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Avalo Therapeutics, Inc. (Nasdaq: AVTX) is a clinical-stage biotechnology company dedicated to addressing immune dysregulation through innovative therapeutics. Headquartered in Wayne, Pennsylvania, and Rockville, Maryland, Avalo Therapeutics focuses on developing treatments for a range of inflammatory diseases.
The company's lead therapeutic candidate is AVTX-009, an anti-IL-1B monoclonal antibody (mAb) aimed at combating inflammatory diseases. Additionally, Avalo's robust pipeline features promising drugs such as quisovalimab (AVTX-002)—an anti-LIGHT mAb—and AVTX-008, a BTLA agonist fusion protein.
Recently, Avalo achieved a significant milestone by eliminating a $35 million debt to Horizon Technology Finance Corporation, showcasing its commitment to financial stability and future growth. With this strengthened balance sheet, the company is poised to advance its leading drug candidates and explore new opportunities in the biotech sector.
Under the leadership of Dr. Garry A. Neil, MD, Avalo’s team brings decades of experience in drug development. Dr. Neil's notable past roles include Group President of Pharmaceutical R&D at Johnson & Johnson and Chairman of Arena Pharmaceuticals, which was acquired by Pfizer for $6.7 billion in 2022. This experienced team is dedicated to bringing innovative treatments to market and improving patients' lives.
Latest News: In September 2023, Avalo announced the full repayment of its $35 million debt to Horizon Technology Finance Corporation ahead of schedule. This accomplishment highlights the company’s financial discipline and readiness to focus on advancing its core immunology assets, including AVTX-002 and AVTX-008, which target the LIGHT-signaling network and BTLA pathway, respectively.
About AVTX-009: AVTX-009 is designed to target IL-1B, an inflammatory cytokine implicated in various diseases. By inhibiting IL-1B, AVTX-009 aims to reduce inflammation and treat conditions like rheumatoid arthritis and other chronic inflammatory diseases.
About quisovalimab (AVTX-002): Quisovalimab is unique in targeting the LIGHT-signaling network, which plays a pivotal role in immune response. By moderating LIGHT levels, AVTX-002 has shown promise in treating acute and chronic inflammatory conditions, including Crohn's Disease and COVID-19 induced acute respiratory distress syndrome.
About AVTX-008: This drug candidate is a fully human BTLA agonist fusion protein, targeting the BTLA pathway to regulate immune responses. It's in the IND-enabling stage and represents a potential best-in-class therapy for immune-mediated diseases.
Avalo Therapeutics continues to leverage its strategic partnerships and scientific expertise to drive its pipeline forward, aiming to deliver groundbreaking treatments and address unmet medical needs in immune dysregulation.
Avalo Therapeutics has received $69.4 million in gross proceeds from the full exercise of warrants issued in a March 2024 private placement. The warrants were exercised at $5.796933 per underlying share, resulting in the issuance of 781,259 common stock shares and 11,186.267 series C non-voting convertible preferred stock shares. This exercise brings the total gross proceeds from the transaction to $185 million, extending the company's cash runway into at least 2027. The private placement was led by Commodore Capital and TCGX, with participation from several other investors. As of November 8, 2024, Avalo has 10,463,633 common stock shares and 24,895.92 series C preferred stock shares outstanding.
Avalo Therapeutics (Nasdaq: AVTX) has announced its participation in two major investor conferences. The company's CEO and Board Chairman, Garry A. Neil, M.D., will present at the Stifel 2024 Healthcare Conference in New York on November 18, 2024, at 3:35 PM ET, and the Piper Sandler 36th Annual Healthcare Conference in New York on December 5, 2024, at 11:00 AM ET.
Live webcasts and replays will be accessible through the Investors section of Avalo's website under 'News / Events,' with recordings available for at least 30 days after the presentations.
Avalo Therapeutics (AVTX) reported significant Q3 2024 developments, including dosing the first patient in Phase 2 LOTUS trial of AVTX-009 for hidradenitis suppurativa treatment. The company's cash position reached $82 million as of September 30, 2024, with an additional $58 million from warrant exercises in Q4. Research and development expenses increased to $9.5 million, up from $1.2 million in Q3 2023. The company reported net income of $23 million for Q3 2024, compared to a $5.2 million loss in Q3 2023. Current cash runway is expected to extend into at least 2027.
Avalo Therapeutics (Nasdaq: AVTX) has announced the dosing of the first patient in its Phase 2 LOTUS trial for AVTX-009, a treatment for hidradenitis suppurativa (HS). The global study will involve approximately 180 adults with moderate to severe HS, evaluating two dose regimens of AVTX-009 against a placebo. AVTX-009 is a humanized monoclonal antibody that targets interleukin-1β.
The randomized, double-blind trial will assess efficacy and safety over a 16-week treatment phase. The primary endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include HiSCR50 and HiSCR90 achievement, changes in severity scores, and reduction in skin pain. Topline data is expected in 2026.
Avalo Therapeutics (Nasdaq: AVTX) has announced its participation in two upcoming investor conferences in September 2024. Garry A. Neil, M.D., the company's Chief Executive Officer and Chairman of the Board, will be presenting at both events:
1. H.C. Wainwright 26th Annual Global Investment Conference (September 9-11, 2024): A pre-recorded presentation will be available on September 9 at 7:00 AM ET.
2. Stifel 2024 Virtual Immunology and Inflammation Summit: Dr. Neil will participate in a fireside chat on September 17 at 9:30 AM ET.
Webcasts of both presentations will be accessible on Avalo's website under the 'News/Events' page in the Investors section.
Avalo Therapeutics (Nasdaq: AVTX) reported Q2 2024 financial results and business updates. Key highlights include:
- Expected enrollment of first patient in Phase 2 LOTUS Trial of AVTX-009 for hidradenitis suppurativa in H2 2024
- Appointment of Dr. Mittie Doyle as CMO and Paul Varki as CLO
- Cash position of $93.4 million as of June 30, 2024, with runway into 2027
- Net loss of $22.8 million for H1 2024, up $4.7 million from H1 2023
- IND for AVTX-009 in hidradenitis suppurativa activated in July 2024
- Plans to develop AVTX-009 in at least one other chronic inflammatory indication
The company's focus remains on initiating the LOTUS Trial and announcing a second indication in H2 2024.
Avalo Therapeutics (Nasdaq: AVTX) has appointed Dr. Mittie Doyle as its new Chief Medical Officer. Dr. Doyle brings over 20 years of experience in the pharmaceutical/biotech industry, with expertise in immunology, rheumatology, and dermatology. She joins Avalo from Aro Biotherapeutics, where she served as CMO since 2021. Dr. Doyle will play a important role in advancing AVTX-009 for hidradenitis suppurativa treatment and exploring its potential in other inflammatory conditions.
As part of her appointment, Dr. Doyle received a non-qualified stock option to purchase 234,000 shares of Avalo's common stock, vesting over four years. The company is preparing to initiate the Phase 2 LOTUS Trial for hidradenitis suppurativa patients, with Dr. Doyle's leadership expected to be invaluable in this process.
Avalo Therapeutics announced the FDA has activated their IND application for AVTX-009, an anti-IL-1β monoclonal antibody, to treat hidradenitis suppurativa (HS). This green light allows Avalo to proceed with its Phase 2 LOTUS trial, aimed at evaluating the efficacy and safety of AVTX-009 in patients with moderate to severe HS. The company plans to enroll approximately 180 patients in this double-blind, placebo-controlled trial, with the first participant expected this year. Primary efficacy will be measured by the proportion of patients achieving a 75% reduction in HS symptoms by Week 16. Avalo's CEO, Dr. Garry Neil, expressed confidence in AVTX-009's potential as a best-in-class treatment due to its target specificity, half-life, and potency.
Avalo Therapeutics has appointed Paul Varki as its new Chief Legal Officer (CLO). This strategic hire follows Avalo's recent acquisition and private placement. Paul Varki brings over 20 years of experience in the pharmaceutical and biotech industry, having served in various legal roles at companies such as Idorsia Pharmaceuticals, Amarin , Braeburn Pharmaceuticals, Egalet Pharma, GSK, and Reed Smith LLP. Varki holds a J.D. from Temple University, an MPH from George Washington University, and a Bachelor's degree from the College of William and Mary.
Alongside this appointment, Avalo's Board of Directors has approved a non-qualified stock option grant to Varki, entitling him to purchase 150,000 shares of Avalo's common stock. The options will vest over a four-year period, with a 12-month cliff. This grant is intended to incentivize Varki's long-term commitment to Avalo, aligning with Nasdaq Listing Rule 5635(c)(4).
Avalo Therapeutics announced that CEO and Chairman Garry A. Neil, M.D., will present at the Oppenheimer Novel Targets in Immunology Summit. The presentation will take place on June 24, 2024, at 11:45 AM ET in New York, NY. Dr. Neil will discuss novel immunological mechanisms for dermatological disorders.
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