Clinical Trials and Development - Gedatolisib is currently being evaluated in multiple clinical trials, including the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer, with the first patient dosed in December 2022[69]. - The VIKTORIA-1 trial aims to enroll 351 subjects with PIK3CA WT tumors, with topline data expected in Q3 2025, while enrollment for PIK3CA MT tumors is ongoing[70]. - The company has initiated a Phase 1b/2 trial (CELC-G-201) for gedatolisib in combination with darolutamide for patients with metastatic castration-resistant prostate cancer, with the first patient dosed in February 2024[71]. - Site activation for the VIKTORIA-2 Phase 3 trial is underway, with the first patient expected to be dosed in Q2 2025[76]. - The company initiated the VIKTORIA-1 Phase 3 clinical trial in 2022 and plans to report topline data in the fourth quarter of 2025[81]. - The company has initiated a second Phase 3 clinical trial, VIKTORIA-2, with the first patient dosing planned for the second quarter of 2025[82]. Financial Performance - For the three months ended March 31, 2025, the company reported a net loss of approximately $37.0 million, compared to a net loss of $21.6 million for the same period in 2024, representing a 71% increase in losses[89]. - Research and development expenses for the three months ended March 31, 2025, were approximately $32.2 million, an increase of $11.6 million or 56% compared to the same period in 2024[90]. - General and administrative expenses for the three months ended March 31, 2025, were approximately $3.9 million, reflecting an increase of $2.1 million or 112% compared to the same period in 2024[92]. - Interest expense for the three months ended March 31, 2025, was $3.2 million, an increase of $1.8 million or 127% compared to the same period in 2024[94]. - Net cash used in operating activities was approximately $35.9 million for the three months ended March 31, 2025, compared to $17.1 million for the same period in 2024[110][111]. - Net cash provided by investing activities was approximately $24.3 million for the three months ended March 31, 2025, compared to $3.5 million for the same period in 2024[112][113]. - Net cash provided by financing activities was approximately $5.6 million for the three months ended March 31, 2025, primarily from the exercise of 695,650 common stock warrants at an exercise price of $8.05[114]. - The company raised an aggregate of approximately $374.6 million of net proceeds through sales of its securities from inception through March 31, 2025[96]. - The company has an accumulated deficit of approximately $308.9 million as of March 31, 2025[79]. Revenue Potential and Market Position - The company estimates peak revenue potential for gedatolisib in the second-line indication could exceed $2 billion with 40% market penetration if FDA approval is obtained for both PIK3CA WT and MT populations[75]. - Gedatolisib's unique mechanism of action allows for comprehensive inhibition of the PI3K/AKT/mTOR pathway, potentially overcoming resistance seen with isoform-specific inhibitors[60]. - The company has exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer, enhancing its competitive position in the market[59]. Safety and Efficacy - Gedatolisib has shown a high overall response rate (ORR) of 85% in treatment-naïve patients and 63% in all evaluable patients in the Phase 1b clinical trial[66]. - The median progression-free survival (PFS) for treatment-naïve patients receiving gedatolisib combined with palbociclib plus letrozole was 48.6 months[67]. - Gedatolisib's safety profile is favorable, with only 7% of patients experiencing Grade 3 or 4 hyperglycemia in clinical trials, compared to 39% for an FDA-approved oral PI3K inhibitor[63]. Future Expectations and Risks - The company expects research and development expenses to increase as it continues to develop gedatolisib and conduct multiple clinical trials[106]. - The company believes its current cash, cash equivalents, and short-term investments will be sufficient to finance clinical development activities through 2026[107]. - The company may seek to raise additional capital through various means, which could result in dilution to existing shareholders[108]. - The company anticipates increased costs associated with being a public company and plans to raise capital to fund its operations and expansion[120]. - The company faces known and unknown risks that may materially affect its results, including challenges in developing and commercializing gedatolisib[121]. - There are uncertainties and costs associated with clinical studies and the complexity of demonstrating safety and efficacy for regulatory approval[121]. - The company may encounter difficulties in managing growth, such as hiring and retaining qualified personnel[121]. - Changes in government regulations and tightening credit markets could impact the company's access to capital[121]. - The company has no obligation to update forward-looking statements unless required by law[122]. - As a smaller reporting company, the company is not required to provide disclosures about market risk[123].

Table of Contents SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ______________ Commission file number: 001-39126 CNS Pharmaceuticals, Inc. (Name of registrant as specified in its charter) Nevada 82-2318545 (State or ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-40615 QUANTUM COMPUTING INC. (Exact name of registrant as specified in its charter) | Delaware | 82-4533053 | | --- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2025 OR ENDRA LIFE SCIENCES INC. (Exact name of registrant as specified in its charter) Delaware 26-0579295 (State of incorporation) (I.R.S. Employer Identification No.) 3600 Green Court, Suite 350, Ann Arbor, MI 48105-1570 (Address of principal executive of ice) (Zip code) (734) 335-046 ...

Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41615 Mangoceuticals, Inc. (Exact name of Registrant as specified in its charter) Texas 87-3841292 (State or other jurisdiction ...

EX-99.1 2 endra_ex991.htm PRESS RELEASE EXHIBIT 99.1 ENDRA Life Sciences Provides a Business Update and Reports First Quarter 2025 Financial Results ANN ARBOR, Mich. (May 15, 2025) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS®), today provided a business update and reported financial results for the three months ended March 31, 2025. Business Update Incorporating Liver Diagnostics into the Management of Metabolic Disease ENDRA recently announced a strate ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 P3 Health Partners Inc. (Exact name of registrant as specified in its charter) For the transition period from to Commission File Number: 001-40033 (State or other jurisdiction of incorporation or orga ...

Clinical Development - OS Therapies achieved full enrollment of 41 patients in the clinical study for OST-HER2 by October 2023, with the Phase IIb trial achieving its primary endpoint with statistical significance in Q1 2025[190] - The company plans to request a Type B or Type C FDA meeting in Q2 2025 to discuss the data and the path to a Biologics License Application (BLA) for OST-HER2[190] - The company plans to evaluate OST-HER2's potential use in other solid tumors, including breast, esophageal, and lung cancers, following FDA approval[190] - The HER2 Assets include two investigational new drug filings with the FDA for non-small cell lung cancer and prostate cancer[199] Financial Performance - For the three months ended March 31, 2025, research and development expenses were approximately $1.3 million, a significant increase from approximately $0.4 million for the same period in 2024, primarily due to increased vendor expenses related to the Phase IIb clinical trial[223] - General and administrative expenses for the three months ended March 31, 2025, were approximately $3.7 million, compared to $0.3 million for the same period in 2024, largely attributed to marketing costs and advisory fees associated with PIPE Financing[224] - The net loss for the three months ended March 31, 2025, was approximately $3.9 million, compared to a net loss of approximately $1.5 million for the same period in 2024, reflecting ongoing operational challenges[223] - As of March 31, 2025, the company had cash of approximately $3.0 million, down from $5.5 million as of December 31, 2024, indicating a need for additional funding[228] - The total gross proceeds from private placements and the initial public offering amounted to $34.6 million as of March 31, 2025, which is expected to support operations for the next nine to 12 months[228] - The fair value adjustment of the warrant liability was $1.1 million for the three months ended March 31, 2025, compared to $0 million for the same period in 2024, indicating increased volatility in the company's financial instruments[226] - The company reported cash used in operating activities of approximately $3.4 million for the three months ended March 31, 2025, compared to $0.6 million for the same period in 2024, highlighting increased operational expenditures[229] - The cumulative accrued dividend for Series A preferred stock as of March 31, 2025, was $375,000, unchanged from December 31, 2024, reflecting the conversion of preferred shares into common stock[217] - The company has incurred significant operating losses since inception, with an accumulated deficit of approximately $41 million as of March 31, 2025[227] - For the three months ended March 31, 2025, net cash provided by financing activities was approximately $1.1 million, compared to $0.7 million for the same period in 2024[234] Financing Activities - On December 24, 2024, OS Therapies entered into a PIPE Financing agreement, raising gross proceeds of approximately $7.1 million through the issuance of 1,775,750 shares of Series A Preferred Stock and warrants[192] - The PIPE Purchase Agreement requires stockholder approval for transactions related to the financing, with a special meeting held by April 9, 2025[193] - Ayala has agreed to a 180-day lock-up period for the shares received in the transaction, subject to certain exceptions[203] - The company is committed to filing registration statements for the resale of shares related to the acquisition within 75 days after the closing of the transaction[202] - The company raised total gross proceeds of $19,426,449 from accredited investors through seven separate private financing transactions involving convertible notes from July 2018 to April 2024[235] - The company issued demand promissory notes totaling $250,000 with an interest rate of 8% per annum, which were fully repaid by August 14, 2024[236][237] - The PIPE Financing on December 24, 2024, resulted in gross proceeds of approximately $7,103,000, with the issuance of 1,775,750 shares of Series A Preferred Stock and corresponding Series A Warrants[240] Asset Acquisition - The acquisition of HER2 Assets from Ayala Pharmaceuticals was completed on April 9, 2025, for an aggregate purchase price of $8 million, including $7.5 million in common stock[199][200] - The company acquired HER2 Assets from Ayala on April 9, 2025, which resulted in changes to milestone payments and royalty considerations[250] - The company is required to pay BlinkBio a total of $22,375,000 in milestone payments related to the development of products utilizing BlinkBio's proprietary technology[254] - As of March 31, 2025, the company had paid a total of $2,925,000 to Advaxis, including a $1,550,000 license commencement payment and $1,375,000 for milestone achievements[246] Regulatory and Compliance - The company has no off-balance sheet arrangements during the presented periods[259] - The company has elected to use the extended transition period under the JOBS Act for new or revised financial accounting standards[261] - The company will remain an emerging growth company until total annual gross revenues reach $1.235 billion or more[262]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of ev ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-40877 CERO THERAPEUTICS HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 81-4182129 (State or other juri ...