GlycoMimetics Reports Highlights and Financial Results for Third Quarter 2023

On November 3, 2023 GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, reported its financial results and highlights for the third quarter ended September 30, 2023. Cash and cash equivalents as of September 30, 2023 were $49.4 million (Press release, GlycoMimetics, NOV 3, 2023, View Source [SID1234636883]).

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"We look ahead to 2024 with anticipation and excitement. Topline results for our pivotal Phase 3 study of uproleselan in relapsed/refractory AML remain on track by the end of Q2 and together with our potential NDA filing before the end of 2024 represent a transformational opportunity for patients, clinicians, and our company," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "Our progress toward these important milestones, along with the upcoming presentation of independent data on uproleselan at ASH (Free ASH Whitepaper) and the expected initial results of our Phase 1a GMI-1687 study by end of Q1 2024, demonstrate our ability and ambition to deliver our development strategy and move closer to becoming a commercial stage company."

Operational Highlights

Uproleselan

In Q2, GlycoMimetics announced U.S. Food and Drug Administration (FDA) clearance of a protocol amendment to the company’s pivotal Phase 3 study of uproleselan for R/R AML. This amendment provides for a time-based analysis of the primary endpoint of overall survival after a defined cutoff date, if the 295 survival events of the originally planned event-driven analysis have not been observed by that date. With the addition of the time-based analysis, the company expects topline results by the end of Q2 2024.
The National Cancer Institute (NCI) Alliance for Clinical Trials in Oncology will conduct a planned interim analysis of event-free survival in 267 patients randomized to its Phase 2/3 clinical trial (NCI protocol A041701) evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. Enrollment of the Phase 2 portion of the study was completed in December of 2021. The company reiterates that when available, it will share these results.
The company agreed with the European Medicines Agency on a Pediatric Investigational Plan (PIP), which followed the prior agreement with the FDA in Q2 2023 on an initial Pediatric Study Plan (iPSP). The PIP and iPSP each include a deferral for study completion, and a waiver for children less than 28 days of age. As part of the pediatric plans, an NCI sponsored Phase 1/2 pediatric trial is currently being conducted by the Children’s Oncology Group Pediatric Early Phase Clinical Trials Network. The Phase 1/2 dose escalation study (NCI protocol PEPN2113) evaluates the safety and preliminary activity of uproleselan plus fludarabine and high dose cytarabine in pediatric AML patients after two or more prior therapies. The first patient in the Phase 1 portion of the study has been dosed with an expected enrollment of 18 patients.
Updated clinical data from an investigator-initiated trial studying the use of uproleselan in combination with chemotherapy for patients with treated secondary AML has been accepted for poster presentation at the ASH (Free ASH Whitepaper) Annual Meeting in December. Investigators at MD Anderson Cancer Center are conducting the Phase 1b/2 clinical trial to evaluate safety, tolerability, and preliminary efficacy of uproleselan added to cladribine and low dose cytarabine in patients with this difficult to treat subset of AML.
GMI-1687

In August, GlycoMimetics initiated a Phase 1a double-blind, single-center, randomized, placebo-controlled, sequential, single ascending dose trial in healthy adult volunteers. It is expected to enroll approximately 40 subjects. Eligible subjects will receive a single dose of GMI-1687 or placebo (6:2 ratio) via subcutaneous injection. Safety, tolerability, and pharmacokinetics of up to five dose levels (3.3, 10, 20, 40, and 80 mg) will be evaluated. GMI-1687 is a highly potent E-selectin antagonist that has potential application in inflammatory diseases with initial focus on sickle cell disease. Initial results are expected by the end of Q1 2024.
Third Quarter 2023 Financial Results:

Cash position: As of September 30, 2023, GlycoMimetics had cash and cash equivalents of $49.4 million as compared to $47.9 million as of December 31, 2022.
R&D Expenses: The company’s research and development expenses increased to $5.3 million for the quarter ended September 30, 2023, as compared to $4.9 million for the same period in 2022. The increased expenses were primarily due to the clinical development costs related to the Phase 1a trial of GMI-1687 in healthy adult volunteers, which was initiated in August 2023; the increase was partially offset by decreased personnel-related and stock-based compensation costs due to a lower number of personnel than in the prior year.
G&A Expenses: The company’s general and administrative expenses increased to $4.5 million for the quarter ended September 30, 2023, as compared to $3.8 million for the same period in 2022. The increased expenses were primarily due to higher personnel-related expenses and higher professional fees as the company advances uproleselan and prepares for potential regulatory filing and commercialization.
Shares Outstanding: Shares of common stock outstanding as of September 30, 2023 were 64,368,843.
The company will host a conference call and webcast today at 8:30 a.m. ET. To access the call by phone, please go to this registration link, and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class E-selectin antagonist. Uproleselan (yoo’ pro le’se lan), currently in a broad development program including a late-stage Phase 3 trial in acute myeloid leukemia (AML), has received Breakthrough Therapy and Fast Track designations from the FDA and Breakthrough Therapy designation from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin binding and stimulation of myeloid cells. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect. Uproleselan is intended to enable a novel approach to disrupting established mechanisms of leukemic cell resistance.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly potent E-selectin antagonist that has been shown in animal models to be fully bioavailable following subcutaneous administration. This second-generation compound is currently being studied in a Phase 1a double-blind, single-center, randomized, placebo-controlled, sequential, single ascending dose trial in healthy adult volunteers. GMI-1687 is believed to have potential application in inflammatory diseases, and the company’s initial development focus is treatment of sickle cell disease (SCD). E-selectin is believed to play a major role in vaso-occlusive crisis (VOC), the vascular clots and blockages that cause pain crises in people living with SCD. Administration of GMI-1687 via subcutaneous injection, if successfully developed in the clinic, may enable the drug to address current challenges of IV therapies for SCD as well as offer a potential point-of-care treatment option at the onset of VOC.

Coherus Presents Data from Next-generation Immuno-oncology Programs at 38th Annual Meeting of Society for Immunotherapy of Cancer (SITC)

On November 3, 2023 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), reported that data from three immuno-oncology pipeline programs at the 38th Annual Meeting of SITC (Free SITC Whitepaper) taking place November 1 – 5, 2023 at the San Diego Convention Center in San Diego, CA (Press release, Coherus Biosciences, NOV 3, 2023, View Source [SID1234636882]). Preclinical data presented support differentiated mechanisms of its next-generation immunotherapies potentially enabling the antitumor immune activation in more cancer patients and enhanced treatment outcomes.

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"These data presented at SITC (Free SITC Whitepaper) highlight the complementary mechanisms that we have in our innovative immunotherapy portfolio, including anti-PD-1, anti-IL27 and anti-CCR8, and the promise of novel immuno-oncology treatment combinations that may overcome the challenging tumor microenvironment," said Theresa LaVallee, Ph.D., Coherus’ chief development officer. "LOQTORZI is the first approved treatment option for patients with nasopharyngeal carcinoma (NPC), and we will continue to generate and use data to optimize our clinical development plans through the selection of additional tumor types and immuno-oncology combinations that can have the greatest impact on extending survival for cancer patients."

Casdozokitug (CHS-388, formerly SRF388), a first-in-class anti-IL-27 antibody
Interleukin (IL)-27 is an immunoregulatory cytokine involved in resolving inflammation and inhibiting anti-tumor immune responses. Blocking IL-27 with casdozokitug in clinical trials has led to monotherapy tumor growth inhibition and partial responses in patients with non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) (NCT04374877) and ongoing trials are studying combinations with PD-1/PD-L1 pathway blockade in NSCLC and hepatocellular carcinoma (HCC). Data presented at SITC (Free SITC Whitepaper) 2023 demonstrate IL-27-mediated gene expression, highlighting its critical role in immune suppressive mechanisms in the tumor microenvironment and importance as a new target for cancer treatment, as well as an opportunity to identify biomarkers that could determine patients most likely to respond to anti-IL-27 treatment.

Abstract #1351: Identifying IL-27 dependent biomarkers in lymphocytes, NK cells, and myeloid cells in peripheral blood and the tumor microenvironment
Date and Time: Friday, November 3, 9 a.m.–7 p.m. Pacific Daylight Time (PDT)
Location: Exhibit Halls A and B1 – San Diego Convention Center

Poster presentation data are summarized as follows:

In human immune cells from peripheral blood, IL-27 induces the expression of interferon (IFN)-stimulated genes, which are associated with drug resistance in cancer
Although many known IFN-responsive genes were induced by both IFNs and IL-27 treatment, distinct gene expression was observed in different immune cell types
IL-27 and IFNs induce unique gene expression in different cell types, for example, GBP5 (guanylate-binding protein 5) and IRF1 (interferon regulatory factor 1), two interferon stimulated genes, are preferentially elevated by IL-27 in NK cells and CD8+ T cells
Immunohistochemistry (IHC) analysis of treatment-naïve NSCLC tumor samples showed that IL-27+ macrophages are co-localized with GBP5+ T-cell-rich areas in the TME
These studies lend insights into the immune interplay between IFNs and IL-27 signaling across different immune cells and within the TME and ascertain the immunosuppressive role of IL-27 and may inform casdozo clinical development.
CHS-114 (formerly SRF114), an anti-CCR8 antibody
CCR8 is a chemokine receptor predominantly expressed by tumor infiltrating Tregs that suppress the body’s natural anti-cancer immune response. Targeting CCR8 is a promising potential therapeutic strategy designed to deplete Tregs, reshape the tumor microenvironment and enhance anti-tumor immune response. CHS-114 is designed to selectively target human CCR8 and preferentially depletes CCR8+ Treg cells and not T effector (Teff) cells in tumors or normal tissue. Data presented demonstrate the role of CCR8+ Tregs as dominant immunosuppressive cells in the TME and highlight head and neck squamous cell carcinoma (HNSCC) as a promising tumor type in which CHS-114 could have anti-tumor activity as monotherapy or in combination with an anti-PD1 antibody. CHS-114 is currently being evaluated in a Phase 1 clinical trial (NCT05635643).

Abstract #1354: Anti-CCR8 antibody SRF114 depletes tumor-infiltrating regulatory T cells in dissociated tumors from patients with head and neck squamous cell carcinoma
Date and Time: Saturday, November 4, 9 a.m.–8:30 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Poster presentation data are summarized as follows:

Chemokine receptor 8 (CCR8) expression is highly enriched on intratumoral Tregs within the TME cells, particularly in HNSCC
In multiple model systems, CHS-114, a cytolytic antibody selective for CCR8, activates natural killer (NK) cells and specifically induces NK-mediated cytotoxicity against tumor-infiltrating CCR8+ Tregs and results in the expansion of effector CD8 T cells
Enhanced antitumor immunity is observed with combination of Anti-CCR8 and anti-PD-1 combination treatment
CHS-114, a CCR8-specific cytotoxicity-inducing antibody that preferentially depletes CCR8+ Treg cells and not T effector (Teff) cells, is currently being evaluated in a Phase 1 clinical trial (NCT05635643).
LOQTORZI (toripalimab-tpzi), a next generation anti-PD-1 antibody
PD-L1 is a protein found on the surface of some cancer cells that can help evade the body’s immune system by suppressing T cell activation and inhibiting the T cell’s ability to kill cancer cells. LOQTORZI is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD⁠-⁠1 receptor at a unique site with high affinity to activate antitumor immunity. Data presented compare mechanistic data for LOQTORZI to commercially available anti-PD-1 monoclonal antibodies and demonstrate higher expression of key immune system biomarkers with LOQTORZI. Additionally, LOQTORZI in combination with chemotherapy shows enhanced clinical efficacy irrespective of PD-L1 status across multiple tumor types in post hoc analyses of 3 randomized controlled clinical trials in NPC, NSCLC and esophageal squamous-cell carcinoma (ESCC). LOQTORZI (toripalimab-tpzi) was recently approved by the U.S. Food and Drug Administration (FDA) for metastatic or recurrent NPC as first-line treatment in combination with chemotherapy or as second- or greater-line monotherapy treatment.

Abstract #468: Characteristics of toripalimab: a next generation anti-PD-1 antibody with potent T cell activation and enhanced clinical efficacy irrespective of PD-L-1 status
Date and Time: Saturday, November 4, 9 a.m.–8:30 p.m. PDT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Poster presentation data are summarized as follows:

Toripalimab in combination with chemotherapy demonstrates clinical efficacy irrespective of PD-L1 status
Toripalimab exhibits a 12-fold higher binding affinity to PD-1 compared to pembrolizumab
Toripalimab promotes a stronger Th1-mediated response than pembrolizumab in vitro in human peripheral blood mononuclear cells (PBMCs)
Toripalimab induced an elevated IFN- gene signature in NSCLC dissociated tumor cells with different kinetics and higher intensity compared to pembrolizumab
In comparison to other commercially available anti-PD-1 antibodies, toripalimab exhibits the lowest potential for partial agonism by recruiting low levels of SHP1 and SHP2, negative regulators of T cell activation
About LOQTORZI (toripalimab-tpzi)
LOQTORZI is a next generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD⁠-⁠1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types.
For more information, please see LOQTORZI.com for FDA-approved indications and full prescribing information.

About Casdozokitug
Casdozokitug (formerly SRF388) is a first-in-class human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Particular tumor types have been identified where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. Furthermore, a potential biomarker associated with IL-27 has been identified that may be useful in helping identify patients most likely to respond to casdozokitug. It is the first IL-27 antibody to enter the clinic.

About CHS-114
CHS-114 (formerly SRF114) is a human, cytolytic anti-CCR8 antibody designed to preferentially deplete CCR8+ Treg cells within the tumor microenvironment and not T effector (Teff) calls in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) pathways to deplete intertumoral Treg cells. In addition, CHS-114 reduced tumor growth in murine models. CHS-114 is currently being evaluated in a Phase 1 clinical trial (NCT05635643) as a therapeutic candidate that holds the potential to drive anti-tumor immunity in patients.

Cimeio Therapeutics Announces Poster Presentations at ASH 2023

On November 3, 2023 Cimeio Therapeutics, a biotechnology company that is the leader of the field of epitope editing, reported the acceptance of two abstracts to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2023 in San Diego (Press release, Cimeio Therapeutics, NOV 3, 2023, View Source [SID1234636881]).

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The first abstract is titled "Hematopoietic Stem Cells Expressing Engineered CD45 Enable a Near Universal Targeted Therapy for Hematologic Diseases." These data demonstrate that CD45 antibody-drug conjugate (ADC) therapy effectively treated aggressive AML tumors in mouse models. The CD45 ADC therapy was enabled by epitope-edited blood stem cells (HSPCs), which maintain their function but resist depletion by the ADC. This combination therapy could have therapeutic potential in AML and other hematologic malignancies.

The second abstract is titled "Base Edited HSPCs Are Shielded from Targeted CD33 Therapy but Preserve CD33 Expression." This abstract outlines the development of an edited epitope for CD33, which also resists depletion by paired CD33-directed immunotherapies while maintaining its expression. CD33 represents the fourth target Cimeio has demonstrated it can effectively shield from immunotherapy depletion.

"These data represent important steps in our quest to develop a novel therapy with the potential to cure patients with AML," said Cimeio CEO Thomas Fuchs. "This work gives us high confidence that our immunotherapies have the potential to transform the treatment of AML and other hematologic malignancies."

Presentation Details
Title: Hematopoietic Stem Cells Expressing Engineered CD45 Enable a Near Universal Targeted Therapy for Hematologic Diseases
Session Name: 701. Experimental Transplantation: Basic and Translational: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00 PM-8:00 PM
Location: San Diego Convention Center Halls G-H

Title: Base Edited HSPCs Are Shielded from Targeted CD33 Therapy but Preserve CD33 Expression
Session Name: 701. Experimental Transplantation: Basic and Translational: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00 PM-8:00 PM
Location: San Diego Convention Center Halls G-H

Cerus Corporation to Participate in Upcoming Investor Conferences

On November 3, 2023 Cerus Corporation (NASDAQ:CERS) reported that the Company will participate in two upcoming investor conferences (Press release, Cerus, NOV 3, 2023, View Source [SID1234636880]):

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William "Obi" Greenman, Cerus’ president and chief executive officer, is scheduled to participate in a fireside chat at The Stifel 2023 Healthcare Conference on Tuesday, November 14th, at 4:10 p.m. EST, at the Lotte New York Palace Hotel. A live webcast of the fireside chat will be available here. A replay will be available after the event.
Kevin Green, Cerus’ vice president and chief financial officer, is scheduled to participate in a fireside chat at The Stephens Annual Investment Conference on Wednesday, November 15th, at 1:00 p.m. EST, at the Grand Hyatt in Nashville, TN. A live webcast of the fireside chat will be available here. A replay will be available after the event.

Cardinal Health Reports First Quarter Fiscal 2024 Results and Raises Fiscal 2024 Outlook

On November 3, 2023 Cardinal Health (NYSE: CAH) reported first quarter fiscal 2024 revenue of $54.8 billion, an increase of 10% from the first quarter of last year (Press release, Cardinal Health, NOV 3, 2023, View Source [SID1234636879]). First quarter GAAP operating loss was $14 million due to a non-cash, pre-tax goodwill impairment of $581 million related to the Medical segment, due to an increase in the discount rate.² GAAP diluted earnings per share (EPS) were $0.02, primarily due to this impairment, net of tax effects. Non-GAAP operating earnings increased 35% to $571 million in the quarter, driven by significant increases in both Pharmaceutical segment profit and Medical segment profit. Non-GAAP diluted EPS increased 44% to $1.73, reflecting the increase in non-GAAP operating earnings, a lower share count and lower interest and other expense, partially offset by a higher non-GAAP effective tax rate.

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"With strong first quarter results and an improved outlook for the year, we are continuing our operating momentum into fiscal 2024," said Jason Hollar, CEO of Cardinal Health. "In Q1, we delivered significant profit growth in both the Pharmaceutical and Medical segments, which along with our favorable capital structure and opportunistic capital deployment, gives us confidence to raise fiscal 2024 non-GAAP EPS guidance. Across the enterprise, we continue to prioritize focused execution to best serve our customers and create value for our shareholders."

Q1 FY24 summary

Q1 FY24

Q1 FY23

Y/Y

Revenue

$54.8 billion

$49.6 billion

10 %

Operating earnings/(loss)

$(14) million

$137 million

N.M.

Non-GAAP operating earnings

$571 million

$423 million

35 %

Net earnings attributable to Cardinal Health, Inc.

$5 million

$110 million

N.M.

Non-GAAP net earnings attributable to Cardinal Health, Inc.

$433 million

$328 million

32 %

Effective Tax Rate3

122.5 %

(0.7) %

Non-GAAP Effective Tax Rate

22.5 %

16.9 %

Diluted EPS attributable to Cardinal Health, Inc.

$0.02

$0.40

N.M.

Non-GAAP diluted EPS attributable to Cardinal Health, Inc.

$1.73

$1.20

44 %

Segment results

Pharmaceutical segment

Q1 FY24

Q1 FY23

Y/Y

Revenue

$51.0 billion

$45.8 billion

11 %

Segment profit

$507 million

$431 million

18 %

First quarter revenue for the Pharmaceutical segment increased 11% to $51.0 billion, driven by brand and specialty pharmaceutical sales growth from existing customers.

Pharmaceutical segment profit increased 18% to $507 million in the first quarter, driven by a higher contribution from brand and specialty products, including distribution of COVID-19 vaccines, and positive generics program performance.

Medical segment

Q1 FY24

Q1 FY23

Y/Y

Revenue

$3.8 billion

$3.8 billion

— %

Segment profit

$71 million

$(8) million

N.M.

First quarter revenue for the Medical segment was flat at $3.8 billion. This reflects lower PPE volumes and pricing, offset by growth in at-Home Solutions and inflationary impacts, including mitigation initiatives. PPE volumes and pricing includes the impact from the prior year exit of our non-healthcare gloves portfolio in connection with our simplification strategy.

Medical segment profit increased to $71 million in the first quarter, driven by an improvement in net inflationary impacts, including mitigation initiatives.

Fiscal year 2024 outlook1

The company raised its fiscal 2024 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to $6.75 to $7.00, from $6.50 to $6.75.

This guidance includes an update to the company’s Pharmaceutical segment profit outlook for fiscal 2024 to 7% to 9% growth, from 4% to 6% growth. Additionally, the company updated expectations for interest and other to $100 million to $120 million, from $110 million to $130 million, and for diluted weighted average shares outstanding of approximately 249 million, from 250 million to 253 million.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Recent highlights

Cardinal Health initiated a $500M accelerated share repurchase program in the first quarter, which was completed in October.
Cardinal Health began distributing the recently commercialized COVID-19 vaccines to customers following FDA approval in September.
Cardinal Health launched its Kangaroo OMNI Enteral Feeding Pump in the U.S., designed to help provide enteral feeding patients with more options to meet their personalized needs throughout their enteral feeding journey.
Cardinal Health was named to the 100 Best Corporate Citizens ranking by 3BL Media based on an assessment of environmental, social and governance (ESG) transparency and performance of the 1,000 largest public companies in the U.S.
Cardinal Health was named to Seramount’s 2023 lists of 100 Best Companies, Top Companies for Executive Women, and Best Companies for Multicultural Women.
Upcoming webcasted investor events

Evercore ISI Healthcare Conference at 10:00 a.m. EST, November 29, 2023
J.P. Morgan Healthcare Conference, January 8-11, 2024
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. EST to discuss first quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available on the Investor Relations page for 12 months.