DBV Technologies Establishes an At-The-Market (ATM) Program on Nasdaq

On May 2, 2022 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Global Select Market: DBVT) (the "Company"), a clinical-stage biotechnological company, reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC") relating to an At-The-Market offering (the "ATM Program") (Press release, DBV Technologies, MAY 2, 2022, View Source [SID1234613297]). Pursuant to this new financing program, the Company may offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares ("ADS"), each ADS representing one-half of one ordinary share of DBV Technologies, from time to time in sales deemed to be an "at the market offering" pursuant to the terms of a sales agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), acting as sales agent, subject to French regulatory limits. The timing of any sales will depend on a variety of factors. The ATM Program is presently intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM Program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached.

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The Company currently intends to use the net proceeds (after deduction of fees and expenses related to the financing), if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes, at the Company’s discretion.

Jefferies, as sales agent, will use commercially reasonable efforts to arrange on the Company’s behalf for the sale of all ADSs requested to be sold by the Company to eligible investors requesting it, consistent with Jefferies’ normal sales and trading practices. Sales prices may vary based on market prices and other factors. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM Program.

The ADSs and the underlying ordinary shares will be issued through one or more share capital increases without shareholders’ preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to the 28th resolution adopted by the Annual General Meeting of Shareholders held on May 19, 2021 (the "2021 Annual General Meeting") (or any substitute resolutions, adopted from time to time), within the limit of a maximum number of 16,528,961 ordinary shares (being the maximum authorized by the shareholders for such resolution), representing a maximum potential dilution of approximately 30% based on the existing share capital of the Company, it being specified that the number of underlying ordinary shares to be admitted on the regulated market of Euronext in Paris ("Euronext Paris") shall represent, over a period of 12 months,

less than 20% of the ordinary shares already admitted to trading on said market without a French listing prospectus.

The new ordinary shares to be sold in the form of ADSs would be issued in one or more offerings at market prices of the ADSs at the time of pricing of the considered capital increase.

The ATM Program may only be issued to the categories of investors defined in the 28th resolution adopted by the 2021 Annual General Meeting (or any similar resolutions that may be substituted for it in the future), comprising (i) any natural person(s) or legal entity(ies), including companies, trusts, investment funds or other investment vehicle(s), regardless of their form, under French or foreign law, investing on a regular basis in the pharmaceutical, biotechnological or medical technology sector, and/or (ii) French or foreign companies, institutions or entities of any form, carrying out a significant portion of their business in these sectors or in the cosmetics or chemical sector or in the field of medical devices or research in these areas. The new ordinary shares will be admitted to trading on the regulated market of Euronext in Paris and the issued ADSs will trade on the Nasdaq Global Select Market ("Nasdaq").

On an illustrative basis, assuming the issuance of the full amount of $100 million (or €92.7 million (all convenience translations in this press release are based on the noon buying rate of the Federal Reserve Bank of New York in effect as of April 25, 2022, of €1.00 = $1.08) of ADSs under the ATM Program at an assumed offering price of $1.29 (or €1.20), the last reported sale price of the ADSs on Nasdaq on April 29, 2022, a holder of 1.0% of the outstanding Company’s share capital as of the date of this press release, would hold 0.60% of the outstanding Company’s share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release), it being specified that, in any event, the
number of underlying ordinary shares shall not exceed the limit set forth in the 28th resolution adopted by the 2021 Annual General Meeting (or any substitute resolutions, adopted from time to time, including the 18th resolution presented to the shareholders vote at the Annual General Meeting to be held on May 12, 2022) and shall represent, over a period of 12 months, less than 20% of the ordinary shares already admitted to trading on said market without a listing prospectus.

During the term of the ATM Program, the Company will include in the publication of its quarterly results information about its use of the program during the preceding quarter and will also provide an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM Program from time to time.

A shelf registration statement on Form S-3 (including a prospectus) relating to DBV Technologies’ securities, including the ADSs, was filed with the SEC and has been declared effective. Before purchasing ADSs in the offering, prospective investors should read the prospectus supplement and the

accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected]. No prospectus will be subject to the approval of the French Financial Markets Authority (the Autorité des Marchés Financiers or the "AMF") pursuant to Regulation (EU) 2017/1129 of the European Parliament and of the Council dated June 14, 2017, as amended (the "Prospectus Regulation") since the contemplated share capital increase(s) (for the issuance of the ordinary shares underlying the ADSs) would be offered to qualified investors (as such term is defined in Article 2(e) of the Prospectus Regulation) and fall under the exemption provided for in Article 1(5)(a) of the Prospectus Regulation which states that the obligation to publish a prospectus shall not apply to admission to trading on a regulated market of securities fungible with securities already admitted to trading on the same regulated market, provided that they represent, over a period of 12 months, less than 20% of the number of securities already admitted to trading on the same regulated market.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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. In particular, no public offering of the ADSs will be made in Europe.

Information available to the public

Detailed information concerning the Company, in particular with regard to its business, results, forecasts and corresponding risk factors, is provided in the Company’s Annual Report on Form 10-K (the "Annual Report"), filed with the U.S. SEC on March 9, 2022, its 2021 universal registration document (the "URD"), filed with the AMF on March 9, 2022 and under number D.22-0081, as well as in the half-yearly financial report (containing an update of the main information on the Company, its development and its projects) (the "Half-Year Report"), and documents filed with the U.S. SEC from time-to-time (the "SEC Filings"). The Annual Report and SEC Filings are available on the SEC’s website (www.sec.gov). The URD as well as other regulated information are available on the AMF website (www.amf-france.org). All of the foregoing documents are available on the Company’s website and are available free of charge on request at the Company’s registered office at 177-181 avenue Pierre-Brossolette, 92120 Montrouge, France.

Supernus Pharmaceuticals to Announce First Quarter 2022 Financial Results and Host Conference Call on May 9, 2022

On May 2, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report financial and business results for the first quarter of 2022 after the market closes on Monday, May 9, 2022 (Press release, Supernus, MAY 2, 2022, View Source [SID1234613296]).

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Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to present the first quarter 2022 financial and business results on Monday, May 9, 2022 at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be available in the Events & Presentations section of the Supernus website at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference Call Name: Supernus Pharmaceuticals First Quarter 2022 Results Conference Call
Following the live call, a replay will be available on the Company’s website, www.supernus.com, in the Investor Relations section. The webcast will be available on the Company’s website for 60 days following the live call.

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 [SID1234613295]).

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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.

Precision BioSciences to Present Preclinical In Vivo Gene Editing Research at Upcoming American Society of Gene & Cell Therapy 25th Annual Meeting

On May 2, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that four abstracts, including one from a research and license collaboration, were accepted by the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) and will be presented as posters and oral presentations at the upcoming annual meeting on May 16-19, 2022 at the Walter E. Washington Convention Center in Washington, D.C (Press release, Precision Biosciences, MAY 2, 2022, View Source [SID1234613294]).

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Details for the poster and oral presentations can be accessed on the ASGCT (Free ASGCT Whitepaper) website at View Source

Oral Presentations:

Title: Targeting the Hepatitis B cccDNA with a Sequence-Specific ARCUS Nuclease to Eliminate Hepatitis B Virus In Vivo
Date and Time: Tuesday, May 17, 2022, 3:45 PM – 4:00 PM
Session Title: Gene Editing in Cancer and Complex Diseases
Location: Hall E
Abstract #: 447

Title: AAV-Meganuclease-Mediated Gene Targeting Achieves Efficient and Sustained Transduction in Newborn and Infant Macaque Liver1
Date and Time: Wednesday, May 18, 2022, 3:00 PM – 3:15 PM
Session Title: Presidential Symposium and Presentation of Top Abstracts
Location: Hall E
Abstract #: 811

Poster Presentations:

Title: Optimization of Hydroxyacid Oxidase 1 (HAO1) Targeting ARCUS Nucleases for the Treatment of Primary Hyperoxaluria Type 1 (PH1)
Date and Time: Monday, May 16, 2022, 5:30 PM – 6:30 PM
Session Title: Metabolic, Storage, Endocrine, Liver and Gastrointestinal Diseases I
Location & Poster Board Number: Hall D, M-120
Abstract #: 239

Title: ARCUS Gene Editing to Eliminate MELAS-associated m.3243A>G Mutant Mitochondrial DNA
Date and Time: Tuesday, May 17, 2022, 5:30 PM – 6:30 PM
Session Title: Gene Targeting and Gene Correction II
Location & Poster Board Number: Hall D, Tu-66
Abstract #: 561

1 University of Pennsylvania’s Gene Therapy Program presentation sponsored by iECURE.

Alaunos Therapeutics to Present at American Society of Gene and Cell Therapy
25th Annual Meeting

On May 2, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported a poster presentation highlighting the Company’s membrane-bound interleukin-15 (mbIL-15) program as a potentially potent cell therapy targeting hotspot mutations expressed in solid tumors at the 25th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) being held in Washington, D.C. and virtually May 16-19, 2022 (Press release, Alaunos Therapeutics, MAY 2, 2022, View Source [SID1234613293]).

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"We are excited at the opportunity to present new preclinical data in our mbIL-15 program at the ASGCT (Free ASGCT Whitepaper) Annual Meeting. In this study we observed the potential of our Sleeping Beauty transposed mbIL-15 TCR-T cells to deepen clinical responses and improve durability of TCR-T cells targeting hotspot mutations expressed in solid tumors," stated Drew Deniger, Ph.D., Vice President, Research & Development at Alaunos Therapeutics. "We continue to be encouraged by the data and intend to file an IND application for this program in the second half of 2023."

Details of the poster presentation are as follows:

Poster Presentation: Stem-cell memory TCR-T cells targeting hotspot EGFR, KRAS and p53 neoantigens generated through co-expression of membrane-bound Interleukin-15

Session Title: Cancer – Targeted Gene and Cell Therapy I

Session Date/Time: Monday May 16, 2022, 5:30 PM—6:30 PM EST

Poster Board Number: M-234

Location: Walter E. Washington Convention Center, Hall D

Alaunos’ mbIL-15 program has been developed to augment the function of TCR-T cells by co-expression of a more potent and proprietary membrane-bound interleukin-15. In this preclinical study, Alaunos observed that mbIL-15 TCR-T cells specifically targeted and killed tumors expressing matching neoantigen and HLAs with negligible off target effects. Furthermore, Alaunos observed the potential of mbIL-15 to establish long-lived tumor-specific TCR-T cells that have the potential to survive within the circulation and the tumor microenvironment.