce Second Quarter 2021 Financial Results

On August 3, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release second quarter 2021 financial results and provide a Company update after the market closes on Tuesday, August 10, 2021 (Press release, Cumberland Pharmaceuticals, AUG 3, 2021, View Source [SID1234585660]). A conference call and live internet webcast will be held on Tuesday, August 10, 2021, at 4:30 p.m. Eastern Time to discuss the results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 3985462. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of branded prescription products to improve patient care. The Company develops, acquires and commercializes brands for the hospital acute care, gastroenterology and rheumatoid arthritis markets.

The Company’s portfolio of FDA-approved brands includes:

Acetadote (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;
Caldolor (ibuprofen) Injection, for the treatment of pain and fever;
Kristalose (lactulose) for Oral Solution, a prescription laxative, for the treatment of constipation;
Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
RediTrex (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis;
Vaprisol (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
Vibativ (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
The Company also has Phase II clinical programs underway evaluating its product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD").

For more information on Cumberland’s approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the Company’s website www.cumberlandpharma.com.

Unum Group Reports Second Quarter 2021 Results

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

Nordic Nanovector Provides Update on PARADIGME, its Phase 2b Pivotal Trial with Betalutin® in R/R Follicular Lymphoma

On August 3, 2021 Nordic Nanovector ASA (OSE: NANOV) reported an update on the timeline for PARADIGME, its ongoing pivotal Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL) (Press release, Nordic Nanovector, AUG 3, 2021, View Source [SID1234585658]). The Company, having reviewed the recent rate of patient recruitment in discussion with its clinical advisors and in light of the continuing impact from the COVID pandemic, now anticipates the preliminary three-month data readout from PARADIGME during the first half of 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company will host a live webcast and Q&A on Thursday, 5 August 2021, at 08.30 CEST. A link to the webcast will be available in the afternoon on Wednesday, 4 August on www.nordicnanovector.com.

The Company reports that 92 patients have been enrolled into PARADIGME as of 3 August, compared with 83 patients enrolled as of 25 May 2021 and 73 as of 17 February 2021.

While the changes to the PARADIGME protocol and initiatives implemented to improve execution of the trial have positively impacted recruitment, the ongoing COVID pandemic situation, exacerbated by the spread of the more infectious SARS-CoV-2 delta variant, continues to affect the Company’s ability to screen, enrol and treat new patients. This is because the physical condition of the patient population targeted for this study means they are at the greatest risk from COVID-19 infection. As a result, the rate of patient recruitment has been slower than anticipated.

Nordic Nanovector continues to prioritise and commit all necessary resources to the completion of PARADIGME. As part of this prioritisation, Nordic Nanovector has decided to close clinical sites at which enrolment has been particularly challenging and refocus resources on other initiatives; the trial remains open for enrolment at 85 sites. The Company’s current cash position will support its operations into H2 2022.

In addition, the Company confirms it will invest no further funds in its Archer-1 Phase 1b trial investigating Betalutin in combination with rituximab in 2nd-line FL. The findings from this study, announced on 25 May 2021, will be important to inform the future development strategy for Betalutin in 2L FL.

The Company is planning to host an R&D Day for analysts, investors and press in Q4 2021. At the event, senior management and selected external speakers will discuss the positioning of Betalutin as a potential new treatment for R/R FL and outline the strategy for its future development and commercialisation in this indication pending positive results. In addition, the Company will discuss its multiple opportunities to expand the market for Betalutin and present other projects in its portfolio.

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, commented: "The positive changes to the trial protocol and the initiatives we have implemented have increased the rate of recruitment into PARADIGME. However, they have not led to the expected acceleration in enrolment rate due to the spread of the emerging delta variant, which has meant that COVID restrictions have continued to impede the progress of PARADIGME, in common with many other clinical trials. Given this situation, we believe it is prudent to reset the anticipated timeline for completing the study, as we continue to focus on delivering preliminary top line data as soon as possible."