Exact Sciences to participate in November investor conferences

On November 1, 2022 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, NOV 1, 2022, View Source [SID1234622704]).

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Credit Suisse 31st Annual Healthcare Conference, Rancho Palos Verdes
Fireside chat on Tuesday, November 8, 2022 at 2:35 p.m. ET
Jefferies London Healthcare Conference, London
Fireside chat on Tuesday, November 15, 2022 at 10:50 a.m. ET
Evercore ISI HealthCONx Conference, virtual
Fireside chat on Tuesday, November 29, 2022 at 1:50 p.m. ET
Piper Sandler 34th Annual Healthcare Conference, New York
Fireside chat on Wednesday, November 30, 2022 at 4:30 p.m. ET
The webcast can be accessed in the investor relations section of Exact

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

On November 1, 2022 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported financial results for the third quarter of fiscal year 2022.

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Roger Krone, Leidos Chairman and Chief Executive Officer, commented, "Our third quarter results demonstrate the momentum in our business as we continue to report revenue growth at the upper end of our guidance across our diversified portfolio. In addition, our dedicated team delivered earnings in excess of our forecast and generated the highest quarterly cash flow from operations in our history. These results position us well to deliver on our full-year financial targets as we make the world safer, healthier and more efficient."

Revenues for the quarter were $3.61 billion, up 4% compared to the third quarter of 2021; the largest contributors were continued growth of the Navy Next Generation Enterprise Network Recompete (NGEN-R) Service Management, Integration and Transport (SMIT) contract; ramp-up of the National Aeronautics and Space Administration (NASA) Advanced Enterprise Global Information Technology Solutions (AEGIS) contract; and increased deployments on the Defense Healthcare Management System Modernization (DHMSM) program.

Net income was $164 million and diluted EPS was $1.17. Net income and diluted EPS were down 21% and 18% year-over-year, respectively. Net income and diluted EPS include a $16 million unrealized loss associated with the foreign currency forward contract entered into in order to hedge the preliminary purchase price for Cobham Aviation Services Australia ("Cobham") in Australian dollars. In addition, net interest expense increased to $50 million from $47 million in the third quarter of 2021. Weighted average diluted shares for the quarter were 138 million compared to 143 million in the prior year quarter, which benefited from the Accelerated Share Repurchase (ASR) agreement implemented in the first quarter of 2022.

Adjusted EBITDA was $372 million for the third quarter, down 8% year-over-year, and adjusted EBITDA margin decreased from 11.6% to 10.3% over the same period. Profitability in the year-ago quarter was elevated due to temporarily increased workload and decreased indirect expenses as a result of the COVID-19 pandemic as well as an elevated level of write-ups on certain contracts. Adjusted EBITDA and adjusted EBITDA margin increased $6 million and 10 basis points, respectively, compared to the second quarter of 2022. Non-GAAP net income was $221 million for the third quarter, down 15% year-over-year, and non-GAAP diluted EPS for the quarter was $1.59, down 12% year-over-year.

Cash Flow Summary

In the third quarter net cash provided by operating activities was $748 million, or 462% of net income attributable to Leidos shareholders. After adjusting for payments for property, equipment and software, free cash flow was $721 million, resulting in a free cash flow conversion ratio of 329%. In addition, Leidos used $26 million for investing activities and $217 million for financing activities.

Leidos returned $49 million to shareholders in the third quarter as part of its regular quarterly cash dividend program. As of September 30, 2022, Leidos had $807 million in cash and cash equivalents and $5.0 billion of debt.

On October 30, 2022, Leidos completed the acquisition of Cobham Special Mission, which provides airborne border surveillance and search and rescue services to the Australian Federal Government. Purchase consideration was $305 million Australian dollars, subject to working capital adjustments. At the signing of the definitive agreement, Leidos entered into a forward contract for $215 million to offset foreign currency fluctuations of the full purchase consideration. Based on the exchange rate at the close, the translated purchase price was $196 million. We realized a loss of $18 million associated with the foreign exchange forward contract.

On October 28, 2022, the Leidos Board of Directors declared a cash dividend of $0.36 per share to be paid on December 30, 2022, to stockholders of record at the close of business on December 15, 2022.

New Business Awards

Net bookings totaled $4.1 billion in the quarter, representing a book-to-bill ratio of 1.1. As a result, backlog at the end of the quarter was $35.0 billion, of which $7.4 billion was funded. Notable awards in the quarter include:

Sentinel. Leidos was awarded a prime task order by the Department of Defense to enhance technological innovation with a focus on rapid insertion of technologies across the mission spectrum for multiple services, and integrating new technology with existing and legacy systems for increased effectiveness. Leidos will support the government with rapid technology insertion to enhance Command, Control, Computers, Communications, Cyber, Intelligence, Surveillance and Reconnaissance (C5ISR) missions at a global scale. This award enables Leidos to expand its extensive C5ISR portfolio as well as deliver a critical capability towards improved warfighter support. The contract has a total value of $1.5 billion dollars and includes a one-year base period of performance with four one-year options.

U.S. Naval Sea Systems Command (NAVSEA) Medium Unmanned Undersea Vehicle (MUUV). Leidos was selected by the NAVSEA to design and build a MUUV to support intelligence preparation of the operational environment by providing submarine-based autonomous oceanographic sensing and data collection for the Navy. The MUUV will also provide surface-launched and recovered mine countermeasures. The single award, cost-plus-fixed-fee contract holds an approximate value of $358 million if all options are exercised.

Defense Information Systems Agency (DISA) Defense Enclave Services (DES) Task Order. DISA awarded Leidos a task order contract with a total estimated value of $138 million dollars with a five year period of performance. Through the DES contract, Leidos will consolidate enterprise IT services and provide standardized, responsive and cost-effective solutions for more than 370,000 users spanning 22 Department of Defense (DoD) agencies and field activities with over 500 sites both in the U.S. and abroad. This first task order will lay the framework and begin to consolidate, integrate and optimize five agencies on a common network architecture through digital modernization and transformation. The work will focus on mission value and user experience, while improving cybersecurity, network availability and reliability for Fourth Estate agencies.
Forward Guidance

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.

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 November 1, 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 13733461. (Press release, Leidos, NOV 1, 2022, View Source [SID1234622702])

Abstract accepted for poster presentation at the ESMO Immuno-Oncology Congress 2022, Geneva, Switzerland 7-9 December 2022.

On November 1, 2022 Hubro Therapeutics reported that our abstract has been accepted for poster presentation (display) at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2022, Geneva, Switzerland 7-9 December 2022 (Press release, Hubro Therapeutics, NOV 1, 2022, View Source [SID1234622701]). The presentation is supported by the presence of Company employees and the Principal Investigator for the trial.

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Abstract # 514; A Phase I Study of the cancer-specific vaccine FMPV-1 in Healthy Male Subjects to Assess Safety and Immune Response

Veracyte Announces Three Abstracts to Be Presented at SITC 2022 Annual Meeting

On November 1, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that three abstracts highlighting the company’s unique, multi-omics immuno-oncology capabilities and offerings will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting & Pre-Conference Programs (SITC 2022), taking place November 8-12, 2022, in Boston (Press release, Veracyte, NOV 1, 2022, View Source [SID1234622700]).

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"Our comprehensive multi-omics expertise and tools have demonstrated potential to address critical questions related to the newest areas of cancer therapy, including which patients are most likely to benefit from immunotherapies," said Corinne Danan, general manager for Veracyte’s Biopharma business unit. "The abstracts being presented at SITC (Free SITC Whitepaper) 2022 will provide additional insight into how our Veracyte Biopharma Atlas and Brightplex offerings can enhance understanding of the tumor microenvironment to help our biopharma partners confidently advance every step of their oncology drug development programs."

Following are details of the Veracyte abstracts that will be shared during poster sessions at the SITC (Free SITC Whitepaper) 2022 Annual Meeting. Poster sessions will be held in the Boston Convention and Exhibition Center, Hall C.

Veracyte will also host a symposium at SITC (Free SITC Whitepaper) 2022 to provide additional detail regarding the development of the DLBCL Biopharma Atlas featured in poster 1454. The company’s Biopharma Atlas, generated through unsupervised multi-omics and multimodal assessment of thousands of parameters, may be used to generate customized maps and clusters for patient group identification and clinical outcome interpretation.

About Veracyte’s Biopharma Offerings

Veracyte collaborates with biopharma partners to provide novel insights, expertise and capabilities that empower partners to confidently advance every step of their oncology drug development programs. With an array of offerings that include the Veracyte Biopharma Atlas, Brightplex and Decipher GRID Real World Data (RWD), Veracyte helps address each partner’s unique oncology drug development needs, including therapeutics and diagnostic development, clinical development insights and decisions, clinical trial patient selection, and clinical trial management. For more information, please visit View Source

Results revealed from phase I clinical trial of the first drug to successfully inhibit the MYC gene, which drives many common cancers

On November 1, 2022 Peptomyc reported that Researchers have found that a drug that targets the key, cancer-causing gene, MYC, has for the first time been able to inhibit the function of the gene in a phase I clinical trial (Press release, Peptomyc, NOV 1, 2022, View Source [SID1234622699]). Until now, no other drug has been able to do this safely and effectively.

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Presenting preliminary results from the trial at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) [1] Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, Dr Elena Garralda, Director of the Early Drug Development Unit at Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, and a member of the scientific committee for the meeting, said: "MYC is one of the ‘most wanted’ targets in cancer because it plays a key role in driving and maintaining many common human cancers, such as breast, prostate, lung and ovarian cancer. To date, no drug that inhibits MYC has been approved for clinical use."

Scientists from VHIO developed a mini-protein called OMO-103 that can enter cells and reach the nucleus. In experiments in the lab and in mice, they had shown that it successfully inhibited the ability of MYC to promote tumour growth by blocking MYC’s function of controlling the flow of information from many common genetic mutations found in cancer.

Starting in April 2021 Dr Garralda, in collaboration with two other Spanish sites, enrolled 22 patients to a phase I clinical trial to assess the safety of OMO-103 and to see if there were any early signs of it controlling cancer. The patients had a range of solid tumours, including pancreatic, bowel, and non-small cell lung cancers. They had all been heavily pre-treated, having received between three and 13 other treatments previously.

OMO-103 was given intravenously once a week at six dose levels ranging from 0.48 to 9.72 mg per kg of patient weight. The researchers took biopsies from the tumours at the start of the study and after three weeks of treatment to assess levels of MYC gene activity and other biological indicators for cancer.

By 10 October 2022 [2], eight out of 12 patients who had CT scans after nine weeks had stable disease, with the treatment having stopped the cancer growing. Of these, two had pancreatic cancer, three had colon cancer, one had non-small lung cancer, one had a sarcoma and one had a salivary gland cancer.

Dr Garralda said: "It’s still very early days to assess activity of the drug, but we are seeing stabilisation of disease in some patients. Remarkably, one patient with pancreatic cancer stayed on the study for over six months, his tumour shrank by eight per cent and there was a reduction in tumour-derived DNA circulating in the blood stream. The patient with a salivary gland tumour has stable disease and is still in the study after 15 months.

"The most exciting thing is that biological markers show that we are targeting MYC successfully. In addition, the adverse side effects are mostly mild, which is important when we start to think about next steps and combining OMO-103 with chemotherapy or other therapies."

The most common treatment-related adverse side effects were mild reactions to the intravenous infusion, such as chills, fever, nausea, rash and low blood pressure. Higher dose levels were associated with more reactions to the infusion but were easily treated. Inflammation of the pancreas was the only dose-limiting reaction, which occurred in one patient.

Analysis of how OMO-103 was absorbed and processed in the body indicated that it remained for at least 50 hours in blood serum.

"We have experimental evidence that this could be a significant underestimate of how long the drug remains in the tumour. Evidence from our work in mice suggest drug concentrations in the tumour that are at least four-fold higher than in the blood," said Dr Garralda. "In addition, even after long-term treatment, we could not detect any anti-drug antibodies, which can decrease the amount of drug available and therefore make it less effective."

She concluded: "OMO-103 is the first MYC inhibitor to successfully complete a phase I clinical trial and to be ready to proceed to a phase II trial. We have determined the recommended dose for phase II to be 6.48mg/kg."

Dr James L. Gulley is co-chair of the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium for the NCI and Director of the Medical Oncology Service, Center for Cancer Research, NCI, USA, and was not involved in the research. He said: "MYC plays an important role in many cell-signaling pathways that promote a range of different cancers but has long been perceived as an ‘undruggable’ target. Researchers have spent much time and energy on the search for drugs that target MYC successfully but it has proved hard to develop therapies that are effective but don’t have side effects that are too severe for patients to tolerate. These results showing that patients typically experienced mild adverse side effects to OMO-103 are important when considering next steps and how it might be combined with chemotherapy. We look forward to the results from the phase II trial with interest."

Abstract no: 7, "Dose escalation study of OMO-103, a first in class Pan-MYC-Inhibitor in patients (pts) with advanced solid tumors", Elena Garralda, presented in the ‘New drugs on the horizon’ session, 11.30-13.00 hrs CEST, Friday 28 October.

[1] EORTC [European Organisation for Research and Treatment of Cancer, NCI [National Cancer Institute], AACR (Free AACR Whitepaper) [American Association for Cancer Research]. The Symposium takes place in Barcelona from 26-28 October 2022.[2] These are the latest, updated results.

The study was funded by Peptomy-SL and by funding from the SME Instrument phase II within the EU’s Horizon 2020 programme.