On April 6, 2025 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported preliminary Q1 2025 results that exceeded its outlook for both net sales and adjusted earnings per share (EPS), reflecting strong performances across many growth drivers (Press release, Qiagen, APR 6, 2025, View Source [SID1234651810]).

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Net sales grew approximately 5% (+7% at constant exchange rates, CER) to about $483 million in Q1 2025, surpassing the previously communicated outlook for about 3% CER growth (4% CER core business excluding discontinued products such as NeuMoDx and Dialunox). Adjusted diluted EPS are expected to be at least $0.55 CER compared to the previously communicated outlook for about $0.50 CER.

Sales of the QuantiFERON latent TB test grew about 15% CER as global adoption continues to shift from the skin test to this proven, modern blood-based test. The QIAstat-Dx syndromic testing system advanced above 35% CER on continued demand for respiratory panels along with growth in gastrointestinal and meningitis testing. The QIAcuity digital PCR system and QIAGEN Digital Insights bioinformatics business both delivered high-single-digit CER gains, reflecting solid adoption across research and clinical applications. Additional growth contributions also came from higher sales of PCR consumables and from OEM products. Sample technologies sales declined 1% CER, reflecting the cautious instrument spending environment among some Life Sciences customers.

Given the positive start to 2025, QIAGEN is raising its adjusted diluted EPS outlook for full-year 2025 in light of the strong sales growth in Q1 and the overall current business trends, which includes expected headwinds from the recently announced U.S. import tariffs and a better-than-expected tax environment.

Full-year 2025, adjusted diluted EPS are now expected to be about $2.35 CER, up from the prior full-year outlook for about $2.28 CER, while reaffirming the goal to improve the adjusted operating income margin to above 30% for the year.

QIAGEN will provide additional perspectives on the outlook for full-year 2025 with the publication of full Q1 2025 results on May 7, 2025.

Additionally, QIAGEN now expects to reach the mid-term adjusted operating income margin goal of at least 31% well ahead of the original 2028 timeline, reflecting the stronger-than-anticipated improvements delivered during 2024 and 2025.

On April 4, 2025, Lipella Pharmaceuticals Inc. (the "Company") entered into an At The Market Offering Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC ("Wainwright"), to sell shares of its common stock, par value $0.0001 per share (the "Common Stock") having an aggregate sales price of up to $2,641,881 (the "Shares"), from time to time, through an "at the market offering" program under which Wainwright will act as sales agent (Filing, 8-K, Lipella Pharmaceuticals, APR 4, 2025, View Source [SID1234651819]). The sales, if any, of the Shares made under the ATM Agreement will be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

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The Company has agreed to pay Wainwright a cash commission equal to 3.0% of the aggregate gross proceeds from sales of the Shares and has agreed to provide Wainwright with customary indemnification and contribution rights. The Company has also agreed to reimburse Wainwright for certain specified expenses not to exceed $100,000 in connection with entering into the ATM Agreement. The ATM Agreement contains customary representations and warranties and conditions to the sale of the Shares pursuant thereto.

The Company is not obligated to sell any of the Shares under the ATM Agreement and no assurance can be given that the Company will sell any Shares under the ATM Agreement, or if such sales occur, no assurance can be given as to the price or number of Shares that will be sold, or the dates on which any such sales will take place. The Company or Wainwright may at any time suspend solicitation and offers of Shares thereunder and the ATM Agreement may be terminated by either the Company or Wainwright, as permitted therein. The Company currently intends to use all proceeds raised in connection with the sale of Shares for working capital and general corporate purposes.

The Shares will be issued pursuant to the prospectus supplement (the "Prospectus Supplement"), dated April 4, 2025, to the base prospectus included in the Company’s shelf registration statement on Form S-3 (File No. 333- 276815) filed by the Company with the U.S. Securities and Exchange Commission ("SEC") on February 1, 2024, and declared effective by the SEC on February 8, 2024 (the "Registration Statement").

This Current Report on Form 8-K (this "Form 8-K") shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there by any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

The foregoing description of the ATM Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is attached hereto as Exhibit 10.1 and which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreement were made only for purposes of such agreement and as of specific date, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties. The Company is filing the opinion of its counsel, Sullivan & Worcester LLP, relating to the legality of the issuance and sale of the Shares as Exhibit 5.1 hereto. Exhibit 5.1 is incorporated herein by reference and into the Registration Statement.

On April 4, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported that Chief Executive Officer Shaun Bagai will present at the LD Micro Invitational XV: New York 2025 conference taking place at the Westin Grand Central Hotel, New York, NY on April 10, 2025 (Press release, Renovorx, APR 4, 2025, View Source [SID1234651809]).

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Mr. Bagai will discuss recent corporate milestones, including an update on RenovoRx’s continued momentum of its RenovoCath commercial efforts, including new purchase orders and reorders received from cancer center customers, and the realization of initial revenues from RenovoCath sales.

Mr. Bagai will also discuss progress on RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial. TIGeR-PaC is evaluating RenovoRx’s lead drug-device combination product candidate (intra-arterial delivery of gemcitabine via the RenovoCath catheter, known as IAG) which uses the proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). This combination product candidate, IAG, which is enabled by the FDA-cleared RenovoCath device, is currently under investigation and has not been approved for commercial sale.

Presentation Details:
Date: Thursday, April 10, 2025
Time: 3:30 p.m. ET
Webcast: View Source

To schedule a one-on-one investor meeting with Mr. Bagai, please contact your LD Micro representative or KCSA Strategic Communications at [email protected].

On April 4, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that Immunome management will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on Thursday, April 10, 2025 at 12:45 p.m. Eastern Time (Press release, Immunome, APR 4, 2025, View Source [SID1234651808]).

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Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

On April 4, 2025 SkylineDx, an innovative diagnostics company specializing in molecular diagnostics for oncology, inflammatory, and infectious diseases, reported that Dr. Teresa Amaral, MD, PhD, Head of Skin Cancer Clinical Trials Center, University of Tübingen, Germany, will present groundbreaking new data at the 2025 World Congress of Melanoma (WCM) (Press release, SkylineDx, APR 4, 2025, View Source [SID1234651807]). The presentation will highlight the Merlin CP-GEP (Clinicopathologic and Gene Expression Profile) test’s ability to identify high-risk melanoma patients who did not undergo sentinel lymph node biopsy (SLNB), a critical gap in current melanoma staging methods – showing CP-GEP’s potential in predicting relapse and other long-term survival outcomes [1-2].

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Key Findings from the Study:

Merlin CP-GEP test successfully stratified 930 stage I/II melanoma patients: 879 (94.5%) were Merlin Low-Risk and 51 (5.5%) were Merlin High-Risk.
Patients identified as Low-Risk showed an impressive 5-year and 10-year relapse-free survival (RFS) rate of 96% and 94.5% respectively.
Patients in the Merlin (CP-GEP) High-Risk group were around 20 times more likely to experience a recurrence, compared to the Merlin Low-Risk group. Their 5-year and 10-year RFS was 37.5% for both endpoints. Additionally, High-Risk patients showed significantly increased rates of distant metastasis and melanoma-specific death, reinforcing the clinical value of CP-GEP in identifying patients at risk for recurrence.
While SLNB remains the standard for melanoma staging, many patients classified as low-risk based on traditional methods still experience relapse or even death. The CP-GEP model, which combines gene expression data with clinical factors age and tumor thickness, effectively identified two distinct risk groups among patients who did not undergo SLNB.

Dr. Teresa Amaral shared her thoughts on the study: "The results of this study highlight the potential of the Merlin CP-GEP test to redefine risk assessment for melanoma patients. By identifying high-risk individuals who may not have undergone SLNB, we can better personalize treatment decisions, ultimately improving long-term outcomes for patients."

Dr. Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx, commented, "These results highlight the power of CP-GEP in helping clinicians identify high-risk patients, even in the absence of SLNB status. Additional research is needed but potentially the Merlin High-Risk patients could benefit from systemic therapy to overcome their risk of recurrence, as their RFS is similar to that of patients who are currently eligible for immunotherapy."

SkylineDx remains committed to advancing innovative molecular diagnostic solutions that offer better insights and more personalized treatment options for melanoma patients, ultimately improving their chances for a better outcome.

About the advanced cutaneous melanoma GEP test (Merlin CP-GEP test)

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx BV and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access.