Aptevo Therapeutics Reports Third Quarter Financial Results and Provides Business Update
Aptevo Therapeutics reported a net loss of $6.8 million for Q3 2020, slightly improved from $6.9 million in Q3 2019. The company generated $1.5 million in royalties from Pfizer's RUXIENCE, resulting in a 209% increase from the previous quarter. R&D expenses decreased to $4.5 million from $7.6 million in 2019, primarily due to COVID-19 impacts. Aptevo's cash reserves stood at $27.5 million, extending its runway into 2022. The Phase 1/1b trial for APVO436 continues, with promising preliminary results showing complete remission in two patients.
- Earned $1.5 million in RUXIENCE royalties, a 209% increase from Q2 2020.
- Research and development expenses decreased by $3.1 million to $4.5 million.
- Cash and cash equivalents of $27.5 million extend cash runway into 2022.
- Net loss of $6.8 million for Q3 2020, although slightly improved from $6.9 million in Q3 2019.
- Income from discontinued operations fell by $4.0 million compared to Q3 2019.
Funding Extends Cash Runway Into Q3 2021
SEATTLE, WA / ACCESSWIRE / November 10, 2020 / Aptevo Therapeutics Inc. ("Aptevo" or "the Company") (NASDAQ:APVO), a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ bispecific technology platform, today reported financial results for the third quarter ended September 30, 2020, and provided a business update.
"We are pleased to report progress in our APVO436 Phase 1/1b trial. Dosing in cohorts 1 through 7 has been completed, and enrollment in cohort 8 has commenced. A total of 32 patients have been enrolled to date. In addition to our lead candidate progressing in the clinic, additional ADAPTIR™ candidates continue to develop," said Mr. Marvin White, President and CEO of Aptevo.
Subsequent to quarter end, Aptevo announced preliminary data from cohort 6 of its APVO436 Phase 1/1b trial, including that two patients were in complete remission. "We are greatly encouraged by the complete remission seen in patients in cohort 6, a wonderful outcome for them," said Marvin White, President and CEO of Aptevo Therapeutics. "We are now in a critical phase of the study, as pharmacokinetic modelling suggests that dosing in cohorts 5 through 8 is in a therapeutic range, which could result in potential clinical activity of the drug. We look forward to continuing the dose escalation and monitoring potential clinical responses as we advance through the upcoming dose cohorts," concluded Mr. White.
As previously announced in August, additional non-dilutive funding was secured through a
Aptevo also provided an update on the royalty payments, "In the third quarter of 2020, we earned
Portfolio Update:
APVO436: APVO436 is a novel anti-CD123 x anti-CD3 targeted investigational bispecific antibody therapy being evaluated for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). To date, in our Phase 1/1b trial, dosing in cohorts 1 through 7 has been completed, and enrollment in cohort 8 has commenced. No evidence of dose-limiting toxicities (DLTs) was observed in cohorts 5 through 7. We remain optimistic about the progress of our Phase 1/1b trial and look forward to the commencement of the APVO436 arm of the Leukemia & Lymphoma Society Beat AML clinical trial.
ALG.APV-527: ALG.APV-527, partnered with Alligator Bioscience, targeting 4-1BB and the solid tumor antigen 5T4 an oncofetal antigen, is now Phase 1 ready and we are exploring partnership opportunities for clinical development of this molecule.
APVO603: APVO603, which targets 4-1BB and OX40, has shown what we believe to be promising preclinical activity with the potential to stimulate robust anti-tumor responses by amplifying the cytotoxic function of activated T cells and NK cells. We continue to move this molecule towards the clinic and are currently optimistic about its potential.
Other preclinical candidates: As previously indicated, we plan to announce the selection of another new ADAPTIR candidate later in the year.
Third Quarter 2020 Financial Results Summary
Cash Position: Aptevo had cash and cash equivalents as of September 30, 2020 totaling
Royalty Revenue: Royalty revenue increased by
Research and Development Expenses: Research and development expenses decreased by
General and Administrative Expenses: For the three months ended September 30, 2020, general and administrative expenses decreased by
Other Expense: Other expense consists primarily of gains or losses realized on foreign currency revaluation, costs related to debt extinguishment, accrued exit fees on debt, and interest on debt. Other expense increased by
Discontinued Operations: Income from discontinued operations decreased by
Medexus reported their second quarter 2020 net IXINITY sales to Aptevo in July and made a deferred payment to Aptevo of
Net Income (Loss): Aptevo's net loss from continuing operations for the three month period ended September 30, 2020 was
Aptevo Therapeutics Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts, unaudited)
| September 30, 2020 | December 31, 2019 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 24,942 | $ | 12,448 | ||||
Restricted cash - current | 2,555 | - | ||||||
Royalty receivable | 1,463 | - | ||||||
Prepaid expenses | 1,487 | 1,078 | ||||||
Held for sale assets - current | - | 16,309 | ||||||
Other current assets | 206 | 160 | ||||||
Total current assets | 30,653 | 29,995 | ||||||
Restricted cash | - | 7,498 | ||||||
Property and equipment, net | 3,020 | 3,946 | ||||||
Operating lease right-of-use asset | 2,990 | 3,747 | ||||||
Held for sale assets - non-current | - | 7,465 | ||||||
Other assets | 757 | 757 | ||||||
Total assets | $ | 37,420 | $ | 53,408 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and other accrued liabilities | $ | 3,911 | $ | 6,427 | ||||
Accrued compensation | 2,082 | 2,870 | ||||||
Current portion of long-term debt | - | 19,863 | ||||||
Held for sale liabilities - current | - | 8,135 | ||||||
Other short-term liabilities | 1,424 | 944 | ||||||
Total current liabilities | 7,417 | 38,239 | ||||||
Loan payable - long term | 25,199 | - | ||||||
Operating lease liability | 2,602 | 3,327 | ||||||
Total liabilities | 35,218 | 41,566 | ||||||
Stockholders' equity: | ||||||||
Preferred stock: issued or outstanding | - | - | ||||||
Common stock: and 3,234,232 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 45 | 45 | ||||||
Additional paid-in capital | 180,710 | 179,653 | ||||||
Accumulated deficit | (178,553 | ) | (167,856 | ) | ||||
Total stockholders' equity | 2,202 | 11,842 | ||||||
Total liabilities and stockholders' equity | $ | 37,420 | $ | 53,408 | ||||
Aptevo Therapeutics Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts, unaudited)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
Royalty revenue | 1,463 | - | 1,936 | - | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | (4,494 | ) | (7,596 | ) | (12,940 | ) | (20,355 | ) | ||||||||
General and administrative | (3,215 | ) | (3,863 | ) | (9,671 | ) | (12,671 | ) | ||||||||
Loss from operations | (6,246 | ) | (11,459 | ) | (20,675 | ) | (33,026 | ) | ||||||||
Other expense from continuing operations | (702 | ) | (625 | ) | (973 | ) | (1,639 | ) | ||||||||
Loss on extinguishment of debt | - | - | (2,104 | ) | - | |||||||||||
Loss before income tax | (6,948 | ) | (12,084 | ) | (23,752 | ) | (34,665 | ) | ||||||||
Benefit from income tax | - | 999 | - | 999 | ||||||||||||
Net loss from continuing operations | $ | (6,948 | ) | $ | (11,085 | ) | $ | (23,752 | ) | $ | (33,666 | ) | ||||
Discontinued operations: | ||||||||||||||||
Income from discontinued operations, before income taxes | 157 | 5,160 | 13,055 | 2,391 | ||||||||||||
Income tax expense | - | (999 | ) | - | (999 | ) | ||||||||||
Income from discontinued operations | 157 | 4,161 | 13,055 | 1,392 | ||||||||||||
Net loss | $ | (6,791 | ) | $ | (6,924 | ) | $ | (10,697 | ) | $ | (32,274 | ) | ||||
Net loss from continuing operations per share | $ | (2.15 | ) | $ | (3.44 | ) | $ | (7.35 | ) | $ | (11.98 | ) | ||||
Net income from discontinued operations per share | $ | 0.05 | $ | 1.29 | $ | 4.04 | $ | 0.50 | ||||||||
Basic and diluted net loss per basic share | $ | (2.10 | ) | $ | (2.15 | ) | $ | (3.31 | ) | $ | (11.48 | ) | ||||
Weighted-average shares used to compute per share calculations | 3,232,811 | 3,226,419 | 3,233,257 | 2,810,141 | ||||||||||||
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for the treatment of cancer. The Company's lead clinical candidate, APVO436, and preclinical candidates, ALG.APV-527 and APVO603, were developed based on the Company's versatile and robust ADAPTIR™ modular protein technology platform. The ADAPTIR™ platform is capable of generating highly differentiated bispecific antibodies with unique mechanisms of action for the treatment of different types of cancer. For more information, please visit www.aptevotherapeutics.com
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding potential royalty and milestone payments and the recording of such payments, Aptevo's ability to successfully obtain revenue on terms acceptable to Aptevo, Aptevo's outlook, financial performance or financial condition, Aptevo's estimated cash burn, Aptevo's technology and related pipeline, Aptevo's partnership opportunities, Aptevo's expectations about the advancement of its clinical trials, Aptevo's expectations regarding the effectiveness of its ADAPTIR platform, and any other statements containing the words "believes," "expects," "anticipates," "intends," "plans," "forecasts," "estimates," "will" and similar expressions are 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. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-look
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