- Successfully eliminated
$35 million debt paving the way for future growth and innovation - Divested AVTX-800 series for potential milestone payments of
$45 million , fully focusing the pipeline on Avalo’s promising immunology assets - Disclosed improved cash of approximately
$10.2 million as ofSeptember 30, 2023
Dr.
Corporate Updates:
- In September of 2023, Avalo paid off the remaining
$14.3 million of its original$35 million debt owed to Horizon Technology Finance Corporation (Nasdaq: HRZN). As a result, Avalo’s obligations under the debt agreement were deemed satisfied. - On
October 27, 2023 , Avalo completed the divestiture of its rights, title and interest in, assets relating to AVTX-801, AVTX-802 and AVTX-803 (collectively, the 800 Series) toAUG Therapeutics, LLC (AUG). The Company is entitled to up to$45 million of contingent milestone payments. The Company previously announced it entered into a purchase agreement with AUG to divest the 800 Series onSeptember 12, 2023 .
Program Updates:
- Quisovalimab (AVTX-002): Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases.
- Quisovalimab has shown a rapid and sustained reduction of LIGHT levels, as well as a favorable safety and tolerability profile, in all indications studied including COVID-19 Acute Respiratory Distress Syndrome (ARDS), Crohn’s Disease and Non-Eosinophilic Asthma (NEA).
- Quisovalimab was statistically significant in reducing respiratory failure and mortality in patients hospitalized with COVID-19 ARDS in a randomized placebo-controlled trial. Quisovalimab also demonstrated positive trends in an open-label study in Crohn’s Disease.
- A post-hoc analyses in the PEAK Trial showed a sub-population of NEA patients with baseline LIGHT levels over 125 pg/mL, which represented over 50% of patients, had an approximate 50% reduction in asthma-related events (AREs) for patients treated with quisovalimab compared to placebo.
- Avalo is pursuing funding for the program and is considering a randomized placebo-controlled trial in patients with Ulcerative Colitis or other inflammatory conditions.
- AVTX-008: B and T Lymphocyte Attenuator (BTLA) agonist fusion protein targeting immune dysregulation disorders.
- AVTX-008 is uniquely positioned as a fusion protein with high-binding affinity and serum stability. It utilizes the natural ligand thus it may avoid the potential problems with agonist mAbs.
- Avalo previously identified a lead molecule, is evaluating several immune dysregulation disorders to pursue and plans to rapidly progress the asset to IND, subject to funding.
Third Quarter 2023 Financial Update:
Avalo had
Total operating expenses decreased
The net loss and net loss per share for the nine months ended
Consolidated Balance Sheets
(In thousands, except share and per share data)
(unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 10,180 | $ | 13,172 | ||||
Other receivables | 1,538 | 1,919 | ||||||
Inventory, net | — | 20 | ||||||
Prepaid expenses and other current assets | 940 | 1,290 | ||||||
Restricted cash, current portion | 1 | 15 | ||||||
Total current assets | 12,659 | 16,416 | ||||||
Property and equipment, net | 2,071 | 2,411 | ||||||
14,409 | 14,409 | |||||||
Restricted cash, net of current portion | 131 | 131 | ||||||
Total assets | $ | 29,270 | $ | 33,367 | ||||
Liabilities and stockholders’ equity (deficit) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 789 | $ | 2,882 | ||||
Deferred revenue | — | 88 | ||||||
Accrued expenses and other current liabilities | 5,216 | 13,214 | ||||||
Notes payable, current | — | 5,930 | ||||||
Total current liabilities | 6,005 | 22,114 | ||||||
Notes payable, non-current | — | 13,486 | ||||||
Royalty obligation | 2,000 | 2,000 | ||||||
Deferred tax liability, net | 164 | 141 | ||||||
Derivative liability | 4,950 | 4,830 | ||||||
Other long-term liabilities | 1,456 | 1,711 | ||||||
Total liabilities | 14,575 | 44,282 | ||||||
Stockholders’ equity (deficit): | ||||||||
Common stock—$0.001 par value; 200,000,000 shares authorized at | 192 | 9 | ||||||
Additional paid-in capital | 341,469 | 292,900 | ||||||
Accumulated deficit | (326,966 | ) | (303,824 | ) | ||||
Total stockholders’ equity (deficit) | 14,695 | (10,915 | ) | |||||
Total liabilities and stockholders’ equity (deficit) | $ | 29,270 | $ | 33,367 |
The condensed consolidated balance sheets as of
Consolidated Statements of Operations (Unaudited)
(In thousands, except per share data)
Three Months Ended | Nine Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 236 | $ | 432 | $ | 1,353 | $ | 2,638 | ||||||||
License revenue | — | 14,517 | — | 14,517 | ||||||||||||
Total revenues, net | 236 | 14,949 | 1,353 | 17,155 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of product sales | 247 | 528 | 1,505 | 2,814 | ||||||||||||
Research and development | 1,249 | 7,042 | 11,917 | 25,136 | ||||||||||||
Selling, general and administrative | 2,490 | 3,284 | 7,624 | 17,752 | ||||||||||||
Amortization expense | — | — | — | 38 | ||||||||||||
Total operating expenses | 3,986 | 10,854 | 21,046 | 45,740 | ||||||||||||
(3,750 | ) | 4,095 | (19,693 | ) | (28,585 | ) | ||||||||||
Other expense: | ||||||||||||||||
Interest expense, net | (1,553 | ) | (898 | ) | (3,498 | ) | (3,221 | ) | ||||||||
Change in fair value of derivative liability | 100 | — | (120 | ) | — | |||||||||||
Other expense, net | (17 | ) | — | (42 | ) | (20 | ) | |||||||||
Total other expense, net | (1,470 | ) | (898 | ) | (3,660 | ) | (3,241 | ) | ||||||||
(Loss) income before taxes | (5,220 | ) | 3,197 | (23,353 | ) | (31,826 | ) | |||||||||
Income tax expense | 8 | 5 | 23 | 20 | ||||||||||||
Net (loss) income and comprehensive loss | $ | (5,228 | ) | $ | 3,192 | $ | (23,376 | ) | $ | (31,846 | ) | |||||
Net (loss) income per share of common stock, basic and diluted | $ | (0.11 | ) | $ | 0.34 | $ | (0.96 | ) | $ | (3.39 | ) |
The unaudited condensed consolidated statements of operations for the three and nine months ended
About quisovalimab (AVTX-002)
Quisovalimab is a fully human monoclonal antibody (mAb), directed against human LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator (HVEM), a receptor expressed by T lymphocytes). There is increasing evidence that the dysregulation of the LIGHT-signaling network which includes LIGHT, its receptors HVEM and LTβR and the downstream checkpoint BTLA, is a disease-driving mechanism in autoimmune and inflammatory reactions in barrier organs. Therefore, we believe reducing LIGHT levels can moderate immune dysregulation in many acute and chronic inflammatory disorders. Quisovalimab previously demonstrated proof of concept in COVID-19 induced acute respiratory distress syndrome including reduction in mortality and respiratory failure, as well as a positive signal in patients with Crohn’s Disease.
About AVTX-008
AVTX-008 is a fully human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein in the IND-enabling stage. AVTX-008 is differentiated by having specific binding to BTLA, with no binding to LIGHT or CD160. AVTX-008 also has high-serum stability and solubility.
About
LIGHT and its signaling receptors, HVEM (TNFRSF14), and lymphotoxin β receptor (TNFRSF3), form an immune regulatory network with two co-receptors of herpesvirus entry mediator, checkpoint inhibitor B and T Lymphocyte Attenuator (BTLA), and CD160 (the LIGHT-signaling network). Accumulating evidence points to the dysregulation of the LIGHT network as a disease-driving mechanism in autoimmune and inflammatory reactions in barrier organs. Therefore, we believe reducing LIGHT levels can moderate immune dysregulation in many acute and chronic inflammatory disorders.
For more information about Avalo, please visit www.avalotx.com.
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: the future financial and operational outlook; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; the development of product candidates or products; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Avalo’s management but are subject to significant risks and uncertainties, including: Avalo's cash position and the need for it to raise additional capital in the near future; the results of our clinical and pre-clinical studies; drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic and the war in
For media and investor inquiries
ir@avalotx.com
410-803-6793
or
ICR Westwicke
Chris.brinzey@westwicke.com
339-970-2843
Source:
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