| Over a month ago | ||||
Jefferies analyst Chris… Jefferies analyst Chris Howerton downgraded Avalo Therapeutics to Underperform from Hold with a price target of $3, down from $4.50, citing what the firm views as an unfavorable risk-reward given sector sentiment and capital risk. | ||||
SVB Securities and RBC… SVB Securities and RBC Capital are acting as joint book running managers for the offering. | ||||
Avalo Therapeutics… Avalo Therapeutics announced that it has commenced a proposed underwritten public offering of shares of its common stock and warrants to purchase shares of its common stock. SVB Securities and RBC Capital Markets are acting as joint bookrunning managers for the offering. | ||||
Avalo Therapeutics… Avalo Therapeutics completed enrollment of the 80 patients targeted for the Phase 2 PEAK Trial evaluating AVTX-002 in patients with Non-Eosinophilic Asthma. Avalo will allow additional patients currently in the run-in period to complete enrollment. Topline data from the clinical trial are expected to be released in the second quarter of 2023. The Phase 2 PEAK Trial is a randomized, double-blind, placebo-controlled, parallel group trial designed to evaluate the safety and efficacy of AVTX-002 for the treatment of poorly controlled NEA. Following 12 weeks of treatment, the efficacy and safety of AVTX-002 will be evaluated compared with placebo. The primary endpoint is the proportion of patients who experience any of the following asthma-related events: greater than or equal to6 additional reliever puffs of a short-acting beta-agonist in a 24-hour period on 2 consecutive days, or increase in inhaled corticosteroid dose greater than or equal to4 times than the dose at baseline, or a decrease in peak flow of 30% or more on 2 consecutive days of treatment, or an asthma exacerbation requiring the use of systemic corticosteroids for at least 3 days, or a hospitalization or emergency room visit because of an asthma exacerbation. | ||||
| Over a quarter ago | ||||
Oppenheimer analyst… Oppenheimer analyst Leland Gershell lowered the firm's price target on Avalo Therapeutics to $10 from $17 and keeps an Outperform rating on the shares. The analyst notes Avalo reported Q3 net gain of $3.2M, reflective of the $14.5M upfront received on AVTX-007's out-license, and announced its sale of rights to future payments on -007/other out-licensed assets for $5M in deal to close this month. | ||||
Program Updates and… Program Updates and Milestones: AVTX-002: NEA: Topline data expected in the first half of 2023 from the Phase 2 PEAK trial evaluating the safety and efficacy of AVTX-002 in approximately 80 patients with poorly controlled NEA. AVTX-008: Avalo identified a lead molecule and is currently evaluating several immune dysregulation disorders, with a target IND submission planned in 2024. AVTX-803: Pivotal data expected in the first half of 2023 from the pivotal LADDER trial evaluating the safety and efficacy of AVTX-803 in approximately 2 patients with LAD II. | ||||
Reports Q3 revenue… Reports Q3 revenue $14.949M, consensus $1.08M. "We have made great operational progress on the enrollment of our Phase 2 PEAK trial of AVTX-002 in NEA. We expect to complete enrollment by the end of the year, which keeps us on track to release topline data in the first half of 2023," said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. "Additionally, we expect to further strengthen our balance sheet with the $5 million to be received from the sale of economic rights of previously out-licensed assets upon the transaction closing, which further demonstrates the execution of our strategy to utilize business development to fund our core programs. Once completed, we will have raised $20 million through nondilutive transactions since August. Avalo is focused on closing out the year with further operational and strategic success." | ||||
Avalo Therapeutics (AVTX)… Avalo Therapeutics (AVTX) announced it entered into a purchase agreement to sell its economic rights to future payments for previously out-licensed assets including AVTX-007, AVTX-501, and AVTX-611 to ES Therapeutics in exchange for $5.0 million. The sale is expected to close in November. "This transaction will strengthen our balance sheet and further demonstrates the execution of our strategy to utilize business development to fund our core programs," said Garry Neil, MD, Chief Executive Officer and Chairman of the Board of Avalo Therapeutics. "Once completed, we will have raised $20 million of nondilutive funding since August. These transactions meaningfully improve our financial position and support our lead asset, AVTX-002, which remains on track to deliver data from our Phase 2 PEAK trial in non-eosinophilic asthma in the first half of next year." Pursuant to the purchase agreement, at the closing of the transaction Avalo will sell to ES all of Avalo's rights to any milestone payments under the Asset Purchase Agreement, dated August 14, 2017, by and between Avalo and Janssen Pharmaceuticals (JNJ), and any future milestone and royalty payments under the License Agreement, dated July 29, 2022, by and between Apollo AP43 Limited and Avalo, and will waive all rights, including all payments due to Avalo from ES, under the Assignment of License Agreement, dated August 8, 2019, by and among Avalo, ES and Armistice Capital Master Fund. The purchase agreement contains customary representations and warranties and covenants of the Company and ES. ES is an affiliate of Armistice, which is a significant stockholder of the Company. | ||||
Avalo Therapeutics… Avalo Therapeutics announced that its human B and T Lymphocyte Attenuator agonist fusion protein, AVTX-008, has now entered IND-enabling studies, with a target IND submission date of 2024. The company is currently evaluating a number of immune dysregulation disorders to pursue. BTLA is an immune checkpoint and a key component of the LIGHT-signaling network and complements AVTX-002, the company's fully human anti-LIGHT monoclonal antibody, currently in the Phase 2 PEAK Trial for non-eosinophilic asthma. In June 2021, Avalo acquired rights to the BTLA fusion protein technology discovered by Dr. Carl Ware and colleagues at the Sanford Burnham Prebys in La Jolla, CA. Under the terms of the agreement, Avalo obtained an exclusive license to a portfolio of issued patents and patent applications covering a lead molecule and derivatives. Avalo has identified a lead, has initiated IND-enabling activities and expects to submit an IND in 2024. | ||||
Reports Q2 revenue… Reports Q2 revenue $1.03M, consensus $790,000. "We have made significant progress advancing our clinical trials while also securing critical nondilutive capital since our first quarter business update," said Dr. Garry Neil, President and Chief Executive Officer of Avalo Therapeutics. "We are pleased to have enrolled the first patient in both our Phase 2 PEAK trial of AVTX-002 in NEA as well as our pivotal LADDER trial of ATX-803 in LAD II. Additionally, it's critically important that we secured approximately $15 million of initial consideration from our license and transfer of our AVTX-007 program. The transaction allows us to operationally and financially focus on our most promising programs, most notably AVTX-002." | ||||
