On March 16, 2021 Biodesix, Inc. (NASDAQ: BDSX) a leading data-driven diagnostic solutions company with a focus in lung disease, reported financial and operating results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update (Press release, Biodesix, MAR 16, 2021, View Source [SID1234576725]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We had a very productive fiscal year and fourth quarter highlighted by strong revenue growth resulting from our ability to shift gears and offer COVID-19 testing services to assist the nation in the midst of a global pandemic," stated Scott Hutton, Chief Executive Officer of Biodesix. "During this time, we also maintained our focus on the core strategic business of lung diagnostic testing and biopharma services and expect strong growth in 2021. Overall, 2020 was a transformative year for Biodesix and we are excited about the growth of our commercial organization, expansion of our clinical pipeline, and new clinical data, to quickly and positively impact the lives of patients in 2021."

Full Year and Fourth Quarter 2020 Financial Results

Successful initial public offering (IPO) raising net proceeds of $63.8 million;
Record annual revenue of $45.6 million, an increase of 86% over 2019 annual revenue;
Fourth quarter revenue of $27.0 million, an increase of 194% and 227%, respectively, over the third quarter 2020 and fourth quarter 2019;
Fourth quarter COVID-19 testing revenue of $21.4 million, a 287% improvement over third quarter 2020;
Fourth quarter lung diagnostic revenue of $3.7 million, a 22% improvement and 20% decline, respectively, over third quarter 2020 and fourth quarter 2019;
Fourth quarter 2020 services revenue of $1.9 million, a 198% improvement and 48% decline, respectively, over third quarter 2020 and fourth quarter 2019;
Fourth quarter gross profit of $12.4 million, a 133% and 92% increase, respectively, over third quarter 2020 and fourth quarter 2019;
Annual non-cash stock compensation expense of $3.7 million as compared to $0.2 million in 2019;
Strengthen balance sheet with $62.1 million of cash and cash equivalents as of December 31, 2020, an increase of $56.8 million over the comparable prior year period.
Business Highlights

As part of the Biodesix data-driven approach, the company continues to build strong clinical evidence to establish the value and utility of the Biodesix lung diagnostics portfolio.

Published an extended analysis of data from the company’s Nodify XL2 lung nodule test in the American College of Chest Physicians (CHEST 2020) Journal demonstrating that all nodules in the study group that were established as benign after one year remained benign after two years.
Presented data from three studies at the American College of Chest Physicians (CHEST 2020) Annual Meeting highlighting the clinical value of the company’s Nodify XL2 and Nodify CDT lung nodule risk assessment suite and the utility of Nodify Lung Risk Assessment tests in helping physicians to reduce unnecessary procedures on benign nodules and delays in diagnosis of malignant nodules.
Initiated recruitment in the Nodify XL2 Classifier Prospective Study in Low to Moderate Risk Lung Nodules (ALTITUDE) with the intent to assess how clinical decision making can be impacted by the introduction of Nodify Lung test results into risk assessment.
Showcased data from multiple studies at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) demonstrating individual patient’s immune profile capabilities in providing information to support treatment decisions for patients diagnosed with advanced non-small cell lung cancer (NSCLC).
Announced collaboration with HiberCell to further the development of an enzyme-linked immunosorbent assay (ELISA) as a companion diagnostic in future registration trials in breast cancer for Imprime PGG programs.
Announced publication of a peer-reviewed study supporting its patented blood collection device (BCD). The device is designed to streamline whole blood specimen collection and transportation to the laboratory while delivering diagnostic test results that are equivalent to traditional methods.
In addition to the significant accomplishments associated with our lung diagnostic advances, the Company continued to advance their partnerships and services related to COVID-19.

Announced strategic partnerships with both Purdue University and the Chicago Public School System for COVID-19 testing to safely reopen schools.
Published a paper demonstrating a new AI-based algorithm that can rapidly and accurately help physicians predict risk of severe outcomes for patients with COVID-19 infection utilizing readily available patient data collected upon hospital admission.
"During the fourth quarter, we continued to add to the growing body of published evidence demonstrating the value of the clinical information delivered by our suite of commercially available lung disease diagnostic tests," said Hutton. "Looking ahead, we are cautiously optimistic that a more normalized business environment will reemerge later this year, setting the stage for more robust growth in our core lung diagnostic business. We expect modest gross margin percentage expansion for 2021 as compared to 2020 as we continue to experience near-term strength in our COVID-19 diagnostic testing, which on average has lower overall gross margin percentages than our lung diagnostic testing services. We were particularly pleased to show revenue growth in the fourth quarter over the third quarter in our lung diagnostic testing services and biopharma services even while COVID-19 cases surged, and healthcare practitioners and facilities remained focused on fighting the pandemic."

"At the same time, our COVID-19 testing services delivered strong revenue growth, as evidenced by our strategic partnerships that benefited our fourth quarter 2020. In addition, we continue to expand the reach of our COVID-19 testing services with our recently announced partnership with Purdue University and the Chicago Public School System, one of the largest in the country, in an effort to safely reopen schools for in-person learning."

Conference call and webcast information

Management will host an investor conference call and webcast today, March 16, 2021 at 4:30 p.m. Eastern Time.

An archived replay of the webcast will be available on the company’s website for a period of 90 days.

On March 16, 2021 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, reported it is joining forces with AccessHope to offer a world-class service experience to people who use Galleri, GRAIL’s first-of-kind multi-cancer early detection blood test (Press release, Grail Bio, MAR 16, 2021, View Source [SID1234576742]). This collaboration is part of GRAIL’s effort to help patients and their healthcare providers achieve favorable outcomes by making the test experience, from blood draw to cancer care, as seamless as possible.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AccessHope, a company that provides cancer expertise to employers and their healthcare partners, will offer Galleri users coordination services during the test experience, including access to a support team for guidance and information. AccessHope also will provide support to physicians as they determine next steps to evaluate a positive Galleri test result.

"Most cancers are diagnosed too late, when outcomes are poor," said Dr. Joshua Ofman, chief medical officer and head of external affairs at GRAIL. "The introduction of Galleri as a complement to recommended cancer screening tests provides an opportunity to fundamentally change the way that we detect cancer. Best-in-class expert services like those offered by AccessHope will be an essential part of GRAIL supporting providers and their patients from test to diagnosis to treatment."

GRAIL previously announced it will introduce Galleri in the second quarter of 2021. An earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers — over 45 of which lack recommended screening tests today — with a low false positive rate of less than 1%. When a cancer signal is detected, Galleri can determine where in the body the cancer is located with high accuracy, all from a single blood draw. This is critical to help guide diagnostic follow-up and care.

"The rising cost of cancer care — coupled with the extraordinary rate of innovation and changes in best practices — make early detection even more vital when it comes to improving a patient’s healthcare experience, outcomes, value, and care," said Mark Stadler, CEO of AccessHope. "Our mission at AccessHope is to deploy the latest cancer care knowledge to the places and people who need it most when it is most valuable. Providing support services for Galleri offers another way we can touch more lives and extend our mission."

Galleri, which will require a prescription, will be available initially through partner health systems, medical practices, and self-insured employers.

Cancer is projected to become the world’s leading cause of death in 2021. In the U.S., more than 600,000 people died from cancer last year. This is in large part because the majority of cancers are found too late when outcomes are often fatal. Recommended screening tests in the U.S. save lives, but they only cover five cancers and screen for a single cancer at a time. In fact, cancers responsible for 71% of cancer deaths have no recommended early detection screening at all.

On March 16, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported the closing of its previously announced underwritten public offering of 2,078,214 shares of its common stock, offered at a price of $7.00 to the public, which includes the full exercise of the underwriter’s over-allotment option to purchase additional shares (Press release, Cyclacel, MAR 16, 2021, View Source [SID1234576813]). The gross proceeds to the Company from this offering are approximately $14.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. Existing and new institutional investors participated in the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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. acted as the sole book-running manager, and Ladenburg Thalmann & Co. Inc., Roth Capital Partners, and Brookline Capital Markets, a division of Arcadia Securities, LLC acted as co-managers for the public offering.

This offering was 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 relating to the offering was filed with the SEC on March 11, 2021 and is available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the offering was filed with the SEC and is available on the SEC’s web site at www.sec.gov. Before investing in the offering, you should read the prospectus supplement and the accompanying prospectus in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the Company and the offering. Copies of the final 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].

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 16, 2021 Fresenius reported that Susanne Zeidler and Dr. Frank Appel proposed for election to the Supervisory Board of Fresenius Management SE (Press release, Fresenius, MAR 16, 2021, View Source [SID1234576726]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Michael Sen (52) will become the new Chief Executive Officer of Fresenius Kabi AG. The Supervisory Board of Fresenius Management SE has unanimously appointed him to the Management Board of Fresenius effective on April 12, 2021. He succeeds Mats Henriksson (53), who is leaving the company due to different views on Fresenius Kabi’s future direction.

Michael Sen was a member of the Management Board of Siemens AG from April 2017 to March 2020, where he was responsible for the healthcare business Siemens Healthineers and for Siemens’ energy business. Prior to that, from 2015 to 2017, he was Chief Financial Officer of E.ON SE. At the start of his professional career, Michael Sen completed an apprenticeship at Siemens in Berlin and then studied business administration at the Technical University of Berlin. After graduation, he took on various management roles at Siemens starting in 1996 in both operating businesses and central divisions. From 2008 to 2015, he was a member of the Executive Team and CFO of Siemens Healthcare.

Mats Henriksson joined the Management Board of Fresenius Kabi on September 1, 1999. From 2001 to February 2012, he was responsible for the company’s Asia-Pacific region. From March 1, 2012, he served as Deputy Chairman of the Management Board of Fresenius Kabi, and on January 1, 2013 was appointed Chairman of the Management Board of Fresenius Kabi.

Dr. Gerd Krick, Chairman of the Supervisory Board of Fresenius, said: "Mats Henriksson played a major role in the development of Fresenius Kabi from the very beginning. From the acquisition and integration of Pharmacia & Upjohn, which became Fresenius Kabi in 1999, to the very successful expansion in Asia under his responsibility and the entry into the promising biosimilars business, he has made numerous important contributions to the growth of this Fresenius business segment. Mats Henriksson is handing over a well-managed business to his successor. On behalf of the entire Supervisory Board, I would like to thank him most sincerely. I wish him every success and the best for his future."

Wolfgang Kirsch, the designated Chairman of the Supervisory Board of Fresenius, said: "Fresenius has developed extremely dynamically and successfully over the past years, from a medium-sized company to a global healthcare group with sales of more than €36 billion today. With the recently presented growth strategy, the Management Board, under the proven leadership of Stephan Sturm, is setting the course for the company’s sustained, successful further development. My colleagues on the Supervisory Board and I fully support this strategy, including the announced, ongoing and open review of the Group structure. Michael Sen is an experienced manager in the healthcare sector who complements our team very well. The Management Board of Fresenius is ideally positioned to successfully implement the strategy in the coming years and to continue Fresenius’ growth story."

Stephan Sturm, CEO of Fresenius, said: "I have worked closely, trustfully and successfully with Mats Henriksson for many years. I thank him, and I personally wish him all the best. At the same time, I look forward to working with Michael Sen in the future. Fresenius Kabi’s business addresses several attractive growth areas in medicine. It is and will remain of central strategic importance for our healthcare group. Together, we will work in the coming years to make this company even stronger – for the benefit of the growing number of patients who depend on our important drugs and products and for our shareholders."

Michael Sen said: "Fresenius Kabi is committed to improving the quality of life of patients around the world. In my future role, I would like to continue to put patient well-being at the center of everything we do and play my part in continuing the company’s successful development. I am very much looking forward to working with Stephan Sturm and the entire team on the Management Board of Fresenius, and of course with my more than 40,000 new colleagues at Fresenius Kabi worldwide. With courage, dedication and creativity, we can and will still achieve a lot together."

The Supervisory Board of Fresenius Management SE also unanimously resolved to propose Susanne Zeidler (60), Chief Financial Officer of Deutsche Beteiligungs AG (DBAG) since November 2012, and Dr. Frank Appel (59), Chief Executive Officer of Deutsche Post DHL Group since February 2008, for election to the Supervisory Board of Fresenius Management SE.

Susanne Zeidler worked for the auditing and consulting firm KPMG between 1990 and 2010. Lastly, as a partner, she was responsible for KPMG’s business with foundations and other non-profit organizations, which, as a qualified auditor and tax advisor, she had helped to establish from 2006 onwards. Prior to that, from 1990 to 1999, she was involved in the valuations of medium-sized and listed companies in various industries, and between 2000 and 2005 was the partner responsible for KPMG’s internal audit review. Before joining the Management Board of DBAG, Susanne Zeidler was Managing Director at the headquarters of the international charity organization "Kirche in Not" ("Aid to the Church") from the beginning of 2011.

Dr. Frank Appel has worked for Deutsche Post DHL Group since 2000, initially as Managing Director Corporate Development, and from 2002 as Board Member responsible for Global Business Services and Key Account Management Global Customer Solutions. In 2005, he was responsible for the acquisition and integration of the British logistics company Exel. In February 2008, he was appointed Chief Executive Officer. A graduate chemist with a PhD in neurobiology, he began his professional career in 1993 at the management consultancy McKinsey, where he became a member of German Business Management in 1999 before joining Deutsche Post DHL Group.

As already announced in October 2020, Dr. Gerd Krick (82) will leave the Supervisory Boards of Fresenius Management SE and the listed Fresenius SE & Co. KGaA when his term ends at the close of the Annual General Meeting in May 2021. Wolfgang Kirsch (65), a member of the Supervisory Board of Fresenius Management SE since January 1, 2020, is to take over from him as Chairman of both Supervisory Boards. In recognition and deep appreciation of his long decades of accomplishment and invaluable work on behalf of Fresenius, Dr. Krick shall be named Honorary Chairman of both Supervisory Boards.

Klaus-Peter Müller (76) will be stepping down from the Supervisory Board of Fresenius Management SE at the end of his term in May 2021. At the listed Fresenius SE & Co. KGaA, Klaus-Peter Müller will stand for reelection to the Supervisory Board at the Annual General Meeting in May with the aim of chairing the Audit Committee for a further year.

On March 16, 2021 Repertoire Immune Medicines, a clinical-stage biotech company creating a new category of immune therapies for cancer, autoimmunity and infectious disease, reported that John Cox, Chief Executive Officer, will present at the Oppenheimer 31st Annual Healthcare Conference on Thursday, March 18, 2021, at 10:00 a.m. ET (Press release, Repertoire, MAR 16, 2021, View Source [SID1234576743]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!