On March 31, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) ("CTI"), a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers, reported the pricing of its previously announced underwritten public offering of 14,260,800 shares of its common stock and 600 shares of its series X1 preferred stock (the "Series X1 Preferred") (Press release, CTI BioPharma, MAR 31, 2021, View Source [SID1234577458]). In addition, CTI has granted the underwriters a 30-day option to purchase up to an additional 2,139,120 shares of its common stock on the same terms and conditions. The offering price to the public of a share of common stock is $2.50 and the offering price to the public of a share of Series X1 Preferred Stock is $25,000. Each share of Series X1 Preferred will be convertible into 10,000 shares of common stock at the election of the holder, subject to beneficial ownership conversion limits applicable to the Series X1 Preferred.

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All of the securities in the offering are being sold by CTI. The gross proceeds to CTI from this underwritten public offering are expected to be approximately $50.7 million, before deducting the underwriting discount and other estimated offering expenses payable by CTI. The offering is expected to close on or about April 6, 2021, subject to the satisfaction of customary closing conditions.

CTI intends to use the proceeds from the proposed sale of its shares of common stock and Series X1 Preferred Stock for commercialization activities for pacritinib, general working capital and corporate purposes.

Stifel and JMP Securities are acting as joint book-running managers for the offering. BTIG is acting as lead manager for the offering.

The offering is being made pursuant to a registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and subsequently was declared effective by the SEC. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus relating to these securities may be obtained by sending a request to Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery St, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected], or JMP Securities LLC, 600 Montgomery St, Suite 1100, San Francisco, CA 94111, Attn: Prospectus Department, telephone: 415-835-8900.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will 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 March 31, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the completion of its previously-announced sale of a portfolio of select products to Orifarm Group ("Orifarm") for a total value of up to $670 million USD (Press release, Takeda, MAR 31, 2021, View Source [SID1234577457]). The portfolio includes approximately 130 over-the-counter (OTC) and prescription pharmaceutical products sold in Europe, and two manufacturing sites located in Denmark and Poland. This divestment agreement was first announced in April 2020.

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The divested portfolio includes OTC products and food supplements, plus select products within the Cardiovascular, Anti-inflammatory, Respiratory, and Endocrinology therapeutic areas, primarily sold in Denmark, Norway, Belgium, Poland, Finland, Sweden, the Baltics and Austria. The portfolio generated FY2020 net sales of approximately $240 million USD, driven by sales of cough/cold and vitamin OTC brands, along with prescription products such as Warfarub and Levaxin, and other strong regional brands. The products, while addressing key patient needs in these countries, are outside of the business areas Takeda has chosen as core to its global long-term growth.

As previously announced, Takeda and Orifarm have also entered into manufacturing and supply agreements under which Takeda will continue to manufacture select products on behalf of Orifarm. In addition, approximately 600 employees from the manufacturing sites, sales and marketing professionals and others supporting the divested portfolio and manufacturing sites have transitioned to Orifarm.

Takeda remains focused on executing its long-term growth strategy to optimize our business mix around our key business areas, and simplifying our operations to better serve patients by delivering innovative treatments in these areas.

The Company intends to use the proceeds from the sale to reduce its debt and accelerate deleveraging towards its target of 2x net debt/adjusted EBITDA within Fiscal Years 2021–2023.

Takeda has exceeded its $10 billion non-core asset divestiture target and has announced 12 deals since January 2019 to date for a total aggregate value of up to approximately $12.9 billion.

On March 31, 2021 Kiromic BioPharma (NASDAQ: KRBP), a pre-clinical stage biotechnology company using its proprietary DIAMOND artificial intelligence ("A.I.") platform to improve drug discovery and development with a therapeutic focus on immune-oncology, reported its financial results for the year ended December 31, 2020, and provided an update on its corporate developments (Press release, Kiromic, MAR 31, 2021, View Source [SID1234577456]).

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"Kiromic BioPharma achieved important scientific and operational milestones during the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing in Q3 2021," said Dr. Maurizio Chiriva-Internati, CEO and President of Kiromic BioPharma. "We are thankful to our employees and collaborators who have maintained this high level of execution in the middle of the hard challenges posed by the COVID-19 pandemic."

Our approach and goal is to defeat cancer by developing immunotherapies that rely on improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current array of immunotherapies using older targets.

Corporate and Scientific Highlights

Initial Public Offering Completion – On October 20, 2020, we completed our IPO, raising $15 million of gross proceeds, significantly strengthening the Company’s balance sheet to support the continued development of our promising pipeline of targeted cancer therapies.

Two IND Application Filings – On December 17, 2020 we filed two applications with the U.S. Food and Drug Administration ("FDA"). The first IND was for a Phase 1 clinical trial of intravenously ("IV") administered allogeneic CAR-T for epithelial ovarian carcinoma ("EOC") and malignant pleural mesothelioma ("MPM"). The second IND was for a Phase 1 clinical trial of an intrapleural/intraperitoneal (IP) administered allogeneic CAR-T for EOC and MPM.

Since filing the original INDs in December 2020, the Company has had communications with the FDA, and numerous consults with scientific board and clinical advisors regarding resubmission. In March 2021, we announced that we planned to resubmit the two INDs.

The revised INDs will be for first in-human dosing of our Off-the-Shelf, Allogeneic Gamma-Delta T cell therapy for metastatic and progressive locally advanced solid malignancies.

The revised INDs have protocols which retain approximately 80% of the original INDs.

Longwood University Licensing Agreement – On November 30, 2020, we executed a licensing agreement for chPD1 with Longwood University. This marks a major milestone for Kiromic CAR-T development. With chPD1, we believe our chimeric PD1 CAR-T will be able to overcome the challenging tumor micro-environment (TME) which has plagued other CAR-T programs, while making Kiromic the only CAR-T development program with a built-in capability to meet other CAR-T programs head-on who do not have a bundled chPD1 CAR-T.

GMP Facility Completion – As of September 30, 2020, the key features of the GMP facility have been completed, clearing the path for the production of off-the-shelf Gamma-Delta-T cells, a novel approach to CAR-T cell therapy, which will be evaluated in the upcoming clinical trials.
FY 2020 Financial Highlights

Cash Position: Cash and cash equivalents were $10,150,500 as of December 31, 2020, compared to $1,929,100 as of December 31, 2019. The increase was primarily due to cash inflows of $15,805,600 attributable to financing activities related to the issuance of common stock from the initial public offering, issuance of Series B Preferred Stock and proceeds net of repayments from the Paycheck Protection Program loan. These inflows were offset by outflows of $6,126,600 and $1,457,600 attributable to operating activities and investing activities, respectively.

R&D Expenses: Research and development expenses were $5,052,900 for the year ended December 31, 2020, compared to $1,201,700 for the year ended December 31, 2019. The increase was primarily attributable to augmented headcount, increased square footage to our Houston, TX leased facilities, in-vitro experimentation costs, and intellectual property costs.

G&A Expenses: General and administrative expenses were $14,144,000 for the year ended December 31, 2020, compared to $2,503,700 for the year ended December 31, 2019. This increase was primarily due to increased stock compensation expenses and personnel expenses.

Net Loss: Net loss was $19,200,200 for the year ended December 31, 2020, compared to a net loss of $3,727,900 for the year ended December 31, 2019.

Dr. Chiriva-Internati continued, "Developing live-cell therapies by leveraging artificial intelligence is central to transforming the cost and efficiency of the immune-oncology field and improving the potential for off-the-shelf therapies for cancer patients. We believe our approach will help us design more efficient pre-clinical validation studies and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market. DIAMOND is central to our process in achieving this outcome rapidly and with reduced costs," concluded Dr. Chiriva-Internati.

On March 31, 2021 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, reported that it had closed its Series F Preferred Stock Financing on March 26, 2021 (Press release, Guided Therapeutics, MAR 31, 2021, View Source [SID1234577454]). This oversubscribed sale of 2,114 Series F Preferred Shares resulted in gross proceeds to the Company of $2,114,000, netting approximately $1,980,000 after legal costs, fees and commissions of approximately $134,000 (6.3%). In addition, as board approved non-cash transactions, three of the Company’s officers exchanged and forgave a total of $321,554 in debt owed to them by the Company into 235 Series F Preferred Shares under the same terms as the non-affiliated cash investors.

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The two most important uses of proceeds from the Series F Financing included 1) making the final payment of $750,000 to GPB Holdings, LLC, completed on January 8, 2021, and 2) allocate most of the remainder to completing the U.S. FDA clinical trial for the LuViva Advanced Cervical Scan. The clinical sites currently are reviewing the study protocol that was developed by the Company, which implemented recommendations made by the U.S. FDA. It is expected the trial will begin in the second quarter of 2021. The Company’s primary objective this year is completing the clinical trial of approximately 400 women and filing the results with the FDA.

The Series F Preferred shares are convertible at a fixed price of 25 cents per share, carry a 6% annual dividend and could potentially include an additional dividend of 15% after twelve months if the Company is unable to uplist to a national exchange or complete its FDA study. The dividends can be paid in cash or common shares at the option of the Company. Aspen Capital acted as Financial Advisor to the Company with respect to certain Canadian investments.

"Now that the Series F Financing has closed, netting sufficient funds, we can turn our full attention to completing the FDA study without delay," said Gene Cartwright, Guided Therapeutics CEO, adding, "At the same time, we have made great strides in cleaning up our balance sheet and have significantly reduced our liabilities, thereby setting the stage for a potential uplist to a national exchange, concomitant with the U.S. FDA study and significant progress in China."

On March 31, 2021 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in aggressive cancers, reported plans to present at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, held virtually from April 10-15, 2021 (Press release, Boundless Bio, MAR 31, 2021, View Source [SID1234577453]). The poster presentation will show how ecDNA mediates resistance to targeted therapy via oncogene switching and will highlight the urgent need to develop innovative new therapeutic approaches for gene amplified tumors that are driven by ecDNA.

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Presentation details:

Title: Extrachromosomal DNA (ecDNA)-driven switching of oncogene dependency facilitates resistance to targeted therapy
Session Title: Drug Resistance in Molecular Target Therapeutics
Session Category: PO.ET03.01
Abstract Number: 1089
Date and Time: April 10, 2021, 8:30 a.m. – 11:59 p.m. ET

About ecDNA

Extrachromosomal DNA, or ecDNA, are distinct circular units of DNA lacking centromeres but containing functional genes, including oncogenes, that are separated from tumor cell chromosomes. ecDNA replicate within cancer cells and can be passed to daughter cells asymmetrically during cell division, thereby constituting a primary driver of focal gene amplification and copy number heterogeneity in cancer. By leveraging the plasticity afforded by ecDNA, cancer has the ability to increase or decrease copy number of select oncogenes located on ecDNA to enable survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment resistance. ecDNA are not found in healthy cells but are present in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.