- Topline data from Phase 2 LOTUS Trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026
- Appointed Jennifer Riley as Chief Strategy Officer
- Cash on hand of approximately $135 million as of December 31, 2024 expected to provide runway into at least 2027
"2024 was a transformational year for Avalo, and I am proud of the accomplishments the team has made in a short amount of time,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. "In March 2024, we acquired AVTX-009, a promising monoclonal antibody targeting interleukin-1β. We filed our IND application with the FDA, designed and launched the Phase 2 LOTUS trial in hidradenitis suppurativa ("HS”) and rapidly progressed its initiation, including IND activation in July and enrollment of the first patient in October. Our primary focus in 2025 is executing the LOTUS trial to release data in 2026, while exploring broader applications for AVTX-009 and announcing a second indication.”
Recent Corporate Highlights and Upcoming Anticipated Milestones:
- Initiation of Phase 2 LOTUS trial: The global study design includes approximately 180 adults with HS to evaluate the efficacy and safety of subcutaneous bi-weekly and monthly dosing regimens compared to placebo.
- Topline data is expected in 2026.
- Second Indication Exploration: Avalo continues to evaluate AVTX-009 for additional immune-mediated diseases with plans to announce a second indication.
- Appointment of Jennifer Riley as Chief Strategy Officer: Effective January 1, 2025, Ms. Riley is guiding strategy and pipeline planning for HS and other inflammatory market opportunities.
- Cash and cash equivalents were $134.5 million as of December 31, 2024, supported by $185 million in gross proceeds received from a private placement in 2024. Net cash used in operating activities was $49.1 million for the year ended December 31, 2024, which includes $12.5 million of milestone payments to former shareholders of AlmataBio, Inc. pursuant to the terms of the acquisition. The Company's current cash on hand is expected to fund operations into at least 2027.
- Research and development expenses were $24.4 million in 2024, an increase of $10.7 million from 2023, driven by costs of the Phase 2 LOTUS trial, which were partially offset by discontinued legacy program expenses from the prior year.
- General and administrative expenses were $17.2 million in 2024, an increase of $6.9 million from 2023, primarily driven by employee compensation costs, including stock-based compensation expense, as well as increased consulting, legal and other professional expenses following and largely related to the acquisition and financing in the first quarter of 2024.
- Net loss was $35.1 million for 2024, an increase of $3.6 million from the net loss of $31.5 million in 2023, mainly driven by a $39.7 million increase in operating expenses; this was partially offset by a $37.7 million increase in other income primarily related to the warrants issued as part of the private placement in 2024. The increase in operating expenses was attributable to a $27.6 million acquired in-process research and development charge for the acquisition of AlmataBio, Inc, as well as increases to research and development expenses and the general and administrative expenses as discussed above. Basic net loss per share, based on 4,426,149 weighted average common shares, was $7.94 for 2024 compared to a basic net loss per share of $113.58, based on 227,727 weighted average common shares outstanding, for 2023. Diluted net loss per share, based on 7,496,389 weighted average diluted common shares and which excludes the change in fair value of the warrant liability from diluted net loss, was $20.91 for 2024 compared to $113.58, based on 227,727 weighted average diluted common shares outstanding, for 2023.
(In thousands, except share and per share data)
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 134,546 | $ | 7,415 | ||||
| Other receivables | 611 | 136 | ||||||
| Prepaid expenses and other current assets | 3,714 | 843 | ||||||
| Restricted cash, current portion | 19 | 1 | ||||||
| Total current assets | 138,890 | 8,395 | ||||||
| Property and equipment, net | 1,209 | 1,965 | ||||||
| Goodwill | 10,502 | 10,502 | ||||||
| Restricted cash, net of current portion | 131 | 131 | ||||||
| Total assets | $ | 150,732 | $ | 20,993 | ||||
| Liabilities, mezzanine equity and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 283 | $ | 446 | ||||
| Accrued expenses and other current liabilities | 6,317 | 4,172 | ||||||
| Derivative liability, current | 360 | - | ||||||
| Total current liabilities | 6,960 | 4,618 | ||||||
| Royalty obligation | 2,000 | 2,000 | ||||||
| Deferred tax liability, net | 270 | 155 | ||||||
| Derivative liability, non-current | 8,120 | 5,550 | ||||||
| Other long-term liabilities | 350 | 1,366 | ||||||
| Total liabilities | 17,700 | 13,689 | ||||||
| Mezzanine equity: | ||||||||
| Series D Preferred Stock-$0.001 par value; 1 and 0 shares of Series D Preferred Stock authorized at December 31, 2024 and 2023, respectively; 1 and 0 shares of Series D Preferred Stock issued and outstanding at December 31, 2024 and 2023, respectively | - | - | ||||||
| Series E Preferred Stock-$0.001 par value; 1 and 0 shares of Series E Preferred Stock authorized at December 31, 2024 and 2023, respectively; 1 and 0 shares of Series E Preferred Stock issued and outstanding at December 31, 2024 and 2023, respectively | - | - | ||||||
| Stockholders' equity: | ||||||||
| Common stock-$0.001 par value; 200,000,000 shares authorized at December 31, 2024 and 2023; 10,471,934 and 801,746 shares issued and outstanding at December 31, 2024 and 2023, respectively | 10 | 1 | ||||||
| Series C Preferred Stock-$0.001 par value; 34,326 and 0 shares of Series C Preferred Stock authorized at December 31, 2024 and 2023, respectively, 24,896 and 0 shares of Series C Preferred Stock issued and outstanding at December 31, 2024 and 2023, respectively | - | - | ||||||
| Additional paid-in capital | 503,285 | 342,437 | ||||||
| Accumulated deficit | (370,263 | ) | (335,134 | ) | ||||
| Total stockholders' equity | 133,032 | 7,304 | ||||||
| Total liabilities, mezzanine equity and stockholders' equity | $ | 150,732 | $ | 20,993 | ||||
Consolidated Statements of Operations
(In thousands, except per share data)
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 441 | $ | 1,408 | ||||
| License and other revenue | - | 516 | ||||||
| Total revenues, net | 441 | 1,924 | ||||||
| Operating expenses: | ||||||||
| Cost of product sales | (366 | ) | 1,284 | |||||
| Research and development | 24,437 | 13,784 | ||||||
| Acquired in-process research and development | 27,641 | - | ||||||
| General and administrative | 17,241 | 10,300 | ||||||
| Goodwill impairment | - | 3,907 | ||||||
| Total operating expenses | 68,953 | 29,275 | ||||||
| Loss from operations | (68,512 | ) | (27,351 | ) | ||||
| Other income (expense): | ||||||||
| Excess of initial warrant fair value over private placement proceeds | (79,276 | ) | - | |||||
| Change in fair value of warrant liability | 121,611 | - | ||||||
| Private placement transaction costs | (9,220 | ) | - | |||||
| Change in fair value of derivative liability | (2,930 | ) | (720 | ) | ||||
| Interest income (expense), net | 3,317 | (3,417 | ) | |||||
| Other expense, net | (5 | ) | (42 | ) | ||||
| Total other income (expense), net | 33,497 | (4,179 | ) | |||||
| Loss before income taxes | (35,015 | ) | (31,530 | ) | ||||
| Income tax expense | 114 | 14 | ||||||
| Net loss | $ | (35,129 | ) | $ | (31,544 | ) | ||
| Net loss per share of common stock: | ||||||||
| Basic | $ | (7.94 | ) | $ | (113.58 | ) | ||
| Diluted | $ | (20.91 | ) | $ | (113.58 | ) | ||
About Avalo Therapeutics
Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo's lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases. For more information about Avalo, please visit www.avalotx.com.
About AVTX-009
AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1β is implicated in many autoimmune and inflammatory diseases. IL-1β is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1β could be effective in hidradenitis suppurativa and a variety of inflammatory diseases in dermatology, gastroenterology, and rheumatology.
About the LOTUS Trial
The LOTUS Trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two AVTX-009 dose regimens to evaluate the efficacy and safety of AVTX-009 in approximately 180 adults with moderate to severe hidradenitis suppurativa. Subjects will be randomized (1:1:1) to receive either one of two dosing regimens of AVTX-009 or placebo during a 16-week treatment phase. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Secondary objectives include but are not limited to: proportion of patients achieving HiSCR50 and HiSCR90 as well as change from baseline in: International HS Severity Score System (IHS4), draining fistula count, abscess and inflammatory nodule (AN) count and patients achieving at least a 30% reduction on a numerical rating scale in Patient's Global Assessment of Skin Pain (PGA Skin Pain). The number of patients with anti-drug antibodies, safety, and tolerability will b