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Aptevo Therapeutics Reports Third Quarter Financial Results With Business Highlights
Business Highlights
- Enrollment and dosing have commenced in Part 2 (Expansion Phase) of Company's multicenter 5001 Phase 1B clinical trial to evaluate APVO436 in adult patients with acute myeloid leukemia (AML).
- Reported 3 publications in two peer-reviewed journals ( Cancers[Basel]) and Frontiers in Aging) regarding the salient features of the data obtained during Part 1 (Dose escalation phase) of the 5001 APVO436 Phase 1B trial.
- Participated in Euroleukemia2021 Meeting with an oral and a poster presentation.
- Showcased the Company's preclinical assets, APVO442 and APVO603, and their potential to improve efficacy in the treatment of solid tumors and participated in discussions about risk mitigation in cell engager candidates at the Virtual Cell Engager Summit.
- Presented the unique aspects of the Company's proprietary ADAPTIR AND ADAPTIR-FLEX platforms at the
Cambridge Health Institute PEGS Virtual Conference . - platforms at the
Cambridge Health Institute PEGS Virtual Conference .
"I am excited about our clinical progress in the third quarter, as we initiated enrollment and dosing in our APVO436 Phase 1b expansion trial. We look forward to receiving data from this trial in the first half of next year and will use the outcomes to inform our go-forward clinical strategy for this promising lead clinical candidate with the potential to impact existing standard of care for acute myeloid leukemia," said
Third Quarter 2021 Financial Results Summary
Cash Position : Aptevo had cash and cash equivalents as of
Royalty Revenue: Royalty revenue was
Research and Development Expenses : Research and development expenses decreased to
General and Administrative Expenses : For the three months ended
Other Expense, Net: Other expense, net consists primarily of costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt. Other expense, net was
Discontinued Operations: Income from discontinued operations was approximately
Net Loss : Aptevo's net loss for the three-month period ended
Liability Related to Sale of Future Royalties: We treat the Royalty Purchase Agreement with HCR as a debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liabilities related to sale of future royalties and the debt amortization are based on our current estimates of future royalties expected to be paid over the life of the arrangement. We will periodically assess the expected royalty payments using projections from external sources. To the extent our estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. We are not obligated to repay the proceeds received under the Royalty Purchase Agreement with HCR.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts, unaudited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$ | 52,118 | $ | 39,979 | ||||
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Restricted cash - current
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1,259 | 2,555 | ||||||
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Royalty receivable
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3,096 | 2,369 | ||||||
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Prepaid expenses
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2,391 | 2,228 | ||||||
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Other current assets
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9 | 133 | ||||||
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Total current assets
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58,873 | 47,264 | ||||||
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Property and equipment, net
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2,521 | 2,815 | ||||||
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Operating lease right-of-use asset
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1,865 | 2,722 | ||||||
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Other assets
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746 | 746 | ||||||
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Total assets
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$ | 64,005 | $ | 53,547 | ||||
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LIABILITIES AND STOCKHOLDERS' EQUITY
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Current liabilities:
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Accounts payable and other accrued liabilities
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$ | 3,687 | $ | 5,583 | ||||
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Accrued compensation
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1,565 | 2,757 | ||||||
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Liability related to the sale of future royalties, net - short-term
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13,369 | - | ||||||
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Current portion of long-term debt
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11,167 | 5,000 | ||||||
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Other current liabilities
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2,592 | 1,199 | ||||||
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Total current liabilities
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32,380 | 14,539 | ||||||
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Liability related to the sale of future royalties, net - long-term
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18,711 | - | ||||||
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Loan payable - long-term
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4,012 | 20,054 | ||||||
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Operating lease liability
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1,610 | 2,360 | ||||||
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Total liabilities
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56,713 | 36,953 | ||||||
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Stockholders' equity:
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Preferred stock:
issued or outstanding
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- | - | ||||||
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Common stock:
and 4,410,909 shares issued and outstanding at
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47 | 46 | ||||||
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Additional paid-in capital
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215,036 | 202,154 | ||||||
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Accumulated deficit
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(207,791 | ) | (185,606 | ) | ||||
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Total stockholders' equity
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7,292 | 16,594 | ||||||
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Total liabilities and stockholders' equity
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$ | 64,005 | $ | 53,547 | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts, unaudited)
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For the Three Months Ended |
For the Nine Months Ended |
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2021 | 2020 | 2021 | 2020 | ||||||||||||
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Royalty revenue
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3,096 | 1,463 | 8,627 | 1,936 | ||||||||||||
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Operating expenses:
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Research and development
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(4,367 | ) | (4,494 | ) | (14,451 | ) | (12,940 | ) | ||||||||
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General and administrative
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(3,479 | ) | (3,215 | ) | (11,536 | ) | (9,671 | ) | ||||||||
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Loss from operations
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(4,750 | ) | (6,246 | ) | (17,360 | ) | (20,675 | ) | ||||||||
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Other expense:
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Other expense from continuing operations, net
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(2,327 | ) | (702 | ) | (5,451 | ) | (973 | ) | ||||||||
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Loss on extinguishment of debt
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- | - | - | (2,104 | ) | |||||||||||
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Net loss from continuing operations
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$ | (7,077 | ) | $ | (6,948 | ) | $ | (22,811 | ) | $ | (23,752 | ) | ||||
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Discontinued operations:
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Income from discontinued operations
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$ | 80 | $ | 157 | $ | 626 | $ | 13,055 | ||||||||
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Net loss
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$ | (6,997 | ) | $ | (6,791 | ) | $ | (22,185 | ) | $ | (10,697 | ) | ||||
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Net loss from continuing operations per share
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$ | (1.45 | ) | $ | (2.15 | ) | $ | (4.94 | ) | $ | (7.35 | ) | ||||
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Net income from discontinued operations per share
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$ | 0.02 | $ | 0.05 | $ | 0.14 | $ | 4.04 | ||||||||
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Basic and diluted net loss per basic share
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$ | (1.43 | ) | $ | (2.10 | ) | $ | (4.80 | ) | $ | (3.31 | ) | ||||
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Weighted-average shares used to compute per share calculations
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4,891,881 | 3,232,811 | 4,617,357 | 3,233,257 | ||||||||||||
About
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy and safety of its therapeutic candidates and potential use of any such candidates as therapeutics for treatment of disease, advancement of its clinical trials and its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "optimism," "potential," "designed," "engineered," "breakthrough," "innovative," "innovation," "promising," "plans," "forecasts," "estimates," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.
There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; adverse developments in the
CONTACTS:
Investors
Email: IR@apvo.com or Millerm@apvo.com
Phone: 206-859-6629
Media
Email: jabraham@jqapartners.com
Phone: 917-884-7378
SOURCE:
accesswire.com
https://www.accesswire.com/672494/Aptevo-Therapeutics-Reports-Third-Quarter-Financial-Results-With-Business-Highlights