On July 12, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported it has reached a key milestone on the path to commercialization of Rhenium-186 NanoLiposome (186RNL) as the Company completed the technology transfer and initiation of cGMP manufacturing of the 186RNL drug intermediate with Piramal Pharma Solutions (PPS) (Press release, Cytori Therapeutics, JUL 12, 2022, View Source [SID1234616607]). Additionally, the intermediate drug product is in stability testing and compliant with U.S. Food and Drug Administration (FDA) guidance for manufacture of liposomal products for use in late-stage clinical trials and commercialization.

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In early 2021, Plus Therapeutics entered into a master services agreement with PPS for the development, manufacture and supply of the Company’s 186RNL drug intermediate product and has now completed the associated technology transfer of analytical test methods and development activities with PPS.

"The Company has met another significant CMC milestone by having fully compliant 186RNL intermediate, and is on time and on budget to have GMP drug availability in the second half of 2022 for ongoing and planned clinical trials in adults with recurrent glioblastoma, leptomeningeal metastases and future disease targets," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Furthermore, in the third quarter of 2022, we plan to issue specific guidance on feedback obtained from two FDA meetings, one based on potential acceptability of Plus Therapeutics’ CMC package and one for feedback on our future plans for clinical development of 186RNL for recurrent glioblastoma."

On July 12, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, reported that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor to issue 1,774,309 shares of common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to an aggregate of 1,774,309 shares of common stock and Series B warrants to purchase up to an aggregate of 1,774,309 shares of common stock, at a purchase price of $2.818 per share of common stock (or pre-funded warrant) and associated warrants, in a private placement priced at-the-market under Nasdaq rules, for expected gross proceeds to Histogen of approximately $5 million, before deducting placement agent fees and other offering expenses payable by the Company (Press release, Conatus Pharmaceuticals, JUL 12, 2022, View Source [SID1234616606]).

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

Each share of common stock (or pre-funded warrant) was sold in the private placement together with a Series A warrant to purchase one share of common stock and a Series B warrant to purchase one share of common stock. The Series A warrants have an exercise price of $2.568 per share of common stock, will be exercisable commencing immediately upon issuance for a period of five and one-half years from the date of issuance. The Series B warrants have an exercise price of $2.568 per share of common stock, will be exercisable commencing immediately upon issuance for a period of eighteen months from the date of issuance.

The closing of the private placement is expected to occur on or about July 15, 2022, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The Company also has agreed that certain warrants to purchase an aggregate of 447,800 shares of common stock of the Company that were issued to such investor in November 2020 through December 2021 with exercise prices ranging from $8.50 to $34.00 per share and expiration dates ranging from May 18, 2026 to June 21, 2027, will be amended, among others, to have a reduced exercise price of $2.568 per share, will expire five and one-half years following the closing of the private placement, at an additional offering price of $0.0316 per amended warrant.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities 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. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of common stock to be issued to the investors (including the shares of common stock issuable upon the exercise of the warrants) no later than 15 days and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 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.

On July 12, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that an article highlighting preclinical data from BT7480, a Bicycle tumor-targeted immune cell agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137 (4-1BB), was published in the Journal of Medicinal Chemistry (Press release, Bicycle Therapeutics, JUL 12, 2022, View Source [SID1234616605]). The article, titled "Discovery and Optimization of a Synthetic Class of Nectin-4-Targeted CD137 Agonists for Immuno-oncology" is available at the publications section of the Bicycle website at this link.

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"CD137 is a co-stimulatory receptor on immune cells that can drive anti-tumor immunity and Nectin-4 is a cell adhesion molecule that is overexpressed in a wide range of solid tumors. We discovered BT7480 by using a series of novel Bicycles targeting CD137, which were conjugated to novel Bicycles targeting Nectin-4," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "The work that was published today demonstrated our goal to discover a Nectin-4-targeted CD137 agonist clinical candidate with unique properties – small size, dependency on binding to Nectin-4 bearing tumor cells for activity and very potent CD137 agonism. Furthermore, we engineered the molecule so that it could be dosed once a week in the clinic. We deployed a multipronged approach to optimize the molecule’s affinity to both targets, linker length, binder stoichiometry, solubility, and pharmacokinetic properties. By exploring the valency of the Bicycles in rodent studies, it was demonstrated that the 1:2 format Nectin-4/CD137 may lead to promising immune response in solid tumors. BT7480 is currently in Phase I development with dose escalation ongoing."

On July 12, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the second quarter of 2022 after the market close on Monday, August 8th, 2022 (Press release, Akoya Biosciences, JUL 12, 2022, View Source [SID1234616604]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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Investors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

On July 12, 2022 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, reported that effective August 8, 2022, Jackie Fouse, Ph.D., will transition to the role of chair of the board of directors and Brian Goff will assume the role of chief executive officer (Press release, Agios Pharmaceuticals, JUL 12, 2022, View Source [SID1234616603]). Mr. Goff will also serve as a member of Agios’ board of directors. Current chairman, David Schenkein, M.D., will remain on the board as a director.

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"Throughout our history, Agios has engaged in deliberate and thoughtful long-term planning to drive positive impact for our people and patients. The team’s consistent execution – reflected in the divestiture of our oncology portfolio, the approval of our first genetically defined disease medicine and the initiation of pivotal trials in thalassemia and sickle cell disease – put Agios in a position of strength and great promise for the future," said Dr. Fouse. "The time is right to evolve our leadership and deepen our genetically defined disease skill set to further drive our ability to develop life-changing treatments. Brian’s strong track record of leading rare disease product launches to drive their impact for patients, building and scaling companies’ rare disease capabilities and leading high-performing, diverse teams with strong cultures make him the right next leader for Agios. I look forward to working with him closely as he transitions into his new role and as I continue my commitment to Agios as chair of the board."

"I am delighted and honored to lead Agios at this incredibly exciting time and to have the opportunity to advance its purpose of bringing meaningful new therapies to people with genetically defined diseases," said Mr. Goff. "Rare and genetically defined diseases have been my focus and passion for the past decade, and Agios is well positioned to profoundly change patients’ lives across a variety of diseases with the recent launch of PYRUKYND in adult PK deficiency, a promising clinical and preclinical pipeline based on our expertise in cellular metabolism and our talented and dedicated team. I am grateful to Jackie for serving as our new board chair as we carry forward the momentum and the patient-oriented culture she has strengthened at Agios."

Mr. Goff joins Agios with more than thirty years of experience in the biopharmaceutical industry. Most recently he was executive vice president, chief commercial and global operations officer at Alexion Pharmaceuticals, where he was responsible for leading the global commercial and operations teams prior to the company’s acquisition by AstraZeneca in July 2021. Before joining Alexion, Mr. Goff was chief operating officer and a member of the board of directors of Neurovance. Prior to joining Neurovance, Mr. Goff served as Baxalta’s executive vice president and president of the hematology division. He previously served with Baxter Healthcare Corporation as global hemophilia franchise head. Earlier in his career, Mr. Goff held positions of increasing responsibility in sales and marketing with Novartis Pharmaceuticals and the pharmaceutical division of Johnson & Johnson. Mr. Goff has an MBA from the Wharton School at the University of Pennsylvania and a Bachelor of Arts from Skidmore College.

Dr. Fouse joined Agios as a member of the board of directors in 2017 and has served as chief executive officer since 2019. She led the company’s strategic pivot to focus on developing and commercializing innovative treatments for genetically defined diseases. In February 2022, the U.S. Food and Drug Administration (FDA) approved the company’s first genetically defined disease product, PYRUKYND (mitapivat), for the treatment of hemolytic anemia in adults with PK deficiency, the first disease-modifying therapy for this rare, debilitating, lifelong blood disease. Through Jackie’s orchestration of the sale of the company’s commercial, clinical and research-stage oncology portfolio to Servier, Agios received an upfront payment of $1.8 billion, with $200 million in potential future milestone payments. This transaction strengthened the balance sheet and positioned the company to accelerate and advance its genetically defined disease portfolio.

"At every step of Agios’ journey, our board and leadership team give careful consideration to what should come next for the company. With the appointment of Brian, we are putting in place the right next CEO who possesses the experience in rare and genetically defined diseases, including hematology, to drive our strategy forward and deepen our ability to deliver for patients and shareholders," said Dr. Schenkein, current chairman of the Agios board of directors. "Thanks to Jackie’s leadership, Agios is well positioned for its next chapter. She successfully shifted the company focus to genetically defined diseases, strengthened our balance sheet, achieved our first FDA approval in our hemolytic anemia program, continued to foster a culture of connections and respect and thoughtfully addressed issues of social justice. On behalf of the entire board of directors, I want to thank Jackie for her incredible leadership and commitment to patients; she will undoubtedly continue to provide Agios and Brian with valuable strategic guidance and perspective as she takes on the role of chair of the board of directors."

Conference Call Information
Agios will host a virtual investor webcast today at 4:30 p.m. ET with Jackie Fouse and Brian Goff to discuss Agios’ CEO transition. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.