Asgard Therapeutics highlighted as finalist of the 2021 Merck EU Advance Biotech Grants Program

On May 17, 2021 Asgard Therapeutics reported that it was shortlisted as a finalist of the 2021 Merck EU Advance Biotech Grants Program (Press release, Asgard Therapeutics, MAY 17, 2021, View Source [SID1234580109]). This program aims to support emerging biotech companies pushing innovative drugs to the market by allowing grant recipients to receive free products and services.

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Ascendis Pharma A/S Announces First Quarter 2021 Financial Results and Business Update Conference Call on May 27

On May 17, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will hold a conference call and live webcast on Thursday, May 27, 2021 at 4:30 p.m. Eastern Time (ET) to review its first quarter 2021 financial results and provide a business update (Press release, Ascendis Pharma, MAY 17, 2021, View Source [SID1234580108]).

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Conference Call Details

Date Thursday, May 27, 2021
Time 4:30 p.m. ET/1:30 p.m. Pacific Time
Dial In (U.S.) 844-290-3904
Dial In (International) 574-990-1036
Access Code 4986247
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

ADC Therapeutics Announces Receipt of $50 Million Second Tranche of Convertible Credit Facility with Deerfield

On May 17, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported the receipt of the $50 million second tranche under its convertible credit facility with Deerfield Partners, L.P. and certain of its affiliates (collectively, Deerfield) (Press release, ADC Therapeutics, MAY 17, 2021, View Source [SID1234580107]). Under the terms of the Facility Agreement dated April 24, 2020, Deerfield agreed to provide to the Company up to $115 million in financing consisting of two separate tranches. The first $65 million was received upon completion of the Company’s initial public offering in May 2020, and the second tranche of $50 million has now been received following the recent U.S. Food and Drug Administration (FDA) accelerated approval of ZYNLONTA (loncastuximab tesirine-lpyl).

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"Following the recent approval of ZYNLONTA, we are pleased to further strengthen our balance sheet with the $50 million second tranche draw down," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "These funds will support the continued execution of our launch and advancement of our deep pipeline of next-generation ADCs."

Pursuant to a related Registration Rights Agreement with Deerfield, the Company will file a registration statement on Form F-3 with the U.S. Securities and Exchange Commission within 15 days. In the event that in the future Deerfield elects to exercise its conversion option with respect to the convertible notes issued under the Facility Agreement, this registration statement will allow Deerfield to sell the resulting shares. ADC Therapeutics will not sell any securities under this registration statement.

Aclaris Therapeutics to Participate in the Jefferies Virtual Healthcare Conference

On May 17, 2021 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that Dr. Neal Walker, President and CEO of Aclaris, will present a company overview at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 1:00 p.m. ET (Press release, Aclaris Therapeutics, MAY 17, 2021, View Source [SID1234580106]). Management will be available June 1st throughout the day for virtual one-on-one meetings.

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A live video webcast of the presentation may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

Aerpio Pharmaceuticals and Aadi Bioscience Enter into a Definitive Merger Agreement

On May 17, 2021 Aerpio Pharmaceuticals, Inc. ("Aerpio") (Nasdaq: ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2, and Aadi Bioscience, Inc. ("Aadi"), a privately-held biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported their entry into a definitive merger agreement (Press release, Aadi, MAY 17, 2021, View Source [SID1234580105]). Following the proposed merger, Aerpio will change its name to "Aadi Bioscience, Inc." and the combined public company will focus on advancing Aadi’s lead product candidate, FYARROTM (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009).

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In support of the merger, Aerpio has entered into subscription agreements to raise $155 million in a Private Investment in Public Equity (PIPE) financing led by Acuta Capital Partners and KVP Capital and including Avoro Capital Advisors; Avoro Ventures; Venrock Healthcare Capital Partners; BVF Partners, L.P.; Vivo Capital; Alta Bioequities, L.P.; Rock Springs Capital; RTW Investments, LP; Acorn Bioventures; and Serrado Capital LLC as well as other undisclosed institutional investors.

The PIPE financing is expected to be consummated concurrently with the closing of the merger. Proceeds from the PIPE financing are intended to be used for commercialization of FYARRO in advanced malignant PEComa and a planned tumor-agnostic registrational trial in solid tumors harboring inactivating alterations in the mTOR pathway genes TSC1 and TSC2 expected to be initiated by the end of 2021. Aadi’s first indication, advanced malignant PEComa, is an ultra-rare sarcoma enriched in TSC1 and TSC2 alterations. Aadi has received Orphan designation, Fast Track designation and Breakthrough Therapy designation from the FDA for FYARRO for the treatment of patients with advanced malignant PEComa. Together with the cash expected from both companies at closing, the net proceeds of the PIPE financing are expected to fund the company into 2024, enabling potential approval and commercial launch in PEComa as well as completion of a registrational trial in tumors harboring TSC1 or TSC2 inactivating alterations.

Caley Castelein, a board member of Aerpio and the proposed chairman of the combined company stated, "Aerpio’s board of directors diligently undertook a comprehensive strategic review and has concluded that the proposed transaction with Aadi is in the best interest of our shareholders. We believe Aadi’s late-stage development program may offer significant medical benefit to PEComa patients and important potential for patients with tumors harboring TSC1 or TSC2 inactivating alterations."

Dr. Neil Desai, founder and chief executive officer of Aadi, added, "FYARRO met its safety and efficacy endpoints in our study in patients with advanced malignant PEComa2 and this finding supports our approach of targeting mTOR pathway altered cancers with FYARRO. We are excited about the next chapter of growth for Aadi, thankful for the support of our investors, and are energized to continue to develop important new treatment options for our patients."

Anupam Dalal, chief investment officer of Acuta Capital Partners stated, "Together with a group of renowned institutional investors, we are excited to partner with Aadi as it advances FYARRO and strives to unlock the potential of mTOR as a therapeutic target."

Upon closing of the transaction, the combined company will be led by Aadi’s chief executive officer, Neil Desai, and headquartered in Los Angeles, California. Aadi’s board members Neil Desai and Richard Maroun; Aadi’s board observer Karin Hehenberger; and current Aerpio board members Anupam Dalal and Caley Castelein will be members of the board of directors of the combined company. In addition, Behzad Aghazadeh, managing partner of Avoro Capital Advisors and Avoro Ventures, will also join the board of the combined company upon the closing of the transaction.

About the Proposed Transaction

Under the terms of the merger agreement, shareholders of Aadi will receive shares of newly issued Aerpio common stock. On a pro forma basis, shareholders of Aadi will own approximately 66.8% and shareholders of Aerpio will own approximately 33.2% of the combined company upon the closing of the merger, prior to the additional PIPE financing transaction. Following the closing of the concurrent PIPE financing, Aerpio shareholders will own approximately 14.7% of the combined company. The actual allocation is subject to adjustment based on Aerpio’s cash balance at the time of closing.

The terms of the merger agreement contemplate that a non-transferable contingent value right (a "CVR") will be distributed to Aerpio shareholders as of immediately prior to the effective time of the merger, entitling CVR holders to receive net proceeds received by Aerpio, if any, associated with Aerpio’s legacy assets. The terms and conditions of the CVRs will be pursuant to a CVR Agreement Aerpio will enter into prior to the closing of the merger (the "CVR Agreement").

The merger agreement has been approved by the boards of directors of both companies. The transaction is expected to close in the third quarter of 2021, subject to approval by Aerpio’s shareholders, the completion of the PIPE financing, and customary closing conditions. The PIPE financing is expected to close concurrently with, and is conditioned upon, the closing of the merger.

Additional information about the transaction will be provided in a Current Report on Form 8-K that will be filed by Aerpio with the Securities and Exchange Commission ("SEC") and will be available at www.sec.gov.

Ladenburg Thalmann & Co. Inc. is acting as financial advisor to Aerpio for the transaction and Goodwin Procter LLP is serving as its legal counsel. Perella Weinberg Partners LP and Piper Sandler & Co. are acting as financial advisors to Aadi for the transaction and Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel to Aadi. Jefferies LLC; Cowen and Company, LLC; and Piper Sandler & Co. are acting as placement agents for the PIPE financing.