- Affimed's Phase 1b combination study of AFM13, a CD30/CD16A TandAb, with Keytruda ® (pembrolizumab) in Hodgkin lymphoma (HL) is ongoing and now recruiting into the second dose cohort. The Company intends to provide a first update on the study by the end of 2016 or first quarter of 2017.
- In the Phase 2a monotherapy trial for AFM13 in HL sponsored by the German Hodgkin Study Group (GHSG), Affimed is working with the sponsor to revise the study protocol, and anticipates providing an update on the revised in- and exclusion criteria and overall study design by the end of 2016. The study remains open and recruiting under the original study protocol to gain insights into specific patient subsets.
- Affimed intends to conduct a Company-sponsored trial for AFM13 in CD30-positive lymphoma, including T-cell lymphoma (TCL). Affimed plans to integrate translational aspects of the Phase 1b/2a study in CD30-positive lymphoma with cutaneous manifestation into this trial that previously had been planned as an investigator-sponsored translational trial to be led by Columbia University.
- The Company has decided to advance AFM24, an EGFRwt/CD16A TandAb, in solid tumors and has selected a development candidate for AFM24 in indications such as lung, head and neck and colon cancers. In vitro, AFM24 has shown higher antigen-specific cytotoxic activity compared to cetuximab, including in cells expressing the proto-oncogene ras. Preclinical toxicity evaluation is ongoing and Affimed intends to provide an update on the AFM24 program in the first half of 2017.
- In its discovery program for multiple myeloma (MM), Affimed is developing AFM26, a bispecific molecule targeting BCMA/CD16A. MM is characterized by very high serum levels of M-protein, which consists of immunoglobulins produced by an excess of plasma cells in MM patients. In line with results from the Company's other NK-cell TandAbs, AFM26 displays very strong in vitro antigen-specific cytotoxicity, with NK-cell binding even in the presence of high levels of IgG. Preclinical investigations are ongoing. In addition to this program, Affimed is pursuing a trispecific approach to treat MM, with molecules designed to bind various tumor-specific targets including BCMA.
- The Company has initiated a Phase 1 dose-escalation trial of its CD19/CD3 TandAb AFM11 in patients with relapsed and refractory acute lymphocytic leukemia (ALL) and has enrolled the first patient. The study is being conducted in Eastern Europe, Russia and Israel.
- Recruitment into Affimed's Phase 1 study in non-Hodgkin lymphoma (NHL) for AFM11 is slower than expected and the Company has responded to this by initiating new trial sites in Eastern Europe and the U.S. Affimed no longer expects to present data by year end and intends to provide an update on the study timelines in the first half of 2017.
- Amphivena Therapeutics, Inc. plans to initiate a Phase 1 clinical trial for its T-cell-engager AMV564, a molecule developed from Affimed's TandAb platform, in patients with acute myeloid leukemia (AML). AMV564 is a bispecific TandAb targeting CD33 on tumor cells and CD3 on T-cells. Together with the existing investor consortium, Affimed is financially supporting clinical development of AMV564 with up to €1.5 million in a Series A extension financing of Amphivena, €1.0 of which was invested in September 2016.
- MHC-peptides are a class of potentially highly specific tumor antigens, but so far, generation of antibodies against these peptides has been reported to be extremely challenging. Affimed has successfully generated a number of T-cell TandAbs specifically binding MHC-peptide complexes. Early preclinical evaluation of one of these molecules has demonstrated potent in vitro killing only for tumor cells endogenously expressing the targeted MHC-peptide complex, control cell lines were not lysed. Affimed continues to explore these MHC-peptide-specific TandAbs, which have the potential to mediate selective and dose-dependent lysis of MHC-target-positive cells.
Net cash used in operating activities was €25.5 million for the nine months ended September 30, 2016 compared to €14.5 million for the nine months ended September 30, 2015. The increase was primarily related to higher cash expenditure for research and development (R&D) in connection with our development and collaboration programs.Revenue for the third quarter of 2016 was €0.9 million compared to €1.2 million for the third quarter of 2015. Revenue in both periods was derived from Affimed's collaborations with Amphivena and AbCheck Service Revenue. R&D expenses for the third quarter of 2016 were €8.8 million compared to €6.4 million for the third quarter of 2015. The increase was primarily related to higher expenses for AFM11, preclinical programs and infrastructure. G&A expenses for the third quarter of 2016 were nearly unchanged with €2.2 million compared to €2.1 million for the third quarter of 2015. Net loss for the third quarter of 2016 was €10.3 million, or €0.31 per common share, compared to a net loss of €7.3 million, or €0.24 per common share, for the third quarter of 2015. The increase in net loss was primarily related to increased spending on R&D for AFM11, preclinical programs and infrastructure. In addition, the result was affected by lower revenue and lower other income. Note on IFRS Reporting Standards Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro. Please refer to Affmed's SEC filings for the notes that accompany its financial statements and should be read in conjunction therewith. Conference call and webcast information Affimed's management will host a conference call to discuss the company's financial results and recent corporate developments today at 8:30 a.m. ET. A webcast of the conference call can be accessed in the "Events" section on the "Media" page of the Affimed website at http://www.affimed.com/events.php. A replay of the webcast will be available on Affimed's website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call. About Affimed N.V. Affimed (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK- and T-cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases. For more information, please visit www.affimed.com. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates our intellectual property position, our collaboration activities, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks uncertainties and other factors described under the heading "Risk Factors" in Affimed's filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future. IR Contact:Caroline Stewart, Head IRPhone: +1 347394 6793E-Mail: IR@affimed.com or firstname.lastname@example.org Media Contact:Anca Alexandru, Head of Communications, EU IRPhone: +49 6221 64793341E-Mail: email@example.com AFFIMED N.V. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Affimed N.V. Unaudited condensed consolidated statement of comprehensive loss (in € thousand)
|For the three months ended September 30||For the nine months ended September 30|
|Other income - net||298||19||631||143|
|Research and development expenses||(6,448||)||(8,760||)||(14,974||)||(24,456||)|
|General and administrative expenses||(2,068||)||(2,181||)||(5,592||)||(6,239||)|
|Finance income / (costs) - net||(193||)||(311||)||108||(1,183||)|
|Loss before tax||(7,256||)||(10,295||)||(13,924||)||(26,792||)|
|Loss for the period||(7,292||)||(10,295||)||(13,960||)||(26,794||)|
|Total comprehensive loss||(7,292||)||(10,295||)||(13,960||)||(26,794||)|
|Loss per share in € per share (undiluted = diluted)||(0.24||)||(0.31||)||(0.52||)||(0.81||)|
|December 31, 2015||September 30, 2016|
|Leasehold improvements and equipment||915||845|
|Trade and other receivables||915||2,337|
|Cash and cash equivalents||76,740||35,693|
|EQUITY AND LIABILITIES|
|Total non-current liabilities||3,104||1,685|
|Trade and other payables||4,444||6,327|
|Total current liabilities||8,944||8,351|
|TOTAL EQUITY AND LIABILITIES||79,322||53,235|
|For the nine months ended September 30|
|Cash flow from operating activities|
|Loss for the period||(13,960||)||(26,794||)|
|Adjustments for the period:|
|- Income taxes||36||2|
|- Depreciation and amortization||240||293|
|- Share based payments||1,453||2,719|
|- Finance income / costs - net||(108||)||1,183|
|Change in trade and other receivables||(508||)||(1,398||)|
|Change in inventories||(40||)||(25||)|
|Change in other assets||0||(151||)|
|Change in trade, other payables and deferred revenue||(1,218||)||(1,080||)|
|Cash used in operating activities||(14,105||)||(25,251||)|
|Net cash used in operating activities||(14,526||)||(25,546||)|
|Cash flow from investing activities|
|Purchase of intangible assets||(10||)||(21||)|
|Purchase of leasehold improvements and equipment||(204||)||(194||)|
|Cash paid for investments in financial assets||0||(27,088||)|
|Cash received from maturity of financial assets||0||13,536|
|Net cash used for investing activities||(214||)||(13,767||)|
|Cash flow from financing activities|
|Proceeds from issue of common shares||37,524||0|
|Transactions costs related to issue of common shares||(3,090||)||0|
|Repayment of borrowings||0||(1,079||)|
|Cash flow from financing activities||34,434||(1,079||)|
|Net changes to cash and cash equivalents||19,694||(40,392||)|
|Cash and cash equivalents at the beginning of the period||39,725||76,740|
|Exchange-rate related changes of cash and cash equivalents||1,006||(655||)|
|Cash and cash equivalents at the end of the period*||60,425||35,693|
|*Total cash and cash equivalents and financial assets as of September 30, 2016: 49,133 (September 30, 2015: 60,425)|
|Issued capital||Capital reserves||Accumulated deficit||Total equity|
|Balance as of January 1, 2015||240||131,544||(99,989||)||31,795|
|Issue of common shares||57||33,433||33,490|
|Exercise of share based payment awards||2||942||944|
|Equity-settled share based payment awards||1,453||1,453|
|Loss for the period||(13,960||)||(13,960||)|
|Balance as of September 30, 2015||299||167,372||(113,949||)||53,722|
|Balance as of January 1, 2016||333||187,169||(120,228||)||67,274|
|Equity-settled share based payment awards||2,719||2,719|
|Loss for the period||(26,794||)||(26,794||)|
|Balance as of September 30, 2016||333||189,888||(147,022||)||43,199|