As biotech investors know, companies in the industry can sometimes earn significant returns in relatively short periods, like a year, thanks to excellent clinical or regulatory progress. And based on Wall Street's projections, several notable biotechs could see their shares soar in the next 12 months.Of course, it wouldn't be wise to rush to invest in these companies for that reason alone, but it might be worth looking deeper into what the Street considers severely undervalued drugmakers. Read on to learn m ...

Sunshine Biopharma Inc. SBFM traded higher on Wednesday, with a session volume of 19.07 million compared to an average volume of 88.16K, according to data from Benzinga Pro.The company on Wednesday announced that it has completed additional studies on orthotopic human tumor models in mice confirming its K1.1 mRNA Lipid Nanoparticle (K1.1-mRNA-LNP) product as a therapeutic agent for human hepatocellular carcinoma.Human hepatocellular carcinoma (HCC) is the third leading cause of cancer-related deaths worldwi ...

BOSTON, April 02, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced that John Celebi, President and Chief Executive Officer, will participate in the New Radiotherapy and Targeted Therapy Approaches panel at the Canaccord Genuity Horizons in Oncology Virtual Conference on Monday, April 7 at 2:00 p.m. ET. About Sensei Biotherapeutics Sensei Bi ...

Core Insights - Mainz Biomed reported a 33% year-over-year increase in lab network revenue, driven by strong demand for its ColoAlert® product in Europe [1][3] - The company achieved a 30% reduction in operating loss and an 18% decrease in net loss, attributed to targeted cost reductions and a sharper strategic focus [1][3] - Strategic partnerships with industry leaders, including collaborations with Thermo Fisher Scientific and Quest Diagnostics, mark significant progress for the company [3][5] Financial Performance - For the year ended December 31, 2024, Mainz Biomed's revenue was $893,991, slightly down from $895,479 in 2023 [9] - The gross profit increased to $574,883, resulting in a gross margin of 64%, up from 57% in the previous year [9] - Operating expenses decreased significantly to $19,270,291 from $27,154,341 in 2023, leading to a loss from operations of $18,695,408, down from $26,644,682 [10] Strategic Initiatives - The company is focusing on three key initiatives for 2025: expanding the ColoAlert® business in Europe, developing a next-generation colorectal cancer screening product, and conducting a 2,000 patient study (eAArly DETECT 2) [3][5] - Mainz Biomed's eAArly DETECT study demonstrated a 97% sensitivity for colorectal cancer and 82% for advanced precancerous lesions, with 100% detection of high-grade dysplasia in advanced precancerous patients [3][7] Corporate Developments - Mainz Biomed regained compliance with Nasdaq listing requirements, confirming its continued presence on the Nasdaq Capital Market [7] - The company has initiated the eAArly DETECT 2 study, which aims to validate its next-generation colorectal cancer test and is on track to report results by the end of 2025 [7][9] - A license agreement with Liquid Biosciences was signed to access novel mRNA biomarkers for early pancreatic cancer detection, showing promising preliminary results [7][9]

Core Insights - Allarity Therapeutics has made significant advancements in the development of stenoparib, a dual PARP/WNT pathway inhibitor, particularly for advanced ovarian cancer treatment [1][2] - The company has undergone a strategic realignment to focus exclusively on stenoparib, discontinuing other clinical programs, which has accelerated progress in its clinical trials [2][3] - Financially, Allarity has strengthened its position, with a cash balance of approximately $25 million at the end of Q1 2025, providing a runway into 2027 for ongoing clinical activities [2][9] Clinical and Drug Development Progress - In 2024, Allarity executed a strategic realignment to focus solely on stenoparib, leading to accelerated progress in its clinical program [2] - The company reported a cash and cash receivable balance of $20.9 million as of December 31, 2024, which is expected to fund operations into 2027 [2][9] - Stenoparib has shown durable clinical benefits in heavily pre-treated ovarian cancer patients, with some patients remaining on treatment for over 17 months [3][4] Leadership Changes - Thomas Jensen has been appointed as the permanent CEO, transitioning from interim status, with a focus on advancing Allarity's strategic and clinical goals [8] - Key appointments include Jeremy Graff as President and Chief Development Officer, and Jose Iglesias as Consultant Chief Medical Officer, both bringing extensive oncology experience [8] Financial Strengthening and Corporate Development - The company reported a net loss of $24.5 million for 2024, an increase from $11.9 million in 2023, largely due to a non-cash impairment charge and costs related to an SEC investigation [10][21] - Allarity has implemented cost-reduction initiatives to strengthen financial sustainability while prioritizing stenoparib's advancement [8] - A $5 million share repurchase program has been authorized to reinforce long-term shareholder value [8] Regulatory and Compliance Resolutions - Allarity has resolved outstanding regulatory matters with the SEC related to past disclosures, allowing the company to focus on clinical and corporate progress [8] - The company regained compliance with Nasdaq listing requirements following a successful hearing [8]

For more details visit: www.aacr.org/meeting/aacr-annual-meeting-2025/abstracts. About IN8bio IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer and autoimmune diseases. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company's lead program, INB-100, is focused on acute myeloid leukemia evaluating haplo-matched allogeneic ...

Core Insights - Elicio Therapeutics has made significant advancements in its cancer immunotherapy pipeline, notably completing enrollment in its first randomized Phase 2 clinical trial, AMPLIFY-7P, which is expected to yield interim analysis results in Q3 2025 [2][5] - The company has aligned with the FDA on key elements for the Phase 3 study design of ELI-002, focusing on dose, patient population, and primary endpoint analysis [1][5] - Elicio has strengthened its cash position, with expectations to support operations into Q4 2025, beyond the upcoming interim analysis [1][8] Recent Highlights - Elicio presented promising Phase 1a data for ELI-002, showing a strong correlation between T cell response and anti-tumor activity across two monotherapy trials involving 39 patients [2] - The Phase 2 AMPLIFY-7P trial has successfully enrolled 144 patients with post-resection mKRAS pancreatic ductal adenocarcinoma, randomized 2:1 to receive ELI-002 or standard care [5] - Updated results from the Phase 1a AMPLIFY-201 trial indicated a median recurrence-free survival of 16.3 months and a median overall survival of 28.9 months [5] Financial Overview - Research and development expenses for 2024 were $33.7 million, up from $23.8 million in 2023, primarily due to clinical trial costs [6] - General and administrative expenses decreased slightly to $11.3 million in 2024 from $11.9 million in 2023 [6] - The net loss for 2024 was $51.9 million, compared to $35.2 million in 2023, with a net loss per share of $4.25 [7] Cash Position - As of December 31, 2024, Elicio had cash and cash equivalents of $17.6 million, an increase from $12.9 million in 2023 [7][10] - The company anticipates that its current cash position, bolstered by a $10 million direct offering in January 2025, will support operations into Q4 2025 [8] Upcoming Milestones - The DFS event-driven interim analysis for the Phase 2 AMPLIFY-7P trial is expected in Q3 2025, contingent on the rate of event accrual [5] - Elicio aims to finalize the pivotal Phase 3 trial protocol for ELI-002 in resected mKRAS pancreatic ductal adenocarcinoma in the second half of 2025 [5]

GeoVax Labs (GOVX) Q4 2024 Earnings Call March 27, 2025 04:30 PM ET Company Participants David Dodd - Chairman, President & CEOMark Reynolds - CFOJohn Sharkey - Vice President of Business DevelopmentKelly McKee - Chief Medical OfficerLaura Suriel - Equity Research Associate Conference Call Participants Max Gadicke - Investor relations & Senior AnalystJonathan Aschoff - Managing Director, Senior Research AnalystRobert Leboyer - Senior Biotechnology Analyst Operator Good afternoon, and welcome everyone to the ...

Core Insights - Mainz Biomed has initiated the eAArly DETECT 2 study to evaluate its next-generation colorectal cancer test, aiming to confirm previous results in detecting advanced precancerous lesions [1][2][3] - The study will enroll approximately 2,000 average-risk patients and is expected to report top-line results in the fourth quarter of 2025 [1][2] - The company plans to finalize protocols for its U.S. pivotal study, ReconAAsense, based on the outcomes of the eAArly DETECT 2 study, with initiation targeted for 2026 [2] Group 1 - The eAArly DETECT 2 study aims to validate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which can identify advanced adenomas and early-stage colorectal cancer [3] - The study integrates proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test to enhance diagnostic sensitivity and specificity for early-stage colorectal cancer [1][3] - The first patient has been enrolled, marking the formal commencement of the study after months of preparatory work [3] Group 2 - Mainz Biomed's flagship product, ColoAlert®, is a non-invasive early-detection diagnostic test for colorectal cancer, currently marketed across Europe [4] - The company is also developing PancAlert, an early-stage pancreatic cancer screening test based on real-time PCR multiplex detection of molecular-genetic biomarkers [4]

Core Insights - LIXTE Biotechnology Holdings, Inc. has initiated two new clinical trials in collaboration with MD Anderson and the Netherlands Cancer Institute, focusing on treatments for ovarian and colorectal cancer [1][3] - The company has secured an exclusive patent license agreement with the NIH for LB-100, which aims to enhance cancer immunotherapies [1] - Recent publications in prominent medical journals EMBO and Cancer Discovery support LIXTE's clinical trial program, highlighting the potential of LB-100 in cancer treatment [1][6] Clinical Trials - LIXTE is conducting trials for ovarian cancer at M.D. Anderson Cancer Center and Northwestern University, with support from GSK [2][3] - A colorectal cancer trial is being conducted at the Netherlands Cancer Institute, supported by F. Hoffmann-La Roche [3][6] - The first patient has been dosed in a Phase 1b/2 trial combining LB-100 with GSK's immunotherapy for ovarian clear cell carcinoma [6] Intellectual Property and Research - LIXTE has received a Notice of Allowance from the USPTO for a patent related to the modulation of immune response using LB-100 [6] - Studies published in Cancer Discovery and EMBO indicate that LB-100 can alter cancer cells to enhance their vulnerability to immunotherapy [6] Financial Activities - The company completed a registered direct offering, raising approximately $1,050,000 for working capital and corporate purposes [6]