Quince Therapeutics to Present at Oppenheimer 35th Annual Healthcare Life Sciences Conference

On February 5, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, will participate in a fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference, a virtual event, on Wednesday, February 12, 2025 beginning at 2:00 p.m. Eastern Time (Press release, Quince Therapeutics, FEB 5, 2025, View Source [SID1234650059]).

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A live webcast of the fireside chat will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.

QIAGEN delivers solid Q4 2024 growth ahead of outlook

On February 5, 2025 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported financial results for the fourth quarter and full-year 2024 (Press release, Qiagen, FEB 5, 2025, View Source [SID1234650058]).

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Net sales for Q4 2024 increased 2% to $521 million compared to Q4 2023, while sales at constant exchange rates (CER) of $525 million rose 3% and were above the outlook for at least $520 million CER and core sales (excluding discontinued products such as NeuMoDx and Dialunox) rose 4% CER. The adjusted operating income margin improved by 2.6 percentage points to 30.6%, driven by efficiency gains and benefits from the NeuMoDx decision, enabling reinvestments into targeted growth initiatives. Adjusted diluted earnings per share (EPS) were $0.61, and CER results of $0.61 were above the outlook for at least $0.60 CER.

QIAGEN expects the solid growth pace in H2 2024 to continue in 2025. Net sales are expected to rise about 4% CER (and core sales growth of about 5% CER). Adjusted diluted EPS is expected to be at least $2.28 CER, driven by a goal to improve the adjusted operating income margin by at least 150 basis points to above 30% while absorbing lower non-operating income contributions than in 2024.

"Our teams at QIAGEN concluded 2024 with a solid performance in the fourth quarter, exceeding our outlook for net sales and profitability. These results underscore the resilience of our portfolio, with over 85% of sales coming from highly recurring revenues, and our focus on delivering solid profitable growth in an ongoing challenging environment," said Thierry Bernard, CEO of QIAGEN.

"Our solid sales growth in the second half of 2024 mirrors our plans for further strong growth in 2025 as we reconfirm our 2028 targets. QIAstat-Dx exceeded expectations with four FDA clearances for our syndromic testing system in 2024 and one already in 2025, coupled with over 660 placements in 2024 that was ahead of our target. QuantiFERON delivered 11% CER growth for 2024, with significant opportunities for further expansion since only 40% of the global latent TB testing market has so far been converted from the outdated skin test. QIAcuity also delivered solid growth despite challenging instrument purchase trends as we expanded digital PCR into clinical use in 2024 while expanding our presence with academia, pharma and other customers."

"We are pleased with our 2024 results that featured strong free cash flow combined with solid sales growth and a significant increase in the outlook for adjusted EPS during the year thanks to operational profitability improvements. Our confidence in QIAGEN’s future is reflected in the return of about $300 million to shareholders in January through a synthetic share repurchase. We remain well-positioned to execute on our 2028 commitments for solid profitable growth, supported by our differentiated portfolio and disciplined capital allocation that seeks to strengthen our business while increasing returns to shareholders," said Roland Sackers, CFO of QIAGEN.

Please find the full press release incl. tables as a PDF for download at the top of this page.

Investor presentation and conference call

A conference call is scheduled for Thursday, February 6, 2025, at 16:00 Frankfurt Time / 15:00 London Time / 10:00 New York Time. A live audio webcast will be accessible in the investor relations section of the QIAGEN website (www.qiagen.com), with a recording available after the event. The presentation will be published ahead of the call in this section: QIAGEN Investor Relations – Events and Presentations.

Use of adjusted results

QIAGEN reports adjusted results, as well as results on a constant exchange rate (CER) basis, along with other non-U.S. GAAP (generally accepted accounting principles) measures, to provide deeper insights into its performance. These include metrics such as core sales (excluding discontinued products), adjusted gross margin, adjusted gross profit, adjusted operating income, adjusted operating expenses, adjusted operating income margin, adjusted net income, adjusted net income before taxes, adjusted diluted EPS, adjusted EBITDA, adjusted EPS, adjusted income taxes, adjusted tax rate, and free cash flow. Free cash flow is calculated by subtracting capital expenditures for property, plant and equipment from cash flow from operating activities. Adjusted results are non-GAAP financial measures that QIAGEN considers complementary to GAAP-reported results but not as substitutes. These measures exclude items that QIAGEN believes are outside of ongoing core operations, fluctuate significantly between periods, or hinder the comparability of results with competitors and prior periods. QIAGEN also uses non-GAAP and constant currency financial measures internally in planning, forecasting and reporting, and also for employee compensation. Additionally, adjusted results are used to compare current performance with historical results, which have consistently been presented on an adjusted basis.

Protara Therapeutics to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference

On February 5, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that management will participate in a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Wednesday, February 12, 2025, at 12:40 pm ET (Press release, Protara Therapeutics, FEB 5, 2025, View Source [SID1234650057]).

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A live webcast of the fireside chat can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived for a limited time following the presentation.

PDS Biotech Reaffirms Guidance for First Quarter Initiation of VERSATILE-003 Phase 3 Clinical Trial in HPV16-Positive
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

On February 5, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year (Press release, PDS Biotechnology, FEB 5, 2025, View Source [SID1234650056]).

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PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical results here.)

"The integral elements for trial initiation are ready, including alignment with the FDA," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We look forward to initiating VERSATILE-003 this quarter and advancing the combination of Versamune HPV plus pembrolizumab to potentially provide improved outcomes for patients with HPV16-positive R/M HNSCC."

HPV16-positive patients represent a large, fast-growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. A recently validated companion diagnostic to confirm HPV16-positive HNSCC will be utilized during the patient screening process of the VERSATILE-003 trial.

"HPV16-positive HNSCC is poised to become the dominant type of HNSCC in the US and EU," said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. "Confirming HPV16 status with a potentially commercializable test is essential to effectively identifying the patients suitable to receive Versamune HPV. This will be the first investigational use of this type of companion diagnostic in a Phase 3 clinical trial in HNSCC."

For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer

On February 5, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported that the external Safety Review Committee recommended that the Company’s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to cohort 5, 22mg capsule, without modification (Press release, Pasithea Therapeutics, FEB 5, 2025, View Source [SID1234650055]). This recommendation was based on the review of the safety data from three patients in cohort 4A (15mg capsule) and the absence of any dose limiting toxicities (DLT’s). In addition, no rash has been observed to date in any of the first 14 patients who have been dosed with PAS-004 in either capsule (12 patients) or tablet (2 patients) formulation. Rash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the high discontinuation rate in real world practice.

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"As we are observing substantial exposure levels of PAS-004, we remain encouraged by the safety profile PAS-004 continues to exhibit," stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "With the differentiated profile of PAS-004, we believe it is possible that this highly specific macrocyclic MEK inhibitor with a half life of greater than 60 hours may change the treatment paradigm for patients with NF1 and inoperable plexiform neurofibromas. We are looking forward to presenting updated pharmakokinetic (PK) and pharmacodynamic (PD) data during Q1 2025."

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).