FDA Approval and Product Launch - Abeona Therapeutics received FDA approval for ZEVASKYN™, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1] - The U.S. launch of ZEVASKYN is underway with the activation of the first Qualified Treatment Center (QTC) at Lurie Children's Hospital, expecting to treat the first patient in Q3 2025 [4] Financial Performance - Cash, cash equivalents, restricted cash, and short-term investments totaled $84.5 million as of March 31, 2025, down from $98.1 million as of December 31, 2024 [7] - The net loss for Q1 2025 was $12.0 million, or $0.24 loss per share, significantly improved from a net loss of $31.6 million, or $1.16 loss per share, in Q1 2024 [9] - Abeona's total assets decreased to $99.4 million as of March 31, 2025, from $108.9 million as of December 31, 2024 [18] Research and Development Expenses - Research and development expenses increased to $9.9 million for Q1 2025, compared to $7.2 million for the same period in 2024, primarily due to increased headcount for ZEVASKYN's commercial launch [8] - General and administrative expenses rose to $9.8 million in Q1 2025 from $7.1 million in Q1 2024, reflecting increased staffing for the ZEVASKYN launch [8] Sales and Market Access - Abeona entered into a sales agreement for a priority review voucher (PRV) for gross proceeds of $155 million, which will fund operations for over two years [6] - Abeona has executed value-based agreements with commercial payer groups covering approximately 100 million commercially-insured lives to ensure broad access to ZEVASKYN [5] - The company is actively discussing further access expansion for ZEVASKYN with multiple commercial and government payers [5]

Financial Performance - MiNK Therapeutics reported a cash balance of $3.2 million at the end of Q1 2025, down from $4.6 million at the end of Q4 2024[10] - Cash used in operations for Q1 2025 was $1.3 million, a decrease of 48% compared to $2.5 million in Q1 2024[8] - The net loss for Q1 2025 was $2.8 million, or $0.70 per share, compared to a net loss of $3.8 million, or $1.10 per share, in Q1 2024[8] - Research and development expenses decreased to $1.3 million in Q1 2025 from $2.6 million in Q1 2024, reflecting a reduction of 50%[14] Clinical Development - MiNK is actively enrolling patients in a Phase 2 trial for gastric cancer, with new data showing promising results in PD-1–resistant tumors[6] - The company is pursuing broader patient access through clinical trials and compassionate use programs for its iNKT therapy in ARDS[6] - A peer-reviewed publication is expected in the first half of 2025 detailing a complete remission case in a patient with metastatic testicular cancer treated with agenT-797[6] Strategic Initiatives - MiNK has been selected for probable funding by NIAID to support its allogeneic iNKT program in GvHD, with a formal award expected by June 2025[6] - The company is engaged in advanced discussions for strategic partnerships in oncology, immune-mediated diseases, and next-generation engineered cell therapies[3] - MiNK's iNKT platform is positioned to deliver off-the-shelf therapies to patients with urgency, focus, and scale, leveraging clinical advances and expanded access to non-dilutive capital[2]

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 ☐ 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 001-41967 DT Cloud Acquisition Corporation (Exact name of registrant as specified in its charter) Cayman Islands n/a (St ...

Washington, D.C. 20549 FORM 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ 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 001-41967 DT Cloud Acquisition Corporation (Exact name of registrant as specified in its charter) Cayman Islands n/a (St ...

Table of Contents 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: 001-42270 Zenas BioPharma, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdicti ...

Financial Performance - As of March 31, 2025, the company reported an accumulated deficit of $321.3 million, up from $308.9 million as of December 31, 2024[199]. - Revenues for the three months ended March 31, 2025, were $13.6 million, a decrease of 22.3% compared to $17.5 million for the same period in 2024[232]. - The net loss attributable to the company for the three months ended March 31, 2025, was $12.4 million, compared to a net loss of $9.8 million in the same period of 2024[232]. - Adjusted EBITDA loss for the three months ended March 31, 2025, was $8.3 million, an increase from a loss of $5.1 million in the same period of 2024[232]. - Total revenue decreased by $3.8 million, or 21.9%, to $13.6 million for the three months ended March 31, 2025, from $17.5 million for the same period in 2024[274]. - Gross profit for the three months ended March 31, 2025, was $8.8 million, down from $11.6 million in 2024, reflecting a gross profit margin of 64.2% compared to 66.6%[272]. - Loss from operations increased to $9.5 million for the three months ended March 31, 2025, compared to a loss of $7.8 million in 2024[272]. Cash and Financing - The company had cash and cash equivalents of $3.2 million as of March 31, 2025, compared to $4.3 million as of December 31, 2024[199]. - Cash provided by financing activities for the three months ended March 31, 2025, was $5.3 million, primarily from short-term bridge financing[315]. - The company expects to use proceeds from various financing activities for general working capital purposes[301]. - The company entered into a Loan and Security Agreement on April 23, 2024, providing for a term loan of $2.2 million and additional delayed draw term loans of up to $2.8 million[216]. - The company generated gross proceeds of $6.7 million from the 2022 Private Placement, completed on November 18, 2022[206]. - The company completed multiple placements under the 2023 Multi-Tranche Private Placement, raising a total of $5.0 million through various transactions[209][210][211]. - The company may issue up to $9.0 million in shares of Senior Preferred Stock under the 2023 Multi-Tranche Private Placement, with the initial placement generating $2.0 million from the sale of 280,899 shares[298]. Operational Challenges - The company has incurred recurring net operating losses and negative cash flows from operations, indicating ongoing financial challenges[199]. - The company anticipates supply challenges during 2025 due to geopolitical disruptions and inflationary pressures affecting production lead times[245]. - The U.S. Federal administration has increased tariffs on goods imported from Israel to 10%, impacting the company's cost of goods and potentially leading to margin erosion[243][245]. - The company has ceased direct sales operations in 14 countries since June 2020, focusing on the U.S. market to improve profitability[239]. - The decline in lease program revenues in the first three months of 2025 was attributed to a strategy prioritizing cash deals and economic uncertainty impacting customers' financing capabilities[252]. Sales and Revenue Sources - Approximately 25% of the company's aesthetic system revenues were derived from internal lease programs in the three months ended March 31, 2025, consistent with the same period in 2024[226]. - Approximately 68% of total system revenues for the three months ended March 31, 2025, were derived from traditional sales, compared to 62% for the same period in 2024[253]. - Revenues from internal financing programs accounted for approximately 25% of total system revenues for both the three months ended March 31, 2025, and 2024[252]. - Revenues from distributor sales decreased to approximately 7% of total system revenues for the three months ended March 31, 2025, down from 13% in 2024[256]. - A total of 196 systems were delivered in the three months ended March 31, 2025, down from 314 systems delivered in the same period of 2024, representing a decline of 37.5%[238]. - The company sold 196 systems in Q1 2025, a decrease of 37.5% from 314 systems sold in Q1 2024, with systems revenue from internal lease programs remaining at approximately 25%[275]. Expenses and Cost Management - Operating expenses totaled $18.3 million for the three months ended March 31, 2025, compared to $19.4 million in 2024, with selling and marketing expenses at $7.0 million[272]. - Total operating expenses were $18.3 million in Q1 2025, a decrease of $1.1 million, or 5.8%, compared to $19.4 million in Q1 2024[279]. - Selling and marketing expenses decreased by $0.4 million, or 5.2%, in Q1 2025, but as a percentage of total revenues, they increased from 42.2% to 51.2%[280]. - General and administrative expenses decreased by $0.5 million, or 5.0%, in Q1 2025, but increased as a percentage of total revenues from 58.6% to 71.4%[281]. - Research and development expenses are expected to increase in absolute dollars as the company continues to invest in new products and technologies[265]. - Research and development expenses decreased by $0.2 million, or 12.8%, in Q1 2025, with an increase in percentage of total revenues from 10.2% to 11.4%[282]. Regulatory and Compliance - The company has received regulatory clearance for twelve novel aesthetic technology platforms, including ARTAS and NeoGraft systems, enhancing its product offerings[229]. - The allowance for expected credit losses as of March 31, 2025, was $3.1 million, representing approximately 11% of gross outstanding accounts receivable, down from $5.3 million or 13% as of March 31, 2024[241][248]. - The allowance for expected credit losses is based on customer account collectability assessments and aging of invoices, reflecting the company's best estimate of probable credit losses[327]. - Warranty accruals are recorded at the time of sale, based on historical costs and management estimates, with a one-year warranty period for systems sold[328]. - Stock-based compensation costs are recognized based on fair values, using the Black-Scholes option-pricing model for estimating stock options[329][330]. Market and Economic Conditions - The company operates directly in 11 international markets through 9 offices, including the United States, Canada, and China[231]. - The company expects a shift in the ratio of lease program sales to traditional sales to approximately 30:70 for the remainder of 2025 and beyond[286]. - The company anticipates that inventory levels will remain relatively flat in the short term but will increase at a lower rate than revenue growth over the longer term[286]. - The company is restricted by covenants in its loan agreements, which may limit its ability to incur additional indebtedness[306]. Accounting and Reporting - Revenue is recognized based on ASC 606, which includes five steps for contract identification and performance obligation satisfaction[323]. - Long-term receivables are related to internal lease programs with payment terms exceeding one year, discounted at implicit interest rates between 8% and 10%[325]. - Recent accounting pronouncements are detailed in the quarterly report, affecting financial statement presentation and recognition[333]. - As a smaller reporting company, the company is not required to provide disclosures about market risk[334].

- Reiterates 2025 outlook - TOMBALL, Texas -- (BUSINESS WIRE) -- Acuren Corporation (NYSE American: TIC) ("Acuren" or the "Company"), a leading provider of critical asset integrity services, today reported its financial results for the three months ended March 31, 2025. Exhibit 99.1 - Revenue of $234.2 million, up 5.0% driven by deeper service line penetration with recurring customers and market share Acuren Corporation Announces Results for the First Quarter 2025 gains - Capital Resources and Liquidity At ...

Regulatory Approvals - Invivyd, Inc. received emergency use authorization (EUA) from the FDA for PEMGARDA on March 22, 2024, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents [156]. - The company received Emergency Use Authorization (EUA) from the FDA for PEMGARDA on March 22, 2024 [181]. Financial Performance - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, with an accumulated deficit of $918.3 million as of the same date [165]. - Product revenue, net was $11.3 million for the three months ended March 31, 2025, compared to $0 for the same period in 2024, reflecting sales from the launch of PEMGARDA [191]. - The company reported a net loss of $16.3 million for the three months ended March 31, 2025, a decrease from a net loss of $43.5 million in the same period of 2024 [206][207]. - Other income decreased to $0.6 million for the three months ended March 31, 2025, from $2.6 million in 2024, primarily due to interest earned on invested cash balances [197]. - The company incurred a net cash used in operating activities of $21.1 million for the three months ended March 31, 2025, compared to $50.2 million for the same period in 2024, indicating a 58.1% improvement [205][207]. - The company reported a net decrease in cash and cash equivalents of $21.3 million for the three months ended March 31, 2025, compared to a decrease of $11.3 million in the same period of 2024 [205]. Research and Development - The ongoing Phase 1 clinical trial of VYD2311 is evaluating safety, tolerability, pharmacokinetics, and immunogenicity, with positive clinical data reported for both safety and pharmacokinetics [157]. - The company aims to develop monoclonal antibodies (mAbs) for serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications [158]. - The company expects research and development expenses to increase as it advances VYD2311 through clinical development and seeks regulatory approval for its product candidates [177]. - Research and development expenses decreased by $20.5 million to $10.6 million for the three months ended March 31, 2025, from $31.2 million in 2024 [196]. - Acquired in-process research and development expenses consist primarily of costs related to acquiring rights to Adimab's antibodies for COVID-19 and SARS [182]. Commercialization and Expenses - Invivyd, Inc. has incurred significant commercialization expenses related to product manufacturing, marketing, sales, and distribution of PEMGARDA [166]. - The company anticipates ongoing expenses related to the commercialization of PEMGARDA and the development of other product candidates, which may lead to continued operating losses [198]. - Selling, general and administrative expenses increased by $1.8 million to $16.8 million for the three months ended March 31, 2025, compared to $14.9 million in 2024 [196]. - Cost of product revenue was $0.8 million for the three months ended March 31, 2025, with no cost recorded for the same period in 2024 [192]. - The company has committed to noncancelable purchase obligations of $27.4 million related to commercial drug substance and drug product manufacturing, expected to be paid in 2025 [214]. Funding and Liquidity - Invivyd, Inc. has financed operations primarily with net proceeds of $464.7 million from preferred stock sales and $327.5 million from its IPO [164]. - The company expects to require additional funding to support ongoing operations and growth strategy, with substantial doubt about its ability to continue as a going concern without securing additional funds [169]. - The company entered into a Loan Agreement providing for a senior secured term loan facility of up to $30 million, with terms including a repayment period starting March 1, 2029 [203][204]. - The company raised $39.3 million from the sale of 9,000,000 shares of common stock at an average price of $4.50 per share under a Sales Agreement in February 2024 [202]. - The company expects to finance operations through a combination of revenue contributions, equity offerings, and debt financing, indicating a focus on maintaining liquidity [213]. - The company has substantial doubt about its ability to continue as a going concern, as it may not have sufficient cash to fund operations beyond one year from the issuance of its financial statements [212]. Inventory and Manufacturing - The company has capitalized inventory costs since March 2024, which would have resulted in reported margins approaching 80% if pre-EUA manufacturing costs had been capitalized [193]. - The company is actively monitoring SARS-CoV-2 variants and reported continued neutralizing activity of PEMGARDA against variants KP.3.1.1 and LB.1 [161]. - The company has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles [162]. Accounting and Compliance - The JOBS Act allows emerging growth companies to delay the adoption of new accounting standards until they apply to private companies [220]. - Companies are exempt from compliance with the auditor attestation requirement for internal control over financial reporting [221]. - Reduced disclosure obligations regarding executive compensation are available for smaller reporting companies [221]. - Exemptions from non-binding advisory votes on executive compensation and stockholder approval of golden parachute payments are provided [221]. - Companies are not required to disclose quantitative and qualitative information about market risk as they qualify as smaller reporting companies [222].

Financial Performance - Net sales for the three months ended March 31, 2025, were $12.1 million, a 13.7% decrease from $14.1 million in the same period of 2024[2] - Gross profit increased by $100,000 or 6.7% to $2.0 million, with gross profit as a percentage of sales rising to 16.8%, an increase of 320 basis points from 13.6% in 2024[2] - Operating expenses increased by $615,000 or 28.4%, primarily due to a $412,000 increase in non-cash stock compensation expense[2] - Operating loss was $746,000, compared to an operating loss of $259,000 in 2024[2] - Net loss for the first quarter of 2025 increased by $282,000 to $988,000[2] - Adjusted EBITDA improved to $576,000, representing a 59.1% increase over 2024[4] Operational Metrics - The Book-to-Bill ratio was 1.34 to 1.00 at the end of the first quarter of 2025, nearly a 20% improvement from the prior year[4] - Funded backlog of firm customer orders increased by $2.7 million or 2.3%, while total backlog continues to exceed a quarter of a billion dollars[9] Future Outlook - The company reaffirms belief that full-year 2025 results will exceed those of 2024[9] - Operating loss increased primarily due to higher non-cash stock compensation expenses, which accounted for 67% of the increase in operating expenses[4]

Financial Performance - Total revenue for Q1 2025 was $13.6 million, down 22% year-over-year from $17.5 million in Q1 2024[6] - U.S. revenue decreased by $1.7 million, or 16.5%, to $8.4 million, while international revenue decreased by $2.2 million, or 29.3%, to $5.2 million[7] - Gross profit for Q1 2025 decreased by $2.9 million, or 25%, to $8.8 million, with a gross margin of 64.2% compared to 66.6% in Q1 2024[8] - Revenue for the three months ended March 31, 2025, was $13,643 million, a decrease of 22.3% compared to $17,479 million in the same period of 2024[22] - Net loss for the three months ended March 31, 2025, was $12,366 million, compared to a net loss of $9,789 million in the same period of 2024, representing a 26.1% increase in losses[22] - Adjusted EBITDA for the three months ended March 31, 2025, was $(8,344) million, compared to $(5,118) million in the same period of 2024, indicating a worsening operational performance[27] Operating Expenses - Operating expenses for Q1 2025 decreased by $1.1 million, or 6%, to $18.3 million, reflecting cost containment efforts[9] - Total operating expenses for the three months ended March 31, 2025, were $18,283 million, down from $19,407 million in the same period of 2024, a decrease of 5.8%[22] - Cash used in operating activities for the three months ended March 31, 2025, was $(6,310) million, compared to $(2,878) million in the same period of 2024, reflecting increased cash outflows[24] Cash and Debt - Cash and cash equivalents as of March 31, 2025, were $3.2 million, down from $4.3 million at the end of 2024[12] - Total debt obligations decreased to approximately $35.5 million from $39.7 million as of December 31, 2024[12] - Cash and cash equivalents and restricted cash at the end of the period were $3,199 million, down from $5,087 million at the end of the same period in 2024[24] Shareholder Impact - The net loss attributable to stockholders for Q1 2025 was $12.4 million, or $17.44 per share, compared to a net loss of $9.8 million, or $16.91 per share in Q1 2024[11] - The weighted-average number of shares used in the basic and diluted loss per share calculation increased to 709 million in 2025 from 579 million in 2024[22] Strategic Actions - The company is not providing full-year 2025 financial guidance due to ongoing evaluations of strategic alternatives and potential trade disruptions[13] - The company completed a registered direct offering, raising approximately $1.1 million and $1.57 million from two separate transactions in April 2025[6] - The company intends to challenge the Canada Revenue Agency's assessment regarding the denial of CEWS claims, which could impact future cash flows[29] Foreign Exchange - The company experienced a foreign exchange gain of $(119) million for the three months ended March 31, 2025, compared to a loss of $324 million in the same period of 2024[27] Loss on Debt - The company reported a loss on debt extinguishment of $1,049 million for the three months ended March 31, 2025[27] Revenue Sources - The percentage of total systems revenue derived from the company's internal lease programs was approximately 25% in Q1 2025, consistent with the prior year[7]