Select Medical Holdings Corporation Announces Business Outlook for 2020 and Release Date for Fourth Quarter and Full Year 2019 Financial Results

On January 27, 2020 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM), reported its business outlook for calendar year 2020 (Press release, Select Medical, JAN 27, 2020, View Source [SID1234553600]).

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Select Medical expects consolidated net operating revenues for the full year 2020 to be in the range of $5.575 billion to $5.675 billion. Select Medical expects net income before interest, income taxes, depreciation and amortization, stock compensation expense, other income/(expense), and equity in earnings/(losses), or Adjusted EBITDA for the full year 2020 to be in the range of $725 million to $760 million. Select Medical expects fully diluted income per common share for the full year 2020 to be in the range of $1.27 to $1.46.

Select Medical assumed total shares outstanding of 134.5 million when preparing the above business outlook for 2020. This share count includes unvested restricted shares, which have participation rights and are allocated an equitable portion of earnings under the two-class method for calculating income per common share.

The following is a reconciliation of full year 2020 Adjusted EBITDA expectations as computed to the low and high points of the range to the closet comparable GAAP financial measure. Refer to Select Medical’s most recent Form 10-Q filing for a discussion of Select Medical’s use of Adjusted EBITDA in evaluating financial performance and determining resource allocation. Each item presented in the table below is an estimation of full year 2020 expectations (dollars in millions).

Select Medical will release the financial results for its fourth quarter and full year ended December 31, 2019 on Thursday, February 20, 2020 after the market closes.

Select Medical will host a conference call regarding its fourth quarter and full year ending December 31, 2019 results on Friday, February 21, 2020 at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 8644656. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 12:00pm ET, February 28, 2020. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 8644656. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

Select Medical is one of the largest operators of critical illness recovery hospitals, rehabilitation hospitals, outpatient rehabilitation clinics, and occupational health centers in the United States based on the number of facilities. Our reportable segments include the critical illness recovery hospital segment, the rehabilitation hospital segment, the outpatient rehabilitation segment, and the Concentra segment. As of December 31, 2019, Select Medical operated 101 critical illness recovery hospitals in 28 states, 29 rehabilitation hospitals in 12 states, and 1,740 outpatient rehabilitation clinics in 37 states and the District of Columbia. Select Medical’s joint venture subsidiary Concentra operated 521 occupational health centers in 41 states. Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. At December 31, 2019, Select Medical had operations in 47 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.

Certain statements contained herein that are not descriptions of historical facts are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements due to factors including the following:

changes in government reimbursement for our services and/or new payment policies may result in a reduction in net operating revenues, an increase in costs, and a reduction in profitability;
the failure of our Medicare-certified long term care hospitals or inpatient rehabilitation facilities to maintain their Medicare certifications may cause our net operating revenues and profitability to decline;
the failure of our Medicare-certified long term care hospitals and inpatient rehabilitation facilities operated as "hospitals within hospitals" to qualify as hospitals separate from their host hospitals may cause our net operating revenues and profitability to decline;
a government investigation or assertion that we have violated applicable regulations may result in sanctions or reputational harm and increased costs;
acquisitions or joint ventures may prove difficult or unsuccessful, use significant resources or expose us to unforeseen liabilities;
our plans and expectations related to our acquisitions and our ability to realize anticipated synergies;
private third-party payors for our services may adopt payment policies that could limit our future net operating revenues and profitability;
the failure to maintain established relationships with the physicians in the areas we serve could reduce our net operating revenues and profitability;
shortages in qualified nurses, therapists, physicians, or other licensed providers could increase our operating costs significantly or limit our ability to staff our facilities;
competition may limit our ability to grow and result in a decrease in our net operating revenues and profitability;
the loss of key members of our management team could significantly disrupt our operations;
the effect of claims asserted against us could subject us to substantial uninsured liabilities;
a security breach of our or our third-party vendors’ information technology systems may subject us to potential legal and reputational harm and may result in a violation of the Health Insurance Portability and Accountability Act of 1996 or the Health Information Technology for Economic and Clinical Health Act; and
other factors discussed from time to time in our filings with the Securities and Exchange Commission (the "SEC"), including factors discussed under the heading "Risk Factors" of the quarterly reports on Form 10-Q and of the annual report on Form 10-K for the year ended December 31, 2018.
Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements, whether as a result of any new information, future events, or otherwise. You should not place undue reliance on our forward-looking statements. Although we believe that the expectations reflected in forward-looking statements are reasonable, we cannot guarantee future results or performance.

Cannabics Pharmaceuticals Study Shows Cannabinoids CBC and CBG Exhibit Anti-Tumor Properties on Gastrointestinal Cancer Cells

On January 27, 2020 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, reported that in a series of tests conducted at the company’s High Through-put Screening (HTS) facility in Israel, it has been shown that the cannabinoids CBC (Cannabichromene) and CBG (Cannabigerol) both exhibit anti-tumor properties, tested on human Gastrointestinal Cancer Cells (Press release, Cannabics Pharmaceuticals, JAN 27, 2020, View Source [SID1234553599]).

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Cannabinoid extract causing necrosis in Gastrointestinal cancer cell line. The Yellow color is a marker for necrosis. On the right – control, on the left – after treatment with cannabinoids
Cannabinoid extract causing necrosis in Gastrointestinal cancer cell line. The Yellow color is a marker for necrosis. On the right – control, on the left – after treatment with cannabinoids
CBC is an additional non-psychoactive cannabinoid and is one of the naturally occurring Phyto-cannabinoids. It bears a host of potential positive therapeutic qualities and may promote antimicrobial, anti‐inflammatory, analgesic, and neurogenesis activity. It is particularly found in younger Cannabis plants, albeit in small quantities.

In these tests, the HTS platform was utilized to screen the necrotic effects of a variety of cannabinoids on human Gastrointestinal cancer cells, in addition to other cancer types previously tested. CBC and CBG were both shown to induce significantly higher rates of necrosis in these cancer cells compared to other cannabinoids, thus strengthening previously obtained results.

Dr. Yaakov Waksman, the company’s head of cannabidiol research, said, "My working assumption is that these results show that a correlation may exist between a cannabinoid’s Topological Polar Surface Area (TPSA) value and its ability to induce anti-tumor activity, diminishing cancer cell’s viability rates. CBC and CBG, as neutral cannabinoids, were both found to have a TPSA value which allows the cannabinoid molecule to penetrate a cancer cell’s membrane, whereas their acidic form (CBCA and CBGA) – do not. This could explain the difference in anti-tumor activity rates demonstrated".

Dr. Eyal Ballan, CTO and Co-Founder, commented, "Gastrointestinal cancers are amongst the leading and most wide-spread causes of cancer-related deaths worldwide. We are intrigued by the results we have obtained in the lab, and our aim is to consider placing an emphasis on this organ system, and to further explore the differential anti-tumor properties of cannabinoids. We believe that these preliminary results vindicate our vision; which is to bring personalization into cannabinoid-based cancer treatments."

Data from OncoSec’s Visceral Lesion Applicator (VLA) to be Presented at the Society of Interventional Oncology Annual Meeting

On January 27, 2020 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported data from initial feasibility studies of its novel visceral lesion applicator (VLA) have been accepted to be presented at the Annual Meeting of the Society of Interventional Oncology in New Orleans from January 30 – February 3, 2020 (Press release, OncoSec Medical, JAN 27, 2020, View Source [SID1234553598]).

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The Company’s visceral lesion applicator (VLA) technology is designed to treat non-cutaneous, internal tumors through the direct delivery of OncoSec’s lead product candidate, TAVO (plasmid-based interleukin-12), or other immunologically relevant genes. Visceral lesions are typically difficult to treat, and include gastrointestinal tumors, pancreatic tumors, and hepatocellular carcinomas.

The study, titled, "Novel Controlled Delivery of Potent Anti-Cancer Immunotherapy Directly to Deep Visceral Lesions," will be featured in a poster displayed throughout the Society of Interventional Oncology’s annual meeting from January 30 – February 3, 2020 at the New Orleans Marriott.

About the Society of Interventional Oncology
The SIO Annual Scientific Meeting offers sessions on medical technology and how to implement new technology in oncologic practice. The conference provides a multi-disciplinary approach to cancer care. The annual meeting brings together international health care providers for international sharing of ideas. The conference leverages a combination of state-of-the-art lectures, panel discussions, invited papers, and selected abstracts of basic, translational, and clinical research to promote meaningful dialogue.

NCCN Oncology Research Program to Oversee Trials of the FGFR Inhibitor Futibatinib in Tumors with Aberrant FGFR Expression, in Collaboration with Taiho Oncology

On January 27, 2020 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported plans to evaluate futibatinib (TAS-120), a potent and selective inhibitor of the fibroblast growth factor receptor (FGFR) (Press release, NCCN, JAN 27, 2020, View Source [SID1234553597]). The project will include pre-clinical, translational and clinical trials using futibatinib as monotherapy and in biologically relevant combination regimens for malignancies with FGFR 1-4 aberrations. This project will be the first NCCN research program to study an FGFR inhibitor. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team. The research funding is supported by a $2-million grant from Taiho Oncology.

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"We’re excited to help facilitate new research into innovative ways for managing cancer," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "We still have a lot to learn about FGFR signaling and how to optimally target this receptor as a component of cancer therapy. We look forward to the potential new discoveries that may come from these investigations."

"We are proud to support NCCN ORP research to better understand the optimal role of futibatinib in treating malignancies with FGFR 1-4 aberrations," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "Every day, we are learning more and more about futibatinib, and this research will expand our knowledge of how this investigational compound works, with the goal of being able to better target its use in those who may see the greatest benefit from it."

The first phase of this project will involve the creation of an RFP, which will be distributed in the next few months. The awarded projects will be announced following review of submitted proposals.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.

ORIC Pharmaceuticals Announces First Patient Dosed in Phase 1b Clinical Trial of ORIC-101 in Combination with XTANDI® for the Treatment of Prostate Cancer in Collaboration with Astellas

On January 27, 2020 ORIC Pharmaceuticals, a privately held, clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported dosing of the first patient in a Phase 1b clinical trial being conducted under a collaboration with Astellas Pharma Inc., to evaluate the combination of ORIC-101, ORIC’s investigational glucocorticoid receptor (GR) antagonist, with XTANDI (enzalutamide) as a treatment for patients with metastatic prostate cancer that is progressing on enzalutamide (Press release, ORIC Pharmaceuticals, JAN 27, 2020, View Source [SID1234553596]).

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Research conducted by ORIC’s co-founder Charles Sawyers, MD, published in Cell, has elucidated that increased expression of GR in prostate cancer is associated with resistance to enzalutamide therapy. Furthermore, preclinical data generated by ORIC demonstrated that inhibition of GR signaling by ORIC‑101 can re-sensitize treatment-resistant prostate cancer models to enzalutamide.

"Enrollment of the first patient in this Phase 1b clinical trial of ORIC-101 marks the second clinical trial for this program and another major milestone for ORIC," said Jacob M. Chacko, MD, Chief Executive Officer. "Just as the glucocorticoid receptor has been linked to treatment resistance for multiple classes of chemotherapeutics across a variety of solid tumors, there are also strong scientific rationale and preclinical evidence supporting its linkage to prostate cancer resistance. We are delighted to collaborate with Astellas on this important study assessing the potential of ORIC-101 to benefit patients with metastatic prostate cancer that has progressed on enzalutamide, for which there are limited treatment options today."

The Phase 1b trial is a multi-center, open label, dose finding study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ORIC-101 combined with enzalutamide when administered to patients with metastatic prostate cancer that has progressed on enzalutamide. Once the recommended Phase 2 dose of ORIC-101 in combination with enzalutamide has been identified, the study will enroll patients into expansion cohorts based upon GR expression using ORIC’s proprietary immunohistochemistry assay.

"Despite the introduction of novel antiandrogen therapies for the treatment of prostate cancer, such as enzalutamide, the majority of responsive patients will ultimately become treatment resistant, resulting in poor prognoses for men diagnosed with this devastating condition," said Pratik S. Multani, MD, Chief Medical Officer. "We are excited to evaluate the therapeutic potential of ORIC-101 to overcome what we believe may be a key mechanism of resistance to antiandrogen therapy."

Under the terms of the clinical trial collaboration and supply agreement with Astellas, ORIC is sponsoring and conducting the Phase 1b study of ORIC-101 in combination with enzalutamide. Astellas, which commercializes XTANDI in the United States with Pfizer Inc, is providing enzalutamide for the study. ORIC maintains global development and commercial rights to ORIC-101 and rights to develop the program in combination with other agents.

Further details about the clinical study are available at ClinicalTrials.gov (NCT04033328).

About Metastatic Prostate Cancer

In the United States, prostate cancer is the second most prevalent cancer in men and the second leading cause of cancer death in men. The American Cancer Society estimates there are approximately 175,000 new cases of prostate cancer and over 30,000 deaths from the disease in the U.S. annually.

In men with prostate cancer, the disease is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body, such as the bones, lymph nodes, bladder and rectum. Men are considered hormone (or castration) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels. Men are considered castration-resistant if their disease progresses despite androgen deprivation therapy and is often correlated with rising levels of prostate-specific antigen. Over 50,000 men are estimated to develop metastatic prostate cancer in the U.S. annually.