Elusys Therapeutics Finalizes HHS Contract to Deliver ANTHIM®, Its Treatment for Inhalation Anthrax, to the U.S. Department of Health and Human Services

On January 31, 2022 Elusys Therapeutics, Inc. (Elusys) reported that it has finalized a contract with the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) for the continued supply of ANTHIM (obiltoxaximab), an anthrax antitoxin, for use against a potential anthrax attack (Press release, NightHawk Biosciences, JAN 31, 2022, View Source [SID1234612541]).

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"Elusys is pleased to continue its successful track record of supplying a critical medicine to treat the deadly effects of anthrax exposure," said Elizabeth Posillico, president and chief executive officer of Elusys. "ANTHIM is a key therapeutic in the U.S. government’s preparedness strategy to protect the U.S. population against natural and man-made biothreats."

The contract for the procurement of ANTHIM consists of a base period of performance, valued at $50 million, which has been fulfilled. The contract includes options valued up to $31 million. If all options are exercised, the total contract value will be $80,864,000 with completion of the contract expected by the first half of 2023. Contract 75A50121C00073 is funded by HHS ASPR.

As previously announced, Elusys has executed a definitive merger agreement with Heat Biologics, Inc. (NASDAQ: HTBX), pursuant to which Elusys will merge into a wholly owned subsidiary of Heat. The acquisition is expected to close during the first quarter of 2022 and is subject to customary closing conditions.

About ANTHIM
ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.

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. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.

Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

IMPORTANT SAFETY INFORMATION Including BOXED WARNING

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.

WARNINGS AND PRECAUTIONS
Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.

ADVERSE REACTIONS
The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.

USE IN SPECIFIC POPULATIONS
Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.

Entry into a Material Definitive Agreement

On January 31, 2022, Oncotelic Therapeutics, Inc. (the "Company") reported that entered into an Unsecured Convertible Note Purchase Agreement (the "Purchase Agreement") with Golden Mountain Partners, LLC (the ("Holder"), pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million (the "Note"), which Note is convertible into shares of the Company’s common stock, par value $0.01 per share ("Common Stock") (Filing, 8-K, Mateon Therapeutics, JAN 31, 2022, View Source [SID1234607613]). The Note and Purchase Agreement are both part of a series of a cumulative funding of upto $1.5 million in three equal monthly instalments. The Note was entered into as continuation of the relationship between the Company and the Holder.

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The Purchase Agreements and the Notes contain identical terms to the securities purchase agreements (and promissory notes issued thereunder), to Golden Mountain Partners, LLC on October 25, 2021. The Prior Issuances were previously reported on our Current Report on Form 8-K filed with the Securities and Exchange Commission ("SEC") on October 28, 2021.

The Note carries an interest rate of 2% per annum and matures on the earlier of (a) the one-year anniversary of the date of the Agreement, or (b) the acceleration of the maturity of the Note by Holder upon occurrence of an Event of Default (as defined below). The Note contains a voluntary conversion mechanism whereby the Holder may convert the outstanding principal and accrued interest under the terms of the Note into shares of Common Stock (the "Conversion Shares"), at the consolidated closing bid price of the Company’s Common Stock on the applicable OTC Market as of the date the Company receives a Notice of Conversion (as defined in the Note) from Holder. Prepayment of the Note may be made at any time by payment of the outstanding principal amount plus accrued and unpaid interest. The Note contains customary events of default (each an "Event of Default"). If an Event of Default occurs, at the Holder’s election, the outstanding principal amount of the Note, plus accrued but unpaid interest, will become immediately due and payable in cash. The Purchase Agreement requires the Company to use of the proceeds received under the Note to support payroll.

The issuance of the Note is exempt from the registration requirements of the Securities Act of 1933, as amended ("Securities Act"), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as provided in Rule 506 of Regulation D promulgated thereunder. The shares of Common Stock issuable upon conversion of the Note have not been registered under the Securities Act or any other applicable securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.

The foregoing descriptions of the Purchase Agreement and the Note are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibit 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference.

Novo Nordisk A/S – Share repurchase programme

On January 31, 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, JAN 31, 2022, View Source [SID1234607578]). This programme is part of the overall share repurchase programme of up to DKK 20 billion to be executed during a 12-month period beginning 3 February 2021 b.

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Under the programme initiated 5 November 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.7 billion in the period from 11 November 2021 to 1 February 2022.

With the transactions stated above, Novo Nordisk owns a total of 33,301,721 B shares of DKK 0.20 as treasury shares, corresponding to 1.4% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Ember Technologies and Cardinal Health Partner to Transform the Pharmaceutical Cold Chain

On January 31, 2022 Ember Technologies, Inc. (Ember) and Cardinal Health (NYSE: CAH) reported a partnership to offer the world’s first self-refrigerated, cloud-based shipping box–the Ember Cube (Press release, Cardinal Health, JAN 31, 2022, View Source [SID1234607546]). Ember and Cardinal Health will collaborate to deliver a cold chain solution that ensures product integrity and security throughout the supply chain, while significantly reducing shipping waste in the transport of temperature-sensitive medicines.

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The Ember Cube is a digital shipping box that features cloud-based temperature reporting, GPS location tracking, and return-to-sender technology, versus the current industry standard for transporting temperature-sensitive medicine which includes single-use ice packs, Styrofoam, and cardboard. The Ember Cube uses an onboard cellular radio to report real-time temperature and humidity tracking and GPS location information that can be viewed via Ember’s proprietary cloud-based dashboard. This patented technology allows for precision control, so medicines and vaccines arrive at the required temperature range, ready for use.

"Since Ember’s inception, it has been our goal to leverage our temperature control technology to serve the healthcare industry, with the ultimate mission of helping to improve and save lives," said Clay Alexander, Founder and Group CEO of Ember. "We have formed a powerful new partnership with Cardinal Health to codevelop and commercialize many of our patented healthcare industry inventions to bring this vision to life."

Cardinal Health plays a leading and critical role in delivering logistics solutions for specialty pharmaceutical products, which often have unique temperature requirements. As global spending on cold-chain pharmaceutical products grows to more than $21 billion by 20241, it will be increasingly critical to support the market with secure and sustainable cold storage solutions. Through its partnership with Ember, Cardinal Health will leverage its technology infrastructure and national presence as a leading distributor of pharmaceutical and medical products to hospitals, pharmacies, and physician clinics to deploy Ember’s cold chain technology, ensuring patients can access life-saving therapies.

"Cardinal Health is investing in digital solutions and technology to help our healthcare customers solve problems in innovative ways," said Heidi Hunter, President of Cardinal Health Specialty Solutions. "Our partnership with Ember utilizes technology solutions to set a new industry standard for real-time visibility and product integrity, while also providing transformative waste reduction."

"The Ember Cube will be a particularly relevant solution for the many cell and gene therapies that are in the drug development pipeline, due to their temperature sensitivity, high value and need for real-time integrated tracking," added Hunter.

Ember’s return-to-sender technology allows each Ember Cube to be reused hundreds of times, reducing waste, and eliminating single-use packaging. Once a healthcare provider has received its shipment of medicine, the Ember Cube uses its built-in cellular radio to communicate with the shipping service to schedule a pick-up, automatically providing its current GPS location. Once the Ember Cube notifies the shipping service that it is ready to be picked up, it generates a new shipping label on its e-ink screen and is returned to Cardinal Health’s distribution center.

Cardinal Health plans to launch a customer pilot for the Ember Cube in 2022.

Zymeworks Announces Closing of Public Offering and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

On January 31, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the closing of its previously announced underwritten public offering of 11,035,000 common shares, including the exercise in full of the underwriters’ option to purchase 1,875,000 additional shares, and, in lieu of common shares to certain investors, pre-funded warrants to purchase up to 3,340,000 common shares (Press release, Zymeworks, JAN 31, 2022, View Source [SID1234607541]). The common shares were offered at a public offering price of $8.00 per common share and the pre-funded warrants were offered at a public offering price of $7.9999 per pre-funded warrant, which represents the per share public offering price for each common share less the $0.0001 per share exercise price for each pre-funded warrant. The gross proceeds to Zymeworks from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Zymeworks, were approximately $115.0 million.

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Jefferies, Evercore ISI, Stifel and Wells Fargo Securities acted as joint book-running managers for the offering. Raymond James acted as lead co-manager for the offering.

An automatically effective shelf registration statement relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (the "SEC") on October 1, 2021. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected], Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected], or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (833) 690-2713, or by email at [email protected]

No securities were offered or sold, directly or indirectly, in Canada or to any resident of Canada.

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 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.