On March 11, 2021 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the year ended December 31, 2020 (Press release, DBV Technologies, MAR 11, 2021, View Source [SID1234576735]). The financials have been audited by the Company’s statutory auditors and were approved by the Board of Directors on March 11, 2021. The audit report will be issued by the Company’s auditors in March 2021.

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"DBV ended 2020 well positioned to advance Viaskin Peanut towards potential approval in both the United States and European Union," said Daniel Tasse, Chief Executive Officer of DBV Technologies. "We remain focused on advancing our strategic objectives in 2021 and beyond as we continue to work towards improving the lives of patients with food allergies."

Recent Business Developments

Viaskin Peanut US: DBV has commenced a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches in order to identify the best one or two performing patches. All trial participants are expected to complete the trial by the end of March.
DBV plans to advance those patches selected for use in the protein transport study (EQUAL) and adhesion and safety study (STAMP) that will be discussed with the FDA.
Viaskin Peanut EU: DBV received the European Medicines Agency (EMA) Day 120 questions which are consistent with both DBV’s expectations and pre-filing conversations with the EMA. DBV did not receive questions about the impact of adhesion on efficacy.
Full-Year 2020 Financial Highlights1

Cash & Cash Equivalents: cash and cash equivalents as of December 31, 2020 were $196.4 million, compared to $193.3 million as of December 31, 2019. In 2020, cash used in operating activities was $(165.6) million under U.S. GAAP and $(160.9) million under IFRS and cash flows used in investment activities were $(2.9) million. Cash from financing activities were $149.5 million under U.S. GAAP and $144.8 million under IFRS, including $150.0 million received in connection with DBV’s follow-on public offering of its securities in the first quarter of 2020. Based on its current assumptions, DBV expects that its current cash and cash equivalents, will support its operations until the second half of 2022.

Operating Income: operating income was $11.3 million in 2020, compared to $14.7 million in 2019, a decrease of 23.3%. In both 2020 and 2019, operating income was primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science.

Operating Expenses: operating expenses for the year ended December 31, 2020, were $170.1 million under U.S. GAAP and $168.9 million under IFRS, compared to $185.7 million under U.S. GAAP and $185.1 million under IFRS for the year ended December 31, 2019. Excluding restructuring costs discussed below, operating expenses for the year ended December 31, 2020 were $146.6 million under U.S. GAAP and $145.9 million under IFRS. The overall decrease in operating expenses, excluding restructuring costs, was primarily due to the budget discipline measures taken by DBV, in particular the decrease in personnel expenses, which is directly related to the workforce reduction DBV implemented during its global restructuring plan. As a result of the ongoing COVID-19 pandemic, DBV also experienced decrease in other expenses, in particular tradeshows and travel expenses.
Restructuring Costs: restructuring costs, related to DBV’s global restructuring plan announced on June 26, 2020, were $23.6 million under U.S. GAAP and $23.0 million under IFRS for the year ended December 31, 2020, which costs include severance-related expenses, restructuring-related consulting and legal fees and expenses related to impairment of facilities and rights of use assets. DBV expects that the global restructuring plan, which includes significant headcount reductions that DBV anticipates completing by the end of the first quarter of 2021, will result in a remaining global team of 90 individuals. DBV had no restructuring costs in 2019.

Net Loss: Under U.S. GAAP net loss was $(159.6) million for the year ended December 31, 2020, compared to $(172.0) million for the year ended December 31, 2019. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(2.95) and $(4.65) for the years ended December 31, 2020 and 2019, respectively. Under IFRS, net loss was $(159.4) and $(172.5) million for the years ended December 31, 2020 and 2019, respectively, and net loss per share was $(2.95) and $(4.66) for the years ended December 31, 2020 and 2019, respectively.
DBV will host a conference call and live audio webcast on Thursday, March 11, 2021, at 5:00 p.m. ET/11:00 p.m. CET to discuss financial results for the year ended December 31, 2020 and to provide a general corporate update on the status of Viaskin Peanut in the US and EU.

This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50114481.

A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event.

On March 11, 2021 Longboard Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, reported the pricing of its initial public offering of 5,000,000 shares of its common stock at a price to the public of $16.00 per share (Press release, Longboard Pharmaceuticals, MAR 11, 2021, View Source [SID1234576611]). The gross proceeds to Longboard from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $80.0 million.

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Longboard was formed in January 2020 by Arena Pharmaceuticals, Inc. (Arena) to advance a portfolio of centrally acting product candidates designed to be highly selective for specific G protein-coupled receptors (GPCRs).

The shares are expected to begin trading on the Nasdaq Global Market on March 12, 2021, under the symbol "LBPH". The offering is expected to close on March 16, 2021, subject to satisfaction of customary closing conditions. In addition, Longboard has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares are being offered by Longboard.

Citigroup, Evercore ISI, Guggenheim Securities and Cantor are acting as joint book-running managers for the offering.

The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from: Citigroup Global Markets, Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (800) 831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by e-mail at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected]; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, NY 10022, or by e-mail at [email protected].

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and was declared effective on March 11, 2021. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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.

On March 11, 2021 Eli Lilly reported that The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Retsevmo a conditional marketing authorisation for the treatment of RET fusion-positive advanced lung cancer and thyroid cancer (Press release, Eli Lilly, MAR 11, 2021, View Source [SID1234576610]).

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In particular, the authorisation includes Restevmo (selpercatinib) as monotherapy treatment for adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

It also includes the treatment of adults with advanced RET fusion-positive thyroid cancer who require systemic therapy after prior treatment with sorafenib/lenvatinib, and also for adults and adolescents aged 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment.

The MHRA authorisation is based on results from the LIBRETTO-00 Phase I/II trial, a single-arm study of over 700 patients with RET-driven cancers.

The primary analysis included 105 previously treated patients with NSCLC – 64% of these participants responded to treatment with an average duration of response of 17.5 months.

In previously treated RET-mutant MTC patients, the primary analysis of 55 patients had a 69.1% response rate.

"This is good news for patients living with RET-driven cancers as they will soon have a treatment option that targets RET alterations directly," said Yvonne Summers, consultant oncologist at The Christie NHS Foundation Trust.

"With trial results showing median benefit of 17.5 months, this treatment represents a significant advancement in this growing field," she added.

RET fusion-positive tumours occur in 1-2% of NSCLC patients, and are more commonly found in people who are below the age of 60 years.

On March 11, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it intends to offer shares of its common stock for sale in an underwritten public offering (Press release, Cyclacel, MAR 11, 2021, View Source [SID1234576590]). In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the proposed offering are to be sold by Cyclacel.

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Cyclacel intends to use the net proceeds from this offering to support the Company’s growth strategy and for working capital and general corporate purposes, including research and development expenses, and capital expenditures.

Oppenheimer & Co. Inc. is acting as the sole book-running manager for the public offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-231923) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on June 21, 2019. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

On March 11, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported publication of abstracts for three poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Harpoon Therapeutics, MAR 11, 2021, View Source [SID1234576589]). The AACR (Free AACR Whitepaper) Annual Meeting Week 1 will be held virtually from April 10-15, 2021. Posters will be available on Harpoon’s website following the presentations.

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Full abstracts of the following presentations are available online at www.aacr.org:

Title: FLT3-targeting TriTACs are T cell engagers for treatment of acute myeloid leukemia
Abstract #: 913
Presenter: Richard J. Austin, Ph.D.
Session Category: Experimental and Molecular Therapeutics
Session Title: PO.ET01.01 – Antibody Technologies
Date/time: April 10, 2021, 8:30 a.m – 11:59 p.m. EDT

Title: ProTriTAC is a modular and robust T cell engager prodrug platform with therapeutic index expansion observed across multiple tumor targets
Abstract #: 933
Presenter: S. Jack Lin, Ph.D.
Session Category: Experimental and Molecular Therapeutics
Session Title: PO.ET01.02 – Biochemical Modulators of the Therapeutic Index
Date/time: April 10, 2021, 8:30 a.m – 11:59 p.m. EDT

Title: Combinatorial antitumor effects of CD3-based trispecific T cell activating constructs (TriTACs) and checkpoint inhibitors in preclinical models
Abstract #: 1573
Presenter: Mary Ellen Molloy, Ph.D.
Session Category: Immunology
Session Title: PO.IM02.02 – Combination Immunotherapies
Date/time: April 10, 2021, 8:30 a.m – 11:59 p.m. EDT