BioNTech to Report Second Quarter 2022 Financial Results and Operational Update on August 8, 2022

On July 25, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will announce its financial results for the second quarter 2022 on Monday, August 8th, 2022 (Press release, BioNTech, JUL 25, 2022, View Source [SID1234616898]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter 2022.

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To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance.

The slide presentation and audio of the webcast will be available via this link.

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at www.BioNTech.com. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

Soligenix Announces Strategic Partnership with SERB Pharmaceuticals to Supply its Novel Ricin Antigen

On July 25, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that it has signed a worldwide exclusive license to supply its ricin antigen to SERB Pharmaceuticals (SERB), for development of a novel therapeutic treatment against ricin toxin poisoning (Press release, Soligenix, JUL 25, 2022, View Source [SID1234616897]). There is an unmet need for protection against this highly potent toxin for which there is no vaccine or therapeutic intervention available.

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"We are pleased to be partnering with Soligenix on the use of their antigen to accelerate our ricin therapeutic program. With no current therapeutic options, the threat of ricin represents a significant unmet need in the field of biodefense and medical countermeasures," said Anthony Higham, CEO of SERB Pharmaceuticals. "Our expertise in antibody development and the commercial scale manufacturing capabilities acquired with BTG together with SERB’s track record of reliably providing a portfolio of high-quality Chemical, Biological, Radiological, and Nuclear (CBRN) antidotes, uniquely positions us to successfully deliver a solution."

"Beyond our own development of a heat stable ricin vaccine (RiVax) to protect against lethal ricin poisoning, which has been supported with more than $30 million dollars to date by the U.S. government, we felt it important to also partner with SERB in the development of its ricin therapeutic drug candidate," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "SERB is a leader in the field of medical countermeasures to protect the public and military forces. By supplying our novel ricin antigen as an important component of their formulation, we are hopeful that it will assist in accelerating development of this early-stage program."

In pursuit of a ricin antidote, SERB will leverage its unique broad-spectrum polyclonal antibody platform, gained in its acquisition of BTG Specialty Pharmaceuticals. This specialized manufacturing process generates binding fragments from antibodies that are specific to a given antigen, helping to ensure potency and purity. This platform is currently used to manufacture two of the company’s currently marketed products, CroFab and DigiFab.

The antibodies will be generated using a modified form of the ricin toxin, developed by Soligenix. The modifications have removed the biological activity of the protein so that it is not toxic, while still retaining its shape to trigger an effective antibody response.

The specific licensing terms have not been disclosed at this time, but consist of a manufacturing supply agreement and small royalty percentage upon commercialization.

The Ricin Threat
Ricin is a source of concern because it is a relatively easy to obtain, easy to weaponize and highly potent toxin. Ricin can be extracted from the seeds of the castor oil plant, Ricinus communis. Ricin is one of the most toxic biological agents known—a Category B bioterrorism agent and a Schedule number 1 chemical warfare agent.

Ricin has been a threat since governments began experimenting with it during World War I. Most famously used in the assassination of Bulgarian writer Georgi Markov in 1978, ricin has been developed and deployed with alarming frequency. Several ricin attacks have been prevented in Europe and the United States in recent years, ranging from a militant group in Germany prevented from launching a ricin attack by police in 2017 to the 2020 delivery of letters laced with ricin to the White House.

Novo Nordisk A/S – Share repurchase programme

On July 25, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JUL 25, 2022, View Source [SID1234616896]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

Since the announcement 18 July 2022, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 17,031,351 B shares of DKK 0.20 as treasury shares, corresponding to 0.7% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 22 July 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 15,291,358 B shares at an average share price of DKK 763.77 per B share equal to a transaction value of DKK 11,679,094,972

Enveric Biosciences Announces $8 Million Registered Direct Offering and Private Placement, Priced at a Premium to Market Under Nasdaq Rules

On July 25, 2022 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that it has entered into a definitive agreement with an institutional investor for the purchase and sale of 375,000 shares of the Company’s common stock (or pre-funded warrants in lieu thereof), in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Enveric Biosciences, JUL 25, 2022, View Source [SID1234616895]). In addition, the Company has agreed to issue to the investor in the registered direct offering unregistered preferred investment options (the "preferred investment options") to purchase up to 375,000 additional shares of the Company’s common stock. The purchase price for one share of common stock (or pre-funded warrant) and one preferred investment option to purchase one share of common stock is $8.00. The preferred investment options have an exercise price of $7.78 per share, will be immediately exercisable, and will expire five and one-half years from the date of issuance.

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Concurrently with the registered direct offering, the Company entered into definitive agreements with institutional investors for the purchase and sale of 625,000 shares of common stock (or pre-funded warrants in lieu thereof) and preferred investment options to purchase up to 625,000 shares of the Company’s common stock in a private placement priced at-the-market under Nasdaq rules. The purchase price for one share of common stock (or pre-funded warrant) and one preferred investment option to purchase one share of common stock is $8.00. The preferred investment options have an exercise price of $7.78 per share, will be immediately exercisable, and will expire five and one-half years from the date of issuance.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.

The gross proceeds to the Company from the offerings are expected to be $8 million, before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offerings for working capital and general corporate purposes. The closing of the offerings is expected to occur on or about July 26, 2022, subject to the satisfaction of customary closing conditions.

The Company also has agreed that certain existing warrants to purchase up to an aggregate of 122,000 shares of common stock of the Company that were previously issued to the investors, with an exercise price of $27.50 per share and expiration date of February 15, 2027, will be amended effective upon the closing of the offerings so that the amended warrants will have a reduced exercise price of $7.78 per share and will expire five and one-half years following the closing of the offerings.

The shares of common stock, pre-funded warrants and shares of common stock underlying the pre-funded warrants (but excluding the shares of common stock and pre-funded warrants to be issued in the private placement and the preferred investment options and the shares of common stock underlying the preferred investment options) being offered by the Company in the registered direct offering are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-257690) previously filed with the Securities and Exchange Commission (the "SEC") on July 2, 2021, and declared effective by the SEC on July 9, 2021. The offering of the common stock and pre-funded warrants in the registered direct offering is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The preferred investment options to purchase common stock, pre-funded warrants and the shares of common stock offered under the private placement, as well as the preferred investment options being issued to investors in the registered directed offering, are being offered in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, those securities may not be reoffered or resold 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.

Under a registration rights agreement with the investors, the Company is required to file a registration statement with the SEC covering the resale of the shares of the common stock and shares of common stock underlying the pre-funded warrants to be issued in the private placement and the shares of common stock underlying the preferred investment options to be issued in both offerings, within 15 days and to use best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event within 45 days or within 75 days in the event of a full review by the SEC.

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

Athenex Announces Publication of Data from Phase 3 Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients with Metastatic Breast Cancer in the Journal of Clinical Oncology

On July 25, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported the publication of their manuscript, "Open-Label, Randomized, Multicenter, Phase III Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients with Metastatic Breast Cancer" (Press release, Athenex, JUL 25, 2022, View Source [SID1234616894]). The article, along with results, can be found on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Journal’s website at this link.

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"We are pleased with the publication of the phase 3 data, which show that oral paclitaxel plus encequidar significantly improves tumor response in patients with metastatic breast cancer, compared to IV administration. Positive trends were observed in progression free survival and overall survival," said Hope S. Rugo, MD, Professor of Medicine, University of California San Francisco Comprehensive Cancer Center. "With oral administration of paclitaxel plus encequidar, we observed less frequent and less severe neuropathy, which is often a limiting toxicity with IV taxanes. In patients with abnormal liver function, we identified a predisposition to early neutropenia and infections in patents with elevated liver enzymes at baseline, allowing for better toxicity management moving forward. We believe that for appropriate patients with advanced or metastatic breast cancer, this could potentially be an effective at home treatment option."