Updated Time: Agios to Present at the Goldman Sachs 45th Annual Global Healthcare Conference on June 10, 2024 at 8:40 am ET

On June 6, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the time of the company’s presentation at the Goldman Sachs 45th Annual Global Healthcare Conference has been updated to Monday, June 10, 2024 at 8:40 a.m. ET (Press release, Agios Pharmaceuticals, JUN 6, 2024, View Source [SID1234644161]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

Exicure, Inc. Reports Full Year 2023 Financial Results

On June 6, 2024 Exicure, Inc. (Nasdaq: XCUR) has historically been an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. In September 2022, the Company reported a significant reduction in force, suspension of preclinical activities and halting of all research and development, and that the Company was exploring strategic alternatives to maximize stockholder value (Press release, Exicure, JUN 6, 2024, View Source [SID1234644182]).

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2023 Financial Results

Cash Position: Cash and cash equivalents were $0.8 million as of December 31, 2023, as compared to $8.6 million as of December 31, 2022. Subsequent to December 31, 2023, our cash and cash equivalents have decreased to approximately $0.2 million as of May 31, 2024. Subsequent to May 31, 2024, the Company received a $0.7 million loan from DGP Co., Ltd., a significant stockholder. The loan has a maturity of ten months from issuance and interest at a rate of 6.0% per annum is payable at maturity. The Company believes that its cash and cash equivalents are insufficient to continue to fund operations and additional funding is needed in the very near term.

Research and Development (R&D) Expense: Research and development expenses were $1.4 million for the year ended December 31, 2023, as compared to $19.8 million for the year ended December 31, 2022. The decrease in R&D expense for the year ended December 31, 2023 of $18.3 million reflects the stoppage of clinical, preclinical, and discovery program activities and a reduction in employee headcount with lower employee-related expenses and fewer discovery, preclinical, and clinical program activities resulting from the restructuring activities that the Company announced in December 2021 and September 2022.

General and Administrative (G&A) Expense: General and administrative expenses were $12.7 million for the year ended December 31, 2023, as compared to $10.9 million for the year ended December 31, 2022. The increase in G&A expense of $1.8 million for the year ended December 31, 2023 was mostly due to certain expenses that previously had been recorded as research and development expenses, such as office facilities, legal, and payroll related costs, that no longer met the criteria to be classified as research and development expenses due to the shift in our historical business operations discontinuing all research and development activities.

Net Loss: The Company had a net loss of $16.9 million for the year ended December 31, 2023, as compared to a net loss of $2.6 million for the year ended December 31, 2022. Although operating expenses were reduced by more than 50%, there were no revenues to offset these expenses resulting in an increase in net loss of $14.3 million.

Going Concern: Management believes that the Company’s existing cash and cash equivalents is not sufficient to continue to fund operations. The Company has already engaged in significant cost reductions, so our ability to further cut costs and extend the Company’s operating runway is limited. As a result, substantial additional financing is needed in very near term to pay expenses, fund the ongoing exploration of strategic alternatives and pursue any alternatives that may be identified. The Company needs to raise capital to fund its operations. There can be no assurance that such additional financing will be available and, if available, can be obtained on acceptable terms.

Syndax Announces Participation at the Goldman Sachs 45th Annual Global Healthcare Conference

On June 5, 2024 Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, Chief Executive Officer, will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Wednesday, June 12, 2024, at 8:40 a.m. ET (Press release, Syndax, JUN 5, 2024, View Source [SID1234644142]).

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A live webcast of the fireside chat can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

Can-Fite Updates on its Advanced Liver Cancer Pivotal Phase 3 Study

On June 5, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported an update on the status of its oncological lead drug candidate, Namodenoson in the treatment of advanced liver cancer (Press release, Can-Fite BioPharma, JUN 5, 2024, View Source [SID1234644121]). The Phase 3 pivotal study, now has 31 recruiting medical centers in Europe, Israel and the US. Namodenoson has Orphan Drug status with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency, as well as Fast Track Status with the FDA. A compassionate use program has also been ongoing in Israel and Romania.

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In the former Phase 2 study, conducted in patients with advanced liver cancer, Namodenoson prolonged survival, patients had good quality of life, and in two patients, clearance of peritoneal carcinomas have been reported. In addition, one patient had a long term complete response of more than 7 years.

Liver cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. The market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.

The current double blind, placebo-controlled trial, known as LIVERATION, will enroll 450 patients diagnosed with advanced liver cancer (hepato-cellular carcinoma) and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will be randomized to oral treatment with either 25 mg of Namodenoson or a matching placebo, in a ratio of 2:1 given twice daily as a second- or third-line treatment. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

UroGen Pharma to Present at the 45th Annual Goldman Sachs Global Healthcare Conference

On June 5, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that management will participate in a fireside chat at the 45TH Annual Goldman Sachs Global Healthcare Conference to take place June 10-13, 2024 (Press release, UroGen Pharma, JUN 5, 2024, View Source [SID1234644143]).

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Goldman Sachs 45TH Annual Healthcare Conference

Date/ time:

June 11, 2024 at 3:20 PM ET

Format:

Fireside Chat

Location:

Miami, FL

Webcast Link:

here

A webcast from the conference will also be available via the Investors section of UroGen’s corporate website, View Source A replay will be available for approximately 90 days.