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Talphera(TLPH) - 2025 Q1 - Quarterly Report
2025-05-14 21:01
Financial Performance - Total revenue for the three months ended March 31, 2025, was $27,000, compared to $0 for the same period in 2024, indicating a significant increase[18]. - Operating costs and expenses for the three months ended March 31, 2025, were $2,943,000, down 30.5% from $4,237,000 in the same period in 2024[18]. - Net loss for the three months ended March 31, 2025, was $2,593,000, an improvement from a net loss of $3,954,000 in the same period in 2024, representing a 34.4% reduction in losses[18]. - The accumulated deficit increased to $459,823,000 as of March 31, 2025, from $457,230,000 at the end of 2024, indicating ongoing financial challenges[15]. - The net loss for the three months ended March 31, 2025, was $2.6 million, compared to a net loss of $4.0 million for the same period in 2024, indicating a 35% improvement in losses year-over-year[80]. - For the three months ended March 31, 2025, net cash used in operating activities was $3.5 million, reflecting a net loss of $2.6 million[107]. Cash Flow and Liquidity - Cash and cash equivalents decreased to $5,388,000 as of March 31, 2025, from $8,863,000 at the end of 2024, reflecting a cash outflow of $3,475,000 during the quarter[23]. - As of March 31, 2025, the total cash and cash equivalents amounted to $5.388 million, a decrease from $8.863 million as of December 31, 2024, representing a decline of approximately 39.5%[42]. - The company expects to incur significant losses in 2025 and may require additional capital to fund operations before the twelve-month anniversary of the filing date of this report[97][99]. - The company anticipates needing additional capital to fund operations for at least the next twelve months[111]. - Current capital is not expected to be sufficient to fund operations for the next twelve months, raising doubts about the company's ability to continue as a going concern[127]. Shareholder and Equity Information - The company reported a total of 26,268,209 shares used in computing net loss per share for the three months ended March 31, 2025, compared to 24,721,964 shares for the same period in 2024[18]. - The Company issued 3,405,118 shares of common stock at a price of $0.586 per share, generating approximately $4.9 million in gross proceeds from the first closing of the 2025 Private Placement[69]. - The second and third closings of the 2025 Private Placement are contingent upon the enrollment of at least 17 and 35 patients in the Niyad NEPHRO CRRT study, respectively[70]. - As of September 30, 2024, stockholders' equity was reported at $9.6 million, which is below Nasdaq's compliance requirement[104]. - The company expects that if the 2025 Private Placement had closed on March 31, 2025, stockholders' equity would have been adjusted to $10.0 million[104]. Research and Development - The company is focused on developing Niyad™ and LTX-608, with Niyad™ receiving Breakthrough Device Designation status from the FDA[28]. - Research and development expenses for the three months ended March 31, 2025, were $1.169 million, an 18% decrease from $1.433 million in 2024, primarily due to a reduction in employee compensation and related expenses[89]. - The company has entered into an agreement with the FDA to reduce the size of the Niyad registrational study to 70 patients from 166, which may expedite the regulatory review process[77]. - The company is developing Niyad™, which has received Breakthrough Device Designation from the FDA, and expects to submit a PMA application for commercialization in the U.S.[156]. Operational Challenges - Talphera, Inc. has incurred recurring operating losses and negative cash flows since inception, raising substantial doubt about its ability to continue as a going concern[30]. - The company has incurred significant net losses since inception and expects to continue incurring losses in 2025 and beyond, raising doubts about its ability to continue as a going concern[123]. - The company may face delisting from Nasdaq if it cannot regain compliance with continued listing requirements[121]. - The company relies on third-party manufacturers and suppliers, which poses risks to the development of its product candidates[122]. - The company may face significant delays in clinical trials due to challenges in patient enrollment, which could increase development costs and negatively impact the company's valuation[150]. Legal and Regulatory Risks - The company believes ongoing litigation is without merit and intends to vigorously defend against it, although it cannot estimate potential losses from these actions[56]. - The FDA's approval process for the company's product candidates is time-consuming and may be subject to unexpected delays, which could adversely affect the company's financial condition[155]. - The company may face claims of patent infringement from competitors, which could hinder its ability to commercialize products[212]. - Business operations are subject to healthcare laws, with potential penalties for non-compliance impacting financial results[190]. Market and Competitive Environment - The company faces intense competition in the biotechnology and pharmaceutical industries, which may hinder the commercial potential of its products[161]. - Future sales of DSUVIA to the Department of Defense (DoD) are unpredictable and may not meet expectations due to external factors beyond the company's control[137]. - Coverage and adequate reimbursement for the company's product candidates may not be available, impacting profitability and market acceptance[163]. - Legislative and regulatory changes in the healthcare system may negatively affect the reimbursement landscape for the company's products[166]. Intellectual Property and Product Liability - The company is pursuing a number of U.S. patent applications and foreign national applications for its product candidates, but there is no guarantee these will result in issued patents[205]. - The company relies on patents and other intellectual property protections, but third parties may challenge these patents, impacting business operations[208]. - Current product liability insurance may not be sufficient to cover potential claims, and exclusions in the policy could lead to significant financial exposure[203]. - The company faces risks related to product liability claims, which could result in substantial liabilities and damage to its business reputation[202].
Armlogi Holding Corp.(BTOC) - 2025 Q3 - Quarterly Report
2025-05-14 21:00
Financial Performance - Revenue for the three months ended March 31, 2025, was $45.84 million, a 19.5% increase from $38.44 million in the same period of 2024[11] - Net loss for the nine months ended March 31, 2025, was $10.06 million, compared to a net income of $7.18 million for the same period in 2024[11] - For the nine months ended March 31, 2025, total revenue was $139,469,900, representing a 14.6% increase from $121,689,863 in the same period of 2024[37] - The company reported a net loss of $10.1 million for the nine months ended March 31, 2025, compared to a net income of $7.2 million for the same period in 2024[113] - Basic and diluted loss per share for the nine months ended March 31, 2025, was $(0.24), a decrease from earnings per share of $0.18 in the same period of 2024[99] Revenue Breakdown - Transportation services revenue increased to $93,102,755, up 10% from $84,664,603 in the prior year[37] - Warehousing services revenue rose to $46,323,372, reflecting a 26.5% increase from $36,606,859 in the previous year[37] - Revenue from transportation services increased by $3.5 million, or 13.8%, and revenue from warehousing services increased by $4.0 million, or 29.7%, during the three months ended March 31, 2025[117] Costs and Expenses - The company reported a total operating costs and expenses of $10.80 million for the nine months ended March 31, 2025, compared to $8.10 million for the same period in 2024, an increase of 33.4%[11] - Costs of sales for the three months ended March 31, 2025, increased by $10.5 million, or 30.0%, to $45.6 million, driven by higher freight expenses and increased lease and labor costs[116] - Costs of sales for the nine months ended March 31, 2025, increased by $36.9 million, or 35.0%, primarily due to higher freight expenses and increased operational costs[118] Assets and Liabilities - Total assets increased to $178.04 million as of March 31, 2025, from $167.03 million as of June 30, 2024, reflecting a growth of 6.1%[10] - Total stockholders' equity decreased to $30.18 million as of March 31, 2025, down from $39.24 million as of June 30, 2024, a decline of 23.1%[10] - Operating lease liabilities increased to $133.28 million as of March 31, 2025, from $117.34 million as of June 30, 2024, a rise of 13.6%[9] - The company has operating and finance lease liabilities totaling $133,283,706 and $216,373, respectively, as of March 31, 2025[141] Cash Flow - Cash and restricted cash at the end of the nine months period was $9.41 million, compared to $6.05 million at the end of the same period in 2024, an increase of 55.5%[15] - For the nine months ended March 31, 2025, net cash used in operating activities was $(5,641,142), compared to net cash provided of $3,954,416 for the same period in 2024, indicating a $9.6 million decrease in cash inflow[133] - For the nine months ended March 31, 2025, net cash provided by financing activities was $6.6 million, mainly from $8.1 million of net proceeds from the Pre-Paid Advance under the SEPA[138] Shareholder Information - The weighted average number of shares of common stock-basic and diluted increased to 41.71 million for the three months ended March 31, 2025, from 40 million in the same period of 2024[11] - The weighted average number of shares of common stock outstanding was 41,651,007 for the nine months ended March 31, 2025, compared to 40,000,000 for the same period in 2024[99] - The Company issued 434,879 shares of common stock at a price of US$1.73 per share in March 2025, raising US$750,000 through the conversion of the SEPA loan[88] Operational Highlights - The company operates as a third-party logistics provider, focusing on multi-modal transportation and logistics services primarily in the United States[17] - The company operates ten warehouses with a total gross floor area of approximately 3,925,020 square feet as of March 31, 2025[112] - The company has 100% ownership in several subsidiaries, including Armstrong Logistic Inc. and Armlogi Truck Dispatching LLC, incorporated in California[22] Compliance and Regulatory - The company filed its Articles of Incorporation and Bylaws on September 22, 2023, as part of its S-1 registration statement[3.1][3.3] - Certifications of the Principal Executive and Financial Officers were filed in accordance with the Sarbanes-Oxley Act of 2002[31.1][31.2] - The company is in compliance with the Securities Exchange Act of 1934, as indicated by the signatures of authorized representatives[162]
Red Cat (RCAT) - 2025 Q4 - Annual Report
2025-05-14 21:00
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 ☐ 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: 001-40202 Red Cat Holdings, Inc. (Exact name of registrant as specified in its charter) Nevada 88-0490034 (State ...
Calidi Biotherapeutics(CLDI) - 2025 Q1 - Quarterly Results
2025-05-14 21:00
Financial Performance - The company reported a net loss of $5.0 million, or $0.18 per share, for Q1 2025, a decrease from a net loss of $7.2 million, or $2.03 per share, in Q1 2024[7]. - General and administrative expenses decreased to $2.6 million in Q1 2025 from $4.0 million in Q1 2024[8]. - Research and development expenses were $2.4 million for Q1 2025, down from $2.7 million in the same period of 2024[7]. Cash and Assets - The company had approximately $10.6 million in cash as of March 31, 2025, compared to $9.6 million as of December 31, 2024[8]. - Total assets increased to $15.1 million as of March 31, 2025, compared to $14.2 million as of December 31, 2024[16]. - Total current liabilities decreased to $5.4 million as of March 31, 2025, from $9.5 million as of December 31, 2024[16]. Leadership and Development - The company appointed Eric Poma, PhD, as CEO, who has over 30 years of experience in the biopharmaceutical industry[6]. - The FDA cleared the IND application for CLD-201, which targets solid tumors, including breast cancer and head & neck cancer[10]. - The lead candidate from the Redtail platform is currently in IND-enabling studies, focusing on non-small cell lung cancer and ovarian cancer[11]. - New preclinical data on the Redtail platform was presented at the AACR Annual Meeting, highlighting the IL15 superagonist as the first payload for tumor delivery[10].
FIRST LIGHT ACQU(FLAG) - 2025 Q1 - Quarterly Results
2025-05-14 21:00
Exhibit 99.1 Calidi Biotherapeutics Reports First Quarter 2025 Financial Results and Recent Operational Highlights SAN DIEGO, May 14, 2025 -- (Business Wire) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the potential to deliver genetic payloads, today reported its first quarter 2025 operating and financial results and reviewed recent business highlights. "We are extremely ...
Royalty Management (RMCO) - 2025 Q1 - Quarterly Report
2025-05-14 21:00
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 (State or other jurisdiction of incorporation or organization) Florida 86-1599759 (I.R.S. Employer Identification No.) 12115 Visionary Way, Unit 174 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _______ ...
AMER.ACQ.OPPOR.A(AMAO) - 2025 Q1 - Quarterly Report
2025-05-14 21:00
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: 001-40233 ROYALTY MANAGEMENT HOLDING CORPORATION (Exact name of registrant as specified in its charter) (State or other ju ...
Palatin Technologies(PTN) - 2025 Q3 - Quarterly Report
2025-05-14 21:00
Revenue and Sales - For the nine months ended March 31, 2025, the company recognized $0 in product revenue, a decrease from $4,140,090 for the same period in 2024 due to the sale of worldwide rights to Vyleesi[152]. - The company reported a gain of $2,500,000 on the sale of Vyleesi for the nine months ended March 31, 2025, compared to a gain of $7,798,280 for the same period in 2024[159]. - The company has no recurring source of revenue following the sale of worldwide rights to Vyleesi[171]. Research and Development - Research and development expenses for the nine months ended March 31, 2025, were $12,928,391, down from $17,728,516 in the prior year, primarily due to reduced spending on MCr programs[154]. - The Phase 2 clinical trial for PL8177, an oral peptide formulation for ulcerative colitis, reported that one-third of patients achieved clinical remission, while the placebo group saw no clinical remission[143]. - The company plans to file an IND for a novel once-weekly peptide MC4R agonist in 2025, with CMC activities expected to be completed in the first quarter of 2025[145]. - The company intends to utilize existing capital resources for general corporate purposes and working capital, including preclinical and clinical development of its MC1r and MC4r programs[170]. Financial Performance - Selling, general and administrative expenses decreased to $5,176,794 for the nine months ended March 31, 2025, from $8,266,267 in the prior year, due to the elimination of selling expenses related to Vyleesi[158]. - Net cash used in operating activities was $17,217,595 for the nine months ended March 31, 2025, a decrease from $24,988,985 in the prior year, attributed to a reduction in net loss and working capital changes[164]. - For the nine months ended March 31, 2025, net cash provided by investing activities was $2,500,000, a decrease from $12,455,275 for the same period in 2024[165]. - Net cash provided by financing activities for the nine months ended March 31, 2025, was $7,710,261, down from $14,558,216 in the prior year[166]. Liquidity and Funding - As of March 31, 2025, the company had cash and cash equivalents of $2,520,062 and current liabilities of $10,048,349, indicating a significant liquidity challenge[168]. - The company has incurred cumulative negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern for the next year[171]. - Additional funding will be required to complete clinical trials and regulatory submissions, with current economic conditions posing risks to financial stability and capital access[172]. - The company is evaluating strategies for obtaining additional funding, including equity financing and cost reductions, to sustain operations[171]. - The existing cash and cash equivalents are expected to fund operations into the second half of calendar year 2025, contingent on successful funding efforts[171]. Strategic Partnerships - The company is actively engaged in discussions with potential partners for ocular conditions to progress product development and commercialization[143]. - The company aims to maintain strategic alliances and partnerships to facilitate the development and commercialization of its product candidates[146].
Eledon Pharmaceuticals(ELDN) - 2025 Q1 - Quarterly Report
2025-05-14 21:00
Drug Development and Clinical Trials - Eledon Pharmaceuticals is focusing on the development of tegoprubart, an anti-CD40L antibody, for preventing organ rejection and treating ALS [128]. - In January 2023, the company announced plans to prioritize kidney transplantation programs, discontinuing the islet cell transplantation and IgAN programs [131]. - The ongoing Phase 1b trial of tegoprubart reported a mean estimated eGFR of 70.5 mL/min/1.73m² after day 30 post-transplant, compared to historical averages of approximately 53 mL/min/1.73m² [142]. - As of June 2024, interim results indicated that tegoprubart is generally safe and well tolerated, with no cases of hyperglycemia or graft loss reported [142]. - The BESTOW trial, a Phase 2 study comparing tegoprubart to tacrolimus, aims to enroll approximately 120 participants and assess graft function at 12 months post-transplant [143]. - Eledon received regulatory approvals for the Phase 1b trial in the U.S., Canada, the U.K., and Australia, with the first subject dosed in July 2022 [139]. - The company entered a collaborative research agreement with eGenesis in January 2023 to explore tegoprubart in xenotransplantation studies [146]. - Tegoprubart has received orphan designation from the FDA for preventing allograft rejection in pancreatic islet cell transplantation [150]. - The company aims to address the challenges of current immunosuppressive therapies, potentially improving long-term graft survival and reducing the need for repeat transplants [138]. - Eledon acquired Anelixis Therapeutics in September 2020, gaining control over the intellectual property related to tegoprubart [132]. - Tegoprubart is being utilized in a pilot study at the University of Chicago Medicine to assess safety in achieving calcineurin inhibitor-free immunosuppression in T1D patients undergoing islet cell transplantation [151]. - Positive data from the study indicated that the first two subjects achieved insulin independence and normal HbA1c levels, while the third subject reduced insulin use by over 60% within three days post-transplant [152]. - Islet engraftment in subjects treated with tegoprubart was three to five times higher than in those receiving tacrolimus-based immunosuppression, suggesting improved graft survival and function [152]. - The Phase 2a study of tegoprubart for ALS enrolled 54 subjects, with 50 completing all infusions and no serious drug-related adverse events observed [157]. - Tegoprubart demonstrated target engagement in all dose cohorts, with a dose-dependent reduction in inflammatory biomarkers in 20 of 32 pro-inflammatory proteins [157]. Financial Performance and Funding - The 2023 Securities Purchase Agreement resulted in gross proceeds of $35.0 million, with net proceeds of approximately $33.0 million after expenses [163]. - The 2024 Private Placement generated gross proceeds of $50.0 million, with net proceeds of approximately $48.1 million after deducting offering costs [168]. - The 2024 Underwritten Offering closed with gross proceeds of $85 million, resulting in net proceeds of approximately $79.5 million after underwriting discounts and commissions [172]. - The company deprioritized its IgAN program and discontinued all related clinical development activities in 2023 [159]. - The FDA granted orphan drug designation to tegoprubart for ALS in 2018, with ongoing efforts to secure additional financing for further clinical development [156][158]. - Research and development expenses increased by $6.1 million to $13.5 million for the three months ended March 31, 2025, compared to $7.4 million in the same period of 2024 [182]. - General and administrative expenses rose by $1.0 million to $4.4 million for the three months ended March 31, 2025, compared to $3.5 million in 2024 [184]. - The net loss for the three months ended March 31, 2025, was $6.5 million, a decrease of $17.1 million compared to a net loss of $23.6 million in the same period of 2024 [182]. - The fair value of warrant liabilities decreased by $23.4 million to $10.1 million for the three months ended March 31, 2025, compared to a $13.3 million increase in the same period of 2024 [186]. - As of March 31, 2025, the company had cash and cash equivalents and short-term investments totaling $124.9 million, with working capital of $118.5 million [187]. - The company has incurred significant net losses since inception and does not expect to generate revenue from product sales until regulatory approval is obtained [188]. - The company anticipates ongoing increases in expenses as it expands its clinical programs and seeks marketing approval for its product candidates [193]. - The company will require additional financing to advance its drug products through clinical development and to fund operations for the foreseeable future [194]. - The increase in other income, net, was primarily due to a rise in interest income, totaling $1.4 million for the three months ended March 31, 2025, compared to $0.6 million in 2024 [185]. - The company does not have any approved products for commercial sale and has no committed sources of capital, relying primarily on proceeds from stock sales and warrants [188]. - For the three months ended March 31, 2025, the company reported a net cash used in operating activities of $16.1 million, compared to $8.7 million for the same period in 2024, reflecting a significant increase in cash outflow [198][199][200]. - The net loss for the three months ended March 31, 2025, was $6.5 million, a decrease from the net loss of $23.6 million in the same period of 2024 [199][200]. - Net cash provided by investing activities for the three months ended March 31, 2025, was $3.9 million, down from $9.8 million in the same period of 2024 [201][202]. - The company experienced a decrease in accounts payable and accrued expenses by $2.4 million for the three months ended March 31, 2025 [199]. - The company raised capital through private placements and underwritten offerings, which diluted existing stockholders' ownership interests [197]. - The company reported $35.7 million in proceeds from the maturity of available-for-sale short-term investments for the three months ended March 31, 2025 [201]. - The company incurred costs associated with being a public company, which may impact its financial performance [197]. Operational Focus and Future Outlook - The company is focused on the development of tegoprubart, with ongoing clinical trials that may be affected by global macroeconomic conditions [196]. - The company is evaluating the scope of indications for tegoprubart development, which may influence future revenue streams [196]. - The company is actively working on enhancing operational systems and attracting qualified personnel to support its development efforts [196].
Willow Lane Acquisition Corp.(WLAC) - 2025 Q1 - Quarterly Report
2025-05-14 21:00
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 ☐ 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: 001-42400 WILLOW LANE ACQUISITION CORP. (MARK ONE) | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- ...