Part 1

Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024
Central nervous system, Quarter, EMA, Focal seizure, Research, New Drug Application, UCB, FDA, Partnership, Food, Part, Quantitative electroencephalography, SCN8A, Tremor, SCN2A, Safety, PPR, European Medicines Agency, CNS, EEG, Pharmacokinetics, Part 1, Patient, Essential tremor, Medicine, Epilepsy, DEE, Trial of the century, NDA, Ageing, Central nervous system disease, Seizure, Pharmaceutical industry

Fourth Quarter and Full Year 2023 Financial Results:

Key Points: 
  • Fourth Quarter and Full Year 2023 Financial Results:
    As of December 31, 2023, Praxis had $81.3 million in cash and cash equivalents, compared to $100.5 million in cash, cash equivalents and marketable securities as of December 31, 2022.
  • Research and development expenses were $18.4 million for the fourth quarter of 2023, compared to $28.3 million for the fourth quarter of 2022.
  • General and administrative expenses were $9.9 million for the fourth quarter of 2023, compared to $13.1 million for the fourth quarter of 2022.
  • Praxis incurred a net loss of $26.9 million for the fourth quarter of 2023, including $5.7 million of stock-based compensation expense, compared to $41.2 million for the fourth quarter of 2022, including $6.4 million of stock-based compensation expense.

Navitas Semiconductor Announces Record Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 29, 2024
Internet, EV, Failure, Silicon, Zeekr, Research, Epidemic, Part, Growth, OPPO, Samsung, Original equipment manufacturer, BYD, Conference, Smart, GAAP, COVID-19, Silicon carbide, Part 1, Geely, Gallium nitride, Probability, Risk, Volvo, Hyundai, Video game

Gross Margin: GAAP gross margin for the fourth quarter of 2023 was 42.2%, compared to 40.6% in the fourth quarter of 2022 and 32.3% for the third quarter of 2023.

Key Points: 
  • Gross Margin: GAAP gross margin for the fourth quarter of 2023 was 42.2%, compared to 40.6% in the fourth quarter of 2022 and 32.3% for the third quarter of 2023.
  • Non-GAAP gross margin for the fourth quarter of 2023 was 42.2% compared to 40.6% for the fourth quarter of 2022 and 42.1% for the third quarter of 2023.
  • Loss from Operations: GAAP loss from operations for the quarter was $26.8 million, compared to a loss of $31.2 million for the fourth quarter of 2022 and a loss of $28.6 million for the third quarter of 2023.
  • On a non-GAAP basis, loss from operations for the quarter was $9.7 million compared to a loss of $12.4 million for the fourth quarter of 2022 and a loss of $8.7 million for the third quarter of 2023.

Merakris Therapeutics to Release Final Part 1 Data From Phase 2 Multicenter Investigational Drug Study for Dermacyte® Liquid

Retrieved on: 
Tuesday, February 20, 2024
Research Triangle Park, Triangle Park (Quezon City), FDA, Part, Vein, Leg, Skin, Conference, Veterans' affairs, Safety, Therapy, Patent, Part 1, Patient, PST, Clinical trial, Ulcer, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Merakris Therapeutics announced that it will present encouraging safety and efficacy data from the first of a two-part Phase 2 multi-center clinical study of its investigational wound care drug, Dermacyte® Amniotic Wound Care Liquid.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Merakris Therapeutics announced that it will present encouraging safety and efficacy data from the first of a two-part Phase 2 multi-center clinical study of its investigational wound care drug, Dermacyte® Amniotic Wound Care Liquid.
  • The study consented 12 patients who were assessed for eligibility to receive the investigational drug treatment.
  • Preliminary data indicate an 84% average reduction in ulcer surface area for the 9 patients completing the 12-week study.
  • These data are being analyzed by the Merakris scientific team and an independent data safety and monitoring committee and will inform the design of Part 2 of the multi-center clinical study.

Addex ADX71149 Epilepsy Phase 2 Study Completes Recruitment of Patients

Retrieved on: 
Tuesday, November 14, 2023
ClinicalTrials.gov, Safety, Johnson & Johnson, Therapy, Janssen Pharmaceuticals, Cohort, Patient, ADX71149, Part, PAM, Pharmacokinetics, Levetiracetam, Trial of the century, Part 1, IRC, Seizure, Janssen, SIX, Glutamic acid, Part Two, Pharmaceutical industry

53 LR

Key Points: 
  • 53 LR
    Geneva, Switzerland, November 14, 2023 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today announced that the last patient has been randomized in Cohort 2 of the ADX71149 (JNJ-40411813) Phase 2 epilepsy clinical study.
  • The primary efficacy endpoint of this study is time to baseline monthly seizure count.
  • The multi-center Phase 2 study has been designed to assess the efficacy, safety, tolerability, and pharmacokinetics of adjunctive ADX71149 administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam.
  • In addition, patients who complete Part 1 and/or Part 2 of the study have the option to continue treatment in the open-label extension part of the study, which evaluates the long-term efficacy and safety of ADX71149.

BiomX Announces Completion of Patient Dosing in Part 2 of the Phase 1b/2a Study Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

Retrieved on: 
Wednesday, October 4, 2023
Part 1, Trial of the century, Phage therapy, Cystic fibrosis, Part, ECFS, Fright Night Part 2, ERS, Pseudomonas aeruginosa, Congress, Patient, Randomness, Nebulizer, European Respiratory Society, NESS, CF, NYSE, Pharmaceutical industry

CAMBRIDGE, Mass. and NESS ZIONA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the completion of patient dosing in Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”). The Company remains on track to report results from Part 2 of the study in November 2023.

Key Points: 
  • and NESS ZIONA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the completion of patient dosing in Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”).
  • The Company remains on track to report results from Part 2 of the study in November 2023.
  • “BX004 has been designed to address a significant unmet need facing thousands of CF patients who require new treatments to combat persistent and deadly lung infections,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • “With patient dosing now complete in Part 2 of our Phase 1b/2a study, we remain on track to announce results next month.

Homeworld Collective Launches To Unite and Enable Climate Biotechnology Community

Retrieved on: 
Thursday, September 21, 2023
Carbon, Part 1, Schmidt Futures, Optimism, Biotechnology, Education, Life, Seed, Fast Grants, NSF, National Science Foundation, Agriculture, EST, Research, Medicine, Part, Ministry of Energy, Attitude, Science, Interest, CDR, Essay, Climate change, Publication, IPCC, Mining, Doe, Fellow, Protein engineering, Biology, Knowledge, Growth, Climate, Environment, Homeworld, Health, AlphaFold, Renewable energy, Pharmaceutical industry

BOSTON, Sept. 21, 2023 /PRNewswire-PRWeb/ -- Homeworld Collective, the 501(c)(3) nonprofit igniting the growth of climate biotechnology, today introduced their nonprofit as the go-to source for scientists, technologists, entrepreneurs, and funders committed to maximizing the impact of climate biotechnology for planetary health. The launch also coincides with the announcement of their grantmaking system for building the field of climate biotech, Homeworld Garden Grants. In its first cycle, Homeworld Collective will deploy $1M in funding for climate biotech. The organization's goal is to foster a cohesive community across academia, industry, and funders in climate biotech that is organized around clear pathways to impact and develop viable solutions for problems plaguing our planet.

Key Points: 
  • Daniel Goodwin, Ph.D., and Paul Reginato, Ph.D., founders of Homeworld Collective, began building their global community in 2019 after recognizing the dire lack of community, resources, funding, and education in the field of climate biotechnology.
  • Having started as an informal community, Homeworld Collective was officially established as a nonprofit in 2022.
  • "We are empowering an attitude of action-oriented climate optimism," said Paul Reginato, Founding Co-Director of Homeworld Collective.
  • In contrast, climate biotechnology currently lacks the social infrastructure and problem maps that can enable people to connect to impactful work.

Addex ADX71149 Phase 2 Epilepsy Study Expected to Readout Data in Q2 2024

Retrieved on: 
Tuesday, September 5, 2023
Part 1, Epilepsy, Maintenance, IRC, Levetiracetam, PAM, ADX71149, Cohort, LR, Pharmacokinetics, Part, Trial of the century, Janssen Pharmaceuticals, Glutamic acid, Patient, Part Two, Seizure, Johnson & Johnson, Therapy, SIX, ClinicalTrials.gov, Safety, Pharmaceutical industry

Results evaluating the efficacy, safety and tolerability of ADX71149 in combination with levetiracetam or brivaracetam from patient Cohorts 1 and Cohort 2 are anticipated for the second quarter of 2024.

Key Points: 
  • Results evaluating the efficacy, safety and tolerability of ADX71149 in combination with levetiracetam or brivaracetam from patient Cohorts 1 and Cohort 2 are anticipated for the second quarter of 2024.
  • The primary efficacy endpoint of this study is time to baseline monthly seizure count.
  • Collaboration partner Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is responsible for the clinical development of ADX71149.
  • The primary objective of the study is to evaluate the efficacy of ADX71149 in combination with levetiracetam or brivaracetam using a time to baseline seizure count endpoint.

Introducing "Viewpoints": A Public Safety Podcast Powered by Equature

Retrieved on: 
Wednesday, August 23, 2023
POV, Parent, Human, Kid, Part 1, Family, Part, Viewpoints

SOUTHFIELD, Mich., Aug. 23, 2023 /PRNewswire/ -- Public safety professionals nationwide are invited to gain fresh perspectives and valuable insights through "Viewpoints", a podcast proudly powered by Equature.

Key Points: 
  • SOUTHFIELD, Mich., Aug. 23, 2023 /PRNewswire/ -- Public safety professionals nationwide are invited to gain fresh perspectives and valuable insights through "Viewpoints", a podcast proudly powered by Equature.
  • Since its inception in January 2022, this dynamic podcast has aimed to spark meaningful conversations on the public safety profession.
  • The public safety sector is an intricate field that demands dedication and a nuanced understanding of the communities it serves.
  • Cherie Bartram, an experienced, respected voice in public safety, guides listeners through a myriad of topics crucial to the world of public safety.

Zealand Pharma Announces Financial Results for the First Half of 2023

Retrieved on: 
Thursday, August 17, 2023
DREAM, Part 1, SBS, Danske Bank, Maintenance, US Foods, Partnership, Obesity, AE, NASH, Diabetes, Half-life, European Medicines Agency, Line of credit, Weight loss, Aes, NDA, DKK, SAD, G&A, Part, Short bowel syndrome, EMA, Boehringer Ingelheim, Plasma, US, Hypoglycemia, Patient, American Diabetes Association, RCF, Novo Nordisk, Part Two, Overweight, GIP, MAD, MAA, KCNA3, Ageing, BMI, S&M, FDA, Zealand Pharma, ADA, Credit, Food, Pharmacotherapy, Safety, Congenital hyperinsulinism, Pharmaceutical industry, Birth control, CHI

Zealand Pharma is on track to submit the NDA to the US FDA in the second half of 2023.

Key Points: 
  • Zealand Pharma is on track to submit the NDA to the US FDA in the second half of 2023.
  • In the second half of 2023, Zealand aims to enter into a partnership agreement for the commercialization of dasiglucagon in CHI.
  • Boehringer Ingelheim and Zealand Pharma expect to report topline results from the Phase 2 trial with survodutide in NASH in the first half of 2024.
  • Zealand expects to complete pre-clinical activities in the second half of 2023 for the investigational long-acting complement inhibitor.

Indaptus Therapeutics Announces Opening of Next Cohort in Single Dose Ranging Study of Decoy20

Retrieved on: 
Thursday, August 10, 2023
Part 1, Blood pressure, CSO, Chills, Fever, Aes, Toxicity, LPS, Temperature, TLR4, Vomiting, Plasma, Patient, Nausea, Chemokine, Heart rate, Recommended exposure limit, Therapy, Safety, Fatigue, Protocol, Pharmaceutical industry, Vaccine

Four patients were enrolled and evaluable in this cohort.

Key Points: 
  • Four patients were enrolled and evaluable in this cohort.
  • Overall, patients experienced symptoms or adverse events (AEs) that were short-lived and consistent with the mechanism of action of Decoy20.
  • “The safety profile exhibited among the first cohort of patients in our Phase 1 dose ranging study was consistent with the Decoy20 mechanism of action.
  • We expect the enrollment of the next cohort will bring us closer to determination of the recommended phase 2 dose for the multi-dosing part of the trial.