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 September 30, 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 001-33135 Regional Health Properties, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of i ...

Merger and Corporate Structure - The Company completed a merger with Vyome Therapeutics, Inc. on August 15, 2025, resulting in the renaming to Vyome Holdings, Inc.[157] - A private placement raised approximately $5.735 million from the sale of 520,514 shares at $11.02 per share immediately after the merger[175]. - A 1-for-4 reverse stock split was executed on August 15, 2025, reclassifying every four shares into one new share of common stock[176][177]. Product Development and Licensing - The lead program, VT-1953, is a topical gel for treating malignant fungating wounds, with discussions planned with the FDA for a pivotal trial protocol in the first half of 2026[158]. - The Company has commercialized two topical anti-fungal products in India and amended its agreement with Sun Pharma to receive a net service fee for sales instead of handling inventory[160]. - The Company has entered into a licensing agreement with Sun Pharma for the development of Luliconazole topical cream for skin fungal diseases in India[160]. - The Company has not generated any revenue from product sales in the biotechnology segment, focusing instead on development and clinical studies[161]. Financial Performance - Revenue for the nine months ended September 30, 2025, was $283,163, an increase of 44.8% compared to $195,516 for the same period in 2024[197]. - For the three months ended September 30, 2025, revenue was $34,627, a decrease of 58.7% from $84,526 in 2024[205]. - Ingredient sales under the Luliconazole Agreement for the three months ended September 30, 2025, were $26,973, down from $84,129 in 2024, a decline of 67.9%[207]. Expenses and Losses - General and administrative expenses rose significantly to $1,369,365 for the nine months ended September 30, 2025, compared to $651,196 in 2024, reflecting an increase of 110.8%[201]. - The company incurred transactional and financial advisory fees of approximately $7.7 million for the nine months ended September 30, 2025, related to the Merger[204]. - The net loss for the nine months ended September 30, 2025, was $9,198,033, compared to a net loss of $1,140,904 for the same period in 2024, representing an increase in loss of 707.5%[197]. - Research and development expenses decreased to $210,006 for the nine months ended September 30, 2025, from $217,864 in 2024, a reduction of 3.5%[200]. - Research and development expenses decreased to $39,677 in Q3 2025 from $66,815 in Q3 2024, primarily due to resource allocation towards the Merger[208]. - General and administrative expenses increased significantly to $844,344 in Q3 2025 from $246,821 in Q3 2024, driven by legal and professional fees related to the Merger and stock-based compensation of $574,109[209]. Cash Flow and Financing - Net cash used in operating activities was $(2,270,655) for the nine months ended September 30, 2025, compared to $(611,168) in the same period of 2024, indicating a significant increase in operational losses[213][214]. - Cash provided by financing activities rose to $7,890,956 in the nine months ended September 30, 2025, compared to $644,485 in the same period of 2024, primarily from a Private Placement offering[216]. - As of September 30, 2025, the company had a cash balance of approximately $5,707,000 and expects to incur significant expenses as it advances product candidates through development[217]. - Future capital requirements will depend on various factors, including clinical trial costs and commercialization activities, with substantial additional funding needed to support operations[221]. - The company anticipates financing operations through equity offerings and debt financings until it can generate significant product revenues[222]. Research and Clinical Trials - The company has entered into agreements for research and clinical trials, which are generally cancellable upon notice, indicating flexibility in managing commitments[224]. - The company expects research and development costs to increase significantly in the foreseeable future as it commences clinical trials and continues product development[189]. Interest and Fair Value Adjustments - Interest expense decreased to $136,697 for the nine months ended September 30, 2025, from $153,229 in 2024, a reduction of 10.8%[202]. - Interest expense decreased to $25,604 in Q3 2025 from $45,742 in Q3 2024, attributed to the conversion of Convertible Debt in August 2025[210]. - The fair value adjustment for convertible notes improved to $0 in Q3 2025 from $(221,690) in Q3 2024, reflecting changes in Merger completion probabilities[211]. - The company recorded a fair value adjustment of $30,511 for the nine months ended September 30, 2025, compared to a negative adjustment of $(239,686) in 2024[203].

Drug Development and Clinical Trials - Actinium Pharmaceuticals is advancing its lead program ATNM-400, a first-in-class targeted radiotherapy candidate, with preclinical data showing potential efficacy in prostate cancer, non-small cell lung cancer (NSCLC), and breast cancer[81]. - The Iomab-ACT trial for sickle cell disease (SCD) is progressing with increased patient recruitment, expected to yield initial proof of concept data in the first half of 2026[87]. - Actinium Pharmaceuticals is actively seeking strategic partners for Iomab-B, Actimab-A, and Iomab-ACT to enhance development efforts in hematology and cellular therapies[83]. - The combination of ATNM-400 and osimertinib resulted in complete tumor regression in all tumor-bearing animals, suggesting synergistic activity and a potential new treatment approach for NSCLC[103]. - Actimab-A is being developed as a mutation-agnostic therapy for acute myeloid leukemia (AML), with potential as a backbone therapy in combination with various treatments[135]. - A Phase 2/3 trial comparing Actimab-A + CLAG-M to CLAG-M alone in relapsed/refractory AML has been aligned with the FDA, with favorable Phase 1 results showing improved overall response rates and survival outcomes[137]. - The SIERRA trial for Iomab-B demonstrated a durable complete remission (dCR) rate of 22% compared to 0% in the control arm, achieving statistical significance (p-value < 0.0001)[152]. - Actinium expects initial clinical data from the Iomab-ACT trials in the first half of 2026, focusing on targeted conditioning for improved patient access to cell and gene therapies[150]. Financial Performance - Total revenue for the three months ended September 30, 2025, was $90, with no commercial revenue recorded for the same period in 2024[180]. - The company recognized $0.1 million in other revenue during the three months ended September 30, 2025, from a grant awarded by the National Institutes of Health[181]. - Long-term license revenue deferred was $35 million at September 30, 2025, resulting from a license agreement with Immedica for Iomab-B[183]. - Total revenue for the nine months ended September 30, 2025, was $0.1 million, compared to no revenue for the same period in 2024[191]. - Net loss for the three months ended September 30, 2025, was $5.1 million, a decrease of 44.5% from $11.6 million for the same period in 2024[188]. - Net loss for the nine months ended September 30, 2025, was $27.9 million, a decrease of 11.7% from $31.6 million for the same period in 2024[197]. - Cash used in operating activities for the nine months ended September 30, 2025, was $19.3 million, a decrease of 29.3% from $27.3 million in the prior-year period[198]. Research and Development - Research and development expenses for the three months ended September 30, 2025, were $4.2 million, down 57.1% from $9.8 million for the same period in 2024[185]. - Research and development expenses for the nine months ended September 30, 2025, were $16.8 million, a decrease of 33.3% from $25.2 million for the same period in 2024[193]. - The company has conducted 2 Phase 2/3 trials and 4 Phase 1 trials supported by NCI CRADA, with data from over 500 patients treated with Iomab-B and Actimab-A[158]. Strategic Partnerships and Collaborations - Actinium has entered a Cooperative Research and Development Agreement (CRADA) with the NCI to develop Actimab-A, which may accelerate clinical trials and reduce costs[144]. - The myeloMATCH program, part of the CRADA, aims to enroll over 5,000 patients in trials testing precision medicine treatments for AML and MDS across the U.S. and Canada[145]. - The company is seeking a strategic partner for Iomab-B in the U.S. and may consider partnering, divesting, or out-licensing Iomab-B, Actimab-A, or Iomab-ACT for all non-solid tumor indications[156]. Market Opportunities - The company is focusing on expanding ATNM-400's application across multiple solid tumors, with a market potential exceeding $20 billion, addressing over 800,000 new cases annually in the U.S.[88]. - Approximately 226,650 new lung cancer cases are expected in 2025, with 85% being NSCLC, indicating a significant market opportunity for ATNM-400[119]. - Hormone receptor-positive, HER2-negative breast cancer accounts for 70-75% of breast cancer cases, with sales of tamoxifen and trastuzumab reaching approximately $4.0 billion in 2024[123]. - The market for PD-1 inhibitors exceeded $40 billion in global sales in 2024, highlighting the competitive landscape for oncology therapies[124]. - The unmet need for effective therapies in mCRPC and NSCLC presents a significant opportunity for ATNM-400 to address critical gaps in treatment[117]. Manufacturing and Supply Chain - The company has established significant manufacturing and supply chain expertise, delivering over 500 doses for 18 clinical trials without missing a dose[167]. - The proprietary Ac-225 cyclotron manufacturing technology is expected to produce Ac-225 at a cost 10 to 20 times lower than currently available material[166]. Regulatory and Compliance Risks - The Company faces risks common in the biopharmaceutical industry, including regulatory approval delays and competition, which could adversely impact operations[211]. - Ongoing geopolitical conflicts and rising global inflation may contribute to increased market volatility affecting the Company's business[211]. - The recent U.S. federal government shutdown may disrupt the Company's ability to advance clinical trials and secure regulatory approvals[211]. Employee and Operational Insights - As of November 13, 2025, the company had 25 full-time employees, with 20 engaged in research and development and clinical development activities[176]. - Non-cash stock-based compensation expense for the three months ended September 30, 2025, was $0.1 million, a decrease of 92.3% from $1.3 million for the same period in 2024[184]. - General and administrative expenses for the three months ended September 30, 2025, decreased to $1.5 million, a reduction of 46.4% from $2.8 million for the same period in 2024[186].

Financial Performance - Revenues for Q3 2025 were $15,606, a significant decrease from $426,423 in Q3 2024, while revenues for the nine months ended September 30, 2025, were $27,222 compared to $2.2 million in the same period of 2024[8]. - The net loss for Q3 2025 was $4.6 million, compared to a net loss of $3.9 million in Q3 2024, while the net loss for the nine months ended September 30, 2025, was $8.7 million compared to $26.7 million in the same period of 2024[12]. - Revenues for the three months ended September 30, 2024, were $426.4 million, a significant increase from $15.6 million in the same period of 2025[19]. - Net loss attributable to common stockholders for the three months ended September 30, 2024, was $3.9 million, compared to a loss of $4.6 million in the same period of 2025[19]. - Total operating expenses for the nine months ended September 30, 2024, were $27.19 million, compared to $8.71 million in the same period of 2025[19]. Research and Development - R&D expenses increased by 18% to $1.4 million in Q3 2025 from $1.2 million in Q3 2024, while R&D expenses for the nine months ended September 30, 2025, decreased by 23% to $4.1 million from $5.3 million in the same period of 2024[9]. - Research and development expenses for the nine months ended September 30, 2024, totaled $5.34 billion, up from $4.11 billion in the same period of 2025[19]. - The company plans to dose the first patient in a Phase 1 clinical study for HCW9302 in autoimmune disease patients in Q4 2025[3]. - HCW Biologics has opened two clinical sites for a Phase 1 trial evaluating HCW9302 in patients with alopecia areata, a condition affecting approximately 160 million people globally[7]. General and Administrative Expenses - G&A expenses rose by 15% to $1.9 million in Q3 2025 from $1.6 million in Q3 2024, with a 29% increase in the nine-month period to $6.2 million from $4.8 million[10]. Financial Position and Concerns - As of September 30, 2025, the company expressed substantial doubt about its ability to continue as a going concern without additional funding[13]. - Total current assets decreased to $5.70 million as of December 31, 2024, from $1.59 million as of September 30, 2025[21]. - Total liabilities increased to $37.01 million as of December 31, 2024, compared to $27.55 million as of September 30, 2025[21]. - Cash and cash equivalents were $4.67 million as of December 31, 2024, down from $1.10 million as of September 30, 2025[21]. - Accounts payable increased to $22.33 million as of December 31, 2024, from $18.97 million as of September 30, 2025[21]. - The accumulated deficit grew to $100.56 million as of December 31, 2024, compared to $109.24 million as of September 30, 2025[21]. Legal and Compliance - The company received a $2.0 million insurance reimbursement related to legal fees in January 2025, contributing to a net legal recovery of ($1.6) million for the nine months ended September 30, 2025[11]. - The Nasdaq Hearings Panel granted the company continued listing on the Exchange, contingent upon compliance with the Equity Rule by December 31, 2025[14]. Commercial Strategy - The company is seeking a commercial partner for its T-cell engager compounds to enhance cancer treatment efficacy[5].

Production and Operations - Record total production of 23,029 barrels of oil equivalent per day ("Boe/d"), an increase of approximately 10% quarter-over-quarter[7] - Current production rate as of today is approximately 27,000 net Boe/d, reflecting successful execution of the development program[7][9] - The company closed two bolt-on acquisitions, adding approximately 11 net drilling locations and 3,400 net acres[7] Financial Performance - Revenue of $77.7 million, with oil revenue contributing $64.9 million, and an average realized price of $58.70 per barrel for oil[8][15] - Adjusted EBITDA of $56.3 million, an increase of over 45% quarter-over-quarter[8] - Net loss attributable to common stockholders of $22.5 million, or $0.44 basic loss per share[8][14] - For the three months ended September 30, 2025, the net income from continuing operations was $1,287,000, compared to a loss of $11,424,000 for the same period in 2024[26] - Adjusted EBITDA for the three months ended September 30, 2025, was $56,315,000, a significant increase from an adjusted EBITDA of $(7,304,000) in the prior year[26] - For the nine months ended September 30, 2025, the net income from continuing operations was $34,353,000, compared to a loss of $28,975,000 for the same period in 2024[26] - The company expects full-year 2025 net income to be in the range of $192 million to $202 million, with adjusted EBITDA projected between $240 million and $260 million[28] Assets and Liabilities - Total current assets as of September 30, 2025, were $120,977,000, a substantial increase from $18,302,000 as of December 31, 2024[38] - Total assets increased to $939,788,000 as of September 30, 2025, compared to $156,554,000 as of December 31, 2024[38] - Current liabilities rose to $145,010,000 as of September 30, 2025, up from $63,009,000 as of December 31, 2024[38] - The company has a credit facility with long-term liabilities amounting to $417,000,000 as of September 30, 2025, compared to $28,000,000 as of December 31, 2024[38] - The total stockholders' equity increased to $101,837,000 as of September 30, 2025, from $52,768,000 as of December 31, 2024[40] Cash Flow and Investments - Cash flows from operating activities for the nine months ended September 30, 2025, were $67.384 million, a significant increase from a cash outflow of $6.118 million in 2024[44] - The company incurred $608.536 million in net cash used in investing activities during the nine months ended September 30, 2025, primarily due to the Bayswater asset purchase[44] - Proceeds from the issuance of common stock amounted to $43.817 million during the nine months ended September 30, 2025[44] Stock Performance - The company reported a basic and diluted loss per share of $0.44 for the three months ended September 30, 2025, compared to a loss of $0.68 in the same period of 2024[42] - The company issued approximately 3.7 million shares of common stock to Bayswater as part of the Bayswater acquisition[46] Operating Expenses - The company reported a total operating expense of $110.901 million for the nine months ended September 30, 2025, which included $30.353 million in depreciation, depletion, and amortization[42] - The company reported a loss on adjustment to fair value of embedded derivatives, debt, and warrants amounting to $30.451 million for the nine months ended September 30, 2025[42] Guidance and Future Outlook - Full-year guidance for 2025 includes average daily production of 24,000 – 26,000 Boe/d and expected Adjusted EBITDA between $240.0 million and $260.0 million[22] - The company has secured favorable commodity pricing through an expanded hedging program, with prices of $60.45 per barrel through the rest of 2025[23]

Financial Performance - For the three months ended September 30, 2025, the Company reported a net income of $2,877, compared to $3,150 for the same period in 2024, while for the nine months ended September 30, 2025, net income was $10,375, up from $6,278 in 2024[70]. - Total revenue for the three months ended September 30, 2025, was $21,451, a decrease of $2,131 from $23,582 in the same period of 2024; however, revenue for the nine months increased to $70,335 from $59,977 in 2024, primarily due to special barrier project sales[70]. - Operating income for the three months ended September 30, 2025, was $3,854, slightly up from $3,848 in 2024; for the nine months, it increased to $13,759 from $8,031[72]. - Income tax expense for the three months ended September 30, 2025, was $994, with an effective tax rate of 26%, compared to $694 and 18% in 2024; for the nine months, the tax expense was $3,325 at a 24% rate, up from $1,683 at 21%[73]. - Operating income for the nine-month period ended September 30, 2025, was $13,759, compared to $8,031 for the same period in 2024[91]. - Net income for the nine months ended September 30, 2025, was $10,375, compared to $6,278 for the same period in 2024[94]. Sales and Revenue Breakdown - Soundwall sales increased significantly for the three and nine months ended September 30, 2025, with sales of $2,846 for the quarter and $11,832 for the nine months, compared to $1,873 and $7,043 in 2024, respectively[76]. - SlenderWall sales for the three and nine months ended September 30, 2025, were $1,146 and $2,634, respectively, as the Company focused on sales initiatives for this product[79]. - Easi-Set® and Easi-Span building sales increased for both the three and nine-month periods ended September 30, 2025, due to increased sales at all manufacturing plants[82]. - Utility sales decreased significantly for both the three and nine-month periods ended September 30, 2025, but are expected to trend higher for the remainder of 2025[83]. - Royalty income increased for both the three and nine-month periods ended September 30, 2025, driven by higher barrier production volumes from licensees[86]. - Miscellaneous wall sales decreased for the nine-month period ended September 30, 2025, due to lower production volumes compared to 2024[80]. - Barrier sales decreased slightly for the nine-month period ended September 30, 2025, as the company shifted marketing efforts to higher margin barrier rentals[81]. Costs and Expenses - Cost of sales as a percentage of revenue increased to 77% for the three months ended September 30, 2025, compared to 75% in 2024, while it decreased to 74% for the nine months from 77% in 2024[71]. - General and administrative expenses decreased to $1,100 for the three months ended September 30, 2025, from $1,720 in 2024, and to $4,198 for the nine months from $4,938[89]. Cash and Inventory - The company's cash position increased to $13,376 on September 30, 2025, from $7,548 on December 31, 2024[101]. - Inventory increased to $7,890 on September 30, 2025, from $6,677 on December 31, 2024, primarily due to increased finished goods inventory[106]. Sales Backlog - The Company's sales backlog as of November 1, 2025, was approximately $54.8 million, down from $62.8 million a year ago, with most projects expected to be produced within 12 months[74]. - The Company anticipates that the majority of projects in the sales backlog will be produced within 12 months, with some extending several years[110]. Operational Challenges - The Company experienced a ransomware incident in the first quarter of 2025, which is being addressed with network security changes, and no ransom payment was made[66]. - The Company may experience reduced revenues from December through February due to seasonal impacts on the construction industry, necessitating sufficient working capital to fund operations during winter months[108]. Internal Controls and Management - Management identified material weaknesses in internal control over financial reporting, which have not been remediated as of September 30, 2025[112]. - The Company did not maintain appropriately designed entity-level controls impacting the control environment, risk assessment, and monitoring activities[113]. - Management has committed to remediation efforts, including hiring a new Chief Financial Officer with relevant experience in financial reporting and internal controls[117]. - The Company’s consolidated financial statements are believed to present fairly its financial position and results of operations in accordance with U.S. GAAP, despite identified material weaknesses[115]. - There were no changes in the Company's internal control over financial reporting that materially affected its controls during the quarter ended September 30, 2025[117]. - Management did not design and maintain effective processes to ensure all journal entries are properly reviewed and approved prior to posting[116]. Raw Material Costs - Raw material costs used in production have slightly increased for the first nine months of 2025, with expectations of further slight increases for the remainder of 2025[109].

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 quarter ended September 30, 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: 001-41224 Abpro Holdings, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or other jurisdiction ...

Financial Performance - Total revenue for the three months ended September 30, 2025, was $0, a decrease of $0.2 million or -100% compared to $183,000 in the same period of 2024[193]. - For the nine months ended September 30, 2025, total revenue was $0, a decrease of $0.2 million or -100% compared to $183,000 in the same period of 2024[200]. - Net loss for the three months ended September 30, 2025, was $1.657 million, a decrease of $436,000 or 21% compared to a net loss of $2.093 million in 2024[193]. - The net loss for the nine months ended September 30, 2025, was $8.528 million, an increase of $4.631 million or -119% compared to a net loss of $3.897 million in 2024[200]. Expenses - Research and development expenses for the three months ended September 30, 2025, decreased by $0.4 million or -62% to $243,000 from $642,000 in 2024[193][197]. - General and administrative expenses for the three months ended September 30, 2025, decreased by $0.4 million or -26% to $1.093 million from $1.472 million in 2024[193][198]. - Research and development expenses for the nine months ended September 30, 2025, decreased by $1.6 million or -64% to $881,000 from $2.469 million in 2024[200][202]. - General and administrative expenses for the nine months ended September 30, 2025, increased by $0.8 million or 17% to $5.674 million from $4.864 million in 2024[200][203]. Cash and Funding - As of September 30, 2025, the Company had cash of $328, which is insufficient to operate for at least 12 months, raising substantial doubt about its ability to continue as a going concern[212]. - The Company plans to seek additional funding through equity and debt financings, collaboration agreements, and research grants to finance its operations[212]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $(5,386) thousand, a 3% increase compared to $(5,215) thousand for the same period in 2024[217]. - Net cash provided by financing activities decreased by $1.8 million for the nine months ended September 30, 2025, totaling $2,711 thousand compared to $4,495 thousand in 2024[218]. - The Company received net proceeds of $1,840 thousand from the Second Convertible Note and raised $688 thousand from the sale of 91,336 common stock shares in July and August 2025[211]. Compliance and Listing - The Company received a notice from Nasdaq on April 2, 2025, indicating non-compliance with the Minimum Bid Price Requirement, with a closing bid price below $1.00 per share for 30 consecutive business days[206]. - On April 10, 2025, the Company was notified of non-compliance with the MVPHS Requirement, having a Market Value of Publicly Held Shares below $15 million, and the MVLS Requirement, with a Market Value of Listed Securities below $50 million[207]. - The Panel granted the Company's request for continued listing on Nasdaq, with conditions to be met by March 30, 2026, to avoid delisting[210]. Future Plans - The company plans to initiate clinical trials for lead product candidate ABP-102 in the first half of 2026[189]. - The Company expects expenses to increase as it advances preclinical activities and clinical trials for product candidates, including planned Phase 1/2 trials for ABP-102 and Phase 1 trials for ABP-201[214]. - The Company may need to delay, reduce, or eliminate research and development programs if it fails to secure additional funding[213]. Accumulated Deficit - The company had an accumulated deficit of $124.6 million as of September 30, 2025[205].

Financial Performance - "The company reported a revenue increase of 15% year-over-year." [1] - "Net income for the quarter was $2 million, compared to a loss of $1 million in the same quarter last year." [2] - "Earnings per share (EPS) rose to $0.50, up from $0.30 a year ago." [3] Operational Highlights - "The company expanded its market presence in Asia, opening three new offices." [1] - "Production efficiency improved, leading to a 10% reduction in manufacturing costs." [2] - "Customer satisfaction ratings increased to 92%, up from 88% last quarter." [3] Future Outlook - "The management expects revenue growth to continue at a rate of 10-12% for the next fiscal year." [1] - "Plans to launch two new products in the upcoming quarter are underway." [2] - "The company is exploring potential acquisitions to enhance its market position." [3]

Financial Performance - For the three months ended September 30, 2025, the company reported no revenue, a decrease of $80,000 compared to $80,380 in the same period of 2024[90]. - Revenue for the nine months ended September 30, 2025, was $216,117, a decrease of $147,000 from $363,000 in 2024[101]. - The net loss for the three months ended September 30, 2025, was $1,254,000, compared to a net loss of $1,445,000 in the same period of 2024, an improvement of $191,000[90]. - Net loss for the nine months ended September 30, 2025, was $3,888,087, compared to a net loss of $3,574,592 for the same period in 2024[107]. Research and Development (R&D) Expenses - Research and Development (R&D) expenses for the three months ended September 30, 2025, were $721,000, down from $1,047,000 in 2024, reflecting a decrease of $326,000[90]. - R&D expenses for the nine months ended September 30, 2025, were $2,506,028, a decrease of approximately $45,000 from $2,550,852 in 2024[103]. - The company expects substantial increases in expenses related to ongoing R&D activities and anticipates continued operating losses for the foreseeable future[116]. - The increase in expenses was primarily due to ongoing research and development work and active clinical trials for LP-310[126]. Operating Expenses - Total operating expenses decreased to $1,274,000 in Q3 2025 from $1,540,000 in Q3 2024, a reduction of $266,000[90]. - Total operating expenses for the nine months ended September 30, 2025, were $4,175,000, an increase of $183,000 from $3,992,000 in 2024[101]. - General and administrative expenses increased by approximately $60,000 to $552,375 for the three months ended September 30, 2025, compared to $493,102 for the same period in 2024[99]. Cash Flow - Cash and cash equivalents totaled $1,855,771 as of September 30, 2025[106]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $3,785,321, compared to $2,960,334 for the same period in 2024[111]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $3,456,228, reflecting net proceeds from the issuance of preferred stock and warrants[114]. Product Development - The company is developing LP-10 and LP-310 for hemorrhagic cystitis and oral lichen planus, respectively, with LP-310 completing its Phase 2a clinical trial in Q3 2025[85]. - LP-410, an oral formulation for oral graft-versus-host disease, received "orphan drug" designation from the FDA on November 11, 2023[86]. - The company holds two issued patents in the U.S. for LP-10 and LP-310, which are valid until July 11, 2035[87]. - The company has not yet commercialized any products and does not expect to generate revenue from product sales for several years[91]. Staffing and Management Changes - The resignation of the Chief Medical Officer was announced, effective December 4, 2025[89]. Accounting and Reporting - The company has elected to take advantage of the extended transition period for adopting new accounting standards as an emerging growth company[141]. - The company may utilize reduced disclosure requirements, including those related to R&D progress and executive compensation, while maintaining its status as an emerging growth company[142][143]. - Recent accounting pronouncements reviewed by the company are not expected to have a material impact on its financial statements[145]. - As a smaller reporting company, the company is not required to provide certain market risk disclosures[146]. Stock-Based Compensation - Stock-based compensation expense is expected to increase in future periods due to unrecognized stock-based compensation and additional awards granted to attract and retain employees[133]. - The company granted stock options for 55,000 shares at an exercise price of $6.16, with an estimated fair value of $4.40 per share on the grant date[140].