Avalo Reports 2024 Financial Results and Recent Business Updates
Avalo Therapeutics (NASDAQ: AVTX) reported its 2024 financial results and business updates. The company ended 2024 with $134.5 million in cash, supported by a $185 million private placement, providing runway into at least 2027.
Key financial metrics include:
- Net loss of $35.1 million in 2024, up from $31.5 million in 2023
- R&D expenses increased to $24.4 million
- G&A expenses rose to $17.2 million
- Basic net loss per share was $7.94
The company's Phase 2 LOTUS trial for AVTX-009 in hidradenitis suppurativa (HS) is ongoing, with topline data expected in 2026. The trial will evaluate approximately 180 adults with HS. Jennifer Riley joined as Chief Strategy Officer effective January 2025 to guide strategy and pipeline planning.
Avalo Therapeutics (NASDAQ: AVTX) ha riportato i risultati finanziari e gli aggiornamenti aziendali per il 2024. L'azienda ha chiuso il 2024 con 134,5 milioni di dollari in contante, supportata da un collocamento privato di 185 milioni di dollari, garantendo così le risorse fino almeno al 2027.
I principali indicatori finanziari includono:
- Perdita netta di 35,1 milioni di dollari nel 2024, in aumento rispetto ai 31,5 milioni di dollari del 2023
- Le spese per R&S sono aumentate a 24,4 milioni di dollari
- Le spese generali e amministrative sono salite a 17,2 milioni di dollari
- La perdita netta per azione è stata di 7,94 dollari
Il trial di Fase 2 LOTUS per AVTX-009 nella hidradenite suppurativa (HS) è in corso, con i dati preliminari attesi nel 2026. Lo studio valuterà circa 180 adulti con HS. Jennifer Riley è entrata in carica come Chief Strategy Officer a partire da gennaio 2025 per guidare la strategia e la pianificazione del pipeline.
Avalo Therapeutics (NASDAQ: AVTX) informó sobre sus resultados financieros y actualizaciones comerciales para 2024. La compañía terminó 2024 con 134.5 millones de dólares en efectivo, respaldada por una colocación privada de 185 millones de dólares, lo que proporciona recursos hasta al menos 2027.
Los principales indicadores financieros incluyen:
- Pérdida neta de 35.1 millones de dólares en 2024, en comparación con 31.5 millones de dólares en 2023
- Los gastos de I+D aumentaron a 24.4 millones de dólares
- Los gastos generales y administrativos aumentaron a 17.2 millones de dólares
- La pérdida neta por acción fue de 7.94 dólares
El ensayo de Fase 2 LOTUS para AVTX-009 en hidradenitis supurativa (HS) está en curso, con datos preliminares esperados para 2026. El ensayo evaluará aproximadamente a 180 adultos con HS. Jennifer Riley se unió como Directora de Estrategia a partir de enero de 2025 para guiar la estrategia y la planificación del pipeline.
Avalo Therapeutics (NASDAQ: AVTX)는 2024년 재무 결과 및 사업 업데이트를 보고했습니다. 이 회사는 1억 3천 4백 50만 달러의 현금으로 2024년을 마감했으며, 1억 8천 5백만 달러의 사모펀드로 지원받아 최소 2027년까지 자금을 확보했습니다.
주요 재무 지표는 다음과 같습니다:
- 2024년 순손실 3천 5백 10만 달러, 2023년의 3천 1백 50만 달러에서 증가
- 연구개발(R&D) 비용이 2천 4백 40만 달러로 증가
- 일반 관리(G&A) 비용이 1천 7백 20만 달러로 증가
- 주당 기본 순손실은 7.94달러
회사의 AVTX-009에 대한 2상 LOTUS 시험은 hidradenitis suppurativa (HS)에서 진행 중이며, 2026년에 주요 데이터가 예상됩니다. 이 시험은 HS가 있는 약 180명의 성인을 평가할 것입니다. 제니퍼 라일리는 2025년 1월부터 전략 및 파이프라인 계획을 안내하기 위해 최고 전략 책임자로 합류했습니다.
Avalo Therapeutics (NASDAQ: AVTX) a annoncé ses résultats financiers et ses mises à jour commerciales pour 2024. L'entreprise a terminé 2024 avec 134,5 millions de dollars en liquidités, soutenue par un placement privé de 185 millions de dollars, assurant des fonds jusqu'à au moins 2027.
Les principaux indicateurs financiers comprennent :
- Perte nette de 35,1 millions de dollars en 2024, contre 31,5 millions de dollars en 2023
- Les dépenses de R&D ont augmenté à 24,4 millions de dollars
- Les dépenses générales et administratives ont augmenté à 17,2 millions de dollars
- La perte nette par action était de 7,94 dollars
L'essai LOTUS de phase 2 pour AVTX-009 dans l'hidradenite suppurativa (HS) est en cours, avec des données préliminaires attendues en 2026. L'essai évaluera environ 180 adultes atteints de HS. Jennifer Riley a rejoint l'entreprise en tant que Directrice de la Stratégie à compter de janvier 2025 pour guider la stratégie et la planification du pipeline.
Avalo Therapeutics (NASDAQ: AVTX) hat seine finanziellen Ergebnisse und Unternehmensupdates für 2024 veröffentlicht. Das Unternehmen schloss das Jahr 2024 mit 134,5 Millionen Dollar in bar, unterstützt durch eine private Platzierung von 185 Millionen Dollar, die eine finanzielle Basis bis mindestens 2027 bietet.
Wichtige Finanzkennzahlen umfassen:
- Nettoverlust von 35,1 Millionen Dollar im Jahr 2024, ein Anstieg von 31,5 Millionen Dollar im Jahr 2023
- F&E-Ausgaben stiegen auf 24,4 Millionen Dollar
- Allgemeine und Verwaltungskosten stiegen auf 17,2 Millionen Dollar
- Der grundlegende Nettoverlust pro Aktie betrug 7,94 Dollar
Die Phase-2-LOTUS-Studie für AVTX-009 bei hidradenitis suppurativa (HS) läuft, wobei die wichtigsten Daten für 2026 erwartet werden. Die Studie wird etwa 180 Erwachsene mit HS bewerten. Jennifer Riley wird ab Januar 2025 als Chief Strategy Officer tätig sein, um die Strategie und die Planung des Pipelines zu leiten.
- Strong cash position of $134.5 million providing runway into 2027
- Secured $185 million through private placement
- Phase 2 LOTUS trial progressing with clear timeline for 2026 data readout
- Plans to expand AVTX-009 into second indication
- Net loss increased to $35.1 million from $31.5 million year-over-year
- R&D expenses increased by $10.7 million to $24.4 million
- G&A expenses rose by $6.9 million to $17.2 million
- Operating expenses increased by $39.7 million
Insights
Avalo's financial position demonstrates remarkable improvement despite increased operating losses. With
The increased net loss of
Most notably, while losses increased in absolute terms, the per-share metrics improved dramatically with basic net loss per share decreasing from
This financial strengthening comes at an ideal time as the company advances its lead program through mid-stage clinical development, with milestone catalysts expected in 2026. The
Avalo's clinical development strategy with AVTX-009 shows disciplined execution following their strategic acquisition of AlmataBio. The LOTUS trial design warrants attention - a 180-patient global Phase 2 study evaluating both bi-weekly and monthly dosing regimens provides potential for dosing flexibility if successful. This antibody targeting IL-1β addresses a well-established inflammatory pathway with validated clinical significance.
Hidradenitis suppurativa represents a strategic indication choice - a chronic inflammatory skin condition affecting 1-4% of the population with significant unmet needs despite available treatments. The exploration of AVTX-009 for additional immune-mediated conditions signals Avalo's intention to build a pipeline-in-a-product strategy, maximizing return on their IL-1β asset.
The expected 2026 data readout timeline appears realistic for a moderate-sized Phase 2 trial in this indication. With funding secured through 2027, Avalo has appropriately matched their financial runway to extend beyond this critical clinical milestone, providing negotiating leverage for potential partnerships following data release.
The appointment of Jennifer Riley as Chief Strategy Officer suggests appropriate attention to commercial positioning and indication sequencing - critical for maximizing asset value. Her focus on hidradenitis suppurativa and broader inflammatory markets indicates the company is taking a thoughtful approach to pipeline expansion rather than opportunistically pursuing scattered indications.
While topline data remains distant, Avalo appears well-positioned with sufficient resources to thoroughly evaluate AVTX-009's potential in multiple indications before requiring additional capital.
- 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
WAYNE, Pa. and ROCKVILLE, Md., March 20, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced business updates and year-end financial results for 2024.
“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.
2024 Financial Update:
- 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.
Consolidated Balance Sheets
(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— | — | — | ||||||
| Series E Preferred Stock— | — | — | ||||||
| Stockholders’ equity: | ||||||||
| Common stock— | 10 | 1 | ||||||
| Series C Preferred Stock— | — | — | ||||||
| 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 | ||||
The consolidated balance sheets as of December 31, 2024 and 2023 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.
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 | ) | ||
The consolidated statements of operations for the year ended December 31, 2024 and 2023 have been derived from the audited financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
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
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules, abscesses, and tunnels that form in areas of the body such as the armpits, groin, and buttocks, severely impacting the quality of life of affected individuals.1 HS is often underdiagnosed or misdiagnosed and therefore estimates of HS vary between 0.2
Forward-Looking Statements
This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; reliance on key personnel; regulatory risks; integration of AVTX-009 into our operations; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
References
1Patel ZS et al. Curr Pain Headache Rep. 2017;21(12):49.
2Egeberg A, et al. JAMA Dermatol 2016;152:429–34
3Phan K, et al Biomed Dermatol 2020; 4: 2-6
4Jfri, A, et al. JAMA Dermatol. 2021;157(8):924-31
5Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61
For media and investor inquiries
Christopher Sullivan, CFO
Avalo Therapeutics, Inc.
ir@avalotx.com
410-803-6793
or
Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com
FAQ
When will Avalo (AVTX) release topline data for its Phase 2 LOTUS trial in hidradenitis suppurativa?
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