On April 30, 2024 Leidos Holdings, Inc., a FORTUNE 500 innovation company, reported financial results for the first quarter of fiscal year 2024 (Press release, Leidos, APR 30, 2024, View Source [SID1234644729]).

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Thomas Bell, Leidos Chief Executive Officer, commented, "Our strong start to the year demonstrates the team’s ability to deliver for its employees, customers, and shareholders. With greater visibility around customer funding and performance ahead of plan, we are raising guidance on all metrics ahead of our typical pace. We fully expect that 2024 will showcase our commitment to profitable growth. Going forward, our focus remains on operational execution while we develop a robust strategy, invest in disruptive technology-driven solutions, and unlock maximum value through our capability-based organization."

Revenues for the quarter were $3.98 billion, up 7% compared to the first quarter of 2023. Revenues grew year-over-year due to increased demand across all customer segments, especially for managed health services.

For the first quarter, net income was $283 million, or $2.07 per diluted share. Net income and diluted EPS were up 73% and 77% year-over-year, respectively. Net income margin of 7.1% increased from 4.4% in the first quarter of 2023.

Adjusted EBITDA was $490 million for the first quarter, up 42% year-over-year. Record adjusted EBITDA margin of 12.3% increased from 9.4% in the first quarter of 2023. Non-GAAP net income was $313 million for the first quarter, up 53% year-over-year, and non-GAAP diluted EPS for the quarter was $2.29, up 56% year-over-year. The primary drivers of increased profitability were increased volumes on fixed-rate managed health services and improved cost control across the company.

Cash Flow Summary

In the first quarter, Leidos generated $63 million of net cash provided by operating activities and used $12 million in investing activities and $228 million in financing activities. Net cash provided by operating activities was driven by strong EBITDA and collections performance. Days Sales Outstanding (DSO) for the quarter was 62, in line with the first quarter of 2023.

Investing activities consisted primarily of $17 million in property, equipment and software payments, which resulted in quarterly free cash flow of $46 million. Leidos returned $236 million to shareholders in the first quarter, including $183 million in share repurchases and $53 million as part of its regular quarterly cash dividend program. As of March 29, 2024, Leidos had $633 million in cash and cash equivalents and $4.7 billion of debt.

On April 26, 2024, the Leidos Board of Directors declared a cash dividend of $0.38 per share to be paid on June 28, 2024, to stockholders of record at the close of business on June 14, 2024.

Business Development

Net bookings totaled $3.7 billion in the quarter, representing a book-to-bill ratio of 0.9. As a result, backlog at the end of the quarter was $36.6 billion, of which $8.0 billion was funded.

Forward Guidance

Leidos is updating its fiscal year 2024 guidance as follows:

FY24 Guidance

Measure

Current

Prior

Revenues (billions)

$16.0 – $16.4

$15.7 – $16.1

Adjusted EBITDA Margin

Mid-to-High 11%

Mid-to-High 10%

Non-GAAP Diluted EPS

$8.40 – $8.80

$7.50 – $7.90

Cash Flows Provided by Operating Activities (billions)

approximately $1.3

approximately $1.1

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 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 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 at this time. The amounts of these deductions may be material and, therefore, could result in projected net income and diluted EPS being materially less than what may be implied by projected adjusted EBITDA margins and non-GAAP diluted EPS.

On April 30, 2024 JSR reported its Q4 2023 financial results (April 2023 to March 2024) (Presentation, JSR, APR 30, 2024, View Source [SID1234644718]).

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On April 30, 2024 Hanmi reported its first quarter 2024 financial results (Presentation, Hanmi, APR 30, 2024, View Source [SID1234644671]).

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On April 30, 2024 AGV Discovery reported that the first participant was dosed in the Phase 1/2 clinical trial for the evaluation of IPN01194 in patients with MAPKm advanced solid tumors (Press release, AGV Discovery, APR 30, 2024, View Source;refresh=665d5ac4a31081717394116 [SID1234643961]).

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Cédric Boriès, President for AGV Discovery commented, "We are very pleased to announce the first dosing in humans of our drug candidate IPN01194 in collaboration with our partner Ipsen. This represents a very important milestone for us and for the patients we hope to serve. This success is the result and the demonstration of the efficiency of our drug design platform, based on innovative conception approaches".

The Phase 1/2 trial will evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and anti-tumors activity of ERK1/2 inhibitor IPN01194 as single agent in adult participants with advanced solid tumors.

On April 30, 2024 NovAccess Global Inc. (OTCQB: XSNX), a biomedical company developing a novel immunotherapy for patients suffering from cancers of the central nervous system, reported the procurement of a new intellectual property license from Cedars-Sinai Medical Center to further advance the Company’s immunotherapy platform (Press release, NovAccess Global, APR 30, 2024, View Source [SID1234642634]). The license pertains to the use of Isocitrate Dehydrogenase-1 (IDH1), a protein previously known to impact cell metabolism. The Company intends to leverage this license to predict a patient’s likely response to vaccine immunotherapy during their treatment for highly malignant brain tumors, such as glioblastoma.

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IDH1 is commonly mutated in brain and other tumors. Groundbreaking research published by Dr. Chris Wheeler, President, and lead scientist of NovAccess Global’s subsidiary StemVax, LLC, has shown that IDH1 predicts antitumor responses after vaccine therapy through a novel molecular mechanism. The Company assesses that IDH1 expression is likely to discern long-duration from short-duration survivors after vaccine therapy in patients with brain tumors such as glioblastoma. Information derived from the use of IDH1 as a biomarker will help to better inform therapeutic strategy as physicians assess the use of single agent or combination therapies in their treatment of patients facing these life-threatening diagnoses.

NovAccess Global intends to support the development of IDH1 as a biomarker for TRL-AD1, its candidate drug for the treatment of cancers of the central nervous system that in 2022 received Orphan Drug designation by the U.S. Food and Drug Administration (FDA). The Company will assess IDH1 as a companion diagnostic to TRL-AD1 while exploring IDH1’s potential to serve as a prognostic indicator of patient response to currently marketed therapies and those in clinical development.

"Dr. Wheeler’s research continues to lead the industry and is incredibly important to the advancement of our immunotherapy platform for brain tumor treatment and potentially for other cancer therapies," said NovAccess Global’s Chief Executive Officer Dr. Dwain K. Irvin. "In particular, we anticipate his findings from work with IDH1 will complement NovAccess’ TLR-AD1 vaccine approach by allowing selection of the most suitable patients for treatment and thereby maximizing the treatment’s benefits to them. This combination represents a potentially significant breakthrough toward achieving improved outcomes and enhanced life expectancy for those suffering from brain cancer, which may bring relief to many of the approximately 10,000 people per year in America alone dying from this condition."

Cedars-Sinai Medical Center, where Drs. Wheeler and Irvin previously collaborated in optimizing brain tumor vaccines, owns the patent for IDH1’s use as a predictor of brain tumor vaccine success, and is granting an exclusive license for that use to StemVax Therapeutics.

About Dr. Christopher Wheeler, Ph.D., President, StemVax, LLC

Dr. Wheeler has over 30 years of immunology and neurology research experience. His leadership experience is highlighted by his position and previous roles at Cedars-Sinai Medical Center Department of Neurosurgery. Dr. Wheeler was a Professor in the Department for over 20 years, and also served as The Operations Director of Vaccine Manufacturing Laboratory (1997-2018), as part of the Precision Medicine Initiative for Brain Tumors Department of Neurosurgery, and Glioma Immunotherapy Core Director (2003-2018).

In 2023, Dr. Wheeler was appointed as a visiting scientist at UC Santa Cruz, Department of Chemistry & Biochemistry. The UC Santa Cruz Division of Physical & Biological Sciences is a world-leading public research institution with a reputation for instigating some of humanity’s most high-impact discoveries and empowering students with immersive research experiences since 1965. It is part of the University of California, and maintains a mission to serve society through "transmitting advanced knowledge, discovering new knowledge, and functioning as an active working repository of organized knowledge" in the physical & biological sciences.

Dr. Wheeler’s research has been highlighted by publications in numerous high-impact, paradigm shifting manuscripts and several patents. As part of his career achievements, he has executed scientific aspects of commercialization, validation, funding, and marketing for the development of Alzheimer’s Disease (AD) biomarker technology. Dr Wheeler is a 2023 recipient of the prestigious Golden Axon Award presented at the World Brain Mapping Foundation (WBMF) Annual Congress.

StemVax Therapeutics is a Translational Biotechnology Company that develops novel therapies for brain tumor patients. Research is focused on the development of immunotherapeutic approaches to treating patients with Glioblastoma, a devastating brain cancer. Additional research efforts are centered on novel drug development to target Cancer Stem cells and other multi-resistant cancer cells.

StemVax became a wholly owned subsidiary of NovAccess Global, Inc. in October of 2020 to rapidly accelerate its portfolio through clinical trials and successfully bring safe and efficacious novel immunotherapeutics to market. Their mission is to make a difference in Glioblastoma and other brain tumor patients’ lives through novel immunotherapeutics.

About TLR-AD1

TLR-AD1 is designed to activate anti-tumor immune responses against brain tumors using immune-activating dendritic cells combined with the patient’s own tumor proteins. The resulting dendritic cell vaccines are matured with a proprietary combination of Toll-like receptor (TLR) adjuvants to boost their immune-activating potency beyond current vaccine preparations.

The Company’s therapeutic path involves a transformational process where tumor-killing immune responses for malignant glioma (MG) cells are higher than that of previous immunotherapies. This unique process involves the addition of proprietary substances to create a "cocktail" for more personalized treatment that substantially increases clinical benefits for patients.

Glioblastoma is a form of aggressive brain cancer that annually impacts approximately 250,000 people globally and is on the rise in many countries, according to NovAccess scientists and published reports. The market data is more alarming, with glioblastoma accounting for approximately 50% of all malignant brain cancers diagnosed in the United States each year, and more than 10,000 Americans dying from this tumor type annually. Less than 5% of people with this cancer live longer than five years after their diagnosis. The global glioblastoma treatment market was estimated to be valued in excess of $2 billion in 2020, with projections for a compounded annual growth rate of more than 8% throughout the remainder of the decade.

In 2022, the U.S. FDA granted Orphan Drug designation to TRL-AD1. NovAccess Global is preparing to submit an Investigational New Drug (IND) application to the FDA for TLR-AD1. In advance of the IND filing, the Company expects to announce a partnership with a clinical manufacturing organization for vaccine testing and production readiness for phase I-II clinical trials of TLR-AD1.