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Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer

Retrieved on: 
Sunday, April 7, 2024

The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells.

Key Points: 
  • The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells.
  • The persistence of T cels was associated with a longer median recurrence-free survival in cancer vaccine responders.
  • “These new data are an early signal for the potential of our individualized mRNA cancer vaccine approach in this indication with an unmet medical need.
  • Over 80% of the vaccine-induced neoantigen-specific T cells could still be detected up to three years post administration in patients with an immune response.

GeoVax Presents Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine

Retrieved on: 
Thursday, April 4, 2024

ATLANTA, GA, April 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chief Scientific Officer, Mark Newman, PhD, presented data on GEO-CM04S1, the Company’s next-generation Covid-19 vaccine candidate, during the 24th Annual World Vaccine Congress in Washington, DC.

Key Points: 
  • During his presentation, titled “Vaccine Induction of Broadly-Specific Antibody and T Cell Responses to Combat SARS-CoV-2 Variation”, Dr. Newman described GeoVax’s development program for GEO-CM04S1.
  • The data presented were generated in collaboration with scientists at Georgia State University using the human ACE2 transgenic mice, one of the “gold standard” small animal models used for studying Covid vaccines.
  • GEO-CM04S1 incorporates both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce broadly specific antibody and T cell responses.
  • I anticipate similar findings will be observed in our Phase 2 clinical trials as the studies are unblinded later this year.”

Arbutus Biopharma Announces Claim Construction Ruling in its Ongoing Patent Infringement Lawsuit Against Moderna

Retrieved on: 
Thursday, April 4, 2024

8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19.

Key Points: 
  • 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19.
  • The following summarizes the Court’s Opinion:
    The Court agreed with Plaintiffs’ position that the claimed molar percentage (mol.
  • %) ranges can be met by any particle and is not limited to “finished” particles that are not subjected to further process steps.
  • “We are pleased with how the Court construed the disputed claim terms,” said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus Biopharma.

Molecure has published its financial report for 2023 - the company has significantly accelerated the development of its clinical and pre-clinical programmes and plans to make strong progress in research in 2024 and 2025

Retrieved on: 
Wednesday, April 3, 2024

We initiated clinical trials of our drug candidate, which was discovered and brought into clinical trials for cancer patients by Molecure.

Key Points: 
  • We initiated clinical trials of our drug candidate, which was discovered and brought into clinical trials for cancer patients by Molecure.
  • In 2023, our focus was also on preparing for a Phase II clinical trial for OATD 01, Molecure's flagship clinical programme.
  • We are very pleased to report that the first patient has started dosing in a clinical trial at a clinical site in the UK.
  • The Company plans to obtain further grants for projects within the framework of the pipeline developed so far.

Dyadic Reports 2023 Full Year Results and Recent Company Progress

Retrieved on: 
Thursday, March 28, 2024

“In 2023, Dyadic achieved significant milestones in unlocking the potential of its microbial platforms.

Key Points: 
  • “In 2023, Dyadic achieved significant milestones in unlocking the potential of its microbial platforms.
  • We believe that we are well-positioned, both financially and scientifically, to execute our strategic plan with enhanced capabilities and resources.
  • For the year ended December 31, 2023, the Company received a total of approximately $1.3 million in connection with the sale of Alphazyme LLC.
  • Other Income: For the year ended December 31, 2023, the Company had a gain of approximately $1,018,000 from the sale of the Company’s equity interest in Alphazyme, LLC.

Vivos Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Operational Update

Retrieved on: 
Thursday, March 28, 2024

LITTLETON, Colo., March 28, 2024 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders (including all severities of obstructive sleep apnea (OSA in adults)), today reported financial results and operating highlights for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Importantly, Vivos believes that governmental investigations of unrelated third parties with non-FDA approved products in the sleep apnea treatment space adversely impacted new Vivos case starts and VIP enrollments during 2023.
  • Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance.
  • Since then, we’ve received high levels of inquiries related to our Vivos CARE products that treat OSA in adults.
  • A live webcast of the conference call can be accessed on Vivos’ website at https://vivos.com/investor-relations .

Telesis Bio Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024

In discussing the results, Todd R. Nelson Ph.D., Founder and CEO of Telesis Bio said, “I’m pleased with our operating execution in a challenging macro environment during 2023.

Key Points: 
  • In discussing the results, Todd R. Nelson Ph.D., Founder and CEO of Telesis Bio said, “I’m pleased with our operating execution in a challenging macro environment during 2023.
  • For the fourth quarter of 2023, exclusive of non-cash goodwill impairment, operating expense was $10.8 million, a reduction of 24.4% from the prior year’s fourth quarter level of $14.3 million.
  • Some of these cost reductions were completed late in the year and are not fully reflected in results for the fourth quarter of 2023.
  • Exclusive of a $11.4 million fourth quarter 2023 non-cash charge for goodwill impairment, total operating expense for the quarter was $10.8 million, a $3.5 million or 24.4% reduction from the fourth quarter of 2022.

Cartesian Therapeutics Announces Approval of Conversion of Series A Convertible Preferred Stock and Plans to Effect Reverse Stock Split

Retrieved on: 
Thursday, March 28, 2024

During the meeting, Cartesian stockholders approved the issuance of shares of common stock upon conversion of Cartesian’s Series A Non-Voting Convertible Preferred Stock.

Key Points: 
  • During the meeting, Cartesian stockholders approved the issuance of shares of common stock upon conversion of Cartesian’s Series A Non-Voting Convertible Preferred Stock.
  • In addition, stockholders voted to approve a reverse stock split of Cartesian’s issued and outstanding common stock.
  • The reverse stock split will reduce the number of issued and outstanding shares of the Company’s common stock from approximately 165.5 million shares to approximately 5.5 million shares before the automatic conversion of the Company’s Series A Non-Voting Convertible Preferred Stock into common stock, or approximately 17.8 million shares thereafter.
  • The approximately 166.3 thousand shares of Series A Non-Voting Convertible Preferred Stock that remain subject to beneficial ownership limitations will be convertible into approximately 5.5 million shares of common stock for a total of approximately 23.3 million shares of common stock outstanding once converted.

Omega Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Strategic Update

Retrieved on: 
Thursday, March 28, 2024

Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.

Key Points: 
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $6.2 million, compared to $5.7 million for the fourth quarter of 2022.
  • Net loss for the fourth quarter of 2023 was $20.2 million, compared to $30.8 million for the fourth quarter of 2022.
  • The decrease in net loss for 2023 compared to 2022 was primarily due to decreases in R&D expenses.

IMUNON Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024

LAWRENCEVILLE, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.

Key Points: 
  • “We remain on track to report topline results mid-year from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer.
  • In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study.
  • The Company is hosting a conference call to provide a business update, discuss 2023 financial results and answer questions at 10:00 a.m. Eastern time today.
  • To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON 2023 Earnings Call.