On January 31, 2024 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that the first patient has been dosed with the study drugs in a Phase II clinical trial investigating RVU120 in combination with venetoclax for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) – the RIVER-81 study (NCT06191263) (Press release, Ryvu Therapeutics, JAN 31, 2024, View Source [SID1234639758]).

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The primary goal of the RIVER-81 study will be to evaluate safety and efficacy of RVU120 in combination with venetoclax in r/r AML patients who have failed prior venetoclax treatment.
The RIVER-81 study is initially launching at clinical sites in Poland and Italy. Ultimately, the study will expand to other EU and non-EU countries, covering up to 50 clinical sites globally. The planned overall enrollment for the study is up to approx. 98 patients.
The study is part of the RVU120 Development Plan presented in October 2023 and aligns with the company’s cash runway to Q1 2026. Execution of the RIVER-81 study is supported with a PLN 62.3 mln grant from the Polish Medical Research Agency (ABM).
In H1 2024, Ryvu plans to launch four Phase II RVU120 clinical studies and enroll over 100 patients across the studies by the end of the year. Ryvu aims to prioritize further development options in Q1 2025 based on the study outcomes. Clinical trials conducted in various hematological indications and treatment regimens (monotherapy and combination therapy) will contribute to the global RVU120 safety database, which would support potential future regulatory approvals.
RVU120 is a selective, first-in-class dual CDK8/19 kinase inhibitor developed by Ryvu Therapeutics. RVU120 monotherapy has demonstrated positive clinical activity in a Phase Ib study, where 50% of evaluable patients with r/r AML or HR-MDS achieved clinical benefit, including a complete response, a morphologic leukemia-free state, multiple clinically significant blast reductions, hematologic improvements, and reduction of bone marrow fibrosis.

Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics, said:

– Considering the encouraging results from the Phase Ib study of RVU120 as monotherapy for patients with r/r AML and HR-MDS, along with compelling translational evidence of synergistic activity with venetoclax, we have launched the Phase II RIVER-81 study with optimism. AML patients who fail the current standard of care, consisting of venetoclax and a hypomethylating agent, have very few alternative treatment options and a poor prognosis. We are delighted to commence the new Phase II RVU120 study in Poland and Italy, with plans to expand to up to 50 clinical sites globally. Our goal is to bring meaningful clinical benefits to AML patients.

Kamil Sitarz, Ph.D., Chief Operating Officer of Ryvu Therapeutics, said:

– We have successfully confirmed the safety profile of RVU120, and our focus is now on substantiating its efficacy signals. With the activation of dozens of clinical sites globally, we aim to dose over 100 patients across four RVU120 Phase II studies by the end of 2024. Subsequently, and based on treatment outcomes, we will strategically prioritize further development paths. This progress aligns with the RVU120 development plan unveiled in October 2023, supported by secured financing until Q1 2026.

RIVER-81 is a multicenter, open-label clinical trial that aims to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with AML who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent.

The study is divided into two parts. Part 1 aims to identify safe and tolerated doses of RVU120 and venetoclax when used in combination, through dose escalation of both study drugs. In Part 2, the selected doses will be evaluated for both safety and efficacy in a larger group of patients.

The study has received approval from the Competent Authorities in Poland and Italy following a clinical trial application in accordance with the European Union Clinical Trial Regulation (EU-CTR) 536/2014, as well as positive opinions from the respective Ethics Committees, enabling patient enrollment in both countries. Start-up activities in other EU and non-EU countries are currently in progress.

RIVER-81 marks the commencement of the first of four planned RVU120 Phase II clinical studies, scheduled to launch in H1 2024. Following RIVER-81, Ryvu intends to initiate the RIVER-52 study (evaluating RVU120 as a monotherapy in patients with genetically defined subtypes of AML and in patients with HR-MDS). Upcoming plans also include the initiation of the REMARK study (conducted as an investigator-initiated trial, exploring RVU120 as a monotherapy for the treatment of patients with low-risk myelodysplastic syndromes; LR-MDS) and the POTAMI-61 study (evaluating both monotherapy and combination therapy for the treatment of patients with myelofibrosis; MF).

On January 31, 2024 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in a fireside chat at the following investor conferences (Press release, Merus, JAN 31, 2024, View Source [SID1234639757]):

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Guggenheim 6th Annual Biotechnology Conference: Wednesday, February 7, 2024 at 2:30 p.m. ET
Citi’s 2024 Oncology Leadership Summit: Thursday, February 22, 2024 at 9:00 a.m. ET

The webcasts of the presentations will be contemporaneously available on the Investors page of the Company’s website. Archived presentations will also be available there for a limited time after the event.

On January 31, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported that new preclinical data demonstrating the potential of INTASYL self-delivering siRNA targeting Cbl-b improves natural killer (NK) cell activity for adoptive cell therapy and may result in a more effective cell therapy for hematological malignancies will be presented at the 10th Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (ITOC10), which will be held in Munich, Germany from March 21-23, 2024 (Press release, Phio Pharmaceuticals, JAN 31, 2024, View Source [SID1234639756]).

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Presentation Details are as follows:

Title: Enhancing NK cell cytotoxicity against tumor cells with a novel self-delivering RNAi compound targeting Cbl-b
Poster Number: P01.03
Topic: 01.Emerging concepts / New Agents
Presenting Author: Melissa Maxwell
Date and Time: 18:00 hrs Thursday, March 21, 2024
18:00-19:00 hrs Friday, March 22, 2024
Location: Ludwig Maximilian University Campus Großhadern,
Lecture Room 3, Marchioninistrasse 15
81377 Munich, Germany
The poster presentation will be accessible in person and will also be available on March 21st, on Phio’s website.

On January 31, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (Nasdaq: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated targeted agents to treat hematologic malignancies, reported the closing of the previously announced public offering (the "Public Offering") of 5,649,122 common shares of the Company (the "Common Shares") and warrants at a combined offering price of US $1.71 per share (Press release, Aptose Biosciences, JAN 31, 2024, View Source [SID1234639755]). This includes 736,842 Common Shares and warrants pursuant to a full exercise by the underwriter of its over-allotment option. Each Common Share was sold with a warrant to purchase a Common Share (a "Warrant Share") at an exercise price of US $1.71 per Warrant Share.

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Aptose also announced the closing of the previously announced US $4 million private placement (the "Private Placement") of Common Shares with Hanmi Pharmaceutical, Inc. ("Hanmi"), Seoul, South Korea, yielding ownership of 19.03% of the outstanding Common Shares of the Company. Under the terms of the strategic investment, Hanmi purchased each Common Share at a price of US $1.90, representing an 11% premium over the price of the Common Shares issued as part of the Public Offering. The Company also issued Hanmi warrants to purchase Common Shares at an exercise price of US $1.71 per Warrant Share.

Total gross proceeds from the public offering and private placement were approximately $13.7 million, excluding underwriting discounts, placement agent commissions and other offering-related expenses. The total number of Common Shares outstanding after the closing of the Public Offering, including the Over-Allotment Option, and Private Placement is 15,706,810 and warrants outstanding are 8,332,163.

Aptose intends to use the net proceeds of the Public Offering and Private Placement to (i) support clinical trials for tuspetinib; (ii) support manufacture of tuspetinib clinical supplies; and (iii) for working capital and general corporate purposes.

Newbridge Securities Corporation acted as the sole book-running manager for the Public Offering and as placement agent for the Private Placement.

No Common Shares, or Warrants have been offered or sold in Canada as part of the Public Offering or Private Placement. The Public Offering and Private Placement have been subject to the approval of the Toronto Stock Exchange ("TSX") and Nasdaq. For the purposes of TSX approval, the Company is relying on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

The securities sold in the Public Offering were offered by Aptose pursuant to a registration statement on Form S-1 (File. No. 333-275870), including a base prospectus, that was previously filed by Aptose with the Securities and Exchange Commission ("SEC") and was declared effective on January 25, 2024. The Public Offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. Before you invest, you should read the prospectus supplement and the accompanying prospectus and other documents the Company has filed with the SEC for more complete information about the Company and the Public Offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus supplement may be obtained by contacting Newbridge Securities Corporation, Attn: Equity Syndicate Department, 1200 North Federal Highway, Suite 400, Boca Raton, FL 33432, by email at [email protected] or by telephone at (877) 447-9625. The securities to be sold to Hanmi have not been registered under the U.S. Securities Act of 1933, as amended, and will be issued in reliance on an exemption from the registration requirements thereof.

On January 31, 2024 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Thermo Fisher Scientific, JAN 31, 2024, View Source [SID1234639753]).

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Fourth Quarter and Full Year 2023 Highlights

•Fourth quarter revenue was $10.89 billion, 5% lower versus the same quarter last year. Core organic revenue growth declined 4%.
•Fourth quarter GAAP diluted EPS was $4.20, 5% higher versus the same quarter last year, driven by 70 basis points of operating margin expansion.
•Fourth quarter adjusted EPS was $5.67, 5% higher versus the same quarter last year, driven by 100 basis points of adjusted operating margin expansion.

•Full year revenue was $42.86 billion, 5% lower versus prior year. Core organic revenue growth was 1%.
•Full year GAAP diluted earnings per share (EPS) was $15.45.
•Full year adjusted EPS was $21.55.

•During the year, we strengthened our industry leadership, advanced our trusted partner status with our customers, and delivered differentiated financial performance for our shareholders due to strong execution by our global team enabled by our PPI Business System.

•Advanced our proven growth strategy, launching a range of high-impact, innovative new products during the year, highlighted by the groundbreaking Thermo Scientific Orbitrap Astral mass spectrometer, the Applied Biosystems QuantStudio Absolute Q AutoRun dPCR System, the Thermo Scientific Metrios 6 S/TEM, the first FDA-cleared assays for risk assessment and clinical management of preeclampsia, and the Gibco CTS Detachable Dynabeads. During the quarter, we launched the Thermo Scientific Meridian EX System, an electron-beam-based solution for precise defect localization in advanced logic semiconductors and the Thermo Scientific Aquanex Ultrapure Water Purification System, for reliable water purity and operational enhancement in laboratories.

•Continued to further strengthen our industry-leading commercial engine and deepen our trusted partner status during the year, as demonstrated by our differentiated performance in 2023. This included the addition of a new customer excellence center in Europe, partnering and collaborating with customers on innovative new medicines, and leveraging digital tools to further optimize commercial effectiveness and improve the customer experience. During the fourth quarter, we opened a customer experience center for battery manufacturing in Seoul to support our material science customers as they accelerate the development of the next generation of environmentally friendly energy solutions.

•Strong year advancing our corporate social responsibility (CSR) priorities. We accelerated our net-zero roadmap with on-site solar projects and power purchase agreements across the Americas, Europe and Asia Pacific regions, advancing our progress toward our target of utilizing 80% renewable electricity globally by 2030. We also progressed our global health equity initiatives by offering expanded access to advanced genomic testing in low- and middle-income countries and launched new initiatives to continue bringing clinical trials to historically underserved patient populations. We further engaged in supporting local communities through our colleague-led STEM education programs.

•Continued to successfully execute our capital deployment strategy in 2023. During the year we completed the acquisitions of The Binding Site, a leading provider for detection and monitoring of multiple myeloma, and CorEvitas, a leading provider of regulatory-grade, real-world evidence for approved medical treatments and therapies. We also announced an agreement to acquire Olink Holding AB (publ) ("Olink") (Nasdaq: OLK), a leading solution for advanced proteomics discovery and development. Additionally, we returned $3.5 billion of capital to shareholders through stock buybacks and dividends.

"Thanks to the strong contributions from our team, we delivered differentiated performance in 2023 and enabled our customers’ success," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We effectively navigated the challenging macroeconomic conditions by leveraging our PPI Business System to deliver strong financial results."

Casper added, "Our proven growth strategy, capital deployment approach, and PPI Business System, continue to position our company for an even brighter future."

Fourth Quarter 2023

Revenue for the quarter declined 5% to $10.89 billion in 2023, versus $11.45 billion in 2022. Organic revenue was 7% lower, Core organic revenue growth declined 4%, and COVID-19 testing revenue was $0.05 billion.

GAAP Earnings Results

GAAP diluted EPS in the fourth quarter of 2023 was $4.20, versus $4.01 in the same quarter last year. GAAP operating income for the fourth quarter of 2023 was $1.85 billion, compared with $1.86 billion in the year-ago quarter. GAAP operating margin was 17.0%, compared with 16.3% in the fourth quarter of 2022.

Non-GAAP Earnings Results

Adjusted EPS in the fourth quarter of 2023 was $5.67, versus $5.40 in the fourth quarter of 2022. Adjusted operating income for the fourth quarter of 2023 was $2.55 billion, compared with $2.56 billion in the year-ago quarter. Adjusted operating margin was 23.4%, compared with 22.4% in the fourth quarter of 2022.

Full Year 2023

Revenue for the full year declined 5% to $42.86 billion in 2023, versus $44.92 billion in 2022. Organic revenue was 5% lower, Core organic revenue growth was 1%, and COVID-19 testing revenue was $0.33 billion.

GAAP Earnings Results

GAAP diluted EPS for the full year was $15.45, versus $17.63 in 2022. GAAP operating income for 2023 was $6.86 billion, compared with $8.39 billion a year-ago. GAAP operating margin was 16.0%, compared with 18.7% in 2022.

Non-GAAP Earnings Results

Adjusted EPS for the full year was $21.55, versus $23.24 in 2022. Adjusted operating income for the full year was $9.81 billion, compared with $10.99 billion a year-ago. Adjusted operating margin was 22.9%, compared with 24.5% in 2022.

Annual Guidance for 2024

Thermo Fisher is initiating a guidance range for full year 2024 with revenue of $42.1 billion to $43.3 billion and adjusted EPS of $20.95 to $22.00.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (833) 470-1428 within the U.S. or (404) 975-4839 outside the U.S. The access code is 718426. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can also be found in that section of our website under the heading "Financials". A replay of the call will be available under "News, Events & Presentations" through Friday, February 16, 2024.