DBV Technologies Announces Private Placement Financing of $194 Million

On June 9, 2022 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Global Select Market: DBVT), a clinical-stage biopharmaceutical company, reported an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares (Press release, DBV Technologies, JUN 9, 2022, View Source [SID1234615927]). The ordinary shares will be sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the pre-funded warrants will be sold to the purchasers at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant. Gross proceeds from the PIPE financing total approximately $194 million (corresponding to €181 million), before deducting private placement expenses. The closing of the PIPE financing is subject to customary closing conditions and is expected to close on June 13, 2022.

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The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the ordinary shares, including the ordinary shares underlying the pre-funded warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Goldman Sachs Bank Europe SE and SVB Securities LLC acted as placement agents in the private placement.

Braidwell LP, funds advised by Baker Bros. Advisors LP and BpiFrance Participations SA, each a current shareholder of the Company, and Venrock Healthcare Capital Partners, have subscribed respectively an aggregate of $11 million, $38 million, $8 million and $30 million of ordinary shares. Braidwell LP, Baker Bros. Advisors LP and Venrock Healthcare Capital Partners have subscribed respectively an aggregate of $19 million, $41 million, $28 million of pre-funded warrants. Other investors in the private placement include Fairmount, RA Capital Management and Vivo Capital. The price of the ordinary shares and the price of the pre-funded warrants was equal to the average of the closing prices of the Company’s ordinary shares on Euronext Paris over the five (5) trading days prior to the launch of the global offering (i.e. June 8th, 7th, 6th, 3rd and 2nd), with a premium of 0.8%. The new ordinary shares and pre-funded warrants will be issued through a capital increase without shareholders’ pre-emptive rights by means of a reserved offering to specific categories of investors under the provision of Article L. 225-138 of the French Commercial Code and pursuant to the decisions of the Chief Executive Officer dated June 9, 2022 and the Company’s Board of Directors (Conseil d’Administration) dated June 8, 2022, in accordance with the delegations granted pursuant to resolution 18 adopted at the 2022 ordinary and extraordinary meeting of the Company’s shareholders (Assemblée Générale Mixte) held on May 12, 2022. The representatives of Baker Bros. Advisors LP and BpiFrance Participations SA to the Company’s Board of Directors (Conseil d’Administration) did not take part in the vote on the decisions at the meeting of the Board of Directors held on June 8, 2022.

Application will be made to list the new ordinary shares to be issued pursuant to the PIPE financing on the regulated market of Euronext Paris pursuant to a listing prospectus subject to the approval by the Autorité des Marchés Financiers ("AMF") and comprising (i) the 2021 universal registration document filed with the AMF on March 9, 2022 (document d’enregistrement universel 2021) under number D. 22-0081, as completed by an amendment to the 2021 universal registration document to be filed with the AMF on June 9, 2022 and (ii) a Securities Note (Note

d’opération), including (iii) a summary of the prospectus. Copies of the Company’s 2021 universal registration document, as amended, will be available free of charge at the Company’s head office located at 177-181 avenue Pierre Brossolette – 92120 Montrouge – France. The listing prospectus will be published on the AMF’s website at www.amf-france.org.

Concert Pharmaceuticals to Participate in Fireside Chat at The JMP Securities Life Sciences Conference

On June 9, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it will participate in a fireside chat at The JMP Securities Life Sciences Conference on June 16, 2022 at 1:00 p.m. ET in New York, NY (Press release, Concert Pharmaceuticals, JUN 9, 2022, View Source [SID1234615818]).

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A webcast of the JMP fireside chat may be accessed in the Investors section of the Company’s website at www.concertpharma.com. A replay of the webcast will be available on Concert’s website for two weeks following the presentation.

Bayer’s Vividion Emerging as Significant Player in San Diego Biotech Hub

On Bayer AG and its wholly owned San Diego-based subsidiary Vividion Therapeutics, Inc. (Vividion) reported that it will highlight how the two companies have fostered innovation and collaboration through Bayer’s "arm’s length" operating model during a presentation at the 2022 BIO International Convention (Press release, Bayer, JUN 9, 2022, View Source [SID1234615834]).

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Bayer has built a strong partnership with Vividion since its acquisition of the biopharmaceutical company in 2021, deploying an innovative business model that allows Vividion to operate largely autonomously and independently to develop and advance its novel pipeline and platform technologies.

"Vividion’s arm’s length but connected relationship with Bayer has given us a unique and highly desirable operating model," said Jeffrey Hatfield, Chief Executive Officer at Vividion. "The independence has allowed us to keep our entrepreneurial culture, fast decision making and focus on breakthrough innovation, while the connection adds significant technical expertise, global reach and the financial stability of a major pharmaceutical company. With all these strengths, we’ve been able to accelerate progress on our pipeline of novel, previously undruggable target programs this past year, and we look forward to the possibility of delivering multiple programs into the clinic starting next year."

"Our partners thrive when empowered, and our objective is for Vividion to continue to advance innovation in an entrepreneurial environment focused on patient benefits and outcomes," said Marianne De Backer, MBA, Ph.D., Member of the Executive Committee of the Pharmaceuticals Division and Head of Strategy, Business Development & Licensing and Open Innovation at Bayer. "We listen to our partners’ needs and are flexible in the way we steer our engagements. As a result, we are pursuing innovative business models with external innovators, recognizing that today’s life sciences environment requires adaptive, agile approaches to deals and decision making."

By addressing key limitations of conventional drug discovery techniques, Vividion’s proprietary chemoproteomic platform technology allows the company to unlock high value, traditionally undruggable target biology with precision therapeutics for cancers and immune disorders. Recently, Benjamin Cravatt, Professor of Chemistry at The Scripps Research Institute and Vividion’s scientific co-founder, received the prestigious Wolf Prize in Chemistry for this technologic breakthrough. As the most advanced platform of its kind in the industry, Vividion adds another drug discovery engine that will fuel its pipeline with first-in-class medicines at an unprecedented speed to Bayer’s portfolio.

Vividion is already advancing multiple novel biology, first-in-class programs towards the clinic and has more than a dozen similar pipeline opportunities emerging in early discovery. Combining Bayer’s distinguished history and accomplishments in small molecule development with Vividion’s industry-leading chemoproteomic platform engine addresses known limits in the field of drug discovery to identify small molecules for disease-relevant protein targets traditionally thought to be undruggable.

With Vividion’s new, state-of-the-art research campus in San Diego, Bayer has expanded its operations into this fast-growing life sciences cluster. The company is now present in four of the largest biotechnology hubs in the United States – Boston, San Francisco, San Diego and Research Triangle Park, NC.

Details of the Bayer and Vividion presentation at the 2022 BIO Convention in San Diego:

"Cultivating innovation post-acquisition: Bayer and Vividion’s arm’s length model" by Marianne De Backer, Ph.D., EVP, Head of Strategy, Business Development & Licensing and Open Innovation at Bayer, and Jeffrey Hatfield, CEO of Vividion Therapeutics

Monday, June 13, 1:00 PM – 2:00 PM (PDT), San Diego Convention Center, Upper Level, Session Room 3

Pulse Biosciences, Inc. Announces the Closing of its Rights Offering

June 9, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported the closing of its rights offering and the final results thereof (Press release, Pulse Biosciences, JUN 9, 2022, View Source [SID1234615850]).

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The Company received basic subscriptions and over-subscriptions in excess of the $15 million limit in the rights offering. Available Units were allocated proportionately among those rights holders who exercised their over-subscription right based on the number of Units each rights holder subscribed for under its basic subscription rights, in accordance with the procedures described in the prospectus supplement relating to the rights offering. The remaining oversubscription amounts will be returned by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent") to the investors.

The rights offering resulted in the sale of 7,317,072 units (the "Units"), at a price of $2.05 per Unit, with each Unit consisting of one share of the Company’s common stock, par value $0.001 per share, and one warrant to purchase one share of common stock. The common stock and warrants comprising the Units separated upon the closing of the rights offering and were issued individually. 7,317,072 shares of common stock and warrants to acquire up to an additional 7,317,072 shares of common stock were issued in the offering. The Company received aggregate gross proceeds from the rights offering of $15 million. If exercised, additional gross proceeds of up to $15 million may be received through the exercise of warrants issued in the rights offering. Each warrant is exercisable for one share of the Company’s common stock at an exercise price equal to $2.05. Warrants are exercisable immediately and expire on the fifth anniversary of the closing of the rights offering.

Investors who participated in the rights offering should expect to see the shares and warrants issued to them in book-entry, or uncertificated, form. Shares, warrants and any excess subscription payments are expected to be distributed by the Subscription Agent on or about June 13, 2022.

After giving effect to the issuance of 7,317,072 shares of common stock in the rights offering (but excluding up to 7,317,072 shares of common stock underlying the warrants issued in the rights offering), the Company has 37,119,352 shares of common stock issued and outstanding.

The rights offering was made pursuant to the Company’s shelf registration statement on Form S-3, which became effective on August 21, 2020, the prospectus supplement dated May 4, 2022, and the prospectus supplement dated May 19, 2022, on file with the SEC containing the detailed terms of the rights offering. Subscription rights that were not exercised by 5:00 p.m., Eastern Time, on May 26, 2022, have expired.

Anaveon Announces FDA Safe to proceed letter for Investigational New Drug (IND) Application for its no-alpha IL-2 agonist, ANV419

On June 9, 2022 Anaveon, a clinical-stage immuno-oncology company, reported that the U.S. Food and Drug Administration (FDA) has cleared the IND application for ANV419-101, a Phase I/II mono treatment dose confirmation and combination dose-finding, global study, in patients with advanced cutaneous melanoma (Press release, Anaveon, JUN 9, 2022, View Source [SID1234616639]).

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ANV419, a potent IL-2Rbg agonist, preferentially proliferates CD8 and NK cells over regulatory T cells. The safety profile seen to date will allow for the administration of doses inducing maximal pharmacodynamic effects. The most frequent drug related AEs seen in an ongoing trial include mild Grade 1 chills and low-grade fever a few hours after dosing, which resolved with antipyretic treatment.

"We are excited to bring ANV419 to patients who are most likely to benefit from a truly IL-2Rbg-selective high-dose IL-2 approach," said Christoph Bucher, Chief Medical Officer at Anaveon. "We look forward to expanding our clinical program to the US and maximizing the therapeutic potential of ANV419 for patients suffering from cancer."

About the Phase I/II Clinical Trial

The clinical trial is a Phase I/II multiple arm, open-label study in patients with unresectable or metastatic cutaneous melanoma. The study will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different monotherapy doses of ANV419, as well as in combination with anti-PD1 or anti-CTLA4. Up to 130 patients will be enrolled in the clinical trial.