Disclosure of share buyback program pursuant to Art. 5(1) lit. a) of Regulation (EU) No. 596/2014 of the European Parliament and the Council of April 16, 2014 and Art. 2(1) of Delegated Regulation (EU) 2016/1052 of the European Commission of March 8, 2016

On May 2, 2022 The Management Board of BioNTech SE ("BioNTech"), with the approval of the Supervisory Board, reported to carry out a share buyback program with a volume of up to 5,200,000 ADSs of BioNTech SE (ISIN: US09075V1026) and with a value of up to USD 1.5 billion over two years (the "Share Buyback") (Filing, 6-K, BioNTech, MAY 2, 2022, View Source [SID1234613301]). BioNTech expects to use all or a portion of the repurchased ADSs to satisfy upcoming settlement obligations under BioNTech’s share-based payment arrangements. The first tranche of the buyback will commence on May 2, 2022, on the U.S. Nasdaq stock exchange and will be conducted within a six-month period up to November 2, 2022, with a value of up to USD 1.0 billion.

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BioNTech will carry out the Share Buyback in accordance with the provisions of Art. 5 of Regulation (EU) No. 596/2014 and Delegated Regulation (EU) 2016/1052, and on the basis of the authorization granted by the Annual General Meeting (AGM) of BioNTech on August 19, 2019 (as amended by the AGM on June 22, 2021) (the "AGM Authorization"). Pursuant to the AGM Authorization, BioNTech is authorized to acquire treasury shares until August 18, 2024, in accordance with section 71 para. 1 no. 8 of the German Stock Corporation Act (Aktiengesetz, AktG), in an amount of up to 10% of BioNTech’s share capital existing at the time the authorization resolution is adopted. If the shares are repurchased on a stock exchange, the purchase price per share (excluding incidental acquisition costs) shall not exceed the volume-weighted average price of the share during the last five trading days prior to the day of the repurchase by more than 10% and not fall below this price by more than 20%. Therefore, the maximum number of shares that BioNTech is authorised to repurchase under the AGM authorization is 24.6 million shares. In view of BioNTech’s 2022 AGM scheduled for June 1, 2022, no shares or ADS are expected to be repurchased in the period from May 25, 2022, until June 1, 2022. The Share Buyback has also been designed to comply with Rule 10b-18 under the Securities Exchange Act of 1934, as amended.

The Share Buyback will be lead-managed by a credit institution mandated by BioNTech, which will make trading decisions concerning the timing of the purchases of BioNTech’s shares independently of BioNTech within the meaning of Art. 4(2) lit. b) of Delegated Regulation (EU) 2016/1052 and BioNTech will not exercise any influence over the credit institution’s decisions. BioNTech’s right to terminate the credit institution’s mandate remains unaffected and the share buyback may be stopped and continued at any time in accordance with relevant legal requirements.

For the Share Buyback to be covered by the safe harbor regulations for share buybacks and applicable provisions, the credit institution shall comply with all applicable regulatory provisions, in particular, the conditions for trading in Art. 3 of Delegated Regulation (EU) 2016/1052. Art.3 requires, inter alia, that shares may not be purchased at a price higher than the higher of the price of the last independent trade and the highest current independent purchase bid on the trading venue where the purchase is carried out. In addition, no more than 25% of the average daily volume of the shares at the stock exchange on which the purchase is carried out may be purchased. The average daily trading volume of shares is based on the average daily volume traded in the 20 trading days preceding the date of the relevant purchase.

Transactions made under the Share Buyback Program will be duly disclosed pursuant to the requirements of Art. 2 para. 3 of Delegated Regulation (EU) No. 2016/1052 no later than by the end of the seventh trading day following the date of the execution of the transaction in a detailed form and in an aggregated form. BioNTech will publish the disclosed transactions on its website at View Source and will keep that information publicly accessible for a period of at least five years from the date of public disclosure.

Arrowhead Pharmaceuticals to Participate in Upcoming May 2022 Conferences

On May 2, 2022 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming events (Press release, Arrowhead Pharmaceuticals, MAY 2, 2022, View Source [SID1234613317]):

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TIDES USA 2022: Oligonucleotide and Peptide Therapeutics – May 9-12, 2022

Title: Arrowhead’s Approach to Oligonucleotide Scale-Up Manufacturing
Presenter: Michael Lawler, Director, Chemistry, Arrowhead Pharmaceuticals

2022 American Thoracic Society (ATS) International Conference – May 13-18, 2022

Title: Silencing RAGE Expression with a Lung-Targeted RNAi Trigger Delivery Platform Suppresses Pulmonary Allergic Inflammation
Presenter: David Kasahara, Senior Scientist III, Biology, Arrowhead Pharmaceuticals

Title: Silencing Muc5ac Expression with a Lung-Targeted RNAi Trigger Prevents Allergen-Induced Mucoobstruction and Airway Hyperresponsiveness
Presenter: David Kasahara, Senior Scientist III, Biology, Arrowhead Pharmaceuticals

BofA Securities 2022 Healthcare Conference – May 12, 2022, 1:40 p.m. ET

Type: Fireside chat presentation
Presenter: Christopher Anzalone, President and CEO, Arrowhead Pharmaceuticals

2022 RBC Capital Markets Global Healthcare Conference – May 17, 2022, 4:35 p.m. ET

Type: Fireside chat presentation
Presenter: Christopher Anzalone, President and CEO, Arrowhead Pharmaceuticals

UBS Global Healthcare Conference 2022 – May 25, 2022, 12:15 p.m. ET

Type: Fireside chat presentation
Presenter: Vincent Anzalone, Vice President Finance and Investor Relations, Arrowhead Pharmaceuticals

A copy of the presentation materials and webcast links may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

Catamaran Bio to Present Preclinical Data at ASGCT Annual Meeting to Support CAR-NK Approach for Solid Tumors

On May 2, 2022 Catamaran Bio, Inc., a biotechnology company developing off‑the-shelf chimeric antigen receptor (CAR)-NK cell therapies to treat cancer, reported that the company will present two posters at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, being held in Washington, DC, on May 16-18, 2022 (Press release, Catamaran Bio, MAY 2, 2022, View Source [SID1234613333]). Catamaran scientists will present data supporting CAR‑NK cell therapy design strategies to neutralize the immunosuppressive effects of the tumor microenvironment, including use of synthetic biology-enabled chimeric switch receptors which convert the inhibitory signal of TGF-β into positive NK cell activation signals.

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"We look forward to sharing our progress in engineering CAR-NK cells to confer them with the functional attributes to enable durable efficacy in solid tumors," said Vipin Suri, PhD, MBA, Chief Scientific Officer of Catamaran Bio. "Our presentations at ASGCT (Free ASGCT Whitepaper) describe approaches to mitigate the effects of TGF-β, a highly immunosuppressive cytokine known to reduce the anti-tumor activity of immune cells. We will show data on the activities of multiple TGF-β based synthetic receptors that confer a range of benefits to CAR-NK cells and enhance anti-tumor activity in high TGF-β environments."

Details of the poster presentations are as follows:

Presentation Title: Engineered allogeneic CAR natural killer cells resist tumor microenvironment immunosuppression by expression of a TGF-βR2 dominant negative receptor
Session Title: Cancer – Immunotherapy, Cancer Vaccines I
Session Date & Time: Monday May 16, 2022, 5:30 p.m. ET
Location: Hall D
Abstract Number: 313
Poster Board Number: M-194

Presentation Title: A synthetic biology approach to address the immunosuppressive tumor microenvironment: Novel TGF-β switch receptors convert inhibitory signals to enhance NK cell activity
Session Title: Cancer – Immunotherapy, Cancer Vaccines I
Session Date & Time: Monday May 16, 2022, 5:30 p.m. ET
Location: Hall D
Abstract Number: 331
Poster Board Number: M-212

The abstracts will be available on the ASGCT (Free ASGCT Whitepaper) conference website.

Phio Pharmaceuticals Announces Upcoming Presentation of PH-894 Data at ASGCT 25th Annual Meeting 2022

On May 2, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it will present new preclinical data on PH-894 for use in adoptive cell therapy (ACT) at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, which is being held May 16-19, 2022 in-person in Washington, D.C. and virtually (Press release, Phio Pharmaceuticals, MAY 2, 2022, View Source [SID1234613354]).

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Sana Biotechnology to Present Data from Multiple Preclinical Studies at the American Society of Gene and Cell Therapy 25th Annual Meeting

On May 2, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that five abstracts covering preclinical data from its hypoimmune and fusogen platforms were accepted for either oral or poster presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting taking place May 16-19, 2022 in Washington, D.C (Press release, Sana Biotechnology, MAY 2, 2022, View Source [SID1234613415]).

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"We will have a strong presence at ASGCT (Free ASGCT Whitepaper), with presentations of data from multiple technology platforms, including two oral presentations on our hypoimmune platform and two posters on our fusogen platform," said Steve Harr, MD, Sana’s President and CEO. "We remain excited with the progress we are making with these platforms that are targeted to address some of the major challenges faced in the field of gene and cell therapy. Our goal is to file two INDs this year from two of these platforms, with the aim of translating our exciting scientific progress into beneficial therapeutics for patients."

The ASGCT (Free ASGCT Whitepaper) abstracts are available to the public at View Source

Oral Presentations:
Title: Hypoimmune mouse primary pancreatic islet cells survive and functionally rescue allogeneic diabetic mice
Summary: Hypoimmune islet cells transplanted intramuscularly may be capable of persisting and functioning in diabetic patients without immune suppression
Abstract Number: 1244
Session: Cell Therapies for Hematological Disorders
Date/Time: Thursday, May 19, 2022 from 10:30 a.m. – 10:45 a.m. ET

Title: Generation of off-the-shelf allogeneic hypoimmune Tregs
Summary: A method to genetically engineer immune evasive "hypoimmune" regulatory T cells (Tregs) ex vivo that, in the assays tested, are immune evasive, functional, and protected from innate immune reactivity
Abstract Number: 1254
Session: Cell Therapy Product Engineering, Development or Manufacturing
Date/Time: Thursday, May 19, 2022 from 11:15 a.m. – 11:30 a.m. ET

Poster Presentations:
Title: Retargeted "fusosomes" for in vivo delivery to T cells
Summary: In vivo delivery of a CD19 CAR transgene payload with either CD8- or CD4-targeting vectors in Nalm-6 tumor bearing mouse models demonstrated robust production and persistence of CAR T cells, leading to tumor eradication
Abstract Number: 1081
Session: Cancer – Immunotherapy, Cancer Vaccines III
Date/Time: Wednesday, May 18, 2022 from 5:30 p.m. – 6:30 p.m.

Title: Fusosome-targeted gene transfer to human hepatocytes
Summary: Proof of principle data showing efficient delivery of a reporter transgene to human hepatocytes in vivo using a humanized liver mouse model
Abstract Number: 875
Session: RNA Virus Vectors
Date/Time: Wednesday, May 18, 2022 from 5:30 p.m. – 6:30 p.m. ET

Title: A novel VCN assay that detects lentiviral vector integrations while overcoming limitations caused by plasmid residuals
Summary: Data from a novel assay that relies on a unique amplicon and droplet digital PCR process that is specific to only reverse-transcribed self-inactivating viral vector nucleic acids
Abstract Number: M-305
Session: Pharmacology / Toxicology Studies or Assay Development
Date/Time: Monday, May 16, 2022 from 5:30 p.m. – 6:30 p.m. ET
About Hypoimmune Platform
Sana’s hypoimmune platform is designed to create cells ex vivo that can "hide" from the patient’s immune system to enable the transplant of allogeneic cells without the need for immunosuppression. We are applying the hypoimmune technology to both pluripotent stem cells, which can then be differentiated into multiple cell types, and to donor-derived allogeneic T cells, with the goal of making potent and persistent CAR T cells at scale. Preclinical data demonstrates across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. Our most advanced programs utilizing this platform include an allogeneic CAR T program targeting CD19+ cancers and stem-cell derived pancreatic cells for patients with type 1 diabetes.

About Fusogen Platform
Sana is developing re-targetable fusogens as a platform technology to enable the in vivo delivery of genetic payloads to specific cell types. Fusogens can bind to cell-surface proteins on the target cell type and, when combined with delivery vehicles to form fusosomes, deliver a genetic payload directly to the cell’s cytoplasm. We have shown in preclinical studies that we can engineer fusogens to specifically target diverse cell surface receptors that allow cell-specific delivery across multiple different cell types. Our most advanced programs utilizing this platform include in vivo CAR T cell fusosome product candidates targeting CD19+ cancer cells, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and acute lymphocytic leukemia.