On May 15, 2024 TriSalus Life Sciences Inc., (Nasdaq: TLSI), reported its financial results for the first quarter ended March 31, 2024, and provided a business update (Press release, TriSalus Life Sciences, MAY 15, 2024, View Source [SID1234643375]).

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"I’m proud to highlight our strong start in the first quarter of 2024 with 116% growth in revenues compared to the first quarter of 2023 and significantly improving our financial position with our debt financing facility with OrbiMed," said Mary Szela, Chief Executive Officer of TriSalus. "With our recent positive developments in reimbursement, clinical data, and the dedication of our seasoned executive team, we’re confident in our ability to execute our company-building strategy. Our objectives of achieving over 50% top-line revenue growth, advancing our pipeline, and strengthening our operational foundations remain firmly on track."

First Quarter 2024 and Subsequent Highlights

Secured up to $50 million of debt financing with OrbiMed to support TriNav Infusion System growth initiatives

In April, TriSalus announced the closing of a debt financing facility with OrbiMed, a healthcare investment firm. Under the terms of the Credit Agreement with OrbiMed, the Company borrowed $25 million at closing. In addition, an aggregate of up to an additional $25 million is available in two tranches at the Company’s option, subject to the Company’s achievement of certain revenue thresholds.

The $25 million draw, along with cash and cash equivalents on hand of $4 million at March 31, 2024, are expected to provide sufficient cash runway to fund the Company’s operations through the end of 2024. Including our SEPA agreement and other existing sources of liquidity and assuming we achieve the revenue targets and borrow the remaining $25 million of the debt financing, the Company expects to have sufficient cash runway to fund operations through the end of 2025.

Liselotte Hyveled appointed to the Board of Directors

In May, TriSalus announced the appointment of Liselotte Hyveled to its Board of Directors. Ms. Hyveled currently serves as the Chief Patient Officer at Novo Nordisk, where she is responsible for ensuring the integration of patient needs and perspectives into the company’s decision-making processes and operations. She brings over two decades of experience stimulating scientific innovation and advancing pharmaceutical pipelines through research and development excellence.

Financial Results for Q1 2024

Revenue, all of which is from the sale of the TriNav Infusion System, was $6.5 million in the first quarter ended March 31, 2024. This amount represents growth of 116% compared to the first quarter of 2023, primarily due to increased selling resources and continued market share increases.

Gross margins were 85% in the first quarter ended March 31, 2024, versus 78% in the first quarter of 2023. The improvement is due to increased factory volumes and improved operations efficiency.

Operating losses were $11.7 million in the first quarter ended March 31, 2024, versus $10.1 million in the first quarter of 2023. Increased investment in sales and marketing, research and development, as well as general and administrative costs associated with becoming a public company more than offset increased gross profit in 2024.

Net losses available to common stockholders were $13.2 million in the first quarter ended March 31, 2024, versus $8.3 million in the first quarter of 2023. Net losses in 2024 include the impact of non-cash related gains/(losses) on change in fair value of SEPA and warrant liabilities of $2.5 million and change in fair value of contingent earnout liabilities of ($4.0) million. Net losses in 2023 include the impact of non-cash related gains/(losses) on equity issuance of ($1.5) million, extinguishment of tranche liabilities of $0.9 million, and change in fair value of SEPA and warrant liabilities of $2.4 million.

Basic and diluted loss per share for the first quarter ended March 31, 2024, was $0.60 versus $0.57 per share in the first quarter of 2023.

Conference Call

The event will be webcast live on the investor relations section of TriSalus’ website at View Source on May 15, 2024, at 9:00 a.m. EDT. Following the conclusion of the event, a webcast replay will be available on the website for approximately 90 days. Interested parties participating by phone will need to register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin.

On May 15, 2024 Bayer reported initiation of dosing in a Phase I first-in-human clinical study with 225Ac-PSMA-Trillium (BAY 3563254), a next-generation targeted alpha therapy (Press release, Bayer, MAY 15, 2024, View Source [SID1234643373]). The investigational candidate, labeled with actinium-225 and comprising a novel PSMA (prostate-specific membrane antigen) -targeting small molecule with a customized albumin-binding moiety, is designed to potentially improve therapeutic efficacy and reduce side effects in normal organs such as salivary glands. The dose-escalation study (NCT06217822) will evaluate the safety, tolerability and efficacy of 225Ac-PSMA-Trillium in patients with advanced metastatic castration resistant prostate cancer (mCRPC).

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"Despite recent advances in the treatment landscape for prostate cancer, there is still a high unmet need for novel precision therapy options to improve outcomes for patients with metastatic castration-resistant prostate cancer," said Fred Saad, MD, FRCS, Professor and Chairman of Surgery at University of Montreal and Director of Genitourinary Oncology at University of Montreal Hospital Center (CHUM), Canada."225Ac-PSMA-Trillium is a novel approach, which could provide a new treatment to address this unmet need in mCRPC."

"Targeted radionuclide therapy is a strategic pillar of precision oncology at Bayer, holding the promise to shift the treatment paradigm for patients, including those whose disease has developed resistance to other treatments," said Dominik Ruettinger, M.D., Ph.D., Head of Research and Early Development for Oncology at Bayer. "We are excited to announce initiation of the phase I and dosing of the first patient with 225Ac-PSMA-Trillium. With its unique design, we believe it could offer a meaningful benefit for patients with metastatic prostate cancer, and we look forward to advancing the program through clinical development."

Prostate cancer is the second most commonly diagnosed cancer in men1 and a key area of focus at Bayer. Despite significant advances in the last decade, mCRPC remains a deadly disease with a median survival of about 31 months.2 Bayer remains committed to advancing medical innovations for patients across all stages of prostate cancer.

In April, Bayer introduced 225Ac-PSMA-Trillium during the New Drugs on the Horizon session at the AACR (Free AACR Whitepaper) (American Association of Cancer Research) Annual Meeting.3 Along with preclinical in vitro and in vivo characterization, the results were presented for a Phase 0 clinical imaging and dosimetry study conducted in participants with prostate cancer.

About Targeted Alpha Therapy

Targeted alpha therapy is an emerging class of radionuclide therapy that can be used against a variety of tumors. It is designed to deliver alpha particle radiation directly to the tumor inside the body, either via its bone-seeking property (radium-223) or by combining alpha radionuclides, such as actinium-225, with specific targeting moieties. This localized delivery of the radioactive payload induces difficult to repair double-strand DNA breaks in tumor cells; damage that can cause cell cycle arrest or cell death. At the same time, because the energy does not travel very far, there is a potential for reduced damage to nearby normal tissues.

On May 15, 2024 Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, reported data presented by its partners at the University of California, San Francisco (UCSF) on foundational prostate cancer antigen research utilized to inform the development of its mRNA drug candidate, NTX-470 (Press release, Nutcracker Therapeutics, MAY 15, 2024, View Source [SID1234643371]). The data were presented by lead author Elena Montauti, Ph.D., from UCSF on May 4, during the 2024 Annual Meeting of the American Association of Immunologists (AAI) in Chicago.

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It is well established that prostate cancer is a "cold cancer" with low immunogenicity. Its low mutation burden has resulted in very few druggable neoantigens – leaving shared tumor-associated antigens (TAAs) as the primary targets for immunotherapeutic development. However, the larger landscape of which shared prostate TAAs are immunogenic targets is challenging to assess and has not been systemically studied across patients. Further, it is unknown how antigen immunogenicity evolves as the disease progresses. The research presented at AAI aimed to map antigen reactivity in prostate cancer to inform possible combinations of TAAs that could be used as treatment for the disease.

Using its Nutshell technologies, Nutcracker Therapeutics’ scientists worked with UCSF researchers to create mRNAs encoding eight common and shared prostate TAAs, and employed a novel antigen recall assay to systematically study T cell immune responses in blood samples of patients with localized and metastatic prostate cancer. Cellular immune responses to shared TAAs were tracked across cohorts and correlated with treatment and disease outcomes after immunotherapy. Single-cell genomic analysis was used to characterize TAA-reactive T cell effector phenotypes and to track TCR expansion. Together, this in-depth analysis of TAA-reactive cellular responses in prostate cancer patients provides potentially transformative insights for the development of shared antigen-directed immunotherapeutics.

"We’re proud to have a partnership with the talented individuals at the University of California, San Francisco," said Chief Scientific Officer Samuel Deutsch, Ph.D. "The data presented at AAI reflects our deep commitment to new therapeutic strategies for prostate cancer, including the development of NTX-470. We’re hopeful that with our continued work with our partners at UCSF, we can continue conducting research that sheds a light on the unknowns of different cancers, and informs the development of much-needed novel therapeutics – whether by Nutcracker Therapeutics or others in the field."

"There are many knowledge gaps that currently exist in prostate cancer research," said UCSF Assistant Professor of Medicine David Oh, M.D., Ph.D. "The means by which antigen recognition changes as the cancer progresses is still unknown – making it difficult to design and develop effective drugs for more advanced forms of prostate cancer. By systematically researching antigen reactivity using this programmable platform, and relating this to known clinical outcomes after immunotherapy, we aim to lay the groundwork to address these existing knowledge gaps, with the hopes of inspiring the development of a new generation of mRNA-based immunotherapeutics for prostate cancer."

The research presented at AAI was the result of a longstanding partnership between Nutcracker Therapeutics and UCSF. Currently, Nutcracker Therapeutics has partnerships with Dr. Lawrence Fong and Dr. Oh’s labs in cancer immunotherapy. This data – resulting from a collaboration with Dr. Oh – expands upon a previous demonstration of the data by UCSF at last year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in 2023.

Previously, Nutcracker Therapeutics presented preclinical data at this year’s AACR (Free AACR Whitepaper) Annual Meeting for NTX-470. This multimodal mRNA therapy for prostate cancer encodes both PSMA and STEAP1 antigens, and was shown to effectively engage CD3 T cells with reduced off-tumor binding, which may result in diminished treatment toxicity.

On May 15, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, reported that the latest results from five studies have been selected for Poster Presentations at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress (EHA 2024) (Press release, Ascentage Pharma, MAY 15, 2024, View Source;results-from-five-studies-of-ascentage-pharmas-key-drug-candidates-selected-for-presentations-at-2024-european-hematology-association-hybrid-congress-302147047.html [SID1234643370]). These posters will feature olverembatinib (HQP1351), the first and only China-approved third-generation BCL-ABL1 inhibitor; investigational lisaftoclax (APG-2575), a Bcl-2 selective inhibitor; and investigational APG-5918, an EED selective inhibitor.

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The European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress is the largest gathering of the hematology field in Europe. It showcases the most cutting-edge research and state-of-the-art innovative therapies, attracting over 10,000 clinical experts and researchers from more than 100 countries every year. This year, the EHA (Free EHA Whitepaper) Hybrid Congress will take place on June 13 – 16, 2024, in Madrid, Spain.

"I am delighted to showcase the strength and progress of Ascentage Pharma in hematology at this year’s congress, especially the therapeutic potential and clinical value of its drug candidates in chronic myeloid leukemia (CML), Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), multiple myeloma (MM), immunoglobulin light-chain (AL) amyloidosis, and anemia diseases," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We look forward to sharing the detailed results at the congress. In the future, we will continue to advance those development programs in efforts to bring more treatment options to patients around the world."

The five studies to be presented at EHA (Free EHA Whitepaper) 2024 are as follows:

Olverembatinib
Olverembatinib Overcomes Ponatinib and Asciminib Resistance in Patients (Pts) with Heavily Pretreated Chronic Myeloid Leukemia (CML) and Philadelphia-Positive Acute Lymphoblastic Leukemia (Ph⁺ ALL)

• Abstract#: P722
• Presentation Type: Poster presentation
• Topic: Chronic myeloid leukemia – Clinical
• Date & Time: Friday June 14, 2024, 18:00 – 19:00 CEST
• Presenting Author: Dr. Elias Jabbour, The University of Texas MD Anderson Cancer Center

Combination of Third Generation TKI Olverembatinib and Chemotherapy or Blinatumomab for New Diagnosed Adult Ph+ ALL Patients

• Abstract#: P427
• Presentation Type: Poster presentation
• Topic: Acute lymphoblastic leukemia – Clinical
• Date & Time: Friday June 14, 2024, 18:00 – 19:00 CEST
• Presenting Author: Junjie Chen, Nanfang Hospital, Southern Medical University

Patient Reported Outcomes in Adults with TKI-Resistant Chronic Myeloid Leukemia Receiving Olverembatinib-Therapy

• Abstract#: P1862
• Presentation Type: e-Poster presentation
• Topic: Chronic myeloid leukemia – Clinical
• Date & Time: Friday June 14, 2024, 18:00 – 19:00 CEST
• Presenting Author: Lu Yu, Peking University People’s Hospital

Lisaftoclax
Lisaftoclax (APG-2575) Combined with Novel Therapeutic Regimens in Patients (Pts) with Relapsed or Refractory (R/R) Multiple Myeloma (MM) or Immunoglobulin Light-Chain (AL) Amyloidosis

• Abstract#: P917
• Presentation Type: Poster presentation
• Topic: Myeloma and other monoclonal gammopathies – Clinical
• Date & Time: Friday June 14, 2024, 18:00 – 19:00 CEST
• Presenting Author: Dr. Sikander Ailawadhi, Mayo Clinic Florida

APG-5918
Embryonic Ectoderm Development (EED) Inhibitor APG-5918 Improves Chronic Kidney Disease- (CKD)-Induced Hemoglobin (HB) Insufficiency in Preclinical Models of Anemia

• Abstract#: P1550
• Presentation Type: Poster presentation
• Topic: Enzymopathies, membranopathies and other anemias
• Date & Time: Friday June 14, 2024, 18:00 – 19:00 CEST
• Presenting Author: Dr. Eric Liang, Ascentage Pharma Group Inc.

On May 15, 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 financial results for the first quarter, ended March 31, 2024, and provided a corporate update (Press release, Ryvu Therapeutics, MAY 15, 2024, View Source [SID1234643369]).

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Pawel Przewiezlikowski, co-founder, largest shareholder, and Chief Executive Officer of Ryvu Therapeutics, said:
"We are progressing rapidly with our clinical and preclinical pipeline programs and expect several key milestones in 2024. With RVU120 now in Phase II, we have achieved our development goals established last year. By the end of this year, we anticipate RVU120, our first-in-class CDK8/19 inhibitor, enrolling patients across four independent and potentially high-value development paths. We are well-positioned with a cash runway through Q1 2026 and numerous potential non-dilutive capital sources ahead of us."

Q1 2024 SUMMARY AND RECENT CORPORATE EVENTS

RVU120 clinical development plan progress

In early 2024, Ryvu launched two Phase II studies with RVU120: the RIVER-52 study investigating RVU120 as monotherapy in two genetically defined cohorts of patients with r/r AML or HR-MDS, and the RIVER-81 study investigating RVU120 in combination with venetoclax in patients with AML.
POTAMI-61, a Phase II study evaluating the efficacy of RVU120 in patients with myelofibrosis (MF), is expected to initiate in Q3 2024. On March 28, Ryvu signed an agreement with Fortrea for the operational execution of POTAMI-61 clinical study.
REMARK, a Phase II study of RVU120 in patients with low-risk myelodysplastic syndromes (LR-MDS), is expected to initiate in mid-2024. REMARK will be conducted as an investigator-initiated study through the EMSCO network with Prof. Uwe Platzbecker, a globally renowned expert in the field of LR-MDS, as the Coordinating Principal Investigator.
The company plans to enroll approximately 100 patients across all RVU120 Phase II studies this year and aims to present initial Phase II data by the end of 2024.
Preclinical updates

At the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (April 5-10, San Diego, California), Ryvu presented preclinical data from its synthetic lethality pipeline and RVU120:
Ryvu’s PRMT5 inhibitors have potentially best-in-class profiles and favorable drug-like, oral administration properties, including a solid antiproliferative effect on MTAP-deleted cell lines and a good safety window for MTAP WT cells. Ryvu anticipates nominating a PRMT5 clinical candidate and initiation of IND-enabling studies in 2024.
Ryvu’s WRN inhibitor program demonstrates target engagement and selective potency with a synthetic lethal effect, providing pharmacological proof-of-concept; in vivo efficacy studies showed pronounced tumor growth inhibition in an MSI-H colorectal cancer xenograft model and supported WRN inhibition as a new, targeted oncological therapy.
RVU120 shows efficacy both as a monotherapy and synergistically in combination with ruxolitinib in preclinical myeloproliferative neoplasms models (MPN), including myelofibrosis (MF) and polycythemia vera.
UPCOMING INDUSTRY AND INVESTOR EVENTS

Myelofibrosis Webinar, Friday, May 17 at 3:00 PM CEST: Ryvu will host a webinar discussing RVU120 and spotlighting MF. Registration is available at: View Source
10th Annual Oncology Innovation Forum, Chicago, May 31: Ryvu will give a corporate presentation and conduct investor/partner meetings.
Pekao I Technology & Consumer Conference, Warsaw, June 3: Ryvu will conduct investor meetings
Erste | CEE Consumer & Technology Conference 2024, Warsaw, June 4: Ryvu will conduct investor meetings
EHA Congress, Madrid, June 13-16: Ryvu will present clinical and preclinical data from RVU120 and host an exhibition booth; three posters will be presented on RVU120:
Updated data from the Phase Ib trial of RVU120 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndromes (HR-MDS) demonstrate promising clinical activity.
Preclinical data support the synergistic combination of RVU120 and venetoclax in patients with AML, including RVU120’s potential to overcome resistance to venetoclax treatment.
In vivo data further supported CDK8 inhibition as a potential novel therapeutic strategy in myeloproliferative neoplasms (MPNs), focusing on myelofibrosis (MF).
Q1 2024 FINANCIAL UPDATE

Cash Position – On March 31, 2024, Ryvu Therapeutics held $62.7M in cash, cash equivalents, and bonds, compared to $63.7M on December 31, 2023. On May 9, 2024, Ryvu Therapeutics held $59.0M in cash, cash equivalents, and bonds, including €8M of venture debt from the EIB, received on March 13. 2023.

Operating Revenues— In Q1 2024, Ryvu recognized total operating revenues (including grants) of $6.4M, compared to $4.3M in Q1 2023.

Operating costs, related primarily to research and development expenditures, excluding the valuation of NodThera shares and non-cash cost of valuation of the Incentive Program ($0.3M) in Q1 2024, amounted to $11.7M, compared to $7.5M in Q1 2023.

Net Loss Attributable to Common Shareholders – In Q1 2024, the net loss attributable to common shareholders, excluding the non-cash cost of valuation of the Incentive Program, amounted to $4.6M compared to $3.3M in the same period last year.