On January 7, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company expects to report revenue between $645.5 million and $647.5 million for the fourth quarter ended December 31, 2023 (Press release, Exact Sciences, JAN 7, 2024, View Source [SID1234639075]).

The company also announced that Jeff Elliott plans to step down as Executive Vice President and Chief Financial Officer (CFO) in 2024 due to personal reasons. Mr. Elliott will continue in his role as CFO until a successor is appointed. To help facilitate a smooth transition, following the appointment of a successor, Mr. Elliott will serve as a special advisor to the CEO. The company has engaged a nationally recognized executive search firm to review both internal and external candidates for its next CFO.

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Preliminary, Unaudited Fourth Quarter 2023 Financial Results

"Exact Sciences’ fourth quarter results show the strength of our business and reflect our unwavering commitment to help eradicate cancer by preventing it, detecting it earlier, and guiding personalized treatment," said Kevin Conroy, chairman and CEO. "To advance this mission, our team is intensely focused on impacting millions of people’s lives with Cologuard, Oncotype DX, and the next wave of innovative cancer diagnostics."

For the three-month period ended December 31, 2023, as compared to the same period of 2022:

•Total revenue between $645.5 million and $647.5 million, an increase of 17 percent, or 18 percent excluding COVID-19 testing
•Screening revenue between $486.0 million and $487.0 million, an increase of 21 percent
•Precision Oncology revenue between $159.5 million and $160.5 million, an increase of 12 percent

Preliminary, Unaudited 2023 Financial Results

For the twelve-month period ended December 31, 2023, as compared to the same period of 2022:

•Total revenue between $2,498.5 million and $2,500.5 million, an increase of 20 percent, or 23 percent excluding COVID-19 testing
•Screening revenue between $1,864.0 million and $1,865.0 million, an increase of 31 percent

•Precision Oncology revenue between $628.5 million and $629.5 million, an increase of 5 percent
•COVID-19 testing revenue of approximately $6.0 million, a decrease of 90 percent

Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX and therapy selection tests.

2024 Revenue Outlook

The company anticipates revenue of $2.83 billion during 2024.

Chief Financial Officer Succession

"On behalf of the Board and management team, I want to extend our deepest appreciation to Jeff for his steadfast leadership and valuable contributions during his career at Exact Sciences," added Mr. Conroy. "From his early days as VP of Business Development and Strategy to his tenure as COO and CFO, Jeff has helped guide Exact Sciences through incredible growth and transformation. I appreciate him remaining with us to facilitate a seamless leadership transition, and we wish him the very best moving forward."

"It has been a privilege to work alongside such a talented and dedicated team at Exact Sciences," Mr. Elliott said. "With our strong industry leadership, and a growing portfolio of life-changing advanced cancer diagnostics, I am fully confident in Exact Sciences’ continued growth and success. Having dedicated nearly a decade to the Exact Sciences mission, including helping Cologuard grow from its initial phases of commercialization to sustainable financial strength, this represents a natural time to transition from my role and to spend more time with my wife and children."

Important Note Regarding Preliminary, Unaudited Financial Results
Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2023. The revenue ranges presented in this news release for the fourth quarter of 2023 and for the year ended December 31, 2023 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2023. Exact Sciences is in the process of completing its customary year-end close and review procedures as of and for the year ended December 31, 2023, and there can be no assurance that final results for this period will not differ from these estimates. During the course of the preparation of Exact Sciences’ consolidated financial statements and related notes as of and for the year ended December 31, 2023, the company’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.

Exact Sciences plans to report 2023 financial results during its February 2024 earnings call.

About Cologuard
The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuardtest.com. Rx only.

On January 8, 2024 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported progress within the Company’s strategic partnership with Bristol Myers Squibb, further bolstering the joint pipeline of advanced neuroscience programmes (Press release, Evotec, JAN 7, 2024, View Source [SID1234639074]). Evotec receives a US$ 25 m payment to progress further research.

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Evotec and Bristol Myers Squibb entered their strategic neuroscience collaboration in December 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases where there remains a significant unmet medical need for therapies that slow down or reverse disease progression.

The partnership has generated a promising pipeline of discovery to clinical-stage programmes. A first programme, EVT8683, was in-licensed by Bristol Myers Squibb in September 2021 as BMS-986419. Following a successful Phase I study Bristol Myers Squibb announced that a Phase II study for BMS-986419 is scheduled to commence in 2024. In March 2023, Bristol Myers Squibb and Evotec extended and expanded this partnership for an additional 8 years.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "As the first asset from our neuroscience partnership with Bristol Myers Squibb is moving towards a Phase II study, our partnership is still growing in the drug discovery phase as well. We are confident that our unique PanOmics-based and patient-derived cellular models supported drug discovery efforts will deliver new therapeutic options for patients affected by devastating neurological disorders."

On January 7, 2024 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported the appointment of Tim Kelly to the newly created position of chief technology officer (Press release, Caribou Biosciences, JAN 7, 2024, View Source [SID1234639063]). Mr. Kelly brings over 25 years of experience in global clinical and commercial product development, manufacturing, and supply chain operations with large and small biopharmaceutical and cell and gene therapy companies in the US and Europe. In addition, Caribou highlighted successful execution across its allogeneic CAR-T cell therapy platform over the past year and provided an outlook on multiple clinical catalysts planned for 2024.

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"2023 was a year of exceptional progress and leadership for Caribou as we advanced our three clinical programs and strengthened our balance sheet with a public offering and investment from Pfizer. We are excited to kick off 2024 by welcoming Tim Kelly as Caribou’s chief technology officer," said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. "Tim’s extensive experience in global pharmaceutical product development, manufacturing, and commercialization, combined with his proven leadership and strategic vision, will be instrumental as we advance our pipeline and plan for the future. We are pleased to have Tim join us on our mission of bringing transformative therapies to patients with devastating diseases."

Mr. Kelly will lead the company’s technical operations strategy and execution and will report to Dr. Haurwitz. Tim joins Caribou from Oxford Biomedica Solutions, a spin-out of Homology Medicines, offering AAV product development and manufacturing services, where he was chief executive officer and board chair. Prior to Oxford Biomedica Solutions, he was chief operating officer at Homology Medicines, Inc., where he led operations, process and platform development strategy, and product manufacturing strategy for gene therapy and gene editing technology. Earlier, he led technical operations at Sarepta, Shire, UCB, and Biogen, and was a fighter pilot in the US Air Force. Tim earned an MS/MBA from Troy State University and a BS, with an emphasis in engineering mechanics, from the United States Air Force Academy.

"I’m thrilled to join Caribou as the company prepares to initiate its first pivotal trial. The potential of genome editing to revolutionize medicine is undeniable, and Caribou’s innovative chRDNA technology has enabled development of armored allogeneic CAR-T cell therapies that hold immense promise," said Mr. Kelly. "I look forward to leveraging my experience in building and scaling global process and manufacturing operations to ensure provider support and rapid patient access for commercialization and delivery of these potentially transformative therapies."

2023 clinical highlights and corporate accomplishments

Clinical highlights
CB-010, an allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma
•Caribou reported encouraging data (View Source) from the dose escalation portion of the ANTLER Phase 1 trial (View Source) evaluating CB-010 in 16 patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). Dose escalation data showed CB-010’s response rates and safety profile have the potential to rival those of the approved autologous CAR-T cell therapies.
•In the ongoing ANTLER Phase 1 trial, Caribou is enrolling second-line relapsed or refractory large B cell lymphoma (r/r LBCL) patients in the dose expansion portion. Currently, 22 U.S. and 3 international sites are active, with additional site activation underway.
•Caribou provided a regulatory update (View Source) based on feedback from the U.S. Food and Drug Administration (FDA) following a Type B clinical meeting. The company received the FDA’s feedback on a Phase 3 randomized pivotal trial for CB-010 in second-line r/r LBCL stating that Caribou’s proposed comparator arm of platinum-based immunochemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is acceptable.
•To Caribou’s knowledge, CB-010 is the first anti-CD19 allogeneic CAR-T cell therapy to be evaluated in the second-line LBCL setting and it has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations by the FDA for specific indications.

"My enthusiasm for the potential of off-the-shelf cell therapies combined with the encouraging CB-010 dose escalation data prompted me to establish Westmead Hospital as the first international site for the ANTLER trial," said Kenneth Micklethwaite, MD, clinical associate professor at the University of Sydney and hematology staff specialist at the Westmead Hospital. "I look forward to participating in the planned pivotal trial as patients in the second-line setting have an urgent need for treatment given the limitations of current treatment options."

CB-011, an allogeneic anti-BMCA CAR-T cell therapy for multiple myeloma
•Caribou initiated (View Source) the CaMMouflage Phase 1 trial evaluating CB-011 in patients with relapsed or refractory multiple myeloma (r/r MM).
•CB-011 was granted Fast Track (View Source) and Orphan Drug designation by the FDA, which are designed to expedite the development and review processes for promising therapeutic candidates that may fill an unmet medical need.
•CaMMouflage trial enrollment has concluded for dose level 1 (50×106 CAR-T cells, N=3) and dose level 2 (150×106 CAR-T cells, N=3) without any dose-limiting toxicities (DLTs), and the trial is enrolling patients at dose level 3 (450×106 CAR-T cells).

CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy for acute myeloid leukemia
•The investigational new drug (IND) application for CB-012 was cleared by the FDA (View Source) for evaluation in relapsed or refractory acute myeloid leukemia (r/r AML).
•The first clinical sites are active for the AMpLify Phase 1 trial (View Source?term=cb-012&" target="_blank" title="View Source?term=cb-012&" rel="nofollow">View Source;rank=1&tab=table) for CB-012 in r/r AML with additional site activation underway.

Corporate accomplishments
Expanded executive leadership team (View Source) and scientific advisory board (SAB) (View Source)
•Appointed Tim Kelly as Caribou’s chief technology officer, leading the company’s process development and manufacturing organizations.
•Appointed Reigin Zawadzki (View Source) as Caribou’s chief people officer, leading the company’s people strategy.
•Expanded Caribou’s SAB with a renowned lymphoma expert and two leading multiple myeloma experts:
◦Stephen Schuster, MD, (View Source) Robert and Margarita Louis-Dreyfus professor of chronic lymphocytic leukemia and lymphoma and the director of the lymphoma program and lymphoma translational research at the Perelman School of Medicine at the University of Pennsylvania, with Penn Medicine’s Abramson Cancer Center.
◦Sundar Jagannath, MD, (View Source) director of the Center of Excellence for Multiple Myeloma and professor of medicine at the Tisch Cancer Institute of Mount Sinai.
◦Sriram Krishnaswami, PhD, (View Source) vice president and development head for multiple myeloma at Pfizer Oncology’s Global Product Development division.

Armored balance sheet for cash runway into Q4 2025
•Completed successful $134.4 million follow-on financing.
•Received $25 million Pfizer (View Source) investment with proceeds to advance CB-011.
•Reported $396.7 million in cash, cash equivalents, and marketable securities as of September 30, 2023, which is expected to fund the current operating plan into Q4 2025.

2024 anticipated milestones
CB-010: Caribou plans to report initial dose expansion data from the ANTLER trial and share the recommended Phase 2 dose (RP2D) for CB-010 in Q2 2024. The company plans to initiate a Phase 3 pivotal trial evaluating CB-010 in second-line LBCL by year-end 2024.
CB-011: Caribou plans to report initial dose escalation data by year-end 2024.
CB-012: Caribou plans to initiate patient enrollment in the AMpLify Phase 1 clinical trial in r/r AML in H1 2024.

Caribou to present at the 42nd Annual J.P. Morgan Healthcare Conference
Dr. Haurwitz is scheduled to present a corporate update at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024 at 11:15 am PST.

A live webcast of the presentation will be accessible via Caribou’s website on the Events (View Source) page. The archived webcast will be available on the Caribou website for 30 days after the event.

About CB-010
CB-010 is the lead product candidate from Caribou’s allogeneic CAR-T cell therapy platform and is being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). In the ongoing ANTLER Phase 1 trial, Caribou is enrolling second-line patients with large B cell lymphoma (LBCL) comprised of different subtypes of aggressive r/r B-NHL (DLBCL NOS, PMBCL, HGBL, tFL, and tMZL). CB-010 is an allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9 CRISPR hybrid RNA-DNA (chRDNA) genome-editing technology. To Caribou’s knowledge, CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to improve antitumor activity by limiting premature CAR-T cell exhaustion. To Caribou’s knowledge, CB-010 is the first anti-CD19 allogeneic CAR-T cell therapy to be evaluated in the second-line LBCL setting and it has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations by the FDA for specific indications. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov (View Source).

About CB-011
CB-011 is a product candidate from Caribou’s allogeneic CAR-T cell therapy platform and is being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage Phase 1 trial. CB-011 is an allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA genome-editing technology. To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to improve antitumor activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and orphan drug designations by the FDA. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov (View Source).

About CB-012
CB-012 is a product candidate from Caribou’s allogeneic CAR-T cell therapy platform and will be evaluated in the AMpLify Phase 1 clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML). CB-012 is an anti-CLL-1 CAR-T cell therapy engineered with five genome edits, enabled by Caribou’s patented next-generation CRISPR technology platform, which uses Cas12a chRDNA genome editing to significantly improve the specificity of genome edits. To Caribou’s knowledge, CB-012 is the first allogeneic CAR-T cell therapy with both checkpoint disruption, through a PD-1 knockout, and immune cloaking, through a B2M knockout and B2M–HLA-E fusion protein
insertion; both armoring strategies are designed to improve antitumor activity. Additional information on the AMpLify trial (NCT06128044) can be found at clinicaltrials.gov (View Source).

About Caribou’s novel next-generation CRISPR platform
CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Class 2 CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems are capable of editing unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced "chardonnays") that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA technology to carry out high efficiency multiple edits, including multiplex gene insertions, to develop CRISPR-edited therapies.

On January 7, 2024 Affini-T Therapeutics, Inc., a precision immunotherapy company unlocking the power of T cells against oncogenic driver mutations, reported that Jak Knowles, M.D., Co-founder, President and Chief Executive Officer, will present a company overview at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 3:00 p.m. PT (Press release, Affini-T Therapeutics, JAN 7, 2024, View Source [SID1234639043]).

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On January 7, 2024 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation at the 42nd Annual J.P. Morgan Healthcare Conference and 2024 corporate guidance and program updates (Press release, Ideaya Biosciences, JAN 7, 2024, View Source [SID1234639042]).

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42nd Annual J.P. Morgan Healthcare Conference
Tuesday, January 9th, 2024 at 8:15 AM PT (11:15 AM ET)

Presentation by Yujiro S. Hata, Chief Executive Officer followed by analyst-hosted Q&A with Anupam Rama, Managing Director, US SMID Biotechnology Equity Research, J.P. Morgan
IDEAYA’s 2024 corporate guidance and program updates include:

Balance sheet of $511.1 million of cash, cash equivalents and marketable securities as of September 30, 2023, and $134.7 million estimated net proceeds from subsequent follow-on financing and $10 million receivable from GSK, is anticipated to fund operations into 2028
International site activation and double-digit patient enrollment achieved in potential registration-enabling Phase 2/3 clinical trial of darovasertib and crizotinib combination in first-line HLA-A2(-) metastatic uveal melanoma (MUM)
Clinical program update(s) in 2024 for potential registration-enabling Phase 2/3 clinical trial of darovasertib and crizotinib combination in first-line HLA-A2(-) MUM
Targeting clinical efficacy update from Phase 2 company sponsored neoadjuvant uveal melanoma (UM) study in mid-year 2024 and regulatory guidance update in 2024
Targeting ongoing enrollment of IDE397 and AMG 193 Phase 1 combination study in MTAP-deletion solid tumors and development of joint publication strategy in 2024
Anticipate First-Patient-In of Phase 1 IDE397 and Trodelvy clinical combination study in MTAP-deletion bladder cancer in mid-year 2024
Preliminary IDE397 clinical efficacy observed in MTAP deletion solid tumors, including RECIST 1.1 complete response in bladder cancer patient, 33% tumor shrinkage in NSCLC patient by CT/PET, and multiple ctDNA molecular responses in NSCLC and bladder cancer
Targeting IDE161 clinical program update(s) and enabling of clinical combination(s) in 2024
Preliminary IDE161 clinical efficacy observed in HRD solid tumors, including RECIST 1.1 partial responses in priority solid tumor types and >50% PSA reduction in a prostate cancer patient
Targeting ongoing enrollment of IDE161 Phase 1 expansion in HRD solid tumor priority types, including endometrial, colorectal, prostate, and ER+ HER2- breast cancers
Advancing Phase 1 dose escalation for GSK101 (IDE705) Pol Theta Helicase inhibitor, and targeting IND submission in 2024 for Werner Helicase Inhibitor Development Candidate ($7.0 million milestone upon IND clearance) under collaboration with GSK
Targeting multiple wholly-owned next generation development candidate nominations in 2024, including in MTAP-deletion, further advancing IDEAYA’s multi-pronged strategy in MTAP-deletion and AI/ML and structurally-enabled drug discovery platform
IDEAYA’s updated corporate presentation reflecting its 2024 corporate guidance is available on its website, at the Investor Relations page: View Source

A live audio webcast of the event, as permitted by conference host, will be available at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.