LEADING CELL THERAPY BIOTECH COMPANY CHOOSES RESEARCH TRIANGLE FOR ITS NORTH AMERICAN R&D AND MANUFACTURING FACILITY

On May 20, 2021 CARsgen Therapeutics Corporation, an innovative biotechnology company pursuing medicines to treat cancer reported that it will create approximately 200 jobs and invest $157 million in Durham, Governor Roy Cooper (Press release, Carsgen Therapeutics, MAY 20, 2021, View Source [SID1234580460]). The company’s selection of the Research Triangle area will establish its first biomanufacturing site in North America. CARsgen Therapeutics currently has its U.S. clinical development operations in Houston, Texas.

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"Global companies know that North Carolina is a world class leader in biotechnology," said Governor Cooper. "Our state’s skilled workers, educational institutions and business environment provide life science companies with the tools they need to succeed."

CARsgen Therapeutics Corporation, a wholly-owned subsidiary of CARsgen Therapeutics Holdings Limited, is a clinical stage biotechnology company specializing in what’s known as chimeric antigen receptor (CAR) T cell therapies, a type of therapy that engages people’s immune systems in a new way. The therapeutic approach can yield medicines for various human cancers, including leukemia, lymphoma, and solid tumors. The company’s project in North Carolina will establish a 37,000 square foot clinical/early-stage commercial manufacturing facility and then a 100,000 square foot cGMP commercial manufacturing facility in Durham that will eventually produce FDA approved cell therapies.

"We are very excited to receive the JDIG grant approval from the State of North Carolina," said Dr. Zonghai Li, CEO, CSO and Chairman of CARsgen Therapeutics. "CARsgen will continuously develop and embed innovations to advance the revolutionary CAR-T cell therapy for unmet clinical needs. The company has launched clinical studies of our leading CT053 and CT041 CAR-T cell therapies in the United States. The new facilities will expand our global cGMP manufacturing capacity to produce the innovative CAR-T cell products for the U.S. patients."

"It’s exciting to see a company at the cutting-edge of science join our growing biotech industry cluster," said North Carolina Commerce Secretary Machelle Baker Sanders. "From companies exploring gene therapies to the innovative work CARsgen is conducting with immune-oncology, there’s no question that North Carolina will continue to play an important role in the future of this industry and the many lives of those impacted by the life sciences sector."

Although wages will vary by job position, the aggregate average salary of the new positions will reach $76,061, bringing a payroll impact of $15.2 million to the region each and every year. The current average wage in Durham County is $75,892.

CARsgen Therapeutics’ project in North Carolina will be facilitated, in part, by a Job Development Investment Grant (JDIG) approved by the state’s Economic Investment Committee earlier today. Over the course of the 12-year term of this grant, the project is estimated to grow the state’s economy by $1.04 billion. Using a formula that takes into account the new tax revenues generated by the 200 new jobs, the JDIG agreement authorizes the potential reimbursement to the company of up to $1,616,250, spread over 12 years. Over the 12 years, those state tax revenues will exceed $31.1 million.

State payments only occur following performance verification by the departments of Commerce and Revenue that the company has met its incremental job creation and investment targets. JDIG projects result in positive net tax revenue to the state treasury, even after taking into consideration the grant’s reimbursement payments to a given company.

CARsgen’s JDIG agreement also could move as much as $538,750 into the state’s Industrial Development Fund – Utility Account for use by rural communities elsewhere in the state. The Utility Account helps finance necessary infrastructure upgrades in more economically challenged areas of the state to attract future business.

"Durham attracts the most innovative companies in the world and today’s decision continues that positive trend," said N.C. Representative Zack Hawkins. "We welcome these new jobs and the talent they will bring to our area and look forward to the life-saving medicines these employees will bring to people in need."

"Research Triangle Park broke records as one of the nation’s first research parks, but I’m proud we didn’t rest on our laurels," said N.C. Senator Natalie Murdock. "It’s great to see this treasured resource continue to grow and renew itself by attracting new ideas and companies to our area."

Partnering with the North Carolina Department of Commerce and the Economic Development Partnership of N.C. on this project were the North Carolina General Assembly, the North Carolina Community College System, the North Carolina Biotechnology Center, Duke Energy, the City of Durham, Durham County and the Greater Durham Chamber of Commerce.

Checkmate Pharmaceuticals to Present at the Jefferies 2021 Virtual Healthcare Conference

On May 20, 2021 Checkmate Pharmaceuticals Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that Barry Labinger, CEO, will present at the Jefferies Virtual Healthcare Conference from 2:00-2:25pm ET on Tuesday, June 1, 2021 (Press release, Checkmate Pharmaceuticals, MAY 20, 2021, View Source [SID1234580446]). Checkmate will also host 1×1 investor meetings during the conference.

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Checkmate website. An archived copy of the webcast will be available on the Checkmate website for approximately 30 days after the event.

Seelos Therapeutics Announces Pricing of $60 Million Public Offering of Common Stock

On May 20, 2021 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders and rare diseases, reported the pricing of an underwritten public offering of 19,354,840 shares of its common stock, at a price to the public of $3.10 per share (Press release, Apricus Biosciences, MAY 20, 2021, View Source [SID1234580445]). In addition, the Company granted the underwriters a 30-day option to purchase up to 2,903,226 additional shares of its common stock. All of the shares of common stock in the offering are being sold by Seelos.

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Guggenheim Securities and Cantor are serving as joint book-running managers for the offering. BTIG is serving as lead manager for the offering. The Benchmark Company acted as a financial advisor for the offering.

Seelos anticipates the aggregate net proceeds from the offering will be approximately $56.1 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by Seelos, but excluding any exercise of the underwriters’ option to purchase additional shares of common stock. Seelos intends to use an aggregate of $6.3 million of the net proceeds from the offering for the partial repayment of certain outstanding convertible promissory notes and the remainder for general corporate purposes and to advance the development of its product candidates. This offering is expected to close on or about May 24, 2021, subject to the satisfaction of customary closing conditions.

The securities described above were offered by Seelos pursuant to an effective "shelf" registration statement on Form S-3 (File No. 333-251356) previously filed with the Securities and Exchange Commission (the "SEC") on December 15, 2020, amended on December 22, 2020 and declared effective by the SEC on December 23, 2020. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by calling (212) 518-9544 or by e-mail at [email protected].

This press release does 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 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 jurisdiction.

Entry into a Material Definitive Agreement

On May 20, 2021, Pieris Pharmaceuticals, Inc. (the "Company") and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P. (collectively, "BVF") reported that entered into an Exchange Agreement (the "Exchange Agreement") pursuant to which BVF agreed to exchange (the "Exchange") an aggregate of 5,000,000 shares of the Company’s common stock, par value $0.001 ("Common Stock"), owned by BVF for an aggregate of 5,000 shares of the Company’s newly-designated Series E Convertible Preferred Stock, a "toothless" preferred stock, par value $0.001 per share ("Series E Preferred Stock") (Filing, 8-K, Pieris Pharmaceuticals, MAY 20, 2021, View Source [SID1234580441]). The Exchange closed on May 21, 2021.

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As described below, the Series E Preferred Stock has substantially the same terms as the Company’s Series D Convertible Preferred Stock, par value $0.001 per share ("Series D Preferred Stock"), issued in March 2020; Series C Convertible Preferred Stock, par value $0.001 per share ("Series C Preferred Stock"), issued in November 2019; Series B Convertible Preferred Stock, par value $0.001 per share ("Series B Preferred Stock"), issued in January 2019; and Series A Convertible Preferred Stock, par value $0.001 per share ("Series A Preferred Stock"), issued in June 2016, all currently held by entities affiliated with BVF. The shares of Series E Preferred Stock issued in the Exchange are convertible into an aggregate of 5,000,000 shares of Common Stock (subject to adjustment as provided in the Series E Certificate of Designation, as defined below), subject to a 9.99% beneficial ownership blocker provision described below.

As of the date of the Exchange Agreement, BVF represented to the Company that it beneficially owned 5,872,762 shares of Common Stock, representing approximately 9.28% of the shares of Common Stock outstanding as of such date. In addition, BVF holds (i) 2,907 shares of Series A Preferred Stock, which are convertible into 2,907,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series A Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series A Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series A Certificate of Designation; (ii) 5,000 shares of Series B Preferred Stock, which are convertible into 5,000,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series B Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series B Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series B Certificate of Designation; (iii) 3,522 shares of Series C Preferred Stock, which are convertible into 3,522,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series C Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series C Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series C Certificate of Designation; and (iv) 3,000 shares of Series D Preferred Stock, which are convertible into 3,000,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series D Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series D Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series D Certificate of Designation.

A copy of the Exchange Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference. The foregoing is only a brief description of the material terms of the Exchange Agreement, does not purport to be complete and is qualified in its entirety by reference to the full text of the Exchange Agreement. The representations, warranties and covenants made by the Company in the Exchange Agreement were made solely for the benefit of the parties to the Exchange Agreement, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to investors. Moreover, such representations, warranties or covenants were made as of May 20, 2021. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of the Company’s affairs

Immutep announces publication of TACTI-002 and INSIGHT-004 abstracts for ASCO 2021 Annual Meeting

On May 20, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported that data from its TACTI-002 and INSIGHT-004 studies have been published in abstracts available via the links below on the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting’s official website (Press release, Immutep, MAY 20, 2021, View Source [SID1234580430]).

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Poster presentations with new and updated data that are not part of the abstracts will be available on ASCO (Free ASCO Whitepaper).org from 9 am on 4 June 2021 US Eastern time and made available on Immutep’s website at www.immutep.com.

TACTI-002

Title: Results from a phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected metastatic non-small cell lung carcinoma.

Abstract: View Source

Title: Results from a phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected metastatic second- line squamous head and neck carcinoma.
Abstract: View Source

INSIGHT-004

Title: Phase I INSIGHT platform trial: Advanced safety and efficacy data from stratum D evaluating feasibility and safety of eftilagimod alpha (soluble LAG-3 protein) combined with avelumab in advanced solid tumors.
Abstract:  View Source;

About American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Conference
ASCO’s annual meeting represents the world’s largest gathering of oncology physicians, industry representatives, researchers, patient advocates, and investment analysts to discuss cutting-edge clinical research and therapeutics in oncology, and to gain insights for improving cancer care. For additional information on the 2021 ASCO (Free ASCO Whitepaper)’s Annual meeting, please visit View Source

About TACTI-002
TACTI-002 (Two ACTive Immunotherapies) is a Phase II clinical trial being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in up to 183 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

About INSIGHT-004 (also known as INSIGHT Stratum D)
INSIGHT-004 is a Phase I clinical trial and is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being conducted under Immutep’s collaboration with Merck KGaA and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II dose of efti when given in combination with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancers. Avelumab is co-developed and co-commercialised by Merck KGaA, Darmstadt, Germany and Pfizer Inc.