Lilly Declares Second-Quarter 2022 Dividend

On May 2, 2022 The board of directors of Eli Lilly and Company (NYSE: LLY) reported that it has declared a dividend for the second quarter of 2022 of $0.98 per share on outstanding common stock (Press release, Eli Lilly, MAY 2, 2022, View Source [SID1234613281]).

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The dividend is payable on June 10, 2022 to shareholders of record at the close of business on May 16, 2022.

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.

iBio Announces Presentation Highlighting Superior Glycosylation for Antibodies Produced in Plants

On May 2, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported that it will present a poster at the 18th Annual Protein & Antibody Engineering Summit (PEGS) Boston Conference & Expo, May 2-5 (Press release, iBioPharma, MAY 2, 2022, View Source [SID1234613313]).

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Rachel Jordan, PhD, a senior product manager at iBio, will present the poster (#P061), titled "Plant-Made Antibodies Show Superior Glycosylation Homogeneity While Retaining Pharmacokinetic Properties," which highlights:

The production of a single uniform G0 glycosylation pattern, lacking fucose and xylose, of NISTmAb and rituximab when compared to Chinese Hamster Ovary (CHO) cell culture produced antibodies, which contain more heterogeneous glycosylation patterns.

Comparability of in vivo rodent pharmacokinetic profiles for NISTmAb and rituximab produced using mammalian cell culture and the FastPharming System.

How rapid, scalable transient expression in plants of high-quality mAbs for in vivo studies can significantly shorten the time to achieve in vivo proof-of-concept.
More information about producing consistent, high-quality antibodies in the FastPharming System may be accessed in a whitepaper here.

Kiniksa Pharmaceuticals to Report First Quarter 2022 Financial Results on May 3, 2022

On May 2, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Tuesday, May 3, 2022, at 8:30 a.m. Eastern Time to report its first quarter 2022 financial results and corporate activities (Press release, Kiniksa Pharmaceuticals, MAY 2, 2022, View Source [SID1234613410]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours of the event. The conference call can be accessed by dialing (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 7787467.

Nature Paper Identifies “Avidity Escape” as Solid Tumor Evasion Mechanism of CAR T Cell Cancer Therapies

On May 2, 2022 LUMICKS, a leading life science tools company developing instruments and consumables for dynamic single-molecule and cell avidity analysis, reported the publication in Nature of a landmark study, led by researchers at Massachusetts General Hospital, Harvard Medical School and the Broad Institute of MIT and Harvard (Press release, LUMICKS, MAY 2, 2022, View Source;utm_medium=rss&utm_campaign=nature-paper-study-marcela-maus-solid-tumor-evasion [SID1234613282]).

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The study demonstrates the power of LUMICKS’ z-Movi Cell Avidity Analyzer to measure cell avidity, a crucial biomarker for understanding immune cell function and for providing superior predictive information of therapeutic efficacy. The Nature paper (April 16, 2022), entitled "CAR T cell killing requires the IFNγR pathway in solid but not liquid tumors" was published by a pioneering team of chimeric antigen receptor (CAR) T cell researchers led by Dr. Marcela V. Maus, Associate Professor of Medicine at Harvard Medical School and Director of the Cellular Immunotherapy Program at Massachusetts General Hospital.

While CAR T cell therapies have shown great potential in combating blood-related cancers, the more prevalent solid tumors have been far less responsive to this therapeutic approach. This study exposes a groundbreaking discovery about the mechanism solid tumors use to evade CAR T cell therapies. Solid tumor cells avoid CAR T cell killing by down-regulating the adhesion strength or "cell avidity" between the effector and its target, which is an essential step in successfully clearing a solid tumor. Measuring cell avidity should now be an integral part of CAR T cell development programs, to help reduce failure rates of solid tumor clinical trials.

The LUMICKS z-Movi Cell Avidity Analyzer showed that loss of interferon-γ receptor (IFNγR) signaling decreased cell binding avidity between CAR T cells and their target solid tumor cells. The insufficient cell avidity was determined to be the mechanism underpinning poor in vivo therapeutic behavior of CAR T cells, identifying "avidity escape" as a new avoidance mechanism used by solid tumors.

"We are excited about the publication of this seminal paper in Nature that clearly demonstrates the technological and scientific power of measuring cell avidity with the z-Movi Cell Avidity Analyzer, opening the door to new innovations in cell therapy development," said Andrea Candelli, Ph.D., Chief Scientific Officer of LUMICKS. "We are at a watershed moment in the CAR T cell field, and we are excited to empower therapeutic developers with novel insights for successfully harnessing the power of the immune system to treat diseases."

The z-Movi Cell Avidity Analyzer measures cell avidity, or level of binding, between immune cells and their targets, enabling researchers to identify the most potent immunotherapeutic effector cells. This unique technology provides predictive, reproducible, and fast results at single-cell resolution. LUMICKS’ cell avidity solutions use acoustics to measure forces and interactions between cells, with the goal of such research enabling the shortening the drug development cycle of immunotherapies and reducing failure rates in clinical trials. First introduced in 2020, the z-Movi Cell Avidity Analyzer is being rapidly adopted by academic and biopharma laboratories around the world.

About the Study Findings

This study found that, as opposed to blood-based cancers, the loss of genes in the interferon-γ receptor (IFNγR) signaling pathway rendered glioblastoma and other solid tumors more resistant to killing by CAR T cells both in vitro and in vivo. Mechanistically, the loss of IFNγR1 in glioblastoma cells reduced overall CAR T duration of cell binding and cell avidity, as measured using LUMICKS z-Movi Cell Avidity Analyzer. IFNγR signaling was found to regulate critical surface proteins responsible for sufficient adhesion of CAR T cells to mediate therapeutic response through productive cytotoxicity.

This work demonstrates that blood-based tumors and solid tumors differ in their interaction strength with CAR T cells. The study suggests that enhancing binding interactions between T cells and tumor cells may yield improved responses for next generation drugs, especially through new molecular designs that optimize cell avidity strength. This highlights the power of cell avidity measurements as a crucial biomarker for understanding immune cell function and mechanistic guide for successful CAR T engineering.