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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 announced that the first patient has been dosed in the pivotal LADDER trial for their drug AVTX-803, aimed at treating Leukocyte Adhesion Deficiency Type II (LAD II). This Phase 3 trial is randomized, double-blind, and designed to evaluate the drug's efficacy and safety over 16 weeks. AVTX-803 has received multiple designations, including Rare Pediatric Disease and Fast Track. Results are expected in 1H 2023, potentially leading to regulatory approval and a Priority Review Voucher.
Avalo Therapeutics has entered into a worldwide exclusive license agreement with Apollo Therapeutics for AVTX-007, its IL-18 monoclonal antibody. Avalo will receive an upfront payment of approximately $15 million, including $5 million upon agreement execution and $10 million for transfer activities. Apollo will also pay up to $74 million in milestone payments and a small royalty on sales. This agreement will enable Avalo to extend its cash runway and concentrate on its lead molecule, AVTX-002, while transferring clinical development responsibilities to Apollo.
Avalo Therapeutics (Nasdaq: AVTX) announced a one-for-twelve reverse stock split effective July 7, 2022. This move aims to increase the stock price to meet Nasdaq Capital Market listing requirements. Following the split, shares outstanding will decrease from approximately 112.9 million to around 9.4 million. The reverse split will not affect the ownership percentage of stockholders, except those with fractional shares, who will receive whole shares. The company's stock will begin trading on a split-adjusted basis on July 8, 2022.
Avalo Therapeutics (Nasdaq: AVTX) announced that CEO Garry A. Neil will present at the 2022 Jefferies Healthcare Conference on June 9, 2022, at 4:00 PM ET in New York. A live webcast will be available on the Company's website, and a replay will last for 90 days. Avalo Therapeutics focuses on precision medicine, aiming to develop targeted therapeutics for immunology and rare genetic diseases. Their clinical candidates are backed by proven mechanisms and established proof-of-concept to enhance success probability.
Avalo Therapeutics announced the dosing of the first patient in its Phase 2 PEAK trial, investigating AVTX-002 for non-eosinophilic asthma treatment. This randomized, double-blind, placebo-controlled study involves around 80 participants and focuses on the safety and efficacy of AVTX-002 over 12 weeks. The primary endpoint evaluates asthma-related events in patients. With nearly half of asthma patients affected by non-eosinophilic asthma, this trial could address a significant unmet medical need in asthma treatment.
Avalo Therapeutics (Nasdaq: AVTX) will have its CEO, Garry A. Neil, present virtually at the H.C. Wainwright Global Life Sciences Conference from May 23-26, 2022. The pre-recorded presentation will be available on May 24, 2022, at 7:00 AM ET. Investors can access the webcast on the company's website under the 'News/Events' section. Avalo is focused on developing targeted therapeutics for significant unmet clinical needs, particularly in immunology and rare genetic diseases, with a diverse portfolio aimed at delivering meaningful medical impact.
Avalo Therapeutics (AVTX) announced significant updates including the initiation of Phase 2 clinical trials for AVTX-002 in non-eosinophilic asthma and AVTX-803 for leukocyte adhesion deficiency type II. The company executed a workforce reduction of approximately one third to align with pipeline prioritization, aiming to reduce expenses over time. As of March 31, 2022, Avalo reported cash and cash equivalents of $38 million, a decrease driven primarily by operating expenses. The net loss for Q1 2022 was $22.1 million, reflecting continued investment in pipeline development.
Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical-stage precision medicine company, announced participation at Oppenheimer's 32nd Annual Healthcare Conference on March 16, 2022, at 1:20 p.m. ET. The event will showcase Avalo's innovative therapies, focusing on unmet clinical needs in immunology and rare genetic diseases. A live webcast will be available on their website. Avalo emphasizes its commitment to developing targeted therapeutics, and the potential impact of its portfolio aimed at enhancing patient care.
Avalo Therapeutics (AVTX) announced key updates, including the promotion of Dr. Garry Neil to CEO and Chris Sullivan to CFO. The company plans to initiate a Phase 2 trial for AVTX-002 targeting moderate to severe Non-eosinophilic Asthma, with topline data expected in Q4 2022. As of December 31, 2021, Avalo reported cash and equivalents of $54.6 million, a $35.7 million increase from 2020, driven by public offerings and debt facilities. However, total operating expenses rose by $8 million, primarily due to R&D costs.
Avalo Therapeutics has announced a leadership transition with Dr. Garry Neil appointed as Chief Executive Officer, effective February 14, 2022. Chris Sullivan has been promoted to Chief Financial Officer. The previous CEO and CFO, Mike Cola and Schond Greenway, respectively, have stepped down. The Board expressed appreciation for their contributions while highlighting the firm's promising future, particularly with the development of AVTX-002 for inflammatory diseases. Both Neil and Sullivan bring extensive experience to their new roles, aiming to enhance operational success and shareholder value.
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