Gamida Cell Announces the Date of Its First Quarter 2022 Financial Results and Webcast

On May 3, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, reported that the company will host a conference call and live audio webcast on Tuesday, May 10, 2022, at 8:00 a.m. ET to review its first quarter 2022 financial results and provide an update on the company (Press release, Gamida Cell, MAY 3, 2022, View Source [SID1234613432]).

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The webcast will be available on the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 3344029. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

Byondis and medac Enter Into License and Collaboration and Supply Agreements for Anti-HER2 ADC Trastuzumab Duocarmazine (SYD985)

On May 3, 2022 Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, reported that it has entered into a License and Collaboration Agreement and a Supply Agreement with medac GmbH, a privately owned pharmaceutical company based in Germany (Press release, Byondis, MAY 3, 2022, View Source [SID1234613449]). Byondis and medac will partner to commercialize Byondis’ lead program, anti-HER2 antibody-drug conjugate (ADC) trastuzumab duocarmazine (SYD985), pending approval by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory authorities in Europe.

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Under the terms of the agreement, medac receives an exclusive license to commercialize SYD985 in the EU, the UK and further European countries, in all approved indications. Byondis will receive an undisclosed upfront payment and sales royalties. Byondis will also be eligible for payments upon achievement of certain development and sales milestones.

"This collaboration with medac on SYD985 is a crucial step in ensuring that the therapy, once approved, is available to patients, who desperately need other treatment options," said Byondis Founder and Chairman Jacques Lemmens, Ph.D.

"Like Byondis, medac is committed to developing novel therapies, especially in areas of unmet medical need. We believe in the potential of Byondis and SYD985 and look forward to bringing this next generation ADC to patients who need it," said medac Managing Director, CEO Jörg Hans.

Byondis CEO Marco Timmers, Ph.D. added: "We are pleased to have found in medac a true partner who shares our passion for innovation and making a difference in the lives of patients."

SYD985 targets a range of HER2-expressing cancers such as metastatic breast and endometrial (uterine) tumors. Data from the SYD985 pivotal Phase III TULIP study (SYD985.002) in HER2-positive unresectable locally advanced or metastatic breast cancer showed statistically significant progression-free survival (PFS) results compared to physician’s choice (PC) treatment. TULIP continues to study overall survival and a Marketing Authorization Application (MAA) for this initial clinical indication will soon be submitted to the EMA. The ADC is also in a Phase II multiregional clinical trial to evaluate its safety and efficacy in patients with HER2-expressing recurrent, advanced or metastatic endometrial cancer (SYD985.003).

About trastuzumab duocarmazine (SYD985), a Next Generation Antibody-Drug Conjugate
Trastuzumab duocarmazine (SYD985) incorporates Byondis’ distinctive, proprietary duocarmazine linker-drug (LD) technology ByonZine. The ADC is comprised of the anti-HER2 monoclonal antibody trastuzumab, and a cleavable linker-drug called valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA).

The antibody part of trastuzumab duocarmazine binds to HER2 on the surface of the cancer cell and the ADC is internalized by the cell. After proteolytic cleavage of the linker, the inactive cytotoxin is activated and DNA damage is induced, resulting in tumor cell death. SYD985 is considered a form of targeted chemotherapy.

Targovax ASA: Invitation to presentation of Targovax’s first quarter 2022 results, Thursday 12 May

On May 3, 2022 Targovax ASA (OSE: TRVX) reported that it will announce its first quarter 2022 results on Thursday 12 May 2022 (Press release, Targovax, MAY 3, 2022, View Source [SID1234613355]). An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 am CET.

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The results report and the presentation will be available at www.targovax.com in the Investors section from 07:00 am CET.

Presentation

There will be a virtual presentation of the results with a live webcast 12 May at 10.00 am CET. You can join the webcast here. It will be possible to ask questions during the presentation.

Alpine Immune Sciences Announces Participation in May Investor Conferences

On May 3, 2022 Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported that members of its management team will participate at the following investor conferences in May 2022 (Press release, Alpine Immune Sciences, MAY 3, 2022, View Source [SID1234613383]):

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LifeSci Partners Immunology & Inflammation Symposium
Date: Tuesday, May 10, 2022
Time: 3:00 p.m. ET/12:00 p.m. PT
Event: Fireside Chat

BofA Securities Healthcare Conference 2022
Date: Wednesday, May 11, 2022
Time: 7:15 p.m. ET/4:15 p.m. PT
Event: Corporate Presentation

Webcasts of the LifeSci Partners fireside chat and BofA corporate presentation will be available online in the investor relations section of the company’s website at View Source A replay of the fireside chats will be available on the company website for 90 days following the webcast.

Leidos Holdings, Inc. Reports First Quarter Fiscal Year 2022 Results

On May 3, 2022 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported financial results for the first quarter of fiscal year 2022 (Press release, Leidos, MAY 3, 2022, View Source [SID1234613399]).

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Roger Krone, Leidos Chairman and Chief Executive Officer, commented, "Our first quarter marked a strong start to 2022, with record levels of revenues and backlog stemming from our leadership position in the government technology market. We continued to build our reputation and track record of performance in digital technology, cyber, and innovative systems across our diversified, resilient business portfolio. Our strong first quarter results and the improving federal budget picture increase our confidence in delivering on our full-year financial commitments."

Summary Operating Results

* Non-GAAP financial measures should be considered in addition to, but not as a substitute for, the information provided in accordance with GAAP. Management believes that these non-GAAP measures provide another measure of Leidos’ results of operations and financial condition, including its ability to comply with financial covenants. See Non-GAAP Financial Measures at the end of this press release for more information and a reconciliation of our selected reported results to these non-GAAP measures.

Revenues for the quarter were $3.49 billion, up 5% in total and up 4% organically compared to the prior year quarter. Revenues grew across all reportable segments; the largest contributors were the start-up of the Navy Next Generation Enterprise Network Recompete (NGEN-R) Service Management, Integration and Transport (SMIT) contract and the increased deployments on the Defense Healthcare Management System Modernization (DHMSM) program.

Net income was $177 million and diluted EPS was $1.25. Net income and diluted EPS were down 14% and 12% year-over-year, respectively, primarily as a result of the $26 million net benefit from an adjustment to legal reserves related to the Mission Support Alliance (MSA) joint venture recorded in the first quarter of fiscal year 2021. The weighted average diluted share count for the quarter was 140 million compared to 144 million in the prior year quarter. Net income margin decreased from 6.2% to 5.1% year-over-year.

Adjusted EBITDA was $358 million for the first quarter, down 8% year-over-year. Adjusted EBITDA margin decreased from 11.7% to 10.2% over the same period, primarily as a result of the MSA adjustment and a return to more normative indirect spending levels. Non-GAAP net income was $223 million for the first quarter, which was down 10% year-over-year, and non-GAAP diluted EPS for the quarter was $1.58, which was down 9% compared to the first quarter of fiscal year 2021.

Cash Flow Summary

In the first quarter of fiscal year 2022, Leidos generated $93 million of net cash provided by operating activities for an operating cash flow conversion ratio of 53%. After adjusting for payments for property, equipment and software, quarterly free cash flow was $65 million for a free cash flow conversion ratio of 29%.

Leidos used $21 million in investing activities and $519 million in financing activities, which included a $500 million accelerated share repurchase agreement and $51 million in quarterly cash dividends. As of April 1, 2022, Leidos had $297 million in cash and cash equivalents and $5.1 billion of debt.

On April 29, 2022, the Leidos Board of Directors declared that Leidos will pay a cash dividend of $0.36 per share on June 30, 2022 to stockholders of record at the close of business on June 15, 2022.

New Business Awards

Net bookings totaled $5.4 billion in the quarter, representing a book-to-bill ratio of 1.6. As a result, backlog at the end of the quarter was a record $36.3 billion, of which $7.1 billion was funded. Included in the quarterly bookings were several particularly important awards:

Advanced Enterprise Global Information Technology Solutions (AEGIS). Leidos was awarded a prime contract by the National Aeronautics and Space Administration (NASA) to provide telecommunications, cloud and data center services across all of the agency’s centers and facilities. The single award contract has a total estimated value of $2.5 billion and a ten-year period of performance, if all options and award terms are exercised.
National Airspace Systems (NAS) Integration Support Contract (NISC). Leidos will continue its support of air traffic control modernization efforts to the Federal Aviation Administration (FAA) under a new $1.7 billion, 10-year, single-award indefinite-delivery/indefinite-quantity (ID/IQ) contract. Leidos will perform engineering and technical services to integrate new systems, components and equipment into the National Airspace System, including strategic and transition planning, test-and-evaluation, training, automation, flight procedures, security and safety, business intelligence, data analytics and unmanned aircraft systems.
Veterans Benefits Administration (VBA) Medical Disability Examinations (MDE) Services. Leidos was awarded the recompete of its contract to support pre-discharge examinations in the U.S. and a new contract to provide disability examinations in 39 locations outside the U.S. Each multiple award ID/IQ contract has a six-month base period with six one-year options; together, they total approximately $1.7 billion in contract value if all options are exercised. Leidos will leverage the infrastructure and capability built over more than two decades to perform medical disability examinations through multiple delivery models to better serve veterans.
U.S. Navy Surface Combatant Ship Design Engineering Services. The U.S. Navy awarded Gibbs & Cox, a wholly owned subsidiary of Leidos, a contract to provide Surface Combatant Ship Design Engineering Services in support of Future Surface Combatant Programs. Under the contract, Gibbs & Cox will provide services supporting future surface combatants design, with initial focus on the Program Executive Office Ship’s DDG(X) Program Office (PMS 460) industry engagement, DDG(X) design development, and technology integration efforts. The award has a potential value of $319 million with a period of performance through 2027, if all options are exercised.
U.S. Army Gunnery Training Systems Modernization. Leidos was awarded a prime contract by the U.S. Army’s Program Executive Office for Simulation, Training, and Instrumentation to modernize the service’s gunnery training simulation systems. Under the contract, Leidos will perform technology refresh and concurrency updates to the simulators. The single-award ID/IQ contract has a total estimated value of $104 million and a period of performance of five years.

For information regarding adjusted EBITDA margin and non-GAAP diluted EPS, see the related explanations and reconciliations to GAAP measures included elsewhere in this release.

Leidos does not provide a reconciliation of forward-looking adjusted EBITDA margins or non-GAAP diluted EPS to net income attributable to Leidos shareholders, due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because certain deductions for non-GAAP exclusions used to calculate projected net income attributable to Leidos shareholders may vary significantly based on actual events, Leidos is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income attributable to Leidos shareholders at this time. The amounts of these deductions may be material and, therefore, could result in projected net income attributable to Leidos shareholders and diluted EPS being materially less than projected adjusted EBITDA margins and non-GAAP diluted EPS.

Conference Call Information

Leidos management will discuss operations and financial results in an earnings conference call beginning at 8:00 A.M. eastern time on May 3, 2022. Analysts and institutional investors may participate by dialing +1 (877) 869-3847 (toll-free U.S.) or +1 (201) 689-8261 (international callers).

A live audio broadcast of the conference call along with a supplemental presentation will be available to the public through links on the Leidos Investor Relations website (View Source).

After the call concludes, an audio replay can be accessed on the Leidos Investor Relations website or by dialing +1 (877) 660-6853 (toll-free U.S.) or +1 (201) 612-7415 (international callers) and entering conference ID 13728784.