Xilio Therapeutics(XLO) - 2025 Q2 - Quarterly Results
2025-08-14 11:35
[Overview and Highlights](index=1&type=section&id=Xilio%20Therapeutics%20Announces%20Pipeline%20and%20Business%20Updates%20and%20Second%20Quarter%202025%20Financial%20Results) The company announced positive Phase 2 data, progress in its T cell engager programs, and a cash runway through Q3 2026 - Announced updated Phase 2 data for vilastobart at ASCO, demonstrating **deep, durable responses** and a **differentiated safety profile** for an anti-CTLA-4 combination therapy[1](index=1&type=chunk) - The company is **on track to nominate its first development candidates** for wholly owned masked T cell engager programs in the second half of 2025[1](index=1&type=chunk) Financial Position and Runway | Metric | Value | | :--- | :--- | | Cash and cash equivalents (as of June 30, 2025) | $121.6 million | | Anticipated cash runway | Through end of Q3 2026 | [Pipeline and Business Updates](index=1&type=section&id=Pipeline%20and%20Business%20Updates) The company reports progress across its key pipeline assets, including vilastobart, XTX301, XTX501, and masked T cell engagers [Vilastobart (anti-CTLA-4)](index=1&type=section&id=Vilastobart%3A%20tumor-activated%2C%20Fc-enhanced%2C%20high%20af%20inity%20binding%20anti-CTLA-4) Phase 2 data for vilastobart showed a 26% objective response rate in certain CRC patients with a well-tolerated safety profile - Updated Phase 2 data presented at ASCO 2025 demonstrated a preliminary **26% objective response rate (ORR)** in heavily pre-treated metastatic MSS CRC patients without liver metastases[3](index=3&type=chunk) - The therapy showed a **differentiated and well-tolerated safety profile**, with a low incidence of colitis and other immune-related adverse events[3](index=3&type=chunk) - Xilio is actively engaging with strategic partners for potential opportunities to **accelerate and expand the development** of vilastobart[3](index=3&type=chunk) [XTX301 (IL-12)](index=2&type=section&id=XTX301%3A%20tumor-activated%20IL-12) The company is advancing its tumor-activated IL-12, XTX301, under an exclusive license agreement with Gilead - Xilio has an **exclusive license agreement with Gilead Sciences** for its tumor-activated IL-12 program, including XTX301[4](index=4&type=chunk) - **Enrollment in the Phase 1A monotherapy dose escalation** portion of the clinical trial has been completed, with patient evaluation ongoing[4](index=4&type=chunk) [XTX501 (PD-1/IL-2 bispecific)](index=2&type=section&id=XTX501%3A%20masked%20PD-1%2FIL-2%20bispecific) The novel tumor-activated bispecific XTX501 is progressing through IND-enabling studies, with an IND submission planned for mid-2026 - XTX501 is currently **advancing in investigational new drug (IND)-enabling studies**[5](index=5&type=chunk) - The company plans to **submit an IND application for XTX501 in the middle of 2026**[5](index=5&type=chunk) [Masked T Cell Engager Programs](index=2&type=section&id=Masked%20T%20Cell%20Engager%20Programs) The company is developing multiple preclinical masked T cell engager programs using its proprietary ATACR and SEECR formats - The pipeline includes wholly owned programs targeting **PSMA, CLDN18.2, and STEAP1**, plus a collaboration with AbbVie[6](index=6&type=chunk) - The programs utilize two proprietary formats: the bispecific **ATACR** (activated cell engager) and the tri-specific **SEECR** (selective effector-enhanced cell engager)[7](index=7&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) The company provided a development candidate timeline, closed a public offering, and appointed a new board member Development Candidate Nomination Timeline | Program | Format | Anticipated Nomination | | :--- | :--- | :--- | | PSMA | ATACR | Q3 2025 | | CLDN18.2 | ATACR | Q4 2025 | | STEAP1 | SEECR | H1 2026 | - In June 2025, Xilio closed a follow-on public offering, receiving initial gross proceeds of approximately **$50.0 million**, with potential for up to an additional **$100.0 million** if all associated warrants are exercised[9](index=9&type=chunk) - Akintunde (Tunde) Bello, Ph.D., was appointed to the company's board of directors in June 2025[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported increased revenue and operating expenses for Q2 2025 and provided financial guidance through Q3 2026 [Q2 2025 Financial Highlights](index=3&type=section&id=Q2%202025%20Financial%20Highlights) Collaboration revenue grew to $8.1 million while net loss increased to $15.8 million, with a strengthened cash position of $121.6 million Q2 2025 Financial Performance (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration & License Revenue | $8.1M | $2.4M | +238% | | R&D Expenses | $15.3M | $11.2M | +37% | | G&A Expenses | $7.1M | $5.8M | +22% | | Net Loss | $15.8M | $13.9M | +14% | | Net Loss per Share | $(0.16) | $(0.24) | N/A | | Cash & Cash Equivalents (period end) | $121.6M | N/A | N/A | [Financial Guidance](index=3&type=section&id=Financial%20Guidance) The company's current cash position is expected to fund operations and capital expenditures through the end of Q3 2026 - The company expects its cash and cash equivalents as of June 30, 2025, to fund operating expenses and capital expenditure requirements **through the end of Q3 2026**[11](index=11&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) The report includes condensed consolidated balance sheets and statements of operations for the period ending June 30, 2025 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $133.8 million driven by a rise in cash, while total liabilities grew to $126.7 million Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $121,551 | $55,291 | | Total assets | $133,813 | $71,075 | | **Liabilities & Equity** | | | | Deferred revenue | $70,910 | $32,780 | | Common stock warrant liabilities | $38,550 | $0 | | Total liabilities | $126,744 | $53,477 | | Stockholders' equity | $7,069 | $17,598 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $15.8 million for the three months ended June 30, 2025, on revenues of $8.1 million Statement of Operations Summary (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Collaboration and license revenue | $8,084 | $2,357 | | Research and development | $15,330 | $11,216 | | General and administrative | $7,120 | $5,815 | | Total operating expenses | $22,450 | $17,061 | | Loss from operations | $(14,366) | $(14,704) | | Net loss | $(15,844) | $(13,925) | | Net loss per share | $(0.16) | $(0.24) |
MiNK Therapeutics(INKT) - 2025 Q2 - Quarterly Results
2025-08-14 11:35
EXHIBIT 99.1 MiNK Therapeutics Reports Clinical and Strategic Milestones and Second Quarter 2025 Results NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced financial results for the second quarter ended June 30, 2025, and provided a business update highlighting major clinical achievements, a strengthened balance sheet, and expanded ...
AFC Gamma(AFCG) - 2025 Q2 - Quarterly Results
2025-08-14 11:35
[Second Quarter 2025 Financial Highlights and Strategic Announcements](index=1&type=section&id=Q2_2025_Financial_Highlights_Strategic_Announcements) AFC reported a GAAP net loss of $(13.2) million and Distributable Earnings of $3.4 million, also announcing an expanded investment mandate and proposed BDC conversion [Summary of Q2 2025 Results](index=1&type=section&id=Summary_Q2_2025_Results) AFC reported a GAAP net loss of $(13.2) million and Distributable Earnings of $3.4 million for Q2 2025, with per-share figures of $(0.60) and $0.15 respectively Q2 2025 Key Financial Highlights | Metric | Amount | | :------------------------------------ | :------------- | | GAAP Net Loss | $(13.2) million | | GAAP Net Loss per Share | $(0.60) | | Distributable Earnings | $3.4 million | | Distributable Earnings per Share | $0.15 | [Key Strategic Initiatives](index=1&type=section&id=Key_Strategic_Initiatives) AFC plans to expand its investment mandate to include secured loans for ancillary cannabis and middle-market companies, and proposes converting to a BDC, pending shareholder approval - **Expansion of Investment Mandate**: Approved an amendment to include secured loans to ancillary cannabis businesses and public/private middle-market companies operating outside the cannabis industry[4](index=4&type=chunk) - **Proposed Conversion to BDC**: Intention to convert from a commercial mortgage REIT to a BDC, subject to shareholder approval, to pursue a broader array of investment opportunities[5](index=5&type=chunk) [Management Commentary](index=1&type=section&id=Management_Commentary) CEO Dan Neville emphasized resolving non-accrual credits and evaluating cannabis opportunities, highlighting the BDC conversion as a milestone to expand the investable universe beyond mortgage REIT limitations [CEO Statement](index=1&type=section&id=CEO_Statement) CEO Dan Neville highlighted the company's focus on resolving non-accrual credits and selectively evaluating opportunities with established cannabis operators, emphasizing that the proposed BDC conversion is a significant milestone, enabling the company to overcome limitations of its mortgage REIT structure in the capital-intensive cannabis industry and expand its investable universe to include non-real estate covered and ancillary businesses - **Operational Focus**: Focused on working through non-accrual credits and selectively evaluating opportunities with established operators of scale in attractive cannabis markets[3](index=3&type=chunk) - **Rationale for BDC Conversion**: The conversion would significantly expand the investable universe, allowing lending to ancillary cannabis businesses and non-real estate covered, vertically integrated operators, addressing limitations of the mortgage REIT structure in the capital-intensive cannabis industry[6](index=6&type=chunk) [Company Profile](index=2&type=section&id=Company_Profile) Advanced Flower Capital Inc. (AFCG) is a commercial mortgage REIT specializing in senior secured mortgage loans and other debt securities for cannabis industry operators in legalized states [About Advanced Flower Capital](index=2&type=section&id=About_Advanced_Flower_Capital) Advanced Flower Capital Inc. (AFCG) is a commercial mortgage real estate investment trust (REIT) primarily originating, structuring, underwriting, investing in, and managing senior secured mortgage loans and other debt securities, with a specialization in loans to cannabis industry operators in states that have legalized medical and/or adult-use cannabis - **Business Model**: Operates as a commercial mortgage REIT, primarily originating, structuring, underwriting, investing in, and managing senior secured mortgage loans and other debt securities[13](index=13&type=chunk) - **Investment Focus**: Specializes in loans to cannabis industry operators in legalized states, with loans typically secured by quality real estate assets, license value, and cash flows, ranging from **$10 million to over $100 million**[13](index=13&type=chunk) [Detailed Second Quarter 2025 Financial Performance](index=1&type=section&id=Detailed_Q2_2025_Financial_Performance) AFC reported a GAAP net loss of $(13.2) million and Distributable Earnings of $3.4 million for Q2 2025, with a detailed reconciliation of these figures and a declared common stock dividend [GAAP Net Loss and Distributable Earnings](index=1&type=section&id=GAAP_Net_Loss_Distributable_Earnings) AFC reported a GAAP net loss of $(13.2) million and Distributable Earnings of $3.4 million for Q2 2025, with per-share figures of $(0.60) and $0.15 respectively Q2 2025 Financial Results (Three Months Ended June 30, 2025) | Metric | Amount | | :------------------------------------ | :------------- | | Net (loss) income | $(13,164,651) | | Distributable earnings | $3,384,328 | | Basic weighted average shares outstanding | 22,114,341 | | Distributable earnings per basic weighted average share | $0.15 | [Reconciliation of GAAP Net Income (Loss) to Distributable Earnings](index=4&type=section&id=Reconciliation_GAAP_Net_Income_to_Distributable_Earnings) The reconciliation table details adjustments made to GAAP Net income (loss) to arrive at Distributable Earnings, showing a $14.1 million provision for current expected credit losses for Q2 2025 Reconciliation of GAAP Net Income (Loss) to Distributable Earnings (Three Months Ended June 30, 2025 vs. 2024) | Metric | June 30, 2025 | June 30, 2024 | | :------------------------------------------ | :------------- | :------------- | | Net (loss) income | $(13,164,651) | $16,446,121 | | Stock-based compensation expense | $484,502 | $369,343 | | Unrealized losses (gains) or other non-cash items | $1,055,970 | $1,420,001 | | Provision for (reversal of) current expected credit losses | $14,074,320 | $(6,190,240) | | TRS loss (income), net of dividends | $934,187 | $(624,235) | | **Distributable earnings** | **$3,384,328** | **$11,420,990** | | Basic weighted average shares outstanding | 22,114,341 | 20,400,004 | | Distributable earnings per basic weighted average share | $0.15 | $0.56 | [Common Stock Dividend](index=2&type=section&id=Common_Stock_Dividend) On July 15, 2025, Advanced Flower Capital paid a regular cash dividend of $0.15 per common share for the second quarter of 2025 to shareholders of record as of June 30, 2025 Q2 2025 Common Stock Dividend | Metric | Value | | :-------------------- | :---- | | Dividend per share | $0.15 | | Payment Date | July 15, 2025 | | Record Date | June 30, 2025 | [Strategic Business Developments](index=1&type=section&id=Strategic_Business_Developments) AFC is expanding its investment mandate to include secured loans to ancillary cannabis and middle-market companies, alongside a proposed conversion to a BDC to broaden investment opportunities [Expansion of Investment Mandate](index=1&type=section&id=Expansion_Investment_Mandate) AFC's Board approved expanding its investment mandate to include secured loans for ancillary cannabis businesses and public/private middle-market companies outside the cannabis industry, adhering to REIT obligations - **New Investment Areas**: Expanded mandate to include secured loans to ancillary cannabis businesses and public/private middle-market companies operating outside the cannabis industry[4](index=4&type=chunk) [Proposed Conversion to Business Development Company (BDC)](index=1&type=section&id=Proposed_Conversion_to_BDC) AFC announced its intention to convert from a commercial mortgage REIT to a BDC, pending shareholder approval, to significantly expand the investable universe, allowing lending to ancillary cannabis businesses and non-real estate covered operators - **Conversion Rationale**: The current mortgage REIT structure limits lending opportunities in the capital-intensive cannabis industry due to many operators not owning real estate[6](index=6&type=chunk) - **Expanded Investable Universe**: Conversion to a BDC would allow lending to ancillary cannabis businesses with high growth potential and non-real estate covered, vertically integrated operators, as well as direct lending opportunities in other private and public middle-market companies[6](index=6&type=chunk)[7](index=7&type=chunk) - **Approval Requirement**: The proposed conversion is subject to shareholder approval of a new investment advisory agreement with its Manager that complies with the Investment Company Act of 1940[8](index=8&type=chunk) [Non-GAAP Financial Measures](index=3&type=section&id=Non_GAAP_Financial_Measures) Distributable Earnings is a non-GAAP financial measure used by AFC to evaluate performance by excluding certain non-cash and GAAP adjustments not indicative of current loan activity, serving as a factor in dividend authorization [Definition and Rationale for Distributable Earnings](index=3&type=section&id=Definition_Rationale_Distributable_Earnings) Distributable Earnings is a non-GAAP financial measure used by AFC to evaluate performance by excluding certain non-cash and GAAP adjustments not indicative of current loan activity, defined as GAAP net income (loss) adjusted for specific items, and serves as a factor in dividend authorization - **Definition**: Distributable Earnings is GAAP net income (loss) excluding stock-based compensation, depreciation/amortization, unrealized gains/losses, provision for current expected credit losses, TRS (income) loss, and certain one-time non-cash charges[16](index=16&type=chunk) - **Purpose**: Used to evaluate performance by excluding effects of certain transactions and GAAP adjustments not necessarily indicative of current loan activity and operations, and is a factor considered by the Board of Directors in authorizing dividends[14](index=14&type=chunk)[17](index=17&type=chunk) - **Limitations**: It is a non-GAAP measure and should not be considered a substitute for GAAP net income; methodology may differ from other REITs, impacting comparability[18](index=18&type=chunk) [Investor Information](index=2&type=section&id=Investor_Information) Advanced Flower Capital provides investors with access to its Q2 2025 earnings presentation and Form 10-Q filing, and will host a conference call on August 14, 2025, to discuss quarterly financial results [Investor Resources and Conference Call](index=2&type=section&id=Investor_Resources_Conference_Call) Advanced Flower Capital provides investors with access to its 'Second Quarter 2025 Earnings Presentation' and its Form 10-Q filing via its website, and will host a conference call on August 14, 2025, at 10:00 am ET to discuss quarterly financial results, with options for live audio webcast and telephone participation - **Available Resources**: Q2 2025 Earnings Presentation and Quarterly Report on Form 10-Q are available on advancedflowercapital.com under the Investor Relations section[10](index=10&type=chunk)[11](index=11&type=chunk) - **Conference Call**: Scheduled for August 14, 2025, at 10:00 am ET, with live audio webcast and telephone registration available; the complete webcast will be archived for 90 days[12](index=12&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward_Looking_Statements) This section contains a standard disclaimer regarding forward-looking statements, indicating they reflect current views and projections but are subject to inherent uncertainties and risks, with no obligation to publicly update or revise them unless required by law [Disclaimer Regarding Forward-Looking Statements](index=4&type=section&id=Disclaimer_Forward_Looking_Statements) This section contains a standard disclaimer regarding forward-looking statements, indicating they reflect current views and projections but are subject to inherent uncertainties and risks, advising that actual results may differ materially due to factors such as the Manager's ability to locate loan opportunities, market demand, and credit losses, and disclaiming any obligation to publicly update or revise these statements unless required by law - **Nature of Statements**: Reflects current views and projections regarding future events and financial performance, identified by words such as 'believes,' 'expects,' 'will,' 'intends,' etc[20](index=20&type=chunk) - **Risk Factors**: Subject to inherent uncertainties, including the Manager's ability to locate suitable loan opportunities, demand for cannabis cultivation and processing facilities, and management's current estimate of expected credit losses, which could cause actual results to differ materially[20](index=20&type=chunk) - **No Obligation to Update**: The company does not undertake any obligation to publicly update or revise any forward-looking statements, except as required by law[20](index=20&type=chunk) [Contact Information](index=5&type=section&id=Contact_Information) Contact details for investor relations and media inquiries are provided for Advanced Flower Capital Inc [Investor and Media Contacts](index=5&type=section&id=Investor_Media_Contacts) Contact details for investor relations and media inquiries are provided for Advanced Flower Capital Inc - **Investor Relations Contact**: Robyn Tannenbaum, **(561) 510-2293**, ir@advancedflowercapital.com[22](index=22&type=chunk) - **Media Contact**: Collected Strategies, Jim Golden / Jack Kelleher, AFCG-CS@collectedstrategies.com[22](index=22&type=chunk)
Lexeo Therapeutics(LXEO) - 2025 Q2 - Quarterly Report
2025-08-14 11:33
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-4012572 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | 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 June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN ...
Blue Water Biotech(BWV) - 2025 Q2 - Quarterly Report
2025-08-14 11:32
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 June 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: 001-41294 Onconetix, Inc. (Exact name of registrant as specified in its charter) | Delaware | 83-2262816 | | --- | --- | | (State or ...
Onconetix(ONCO) - 2025 Q2 - Quarterly Report
2025-08-14 11:32
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) (Former name, former address and former fiscal year, if changed since last report) Securities registered pursuant to Section 12(b) of the Act: For the transition period from to Commission Fi ...
Lexeo Therapeutics(LXEO) - 2025 Q2 - Quarterly Results
2025-08-14 11:31
[Executive Summary & Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Highlights) [Key Operational and Financial Highlights](index=1&type=section&id=Key%20Operational%20and%20Financial%20Highlights) Lexeo Therapeutics reported significant operational progress in Q2 2025, including Breakthrough Therapy designation for LX2006, selection for the FDA's CDRP program, continued dosing in the LX2020 trial, and a new strategic partnership for non-viral RNA therapeutics. Financially, the company secured an $80 million equity financing, extending its operational runway into 2028, and appointed Louis Tamayo as Chief Financial Officer - **Breakthrough Therapy designation** granted for LX2006 based on interim Phase I/II data demonstrating clinically meaningful improvements in cardiac and neurologic measures of Friedreich ataxia[1](index=1&type=chunk)[3](index=3&type=chunk) - LX2006 selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (**CDRP program**) to facilitate CMC registrational readiness and support faster patient access[1](index=1&type=chunk)[4](index=4&type=chunk) - **Eight participants** dosed in Phase I/II clinical trial (HEROIC-PKP2) of LX2020 for PKP2-ACM; interim clinical data update on track for second half of 2025[1](index=1&type=chunk)[4](index=4&type=chunk) - **Strategic partnership** announced with Perceptive Xontogeny Venture Funds and venBio Partners to advance non-viral, RNA-based therapeutics for genetic cardiac diseases[1](index=1&type=chunk)[6](index=6&type=chunk) - **$80 million equity financing** closed to support development of clinical stage pipeline[1](index=1&type=chunk)[6](index=6&type=chunk) - Cash, cash equivalents and investments in marketable securities of **$152.5 million** expected to provide operational runway into **2028**[1](index=1&type=chunk)[6](index=6&type=chunk) - **Louis Tamayo** appointed **Chief Financial Officer**[1](index=1&type=chunk)[6](index=6&type=chunk) [Business and Program Updates](index=1&type=section&id=Business%20and%20Program%20Updates) [LX2006 in Friedreich Ataxia (FA)](index=1&type=section&id=LX2006%20in%20Friedreich%20Ataxia%20(FA)) LX2006 received FDA Breakthrough Therapy designation and was selected for the CDRP program, accelerating its path to a registrational study expected to begin in early 2026 with potential efficacy data in 2027. The CLARITY-FA natural history study is enrolling to serve as an external control, and LX2006 continues to demonstrate a generally well-tolerated safety profile - In July 2025, LX2006 received **FDA Breakthrough Therapy designation** based on interim clinical data demonstrating clinically meaningful improvements in cardiac and neurologic measures of FA[4](index=4&type=chunk) - LX2006 selected for FDA Chemistry, Manufacturing, and Controls (CMC) Development Readiness Pilot (**CDRP program**) to accelerate CMC registrational readiness[4](index=4&type=chunk) - Lexeo expects final alignment with FDA on the LX2006 registrational study in **late Q3 to early Q4 2025**, with initiation planned for **early 2026** and potential efficacy readout in **2027**[4](index=4&type=chunk) - The **CLARITY-FA natural history study** is currently enrolling and is expected to serve as a concurrent external control arm for the planned registrational study[4](index=4&type=chunk) - LX2006 continues to be **generally well tolerated** with no clinically significant complement activation and no new treatment-related serious adverse events[4](index=4&type=chunk) [LX2020 in PKP2-ACM](index=1&type=section&id=LX2020%20in%20PKP2-ACM) Eight participants have been dosed in the HEROIC-PKP2 Phase I/II clinical trial for LX2020, across three cohorts, with the high-dose Cohort 3 still enrolling. The therapy has shown a generally well-tolerated safety profile, and interim clinical data is anticipated in the second half of 2025 - **Eight participants** have been dosed to date in the HEROIC-PKP2 Phase I/II clinical trial for LX2020, including **three in Cohort 1** (low dose), **three in Cohort 2** (high dose), and **two in dose-expansion Cohort 3** (high dose)[4](index=4&type=chunk) - **Cohort 3** is still enrolling, and up to **two additional participants** may be dosed in this cohort[4](index=4&type=chunk) - LX2020 has been **generally well tolerated** with no clinically significant complement activation and no treatment-related serious adverse events to date across all dose cohorts[4](index=4&type=chunk) - Lexeo expects to share an interim clinical data update in the **second half of 2025**[4](index=4&type=chunk) [Strategic Developments & Corporate Updates](index=2&type=section&id=Strategic%20Developments%20%26%20Corporate%20Updates) [Equity Financing](index=2&type=section&id=Equity%20Financing) Lexeo closed an $80 million equity financing in May 2025, which is expected to fund operations into 2028, covering a potential efficacy readout for the LX2006 registrational study in 2027 - Closed an **$80 million equity financing** in **May 2025** to further advance development of its clinical stage genetic medicine candidates[6](index=6&type=chunk) - Lexeo anticipates that current cash, cash equivalents and marketable securities will be sufficient to fund operating and capital expenditures into **2028**, through a potential efficacy readout for the registrational study of LX2006 in **2027**[6](index=6&type=chunk) [Research Collaboration](index=2&type=section&id=Research%20Collaboration) In June 2025, Lexeo announced a strategic partnership with Perceptive Xontogeny Venture Funds and venBio Partners to develop non-viral RNA-based therapies for genetic cardiac diseases. The partners will contribute up to $40 million in financing to a new entity, with Lexeo contributing expertise and intellectual property for an equity position, milestone payments, royalties, and opt-in rights - **Strategic partnership** announced in **June 2025** with Perceptive Xontogeny Venture Funds and venBio Partners to develop therapies for genetic cardiac diseases utilizing a novel non-viral RNA platform[6](index=6&type=chunk) - PXV Funds and venBio will contribute up to **$40 million** in private equity financing to a new entity[6](index=6&type=chunk) - Lexeo is contributing expertise and know-how in cardiac genetic medicines, preclinical intellectual property and technology to the partnership, with a **double-digit percentage equity position** in the new entity at transaction close alongside entitlement to future milestone payments, royalties, and opt-in rights[6](index=6&type=chunk) [New Leadership Appointment](index=2&type=section&id=New%20Leadership%20Appointment) Louis Tamayo was appointed Chief Financial Officer, succeeding Kyle Rasbach. Mr. Tamayo brings extensive commercial finance experience from Siemens Healthineers AG, Becton, Dickinson and Company, and Pfizer, and will support Lexeo's late-stage clinical and commercialization plans - **Louis Tamayo** has been appointed **Chief Financial Officer**, succeeding Kyle Rasbach[6](index=6&type=chunk) - Mr. Tamayo will support Lexeo's **late-stage clinical and commercialization plans** as LX2006 development accelerates and LX2020 development continues, alongside strategic planning, portfolio management, capital allocation, and other financial operations[6](index=6&type=chunk) - Mr. Tamayo brings extensive commercial finance experience, having previously served as Senior Vice President at Siemens Healthineers AG, and held roles at Becton, Dickinson and Company and Pfizer[6](index=6&type=chunk) [Recent Data Presentations](index=2&type=section&id=Recent%20Data%20Presentations) Lexeo presented new data at ASGCT on AAV manufacturing optimization via its Sf9-baculovirus process, demonstrating high purity, potency, improved scalability, and reduced cost. The company also presented data at the Global Cell and Gene Therapy Summit reviewing the favorable complement profile of AAVrh10, with no clinically significant complement activation observed in three gene therapy studies - Lexeo presented new data at the 28th American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on AAV manufacturing optimization via the Company's Sf9-baculovirus process, showing **high purity and potency** of yields with **improved scalability** and **reduced cost**[6](index=6&type=chunk) - Lexeo also presented data at the Global Cell and Gene Therapy Summit reviewing the **favorable complement profile** of AAVrh10 based on clinical monitoring experience across three gene therapy studies in FA and PKP2, with **no clinically significant events** related to complement activation observed[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) [Financial Summary](index=2&type=section&id=Financial%20Summary) For the three months ended June 30, 2025, Lexeo reported a net loss of $26.1 million, or $0.60 per share, compared to a net loss of $21.2 million, or $0.64 per share, in the prior year period. Research and development expenses decreased slightly, while general and administrative expenses significantly increased. The company's cash position as of June 30, 2025, was $152.5 million, projected to fund operations into 2028 Key Financial Metrics (Three Months Ended June 30) | Financial Metric (in thousands) | 2025 | 2024 | Change (YoY) | | :-------------------------------------------- | :--- | :--- | :----------- | | Research and Development Expenses | $14,721 | $16,560 | -$1,839 | | General and Administrative Expenses | $15,967 | $6,990 | +$8,977 | | Total Operating Expenses | $30,688 | $23,550 | +$7,138 | | Operating Loss | $(30,688) | $(23,550) | -$(7,138) | | Net Loss | $(26,103) | $(21,238) | -$(4,865) | | Net Loss per Common Share (basic and diluted) | $(0.60) | $(0.64) | +$0.04 | - Net loss increased to **$26.1 million** in Q2 2025 from **$21.2 million** in Q2 2024[6](index=6&type=chunk)[9](index=9&type=chunk) - General and Administrative expenses significantly increased to **$16.0 million** in Q2 2025 from **$7.0 million** in Q2 2024[6](index=6&type=chunk)[9](index=9&type=chunk) - Cash, cash equivalents, and investments in marketable securities were **$152.5 million** as of June 30, 2025, which Lexeo believes will be sufficient to fund operations into **2028**[6](index=6&type=chunk)[10](index=10&type=chunk) [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) The condensed statements of operations show a net loss of $26.1 million for Q2 2025 and $58.8 million for the six months ended June 30, 2025. Total operating expenses increased significantly year-over-year for both the quarter and year-to-date periods, primarily driven by general and administrative costs Condensed Statements of Operations (Unaudited, in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $14,721 | $16,560 | $31,892 | $32,302 | | General and administrative | $15,967 | $6,990 | $32,601 | $14,539 | | Total operating expenses | $30,688 | $23,550 | $64,493 | $46,841 | | Operating loss | $(30,688) | $(23,550) | $(64,493) | $(46,841) | | Net loss | $(26,103) | $(21,238) | $(58,759) | $(42,920) | | Net loss per common share, basic and diluted | $(0.60) | $(0.64) | $(1.53) | $(1.41) | | Weighted average number of shares outstanding | 43,573,628 | 33,001,946 | 38,372,704 | 30,490,892 | - Total operating expenses for the three months ended June 30, 2025, were **$30.7 million**, an increase from **$23.6 million** in the prior year period[9](index=9&type=chunk) - Total operating expenses for the six months ended June 30, 2025, were **$64.5 million**, up from **$46.8 million** in the prior year period[9](index=9&type=chunk) [Condensed Balance Sheet Data](index=4&type=section&id=Condensed%20Balance%20Sheet%20Data) As of June 30, 2025, Lexeo's cash, cash equivalents, and investments in U.S. Treasury securities increased to $152.5 million from $128.5 million at December 31, 2024. Total assets also increased, while total liabilities saw a moderate rise Condensed Balance Sheet Data (Unaudited, in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------------------------------ | :------------ | :---------------- | :----- | | Cash, cash equivalents, and investments in U.S. Treasury securities | $152,506 | $128,530 | +$23,976 | | Total assets | $176,068 | $146,942 | +$29,126 | | Total liabilities | $37,850 | $30,100 | +$7,750 | | Total stockholders' equity | $138,218 | $116,842 | +$21,376 | - Cash, cash equivalents, and investments in U.S. Treasury securities increased by **$23.98 million** from December 31, 2024, to June 30, 2025[10](index=10&type=chunk) [About Lexeo Therapeutics](index=2&type=section&id=About%20Lexeo%20Therapeutics) [Company Overview](index=2&type=section&id=Company%20Overview) Lexeo Therapeutics is a New York City-based clinical stage genetic medicine company focused on developing novel treatments for cardiovascular diseases by targeting underlying genetic causes. Its pipeline includes LX2006 for Friedreich ataxia cardiomyopathy and LX2020 for PKP2 arrhythmogenic cardiomyopathy - Lexeo Therapeutics is a New York City-based, **clinical stage genetic medicine company** dedicated to reshaping heart health by applying pioneering science to fundamentally change how cardiovascular diseases are treated[5](index=5&type=chunk) - The Company is advancing a portfolio of therapeutic candidates that take aim at the underlying genetic causes of conditions, including **LX2006** in **Friedreich ataxia cardiomyopathy (FA)** and **LX2020** in **plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy**[5](index=5&type=chunk) [Legal & Contact Information](index=3&type=section&id=Legal%20%26%20Contact%20Information) [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) The report contains forward-looking statements subject to various risks and uncertainties, including those related to clinical trials, regulatory approvals, and financial resources. Lexeo advises against undue reliance on these statements and disclaims any obligation to update them, except as required by law, under the protection of the Private Securities Litigation Reform Act of 1995 - Certain statements in this press release may constitute **'forward-looking statements'** regarding Lexeo's product candidates, clinical trials, regulatory developments, and financial condition[7](index=7&type=chunk) - These forward-looking statements are subject to various risks and uncertainties, including those set forth in Lexeo's SEC filings, and actual results could be materially different[7](index=7&type=chunk) - Lexeo claims the protection of the Safe Harbor contained in the **Private Securities Litigation Reform Act of 1995** for forward-looking statements and expressly disclaims any obligation to update or alter any statements, except as required by law[7](index=7&type=chunk) [Media and Investor Contacts](index=3&type=section&id=Media%20and%20Investor%20Contacts) Contact information is provided for media inquiries (Media@lexeotx.com) and investor relations (Carlo Tanzi, Ph.D., ctanzi@kendallir.com) - Media inquiries can be directed to **Media@lexeotx.com**[8](index=8&type=chunk) - Investor inquiries can be directed to **Carlo Tanzi, Ph.D.**, at **ctanzi@kendallir.com**[8](index=8&type=chunk)
Abeona Therapeutics(ABEO) - 2025 Q2 - Quarterly Report
2025-08-14 11:31
[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for June 30, 2025, reflect significant financial improvement, driven by a $152.4 million PRV gain and resulting in $96.8 million net income [Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets significantly increased to $246.2 million, primarily due to a rise in cash and cash equivalents, leading to positive stockholders' equity Balance Sheet Highlights ($ in thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $163,535 | $23,357 | | Total current assets | $232,262 | $100,853 | | Total assets | $246,233 | $108,931 | | **Liabilities & Equity** | | | | Total liabilities | $82,657 | $64,900 | | Total stockholders' equity | $163,576 | $44,031 | | Total liabilities and stockholders' equity | $246,233 | $108,931 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) For the six months ended June 30, 2025, the company achieved a net income of $96.8 million, a significant turnaround from a $24.2 million loss in 2024, primarily due to a $152.4 million PRV gain Income Statement Highlights ($ in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | License and other revenues | $400 | $0 | | Research and development | $15,884 | $16,425 | | Selling, general and administrative | $26,935 | $15,769 | | Loss from operations | ($42,519) | ($32,194) | | Gain from sale of priority review voucher, net | $152,366 | $0 | | Net income (loss) | $96,804 | ($24,172) | | Basic income (loss) per common share | $1.89 | ($0.72) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash increased by $140.2 million to $163.9 million, driven by $160.1 million from investing activities, primarily the PRV sale Cash Flow Summary ($ in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($37,186) | ($27,222) | | Net cash provided by (used in) investing activities | $160,101 | ($51,949) | | Net cash provided by financing activities | $17,263 | $99,124 | | Net increase in cash, cash equivalents and restricted cash | $140,178 | $19,953 | | Cash, cash equivalents and restricted cash at end of period | $163,873 | $34,764 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's transition to a commercial-stage entity, highlighting the $152.4 million PRV sale, initial license revenue, inventory capitalization, and sufficient capital for the next 12 months - On April 28, 2025, the FDA approved ZEVASKYN™ for the treatment of wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB), marking the company's transition to a commercial-stage biopharmaceutical company[25](index=25&type=chunk) - Following FDA approval, the company began capitalizing inventory costs related to ZEVASKYN™ As of June 30, 2025, inventory consisted of **$2.7 million** in raw materials[32](index=32&type=chunk)[13](index=13&type=chunk) - In June 2025, a third party exercised an option to license certain of the company's AAV capsids, resulting in **$0.4 million** of license revenue The agreement includes potential future milestone and royalty payments[97](index=97&type=chunk)[99](index=99&type=chunk) - The company sold a Priority Review Voucher (PRV) in June 2025, receiving gross proceeds of **$155.0 million** and recognizing a net gain of **$152.4 million** after transaction costs[118](index=118&type=chunk) - The company recorded an income tax expense of **$15.5 million** for the first half of 2025, driven by the pre-tax income from the PRV sale The company is assessing the impact of new tax legislation which may reduce its 2025 tax liability[114](index=114&type=chunk)[117](index=117&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transition to a commercial-stage entity, highlighting the $155.0 million PRV sale, ZEVASKYN™ commercial launch preparations, and sufficient liquidity for the next 12 months - Abeona is now a commercial-stage company after the FDA approved ZEVASKYN™ on April 28, 2025, for treating wounds in RDEB patients[121](index=121&type=chunk) - The company sold its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of **$155.0 million**, with the transaction closing on June 27, 2025[122](index=122&type=chunk) - Commercial launch of ZEVASKYN™ is underway, with the first Qualified Treatment Center (QTC) activated in May 2025 and treatments expected to start in Q3 2025[123](index=123&type=chunk) - As of June 30, 2025, cash resources were **$225.9 million**, which management believes is sufficient to fund operations for at least the next 12 months[167](index=167&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) For Q2 2025, net income reached $108.8 million, primarily due to the $152.4 million PRV gain, while R&D decreased 36% and SG&A increased 98% due to commercialization efforts Financial Performance ($ in thousands) | Item | Q2 2025 | Q2 2024 | Change (%) | | :--- | :--- | :--- | :--- | | License and other revenues | $400 | $0 | 100% | | Research and development | $5,943 | $9,218 | (36)% | | Selling, general and administrative | $17,149 | $8,646 | 98% | | Gain from sale of PRV, net | $152,366 | $0 | 100% | | Net income | $108,833 | $7,406 | 1,370% | - The decrease in Q2 R&D spending was primarily due to **$1.4 million** of costs capitalized into inventory and **$4.9 million** of production costs reclassified as SG&A following ZEVASKYN™'s FDA approval[132](index=132&type=chunk) - The increase in Q2 SG&A expenses was driven by approximately **$4.9 million** in reclassified production costs and a **$3.7 million** increase in salaries, stock-based compensation, and other professional fees related to commercial launch preparations[134](index=134&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity significantly improved to $225.9 million as of June 30, 2025, primarily from the $155.0 million PRV sale, with current capital sufficient for the next 12 months Cash Flow Summary ($ in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($37,186) | ($27,222) | | Net cash provided by (used in) investing activities | $160,101 | ($51,949) | | Net cash provided by financing activities | $17,263 | $99,124 | - The company's principal source of liquidity is its **$225.9 million** in cash resources as of June 30, 2025, which includes the proceeds from the PRV sale[167](index=167&type=chunk) - During the first six months of 2025, the company raised **$17.3 million** in net proceeds from selling **3,510,889 shares** under its ATM Agreement As of June 30, 2025, up to **$51.5 million** remains available for sale under the agreement[168](index=168&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the current reporting period - The company has indicated that quantitative and qualitative disclosures about market risk are not applicable[178](index=178&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that the company's Disclosure Controls and Procedures were effective as of June 30, 2025[180](index=180&type=chunk) - No changes occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[181](index=181&type=chunk) [PART II - OTHER INFORMATION](index=40&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the current period - There are no legal proceedings to report[184](index=184&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) The company highlights new risks related to commercializing its first product, ZEVASKYN™, including revenue generation challenges, NOL limitations, and potential government agency disruptions - As a newly commercial-stage company with its first approved product, ZEVASKYN™, it is difficult to assess future viability, and the company may not be able to sustain profitability[186](index=186&type=chunk) - The company's ability to generate significant revenue depends on the successful commercialization of ZEVASKYN™, which involves overcoming challenges in market acceptance, reimbursement, and patient identification[187](index=187&type=chunk)[188](index=188&type=chunk) - The company's ability to use its **$416.1 million** in U.S. federal net operating loss (NOL) carryforwards may be materially limited due to multiple historical ownership changes under Section 382, with a full analysis expected by year-end 2025[191](index=191&type=chunk)[192](index=192&type=chunk) - Disruptions at the FDA and other government agencies, such as those caused by funding shortages, hiring freezes, or reorganization, could delay or prevent product approvals and commercialization, negatively impacting the business[194](index=194&type=chunk) [Unregistered Sale of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sale%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q2 2025, the company reported the surrender of **885** common shares at **$6.24** per share to satisfy tax withholding obligations from restricted stock vesting Shares Surrendered for Tax Withholding | Period | Shares Purchased | Average Price Paid per Share ($) | | :--- | :--- | :--- | | June 1, 2025 - June 30, 2025 | 885 | $6.24 | | **Total Q2 2025** | **885** | **$6.24** | - The shares were surrendered to the company to cover tax withholding obligations from the vesting of restricted stock awards[199](index=199&type=chunk) [Other Information](index=43&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q2 2025 - No directors or executive officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the second quarter of 2025[201](index=201&type=chunk) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the PRV Asset Purchase Agreement, officer certifications, and interactive data files - Key exhibits filed include the Priority Review Voucher Asset Purchase Agreement dated May 9, 2025, and certifications from the Principal Executive Officer and Principal Financial Officer[207](index=207&type=chunk)
AFC Gamma(AFCG) - 2025 Q2 - Quarterly Report
2025-08-14 11:31
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 June 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: 001-39995 ADVANCED FLOWER CAPITAL INC. (Exact name of registrant as specified in its charter) Maryland 85-1807125 (State or ...
Cellectar Biosciences(CLRB) - 2025 Q2 - Quarterly Results
2025-08-14 11:30
Intend to Pursue an NDA Submission to the U.S. FDA under Accelerated Approval Pathway for Iopofosine I 131 for the Treatment of Waldenstrom Macroglobulinemia (WM) Subject to Suf icient Funding and Once the Confirmatory Trial is Underway Continue to Work with the EMA Toward a Potential Submission of Iopofosine I 131 for Conditional Approval in the EU; Decision expected late 3Q early 4Q 2025 Exhibit 99.1 Cellectar Biosciences Reports Second Quarter 2025 Financial Results and Provides a Corporate Update On tra ...