Lucid Diagnostics(LUCD) - 2025 Q1 - Quarterly Results
2025-05-14 12:20
Exhibit 99.1 Lucid Diagnostics Provides Business Update and Reports First Quarter 2025 Financial Results Processed 3,034 EsoGuard tests and recognized revenue of $0.8 million in 1Q25 Secured capital to extend runway well past key upcoming reimbursement milestones; ended 1Q25 with over $40 million in proforma cash Conference call and webcast to be held today, May 14, at 8:30 AM EDT NEW YORK, May 14, 2025 - Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention ...
Synthetic Biologics(TOVX) - 2025 Q1 - Quarterly Report
2025-05-14 12:15
Financial Performance - The net loss for the three months ended March 31, 2025, was $4.3 million, or ($1.55) per common share, compared to a net loss of $5.2 million, or ($7.53) per common share for the same period in 2024[229]. - Cash and cash equivalents totaled $10.0 million as of March 31, 2025, a decrease of $1.6 million from December 31, 2024[231]. - The accumulated deficit was $339.3 million as of March 31, 2025, with expectations of continued losses in the foreseeable future[230]. - Cash used in operating activities was $4.8 million during the three months ended March 31, 2025, compared to $4.9 million for the same period in 2024[236]. - Total research and development expenses for the three months ended March 31, 2025, were $2.968 million, down from $3.459 million in 2024[227]. - Research and development expenses decreased to $3.0 million for the three months ended March 31, 2025, from approximately $3.5 million for the same period in 2024, a decrease of 14%[225]. - General and administrative expenses decreased to $1.4 million for the three months ended March 31, 2025, from $1.9 million for the same period in 2024, a decrease of 25%[224]. - Cash provided by financing activities during the three months ended March 31, 2025, included $1.7 million received for the research and development tax credit[238]. - As of early May 2025, cash position was $14.1 million, expected to fund operations into the first quarter of 2026[232]. - Future clinical trials for VCN-01, SYN-004, and SYN-020 will require significant financing, and the company does not currently have committed sources of funding[235]. Clinical Trials and Product Development - The lead product candidate, VCN-01, is currently in a Phase 2b clinical study for pancreatic cancer, with positive topline outcomes indicating a median overall survival (OS) of 10.8 months for patients receiving VCN-01 plus standard-of-care chemotherapy compared to 8.6 months for those receiving standard care alone[145][149]. - In the VIRAGE trial, patients receiving two doses of VCN-01 showed a median OS of 14.8 months compared to 11.6 months for those receiving standard care, suggesting a significant benefit from the additional dose[146]. - The Phase 2b clinical trial of VCN-01 in combination with nab-paclitaxel and gemcitabine is ongoing, with additional studies evaluating VCN-01 in other cancer types[154]. - The Phase 2b clinical trial VIRAGE for VCN-01 in combination with gemcitabine and nab-paclitaxel has enrolled 92 evaluable patients, achieving the target enrollment by September 23, 2024[157]. - Topline data for the VIRAGE Phase 2b clinical trial is anticipated for Q2 2025[157]. - The FDA granted Fast Track Designation to VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma on May 23, 2024[161]. - An Independent Data Monitoring Committee confirmed that VCN-01 was well tolerated in the Phase 2b trial, with adverse events consistent with prior trials and less frequent after the second dose[164]. - The clinical trial for VCN-01 in retinoblastoma showed positive topline data, with no dose-limiting toxicities and treatment-related adverse events primarily Grade 1 or 2[165][166]. - The Phase 1 trial combining VCN-01 with durvalumab showed well-tolerated results, with sustained blood levels of VCN-01 and increased tumor inflammation markers[173]. - The ongoing studies suggest that VCN-01 may enhance the potential antitumor effects of co-administered huCART-meso cells in patients with unresectable or metastatic pancreatic adenocarcinoma[176]. - The Phase 1 trial of huCART-meso cells combined with VCN-01 showed overall survival (OS) of 10.4 months in the concomitant cohort and 15.5 months in the sequential cohort at a dose of 3.3×10^12 viral particles (vp), with OS reaching 17.3 months at a dose of 1×10^13 vp[178]. - 61.1% of patients (11 out of 18) were alive for more than 12 months, indicating a promising trend in disease stabilization[178]. - VCN-01 demonstrated biological activity with replication observed and increased serum hyaluronidase levels maintained for over six weeks[178]. - The safety profile of VCN-01 was consistent with expectations from monotherapy studies, with 66.6% of patients showing tumor shrinkage when receiving huCART-meso after VCN-01[179]. - A new next-generation mesothelin-specific CAR-T is being developed, which may be evaluated in combination with VCN-01 in future clinical trials[180]. - The Phase 1 clinical study of SYN-004 (ribaxamase) aims to prevent antibiotic-mediated microbiome damage and is currently in a randomized, double-blinded, placebo-controlled trial with 36 evaluable adult allogeneic HCT recipients[186][187]. - SYN-020, a recombinant version of bovine Intestinal Alkaline Phosphatase, is being developed to mitigate intestinal damage caused by radiation therapy, with production costs anticipated to be significantly lower than current market rates[192]. - The Phase 1 clinical study of SYN-020 demonstrated a favorable safety profile with no serious adverse events reported, and it was well tolerated across all dose levels[196]. - The company has received a study-may-proceed letter from the FDA for SYN-020, allowing for further clinical development[195]. - Phase 1 data from SAD and MAD studies support the development of SYN-020 for multiple clinical indications, including NAFLD and aging-related diseases[198]. Funding and Grants - The company completed a public offering on May 8, 2025, raising approximately $7.5 million through the sale of 1,990,900 shares of Common Stock and warrants[134]. - The company received €2.28 million (approximately $2.54 million) from the Spanish government's National Knowledge Transfer Program to support the THERICEL project, which includes a €1.3 million loan and a €0.95 million grant[139]. - The company received $1.7 million from the 2023 Research and Development rebate program sponsored by the Spanish government[138]. Intellectual Property and Licensing - The company is exploring value creation options for its previous assets, SYN-004 and SYN-020, including out-licensing or partnering[133]. - The ongoing clinical trials and product developments are supported by a growing intellectual property portfolio, with efforts to maintain and build patent applications[183]. - The company has over 130 U.S. and foreign patents and over 65 patents pending, supporting its various programs[208]. - The SYN-004 program is supported by patents that will expire in at least 2031, covering compositions of matter and uses of beta-lactamases[209]. - The VCN-01 and VCN-11 programs are supported by patents that provide coverage for engineered oncolytic adenoviruses, with some patents expiring as late as 2037[211]. - The company entered into an agreement with Massachusetts General Hospital for an exclusive license related to IAP technology, which expired unexercised on July 1, 2024[197]. Manufacturing and Development - The THERICEL program is advancing a proprietary A549 suspension cell line to enhance the efficiency and reduce the cost of manufacturing VCN-01 for clinical trials[205]. - Preclinical data indicated that the ABD-containing virus VCN-11 induced 450 times more cytotoxicity in tumor cells compared to normal cells, demonstrating a low toxicity profile[203].
Allurion Technologies(ALUR) - 2025 Q1 - Quarterly Results
2025-05-14 12:15
Exhibit 99.1 Allurion Reports First Quarter 2025 Financial Results and Provides Business Update NATICK, Mass.—May 14, 2025 — (BUSINESS WIRE) — Allurion Technologies, Inc. (NYSE: ALUR) ("Allurion" or the "Company"), a pioneer in metabolically healthy weight loss, today announced its financial results for the first quarter and provided a business update. Recent Company Highlights and Outlook "We are excited about our strong start to 2025, a year we expect to be rich in potential catalysts," said Dr. Shantanu ...
ADC Therapeutics(ADCT) - 2025 Q1 - Quarterly Results
2025-05-14 12:14
Financial Performance - ZYNLONTA generated net product revenues of $17.4 million for Q1 2025, compared to $17.8 million in Q1 2024[5] - Total revenue for Q1 2025 was $23.033 million, a 27.5% increase from $18.053 million in Q1 2024[22] - Product revenues decreased slightly to $17.404 million from $17.848 million, a decline of 2.5% year-over-year[22] - License revenue and royalties increased to $5.6 million in Q1 2025 from $0.2 million in Q1 2024, including a $5.0 million milestone payment from Health Canada[5] Expenses - Research and Development (R&D) expenses rose to $28.9 million in Q1 2025, up from $25.7 million in Q1 2024, primarily due to increased spending on next-generation ADCs[5] - Selling and Marketing (S&M) expenses decreased to $10.6 million in Q1 2025 from $11.4 million in Q1 2024, attributed to lower marketing costs[5] - General & Administrative (G&A) expenses fell to $10.0 million in Q1 2025 from $12.0 million in Q1 2024, mainly due to reduced professional fees[5] - Total operating expenses for Q1 2025 were $51.497 million, a marginal decrease of 0.3% from $51.666 million in Q1 2024[25] - Share-based compensation expense rose significantly to $2.421 million from $158, a 1,432% increase[25] Net Loss - Net loss for Q1 2025 was $38.6 million, or $0.36 per share, an improvement from a net loss of $46.6 million, or $0.56 per share, in Q1 2024[5] - Adjusted net loss for Q1 2025 was $24.0 million, or $0.22 per share, compared to an adjusted net loss of $31.1 million, or $0.38 per share, in Q1 2024[5] - Net loss for Q1 2025 was $38.602 million, compared to a net loss of $46.606 million in Q1 2024, reflecting an improvement of 17.3%[22] - Adjusted net loss for Q1 2025 was $23.963 million, down from $31.147 million in Q1 2024, indicating a 23.0% reduction[25] Cash Position - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million as of December 31, 2024, with a cash runway expected to extend into the second half of 2026[6] - Cash and cash equivalents as of March 31, 2025, were $194.701 million, down from $250.867 million at the end of 2024[24] Clinical Trials - LOTIS-7 trial reached 40 patient enrollments, with updates expected in the second half of 2025[3] - ZYNLONTA plus glofitamab demonstrated an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% in the LOTIS-7 trial[3] Shareholder Information - The weighted average shares outstanding increased to 107,202,374 in Q1 2025 from 82,552,322 in Q1 2024[25] - Total liabilities increased slightly to $510.762 million from $524.622 million, with total shareholders' equity showing a deficit of $238.223 million[24]
Janover (JNVR) - 2025 Q1 - Quarterly Report
2025-05-14 12:11
Revenue Growth - As of March 31, 2025, the annual recurring revenue (ARR) reached approximately $1.4 million, a 379% increase from approximately $287,000 as of March 31, 2024[126]. - Subscription revenue increased to approximately $191,000 in Q1 2025 from approximately $73,000 in Q1 2024, representing a growth of 161%[162]. - Revenue for Q1 2025 was approximately $287,000, a decrease of $124,000 or 30% compared to Q1 2024 revenue of approximately $411,000[161]. - Subscription revenue is derived from various SaaS platforms, including Janover Pro, Janover Connect, and Janover Insurance, with revenue recognized over the term of customer contracts[181]. Financial Performance - Total operating expenses for Q1 2025 were approximately $1.17 million, down $259,000 or 18% from approximately $1.43 million in Q1 2024[161]. - Net loss for Q1 2025 was approximately $778,000, a reduction of $186,000 or 19% compared to a net loss of approximately $964,000 in Q1 2024[161]. - Cash used in operating activities decreased to approximately $786,000 in Q1 2025 from approximately $1.1 million in Q1 2024, a reduction of $360,000[174]. - General and administrative expenses decreased by approximately $215,000 or 28% to approximately $544,000 in Q1 2025 from approximately $759,000 in Q1 2024[167]. - Sales and marketing expenses increased by approximately $49,000 or 12% to approximately $465,000 in Q1 2025, primarily due to increased online advertising costs[165]. Capital and Investment - The company has purchased approximately $103 million in Solana (SOL), including staking rewards, as part of its treasury strategy[133]. - The company aims to generate incremental revenue through staking SOL rewards and validator-based monetization[124]. - The company has invested approximately $103 million in SOL, including staking rewards, as part of its capital allocation strategy[157]. - The company entered into a securities purchase agreement for gross proceeds of approximately $24.0 million, issuing 315,838 shares of common stock at $46.00 per share[158]. - The company acquired Solsync Solutions Partnership, a SOL validator business, for $3.5 million, integrating its staking rewards into the company's revenue streams[159]. Treasury and Compliance - The company adopted a new treasury policy to allocate its treasury reserve primarily to digital assets, starting with SOL[146]. - The company regained compliance with Nasdaq's minimum closing bid price requirement, maintaining a minimum closing bid price of $1.00 per share for at least 10 consecutive trading days[140]. - A change in control occurred when DeFi Dev LLC and NS Corp purchased approximately 51.0% of the company's common stock for $4 million[141][142]. - The company issued approximately $42.0 million in convertible notes, which are convertible into common stock at a price of $68.19 per share[147][149]. Future Outlook - The company plans to focus on expanding net revenue retention (NRR) and average contract values (ACV) to enhance revenue predictability[134]. - The company plans to continue investing in research and development, sales and marketing, and general and administrative expenses to drive growth[172]. - The Company expects to continue generating operating losses as it focuses on revenue growth, but anticipates a decline in these losses as subscription software revenue increases[176]. Miscellaneous - The company serves hundreds of thousands of web users annually, applying for billions of dollars in debt financing, including over 10% of banks in America[118]. - The average fee earned per transaction is approximately 1% of the loan amount, generally earned at the time of closing[121]. - The Company recorded an impairment of approximately $83,000 related to the Groundbreaker brand during the fourth quarter of fiscal 2024, which has since been rebranded to Janover Connect[183]. - The Company does not believe inflation has materially affected its results of operations during the periods presented[189]. - The Company has not had any off-balance sheet arrangements during the periods presented[185]. - The Company’s revenue recognition follows ASC 606, ensuring that revenue is recognized when control of goods or services is transferred to customers[178]. - The Company’s cash consists of readily available checking accounts and short-term money market fund investments, with historical fluctuations in interest income being insignificant[188].
Synthetic Biologics(TOVX) - 2025 Q1 - Quarterly Results
2025-05-14 12:10
Recent Highlights and Anticipated Milestones Exhibit 99.1 Theriva™ Biologics Reports First Quarter 2025 Operational Highlights and Financial Results - VCN-01 Achieves Primary Efficacy and Safety Endpoints for Pancreatic Ductal Adenocarcinoma in VIRAGE Phase 2b Clinical Trial - - Closed a public offering on May 8, 2025, raising the Company's cash balance and extending its cash runway into the first quarter of 2026 - Rockville, MD, May 14, 2025 – Theriva™ Biologics (NYSE American: TOVX), a diversified clinica ...
Aprea Therapeutics(APRE) - 2025 Q1 - Quarterly Report
2025-05-14 12:10
Table of Contents 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 001-39069 Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-2246769 (State or other ...
AlloVir(ALVR) - 2025 Q1 - Quarterly Results
2025-05-14 12:09
Business Highlights • Kalaris is currently enrolling a Phase 1, single ascending dose trial to assess the safety, pharmacokinetics, and preliminary treatment effect of TH103 in nAMD patients. Initial clinical data is expected in the fourth quarter of 2025. • As previously announced, Kalaris completed its merger with AlloVir in March 2025. • As recently announced, Kalaris therapeutics had expanded its Board of Directors with the appointment of Leone Patterson as a director and Chair of the Audit Committee. E ...
IO Biotech(IOBT) - 2025 Q1 - Quarterly Results
2025-05-14 12:06
Recent Business Highlights • The company's pivotal Phase 3 trial (IOB-013/KN-D18) is progressing as planned with the readout of the primary endpoint of progression free survival (PFS) still expected in the third quarter of 2025. The trial is evaluating the company's lead investigational vaccine, Cylembio® (imsapepimut and etimupepimut, adjuvanted), in combination with Merck's (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of advanced mela ...
Aprea Therapeutics(APRE) - 2025 Q1 - Quarterly Results
2025-05-14 12:05
Exhibit 99.1 Aprea Therapeutics Reports First Quarter 2025 Financial Results and Provides a Clinical Update ATRN-119, our ATR inhibitor, exhibits early evidence of single agent, anti-tumor activity and is progressing toward the recommended Phase 2 dose (RP2D) in the ongoing ABOYA-119 clinical trial Three patients in the 550 mg twice daily cohort in the ongoing ABOYA-119 clinical trial demonstrated tumor shrinkage of 7%, 14% and 21% ACESOT-1051, the Phase 1 trial of WEE1 inhibitor APR-1051, continues to adva ...