On November 9, 2021 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported data showing the mechanisms by which IGV-001 produces broad immune activation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Imvax, NOV 9, 2021, View Source [SID1234594941]). The data from in vitro and in vivo studies highlight the effects of IGV-001 on inducing both innate and adaptive immune responses to tumor cells and point to the potential mechanism behind observed clinical activity for IGV-001 in the treatment of glioblastoma.

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!

"These exciting mechanistic data substantiate the anti-tumor effects we’ve observed in prior clinical trials of IGV-001. The insights reported here will inform our ongoing clinical development of IGV-001 for glioblastoma, a disease in great need of effective new treatments," said John P. Furey, Chief Executive Officer. "Importantly, these studies also underscore the potential expansion of Imvax’s approach to a wide range of solid tumors and bolster our ongoing preclinical work in hepatocellular, ovarian, pancreatic, and other cancers."

For these in vitro studies, IGV-001 was prepared with patient tumor cells. It was then co-cultured with patient-derived peripheral blood mononuclear cells (PBMCs) to evaluate activated and memory T cell subsets and responses. These studies found an elevated percentage of activated potentially anti-tumor CD4 and CD8 T cells as well as increased central and effector memory phenotypes in both T cell subsets compared to IMV-001-treated PBMC controls. Tumor cells treated with Insulin-like Growth Factor-1 Receptor antisense ‘IMV-001’ also released significantly more (p<0.01) ATP than untreated or sense oligonucleotide-treated controls, suggesting immunogenic cell death.

In vivo studies were performed on C57BL/6 albino mice. Biodiffusion chambers were loaded with either IMV-001 or a saline control, plus GL261-Luc cells, irradiated and implanted into the mice’s flanks for 48 hours, similar to the combination product dosed in investigator-initiated Phase 1 studies of IGV-001 and planned for dosing in the Company’s upcoming Phase 2 clinical trial (NCT04485949). GL261-Luc intracranial tumor challenge was conducted 28 days after chamber implantation. At the termination of the study, 58 days post–intracranial tumor challenge, 59% of IGV-001-treated mice were alive and continued to gain weight, whereas all mice in the control group died by day 24 (p<0.001). Additionally, IGV-001-treated mice with lower tumor burden had less circulating IL-6 (P<0.01), pointing to a means of quantifying IGV-001’s suppression of tumor growth. Finally, Elispot assays demonstrated that mice treated with IGV-001 showed enhanced T cell IFNγ responses to tumor cell antigens, compared to controls.

On November 9, 2021 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following upcoming conferences (Press release, Horizon Therapeutics, NOV 9, 2021, View Source [SID1234594957]):

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!

Guggenheim 3rd Annual Neuro/Immunology Conference (Virtual)

Date: Monday, Nov. 15, 2021
Presentation Time: 9 a.m. ET
Stifel 2021 Health Care Conference (Virtual)

Date: Tuesday, Nov. 16, 2021
Presentation Time: 2 p.m. ET
Piper Sandler 33rd Annual Health Care Conference (Virtual)

Date: Tuesday, Nov. 30, 2021
Presentation Time: 9 a.m. ET
These conference presentations will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcasts will be available following the events.

On November 9, 2021 Signify Health, Inc. (NYSE: SGFY), a leading healthcare platform that leverages advanced analytics, technology and nationwide healthcare networks to create and power value-based payment programs, reported the Company’s financial results for the third quarter of 2021 and nine months ended September 30, 2021 (Press release, Signify Health, NOV 9, 2021, View Source [SID1234594993]).

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!

"Year-to-date through the end of September, our broad network of highly qualified doctors and nurse practitioners performed over 1.4 million comprehensive in-home evaluations that aid care gap closures, address social determinants of health, and assess behavioral needs," said Kyle Armbrester, Chief Executive Officer of Signify Health. "Our team of clinicians, working together with our social and engagement coordinators, compassionately interacts with a growing number of individuals across the entire country to connect and drive engagement with the broader healthcare system to have more healthy, happy days at home. While doing this important work, we achieved strong financial performance in the third quarter and for the nine-months ended September 30, 2021, as increasing customer demand for our in-home evaluations drove strong Home & Community Services results in the third quarter and is expected to create strong momentum going into 2022."

Mr. Armbrester continued, "In our Episodes of Care Services segment, we continue to deliver strong savings to our customers and ensure superior care to individuals during their healthcare episodes. We are on track to deliver a 2021 program size exit run rate of approximately $6 billion in our episodes business, setting up strong BPCI-A program size for 2022. Additionally, we continue to expand our Networks of Distinction for the future growth of our non-BPCI-A episodes of care business."

Third Quarter 2021 Financial Results

Total revenue for the third quarter of 2021 increased 29% to $ 199.2 million, up from $154.7 million in the same period a year ago. Overall growth in the third quarter of 2021 was driven by strength in Home & Community Services (HCS).
HCS revenue grew to $169.1 million in the third quarter of 2021, an increase of 47% over the same period a year ago, due to in-home evaluation (IHE) volume of approximately 488 thousand in the quarter compared to approximately 362 thousand in the third quarter of 2020.
Third quarter 2021 revenue was $30.1 million for the Episodes of Care Services (ECS) segment compared to $40.0 million in the same period a year ago. The decline was primarily due to the adverse impact of COVID-19 on program size and the savings rate. Additionally, there was approximately $9.2 million of revenue recorded during the three months ended September 30, 2020 reflecting positive changes in estimates based on new information received ahead of the reconciliation due in the fourth quarter 2020. The new information included the impact of COVID-19 on program size and the subsequent options CMS offered to providers that had an overall beneficial impact on savings rates.
Third quarter 2021 total net income was $29.3 million, compared to a net loss of $13.3 million for the same period a year ago, due to the improvement in operating performance as well as the quarterly revaluation of customer Equity Appreciation Rights agreements, or EARs. The EARs are marked to market each quarter and this resulted in a credit of $27.3 million reflecting the current lower value of the stock.
Non-GAAP Adjusted EBITDA1 for the third quarter of 2021 increased 46% to $42.0 million, compared to $28.7 million for the third quarter of 2020, driven primarily by HCS growth, partially offset by higher operating expenses related to investments made to support our growth and technology. Non-GAAP Adjusted EBITDA margin1 for the third quarter of 2021 was 21.1%, a 250-basis point improvement from the third quarter of 2020.
Nine Months Ended September 30, 2021 Financial Results

Total revenue for the nine months ended September 30, 2021 increased 42% to $592.0 million, up from $417.1 million in the same period a year ago. Overall growth for the nine-month period ended September 30, 2021 was driven by momentum in HCS.
HCS revenue for the nine months ended September 30, 2021 was $496.9 million, a 65% increase from the nine-months ended 2020, due to an increase in IHE volume to approximately 1.447 million compared to approximately 963 thousand in the same period of 2020 and the lower relative volume of virtual IHEs in 2021 when compared to 2020. Virtual IHEs have a lower cost per evaluation than in-person IHEs.
ECS revenue for the nine months ended September 30, 2021 decreased 17% compared to the prior year period to $95.1 million, reflecting lower program size and savings rates due to the impact of COVID-19.
Net loss for the nine months ended September 30, 2021 was $22.5 million, compared to a net loss of $15.2 million in the comparable period a year ago.
Non-GAAP Adjusted EBITDA1 for the nine months ended September 30, 2021 increased 52% to $131.0 million, compared to $86.0 million for the same period in 2020, driven primarily by HCS growth. Non-GAAP Adjusted EBITDA margin1 for the nine months ended September 30, 2021 was 22.1%, a 150-basis point improvement from the same period a year ago.
2021 Outlook

Signify Health is raising its total revenue and adjusted EBITDA guidance ranges for 2021 as follows:

Total GAAP revenue in the range of $755 million to $770 million; and
Total adjusted EBITDA1 in the range of $160 million to $170 million.

We are providing estimates for key performance indicators for the full year 2021, as follows:

Reflecting continued strength in Home and Community Services, we now expect IHEs in the range of approximately 1.815 to 1.855 million
For Episodes of Care Services, we are maintaining our estimates of:
ECS segment weighted average program size of approximately $4.9 to $5.1 billion dollars; and
ECS segment weighted average savings rate of approximately 6.1% to 6.4%
1Adjusted EBITDA and Adjusted EBITDA margin are non-GAAP financial measures. Refer to the reconciliation in "Non-GAAP Financial Measures." We have not reconciled 2021 guidance for adjusted EBITDA to net income (loss), the most directly comparable GAAP measure, and have not provided forward-looking guidance for net income (loss) because of the uncertainty around certain items that may impact net income (loss), including, among others, stock-based compensation and the fair valuation of the EARs, that are not within our control or cannot be reasonably estimated.

Conference Call Information

Signify Health will host a conference call to discuss the Company’s third quarter 2021 results on November 10, 2021 at 8:30am ET. A live audio webcast of the conference call may be accessed through the investor relations section of Signify Health’s website at investors.signifyhealth.com/events/default.aspx and will be available for replay through January 10, 2022.

On November 9, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the three- and nine-months ending September 30, 2021 and provided a corporate update (Press release, Altimmune, NOV 9, 2021, View Source [SID1234595124]).

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 third quarter was a momentous time for our pemvidutide (ALT-801) program, as we delivered on positive topline data for the 12-week Phase 1 trial, cleared an IND in non-alcoholic steatohepatitis (NASH) with the FDA and initiated a 12-week Phase 1b study in non-alcoholic fatty liver disease (NAFLD)," remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. "In addition to the previously announced 12-week data showing double-digit weight loss in the 1.8 mg arm without the need for dose titration, we now have MRI-PDFF data in a subset of subjects with hepatic steatosis, or fatty liver, from that study demonstrating a remarkable reduction in liver fat to undetectable levels after only 6 weeks of pemvidutide treatment. These findings show the potential of pemvidutide in the treatment of both obesity and NASH, and we look forward to sharing the data from our ongoing Phase 1b trial in NAFLD and initiating Phase 2 trials for obesity and NASH in 2022."

Program Highlights:

Pemvidutide1 (ALT-801)

Announced weight loss data from 12-week Phase 1 clinical trial of pemvidutide in overweight and obese subjects

Subjects achieved mean weight losses of 4.9%, 10.3%, and 9.0% at 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively
Once-weekly dosing regimen was well-tolerated without dose titration
Clinically meaningful reductions in serum lipids and blood pressure
No discontinuations due to adverse events
Obesity program advancing towards 48-week Phase 2 trial in the first half of 2022

Investigational New Drug application (IND) for obesity expected to be submitted by year end 2021
48-week Phase 2 obesity study expected to commence in the first half of 2022
1 proposed INN

Reduction in liver fat by MRI-PDFF exploratory analysis in recently completed Phase 1 study

MRI-PDFF data on liver fat content have now been analyzed through 6 weeks of treatment. While the trial inclusion criteria did not pre-specify a minimum liver fat content, the study did enroll a number of subjects with hepatic steatosis or fatty liver, defined as liver fat content greater than or equal to 5%. Five subjects had baseline hepatic steatosis (liver fat content ranging from 5.5 to 19.5%) and received pemvidutide at 1.8 mg or 2.4 mg dose levels. In each of these subjects, liver fat levels fell to undetectable levels within 6 weeks of treatment, representing a greater than 90% reduction in the liver fat content. These findings reinforce the results from preclinical studies of pemvidutide, which demonstrated statistically greater reductions in liver fat than an equivalent dose of semaglutide and confirm the combined beneficial effects of weight loss and glucagon on liver fat metabolism.

Pemvidutide IND application for NASH cleared and enrollment initiated in Phase 1b clinical trial in NAFLD, with topline data expected in the first half of 2022

The Phase 1b, 12-week NAFLD trial is being conducted in the US, with Dr. Stephen A. Harrison serving as Principal Investigator
The study will include diabetic and non-diabetic subjects, with a primary efficacy end point of the change in liver fat as measured by MRI-PDFF, and a key secondary endpoint of weight loss at Week 12
A 52-week biopsy driven Phase 2 NASH trial is expected to follow the conclusion of the NAFLD trial

Additional activities for continued development of pemvidutide

Drug-drug interaction trial of pemvidutide has been initiated in Australia, with results expected in the first half of 2022
A 12-week study to be initiated in Q1 2022 in the US to further characterize safety and pharmacokinetics of pemvidutide in diabetic subjects
HepTcell

Enrollment progressing in international Phase 2 clinical trial in chronic hepatitis B subjects, with topline data expected in the second half of 2022
Study readouts to include virological markers of hepatitis B infection
Financial Results for the Three and Nine Months Ended September 30, 2021

Altimmune had cash, cash equivalents, short-term investments and restricted cash totaling $199.9 million at September 30, 2021 compared to $216.0 million at December 31, 2020.
Revenue was $0.2 million for the three months ended September 30, 2021 compared to $2.9 million in the same period in 2020. The change in revenue quarter over quarter was primarily due to a decrease in MTEC/DoD revenue during the current period due to the timing of clinical trials and development activities for T-COVID.
Research and development expenses were $29.2 million for the three months ended September 30, 2021, compared to $17.0 million in the same period in 2020. The change was primarily the result of increased expenses related to development activities for the Company’s COVID-19 programs, offset by a decrease in the fair value of contingent consideration liability connected with the acquisition and development of pemvidutide.
General and administrative expenses were consistent period-over-period with $4.2 million recognized for the three months ended September 30, 2021 and $4.2 million in the same period in 2020.
Net loss for the three months ended September 30, 2021 was $33.5 million, or $0.81 net loss per share, compared to $17.8 million in the same period in 2020, or $0.54 net loss per share. Net loss for the nine months ended September 30, 2021 was $73.2 million, or $1.79 net loss per share, compared to $38.4 million in the same period in 2020, or $1.74 net loss per share.

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

About Pemvidutide
Pemvidutide (proposed INN, formerly known as ALT-801) is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist for obesity and non-alcoholic steatohepatitis (NASH). Altimmune believes the treatment of obesity is the cornerstone of treating NASH and its co-morbidities and views these conditions as significant unmet medical needs.

About HepTcell
HepTcell is a novel immunotherapeutic comprised of nine synthetic peptides representing conserved hepatitis B (HBV) sequences formulated with IC31, a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses against all HBV genotypes towards a functional cure for chronic HBV in patients of diverse genetic backgrounds.

On November 9, 2021 Kureha Corporation reported (Press release, Kureha Corporation, NOV 9, 2021, View Source [SID1234595210])

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!

FY2021 half-year operating profit at ¥11.4bn (up 84% YOY, up 52% from initial forecast); Full-year forecast revised upward to ¥19.5bn (up 13% YOY, up 30% from initial forecast)
◼ FY2021 year-end dividend forecast raised to ¥100 per share, up from ¥85 in prior year
◼ FY2021 business conditions characterized by:-Pandemic-impacted consumer behaviors (under stay-home restrictions) and robust outdoor leisure demand persisting during 1H, which is likely to diminish in 2H-Continued strong demand for automotive lithium-ion batteries as EV production and sales expand across the globe, driven by nations’ environment and economic initiatives-Surging fuel and raw materials prices due to tight oil supply, natural resources deficit and logistics/supply chain disruptions in post-pandemic recovery-Impact of reduced car production on Kureha Group businesses is limited and minimal
◼ Kureha Group has implemented strategic measures to:-Increase sales volumes of high-margin grades and items in PVDF, PPS, ‘NEW Krewrap’ and other product lines, while reducing cost via improved efficiency and expanded production output-Adjust sales prices to align with rising fuel and raw material costs Further risks:-Restriction of energy use in China may affect local manufacturing operations (Changshu PVDF facilities) and procurement of raw materials for PVDF manufacturing in Japan (Iwaki Factory)- Delays in reflecting a further and rapid rise in fuel/raw material prices

Factors attributing to changes in operating profit
AM: Increased sales volumes of PVDF, PPS and other advanced materials
SC: Industrial chemicals returned to generating profit
SP: Higher home products and packaging film volumes
CO: Profit maintained despite delays in civil engineering projects
OO: Absence of prior year’s post-typhoon waste treatment projects

Factors attributing to changes in operating profit
AM: Better-than-expected volume growth for PVDF and carbon products, an increase in equity in PPSrelated affiliate’s earnings
SC: Front-loaded deliveries of agrochemicals (2H→1H) SP: Continued pandemic-impacted demand for home products, fewer expenses
CO: Improved sales cost due to mix changes and cost reduction
OO: Higher sales volumes in the low-PCB waste treatment business