On May 7, 2025 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported strong Q1 2025 results in line with the preliminary announcement and reaffirmed its FY 2025 outlook based on the solid start to the year and evolving macroeconomic trends (Press release, Qiagen, MAY 7, 2025, View Source [SID1234652647]).

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As announced on April 6, net sales in Q1 2025 rose 5% to $483 million from Q1 2024, with 7% growth at constant exchange rates (CER) well above the outlook. Core sales (excludes discontinued products such as NeuMoDx and Dialunox) also rose 7% CER. The adjusted operating income margin improved by 4.1 percentage points to 29.8%, supported by broad efficiency gains and the 2024 decision to discontinue the NeuMoDx clinical PCR testing system. Adjusted diluted earnings per share (EPS) were $0.55, and results of $0.56 CER exceeded the outlook for at least $0.50 CER.

In view of the Q1 2025 results, as well as ongoing macro trends (including U.S. and China import tariffs), QIAGEN reaffirms its FY 2025 net sales outlook for about 4% CER (core sales growth of about 5% CER). The outlook for adjusted EPS was upgraded in April to about $2.35 CER. QIAGEN also reaffirmed its 2025 adjusted operating income margin target for above 30%, and expects to reach its mid-term margin goal of at least 31% well ahead of the original 2028 target.

"QIAGEN delivered a solid start to 2025, exceeding our outlook on both sales and adjusted earnings. Our growth pillars QIAstat-Dx and QuantiFERON both posted double-digit sales gains, while QIAcuity and QIAGEN Digital Insights both continued to build momentum and in Sample technologies we are focusing on automation and preparing for new instrument launches. These advancements highlight the execution of our focused strategy and our ability to perform amid global uncertainty. We have reaffirmed our full-year 2025 targets and remain committed to delivering solid, profitable growth as a foundation for achieving our 2028 ambitions," said Thierry Bernard, CEO of QIAGEN.

"We maintained strong financial discipline in the first quarter, generating solid cash flow levels while funding key investments and advancing efficiency initiatives. This strength has enabled QIAGEN to expand our capital allocation strategy with the proposal to initiate an annual dividend and also to seek shareholder approval for a new synthetic share repurchase authorization. These actions reflect our commitment to creating greater value by generating operational leverage and strong cash flows while increasing returns," 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, May 8, 2025, at 15:00 Frankfurt Time / 14:00 London Time / 09:00 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.

On May 7, 2025 Priothera Ltd., a late-stage biopharma company pioneering the development of mocravimod, a novel oral sphingosine 1 phosphate (S1P) receptor modulator, to treat hematologic malignancies, reported the appointment of Jens Hasskarl, MD, PhD, as Chief Medical Officer (CMO) (Press release, Priothera, MAY 7, 2025, View Source [SID1234652646]). Dr. Hasskarl will oversee the global Phase 3 clinical study MO-TRANS of mocravimod, which is being developed as an adjunctive treatment in acute myeloid leukemia (AML) to enhance the curative potential of allogeneic hematopoietic cell transplantation (allo-HCT).

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Dr. Hasskarl brings over two decades of international leadership experience in clinical development, translational science and medical affairs across top-tier pharma, biotech and academic institutions. Most recently, he served as CMO at Advesya AG, where he led the strategic development of novel immunotherapies in haemato-oncology and autoimmunity. He previously held senior executive roles at Tigen Pharma, Celgene and Novartis, where he was instrumental in the development and global approval of multiple cellular therapies including Breyanzi, Abecma and Kymriah.

"Jens’ deep expertise in hematology, cellular therapy and translational drug development, combined with his entrepreneurial mindset and proven track record in leading successful global clinical programs, make him the ideal fit," said Florent Gros, Co-Founder and CEO of Priothera. "His insight and leadership will be critical as we prepare for the final phase of clinical execution and regulatory engagement for mocravimod. We would like to thank Dr. Elisabeth Kueenburg, Priothera’s former CMO, for her contributions and wish her every success in her future endeavors."

"I am thrilled to join Priothera during such an exciting phase," said Dr. Hasskarl, CMO of Priothera. "The company’s science-driven approach and commitment to improving outcomes for patients with AML aligns perfectly with my focus on advancing innovation in hematology. I look forward to working closely with the team to bring this promising therapy to patients worldwide."

Dr. Hasskarl holds an MD and PhD from Heidelberg University and the German Cancer Research Center. He completed a postdoctoral fellowship at Harvard Medical School and holds a diploma in Health Economics. He is a board-certified Internist with a specialty in hematology and oncology and continues to lecture at Freiburg Medical School in Germany.

On May 7, 2025 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) reported it is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer (Press release, Phio Pharmaceuticals, MAY 7, 2025, View Source [SID1234652645]). Phio reported that a complete pathologic response (100% tumor clearance) has been reported for 2 of 3 patients with cutaneous squamous cell carcinoma (cSCC) treated in the third dose cohort. The third patient was reported as having a pathologic non-response (<50% tumor clearance).

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"These positive outcomes continue to indicate that PH-762 may present a viable non-surgical alternative in this large and continually expanding skin cancer market," said Robert Bitterman, President and CEO of Phio Pharmaceuticals.

Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cSCC, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma.

To date, a total of 10 patients with cutaneous carcinomas have been treated in Cohorts 1, 2 and 3. These cohorts included 9 patients with cSCC and 1 patient with metastatic melanoma. At day 36 (planned tumor excision), of the 9 patients with cSCC, 4 patients had a pathologic complete response (100% tumor clearance). One patient had a near complete response (>90% clearance) and 1 patient had a partial response (>50% clearance). The other 3 cSCC and one metastatic melanoma patient had a pathologic non-response (< 50% clearance). Patients with pathologic complete response (100% tumor clearance) may have visual signs of residual scar or subdermal inflammation prior to resection. No patients, however, exhibited clinical progression of disease.

To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. The fourth cohort is currently enrolling patients; Phio expects to complete enrollment in the trial in the third quarter of 2025.

"The continued positive pathologic responses in this clinical trial of intratumoral PH-762 for cutaneous carcinoma increases our understanding of the potential therapeutic benefit for this immunotherapy. The safety profile supports ongoing dose escalation," said Mary Spellman, MD, Phio’s acting Chief Medical Officer.

On May 7, 2025 Pasithea Therapeutics, Corp. ("Pasithea," or the "Company") (Nasdaq: KTTA; KTTAW), 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 the closing of its previously announced public offering of 3,571,428 shares of its common stock (or pre-funded warrants in lieu thereof) and accompanying Series C warrants to purchase up to 3,571,428 shares of common stock and Series D warrants to purchase up to 3,571,428 shares of common stock, at a combined offering price of $1.40 per share of common stock (or per pre-funded warrant in lieu thereof) and accompanying warrants (Press release, Pasithea Therapeutics, MAY 7, 2025, View Source [SID1234652644]).

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The Series C warrants have an exercise price of $1.40 per share, are exercisable upon issuance and will expire five years thereafter. The Series D warrants have an exercise price of $1.40 per share, are exercisable upon issuance and will expire 18 months thereafter. Simultaneously with the closing of the offering, certain investors exercised Series D warrants to purchase an aggregate of 914,286 shares of common stock, resulting in additional gross proceeds to the Company of approximately $1.3 million.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

Total gross proceeds to the Company from the offering were $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The aggregate gross proceeds from the offering and the exercise of the Series D warrants were approximately $6.3 million. The Company intends to use the total net proceeds received from the offering for general corporate purposes, which includes, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company’s technologies, licensing activities related to its current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-286889) originally filed with the Securities and Exchange Commission ("SEC") on May 1, 2025 and declared effective on May 6, 2025. The offering was made only by means of a prospectus, which is part of the effective registration statement. A final prospectus relating to the offering has been filed with the SEC and is available for free on the SEC’s website located at View Source Electronic copies of the final prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other 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.

On May 7, 2025 NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, reported an upcoming presentation on Phase 1 clinical data from the Company’s Phase 1/2a trial evaluating troculeucel, cryopreserved expanded autologous NK cell therapy, in patients with moderate Alzheimer’s disease (AD), at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting, which will take place in New Orleans, Louisiana from May 13–17, 2025 (Press release, NKMax America, MAY 7, 2025, View Source [SID1234652643]).

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Presentation Details

Title: Use of Expanded Non-genetically Modified Natural Killer Cells (Troculeucel) with Enhanced Cytotoxicity in Patients with Alzheimer’s Disease. Preliminary Clinical and Biomarker Results.

Presenting Author: Paul Y. Song, M.D.

Session Details: Gene Therapy Clinical Trials – Oral Presentation

Location: NOLA Theater B

Presentation Date & Time: Wednesday, May 14, 2025; 2:30–2:45 PM, Central Time

Previously disclosed data for troculeucel in Alzheimer’s disease and solid tumors can be found on the

Company’s website at View Source News releases containing troculeucel clinical trial updates and regulatory approvals can be found on the News page of the Company’s website at View Source

About Troculeucel

Troculeucel is a novel cell-based, patient specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name ("INN") for SNK01 assigned by the World Health Organization ("WHO"). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen’s journey toward bringing this therapy to market.