On October 22, 2024 Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, reported financial results for the third quarter ended September 30, 2024 (Press release, Quest Diagnostics, OCT 22, 2024, View Source [SID1234647310]).

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"We delivered a strong third quarter, with total revenue growth of 8.5%, including 4.2% organic growth," said Jim Davis, Chairman, CEO and President. "Our performance was driven by new customer wins and expanded business with physicians and hospitals as well as recent acquisitions, including LifeLabs. We are now on track to complete eight acquisitions by year’s end that meet our criteria for profitability, growth and returns."

"We have increased our 2024 revenue guidance due to contributions from recent acquisitions and have maintained the midpoint of our adjusted EPS guidance despite the impact of Hurricane Milton in the fourth quarter," Mr. Davis continued. "Given the strength of our business and revenue from acquisitions, we are well positioned to drive accelerated revenue and earnings growth in 2025."

Three Months Ended September 30,

Nine Months Ended September 30,

2024

2023

Change

2024

2023

Change

(dollars in millions, except per share data)

Reported:

Net revenues

$ 2,488

$ 2,295

8.5 %

$ 7,251

$ 6,964

4.1 %

Diagnostic Information Services revenues

$ 2,427

$ 2,228

9.0 %

$ 7,058

$ 6,755

4.5 %

Revenue per requisition

3.3 %

1.7 %

Requisition volume

5.5 %

2.7 %

Organic requisition volume

0.5 %

0.7 %

Operating income (a)

$ 330

$ 342

(3.3) %

$ 985

$ 995

(1.0) %

Operating income as a percentage of net revenues (a)

13.3 %

14.9 %

(1.6) %

13.6 %

14.3 %

(0.7) %

Net income attributable to Quest Diagnostics (a)

$ 226

$ 225

0.5 %

$ 649

$ 662

(1.9) %

Diluted EPS (a)

$ 1.99

$ 1.96

1.5 %

$ 5.74

$ 5.79

(0.9) %

Cash provided by operations

$ 356

$ 207

72.5 %

$ 870

$ 745

17.0 %

Capital expenditures

$ 106

$ 105

1.0 %

$ 302

$ 336

(10.4) %

Adjusted (a):

Operating income

$ 385

$ 380

1.3 %

$ 1,132

$ 1,119

1.1 %

Operating income as a percentage of net revenues

15.5 %

16.6 %

(1.1) %

15.6 %

16.1 %

(0.5) %

Net income attributable to Quest Diagnostics

$ 262

$ 254

3.1 %

$ 758

$ 749

1.2 %

Diluted EPS

$ 2.30

$ 2.22

3.6 %

$ 6.70

$ 6.56

2.1 %

(a)

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Updated Guidance for Full Year 2024

The company updates its full year 2024 guidance as shown in the table below. The updated guidance reflects the impact of recent acquisitions including LifeLabs as well as the impact from Hurricane Milton in the fourth quarter. The company projects the disruption from Hurricane Milton to negatively impact net revenues by approximately $15 million and EPS by approximately 8 cents in the fourth quarter.

Updated Guidance

Prior Guidance

Low

High

Low

High

Net revenues

$9.80 billion

$9.85 billion

$9.50 billion

$9.58 billion

Net revenues increase

5.9 %

6.5 %

2.7 %

3.5 %

Reported diluted EPS

$7.60

$7.70

$7.57

$7.77

Adjusted diluted EPS

$8.85

$8.95

$8.80

$9.00

Cash provided by operations

Approximately $1.3 billion

Approximately $1.3 billion

Capital expenditures

Approximately $420 million

Approximately $420 million

On October 22, 2024 Orna Therapeutics, a biotechnology company dedicated to designing and delivering a new class of circular RNA medicines and unprecedented lipid nanoparticle (LNP) delivery solutions for oncology and autoimmune diseases, reported a poster highlighting preclinical data from its SiTu Editing in the Marrow (STEM) in vivo CRISPR editing platform at the European Society of Gene & Cell Therapy Annual Congress taking place October 22-25 in Rome (Press release, Orna Therapeutics, OCT 22, 2024, View Source [SID1234647309]).

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The data show dramatically improved editing rates from single digits to roughly 80% in primary hematopoietic stem progenitor cells (HSPCs) from healthy donors. Orna’s STEM technology is geared to address beta-hemoglobinopathies including sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

While significant progress has been made with two recent U.S. Food and Drug Administration approvals for SCD and TDT using ex vivo approaches, patient journeys involve lengthy wait times for treatment at specialized centers and harsh therapeutic regimens that come with serious safety risks that can limit eligibility. By contrast, in vivo delivery of gene editing therapies offers a simple, off-the-shelf treatment that can be administered in an outpatient setting.

"Our results are highly promising and demonstrate the powerful potential of Orna’s type V editors when combined with HSPC-targeted RNA delivery to enable in vivo delivery without the need for a targeting ligand or antibody fragment," said Robert Mabry, Chief Scientific Officer for Orna. "Orna Therapeutics is pioneering an entirely new approach to genome engineering through the development of our gene editing and in vivo delivery platforms, which could offer more patients access to less toxic and complicated cell-based therapies."

Utilizing a high-throughput barcoding screening approach in non-human primates (NHPs), the company identified a series of LNPs that demonstrated tropism to a rare population of CD34+ HSPCs that reside in the bone marrow. The technology allows for repeat dosing, which is not currently feasible for viral-based delivery approaches.

The lead HSPC-tropic LNP candidate was found to have greater than 70% reporter-positive bulk CD34+ cells and greater than 95% reporter positive long-term HSCs in humanized mice. Furthermore, when tested individually in NHPs, the LNP candidate showed robust delivery to the bone marrow – revealing an average of 24% reporter positive HSPCs, while multiple doses achieved up to 30% editing.

On October 22, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT) (the "Company") reported updated data from its Phase 1/2 Study of ONCT-534 for the treatment of patients with relapsed or refractory metastatic Castration-Resistant Prostate Cancer (mCRPC) (Press release, Oncternal Therapeutics, OCT 22, 2024, View Source [SID1234647308]).

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Based on initial pharmacokinetic results, two additional dosing cohorts with twice daily (BID) oral dosing of ONCT-534 had been incorporated in the Phase 1/2 study ONCT-534-101 (NCT05917470). Overall, fifteen patients received ONCT-534 once daily (QD) in six dosing cohorts and six patients received ONCT-534 BID in two dosing cohorts. Based on a data cut off of September 30, 2024, the BID dosing schedule was well tolerated, with no related Grade 3 or higher toxicities. One patient, who experienced a rising PSA on ONCT-534 at 160 mg BID, had a subsequent 50% reduction in PSA after four weeks of ONCT-534 at 300 mg BID, and at the same time the CAT Scan showed a 16% reduction in target lesions compared to baseline. Enumeration and biomarker analysis of circulating tumor cells (CTCs) showed promising effects on expression of androgen receptor (AR)-regulated genes, and AR nuclear translocation in six additional patients. CTC analysis also showed that some patients who did not respond to ONCT-534 had prostate cancer that had developed neuroendocrine features, which are associated with AR independent disease.

"While we still believe the decision to discontinue the ONCT-534-101 clinical trial remains the correct one in the current biotechnology environment, the updated clinical results highlight the potential of ONCT-534 in prostate cancer. We believe there is value in exploring BID dosing further, as well as studying ONCT-534 in earlier lines of therapy for advanced prostate cancer," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We continue to explore strategic alternatives for our product candidates, including ONCT-534, ONCT-808, zilovertamab and ONCT-216 in an ongoing effort to maximize value to our shareholders."

On October 22, 2024 NanoCell Therapeutics, Inc. ("NanoCell"), a company developing in-vivo cell engineering solutions based on its proprietary non-viral, DNA-based gene therapy platform, reported that the team will present at several upcoming investor and scientific conferences (Press release, NanoCell Therapeutics, OCT 22, 2024, View Source [SID1234647306]).

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Initial data from the company’s ongoing preclinical studies on targeted lipid nanoparticle (tLNP) technology for in vivo CAR-T cell generation will be presented at the ESGCT by Dr. Jacek Lubelski, NanoCell’s Chief Technology Officer. The presentation will highlight preclinical results demonstrating the ability of the company’s novel tLNP technology to generate persistent CAR-T cells in vivo, showing tumor control and extended survival in a human PBMC engrafted mouse model of B-cell leukemia.

At the SITC (Free SITC Whitepaper) 39th Annual Meeting and the SITC (Free SITC Whitepaper) Immune Engineering Workshop in Houston, Texas, Dr. Lubelski will present new data from the company’s non-viral vector platform research program.

NanoCell will participate in two upcoming investor conferences. Dr. Maurits Geerlings, CEO, will join a panel discussion and host investor meetings at the Longwood Healthcare Leaders Boston CEO Forum (October 28-29, 2024), followed by one-on-one investor meetings at BioEurope in Stockholm (November 4-6, 2024).

Presentation Details:

European Society of Gene & Cell Therapy (ESGCT):
Oral Presentation: "tLNPs can effectively deliver DNA to T-cells and generate long-acting CAR-T cells in vivo"
Number: OR050
Session: Parallel Session 6c: Non Viral Vectors / Nanotechnology I
Location: Meeting Room 2
Timing: Wednesday, October 23rd, 2024,
Timing: 17:30-19:30

Presentation Details:

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting:
Poster Presentation
Title: "Efficient generation of long-lasting CAR-T cells in vivo using novel non-viral vector"
Abstract Number: 284
Timing: November 8-10, 2024
Location: Houston, TX

Additional Poster Abstract Presentation:

SITC Immune Engineering Workshop:
Titel: "Efficient generation of long-lasting CAR-T cells in vivo using novel non-viral vector"
Timing: November 7, 2024
Location: Houston, TX

Investor Conferences

Event Details:
Longwood Healthcare Leaders Boston CEO Forum
Investor 1:1 Meetings and Panel
Title: Innovation in Cell Therapy
Timing: October 28-29, 2024
Venue: Mandarin Oriental Boston, 776 Boylston Street, Boston, MA, USA

Event Details:
BioEurope
Investor 1:1 Meetings
Company Overview
Timing: November 4–6, 2024
Venue: Stockholmsmässan, Mässvägen 1, 125 30 Älvsjö, Stockholm, Sweden

On October 22, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, reported data from the clinical and preclinical development of its novel first-in-class lead radiopharma program based on MNPR-101 at the European Association of Nuclear Medicine (EANM) 2024 Annual Congress held in Hamburg, Germany (Press release, Monopar Therapeutics, OCT 22, 2024, View Source [SID1234647304]). MNPR-101-Lu radiation dosimetry analytics using human data from MNPR-101-Zr show a favorable organ safety profile at high Lu-177 therapeutic dose levels. The slides for Monopar’s oral presentation can be found at the following link: View Source

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Monopar’s presentation, accepted as a "Top-Rated Oral Presentation" within the Scientific Program, illustrates the potential of the urokinase plasminogen activator receptor (uPAR) as a promising radiopharma target in solid tumors. Preclinical and clinical data show favorable biodistribution, tumor uptake, and low off-target binding of Monopar’s uPAR-targeted radiopharmaceuticals MNPR-101-Zr and MNPR-101-Lu. "We were able to optimize our uPAR-targeted radiopharmaceuticals in preclinical studies, and the data show these efforts have translated directly into humans with encouraging tumor uptake. Even at the highest Lu-177 therapeutic antibody dose we are aware of in the clinic, we estimate a favorable radiation dosimetry safety profile for off-target effects such as bone marrow exposure," said Andrew Cittadine, Monopar’s Chief Operating Officer.

Further information about the MNPR-101-Lu Phase 1a trial is available at www.ClinicalTrials.gov under study identifier NCT06617169. Further information about the MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial is available at www.ClinicalTrials.gov under study identifier NCT06337084.