Clinical trial

Dyadic Announces Closing of Private Placement of $6.0 Million Convertible Notes to Accelerate Near-Term Revenue Growth and Commercialization

Retrieved on: 
Monday, March 11, 2024

The Convertible Notes will be senior, secured obligations of Dyadic and its affiliates, and interest will be payable quarterly in cash on the principal amount equal to 8% per annum.

Key Points: 
  • The Convertible Notes will be senior, secured obligations of Dyadic and its affiliates, and interest will be payable quarterly in cash on the principal amount equal to 8% per annum.
  • The Convertible Notes will mature on March 8, 2027 (the “Maturity Date”), unless earlier converted, repurchased, or redeemed in accordance with the terms of the Convertible Notes.
  • The Convertible Notes will be convertible into shares of Dyadic’s Class A common stock (the “Common Stock”), at the option of the holders of the Convertible Notes (the “Noteholders”) at any time prior to the Maturity Date.
  • “I would like to extend our gratitude to long-term shareholders for their steadfast support.

Lexicon Pharmaceuticals Reports Fourth Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024

ET

Key Points: 
  • ET
    THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended December 31, 2023 and provided an update on key corporate milestones.
  • “2023 was a pivotal year for Lexicon,” said Lonnel Coats, Lexicon’s chief executive officer.
  • Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2023 compared to the fourth quarter and full year of 2022.
  • Revenues: Revenues for the fourth quarter and full year of 2023 were $0.7 million and $1.2 million, respectively, primarily from the commercialization of INPEFA.

INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps

Retrieved on: 
Monday, March 11, 2024

INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.

Key Points: 
  • INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
  • “In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.”
    INHALE-3 is a 17-week randomized controlled trial with a 13-week extension.
  • Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label.
  • For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal.

BioNTech to Present Clinical Data Updates for Personalized mRNA-based and Targeted Oncology Candidates at AACR 2024

Retrieved on: 
Monday, March 11, 2024

MAINZ, Germany, March 11, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected candidates from its oncology pipeline at the American Association for Cancer Research (“AACR”) Annual Meeting 2024 in San Diego, California, from April 5-10, 2024.

Key Points: 
  • MAINZ, Germany, March 11, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected candidates from its oncology pipeline at the American Association for Cancer Research (“AACR”) Annual Meeting 2024 in San Diego, California, from April 5-10, 2024.
  • The oral and poster presentations will feature BioNTech’s investigational mRNA-based cancer vaccine and novel investigational antibody-drug conjugate (“ADC”) approaches.
  • BioNTech has established a diversified clinical oncology pipeline of more than 20 clinical programs along mRNA-based therapeutic cancer vaccines, targeted therapies comprising cell therapies and ADCs, and novel immunomodulators in unmet medical need solid tumor indications.
  • These candidates are currently being evaluated in more than 30 clinical studies, including nine programs in advanced Phase 2 trials and two candidates in pivotal Phase 3 trials.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Mobileye, BioVie, ADM, and B. Riley and Encourages Investors to Contact the Firm

Retrieved on: 
Sunday, March 10, 2024

Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.

Key Points: 
  • Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.
  • Upon trial completion, the Company found significant deviation from protocol and Good Clinical Practice (GCP) violations at 15 sites.
  • As alleged, Defendants’ accounting practices for the segment misrepresented its true financial results and prospects, including its operating profits (“OP”).
  • For more information on the B. Riley class action go to: https://bespc.com/cases/RILY

MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day

Retrieved on: 
Sunday, March 10, 2024

In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.

Key Points: 
  • In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.
  • Treatment with sonelokimab resulted in unprecedented improvements in composite scores that reflect responses in different domains simultaneously.
  • In all composite scores, sonelokimab showed 16-29 percentage point differences to the reference adalimumab arm, comparatively higher to competitors using the same reference arm.
  • The discontinuation rate of the second part of ARGO remained low at 5%, in line with other sonelokimab trials.

Alumis Presents Positive Data from Phase 2 Clinical Trial of ESK-001, an Oral Allosteric TYK2 Inhibitor for the Treatment of Plaque Psoriasis, at AAD Annual Meeting

Retrieved on: 
Saturday, March 9, 2024

SOUTH SAN FRANCISCO, Calif., March 09, 2024 (GLOBE NEWSWIRE) -- Alumis Inc., a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced the presentation of positive clinical data from a Phase 2 clinical trial of ESK-001, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate-to-severe plaque psoriasis. These data were presented during a late-breaking session at the American Academy of Dermatology (AAD) Annual Meeting being held March 8-12 in San Diego, California.

Key Points: 
  • These data were presented during a late-breaking session at the American Academy of Dermatology (AAD) Annual Meeting being held March 8-12 in San Diego, California.
  • The STRIDE trial enrolled 228 patients who were randomized to one of five ESK-001 dose cohorts, or placebo.
  • These data support the planned initiation of Phase 3 clinical trials of ESK-001 in moderate-to-severe plaque psoriasis in the second half of 2024.
  • “The Phase 2 clinical program was designed to evaluate the effect of different degrees of target inhibition on safety and clinical efficacy in psoriasis.

SciSparc Announces Enrollment of First Patient for its Clinical Trial for Children with Autism Spectrum Disorder

Retrieved on: 
Friday, March 8, 2024

“Scientific innovation cannot forge ahead without patients that are willing to work with the scientific community by participating in clinical trials.

Key Points: 
  • “Scientific innovation cannot forge ahead without patients that are willing to work with the scientific community by participating in clinical trials.
  • The enrollment of our first patient means that we are moving towards a new frontier in the treatment of ASD,” said Oz Adler, SciSparc’s Chief Executive Officer.
  • “We are pleased to enroll the first patient in the trial, which will further our understanding of the potential role of SCI-210 in the treatment of ASD symptoms."
  • The Company's goal is to sell SCI-210 first in Israel and then in other countries, subject to obtaining the requisite regulatory approvals.

Bio-Path Holdings Reports Full Year 2023 Financial Results

Retrieved on: 
Friday, March 8, 2024

“2023 was a year of focused execution, as evidenced by the continued progress across our pipeline of DNAbilize programs,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

Key Points: 
  • “2023 was a year of focused execution, as evidenced by the continued progress across our pipeline of DNAbilize programs,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.
  • As of December 31, 2023, the Company had cash of $1.1 million, compared to $10.4 million as of December 31, 2022.
  • Net cash provided by financing activities for the year ended December 31, 2023 was $2.2 million.
  • ET to review these full-year 2023 financial results and to provide a general update on the Company.

IGM Biosciences Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 7, 2024

MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.

Key Points: 
  • MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.
  • Collaboration Revenue: For the fourth quarter and year ended 2023, collaboration revenues were $0.7 million and $2.1 million, respectively, compared to $0.4 million and $1.1 million for the fourth quarter and year ended 2022, respectively.
  • Research and Development (R&D) Expenses: For the fourth quarter and year ended 2023, R&D expenses were $54.2 million and $215.5 million, respectively, compared to $45.0 million and $179.3 million for the fourth quarter and year ended 2022, respectively.
  • General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2023, G&A expenses were $11.6 million and $50.1 million, respectively, compared to $11.6 million and $49.7 million for the fourth quarter and year ended 2022, respectively.