Summary of Avalo Therapeutics (AVTX) Conference Call Company Overview - **Company**: Avalo Therapeutics (AVTX) - **Lead Asset**: AVTX009NHS, targeting hidradenitis suppurativa (HS) Key Points and Arguments Industry and Market Dynamics - **Hidradenitis Suppurativa (HS)**: A chronic inflammatory skin condition with significant unmet medical needs, particularly among patients who do not respond to existing treatments like TNF inhibitors and IL-17 therapies [37][39] - **Current Treatment Landscape**: Approximately 50% of HS patients do not achieve remission with current biologics, indicating a large unsatisfied patient population seeking new treatment options [38] AVTX009NHS Mechanism and Efficacy - **Mechanism of Action**: AVTX009 targets IL-1 beta, which is identified as a key inflammatory driver in HS, with levels in lesions being 133 times higher than normal [11][12] - **Comparison with Other Treatments**: - Lutekizumab, another IL-1 beta targeting drug, has shown efficacy but has potential flaws that AVTX009 aims to address, such as a bispecific mechanism that may not effectively target the disease [5][20] - AVTX009 has a significantly higher affinity (15-30 times) compared to lutekizumab and can achieve better neutralization of IL-1 beta in lesions [18][24] Clinical Development and Study Design - **Phase II LOTUS Study**: - Designed to evaluate the efficacy of AVTX009 with a focus on rapid response using a loading dose of 600 mg followed by 300 mg every four weeks [30][31] - The study aims to enroll a diverse patient population, including those with moderate to severe HS, while ensuring robust data collection through rigorous investigator training [35][36] Safety and Long-term Use - **Safety Profile**: AVTX009 is characterized as a true anti-inflammatory drug rather than an immunosuppressant, reducing concerns about opportunistic infections and cancer risks associated with other treatments [10][13] - **Long-term Efficacy**: The drug's mechanism is expected to maintain lower IL-1 beta levels, promoting healing of lesions and reducing inflammation over time [24] Future Opportunities - **Expansion Potential**: There are plans to explore AVTX009 in other indications driven by IL-1 beta, such as inflammatory bowel disease (IBD) and various forms of arthritis, indicating a broad pipeline potential [44][45] - **Market Positioning**: The company aims to position AVTX009 as a first-line therapy in HS, capitalizing on the dissatisfaction with current treatment options and the need for new mechanisms [41] Conclusion - **Outlook**: The company is optimistic about the upcoming data release in mid-2026 and believes that AVTX009 has the potential to significantly improve treatment outcomes for HS patients, addressing a critical gap in the current market [47]

Financial Performance - Avalo generated a net loss of $13.1 million for the three months ended March 31, 2025, with negative cash flows from operations of $9.5 million[152]. - Net cash used in operating activities was $9.5 million for the three months ended March 31, 2025, compared to $6.2 million for the same period in 2024[169]. - Other income, net increased by $90.0 million for the three months ended March 31, 2025, primarily due to the absence of prior period private placement transaction costs[164]. - For the three months ended March 31, 2024, net cash provided by financing activities was $115.6 million from a private placement investment, offset by transaction costs of $7.0 million[173]. - There was no net cash provided by financing activities for the three months ended March 31, 2025[173]. Expenses - Research and development expenses increased by $7.0 million to $9.1 million for the three months ended March 31, 2025, primarily due to a $3.8 million increase in clinical expenses related to the LOTUS trial[158]. - General and administrative expenses rose by $2.4 million to $5.5 million for the three months ended March 31, 2025, driven by a $1.6 million increase in stock-based compensation[162]. - Stock-based compensation expense increased by $1.0 million to $1.3 million for the three months ended March 31, 2025, due to option and restricted stock unit grants[160]. Cash Position - The Company had $125.0 million in cash and cash equivalents as of March 31, 2025, sufficient to fund operations into at least 2027[153]. - The Company plans to balance cash levels with projected needs to withstand funding uncertainties, potentially through equity sales or strategic collaborations[153]. - The Company expects future cash used in operating activities to increase due to ongoing development plans for AVTX-009[171]. Clinical Trials - The Phase 2 LOTUS trial of AVTX-009 is evaluating efficacy in approximately 180 adults with moderate to severe hidradenitis suppurativa[149]. Accounting Policies - The company adheres to GAAP in preparing its financial statements, utilizing estimates and assumptions that impact reported assets, liabilities, revenue, and expenses[175]. - There have been no significant changes to the company's critical accounting policies during the three months ended March 31, 2025[175]. - The company does not have any off-balance sheet arrangements as defined by SEC rules[176]. - As a smaller reporting company, the company is not required to provide certain market risk disclosures[177].

Exhibit 99.1 Avalo Reports First Quarter 2025 Financial Results and Recent Business Updates WAYNE, PA, May 12, 2025 — Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced business updates and financial results for the first quarter of 2025. "We have made considerable progress in our Phase 2 LOTUS trial in hidradenitis suppurativa (HS) with site activations, screenings and enrollment progress all in line with our ori ...

Mike Heffernan appointed as Chairman of the Board Topline data from Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026 Cash on hand of approximately $125 million as of March 31, 2025 expected to provide runway into 2027, with optionality to extend into 2028 WAYNE, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced business updates an ...

Avalo Therapeutics (AVTX) 2025 Conference May 08, 2025 03:00 PM ET Speaker0 At the the Citizens Life Science Conference. Excited to be joined next by, Avalo Therapeutics. Avalo is a company focused on, targeting an immune mediated disease. The the lead program is in Hydrodentis Supertiva and phase two trials ongoing now and data expected next year. Welcome Gary McNeil, the CEO. Appreciate you being here and looking forward to the presentation. Speaker1 Thank you, yeah, it's really exciting to be here. Even ...

WAYNE, Pa. and ROCKVILLE, Md., April 30, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced that Dr. Garry Neil, Chief Executive Officer of Avalo, will present at the Citizens Life Sciences Conference in New York on Thursday, May 8, 2025, at 3:00 pm ET. Live webcasts and replays, when available, can be found under "News / Events" in the Investors section of the Avalo Therapeutics website a ...

WAYNE, Pa. and ROCKVILLE, Md., March 26, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (NASDAQ:AVTX), a clinical-stage biotechnology company dedicated to treating immune dysregulation, today announced the appointment of Michael Heffernan as Chairman of the Board of Directors ("Board"). Mr. Heffernan will succeed Dr. Garry Neil as Chairman of the Board. Dr. Neil will continue as a Board member and Chief Executive Officer (CEO) of the Company. "We are thrilled to welcome Michael to Avalo's Board of Direct ...

On Monday, Stifel initiated coverage on Avalo Therapeutics, Inc. AVTX. Avalo’s lead asset is AVTX-009, an anti-IL-1β mAb targeting inflammatory diseases.The company initiated a Phase 2 LOTUS trial, which will include approximately 180 adults with hidradenitis suppurativa (HS), to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo. Topline data is expected in 2026.Avalo continues to evaluate AVTX-009 for additional immune-mediated diseases with plans to ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 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 No. 001-37590 AVALO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) 540 Gaither Road, Su ...

Financial Performance - Avalo Therapeutics reported a net loss of $35.1 million for 2024, an increase of 11.4% from the net loss of $31.5 million in 2023[8]. - Basic net loss per share was $7.94 for 2024, compared to $113.58 for 2023, reflecting a significant increase in the number of shares outstanding[8]. Cash Position - Cash and cash equivalents were approximately $134.5 million as of December 31, 2024, supported by $185 million in gross proceeds from a private placement in 2024[8]. - Total assets increased to $150.7 million as of December 31, 2024, compared to $21.0 million in 2023[9]. Research and Development - Research and development expenses increased to $24.4 million in 2024, up 78% from $13.7 million in 2023, primarily due to costs associated with the Phase 2 LOTUS trial[8]. - The Phase 2 LOTUS trial for AVTX-009 is expected to enroll approximately 180 adults, with topline data anticipated in 2026[5]. - The company plans to explore additional indications for AVTX-009 beyond hidradenitis suppurativa[5]. Administrative Expenses - General and administrative expenses rose to $17.2 million in 2024, an increase of 67% from $10.3 million in 2023, driven by higher employee compensation and professional fees[8]. Strategic Appointments and Focus - The company appointed Jennifer Riley as Chief Strategy Officer, effective January 1, 2025, to guide strategy and pipeline planning[5]. - Avalo's primary focus for 2025 is executing the LOTUS trial and releasing data in 2026[2].