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Swiftmerge Acquisition (IVCP) - 2025 Q1 - Quarterly Report
2025-05-15 20:01
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 | Delaware | 1311 | 98-1582153 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classification Code Number) | Identification Number) | (469) 398-2200 (Registrant's telephone number, including area cod ...
Outlook Therapeutics(OTLK) - 2025 Q2 - Quarterly Report
2025-05-15 20:01
Product Development and Market Approval - ONS-5010/LYTENAVA is the first ophthalmic formulation of bevacizumab approved in the EU and UK for wet AMD, with plans to launch in the US in Q2 2025[110]. - The FDA issued a Complete Response Letter for the BLA of ONS-5010/LYTENAVA on August 29, 2023, citing CMC issues and the need for an additional clinical trial[115]. - The NORSE EIGHT trial, involving 400 subjects, did not meet the pre-specified non-inferiority endpoint at week 8, but showed improvement in vision and a favorable safety profile[119]. - The mean improvement in best corrected visual acuity (BCVA) was +4.2 letters for ONS-5010/LYTENAVA and +6.3 letters for ranibizumab at week 8[119]. - The FDA's PDUFA goal date for a decision on the resubmitted BLA is August 27, 2025, with potential for 12 years of regulatory exclusivity if approved[116]. - The company has agreements with the FDA on SPAs for three additional registration clinical trials for ONS-5010/LYTENAVA[121]. Financial Performance and Losses - The company reported a net loss of $46.4 million for the three months ended March 31, 2025, compared to a net loss of $114.3 million for the same period in 2024, reflecting a decrease of $67.9 million[146]. - The company anticipates incurring additional losses until significant sales of ONS-5010/LYTENAVA or other product candidates can be generated[125]. - The company has substantial doubt about its ability to continue as a going concern, as existing cash and cash equivalents are insufficient to fund operations for the next year[127]. - Net loss for the six months ended March 31, 2025 was $28.98 million, a significant improvement compared to a net loss of $125.47 million for the same period in 2024, reflecting a change of $96.49 million[155]. - The company has incurred net losses and negative cash flows from operations, funding its activities with $584.0 million in net proceeds from equity and debt securities[163]. Research and Development Expenses - Research and development expenses decreased by $9.1 million to $4.4 million for the three months ended March 31, 2025, primarily due to a reduction in expenses related to the ONS-5010/LYTENAVA development[147]. - Research and development expenses for the six months ended March 31, 2025 decreased by $4.0 million to $14.1 million compared to $18.0 million for the same period in 2024, primarily due to a $3.3 million decrease in ONS-5010/LYTENAVA development expenses[156]. General and Administrative Expenses - General and administrative expenses increased by $2.6 million to $8.0 million for the three months ended March 31, 2025, driven by prelaunch expenses for ONS-5010/LYTENAVA in Europe[148]. - General and administrative expenses increased by $8.7 million to $19.9 million for the six months ended March 31, 2025, driven by $4.7 million in prelaunch expenses for ONS-5010/LYTENAVA in Europe[157]. Financing and Capital Management - The company has funded operations with $584.0 million in net proceeds from equity and debt securities and $29.0 million from collaboration and licensing agreements as of March 31, 2025[125]. - The company anticipates needing additional financing to fund operations and fully commercialize ONS-5010/LYTENAVA, exploring various strategic opportunities for funding[164]. - The company sold 1,926,742 shares of common stock under the At-the-Market Offering, generating approximately $3.2 million in net proceeds during the six months ended March 31, 2025[166]. - On March 13, 2025, the company issued an unsecured convertible promissory note for $33.1 million to pay off the December 2022 Note[170]. - The company recognized warrant inducement charges associated with warrants exercised, resulting in net proceeds of $15.9 million from the Warrant Inducement Transaction[171]. - The company plans to finance future operations through licensing arrangements, equity issuance, and potential product sales, with risks of dilution and unfavorable terms[178]. Market Overview - The total anti-VEGF retina market in Europe is estimated at approximately $3.6 billion, with around 1.52 million treated patients and 8.3 million total anti-VEGF units[111]. - The US anti-VEGF retina market is estimated at $8.5 billion, with 55% of off-label repackaged bevacizumab injections used as first-line agents[112]. - The global market for anti-VEGF retina is approximately $16 billion[113]. Economic Factors - Macroeconomic factors, including inflation and interest rates, may adversely affect the rollout of LYTENAVA in key markets[122]. Cash Flow and Operating Activities - Net cash used in operating activities for the six months ended March 31, 2025, was $27.6 million, primarily due to a net loss of $29.0 million[180]. - Net cash provided by financing activities during the same period was $20.2 million, driven by proceeds from the issuance of the March 2025 Note and warrant exercises[182]. Warrant and Liability Management - The loss from change in fair value of warrant liability was $42.3 million for the six months ended March 31, 2025, compared to a gain of $49.7 million for the same period in 2024, reflecting a change of $92.0 million[155]. - Syntone agreed to exercise existing warrants for 1,071,429 shares at a reduced price of $2.51, with potential net proceeds of approximately $2.4 million pending regulatory approval[172]. - The conversion price for the March 2025 Note is set at $2.26 per share, subject to adjustments based on market conditions[190].
Minim(MINM) - 2025 Q1 - Quarterly Report
2025-05-15 20:01
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 (Exact Name of Registrant as Specified in its Charter) Delaware 04-2621506 (State or Other Jurisdiction of Incorporation or Organization) Flat A1, 29/F, Block A, TML Tower, 3 Hoi Shing Road, Tsuen Wan, Hong Kong (Address of Principal Executive Of ices) (Zip Code) For the quarterly period ended March 31, 2025 or Registrant's Tel ...
Treasure (TGL) - 2025 Q3 - Quarterly Report
2025-05-15 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 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 001-4147 Treasure Global Inc (Exact name of registrant as specified in its charter) Delaware 36-4965082 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 (State or o ...
SCYNEXIS(SCYX) - 2025 Q1 - Quarterly Report
2025-05-15 20:01
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 to Commission File Number 001-36365 SCYNEXIS, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpo ...
Applied DNA Sciences(APDN) - 2025 Q2 - Quarterly Report
2025-05-15 20:01
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: 001-36745 Applied DNA Sciences, Inc. (Exact name of registrant as specified in its charter) | Delaware | 59-2262718 | | --- ...
Traws Pharma, Inc.(TRAW) - 2025 Q1 - Quarterly Report
2025-05-15 20:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Traws Pharma, Inc. (Exact name of registrant as specified in its charter) Delaware 22-3627252 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 12 Penns Trail, Newtown, PA 18940 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) ...
Onconova Therapeutics(ONTX) - 2025 Q1 - Quarterly Report
2025-05-15 20:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 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 Registrant's telephone number, including area code: (267) 759-3680 Securities registered pursuant to Section 12(b) of the Act: Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Traws Pharma ...
Gossamer Bio(GOSS) - 2025 Q1 - Quarterly Report
2025-05-15 20:01
Financial Performance - Total revenue for the three months ended March 31, 2025, was $9.889 million, compared to $0 in the same period in 2024, representing a significant increase [127]. - The net loss for the three months ended March 31, 2025, was $36.638 million, an improvement of $5.290 million compared to a net loss of $41.928 million in 2024 [127]. - Revenue for the three months ended March 31, 2025, was $9.9 million, primarily from collaboration with Chiesi, including a one-time development cost reimbursement [128]. Research and Development - Research and development expenses for the three months ended March 31, 2025, were $38.041 million, an increase of $5.649 million from $32.392 million in 2024 [127]. - Research and development expenses increased to $38.0 million for the three months ended March 31, 2025, up from $32.4 million in the same period of 2024, reflecting a $5.6 million increase mainly due to costs for seralutinib [129]. - The company has an accumulated deficit of $1.305 billion as of March 31, 2025, reflecting the ongoing investment in research and development [111]. Expenses - General and administrative expenses decreased to $8.658 million in the first quarter of 2025 from $9.567 million in 2024, a reduction of $909,000 [127]. - General and administrative expenses decreased to $8.7 million for the three months ended March 31, 2025, down from $9.6 million in 2024, primarily due to a $1.6 million decrease in stock-based compensation [131]. Cash and Liquidity - As of March 31, 2025, the company had $257.9 million in cash, cash equivalents, and marketable securities, providing a solid financial foundation for ongoing operations [110]. - Cash, cash equivalents, and marketable securities totaled $257.9 million as of March 31, 2025, providing liquidity for ongoing operations [136]. - Net cash used in operating activities for the three months ended March 31, 2025, was $39.7 million, compared to $52.3 million in the same period of 2024 [143]. - Investing activities provided approximately $22.1 million of cash during the three months ended March 31, 2025, primarily from maturities of marketable securities [146]. - Financing activities generated $0.5 million of cash for the three months ended March 31, 2025, mainly from the issuance of common stock [148]. Future Outlook - The company expects to incur significant operating losses for the foreseeable future as it continues the development of seralutinib and seeks regulatory approvals [111]. - Future capital requirements will depend on various factors, including the costs of clinical trials for seralutinib and the ability to generate product revenues [152]. - The company expects to finance its cash needs through equity offerings, debt financings, or other capital sources until it can generate substantial product revenues [113]. - The company expects to finance cash needs through equity offerings, debt financings, or collaborations, but may face challenges in raising additional funds [153]. Clinical Development - The company anticipates activating the first clinical sites for the global registrational Phase 3 SERANATA Study for PH-ILD in the fourth quarter of 2025 [108]. - Under the Chiesi Collaboration Agreement, the total potential transaction value includes a one-time $160 million development cost reimbursement payment [112].
Planet Green (PLAG) - 2025 Q1 - Quarterly Report
2025-05-15 20:01
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: 001-34449 PLANET GREEN HOLDINGS CORP. (Exact name of registrant as specified in its charter) (State or other jurisdicti ...