Precision BioSciences Enters Into Private Convertible Note Financing

On January 16, 2019 Precision BioSciences ("Precision" or the "Company"), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS genome editing platform, reported that it has entered into an agreement for the issuance and sale of convertible promissory notes in a private placement transaction in the aggregate principal amount of approximately $40 million, which will bring the Company’s total capital generated in the last year to over $150 million and total funding since inception to over $300 million (Press release, Precision Biosciences, JAN 16, 2019, View Source [SID1234534181]). Contributors to this financing were largely first-time investors in the Company.

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Investors in Precision now include ArrowMark Partners, Franklin Templeton, Cowen Healthcare Investments, venBio, F-Prime, RA Capital Management, Brace Pharma Capital, Pontifax AgTech, OCV Partners, DSAM, Adage Capital Management, Cormorant Asset Management, Gilead Sciences, Laurion Capital Management, Vivo Capital, Lilly Asia Ventures, Alexandria Venture Investments, Ridgeback Capital, Ditch Plains Capital Management, Agent Capital, entities affiliated with Leerink Partners, Amgen Ventures, Osage University Partners, DUMAC and the Longevity Fund.

Entry into a Material Definitive Agreement

On January 19, 2019 On January 19, 2019, Shanghai Cellular Biopharmaceutical Group Ltd. ("CBMG Shanghai"), a controlled entity of Cellular Biomedicine Group, Inc. (the "Company"), reported that it has entered into a credit agreement (the "Credit Agreement") with China Merchants Bank, Shanghai Branch (the "Merchants Bank") (Filing, 8-K, Cellular Biomedicine Group, JAN 19, 2019, View Source [SID1234532905]). Pursuant to the Credit Agreement, the Merchants Bank agreed to extend credit of up to RMB 100 million (approximately $14.7 million) to CBMG Shanghai via revolving and/or one-time credit lines. The types of credit available under the Credit Agreement, include, but not limited to, working capital loans, trade financing, commercial draft acceptance, letters of guarantee and derivative transactions. The credit period under the Credit Agreement runs until December 30, 2019. As of the date of this Current Report on Form 8-K, no amounts had been drawn down under the Credit Agreement.

Pursuant to the Credit Agreement, CBMG Shanghai will enter into a supplemental agreement with the Merchants Bank prior to the applicable drawdown that will set forth the terms of each borrowing thereunder (except for working capital loans), including principal, interest rate, term of loan and use of borrowing proceeds. With regard to working capital loans to be provided pursuant to the Credit Agreement, CBMG Shanghai shall submit a withdrawal application that includes the principal amount needed, purposes of the loan and a proposed quarterly interest rate and term of the loan for the Merchants Bank’s review and approval. The terms approved by the bank will govern such working capital loans. The bank has the right to adjust the interest rate for working capital loans from time to time based on changes in national policy, changes in interest rate published by the People’s Bank of China, credit market conditions and the bank’s credit policies. Upon CBMG Shanghai’s non-compliance with the agreed use of loan proceeds, the interest rate for the amount of loan proceeds improperly used will be the original rate plus 100% starting on the first day of such use. If CBMG Shanghai fails to pay a working capital loan on time, an extra 50% interest will be charged on the outstanding balances starting on the first day of such default.

Under the Credit Agreement, CBMG Shanghai has the obligation to notify the Merchants Bank prior to certain corporate actions and assist the bank in taking measures to ensure repayment of the loans provided under the Credit Agreement upon occurrence of such events. Such corporation actions include: (i) major financial losses and assets losses, (ii) loans to or guarantees for third parties or mortgages on its properties, (iii) revocation or cancellation of business license or applications for bankruptcy, (iv) major operational or financial crises of its controlling shareholder or other related entities that affect its business operations, (v) related party transactions that involve 10% or more of CBMG Shanghai’s net assets and (vi) legal proceeding that have material adverse effects on its operations or financial condition. Pursuant to the Credit Agreement, CBMG Shanghai cannot enter into a merger, an acquisition or a joint venture, transfer its equity interest or consummate a reorganization or share ownership restructuring without prior written consent of the Merchants Bank. The Credit Agreement also contains a covenant requiring that CBMG Shanghai maintain or improve its existing operations and preserve or increase the value of its existing assets.

Events of default under the Credit Agreement include, among other matters, CBMG Shanghai’s failure to perform its obligations thereunder, untrue or inaccurate representations, use of loan proceeds for purposes that are inconsistent with the Credit Agreement or related agreements. Additionally, a default under any other loan agreement of CBMG Shanghai that is not cured within three months of such default shall be deemed an event of default under the Credit Agreement. Upon the occurrence of an event of default, the Merchant Bank has the right to reduce the credit available under the Credit Agreement, suspend the use of the remaining credit by CBMG Shanghai and declare all outstanding balance to become immediately due and payable.

Pursuant to a pledge agreement which became enforceable upon execution of the Credit Agreement, Cellular Biomedicine Group Ltd. (HK), a wholly owned subsidiary of the Company ("CBMG HK"), provided a guarantee of CBMG Shanghai’s obligations under the Credit Agreement. In connection with such guarantee, CBMG HK deposited $17,000,000 into its account at the Merchants Bank for a 12-month period starting January 7, 2019 and also granted the Merchants Bank a security interest in the cash deposited.

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Stemline Therapeutics Closes $92 Million Public Offering of Common Stock

On January 18, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported the closing of a previously announced underwritten public offering of 10,222,222 shares of its common stock, which included the exercise in full of the option to purchase 1,333,333 additional shares, at a price of $9.00 per share (Press release, Stemline Therapeutics, JAN 18, 2019, View Source [SID1234532779]). The gross proceeds to Stemline from the offering, including the exercise of the option to purchase additional shares, before deducting underwriting discounts, commissions and other offering expenses payable by Stemline, were $92 million.

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J.P. Morgan Securities LLC and Cowen and Company, LLC acted as joint book-running managers for the offering. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC acted as co-lead managers and Roth Capital Partners, LLC, ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, National Securities Corporation, and Aegis Capital Corp. acted as co-managers for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL‑401) including clinical trials for additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other diseases; (ii) clinical development of SL‑801, SL‑701 and potentially SL-901; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.
Stemline has filed a prospectus supplement to its shelf registration statement on Form S-3 (File No. 333-219794) with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. The prospectus supplement is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by email at [email protected].

The offering of these securities was made under an effective shelf registration statement on file with the SEC. 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 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.

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other diseases

Bausch Health Companies Inc. Will Release Fourth-Quarter And Full-Year 2018 Financial Results On February 20

On January 18, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its fourth-quarter and full-year 2018 financial results on Wednesday, Feb. 20, 2019 (Press release, Valeant, JAN 18, 2019, View Source [SID1234532780]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EST to discuss the results and provide a business update . All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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Conference Call Details

Date:

Wednesday, Feb. 20, 2019

Time:

8:00 a.m. EST

Webcast:

View Source

Participant Event Dial-in:

+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)

Participant Passcode:

4514727

Replay Dial-in:

+1 (877) 344-7529 (North America)

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)

Replay Passcode:

10127646 (replay available until Feb. 27, 2019)

Obsidian Therapeutics Announces Strategic Collaboration with Celgene to Develop Novel Cell Therapies with Tunable Immunomodulatory Factors, Opening Potential for CAR-T and Other Cellular Medicines in New Settings

On January 18, 2019 Obsidian Therapeutics, a biotechnology company developing cell therapies with pharmacologic operating systems, reported a strategic collaboration with Celgene Corporation (NASDAQ: CELG) for the discovery and development of novel, regulated cell therapies that utilize Obsidian’s Destabilizing Domain (DD) technology (Press release, Obsidian Therapeutics, JAN 18, 2019, View Source [SID1234532782]). Specifically, the collaboration is based on Obsidian’s DD technology for the controlled expression of two immunomodulatory factors, IL12 and CD40L, that have the potential to augment the power of adoptive cell therapies but require precise control to optimize their therapeutic benefit.

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This multi-year collaboration provides Celgene with the exclusive option to in-license worldwide rights for cell therapy candidates that incorporate DD-regulated IL12 or CD40L for the treatment of cancer. The collaboration includes an upfront payment and equity investment by Celgene, and potential future milestone and royalty payments.

"Obsidian’s technology has the potential to unlock the activity of cell therapy in a number of new settings, particularly against solid tumor malignancies, and this is a prime example of the new technologies that we see enabling broader applications for CAR-T and cell therapies for the treatment of cancer," said Robert Hershberg, MD, PhD, Executive Vice President, Business Development & Global Alliances for Celgene Corporation. "We value the innovation that the Obsidian team can bring and we look forward to working together to bring powerful new immunotherapies to patients."

This strategic agreement is Obsidian’s first collaboration with a major pharmaceutical company to deploy its DD technology. Obsidian’s technology enables integration and precise pharmacologic control of potent new activities in cell therapies and offers additional capabilities to Celgene’s portfolio of cellular immunotherapies for cancer.

"This collaboration focuses the Obsidian team on product development, accelerates the advance of our innovative technology toward clinical applications, and positions us to expand our own platform and portfolio," said Michael Gilman, PhD, CEO of Obsidian. "We are thrilled to be partnering with Celgene and will benefit from their capabilities in the development and commercialization of cancer medicines. We share an ambitious vision of the potential for cell therapy to benefit patients with cancer and look forward to working together with the Celgene team to realize it."

About Obsidian’s Destabilizing Domain Technology

Obsidian is developing cell therapies that incorporate Destabilizing Domains (DDs) to regulate expression of immunomodulatory factors, thereby providing precise pharmacologic control of the potent activity of these agents to optimize their safety and efficacy in engineered cell therapies. DDs are small, human protein domains that confer conditional stability to a fused payload protein that is engineered into a cell or gene therapy product. In the absence of a specific small-molecule ligand, the fusion protein is rapidly degraded, whereas in the presence of the ligand the fusion protein becomes stable and functional. Obsidian uses this approach to equip engineered cell therapies with controllable functions that can be precisely and dynamically tuned by the administration of small-molecule medicines that are currently approved, readily available, and can be dispensed by the treating physician.