On June 11, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has entered into definitive agreements with fundamental healthcare investors for the purchase and sale of 14,000,000 of its shares of common stock at a purchase price of $1.25 per share in a registered direct offering (Press release, Curis, JUN 11, 2020, View Source [SID1234560994]). The closing of the offering is expected to occur on or about June 15, 2020, subject to the satisfaction of customary closing conditions.

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JonesTrading Institutional Services LLC ("JonesTrading") is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be $17.5 million, before deducting the placement agent’s fees and other offering expenses payable by Curis.

Curis intends to use the net proceeds from the public offering, together with its existing cash, cash equivalents and investments, to continue development of CA-4948 and CI-8893, and for general working capital and capital expenditures.

The shares are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the United States Securities and Exchange Commission ("SEC") on May 3, 2018, and declared effective by the SEC on May 17, 2018. A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement. When available, electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing [email protected].

On June 11, 2020 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it has entered into an agreement to divest a portfolio of select non-core over-the-counter (OTC) and prescription pharmaceutical products sold exclusively in Asia Pacific to Celltrion Inc. ("Celltrion"), an Incheon, South Korea-based biopharmaceutical company specializing in the research, development and manufacturing of small molecules, biosimilars and innovative drugs (Press release, Takeda, JUN 11, 2020, View Source [SID1234561010]). Takeda will receive $266 million USD upfront in cash and up to an additional $12 million USD in potential milestone payments, subject to customary legal and regulatory closing conditions.

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The portfolio to be divested to Celltrion includes a variety of OTC products and pharmaceutical products in the Cardiovascular, Diabetes and General Medicine therapeutic areas sold predominantly in Australia, Hong Kong, Macau, Malaysia, Philippines, Singapore, South Korea, Taiwan and Thailand, which are part of Takeda’s Growth & Emerging Markets Business Unit. The portfolio generated FY 2018 net sales of approximately $140 million USD, driven by strong sales of prescription products Nesina and Edarbi. While the products included in the sale continue to play important roles in meeting patient needs in these countries, they are outside of Takeda’s chosen business areas – Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience – that are core to its global long-term growth strategy.

"Across our Growth & Emerging Markets, Takeda must focus on accelerating the commercial availability of our highly innovative medicines for patients living with complex and rare conditions, and expanding our approach to Access to Medicines across the Region," said Ricardo Marek, President, Growth & Emerging Markets Business Unit, Takeda. "Doing so, better addresses patient unmet needs. While we remain committed to Asia Pacific, and the Emerging Markets, divesting non-core products helps achieve those goals."

"This announcement marks continued progress on our commitment to divest non-core products as we remain focused on maintaining our financial discipline and rapid deleveraging following our acquisition of Shire," said Costa Saroukos, Chief Financial Officer, Takeda. "One of several transactions since the launch of the divestment program, the sale announced today will further focus Takeda on our five key business areas and our pipeline of innovative medicines. We look forward to continuing to execute and deliver on Takeda’s financial commitments, including paying down debt and focusing our portfolio."

Takeda has made strong progress on its ongoing divestiture program. In March 2020, Takeda completed sales of non-core assets spanning the Russia-CIS region to STADA for $660 million USD and in countries spanning the Near East, Middle East and Africa region to Acino for $200 million USD. In July 2019, Takeda completed the divestiture of Xiidra to Novartis for up to $5.3 billion USD. Additionally, earlier this year, Takeda announced the sales of non-core products in Latin America to Hypera Pharma for $825 million USD and in Europe to Orifarm Group for up to approximately $670 million USD, including the sale of two manufacturing sites in Denmark and Poland.

Takeda intends to use the proceeds from its divestitures to continue to reduce its debt and accelerate deleveraging toward its target of 2x net debt/adjusted EBITDA within March 2022 – March 2024.

Transaction Details

Takeda has entered into an agreement to sell a portfolio of 18 select OTC and prescription pharmaceutical assets sold in Australia, Hong Kong, Macau, Malaysia, Philippines, Singapore, South Korea, Taiwan and Thailand to Celltrion for a total value of up to $278 million USD. Takeda will receive $266 million USD upfront in cash and up to an additional $12 million USD in potential milestone payments, subject to customary legal and regulatory closing conditions.

Takeda and Celltrion have also entered into a manufacturing and supply agreement under which Takeda will continue to manufacture the portfolio of divested products and supply them to Celltrion. Under the terms of the agreement, Celltrion will acquire the rights, title and interest to the products in the portfolio exclusive to these countries.

The transaction is expected to close by end of the calendar year, subject to the satisfaction of customary closing conditions, receipt of required regulatory clearances and, where applicable, compliance with local works council requirements. Until then, Takeda remains the owner of these products and responsible for ensuring patient access to them.

Takeda is being advised by BofA Securities as its financial advisor and White & Case is its legal advisor in this transaction.

On June 11, 2020 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported the closing of an underwritten public offering of 7,108,796 shares of its common stock, which included 927,324 shares that were issued pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $28.31 per share (Press release, Fate Therapeutics, JUN 11, 2020, View Source [SID1234560995]). Aggregate gross proceeds from this offering, including exercise of the option, were approximately $201.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, including the construction, commissioning and qualification of its new facility, the conduct of preclinical research and development, and for general corporate purposes.

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Subject to the expiration or early termination of applicable waiting periods relating to certain antitrust filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the Company also expects to sell to Johnson & Johnson Innovation-JJDC, Inc. in a private placement, 1,766,160 shares of common stock for an aggregate purchase price of approximately $50.0 million, at a price per share equal to the price to the public in the underwritten public offering.

Jefferies, SVB Leerink, Barclays and Guggenheim Securities acted as joint book-running managers for the offering. Mizuho Securities acted as lead manager for the offering, and H.C. Wainwright & Co. acted as co-manager for the offering.

The securities described above were offered by Fate Therapeutics pursuant to a shelf registration statement on Form S-3 (File No. 333-228513) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A final prospectus supplement related to the offering was filed with the SEC with a filing date of June 10, 2020 and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the securities offered may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 547-6340; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6218 or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847 or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

On June 11, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the 2020 Raymond James Human Health Innovation Conference on June 18, 2020 at 9:40 am Eastern Time (Press release, Lineage Cell Therapeutics, JUN 11, 2020, View Source [SID1234561011]). Interested investors can access the live presentation on the Events and Presentations section of Lineage’s website.

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The archived presentation will be posted on the Events and Presentations section of Lineage’s website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

On June 11, 2020 Immunomic Therapeutics, Inc. reported that it will present preclinical data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses when used with its investigational UNITE vaccine, ITI-3000, in mice (Press release, Immunomic Therapeutics, JUN 11, 2020, View Source [SID1234560996]). UNITE fuses a tumor-associated antigen, here a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV), with lysosomal-associated membrane protein 1 (LAMP1). This lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response, as ITI-3000 activated antigen-specific CD4+ T cells in vivo. The data will be presented at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II, June 22-24, 2020.

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"ITI-3000 is an innovative and novel targeted approach to a MCPγV vaccine," says Teri Heiland, Ph.D., Immunomic’s Chief Scientific Officer. "We are highly encouraged by this data and look forward to continuing to advance ITI-3000 toward the clinic."

The majority of Merkel cell carcinomas (MCC) are associated with Merkel cell polyomavirus (MCPyV) infection, making LT an attractive target for therapeutic cancer vaccines. MCPγV integrates into the host genome, resulting in expression of a truncated form of the viral LT in infected cells. While induction of tumor-reactive CD8+ T cells is a major goal of cancer therapy, CD4+ T cells provide essential support to CD8+ T cells by promoting their expression of cytotoxic effector molecules and increasing their migratory capacity. Cytokines secreted by CD4+ T cells, such as IFNγ, can also exert desirable effects on the tumor microenvironment. Hence, a cancer vaccine that promotes potent, antigen-specific CD4+ T cell responses to MCPγV-LT may drive robust anti-tumor immune responses.

Poster Title: LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses and prevents tumor growth

Session Category: Immunology

Session Type: Poster Session

Session Title: Vaccines

Poster Number: 4585

Poster Session Date and Time: June 22, 2020 9AM-6PM

Location: Virtual Poster Presentation

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.