Press Release - November 19, 2019
Heidelberg, Germany, November 19, 2019 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, today reported financial results for the quarter ended September 30, 2019 and provided an update on clinical and corporate developments.
“We are excited to commence patient dosing in our Phase 2 study of AFM13 in support of registration, bringing us one step closer to delivering a potential new treatment for pTCL patients, who have very few treatment options,” said Dr. Adi Hoess, Affimed’s CEO. “In addition, the IND for the first ever clinical trial bringing together an innate cell engager (AFM13) and adoptive NK cell transfer has cleared. This study of AFM13 and MD Anderson’s NK cell product could address a much broader group of patients with CD30-expressing lymphomas, including Hodgkin lymphoma, cutaneous T-cell lymphoma and diffuse large B-cell lymphoma.”
Dr. Hoess commented, “Cassandra’s deep expertise in drug development and strong leadership skills have been, and will continue to be, a tremendous asset to Affimed and our clinical team as we advance our pipeline of innate cell engagers. I would also like to thank Leila for her many contributions to Affimed and wish her success in her future endeavors.”
(Figures for the third quarter and nine months ended September 30, 2019 and 2018 are unaudited.)
Cash, cash equivalents and current financial assets totaled €76.5 million as of September 30, 2019, compared to €108.8 million as of December 31, 2018. In November 2019, Affimed completed a public equity offering with net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, of approximately $32 million (€29 million). Based on its current operating and budget assumptions, the company anticipates that its cash, cash equivalents and current financial assets as of September 30, 2019, together with the proceeds from the stock offering, will enable the Company to fund its planned clinical development and early development activities at least into the fourth quarter of 2021.
Net cash used in operating activities was €30.6 million for the nine months ended September 30, 2019, compared to net cash used in operating activities of €24.9 million for the nine months ended September 30, 2018. The increase is primarily due to higher cash expenditure for research and development efforts.
Total revenue was €2.1 million for the three months ended September 30, 2019 compared to €0.3 million for the three months ended September 30, 2018. The increase in revenue is attributable to the recognition of €1.9 million as revenue from the Genentech collaboration in the third quarter of 2019.
Research and development (R&D) expenses for the third quarter of 2019 were €11.7 million, compared to R&D expenses for the third quarter of 2018 of €9.8 million. The increase was primarily related to higher expenses related to manufacturing activities for clinical study material for AFM13, startup activities for the AFM13 registration study in pTCL and early stage development and discovery activities.
General and administrative expenses for the third quarter of 2019 were €2.8 million compared to €2.4 million for the third quarter of 2018.
Net loss was €10.9 million, or €0.17 per common share, for the third quarter of 2019, compared to a net loss of €12.0 million, or €0.19 per common share, for the third quarter of 2018.
Affimed prepares and reports the consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.
Affimed will host a conference call and webcast today, Tuesday, November 19, 2019 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial +1 (631) 510-7495 for U.S. callers, or +44 (0) 2071 928000 for international callers, and reference conference ID 8758067 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts_cp/. A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.
Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer. Affimed’s fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The Company is developing single and combination therapies to treat hematologic and solid tumors. For more information, please visit www.affimed.com.
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, the value of our ROCK® platform, 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.
Gregory Gin, Head of Investor Relations