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Delcath Systems to Present at Upcoming Virtual Investor Conferences

On February 10, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that management will participate at these upcoming virtual investor conferences (Press release, Delcath Systems, FEB 10, 2022, View Source [SID1234608004]):

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The BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
February 17, 2022, at 11:00 AM ET
This is a BTIG hosted event and will not be webcast. Please contact your BTIG representative for further information.

2022 SVB Leerink Global Healthcare Conference
February 18, 2022, at 9:20 AM ET
Webcast link: View Source
To learn more or to schedule a one-on-one meeting with management, please contact your conference representative or [email protected].

Signify Health to acquire Caravan Health, accelerating the movement to value-based healthcare

On February 10, 2022 Signify Health, Inc. (NYSE: SGFY), a leading value-based healthcare platform that leverages advanced analytics, technology and nationwide healthcare provider networks, reported it has signed an agreement to acquire Caravan Health, a leader in enabling accountable care organizations (ACOs) to excel in population health management and value-based payment programs, for an initial purchase price of approximately $250 million in a combination of cash and Signify Health common stock (Press release, Signify Health, FEB 10, 2022, View Source [SID1234608003]). The transaction also includes contingent additional payments of up to $50 million based on the future performance of Caravan. Caravan Health will join Signify Health in supporting a wide spectrum of advanced payment models, enabling providers to assume various levels of risk and collaborate in ways that support their goals to improve health outcomes while lowering costs across the care continuum.

This combination unites two leaders in value-based payment models covering a broad range of risk-based and shared savings models, from advanced primary care payment to specialty care bundles to total cost of care contracts. Caravan Health brings key technology, insights, and transformation services to community hospitals, physician practices and clinics looking to succeed in accountable care and other commercial risk arrangements. Signify Health brings technology, analytics, and management expertise in episodes of care and bundled payments. Together, the companies will be supporting approximately $10 billion in total medical spend under management.

Upon closing, Caravan Health and Signify Health will have one of the largest national networks of providers engaged in risk-based payment models. Beyond Signify’s current network of over 3,000 physician practices and facilities contracted in value-based arrangements, Caravan adds more than 200 health systems and 100 Federally Qualified Health Centers with more than 10,000 primary care providers that collectively manage over 500,000 patients, most of whom are medically underserved and struggle to access care. Signify is well positioned to address these persistent access issues by assisting these providers, extending their capacity to engage patients in the home and virtually through Signify Health’s national mobile network of approximately 10,000 credentialed physicians and nurse practitioners, and over 600 engagement, clinical, and social care coordinators. In conjunction with Caravan Health’s proprietary software, Signify’s mobile network can be aimed at helping the patients that need it most, extending the resources of often-stretched local care teams, and giving patients the care they need, when and where they need it.

The companies also will focus on leveraging Signify Health’s deep payor relationships to increase provider participation in, and access to, commercial value-based care programs. Combining Signify Health’s and Caravan Health’s value-based offerings increases the percentage of patients in a provider’s panel that are covered by value-based arrangements, thereby making them more attractive and helping to drive care redesign.

"A strategic focus for Signify Health has been driving more participation and success in value-based payment arrangements in alignment with our commercial payor clients. This focus also

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supports critical imperatives from the Centers for Medicare & Medicaid Services (CMS) to improve health equity and have everyone in Medicare fee-for-service aligned to an accountable relationship by 2030," said Kyle Armbrester, CEO of Signify Health. "We are thrilled to welcome Caravan Health’s team as we build the infrastructure and payment models that are needed to achieve patient-centric, holistic care and better outcomes for everyone, especially the underserved."

"This is an exciting opportunity to leverage the combined technology, tools and expertise of Caravan and Signify to all move forward toward better patient care while helping providers achieve financial sustainability," said Lynn Barr, Founder and Chairwoman of Caravan Health. "We share with Signify Health a deep commitment to doing everything possible to help those we serve live their best life and look forward to accelerating our collective mission to create a healthcare system that works better for all of us." Upon closing, Ms. Barr will become Chief Innovation Officer of Signify Health and Tim Gronniger, CEO of Caravan Health, will become EVP, Accountable Care and CEO of Caravan Health.

Strategic and Financial Benefits

•Accelerates Diversification Strategy: The combination supports Signify Health’s diversification strategy to offer a comprehensive platform and solution set supporting and integrating episodes and total cost of care risk arrangements across Medicare programs (namely, Bundled Payments for Care Improvement – Advanced and the Medicare Shared Savings Program) and commercial payors with Medicare Advantage, Commercial, and Managed Medicaid lines of business.

•Creates An End-to-End Suite of Value-Based Care Enablement Capabilities: The combined company will be well-positioned to manage total cost of care through an integrated suite of capabilities. These capabilities include Caravan Health’s population-based insights and management expertise to promote prevention and wellness and manage chronic disease, while Signify Health brings episodes of care analytics to support the identification and management of specialty care needs. Additionally, Signify Health’s expertise in post-acute performance management, care transition services, and in-home evaluations will help drive more coordinated care within and beyond the clinical environment.

•Advances Value Proposition to Drive Growth: Together, Signify Health and Caravan Health will be better positioned to enable organizations to manage larger populations covered by value-based arrangements, and to drive more coordinated clinical and social care across the healthcare continuum. Signify Health’s customers and program sponsors, which are composed of Medicare Advantage, Medicaid, and Commercial managed care organizations, as well as state governments and employers, have been asking the Company to broaden the scope of its risk contracts to encompass a greater portion of the total medical spend in a health plan. Caravan Health brings complementary expertise in practice transformation and helping providers succeed in total costs of care risk-sharing models. The integration of two leading value-based payment conveners will increase the depth and breadth of a combined network of at-risk care providers ready to engage on advanced alternative payment models where providers and payers are aligned toward achieving better outcomes for a lower cost.

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•Creates Significant Financial Benefits: The addition of Caravan Health will expand Signify Health’s addressable market by creating new opportunities through ACOs while also providing expanded services for Signify Health customers. Signify Health intends to integrate the two companies to maximize the value of their combined offerings.

Signify Health expects Caravan Health to be accretive to 2022 revenue and adjusted EBITDA and intends to provide specific guidance for the combined entity on its fourth quarter 2021 earnings conference call scheduled for March 3, 2022 at 8:30 a.m. ET.

Transaction summary

Signify Health has agreed to acquire Caravan Health for an initial purchase price of approximately $250 million, consisting of $190 million in cash and $60 million in Signify Health common stock. In addition to the initial purchase price, the transaction includes contingent additional payments of up to $50 million based on the future performance of Caravan Health. The transaction is subject to customary closing conditions and is expected to close in the first quarter of 2022.

Conference Call to Discuss the Acquisition

Signify Health will host a conference call today, Thursday, February 10, 2022 at 8:30 a.m. ET to discuss the announcement. The call can be accessed by dialing (844) 200-6205 for U.S. participants, or +1 (929) 526-1599 for international participants, enter access code 483718; or via a live audio webcast that will be available on the investor relations website event page or by using the following link View Source A replay will be available via webcast for on-demand listening shortly after the completion of the call, at the same web link, and will remain available for approximately 60 days.

Enveric Biosciences Announces Proposed Public Offering

On February 10, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience company developing next-generation, psychedelic-inspired mental health, and oncology treatments, reported that it intends to offer shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase common stock for sale, subject to market and other conditions, in an underwritten public offering (Press release, Enveric Biosciences, FEB 10, 2022, View Source [SID1234608001]). All of the securities to be sold in the offering are to be offered by Enveric. The Company intends to use the net proceeds from this offering for working capital and to fund other general corporate purposes. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-257690) previously filed with the U.S. Securities and Exchange Commission (the "SEC") that was declared effective by the SEC on July 9, 2021. The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Enveric may file with the SEC. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Enveric has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Enveric and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2022 Financial Results and Provides Business Update

On February 10, 2022 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, reported business and financial results for the first fiscal quarter of 2022 ended December 31, 2021 (Press release, Citius Pharmaceuticals, FEB 10, 2022, View Source [SID1234608000]).

Fiscal Q1 2022 Business Highlights and Subsequent Developments

Pivotal Phase 3 trial of I/ONTAK (E7777) completed in December 2021 with topline results anticipated in the first half of 2022 and a biologics license application (BLA) submission planned in the second half of 2022;
Mino-Lok Phase 3 trial completion anticipated in 2022; and,
Regulatory, manufacturing, clinical and commercial capabilities expanded to support late-stage pipeline with the addition of seasoned executives with extensive pharmaceutical industry experience:
Catherine Kessler MS – EVP, Regulatory Affairs
Kelly Creighton, PhD – EVP, Chemistry, Manufacturing and Controls
Kevin Carey – VP, Program Management
Preeti Singh, MD – Medical Director
Financial Highlights

Cash and cash equivalents of $65.4 million as of December 31, 2021;
R&D expenses were $5.5 million for the first quarter ended December 31, 2021, compared to $6.2 million for the first quarter ended December 31, 2020;
G&A expenses were $2.9 million for the first quarter ended December 31, 2021, compared to $1.7 million for the first quarter ended December 31, 2020;
Stock-based compensation expense was $0.9 million for the first quarter ended December 31, 2021, compared to $0.3 million for the first quarter ended December 31, 2020; and,
Net loss was $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2021, compared to a net loss of $8.1 million, or ($0.15) per share for the first quarter ended December 31, 2020.
"We anticipate 2022 will be a year of important catalysts for Citius. The timeline for the I/ONTAK program remains on track, with topline results anticipated in the first half of 2022, followed by a planned BLA filing in the second half of the year. Moreover, the FDA confirmed that no pediatric study will be required for I/ONTAK, further de-risking this asset," stated Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals.

"Covid-19 continues to pose a challenge to the Mino-Lok Phase 3 trial. We remain committed to completing the trial this year and believe we are well-positioned to continue our efforts as Covid-19 infections and hospitalizations subside, restrictions are lifted and the overall environment for clinical trials improves. These efforts include active engagement with our existing sites, and evaluation of additional trial sites. We continue to believe that there is a significant unmet medical need to salvage catheters so that critically ill patients need not undergo the painful and costly removal and replacement of a central venous line. Our primary focus remains to execute a plan that ensures we have a robust dataset that maximizes the potential success of Mino-Lok," added Mr. Holubiak.

"To further support the launch of our two late-stage product candidates, I/ONTAK and Mino-Lok, if approved, and to advance our other pipeline programs, we have added several key regulatory, clinical, commercial and manufacturing industry veterans to our team. Their expertise will help propel our activities to bring these important products to market, and our strong balance sheet continues to support these efforts. We look forward to sharing our value-creating milestones with our stakeholders in the coming months," concluded Mr. Holubiak.

Key Recent Hires

Catherine Kessler, MS – EVP, Regulatory Affairs

Ms. Kessler is a well-respected biotech executive with more than 25 years of experience in the pharmaceutical industry, including 20 years of experience in regulatory affairs and 16 years of expertise in managing regulatory affairs and operations activities supporting early and late-stage product development in multiple therapeutic areas. She has prepared regulatory submissions for the US FDA, EMEA and other regulatory authorities for investigational drugs. Catherine’s deep expertise in developing regulatory paths to market for unique investigational products, engaging health authorities through complex stages of clinical development, tactical aspects of regulatory applications, and efficient resourcing of application-related activities will allow her to successfully chart the regulatory paths for each of the pipeline programs at Citius.

Kelly Creighton, PhD – EVP, Chemistry, Manufacturing and Controls

Mr. Creighton is a senior regulatory affairs and quality assurance expert with nearly two decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene and cellular therapies, and combination products. He joined Citius from Clinipace Worldwide, a leading global contract research organization. As head of global CMC regulatory activities for investigational products, he has led teams throughout North America, Europe and the Asia Pacific region overseeing submissions and negotiations with regulatory authorities, as well as biosafety and environmental agencies in each of these regions. Kelly has directed the implementation of multiple CMC development plans including: contract manufacturing organization selection, product manufacturing, analytical development, product characterization, specification establishment, container closure systems and stability requirements. Twenty products for which he prepared regulatory marketing applications (NDAs, ANDAs, and BLAs) were approved in the US and EU.

Kevin Carey – VP, Program Management

Mr. Carey is a seasoned pharmaceutical executive with more than 20 years of experience in complex global pharmaceutical project management, and more than 10 years of experience in combination drug/device development. Kevin has managed all phases of the pharmaceutical drug development lifecycle including discovery and development, preclinical research, clinical research, and FDA drug review and approval, including seven NDA submissions and approvals throughout his career. Mr. Carey joined Citius from Dr. Reddy’s Laboratories where he was a Senior Director and head of the Program and Alliance Management Office, and was integral to the I/ONTAK (E7777) program.

Preeti Singh, MD – Medical Director

Dr. Singh is an accomplished clinical strategy and development leader with more than a decade of experience in drug development from proof-of-concept studies to Phase 3 trials and life cycle management in the areas of oncology, dermatology, neurology, and pediatric and adult gastroenterology. She brings diverse and well-rounded experience in medical affairs, drug commercialization and strategy, with extensive knowledge of new drug approval and regulatory compliance, to the newly formed role at Citius. Dr. Singh joined Citius from Dr. Reddy’s Laboratories where she was the Subject Matter Expert on I/ONTAK (E7777).

FIRST QUARTER ENDED DECEMBER 31, 2021 Financial Results:

Liquidity

As of December 31, 2021, the Company had $65.4 million in cash and cash equivalents and no debt.

As of December 31, 2021, the Company had 146,012,169 common shares issued and outstanding.

The Company estimates that its available cash resources will be sufficient to fund its operations through March 2023.

Research and Development (R&D) Expenses

R&D expenses were $5.5 million for the fiscal quarter ended December 31, 2021, compared to $6.2 million for the fiscal quarter ended December 31, 2020. The decrease of $0.7 million is primarily due to a $4.8 million decrease in research and development expenses related to our proposed novel cellular therapy for ARDS offset by increases in R&D expenses related to I/ONTAK, Mino-Lok, Halo-Lido and Mino-Wrap. During the three months ended December 31, 2020, we expensed a $5,000,000 license fee paid to Novellus.

We expect that research and development expenses will increase in fiscal 2022 as we continue to focus on our Phase 3 trials for Mino-Lok and I/ONTAK, progress the Halo-Lido product candidate, and continue our research and development efforts related to ARDS and Mino-Wrap.

General and Administrative (G&A) Expenses

G&A expenses were $2.9 million for the fiscal quarter ended December 31, 2021, compared to $1.7 million for the fiscal quarter ended December 31, 2020. The increase of $1.2 million is primarily due to costs associated with additional compensation costs for new employees and performance bonuses. General and administrative expenses consist primarily of compensation costs, professional fees related to our capital raising activities, corporate development services, and investor relations.

Stock-based Compensation Expense

For the fiscal quarter ended December 31, 2021, stock-based compensation expense was $0.9 million as compared to $0.3 million for the prior year period. The increase primarily reflects expenses related to new grants made by Citius to employees, directors and consultants.

Net loss

Net loss was $9.2 million, or ($0.06) per share for the fiscal quarter ended December 31, 2021, compared to a net loss of $8.1 million, or ($0.15) per share for the fiscal quarter ended December 31, 2020. The increase in net loss is primarily due an increase in general and administrative expenses.

SystImmune Inc Announces Appointment of Martín Sebastian Olivo, M.D. as Chief Medical Officer

On February 10, 2022 SystImmune, Inc. a clinical-stage company developing innovative cancer therapeutics, including novel bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs), reported the appointment of Martin Sebastian Olivo, M.D. as Chief Medical Officer, effective on February 7, 2022 (Press release, SystImmune, FEB 10, 2022, View Source [SID1234607999]). Dr. Olivo joined SystImmune, Inc. from Protara Therapeutics, Inc. where he served as the Chief Medical Officer and led the advancement of the early-stage clinical effort in the area of non-muscle invasive bladder cancer. Dr. Olivo brings decades of experience in oncology clinical research and global drug development.

"It is our honor to welcome Dr. Olivo to our team," said Dr. Yi Zhu, the Chief Executive Officer of SystImmune, Inc. "As the leader of the clinical development arm of SystImmune, Inc. Dr. Olivo will be instrumental in advancing and expanding the global clinical impact of our pipeline. With several ongoing Phase II & Phase I trials, there is a huge opportunity for Dr. Olivo to leverage his strengths in product development among several oncology indications."

"I feel fortunate to join SystImmune, Inc. at this stage," said Dr. Olivo. "SystImmune, Inc. has the potential to play a meaningful role in the treatment of difficult to treat cancers and I’m looking forward to working with the many talented individuals to advance transformative therapies for people with cancer."

Before assuming his most recent role at Protara Therapeutics, Inc., Dr. Olivo led late-stage clinical efforts in breast cancer therapeutics development as the Vice President of Clinical Development at Gilead Sciences, Inc., (formerly Immunomedics, Inc.) from Aug 2018 to April 2021. Earlier, Dr. Olivo served as the Global Clinical lead at Daiichi Sankyo Cancer Enterprise, where he established a comprehensive clinical development plan to advance ADC therapeutics for IND filing in the US. Prior to that, Dr. Olivo served several roles with increasing responsibilities in the oncology group at Eisai Inc.

Dr. Olivo earned his M.D. from the University of Buenos Aires and his M.S. in Clinical and Pharmacological Research from Austral University in Buenos Aires. He also completed advanced training as a Clinical Oncologist at the University of Salvador. Dr. Olivo then held various academic and clinical positions at the School of Medicine at the University of Buenos Aires, Hospital "Dr. Enrique Tornú" and the National Cancer Institute of Canada Clinical Trials Group.