Blue Water Biotech Announces Exercise of Warrants and Issuance of New Warrants in A Private Placement For $2.7 Million Gross Proceeds

On August 1, 2023 Blue Water Biotech, Inc. ("Blue Water" or the "Company") (Nasdaq: BWV), reported it has entered into a definitive agreement for the exercise of certain existing warrants to purchase 2,486,214 shares of its common stock at a reduced exercise price of $1.09 per share, in exchange for new warrants as described below (Press release, Onconetix, AUG 1, 2023, View Source [SID1234641114]). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $2.7 million, before deducting placement agent fees and other offering expenses payable by the Company. The transaction is expected to close on or about August 2, 2023, subject to satisfaction of customary closing conditions.

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H.C. Wainwright is acting as the exclusive placement agent for this transaction.

The Company expects to use the net proceeds from the transaction for working capital and general corporate purposes, including executing on launch activities for Blue Water’s commercial portfolio announced in a letter to shareholders issued earlier this month.

The shares of common stock issuable upon exercise of the existing warrants are registered pursuant to an existing registration statement on a Post-Effective Amendment No. 1 to Form S-1 on Form S-3 (File No. 333-267142), declared effective by the Securities and Exchange Commission (the "SEC") on May 4, 2023.

In consideration for the immediate exercise of the existing warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The shares of common stock issuable upon exercise of the new warrants is subject to stockholder approval. The Company agreed to convene a stockholders’ meeting on or before 90 days following the closing date of the transaction to obtain such approval. The new warrants will be exercisable for up to an aggregate of 4,972,428 shares of common stock, at an exercise price of $1.09 per share and have a term of exercise equal to five years from the date of stockholder approval.

The new warrants offered in the private placement have not been registered under the 1933 Act, or applicable under state securities laws. Accordingly, the new warrants and shares of common stock issuable upon the exercise of the new warrants 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. As part of the offering, the Company has agreed to file a resale registration statement on Form S-3 with the SEC as soon as practicable to register the resale of the shares of common stock issuable upon the exercise of the new warrants issued in the private placement, and to have such resale registration statement declared effective within 90 days following the date of the agreement.

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

Mundipharma International Corporation Limited, Mundipharma Medical Company, and Acrotech Biopharma Inc. Enter Agreement to Transfer License of FOLOTYN® (Pralatrexate) in China to CASI Pharmaceuticals

On August 1, 2023 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the execution of an Assignment Agreement (the "Agreement") with Mundipharma International Corporation Limited ("MICL"), Mundipharma Medical Company ("MMCo"), and Acrotech Biopharma Inc. ("Acrotech") for the commercialization of FOLOTYN (Pralatrexate) in the People’s Republic of China ("China") (Press release, CASI Pharmaceuticals, AUG 1, 2023, View Source [SID1234640200]).

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FOLOTYN (Pralatrexate) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma ("PTCL"). This product was approved by both the US Food and Drug Administration ("FDA") and China’s National Medical Products Administration (NMPA) for PTCL. Under the terms of the Agreement, CASI will assume MICL’s rights and obligations with respect to the commercialization of FOLOTYN in China.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are very pleased to add FOLOTYN, another unique and approved drug product to our commercial portfolio. The licensing of FOLOTYN is consistent with the company’s strategy to grow our hematological malignancy therapeutic area franchise. We will leverage CASI’s existing sales and commercial team’s established capabilities and infrastructure to launch and commercialize FOLOTYN."

"CASI has proven and strong capability to commercialize proprietary medications and are extremely pleased to broaden our existing relationship with them. We look forward to this exciting launch and bringing this novel medicine to PTCL patients in China," said Dr. Ashish Anvekar, President of Acrotech Biopharma.

2023 Annual Report

On August 1, 2023 Pierre Fabre reported 2023 Annual Report (Presentation, Pierre Fabre, AUG 1, 2023, View Source [SID1234639494]).

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Tetra Bio-Pharma Voluntary Bankruptcy

On August 1, 2023 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTC:TBPMF) (FRA:JAM1) a leader in cannabinoid-derived drug discovery and development reported that it has made a voluntary assignment into bankruptcy under the Bankruptcy and Insolvency Act (Canada). HOULE ROY S.A. (the "Trustee") has been appointed as Tetra’s trustee in bankruptcy (Press release, Tetra Bio Pharma, AUG 1, 2023, View Source [SID1234635190]).

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On March 7, 2023, the corporation announced that the Ontario Securities Commission rejected an application for a Management Cease Trade Order (MCTO). The rejected MCTO prevented the corporation from negotiating any securities to continue to finance the corporation and blocked Tetra from paying debt with shares. Based on these events the corporation had no other choice but to make a voluntary assignment into bankruptcy.

First half of 2023: Boehringer Ingelheim sees strong growth and expansion in key therapy areas

On August 1, 2023 Boehringer Ingelheim, a leading research-driven biopharmaceutical company, reported it continues to advance its pipeline in both Human Pharma and Animal Health expanding across its key therapy areas (Press release, Boehringer Ingelheim, AUG 1, 2023, View Source,first%20six%20months%20of%202023. [SID1234635014]).

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Currency-adjusted net sales rose by 9.7 percent to 12.2 billion EUR driven by high demand for medications during the first six months of 2023, driven by strong momentum in Jardiance for Human Pharma and NexGard for Animal Health.

"True innovation addressing high unmet patients’ needs has enabled us to reach ever more patients in the first half of this year," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "Persistent and above-average investments in our pipeline during the last years have resulted in many new treatment options for patients in the years to come, thus transforming lives for generations."

Boehringer Ingelheim continued expanding its pipeline portfolio through in-house as well as external innovation – 15 new innovation partnerships were formed in areas such as cancer immunology, fibrotic lung diseases and retinal diseases. Overall, the company has committed to invest 25 billion EUR in Research & Development and an additional 7 billion EUR for new production technologies over the next five years.

Net sales in Human Pharma were up 11.3 percent (currency-adjusted) at 9.6 billion EUR in the first half of the year, mainly driven by the Jardiance family at 3.5 billion EUR and the respiratory medicine OFEV at 1.7 billion EUR.

Jardiance experienced strong momentum in the first six months of 2023. It is expected to grow following additional regulatory action for treatment of chronic kidney disease. Worldwide 850 million people1 live with this disease. With the addition to existing indications in type 2 diabetes and heart failure, Jardiance will potentially be able to help manage cardio-renal-metabolic conditions. Over 1 billion people live with cardio-renal-metabolic conditions globally1.

In oncology, the company’s MDM2-p53 antagonist brigimadlin has advanced into the pivotal trial for the treatment of dedifferentiated liposarcoma, a rare cancer with limited treatment options so far. The clinical development of two additional investigational therapies (zongertinib, also known as BI 1810631, and BI 764532) from the oncology pipeline has been accelerated based upon positive early clinical data.

The PDE4B inhibitor BI 1015550 is now in two clinical Phase III trials for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis. Patient recruitment for trial investigating BI 1015550 in IPF is well ahead of plan.

"We have become very successful in bringing new products through our pipeline addressing patients’ needs faster," said Michael Schmelmer, Member of the Board of Managing Directors, responsible for Finance & Group Functions. "We expect to further increase our R&D spending as clinical trials progress into late-stage phases."

Animal Health recorded growth in Pets and Livestock, with sales increasing by 3.8 percent (currency-adjusted) to 2.5 billion EUR in the first six months of the year. Net sales of NexGard, a flea and tick prevention for dogs and cats, increased 9.2 percent (currency-adjusted) to 644 million EUR, while Ingelvac Circoflex, a vaccine used to protect pigs against porcine circovirus type 2, rose 8.7 percent to 127 million EUR.

In addition, the company complemented its market-leading NexGard portfolio through FDA approvals for NexGard PLUS, a new monthly combination product for dogs that protects against fleas, ticks, heartworm disease, roundworms and hookworms, and NexGard COMBO, the first-and-only feline broad-spectrum parasite protection that treats tapeworms.

The Animal Health business has made further progress in the pipeline development in infectious and non-infectious diseases for Pets and Livestock and is preparing for the launch of a highly innovative oral product for diabetes in cats.

For the remainder of the year Boehringer Ingelheim expects more progress in its innovation efforts, such as data readout for a Phase III trial with empagliflozin in patients after myocardial infarction and upcoming regulatory action for OFEV in children and adolescents between 6-17 years with interstitial lung disease.

Looking forward, the company aims to achieve more than 30 new medical approvals in Human Pharma by 2029 and expects around 20 product launches in Animal Health through 2025.