On April 29, 2024 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the first quarter of 2024 (Press release, Qiagen, APR 29, 2024, View Source [SID1234642431]).

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Net sales declined 5% to $459 million, while results at constant exchanges rates (CER) of $462 million were above the outlook for at least $455 million CER. The adjusted operating income margin rose to 25.7% from 25.6% in the year-ago period on realized efficiency gains while supporting investments into the portfolio. Adjusted diluted earnings per share (EPS) were $0.46, and results at CER were $0.47 and above the outlook for at least $0.44 CER.

For 2024, QIAGEN has reaffirmed its outlook for net sales of at least $2.0 billion CER. Adjusted diluted EPS are expected to be at least $2.10 CER, led by the adjusted operating income margin rising to above 28% of sales for FY 2024 compared to 26.9% in 2023 while supporting investments.

"Our results for the first quarter of 2024 show QIAGEN is on track to achieve the goals that we have set for the year. They also showcase the areas of resilient growth from our strategic investments – particularly with the double-digit sales growth in QuantiFERON, QIAstat-Dx and QIAcuity – as well as our commitment to improving efficiency," said Thierry Bernard, Chief Executive Officer of QIAGEN.

"As we move on from the pandemic, we are steadfast in our commitment to driving innovation given our ongoing high level of R&D investments that help strengthen our portfolio. QuantiFERON sales continued to grow as we drive conversion of latent TB testing to the modern blood-based test. QIAstat‑Dx sales were also robust, with growth in both respiratory and non-respiratory panels for syndromic testing. Building on the tremendous acceptance of QIAcuity among our customers, we are democratizing access to this powerful digital PCR technology and expanding into new oncology applications that can improve healthcare. As we navigate a challenging macro environment, we are well-positioned in 2024 and determined to deliver on our full-year outlook."

Roland Sackers, Chief Financial Officer of QIAGEN, said: "Our strong operating income margin in Q1 2024 reflects our dedication to efficiency and growth-focused investments despite cautious instrument purchases. As we introduce new products and elevate customer engagement, our commitment to enhancing value for our shareholders remains strong. Having completed the $300 million synthetic share repurchase in January, we continue to explore opportunities to maximize our business thanks to our healthy balance sheet and strong cash flow through disciplined capital allocation."

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 planned for Tuesday, April 30, 2024 at 15:00 Frankfurt Time / 14:00 London Time / 9:00 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a recording will also be made available after the event. A presentation will be available before the conference call at View Source

On April 29, 2024 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 indications, reported the acceptance of an abstract for poster presentation at the American Society of Cancer Oncology ("ASCO"), which will be held in Chicago from May 31 – June 4, 2024 (Press release, Pasithea Therapeutics, APR 29, 2024, View Source [SID1234642430]).

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Session titles and information for the abstract are listed below and now available on the ASCO (Free ASCO Whitepaper) online program planner.

PAS-004: A novel macrocyclic MEK inhibitor to inhibit cancer cell growth in vitro and tumor growth in mouse xenograft studies.

Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: 6/1/2024, 9:00 AM – 12:00 PM CDT
Abstract Number: 3126
Speaker / lead author: Graeme Currie, PhD

The poster will be available at www.pasithea.com/publications following the presentation.

PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, with an expected extended half-life which may provide better compliance rates, as well as improved efficacy in NF1. Macrocycles are known to exhibit stronger binding, better solubility and longer half-life with more selectivity and less off target effect as compared to acyclic small molecules.

About PAS-004

PAS-004 is a small molecule allosteric inhibitor of MEK 1/2, which are dual-specificity protein kinases, in the MAPK signaling pathway. The MAPK pathway has been implicated in a variety of diseases, as it functions to drive cell proliferation, differentiation, survival and a variety of other cellular functions that, when abnormally activated, are critical for the formation and progression of tumors, fibrosis and other diseases. MEK inhibitors block phosphorylation (activation) of extracellular signal-regulated kinases (ERK). Blocking the phosphorylation of ERK can lead to cell death and inhibition of tumor growth. Existing FDA approved MEK inhibitors are marketed for a range of diseases, including certain cancers and neurofibromatosis type 1 (NF1). We believe these MEK inhibitors suffer from certain limitations, including known toxicities. Unlike current FDA approved MEK inhibitors, PAS-004 is macrocyclic, which we believe may lead to improved pharmacokinetic and safety (tolerability) profiles. Cyclization offers rigidity for stronger binding with drug target receptors. PAS-004 was designed to provide a longer half-life with what we believe is a better therapeutic window. Further, we believe the potency and safety profile that PAS-004 has demonstrated in preclinical studies may also lead to stronger and more durable response rates and efficacy, as well as better dosing schedules. PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies. Additionally, PAS-004 has received orphan-drug designation from the FDA for the treatment of NF1.

On April 29, 2024 Oncotelic Therapeutics, Inc. (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or "Our"), reported that it has entered into a binding term-sheet with Mosaic ImmunoEngineering, Inc. (OTCPK: CPMV) ("Mosaic") under which Mosaic will acquire rights to Oncotelic’s clinical-stage necroptosis cancer therapies (Press release, Oncotelic, APR 29, 2024, View Source [SID1234642429]). Oncotelic’s necroptosis therapeutics work by disrupting tumor blood flow resulting in immunogenic tumor cell death through "death receptor" activation which can result in a robust anti-cancer immune response. In addition to the clinical stage assets, Mosaic will have access to Oncotelic’s proprietary Artificial Intelligence ("AI") technologies for identifying immunotherapy combinations.

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Pursuant to the binding term-sheet, Mosaic will issue to Oncotelic $15 million in CPMV shares upon execution of the definitive purchase agreement along with additional milestones allowing Oncotelic to earn up to an additional $15 million in shares of CPMV. The Mosaic team, which has broad experience in bringing oncology and orphan drug products to market with a combined experience including well over 30 FDA and worldwide product approvals, will be responsible for advancing the development of the technologies. Both companies will work closely together to ensure a smooth transfer of the technologies from Oncotelic to Mosaic. Oncotelic will provide short-term financial support for the program while the teams work together to achieve both short-term and long-term financing goals. Pursuant to the binding term sheet, the parties agreed to negotiate in good faith towards the execution of the Definitive Agreements and the closing of the transactions contemplated thereby, which will be subject to customary due diligence and other conditions as described in the binding term sheet.

"This will be the second transaction for capitalizing on our assets and building shareholder value. The first being the successful transition of OT-101 to our joint venture ("JV") with Dragon Capital Overseas, Limited. The JV is expected to list for an IPO, as well as the completion of establishing a research and manufacturing facility headquartered in San Diego, California." expressed Dr. Vuong Trieu, CEO of Oncotelic.

"We are very pleased to have this opportunity to bring these clinical stage assets that have promise for the treatment of multiple types of cancer into Mosaic. We anticipate that the initial application of the technology will be in areas with high unmet medical need such as uveal melanoma and retinoblastoma. We look forward to working with the Oncotelic team to advance the program." said Steven King, President and CEO of Mosaic.

On April 29, 2024 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that management will participate in the following investor conferences during the month of May (Press release, Inovio, APR 29, 2024, View Source [SID1234642428]):

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The Citizens JMP Life Sciences Conference
Date: Tuesday, May 14, 2024
Time: 11:30 AM ET
Presenter: Dr. Jacqueline Shea, President & CEO
Format: Fireside Chat

RBC Capital Markets 2024 Global Healthcare Conference
Date: Wednesday, May 15, 2024
Time: 10:00 AM ET
Presenter: Dr. Jacqueline Shea, President & CEO
Format: Fireside Chat

H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ
Date: Monday, May 20, 2024
Time: 12:30 PM ET
Presenter: Dr. Jacqueline Shea, President & CEO
Format: Fireside Chat

During the conferences, Dr. Shea and members of INOVIO’s management team will conduct one-on-one meetings with registered investors.

Webcasts of the fireside chats will be available on the INOVIO Investor Relations Events page at View Source Replays of the webcasts will be available for 90 days after the date of the presentation.

On April 29, 2024 Immix Biopharma, Inc. ("Immix Biopharma", "Company", "We" or "Us", Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, reported that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of multiple myeloma (Press release, Immix Biopharma, APR 29, 2024, View Source [SID1234642427]).

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"Frail patients, heavily represented in our NEXICART-1 clinical trial, remain an area of unmet medical need and are a significant portion of the relapsed/refractory multiple myeloma population," said Ilya Rachman, MD PhD, Chief Executive Officer, Immix Biopharma. "We believe EU orphan drug designation for NXC-201 affirms the potential clinical impact of NXC-201 in this sizable population."

Gabriel Morris, Chief Financial Officer, Immix Biopharma added, "We believe NXC-201’s observed favorable tolerability profile and ‘Single Day CRS’ across a robust clinical dataset could enable an attractive option for frail relapsed/refractory multiple myeloma patients in addition to our lead indication, relapsed/refractory AL Amyloidosis, and our active NXC-201 expansion into other autoimmune diseases."

According to Davis et al., 2023 Transplantation and Cellular Therapy, commercial CAR-Ts produced 6.9 months median progression free survival in frail relapsed/refractory multiple myeloma patients in a real-world setting. 61% of patients in the dataset were considered frail.

Orphan drug designation in the European Union (EU) is granted by the EC based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products. To qualify for orphan drug designation, a candidate therapy must be intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that occurs in not more than five in 10,000 people in the EU. The designation provides regulatory, financial and commercial incentives to develop therapies for rare diseases where there are either no satisfactory treatment options or significant benefit to those affected by the disease.