Avalo Therapeutics Inc - AVTX STOCK NEWS

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.

Avalo Therapeutics, Inc. (Nasdaq: AVTX) provided business updates and financial results for Q1 2024, highlighting progress on AVTX-009 trial in hidradenitis suppurativa, cash position of $110 million, and plans for future drug development. The company reported a net loss of $121.3 million, attributed to warrant fair value and acquisition expenses.