On October 15, 2024 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2024. "Johnson & Johnson’s strong results in the third quarter reflect the unique breadth of our business and commitment to delivering the next wave of healthcare innovation," said Joaquin Duato, Chairman and Chief Executive Officer (Press release, Johnson & Johnson, OCT 15, 2024, View Source [SID1234647203]). "During the quarter, we advanced our pipeline with regulatory approvals for TREMFYA and RYBREVANT, submitted an IDE for our general surgery robotic system, OTTAVA, and launched VELYS Spine and Shockwave E8 IVL Catheter, further strengthening our confidence in our near-and long-term growth targets."
Unless otherwise noted, the financial results and earnings guidance included below reflect the continuing operations of Johnson & Johnson.

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Overall financial results
Q3
($ in Millions, except EPS) 2024 2023 % Change
Reported Sales
$22,471
$21,351
5.2%
Net Earnings
$2,694

$4,309
(37.5)%
EPS (diluted)
$1.11

$1.69
(34.3)%
Q3
Non-GAAP* ($ in Millions, except EPS) 2024 2023 % Change
Operational Sales1,2
6.3%
Adjusted Operational Sales1,3
5.4%
Adjusted Operational Sales ex. COVID-19 Vaccine1,3

5.6%
Adjusted Net Earnings1,4
$5,876
$6,777
(13.3)%
Adjusted EPS (diluted)1,4
$2.42
$2.66
(9.0)%
Free Cash Flow (YTD)6,7
~$14,000
$11,974

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
4Excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
6Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings.
7Q3 YTD 2024 is estimated as of October 15, 2024. Q3 YTD 2023 includes approximately 8 months contribution from the Consumer Health segment.
Note: values may have been rounded

Regional sales results
Q3 % Change
($ in Millions) 2024 2023 Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$12,909
$11,996
7.6%
7.6
–
6.5
International
9,562
9,355
2.2
4.6
(2.4)
4.0
Worldwide
$22,471
$21,351
5.2%
6.3
(1.1)
5.4

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Segment sales results
Q3 % Change
($ in Millions) 2024 2023 Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$14,580
$13,893
4.9%
6.3
(1.4)
6.4
MedTech
7,891
7,458
5.8
6.4
(0.6)
3.7
Worldwide
$22,471
$21,351
5.2%
6.3
(1.1)
5.4

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Third Quarter 2024 segment commentary:
Operational sales* reflected below excludes the impact of translational currency.
Innovative Medicine
Innovative Medicine worldwide operational sales grew 6.3%. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), Other Oncology, and CARVYKTI (ciltacabtagene autoleucel) in Oncology, TREMFYA (guselkumab) in Immunology, SPRAVATO (esketamine) in Neuroscience, and OPSUMIT (macitentan) in Pulmonary Hypertension. Growth was partially offset by STELARA (ustekinumab) and SIMPONI/SIMPONI ARIA (golimumab) in Immunology.

MedTech
MedTech worldwide operational sales grew 6.4%*, with net acquisitions and divestitures positively impacting growth by 2.7%. Operational sales growth was driven primarily by electrophysiology products and Abiomed in Cardiovascular, previously referred to as Interventional Solutions, contact lenses in Vision and wound closure products in General Surgery. Growth was partially offset by endocutter products in Advanced Surgery.

Full-year 2024 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
Johnson & Johnson is updating its 2024 guidance, including adjusted operational EPS guidance, to reflect improved performance and the impact from the recent acquisition of V-Wave.

Non-GAAP* 2024
July 2024 Adjusted Operational EPS1,2
$10.05
Improved performance outlook $0.10
October 2024 Adjusted Operational EPS1,2 pre-M&A
$10.15
M&A impact (V-Wave) ($0.24)
October 2024 Adjusted Operational EPS1,2
$9.91

1Non-GAAP financial measure; excludes the impact of translational currency
2Non-GAAP financial measure; excludes intangible amortization expense and special items
Note: Adjusted operational EPS figures reflect midpoint of issued guidance

($ in Billions, except EPS) October 2024 July 2024
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
5.7% – 6.2% / 6.0% 5.5% – 6.0% / 5.8%
Operational Sales2,5/ Mid-point
Change vs. Prior Year / Mid-point
$89.4B – $89.8B / $89.6B
6.3% – 6.8% / 6.6%
$89.2B – $89.6B / $89.4B
6.1% – 6.6% / 6.4%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$88.4B – $88.8B / $88.6B
5.1% – 5.6% / 5.4%
$88.0B – $88.4B / $88.2B
4.7% – 5.2% / 5.0%
Adjusted Operational EPS (Diluted)2,4/ Mid-point
Change vs. Prior Year / Mid-point
$9.86 – $9.96 / $9.91
(0.6)% – 0.4% / (0.1)%
$10.00 – $10.10 / $10.05
0.8% – 1.8% / 1.3%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$9.88 – $9.98 / $9.93
(0.4)% – 0.6% / 0.1%
$9.97 – $10.07 / $10.02
0.5% – 1.5% / 1.0%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2Non-GAAP financial measure; excludes the impact of translational currency
3Calculated using Euro Average Rate: October 2024 = $1.09 and July 2024 = $1.08 (Illustrative purposes only)
4Non-GAAP financial measure; excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
Note: percentages may have been rounded
Other modeling considerations will be provided on the webcast.

Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com.
Regulatory
Johnson & Johnson submits application to the European Medicines Agency for DARZALEX (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients1
Press Release
Johnson & Johnson files for U.S. FDA approval of DARZALEX FASPRO-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned
Press Release
DARZALEX (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Press Release
RYBREVANT (amivantamab-vmjw) plus standard of care approved in the U.S. as first and only targeted regimen to cut risk of disease progression by more than half in second-line EGFR-mutated advanced lung cancer
Press Release
Johnson & Johnson seeks first EU approval of nipocalimab to treat a broad population of patients living with antibody-positive generalised myasthenia gravis
Press Release
TREMFYA (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease
Press Release

Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalized myasthenia gravis
Press Release
European Commission approves RYBREVANT (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer after failure of prior therapy
Press Release
European Commission approves BALVERSA (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer
Press Release
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible
Press Release
Johnson & Johnson seeks U.S. FDA approval of SPRAVATO (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
Press Release
Data Releases
TREMFYA (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn’s disease and ulcerative colitis1
Press Release
CARVYKTI is the first and only cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line
Press Release
DARZALEX (daratumumab)-based maintenance regimens show clinically meaningful deep and durable responses in transplant-eligible patients with newly diagnosed multiple myeloma
Press Release
Novel combination of TALVEY (talquetamab-tgvs) and TECVAYLI (teclistamab-cqyv) suggests high response rates and durable responses in triple-class refractory patients with relapsed or refractory multiple myeloma, including those with extramedullary disease
Press Release
TALVEY (talquetamab-tgvs) and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) based combination shows deep and durable responses in patients with relapsed or refractory multiple myeloma
Press Release
Johnson & Johnson is transforming solid tumor cancer outcomes with new data at the 2024 World Conference on Lung Cancer and European Society for Medical Oncology Congress
Press Release
Groundbreaking nipocalimab study of pregnant individuals at high risk for early onset severe hemolytic disease of the fetus and newborn published in The New England Journal of Medicine
Press Release
Product Launch
Johnson & Johnson MedTech Launches VOLT Plating System1
Press Release
Johnson & Johnson Rolls Out New TECNIS Odyssey Next-Generation Intraocular Lens Offering Cataract Patients Precise Vision at Every Distance in Any Lighting
Press Release
Shockwave Medical Expands U.S. Peripheral IVL Portfolio with Enhanced Catheter
Press Release
DePuy Synthes Launches its First Active Spine Robotics and Navigation Platform

Other
Johnson & Johnson Completes Acquisition of V-Wave1
Press Release
Johnson & Johnson Announces that its Subsidiary, Red River Talc LLC, has Filed a Voluntary Prepackaged Chapter 11 Case to Resolve All Current and Future Ovarian Cancer Talc Claims
Press Release
Johnson & Johnson’s Executive Vice President, Chief Human Resources Officer Peter Fasolo to Retire; Kristen Mulholland Named Chief Human Resources Officer, Effective October 1, 2024
Press Release

1Subsequent to the quarter

Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company’s website at events-and-presentations.

On October 15, 2024 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IMM-1-104 in the treatment of pancreatic cancer (Press release, Immuneering, OCT 15, 2024, View Source [SID1234647202]). IMM-1-104 is currently being evaluated in a Phase 2a clinical trial in patients with advanced solid tumors, including pancreatic cancer, in which positive initial response data was recently reported for first line pancreatic cancer patients treated in combination with modified gemcitabine/nab-paclitaxel.

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"The FDA’s granting of orphan drug designation for IMM-1-104 underscores the urgent need for new therapies that meaningfully improve outcomes for pancreatic cancer patients and represents an important milestone in the development of our lead asset," said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. "I believe our recently announced positive initial Phase 2a data, from our arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in pancreatic cancer, speaks to IMM-1-104’s potential to improve upon the current standard of care in this indication. Importantly, in the same trial we are also studying IMM-1-104 in combination with modified FOLFIRINOX, as well as in monotherapy for pancreatic cancer. We look forward to providing initial data from at least one additional arm of the Phase 2a portion of our Phase 1/2a trial before the end of the year."

FDA orphan drug designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation may qualify sponsors for incentives, including tax credits for qualified clinical trials, exemptions from certain FDA fees and additional time for post-approval marketing exclusivity. Earlier this year, Immuneering was granted FDA Fast Track designation for IMM-1-104 for the treatment of both first and second-line pancreatic cancer.

About IMM-1-104

IMM-1-104 aims to achieve universal-RAS activity that selectively impacts cancer cells to a greater extent than healthy cells, through Deep Cyclic Inhibition of the MAPK pathway with once-daily dosing. IMM-1-104 is currently being evaluated in a Phase 1/2a study in patients with advanced solid tumors harboring RAS mutations (NCT05585320).

On October 15, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it has completed the 0.09 mg/kg dose group of the Phase 1 dose escalation portion of the Acclaim-3 clinical trial of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with Tecentriq (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) (Press release, Genprex, OCT 15, 2024, View Source [SID1234647201]). In addition, the Safety Review Committee (SRC) has approved escalation to the highest dose group of 0.12 mg/kg. The combination of REQORSA and atezolizumab previously received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for the treatment of the Acclaim-3 patient population and the FDA has also granted Orphan Drug Designation to REQORSA for the treatment of SCLC.

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"We believe the SRC’s recommendation to advance to the highest dose group of the Phase 1 portion of the trial is another clinical validation for our REQORSA development program," said Ryan Confer, President and Chief Executive Officer. "We are proud of the achievements so far in the Phase 1 portion of the trial, which has demonstrated a favorable safety profile for REQORSA in the first trial to use REQORSA for SCLC patients. We look forward to continuing to treat these patients while we work toward bringing new therapies to lung cancer patients with unmet medical need."

There were no dose limiting toxicities (DLTs) in this dose group and the SRC recommended moving up to the highest dose group planned in the trial. As previously announced, the first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 trial had a partial remission, which is defined as at least a thirty percent (30%) decrease in tumor size, from prior to the start of maintenance therapy to the time of the CT scan performed after two cycles of maintenance therapy. A CT scan performed after four cycles of maintenance therapy (three months), confirmed that the patient had a 30% decrease in tumor size in measurable lesions; however, one lesion not previously measurable had grown in size, thus leading to a conclusion of disease progression at that time. As the maintenance therapy consists of REQORSA and Tecentriq, and the patient had already received four cycles of Tecentriq during induction therapy and thus responses to Tecentriq would likely have occurred earlier, the Company believes this suggests that REQORSA may be providing clinical benefit.

The SRC is comprised of three physicians who are principal investigators in the trial. The SRC may recommend that the trial continue at the same dose or at a lower dose, that it escalate to a higher dose, or that the study be terminated altogether due to safety concerns.

In the Phase 1 dose escalation portion of the Acclaim-3 clinical trial, patients are treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 1 escalation portion is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D).

The Phase 1 portion of the trial has two dose groups: 0.09 mg/kg, which has been completed, and 0.12 mg/kg which will now be enrolled. After the Phase 1 portion is complete, the Phase 2 expansion portion will enroll 50 patients at 10 to 15 U.S sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company continues to anticipate completion of enrollment in the Phase 1 dose escalation portion of the trial and to start the Phase 2 expansion portion in the second half of 2024, dependent on the number of patients needed to be enrolled in the 0.12 mg/kg dose group.

Data presented at the October 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) from studies in humanized mouse models of SCLC show that the combination of REQORSA and atezolizumab provides significantly better control of xenograft tumor growth than either agent alone. The data from these studies also demonstrated increased immune cell infiltration in the tumors with the combination of REQORSA and Tecentriq compared to Tecentriq alone.

About Acclaim-3

The Acclaim-3 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, Reqorsa Gene Therapy, in combination with Genentech, Inc.’s Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.

On October 15, 2024 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 3,016 million in the third quarter of 2024 (Press release, Genmab, OCT 15, 2024, View Source [SID1234647200]). Net trade sales were USD 1,684 million in the U.S. and USD 1,332 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

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On October 15, 2024 Circle Pharma, Inc., a clinical-stage biopharmaceutical company dedicated to discovering and developing a new generation of macrocycle therapies, reported that the first patient cohort has been dosed in the phase 1 trial of CID-078, the company’s first-in-class oral cyclin A/B RxL inhibitor (Press release, Circle Pharma, OCT 15, 2024, View Source;utm_medium=rss&utm_campaign=circle-pharma-announces-first-patients-dosed-in-phase-1-clinical-trial-of-first-in-class-oral-cyclin-a-b-rxl-inhibitor-brcid-078-for-advanced-solid-tumors [SID1234647199]). The trial will evaluate CID-078 in patients with advanced solid tumors, including tumors with elevated E2F transcription factor activity, such as small cell lung cancer, triple negative breast cancer and ER+ HER-2- breast cancer following CDK 4/6-inhibitor therapy.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are thrilled that the IND for CID-078 was cleared at the end of the 30-day regulatory review period and that CID-078 has now moved into human dosing at a consortium of world class cancer centers. This will allow our investigators to generate clinical proof-of-concept data which will inform CID-078’s potential impact in settings of high unmet medical need as well as validate Circle Pharma’s proprietary MXMO macrocycle platform for difficult-to-drug targets in cancer and other serious diseases," said David J. Earp, JD, Ph.D., CEO of Circle Pharma.

CID-078 is designed to selectively inhibit key protein-to-protein interactions involving cyclins A and B, both of which have been implicated in the proliferation and survival of cancer cells. The research program builds on work performed in the laboratory of Nobel Laureate and Circle Pharma’s Scientific Advisory Board Chair, William G. Kaelin Jr., MD, who demonstrated synthetic lethality through the disruption of these cyclins in settings of dysregulated cell cycle control and elevated E2F activity.

Geoffrey Shapiro, MD, Ph.D., senior vice president, Development Therapeutics at Dana-Farber Cancer Institute and professor of medicine at Harvard University, stated, "Disrupting the ability of E2F-driven cancer cells to turn off E2F at the appropriate time in the cell cycle has been shown to selectively induce apoptosis. Until now there hasn’t been a selective therapeutic agent to exploit this observation and so I am extremely excited to see Circle Pharma’s cyclin A/B RxL inhibitor move into the clinic."

All patients in the cohort are enrolled at The START Center for Cancer Research, Midwest, Grand Rapids, MI. Other clinical sites currently open include The START Center for Cancer Research, West Valley City, UT, and NEXT Oncology in San Antonio, TX. Additional clinical sites are planned to open soon.

Circle Pharma’s Phase 1 clinical trial (NCT06577987) is an open label, multi-center dose escalation and expansion study that is expected to enroll up to 100 patients. The study will evaluate the safety, pharmacokinetics and pharmacodynamics of CID-078 as well as preliminary anti-tumor activity in solid tumors. Circle Pharma anticipates reporting preliminary safety and anti-tumor data from the Phase 1 study in 2025.

About CID-078, Circle Pharma’s Cyclin A/B RxL Inhibitor Program

CID-078 is an investigational orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma’s investigational cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple xenograft models. Based on these findings CID-078 has progressed to a Phase 1 clinical study (NCT06577987).