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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Avalo Therapeutics Inc | NASDAQ:AVTX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.21 | -1.98% | 10.39 | 10.09 | 10.60 | 10.932 | 10.0901 | 10.61 | 52,648 | 01:00:00 |
“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.”
Business Updates:
Program Updates and Milestones:
Second Quarter 2022 Financial Update:
Avalo had $11.2 million in cash and cash equivalents as of June 30, 2022, representing a $43.4 million decrease as compared to December 31, 2021. The decrease was primarily driven by operating expenditures to fund and support pipeline development and a $15.0 million partial prepayment under the Loan Agreement. Subsequent to June 30, 2022, Avalo received the approximate $15 million of upfront payment from its transfer of AVTX-007.
Total operating expenses decreased $16.7 million for the six months ended June 30, 2022 as compared to the same period in 2021. Research and development expenses decreased $19.7 million due to a $10.0 million upfront license fee incurred in the first quarter of 2021, which did not repeat, and a $9.2 million reduction due to specific timing of manufacturing, non-clinical activities and clinical trial activities. Selling, general and administrative expenses increased $1.7 million mainly due to severance and stock-based compensation expense driven by headcount reductions from the pipeline prioritization plan announced in the first quarter of 2022 and other separations, partially offset by decreases to legal, consulting and marketing expenses from cost savings initiatives. Cost of product sales increased $2.1 million due to the net profit share of our non-core commercialized product, Millipred®, that began in the third quarter of 2021. Additionally, in the second quarter of 2022, we fully reserved the $1.0 million receivable due in December 2024 pursuant to the transition service agreement with the third party that previously managed Millipred®’s commercial operations. The net loss and change in net loss was largely driven by operating expenses.
Condensed Consolidated Balance Sheets (Unaudited) (In thousands, except share and per share data)
June 30, 2022 | December 31, 2021 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 11,249 | $ | 54,585 | ||||
Accounts receivable, net | 544 | 1,060 | ||||||
Other receivables | 1,306 | 3,739 | ||||||
Inventory, net | 23 | 38 | ||||||
Prepaid expenses and other current assets | 1,885 | 2,372 | ||||||
Restricted cash, current portion | 14 | 51 | ||||||
Total current assets | 15,021 | 61,845 | ||||||
Property and equipment, net | 2,567 | 2,695 | ||||||
Other long-term asset | — | 1,000 | ||||||
Intangible assets, net | — | 38 | ||||||
Goodwill | 14,409 | 14,409 | ||||||
Restricted cash, net of current portion | 227 | 227 | ||||||
Total assets | $ | 32,224 | $ | 80,214 | ||||
Liabilities and stockholders’ (deficit) equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,164 | $ | 3,369 | ||||
Accrued expenses and other current liabilities | 13,231 | 16,519 | ||||||
Total current liabilities | 15,395 | 19,888 | ||||||
Notes payable, non-current | 18,713 | 32,833 | ||||||
Royalty obligation | 2,000 | 2,000 | ||||||
Deferred tax liability, net | 128 | 113 | ||||||
Other long-term liabilities | 1,939 | 2,298 | ||||||
Total liabilities | 38,175 | 57,132 | ||||||
Stockholders’ (deficit) equity: | ||||||||
Common stock—$0.001 par value; 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 9,405,724 and 9,399,517 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively1 | 9 | 9 | ||||||
Additional paid-in capital1 | 291,244 | 285,239 | ||||||
Accumulated deficit | (297,204 | ) | (262,166 | ) | ||||
Total stockholders’ (deficit) equity | (5,951 | ) | 23,082 | |||||
Total liabilities and stockholders’ (deficit) equity | $ | 32,224 | $ | 80,214 |
1 Results have been retroactively adjusted to reflect the 1-for-12 reverse stock split effected on July 7, 2022.
The unaudited condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021 have been derived from the reviewed 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.
Condensed Consolidated Statements of Operations (Unaudited)(In thousands, except per share data)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 1,033 | $ | 2,730 | $ | 2,206 | $ | 3,204 | ||||||||
License revenue | — | 625 | — | 625 | ||||||||||||
Total revenues, net | 1,033 | 3,355 | 2,206 | 3,829 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of product sales | 1,567 | 83 | 2,286 | 159 | ||||||||||||
Research and development | 8,510 | 12,569 | 18,094 | 37,774 | ||||||||||||
Selling, general and administrative | 2,784 | 7,404 | 14,468 | 12,751 | ||||||||||||
Amortization expense | — | 428 | 38 | 853 | ||||||||||||
Total operating expenses | 12,861 | 20,484 | 34,886 | 51,537 | ||||||||||||
(11,828 | ) | (17,129 | ) | (32,680 | ) | (47,708 | ) | |||||||||
Other expense: | ||||||||||||||||
Other expense, net | — | (5 | ) | (20 | ) | (5 | ) | |||||||||
Interest expense, net | (1,154 | ) | (239 | ) | (2,323 | ) | (222 | ) | ||||||||
Total other expense, net from continuing operations | (1,154 | ) | (244 | ) | (2,343 | ) | (227 | ) | ||||||||
Loss from continuing operations before taxes | (12,982 | ) | (17,373 | ) | (35,023 | ) | (47,935 | ) | ||||||||
Income tax expense (benefit) | 5 | (199 | ) | 15 | (188 | ) | ||||||||||
Loss from continuing operations | $ | (12,987 | ) | $ | (17,174 | ) | $ | (35,038 | ) | $ | (47,747 | ) | ||||
Income (loss) from discontinued operations | — | 69 | — | (38 | ) | |||||||||||
Net loss | $ | (12,987 | ) | $ | (17,105 | ) | $ | (35,038 | ) | $ | (47,785 | ) | ||||
Net loss per share of common stock, basic and diluted1: | ||||||||||||||||
Continuing operations | $ | (1.38 | ) | $ | (2.12 | ) | $ | (3.73 | ) | $ | (5.97 | ) | ||||
Discontinued operations | 0.00 | 0.01 | 0.00 | 0.00 | ||||||||||||
Net loss per share of common stock, basic and diluted | $ | (1.38 | ) | $ | (2.11 | ) | $ | (3.73 | ) | $ | (5.97 | ) | ||||
Net loss per share of preferred stock, basic and diluted1: | ||||||||||||||||
Continuing operations | $ | (0.88 | ) | $ | (2.49 | ) | ||||||||||
Discontinued operations | 0.00 | 0.00 | ||||||||||||||
Net loss per share of preferred stock, basic and diluted | $ | (0.88 | ) | $ | (2.49 | ) |
1 Results have been retroactively adjusted to reflect the 1-for-12 reverse stock split effected on July 7, 2022.
The unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2022 and 2021 have been derived from the reviewed 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 leading clinical-stage precision medicine company that discovers, develops, and commercializes targeted therapeutics for patients with significant unmet clinical need in immunology and rare genetic diseases. The Company has built a diverse portfolio of innovative therapies to deliver meaningful medical impact for patients in urgent need. The Company’s clinical candidates commonly have a proven mechanistic rationale, biomarkers and/or an established proof-of-concept to expedite and increase the probability of success.
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; the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; 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; 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, including as a result of recent management changes; regulatory risks; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic and tensions in Ukraine; and those other risks detailed in Avalo’s filings with the SEC. 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.
For media and investor inquiries
Christopher Sullivan, CFO Avalo Therapeutics, Inc.ir@avalotx.com410-803-6793
or
Chris BrinzeyICR WestwickeChris.brinzey@westwicke.com339-970-2843
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