Nanobiotix to Provide Operational Update and Report Full Year 2022 Financial Results on March 28, 2023

On March 14, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that it will provide an operational update and report its financial results for full-year ending December 31, 2022, on Tuesday, March 28, 2023, after the close of the US market (Press release, Nanobiotix, MAR 14, 2023, View Source [SID1234628680]).

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This release will be followed by a conference call and live audio webcast on Wednesday, March 29, 2023, at 2:00 PM CET/8:00 AM EDT, prior to the open of the US market. During the call, Laurent Levy, chief executive officer, and Bart Van Rhijn, chief financial officer, will briefly review the Company’s year-end results and provide an update on business activities before taking questions from analysts and investors. Investors are invited to email their questions in advance to [email protected].

Details for the call are as follows:

Dial-In Information:

Live (US): 1-877-423-9813

Live France: 0 800 912 848

Live (international): 1-201-689-8573

A live webcast of the call may be accessed by visiting the investors section of the Company’s website at www.nanobiotix.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored Phase 1 dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a Phase 3 global registrational study was launched in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company-sponsored Phase 1 clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC, or lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

HUTCHMED Announces Closing of Fruquintinib License to Takeda Outside China

On March 14, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM, HKEX:​13) reported that, further to its announcement on January 23, 2023 and following the completion of customary closing conditions including antitrust regulatory reviews, the exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited (TSE:​4502, NYSE:​TAK) to further the global development, commercialization and manufacture of fruquintinib outside China has closed (Press release, Hutchison China MediTech, MAR 14, 2023, View Source [SID1234628679]).

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With a strong preclinical and clinical profile, fruquintinib offers a potential new treatment option for patients with refractory metastatic colorectal cancer ("CRC"), supporting the shared goal of Takeda and HUTCHMED to improve the lives of those living with cancer worldwide. Takeda is now responsible for the development, commercialization and manufacture of fruquintinib in all included territories worldwide excluding mainland China, Hong Kong and Macau, where it is marketed by HUTCHMED.

Following the closing of the exclusive license agreement, HUTCHMED Limited will receive US$400 million shortly, and is eligible to receive up to US$730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales. Marketing authorization submissions in the U.S., Europe and Japan are planned to complete in 2023, with the rolling submission to the U.S. Food and Drug Administration ("FDA") initiated in December 2022.

About Fruquintinib
Fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity with the intention of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. Fruquintinib has been generally well tolerated in patients to date, and is being investigated in combinations with other anti-cancer therapies.

CRISPR Therapeutics to Present at the American Association for Cancer Research 2023 Annual Meeting

On March 14, 2023 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported an oral presentation of preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Annual Meeting, taking place April 14 – 19, 2023, in Orlando, FL (Press release, CRISPR Therapeutics, MAR 14, 2023, View Source [SID1234628678]).

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Title: CTX112 and CTX131: Next-generation CRISPR/Cas9-engineered allogeneic (allo) CAR T cells incorporating novel edits that increase potency and efficacy in the treatment of lymphoid and solid tumors
Session Type: Drug Development Special Track Session
Session Title: New Drugs on the Horizon: Part 1
Location: Tangerine Ballroom 2, Convention Center
Date and Time: April 16, 2023, 1:25 – 1:40 p.m. ET

The data are embargoed until the beginning of the Drug Development Special Track Session: New Drugs on the Horizon: Part 1 at 1:00 p.m. ET on April 16, 2023. A copy of the presentation will be available at www.crisprtx.com once the presentation concludes.

Cellectis Announces Poster Presentation on TALEN®-edited MUC1 CAR T-cells Targeting Triple Negative Breast Cancer at the American Association of Cancer Research (AACR) Annual Meeting

On March 14, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that preclinical data exploring purposeful armoring of CAR T-cells to enhance efficacy of MUC1 CAR T-cells in targeting triple-negative breast cancer, will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in Orlando, Florida on April 14-19, 2023 (Press release, Cellectis, MAR 14, 2023, View Source [SID1234628677]).

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"We are proud to present updated preclinical data on our product candidate UCARTMUC1 for solid tumors at AACR (Free AACR Whitepaper) 2023" said Laurent Poirot, Ph.D., Senior Vice President Immunology at Cellectis. "As immune-therapies continue to develop for solid tumors, the tumor microenvironment (TME) poses many challenges that CAR T-cells need to overcome for efficient tumor cell clearance. Our preclinical data make us confident that UCART MUC1 could be a valuable product candidate for patients with highly unmet medical needs."

Presentation includes:

Poster presentation:

Therapeutic options for triple negative breast cancer (TNBC) remain limited to date despite it being the most aggressive subtype of breast cancers and carrying the poorest prognosis. Tumor-associated MUC1 antigen is overexpressed in a large number of TNBC patients offering an effective discriminatory target for CAR T-cell therapy.

Cellectis will present innovative strategies exploring purposeful armoring of CAR T-cells to boost efficiency while preserving safety. To maintain anti-tumor CAR T-cell activity and proliferation in the hostile TME of solid tumors, Cellectis developed state-of-the-art multiplexed gene editing using high precision TALEN technology. With that aim, we armored allogeneic CAR T-cells with specific attributes to locally release immune inflammatory cytokines and protect from inhibitory effects of the TGFB1 and PD1 pathways. A combination of strategies using allogeneic CAR T-cells with diverse attributes were evaluated against TNBC tumors in various in vivo pre-clinical models. The recirculation pattern of MUC1 CAR T-cells was also explored in relationship with their delivery routes.

Title: Deciphering the benefits of variable delivery routes and molecular armoring to enhance efficacy of MUC1-CAR T-cells in targeting triple-negative breast cancer

Session Title: Adoptive Cell Therapy 1

Presenter: Piril, Erler, Ph.D., Scientist II, Immuno-Oncology, Cellectis

Session Date and time: Sunday April 16, 2023, 1:30-5:00 PM ET
Location: Section 37
Poster Board Number: 14
Abstract Presentation Number: 899

Entry into a Material Definitive Agreement

On March 14, 2023 Seelos Therapeutics, Inc. (the "Company") reported that it has entered into a securities purchase agreement (the "Securities Purchase Agreement") with certain purchasers identified on the signature pages thereto (the "Purchasers"), pursuant to which the Company agreed to issue and sell 12,059,298 shares (the "Shares") of its common stock, par value $0.001 per share (the "Common Stock"), pre-funded warrants to purchase up to 9,340,702 shares of Common Stock (the "Pre-Funded Warrants") and accompanying common stock warrants to purchase up to 26,750,000 shares of Common Stock (the "Common Warrants" and together with the Pre-Funded Warrants, the "Warrants") in a registered direct offering (the "Offering") (Filing, 8-K, Apricus Biosciences, MAR 14, 2023, View Source [SID1234628675]). The Shares and the Warrants were offered by the Company pursuant to its shelf registration statement on Form S-3 (File No. 333-251356) filed with the Securities and Exchange Commission (the "Commission") on December 15, 2020, as amended by Amendment No. 1 thereto filed with the Commission on December 22, 2020 and declared effective on December 23, 2020 (as amended, the "Registration Statement").

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The exercise price of the Common Warrants is $0.60 per share, subject to adjustment as provided therein, and the Common Warrants will be exercisable beginning on the six month anniversary of the issuance date and will expire on the date that is five and a half years following the original issuance date. Each holder of a Common Warrant will not have the right to exercise any portion of its Common Warrant if the holder, together with its affiliates, would beneficially own in excess of 4.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise (the "Common Warrant Beneficial Ownership Limitation"); provided, however, that upon 61 days’ prior notice to the Company, the holder may increase the Common Warrant Beneficial Ownership Limitation, but not to above 9.99%. The exercise price and number of shares of Common Stock issuable upon the exercise of the Common Warrants will be subject to adjustment in the event of any stock dividend, stock split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants. If a registration statement covering the issuance of the shares of Common Stock issuable upon exercise of the Common Warrants is not available for the issuance, then the holders may exercise the Common Warrants by means of a "cashless exercise."

The exercise price of the Pre-Funded Warrants is $0.001 per share, subject to adjustment as provided therein, and the Pre-Funded Warrants will be exercisable immediately. Each holder of a Pre-Funded Warrant will not have the right to exercise any portion of its Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise (the "Pre-Funded Warrant Beneficial Ownership Limitation"); provided, however, that upon 61 days’ prior notice to the Company, the holder may increase the Pre-Funded Warrant Beneficial Ownership Limitation, but not to above 9.99%. The exercise price and number of shares of Common Stock issuable upon the exercise of the Pre-Funded Warrants will be subject to adjustment in the event of any stock dividend, stock split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Pre-Funded Warrants. The holders may exercise the Pre-Funded Warrants by means of a "cashless exercise."

The Warrants are not and will not be listed for trading on any national securities exchange or other nationally recognized trading system.

The combined purchase price for one Share and accompanying Common Warrants to purchase shares of Common Stock for each Share purchased was $0.525. The combined purchase price for one Pre-Funded Warrant to purchase one share of Common Stock and accompanying Common Warrants to purchase shares of Common Stock for each share of Common Stock subject to a purchased Pre-Funded Warrant was $0.524. The closing of the Offering occurred on March 14, 2023. The Company expects the aggregate net proceeds from the Offerings, after deducting the fees payable to financial advisors and other estimated offering expenses, to be approximately $10.3 million. The Company intends to use the aggregate net proceeds for general corporate purposes and to advance the development of its product candidates. The Company may also use the net proceeds from the Offering to make periodic principal and interest payments under, or to repay all or a portion of, its outstanding convertible promissory note issued in November 2021

The Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing. Under the Purchase Agreement, the Company and each of its directors and executive officers has agreed, subject to certain exceptions, not to enter into any agreement to issue or announce the issuance or proposed issuance of any Common Stock or Common Stock equivalents until the date (the "Trigger Date") that is one trading day following the earlier of: (i) the date of public announcement by the Company of the full readout of the Phase 2 data with respect to SLS-002 in acute suicidal ideation and behavior in patients with major depressive disorder, and (ii) the date on which the VWAP (as defined in the Warrants) of the Common Stock is at or above $2.00 (subject to adjustment for reverse and forward share splits, recapitalizations and similar transactions following March 10, 2023) for three consecutive trading days. The Company also agreed that until the earlier of (X) such time as no Purchaser holds any of the Warrants, and (Y) three years after the Trigger Date, the Company will not effect or enter into an agreement to effect any issuance of shares of Common Stock or Common Stock equivalents involving an at-the-market offering or variable rate transaction; provided that the foregoing restriction will cease to apply to at-the-market offerings commencing on the earlier of: (I) such time as no Purchaser holds any Warrants, and (II) the one year anniversary of the Trigger Date.

The foregoing summaries of the Purchase Agreement and the Warrants do not purport to be complete and are qualified in their entirety by reference to the full texts of the form of Purchase Agreement, the form of Common Warrant and the form of Pre-Funded Warrant that are filed herewith as Exhibits 10.1, 4.1 and 4.2, respectively.

The representations, warranties and covenants contained in the Purchase Agreement and the Warrants were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to the Purchase Agreement and the Warrants, respectively, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement and the Warrants are incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement and the Warrants, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Commission.

The legal opinion, including the related consent, of Brownstein Hyatt Farber Schreck, LLP relating to the issuance and sale of the Shares and the Warrant Shares is filed as Exhibit 5.1 hereto. The legal opinion, including the related consent, of Paul Hastings LLP relating to the issuance and sale of the Warrants is filed as Exhibit 5.2 hereto.

This report does 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 the registration or qualification under the securities laws of any such state or jurisdiction.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements that involve risks and uncertainties, including, but not limited to, statements related to the amount of proceeds expected from the Offerings and the expected use of such proceeds. The risks and uncertainties involved include the Company’s financial position, market conditions and other risks detailed from time to time in the Company’s periodic reports and other filings with the Commission. You are cautioned not to place undue reliance on forward-looking statements, which are based on the Company’s current expectations and assumptions and speak only as of the date of this Current Report on Form 8-K. The Company does not intend to revise or update any forward-looking statement in this Current Report on Form 8-K as a result of new information, future events or otherwise, except as required by law.