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Aptevo Therapeutics Reports 2018 Financial Results and Provides Business Update
Achieves Record Annual IXINITY® Net Revenue of
Advances APVO436 Into Phase 1/1b Clinical Trial for Treatment of Acute Myeloid Leukemia and High-Grade Myelodysplastic Syndrome
Receives Authorization to Commence Dosing in Phase 1 Clinical Trial of APVO210; Dosing Scheduled to Begin
Progresses Novel 4-1BB/5T4 Bispecific Antibody ALG.APV-527 Towards CTA Filing in Q4 2019
“Aptevo continued to make important progress in 2018 in both our pipeline and commercial programs setting up 2019 as a pivotal year for the Company,” said
We also reached a key milestone in 2018 – advancing our lead, next-generation ADAPTIR™ bispecific antibody candidate, APVO436, into clinical development. We are particularly excited about this achievement as pre-clinical data for APVO436 has shown promising attributes, specifically by inducing lower levels of several key T cell cytokines compared to a competitor candidate, which have been associated with serious adverse events in clinical studies with other T-cell engagers. We look forward to evaluating this attribute in our clinical studies, as it would represent an important advantage for our molecule vis-à-vis other bispecific approaches.
With APVO436 solidly on track, we are poised to also begin a Phase 1 study this month of our second ADAPTIR candidate, APVO210 – a novel bispecific antibody intended for the treatment of autoimmune and inflammatory diseases. The Phase 1 study, which is being conducted in
With two novel ADAPTIR bispecific candidates now advancing in the clinic towards important data read-outs later this year, IXINITY revenues growing, and the proceeds from our equity offering completed in
2018 Highlights
IXINITY
- Achieved record year-over-year annual IXINITY net revenue of
$23.1 million in 2018, representing a 111% increase compared to revenue of$10.9 million in 2017 - Continued to expand the patient base for IXINITY bringing additional new Hemophilia B patients onto therapy throughout the year
- Improved supply chain logistics and cost efficiencies for IXINITY by contracting with new third-party logistics providers
- Presented new data from a small retrospective study of IXINITY at the Thrombosis and Hemostasis 2018
Summit of North America annual meeting describing patient-reported outcomes data for IXINITY for various clinical and quality of life measures; overall, respondents in this study reported a high level of satisfaction with IXINITY with low annualized bleed rates and a positive impact on quality of life scores - Introduced new growth initiatives for IXINITY (launch of new 3,000 IU assay; pediatric clinical trial, and pursuit of ex-US distribution and partnership opportunities) commencing in 2019; the initiation of the pediatric trial is required for the pursuit of business in markets such as Europe
ADAPTIR Pipeline (APVO436 / APVO210 / ALG.APV-527)
- Commenced patient dosing in a Phase 1/1b open-label, dose-escalation study of APVO436 in patients with Acute Myeloid Leukemia (AML) and High-Grade Myelodysplastic Syndrome (MDS); anticipate reporting preliminary anti-drug antibody (ADA) read-out in Q3 2019 and reporting preliminary Phase 1 safety data in Q4 2019
- Presented comprehensive new pre-clinical data for APVO436 at the
American Association for Cancer Research (AACR) Annual Meeting demonstrating potent T cell-directed tumor killing with reduced cytokine release in pre-clinical studies compared to an Aptevo-generated competitor bispecific construct - Completed preparations to begin a Phase 1 clinical study of APVO210 evaluating single and multiple ascending doses in healthy volunteers; APVO210 is being developed for the treatment of autoimmune and inflammatory diseases
- Received authorization in
Australia to commence dosing in APVO210; Phase 1 clinical trial scheduled to beginMarch 2019 with initial results for the single dose group cohort anticipated in Q3 2019 and preliminary Phase 1 safety data in Q4 2019 - Published comprehensive pre-clinical data in the journal, Frontiers in Immunology, showing that APVO210 has a unique mechanism of action for delivering the cytokine, IL-10, which can generate antigen specific T-regulatory cells, and suppress inflammation and immune activation without stimulating pro-inflammatory cytokines
- Advanced ALG.APV-527 (partnered with
Alligator Bioscience ) which targets 4-1BB, a co-stimulatory receptor found on activated T cells and 5T4 (a solid tumor antigen) illustrating the capability of the ADAPTIR platform to generate immunotherapeutic antibodies with different mechanisms of immune system engagement. A bispecific candidate targeting 4-1BB and the tumor antigen 5T4 is a novel approach with potential to improve clinical outcomes in several solid tumors; anticipate filing a clinical trial authorization (CTA) in Q4 2019 - Presented new pre-clinical data for ALG.APV-527 at several industry conferences showing that it has the potential to selectively activate and enhance tumor-specific T cell responses at the tumor site without triggering systemic immune activation, supporting the advantages of this novel pathway for tumor immunotherapy
- Focused Aptevo’s ADAPTIR portfolio on next-generation ADAPTIR candidates that have the potential to provide increased stability, improved potency and an improved cytokine release profile
Corporate
- Increased Aptevo’s available cash by approximately
$18 million through the execution of a new term loan agreement with MidCap Financial extending the interest only repayment period toFebruary 1, 2020 with an opportunity for further deferral throughAugust 1, 2020 - Executed a share purchase agreement with
Lincoln Park Capital (LPC) establishing a three-year,$35 million equity line with LPC - Announced significant reduction in 2019 cash burn rate; estimate 2019 cash burn of between
$36-$40 million from$55-$60 million in 2018 - Completed a public equity offering in
March 2019 raising gross proceeds of approximately$22 million for Aptevo, strengthening the company’s balance sheet and providing additional cash runway beyond validating clinical milestones in the APVO436 and APVO210 Phase 1 clinical development programs anticipated in Q3 and Q4 2019
2018 Summary Financial Results
Cash Position: Aptevo had cash, cash equivalents, and short-term investments as of
Product Revenue: Revenue for IXINITY for the year ended
Collaborations revenue for 2017 was due to a one-time recognition of the remaining deferred revenue related to Aptevo’s collaboration with
Cost of Product Sales: Cost of product sales increased by
The increase in cost of product sales is mainly due to the increase in product sales, as well as lower cost of inventory in 2017 due to inventory being received in settlement against an outstanding inventory credit.
Research and Development Expenses: Research and development expenses increased by
Selling, General and Administrative Expenses: Selling, general and administrative expenses decreased by
Net Income (Loss): Aptevo’s net loss for the year ended
Aptevo 2019 Milestones:
- Commence Phase 1 clinical trial of APVO210
Mid 2019
- Launch new 3,000 IU IXINITY assay
Q3 2019
- Commence patient dosing in Phase 4 IXINITY study
- Report preliminary ADA read-out for APVO436 in going Phase 1 study
- Report initial results of APVO210 single dose cohorts
- Disclose new ADAPTIR molecule with new MOA
Q4 2019
- Report preliminary Phase 1 safety data for APVO436
- Report preliminary Phase 1 safety data for APVO210
- File CTA submission for Phase 1 study of ALG.APV-527
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
| As of December 31, | ||||||||
| 2018 | 2017 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 30,635 | $ | 7,095 | ||||
| Short-term investments | — | 73,688 | ||||||
| Accounts receivable | 5,220 | 2,141 | ||||||
| Inventories | 1,785 | 1,028 | ||||||
| Prepaid expenses | 6,907 | 4,022 | ||||||
| Other current assets | 4,142 | 6,710 | ||||||
| Restricted cash | — | 400 | ||||||
| Total current assets | 48,689 | 95,084 | ||||||
| Restricted cash, net of current portion | 7,448 | 10,000 | ||||||
| Property and equipment, net | 5,202 | 5,843 | ||||||
| Intangible assets, net | 5,250 | 6,080 | ||||||
| Other assets | 905 | — | ||||||
| Total assets | $ | 67,494 | $ | 117,007 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and other accrued liabilities | $ | 11,671 | $ | 7,350 | ||||
| Accrued compensation | 3,898 | 4,626 | ||||||
| Sales rebates and discounts payable | 1,245 | 623 | ||||||
| Current portion of long-term debt | — | 3,333 | ||||||
| Other current liabilities | 796 | 2,578 | ||||||
| Total current liabilities | 17,610 | 18,510 | ||||||
| Long-term debt, net | 19,278 | 15,728 | ||||||
| Other liabilities | 200 | 734 | ||||||
| Total liabilities | 37,088 | 34,972 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock: $0.001 par value; 15,000,000 shares authorized, zero shares issued or outstanding |
— | — | ||||||
| Common stock: $0.001 par value; 500,000,000 shares authorized; 22,808,416 and 21,605,716 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively |
23 | 22 | ||||||
| Additional paid-in capital | 157,791 | 155,837 | ||||||
| Accumulated other comprehensive loss | — | (105 | ) | |||||
| Accumulated deficit | (127,408 | ) | (73,719 | ) | ||||
| Total stockholders' equity | 30,406 | 82,035 | ||||||
| Total liabilities and stockholders' equity | $ | 67,494 | $ | 117,007 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| For the Year Ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenues: | ||||||||
| Product sales | $ | 23,067 | $ | 10,949 | ||||
| Collaborations | — | 3,709 | ||||||
| Total revenues | 23,067 | 14,658 | ||||||
| Costs and expenses: | ||||||||
| Cost of product sales | 11,214 | 5,010 | ||||||
| Research and development | 35,385 | 29,021 | ||||||
| Selling, general and administrative | 28,133 | 34,576 | ||||||
| Loss from operations | (51,665 | ) | (53,949 | ) | ||||
| Other expense: | ||||||||
| Other expense, net | (2,024 | ) | (1,944 | ) | ||||
| Loss before income taxes | (53,689 | ) | (55,893 | ) | ||||
| Benefit from income taxes | — | 23,301 | ||||||
| Net loss from continuing operations | (53,689 | ) | (32,592 | ) | ||||
| Discontinued operations (Note 2): | ||||||||
| Income from discontinued operations, before income taxes | — | 62,864 | ||||||
| Income tax expense | — | (23,299 | ) | |||||
| Income from discontinued operations | — | 39,565 | ||||||
| Net income (loss) | $ | (53,689 | ) | $ | 6,973 | |||
| Basic and diluted net income (loss) per share: | ||||||||
| Net loss from continuing operations | $ | (2.39 | ) | $ | (1.53 | ) | ||
| Net income from discontinued operations | $ | — | $ | 1.86 | ||||
| Net income (loss) | $ | (2.39 | ) | $ | 0.33 | |||
| Weighted-average shares used to compute per share calculation | 22,500,053 | 21,335,157 | ||||||
About
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 milestone payments, Aptevo’s outlook, financial performance or financial condition, Aptevo’s technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, milestones, 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-looking statement to reflect new information, events or circumstances.
There are a number of 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 research and development; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in Aptevo’s filings with the
Source:
Senior Director, Investor Relations and Corporate Communications
206-859-6628
JurchisonS@apvo.com
Source: Aptevo Therapeutics Inc.