Nusano to Participate in Isotope and Radiopharmaceutical Conferences

On July 20, 2023 Nusano, Inc., a company working to stabilize and enable the production of cancer-fighting radioisotopes, reported participation in two conferences in July 2023 (Press release, Nusano, JUL 20, 2023, View Source [SID1234633335]). Nusano CEO Chris Lowe will present an overview of the company’s breakthrough radioisotope production platform at the 2nd Annual Targeted Radiopharmaceuticals Summit on July 26 in Boston. Nusano is also presenting two abstracts in oral presentations at the 11th International Conference on Isotopes, in Saskatoon, Saskatchewan, Canada on July 26 and 27.

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Additional presentation details:

2ND ANNUAL TARGETED RADIOPHARMACEUTICALS SUMMIT (BOSTON)
TITLE: Supplying the Fight Against Cancer: Nusano’s Breakthrough Radioisotope Production Platform
WHO: Chris Lowe, CEO
SESSION: Targeted Radiopharmaceuticals in the US: The Past, the Present & the Future
WHEN: Wednesday, July 26, 2023 at 10:00 AM EDT

11TH INTERNATIONAL CONFERENCE ON ISOTOPES (SASKATOON, SASK.)
ABSTRACT: Nusano Targetry for the Production of Medical Isotopes
WHO: Greg Moffitt, PhD, Director of Target Development
SESSION: Accelerator Produced Radioisotopes
WHEN: Wednesday, July 26, 2023, 3:00 PM – 4:30 PM CST*

ABSTRACT: Alpha Production Routes for Medical Radioisotopes
WHO: Richard Sisson, Targetry Nuclear Engineer
SESSION: Accelerator Produced Radioisotopes II
WHEN: Thursday, July 27, 2023, 9:50 AM – 11:30 AM CST*
* Concurrent session presentations of 15 minutes, with a question-and-answer period at the end of the session.

LIXTE Biotechnology Announces Pricing of $3.5 Million Registered Direct Offering and Concurrent Private Placement Priced At-the-Market under Nasdaq Rules

On July 20, 2023 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) ("LIXTE" or the "Company") reported it has entered into a securities purchase agreement with a single health-care focused, institutional investor for the purchase and sale of 583,334 shares of common stock (or common stock equivalents in lieu thereof) in a registered direct offering and common warrants to purchase up to 583,334 shares of common stock in a concurrent private placement (together with the registered direct offering, the "Offering") at a purchase price of $6.00 per common share, priced "at-the-market" under Nasdaq rules (Press release, Lixte Biotechnology, JUL 20, 2023, View Source [SID1234633333]). The common warrants issued pursuant to the concurrent private placement will have an exercise price of $6.00 per share, will be exercisable immediately upon issuance and will expire 5 years from issuance.

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The closing of the Offering is expected to occur on or about July 20, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $3,500,000, excluding any proceeds that may be received upon the exercise of the warrants and before deducting placement agent fees and other offering expenses payable by the Company.

A.G.P./Alliance Global Partners is acting as sole placement agent for the Offering.

The common stock and common stock equivalents in lieu thereof will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No. 333-252430) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective by the SEC on February 5, 2021. The common warrants will be issued in a concurrent private placement. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and once filed, will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022, or by telephone at (212) 624-2060, or by email at [email protected].

The private placement of the common warrants will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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.

JOHNSON & JOHNSON REPORTS 2023 SECOND-QUARTER RESULTS

On July 20, 2023 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2023 (Press release, Johnson & Johnson, JUL 20, 2023, View Source [SID1234633332]). "Our robust performance in the second quarter and first half of 2023 is a testament to the hard work and commitment of our colleagues around the world," said Joaquin Duato, Chairman of the Board and Chief Executive Officer. "We are entering the back half of the year from a position of strength with numerous catalysts, including becoming a two-sector company focused on Pharmaceutical and MedTech innovation."

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OVERALL FINANCIAL RESULTS:
overallresultsqtd.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items
Note: values may have been rounded

REGIONAL SALES RESULTS:
regionalsalesqtd.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT SALES RESULTS:
segmentsalesqtd.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: Values may have been rounded

SECOND QUARTER 2023 SEGMENT COMMENTARY:
Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Pharmaceutical
Pharmaceutical worldwide adjusted operational sales grew 3.9%*. Excluding the COVID-19 Vaccine, adjusted operational sales grew 6.2%*. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), and CARVYKTI (ciltacabtagene autoleucel) in Oncology, STELARA (ustekinumab) and TREMFYA (guselkumab) in Immunology, UPTRAVI (selexipag) and OPSUMIT (macitentan) in Pulmonary Hypertension, and SPRAVATO (esketamine) in Neuroscience. Growth was partially offset by ZYTIGA (abiraterone acetate) and IMBRUVICA (ibrutinib) in Oncology, COVID-19 Vaccine (Ad26.COV2.S) in Infectious Diseases, and REMICADE (infliximab) in Immunology.

MedTech
MedTech worldwide adjusted operational sales grew 9.9%*, driven primarily by electrophysiology products in Interventional Solutions, trauma in Orthopaedics, wound closure products in General Surgery, biosurgery in Advanced Surgery, and contact lenses in Vision. MedTech worldwide operational sales grew 14.7%*, with the acquisition of Abiomed contributing 4.8%.

Consumer Health
Consumer Health worldwide adjusted operational sales increased 7.7%* largely driven by over-the-counter (OTC) products. Major contributors to growth in OTC were TYLENOL and MOTRIN analgesics, upper respiratory products, international smoking cessation products, and IMODIUM in digestive health products. Additional contributors to growth were NEUTROGENA in Skin Health/Beauty products and Women’s Health products outside the United States.

NOTABLE NEW ANNOUNCEMENTS 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.

Regulatory Janssen Marks First Approval Worldwide for AKEEGA (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorisation for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations Press Release
Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation Press Release
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH) Press Release
Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma Press Release
Data Release Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti-PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer Press Release
First Phase 3 TREMFYA (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis Press Release
New Data Published on Biosense Webster QDOT MICRO Catheter – the Latest Advancement in Focal RF Ablation for Treating AFib Press Release
Janssen to Highlight Scientific Advances and Commitment to Transform Cancer Care at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) with More than 90 Presentations Showcasing Robust, Differentiated Portfolio and Pipeline in Hematologic Malignancies and Solid Tumors Press Release
New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) Press Release
Janssen Announces Positive Topline Results for JNJ-2113—a Novel, First and Only Oral IL-23 Receptor Antagonist Peptide in Development for Moderate-to-Severe Plaque Psoriasis1
Press Release
Treatment with RYBREVANT (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer1
Press Release

Other Johnson & Johnson Announces Launch of Kenvue Inc. IPO Roadshow Press Release
Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies Press Release

Subsequent to the quarter

FULL-YEAR 2023 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.
($ in Billions, except EPS)
July 2023
April 2023
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
6.0% – 7.0% / 6.5%
4.5% – 5.5% / 5.0%
Operational Sales2,5/ Mid-point
Change vs. Prior Year / Mid-point
$99.3B – $100.3B / $99.8B
7.0% – 8.0% / 7.5%
$97.9B – $98.9B / $98.4B
5.5% – 6.5% / 6.0%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$98.8B – $99.8B / $99.3B
6.5% – 7.5% / 7.0%
$97.9B – $98.9B / $98.4B
5.5% – 6.5% / 6.0%
Adjusted Operational EPS (Diluted)2,4/ Mid-point
Change vs. Prior Year / Mid-point
$10.60 – $10.70 / $10.65
4.5% – 5.5% / 5.0%
$10.50 – $10.60 / $10.55
3.5% – 4.5% / 4.0%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.70 – $10.80 / $10.75
5.5% – 6.5% / 6.0%
$10.60 – $10.70 / $10.65
4.5% – 5.5% / 5.0%

ImmunityBio Announces Execution of $40 Million Equity Financing with Institutional Investors

On July 20, 2023 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that it has executed financing to provide further working capital and support its ongoing business operations (Press release, ImmunityBio, JUL 20, 2023, View Source [SID1234633331]). The Company entered into a securities purchase agreement for a registered direct offering with multiple institutional investors, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $40 million before deducting any offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gross proceeds of up to $48 million. In addition, in connection with the current financing, the Company agreed to amend the terms of the existing warrants issued in February 2023 so that the pricing and term of such warrants match the newly issued warrants.

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Jefferies LLC is acting as the exclusive placement agent for the registered direct offering.

The securities to be sold by the Company are offered under its shelf registration statement on Form S-3 (Registration No. 333-269608). A final prospectus supplement, which contains additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement may be obtained for free by contacting Jefferies, LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected].

Before investing in this offering, interested parties should read the prospectus supplement, the accompanying prospectus, and the other documents that are incorporated by reference in such prospectus supplement and the accompanying prospectus in their entirety.

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.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Second Quarter of 2023

On July 20, 2023 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 2,431 million in the second quarter of 2023 (Press release, Genmab, JUL 20, 2023, View Source [SID1234633330]). Net trade sales were USD 1,322 million in the U.S. and USD 1,110 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

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