Survival

Lyell Immunopharma Reports Business Highlights and Financial Results for the Fourth Quarter and Full Year 2023

Retrieved on: 
Wednesday, February 28, 2024

The study includes patients with relapsed or refractory triple-negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC).

Key Points: 
  • The study includes patients with relapsed or refractory triple-negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC).
  • The increase in fourth quarter 2023 non-GAAP R&D expenses was driven by an increase in research and laboratory costs primarily associated with clinical trials.
  • The decrease in both fourth quarter 2023 and annual 2023 G&A expenses were both primarily driven by decreases in non-cash stock-based compensation.
  • The decrease in 2023 non-GAAP G&A expenses was driven by a decrease in legal and corporate expenses.

Longeveron Reports Year-End 2023 Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 27, 2024

Grant revenue for the years ended December 31, 2023 and 2022 was less than $0.1 million and $0.3 million, respectively.

Key Points: 
  • Grant revenue for the years ended December 31, 2023 and 2022 was less than $0.1 million and $0.3 million, respectively.
  • Other Expense (Income), net: Other expense for the years ended December 31, 2023 and 2023 was $0.4 million and $0.8 million, respectively.
  • Other expense for 2023 decreased mainly as a result of non-operating lawsuit expenses of $1.4 million in 2022, compared to less than $0.1 million in 2023.
  • ET to discuss the Company’s third quarter 2023 financial results and provide a business update.

Memorial Sloan Kettering Cancer Center Now Enrolling Patients in Phase 1/2 Clinical Trial of IMUNON’s IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer

Retrieved on: 
Tuesday, February 27, 2024

LAWRENCEVILLE, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer. IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in the Phase 2 OVATION 2 Study for the localized treatment of advanced ovarian cancer.

Key Points: 
  • LAWRENCEVILLE, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer.
  • IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in the Phase 2 OVATION 2 Study for the localized treatment of advanced ovarian cancer.
  • We believe this combination therapy holds promise based on our preclinical animal studies, which showed strong synergies between IMNN-001 and bevacizumab.
  • Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy plus bevacizumab vs. chemotherapy plus bevacizumab and IMNN-001.

Snail’s Innovates Development Pipeline with AI Technology

Retrieved on: 
Tuesday, February 27, 2024

By consistently evaluating the latest AI tools, Snail Games is introducing pivotal advancements in game development.

Key Points: 
  • By consistently evaluating the latest AI tools, Snail Games is introducing pivotal advancements in game development.
  • The Company is transforming the art pipeline with cutting-edge text-to-3D model technology and pioneering the generation of resources and biomes on a planetary scale.
  • These AI-driven innovations are not only enhancing development efficiency but also enabling the creation of more immersive and engaging gaming worlds.
  • “Our evaluation and integration of AI technology into our development process is a step forward in our mission to deliver high-quality, engaging, and accessible games,” said Jim Tsai, CEO of Snail, Inc. “Our major endeavors are grounded in our player-first strategy and our exploration of new frontiers in game development.”

Krystal Biotech Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Monday, February 26, 2024

(the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today reported financial results and key business updates for the fourth quarter and year ending December 31, 2023.

Key Points: 
  • (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today reported financial results and key business updates for the fourth quarter and year ending December 31, 2023.
  • Financial results for the quarter ended December 31, 2023:
    Cash, cash equivalents, and investments totaled $594.1 million on December 31, 2023.
  • The Company recorded net product revenue of $42.1 million from sales of VYJUVEK during the quarter ended December 31, 2023.
  • For additional information on the Company’s financial results for the year ended December 31, 2023, please refer to the Form 10-K filed with the Securities and Exchange Commission.

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 26, 2024

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.

Celldex Therapeutics Presents Positive 12 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria

Retrieved on: 
Saturday, February 24, 2024

HAMPTON, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease. The studies will continue dosing patients until week 52. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Treatment options for patients with CSU are limited and there are no approved therapies for patients who are not adequately controlled by omalizumab. The data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin, in a late breaking oral presentation (L18) as part of the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2024.

Key Points: 
  • HAMPTON, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease.
  • Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival.
  • CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes.
  • Importantly, barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.

Biodexa Announces Positive Top Line Phase I Clinical Trial Results for Diffuse Midline Glioma and Provides R&D Update

Retrieved on: 
Friday, February 23, 2024

Nine patients were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M group (optimal dose), n=2).

Key Points: 
  • Nine patients were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M group (optimal dose), n=2).
  • Although the study was not powered to reliably demonstrate efficacy, median overall survival (OS) of patients in the study was 16.5 months.
  • This compares favourably with median survival rate in a cohort of 316 cases of 10.0 months (Jansen et al, 2015.
  • The results of the experiment were inconclusive in that they did not correlate with the results previously seen in in vitro and in vivo studies of tolimidone.

Athira Pharma Reports Full Year 2023 Financial Results and Pipeline and Business Updates

Retrieved on: 
Thursday, February 22, 2024

BOTHELL, Wash., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today reported financial results for the year ended December 31, 2023, and reviewed recent pipeline and business updates.

Key Points: 
  • In December 2023, the Company announced encouraging results from the exploratory Phase 2 SHAPE clinical trial to evaluate fosgonimeton in patients with Parkinson's disease dementia and dementia with Lewy bodies.
  • In May 2023, Athira selected the 40 mg dose for further development and potential regulatory approval.
  • In January 2024, Athira completed enrollment of the LIFT-AD study, randomizing approximately 315 patients in the primary analysis population.
  • In December 2023, Athira announced encouraging results from the exploratory SHAPE Phase 2 clinical trial of fosgonimeton for the potential treatment of Parkinson's disease dementia and dementia with Lewy bodies.

Challenges for the Restaurant Industry Persist into 2024 after Record Breaking Bankruptcies

Retrieved on: 
Thursday, February 22, 2024

Toronto, Feb. 22, 2024 (GLOBE NEWSWIRE) -- The restaurant industry is preparing for a tough first half of 2024.

Key Points: 
  • Toronto, Feb. 22, 2024 (GLOBE NEWSWIRE) -- The restaurant industry is preparing for a tough first half of 2024.
  • It also leads to a notable upsurge in closures in 2023, with bankruptcies up 44% – the highest annual figure in a decade.
  • One of the main factors driving this difficult environment is weak sales, which are expected to persist in winter/spring of 2024.
  • Overall annual full-service restaurant sales are forecast to grow by a modest 2.8% in 2024, followed by a 4.9% increase in 2025.