Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that the Company executed a distribution agreement with Nipro Medical Corporation ("Nipro"), as part of Nipro Corporation Japan, a leader in the global healthcare and medical device industry.
Under the terms of the agreement, Rockwell Medical will supply Nipro with the Company's liquid and dry acid and bicarbonate hemodialysis concentrates, as well as its dry acid concentrates mixer, for which Nipro has the right to distribute the Company's products globally, excluding the United States. The agreement will remain in effect for two years with the option to extend the agreement for an additional one-year period and includes product purchasing minimums of $5.0 million for the first year and incremental increases each subsequent year.
Emergent BioSolutions Inc. (NYSE: EBS) today announced the closing of a new credit facility agreement with Oak Hill Advisors for a term loan of up to $250 million (the “New Term Loan”). Emergent used a portion of the proceeds of the New Term Loan to repay all amounts outstanding under the senior term loan facility under the Amended and Restated Credit Agreement, dated October 15, 2018, by and among Emergent, the lenders party thereto from time to time, and Wells Fargo Bank, National Association, as the Administrative Agent (as amended, the “Prior Credit Agreement”), which was scheduled to mature in May 2025. The New Term Loan maturity extends up to five years, through August 2029. Excess proceeds from the refinancing will result in additional cash to the balance sheet. Emergent also terminated its obligations under the senior term loan facility and the revolving credit facility under the Prior Credit Agreement.
“For the past 18 months, Emergent has executed on a series of actions to strengthen the balance sheet and streamline operations,” said Joe Papa, president and CEO of Emergent. “These steps, which include finalizing several asset/site divestures, resolving legacy issues, and now, securing this significant debt refinancing, are critical to stabilizing our financial profile.”
In connection with the execution of the New Term Loan, Emergent issued the lenders warrants to purchase 2.5 million shares of common stock with a strike price at a premium to the volume weighted average price per share for the 30 trading days ending on, but excluding, the 10th business day following the closing date (the “30-Day VWAP”). In addition, subject to certain limitations Emergent agreed to issue the lenders shares of common stock with an aggregate value of $10 million at a price per share equal to the 30-Day VWAP.
Company is debt-free with no outstanding notes
Balance sheet provides sufficient runway for ongoing operations
TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announces dosing of 5 new patients in the ACHIEVE Phase 2b trial ongoing in the UK.
Currently, the trial has successfully dosed 6 patients with their first of 4 possible doses at the higher dose level. Each 5mL dose contains up to 230 million gamma delta T cells, and a patient is expected to receive up to an approximate 1 billion gamma delta T cells over four doses. Five patients have received their second dose, with 2 of these patients having also received their third dose. This correlates with TCBP's step-wise approach to process improvements, as implemented in Q4 2023, and further steps taken to amend the trial protocol in the first quarter of 2024. New patients will continue to be identified, screened, and enrolled into the study.
"TCBP is excited to announce our rapid progression in the ACHIEVE Phase 2b trial with very strong enrolment in the second part of the trial using the higher dose," stated, Bryan Kobel, CEO of TC BioPharm. "TCB008 is potentially a game-changing monotherapy for blood cancers, and the strong recruitment and patient retention rates are testament to clinician/physician interest in TCB008 as a monotherapy in leukemia. We're proud of the milestones accomplished to date, having rapidly dosed 6 patients with an additional 10 patients lined up. It is encouraging to see re-dosing of several patients, which we believe reflects positively on the steps the organization took in 2023 and early 2024. TCBP remains poised to execute on our clinical trial plans in 2024 and into 2025, including ACHIEVE and ACHIEVE2, as well as our expanded manufacturing capabilities to enhance our operational capabilities and our economic efficiencies."
The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease.
Dyne Therapeutics Inc. (NASDAQ:DYN) announced new clinical data from its ongoing Phase 1/2 DELIVER trial of DYNE-251 in patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
This assessment of the DELIVER trial evaluating DYNE-251 includes 6-month biomarker and functional data from 8 male patients enrolled in the 20 mg/kg (approximate PMO dose) cohort who were randomized to receive DYNE-251 or placebo once every four weeks and 12-month functional data from 6 participants in the 10 mg/kg cohort.
At a 20-mg/kg dose level, given every four weeks, DYNE-251 resulted in a mean absolute dystrophin expression of 3.71% of normal, without adjusting for muscle content.
The company noted that the expression level is more than ten times higher than in a reference clinical trial assessing the weekly standard of care treatment Sarepta Therapeutics Inc’s (NASDAQ:SRPT) EXONDYS 51 (eteplirsen), where dystrophin expression was at 0.3% normal.
After controlling for patients’ muscle content, the company said that the mean absolute dystrophin expression jumped to 8.72%, which exceeds levels typically recorded in studies evaluating other investigational oligomers for DMD.
These results are in line with six-month data Dyne released in May for patients treated with the 10-mg/kg dose of DYNE-251.
Patients treated with 10 mg/kg of DYNE-251 Q4W had a mean absolute dystrophin level of 3.22% of normal and a 2.97% change (unadjusted for muscle content) from baseline at six months.
When adjusting for muscle content, the DYNE-251 treated group reached 7.64% mean absolute dystrophin.
Dyne Therapeutics says meaningful improvements in multiple functional endpoints were observed in the 20 mg/kg and 10 mg/kg DYNE-251 Q4W groups. The 10 mg/kg cohort showed continued improvement in all reported measures from 6 to 12 months.
DYNE-251 demonstrated a favorable safety profile, and most treatment-emergent adverse events were mild or moderate.
Dyne says it is initiating registrational cohorts in the DELIVER trial and plans to provide an update on the path to registration by the end of 2024.
https://finance.yahoo.com/news/muscle-disease-drug-developer-dyne-163701392.html
──Reported Positive Phase 2 Results Demonstrating Safety and Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis (PSC)──
──Establishes Clinical Proof-of-Concept for Disease-Modifying Potential of CM-101 and Provides Foundation for Advancing to PSC Phase 3 Pivotal Trial──
──Completed PIPE Financing Including Major New and Existing Investors that Extends Cash Runway Through Beginning of 2026──
──On Track to Achieve Key Clinical Milestones in First Quarter of 2025; Continuing Discussions with Potential Partners──
