On January 28, 2021 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the US Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to the company’s novel Bcl-2 inhibitor, APG-2575, for the treatment of patients with follicular lymphoma (FL) (Press release, Ascentage Pharma, JAN 28, 2021, View Source [SID1234574432]). This is the fifth ODD granted to the company’s core asset APG-2575 by the US FDA, following the previous ODDs for the treatment of Waldenström macroglobulinemia (WM), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and acute myeloid leukemia (AML). To date, four of Ascentage Pharma’s investigational drug candidates have been granted a total of ten ODDs by the US FDA, a record number for any Chinese biopharmaceutical company.

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The term "orphan drugs" refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. In the United States, an orphan indication is defined as a disease or condition with a prevalence of less than 200,000 patients in the country. Since the Orphan Drug Act was passed in 1983, the US government has provided incentives and policy support to encourage development of orphan drugs. Therapies granted ODDs by the FDA are qualified for various development incentives, including a tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, possible research grant awarded by the FDA, and most importantly, 7 years of US market exclusivity upon approval.

FL is a heterogeneous disease and the second most common subtype of non-Hodgkin lymphoma (NHL) among adult patients in the US, accounting for about 20% of all NHL incidences[1]. Defined as a proliferation of malignant germinal center B cells, FL is also the most common subtype of indolent B-cell lymphoma[1],[2]. Although currently available therapies have significantly improved the overall survival of patients with FL, the disease still remains incurable[2],[3]. Majority of patients with FL relapse or experience disease progression after receiving the initial therapy, and experience multiple relapses thereafter requiring subsequent lines of therapy[4]. Despite the multiple treatment options for newly diagnosed and relapsed/refractory FL (r/r FL), FL still represents an unmet medical need, especially in those patients who are at high risk, relapsed early, have histological transformation, relapsed from available treatment options, or developed intolerance to available therapies.

APG-2575 is a novel, orally administered small-molecule Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 to restore the normal apoptosis process in cancer cells. APG-2575 is the first China-developed Bcl-2 inhibitor entering clinical development in China. Previously, APG-2575 had received clearances and approvals for multiple Phase Ib/II clinical studies in China, Australia, and the US, and is currently being developed in a range of hematologic malignancies globally.

"This ODD from the FDA is the fifth one granted to APG-2575, a key drug candidate in our apoptosis-targeting pipeline, also the tenth obtained by the company. This latest designation enhances our leadership position in terms of the number of ODDs obtained by any Chinese biopharmaceutical company, further demonstrating our capabilities in innovation globally," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We hope the FDA’s policy supports for orphan drug development will enable us to further accelerate the clinical development of APG-2575 and other ODD designated drug candidates in our pipeline, which hopefully can soon bring novel therapeutics to patients in need."

On January 28, 2021 Adamis Pharmaceuticals Corporation (Nasdaq: ADMP), a specialty biopharmaceutical company focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, reported that it intends to offer to sell shares of its common stock in an underwritten public offering (Press release, Adamis Pharmaceuticals, JAN 28, 2021, View Source [SID1234574418]). The company expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Raymond James & Associates, Inc. will act as the sole book-running manager for the proposed offering.

The company intends to use the net proceeds from this offering for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials relating to its products and product candidates, capital expenditures, manufacturing, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.

The securities described above will be offered by the company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226100) previously filed with and declared effective by the Securities and Exchange Commission (SEC) on July 18, 2018. A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at [email protected], or by accessing the SEC’s website at www.sec.gov.

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the company has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about the company.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities described herein, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On January 28, 2021 Sana Biotechnology reported that terms for its IPO to raise $323 million (Press release, Sana Biotechnology, JAN 28, 2021, View Source [SID1234574413]).

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The Seattle, Wash.-based biotech company says it will raise the funds by offering 15 million shares at $20 to $23 per share. Michelle Seitz, Chairman and CEO of Russell Investments, was recently appointed the company’s chief financial advisor and will assist in the company’s financial planning and decision-making. BioSpace’s NextGen Bio "Class of 2021" recently named Sana Biotechnology as its top new life sciences companies to watch out for in 2021.

Under the terms of the newly announced IPO, Sana Biotechnology would command a market value of $4.0 billion at the midpoint of the proposed range. The recent filing of the $150 million IPO from Sana Biotechnology may not reflect the company’s likely market valuation, which experts expect to range between $9 billion and $12 billion.

The company plans to list itself on the Nasdaq under SANA. Joint bookrunners on the deal include Morgan Stanley, Goldman Sachs, J.P. Morgan and BofA Securities. Sana Biotechnology expects to price during the week of February 1, 2021.

Prime focuses of startup company Sana Biotechnology include the development of in vivo and ex vivo cell engineering platforms licensed from Harvard University to discover novel treatments across several therapeutic areas that currently have unmet treatment needs. Therapeutic areas of particular interest to the company include oncology, diabetes, central nervous system (CNS) disorders, cardiovascular diseases and genetic disorders.

Currently, all of Sana Biotechnology’s candidates are in preclinical development, and Investigation New Drug (IND) applications are expected to be submitted to the U.S. Food and Drug Administration some time in 2022 and 2023.

"We are excited to have placed this important technology with Sana, a startup which has assembled a world-class team to advance the development of allogeneic (off-the-shelf) cell therapies," said Harvard OTD’s Vivian Berlin, Managing Director, Strategic Partnerships, in a statement. "The company’s leadership, vision, and focus on scaled solutions give us confidence that this groundbreaking technology can be developed and deployed to the fullest extent possible for patients."

In summer 2020, Sana Biotechnology raised up to $700 million in initial financing to advance its discovery and development initiatives. This financing round saw funds from several investors, including Canada Pension Plan Investment Board, Baillie Gifford, Alaska Permanent Fund, the Public Sector Pension Investment Board, Bezos Expeditions, GV, Omega Funds and Altitude Life Science Ventures, among other unnamed institutions.

Sana Biotechnology said that the initial $700 million funding went into a pool to support both IND-enabling and initial clinical studies for different treatment candidates, in addition to further expanding the company’s manufacturing capabilities and helping to buildout of its enabling technologies portfolio.

Back in October 2020, Sana Biotechnology acquired Oscine, a company focused on the development of disease-modifying or potentially curative cell therapies for brain and CNS diseases. The acquisition integrated Oscine’s glial progenitor cell program, in addition to other technologies, to expand on Sana Biotechnology’s broader technology platform and initiatives. Detailed financial terms of the merger were not initially described in the announcement of the deal.

On January 28, 2021 Locust Walk Partners reported compiles key statistics and trends on strategic transactions and financings (Press release, Locust Walk Partners, JAN 28, 2021, View Source;utm_medium=rss&utm_campaign=2020yearendreport [SID1234574412]). Our 2020 Year End Report: Global Trends in Biopharma Transactions applies the latest data to analyze current activities in the life science deal landscape.

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2020 turned out to be a record year for financings across the globe, in the US, Europe and Asia alike. Will the treasure chest of private capital begin to run low or stack higher in the new year? Perhaps we’ll see an increase in licensing transactions or M&A as capital is put to work and begins to bear fruit. We look forward to following the trend lines in Q1 2021.

A few more key insights across geographies from 2020:

United States

Approval of two COVID-19 vaccines led biopharma indices and the S&P 500 to finish the year in an upswing
The healthy domestic biopharma IPO landscape established 2020 as a record year for deal value, with SPAC exchange listings and SPAC IPO aggregate deal value also reaching record highs
Public and private financing activity remains notably robust, as companies seek to take advantage of the open IPO window and positive industry perceptions from investors
Private financings in Q4 closed out the strongest year on record, and 2019/2020 biopharma IPOs continue to perform well in the public markets, suggesting investors are bullish long-term on new biopharma opportunities
M&A activity has lacked the ‘mega deals’ of prior years, but strong deal flow among licensing deals and a spike in M&A deal volume in Q4 demonstrate sustained interest in strategic transactions
Europe

European biotech financings set a historical record this year with no signs of slowing, considering Q4 had the highest volume to date
Financings in Europe were weighted more heavily towards earlier stage investments in Q4 as in the robust market environment investors are willing to infuse capital into more risky, earlier stage rounds
Despite the high influx of capital into private markets, the public European biopharma markets slowed with only one IPO in Q4 2020
The total value of M&A deals increased significantly in Q4 and is expected to continue gaining momentum through 2021 as a few large deals have already been announced
Japan

Another strong year in licensing, led by Daiichi Sankyo’s second ADC deal with AstraZeneca in a row. Number of deals with over $10M in deal value was 31 (1 less from 2019) but aggregate deal value was up 5% from 2019
More noticeable in 2020 was the volume and total size of venture financing (24 deals and $159M, respectively) which vastly surpassed the previous record set in 2018 (14 deals and $114M, respectively)
China

China continues its torrid pace of in-licensing deals (75 in 2020, up 7% from 2019) and features transactions with substantial size, including 6 deals with upfront payment of $30M and above.
New drug candidates by Chinese companies are starting to be recognized, as there were 13 out-licensing deals announced, many with major pharma companies such as Abbvie, Bayer, Eli Lilly and Pfizer
Financing in biotech benefitted from the growing interest in health care due to emergence of COVID-19, as 28 companies went public and venture investment volume and aggregate venture investment amount far exceed past results​

On January 28, 2021, Ligand Pharmaceuticals Incorporated (the "Company") reported that entered into amendments (the "Amendments") with Barclays Bank PLC, Deutsche Bank AG, London Branch, and Goldman Sachs & Co. LLC (together, the "Option Counterparties") to the convertible note hedge transactions, dated May 17, 2018 and May 18, 2018 (collectively, the "Convertible Note Hedge Transactions") it initially entered into in connection with the issuance of its 0.75% convertible senior notes due 2023 (the "2023 Notes") (Filing, 8-K, Ligand, JAN 28, 2021, View Source [SID1234574376]). The Company entered into the Amendments following the repurchases of approximately $20.3 million in principal of the 2023 Notes for approximately $19.1 million in cash, including accrued interest of $0.1 million, during the quarter ended December 31, 2020. The Amendments provide that the options under the Convertible Note Hedge Transactions corresponding to such repurchased 2023 Notes will remain outstanding notwithstanding such repurchases.

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