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AlloVir Presents Positive Final Results From A Phase 2 Randomized, Placebo-Controlled Trial Evaluating Posoleucel Treatment of BK Infection in Kidney Transplant Recipients at the American Transplant Congress (ATC 2023)

AlloVir Presents Positive Final Results From A Phase 2 Randomized, Placebo-Controlled Trial Evaluating Posoleucel Treatment of BK Infection in Kidney Transplant Recipients at the American Transplant Congress (ATC 2023)

Posoleucel demonstrated clinically meaningful reductions in BK viral load as compared to placebo with the greatest antiviral activity seen among patients with higher viral loads and those who received more frequent posoleucel dosing

At Week 24, the percentage of patients with a ≥1-log viral load reduction in the biweekly dosing group was 50% (10/20) vs. 28% (5/18) in the monthly dosing group and 14% (2/14) in the placebo group

In the high viral load stratum (≥10,000 copies/mL), 69% (11/16) of patients who received posoleucel overall and 75% (6/8) of patients in the biweekly dosing group, achieved a ≥1-log viral load reduction vs. 25% (1/4) of patients in the placebo group

Biomarker data demonstrate that BK viral load reductions coincided with substantial expansion of functional BK-directed T cells specific for both posoleucel-targeted and non-targeted antigens – indicating both direct and bystander T cell benefit not observed in placebo patients

Repeat administration of posoleucel was generally well tolerated, with balanced safety across posoleucel dosing groups and placebo

WALTHAM, Mass.–(BUSINESS WIRE)–
AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today announced the presentation of final results from a Phase 2 study of posoleucel, an investigational, allogeneic, off-the-shelf, multi-virus-specific T cell (VST) therapy, being studied for the treatment of BK viremia in adult kidney transplant recipients. The findings, presented yesterday at the American Transplant Congress (ATC 2023) in San Diego, CA, during a late-breaking oral abstract session (LB001), support the safety and antiviral activity of posoleucel in adult kidney transplant recipients with BK virus (BKV) infection. Currently, there are no effective treatment options for BKV infection. Top line data were shared earlier this year.

“Our virus-specific T cell therapies have the potential to offer new hope to immunocompromised patients by preventing or treating devastating viral infections such as that caused by BKV,” said Diana Brainard, M.D., CEO, AlloVir. “The Phase 2 data presented at ATC continue to support the potential benefits of posoleucel use across transplant indications. The patients treated with posoleucel had greater increases in BKV-specific T cells as compared to placebo patients, and these cells persisted through week 24 post-dose, which reinforces posoleucel’s mechanism of action. Additionally, in posoleucel-infused patients we see bystander benefit with endogenous BKV-specific T cell activation, increasing the likelihood of durable benefit. As we continue enrollment in three Phase 3 clinical studies exploring the potential of posoleucel to prevent or treat infections in allo-HCT patients, we are also consulting with key opinion leaders and preparing to meet with the FDA to gain alignment on a Phase 3 clinical study design to evaluate posoleucel’s treatment of BKV infection in kidney transplant patients.”

BKV infection poses a significant threat to kidney graft survival. Over 90,000 kidney transplants are currently performed each year globallyi, and the virus reactivates in up to 20% of these patients.ii In patients who have reactivated BKV, a substantial portion will develop high-level viremia. Approximately half of those will develop BKV-associated nephropathy (BKVAN)iii, which can lead to decreased kidney survival and a return to end-stage renal disease and dialysis.

About the Phase 2 Study

The Phase 2 study evaluated the safety and efficacy of posoleucel to treat BKV infection in adult kidney transplant recipients with plasma BK viral load between 350-10,000,000 copies/mL (stratified by low (<10,000 copies/mL) or high (≥10,000 copies/mL) viral load at study screening). Consensus groups, including the American Society of Nephrology and the American Society of Transplantation, consider BK viral load of greater than or equal to 10,000 copies/mL to be presumptive BKVAN. The primary endpoint of the study was the safety and tolerability of posoleucel versus placebo, and the secondary endpoint of the study was the change in BK viral load in patients receiving posoleucel versus those receiving placebo. Top line results from this study were shared earlier this year.

About BK Viremia in Kidney Transplant Recipients

Due to the long-term immunosuppression required to prevent graft rejection, solid organ transplant recipients are at high risk for reactivating common viruses that are typically controlled by the body’s natural immune system. Uncontrolled, these viruses can have devastating consequences.

There are no approved or effective antiviral treatments for BKV infection. The only approach to managing BKV infection is a reduction in immunosuppression to allow the body’s immune system to fight the virus; this is typically triggered by a plasma BK viral load that nears or exceeds 10,000 copies/mL. However, this reduction in immunosuppression can also lead to graft rejection, mediated by alloreactive T cells, and the development of donor-specific antibodies, putting the success of the kidney transplant at risk.

BK virus-specific T cells appear to play a key role in protection against disease. Kidney transplant recipients who do not develop BKVAN have been shown to have approximately 10-fold higher BKV-specific T cell responses versus those with BKVAN. Kidney transplant recipients with BK viremia who develop robust BKV-specific T cell responses have also been shown to clear the virus, while those who progressed to BKVAN required interventions such as a reduction in immunosuppression. These data suggest that VST therapy may help manage BKV infection and BKVAN.

About Posoleucel

AlloVir’s lead product, posoleucel, is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus-specific T cell therapy targeting six viral pathogens in immunocompromised individuals: adenovirus (AdV), BKV, cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV). In a Phase 2 open-label study of posoleucel for the prevention of clinically significant infections due to the six viruses posoleucel targets, 88% of allo-HCT patients who received posoleucel remained free of clinically significant infections through week 14, the primary endpoint. Moreover, the non-relapse mortality rate in patients who received posoleucel was 0% through the 52-week follow-up visit. Additionally, in the positive Phase 2 proof-of-concept CHARMS treatment study which enrolled allo-HCT recipients infected by one or more of the six viruses posoleucel targets, more than 90% of patients who failed conventional treatment and received posoleucel demonstrated a complete or partial clinical response based on predefined criteria.

Based on the strength of the posoleucel Phase 2 data for both prevention and treatment, the FDA has granted posoleucel Regenerative Medicine Advanced Therapy (RMAT) designation for each of the three indications being evaluated in Phase 3 clinical trials – for the treatment of hemorrhagic cystitis (HC) caused by BKV, for the treatment of AdV infection in adults and children following allo-HCT, and for the prevention of clinically significant infections and disease caused by posoleucel’s six target viruses. The FDA also granted posoleucel Orphan Drug Designation for the treatment of virus-associated HC. The European Medicines Agency (EMA) has granted posoleucel PRIority MEdicines (PRIME) designation for the treatment of serious infections with AdV, BKV, CMV, EBV and HHV-6, and Orphan Medicinal Product designation as a potential treatment of viral diseases and infections in patients undergoing HCT.

About AlloVir

AlloVir is a leading late-clinical stage, cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company’s innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single- and multi-virus-specific T cells for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir’s technology and manufacturing process enable the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information, visit www.allovir.com or follow us on Twitter or LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the potential of posoleucel as a treatment of BKV in kidney transplant recipients, the safety and antiviral activity of posoleucel in adult kidney transplant recipients with BK infection, AlloVir’s development and regulatory status of our product candidates, the planned conduct of its preclinical studies, and clinical trials and its prospects for success in those studies and trials, and its strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the safety and efficacy of posoleucel as a treatment of BKV in kidney transplant patients, AlloVir’s financial results, the timing for the initiation and successful completion of AlloVir’s clinical trials of its product candidates, whether and when, if at all, AlloVir’s product candidates will receive approval from the U.S. Food and Drug Administration (FDA), or other foreign regulatory authorities, competition from other biopharmaceutical companies, supply chain, and business operations and other risks identified in AlloVir’s SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

i Kidney transplants worldwide by region 2021 | Statista

ii Gras J, Le Flécher A, Dupont A, et al. Characteristics, risk factors and outcome of BKV nephropathy in kidney transplant recipients: a case-control study. BMC Infect Dis. 2023;23:74.

iii Hirsch HH, Randhawa PS. BK polyomavirus in solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33:e13528.

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[email protected]

KEYWORDS: California Massachusetts United States North America

INDUSTRY KEYWORDS: Health Infectious Diseases Surgery Other Health Clinical Trials Pharmaceutical Biotechnology

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Vast Advances Utility-Scale Concentrated Solar Thermal Plant as Worley Commences Engineering

Vast Advances Utility-Scale Concentrated Solar Thermal Plant as Worley Commences Engineering

Basic engineering of Vast’s 30MW VS1 Port Augusta CSP Project to be completed by July with groundbreaking slated for 2024

SYDNEY, Australia–(BUSINESS WIRE)–
Vast Solar Pty Ltd (Vast), a renewable energy company specialising in concentrated solar thermal power (CSP) energy systems that generate zero-carbon, utility-scale, dispatchable electricity and industrial process heat, today announced it has awarded Worley Ltd. (Worley) (ASX: WOR) key engineering contracts for its VS1 CSP project.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230605005052/en/

Vast’s 1.1 MW CSP Demonstration Plant in Forbes, Australia was operated for 32 months (Photo: Business Wire)

Vast’s 1.1 MW CSP Demonstration Plant in Forbes, Australia was operated for 32 months (Photo: Business Wire)

VS1 is a 30MW / 288 MWh CSP plant being built in Port Augusta, South Australia. Utilising Vast’s proprietary modular tower CSP v3.0 technology, VS1 will generate clean, low-cost, dispatchable power with over 8 hours of thermal energy storage. The project will create dozens of green manufacturing jobs, hundreds of jobs during construction and long-term plant operations roles.

Vast has appointed Worley and its specialist consulting division, Advisian, to complete VS1 basic engineering by July 2023, followed by front-end engineering design (FEED) in the balance of this calendar year. Construction of VS1 is on track to begin in 2024.

“With strong expertise in CSP, Worley and Advisian are the ideal engineering partners for VS1, which will utilise our industry-leading technology to capture and store the sun’s energy during the day before generating heat and dispatchable power during the day or night,” said Craig Wood, CEO of Vast.

“Vast has a long-standing relationship with Worley and Advisian dating back to assistance with the engineering and commissioning of our 1.1MW grid connected Jemalong demonstration plant,” added Wood. “Their skill in integrating our technology with major packages to be delivered by key equipment partners from around the world will allow VS1 to progress towards FID late this year.”

“Worley is pleased to continue their support of Vast Solar with the provision of specialist engineering skills. This work aligns with our corporate ambition to be recognized globally as leader in sustainability solutions and delivering a more sustainable world,” said Peter Israel, Power & Energy Transition Practice Manager of Worley.

Vast’s proprietary CSP v3.0 technology has received significant support from the Australian government. Most recently, the Australian Renewable Energy Agency (ARENA) announced it has approved up to AUD$65 million in funding to support construction of VS1.

VS1 will be co-located with Solar Methanol 1 (SM1), a world-first green methanol demonstration plant which, in February, was selected to receive AUD$19.48 million and EUR13.2 million from a collaboration between the Australian and German governments, respectively. SM1 will use zero emissions dispatchable electricity and heat from VS1 to produce green methanol for use as a sustainable shipping fuel.

About Vast

Vast is a renewable energy company that has CSP systems to generate, store and dispatch carbon free, utility-scale electricity, industrial heat, and to enable the production of green fuels. Vast’s CSP v3.0 approach to CSP utilizes a proprietary, modular sodium loop to efficiently capture and convert solar heat into these end products.

On February 14, 2023, Vast announced a business combination agreement with Nabors Energy Transition Corp. (NYSE: NETC). The combined entity would be named Vast and its securities are expected to be listed on the New York Stock Exchange under the ticker symbol “VSTE” while remaining headquartered in Australia.

Visit www.vast.energy for more information.

About Worley

Worley is a global company headquartered in Australia and our purpose is delivering a more sustainable world. Worley is a leading global provider of professional project and asset services in the energy, chemicals and resources sectors. As a knowledge-based service provider, we use our knowledge and capabilities to support our customers to reduce their emissions and move towards a low carbon future.

Worley Limited is listed on the Australian Securities Exchange (ASX: WOR).

About Nabors Energy Transition Corp.

Nabors Energy Transition Corp. (NYSE: NETC, NETC.WS, NETC.U) is a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses or entities. NETC was formed to identify solutions, opportunities, companies or technologies that focus on advancing the energy transition; specifically, ones that facilitate, improve or complement the reduction of carbon or greenhouse gas emissions while satisfying growing energy consumption across markets globally.

NETC is an affiliate of Nabors Industries Ltd. (Nabors), a leading provider of advanced technology for the energy industry. By leveraging its core competencies, particularly in drilling, engineering, automation, data science and manufacturing, Nabors, which owns the global industry’s largest fleet of land drilling rigs and equipment, is committed to innovate the future of energy and enable the transition to a lower-carbon world.

Important Information about the Business Combination and Where to Find It

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or constitute a solicitation of any vote or approval.

In connection with the proposed business combination (the Business Combination) between Vast and Nabors Energy Transition Corp. (NETC), Vast has filed a Registration Statement on Form F-4 (the Registration Statement) with the U.S. Securities and Exchange Commission (the SEC), which includes (i) a preliminary prospectus of Vast relating to the offer of securities to be issued in connection with the proposed Business Combination and (ii) a preliminary proxy statement of NETC to be distributed to holders of NETC’s capital stock in connection with NETC’s solicitation of proxies for the vote by NETC’s stockholders with respect to the proposed Business Combination and other matters described in the Registration Statement. NETC and Vast also plan to file other documents with the SEC regarding the proposed Business Combination. After the Registration Statement has been declared effective by the SEC, a definitive proxy statement/prospectus will be mailed to the stockholders of NETC. INVESTORS AND SECURITY HOLDERS OF NETC AND VAST ARE URGED TO READ THE REGISTRATION STATEMENT, THE PROXY STATEMENT/PROSPECTUS CONTAINED THEREIN (INCLUDING ALL AMENDMENTS AND SUPPLEMENTS THERETO) AND ALL OTHER DOCUMENTS RELATING TO THE PROPOSED BUSINESS COMBINATION THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED BUSINESS COMBINATION.

Investors and security holders will be able to obtain free copies of the proxy statement/prospectus and other documents containing important information about NETC and Vast once such documents are filed with the SEC, through the website maintained by the SEC at http://www.sec.gov. In addition, the documents filed by NETC may be obtained free of charge from NETC’s website at www.nabors-etcorp.com or by written request to NETC at 515 West Greens Road, Suite 1200, Houston, TX 77067.

Participants in the Solicitation

NETC, Nabors, Vast and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of NETC in connection with the proposed Business Combination. Information about the directors and executive officers of NETC is set forth in the Registration Statement Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the Registration Statement, the proxy statement/prospectus and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of these documents as described in the preceding paragraph.

Forward Looking Statements

The information included herein and in any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of present or historical fact included herein, regarding the proposed Business Combination, NETC’s and Vast’s ability to consummate the proposed Business Combination, the benefits of the proposed Business Combination and NETC’s and Vast’s future financial performance following the proposed Business Combination, as well as NETC’s and Vast’s strategy, future operations, financial position, estimated revenues and losses, projected costs, prospects, plans and objectives of management are forward-looking statements. When used herein, including any oral statements made in connection herewith, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on NETC and Vast management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Except as otherwise required by applicable law, NETC and Vast disclaim any duty to update any forward-looking statements, all of which are expressly qualified by the statements in this section, to reflect events or circumstances after the date hereof. NETC and Vast caution you that these forward-looking statements are subject to risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of NETC and Vast. These risks include, but are not limited to, general economic, financial, legal, political and business conditions and changes in domestic and foreign markets; the inability to complete the Business Combination or the convertible debt and equity financings contemplated in connection with the proposed Business Combination (the “Financing”) in a timely manner or at all (including due to the failure to receive required stockholder or shareholder, as applicable, approvals, or the failure of other closing conditions such as the satisfaction of the minimum trust account amount following redemptions by NETC’s public stockholders and the receipt of certain governmental and regulatory approvals), which may adversely affect the price of NETC’s securities; the inability of the Business Combination to be completed by NETC’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by NETC; the occurrence of any event, change or other circumstance that could give rise to the termination of the Business Combination or the Financing; the inability to recognize the anticipated benefits of the proposed Business Combination; the inability to obtain or maintain the listing of Vast’s shares on a national exchange following the consummation of the proposed Business Combination; costs related to the proposed Business Combination; the risk that the proposed Business Combination disrupts current plans and operations of Vast, business relationships of Vast or Vast’s business generally as a result of the announcement and consummation of the proposed Business Combination; Vast’s ability to manage growth; Vast’s ability to execute its business plan, including the completion of the Port Augusta project, at all or in a timely manner and meet its projections; potential disruption in Vast’s employee retention as a result of the proposed Business Combination; potential litigation, governmental or regulatory proceedings, investigations or inquiries involving Vast or NETC, including in relation to the proposed Business Combination; changes in applicable laws or regulations and general economic and market conditions impacting demand for Vast’s products and services. Additional risks are set forth in the section titled “Risk Factors” in the Registration Statement and other documents filed, or to be filed, by NETC and Vast with the SEC. Should one or more of the risks or uncertainties described herein and in any oral statements made in connection therewith occur, or should underlying assumptions prove incorrect, actual results and plans could differ materially from those expressed in any forward-looking statements.

Vast

For Investors:

Caldwell Bailey

ICR, Inc.

[email protected]

For US Media:

Matt Dallas

ICR, Inc.

[email protected]

For Australian media:

Nick Albrow

Wilkinson Butler

[email protected]

Nabors Energy Transition Corp. Contacts

For Investors:

William C. Conroy, CFA

Vice President – Corporate Development & Investor Relations

[email protected]

For Media:

Brian Brooks

Senior Director, Corporate Communications

[email protected]

KEYWORDS: Australia/Oceania Australia

INDUSTRY KEYWORDS: Alternative Energy Energy Other Energy

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Vast’s 1.1 MW CSP Demonstration Plant in Forbes, Australia was operated for 32 months (Photo: Business Wire)
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ProPetro Announces Credit Expansion and Extension to 2028

ProPetro Announces Credit Expansion and Extension to 2028

MIDLAND, Texas–(BUSINESS WIRE)–
ProPetro Holding Corp. (“ProPetro” or “the Company”) (NYSE: PUMP) today announced the expansion and extension of its existing asset-based loan facility (the “Amended ABL”) to a new five-year term and an expansion of commitments from $150 million to $225 million. The Amended ABL will extend the maturity from 2027 to 2028 and, through updated advance formulas and other provisions, provide enhanced availability and liquidity for the Company.

David Schorlemer, the Company’s Chief Financial Officer, commented, “We want to recognize and thank our blue-chip financial partners for their continued support of ProPetro and the oil and gas industry as we help our customers produce affordable, safe, and reliable energy for the world. We believe that in today’s environment of limited capital, our ABL credit facility provides the lowest cost and most desirable capital source, along with a strong equity base, to support our long-term business strategy. We believe this facility, along with our working capital and cash flow from operations, will continue to provide strong liquidity to support ProPetro’s business into the future.”

Barclays will continue to serve as the agent of the Amended ABL along with other participants, namely, JPMorgan Chase, Bank of America, and Goldman Sachs.

About ProPetro

ProPetro Holding Corp. is a Midland, Texas-based oilfield services company providing premium completions services to leading upstream oil and gas companies engaged in the exploration and production of North American unconventional oil and natural gas resources. We help bring reliable energy to the world. For more information visit www.propetroservices.com.

Forward-Looking Statements

Except for historical information contained herein, the statements and information in this news release and discussion in the scripted remarks described above are forward-looking statements that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Statements that are predictive in nature, that depend upon or refer to future events or conditions or that include the words “may,” “could,” “plan,” “project,” “budget,” “predict,” “pursue,” “target,” “seek,” “objective,” “believe,” “expect,” “anticipate,” “intend,” “estimate,” and other expressions that are predictions of, or indicate, future events and trends and that do not relate to historical matters identify forward-looking statements. Our forward-looking statements include, among other matters, statements about the supply of and demand for hydrocarbons, our business strategy, industry, future profitability, expected fleet utilization, sustainability efforts, the future performance of newly improved technology, expected capital expenditures, the impact of such expenditures on our performance and capital programs and our fleet conversion strategy. A forward-looking statement may include a statement of the assumptions or bases underlying the forward-looking statement. We believe that we have chosen these assumptions or bases in good faith and that they are reasonable.

Although forward-looking statements reflect our good faith beliefs at the time they are made, forward-looking statements are subject to a number of risks and uncertainties that may cause actual events and results to differ materially from the forward-looking statements. Such risks and uncertainties include the volatility of oil prices, the operational disruption and market volatility resulting from the COVID-19 pandemic, the global macroeconomic uncertainty related to the Russia-Ukraine war, general economic conditions, including the impact of continued inflation, central bank policy actions, bank failures, and the risk of a global recession, and other factors described in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, particularly the “Risk Factors” sections of such filings, and other filings with the Securities and Exchange Commission (the “SEC”). In addition, the Company may be subject to currently unforeseen risks that may have a materially adverse impact on it, including matters related to shareholder litigation. Accordingly, no assurances can be given that the actual events and results will not be materially different than the anticipated results described in the forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements and are urged to carefully review and consider the various disclosures made in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings made with the SEC from time to time that disclose risks and uncertainties that may affect the Company’s business. The forward-looking statements in this news release are made as of the date of this news release. ProPetro does not undertake, and expressly disclaims, any duty to publicly update these statements, whether as a result of new information, new developments or otherwise, except to the extent that disclosure is required by law.

David Schorlemer

Chief Financial Officer

[email protected]

432-227-0864

Matt Augustine

Director, Corporate Development and Investor Relations

[email protected]

432-848-0871

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Oil/Gas Energy

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Glaukos Achieves Pipeline Milestone with Enrollment Completion in Phase 3 Confirmatory Trial for Epioxa (Epi-on)

Glaukos Achieves Pipeline Milestone with Enrollment Completion in Phase 3 Confirmatory Trial for Epioxa (Epi-on)

Enrollment Completion Achieved in Less Than Six Months from Trial Commencement, Ahead of Original Timing Expectations

Phase 3 Confirmatory Trial Results Together with Already-Completed First Phase 3 Trial Expected to Support Glaukos’ Targeted NDA Submission for Epioxa by the End of 2024

ALISO VIEJO, Calif.–(BUSINESS WIRE)–
Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the completion of enrollment and randomization in its second Phase 3 confirmatory pivotal trial for Epioxa™ (Epi-on), its next-generation corneal cross-linking therapy for the treatment of keratoconus.

“The expeditious enrollment completion in the Epioxa Phase 3 confirmatory trial, which only commenced earlier this year, is a testament to the favorable risk-benefit profile of this next-generation therapy as well as our team’s hard work in bringing this important therapy one step closer to patients suffering from keratoconus, a sight-threatening corneal disease,” said Thomas Burns, Glaukos chairman and chief executive officer. “We appreciate the commitment and dedication of the clinical investigators, who played a vital role in helping to achieve this enrollment milestone ahead of our original timing expectations. We look forward to following these patients’ outcomes as we target a U.S. New Drug Application (NDA) submission for Epioxa by the end of 2024.”

The Epioxa multi-center, randomized, placebo and sham procedure controlled, Phase 3 confirmatory pivotal trial randomized 312 eyes and was designed to evaluate the safety and efficacy of Glaukos’ Epioxa therapy in impeding the progression of, and/or reducing maximum corneal curvature (Kmax) in eyes with progressive keratoconus. Kmax is an objective measurement of the steepest corneal curvature based on corneal topography, where an increasing Kmax denotes corneal steepening and keratoconus disease progression. The study eyes were randomized in a 2:1 ratio to receive Epioxa therapy or placebo and sham procedure control treatment. The study’s primary efficacy endpoint is the mean change in Kmax from baseline to Month 12. Based on an agreement with the U.S. Food and Drug Administration (FDA), the study will be considered a success if the difference between the treatment and control arm in the primary efficacy endpoint is statistically significant and the difference is ≥ 1.0 diopter (D).

Results from this second Phase 3 confirmatory pivotal trial together with the already-completed first Phase 3 pivotal trial are expected to support Glaukos’ targeted NDA submission for Epioxa by the end of 2024. As a reminder, the U.S. FDA has confirmed Glaukos’ first Phase 3 pivotal trial for Epioxa, which met the pre-specified primary efficacy endpoint, would be adequate to support the submission and review of an eventual NDA, in conjunction with this second Phase 3 trial.

As Glaukos continues to advance its clinical plans for Epioxa, it remains well-positioned to serve keratoconus patients with its first-generation corneal cross-linking therapy, Photrexa®, or Epi-off, which remains the only FDA-approved treatment shown to slow and halt the progression of keratoconus.

About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and continues to develop a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.

Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the timing and extent to which we obtain regulatory approval for investigational products such as Epioxa, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for this product, and the continued efficacy and safety profile of this product as reported in the pivotal trials and other clinical studies. These and other risks, uncertainties and factors related to Glaukos, and our business are described in detail under the caption “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on May 4, 2023. Our filings with the SEC are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

Media Contact:

Michele Gray

(917) 449-9250

[email protected]

Investor Contact:

Chris Lewis

Vice President, Investor Relations & Corporate Affairs

(949) 481-0510

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Health Health Technology Clinical Trials Pharmaceutical Optical Biotechnology

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Bausch + Lomb Launches Bausch + Lomb INFUSE® Multifocal Silicone Hydrogel Contact Lenses in the United States

Bausch + Lomb Launches Bausch + Lomb INFUSE® Multifocal Silicone Hydrogel Contact Lenses in the United States

New Multifocal Daily Disposable Lens Provides Clear Vision at All Distances, All-Day Comfort and Helps Minimize Contact Lens Dryness

VAUGHAN, Ontario–(BUSINESS WIRE)–
Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced the U.S. launch of Bausch + Lomb INFUSE® Multifocal silicone hydrogel (SiHy) daily disposable contact lenses. Featuring a next-generation material infused with ProBalance Technology™ for all-day comfort and the company’s unique 3-Zone Progressive™ design, the new lens addresses the dynamic vision needs of patients with presbyopia by delivering clear vision with seamless transitions across near, intermediate and distance vision while helping to minimize contact lens dryness.

“Presbyopic patients have unique vision needs due to their age and lifestyle. Our Bausch + Lomb INFUSE Multifocal SiHy contact lenses were designed to directly address the common problems that they experience with multifocal contact lenses, such as contact lens dryness, which nearly 70% of multifocal contact lens wearers report experiencing during lens wear,”1† said Yang Yang, senior vice president, Vision Care, Bausch + Lomb. “With the prevalence of presbyopia estimated to be nearly 80% by age 45-55 in North America, and an increasing aging society in the United Statesthat spends more than nine hours a day on digital devices, we are proud to use our latest science and contact lens technologies to provide eye care professionals and their patients with this new innovative multifocal lens option.”2-4

Bausch + Lomb INFUSE Multifocal contact lenses are made with a next generation SiHy daily disposable lens material (kalifilcon A) that combines exceptional breathability for healthy lens wear with a low modulus and high moisture, allowing the lens to maintain 96% of its moisture for a full 16 hours.5 The lens material is infused with ProBalance Technology™, which includes a unique combination of ingredients inspired by the Tear Film and Ocular Surface Society’s DEWS II report and is released during lens wear to help maintain ocular surface homeostasis and minimize contact lens dryness. The unique 3-Zone Progressive™ design delivers excellent near and intermediate vision without compromising distance vision.

According to a recent study, 90% of presbyopic patients surveyed agreed Bausch + Lomb INFUSE Multifocal contact lenses allow them to effortlessly move from various tasks throughout the day.6 In addition, eye care professionals surveyed agreed that Bausch + Lomb INFUSE Multifocal lenses were easy to fit for 99% of patients.7

“Ocular surface changes that occur with age, as well as lifestyle changes such as increasing digital device usage, can have an impact on presbyopic patients, leading them to experience eye strain and other eye symptoms. As a result, multifocal lens fitting can sometimes prove to be a challenge, particularly with patients who express comfort and vision concerns,” said Mile Brujic, O.D., Premier Vision Group, Bowling Green, OH. “Bausch + Lomb INFUSE Multifocal contact lenses demonstrate consistent focusing power in each zone of vision, help ensure a smooth, wettable surface for patient comfort and are easy to fit.”

In addition, eye care practitioners and contact lens wearers are encouraged to use Bausch + Lomb’s complementary contact lens recycling program to properly recycle their used contact lens materials, including Bausch + Lomb INFUSE Multifocal contact lenses, blister packs and top foils. For more information on the ONE by ONE Recycling program, including how to participate, visit www.bauschrecycles.com.

About Presbyopia

Presbyopia is a natural, gradual loss of the eye’s ability to focus on nearby objects. It is a normal part of aging that becomes noticeable around the age of 40 and continues to worsen until around the age of 65. People tend to become aware of presbyopia when they need to start holding reading material at arm’s length, if they experience blurred vision at a normal reading distance or if they have eye strain or headaches after reading or doing close-up work. A basic eye exam can confirm presbyopia, which can be corrected with the use of contact lenses and/or spectacles.8

About the ONE by ONE Recycling Program

The Bausch + Lomb ONE by ONE Recycling program is the first and only sponsored contact lens recycling program in the United States. This award-winning program collects used contact lenses, top foil and opened plastic blister packs from any brand and is available to contact lens wearers and eye care professionals. Nearly 13,000 eye care practices are registered as official recycling centers of the program. To participate, contact lens wearers can bring their used contact lenses and packaging to one of these practices, which collects the used lens materials in a custom recycling bin provided by Bausch + Lomb. Once the bin is filled, the optometry practice ships the materials to TerraCycle for proper recycling using a Bausch + Lomb pre-paid shipping label.

About Bausch + Lomb

Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Twitter, LinkedIn, Facebook and Instagram.

Forward-looking Statements

This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch + Lomb, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

†From a study that assessed the tear film, ocular surfaces and symptoms of ocular discomfort in 150 presbyopes before and after contact lens wear.

References

  1. Du Toit R, Situ P, Simpson T, Fonn D. The effects of six months of contact lens wear on the tear film, ocular surfaces and symptoms of presbyopes. Optom Vis Sci. 2001;78(6):455-462.

  2. Zebardast N, Friedman DS, Vitale S. The Prevalence and Demographic Associations of Presenting Near-Vision Impairment Among Adults Living in the United States. Am J Ophthalmol. 2017;174:134-144.

  3. The Administration for Community Living. 2021 Profile of Older Americans. Retrieved from: https://acl.gov/sites/default/files/Profile%20of%20OA/2021%20Profile%20of%20OA/2021ProfileOlderAmericans_508.pdf.

  4. The Vision Council. Hindsight 20/20/20: protecting your eyes from digital devices. 2015 Digital Eye Strain Report. thevisioncouncel.org.

  5. Data on file. Bausch & Lomb Incorporated. Rochester, NY.

  6. Results from a 20-site, 3-week study of Bausch + Lomb INFUSE Multifocal contact lenses on habitual multifocal soft contact lens wearers. 290 subjects completed a lens performance rating survey following the 3-week follow-up visit. Performance was rated using a 7-point agree/disagree scale.

  7. Results from a 20-site, 3-week study of Bausch + Lomb INFUSE® Multifocal contact lenses on habitual multifocal soft contact lens wearers. Eye Care Professionals evaluated fit/performance following the 3-week follow-up visit with survey responses for 292 subjects.

  8. The Mayo Clinic. Presbyopia. Accessed on April 13, 2023. https://www.mayoclinic.org/diseases-conditions/presbyopia/symptoms-causes/syc-20363328.

© 2023 Bausch + Lomb.

IMF.0039.USA.23

Investor:

Allison Ryan

[email protected]

(877) 354-3705 (toll free)

(908) 927-0735

Media:

Lainie Keller

[email protected]

(908) 927-1198

Kristy Marks

[email protected]

(908) 927-0683

KEYWORDS: United States North America Canada

INDUSTRY KEYWORDS: Other Retail Health Retail Optical Specialty

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Chimera Announces Revised Ex-Dividend Date for Second Quarter Preferred Stock Cash Dividend – Payment Amount, Payable Date and Record Date Unchanged

Chimera Announces Revised Ex-Dividend Date for Second Quarter Preferred Stock Cash Dividend – Payment Amount, Payable Date and Record Date Unchanged

NEW YORK–(BUSINESS WIRE)–
Chimera Investment Corporation, Inc. (NYSE: CIM) (the “Company”) today announces a correction to the ex-dividend date for the dividend payments on June 30, 2023 for the 8% Series A Cumulative Redeemable Preferred Stock, 8% Series B Fixed-to-Floating Rate Cumulative Redeemable Preferred Stock, 7.75% Series C Fixed-to-Floating Rate Cumulative Redeemable Preferred Stock and 8% Series D Fixed-to-Floating Rate Cumulative Redeemable Preferred Stock (together, the “Preferred Stock”). The ex-dividend date will be June 16, 2023 rather than the previously announced date of June 19, 2023, due to the statutory holiday on June 19, 2023. All other dates and information relating to the Preferred Stock dividend payments on June 30, 2023, as previously communicated in the Company’s June 1, 2023 press release, remain unchanged.

Disclaimer

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Actual results may differ from expectations, estimates and projections and, consequently, readers should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “target,” “assume,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among other things, those described in our most recent Annual Report on Form 10-K, and any subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, under the caption “Risk Factors.” Factors that could cause actual results to differ include, but are not limited to: our business and investment strategy; our ability to accurately forecast the payment of future dividends on our common and preferred stock, and the amount of such dividends; our ability to determine accurately the fair market value of our assets; availability of investment opportunities in real estate-related and other securities, including our valuation of potential opportunities that may arise as a result of current and future market dislocations; effect of the novel coronavirus (or COVID-19) pandemic on real estate market, financial markets and our Company, including the impact on the value, availability, financing and liquidity of mortgage assets; how COVID-19 may affect us, our operations and our personnel; our expected investments; changes in the value of our investments, including negative changes resulting in margin calls related to the financing of our assets; changes in interest rates and mortgage prepayment rates; prepayments of the mortgage and other loans underlying our mortgage-backed securities, or RMBS, or other asset-backed securities, or ABS; rates of default, delinquencies or decreased recovery rates on our investments; general volatility of the securities markets in which we invest; our ability to maintain existing financing arrangements and our ability to obtain future financing arrangements; our ability to effect our strategy to securitize residential mortgage loans; interest rate mismatches between our investments and our borrowings used to finance such purchases; effects of interest rate caps on our adjustable-rate investments; the degree to which our hedging strategies may or may not protect us from interest rate volatility; the impact of and changes to various government programs, including in response to COVID-19; impact of and changes in governmental regulations, tax law and rates, accounting guidance, and similar matters; market trends in our industry, interest rates, the debt securities markets or the general economy; estimates relating to our ability to make distributions to our stockholders in the future; our understanding of our competition; availability of qualified personnel; our ability to maintain our classification as a real estate investment trust, or, REIT, for U.S. federal income tax purposes; our ability to maintain our exemption from registration under the Investment Company Act of 1940, as amended, or 1940 Act; our expectations regarding materiality or significance; and the effectiveness of our disclosure controls and procedures.

Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Chimera does not undertake or accept any obligation to release publicly any updates or revisions to any forward-looking statement to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. Additional information concerning these, and other risk factors is contained in Chimera’s most recent filings with the Securities and Exchange Commission (SEC). All subsequent written and oral forward-looking statements concerning Chimera or matters attributable to Chimera or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above.

Readers are advised that the financial information in this press release is based on company data available at the time of this presentation and, in certain circumstances, may not have been audited by the Company’s independent auditors.

Investor Relations

888-895-6557

www.chimerareit.com

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Professional Services Finance

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Framework Incorporating DecisionDx®-SCC Test Results into Clinical Decision-Making for Patients with High-Risk Cutaneous Squamous Cell Carcinoma Published in Clinical, Cosmetic and Investigational Dermatology

Framework Incorporating DecisionDx®-SCC Test Results into Clinical Decision-Making for Patients with High-Risk Cutaneous Squamous Cell Carcinoma Published in Clinical, Cosmetic and Investigational Dermatology

Treatment algorithm can assist clinicians in tailoring their care for patients with high-risk cutaneous squamous cell carcinoma (cSCC) based on individual patient’s unique tumor biology, while adhering to guideline recommendations

FRIENDSWOOD, Texas–(BUSINESS WIRE)–
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of a paper in Clinical, Cosmetic and Investigational Dermatologyhighlighting a clinician-derived, real-world algorithm that provides a framework to incorporate DecisionDx®-SCC test results into clinical practicewithin National Comprehensive Cancer Network (NCCN) guideline recommendations.1 This framework for stratifying patients with advanced cSCC includes a treatment algorithm that demonstrates how use of DecisionDx-SCC test results can assist clinicians in identifying personalized, risk-aligned treatment pathway improvements for patients with high-risk cSCC, based on the patient’s tumor biology, which may help improve their disease outcome.

“While current guidelines and staging frameworks for cSCC provide guidance for stratifying patients based on their risk of metastasis, the recommendations can be challenging to implement as they are based on a broad set of clinicopathologic risk factors,” said first author Gaurav Singh, M.D., M.P.H., F.A.A.D., board-certified dermatologist and fellowship-trained Mohs surgeon in Milwaukee. “The algorithm that we developed is not meant to challenge these established guidelines. Rather, it is designed to enhance existing risk-stratification approaches by integrating a patient’s tumor biology into the decision-making process through the use of DecisionDx-SCC test results and providing options for clinicians to consider when deciding future steps in the care of each patient.”

The DecisionDx-SCC test has been validated to independently identify cSCC patients who have tumors with high metastatic potential. In the study, three private-practice Mohs surgeons, who routinely use the test to risk-stratify their high-risk cSCC patients, merged their management approaches for three real-world, high-risk cSCC patients into a singular algorithm that provides a framework for incorporating each of the test’s three potential results into current NCCN guidelines. This algorithm adds greater specificity to the broad guidelines for the treatment of high-risk cSCC patients, including surveillance imaging, sentinel lymph node biopsy, adjuvant radiation therapy and clinical follow-up, which frequently result in disparities in clinical practice and management, and provide guidance on how to use each based on the patient’s DecisionDx-SCC test results.

The three patient cases discussed in the paper provide support for the clinical utility of DecisionDx-SCC to provide a more definitive, risk-aligned use of these treatment modalities in an effort to improve patient care and overall health outcomes. In all three cases presented in the study, use of the algorithm incorporating DecisionDx-SCC test results led to no evidence of disease recurrence or metastasis post-treatment, based on the timing described in the study. The study findings support the use of DecisionDx-SCC test results within established guidelines to enable personalized, risk-aligned management of high-risk cSCC patients and the allocation of healthcare resources to patients at the highest risk of a poor outcome.

About DecisionDx®-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (moderate) or Class 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management. More information about the disease and test can be found at www.CastleTestInfo.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, Twitter and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the potential of DecisionDx-SCC test results to assist clinicians in (i) tailoring their care for patients with high-risk cSCC based on the patient’s unique tumor biology, while adhering to guideline recommendations, and (ii) identifying personalized, risk-aligned treatment pathway improvements for patients with high-risk cSCC, based on the patient’s tumor biology, which may help improve their disease outcome. The words “can,” “may” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results shown in this study, including with respect to the discussion of DecisionDx-SCC in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

  1. Singh G, Tolkachjov SN, Farberg AS. Incorporation of the 40-Gene Expression Profile (40-GEP) Test to Improve Treatment Decisions in High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) Patients: Case Series and Algorithm. Clin Cosmet Investig Dermatol. 2023;16:925-935. https://doi.org/10.2147/CCID.S403330

Investor Contact:

Camilla Zuckero

[email protected]

Media Contact:

Allison Marshall

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Science Other Science Biotechnology Research Oncology Health Genetics Clinical Trials

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Seres Therapeutics and Nestlé Health Science Announce U.S. Commercial Availability of VOWST™, the First and Only FDA-Approved Microbiota-Based Oral Therapeutic for Prevention of Recurrence of C. Difficile Infection

Seres Therapeutics and Nestlé Health Science Announce U.S. Commercial Availability of VOWST™, the First and Only FDA-Approved Microbiota-Based Oral Therapeutic for Prevention of Recurrence of C. Difficile Infection

– VOWST is now available by prescription in the U.S. for adult patients following antibiotic treatment for recurrent CDI –

– VOWST Voyage™ Support Program to help reduce out-of-pocket patient costs for eligible patients and facilitate treatment start –

CAMBRIDGE, Mass. & HOBOKEN, N.J.–(BUSINESS WIRE)–Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science today announced that VOWST™ (fecal microbiota spores, live-brpk) is now commercially available for patients. VOWST,formerly called SER-109, is the first and only U.S. Food and Drug Administration (FDA)-approved orally administered microbiota-based therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is not indicated for the treatment of CDI.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230605005120/en/

“The commercial availability of VOWST provides a new oral dosing option that has demonstrated efficacy in the prevention of further recurrences of rCDI, including those who have experienced a first recurrence. We look forward to helping patients who have this potentially life-threatening disease,” said Eric Shaff, President and Chief Executive Officer at Seres.

“At Nestlé Health Science, we are leveraging our strong existing infrastructure, including our gastrointestinal sales force and payer access team, to commercialize VOWST and provide this product to those who need it most,” said Greg Behar, Chief Executive Officer, Nestlé Health Science. “Since the approval of VOWST, our teams have engaged with healthcare professionals and are committed to facilitating patient access.”

“As a treating physician, I am pleased to now have the ability to prescribe VOWST, a 3-day oral regimen, to eligible patients in my practice,” said Carl Crawford M.D., Assistant Professor of Clinical Medicine at Weill Cornell Medical College. “Recurrent C. difficile infection is a challenging and debilitating disease, and VOWST has potential to make a meaningful impact to this patient community.”

VOWST Voyage™

Seres Therapeutics and Nestlé Health Science are committed to broad access for appropriate patients. The VOWST Voyage Support Program offers a range of resources and programs designed to help eligible patients prescribed VOWST access and initiate treatment. The program includes the VOWST Co-Pay Savings Program for eligible, commercially insured patients to help reduce their out-of-pocket costs.

Information on the VOWST Voyage Support Program is available at VowstHCP.com or by calling 888-356-5444.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST

INDICATION

VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

Limitation of Use: VOWST is not indicated for treatment of CDI.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.

Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.

ADVERSE REACTIONS

The most common adverse reactions (reported in ≥5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).

To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.

DRUG INTERACTIONS

Do not administer antibacterials concurrently with VOWST.

Please see Full Prescribing Information and Patient Information

About Recurrent C. difficile Infection (rCDI)

Recurrent C. difficile infection is a gastrointestinal infection caused by C. difficile bacteria. rCDI is linked to dysbiosis of the gastrointestinal microbiome and is associated with increased morbidity and mortality. CDI has been characterized as an Urgent Health Threat by the Centers for Disease Control and Prevention (CDC). rCDI results in a substantial burden on the healthcare system1 with the average rCDI-related annual costs per patient at approximately $43K.2

About Seres Therapeutics

Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres’ lead program, VOWST™, obtained U.S. FDA approval in April 2023 as the first orally administered microbiota-based therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI and is being commercialized in collaboration with Nestlé Health Science. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation. The Company is also conducting research to inform further development of microbiome therapeutics for ulcerative colitis. For more information, please visit www.serestherapeutics.com.

About Nestlé Health Science

Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé. We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 12,000 employees around the world, with products available in more than 140 countries. For more information, please visit www.nestlehealthscience.us.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the commercial success of VOWST, our ability to supply VOWST to the market, the success of the VOWST Voyage program and other statements which are not historical fact.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; the unknown degree and competing factors of market acceptance for VOWST; the competition we will face; our ability to protect our intellectual property; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC), on May 9, 2023, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

References

  1. U.S. Bureau of Labor Statistics. CPI Inflation Calculator. U.S. Bureau of Labor Statistics. Published 2022. https://www.bls.gov/data/inflation_calculator.htm. CPI inflation adjusted to March 2023.
  2. Rodrigues R, Barber GE, Ananthakrishnan AN. A Comprehensive Study of Costs Associated With Recurrent Clostridium difficile Infection. Infect Control Hosp Epidemiol. 2016;38:196-202. DOI: 10.1017/ice.2016.246

Seres IR and PR Contact:

Carlo Tanzi, Ph.D.

[email protected]

Nestlé Health Science PR Contact:

Lindsay Yanek

[email protected]

KEYWORDS: United States North America Massachusetts New Jersey

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical General Health Health FDA Infectious Diseases

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SAIC Announces First Quarter of Fiscal Year 2024 Results

SAIC Announces First Quarter of Fiscal Year 2024 Results

  • Revenues of $2.03 billion; 2% revenue growth, 3.5% growth adjusted for impact of deconsolidation of Forfeiture Support Associates joint venture
  • Net income of $98 million; Adjusted EBITDA(1) of $189 million or 9.3% as a % of revenues
  • Diluted earnings per share: $1.79; Adjusted diluted earnings per share(1): $2.14
  • Net bookings of $2.1 billion resulting in a book-to-bill of 1.1x in the quarter
  • Company increases revenue and adjusted diluted EPS(1) guidance for fiscal year 2024

RESTON, Va.–(BUSINESS WIRE)–
Science Applications International Corporation (NYSE: SAIC), a premier Fortune 500® technology integrator driving our nation’s digital transformation across the defense, space, civilian, and intelligence markets, today announced results for the first quarter ended May 5, 2023.

“We reported strong financial results in our first quarter as evidenced by continued momentum in revenue growth and margin improvement,” said SAIC CEO Nazzic Keene. “Our results and commitment to our strategy position us well to deliver upon the multi-year targets we provided at our 2023 Investor Day as we remain focused on driving long-term shareholder value.”

First Quarter of Fiscal Year 2024: Summary Operating Results

 

Three Months Ended

 

May 5,

2023

 

Percent

change

 

April 29,

2022

 

(in millions, except per share amounts)

Revenues

$

2,028

 

 

2

%

 

$

1,996

 

Operating income

 

157

 

 

26

%

 

 

125

 

Operating income as a percentage of revenues

 

7.7

%

 

140 bps

 

 

6.3

%

Adjusted operating income(1)

 

152

 

 

13

%

 

 

134

 

Adjusted operating income as a percentage of revenues

 

7.5

%

 

80 bps

 

 

6.7

%

Net income

 

98

 

 

32

%

 

 

74

 

EBITDA(1)

 

194

 

 

18

%

 

 

164

 

EBITDA as a percentage of revenues

 

9.6

%

 

140 bps

 

 

8.2

%

Adjusted EBITDA(1)

 

189

 

 

9

%

 

 

173

 

Adjusted EBITDA as a percentage of revenues

 

9.3

%

 

60 bps

 

 

8.7

%

Diluted earnings per share

$

1.79

 

 

39

%

 

$

1.29

 

Adjusted diluted earnings per share(1)

$

2.14

 

 

14

%

 

$

1.88

 

Net cash provided by operating activities

$

82

 

 

(31

)%

 

$

118

 

Free cash flow(1)

$

76

 

 

(33

)%

 

$

113

 

(1)Non-GAAP measure, see Schedule 5 for information about this measure.

First Quarter Summary Results

Revenues for the quarter increased $32 million or 2% compared to the same period in the prior year primarily due to ramp up on existing and new contracts, partially offset by contract completions and $37 million due to the deconsolidation of the Forfeiture Support Associates J.V. (FSA). Adjusting for the impact of the deconsolidation of FSA, revenues grew 3.5%.

Operating income as a percentage of revenues increased from the comparable prior year period primarily due to lower indirect costs, lower acquisition and integration costs, and a $7 million gain recognized from the deconsolidation of FSA.

Adjusted EBITDA(1) as a percentage of revenues for the quarter increased to 9.3% from 8.7% for the same period in the prior year primarily due to lower indirect costs and improved profitability across our contract portfolio.

Diluted earnings per share for the quarter was $1.79 compared to $1.29 in the prior year quarter. Adjusted diluted earnings per share(1) for the quarter was $2.14 compared to $1.88 in the prior year quarter. The weighted-average diluted shares outstanding during the quarter decreased to 54.8 million from 56.6 million during the prior year quarter.

Cash Generation and Capital Deployment

Cash flows provided by operating activities for the first quarter decreased $36 million compared to the prior year quarter, primarily due to the timing of payroll payments, partially offset by the timing of customer collections and vendor payments, and cash payments during the prior year associated with certain change in control provisions related to the acquisition of Halfaker and Associates, LLC.

During the quarter, SAIC deployed $97 million of capital, consisting of $70 million of plan share repurchases, $21 million in cash dividends, and $6 million of capital expenditures. In addition, SAIC received a $355 million refundable cash deposit during the quarter for the anticipated sale of our logistics and supply chain management (L&SCM) business which closed subsequent to the end of the quarter.

Quarterly Dividend Declared

As previously announced, subsequent to quarter end, the Company’s Board of Directors declared a cash dividend of $0.37 per share of the Company’s common stock payable on July 28, 2023 to stockholders of record on July 14, 2023. SAIC intends to continue paying dividends on a quarterly basis, although the declaration of any future dividends will be determined by the Board of Directors each quarter and will depend on earnings, financial condition, capital requirements and other factors.

(1)Non-GAAP measure, see Schedule 5 for information about this measure.

Backlog and Contract Awards

Net bookings for the quarter were approximately $2.1 billion, which reflects a book-to-bill ratio of 1.1 and a trailing twelve months book-to-bill ratio of 1.0. SAIC’s estimated backlog at the end of the quarter was approximately $23.8 billion. Of the total backlog amount, approximately $3.9 billion was funded.

Notable New Business Awards:

Defense Counterintelligence and Security Agency One IT: SAIC was awarded an $889 million contract by the Federal Systems Integration and Management Center (FEDSIM) in support of Defense Counterintelligence and Security Agency (DCSA) to develop and implement One IT. One IT provides IT modernization to DCSA’s systems. As the prime contractor for One IT, SAIC will support DCSA as it simplifies and standardizes the agency’s IT environment, including cloud readiness. SAIC’s work will include planning and systems architecture development; digital; network, database and storage engineering; service desk support; cybersecurity and IT application development and sustainment. SAIC will also provide services to help DCSA meet centralized IT solution requirements for the National Industrial Security Programs (NISP) and National Industrial Security Systems (NISS) applications.

Notable Space and Intelligence Community Awards:

U.S. Space and Intelligence Community: During the quarter, SAIC was awarded approximately $540 million of contract awards by space and intelligence community organizations, excluding the DCSA One IT program mentioned previously. These awards represent a combination of new business and recompetes.

Other Notable News

SAIC Announces CEO Transition: SAIC announced the appointment of Toni Townes-Whitley to become CEO and join SAIC’s Board of Directors, effective October 2, 2023. She will succeed Nazzic S. Keene, who has decided to retire as CEO and from the SAIC Board of Directors, also effective October 2, 2023.

SAIC Sells its Logistics and Supply Chain Management Business: Subsequent to the end of the quarter, SAIC sold its logistics and supply chain management business to ASRC Federal Holding Company, LLC (ASRC Federal), a subsidiary of Arctic Slope Regional Corporation, for $355 million in cash. SAIC’s logistics and supply chain solutions were used by the Defense Logistics Agency to manage multiple supply chains for the agency’s customers. The divestiture is consistent with SAIC’s broader strategy to focus on Growth & Technology Accelerants and on innovative, platform-agnostic solutions that add shareholder value.

SAIC Invests in Morpheus Data: SAIC announced a $5 million strategic investment in Morpheus Data, a leading provider of cloud automation and platform engineering solutions. Morpheus’ software will be the orchestration engine within CloudScendTM, SAIC’s cohesive suite of solutions for customers exploring, migrating and operating within the cloud environment. CloudScend has had an essential role in driving SAIC’s growth in the Secure Cloud market, which represents over $1 billion in annual revenue for SAIC.

SAIC Enters Exclusive Agreement to Provide Integrated Space Capabilities for GomSpace North America: SAIC signed an exclusive agreement to provide new space-based mission capabilities leveraging CubeSats and SmallSats to U.S.-based customers. With this partnership, SAIC becomes the exclusive U.S. integrator of GomSpace satellites and licensed product distributor, services reseller and space vehicle and mission integrator for GomSpace’s U.S. government customers. Together the companies will develop a joint technology roadmap, which will lead to the development of new space capabilities.

SAIC Introduces New Tool for Encrypted Search and Data Sharing: SAIC introduced its new encrypted query analytics and data retrieval (EQADR) platform. The platform enables next-generation, cryptographic, cross-boundary data search, retrieval and analytics. EQADR was developed to offer quick, secure and efficient data search and retrieval. EQADR’S cross-domain strategy delivers targeted, on-demand queries from higher-side networks to lower-side networks while securing sources, methods and analytical tradecraft. The platform is built to handle the transfer of sensitive data, allowing search terms to remain hidden and it can efficiently sift through open-source data, reduce classified-data storage costs and share intellectual property.

Fiscal Year 2024 Guidance

The table below summarizes fiscal year 2024 guidance and represents our views as of June 5, 2023.

 

CURRENT

PRIOR

 

Fiscal Year

Fiscal Year

 

2024 Guidance

2024 Guidance

Revenue

$7.125B – $7.225B

$7.05B – $7.20B

Adjusted EBITDA Margin(1)

9.2% – 9.4%

9.2% – 9.4%

Adjusted Diluted EPS(1)

$7.00 to $7.20

$6.80 – $7.00

Transaction-Adjusted Free Cash Flow(1)

$460M – $480M(2)

$460M – $480M

Webcast Information

SAIC management will discuss operations and financial results in an earnings conference call beginning at 10:00 a.m. Eastern time on June 5, 2023. The conference call will be webcast simultaneously to the public through a link on the Investor Relations section of the SAIC website (http://investors.saic.com). We will be providing webcast access only – “dial-in” access is no longer available. Additionally, a supplemental presentation will be available to the public through links to the Investor Relations section of the SAIC website. After the call concludes, an on-demand audio replay of the webcast can be accessed on the Investor Relations website.

About SAIC

SAIC® is a premier Fortune 500® technology integrator driving our nation’s technology transformation. Our robust portfolio of offerings across the defense, space, civilian and intelligence markets includes secure high-end solutions in engineering, digital, artificial intelligence and mission solutions. Using our expertise and understanding of existing and emerging technologies, we integrate the best components from our own portfolio and our partner ecosystem to deliver innovative, effective and efficient solutions that are critical to achieving our customers’ missions.

We are approximately 24,000 strong; driven by mission, united by purpose, and inspired by opportunities. SAIC is an Equal Opportunity Employer, fostering a culture of diversity, equity and inclusion, which is core to our values and important to attract and retain exceptional talent. Headquartered in Reston, Virginia, SAIC has annual revenues of approximately $6.9 billion. For more information, visit saic.com. For ongoing news, please visit our newsroom.

GAAP to Non-GAAP Guidance Reconciliation

The Company does not provide a reconciliation of forward-looking adjusted diluted EPS to GAAP diluted EPS or adjusted EBITDA margin to GAAP net income due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including, but not limited to, amortization of acquired intangible assets and acquisition, integration and restructuring costs. As a result, the Company is not able to forecast GAAP diluted EPS or GAAP net income with reasonable certainty. The variability of the above charges may have an unpredictable and potentially significant impact on our future GAAP financial results.

(1)Non-GAAP measure, see Schedule 5 for information about this measure.

(2)Current transaction-adjusted free cash flow guidance excludes expected cash tax and other payments of approximately $82M related to the L&SCM sale which will impact cash flows provided by operating activities in the second, third and fourth quarters of fiscal year 2024.

Forward-Looking Statements

Certain statements in this release contain or are based on “forward-looking” information within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by words such as “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “guidance,” and similar words or phrases. Forward-looking statements in this release may include, among others, estimates of future revenues, operating income, earnings, earnings per share, charges, total contract value, backlog, outstanding shares and cash flows, as well as statements about future dividends, share repurchases and other capital deployment plans. Such statements are not guarantees of future performance and involve risk, uncertainties and assumptions, and actual results may differ materially from the guidance and other forward-looking statements made in this release as a result of various factors. Risks, uncertainties and assumptions that could cause or contribute to these material differences include those discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Legal Proceedings” sections of our Annual Report on Form 10-K, as updated in any subsequent Quarterly Reports on Form 10-Q and other filings with the SEC, which may be viewed or obtained through the Investor Relations section of our website at www.saic.com or on the SEC’s website at www.sec.gov. Due to such risks, uncertainties and assumptions you are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. SAIC expressly disclaims any duty to update any forward-looking statement provided in this release to reflect subsequent events, actual results or changes in SAIC’s expectations. SAIC also disclaims any duty to comment upon or correct information that may be contained in reports published by investment analysts or others.

Schedule 1:

SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

CONDENSED AND CONSOLIDATED STATEMENTS OF INCOME

(Unaudited)
 

 

Three Months Ended

 

May 5,

2023

 

April 29,

2022

 

(in millions, except per share amounts)

Revenues

$

2,028

 

 

$

1,996

 

Cost of revenues

 

1,793

 

 

 

1,770

 

Selling, general and administrative expenses

 

84

 

 

 

92

 

Acquisition and integration costs

 

—

 

 

 

9

 

Other operating income

 

(6

)

 

 

—

 

Operating income

 

157

 

 

 

125

 

Interest expense

 

33

 

 

 

27

 

Other (income) expense, net

 

1

 

 

 

3

 

Income before income taxes

 

123

 

 

 

95

 

Provision for income taxes

 

(25

)

 

 

(21

)

Net income

$

98

 

 

$

74

 

Net income attributable to non-controlling interest

 

—

 

 

 

1

 

Net income attributable to common stockholders

$

98

 

 

$

73

 

Weighted-average number of shares outstanding:

 

 

 

Basic

 

54.3

 

 

 

56.1

 

Diluted

 

54.8

 

 

 

56.6

 

Earnings per share:

 

 

 

Basic

$

1.80

 

 

$

1.30

 

Diluted

$

1.79

 

 

$

1.29

 
Schedule 2:

SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

CONDENSED AND CONSOLIDATED BALANCE SHEETS

(Unaudited)
 

 

May 5,

2023

 

February 3,

2023

 

(in millions)

ASSETS

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

422

 

$

109

Receivables, net

 

995

 

 

936

Inventory, prepaid expenses and other current assets

 

77

 

 

152

Assets held for sale

 

181

 

 

—

Total current assets

 

1,675

 

 

1,197

Goodwill

 

2,851

 

 

2,911

Intangible assets, net

 

980

 

 

1,009

Property, plant, and equipment, net

 

91

 

 

92

Operating lease right of use assets

 

154

 

 

158

Other assets

 

206

 

 

176

Total assets

$

5,957

 

$

5,543

LIABILITIES AND EQUITY

 

 

 

Current liabilities:

 

 

 

Accounts payable and accrued liabilities

$

809

 

$

767

Accrued payroll and employee benefits

 

277

 

 

328

Deposit liability for assets held for sale

 

355

 

 

—

Long-term debt, current portion

 

46

 

 

31

Liabilities held for sale

 

66

 

 

—

Total current liabilities

 

1,553

 

 

1,126

Long-term debt, net of current portion

 

2,329

 

 

2,343

Operating lease liabilities

 

150

 

 

152

Other long-term liabilities

 

233

 

 

218

Equity:

 

 

 

Total common stockholders’ equity

 

1,692

 

 

1,694

Non-controlling interest

 

—

 

 

10

Total stockholders’ equity

 

1,692

 

 

1,704

Total liabilities and stockholders’ equity

$

5,957

 

$

5,543
Schedule 3:

SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

CONDENSED AND CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)
 

 

Three Months Ended

 

May 5,

2023

 

April 29,

2022

 

(in millions)

Cash flows from operating activities:

 

 

 

Net income

$

98

 

 

$

74

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

Depreciation and amortization

 

36

 

 

 

41

 

Amortization of off-market customer contracts

 

(2

)

 

 

(2

)

Amortization of debt issuance costs

 

1

 

 

 

2

 

Deferred income taxes

 

(6

)

 

 

2

 

Stock-based compensation expense

 

12

 

 

 

11

 

Gain on divestiture

 

(7

)

 

 

—

 

Increase (decrease) resulting from changes in operating assets and liabilities, net of the effect of divestitures:

 

 

 

Receivables

 

(127

)

 

 

(89

)

Inventory, prepaid expenses and other current assets

 

4

 

 

 

11

 

Other assets

 

4

 

 

 

3

 

Accounts payable and accrued liabilities

 

113

 

 

 

39

 

Accrued payroll and employee benefits

 

(43

)

 

 

31

 

Operating lease assets and liabilities, net

 

(3

)

 

 

(4

)

Other long-term liabilities

 

2

 

 

 

(1

)

Net cash provided by operating activities

 

82

 

 

 

118

 

Cash flows from investing activities:

 

 

 

Expenditures for property, plant, and equipment

 

(6

)

 

 

(5

)

Purchases of marketable securities

 

(3

)

 

 

(2

)

Sales of marketable securities

 

1

 

 

 

1

 

Proceeds from assets held for sale

 

355

 

 

 

—

 

Cash divested upon deconsolidation of joint venture

 

(8

)

 

 

—

 

Other

 

(3

)

 

 

—

 

Net cash provided by (used in) investing activities

 

336

 

 

 

(6

)

Cash flows from financing activities:

 

 

 

Dividend payments to stockholders

 

(21

)

 

 

(22

)

Principal payments on borrowings

 

(160

)

 

 

(59

)

Issuances of stock

 

4

 

 

 

4

 

Stock repurchased and retired or withheld for taxes on equity awards

 

(88

)

 

 

(84

)

Proceeds from borrowings

 

160

 

 

 

—

 

Distributions to non-controlling interest

 

—

 

 

 

(1

)

Net cash used in financing activities

 

(105

)

 

 

(162

)

Net increase (decrease) in cash, cash equivalents and restricted cash

 

313

 

 

 

(50

)

Cash, cash equivalents and restricted cash at beginning of period

 

118

 

 

 

115

 

Cash, cash equivalents and restricted cash at end of period

$

431

 

 

$

65

 
Schedule 4:

SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

BACKLOG

(Unaudited)

The estimated value of our total backlog as of the dates presented was:
 

 

May 5,

2023

February 3,

2023

 

(in millions)

Funded backlog

$

3,899

$

3,554

Negotiated unfunded backlog

 

19,895

 

20,248

Total backlog

$

23,794

$

23,802

Backlog represents the estimated amount of future revenues to be recognized under negotiated contracts and task orders as work is performed and excludes contract awards which have been protested by competitors until the protest is resolved in our favor. SAIC segregates backlog into two categories, funded backlog and negotiated unfunded backlog. Funded backlog for contracts with government agencies primarily represents contracts for which funding is appropriated less revenues previously recognized on these contracts, and does not include the unfunded portion of contracts where funding is incrementally appropriated or authorized by the U.S. government and other customers even though the contract may call for performance over a number of years. Funded backlog for contracts with non-government agencies represents the estimated value of contracts which may cover multiple future years under which SAIC is obligated to perform, less revenues previously recognized on these contracts. Negotiated unfunded backlog represents the estimated future revenues to be earned from negotiated contracts for which funding has not been appropriated or authorized, and unexercised priced contract options. Negotiated unfunded backlog does not include any estimate of future potential task orders expected to be awarded under indefinite-delivery, indefinite-quantity (IDIQ), U.S. General Services Administration (GSA) schedules or other master agreement contract vehicles, with the exception of certain IDIQ contracts where task orders are not competitively awarded and separately priced but instead are used as a funding mechanism, and where there is a basis for estimating future revenues and funding on future anticipated task orders.

Schedule 5:

SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

NON-GAAP FINANCIAL MEASURES

(Unaudited)

This schedule describes the non-GAAP financial measures included in this earnings release. While we believe that these non-GAAP financial measures may be useful in evaluating our financial information, they should be considered as supplemental in nature and not as a substitute for financial information prepared in accordance with GAAP. Reconciliations, definitions, and how we believe these measures are useful to management and investors are provided below. Other companies may define similar measures differently.
 

EBITDA, Adjusted EBITDA and Adjusted Operating Income

 

Three Months Ended

 

May 5,

2023

 

April 29,

2022

 

(in millions)

Net income

$

98

 

 

$

74

 

Interest expense and loss on sale of receivables

 

36

 

 

 

28

 

Interest income

 

(1

)

 

 

—

 

Provision for income taxes

 

25

 

 

 

21

 

Depreciation and amortization

 

36

 

 

 

41

 

EBITDA(1)

 

194

 

 

 

164

 

EBITDA as a percentage of revenues

 

9.6

%

 

 

8.2

%

Acquisition and integration costs

 

—

 

 

 

9

 

Restructuring and impairment costs

 

1

 

 

 

—

 

Gain on divestitures, net of transaction costs

 

(6

)

 

 

—

 

Adjusted EBITDA(1)

$

189

 

 

$

173

 

Adjusted EBITDA as a percentage of revenues

 

9.3

%

 

 

8.7

%

Operating income

$

157

 

$

125

 

Operating income as a percentage of revenues

 

7.7

%

 

6.3

%

Acquisition and integration costs

 

—

 

 

9

 

Restructuring and impairment costs

 

1

 

 

—

 

Gain on divestitures, net of transaction costs

 

(6

)

 

—

 

Adjusted operating income(1)

$

152

 

$

134

 

Adjusted operating income as a percentage of revenues

 

7.5

%

 

6.7

%

EBITDA is a performance measure that is calculated by taking net income and excluding interest and loss on sale of receivables, provision for income taxes, and depreciation and amortization. Adjusted EBITDA and adjusted operating income are performance measures that exclude the impact of non-recurring transactions that we do not consider to be indicative of our ongoing operating performance. The acquisition and integration costs relate to the Company’s acquisitions. The gain on divestitures includes gain associated with the deconsolidation of FSA. We believe that these performance measures provide management and investors with useful information in assessing trends in our ongoing operating performance and may provide greater visibility in understanding the long-term financial performance of the Company.

(1)Non-GAAP measure, see above for definition.

Schedule 5 (continued):

SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

NON-GAAP FINANCIAL MEASURES

(Unaudited)

Adjusted Diluted Earnings Per Share

 

Three Months Ended

 

May 5,

2023

 

April 29,

2022

Diluted earnings per share

$

1.79

 

 

$

1.29

 

 

 

 

 

Acquisition and integration costs and restructuring and impairment costs, divided by diluted ‘weighted-average number of shares outstanding’ (WASO)

 

0.02

 

 

 

0.16

 

Tax effect of acquisition and integration costs and restructuring and impairment costs, divided by diluted WASO

 

—

 

 

 

(0.03

)

Net effect of acquisition and integration costs and restructuring and impairment costs, divided by diluted WASO

 

0.02

 

 

 

0.13

 

 

 

 

 

Amortization of intangible assets, divided by diluted WASO

 

0.53

 

 

 

0.58

 

Tax effect of amortization of intangible assets, divided by diluted WASO

 

(0.11

)

 

 

(0.12

)

Net effect of amortization of intangible assets, divided by diluted WASO

 

0.42

 

 

 

0.46

 

 

 

 

 

Gain on divestitures, net of transaction costs, divided by diluted WASO

 

(0.11

)

 

 

—

 

Tax effect of gain on divestitures, net of transaction costs, divided by diluted WASO

 

0.02

 

 

 

—

 

Net effect of gain on divestitures, net of transaction costs, divided by diluted WASO

 

(0.09

)

 

 

—

 

 

 

 

 

Adjusted diluted earnings per share(1)

$

2.14

 

 

$

1.88

 

Adjusted diluted earnings per share is a performance measure that excludes the impact of non-recurring transactions that we do not consider to be indicative of our ongoing operating performance. The acquisition and integration costs relate to the Company’s acquisitions. The gain on divestitures includes gain associated with the deconsolidation of FSA. Adjusted diluted earnings per share also excludes amortization of intangible assets because we do not have a history of significant acquisition activity, we do not acquire businesses on a predictable cycle, and the amount of an acquisition’s purchase price allocated to intangible assets and the related amortization term are unique to each acquisition. We believe that this performance measure provides management and investors with useful information in assessing trends in our ongoing operating performance and may provide greater visibility in understanding the long-term financial performance of the Company.

(1)Non-GAAP measure, see above for definition.

Schedule 5 (continued):

SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

NON-GAAP FINANCIAL MEASURES

(Unaudited)
 

Free Cash Flow

  

 

Three Months Ended

 

May 5,

2023

 

April 29,

2022

 

(in millions)

Net cash provided by operating activities

$

82

 

 

$

118

 

Expenditures for property, plant, and equipment

 

(6

)

 

 

(5

)

Cash used (provided) by MARPA Facility

 

—

 

 

 

—

 

Free cash flow(1)

$

76

 

 

$

113

 
 

FY24 Guidance

in millions)

Net cash provided by operating activities

$410 to $430
Expenditures for property, plant, and equipment

Approximately $30

Free cash flow(1)

$380 to $400

L&SCM divestiture transaction fees

Approximately $7

L&SCM divestiture cash taxes

Approximately $75

Transaction-adjusted free cash flow(1)

$460 to $480

Free cash flow is calculated by taking cash flows provided by operating activities less expenditures for property, plant, and equipment and less cash flows from our Master Accounts Receivable Purchasing Agreement (MARPA Facility) for the sale of certain designated eligible U.S. government receivables. Under the MARPA Facility, the Company can sell eligible receivables up to a maximum amount of $300 million. Transaction-adjusted free cash flow excludes cash taxes, transaction fees, and other costs related to the divestiture of the logistics and supply chain management business from free cash flow as previously defined. We believe that free cash flow and transaction-adjusted free cash flow provides management and investors with useful information in assessing trends in our cash flows and in comparing them to other peer companies, many of whom present similar non-GAAP liquidity measures. These measures should not be considered as a measure of residual cash flow available for discretionary purposes.

(1)Non-GAAP measure, see above for definition.

Investor Relations: Joe DeNardi, +1.703.488.8528, [email protected]

Media: Thais Hanson, +1.703.676.8215, [email protected]

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Coya Therapeutics Strengthens Scientific Advisory Board (SAB) with the Addition of Neuroimmunology Pioneer, Dr. Guillaume Dorothée, an Expert on the Role of the Immune System and Regulatory T Cells (Tregs) in Alzheimer’s Disease (AD)

Coya Therapeutics Strengthens Scientific Advisory Board (SAB) with the Addition of Neuroimmunology Pioneer, Dr. Guillaume Dorothée, an Expert on the Role of the Immune System and Regulatory T Cells (Tregs) in Alzheimer’s Disease (AD)

  • Dr. Guillaume Dorothée, Ph.D., is a tenured research director and team head in neuroimmunology at the French National Institute of Health and Medical Research (INSERM) in Paris
  • He is one of the world’s leading experts on the role that the immune system and peripheral-central immune crosstalk play in the pathophysiology of AD
  • His team was the first to illustrate the beneficial role of Regulatory T cells (Tregs) in AD and the therapeutic effects of low dose Interleukin-2 (low dose IL-2) in modifying AD pathology and restoring cognitive function
  • Dr. Dorothée joins an SAB with leading Treg experts including Dr. Shimon Sakaguchi, the discoverer of Tregs, and the chair of Coya’s SAB, Dr. Stanley Appel, who elucidated the role of Tregs in Amyotrophic Lateral Sclerosis (ALS)
  • Dr. Dorothée will play an integral role in guiding Coya on its scientific and clinical strategy in AD and other neurodegenerative diseases

 

HOUSTON–(BUSINESS WIRE)–Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance Treg function, today announced the appointment of Dr. Guillaume Dorothée, Ph.D., to Coya’s SAB, joining a roster of scientific luminaries. Dr. Dorothée will provide insight and perspective into Coya’s clinical programs in ALS and AD, and other indications that Coya is evaluating.

Dr. Dorothée’s seminal work has focused on the role of the immune system and peripheral-central immune crosstalk in the pathophysiology of AD and other neurodegenerative diseases, with a particular interest in neuroinflammation and its effects on beta Amyloid, Tau, and other AD pathology. He has pioneered research into understanding how Tregs critically control immune responses to Beta Amyloid (Toly-Ndour et al, J Immunol, 2011), and how enhancing Tregs with low dose IL-2 plays a beneficial role in the pathophysiology of AD-like amyloid pathology while restoring cognitive function (Dansokho et al, Brain, 2016).

“Coya could not be prouder in having Dr. Dorothée join its SAB. The fact that he discovered the therapeutic role of low dose IL-2 in AD dovetails with Coya’s low dose IL-2 asset, COYA 301, and its highly promising proof of concept clinical data showing cognitive improvement and halting of cognitive decline. He continues to publish on the mechanism of how Tregs are working in AD and we look forward to his active participation in guiding our path forward,” stated, Howard H. Berman, Ph.D., CEO of Coya Therapeutics.

Dr. Dorothée commented: “I am glad and honored to join such eminent scientists on the prestigious SAB of Coya Therapeutics. I am fully convinced that innovative Treg-based immunomodulatory approaches, as developed by Coya, are highly promising therapeutic strategies for the treatment of neurodegenerative disorders and other neuroinflammatory conditions. I will be happy to help Coya Therapeutics in this exciting endeavor.”

About Coya Therapeutics, Inc.

Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s lead therapeutic programs includes Treg-enhancing biologics (COYA 300 Series product candidates) COYA 301 and COYA 302, which are intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. For more information about Coya, please visit www.coyatherapeutics.com

Forward-Looking Statements

This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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