On May 12, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the first quarter 2020, as well as anticipated corporate milestones for 2020 (Press release, Surface Oncology, MAY 12, 2020, View Source [SID1234557561]).

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"I am pleased to report that Surface has made substantial clinical progress to date in 2020; achieving important milestones with both of our highly differentiated lead programs, SRF617 and SRF388, while rapidly working through a safe transition to a largely virtual operation due to the current pandemic," said Jeff Goater, chief executive officer. "Over the past few months, we announced the dosing of the first patients in the Phase 1 dose ascending trials for both of our lead product programs. In partnership with our clinical sites, we are following the latest FDA guidance regarding safe conduct of clinical trials during this time. We look forward to providing our initial clinical update for both programs before the end of this year."

Recent Corporate Highlights:

In March, initiated a Phase 1/1b clinical trial of SRF617, which targets CD39, an important component of the adenosine axis. This trial is designed to provide rapid evaluation of SRF617 via multiple arms, including as a monotherapy and in combination with both chemotherapy and other immuno-oncology agents

In April, initiated a Phase 1 clinical trial of SRF388, which targets the immunosuppressive cytokine IL-27. Surface Oncology is the first company to advance an IL-27 targeted therapy into clinical development. The development of SRF388 is informed by a compelling translational hypothesis in which hepatocellular and renal cell carcinoma are prioritized, both of which are characterized by high levels of circulating EBI3, a subunit of IL-27

Disclosed our development candidate SRF114, a monoclonal antibody targeting the chemokine receptor CCR8. SRF114 is a highly specific antibody that is designed to deplete immuno-suppressive cells present in the tumor microenvironment

Entered into a clinical collaboration with Arcus Biosciences (NYSE: RCUS) in January 2020, to evaluate SRF617 in combination with AB928 (a dual A2a/A2b adenosine receptor antagonist) in clinical trials

Continued progression of the ongoing Phase 1/1b trial of NZV930 (targeting CD73) by Surface Oncology’s partner Novartis

Promoted Lisa McGrath to senior vice president, human resources

Selected Anticipated 2020 Corporate Milestones:

Anticipated preclinical data presentations at multiple key medical and scientific conferences throughout 2020, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting in May and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II in June

Anticipated initial clinical updates for both SRF617 and SRF388 by the end of 2020

Financial Results:

As of March 31, 2020, cash, cash equivalents and marketable securities were $90.1 million, compared to $105.2 million on December 31, 2019.

Revenue recognized in the three months ended March 31, 2020 was $38.6 million, compared to $14.4 million for the same period in 2019. The increase was a result of the expiration of the final Novartis option purchase period in January 2020 and the corresponding recognition of the remaining deferred revenue under the collaboration.

Research and development (R&D) expenses were $11.3 million for the three months ended March 31, 2020, compared to $14.3 million for the same period in 2019. This decrease was primarily driven by a reduction in expenses associated with contract manufacturing and other IND enabling activities, as a result of the SRF617 and SRF388 IND filings in 2019. R&D expenses included $0.7 million in stock-based compensation expense for the three months ended March 31, 2020.

General and administrative (G&A) expenses were $4.8 million for the three months ended March 31, 2020, compared to $5.1 million for the same period in 2019. This decrease was primarily due to decreased personnel costs and professional fees. G&A expenses included $1.2 million in stock-based compensation expense for the three months ended March 31, 2020.

For the three months ended March 31, 2020, net income was $22.6 million, or basic net income per share attributable to common stockholders of $0.81, and diluted net income per share attributable to common stockholders of $0.74. Net loss was $4.2 million for the same period in 2019, or basic and diluted net loss per share attributable to common stockholders of $0.15.

Financial Outlook:

Surface Oncology continues to project that current cash and cash equivalents are sufficient to fund the Company into 2022. Anticipated milestones under the NZV930 collaboration with Novartis and additional capital potentially available under the K2 HealthVentures debt financing, in aggregate, would extend Surface Oncology’s cash runway into the second half of 2022.

On May 12, 2020 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on Tuesday, May 19, 2020 at 8:35 a.m. ET (Press release, Karyopharm, MAY 12, 2020, View Source [SID1234557560]).

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A live webcast of the fireside chat can be accessed on the "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be archived on the Company’s website for 90 days following the fireside chat.

On May 12, 2020 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported certain
differences between its financial forecast on November 6, 2019, for the fiscal year ended March 31, 2020 (April 1, 2019, to March 31, 2020) and the actual results announced today (Press release, Sysmex, MAY 12, 2020, View Source [SID1234557556]). Furthermore, at a meeting of the Managing Board on May 12, 2020, Sysmex resolved to award dividends from surplus as described below, with a record date of March 31, 2020.

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1. Change from Financial Forecasts

(1) Consolidated Financial Results for Fiscal Year from April 1, 2019, to March 31, 2020

(2) Reason

In addition to the impact of the spreading COVID-19 pandemic, major reasons for the change in consolidated net sales were lower-than-expected sales in the hemostasis and urinalysis fields in the United States and sales to distributors in Latin America and the EMEA region, which were lower than forecast. Despite efforts to reduce selling, general and administrative expenses, operating profit, profit before tax and profit attributable to owners of the parent were also below forecast, due to lower sales and a foreign exchange valuation loss.

2. Dividend from Surplus

(2) Reason

In terms of returns to shareholders, we intend to provide a stable dividend on a continuous basis and aim for a consolidated payout ratio of 30% under our basic policy of sharing the successes of our operations in line with business performance. In accordance with this policy, we have set the ordinary year-end dividend for the fiscal year ended March 31, 2020, at ¥36 per share. Accordingly, annual total dividends will be ¥72 and the consolidated payout ratio will be 43.1%. This amounts to an increase of ¥2 in the total dividend for the year, from ¥70 in the fiscal year ended March 31, 2019.

On May 11, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a pioneering, global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs) while lowering costs, reported financial results for the first quarter ended March 31, 2020 (Press release, Orgenesis, MAY 11, 2020, View Source [SID1234561684]).

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First Quarter 2020 Financial Highlights:

Revenue increased 348% to $1.9 million compared to $0.4 million for the first quarter ended March 31, 2019
Achieved net income of $75.6 million, or $4.23 per share, reflecting sale of Masthercell
Cash and cash equivalents were $107.1 million as of March 31, 2020
Vered Caplan, CEO of Orgenesis, commented, "Step by step, our CGT Biotech Platform is gaining traction within the market, as illustrated by the year-over-year growth. In the first quarter of 2020, revenue increased to $1.9 million, or nearly an $8 million revenue run rate compared to $3.1 million for all of 2019. We believe our CGT Biotech Platform is poised for growth this year through industry partnerships that are currently underway with leading research institutes and hospitals around the world."

"Earlier this year, we entered into a collaboration agreement with two of the leading healthcare research institutes in the U.S., whereby we plan to utilize our POCare Network to support their growing development and processing needs in order to advance and accelerate cell and gene-based clinical therapeutic research. We believe these collaborations with such high-profile institutions in the field of cell and gene therapy further validate the significant value proposition of our platform."

"In addition to our POCare Network, we are building our pipeline of POCare Therapeutics and Technologies, with an ultimate goal of providing life-changing treatments to large numbers of patients at reduced costs within the point-of-care setting. Specifically, we are focusing on immuno-oncology, metabolic and autoimmune diseases, as well as anti-viral therapies. Most recently, we completed the acquisition of Tamir Biotechnology, Inc., including ranpirnase, a broad spectrum anti-viral platform. Ranpirnase has demonstrated clinical efficacy against HPV and other hard to target viruses based on its unique mechanism of action of killing the virus and modulating the immune system. Having demonstrated clinical activity against human papillomavirus, as well as preclinical activity against some of the world’s most persistent viral threats, we plan to aggressively pursue a number of complementary approaches with a goal to maximize the potential of ranpirnase."

"We have received approval from regulators to continue working in our research and development labs during the current COVID-19 pandemic, and we are leveraging all our knowledge and expertise in the field of cell and gene therapy, including anti-viral technologies, in an attempt to find potential COVID-19 cures and therapies. Importantly, we have a strong balance sheet and are strategically positioned to bring a variety of therapies to market in a cost-effective, high-quality and scalable manner."

"We also announced a joint venture agreement with RevaTis S.A. to advance the development of autologous therapies utilizing and banking muscle-derived mesenchymal stem cells (mdMSC) as a source of exosomes and other cellular products. Our plan is to combine RevaTis’ patented technique to obtain mdMSCs through a minimally invasive muscle micro-biopsy with our own automated/closed-systems, 3D printing, and bioreactor technologies. The goal of this JV is to lower the costs and accelerate the timeline of bringing these innovative therapies through the clinic and into commercialization."

The Company’s complete financial results are available in the Company’s Form 10-Q filed with the Securities and Exchange Commission on May 8, 2020 which is available at www.sec.gov and on the Company’s website.

On May 11, 2020 ADC Therapeutics SA, a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported that it has launched the initial public offering of 7,355,000 shares of its common shares (Press release, ADC Therapeutics, MAY 11, 2020, View Source [SID1234558147]). In addition, ADC Therapeutics has granted the underwriters an option to purchase up to 1,103,250 additional common shares. The initial public offering price is expected to be between $16.00 and $18.00 per common share. The common shares have been approved for listing on the New York Stock Exchange under the ticker symbol "ADCT."

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Morgan Stanley, BofA Securities and Cowen are acting as joint book-running managers for the offering.

The offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at [email protected]; BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of ADC Therapeutics SA, such as the common shares, in or into Switzerland within the meaning of the Swiss Financial Services Act ("FinSA") and these securities will not be listed or admitted to trading on the SIX Swiss Exchange or on any other regulated trading venue (exchange or multilateral trading facility) in Switzerland. Neither this document nor any other offering or marketing material relating to these securities, such as the common shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares may be publicly distributed or otherwise made publicly available in Switzerland.