On July 20, 2023 Theratechnologies Inc. ("Theratechnologies", the "Company", or "we") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that its Board of Directors approved a consolidation of the issued and outstanding common shares of the Company’s share capital on the basis of one (1) post- consolidation share for each four (4) pre-consolidation shares issued and outstanding (the "Consolidation") (Press release, Theratechnologies, JUL 20, 2023, View Source [SID1234633337]).

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The Consolidation will be effective July 31, 2023, subject to applicable regulatory approvals, including the Toronto Stock Exchange (the "TSX") and the Nasdaq Stock Market ("NASDAQ"). No shareholder approval will be required for the Consolidation to come into effect. The Company expects its common shares will begin trading on the TSX and the NASDAQ on a consolidated basis on or about July 31, 2023.

No fractional common share will be issued in connection with the Consolidation and, in the event that a shareholder would otherwise be entitled to receive a fractional share upon such Consolidation, the number of common shares to be received by such shareholder will be rounded up (if the fraction is half a share or more) or down (if the fraction is less than half a share) to the nearest whole common share, provided that no shareholder shall hold less than a single common share as a result of the Consolidation. As at July 19, 2023, the Company had 96,807,309 common shares issued and outstanding, and the Company expects to have approximately 24,201,835 common shares issued and outstanding upon completion of the Consolidation.

Shareholders who hold their common shares electronically either in direct registered book-entry form via a direct registration system advice/statement ("DRS") with Computershare Trust Company of Canada ("Computershare"), the Company’s transfer agent, or in "street name" through an intermediary like a bank, broker or other nominee, will not need to take any action as the Consolidation should automatically be reflected in the transfer agent’s records and on such shareholders’ next account statement. Intermediaries may have specific procedures for processing the Consolidation, including the treatment of fractional shares.

Shareholders holding paper stock certificates will be sent by Computershare a letter of transmittal which will enable them to exchange their old share certificates for a DRS representing the number of new post-Consolidation common shares they hold. Until surrendered, each stock certificate representing pre-Consolidation common shares will be deemed for all purposes to represent the number of whole post-Consolidation common shares to which the shareholder is entitled as a result of the Consolidation.

Rationale for the Consolidation

On March 7, 2023, the Company announced it had received a notification letter from the NASDAQ advising the Company that it was not in compliance with Listing Rule 5550(a)(2), as the bid price of the Company’s common shares on the NASDAQ had closed at less than US$1.00 per share over the prior 30 consecutive business days (the "Minimum Bid Price Requirement"). In accordance with its Listing Rules, NASDAQ afforded the Company a 180-day period ending August 30, 2023, to regain compliance with the Minimum Bid Price Requirement.

The Consolidation is being implemented by the Company with the objective of increasing the trading price of its common shares and to allow the Company to regain compliance with the Minimum Bid Price Requirement of the NASDAQ and maintain a listing on the NASDAQ which accounts for a large part of the trading in the Company’s common shares.

The Company anticipates that the Consolidation will have a neutral economic effect on shareholders and holders of securities convertible into or exercisable to acquire common shares or correlated with the price thereof, except to the extent the Consolidation will result in fractional common shares.

Proportionate adjustments will be made to the exercise price of outstanding stock options, warrants and other instruments linked to the common shares and the number of common shares underlying such options, warrants and equity-linked instruments to maintain the same economics associated with such instruments post-Consolidation.

On July 20, 2023 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing immunogenic small molecule approaches in oncology, reported that it has expanded its clinical presence to France (Press release, Promontory Therapeutics, JUL 20, 2023, View Source [SID1234633336]). This week the company treated its first four patients in France – at Gustave Roussy and at the Military Hospital (HIA) Bégin in Paris – on the ongoing Phase 2 clinical trial of lead therapeutic candidate, PT-112, in patients with late-stage metastatic castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02266745).

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The Phase 2, open-label, multi-center proof of concept study has the objective of characterizing the benefit-risk ratio and selecting the optimal dose regimen for pivotal development of PT-112, in line with the FDA’s Project Optimus. In addition to proof of concept via safety and efficacy findings among late-stage metastatic patients, the study aims to generate meaningful supportive data via correlative research, for example on immune activation by PT-112 monotherapy, and by examining circulating tumor cell reductions.

Within France, the study is being led by primary investigator Dr. Karim Fizazi, MD, PhD, medical oncologist at Gustave Roussy, and professor of oncology at the University of Paris-Saclay. Gustave Roussy and HIA Bégin, the latter led by investigator Carole Helissey, MD, are the first two of ten sites across France that will recruit patients for the study. Promontory plans to enroll up to 109 patients in total on the study.

"Dr. Fizazi is a global leader in prostate cancer and under his guidance, we are looking forward to treating mCRPC patients in France and further understanding the potential impact of PT-112 on these late-stage mCRPC patients, who currently have few options for life-prolonging therapy," said Promontory Therapeutics Chief Medical Officer Johan Baeck, MD.

"We are very pleased to begin treating patients in France with advanced, metastatic prostate cancer, as part of the ongoing Phase 2 clinical trial of PT-112" said Dr. Fizazi. "Based upon early data, PT-112 has the potential to offer a promising form of immune activation to such patients, who generally do not have effective immunotherapy options to date."

For more information about Promontory’s clinical trials, visit www.PromontoryTx.com.

About PT-112
PT-112 is the first small-molecule conjugate of pyrophosphate in clinical development in oncology. PT-112 has numerous advantages — including its tolerability and inhibition of ribosomal biogenesis (RiBi) which leads to immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and data were published in eClinicalMedicine, part of The Lancet. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in a mini-oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress and the Phase 2a dose confirmation cohort in non-small cell lung cancer (NSCLC) patients was reported at ESMO (Free ESMO Whitepaper) I-O 2022. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) 2020 is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, as detailed in a trial-in-progress poster presentation at ASCO (Free ASCO Whitepaper) GU 2023, and also includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal CRADA with the NCI. Interim data from the NCI study were published at ASCO (Free ASCO Whitepaper) 2023.

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.

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.

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%