On February 19, 2020 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell immunotherapy, reported that management is scheduled to present at two upcoming investor conferences (Press release, Tmunity Therapeutics, FEB 19, 2020, View Source [SID1234554517]).

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Cowen 40th Annual Health Care Conference
Monday, March 2, 2020
1:30 PM ET
Boston, MA

Oppenheimer 30th Annual Healthcare Conference
Wednesday, March 18, 2020
2:45 PM ET
New York, NY

On February 19, 2020 NeoTX Therapeutics, a clinical-stage biotechnology company leveraging its proprietary Selective T cell Redirection (STR) platform to develop targeted anticancer immunotherapies, reported that it has closed a $45 million Series C financing. In conjunction with the financing, former vice chairman of The Blackstone Group, J. Tomilson Hill, Chairman of NDFOS Co., Ltd, Andrew Kim, Paul T. Marinelli and Nobel laureate Dr. Roger Kornberg, the chief scientific officer of NeoTX have joined the NeoTX Board of Directors. To date, NeoTX has raised over $60 million (Press release, NeoTX, FEB 19, 2020, View Source [SID1234554482]). NeoTX plans to use the Series C proceeds to advance its STR platform for the treatment of advanced and metastatic solid tumors as well as to in-license new technologies.

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"With the funds raised in this financing, we intend to complete the dose escalation phase of the Phase 1b trial of naptumomab estafenatox ("Nap") in combination with durvalumab and continue to develop our patented STR platform," said Asher Nathan, chief executive officer of NeoTX. "Our platform, which uniquely leverages the body’s natural antibacterial immune response to selectively redirect T cells to kill the tumor, has the potential to be applicable in a variety of solid tumor indications and in combination with other immunotherapies. We look forward to the clinical advancement of Nap and expanding our platform in order to provide new options to patients suffering from advanced cancers."

The open-label, multicenter, dose-finding Phase 1b study of Nap (NCT03983954) is currently enrolling. Patients are dosed with a combination of Nap and AstraZeneca’s (NYSE: AZN) checkpoint inhibitor IMFINZI (durvalumab). NeoTX aims to establish the maximum tolerated dose before advancing to a larger cohort expansion phase in the Unites States.

On February 19, 2020 H3 Biomedicine, Inc. (H3), a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported the appointment of Antonio Gualberto, MD, PhD, to the position of Chief Medical Officer (CMO) (Press release, H3 Biomedicine, FEB 19, 2020, View Source [SID1234554502]). Dr. Gualberto will oversee global clinical research & development for the H3 pipeline of clinical stage assets.

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"H3 is at a pivotal stage of growth. The breadth of our precision medicine-driven discovery and clinical R&D require a CMO with vast scientific knowledge and leadership expertise," said Lihua Yu, PhD, President and Chief Data Science Officer, H3. "Dr. Gualberto, possesses more than 20 years of experience in developing clinical assets at multiple biopharma companies, his deep acumen and proven success will be instrumental as we work toward our goal of delivering clinically meaningful outcomes for patients with highly unmet medical needs."

Most recently Dr. Gualberto served as co-founder and CMO at Kura Oncology, a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer. At Kura, Dr. Gualberto led the discovery of the mechanism of action and clinical proof-of-concept of farnesyl transferase inhibitors as well as bringing a pipeline of new agents to the clinic. Prior to Kura, Dr. Gualberto held positions of increasing responsibility at EMD Serono, a subsidiary of Merck KGaA, Takeda and Pfizer. Dr. Gualberto received his MD and PhD degrees from the University of Seville in Spain. He also completed several fellowships in the field of Molecular Pathology, was a member of the Berkeley National Laboratory, and held academic faculty positions at Case Western Reserve University and Brown University.

"Our entire organization is thrilled by the appointment of Dr. Gualberto to the position of CMO here at H3," commented Terushige Iike, Chief Executive Officer of H3 and President of the Oncology Business Group at Eisai Co., Ltd. "We eagerly anticipate the progress we will make as a company with Antonio leading our global clinical research & development organization. His expertise and wide experience will be invaluable to H3 as we advance our pipeline of multiple clinical stage assets."

"With the umbrella of support of a global pharmaceutical company such as Eisai, H3 is uniquely positioned as a clinical stage biopharmaceutical company. In creating a prolific drug discovery engine and partnership platform, H3 has shown itself to be a leader in the development of new clinical programs," said Dr. Gualberto. "H3 has a first-rate team that is highly regarded in the Oncology community, with fantastic discovery and development capabilities and I look forward to working closely with our entire organization."

On February 19, 2020 Premier Inc. (NASDAQ: PINC), through its ProvideGx program, reported that it has partnered with Pfizer Inc. to supply Corvert (ibutilide fumarate injection) and Vincristine Sulfate Injection, USP, to healthcare providers, to help stabilize the long-term supply of two vital medications for its members (Press release, Premier, FEB 19, 2020, View Source [SID1234554518]).

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Corvert is an anti-arrhythmic heart medication used to treat atrial fibrillation or atrial flutter. Vincristine is a chemotherapy drug, primarily used to treat childhood cancers such as acute leukemia, and, in combination with other oncolytic agents, Hodgkin’s and non- Hodgkin’s lymphoma, rhabdomyosarcoma, neuroblastoma and Wilms’ tumor.

"Supporting a sustainable supply of these important medicines is a top priority for Premier and our members," said Premier’s President, Michael J. Alkire. "This agreement speaks to the core strengths of the ProvideGx program – our ability to provide both short- and long-term solutions to support our members and patients. Together with our members, we have the nimbleness to act quickly when market events require it, thereby improving access and raising the bar for the entire drug supply chain. Moreover, the goal of ProvideGx is to create market stability and give manufacturers assurances to make the necessary investments for a consistent, long-term supply."

Premier’s ProvideGx program identifies safe, high-quality supply sources for drugs that are or may be at risk of being added to the national drug shortage list. Guided by health systems with more than 1,600 hospitals across the nation, Premier’s ProvideGx program has provided members access to more than 150 drugs that are or have been recently designated as shortage drugs, including metoprolol; cysteine hydrochloride; sodium bicarbonate; diphenhydramine; hydromorphone; lidocaine; morphine; thiamine; phytonadione injection; and emergency, pre-filled syringes of calcium chloride, epinephrine, sodium bicarbonate, atropine sulfate, dextrose and lidocaine. The program plans to introduce additional drugs from a target list of more than 50 products in months to come.

"Patients need continued access to these critical drugs and important treatments, "said Jerry Storm, Senior Vice President of Pharmacy Services at OSF HealthCare of Peoria, IL. "We commend Premier and Pfizer for reaching this deal to support long-term access to these medications now so that we can go back to the business of providing care to our patients that results in outstanding outcomes. Having a reliable supply of these drugs is critical for patients who can’t afford to wait, and crucial for their survival."

ProvideGx is part of Premier’s ongoing effort to help facilitate the availability of high-quality products, including drugs for which there may be supply challenges. In doing so, Premier is working to insulate its members from supply fluctuations that may affect the market at large.

"Over the past several years, Pfizer has made significant advancements in addressing drug shortages, including investing $2 billion to modernize manufacturing and increase capacity," said Suneet Varma, Global President, Pfizer Hospital. "This agreement with Premier continues to build on these efforts — which we hope will ultimately increase patient access to two vital medicines, Corvert and Vincristine — helping to drive market sustainably in the long term."

On February 19, 2020 Integra LifeSciences Holdings Corporation (NASDAQ: IART) reported financial results for the fourth quarter and full year ended December 31, 2019 and issued its financial guidance for 2020, consistent with the preliminary results and guidance provided on January 14, 2020 (Press release, Integra LifeSciences, FEB 19, 2020, View Source [SID1234554483]).

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Highlights:

Fourth Quarter 2019

Reported revenue increased 3.1% to $395.1 million and organic sales increased 4.6% over the fourth quarter 2018.

GAAP earnings per diluted share were $0.18, compared to $0.29 in the fourth quarter 2018.

Adjusted earnings per diluted share were $0.68, compared to $0.65 in the fourth quarter of 2018.

Full-Year 2019
◦
Reported revenue increased by 3.1% to $1,517.6 million, and organic sales increased 4.8% over the full-year 2018.

GAAP earnings per diluted share were $0.58, compared to $0.72 in 2018.

Adjusted earnings per diluted share amounted to $2.74, a 13.2% increase over the prior year, which represents the sixth consecutive year of double-digit growth.

2020 Company Guidance

The Company expects full-year 2020 reported revenue in the range of $1.55 billion to $1.57 billion, representing approximately 3% growth at the midpoint.
◦
The Company expects full-year 2020 organic sales growth, which excludes the effect of foreign currency, acquisitions, divestitures and discontinued products, to be approximately 5%.

The Company expects full-year GAAP earnings per diluted share to be in the range of $1.40 to $1.45, and full-year adjusted earnings per diluted share to be in the range of $3.00 to $3.05.

Fourth Quarter 2019 Financial Summary
Total reported revenues for the fourth quarter were $395.1 million, an increase of $11.8 million, or 3.1%, over the fourth quarter of 2018. Fourth quarter organic sales increased 4.6% over the prior year.
The Company reported GAAP net income of $15.3 million, or $0.18 per diluted share, in the fourth quarter of 2019, compared to GAAP net income of $25.1 million, or $0.29 per diluted share, in the prior year. The decrease was attributable to expenses associated with the Rebound Therapeutics Corporation ("Rebound") acquisition and tax benefits received in the fourth quarter of 2018.
Adjusted EBITDA for the fourth quarter of 2019 was $91.6 million, compared to $88.8 million in the fourth quarter of the prior year. For the fourth quarter of 2019, adjusted EBITDA as a percentage of revenue was 23.2%, unchanged from the prior year period.
Adjusted net income for the fourth quarter of 2019 was $58.9 million, or $0.68 per diluted share, compared to adjusted net income of $56.2 million, or $0.65 per diluted share, in the fourth quarter of 2018.
Cash flows from operations totaled $89.2 million in the fourth quarter and capital expenditures were $22.2 million.

Full-Year 2019 Financial Summary
Total reported revenues for the full-year 2019 were $1,517.6 million, an increase of $45.1 million, or 3.1%, over the prior year. Organic sales for the full-year 2019 increased 4.8% over 2018.
The Company reported GAAP net income of $50.2 million, or $0.58 per diluted share, for the full-year 2019, compared to GAAP net income of $60.8 million, or $0.72 per diluted share in 2018. The decrease was primarily attributable to expenses associated with the Rebound acquisition.
Adjusted EBITDA for the full year 2019 was $368.6 million, an increase of $26.5 million over the prior year. For the full-year 2019, adjusted EBITDA as a percentage of revenue increased 110 basis points to 24.3% from 23.2% in 2018, largely attributable to higher sales and improved gross margin.
Adjusted net income for the full-year 2019 was $237.4 million, or $2.74 per diluted share, compared to $203.5 million, or $2.42 per diluted share in 2018. The increase was largely attributable to higher sales, gross margin expansion and lower net interest expense.
Cash flows from operations totaled $231.4 million for the full-year 2019 and capital expenditures were $69.5 million. Adjusted free cash flow conversion for the trailing twelve months ended December 31, 2019 was 68.2% versus 59.9% for the twelve months ended December 31, 2018.

2020 Financial Guidance
Consistent with guidance provided on January 14, 2020, the Company is reiterating full-year 2020 total revenue guidance in the range of $1.55 billion to $1.57 billion, representing organic sales growth of approximately 5%.
The Company expects GAAP earnings per diluted share for the full year to be between $1.40 and $1.45 and adjusted earnings per diluted share to be in the range of $3.00 to $3.05.

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 that it will exclude in the calculation of organic revenue growth, adjusted EBITDA and adjusted EPS for historical periods and in providing adjusted EPS guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 a.m. ET today, Wednesday, February 19, 2020 to discuss fourth quarter and full-year 2019 financial results, 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, which can be found on the Investor section of the website at investor.integralife.com.
Access to the live call is available by dialing 800-367-2403 and using the passcode 7727863. The call can also be accessed through a webcast via a link provided on the Investor Relations homepage of Integra’s website at investor.integralife.com. Access to the replay is available through February 24, 2020 by dialing 888-203-1112 and using the passcode 7727863. The webcast will also be archived on the website.