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Aptevo Therapeutics Reports 2017 Financial Results and Provides Business Update
Completes Sale of Hyperimmune Commercial Business for up to
Advances Multiple ADAPTIR Candidates with Investigational New Drug Application Filings Planned for Two New Bispecific Antibody Candidates in 2018
Strengthens Aptevo’s Financial Position; Concludes the Year with
“I am proud of the reputation we are building as a company that is execution-oriented with a compelling, differentiated technology platform – our ADAPTIR bispecific antibody platform,” said
“In addition to a strategic partnership with
2017 Operational Highlights
Commercial Portfolio
- Reinitiated new patient acquisition efforts for IXINITY® [Coagulation Factor IX (Recombinant)] following the introduction of new IXINITY supply in May 2017
- Grew IXINITY revenue 12% year-over-year despite the supply interruption and temporary suspension of new patient acquisition activities
- Presented new clinical data evaluating the safety and efficacy of IXINITY in children with Hemophilia B, showing that IXINITY appears to be safe and well tolerated in this subject population
Pipeline
- Announced plans to commence a Phase 2 clinical study of otlertuzumab in a new indication – peripheral T-cell lymphoma (PTCL), which will enroll up to 24 patients with relapsed or refractory PTCL in an open-label, proof-of-concept Phase 2 clinical study evaluating the safety and efficacy of otlertuzumab in combination with bendamustine
- Continued to advance APVO414 in a dose escalation Phase 1 study and presented preliminary data from the continuous infusion dose cohorts
- Expanded Aptevo’s ADAPTIR portfolio and announced the selection of an additional ADAPTIR bispecific antibody candidate, APVO436 – an optimized, next-generation ADAPTIR bispecific molecule targeting the cell-surface receptor CD123 and CD3, which is highly expressed in multiple hematological malignancies, including acute myeloid leukemia (AML)
- Presented new preclinical data on APVO436 at the
American Association for Cancer Research Annual Meeting demonstrating potent immune activation, traditional antibody-like manufacturing characteristics, and an extended half-life in mice of up to 12.5 days - Presented additional preclinical data on APVO436 at the American Society of Hematology 59th Annual Meeting showing broad immunotherapeutic activity against primary human AML cells in vitro, illustrating its utility as a potent and selective immunotherapeutic candidate in the treatment of AML
- Demonstrated the versatility of the ADAPTIR platform with the development of ALG.APV-527, (partnered with
Alligator Bioscience ) which targets a co-stimulatory receptor found on activated T cells, illustrating the capability of the ADAPTIR platform to generate immunotherapeutic antibodies with different mechanisms of immune system engagement, in this case targeting 4-1BB and the tumor antigen, 5T4, which is found on a variety of different types of cancer cells - Initiated CMC and IND-enabling activities for APVO436, APVO210, and ALG.APV-527, and announced plans to file two Investigational New Drug (IND) applications in 2018 for APVO436, being developed for the treatment of AML, and, APVO210, being developed for the treatment of autoimmune and inflammatory diseases
Corporate
- Monetized Aptevo’s non-core commercial assets through the sale of three hyperimmune commercial products, (WinRho® SDF, HepaGam B®, and VARIZIG®) to Saol Therapeutics for total consideration of up to $74.5 million, raising significant non-dilutive funding to support Aptevo’s ongoing commercial and R&D efforts
- Signed a collaboration agreement with Alligator Bioscience to jointly develop and advance a lead bispecific antibody candidate, ALG.APV-527
- Amended the terms of a credit agreement with MidCap Financial allowing Aptevo to retain a $20 million credit facility with MidCap
2017 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
Cost of Product Sales: Cost of product sales decreased by
Research and Development Expenses: Research and development expenses were essentially unchanged year-over year and were
Selling, General and Administrative Expenses: Selling, general and administrative expenses decreased by
Net Income from Discontinued Operations: In connection with the sale of its hyperimmune business, Aptevo reclassified the operating results of the hyperimmune business for all periods presented and the gain recognized on the sale of the hyperimmune business of
Net Income (Loss): Aptevo’s net income for the year ended
Aptevo 2018 Milestones:
- Commence Phase 2 clinical trial of otlertuzumab in PTCL – initiated
January 2018 - Submit an IND application for APVO436 in AML – anticipated Q2 2018
- Complete enrollment of Phase 1 dosing cohorts in APVO414 clinical trial in metastatic castration resistant prostate cancer – anticipated Q3 2018
- Report preliminary otlertuzumab Phase 2 PTCL clinical data – anticipated Q4 2018
- Submit an IND for APVO210 in Autoimmune/Inflammatory Diseases (AIID) – anticipated Q4 2018
- Report preliminary APVO414 Phase 1 dose escalation clinical data – anticipated Q4 2018
- Advance partnership discussions for ADAPTIR platform and product candidates
- Capture increased market share of Hemophilia B market with expanded U.S. sales
- Advance non-disclosed ADAPTIR discovery candidates in immuno-oncology indications
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
| ASSETS | 2017 | 2016 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,095 | $ | 9,676 | ||||
| Short-term investments | 73,688 | 44,849 | ||||||
| Accounts receivable | 2,141 | 307 | ||||||
| Inventories | 1,028 | 461 | ||||||
| Current assets held for sale | — | 10,155 | ||||||
| Restricted cash, current portion | 400 | 400 | ||||||
| Prepaid expenses | 4,022 | 3,540 | ||||||
| Other current assets | 6,710 | 2,026 | ||||||
| Total current assets | 95,084 | 71,414 | ||||||
| Restricted cash, net of current portion | 10,000 | — | ||||||
| Property and equipment, net | 5,843 | 5,910 | ||||||
| Intangible assets, net | 6,080 | 6,910 | ||||||
| Long-term assets held for sale | — | 7,624 | ||||||
| Total assets | $ | 117,007 | $ | 91,858 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and other accrued liabilities | $ | 7,350 | $ | 10,518 | ||||
| Accrued compensation | 4,626 | 4,009 | ||||||
| Deferred revenue, current portion | — | 811 | ||||||
| Current portion of long-term debt | 3,333 | — | ||||||
| Other short-term liabilities | 3,201 | 278 | ||||||
| Current liabilities held for sale | — | 3,928 | ||||||
| Total current liabilities | 18,510 | 19,544 | ||||||
| Deferred revenue, net of current portion | — | 2,896 | ||||||
| Long-term debt, net | 15,728 | 18,383 | ||||||
| Other liabilities | 734 | 469 | ||||||
| Total liabilities | 34,972 | 41,292 | ||||||
| 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; 21,605,716 and 20,271,737 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively |
22 | 20 | ||||||
| Additional paid-in capital | 155,837 | 151,271 | ||||||
| Accumulated other comprehensive loss | (105 | ) | (33 | ) | ||||
| Contribution receivable from former parent | — | (20,000 | ) | |||||
| Accumulated deficit | (73,719 | ) | (80,692 | ) | ||||
| Total stockholders' equity | 82,035 | 50,566 | ||||||
| Total liabilities and stockholders' equity | $ | 117,007 | $ | 91,858 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| For the Year Ended December 31, | ||||||||
| 2017 | 2016 | |||||||
| Revenues: | ||||||||
| Product sales | $ | 10,949 | $ | 9,805 | ||||
| Collaborations | 3,709 | 180 | ||||||
| Total revenues | 14,658 | 9,985 | ||||||
| Costs and expenses: | ||||||||
| Cost of product sales | 5,010 | 12,467 | ||||||
| Research and development | 29,021 | 29,120 | ||||||
| Selling, general and administrative | 34,576 | 36,158 | ||||||
| Impairment of goodwill and intangible assets | — | 71,013 | ||||||
| Loss from operations | (53,949 | ) | (138,773 | ) | ||||
| Other expense: | ||||||||
| Other expense | (1,944 | ) | (810 | ) | ||||
| Total other expense | (1,944 | ) | (810 | ) | ||||
| Loss before income taxes | (55,893 | ) | (139,583 | ) | ||||
| Benefit from income taxes | 23,301 | 19,692 | ||||||
| Net loss from continuing operations | (32,592 | ) | (119,891 | ) | ||||
| Discontinued operations (Note 2): | ||||||||
| Income from discontinued operations, before income taxes | 62,864 | 11,828 | ||||||
| Income tax expense | (23,299 | ) | (4,352 | ) | ||||
| Income from discontinued operations | 39,565 | 7,476 | ||||||
| Net income (loss) | $ | 6,973 | $ | (112,415 | ) | |||
| Basic and diluted net income (loss) per share: | ||||||||
| Net loss from continuing operations | $ | (1.53 | ) | $ | (5.92 | ) | ||
| Net income from discontinued operations | $ | 1.86 | $ | 0.37 | ||||
| Net income (loss) | $ | 0.33 | $ | (5.55 | ) | |||
| Weighted-average shares used to compute per share calculation | 21,335,157 | 20,239,160 | ||||||
Aptevo Product Portfolio
Marketed Product:
- IXINITY (coagulation factor IX [recombinant]) – is a third-generation recombinant human coagulation factor IX approved in
the United States for the control and prevention of bleeding episodes and for perioperative management in adults and children 12 years of age or older with Hemophilia B.
ADAPTIR Clinical and Preclinical Pipeline:
- Otlertuzumab – a monospecific ADAPTIR candidate currently in Phase 2 clinical development for the treatment of peripheral T-cell lymphoma (PTCL). A previous Phase 2 clinical study evaluating otlertuzumab for the treatment of chronic lymphocytic leukemia (CLL) showed that otlertuzumab in combination with bendamustine, compared to bendamustine alone, demonstrated a significant increase in median progression free survival for the combination, from approximately 10 to 16 months.
- APVO414 – a bispecific ADAPTIR candidate, currently in Phase 1 development, targeting prostate specific membrane antigen (PSMA), an enzyme that is expressed on the surface of prostate cancer cells, and, CD3, a component of the T cell receptor complex expressed on all T cells. APVO414 redirects T cells to specifically kill PSMA expressing tumors and is being developed for metastatic castration-resistant prostate cancer, which is advanced prostate cancer that has spread to other organs and no longer responds to hormone blocking therapies.
- APVO436 – a bispecific ADAPTIR candidate currently in preclinical development targeting CD123, a cell surface receptor highly expressed on several hematological malignancies and CD3, a component of the T cell receptor. APVO436 engages T cells to initiate killing of tumor cells. Aptevo intends to file an IND and begin clinical development of APVO436 in 2018.
- ALG.APV-527 – a bispecific antibody candidate, partnered with
Alligator Bioscience , featuring a novel mechanism of action designed to simultaneously target 4-1BB (CD137) and 5T4, a tumor antigen widely overexpressed in a number of different types of cancer. 4-1BB, a costimulatory receptor on T cells, is known to enhance the immune response to cancer through activation of tumor-specific T cells and is believed to be a promising target for new immunotherapeutic approaches. ALG.APV-527 could potentially have utility in the treatment of a broad spectrum of cancers over-expressing the tumor antigen, including breast, cervical, non-small-cell-lung, prostate, renal, gastric, colorectal and bladder cancers. - APVO210 – a bispecific ADAPTIR preclinical candidate with a novel mechanism of action based on targeted cytokine delivery. APVO210 is composed of a humanized anti-CD86 antibody fused with a modified form of IL-10 that specifically induces IL-10 signaling on antigen presenting cells, but not on lymphoid populations. APVO210 functions by suppressing immune responses and inducing certain tolerogenic responses and therefore may have potential benefit for the treatment of autoimmune and inflammatory diseases. Aptevo intends to file an IND for APVO210 in 2018.
- ROR1 Bispecific – a proof-of-concept bispecific candidate targeting ROR1, an antigen found on several solid tumors and hematologic, or blood-related malignancies. Initial preclinical data demonstrate redirected T cell killing of tumors expressing ROR1 in vitro and in vivo in animal models.
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.