On December 14, 2020 Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells, reported the launch, subject to market conditions, of an underwritten public offering of $100 million of its American Depositary Shares ("ADS"), each representing one ordinary share of Cellectis (Press release, Cellectis, DEC 14, 2020, View Source [SID1234572812]). In connection with the offering, Cellectis expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the aggregate offering size on the same terms and conditions.

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Citigroup, Jefferies and Barclays are acting as joint book-running managers for the offering. In addition, William Blair is acting as lead manager and Kempen & Co is acting as co-manager for the offering.

The price in dollars at which ADSs will be sold in the proposed offering, as well as the final number of ADSs will be determined by the board of directors following a bookbuilding process commencing immediately and will not be less than the volume weighted-average of the trading prices of the Company’s ordinary shares on the Euronext Growth Paris over the three trading days prior to pricing of the offering, subject to a maximum discount of 20%. The new ordinary shares underlying the ADSs will be issued through a capital increase without shareholders’ pre-emptive rights under the provisions of Article L. 225-136 of the French Commercial Code and in accordance with the delegations granted pursuant to the Resolutions 18 adopted at the combined meeting of the Company’s shareholders (Assemblée Générale Mixte) held on June 29, 2020.

The Company plans to use the net proceeds of the offering, as follows: approximately $25 million to fund the advancement of one additional UCART product candidate, approximately $20 million to pursue new human therapeutics approaches based on Cellectis’ proprietary gene editing technology outside of oncology, approximately $25 million to fund more activities in Cellectis’ proprietary state-of-the-art manufacturing facility in Raleigh, North Carolina; and the remainder for working capital and other general corporate purposes. Based on the planned use of proceeds from this offering, Cellectis believes that its cash and cash equivalents and cash flow from operations (including payments it expects to receive pursuant to collaboration agreements) as well as government funding of research programs, will be sufficient to fund Cellectis’ operations into 2023.

A shelf registration statement on Form F-3 (including a prospectus) relating to Cellectis’ American Depositary Shares was filed with the Securities and Exchange Commission (the "SEC") and has become effective. Before purchasing American Depositary Shares in the offering, you should read the preliminary prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. You may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone (888) 603-5847 or by email at [email protected].

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.

On December 14, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), reported that it has commenced a proposed underwritten public offering, subject to market and other conditions, to issue and sell $125,000,000 of shares of its common stock (Press release, Castle Biosciences, DEC 14, 2020, View Source [SID1234572828]). In connection with the offering, Castle expects to grant the underwriters a 30-day option to purchase up to an additional $18,750,000 of shares of common stock. All of the shares in the proposed offering will be offered by Castle. 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.

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SVB Leerink and Baird are acting as joint bookrunning managers in the proposed offering. Canaccord Genuity is acting as passive bookrunner and BTIG and Lake Street Capital Markets are acting as co-managers for the offering.

The securities described above are being offered by Castle pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Castle and became effective by rule of the Securities and Exchange Commission (the "SEC") on December 14, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, WI 53202, by telephone at (800) 792-2473, or by email at [email protected].

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 offer or 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.

On December 14, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca reported the initiation of TROPION-Lung01, a global pivotal phase 3 head-to-head study of datopotamab deruxtecan (Dato-DXd; DS-1062), a TROP2 directed antibody drug conjugate (ADC), versus docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations who have previously received platinum-based chemotherapy and immunotherapy (Press release, Daiichi Sankyo, DEC 14, 2020, View Source [SID1234572856]).

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Patients with advanced or metastatic NSCLC without actionable genomic alterations (such as EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET exon 14 skipping) have demonstrated an unmet need after currently approved front-line and second-line therapies are exhausted. Current treatment guidelines recommend varying combinations of platinum-based chemotherapy and/or immune checkpoint inhibitors in the front-line and second-line settings based on lung cancer subtype, immune biomarker status and other factors.1 For patients whose cancer progresses after initial treatment containing a platinum-based chemotherapy and a checkpoint inhibitor, therapeutic options are limited.1

TROP2 expression has been associated with poor overall and disease-free survival in several types of solid tumors. TROP2 expression has been observed in the majority of adenocarcinoma and squamous cell carcinoma NSCLC.2,3,4 There are no TROP2 directed therapies or ADCs currently approved for the treatment of NSCLC.

"We recognize the need to continue to improve treatment for patients with NSCLC who are not eligible for currently approved targeted therapies, particularly those who progress following initial treatment with an immunotherapy and platinum-based chemotherapy," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "This head-to-head trial will determine whether targeting TROP2 with datopotamab deruxtecan will improve survival as compared to the standard therapy used in this setting."

"TROP2 is highly expressed in NSCLC and other cancers, making it a promising target for therapeutic development," said José Baselga, MD, PhD, Executive Vice President, Oncology R&D, AstraZeneca. "This trial will provide an opportunity to evaluate a targeted approach with datopotamab deruxtecan, a potent ADC specifically designed to enhance selective tumor cell death, while reducing systemic exposure to chemotherapy."

TROPION-Lung01 was initiated following the encouraging clinical activity of datopotamab deruxtecan in patients with heavily pre-treated advanced NSCLC observed in the ongoing TROPION-PanTumor01 phase 1 trial, which completed enrollment of patients with lung cancer in October of 2020. Preliminary data from TROPION-PanTumor01 was recently presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (#ASCO20) and updated data will be presented at an upcoming medical meeting.

About TROPION-Lung01

This global, multicenter, randomized, open-label phase 3 trial will evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) versus docetaxel (75 mg/m2) in patients with advanced or metastatic NSCLC without actionable genomic alterations and with progression on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy received either in combination or sequentially.

Approximately 590 patients will be randomized into two arms in a 1:1 ratio to receive either datopotamab deruxtecan or docetaxel. Randomization will be stratified by histology (squamous versus nonsquamous), most immediate prior therapy and geographic region.

The primary trial endpoints are progression-free survival and overall survival. Secondary endpoints include overall response rate, duration of response, time to response, disease control rate and patient reported outcomes. Safety endpoints include treatment emergent adverse events and other safety parameters. Pharmacokinetic and immunogenicity endpoints will also be evaluated.

The study will enroll patients at sites in North America, South America, Europe and Asia. For more information visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cancer and the leading cause of cancer mortality worldwide; there were an estimated 2.1 million new cases of lung cancer in 2018 and 1.8 million deaths.5 NSCLC accounts for 80 to 85 percent of all lung cancers.6

For patients with advanced NSCLC that do not carry actionable genomic alterations (i.e., for which no targeted therapies are approved), treatment has traditionally been limited to platinum chemotherapy.7 The introduction of immune checkpoint inhibitors in the past two decades has offered improved survival rates over traditional chemotherapy regimens, creating new options and shifting treatment to a more personalized approach for subsets of patients with NSCLC. Over the past five years, immunotherapies have become part of the treatment paradigm.7

About TROP2

TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is overexpressed in many cancers.8 TROP2 expression has been associated with poor overall and disease-free survival in several types of solid tumors. TROP2 expression has been observed in up to 64% of adenocarcinoma and up to 75% of squamous cell carcinoma NSCLC.2,3,4 There are no TROP2 directed therapies or ADCs currently approved for the treatment of NSCLC.

About Datopotamab Deruxtecan (Dato-DXd; DS-1062)

Datopotamab deruxtecan (Dato-DXd; DS-1062) is one of three lead DXd antibody drug conjugates (ADCs) in the oncology pipeline of Daiichi Sankyo.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG13 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a tetrapeptide-based cleavable linker with a drug-to-antibody ratio (DAR) of four.

TROPION is the broad and comprehensive clinical development program to evaluate the efficacy and safety of datopotamab deruxtecan across multiple TROP2 cancers as both a monotherapy and in combination with other anticancer treatments. In addition to TROPION-Lung01, datopotamab deruxtecan is currently being evaluated in a number of clinical trials, including TROPION-Lung05, a phase 2 study in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with actionable genomic alterations previously treated with a kinase inhibitor and platinum chemotherapy and TROPION-PanTumor01, a phase 1 study in patients with advanced solid tumors that have progressed on standard treatments or for whom no standard treatment is available, which has completed enrollment of patients into a unresectable advanced NSCLC cohort and is currently enrolling patients into a triple negative breast cancer (TNBC) cohort.

Datopotamab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About the Collaboration between Daiichi Sankyo and AstraZeneca

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan (a HER2 directed ADC) in March 2019, and datopotamab deruxtecan (a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

On December 14, 2020 Ergomed plc (LSE: ERGO) ("Ergomed" or the "Company"), a company focused on providing specialised services to the pharmaceutical industry, reported the acquisition of MS Clinical Services, LLC ("MedSource"), a specialised clinical research organisation (CRO) based in Houston, Texas, USA (Press release, Ergomed Group, DEC 14, 2020, View Source [SID1234575064]).

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Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: "We are delighted to have delivered on our strategic goals in 2020 with the expansion of our US footprint in both the CRO and PV businesses. The addition of MedSource and its complementary expertise in oncology and rare disease will further establish Ergomed as a specialised services provider in the strategically important US market, building on the successful acquisition and integration of Ashfield Pharmacovigilance (now PrimeVigilance USA) earlier this year. We look forward to developing the potential of this new business to offer truly global clinical research services to our international customer base. We are excited to welcome the MedSource team to Ergomed and are eager to work alongside our new colleagues to leverage our combined expertise in complex therapeutic areas for the benefit of our clients and patients worldwide. Looking ahead to 2021 we expect to see continued momentum across the business as we look to increase our footprint in key geographies, and firmly establish Ergomed as a leading global provider of specialist services to the pharmaceutical industry."

Eric Lund, founder of MedSource who will continue in his current role as President of MedSource after the acquisition, said: "I am delighted to be joining the Ergomed Group and continuing my current role. We are confident that this is an important strategic step and natural fit for MedSource, as Ergomed is an exciting, fast-growing global company with a strong reputation in the CRO industry. Our own extensive experience in oncology and rare disease drug development and across product types, clinical trial phases and study designs will complement the services already offered to Ergomed’s international client base. The combined business will be of great benefit to our US clients and employees, providing a seamless service offering into Europe and globally."

Acquisition benefits
MedSource is a full-service CRO with a focus on complex diseases and study designs. MedSource delivers high-quality clinical trials specialising in oncology and rare disease. With over 20 years’ experience, MedSource has participated in more than 200 oncology and rare disease clinical trials.

The acquisition aligns with Ergomed’s strategy to grow its existing profitable services business both organically and through acquisition and advances a number of important strategic objectives for Ergomed, including:

Complementary specialism in oncology and rare disease. The two businesses have core expertise in complex disease areas. The combined business will enable an even greater degree of specialist expertise in high growth sectors of the overall pharmaceutical services market in which Ergomed specialises.

Expanded US presence. The acquisition will further accelerate Ergomed’s growth in the North American market, with additional offices in Houston, Raleigh and Boston in the USA, and Newcastle upon Tyne in the UK. The increased US presence, with the addition of over 110 US-based employees, is expected to drive substantial new awards in the region and increase Ergomed’s pipeline in both the CRO and PV businesses.

Significantly increases Ergomed’s order book. MedSource joins Ergomed with an existing order book of over $41 million, adding to Ergomed’s £151.4 million order book as reported in September 2020 in its H1 2020 interim results, providing high forward visibility of contracted future revenue.

Acquisition terms and MedSource trading history
Under the terms of the equity purchase agreement (the "EPA"), Ergomed has acquired MedSource for an initial consideration comprising $16.2 million in cash paid at the closing of the transaction, up to $1.8 million in Ergomed shares to be issued at a price based on the average daily closing price for 30 days preceding the acquisition and within 15 months of the closing of the transaction, subject to reduction for breaches of representations and warranties, and up to a further $7.0 million payable 90% in cash and 10% in shares depending on MedSource’s financial results in the year to 31 December 2021. The EPA includes customary provisions relating to normalised working capital and representations, warranties and indemnities.

The acquisition will be funded using the Company’s existing cash resources without significant depletion of cash available to fund future organic and inorganic growth.

In its financial year ended 31 December 2019, MedSource recorded total revenues of $31.3 million, comprising service fee revenue of $19.3 million and pass-through revenue of $12.0 million. In 2019 adjusted EBITDA was $1.3 million and net assets were $2.6 million.

The transaction is expected to be immediately accretive and earnings enhancing, with further growth and strategic benefits expected in future years.

Webcast and conference call for analysts:
A webcast and conference call for analysts will be held at 1pm GMT on Monday 14th December.

On December 14, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the closing of its previously announced public offering on a firm commitment basis of 19,161,667 shares of common stock of the Company, including the exercise in full by the underwriter of its option to purchase an additional 2,495,000 shares of common stock, at a price to the public of $4.50 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, DEC 14, 2020, View Source [SID1234576291]).

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses were approximately $86.2 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock were offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock offered has been filed with the SEC and is available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

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.