On October 24, 2019 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2019 (Press release, Integra LifeSciences, OCT 24, 2019, View Source [SID1234542480]).

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Third Quarter 2019 Highlights

Reported revenues were $379.1 million, an increase of 3.6% over the third quarter of 2018, and organic revenues increased 4.7% over the prior year;

Foreign currency exchange rates negatively impacted reported revenues by $2.4 million in the third quarter of 2019;

Adjusted EBITDA margin was 24.2%, an increase of 120 basis points over the third quarter of 2018;

GAAP loss per diluted share was $(0.32), compared to GAAP earnings of $0.15 in the prior year. The GAAP loss was primarily due to a $59.9 million in-process research and development charge related to the acquisition of Rebound Therapeutics Corporation ("Rebound") in the third quarter of 2019. Adjusted earnings per diluted share were $0.68, an increase of 15.3% over the third quarter of 2018;

The Company is tightening its full-year reported revenue guidance to a range of $1.517 billion to $1.522 billion from its prior range of $1.515 billion to $1.525 billion. The Company is reaffirming full-year organic revenue growth of approximately 5%;

The Company is revising its GAAP earnings per diluted share guidance for the full year 2019 to a new range of $0.61 to $0.66 from the prior range of $1.46 to $1.53, a reduction primarily related to Rebound acquisition expenses. The Company is reaffirming guidance for adjusted earnings per diluted share in the range of $2.70 to $2.75.

"We are pleased to have exceeded our third quarter revenue and earnings guidance. For the second quarter in a row, our global CSS segment delivered broad-based strength and drove the outperformance," said Peter Arduini, Integra’s president and chief executive officer. "We have completed all the substantial Codman transition services activities and are reaffirming our full-year 2019 guidance for organic revenue growth and adjusted EPS."
Adjusted EBITDA for the third quarter of 2019 was $91.6 million, or 24.2% of revenue, compared to $84.3 million, or 23.0%, in the third quarter of 2018. The 120-basis point margin improvement was driven by higher revenue and improved operating leverage.
Adjusted net income for the third quarter of 2019 was $58.7 million, an increase of 16.0% from the prior year. The increase in adjusted net income is a result of higher revenues, improved operating leverage and lower interest expense. Adjusted earnings per diluted share for the third quarter of 2019 were $0.68, an increase of 15.3% over the prior year.
The Company reported a GAAP net loss of $(27.6) million, or $(0.32) per diluted share, in the third quarter of 2019, compared to GAAP net income of $13.3 million, or $0.15 per diluted share, in the third quarter of 2018, a decrease mostly attributable to expenses associated with the Rebound acquisition.
2019 Full-Year Outlook
The Company is tightening its full-year reported revenue guidance to a range of $1.517 billion to $1.522 billion from its prior range of $1.515 billion to $1.525 billion. The Company is reaffirming its full-year organic revenue growth guidance of approximately 5%.
The Company is revising its GAAP earnings per diluted share guidance for the full-year 2019 to a new range of $0.61 to $0.66 from the prior range of $1.46 to $1.53 due to higher acquisition and integration-related charges, primarily a $59.9 million in-process research and development expense related to Rebound. The Company is reaffirming guidance for adjusted earnings per diluted share in the range of $2.70 to $2.75.

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 AM ET today, Thursday, October 24, 2019, to discuss financial results for the third quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (800) 367-2403 and using the passcode 7136796. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available through October 29, 2019 by dialing (888) 203-1112 and using the passcode 7136796. The webcast will also be archived on the website.

On October 24, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat age-related diseases and extend healthy lifespan, reported that the company will release its third quarter 2019 financial results after the market closes on Wednesday, November 6, 2019 (Press release, CohBar, OCT 24, 2019, View Source [SID1234542499]). Management will host a conference call with a slide presentation at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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Details for the Conference Call and Slide Presentation:

Date: November 6, 2019
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13694507
Slide Presentation

Go to www.webex.com, click on the ‘Join’ button and enter meeting number 920 124 970 and Password CWBR, or
Go to www.cohbar.com and click on Q3 2019 Shareholder Presentation at top of homepage.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 6, 2019, through 11:59 p.m. Eastern Time on November 27, 2019. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13694507. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

On October 24, 2019 Intellia Therapeutics, Inc. (NASDAQ: NTLA), a leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology is reported one oral presentation and four poster presentations at the 27th Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) meeting taking place October 22-25, 2019, in Barcelona, Spain (Press release, Intellia Therapeutics, OCT 24, 2019, View Source [SID1234542481]).

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"We are excited to share progress across Intellia’s in vivo and ex vivo programs at this important scientific venue," said Laura Sepp-Lorenzino, Ph.D., chief scientific officer, Intellia Therapeutics. "Our data shows the complexity of the edits we are able to make with CRISPR/Cas9, while achieving important therapeutically relevant results. We are building on the success of our modular platform now having demonstrated consecutive targeted knockout and insertion genome edits in preclinical studies. Additionally, we presented data from our engineered cell therapy program, which continues to demonstrate the use of CRISPR/Cas9 for combined knockout and targeted integration in human T cells."

Intellia Demonstrates Consecutive In Vivo Genome Editing in Alpha-1 Antitrypsin Deficiency Mouse Model

Intellia’s oral presentation highlights its alpha-1 antitrypsin deficiency (AATD) study showing that consecutive dosing of two distinct lipid nanoparticle (LNP) formulations, in adult mice, achieves two targeted genome editing events, resulting in knocking out the faulty gene and restoring therapeutic levels of normal alpha-1 antitrypsin protein (hAAT). Intellia’s approach for AATD uses a modular hybrid delivery system combining a non-viral LNP which encapsulates CRISPR/Cas9 with an adeno-associated virus (AAV) carrying donor DNA template. Compared to traditional viral-based delivery of gene editing components, Intellia’s LNP delivery system can overcome the inherent limitations of immunogenicity to facilitate multiple in vivo gene editing events.

In a mouse model harboring the human PiZ allele, the most severe genetic defect in AATD patients, Intellia first reduced expression of the defective protein using gene knockout. Three weeks following the PiZ allele knockout, Intellia inserted the normal human alpha-1 antitrypsin gene, resulting in stable (throughout 12 weeks of observation), therapeutically relevant circulating protein levels. In the study, a sustained reduction of the circulating PiZ protein levels of >98% was observed for over 15 weeks. This is the first in vivo demonstration of a non-viral delivery platform, enabling a consecutive dosing approach for achieving multiple genome edits in the same tissue of the same animal. Intellia’s oral presentation, titled "In Vivo Gene Knockout Followed by Targeted Gene Insertion Results in Simultaneous Reduced Mutant Protein Levels and Durable Transgene Expression," will be given by Anthony Forget, Ph.D., on October 25, 2019. This presentation will be available on Intellia’s website at www.intelliatx.com.

Intellia’s Poster Presentations

WT1-Specific TCR Engineered Cell Therapy Studies

Intellia presented new in vitro data showing that CRISPR/Cas9-mediated genome editing for in locus insertion, combined with endogenous T Cell Receptor (TCR) knockout, leads to significant reduction in mispairing of endogenous and transferred TCR chains. This approach is expected to generate transgenic-TCR (tg-TCR) T cell therapies for hematological cancers and solid tumors. Results demonstrate a highly efficient reduction of >98% in endogenous TCR α and β chains while reaching >70% insertion rates of tg-TCRs without further purification. The poster titled "Engineering of Highly Functional and Specific Transgenic T Cell Receptor (TCR) T Cells Using CRISPR-Mediated In Locus Insertion Combined with Endogenous TCR Knockout," was presented on October 24, 2019, by Birgit Schultes, Ph.D.

Researchers also presented in vitro data showing that a library of WT1-specific TCRs were generated, several of which Intellia is currently evaluating as part of its lead engineered cell therapy program targeting Acute Myeloid Leukemia (AML). This presentation, "Generation of a Library of WT1-Specific T Cell Receptors (TCR) for TCR Gene Edited T Cell Therapy of Acute Leukemia," was presented on October 23, 2019 by Intellia’s collaborator, Erica Carnevale, Ph.D., IRCCS Ospedale San Raffaele.

Primary Hyperoxaluria Study

Intellia showed the continued progression of its modular platform capability using CRISPR/Cas9 to knockout either hydroxyacid oxidase 1 (Hao1) or lactate dehydrogenase A (Ldha), leading to a dose-dependent and persistent reduction of urinary oxalate levels in a Primary Hyperoxaluria Type 1 (PH1) mouse model. Data shows Ldha gene disruption also decreased LDH enzyme activity in the liver and did not impair the disposition of lactate in either wild type or renally-impaired mice. These results highlight the potential of editing genes in the glyoxylate detoxification pathway using a non-viral delivery approach as a one-time treatment option for PH1. These data were presented as a poster, titled "CRISPR/Cas9-Mediated Gene Knockout to Address Primary Hyperoxaluria," by Sean Burns, M.D., on October 24, 2019.

Off-Target Screening Platform

Intellia demonstrated its approach to assess off-target activity to identify highly specific CRISPR/Cas9 guides. Results from targeted off-target sequencing in edited cells showed that biochemical off-target discovery approaches were the most sensitive and accurate. These data were presented as a poster on October 23, 2019, titled "In Silico, Biochemical and Cell-Based Integrative Genomics Identifies Precise CRISPR/Cas9 Targets for Human Therapeutics," by Dan O’Connell, Ph.D.

On October 24, 2019 Asana BioSciences, a clinical stage biopharmaceutical company, reported that it will present ASN007 data on clinical safety and efficacy in solid tumor patients at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference to be held in Boston, MA on October 26-30, 2019 (Press release, Asana BioSciences, OCT 24, 2019, View Source [SID1234542500]). The Scientific Committee selected the ASN007 late breaking abstract submission as one of the top ten abstracts for this year’s program and invited presentation as a short-talk.

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The details of the presentation are as follows:

Abstract number:

666

Title:

Phase 1 clinical safety and efficacy of ASN007, a novel oral ERK1/2 inhibitor, in patients with RAS, RAF or MEK mutant advanced solid tumors

Presenting Author:

Anthony W. Tolcher, MD FRCPC FACP

Director of Clinical Research, NEXT Oncology, San Antonio, TX

Session:

Spotlight on Proffered Papers

Date:

Tuesday, October 29, 2019

Time:

11:50 a.m.-12:30 p.m.

About ASN007

ASN007 is in Phase 1 clinical development. It is a potent inhibitor of the extracellular-signal-regulated kinases ERK1 and ERK2, which are key players in the RAS/RAF/MEK/ERK (MAPK) signaling pathway. ASN007 shows activity in KRAS-driven models, irrespective of subtype mutation, and BRAF models, including RAF/MEK inhibitor-resistant melanoma. ASN007 has a long target residence time and shows activity in preclinical models using an intermittent dosing schedule. ASN007 is being evaluated in patients with advanced solid tumors, including BRAF- and KRAS-mutant cancers (NCT03415126). The once-weekly maximum tolerated dose is determined and selected for the ongoing dose expansion.

On October 24, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on commercializing novel vaccines, reported that it will report third quarter 2019 financial results on Wednesday, November 6, 2019, after the U.S. financial markets close (Press release, Dynavax Technologies, OCT 24, 2019, View Source [SID1234542489]).

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Dynavax will host a conference call and live audio webcast on Wednesday, November 6, 2019 at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the company’s website at www.dynavax.com. Alternatively, participants may dial 800-479-1004 (domestic) or 720-543-0206 (international) and refer to conference ID 5687867.

The archived conference call will be available on Dynavax’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.