On November 9, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will virtually participate in the following upcoming investor conferences (Press release, Jazz Pharmaceuticals, NOV 9, 2021, View Source [SID1234594909]):

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Jefferies London Healthcare Conference on Tuesday, November 16, 2021

The presentation is scheduled for 11:20 – 11:55 a.m. ET / 4:20 – 4:55 p.m. GMT
Evercore ISI HealthCONx Conference on Tuesday, November 30, 2021

The presentation is scheduled for 2:40 – 3:25 p.m. ET / 7:40 – 8:25 p.m. GMT
Jazz will virtually participate in both conferences and webcasts of the presentations will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharma.com. Replays of the webcasts will be available on the website for 30 days.

On November 9, 2021 Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, reported new clinical data from its Phase 1/2 expansion study evaluating the single-agent activity of VT1021 in subjects with pancreatic cancer and recurrent glioblastoma (rGBM) (Press release, Vigeo Therapeutics, NOV 9, 2021, View Source [SID1234594925]). The data is being presented in the poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2021 Annual Meeting, taking place from November 10-14, 2021.

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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

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VT1021 is a first-in-class compound that induces the expression of Tsp-1 in the tumor microenvironment (TME). Tsp-1 then blocks the CD47 immune checkpoint and reprograms the CD36 receptor to induce tumor cell apoptosis, inhibit angiogenesis, and reprogram macrophages from the M2 to M1 phenotype. In the completed open-label, multicenter Phase 1/2 study (NCT03364400), the safety and preliminary anti-tumor efficacy of single-agent VT1021 was evaluated in subjects enrolled in both dose escalation and dose expansion cohorts. Results of the all-comer escalation cohort were presented at SITC (Free SITC Whitepaper) in 2020. In 2021, Vigeo is presenting the results of the expansion cohorts, which focused primarily on pancreatic cancer and rGBM, as well as other indications.

In the pancreatic cancer expansion cohort, VT1021, when administered as a single agent, was able to induce a reduction in tumor volume in 38% of subjects with measurable disease. VT1021 was able to reprogram the immune reactivity of the TME as evidenced by an increase in cytotoxic T lymphocytes (CTLs) as well as in the ratio of M1:M2 macrophages. These findings suggest that VT1021, in addition to its single agent activity, could be a potent and synergistic combination with checkpoint inhibitors.

Consistent with the reprogramming of the TME, Tsp-1 expression was significantly increased by VT1021 treatment across all tumor types. Induction of Tsp-1 protein was observed in circulating PBMCs, platelets and plasma, along with mRNA levels in PBMCs. Additionally, analysis of paired biopsy samples revealed increased Tsp-1 accumulation in MDSCs in the TME. Taken together these findings validate of the biological activity of VT021 via the induction of Tsp-1 in the TME.

"We are highly encouraged by the new data being presented at SITC (Free SITC Whitepaper), which demonstrate both a favorable safety profile for VT1021 as well as early signals of efficacy in pancreatic cancer – especially for those subjects with tumors expressing high levels of both CD47 and CD36," said CEO Jim Mahoney, "Out of 14 patients, 5 patients showed reduction in tumor burden. Based on these findings, we believe that VT1021, a dual-CD47/CD36 modulating agent, has strong potential as a treatment for pancreatic cancer patients."

Vigeo plans to initiate Phase 2/3 studies in both pancreatic cancer and rGBM during the first half of 2022. Vigeo will present additional results from the GBM expansion cohort at the Society for Neuro-Oncology (SNO) Conference in November 2021 in Boston, MA.

Details for the SITC (Free SITC Whitepaper) 2021 presentations are as follows:

Title: Clinical update of VT1021, a first-in-class CD36 and CD47 targeting immunomodulating agent, in subjects with pancreatic cancer and other solid tumors stratified by novel biomarkers
Presenter: Marsha Crochiere, PhD, Director of Translational Sciences, Vigeo Therapeutics
Session: Virtual Poster Hall
Poster #: 369
Date and time: A copy of the poster will be available on-demand starting Friday, November 12th at 7:00 AM ET

Title: Development of Thrombospondin-1 as a clinical pharmacodynamic biomarker for VT1021, a first-in-class therapeutic agent that reprograms the tumor microenvironment.
Presenter: Jian Jenny Chen, PhD, Director Scientific Research and Development, Vigeo Therapeutics
Session: Virtual Poster Hall
Poster #: 375
Date and time: A copy of the poster will be available on-demand starting Friday, November 12th at 7:00 AM ET

About VT1021
Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates the apoptotic and macrophage reprogramming activity of CD36. The result of the dual modulating activity is the induction of apoptosis as well as an increase in both CTL:Treg and M1:M2 macrophage ratio. The biological/therapeutic activity of VT1021 is mediated by the stimulation of thrombospondin-1 (Tsp-1). Through these dual-modulating effects VT1021 reprograms the tumor microenvironment (TME) from one that is immune suppressive, or "cold," to immune enhanced (or sensitized), or "hot," that are more susceptible to attack from the immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.

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.

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"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]):

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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

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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]).

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"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.