On May 7, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the "Company"), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported an update on its financial results and recent business developments for the fiscal quarter ended March 31, 2021 (Press release, Celyad, MAY 7, 2021, View Source [SID1234579455]).

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"We have entered 2021 with ever-increasing enthusiasm around the progress of our programs," commented Filippo Petti, Chief Executive Officer of Celyad Oncology. "Our lead shRNA-based allogeneic candidate, CYAD-211, which is currently being evaluated in the Phase 1 IMMUNICY-1 trial for the treatment of multiple myeloma, has shown no safety concerns nor evidence of Graft-versus-Host Disease (GvHD) at dose level 1. We look forward to announcing additional proof-of-concept data from this trial by the end of second quarter of 2021. In addition, we have continued to enroll patients in the alloSHRINK expansion trial for CYAD-101 and will turn our attention to the KEYNOTE-B79 trial. Lastly, we are planning an R&D day for this summer that will provide an opportunity for our broader team to offer an in-depth overview of our clinical programs and strategy for advancing our next-generation shRNA platform and allogeneic pipeline."

Recent Highlights

Appointment of Dr. Charles Morris as Chief Medical Officer to lead and provide strategic direction for Celyad Oncology’s medical, regulatory, and clinical development activities.
Appointment of Marina Udier, Ph.D. to Board of Directors
Announced a committed equity purchase agreement for up to $40 million in American Depositary Shares (ADSs) with Lincoln Park Capital Fund, LLC ("LPC")
First Quarter 2021 Financial Review

As of March 31, 2021, the Company had cash and cash equivalents of €12.2 million ($14.3 million). Net cash burn during the first quarter of 2021 amounted to €5.1 million ($5.9 million), in line with expectations. In April 2021, the Company raised proceeds of €3.3 million ($4.0 million) from the sale of ADSs to LPC. The Company confirms its previous guidance that its existing cash and cash equivalents combined with the remaining access to the equity purchase agreement established with LPC should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements until mid-2022.

Update on Clinical Programs

CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM

CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex. The Company is currently conducting the first-in-human, open-label, dose-escalation Phase 1 IMMUNICY-1 trial to evaluate the safety and efficacy of a single infusion of CYAD-211 following preconditioning chemotherapy cyclophosphamide and fludarabine in patients with r/r MM. The trial seeks to determine the recommended dose of CYAD-211 for the treatment of patients with r/r MM for further development as well as to establish proof-of-concept that single shRNA-mediated knockdown can generate allogeneic CAR T cells in humans without inducing GvHD. In March, the Company announced that no safety concerns nor evidence of GvHD had been reported in the first three patients treated at dose level 1 (30×106 cells per infusion) of CYAD-211 in the IMMUNICY-1 trial. In first quarter 2021, the Company initiated enrollment in dose level 2 (100×106 cells per infusion). The Company expects to announce additional proof-of-concept data from the IMMUNICY-1 trial by the end of the second quarter of 2021.

CYAD-101 – Allogeneic TIM-based NKG2D CAR T for mCRC

The Company’s first-in-class, non-gene edited clinical candidate, CYAD-101, which co-expresses the NKG2D receptor and the novel inhibitory peptide TCR Inhibitory Molecule (TIM), is currently in the expansion segment of the alloSHRINK Phase 1 trial for the treatment of advanced mCRC. To the Company’s knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication.

Phase 1 alloSHRINK trial is ongoing, in which the Company is evaluating CYAD-101 following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy in refractory mCRC patients, at the recommended dose of one billion cells per infusion. The Company expects to announce preliminary data from the expansion cohort of the trial in mid-2021.
Celyad Oncology will also conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology’s investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI chemotherapy, with MSD’s anti-PD­1 therapy, KEYTRUDA (pembrolizumab) in refractory metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease. The Phase 1b KEYNOTE-B79 trial is expected to be initiated during first half of 2021.
CYAD-02 – Autologous NKG2D receptor-based CAR T for relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndromes (MDS)

Enrollment is ongoing in dose level 3 of the Phase 1 CYCLE-1 trial for the next-generation, autologous NKG2D receptor-based CAR T candidate CYAD-02. The dose-escalation Phase 1 CYCLE-1 trial is evaluating the safety and clinical activity of CYAD-02 following preconditioning chemotherapy in patients with r/r AML and MDS. To date, treatment with CYAD-02 has been generally well-tolerated. Of seven patients evaluable for clinical activity, five patients demonstrated anti-leukemic activity (at least 50% bone marrow blasts decrease), including a very-high risk MDS patient treated at dose level 3 who achieved a marrow complete response.

Next-generation shRNA Multiplex Platform

In 2020, the Company began developing a proprietary shRNA platform utilizing a novel framework to optimize and expand the expression of multiple shRNAs with our All-in-One vector approach. The Company’s novel framework has the capability to knockdown or silence up to six genes simultaneously, while providing several key advantages beyond the Company’s first-generation approach. The Company believes its next-generation shRNA multiplex platform will form the backbone for future allogeneic CAR T candidates, including several programs which are in the discovery phase of development. Our next-generation shRNA platform does not incorporate any of the Horizon Discovery technology.

Upcoming Milestones

Additional proof-of-concept data from the initial dose cohorts of the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected by the end of second quarter of 2021.
Preliminary data from the expansion segment of the alloSHRINK trial evaluating CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients are expected in mid-2021.
Initiation of the Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA in mCRC patients with MSS/pMMR disease is anticipated in the first half of 2021.
Additional data from dose level 3 of Phase 1 CYCLE-1 trial of CYAD-02 for r/r AML and MDS are anticipated in the first half of 2021.
Financial Calendar

First Half 2021 Financial Results …………………… August 4, 2021
Third Quarter 2021 Financial Results ……………… November 10, 2021

On May 7, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported that it will host a conference call and live webcast at 4:30 p.m. ET on Thursday, May 13th, 2021 to report its first quarter 2021 financial results and provide a corporate update (Press release, iTeos Therapeutics, MAY 7, 2021, View Source [SID1234579475]).

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Conference Call

Dial-in numbers: (833) 607-1661 (US/Canada) or (914) 987-7874 (International); Conference ID: 6160559

Webcast

A live audio webcast will be accessible from the Events page of the Company’s IR website at View Source A replay will be available on the Company’s website approximately two hours after completion of the event and for 30 days following the call

On May 7, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at the upcoming Bank of America Health Care Conference on Wednesday, May 12, 2021 at 1:15 p.m. EST / 10:15 a.m. PST (Press release, Coherus Biosciences, MAY 7, 2021, View Source [SID1234579456]).

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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

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The audio portion of the Company presentation will be available on the investors page of the Coherus BioSciences website at View Source

On May 7, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) ("Aurinia" or the "Company") reported its financial results for the first quarter ended March 31, 2021. Amounts, unless specified otherwise, are expressed in U.S. dollars (Press release, Aurinia Pharmaceuticals, MAY 7, 2021, View Source [SID1234579477]).

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"2021 started with the FDA approval of LUPKYNIS, the first FDA-approved oral treatment for active lupus nephritis – a devastating complication of lupus," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Our pivotal decision and work to build a world-class commercial infrastructure prior to approval ultimately led to Aurinia being able to make LUPKYNIS immediately available to patients and physicians following approval. Since that time, the Aurinia team has been encouraged by the feedback we are receiving from physicians and patients and our confidence has only grown as we continue to understand the tremendous need and value of LUPKYNIS, and work to accelerate broader adoption across the underserved LN population."

Recent Highlights

FDA Approval and Commercial Launch of LUPKYNIS

On January 22, 2021, the FDA approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.

Commercial Activities

Engaged with over 6,000 rheumatologists and nephrologists;
Received over 250 patient start forms during the first quarter (covering 48 business days post-FDA approval);
Converted nearly 40% of patient start forms to patients on therapy by the end of the first quarter; and
Launched LUPKYNIS Patient Marketing Campaign, Focus on the Fight, in April 2021.
"Since launch, the commercial team has focused on educating their customers on the urgency needed in reducing proteinuria for patients with active LN. With more than 250 patient start forms and 40% of those patients on therapy after the first two months on the market, more than 6,000 clinical interactions, continued gradual expansion of payor coverage, and our Aurinia Alliance patient support program fully operational, the LUPKYNIS trajectory is on track against our internal projections. Furthermore, we anticipate that our market access will continue to improve as the rate of COVID vaccinations in the United States continues to climb and healthcare centers re-open their doors to patients," commented Max Colao, Chief Commercial Officer at Aurinia.

Upcoming Milestones

Anticipate filing a marketing authorization application (MAA) with the European Medicines Agency (EMA) during the first half of 2021 with partner, Otsuka;
Abstracts discussing voclosporin accepted for presentation at the Annual European Congress of Rheumatology (EULAR 2021 Congress), June 2 – 5, 2021, and at the Nephrology Virtual Congress (ERA-EDTA 2021), June 5 – 8, 2021;
Expect to initiate a study of voclosporin in adolescent patients (VOCAL study) during the second half of 2021; and
Anticipate reporting top-line results from the ongoing AURORA-2 continuation study during the first quarter of 2022.
Financial Liquidity at March 31, 2021

As of March 31, 2021, Aurinia had cash and cash equivalents and investments of $360.9 million compared to $422.7 million at December 31, 2020. The decrease is primarily related to the commercial infrastructure spend to support the launch of LUPKYNIS in addition to an upfront payment made as part of a collaborative agreement with Lonza to build a dedicated manufacturing facility (also referred to as "monoplant") and one-time payment to a related party upon achievement of specific milestones.

Net cash used in operating activities was $53.5 million for the quarter ended March 31, 2021 compared to $22.6 million for the quarter ended March 31, 2020. The increase is primarily due to the commercial infrastructure spend to support the launch of LUPKYNIS in addition to a one-time payment to a related party upon achievement of specific milestones. In the prior year, the Company was still in the development phase of LUPKYNIS and as a result, did not incur any material related selling expenses.

The Company believes that it has sufficient financial resources to fund its current plans, which include funding commercial activities, including our FDA related post approval commitments, manufacturing and packaging of commercial drug supply, conducting our planned research and development (R&D) programs, and operating activities into at least 2023.

Financial Results for the Quarter Ended March 31, 2021

For the quarter ended March 31, 2021, Aurinia recorded a net loss of $50.4 million or $0.40 net loss per common share, as compared to a net loss of $25.9 million or $0.23 net loss per common share for the quarter ended March 31, 2020.

Revenues were $0.9 million and $30 thousand for the quarters ended March 31, 2021 and March 31, 2020, respectively. The increase was the result of the commercial sales of LUPKYNIS, which began in January 2021.

Cost of sales were $48 thousand and nil for the quarters ended March 31, 2021 and March 31, 2020, respectively. The increase was the result of commercial sales of LUPKYNIS and drug substance. Gross margin for the quarter ended March 31, 2021 was approximately 95%.

Selling, general and administrative (SG&A) expenses were $39.3 million and $11.1 million for the quarters ended March 31, 2021 and March 31, 2020, respectively. The increase was primarily due to the expansion of the commercial infrastructure, administrative functions and patient assistance programs to support the launch of LUPKYNIS. SG&A share-based compensation expense for the quarter ended March 31, 2021 was $6.6 million.

R&D expenses were $9.8 million and $13.8 million for the quarters ended March 31, 2021 and March 31, 2020, respectively. The decrease was primarily due to lower Contract Research Organization (CRO) expenses and other third-party clinical trial expenses following the approval of LUPKYNIS, including a reduction in NDA preparation costs, capitalization of supply costs following approval, and termination of the dry eye trial during the fourth quarter of 2020. R&D share-based compensation expense for the quarter ended March 31, 2021 was $1.1 million.

This press release is intended to be read in conjunction with the Company’s unaudited condensed consolidated financial statements and Management’s Discussion and Analysis for the quarter ended March 31, 2021 in the Company’s Quarterly Report on Form 10-Q, which is accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Conference Call Details

Aurinia will host a conference call and webcast to discuss the quarter ended March 31, 2021 financial results today, Thursday, May 6, 2021 at 5:00 p.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1-888-506-0062 (toll-free U.S.) or +1-973-528-0011 (international); entry code: 662377. A replay of the conference call will also be available on Aurinia’s website approximately two hours after the live call is completed.

About Lupus Nephritis

LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

On May 7, 2021 Leidos Holdings, Inc. (NYSE: LDOS) ("Leidos"), a FORTUNE 500 science and technology leader, reported the completed acquisition of Gibbs & Cox, Inc. ("Gibbs & Cox") for approximately $380 million in cash (Press release, Leidos, MAY 7, 2021, View Source;Cox/default.aspx [SID1234579493]). The transaction was previously announced on Feb. 23, 2021. Gibbs & Cox will operate as a wholly owned subsidiary and will be combined with Leidos’ maritime systems division.

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Gibbs & Cox-designed DDG-51 Arleigh Burke-class destroyer

Headquartered in Arlington, Virginia, Gibbs & Cox is the largest independent ship design firm focused on naval architecture and marine engineering. The company’s world class naval architects, designers, engineers and program managers develop innovative vessel designs and naval capabilities. The acquisition positions Leidos to provide a broad set of engineering solutions to the US Navy and to an expanding set of foreign Navies.

"We are delighted to welcome the Gibbs & Cox team to the Leidos family," said Leidos Chairman and CEO Roger Krone. "Gibbs & Cox is widely regarded for developing the most talented and experienced naval designers in the world. We look forward to this new era of innovation while combining the best of both companies."

"We are excited to join Leidos, whose employee culture and history of innovation strongly mirror our own legendary 91-year history", said Gibbs & Cox President and Chief Executive Chris Deegan. "Gibbs & Cox will remain the nation’s largest independent provider of maritime services. The combination of our world-class naval architecture, design and engineering services with Leidos’ speed, security and scale will significantly enhance our combined offerings in the fast growing maritime undersea, autonomous and cyber security segments. We look forward to mapping a new Gibbs & Cox with Leidos for the next 90 years."

Advisors

Citigroup Global Markets Inc. served as exclusive financial advisor and Holland & Knight LLP served as legal advisor to Leidos. Houlihan Lokey served as exclusive financial advisor and Greenburg Traurig, LLP served as legal advisor to Gibbs & Cox in connection with this transaction.