On January 7, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it will present a business overview and provide its 2024 outlook at the 42nd Annual J.P. Morgan Healthcare Conference (Press release, Molecular Partners, JAN 7, 2024, View Source [SID1234639041]).

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Key current program status updates include:

MP0533 (CD33 x CD123 x CD70 x CD3)

The Phase 1/2a trial of MP0533 continues to enroll patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS/AML). Enrolment of patients in dosing cohort 5 is complete, and enrolment in cohort 6, projected as a therapeutically active dose, is now ongoing.
Positive initial data from the first four dosing cohorts indicate acceptable safety and encouraging initial antitumor activity with two responders reported across dosing cohorts 3 and 4. Data were presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2023.
Radio-DARPin Therapy (platform, DLL3)

The Company has entered a strategic collaboration with Orano Med, a leader in targeted alpha therapies, to co-develop 212Pb-based Radio-DARPin Therapies (RDT) for patients with solid tumors. Molecular Partners’ previously disclosed DLL3 program will be the first included in the collaboration. The deal combines the power of DARPins, as a highly differentiated modality for tumor-targeted delivery of radioisotopes, with Orano Med’s leading capabilities in alpha emitter technology and supply to further advance the RDT platform and expand Molecular Partner’s RDT portfolio.
Successful progress and optimization of Molecular Partners’ RDT platform enables expansion of the RDT pipeline. Both reduction of kidney absorption (Stealth-DARPins) and enhanced tumor uptake via half-life engineering were achieved with DARPins for several targets, including DLL3.
Molecular Partners continues to progress its RDT platform and portfolio of projects, both in-house and in partnership with Novartis.
Introduction of the first Switch-DARPin (cKIT x CD16a x CD47)

The multispecific cKIT x CD16a x CD47 Switch-DARPin is the first program of the company’s Switch-DARPin platform for targeted and conditional immune cell activation, designed as next-generation conditioning regimen for HSCT in AML and beyond.
cKIT is a highly attractive target to eliminate HSCs (and leukemia stem cells, LSCs) as it is critical for stem cell maintenance and renewal.
The CD16a DARPin allows engaging NK cells and macrophages to selectively kill HSCs.
Conditional blocking of the "don’t eat me" signal (CD47) only on HSCs via a Switch-DARPin allows leveraging the power of CD47 inhibition without its associated toxicity.
Altogether the cKIT x CD16a x CD47 Switch-DARPin is designed to increase long-term disease control post HSCT in AML patients, including those with poor cytogenetic risk profile, by inducing exhaustive killing of cKIT+ HSCs/LSCs, and to present an alternative approach with better safety profile than standard high-intensity conditioning, thereby allowing use of HSCT for more patients with AML.
The detailed proposed mechanism of action for this Switch-DARPin will be available at www.molecularpartners.com
MP0317 (CD40 x FAP)

The Company presented positive data from its ongoing MP0317 Phase 1 dose-escalation study at SITC (Free SITC Whitepaper) in November 2023, including results from 46 patients with advanced solid tumors.
The data support a favorable safety profile and provide clinical evidence of MP0317-induced, tumor-targeted CD40 activation and related remodeling of the tumor microenvironment.
The Company reports year-end 2023 unaudited* cash and short-term deposits of CHF ~187 million and maintains its guidance of being funded well into 2026.

The company expects milestones in 2024 to include:

Data from projected therapeutically active doses of MP0533 from the Phase 1/2a trial, including safety and efficacy, to be presented in H1.
Lead RDT candidate (DLL3) to be advanced into IND-enabling studies in H1, and nomination of additional targets and lead candidates for the RDT pipeline. Initiation of clinical studies and first-in-human data are expected in 2025.
Initial data from the first program of the company’s Switch-DARPin platform – a cKIT x CD16a x CD47 multispecific DARPin for targeted immune cell activation against HSCs as next-generation conditioning regimen for HSCT in AML patients – to be presented in H1.
The full dataset from the MP0317 Phase 1 dose-escalation in H1.
J.P. Morgan Presentation Details:

Presenter: Molecular Partners CEO Patrick Amstutz
Time (updated): Wednesday, January 10, 2024, at 10:30 am PST (7:30 pm CET)
Location: San Francisco, CA

A webcast will be accessible on the Molecular Partners website, under the Events tab.

In addition to these updates, Novartis has returned the rights to the ensovibep program, previously under investigation for the treatment of COVID-19, to Molecular Partners. Clinical work on the ensovibep program ended in 2022 and the program remains terminated. The abicipar program, previously under investigation for the treatment of nAMD and formerly licensed to Allergan/Abbvie also remains inactive.

*Unaudited financials. Year-end audited results will be available on March 14, 2024.

On January 7, 2024 Vincerx Pharma, Inc. (Nasdaq: VINC) ("Vincerx"), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported promising clinical results from a Phase 1 NIH-sponsored study of enitociclib in combination with venetoclax and prednisone for the treatment of relapsed/refractory lymphoma (Press release, Vincerx Pharma, JAN 7, 2024, View Source [SID1234639040]).

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"Enitociclib continues to differentiate itself in the CDK9 inhibitor field," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "Enitociclib is well tolerated, making it ‘the partner of choice’ for novel combinations. We are pleased to see the high response rate and tolerability of enitociclib in combination with venetoclax and prednisone in patients with hard-to-treat types of non-Hodgkin’s lymphoma such as peripheral T-cell lymphoma (PTCL) and double-hit diffuse large B-cell lymphoma (DH-DLBCL). Previous reports of venetoclax monotherapy in PTCL show low response rates; thus, we believe we are seeing compelling evidence for synergism between enitociclib and venetoclax in this patient population."

Ian Flinn, M.D., Ph.D., Vincerx Scientific Advisory Board member and Chief Scientific Officer of One Oncology, commented, "Outcomes for patients with PTCL are extremely poor, with median progression-free survival and overall survival of 3.1 and 5.5 months, respectively. Currently, clinical trials are considered the best standard of care for patients with relapsed/refractory PTCL, underscoring the substantial unmet medical need in this population."

Dr. Hamdy continued, "In addition to the exciting results with enitociclib, VIP236 and VIP943, the lead drugs from our cutting-edge VersAptx platform, are rapidly progressing through dose-escalation studies. To date, 15 patients with relapsed/refractory advanced or metastatic solid tumors have been treated with VIP236, and we are observing a promising safety profile and preliminary evidence of clinical activity with once every 3-week dosing. Enrollment in the second cohort of the VIP943 trial is nearly complete. Preliminary pharmacokinetic results from the first cohort of our VIP943 antibody drug conjugate (ADC) trial show very little free payload in circulation, consistent with the favorable safety profile observed to date. ADCs and bi-specifics have been limited by numerous safety and efficacy challenges, so the profile we are observing in these initial dose levels is exciting."

About Enitociclib

Enitociclib is a highly selective CDK9 inhibitor that prevents activation of RNA polymerase II, resulting in reduction of known oncogenes MYC and MCL1 (Frigault 2023). It is currently in a dose-escalation Phase 1 trial (NTC05371054), in collaboration with the National Institutes of Health, evaluating the combination of enitociclib, venetoclax, and prednisone in DLBCL and PTCL. Two patients out of three (67%) with PTCL have had a best response of PR. A subject with angioimmunoblastic T-cell lymphoma treated in the first dose level of enitociclib had a PR with a 91% reduction in tumor burden and remains on study for follow-up. A second subject with PTCL who received the second dose level of enitociclib remains on study with a PR with an 86% reduction in pulmonary lesions and resolution of skin lesions. In addition, on the second dose cohort of enitociclib, one patient with DH-DLBCL has achieved a PR after only one cycle of treatment—highlighting the faster response rate with the combination, compared with enitociclib monotherapy. Investigators are pleased with the safety profile of this novel combination (no DLTs have been observed so far) and continue with enrollment. Early-stage clinical studies (n=95) in patients with hematologic malignancies and solid tumors provided enitociclib monotherapy proof-of-concept. Additional combination studies will be determined based on financing/partnering support.

About VIP236

VIP236, the first-in-class small molecule drug conjugate (SMDC) from our VersAptx Platform, consists of an αvβ3 integrin binder, a neutrophil elastase linker cleaved in the tumor microenvironment, and a camptothecin payload optimized for high permeability and low efflux. VIP236 was designed to deliver its payload to advanced/metastatic tumors that express αvβ3. Preclinical data show enhanced efficacy, independent of HER2 status, in patient-derived and cell line-derived gastric cancer models compared with ENHERTU, an approved ADC. VIP236 is being evaluated in a Phase 1 dose-escalation trial treating patients with advanced or metastatic solid tumors (NTC05371054). As VIP236 is a first-in-class drug, the Phase 1 trial is evaluating various dosing schedules. To date, 15 patients with advanced or metastatic disease that has relapsed or is refractory to standard of care have received VIP236; the early safety profile of once every three-week dosing is promising. This schedule also shows early signs of clinical activity. We expect to report preliminary clinical trial data in early 2024.

About VIP943

VIP943, the first ADC from our VersAptx platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with our CellTrapper technology. Our proprietary effector chemistry (linker + payload) was designed to reduce non-specific release of the payload and ensure payload accumulation in cancer cells versus healthy cells. The increased therapeutic index has the potential to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities. VIP943 is in a Phase 1 dose-escalation trial evaluating patients with relapsed/refractory acute myeloid leukemia, myelodysplastic syndrome, and B-cell acute lymphoblastic leukemia who have exhausted standard therapeutic options (NCT06034275). Preliminary pharmacokinetic data from the first cohort shows low levels of unconjugated payload (VIP716) in the circulation as predicted from preclinical experiments. Reduced nonspecific release of payload is one of many features engineered into VIP943 to increase the therapeutic index compared with existing technologies. We expect to expand into additional CD123-positive indications, including TP53 mutated AML, both as monotherapy and in combination, as safety and efficacy data are generated. Preliminary Phase 1 data are expected in mid-2024.

About VersAptx Platform

VersAptx is our versatile and adaptable, next-generation bioconjugation platform. The modular nature of this innovative platform allows us to combine different targeting, linker, and payload technologies to develop bespoke bioconjugates to address different cancer biologies. With this platform (i) antibodies and small molecules can be used to target different tumor antigens, (ii) linkers can be designed to reduce non-specific release of the payload, cleave intracellularly or extracellularly, and conjugate to single or multiple payloads, and (iii) payloads can be designed with reduced permeability using our CellTrapper technology to ensure accumulation in cancer cells or to be permeable for release in the tumor microenvironment. The VersAptx platform allows us to optimize these technologies to a specific target and develop bioconjugates designed to address the safety and efficacy challenges of many ADCs and the needs of cancer patients.

On January 7, 2024 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a plan to return up to approximately $300 million (maximum EUR 273 million) to shareholders through a synthetic share repurchase that combines a direct capital repayment with a reverse stock split (Press release, Qiagen, JAN 7, 2024, View Source [SID1234639039]).

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QIAGEN has decided to implement the maximum $300 million value of the mandate given at the Annual General Meeting in June 2023, where shareholders gave virtually unanimous approval for the related resolutions. This approach is designed to return cash to shareholders in a more efficient way than through a traditional open-market repurchase program. It would also enhance earnings per share (EPS) through the reduction in outstanding shares.

"QIAGEN begins 2024 in a position of strength and positioned for solid growth due to our differentiated portfolio of molecular testing solutions that are helping to advance science and improve outcomes for people around the world," said Thierry Bernard, CEO of QIAGEN. "This repurchase program is a signal of our conviction in QIAGEN, as we continue to focus, invest in profitable growth and create value for our shareholders and other stakeholders."

Roland Sackers, Chief Financial Officer of QIAGEN, said: "A synthetic share repurchase relies on a well-known and proven structure utilized by many Dutch companies to enhance value. After the share repurchase is completed in early 2024, we will continue to have a solid investment-grade profile and a healthy balance sheet combined with strong cash flow generation. We are reviewing other options to create greater value, such as targeted M&A opportunities, that support our profitable growth trends."

This type of share repurchase involves three steps:

The par value of QIAGEN’s common shares (EUR 0.01 per share) will be increased through a transfer from the Share Premium Reserve (included in "Additional Paid-in Capital" on the Company’s balance sheet) to allow for the capital repayment to shareholders.

A reverse stock split will consolidate shares.

The par value will be reduced back to the original level of EUR 0.01 per share and the capital repayment will be paid out directly to shareholders (as of the record date, and where applicable after conversion into U.S. dollars).
The synthetic share repurchase will become effective on January 29, 2024, and will be settled in line with market convention in the subsequent days. Further information on this process will be announced before implementation.

On January 7, 2024 Exelixis, Inc. (Nasdaq: EXEL) reported its preliminary unaudited financial results for the fiscal year 2023, provided financial guidance for fiscal year 2024 and delivered an update on its business (Press release, Exelixis, JAN 7, 2024, View Source [SID1234639038]). Exelixis expects 2024 to be a year of pipeline progress as it advances its portfolio of promising biotherapeutics and small molecule candidates recently highlighted at its 2023 R&D Day and pursues potential near-term label expansion opportunities for CABOMETYX (cabozantinib).

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Preliminary Fiscal Year 2023 Financial Results & 2024 Financial Guidance

Exelixis is providing the following preliminary unaudited 2023 financial results and financial guidance for 2024:

Fiscal Year 2023

Fiscal Year 2024 Guidance

Total revenues

~ $1,830 million

$1,825 million – $1,925 million

Net product revenues

~ $1,630 million

$1,650 million – $1,750 million(1)

Cost of goods sold

~ 4.5%

4% – 5%

Research and development expenses

~ $1,045 million(2)

$925 million – $975 million(3)

Selling, general and administrative expenses

~ $545 million(4)

$425 million – $475 million(5)

Effective tax rate

n/a(6)

20% – 22%

(1)

Exelixis’ 2024 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.2% for both CABOMETYX and COMETRIQ effective on January 1, 2024.

(2)

Includes $34 million of non-cash stock-based compensation expense.

(3)

Includes $40 million of non-cash stock-based compensation expense.

(4)

Includes $72 million of non-cash stock-based compensation expense.

(5)

Includes $60 million of non-cash stock-based compensation expense.

(6)

Preliminary results not yet available.

The preliminary 2023 financial information presented in this press release has not been audited and is subject to change. The complete Exelixis Fourth Quarter and Fiscal Year 2023 Financial Results are planned for release after market on Tuesday, February 6, 2024.

"Supported by strong revenues from cabozantinib, our global oncology franchise, Exelixis is advancing an innovative pipeline of differentiated product candidates that can improve standards of care for cancer patients," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "Our 2024 plans include filing data-driven label expansions for CABOMETYX, accelerating the development of zanzalintinib, XB002, and XL309, and moving three promising preclinical programs into clinical development. The success of our internal drug discovery efforts as highlighted at our recent R&D Day compels a rebalancing of our investment priorities from early-stage research to product development activities. Exelixis will therefore implement a corporate restructuring that will concentrate R&D resources to advance our emerging pipeline, and maintain positive cash flow to support an additional $450 million share repurchase following successful completion of the $550 million share repurchase in 2023. We are taking these steps with the conviction that they are necessary for our continued progress toward the company’s goal of delivering an innovative pipeline of biotherapeutics and small molecules to help patients with cancer and create value for all of our stakeholders."

Corporate Updates

Corporate Restructuring to Rebalance Resources to Drive Pipeline Success: Exelixis will implement a corporate restructuring that will prioritize the advancement of the company’s deep pipeline of clinical and near-clinical programs. As a result, Exelixis is reducing its workforce by approximately 175 employees or 13 percent. Exelixis expects to substantially complete the restructuring in the first quarter of 2024 and recognize a restructuring charge of approximately $25 million.

Appointment of Two New Board Members: As part of the company’s continued board refreshment plan announced last year, Exelixis is announcing two new appointments to its Board of Directors, effective January 5, 2024:

Mary C. Beckerle, Ph.D., Chief Executive Officer of the Huntsman Cancer Institute and Distinguished Professor of Biological and Oncological Sciences at the University of Utah. Since 2006, Dr. Beckerle has had responsibility for the vision, strategic direction, and management of the University’s oncology programs, including research, care, education, and community outreach. A noted cell biologist and cancer researcher, Dr. Beckerle’s work on cytoskeletal dynamics and cell adhesion has led to important advances both in basic and translational science. In addition to Exelixis, Dr. Beckerle serves as an independent director of Johnson & Johnson and Huntsman Corporation.

Gail Eckhardt, M.D., Associate Dean of Experimental Therapeutics at Baylor College of Medicine and Associate Director of Translational Research at the College’s Dan L. Duncan Comprehensive Cancer Center. Dr. Eckhardt is a recognized leader in translational medicine relative to oncology with a particular emphasis on preclinical and early clinical development of molecularly targeted therapies and combination regimens to treat colorectal and other gastrointestinal cancers. She currently serves on the Board of Syros Pharmaceuticals, and as an academic advisor for eleven NCI-designated Cancer Centers, among other roles.

In addition, current Exelixis board member Alan M. Garber, M.D., Ph.D., has notified the company that he will not stand for reelection at the company’s 2024 Annual Meeting of Stockholders later this spring due to his expanded responsibilities at Harvard University. Having served as Harvard’s provost and chief academic officer since 2011, last week Dr. Garber became the University’s interim president.

Announcement of $450 Million Share Repurchase Program for 2024: The Exelixis Board of Directors authorized the repurchase of up to an additional $450 million of the company’s common stock in 2024. As of the end of 2023, Exelixis completed the repurchase of 26.2 million shares of the company’s common stock, or 8% of shares outstanding, for a total of $550 million, fulfilling its commitments under the 2023 Share Repurchase Program announced in March 2023. Share repurchases under the 2024 program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any share repurchases under the share repurchase program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of Exelixis’ common stock and general market conditions.

Anticipated 2024 Cabozantinib Milestones

Cabozantinib Pivotal Trial Data Readouts and Anticipated U.S. Regulatory Filings: Detailed data from CONTACT-02, the phase 3 pivotal trial evaluating the combination of cabozantinib and atezolizumab versus a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable, extrapelvic soft tissue disease who have been previously treated with one NHT, will be the subject of an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Genitourinary Cancers Symposium on January 25, 2024. Positive top-line results indicating that the trial met one of its primary endpoints of progression-free survival (PFS) were announced in August 2023, and the study continues toward the next analysis of the second primary endpoint of overall survival (OS), which is anticipated in 2024. Exelixis will continue its discussions with the U.S. Food and Drug Administration (FDA) on a potential regulatory path forward for cabozantinib in mCRPC. Also anticipated in 2024 is a potential regulatory filing for cabozantinib in advanced neuroendocrine tumors (NET) based on positive results from the pivotal phase 3 CABINET study, which evaluates cabozantinib versus placebo in patients with either advanced pancreatic NET (pNET) or extra-pancreatic NET (epNET) and is conducted by The Alliance for Clinical Trials in Oncology (The Alliance). Detailed data presented at the European Society for Medical Oncology Congress 2023 showed that the study met its primary endpoint, demonstrating dramatic improvement in PFS for patients treated with cabozantinib in both the pNET and epNET cohorts. Exelixis is working with The Alliance to discuss a potential regulatory filing with the FDA and will provide an update when appropriate.

Anticipated Outcome of Cabozantinib Abbreviated New Drug Application (ANDA) Litigation with MSN Pharmaceuticals: The second bench trial for Exelixis’ ongoing ANDA lawsuit against MSN Pharmaceuticals, Inc. concluded in October 2023, and Exelixis anticipates a ruling from the United States District Court for the District of Delaware in the first half of 2024. Exelixis is confident in its cabozantinib patent estate and is vigorously defending the patents at issue.

Upcoming Development Milestones

Zanzalintinib Clinical Progress Anticipated in 2024: Zanzalintinib is a third-generation tyrosine kinase inhibitor (TKI) that Exelixis believes can become the vascular endothelial growth factor receptor TKI of choice as solid tumor therapeutic landscapes continue to evolve. Exelixis is executing on three ongoing pivotal trials of zanzalintinib, STELLAR-303, -304, and -305, in forms of colorectal cancer, non-clear cell renal cell carcinoma, and squamous cell carcinoma of the head and neck, respectively. Zanzalintinib is also the subject of three ongoing earlier-stage trials, STELLAR-001, -002, and -009, intended to evaluate its potential in best-in-class combinations and identify indications for future pivotal trials, with priorities defined by emerging data and potential clinical co-funding opportunities.

XB002 Clinical Progress Anticipated in 2024: XB002 is a next-generation tissue factor (TF)-targeting antibody-drug conjugate (ADC) that Exelixis believes has development potential as a monotherapy and in combination regimens. In 2024, Exelixis is focused on advancing JEWEL-101, the phase 1 study of XB002 alone and in combination with immunotherapy in a variety of solid tumor settings with the goal of prioritizing sensitive tumor types for full development.

XL309 Clinical Progress Anticipated in 2024: XL309 is a potentially best-in-class small molecule inhibitor of USP1, which has emerged as a synthetic lethal target in the context of BRCA-mutated tumors. Exelixis in-licensed XL309 from Insilico Medicine in September 2023, and the process of transferring stewardship of the program’s ongoing phase 1 trial to Exelixis was completed in the fourth quarter of 2023. Exelixis’ clinical development priorities for XL309 include accelerating its development as a potential therapy for tumors that have become refractory to PARP inhibitor (PARPi) therapy, including forms of ovarian, breast, and prostate cancers, pursuing potential PARPi combinations, and moving beyond the PARPi market into new areas.

Anticipated Discovery Milestones

Three Potential Investigational New Drug (IND) Applications in 2024: Exelixis anticipates moving three programs into clinical development this year, including two biotherapeutics and one small molecule compound. The company expects to file an IND application for the XB010 5T4-MMAE ADC program in the first half of 2024, and expects to file IND applications for the XB628 PD-L1-NKG2A bispecific antibody and XL495 small molecule PKMYT1 inhibitor programs in the second half of 2024 if preclinical data continue to be supportive.

Current Development Candidate (DC) Programs and New DC Designations expected in 2024: Exelixis has two DC programs that may be the subjects of IND filings in 2025, including the XB371 TF-Topoisomerase I inhibitor ADC and XB064 ILT-2 monoclonal antibody programs, and the XB033 IL13Ra2-Topoisomerase I inhibitor ADC that may be the subject of an IND filing in 2026. In 2024, the company expects to designate two new programs to DC status, including a small molecule PLK4 inhibitor and an additional ADC.

Presentation and Webcast

Exelixis President and Chief Executive Officer Michael M. Morrissey, Ph.D., will provide a corporate overview and discuss the company’s preliminary fiscal year 2023 financial results, 2024 financial guidance, and key priorities and milestones for 2024 during the company’s presentation at the 42nd Annual J.P. Morgan Healthcare Conference beginning at 4:30 p.m. PT / 7:30 p.m. ET on Monday, January 8, 2024.

To access the webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A replay will also be available at the same location for at least 30 days.

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 [SID1234639037]).

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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.

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.

About Exact Sciences’ Precision Oncology portfolio
Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The OncoExTra test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations. To learn more, visit precisiononcology.exactsciences.com.