Glufosfamide

Eleison to leverage BullFrog Data Networks™ to enhance patient clustering and safety analysis in glufosfamide clinical trials GAITHERSBURG, Md., Feb. 27, 2025 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) (“BullFrog AI” or the “Company”), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, today announced its entry into a collaboration agreement with Eleison Pharmaceuticals Inc. (“Eleison”), a Phase 3 oncology company focused on novel chemotherapeutic treatments for rare cancers. Under the terms of the agreement, BullFrog AI will provide access to its BullFrog Data Networks™ AI solution to enhance clinical trial efficiency and patient insights. Financial terms of the collaboration were not disclosed. “The integration of artificial intelligence in clinical trials represents a transformative shift in how pharmaceutical companies can de-risk drug development and optimize patient outcomes,” said Vin Singh, CEO of BullFrog AI. “We are thrilled to partner with Eleison to apply our bfLEAP® AI technology, which has the potential to refine patient selection, improve trial efficiency, and ultimately accelerate the path to market for life-saving therapies.” Through this collaboration, BullFrog AI will apply its proprietary BullFrog Data Networks™ solution, powered by the bfLEAP® platform, to analyze clinical data from Eleison’s ongoing Phase 3 trial and previous clinical studies of glufosfamide, an investigational treatment for pancreatic cancer. The platform will evaluate the current trajectory of the trial with respect to safety signals, extract predictive biomarkers for efficacy and safety performance from prior studies to support future trial design, and provide data-driven insights to optimize Eleison’s planned clinical trials for inhaled lipid-complexed cisplatin (ILC) and dibromodulcitol (DBD). These insights are expected to streamline trial efficiency and improve decision-making for Eleison’s broader oncology pipeline. Glufosfamide is a third-generation alkylating agent designed for greater specificity and tumor uptake, with reduced systemic toxicities and side effects. It is currently being evaluated by Eleison in a pivotal Phase 3 international randomized clinical trial, for the second-line treatment of patients with pancreatic cancer. Although pancreatic cancer is among the rarer cancer types, it is the third leading cause of death by cancer in the United States. More than 67,000 Americans and 510,000 people worldwide are diagnosed with pancreatic cancer annually. Few therapeutic options exist to treat the disease and five-year survival rates are typically less than 5%. Eleison expects to complete this ongoing Phase 3 trial in 2027. “Our collaboration with BullFrog AI underscores our commitment to innovation in drug development,” said Edwin Thomas, CEO of Eleison. “By leveraging AI-powered analytics, we aim to generate deeper insights into patient responses and safety trends, which will not only benefit our glufosfamide program but also inform the strategic direction of our broader oncology pipeline.” About BullFrog AI BullFrog AI leverages Artificial Intelligence and machine learning to advance drug discovery and development. Through collaborations with leading research institutions, BullFrog AI uses causal AI in combination with its proprietary bfLEAP™ platform to analyze complex biological data, aiming to streamline therapeutics development and reduce failure rates in clinical trials. For more information, visit BullFrog AI at: https://bullfrogai.com About Eleison Pharmaceuticals Eleison’s mission is to acquire and develop drug candidates with existing and significant safety and efficacy data; and ultimately to obtain regulatory approval and commercialize new therapeutics for patients with life-threatening cancers. In addition to its glufosfamide program, the Company has two other programs in late-stage clinical development; ILC in development for small cell lung cancer and pediatric osteosarcoma, and DBD for brain cancers. The Company has entered into development and marketing partnerships with leading pharmaceutical companies in China, S. Korea, and Israel. Eleison was founded in 2009 and is headquartered in Princeton, NJ. Additional information about Eleison can be found at our website www.eleison-pharma.com. Safe Harbor Statement This press release contains forward-looking statements. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as "may," "should," “could,” “will,” "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes" or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur. Contact: Dave Gentry RedChip Companies, Inc. 1-407-644-4256 BFRG@redchip.com Released February 27, 2025

REDWOOD CITY, Calif., May 10 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. , today reported financial results for the first quarter ended March 31, 2006. The net loss for the first quarter of 2006 was $13.8 million compared to $7.5 million for the first quarter of 2005. Research and development expenses were $11.4 million for the first quarter of 2006 versus $5.3 million for the first quarter of 2005. The increase in research and development expenses primarily reflects increased costs of advancing the Company's product pipeline, including Phase 2 and Phase 3 multi-center clinical trials of TH-070 for the treatment of benign prostatic hyperplasia (BPH), an ongoing Phase 3 trial of glufosfamide for the second-line treatment of patients with pancreatic cancer and a Phase 2 trial of glufosfamide in combination with gemcitabine for the first-line treatment of pancreatic cancer. General and administrative expenses were $3.8 million for the first quarter of 2006 versus $2.6 million for the same quarter last year. The increase in general and administrative expenses primarily reflects increased costs associated with being a public company and stock compensation expense recognized under FAS 123(R). Total non-cash stock compensation expense for the Company was $3.0 million for the first quarter of 2006 versus $1.6 million for the first quarter of 2005. Approximately $1.3 million of the increase in non-cash stock compensation is a direct result of adopting FAS 123(R) on January 1, 2006 which requires public companies to expense employee stock awards based on a fair value. The Company recognized revenue of $0.4 million in the first quarter of 2006. As of March 31, 2006, Threshold had $87.4 million in cash and marketable securities. "We continued to achieve our clinical milestones with the completion of enrollment in both the Phase 2 and Phase 3 trials of TH-070 in BPH, and we expect to report the results of these trials around the beginning of the fourth quarter," said Barry Selick, Threshold's chief executive officer. "We are also on track to report results from the Phase 3 glufosfamide trial in second-line pancreatic cancer patients by the end of this year as well." Recent Highlights -- Completed enrollment of Phase 3 trial of TH-070 in BPH patients; -- Completed enrollment of Phase 2 trial of TH-070 in BPH patients; -- Presented positive Phase 1 data on glufosfamide plus gemcitabine in the first-line treatment of advanced solid tumors, including pancreatic cancer, at the American Society of Clinical Oncology (ASCO) 2006 Gastrointestinal Cancers Symposium; -- Continued to enroll patients in a Phase 3 trial of single-agent glufosfamide for second-line treatment of advanced pancreatic cancer; and -- Received important patents related to TH-070 and 2DG from the U.S. Patent and Trademark Office. The Company anticipates the following clinical milestones in 2006: -- Report results from ongoing Phase 2 and Phase 3 trials of TH-070 in BPH around the beginning of the fourth quarter of 2006; -- Report results from a Phase 3 trial of single-agent glufosfamide for second-line treatment of advanced pancreatic cancer by end of 2006; -- Commence three supportive trials with TH-070; and -- Commence at least one additional trial of glufosfamide in a new cancer indication. About Threshold Pharmaceuticals Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics in mid- and late-stage clinical trials for the potential treatment of benign prostatic hyperplasia (BPH), a disease afflicting tens of millions of men worldwide and cancer. By selectively targeting abnormally-proliferating tumor cells, the Company's drug candidates are designed to be potentially more effective and less toxic to healthy tissues than conventional treatments. For additional information, please visit our website ( ). Forward-Looking Statements Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold's product candidates, clinical trial progress and results, and potential therapeutic uses and benefits of our product candidates. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold's ability to complete its anticipated clinical trials, the time and expense required to conduct such clinical trials, and the results of such clinical trials (including product safety issues and efficacy results). Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Annual Report on Form 10-K, which was filed with the Securities Exchange Commission on March 28, 2006 and is available from the SEC's website ( ) and on our website ( ) under the heading "Investors." We undertake no duty to update any forward-looking statement made in this news release. Contact: Denise T. Powell Carolyn Bumgardner Wang Sr. Director, Corporate Communications WeissComm Partners, Inc. Threshold Pharmaceuticals, Inc. 415-946-1065 650-474-8206 carolyn@weisscommpartners.comdpowell@thresholdpharm.com THRESHOLD PHARMACEUTICALS, INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended March 31, 2006 2005 Revenue $359 $-- Operating expenses Research and development 11,438 5,251 General and administrative 3,813 2,565 Total Operating Expenses 15,251 7,816 Loss from operations (14,892) (7,816) Interest and other income 1,072 284 Interest expense (6) (8) Net Loss $(13,826) $(7,540) Net loss per basic and diluted loss per common share $(0.38) $(0.46) Weighted-average shares used in computing basic and diluted loss per common share 35,949 16,340 THRESHOLD PHARMACEUTICALS, INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, December 31, 2006 2005 (unaudited) (1) Assets Cash, cash equivalents and marketable securities $87,447 $99,654 Prepaid expenses and other current assets 1,092 563 Property and equipment, net 2,389 1,667 Other assets 509 217 Total assets $91,437 $102,101 Liabilities and stockholders' equity Total current liabilities $9,846 $9,562 Long-term liabilities (2) 2,781 3,171 Stockholders' equity 78,810 89,368 Total liabilities and stockholders' equity $91,437 $102,101 (1) Derived from audited financial statements (2) Includes $2.5 million deferred revenue related to the development agreement with MedBIC Co. Ltd. Threshold Pharmaceuticals, Inc. CONTACT: Denise T. Powell, Sr. Director, Corporate Communications, ofThreshold Pharmaceuticals, Inc., +1-650-474-8206 ordpowell@thresholdpharm.com; or Carolyn Bumgardner Wang of WeissCommPartners, Inc., +1-415-946-1065 or carolyn@weisscommpartners.com, forThreshold Pharmaceuticals, Inc. Web site: