Arrowhead Pharmaceuticals Presents Interim Clinical Data on ARO-CFB for the Treatment of Complement Mediated Diseases

Arrowhead Pharmaceuticals Presents Interim Clinical Data on ARO-CFB for the Treatment of Complement Mediated Diseases

– Interim data from Phase 1/2a study demonstrate near complete inhibition in hemolytic activity and functional activity of alternative complement pathway

PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced interim results from a Phase 1/2a clinical study of ARO-CFB, the company’s investigational RNA interference (RNAi) therapeutic targeting complement factor B being developed as a potential treatment for complement mediated diseases. The data were presented today, December 11, 2024, at the 8th Complement-Based Drug Development Summit being held in Boston.

“Dysregulated activation of the complement system can lead to progression of certain renal diseases, either by playing a directly pathogenic role, or by amplifying or exacerbating the inflammatory and damaging impact of non-complement disease triggers. In a Phase 1/2a clinical study, ARO-CFB treatment in healthy volunteers achieved deep and durable reductions in the liver production of complement factor B (CFB), which is involved in alternative complement pathway activation and associated with pathogenesis of diseases involving complement activation. Circulating levels of CFB protein were reduced by a mean of up to 90% to date, with additional data from higher doses levels pending, and a duration of response greater than 3 months,” said James Hamilton, M.D., MBA, Chief of Discovery and Translational Medicine at Arrowhead. “ARO-CFB also demonstrated dramatic reductions in measures of alternative complement pathway activation, with mean reductions at or approaching 100% in AH50 and Wieslab AP at multiple dose levels. These interim results in healthy volunteers give us confidence in the potential of ARO-CFB as we seek to complete Part 1 of the study over the coming months, and subsequently look ahead to Part 2 of the study in patients with immunoglobulin A nephropathy, which is the most common glomerular disease worldwide.”

Select ARO-CFB Results

In the ongoing AROCFB-1001 study, ARO-CFB achieved the following key results in normal healthy volunteers as of the interim data cutoff – 15 November 2024:

  • ARO-CFB led to dose dependent reductions in circulating CFB protein by up to 90% with greater than 3 months duration

    • 90% mean reduction achieved after a single dose of 400 mg

    • 90% mean reduction achieved after two doses of 100 mg

  • Single and multiple doses of ARO-CFB led to near complete inhibition of alternative pathway activity based on Wieslab AP

    • 100% mean reduction achieved by week 4 after a single dose at both 200 mg and 400 mg doses

    • 92% and 100% mean reductions were achieved after two doses at 100 mg and 200 mg, respectively

  • Single and multiple doses of ARO-CFB led to near complete inhibition of alternative pathway hemolytic activity, measured by AH50

Safety and Tolerability Results

ARO-CFB has been generally well-tolerated to date with safety data supportive of further clinical development. There have been no treatment emergent adverse events (TEAE) leading to study or study drug discontinuation with most TEAEs being mild in severity.

About ARO-CFB

ARO-CFB is designed to reduce hepatic expression of complement factor B (CFB), which plays an important regulatory role in amplifying complement alternative pathway activation and has been identified as a promising therapeutic target. ARO-CFB is being developed as a potential treatment for complement mediated kidney diseases such as immunoglobulin A nephropathy (IgAN), which is the most common glomerular disease worldwide and carries a high lifetime risk of progression to end-stage renal disease. Additionally, ARO-CFB may have clinical applications in non-renal diseases involving complement activation.

About the AROCFB-1001 Phase 1/2 Study

AROCFB-1001 (NCT06209177) is an ongoing Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-CFB in up to 66 normal healthy volunteers (NHV) and patients with complement mediated kidney disease. In Part 1 of the study, NHVs will receive either one or two doses of ARO-CFB or placebo. In Part 2 of the study, adult patients with IgAN will receive 3 open-label doses of ARO-CFB. The study is designed to assess safety and tolerability and key pharmacodynamic parameters, including the change and percent change from baseline over time in serum CFB, and alternative complement pathway activity via AH50 and Wieslab AP.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

Arrowhead Pharmaceuticals, Inc.

Vince Anzalone, CFA

626-304-3400

[email protected]

Investors:

LifeSci Advisors, LLC

Brian Ritchie

212-915-2578

[email protected]

Media:

LifeSci Communications, LLC

Kendy Guarinoni, Ph.D.

724-910-9389

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Health Genetics Clinical Trials Pharmaceutical Cardiology Biotechnology

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ImmunityBio, Inc. Announces Pricing of Public Offering of Common Stock

ImmunityBio, Inc. Announces Pricing of Public Offering of Common Stock

CULVER CITY, Calif.–(BUSINESS WIRE)–
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the pricing of its previously announced underwritten public offering of an aggregate of 33,333,334 shares of its common stock at a price to the public of $3.00 per share. ImmunityBio has granted the underwriters a 30-day option to purchase up to an additional 5,000,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares were sold by ImmunityBio. Before deducting the underwriting discount and offering expenses payable by ImmunityBio, ImmunityBio expects to receive gross proceeds of approximately $100.0 million, assuming no exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about December 12, 2024 subject to satisfaction of customary closing conditions.

Jefferies and Piper Sandler are acting as joint book-running managers and representatives of the underwriters for the offering. BTIG and H.C. Wainwright & Co. are acting as co-lead managers with D. Boral Capital acting as co-manager for the offering.

ImmunityBio currently intends to use the net proceeds from this offering to progress its continued commercialization of ANKTIVA® for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) with or without papillary tumors, to fund its trials in BCG-naïve NMIBC and non-small cell lung cancer (“NSCLC”), toward further research and development, for working capital needs, and for other general corporate purposes.

A shelf registration statement on Form S-3ASR relating to the common stock offered in the public offering was filed with the Securities and Exchange Commission (the “SEC”) on April 17, 2024 and became automatically effective on April 17, 2024. The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on December 10, 2024 and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the offering will also be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained from: Jefferies LLC, by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected], or Piper Sandler & Co. by mail at Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering was made only by means of a prospectus supplement and accompanying prospectus.

About ImmunityBio, Inc.

ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy platforms, alone and together, act to drive an immune response with the goal of creating durable immune memory generating safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning expectations with respect to the completion of the public offering, and the anticipated use of the net proceeds from the offering. Risks and uncertainties related to these endeavors include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio.

Investors should review the risks and uncertainties contained in ImmunityBio’s filings with the SEC, including the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024, in the preliminary prospectus supplement related to the public offering filed with the SEC on December 10, 2024, and in the final prospectus supplement to be filed with the SEC, as well as other risks set forth in the Company’s other filings with the SEC. ImmunityBio cautions you that the forward-looking information presented in this press release is not a guarantee of future events, and that actual events may differ materially from those described in or suggested by the forward-looking information contained in this press release. Statements in this presentation that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Any forward-looking information presented herein is made only as of the date of this press release, and the Company does not undertake any obligation to update or revise any forward-looking information to reflect changes in assumptions, the occurrence of unanticipated events, or otherwise, except to the extent required by law.

Investors

Hemanth Ramaprakash, PhD, MBA

ImmunityBio, Inc.

+1 858-746-9289

[email protected]

Media

Sarah Singleton

ImmunityBio

+1 415-290-8045

[email protected]

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INDUSTRY KEYWORDS: Infectious Diseases Biotechnology Health Oncology

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Condado Tacos is spicing up their growth plan with a new secret ingredient: PAR Technology’s Data Central

Condado Tacos is spicing up their growth plan with a new secret ingredient: PAR Technology’s Data Central

Rethinking What’s Possible in Restaurant Efficiency, From Kitchen to Counter

NEW HARTFORD, N.Y.–(BUSINESS WIRE)–PAR Technology (NYSE: PAR), a global foodservice technology company, today announces that Condado Tacos, the rapidly growing restaurant brand celebrated for its custom tacos and bold flavors, has selected PAR® Data Central®, to elevate its operations. By implementing this solution, Condado Tacos aims to streamline central-kitchen-to-store logistics, optimize labor and menu performance across all locations, and unlock actionable data insights to drive its next phase of growth.

Every great taco starts with the right ingredients, but when you’re serving thousands of guests across multiple states, ensuring those ingredients are prepped, delivered, and managed seamlessly is a game-changer. As Condado Tacos scales its operations, it’s moving beyond traditional, one-size-fits-all restaurant management tools that once served a smaller setup. Already a familiar partner through the PAR Punchh® loyalty program, Condado Tacos saw PAR Data Central as the holistic solution to power their next growth phase with custom reporting capabilities, optimized labor scheduling, and precise tracking of food costs, all aimed at unlocking new revenue opportunities.

“Growth is about more than just adding locations; it’s about delivering a consistent, memorable experience at every restaurant,” said Zak Palmer, VP of Technology at Condado Tacos. “PAR Data Central has been transformative, giving us real-time visibility into our operations, from central kitchen logistics to each restaurant’s unique inventory and labor needs. It’s allowing us to become more proactive rather than reactive, which is essential as we expand.”

With PAR Data Central’s modules for food & inventory management, labor management & scheduling, enterprise reporting and commissary, Condado Tacos now benefits from a seamlessly integrated solution that adapts to market demands, mitigates workflow disruptions, and uncovers new cost-saving opportunities. By reducing food cost variances, leveraging real-time inventory data for ordering, and optimizing staff schedules with predictive analytics, Data Central assists every location to operate at peak efficiency. By consolidating multiple tools into one platform, PAR has provided Condado Tacos with an all-in-one solution that meets its demands of rapid growth and quality control.

Optimizing their central kitchen was a top priority for Condado Tacos, as centralizing bulk food prep helped ensure food consistency and manage peak-hour demands. However, the brand’s manual inventory tracking couldn’t keep pace with the growing volume of ingredients, leading to increasing food cost variances. PAR Data Central’s Commissary Module transformed this process by automating inventory tracking, providing full visibility into operational logistics, and effectively reducing food cost variances.

“Our goal is to empower brands to grow without limitations, and Condado Tacos is a perfect example of that,” said Savneet Singh, CEO of PAR Technology. “With Data Central, we’re delivering a unified solution that not only supports their growth but fuels it by bringing their data together in one seamless platform, streamlining operations, and elevating the guest experience at every turn. As they expand, we’re thrilled to be the backbone that ensures every taco hits the mark with the same quality and passion their guests know and love.”

With PAR Technology’s robust back-office solution, Condado Tacos is consolidating its operations under one platform. This strategic shift allows the fast-growing brand to scale with confidence, ensuring every taco sold contributes to a stronger bottom line.

For more information on PAR Data Central, please visit partech.com.

PAR Technology:

For over four decades, PAR Technology Corporation (NYSE: PAR) has been at the forefront of technology innovation in foodservice, helping businesses create exceptional guest experiences and connections. Our comprehensive suite of software and hardware solutions, including point-of-sale, digital ordering, loyalty, back-office management, and payments, serves a diverse range of hospitality and retail clients across more than 110 countries. With our “Better Together” ethos, PAR continues to deliver unified solutions that drive customer engagement, efficiency, and growth, all to make it easier for our customers to manage their operations. To learn more, visit partech.com or connect with us on LinkedIn, X (formerly Twitter), Facebook, and Instagram.

Christopher R. Byrnes (315) 743-8376

[email protected], www.partech.com

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Technology Retail Lodging Travel Supply Chain Management Restaurant/Bar Software Cruise Supermarket Specialty Hardware Data Management Food/Beverage Satellite

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Bowman Selected for Boston’s Roslindale and Maverick Squares Transportation Action Plan and Design

Bowman Selected for Boston’s Roslindale and Maverick Squares Transportation Action Plan and Design

RESTON, Va.–(BUSINESS WIRE)–
Bowman Consulting Group Ltd. (the Company or Bowman) (NASDAQ: BWMN), a national engineering services firm delivering infrastructure solutions and program management services to customers who own, develop and maintain the built environment, has been selected by the City of Boston’s Transportation Department (BTD) to oversee planning, engineering and community engagement efforts for the Roslindale and Maverick Squares Transportation Action Plan and Design.

The project aims to enhance multimodal transportation and public spaces in Roslindale Square in Boston’s Roslindale neighborhood and Maverick Square in East Boston, two critical commercial and community hubs located nearly 7.5 miles apart. With a high volume of visitors arriving by transit, bike or foot, the initiative focuses on improving safety, accessibility and connectivity in these neighborhoods.

Bowman will build on the previous planning initiatives in both neighborhoods to develop a comprehensive understanding of the current conditions and design context and work closely with local stakeholders to develop community-informed designs. The Company’s work will be supported by Openbox and KMDG, integrating innovative outreach strategies and creative design approaches to ensure the final plans address the diverse needs of residents, businesses and visitors. In addition to longer-term design plans for key streets and intersections in each square, two low-cost, tactical improvements will be executed as demonstration projects in 2025. These updates will prioritize pedestrian and cyclist safety, improve transit access and enhance public spaces.

This initiative aligns with BTD’s visionary goals outlined in Imagine Boston 2030 and Go Boston 2030, which prioritize safer, more accessible and connected communities. Through targeted transportation and public space improvements in critical hubs like Roslindale and Maverick Squares, Bowman aims to enhance neighborhood vitality while supporting local business growth and sustainability.

About Bowman Consulting Group Ltd.

Headquartered in Reston, Virginia, Bowman is a national engineering services firm delivering infrastructure solutions to customers who own, develop and maintain the built environment. With over 2,300 employees in more than 95 locations throughout the United States, Bowman provides a variety of planning, engineering, geospatial, construction management, commissioning, environmental consulting, land procurement and other technical services to customers operating in a diverse set of regulated end markets. Bowman trades on the Nasdaq under the symbol BWMN. For more information, visit bowman.com or investors.bowman.com.

General Media Contact:

Renee Narvaez

[email protected]

Investor Relations Contacts:

Bruce Labovitz

[email protected]

Betsy Patterson

[email protected]

KEYWORDS: Virginia United States North America

INDUSTRY KEYWORDS: Architecture Construction & Property Engineering Public Transport Urban Planning Other Construction & Property Transport Manufacturing

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ParaZero Announces Significant Order for Drone Safety Systems from a Leading Australian Distributor

Tel Aviv, Israel, Dec. 11, 2024 (GLOBE NEWSWIRE) — ParaZero Technologies Ltd. (Nasdaq: PRZO) (the “Company or “ParaZero”), an aerospace company focused on safety systems for defense and commercial drones and urban air mobility aircrafts, announced today the receipt of an order for its SafeAir™ systems from a significant distributor specializing in drones and drone technology in Australia. This order highlights ParaZero’s growing footprint in the Australian market, built on recent regulatory achievements and strategic partnerships.

ParaZero’s SafeAir™ systems are designed to autonomously detect flight anomalies and deploy a parachute, minimizing risks and ensuring safety in complex drone operations. In October 2023, ParaZero’s technology received approval from the Civil Aviation Safety Authority (CASA), enabling commercial drone flights over populated areas and near people—a landmark regulatory milestone in Australia.

Collaborating with prominent local distributors has been central to ParaZero’s success in the region. By leveraging these partnerships, ParaZero has made its CASA-approved safety systems widely accessible, empowering operators to conduct advanced and safe drone missions.

“This order from a key distributor in Australia emphasizes the trust and demand for our SafeAir™ systems,” said Boaz Shetzer, CEO of ParaZero. “Our continued collaboration with leading players in the drone ecosystem reflects our commitment to advancing safety and enabling new opportunities in the global drone industry. Australia remains a strategic market for us, and we are thrilled to see our technology adopted at scale.”

Australia’s rapidly growing drone industry benefits significantly from safety technologies like ParaZero’s, which facilitate complex operations while ensuring compliance with stringent safety regulations. This order further establishes ParaZero as a preferred partner for distributors and operators seeking cutting-edge drone safety solutions.

About ParaZero Technologies

ParaZero (Nasdaq: PRZO) is a leading developer of autonomous parachute safety systems technologies for commercial and military platforms as well as for urban air mobility (UAM) aircraft. Started in 2014 by a passionate group of aviation professionals and drone industry veterans, ParaZero develops and manufactures smart, autonomous parachute safety systems designed to enable safe flight operations over populated areas and beyond-visual-line-of-sight (BVLOS) as well as for various military applications including Counter UAS. For more information about ParaZero, please visit https://parazero.com/


Forward- looking statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, ParaZero is using forward-looking statements when it commitment to advancing safety and enabling new opportunities in the global drone industry. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on From 20-F for the year ended December 31, 2023. Forward- looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. ParaZero is not responsible for the content of third-party websites.

Investor Relations Contact:

Michal Efraty
Investor Relations
[email protected]



Celcuity Presents Overall Survival Data from Phase 1b Study Evaluating Gedatolisib in Combination with Palbociclib and Endocrine Therapy at the 2024 San Antonio Breast Cancer Symposium

Median overall survival (OS) among patients with HR+, HER2- advanced breast cancer who were treatment-naïve in the advanced setting was 77.3 months

Median OS among patients previously treated with a CDK4/6 inhibitor was 33.9 months

MINNEAPOLIS, Dec. 11, 2024 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced overall survival (OS) data from two patient cohorts evaluated in a Phase 1b trial with gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either letrozole or fulvestrant, in patients with HR+, HER2-advanced or metastatic breast cancer. Results will be presented in a poster session at the San Antonio Breast Cancer Symposium (SABCS) being held December 10-13 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

The poster presents overall survival data among patients with HR+, HER2- advanced breast cancer who were either treatment-naïve (N=41) or whose disease progressed during prior treatment with a CDK4/6 inhibitor (N=27). For the treatment-naïve patient cohort (Escalation Arm A and Expansion Arm A), median OS was 77.3 months (95% CI, 50.3 to 89.0). For the patients previously treated with a CDK4/6 inhibitor and who received the Phase 3 dose of gedatolisib (Expansion Arm D), median OS was 33.9 months (95% CI, 17.8 to 52.3).

“The median OS results reported for gedatolisib in combination with palbociclib and endocrine therapy are encouraging and compare favorably to published data for currently available first- or second-line standard-of-care regimens for patients with HR+/HER2- advanced breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “These results highlight the promising clinical development strategy of simultaneously blocking the ER, CDK4/6, and PAM (PI3K/AKT/mTOR) signaling pathways. This approach provided the rationale for our two Phase 3 clinical trials, the ongoing VIKTORIA-1 and planned VIKTORIA-2, which are and will be evaluating this treatment strategy in patients with HR+, HER2- advanced breast cancer in the second- and first-line setting, respectively.”

This poster, and two additional posters presenting nonclinical data for gedatolisib at the SABCS, are available on the publications page of the Celcuity website.

About Gedatolisib

Gedatolisib is a potent, reversible inhibitor that selectively targets all Class I PI3K isoforms and mTORC1 and mTORC2 to blockade PI3K/AKT/mTOR signaling activity. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K, AKT, or mTOR alone or together. Inhibiting all four Class I PI3K isoforms and mTORC1/2 limits the potential development of drug resistance compared with isoform-specific PI3K, AKT or mTOR specific inhibitors. A robust response rate and a manageable side effect profile were reported for the Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib and endocrine therapy in patients with HR+/HER2- advanced breast cancer. Gedatolisib, in combination with palbociclib and fulvestrant, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of HR+/HER2- advanced breast cancer that has progressed following treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor.

About Celcuity 

Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is enrolling patients. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter.

Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements” including, but not limited to, the design of our clinical trials; the timing of initiating and enrolling patients in, and receiving results and data from, our clinical trials; the costs and expected results from any ongoing or planned clinical trials; the market opportunity for gedatolisib; revenue expectations; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to Celcuity’s lead product candidate, gedatolisib, and its CELsignia platform; our anticipated use of cash; and the strength of our balance sheet. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends” or “continue,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, unforeseen delays in our clinical trials, our ability to obtain and maintain regulatory approvals to commercialize our products, and the market acceptance of such products, the development of therapies and tools competitive with our products, our ability to access capital upon favorable terms or at all, and those risks set forth in the Risk Factors section in Celcuity’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 27, 2024. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law.


View source version of release on GlobeNewswire.com

Contacts: 
Celcuity Inc. 
Brian Sullivan, [email protected]
Vicky Hahne, [email protected]
(763) 392-0123 

ICR Healthcare
Patti Bank, [email protected]
(415) 513-1284



PureTech Founded Entity Seaport Therapeutics Presents Additional Data from Phase 1 Study of SPT-300 at ACNP Annual Meeting 2024

PureTech Founded Entity Seaport Therapeutics Presents Additional Data from Phase 1 Study of SPT-300 at ACNP Annual Meeting 2024

Multiple well-tolerated doses with pharmacodynamic activity were identified and will be included in a planned Phase 2b study in major depressive disorder

BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company, noted that its Founded Entity, Seaport Therapeutics, (“Seaport”) a clinical-stage biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the presentation of additional data from its first-in-human, multi-part Phase 1 study of SPT-300 in healthy volunteers at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, held December 8-11, 2024 in Phoenix, Arizona. SPT-300 is an oral prodrug of allopregnanolone that is designed to retain the pharmacological activity of allopregnanolone, an endogenous neurosteroid. Allopregnanolone has been clinically validated in third-party trials as a rapidly acting antidepressant with anxiolytic effects.

New data presented at the conference include further safety analyses and pharmacokinetic and pharmacodynamic data. Based on the Phase 1 study results, the profile of SPT-300 is suitable for chronic dosing and oral administration at night in the planned Phase 2b placebo-controlled study.

The full text of the announcement from Seaport is as follows:

Seaport Therapeutics Presents Additional Data from Phase 1 Study of SPT-300 at ACNP Annual Meeting 2024

Multiple well-tolerated doses with pharmacodynamic activity were identified and will be included in a planned Phase 2b study in major depressive disorder

BOSTON, December 11, 2024 – Seaport Therapeutics (“Seaport” or the “Company”), a clinical-stage biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced the presentation of additional data from its first-in-human, multi-part Phase 1 study of SPT-300 in healthy volunteers at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, held December 8-11, 2024 in Phoenix, Arizona. SPT-300 is an oral prodrug of allopregnanolone that is designed to retain the pharmacological activity of allopregnanolone, an endogenous neurosteroid. Allopregnanolone has been clinically validated in third-party trials as a rapidly acting antidepressant with anxiolytic effects.

The Phase 1 study enrolled 99 participants (in three parts: double-blind single ascending dose, multiple ascending dose, and open-label food effect) and evaluated oral bioavailability, safety, tolerability, pharmacokinetics and GABAA target engagement. Pharmacodynamic assessments included quantitative electroencephalography (EEG) analyses of brain function and video-oculography (VOG) assessments of eye movement. SPT-300 was well-tolerated, with all adverse events (AE) being mild or moderate, transient and dose-dependent. The most common AE was somnolence, which was mild and transient in all cases. The study showed that SPT-300 had therapeutically relevant blood levels that were up to approximately nine times greater than published data on orally administered unmodified allopregnanolone, which has minimal bioavailability.

New data in the poster presented at the conference include further safety analyses and pharmacokinetic and pharmacodynamic data. In the Phase 1 study, increases in EEG beta frequency power and reduction in saccadic eye velocity were observed at approximately 4 hours post-dose. Somnolence peaked in this same timeframe and diminished by 6 to 8 hours post-dose, consistent with both pharmacodynamic markers and blood levels of allopregnanolone. Based on the Phase 1 study results, the profile of SPT-300 is suitable for chronic dosing and oral administration at night in the planned Phase 2b placebo-controlled study in major depressive disorder with or without anxious distress.

“Together with previous clinical efficacy data, the further analyses of the Phase 1 study demonstrate that these doses of SPT-300 are well-tolerated and have rapidly acting pharmacodynamic activity. This reinforces our confidence in SPT-300 as an oral modulator of GABAA receptors and as a potential rapidly acting antidepressant and anxiolytic agent,” said Tony Loebel, M.D., Chief Medical Officer and President of Clinical Development of Seaport Therapeutics. “There is a great need for innovative neuropsychiatric medicines, and an oral form of allopregnanolone has the potential to provide important advantages that we believe will allow for once-daily use on a chronic basis. We look forward to the next phase of our clinical development plan for SPT-300.”

About SPT-300

SPT-300 (Glyph allopregnanolone), an oral prodrug of allopregnanolone, an endogenous neurosteroid, is in clinical stage development for the treatment of major depressive disorder (MDD) with or without anxious distress. Allopregnanolone has demonstrated therapeutic benefit in a range of neuropsychiatric conditions, but is currently only approved as an intravenous infusion, which has limited the scope of its clinical use. Using the Glyph™ platform, SPT-300 is designed to retain the activity, potency and the breadth of the natural biological response of endogenous allopregnanolone in an oral form, which has the potential to capture clinically important antidepressant and anxiolytic effects. In a Phase 2a clinical study, SPT-300 demonstrated initial proof-of-concept in a validated clinical model of anxiety in healthy volunteers. SPT-300 also demonstrated oral bioavailability, tolerability and γ-aminobutyric-acid type A (GABAA) receptor target engagement in healthy volunteers in a Phase 1 clinical study.

About Seaport Therapeutics

Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph technology platform. All the therapeutic candidates in its pipeline of potentially first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and is guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech’s R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be 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 without limitation those related to Seaport’s development plans for its pipeline of therapeutics for the treatment of depression, anxiety and other neuropsychiatric disorders, potential benefits to patients, and Seaport’s and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

PureTech

Public Relations

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Investor Relations

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Ben Atwell, Rob Winder

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INDUSTRY KEYWORDS: Health Clinical Trials Research Pharmaceutical Science Biotechnology

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Ocugen CEO to Present at Oppenheimer Movers in Rare Disease Summit

MALVERN, Pa., Dec. 11, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen will present at the Oppenheimer Movers in Rare Disease Summit at the Westin Grand Central, New York on Thursday, December 12, 2024.

“I have witnessed firsthand the impact that Ocugen’s modifier gene therapies have made in the lives of patients with retinitis pigmentosa (RP) and Stargardt disease, which are inherited retinal diseases with significant unmet medical need,” said Dr. Musunuri. “In the coming months, I cannot wait to share more data about these two exciting programs—the Phase 3 OCU400 liMeliGhT clinical trial for RP and Phase 1/2 OCU410ST GARDian clinical trial for Stargardt disease.”

Session: Elevator Pitches from Rare Disease Companies with Key Near-term, Potentially Stock-moving Catalysts

Location: Grand Central Ballroom C&D

Time: 2:45-3:30 p.m. ET

In addition to Dr. Musunuri’s session, members of Ocugen’s executive team will conduct one-on-one meetings with investors to highlight the Company’s business and clinical development strategy.

About Ocugen, Inc. 
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Tiffany Hamilton
Head of Communications
[email protected]



ExxonMobil announces plans to 2030 that build on its unique advantages

ExxonMobil announces plans to 2030 that build on its unique advantages

Expects to deliver growth potential of $20 billion in earnings and $30 billion in cash flow1

Key elements of ExxonMobil’s 2030 plan:

  • Increasing Pioneer acquisition average annual synergies by over 50% to more than $3 billion2
  • Growing new business earnings potential to $3 billion3
  • Adding $7 billion more in structural cost savings vs. 3Q2024

  • Increasing Upstream production to 5.4 million oil-equivalent barrels per day with >60% from advantaged assets

  • Growing high-value product sales 80% vs. 2024 that contribute over 40% of 2030 earnings potential for Product Solutions

  • Pursuing up to $30 billion in lower emissions investment opportunities4
  • Investing $27-$29 billion of cash capex in 2025 and $28-$33 billion annually in 2026-2030 to progress attractive long-term opportunities, with base planned capex roughly flat and reinvestment rate declining to 40% from 50% over the plan period5

SPRING, Texas–(BUSINESS WIRE)–
ExxonMobil today announced its Corporate Plan to 2030, creating a platform to further extend the company’s track record of delivering leading shareholder value. The plan reflects the company’s strategy to leverage its unique set of competitive advantages and unrivaled opportunities to create significant upside potential for shareholders. The company expects to deliver incremental growth potential of $20 billion in earnings and $30 billion in cash flow driven by investing in competitively advantaged opportunities, continued excellence in execution, and disciplined cost and capital management.1

“ExxonMobil has a unique set of highly valuable competitive advantages that equip us to do what few companies have ever done – create world-scale solutions to society’s biggest challenges, decade after decade,” said Darren Woods, ExxonMobil Chairman and CEO. “Our steadfast commitment to strengthening these advantages, including an unwavering investment in technology, has led to a history of innovative solutions that meet society’s critical needs, reduce costs, and grow high-value products. That’s a formula for profitable growth and shareholder value through and beyond 2030 – no matter the pace and scale of the energy transition – that truly puts us in a league of our own.”

Consistent execution of ExxonMobil’s strategy and business transformation over the past five years has substantially strengthened its earnings power. On a constant price and margin basis, the company is generating more than $15 billion in earnings and more than $20 billion in cash flow vs. 2019, and has delivered structural cost savings of more than $11 billion year-to-date vs. 2019.6 Cash flow has grown faster than that of any other integrated oil company (IOC) over the past three- and five-year periods.7 That outperformance has translated to shareholder value – ExxonMobil’s total shareholder return leads IOCs year-to-date and over the last three- and five-year periods.8

Financial strength

Over the next six years, the company expects to generate an additional $20 billion in earnings potential and $30 billion in cash flow potential.1 It plans to grow earnings at a CAGR of 10% and cash flow at 8% and has plans to achieve an additional $7 billion in structural cost savings by simplifying business processes, optimizing supply chains, further enhancing maintenance turnaround processes, and modernizing information technology and data management systems.

The Company’s capital allocation approach prioritizes competitively advantaged, high-return, low-cost-of-supply investments. In 2025, the company expects cash capital expenditures to be in the range of $27 to $29 billion, reflecting the first full year of Pioneer in the portfolio and investment to build new businesses with base capex remaining flat. From 2026 to 2030, base capex is consistent, while capex growth is driven by progressing advantaged, long-term opportunities in new businesses, and a few early-stage large projects in the company’s traditional businesses. The reinvestment rate relative to expected cash flow declines 10 percentage points over the plan period.5

“Through 2030, we plan to deploy about $140 billion to major projects and the Permian Basin development program,” added Woods. “We expect this capital to generate returns of more than 30% over the life of the investments.9 Strong investment returns have driven 42 consecutive years of annual dividend growth, a claim only 4% of the S&P 500 can make. This is why, when we list our capital allocation priorities, investing in accretive growth always comes first.”

Cash flow and earnings growth generate a further $165 billion in surplus cash over the plan period driving increased shareholder distributions.10 ExxonMobil has increased its annual dividend per share for 42 consecutive years, and recently increased its quarterly dividend by 4 cents per share effective this quarter. The company continues to expect to repurchase shares at a $20 billion annual pace in 2025, and today announced plans for a further $20 billion of share repurchases in 2026, assuming reasonable market conditions.

Upstream

ExxonMobil continues to strengthen its Upstream portfolio of advantaged assets that offer lower cost of supply and higher returns. By 2030, at a 2024 dollar real Brent price of $65 per barrel, a real Henry Hub price of $3 per mmbtu, and a real TTF price of $6.50 per mmbtu, the company plans to deliver an additional $9 billion in Upstream annual earnings potential – more than 50% higher than in 2024.

With the Pioneer acquisition, the company reached its target of having more than 50% of its total Upstream production from advantaged assets (Permian, Guyana, and LNG) three years earlier than planned. By 2030, more than 60% of the company’s production is expected to come from these advantaged assets, which are expected to grow by an additional 1.2 million oil-equivalent barrels per day (Moebd) during that period. Total Upstream production is expected to reach 5.4 Moebd by 2030, even as the company plans to lower its operated Upstream emissions intensity 40-50% versus 2016.11

Following its acquisition and integration of Pioneer, ExxonMobil expects to achieve more than $3 billion in annual synergies, a more than 50% increase from prior guidance. The company now has the largest contiguous acreage position in the Permian Basin with double the number of low-cost net drilling locations versus the next closest competitor.12 The company is applying its technology advantage to increase capital efficiency and resource recovery and expects to roughly double production in the Permian Basin to approximately 2.3 Moebd by 2030.

ExxonMobil also announced plans for two additional developments in Guyana, Hammerhead and Longtail, bringing the total number of developments to eight by 2030. Total production capacity in Guyana, on an investment basis, is expected to reach 1.7 million barrels per day with gross production growing to 1.3 million barrels per day by 2030.

ExxonMobil has four world-class LNG projects under development and expects to surpass 40 million metric tons per annum of LNG sales by 2030. The addition of these projects further expands the company’s global LNG footprint and market access. The company expects to achieve first LNG sales from the Golden Pass development in the United States and from the Qatar North Field East expansion project near the end of 2025. It also is targeting final investment decisions at Papua New Guinea’s Papua project in 2025 and at Mozambique’s Rovuma development in 2026.

Product Solutions

ExxonMobil’s Product Solutions business is expected to grow annual earnings potential by an additional $8 billion by 2030, at average 2010-2019 margins – a 10% CAGR. About half of the earnings growth is expected to come from advantaged projects and high-value products to meet society’s needs today and well into the future.

The company is on track to start up six advantaged projects in 2025, as many as in the prior five years combined. These projects drive significant volume and mix improvements and include the China chemical complex; a hydrofiner in Fawley, U.K.; the Singapore resid upgrade project; a renewable diesel project in Strathcona, Canada; additional advanced plastics recycling units in Baytown, Texas; and an expansion of the ProxximaTM thermoset resin manufacturing facilities in East Texas.

ProxximaTM has unique properties that will drive substitution in existing markets and expand into new applications like structural composites and steel substitutes – areas where traditional resins struggle to compete. The company is investing in facilities to produce more ProxximaTM feedstock with plans to ramp up capacity to nearly 200,000 metric tons per year by 2030.

ExxonMobil also is growing its carbon materials venture to capture attractive opportunities in battery anode markets. ExxonMobil developed an advanced coke product that delivers a higher performance, differentiated graphite. The result is a battery with up to 30% higher capacity, 30% faster charging time, and extended battery life. The company is working with automobile manufacturers to test this new product, with plans to have its first commercial-scale plant online in 2028 to meet the growing demand for electric vehicle batteries and their components.

Low Carbon Solutions

ExxonMobil is pursuing up to $30 billion of low emission opportunities between 2025 and 2030, with almost 65% spent on reducing emissions for third-party customers. Execution of these opportunities is contingent on the right policy and regulation as well as continued technology and market development. ExxonMobil is pacing investments in new ventures to balance opportunities and risks as markets develop.

ExxonMobil’s Low Carbon Solutions business focuses on three primary verticals: carbon capture and storage, hydrogen, and lithium. These opportunities align with ExxonMobil’s core competencies.

The company is developing the world’s first large-scale carbon capture and storage system, which includes a high-capacity CO2 pipeline network connecting emitters from many industries to permanent subsurface storage capacity throughout the U.S. Gulf Coast.

ExxonMobil expects its low-carbon hydrogen facility in Baytown to be the world’s largest, producing up to 1 billion cubic feet of virtually carbon-free hydrogen per day with about 98% of the CO2 captured and stored. Some of this hydrogen will be used to produce over a million metric tons per year of low-carbon ammonia. The company is working toward a final investment decision in 2025 with the potential to start operations in 2029.

The company is building foundational projects that work with the right policy, today’s technology, and today’s infrastructure. At the same time, ExxonMobil is developing new technologies to reduce the cost of emission reductions, which is the only way to achieve deployment at scale. With supportive policy and growing market interest, the company expects its Low Carbon Solutions business to grow earnings contributions by $2 billion in 2030 versus 2024.

Supporting materials for this press release are available on the ExxonMobil Investor Relations site.

About ExxonMobil

ExxonMobil, one of the largest publicly traded international energy and petrochemical companies, creates solutions that improve quality of life and meet society’s evolving needs.

The corporation’s primary businesses – Upstream, Product Solutions and Low Carbon Solutions – provide products that enable modern life, including energy, chemicals, lubricants, and lower emissions technologies. ExxonMobil holds an industry-leading portfolio of resources, and is one of the largest integrated fuels, lubricants, and chemical companies in the world. ExxonMobil also owns and operates the largest CO2 pipeline network in the United States. In 2021, ExxonMobil announced Scope 1 and 2 greenhouse gas emission-reduction plans for 2030 for operated assets, compared to 2016 levels. The plans are to achieve a 20-30% reduction in corporate-wide greenhouse gas intensity; a 40-50% reduction in greenhouse gas intensity of upstream operations; a 70-80% reduction in corporate-wide methane intensity; and a 60-70% reduction in corporate-wide flaring intensity.

With advancements in technology and the support of clear and consistent government policies, ExxonMobil aims to achieve net-zero Scope 1 and 2 greenhouse gas emissions from its operated assets by 2050. To learn more, visit exxonmobil.com and ExxonMobil’s Advancing Climate Solutions.

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Cautionary Statement

FORWARD-LOOKING STATEMENTS. Statements of future events, conditions, expectations, plans, performance, earnings power, opportunities, potential addressable markets, ambitions, or results in this release are forward-looking statements. Similarly, discussions of future projects or markets for carbon capture, transportation, and storage, biofuels, hydrogen, ammonia, lithium, direct air capture, and other low carbon business plans to reduce emissions and emission intensity of ExxonMobil, its affiliates, or third parties are dependent on future market factors, such as continued technological progress, stable policy support, and timely rule-making and permitting, and represent forward-looking statements. Actual future results, including financial and operating performance; potential earnings, cash flow, surplus cash, dividends, share repurchases, or shareholder returns; total cash capital expenditures and mix, including allocations of capital to low carbon investments; realization and maintenance of structural cost reductions and efficiency gains, including the ability to offset inflationary pressures; plans to reduce future emissions and emissions intensity; ambitions to reach Scope 1 and Scope 2 net zero from operated assets by 2050, to reach Scope 1 and 2 net zero in heritage Upstream Permian Basin unconventional operated assets by 2030 and Pioneer Permian assets by 2035, to eliminate routine flaring in-line with World Bank Zero Routine Flaring, to reach near-zero methane emissions from operated assets and other methane initiatives, to meet ExxonMobil’s emission reduction plans and goals, divestment and start-up plans, and associated project plans as well as technology advances, including in the timing and outcome of projects to capture and store CO2, produce hydrogen and ammonia, produce biofuels, produce lithium, create new advanced carbon materials, and use plastic waste as feedstock for advanced recycling; maintenance and turnaround activity; drilling and improvement programs; price and margin recovery; planned Pioneer or Denbury integration benefits; resource recoveries and production rates; and product sales levels and mix could differ materially due to a number of factors. These include global or regional changes in oil, gas, petrochemicals, or feedstock prices, differentials, seasonal fluctuations, or other market or economic conditions affecting the oil, gas, and petrochemical industries and the demand for our products; new or changing government policies for lower carbon and new market investment opportunities, or policies limiting the attractiveness of investments such as European taxes on energy and unequal support for different methods of carbon capture; consumer preferences including willingness and ability to pay for reduced emissions products; variable impacts of trading activities; the outcome of competitive bidding and project awards; regulatory actions targeting public companies in the oil and gas industry; the development or changes in local, national, or international laws, regulations, and policies affecting our business including with respect to the environment, taxes, and trade sanctions; adoption of regulatory rules consistent with written laws; the ability to realize efficiencies within and across our business lines and to maintain current cost reductions as efficiencies without impairing our competitive positioning; decisions to invest in future reserves; reservoir performance, including variability and timing factors applicable to unconventional projects and the success of new unconventional technologies; the level, outcome, and timing of exploration and development projects and decisions to invest in future resources; timely completion of construction projects; war, civil unrest, attacks against the company or industry, and other political or security disturbances; expropriations, seizures, and capacity, insurance, or shipping limitations by foreign governments or international embargoes; changes in market strategy by national oil companies; opportunities for and regulatory approval of investments or divestments; the outcome of other energy companies’ research efforts and the ability to bring new technology to commercial scale on a cost-competitive basis; the development and competitiveness of alternative energy and emission reduction technologies; unforeseen technical or operating difficulties, including the need for unplanned maintenance; and other factors discussed here and in Item 1A. Risk Factors of our Form 10-K and under the heading “Factors Affecting Future Results” available under the “Earnings” tab through the “Investors” page of our website at www.exxonmobil.com. All forward-looking statements are based on management’s knowledge and reasonable expectations at the time of this release and we assume no duty to update these statements as of any future date. Neither future distribution of this material nor the continued availability of this material in archive form on our website should be deemed to constitute an update or re-affirmation of these figures as of any future date. Any future update of these figures will be provided only through a public disclosure indicating that fact.

Supplemental Information

See the Supplemental Information below through the end of this press release for additional important information required by Regulation G for non-GAAP measures, measures that the company considers useful to investors, and definitions of terms used in herein, including cash capex; cash opex excluding energy and production taxes; earnings and cash flow ex. identified items and working capital / other adjusted to 2024 $65/bbl real Brent and 10-year average Energy, Chemical, and Specialty Products margins; operating costs; shareholder distributions; and structural cost savings. Supplemental Information also includes information on the assumptions used in these materials, including assumptions on future crude oil prices and product margins used to develop outlooks regarding future potential outcomes of current management plans.

IMPORTANT INFORMATION AND ASSUMPTIONS REGARDING CERTAIN FORWARD-LOOKING STATEMENTS. For all price point comparisons, unless otherwise indicated, we assume $65/bbl Brent crude prices, $3/mmbtu Henry Hub gas prices, and $6.5/mmbtu TTF gas prices. Unless otherwise specified, crude prices are Brent prices. These are used for clear comparison purposes and are not necessarily representative of management’s internal price assumptions. Crude and natural gas prices for future years are adjusted for inflation (assumption of 2.5%) from 2024. Operating costs and capex are also inflated consistent with plans done on a country-by-country basis. Energy, Chemical, and Specialty Product margins reflect annual historical averages for the 10-year period from 2010-2019 unless otherwise stated. Lower emissions returns are calculated based on current and potential future government policies based on ExxonMobil projections as of the date of this presentation. These prices are not intended to reflect management’s forecasts for future prices or the prices we use for internal planning purposes. Unless otherwise indicated, asset sales and proceeds and Corporate and Financing expenses are aligned with our internal planning. Corporate and Financing expenses reflect estimated potential debt levels under various disclosed scenarios. All references to production rates, project capacity, resource size, and acreage are on a net basis, unless otherwise noted. All references to tons refer to metric tons, unless otherwise noted.

ExxonMobil has business relationships with thousands of customers, suppliers, governments, and others. For convenience and simplicity, words such as venture, joint venture, partnership, co-venturer, operated by others, and partner are used to indicate business and other relationships involving common activities and interests, and those words may not indicate precise legal relationships.

Competitor data and ExxonMobil data used for comparisons to competitor data are sourced from publicly available information and FactSet and are done so consistently for each company in the comparison. Future competitor data and future ExxonMobil data used for comparison to future competitor data, unless otherwise noted, are sourced from FactSet and have not been independently verified by ExxonMobil or any third party. We note that certain competitors report financial information under accounting standards other than U.S. GAAP (i.e., IFRS).

Our capital allocation plans do not extend beyond 2030. Statements about our businesses that reference periods beyond 2030 are made on a basis consistent with ExxonMobil’s Global Outlook, which is publicly available on our website.

Frequently Used Terms and Non-GAAP Measures

Advantaged assets (Advantaged growth projects). When used in reference to our Upstream business, includes Permian (heritage Permian and Pioneer), Guyana, and LNG.

Advantaged projects. Capital projects and programs of work that contribute to Energy, Chemical, and/or Specialty Products segments that drive integration of segments/businesses, increase yield of higher value products, or deliver higher than average returns.

Capital and exploration expenditures (Capital expenditures, Capex). Represents the combined total of additions at cost to property, plant and equipment, and exploration expenses on a before-tax basis from the Consolidated Statement of Income. ExxonMobil’s Capex includes its share of similar costs for equity companies. Capex excludes assets acquired in nonmonetary exchanges, the value of ExxonMobil shares used to acquire assets, and depreciation on the cost of exploration support equipment and facilities recorded to property, plant and equipment when acquired. While ExxonMobil’s management is responsible for all investments and elements of net income, particular focus is placed on managing the controllable aspects of this group of expenditures.

Cash capital expenditures (Cash Capex) (Non-GAAP). Sum of Additions to property, plant and equipment; Additional investments and advances; and Other investing activities including collection of advances; reduced by Inflows from noncontrolling interests for major projects, each from the Consolidated Statement of Cash Flows. Prior to fourth quarter 2024, Inflows from noncontrolling interests for major projects was included within Changes in noncontrolling interests on the Consolidated Statement of Cash Flows. This measure is useful for investors to understand the current period cash impact of investments in the business.

Cash operating expenses (cash opex) excluding energy and production taxes (non-GAAP). Subset of total operating costs that are stewarded internally to support management’s oversight of spending over time. This measure is useful for investors to understand our efforts to optimize cash through disciplined expense management for items within management’s control.

Compound annual growth rate (CAGR). Represents the consistent rate at which an investment or business result would have grown had the investment or business result compounded at the same rate each year.

Distributions to shareholders (shareholder distributions). The Corporation distributes cash to shareholders in the form of both dividends and share purchases. Shares are acquired to reduce shares outstanding and to offset shares or units settled in shares issued in conjunction with company benefit plans and programs. For the purposes of calculating distributions to shareholders, the Corporation includes only the cost of those shares acquired to reduce shares outstanding.

Divestments. Refers to asset sales; results include associated cash proceeds and production impacts, as applicable, and are consistent with our internal planning.

Earnings (loss) excluding Identified Items (Earnings ex. Ident. Items) (non-GAAP). Earnings (loss) excluding individually significant non-operational events with, typically, an absolute corporate total earnings impact of at least $250 million in a given quarter. The earnings (loss) impact of an Identified Item for an individual segment may be less than $250 million when the item impacts several periods or several segments. Earnings (loss) excluding Identified Items does include non-operational earnings events or impacts that are generally below the $250 million threshold utilized for Identified Items. When the effect of these events is significant in aggregate, it is indicated in analysis of period results as part of quarterly earnings press release and teleconference materials. Management uses these figures to improve comparability of the underlying business across multiple periods by isolating and removing significant non-operational events from business results. The Corporation believes this view provides investors increased transparency into business results and trends and provides investors with a view of the business as seen through the eyes of management. Earnings (loss) excluding Identified Items is not meant to be viewed in isolation or as a substitute for net income (loss) attributable to ExxonMobil as prepared in accordance with U.S. GAAP.

Heritage Permian. Permian basin assets excluding assets acquired as part of the acquisition of Pioneer Natural Resources that closed in May 2024.

High-value products. Includes performance products and lower-emissions fuels.

Industry-leading results (industry-leading returns, industry-leading financial performance, industry-leading shareholder value). Includes our leadership in metrics such as earnings, cash flow, dividends paid, share buybacks, and total shareholder return versus the IOCs. Similar terms, such as industry-leading performance or industry-leading shareholder value, refer to our leadership versus the IOCs in metrics such as production or individual terms such as return on capital employed and total shareholder return as applicable in the context presented.

IOCs. Unless stated otherwise, IOCs include each of BP, Chevron, Shell, and TotalEnergies.

Lower-emission fuels. Fuels with lower life cycle emissions than conventional transportation fuels for gasoline, diesel, and jet transport.

Operating costs (Opex) (non-GAAP). Operating costs are the costs during the period to produce, manufacture, and otherwise prepare the company’s products for sale – including energy, staffing, and maintenance costs. They exclude the cost of raw materials, taxes, and interest expense and are on a before-tax basis. While ExxonMobil’s management is responsible for all revenue and expense elements of net income, operating costs, as defined above, represent the expenses most directly under management’s control, and therefore are useful for investors and ExxonMobil management in evaluating management’s performance.

Performance products (performance chemicals, performance lubricants). Refers to products that provide differentiated performance for multiple applications through enhanced properties versus commodity alternatives and bring significant additional value to customers and end-users.

Project. The term “project” as used in this presentation can refer to a variety of different activities and does not necessarily have the same meaning as in any government payment transparency reports. Projects or plans may not reflect investment decisions made by the company. Individual opportunities may advance based on a number of factors, including availability of supportive policy, technology for cost-effective abatement, and alignment with our partners and other stakeholders. The company may refer to these opportunities as projects in external disclosures at various stages throughout their progression.

Reinvestment rate. Cash capex as a percentage of cash flow from operations excluding identified items and working capital / other.

Returns, rate of return, investment returns, project returns, IRR. Unless referring specifically to ROCE or external data, references to returns, rate of return, IRR, and similar terms mean future discounted cash flow returns on future capital investments based on current company estimates. Investment returns exclude prior exploration and acquisition costs.

Structural cost savings (structural cost reductions, structural cost efficiencies, structural efficiencies, structural cost improvements). Structural cost savings describe decreases in cash opex excluding energy and production taxes as a result of operational efficiencies, workforce reductions, divestment-related reductions, and other cost-savings measures, that are expected to be sustainable compared to 2019 levels. Relative to 2019, estimated cumulative structural cost savings totaled $11.3 billion as of September 30, 2024. The total change between periods in expenses will reflect both structural cost savings and other changes in spend, including market factors, such as inflation and foreign exchange impacts, as well as changes in activity levels and costs associated with new operations, mergers and acquisitions, new business venture development, and early-stage projects. Estimates of cumulative annual structural savings may be revised depending on whether cost reductions realized in prior periods are determined to be sustainable compared to 2019 levels. Structural cost savings are stewarded internally to support management’s oversight of spending over time. This measure is useful for investors to understand our efforts to optimize spending through disciplined expense management.

Structural earnings improvements (structural improvements, growing earnings power, improved earnings power). Structural earnings improvements consist of efforts to improve earnings on a like-for-like price and margin basis and incorporate improvement efforts by the corporation such as growing advantaged assets, improving mix, and reducing structural costs.

Synergies. Synergies refer to pre-tax increases in cash flow due to factors such as higher resource recovery, lower development costs, lower operating costs, among others.

Technology investments. Expenditures to fund and support the activities of the ExxonMobil Technology and Engineering Company, which includes research, development, engineering, and information technology. Other technology expenditures are not included in the definition for this disclosure.

Total shareholder return (TSR). For the purposes of this disclosure, total shareholder return is as defined by FactSet and measures the change in value of an investment in common stock over a specified period of time, assuming dividend reinvestment. For this purpose, FactSet assumes dividends are reinvested in stock at market prices on the ex-dividend date. Unless stated otherwise, total shareholder return is quoted on an annualized basis.

Supplemental Information

Reconciliation of 2019 Earnings and Cash Flow from Operations

 

2019 Earnings (Billion USD)

TOTAL

Earnings (U.S. GAAP)

14.3

Asset Management

(3.7)

Impairment

0.0

Tax / Other Items

(1.1)

Earnings ex. Identified Items

9.6

Adjustment to 2024 $65/bbl real Brent and 10-year average Energy, Chemical, and

Specialty Product margins

0.6

Earnings, ex. identified items and adjusted to 2024 $65/bbl real Brent and 10-year average Energy, Chemical, and Specialty Product margins

10.2

 

2019 Cash Flow from Operations (Billion USD)

 

Earnings, ex. identified items and adjusted to 2024 $65/bbl real Brent and 10-year average Energy, Chemical, and Specialty Product margins

10.2

Depreciation, ex. identified items

19.0

Cash flow from operating activities, ex. Identified items (excluding working capital / other), adjusted to 2024 $65/bbl real Brent and 10-year average Energy, Chemical, and Specialty Product margins

29.2


Calculation of Structural Cost Savings (Billion USD)

2019

2023

YTD’23

YTD’24

 

Components of operating costs

 

 

 

 

 

From ExxonMobil’s Consolidated statement of income

(U.S. GAAP)

 

 

 

 

 

Production and manufacturing expenses

36.8

36.9

27.0

28.8

 

Selling, general and administrative expenses

11.4

9.9

7.3

7.4

 

Depreciation and depletion (includes impairments)

19.0

20.6

12.9

16.9

 

Exploration expenses, including dry holes

1.3

0.8

0.6

0.6

 

Non-service pension and postretirement benefit expense

1.2

0.7

0.5

0.1

 

Subtotal

69.7

68.9

48.3

53.7

 

ExxonMobil’s share of equity company expenses (non-GAAP)

9.1

10.5

7.4

7.1

 

Total adjusted operating costs (non-GAAP)

78.8

79.4

55.7

60.8

 

 

 

 

 

 

 

Total adjusted operating costs (non-GAAP)

78.8

79.4

55.7

60.8

 

Less:

 

 

 

 

 

Depreciation and depletion (includes impairments)

19.0

20.6

12.9

16.9

 

Non-service pension and postretirement benefit expense

1.2

0.7

0.5

0.1

 

Other adjustments (including equity company depreciation and depletion)

3.6

3.7

2.3

2.5

 

Total cash operating expense (cash opex) (non-GAAP)

55.0

54.4

40.0

41.3

 

Energy and production taxes (non-GAAP)

11.0

14.9

11.0

10.3

 

Total cash operating expenses (cash opex) excluding energy and production taxes (non-GAAP)

44.0

39.5

29.0

31.0

 

 

 

 

 

 

 

 

 

vs. 2019

 

vs. 2023

Cumulative

Total cash operating expenses (cash opex) excluding energy and production taxes (non-GAAP)

 

-4.5

 

+2.0

 

Market

 

+3.6

 

+0.4

 

Activity/Other

 

+1.6

 

+3.2

 

Structural cost savings

 

-9.7

 

-1.6

-11.3

___________________

1 Increases are versus 2024. Earnings and cash flow from operations exclude identified items and are adjusted to 2024 $65/bbl real Brent (assumes annual inflation of 2.5%) and 10-year average Energy, Chemical, and Specialty Product margins, which refer to the average of annual margins from 2010-2019. Cash flow from operations also excludes working capital/other.

2 $3 billion in Pioneer synergies is a >50% increase vs. prior disclosures and is based on a 10-year average.

3 $3 billion by 2030 subject to additional investment by ExxonMobil, final 45V regulations for hydrogen production credits, and receipt of government permitting for carbon capture and storage projects.

4 Lower emissions cash capex includes cash capex attributable to carbon capture and storage, hydrogen, lithium, biofuels, ProxximaTM, Carbon Materials, and activities to lower ExxonMobil’s emissions and/or third party (3P) emissions. Planned spend is from 2025-2030.

5 See below for definition of reinvestment rate. Cash flow from operations excludes identified items and working capital/other is adjusted to 2024 $65/bbl real Brent (assumes annual inflation of 2.5%) and 10-year average Energy, Chemical, and Specialty Product margins, which refer to the average of annual margins from 2010-2019.

6 Earnings and cash flow from operations exclude identified items and are adjusted to 2024 $65/bbl real Brent (assumes annual inflation of 2.5%) and 10-year average Energy, Chemical, and Specialty Product margins, which refer to the average of annual margins from 2010-2019. Cash flow from operations also excludes working capital/other.

7 Third-party cash flow refers to cash flow excluding working capital/other and is calculated as earnings sourced from FactSet plus depreciation sourced from FactSet. 2019 to 2023 figures are actuals. 2024 figures are consensus estimates as of December 5, 2024. Three- and five-year CAGRs are from 2021 to 2024E and 2019 to 2024E respectively.

8 Calculated as of November 29, 2024.

9 Major investments represents investments over $500 million that are expected to start up between 2025 and 2030. Includes pre-2025 capex spend on these investments, except for the Permian work program, which is limited to capex between 2025-2030. Calculations for full-life major investments returns are based on ExxonMobil internal project plans for investments over $500 million that are expected to start up between 2025 and 2030 and the Permian work program. Calculations include internal project plan price assumptions.

10 Surplus cash is calculated assuming 2024 $65 real Brent (assumes annual inflation of 2.5%) and 10-year average Energy, Chemical, and Specialty Product margins, which refer to the average of annual margins from 2010-2019. Any decisions on future dividend levels are at the discretion of the Board of Directors. This calculation assumes dividends are held flat relative to 4Q24 levels. The PP&E / I&A factor includes changes in non-controlling interests. 3Q24 cash balance excludes a $5 billion minimum cash assumption.

11 Plans based on Scope 1 and Scope 2 emissions from operated assets. Intensity is calculated as emissions per metric ton of throughput/production. ExxonMobil reported emissions, reductions, and avoidance performance data are based on a combination of measured and estimated emissions data using reasonable efforts and collection methods. Calculations are based on industry standards and best practices, including guidance from the American Petroleum Institute (API) and Ipieca. There is uncertainty associated with the emissions, reductions, and avoidance performance data due to variation in the processes and operations, the availability of sufficient data, quality of those data, and methodology used for measurement and estimation. Performance data may include rounding. Changes to the performance data may be reported as part of the Company’s annual publications as new or updated data and/or emission methodologies become available. We are working to continuously improve our performance and methods to detect, measure and address greenhouse gas emissions. ExxonMobil works with industry, including API and Ipieca, to improve emission factors and methodologies, including measurements and estimates. ExxonMobil’s plans regarding expected GHG emissions reductions by 2030 can be found in our 2024 Advancing Climate Solutions report.

12 Based on Enverus 2024 Permian Basin Play Fundamentals article with updated data as of 10/2024 | Locations normalized to 10,000-foot laterals; Peers include Apache Corporation, BP, ConocoPhillips, Coterra Energy, Chevron, Devon Energy, Diamondback Energy, EOG Resources, Matador Resources, Ovintiv, Occidental, and Permian Resources. PV-10 Breakeven @ 20:1 WTI:HH ($/bbl).

 

ExxonMobil Media Relations

(737) 272-1452

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Energy Other Energy Oil/Gas

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CareDx Partners with TC BioPharm to Support ACHIEVE Clinical Trial Using AlloCell for Pharmacokinetic Monitoring of Allogeneic Cell Therapy

CareDx Partners with TC BioPharm to Support ACHIEVE Clinical Trial Using AlloCell for Pharmacokinetic Monitoring of Allogeneic Cell Therapy

CareDx Continues Strategic Expansion into Hematology Oncology with Pharmacokinetic and Monitoring Assays for Cell Therapy Patients

BRISBANE, Calif.–(BUSINESS WIRE)–
CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that CareDx will partner with TC BioPharm to perform pharmacokinetic analysis using its AlloCell™ solution in the ACHIEVE clinical trial.

AlloCell has been used in ten prior cell therapy clinical trials and with the addition of the ACHIEVE trial is being actively used in four clinical trials.

The ACHIEVE clinical trial is an adaptive, open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008, an allogeneic gamma-delta T-cell therapy for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).

“This partnership builds upon our growth strategy to expand into hematology oncology with pharmacokinetic and monitoring assays for patients undergoing cell therapy,” said Marica Grskovic, PhD, CareDx Chief Strategy Officer. “We are thrilled to continue to progress the science of allogeneic cell therapy for patients battling acute myeloid leukemia.”

“Our partnership with CareDx is a significant milestone,” said Alison Bracchi, Executive Vice President of Clinical Operations at TC BioPharm. “The collaboration is pivotal to the development and optimization of TCB008 as a therapy for acute myeloid leukemia and other blood cancers.”

CareDx’s AlloCell test, a sensitive solution for pharmacokinetic monitoring of allogeneic immune and stem cell therapies will be used to evaluate the expansion and persistence of TCB008 in patients enrolled in the ACHIEVE trial. It is expected that the expansion and persistence data will provide an understanding of the duration and effect of TCB008 gamma-delta T-Cells in reconstituting the immune system of acute myeloid leukemia patients enrolled in the ACHIEVE trial.

About CareDx – The Transplant Company

CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com.

Forward Looking Statements

This press release includes forward-looking statements related to CareDx, Inc. and its strategic partnership with TC BioPharm, including statements regarding the partnership’s ability to drive innovation, the ACHIEVE clinical trial, and the potential benefits and results that may be achieved with AlloCell. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond CareDx’s control, that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of the strategic partnership of the ACHIEVE clinical trial, or of AlloCell itself. These statements are also subject to general economic and market factors; and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, the Quarterly Report on Form10-Q for the quarter ended September 30, 2024 filed by CareDx with the SEC on November 4, 2024, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements,whether as a result of new information, future events or otherwise.

CareDx

Media Contacts

Anna Czene

818-731-2203

[email protected]

Investor Relations

Greg Chodaczek

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Oncology Health Surgery Clinical Trials Pharmaceutical Biotechnology

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