Cellectis and Servier Execute the Amendment Confirming the Expansion of their Collaboration on UCART19 Products

On March 4, 2020 Cellectis(Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), and Servier, an international pharmaceutical company, reported the execution of the amendment to the agreement initially signed between the two companies in 2014 and modified in 2019 (Press release, Cellectis, MAR 4, 2020, https://www.cellectis.com/en/press/cellectis-and-servier-execute-the-amendment-confirming-the-expansion-of-their-collaboration-on-ucart19-products/ [SID1234555172]). This amendment follows the execution of the binding term sheet announced on February 18, 2020.

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Under this amendment, Cellectis grants to Servier an expanded exclusive worldwide license to develop and commercialize all next generation gene-edited allogeneic CAR T-cell products targeting CD19, including rights to ALLO-501A, an anti-CD19 candidate in which the rituximab recognition domains have been removed, either directly or through its US sublicensee, Allogene Therapeutics.

Financial terms are improved to include an additional USD 27.6 million (EUR 25 million) upfront payment, as well as up to USD 410 million (EUR 370 million) in clinical and commercial milestones. The royalty rate is increased from tiered high single-digit royalties to flat low double-digit royalties based on net sales of products.

In addition, Cellectis regains exclusive control over the five undisclosed allogeneic CAR T-cell targets previously covered by the initial agreement.

About UCART19/ALLO-501 and ALLO-501A

UCART19/ALLO-501 and ALLO-501A are two anti-CD19 allogeneic CAR-T product candidates being jointly developed under a clinical development collaboration between Servier and Allogene Therapeutics based on an exclusive license granted by Cellectis to Servier.

Such products utilize Cellectis’ technologies, including TALEN gene editing technology pioneered and controlled by Cellectis. Servier grants to Allogene exclusive rights to UCART19 in the US while Servier retains exclusive rights for all other countries.

Amunix Raises $73 Million in Series A Financing Led by Omega Funds

On March 4, 2020 Amunix Pharmaceuticals, Inc. ("Amunix"), a biopharmaceutical company focused on developing prodrugs to bring the promise of potent immune-activating biotherapeutics to patients with solid tumor cancers, reported the successful completion of an oversubscribed $73 million Series A financing (Press release, Amunix, MAR 4, 2020, View Source [SID1234555171]). Boston-based Omega Funds led the financing, with participation from existing investor Frazier Healthcare Partners and new investors Longitude Capital, Redmile Group, Polaris Partners, Casdin Capital, Two River, Venrock, and Delian Capital.

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Amunix is focused on advancing a pipeline of novel T cell engagers (XPATs) and cytokines (XPACs) that are selectively activated in the tumor microenvironment and are designed to overcome toxicity and immunogenicity challenges common to both therapeutic classes. Both the XPAT and XPAC platforms leverage the company’s clinically validated XTEN technology, which has demonstrated low immunogenicity, to generate prodrugs.

Amunix plans to utilize the Series A proceeds, along with the $40 million upfront payment from a Roche licensing agreement announced in January 2020, to advance its lead development candidate, AMX-818, an XPAT T cell engager targeting HER2+ solid tumors into the clinic, to progress earlier discovery stage XPAT programs and to initiate XPAC discovery work. The company plans to relocate to South San Francisco later this year to better take advantage of the talent pool.

As part of the Series A financing, Otello Stampacchia, Ph.D., Managing Director and Founder of Omega Funds; David Hirsch, M.D., Ph.D., Managing Director and Founder of Longitude Capital; and James Brush, M.D., Partner at Frazier Healthcare Partners, will join Amunix’s Board of Directors.

"The completion of our Series A financing marks a critical milestone for Amunix, as the investment affords us a significant financial runway to advance our novel pipeline of T cell engagers and cytokines targeting a spectrum of solid tumors," said Angie You, Ph.D., Chief Executive Officer at Amunix. "Biologic immune activators hold tremendous untapped promise to help many cancer patients achieve better outcomes. We are focused on making this promise a reality by leveraging our clinically validated prodrug platform to deliver T cell engager and cytokine therapies that combine potency with an augmented safety profile and unique ability to evade an undesirable immune response. Our XPAT T cell engager platform holds the potential to deliver off-the-shelf therapies capable of redirecting T cells in the body to fight solid tumors."

Dr. Stampacchia commented, "We are delighted to have successfully led this financing for Amunix, especially in the current market environment. We are glad to have attracted a syndicate of sophisticated, long-term investors who are familiar with this ever more important therapeutic modality. We look forward to deploying this important platform to address the limitations of other approaches in the space. We see in Amunix’s next-generation XPAT T cell engager platform a great potential to address the biggest hurdle to bringing the benefits of this class to solid tumor cancers patients: on-target off-tumor toxicity."

Since its founding in 2006, Amunix has operated as a technology licensing company, forging agreements with multiple leading biopharmaceutical companies to leverage XTEN, a proprietary half-life extension technology, and Pro-XTEN, a next-generation prodrug technology. Pro-XTEN utilizes a protease-releasable XTEN polypeptide as a mask, thus enabling localized activation of potent therapies. Pro-XTEN has been clinically validated, with the most advanced program utilizing the technology currently in a pivotal Phase 3 study for a non-oncology indication. Under the leadership of Dr. You, who was appointed CEO in January 2019, Amunix has focused its internal efforts on advancement of the XPAT and XPAC platforms and the company’s proprietary pipeline.

In collaboration with Volker Schellenberger, Ph.D., Amunix’s co-founder and current President and Chief Technology Officer, Dr. You has recruited a high-caliber executive team who brings immuno-oncology experience relevant to the company’s platforms, as well as the necessary expertise to advance its pipeline through approval and launch. In addition to Drs. Schellenberger and You, Amunix’s leadership team includes Mika Derynck, M.D., Chief Medical Officer, formerly Global Head for Cancer Immunotherapy, GI/GU Cancers, Angiogenesis Franchises and China Oncology Development at Genentech; Maninder Hora, Ph.D., Chief Technical Operations Officer, formerly Chief Technical Operations Officer at Nektar Therapeutics; Bryan Irving, Ph.D., Chief Scientific Officer, formerly Chief Scientific Officer at Five Prime Therapeutics; and Darcy Mootz, Ph.D., Chief Business Officer, formerly Chief Business Officer of ORIC Pharmaceuticals.

Avid Bioservices Declares Quarterly Dividend on Its Series E Convertible Preferred Stock

On March 4, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that its Board of Directors has declared a quarterly cash dividend payment on the Company’s 10.50% Series E Convertible Preferred Stock (the "Series E Preferred Stock") (Press release, Avid Bioservices, MAR 4, 2020, View Source [SID1234555170]).

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The quarterly dividend on the Series E Preferred Stock is payable on April 1, 2020 to holders of record at the close of business on March 16, 2020.

The quarterly dividend payment on the Series E Preferred Stock will be $0.65625 per share, which is equivalent to an annualized 10.50% per share, based on the $25.00 per share stated liquidation preference, accruing from January 1, 2020 through March 31, 2020. The Series E Preferred Stock is listed on the NASDAQ Capital Market and trades under the ticker symbol "CDMOP".

AMAG PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

On March 4, 2020 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2019 (Press release, AMAG Pharmaceuticals, MAR 4, 2020, View Source [SID1234555169]). Total revenues for the full year of 2019 totaled $327.8 million, including revenue of $167.9 million from Feraheme (ferumoxytol injection), revenue of $122.1 million from Makena (hydroxyprogesterone caproate injection), and revenue of $21.4 million from Intrarosa (prasterone). The company reported an operating loss of $445.5 million and an adjusted EBITDA loss of $65.0 million in 2019.1

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"Our financial results reported today reflect the successes and challenges of 2019. While we achieved record revenue for Feraheme and gained our third FDA approval in two years, we faced some challenges, namely the readout of the PROLONG study and the October Advisory Committee for Makena," said William Heiden, AMAG’s president and chief executive officer. "We acknowledged the Makena challenges in our recently-completed strategic review, resulting in our decision to divest Intrarosa and Vyleesi. We believe this decision will position the company well to focus on the continuing development of ciraparantag and AMAG-423, drive continued growth of Feraheme, and continue our work to retain patient access to Makena. Preparing for the future, the board of directors has initiated a search for my successor to lead the company on the next leg of the AMAG journey, serving shareholders and patients with unmet medical needs."

Akari Therapeutics, Plc Announces Closing of $9.5 Million Private Placement

On March 4, 2020 Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, reported it had closed its previously announced private placement, issuing an aggregate of 5,620,296 American Depositary Shares (the "ADSs") at $1.70 per ADS for aggregate gross proceeds of approximately $9.5 million to certain accredited and institutional investors, led by existing investors of the Company, including Dr. Ray Prudo, the Company’s Chairman (Press release, Akari Therapeutics, MAR 4, 2020, View Source [SID1234555168]). The offering initially closed on February 25, 2020 and a final closing was held on March 3, 2020. Additionally, for each ADS purchased, the investors received an unregistered warrant to purchase one-half of an ADS. The warrants are immediately exercisable and will expire five years from issuance at an exercise price of $2.20 per ADS.

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Paulson Investment Company, LLC, acted as the exclusive placement agent in connection with this offering.

This press release shall not constitute an offer to sell or the solicitation to buy nor shall there be any sale of the ADSs or warrants 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.

The ADS and warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon exercise of the warrants, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.