On April 19, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported Jesse Ledger, Miravo’s President & Chief Executive Officer and Mary-Jane Burkett, Miravo’s Vice President & Chief Financial Officer will be presenting at the Bloom Burton & Co. Healthcare Investor Conference (Press release, Nuvo Pharmaceuticals, APR 19, 2022, View Source [SID1234612489]).

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Bloom Burton & Co. Healthcare Investor Conference

The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly traded and private companies through presentations and private meetings.

About Bloom Burton & Co.

Bloom Burton & Co. is a firm dedicated to accelerating returns in the healthcare sector for both investors and companies. Bloom Burton has an experienced team of medical, scientific, pharmaceutical, legal and capital markets professionals who perform a deep level of diligence, which combined with our creative and entrepreneurial approach, assists our clients in achieving the right monetization events. Bloom Burton and its affiliates provide capital raising, M&A advisory, equity research, business strategy and scientific consulting, advisory on direct investing and company creation and incubation services. Bloom Burton Securities Inc. is a member of the Investment Industry Regulatory Organization of Canada (IIROC) and is also a member of the Canadian Investor Protection Fund (CIPF).

On April 19, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that it will report first quarter 2022 financial results after the close of the U.S. financial markets on Wednesday, May 4, 2022 and will hold a conference call that same day beginning at 4:30 p.m. Eastern time (Press release, Ligand, APR 19, 2022, View Source [SID1234612488]). Speakers on the call will include Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg.

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On April 19, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that collaborating with Xcell Biosciences, Inc. (Xcellbio), a leading developer of cell and gene therapy technologies, to advance critical work that helps clients effectively bring innovative cell and gene therapies to market (Press release, LabCorp, APR 19, 2022, View Source [SID1234612487]).

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Through their collaboration, Labcorp and Xcellbio will work on a series of projects focused on improving the safety and efficacy of cell and gene therapies (CGTs). This strengthens Labcorp’s commitment to growing its global, comprehensive suite of CGT capabilities, and it supports pharmaceutical and biotechnology companies’ efforts to expedite therapeutic development.

"Labcorp is firmly committed to helping our clients bring new treatment options to patients in need while revolutionizing the future of medicine with cell and gene therapies," said Dr. Maryland Franklin, vice president and enterprise head of cell and gene therapy at Labcorp. "By pairing the scale and breadth of our enterprise-wide CGT solutions with Xcellbio’s powerful technology, we have an opportunity to enhance and accelerate the CGT development experience. It’s another way Labcorp is carrying out its mission to improve health and improve lives."

CGTs modify a person’s genes to treat disease by inactivating or replacing a disease-causing gene, or introducing a new or modified cell or gene. CGTs are being tested for use in the treatment of many diseases, including Parkinson’s disease, an array of rare diseases, and both solid tumors and blood-based cancers. The projects included in the collaboration will use Xcellbio’s AVATAR incubator system to grow and expand research-grade CAR-T cell material used to attack cancer cells. This work helps demonstrate the power of understanding the parameters of the tumor microenvironment in the creation of CAR-T cells with improved performance. In addition, the technology will be used to acclimate cancer cells to more physiologic conditions and expand 3D modeling for in vitro CAR-T testing.

"We’re continuously striving to advance cell and gene therapy development through technology innovations that enable the precise control of cell populations to enhance the potency and persistence needed for optimal patient outcomes," said Brian Feth, CEO of Xcellbio. "The exciting projects we’re undertaking with Labcorp allow our shared clients to harness the institutional knowledge and resources of a global organization to craft innovative approaches to develop potentially curative treatments."

The collaboration—the latest in Labcorp’s string of recent CGT-focused relationships—follows the company’s strategic investment in Xcellbio in November 2021. It also underscores Labcorp’s efforts to address the unique needs of complex CGT development through industry connectivity. Labcorp is committed to enhancing its CGT solutions across the entire development continuum through investments in its people, operations and technology, and through external collaborations.

Labcorp is offering clients access to a dedicated team of CGT leaders with deep expertise in all aspects of the development process. Clients are further supported by a multi-disciplinary group of operational, medical and regulatory members from across the enterprise, providing comprehensive and strategic insights that enable increased efficiency and reduced risk through critical development milestones.

With more than 20 years of experience in delivering development solutions for advanced therapies such as CGT products, Labcorp employs a personalized approach to bring clients customized solutions on a global scale. These range from preclinical discovery and development to comprehensive clinical trials and commercialization services. The company has helped support the development of all six U.S. Food and Drug Administration (FDA)-approved CAR-T cell therapies, as well as both FDA-approved gene replacement therapies.

Learn more about Labcorp’s CGT capabilities and the collaboration with Xcellbio during an upcoming thought leadership workshop, "Strategies and Approaches to Optimize Your Non-clinical and Clinical Development for Cell and Gene Therapies," to be held on Monday, May 16, 2022, during the annual meeting of the American Society of Gene and Cell Therapy. More information is available here.

On April 19, 2022 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2022 (Press release, Johnson & Johnson, APR 19, 2022, View Source [SID1234612486]). "Our first quarter results demonstrate strong performance across the enterprise, despite macro-economic headwinds. I am incredibly proud of Johnson & Johnson’s 144,000 employees for their relentless passion and Credo-based commitment to delivering transformative healthcare solutions to patients and customers around the world," said Joaquin Duato, Chief Executive Officer. "Looking ahead, I remain confident in the future of Johnson & Johnson as we continue advancing our portfolio and innovative pipeline."

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FIRST QUARTER 2022 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide adjusted operational sales, which exclude the net impact of acquisitions and divestitures and translational currency, increased 1.6%* primarily driven by over-the-counter (OTC) products. Major contributors to growth in OTC were upper respiratory products, TYLENOL and MOTRIN analgesics, and IMODIUM in digestive health products. Growth was partially offset by external supply constraints mainly impacting Skin Health / Beauty.

Pharmaceutical
Pharmaceutical worldwide adjusted operational sales, which exclude the net impact of acquisitions and divestitures and translational currency, grew 9.3%* driven by DARZALEX (daratumumab), a biologic for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, and INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults. Also contributing to growth were sales of the Janssen COVID-19 Vaccine (Ad26.COV2.S) for the prevention of the SARS-CoV-2 virus. This growth was partially offset by declines in sales of REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, XARELTO (rivaroxaban), a direct oral anticoagulant, and ZYTIGA (abiratone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.

MedTech
MedTech worldwide adjusted operational sales, which exclude the net impact of acquisitions and divestitures and translational currency, grew 8.6%*, driven by electrophysiology products in Interventional Solutions, contact lenses and surgical vision products in Vision, wound closure products in General Surgery, biosurgery in Advanced Surgery, and hips, trauma, and knees in Orthopaedics.

NOTABLE NEW ANNOUCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investors section of the company’s website at news releases, as well as www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

FULL-YEAR 2022 GUIDANCE:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Please note that the Company has suspended guidance on its COVID-19 Vaccine sales. The table below excludes COVID-19 Vaccine sales from Adjusted Operational Sales, Operational Sales, and Estimated Reported Sales.

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.

On April 19, 2022 Heat Biologics, Inc. ("Heat") (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing novel biodefense assets and first-in-class therapies to modulate the immune system, reported that it is changing the name of the Company to NightHawk Biosciences, Inc., effective May 3, 2022, to better reflect the Company’s evolution, including expansion of its therapeutic pipeline, the vertical integration of capabilities from drug discovery to manufacturing and commercialization, as well as the Company’s new biodefense capabilities (Press release, Heat Biologics, APR 19, 2022, View Source [SID1234612484]). In connection with the name change, the Company’s ticker will change to "NHWK," effective May 3, 2022. The livestream event, held at the Purple Masque Theatre at Kansas State University in Manhattan, Kansas and other locations, is available on the Company’s new website at: NightHawkBio.com.

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NightHawk will focus on rapid and efficient drug development through its integrated ecosystem of subsidiary companies, which includes Skunkworx Bio (Skunkworx), Heat Biologics (Heat), Pelican Therapeutics (Pelican), Scorpion Biological Services (Scorpion) and Elusys Therapeutics (Elusys). The Company believes this fully-integrated ecosystem enables a more rapid delivery of medical innovations with increased quality and efficiency.

During the event, the Company announced several key corporate developments, including:

Discovery subsidiary Skunkworx continues to make progress across a variety of infectious disease, biodefense and oncology-related indications, with an intended public announcement of these programs set to occur later this year.
Scorpion is expected to host the grand opening of its San Antonio facility following completion of construction in Q3, 2022.
PTX-35 is nearing final enrollment in its last cohort of its Phase 1 solid tumor trial, and just recently announced a presentation of new data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper).
A planned research collaboration with Kansas State University’s Biosecurity Research Institute on its RapidVax biodefense program.
Expanded efforts by biodefense Elusys Therapeutics to support international sales of ANTHIM (obiltoxaximab). ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. Additional details are available at View Source
Richard Myers, who previously served as the Chairman of the Joint Chiefs of Staff before serving as President of Kansas State University, will become Chairman of NightHawk’s BioThreat Advisory Board.
Jeff Wolf, Chief Executive Officer of NightHawk, commented, "Over the past 18 months, we’ve built a powerful drug discovery engine in our SkunkWorx subsidiary. We’ve been building our Scorpion subsidiary to deliver world-class biomanufacturing. And we announced the acquisition of Elusys Therapeutics, a biodefense company, which we intend to grow into a biodefense powerhouse."

Mr. Wolf added, "The pandemic highlighted the fact that the development of new drugs is tremendously slow, encumbered, and expensive. These are enormous barriers to American progress. We believe the solution is full integration of discovery, preclinical testing and manufacturing, optimized to quickly and efficiently deliver drugs to the people who need them."

Mr. Wolf continued, "The NightHawk model represents a new way of thinking and is designed to combine speed and agility with the full-integration of discovery, development and manufacturing. We are excited to continue to build and enhance this ecosystem under the NightHawk banner."