Decibel Therapeutics to Present at the Barclays Gene Editing & Gene Therapy Summit

On November 8, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported its participation in the fifth annual Barclays Gene Editing & Gene Therapy Summit on Monday, November 15, 2021 (Press release, Decibel Therapeutics, NOV 8, 2021, View Source [SID1234594719]). Laurence Reid, Ph.D., Chief Executive Officer of Decibel, will participate in a fireside chat at 3:30 pm ET and in a panel discussion titled "Addressing Development Challenges and the Regulatory Hurdles" at 4:45 pm ET.

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A live webcast of the fireside chat may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the fireside chat.

Blackstone Life Sciences to invest up to $250 million in Autolus Therapeutics to develop obe-cel in adult Acute Lymphoblastic Leukemia (ALL) and advance broader platform

On November 8, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, and Blackstone Life Sciences reported that the two companies have entered into a strategic collaboration and financing agreement under which funds managed by Blackstone (NYSE: BX) will provide up to $250 million in equity and product financing to support Autolus’ advancement of its CD19 CAR T cell investigational therapy product candidate, obecabtagene autoleucel (obe-cel), as well as next generation product therapies of obe-cel in B-cell malignancies (Press release, Blackstone Life Sciences, NOV 8, 2021, View Source [SID1234594735]).

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As part of this $250 million transaction, Blackstone is committing to invest $150 million in product financing to support obe-cel development and commercialization, with $50 million payable upon closing of the transaction and the remainder payable based on certain development and regulatory achievements. Blackstone has also agreed to purchase $100 million of Autolus’ American Depositary Shares (ADS) in a private placement, which is subject to customary closing conditions. In connection with the collaboration, Blackstone received the right to nominate a member to Autolus’ board of directors.

The transaction continues Blackstone’s commitment to the UK economy which has seen the firm invest more than $18 billion across 44 investments headquartered in UK. These investments support more than 27,000 direct jobs and help make Blackstone the UK’s biggest foreign investor over the past 10 years.

"Autolus is a world-class company with an innovative platform and the potential to deliver best-in-class, lifesaving treatments to patients suffering from cancer," said Dr. Nicholas Galakatos, Global Head of Blackstone Life Sciences. "Our investment in these next generation cell therapies exemplify our conviction in the quality and promise of the life sciences sector in the UK. We look forward to building on this investment in the years to come."

"We welcome Blackstone Life Sciences to join our drive to change the outlook for leukemia and lymphoma patients, notably those with acute lymphoblastic leukemia. Blackstone’s investment and expertise will support the development and preparation for commercialization of obe-cel and put the program and the Company on a strong financial footing as we are approaching the read-out from the potentially pivotal FELIX clinical trial during the course of 2022," said Dr. Christian Itin, Chief Executive Officer of Autolus.

"We are excited to collaborate with Autolus in support of their innovative platform pursuing safer, more durable, therapies with the potential to be lifesaving options for patients with ALL and beyond. We see a significant opportunity to improve the outlook for cancer patients who are facing a devastating course of their disease," said Nicholas Simon, Senior Managing Director of Blackstone Life Sciences. "This investment continues to build on our conviction in not just innovative cell and gene therapies, but also supporting innovation in the United Kingdom and Europe broadly."

UK Science Minister George Freeman said: "This is another vote of confidence in the quality of life science in the UK, reinforcing our reputation as a world leader in discovering new cures for currently untreatable diseases like Autolus’ T cell therapy drugs for leukemia. Big investments like these give real hope to those suffering from diseases like leukemia – and create high skill jobs & opportunities in the development and manufacturing of treatments to help develop and boost our life science clusters all around the UK."

Autolus recently announced plans to build a dedicated manufacturing facility in Stevenage, UK to help secure global commercial launch capacity for obe-cel with a 70,000 square foot building. The ground-breaking ceremony for this new facility is due to be held today, with building works commencing imminently.

Moelis & Company LLC acted as financial advisor. Cooley LLP and Cooley (UK) LLP acted as legal advisor to Autolus, and Goodwin Procter LLP acted as legal advisor to Blackstone.

About the Transaction

The strategic financing collaboration by Autolus and Blackstone Life Sciences is expected to support the development and preparation for commercialization of Autolus’ product candidate, obe-cel. As part of this $250 million transaction, Blackstone is committing to invest an aggregate of $150 million in product financing to support Autolus’ development and potential commercialization of obe-cel, with $50 million payable upon closing of the transaction and the remainder (up to $100 million) payable based on certain development and regulatory achievements. In return for this strategic investment, Autolus has agreed to pay Blackstone a capped single digit royalty plus milestone payments based on net sales of obe‐cel. In addition, Blackstone will receive a warrant to purchase up to $24 million worth of Autolus ADSs at an exercise price premium to market. Blackstone has also agreed to make a $100 million equity investment in Autolus which is expected to close on or about November 12, 2021, subject to customary closing conditions. In connection with the collaboration, Blackstone received the right to nominate a member to Autolus’ board of directors.

ANI Pharmaceuticals, Inc. Announces Closing of $75 Million Public Offering of Common Stock

On November 8, 2021 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) (ANI or the Company) reported the closing of its previously announced underwritten public offering (Press release, ANI Pharmaceuticals, NOV 8, 2021, View Source [SID1234594752]). A total of 1,500,000 shares of its common stock were sold at a public offering price of $50.00 per share. The gross proceeds of the offering to the Company are $75 million, before deducting the underwriting discounts and commissions and offering expenses. In addition, ANI granted the underwriters a 30-day option to purchase up to an additional 225,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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Guggenheim Securities acted as lead book-running manager for the offering. Raymond James also acted as book-running manager for the offering. H.C. Wainwright & Co. acted as lead manager for the offering.

The securities described above were offered by ANI pursuant to a shelf registration statement on Form S-3 (File No. 333-239771), which was filed by the Company with the Securities and Exchange Commission (SEC) on July 9, 2020 and was declared effective by the SEC on July 17, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on November 3, 2021 and is available on the SEC’s website at View Source A final prospectus supplement relating to and describing the terms of the offering was also filed with the SEC and is available on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected], and from Raymond James & Associates, Inc. Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

Tempest Further Bolsters Patent Portfolio with Issuance of Multiple Patents for TPST-1495

On November 8, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported that the U.S. Patent and Trademark Office has issued multiple patents covering composition of matter for the company’s therapeutic product candidate TPST-1495, an orally available small molecule designed to selectively block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway (Press release, Tempest Therapeutics, NOV 8, 2021, View Source [SID1234594779]).

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"We have shown in pre-clinical studies that our approach to inhibit signaling through both EP2 and EP4 receptors with our TPST-1495 dual antagonist confers significantly increased potency compared to single EP4 inhibitors, as well as improvement over other prostaglandin-inhibition approaches including NSAIDs, and could represent an important evolution in the targeting of this pathway in oncology," said Tom Dubensky, president of Tempest. "Prostaglandin signaling drives a wide range of cancers as well as resistance to immune checkpoint inhibitor therapies, so we are excited about the potential of our ongoing clinical evaluation of TPST-1495. The intellectual property portfolio covering TPST-1495 and its uses is important to protect the differentiated properties of this molecule."

The patent portfolio now includes U.S. Patent Numbers 10,968,201 and 11,066,405, as well as a number of pending applications in the United States and other markets outside of the United States. The pending applications cover compositions of matter and methods of use, which further strengthen Tempest’s intellectual property for the combined inhibition of EP2 and EP4 prostaglandin PGE2 receptor signaling.

About TPST-1495

TPST-1495 is an orally-available small molecule designed to block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway, while sparing the homologous but differentially active EP1 and EP3 receptors. PGE2 signaling through EP2 and EP4 has been observed both to enhance tumor progression and promote immune suppression. Tempest has conducted head-to-head preclinical studies comparing TPST-1495 to single antagonists of EP2 and EP4 and observed significantly enhanced activity of TPST-1495 in both overcoming PGE2-mediated suppression of human immune cells in vitro, as well as significantly increased anti-tumor activity in mouse models of human colorectal cancer. Tempest is currently evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and possible anti-tumor activity of TPST-1495 in a multicenter Phase 1a/1b dose and schedule optimization study in subjects with advanced solid tumors, with the potential to expand in indications known to be prostaglandin-driven, including colorectal cancer, or CRC, and in a tumor indication-agnostic, biomarker-selected cohort.

Atara Biotherapeutics to Participate at Three Upcoming Investor Conferences

On November 8, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Pascal Touchon, President and Chief Executive Officer of Atara, will participate at three upcoming virtual conferences (Press release, Atara Biotherapeutics, NOV 8, 2021, View Source [SID1234594704]).

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Cowen 5th Annual IO Next Summit
Fireside chat on Monday, November 15, 2021 at 9:45 a.m. EST

Stifel 2021 Virtual Healthcare Conference
Fireside chat on Monday, November 15, 2021 at 4:40 p.m. EST

Evercore ISI 4th Annual HealthCONx Virtual Conference
Fireside chat on Tuesday, November 30, 2021 at 10:05 a.m. EST

Live video webcasts will be available by visiting the Investor Events and Presentations section of atarabio.com. Archived replays will be available on the Company’s website for 30 days following the live webcasts.