Intensity Therapeutics to Present Preliminary Data from Clinical Study of INT230-6 at Upcoming Medical Conferences

On October 17, 2018 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary immune cell-activating cancer treatments, reported that preliminary data from a Phase 1/2 clinical study of INT230-6 will be presented in poster sessions at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, which is being held October 19-23 in Munich, Germany, and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC (Press release, Intensity Therapeutics, OCT 17, 2018, View Source [SID1234530320]).
Details of the posters are below.

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ESMO 2018 Congress

Title: Phase 1/2 trial evaluation of intratumoral INT230-6 for the treatment of solid tumors

Abstract Number: 4458

Presentation Number: 1160P

Session: Poster Display Session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

Date/Time: October 20, 2018, 12:30 p.m. CEST

Location: Hall A3; Poster Area Networking Hub, ICM München

Presenter: Anthony El-Khoueiry, MD (University of Southern California, USA)

For more information about the ESMO (Free ESMO Whitepaper) 2018 Congress, please visit View Source

SITC Annual Meeting

Title: Phase 1/2 evaluation of intratumoral INT230-6 for the treatment of solid tumors

Poster Number: P622

Poster Hall Hours: November 9, 8 a.m.-8 p.m.; November 10, 8 a.m.-8:30 p.m. EST

Poster Presentation Hours: November 10, 12:20-1:50 p.m. and 7-8:30 p.m. EST

Poster Hall Location: Hall E; Walter E. Washington Convention Center

Presenter: Anthony Olszanski, MD, RPh (Fox Chase Cancer Center)

For more information about the SITC (Free SITC Whitepaper) Annual Meeting, please visit View Source

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

About the Phase 1/2 Clinical Study

INT230-6 is being evaluated in a Phase 1/2 clinical study in patients with different types of advanced solid tumor malignancies. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6. Secondary assessments are the measurement of injected and bystander tumor responses, and determination of the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. The study includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered. Data will be used to assess the progression free and overall survival in patients receiving INT230-6. For more information, please visit www.clinicaltrials.gov (NCT03058289).

Acorda Third Quarter 2018 Update: Webcast/Conference Call Scheduled for October 31, 2018

On October 17, 2018 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported that it will host a conference call and webcast to report its third quarter 2018 update and financial results on Wednesday, October 31 at 8:30 a.m. ET (Press release, Acorda Therapeutics, OCT 17, 2018, View Source [SID1234530263]).

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To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 4468928. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on October 31, 2018 until 11:59 p.m. ET on November 30, 2018. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 4468928. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Nicox Third Quarter 2018 Business Update and Financial Highlights

On October 17, 2018 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported its upcoming milestones and operational highlights, as well as revenue and cash position for Nicox and its subsidiaries (the "Nicox Group") as of September 30, 2018 (Press release, NicOx, OCT 17, 2018, View Source [SID1234530253]).

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Key Upcoming Milestones
Q1 2019: Planned Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) for NCX 4251 to enable a Phase 2 clinical study1 in patients with acute exacerbations of blepharitis.
Q1 2019: Expected delivery of ZERVIATETM (cetirizine ophthalmic solution), 0.24% commercial product to partner Eyevance Pharmaceuticals LLC, followed by a commercial launch in the U.S. planned for the spring 2019 allergy season.
H2 2019: Expected top-line data from the NCX 470 Phase 2 clinical study for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Third Quarter 2018 and Recent Operational Highlights
In September 2018, Nicox and Fera Pharmaceuticals amended their 2015 agreement granting Fera exclusive rights to develop and commercialize naproxcinod for the U.S. market. The development of naproxcinod will focus on an undisclosed rare disease for which Fera expects to apply for an Orphan Drug Designation from the FDA. Nicox will be eligible to potentially receive a single $40 million sales-based milestone if naproxcinod reaches $1 billion yearly sales (for any indication) in the U.S. Royalties remain at 7% of net sales of naproxcinod in the U.S. Fera remains responsible for all clinical development, manufacturing, regulatory, and commercialization activities.
In Q3 2018, our lead product candidate NCX 470, a novel second generation nitric oxide (NO)-donating prostaglandin analog entered Phase 2 clinical study to evaluate its efficacy and safety compared to latanoprost 0.005% for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension and to select the optimal Phase 3 dose. The study is expected to randomize 420 patients in clinical sites across the U.S. Top-line data are expected in the second half of 2019.
Third Quarter 2018 Financial Highlights
As of September 30, 2018, the Nicox Group had cash and cash equivalents of €25.7 million as compared with €32.7 million at June 30, 2018 and €41.4 million at December 31, 2017. Net revenue2 for the third quarter of 2018 was $0.438 million, comprised exclusively of royalties on third quarter 2018 sales of VYZULTATM by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox. This represents an increase of 66% in net revenue3 received by Nicox compared to the second quarter of 2018. The Nicox Group recorded no revenues for the third quarter of 2017.

OncoCyte Corporation to Present at the BIO CEO Investor Forum

On October 17, 2018 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported that William Annett, President and Chief Executive Officer, will provide a corporate overview at the BIO Investor Forum, being held October 17-18, 2018 in San Francisco, California (Press release, BioTime, OCT 17, 2018, View Source;p=RssLanding&cat=news&id=2372038 [SID1234530002]).

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OncoCyte Corporation Presentation Details:
Date: Thursday, October 18
Time: 10:45am Pacific Time/1:45pm Eastern Time
Location: Westin St. Francis Hotel, Yorkshire Room
Webcast: http://www.veracast.com/webcasts/bio/investorforum2018/94207593256.cfm

Abbott Reports Third-Quarter 2018 Results

On October 17, 2018 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2018 (Press release, Abbott, OCT 17, 2018, View Source [SID1234529970]).

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Third-quarter worldwide sales of $7.7 billion increased 12.1 percent on a reported basis and 7.8 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.31 in the third quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.75.
Abbott narrowed its full-year 2018 diluted EPS guidance range from continuing operations on a GAAP basis to $1.33 to $1.35 and adjusted diluted EPS from continuing operations to $2.87 to $2.89.
In the U.S., Abbott received FDA approval of its FreeStyle Libre 14 day sensor, making it the longest lasting wearable glucose sensor available. In October, Abbott obtained CE Mark for its FreeStyle Libre 2 system, a next-generation product offering with optional real-time alarms.

FreeStyle Libre achieving rapid market uptake, with third-quarter worldwide sales of $304 million, an increase of 101 percent versus prior year.
In July, Abbott received U.S. FDA approval for its third-generation version of its minimally invasive MitraClip heart valve repair device. This new version includes design advancements that simplify the procedure and enable more patients to be treated with MitraClip.
In September, Abbott announced positive clinical results from its landmark COAPT study, which demonstrated that its minimally invasive MitraClip heart valve repair device improved survival and clinical outcomes for select patients with functional mitral regurgitation, a leaky heart valve resulting from advanced heart failure. The COAPT study data will be submitted to the U.S. FDA to support consideration of an expanded indication for MitraClip.
"We achieved another quarter of strong growth and our new product pipeline continues to be highly productive," said Miles D. White, chairman and chief executive officer, Abbott. "In spite of increasing currency headwinds, we’re well-positioned to achieve the upper end of our initial full-year guidance."

* See note on organic growth below.

THIRD-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes prior year results for the Abbott Medical Optics (AMO) and St. Jude Medical vascular closure businesses, which were divested during the first quarter 2017;
Excludes the current and prior year results for Rapid Diagnostics, which reflect results for Alere Inc., which was acquired on Oct. 3, 2017; and
Excludes the impact of foreign exchange.
Following are sales by business segment and commentary for the third quarter and first nine months of 2018:

* Total 2018 Abbott sales from continuing operations include Other Sales of $45 million.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Third-quarter 2018 worldwide sales of $7.7 billion increased 12.1 percent on a reported basis. On an organic basis, worldwide sales increased 7.8 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 4.0 percent on a reported basis in the third quarter, including an unfavorable 2.1 percent effect of foreign exchange, and increased 6.1 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 6.6 percent on a reported basis in the third quarter, including an unfavorable 1.9 percent effect of foreign exchange, and increased 8.5 percent on an organic basis. International pediatric sales increased 7.4 percent on a reported basis, including an unfavorable 3.5 percent effect of foreign exchange, and increased 10.9 percent on an organic basis. Strong performance in the quarter was led by above-market growth in the U.S. and double-digit growth in both Asia and Latin America.

Worldwide Adult Nutrition sales increased 0.8 percent on a reported basis in the third quarter, including an unfavorable 2.4 percent effect of foreign exchange, and increased 3.2 percent on an organic basis. International adult sales increased 2.9 percent on a reported basis, including an unfavorable 4.2 percent effect of foreign exchange, and increased 7.1 percent on an organic basis. Sales performance was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand. U.S. sales were negatively impacted by Abbott’s wind down of a non-core product line.

Diagnostics

* Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

* Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

Worldwide Diagnostics sales increased 42.6 percent on a reported basis in the third quarter. On an organic basis, sales increased 7.5 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Core Laboratory Diagnostics sales increased 5.2 percent on a reported basis in the third quarter, including an unfavorable 2.9 percent effect of foreign exchange, and increased 8.1 percent on an organic basis, reflecting above-market growth in the U.S. and internationally.

Molecular Diagnostics sales increased 4.7 percent on a reported basis in the third quarter, including an unfavorable 1.4 percent effect of foreign exchange, and increased 6.1 percent on an organic basis. Worldwide sales were led by growth in infectious disease testing, Abbott’s core area of focus in the molecular diagnostics market.

Point of Care Diagnostics sales increased 3.7 percent on a reported basis in the third quarter, including an unfavorable 0.3 percent effect of foreign exchange, and increased 4.0 percent on an organic basis, led by strong international growth of Abbott’s i-STAT handheld system.

Rapid Diagnostics worldwide sales of $481 million were led by cardiometabolic testing.

Established Pharmaceuticals sales decreased 0.9 percent on a reported basis in the third quarter, including an unfavorable 6.8 percent effect of foreign exchange, and increased 5.9 percent on an organic basis. As expected, sales growth in the quarter was negatively impacted by a comparison versus the third-quarter 2017, when sales were higher than normal due to channel restocking across the market after implementation of a new tax system in India.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 2.1 percent on a reported basis in the third quarter, including an unfavorable 8.9 percent effect of foreign exchange, and increased 6.8 percent on an organic basis. Sales growth was led by double-digit growth in China and Russia. Excluding the negative impact from prior year purchasing patterns associated with the implementation of a new tax system in India, Abbott’s Key Emerging Markets sales would have increased high-single digits on an organic basis in the third quarter.

Worldwide Medical Devices sales increased 8.4 percent on a reported basis in the third quarter. On an organic basis, sales increased 9.8 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

In Electrophysiology, growth was led by strong performance in cardiac mapping and ablation catheters as well as strong growth of Abbott’s Confirm RxTM Insertable Cardiac Monitor (ICM), the world’s first and only smartphone-compatible ICM designed to help physicians remotely identify cardiac arrhythmias.

Growth in Structural Heart was driven by several product areas across Abbott’s broad portfolio, including AMPLATZERTM PFO Occluder, a device designed to close a hole-like opening in the heart, and MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation, a leaky heart valve. In September, Abbott announced positive clinical results from its landmark COAPT study, which demonstrated that MitraClip improved survival and clinical outcomes for select patients with functional mitral regurgitation. The COAPT study data will be submitted to the U.S. FDA to support consideration of an expanded indication for MitraClip.

In Diabetes Care, sales increased 37.4 percent on a reported basis and 39.8 percent on an organic basis, led by rapid market uptake of FreeStyle Libre, Abbott’s revolutionary sensor-based continuous glucose monitoring system, which removes the need for routine fingersticks1 for people with diabetes. During the quarter, Abbott received U.S. FDA approval of its FreeStyle Libre 14 day sensor, the longest lasting glucose wearable sensor available. In October, Abbott obtained CE Mark for its FreeStyle Libre 2 system, a next-generation product offering optional real-time alarms.

ABBOTT’S FULL-YEAR EARNINGS-PER-SHARE GUIDANCE

Abbott is narrowing its 2018 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) to $1.33 to $1.35.

Abbott forecasts net specified items for the full year 2018 of approximately $1.54 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses.

Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $2.87 to $2.89 for the full year 2018.

Abbott is issuing fourth-quarter 2018 guidance for diluted earnings per share from continuing operations under GAAP of $0.39 to $0.41. Abbott forecasts specified items for the fourth quarter 2018 of $0.41 primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.80 to $0.82 for the fourth quarter.

ABBOTT DECLARES 379TH CONSECUTIVE QUARTERLY DIVIDEND

On Sept. 13, 2018, the board of directors of Abbott declared the company’s quarterly dividend of $0.28 per share. Abbott’s cash dividend is payable Nov. 15, 2018, to shareholders of record at the close of business on Oct. 15, 2018.

Abbott has increased its dividend payout for 46 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.